PHARMACY TECHNICIAN OVERVIEW

ROLES OF THE PHARMACY TECHNICIAN AND PHARMACIST

Pharmacy technicians support the pharmacist by performing various tasks throughout the
pharmacy, and they play a critical role on the health care team. Because the pharmacy industry is so
dynamic, and because the roles of both pharmacists and pharmacy technicians are expanding, the
scope of practice for pharmacy technicians relies heavily on a well-trained, certified workforce. scope of practice. Tasks
Passing a national certification exam demonstrates competency to perform the duties of a pharmacy pharmacy technicians can
technician. In fact, many state boards of pharmacy differentiate between certified and noncertified perform based on their
pharmacy technicians by allowing certified technicians to perform more duties, such as obtaining license, registration, and
medication histories, filling prescriptions, and compounding. The reason behind allowing certain
certification that do not
require clinical judgment.
tasks to be performed only by certified individuals is that the overriding goal is to maintain the
highest standard in patient safety. Having a well-trained, certified pharmacy technician workforce
is critical to maintaining well-operated, efficient, and patient-centric pharmacies in all settings.
That said, there are distinctions between the roles of the pharmacist and the pharmacy technician.
This lesson will clarify the line between the roles.

Technician Duties
The scope of practice includes tasks that pharmacy technicians can legally perform under their
license, registration, or certification. Technician responsibilities do not require clinical judgment,
such as the decision to dispense or not dispense a medication, or deciding if a dose is correct.
Nonetheless, pharmacy technicians do perform numerous tasks in the pharmacy while ensuring
that they adhere to all state, federal, and organizational laws and regulations. They may be the first
contact a patient has with the pharmacy because they answer the telephone and handle questions
that do not require a pharmacist’s expertise or judgment. clinical judgment. The
thought process that allows
Technicians can answer questions about the price of insulin or how many refills a prescription
health care providers to
has left, for instance. They triage all other phone calls to the pharmacist, such as safety of taking arrive at a conclusion.
warfarin and aspirin at the same time or what to do about a missed dose.

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Processing and Preparing Prescriptions

Pharmacy technicians can process an electronic prescription and, in some states, a written,
telephoned, or verbal prescription. Most prescriptions are electronic; they tend only to be written if
the prescriber did not have access to the electronic record. Processing includes entering prescriptions
into the database with attention to detail to ensure accuracy of prescription labels. Technicians can
submit refill requests electronically to providers’ offices through the health care interface network
or by fax or phone and add authorizations to prescriptions after receiving physician approval.

The pharmacy technician can prepare prescriptions by counting or pouring medications and labeling
containers. Other tasks include performing calculations, reconstituting powders, and compounding
preparations. They can compound sterile and nonsterile products, including eyedrops, antibiotics,
chemotherapy, and total parenteral nutrition. They also place completed prescriptions in the
pickup area, organizing prescriptions alphabetically by the patient’s last name and ensuring proper
placement of refrigerated medications and appropriate labeling of items needing reconstitution.
Repacking bulk medication in unit dose packaging is another responsibility of pharmacy
technicians.

Inventory and Supplies

When it comes to inventory and supplies, pharmacy technicians keep pharmacies adequately stocked
with prescription vials, caps, bottles, and other supplies. They restock at the end of each shift and
make note of items that need to be reordered. They can also order medications and stock pharmacy
department shelves with medications when they arrive from suppliers, being mindful to compare
invoices against medications received as soon as they arrive. This may include ordering medications over-the-counter (OTC).
Medication available for
for and stocking over-the-counter (OTC) departments. In inpatient settings, pharmacy technicians
purchase without a prescription.
restock medication dispensing machines, floor stock requests, and crash carts. Pharmacy
technicians also check expiration dates and add or delete inventory based on the pharmacy’s needs.
They can also remove recalled, discontinued, expired, and overstocked products from inventory and
quarantine products to prevent accidental dispensing.

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Housekeeping and Other Responsibilities

Pharmacy technicians may also handle housekeeping responsibilities within the pharmacy, such as
maintaining a clean work environment in the pharmacy and patient care areas.

This entails cleaning counting trays in the community pharmacy with 70% isopropyl alcohol
throughout the day and cleaning laminar flow hoods in the hospital setting with sterile 70%
isopropyl alcohol on a routine schedule. Some of the other tasks assumed by pharmacy technicians
include:

⦁ preparing insurance claims for online adjudication by entering the patient’s insurance information
into the computer and submitting the claim for the prescription electronically to the third-party
payer

⦁ helping patients locate OTC medications

⦁ completing purchase transactions on cash registers, recording in logs when necessary, and
documenting behind-the-counter sales of pseudoephedrine and some Schedule V drugs

⦁ identifying medication prescribing and use patterns requiring pharmacist intervention, such as
abnormally large prescription quantities and multiple early refills on controlled medications

⦁ performing unit inspections of all areas in an institution where medications are stored monthly;
this applies to inpatient settings that store medications outside of the pharmacy, such as at
nurses’ stations
protected health information
⦁ documenting hospital patients’ lists of medications prescribed and taken through medication (PHI). Any health information
reconciliation process used to identify an individual.

⦁ offering and drawing up vaccines for patients and completing the associated paperwork; in some
states technicians can be certified to administer vaccines drug utilization review (DUR).
An authorized, structured,
⦁ gathering and ensuring confidentiality of protected health information (PHI) and other information ongoing review of health
necessary to complete patient profiles care provider prescribing,
pharmacist dispensing, and
⦁ notifying the pharmacist of any drug utilization review (DUR) warnings or concerns
patient use of medication
to ensure patient safety.
It reviews interactions,
allergies, duplicate/similar
medications, dose, and
other safety parameters.

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Pharmacist Duties CHALLENGE

A licensed pharmacist must perform all tasks
in the pharmacy that require use of clinical 1. Label each responsibility with either “Pharmacy Technician” or “Pharmacist.”
judgment. Whenever there is a question of A. Restock vials and lids.
who can perform certain tasks, seek out the B. Perform a drug therapy review.
pharmacist for clarification. Duties reserved C. Perform MTM.
exclusively to the pharmacist include receiving D. Prepare the prescription by counting tablets.
oral prescriptions from prescribers or prescribers’ E. Repackage bulk medications into unit dose.
authorized designees. This refers primarily to new F. Perform final product verification.
telephone prescriptions and refill authorizations Pharmacy Technician: A, D, E; Pharmacist: B, C, F
where there are changes to the prescriptions. 2. Which of the following activities should only be performed by a pharmacist?
The pharmacy technician can then process the A. Ordering medications from a supplier
transcribed prescriptions. Only the licensed B. Keeping the pharmacy area clean
pharmacist should consult with prescribers or C. Compounding sterile and nonsterile prescriptions
prescribers’ designees about patient prescriptions D. Recommending OTC medications based on manifestations
and/or recommend changes to prescriptions D. A technician can help a patient find OTC medication on the shelf, but only a pharmacist
based on DUR, insurance formularies, and patient can recommend an OTC medication based on manifestations. Technicians are usually
requests. Pharmacists are also responsible for the in charge of medication ordering. Technicians and pharmacists should keep the area
clean. Certified technicians are allowed to perform compounding in some states.
following:
3. A patient presents to the pharmacy stating they have a red rash on their abdomen
⦁ performing and documenting final product that they noticed after recently starting a medication. What should be the technician’s
verification prior to dispensing to patients response?
The technician should direct the patient to the counseling area and inform them that they
⦁ consulting with patients about prescribed will retrieve a pharmacist to speak to them. They should alert the pharmacist that a patient
medication use, adherence, and other has a question in the counseling area. Obtaining the patient’s name and date of birth
can help the pharmacist review the patient’s profile prior to talking to the patient.
health issues

⦁ performing medication therapy management

(MTM) —a service to improve patient outcomes
medication therapy management (MTM). A service
through a review of a patient’s profile and prescribed medications—as necessary
provided by a pharmacist to improve patient outcomes,
⦁ recommending OTC medications based on patients’ manifestations recommend changes to a patient’s medication therapy,
and/or educate the patient on their medications.
⦁ overseeing all functions performed by the pharmacy technician It is an opportunity for pharmacists to recommend
most cost-effective options to the patient’s physician;
identify drug-drug interactions, side effects, and
adverse effects; suggest lifestyle changes; and discuss
the importance of adherence to medication regimens.

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PHARMACY SECURITY legend medications. A medication,

Due to the presence of legend medications and PHI, security of the pharmacy is critical. When it chemical, or substance that has been
comes to access, only pharmacists, pharmacy technicians, and cashiers are permitted in the
approved by the FDA and can only be
distributed to patients if they have a
pharmacy. All other access must be approved by a pharmacist. Any time a pharmacist is not on
prescription from a licensed medical
duty, the pharmacy should be closed and locked. Verify the identification badges of law
practitioner, as required by federal or
enforcement, state board of pharmacy inspectors, and Food and Drug Administration (FDA) personnel state law. Also called a prescription
before allowing entrance. Notify the pharmacist on duty immediately if any of these agencies medication. These medications
request access to the pharmacy. Do not share codes to gain access to the pharmacy with carry the federal legend: “Federal
unauthorized personnel. Access codes should be individualized for each authorized person and law prohibits the dispensing of this
changed regularly. They should be inactivated upon termination or resignation of personnel. medication without a prescription.”

Pharmacy security also includes securing medications and protecting patient information. Store board of pharmacy. State boards
controlled substances in one of two ways: locked in a secure cabinet or spread among other that regulate pharmacy practice.
medications on the shelf in the pharmacy. Digital security is also critical because electronic health
Food and Drug Administration
records contain patient PHI. HIPAA security standards are crucial in pharmacies to ensure privacy
(FDA). Federal agency within the
of patients’ PHI. Pharmacies must implement robust HIPAA security measures to ensure the Department of Health and Human
confidentiality, integrity, and availability of patient data. This includes safeguarding electronic Services that regulates the manufacture
health records and other PHI against unauthorized access, use, or disclosure. Pharmacies must and safeguarding of medications.
conduct regular risk assessments, implement strong access controls, use encryption for data
transmission, and maintain secure systems to prevent data breaches.
Training staff on HIPAA regulations and ensuring adherence to security
protocols are essential steps in maintaining HIPAA security in pharmacies. CHALLENGE

Likewise, the security of controlled substances in a pharmacy is of utmost 1. Which of the following are ways that controlled
substances can be stored in the pharmacy? (Select all
importance. The measures prevent diversion and ensure adherence to that apply.)
regulatory requirements. Pharmacies must adhere to strict protocols A. Controlled substances can be stored together on the
for storing, handling, and dispensing controlled substances to prevent shelf.
unauthorized access and misuse. This includes ensuring controlled substance B. Controlled substances can be stored together in a
inventories are securely locked and accessible only to authorized personnel. locked cabinet.
Pharmacies must also conduct regular audits and reconciliations of controlled C. Controlled substances can be stored spread among
substance inventory to detect discrepancies or potential diversion. other medications on the shelf.
D. Controlled substances can be stored with OTC
Additionally, pharmacies must adhere to state and federal regulations for medications.
recordkeeping, reporting, and disposal of controlled substances to maintain If controlled substances are stored together, they need
to be in a locked cabinet. Controlled substances can also
accountability and prevent illicit distribution. By prioritizing the security of
be spread throughout the shelf with other medications.
controlled substances, pharmacies contribute to public safety. Controlled substances must be stored with legend drugs.

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MEDICATION RECONCILIATION AND

MEDICATION THERAPY MANAGEMENT
Two newer areas in which pharmacy technicians are playing a critical role are medication
reconciliation and medication therapy management (MTM). Some pharmacy technicians are
choosing to specialize in medication reconciliation and aiding with MTM. Both roles require skilled
communication with patients and caregivers. Medication reconciliation technicians work primarily
in hospital emergency departments and surgical centers to interview patients about medications
they are taking. The pharmacist performs the clinical tasks associated with MTM using the
information gathered from the patient by the pharmacy technician. This lesson offers specifics on
the duties of pharmacy technicians performing medication reconciliation and assisting with MTM.

Medication Reconciliation
A pharmacy technician can perform medication reconciliation. They may need to contact a
community pharmacy to secure this information. The pharmacy technician then documents a
patient’s list of prescription medications, OTC medications, and herbal supplements on a form or
in the electronic health record for the providers or pharmacist to review. The list should be specific
and contain the medication, dose, frequency, and route of administration. The technician would
then schedule an appointment for the patient with the pharmacist and, later, bill insurance for
any service the pharmacist provides. Completing these tasks before the appointment allows the
pharmacist to focus on the evaluation of the patient’s chart and identify areas of concern.

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Medication Therapy Management Technicians Play a Role in

MTM allows pharmacists to recommend changes to a patient’s medication therapy and/or MTM
educate the patient on their medications. It is an opportunity for pharmacists to recommend
the most cost-effective options to the patient’s physician; identify drug-drug interactions, side Technicians play a critical role in MTM in
that they can help identify patients who
effects, and adverse effects; suggest lifestyle changes; and discuss the importance of adherence
would benefit from MTM services, such as
to medication regimens. In other words, MTM promotes patient wellness through education and patients who take multiple medications,
recommendations. Technicians play a critical role in MTM in that they can help identify patients have multiple health conditions, or
who would benefit from MTM services, such as patients who take multiple medications, have take medications that require special
monitoring.
multiple health conditions, or take medications that require special monitoring. Once they have
identified an ideal candidate, the technician can explain and offer the service to the patient. After
an MTM meeting with a pharmacist, the pharmacy technician follows up with patients to ensure
they understand and can adhere to any therapy changes.

They discuss the importance of adherence to prescribed medications and address any concerns or
questions patients may have. It is important to note that MTM can affect pharmacy revenue. If an
insurance plan determines that a pharmacy’s poor patient medication adherence (or other factors)
has lowered its star ratings, the plan might take payment back from the pharmacy via direct and
indirect remuneration, reduce future reimbursement rates, or cease to contract with the pharmacy.
Star ratings are used to evaluate the performance of MTM programs offered by pharmacies.
Higher star ratings indicate better patient outcomes, adherence, and overall effectiveness of the
MTM services provided. Pharmacies with higher star ratings often receive preferential treatment
from payers and may be eligible for additional incentives or reimbursements, while lower-rated
pharmacies may face challenges in securing contracts or maintaining competitiveness in the
market. Loss of any contract, particularly Centers for Medicare & Medicaid Services contracts, would
result in significant loss of revenue for a pharmacy.

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ADHERENCE AIDS AND DEVICES

Patient adherence is critical to managing disease states. Adherence is when patients take prescribed
medication exactly as directed and follow through with all follow-up appointments and labs.
Patients should take ownership in adhering to their medication protocols, but adherence aids are
available to assist them. Pharmacy technicians have a role in promoting better health outcomes for
patients. They can educate patients on the adherence aids available and enroll them in programs,
discussed in this lesson, that will help them to maintain their medication regimens more easily.

Automatic Refills
Pharmacy technicians play a crucial role in aiding patients with medication adherence. Specifically,
they can introduce, offer, and facilitate enrollment in automatic refill programs and phone/text
reminders tailored to each patient’s needs. This personalized approach ensures that individuals
managing chronic conditions adhere to their prescribed medications effectively, promoting better
health outcomes and improved quality of life.

Once enrolled in an automatic refill program, a patient’s medications will be automatically refilled
by the pharmacy a few days before the patient would normally run out, and a phone call or text
reminder will notify the patient that the medication is ready to pick up. There can be restrictions
on types of medications that can be automatically refilled, as well as restrictions by payers such
as Medicaid plans. For example, Medicare paid items are not allowed to be set up for automatic
refills. The patient must request these each time to prevent Medicare fraud where a pharmacy
would automatically bill Medicare for a product even if the patient doesn’t need it. Always follow
the pharmacy’s policies and procedures when enrolling prescriptions in auto-refill programs. As
an alternative to automatic refills, some pharmacies have the ability to set up software alerts so
that they can provide a phone call reminder to patients who do not refill maintenance medications
on time. This phone call can also be an opportunity for the pharmacist to review any problems the
patient might be having with the medication.

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Medication Reminder Tools

Weekly medication containers are another tool pharmacy technicians can recommend to
patients to assist with medication adherence. Patients transfer their medications from the
original prescription bottles to the weekly planner by placing all the medications for each
day or time of day in their own compartments. This low-tech, inexpensive tool allows the
patient to see if they have taken their medication for the day or time. Patients can avoid
under- or overdosing with this device.

Patients who have arthritis limiting their movements, for instance, can benefit from a
weekly planner that is programmed to open automatically at certain times. Moreover,
audible alarms or vibrations from watches and smartphones can assist patients who have
visual or hearing impairments. Some companies make smart pill bottles that can sense
or record when a bottle has been opened and transmit that information to a pharmacy. A
pharmacy technician can then send a missed dose reminder to patients using those smart
pill bottles. Some pharmacies also offer services, such as bubble packing or PillPack, that
allow all medications for a certain day or time to be packaged together. This can make taking
medications easier and safer for certain patients.

The pharmacy technician has an important role in aiding in patient adherence. The pharmacy
technician should be aware of the aid and device options and their best uses, cost, availability, and
pros and cons so they can recommend the best adherence aids on the market to meet each patient’s
needs and budget.

CHALLENGE

1. Amy presents to the pharmacy with a bag of medications used to treat the following conditions:
diabetes mellitus, hypertension, and glaucoma. How can the technician help with medication
adherence?
This patient is probably on multiple medications that need to be taken multiple times a day.
Suggest a weekly medication planner with multiple time slots per day. Recommend using
a calendar to mark off the day after the patient administers their eyedrops.

2. How might a pharmacy technician tailor a medication adherence strategy for a patient with visual
impairment compared to a patient with arthritis?
Visual impairment: Audible planners, assistance with weekly med planners, automatic refills Arthritis:
Easy-open containers, weekly med planners, med planners that open automatically

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PHARMACY MEDICAL TERMINOLOGY

Understanding medical terminology is paramount in the daily operations of a pharmacy where
precision and clarity are vital. Imagine a scenario where a pharmacy receives a prescription for a
patient experiencing nasal congestion. The pharmacy technician will use medical terminology, often
based on Greek or Latin prefixes, roots, and suffixes. Prefixes are found at the beginning of a word,
roots are usually in the middle, and suffixes are at the end. For example, the word “rhinitis” is
made of the root word “rhin-” (nose) and the suffix “-itis” (inflammation). Armed with knowledge
of roots, prefixes, and suffixes, the pharmacy technician will recognize the term “rhinitis,”
inflammation of the nose, in the prescription. This comprehension enables accurate dispensing and
counseling tailored to the patient’s needs, underscoring the critical role of medical terminology in
facilitating effective communication and patient care. This lesson covers major pharmacy medical
terminology important for the pharmacy technician to know, including abbreviations for frequency
of dosage and routes of administration and medication classes for different bodily systems.

Signa Codes and Abbreviations

Prescriptions are submitted to the pharmacy using signa (sig) codes. Sig codes are used to describe
routes of administration, frequency, and other instructions. See Tables 1.1, 1.2 and 1.3.

TABLE 1.1 Route of Administration TABLE 1.1 Route of Administration

ABBREVIATION MEANING ABBREVIATION MEANING

ad* right ear ou* both eyes

as* left ear po by mouth

au* both ears pr rectal

bu buccal pv vaginal

im intramuscular sc*, sq*, sub q* subcutaneous

it intrathecal sl sublingual

nare nostril *This abbreviation is on either the Institute for Safe

Medication Practices error-prone abbreviation list or
od* right eye The Joint Commission’s “do not use” abbreviations
list because they can cause confusion. Some are still
os* left eye
used in practice.

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TABLE 1.2 Frequency TABLE 1.3 Other Abbreviations

ABBREVIATION MEANING ABBREVIATION MEANING

ac before meals aaa apply to affected area

bid twice daily gtts drops
hs* at bedtime ha headache
pc after meals qs quantity sufficient
prn as needed ung ointment
qh every hour
qid 4 times a day
tid 3 times a day
wa while awake

CHALLENGE

1. Match the abbreviation with the correct meaning.

A. qid 1. Intramuscular
B. os 2. Left eye
C. pc 3. Drops
D. gtts 4. 4 times daily
E. im 5. After meals
Qid: 4 times a day, os: left eye, pc: after meals, gtts: drops, im: intramuscular

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Medication Class Tables

Providers prescribe several common medication classes to treat various health conditions. These
include antibiotics, such as penicillin or cephalosporins, to combat bacterial infections. Another
essential class is analgesics, like ibuprofen or acetaminophen, to alleviate pain and reduce fever.
Antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants,
manage depression and anxiety disorders. Additionally, medications like statins are prescribed to
lower cholesterol levels and reduce the risk of heart disease. Each medication class plays a crucial
role in maintaining and restoring health and in addressing specific medical needs across diverse
patient populations.

TABLE 1.4 Medication Classes Used for the Cardiovascular System

COMMONLY USED
MEDICATION CLASSES GENERIC NAME USES PREFIXES OR SUFFIXES

Nitrates Isosorbide mononitrate Antianginal nitr-

Calcium channel blockers Nifedipine Antianginal -pine

Antiarrhythmic
Beta-blockers Atenolol Antianginal -lol
Antiarrhythmic
Antihypertensive
HMG-CoA reductase inhibitors Atorvastatin Antihyperlipidemic -statin

Fibric acid derivatives Fenofibrate Antihyperlipidemic -fibr

Alpha-blockers Terazosin Antihypertensive
ACE inhibitors Benazepril Antihypertensive -pril
Angiotensin receptor blockers Irbesartan Antihypertensive -sartan

Loop diuretics Furosemide Antihypertensive -mide

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TABLE 1.4 Medication Classes Used for the Cardiovascular System

COMMONLY USED
MEDICATION CLASSES GENERIC NAME USES PREFIXES OR SUFFIXES

Thiazide diuretics Hydrochlorothiazide Antihypertensive -thiazide

Potassium-sparing diuretics Spironolactone Antihypertensive
Antiplatelets Clopidogrel Thrombus

TABLE 1.5 Medication Classes Used for the Gastrointestinal System

MEDICATION CLASSES GENERIC NAME USES COMMONLY USED PREFIXES OR SUFFIXES

Anticholinergics Dicyclomine Antiemetic

Antacids Magnesium GERD
H2 blockers Famotidine GERD -tidine
Proton pump inhibitors Esomeprazole GERD -prazole
Osmotic laxatives Polyethylene glycol Constipation
Stool softeners Docusate sodium Constipation

CHALLENGE

1. Match the medication class with the correct usage. 2. Match the medication class with the correct suffix
A. Potassium-sparing 1. Antianginal or generic name.
diuretics 2. Antihypertensive A. Stool softeners 1. Polyethylene glycol
B. Antiplatelets 3. Antihyperlipidemic B. H2 blockers 2. Esomeprazole
C. Nitrates 4. Thrombus C. Osmotic laxatives 3. Antiemetic
D. HMG-CoA reductase D. Anticholinergics 4. GERD
inhibitors E. Proton pump 5. Constipation
Potassium-sparing diuretics: antihypertensive, inhibitors
antiplatelets: thrombus, nitrates: antianginal, HMG- Stool softeners: constipation, H2 blockers: GERD,
CoA reductase inhibitors = antihyperlipidemic osmotic laxatives: polyethylene glycol, anticholinergics:
antiemetic, proton pump inhibitors: esomeprazole

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TABLE 1.6 Medication Classes Used for the Musculoskeletal System

COMMONLY USED
MEDICATION CLASSES GENERIC NAME USES PREFIXES OR SUFFIXES

Disease-modifying antirheumatic drugs Methotrexate Antirheumatic -ine

Xanthine oxidase inhibitors Allopurinol Gout -inol
Nonsteroidal anti-inflammatory drugs Ibuprofen Anti-inflammatory -ofen
COX-2 inhibitors Celecoxib Pain, anti- -oxib
inflammatory
Bisphosphonates Alendronate Osteoporosis -onate
Muscle relaxants Cyclobenzaprine Muscle relaxation -prine

CHALLENGE

1. Match the following medication class with the correct use.

A. COX-2 inhibitors 1. Antirheumatic
B. Bisphosphonates 2. Gout
C. Disease-modifying antirheumatic drugs 3. Pain
D. Xanthine oxidase inhibitors 4. Anti-inflammatory
E. Nonsteroidal anti-inflammatory drugs 5. Osteoporosis
COX-2 inhibitors: pain, bisphosphonates: osteoporosis, disease-modifying antirheumatic drugs: antirheumatic,
xanthine oxidase inhibitors: gout, nonsteroidal anti-inflammatory drugs: anti-inflammatory

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TABLE 1.7 Medication Classes Used for the Nervous System (continued)
GENERIC COMMONLY USED
MEDICATION CLASSES NAMES USES PREFIXES OR SUFFIXES

Benzodiazepines Lorazepam Antianxiety, anticonvulsant -zepam, -zolam

Tricyclic antidepressants Amitriptyline Antidepressant -tyline
Serotonin-norepinephrine Duloxetine Antidepressant
reuptake inhibitors
SSRIs Citalopram Antidepressant, antianxiety
Atypical antipsychotics Quetiapine Antipsychotic -pine
Prostaglandin analogs Latanoprost Glaucoma -oprost
Alpha agonists Brimonidine Glaucoma -ine
Narcotic analgesics Morphine Pain

CHALLENGE

1. Match the following medication class with the correct prefix or suffix.
A. Tricyclic antidepressants 1. -pine
B. Benzodiazepines 2. -tyline
C. Atypical antipsychotics 3. -oprost
D. Prostaglandin analogs 4. -ine
E. Alpha agonists 5. -zepam, -zolam
Tricyclic antidepressants: -tyline, benzodiazepines: -zepam, -zolam, atypical
antipsychotics: -pine, prostaglandin analogs: -oprost, alpha agonists: -ine

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TABLE 1.8 Medication Classes Used for the Reproductive System CHALLENGE

GENERIC COMMONLY USED 1. Match the following medication

MEDICATION CLASSES NAME USES PREFIXES OR SUFFIXES class with the correct use or
prefix/suffix.
Phosphodiesterase inhibitors Sildenafil Erectile dysfunction -afil
A. Anabolic steroids
Estrogens Estradiol Oral contraceptives, hormone estra- B. Phosphodiesterase inhibitors
replacement therapy
C. Estrogens
Progestins Progesterone Oral contraceptives, hormone progester- D. Progestins
replacement therapy 1. Estra-
Anabolic steroids Testosterone Male hypogonadism testo- 2. Progester-
3. Erectile dysfunction
4. Testo-
TABLE 1.9 Medication Classes Used for the Urogenital System Anabolic steroids: testo-,
GENERIC COMMONLY USED phosphodiesterase inhibitors:
MEDICATION CLASSES NAME USES PREFIXES OR SUFFIXES erectile dysfunction, estrogens:
estra-, progestins: progester-
Anticholinergics Oxybutynin Incontinence 2. Match the medication class with
Alpha-blockers Doxazosin Benign prostatic hyperplasia -azosin its uses or commonly used prefix
or suffix.
Antibiotics Nitrofurantoin Urinary tract infections, A. Anticholinergics
sexually transmitted infections
B. Alpha-blockers
Testosterone 5⍺-reductase Finasteride Benign prostatic hyperplasia -asteride C. Antibiotics
inhibitors D. Antivirals
E. Antifungals
TABLE 1.10 Medication Classes Used for the Integumentary System 1. Incontinence
2. Urinary tract infections,
MEDICATION CLASSES GENERIC NAME USES COMMONLY USED PREFIXES OR SUFFIXES sexually transmitted infections
Corticosteroids Predinisone Anti-inflammatory -sone 3. -vir
4. -azosin
Antibiotics Amoxicillin Bacterial infection
5. -azoles
Antifungals Ketoconazole Fungal infection -azole Anticholinergics: incontinence,
alpha-blockers: -azosin, antibiotics:
Antivirals Oseltamivir Viral infection -vir urinary tract infections, sexually
transmitted infections, antivirals:
-vir, antifungals: -azoles

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TABLE 1.11 Medication Classes Used for the Immune System

MEDICATION COMMONLY USED PREFIXES
CLASSES GENERIC NAME USES OR SUFFIXES

Antivirals Acyclovir Herpes virus -vir

Beta-lactam Amoxicillin Bacterial infection -cillin
antibiotics
Sulfa antibiotics Sulfamethoxazole-trimethoprim Bacterial infection ulfa-
Topical antibiotics Mupirocin Bacterial infection
Fluoquinolone Ciprofloxacin Bacterial infection -floxacin
antibiotics
Lincosamide Clindamycin Bacterial infection -mycin
Antifungal Fluconazole Fungal infections -zole

TABLE 1.12 Medication Classes Used for the Respiratory System

MEDICATION CLASSES GENERIC NAME USES COMMONLY USED PREFIXES OR SUFFIXES

Antihistamines Loratadine Allergies -adine

Bronchodilators Albuterol Antiasthmatic -terol
Corticosteroids Fluticasone Anti-inflammatory -sone
Expectorants Guaifenesin Congestion
Antitussives Benzonatate Cough

CHALLENGE

1. Match the medication class with its uses or commonly used prefix or suffix.
A. Antihistamines 1. sone
B. Corticosteroids 2. -terol
C. Expectorants 3. Allergies
D. Bronchodilators 4. Cough
E. Antitussives 5. Congestion
Antihistamines: allergies, corticosteroids: -sone, expectorants: congestion, bronchodilators: -terol, antitussives: cough

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TABLE 1.13 Medication Classes Used for the Endocrine System

COMMONLY USED
MEDICATION CLASSES GENERIC NAME USES PREFIXES OR SUFFIXES

Insulin Insulin degludec Diabetes

Sulfonylureas Glimiperide Diabetes
Selective sodium-glucose Canagliflozin Diabetes -gliflozin
transport 2 inhibitors
Biguanides Metformin Diabetes
Thiazolidinediones Pioglitazone Diabetes -glitazone
Bisphosphonates Alendronate Osteoporosis prevention -dronate
Glucagonlike peptide-1 agonists Dulaglutide Diabetes -glutide

CHALLENGE

1. Which of the following medication classes are used to treat diabetes? (Select all that apply.)
A. Bisphosphonates
B. Insulin
C. Sulfonylureas
D. Biguanides
B, C, D. Insulin, sulfonylureas, and biguanides are used to treat diabetes.
Bisphosphonates are used for osteoporosis prevention.

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COMMUNICATION AND CUSTOMER SERVICE Professionalism Tip:

Learning to communicate effectively with external customers, such as patients and Communicating With Patients
caregivers, and internal customers, such as staff and health care professionals, takes practice.
Technicians should limit medical
Communication is a soft skill that requires adaptability, respect, and cultural awareness. This terminology when communicating
lesson touches on adapting techniques to the audience and using clinical empathy and cultural with patients.
sensitivity in all communication.

Adaptability
Tailor interactions with patients, caregivers, and health care professionals to their level of
understanding. For example, when communicating with a provider or insurance company, medical
terms are acceptable to use. When interacting with patients and caregivers, it’s crucial for pharmacy
professionals to adapt their communication style by avoiding complex medical terminology that
might be confusing or overwhelming. Instead, use plain language and provide explanations in a
clear, understandable manner to enhance patient comprehension and foster better engagement in
their care. By tailoring interactions based on the individual’s level of understanding, pharmacy
professionals can ensure effective communication and promote patient empowerment in managing
their health.

Respect
All patients deserve to be treated with respect and dignity regardless of sexual orientation, age, race,
religion, gender identity, or medical conditions. In addition to treating patients with respect and
dignity regardless of various personal characteristics, pharmacy professionals should also ensure a
welcoming and inclusive environment.

This includes actively listening to patients’ concerns, addressing them empathetically, and involving
patients in decision-making about their health care. Furthermore, pharmacy technicians should
expect to be treated with the same level of respect and professionalism by colleagues, supervisors,
and patients. Mutual respect fosters a positive work culture, enhances teamwork, and contributes to
overall job satisfaction and well-being among pharmacy staff.

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Cultural Sensitivity Professionalism Tip: Empathy

Cultural sensitivity means having awareness, knowledge, and respect of cultural An empathetic pharmacy technician engages
beliefs that differ from one’s own. Respect the cultural differences of others, regardless with patients through active listening, respectful
of personal values. Knowledge of different customs, beliefs, and cultures enables communication, and having a sensitivity to their needs.
culturally competent care. Some situations that require cultural awareness, suspension Ensuring personalized and efficient care with a patient
is another way to display empathy. An example is when
of judgment, and respect on the part of the pharmacy technician include filling a pharmacy technician takes the time to respectfully
prescriptions for birth control, hormone replacement, and emergency contraceptives. ask questions and listen to responses that a patient
provides with a medication course of therapy. Any
questions that pertain to a clinical nature are answered
Clinical Empathy by a pharmacist.

Clinical empathy is the ability

of health care providers to
understand and share the CHALLENGE
feelings and experiences of their 1. Which of the following scenarios best exemplifies the importance of cultural awareness, respect, and
patients while maintaining a dignity in health care communication?
professional demeanor. It involves A. Speaking to a health care professional using complex medical terminology
actively listening to patients, B. Dismissing a patient’s concerns based on personal beliefs
acknowledging their emotions, and C. Tailoring communication about birth control options to respect diverse cultural perspectives
demonstrating compassion and D. Ignoring a patient’s preferred pronouns during a consultation
understanding in the context of C. Tailoring communication best reflects the importance of considering cultural differences and respecting
their medical care. Clinical empathy diverse perspectives, particularly regarding sensitive topics like birth control. It demonstrates an understanding
of the need to adapt communication to different cultural norms and values. Using medical terminology does
is essential for building trust,
not directly relate to cultural awareness or respect, but rather to adaptability in communication. While using
improving patient satisfaction, and medical terminology may be appropriate in certain contexts, it does not necessarily reflect cultural sensitivity.
ultimately enhancing the quality of Dismissing concerns demonstrates a lack of respect and dignity but does not specifically address cultural
awareness. Dismissing a patient’s concerns based on personal beliefs is an example of unethical behavior. Ignoring
health care. pronouns highlights a failure to respect the patient but does not specifically pertain to cultural awareness.

2. How do cultural awareness and respect come into play when filling prescriptions for sensitive
medications like birth control, hormone replacement, and emergency contraceptives? Provide
examples to support your answer.
In the health care setting, cultural awareness, respect, and adaptability are crucial elements of effective
communication, especially when dealing with sensitive topics such as birth control, hormone replacement
therapy, or emergency contraceptives. Cultural awareness involves understanding the diverse beliefs,
values, and customs of patients from different backgrounds. This awareness informs respectful
communication that acknowledges and honors individual preferences and cultural norms. For instance,
some cultures may have specific taboos or stigmas associated with contraception or hormone therapy,
and health care professionals need to navigate these sensitivities with empathy and understanding.

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PRODUCT VERIFICATION AND PHARMACY LAYOUT

Pharmacists must verify the final product verification release to the patient. The verification of a
prescription involves a detailed process to ensure accuracy, safety, and adherence before dispensing
medication to a patient. A pharmacy technician plays a crucial role in ensuring the accuracy and
safety of prescription verification. They assist pharmacists by meticulously reviewing prescriptions
for completeness, accuracy, and legality. This involves verifying patient information, dosage
instructions, medication interactions, and potential allergies. Pharmacy technicians also check
for proper labeling and packaging of medications before handing them off to the pharmacist for
final verification.

The design of the pharmacy layout and workflow ensures that this verification process occurs for
every prescription that leaves the pharmacy. Pharmacy technicians are instrumental in this process.
This lesson describes the pharmacy’s layout, how it makes sense for the flow of pharmacy activities,
and how it decreases the likelihood of errors.

Pharmacy Layout and Workflow in the Community Setting

In the community setting, pharmacies generally have an intake area, a processing area, a processed
prescriptions area, and an out window. This section discusses each of these areas in turn.

Intake Area
Patients drop written prescriptions off in the intake area. Pharmacy technicians are usually the first
people to communicate with patients and ultimately make the initial impression here in this area.
Keep the intake area clean, uncluttered, and structured to facilitate a positive first impression. When
patients leave prescriptions, scan them promptly for all necessary and appropriate information. This
prevents patient callbacks and delays. This is the area where staff members check the patient in or
receive information as to why the patient is there.

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Processing Area
Generally, this area is where data entry and prescription processing occur. For that reason,
the environment should be as free from distractions as possible. Accurate data entry creates a
comprehensive patient record from which important decisions regarding the patient’s health
are made. Within the processing area, there should be sub-areas for prescriptions that require
processing, are awaiting preparation or dispensing, are requiring verification, and are needing
intervention. Each prescription will have a separate bin or tote to prevent mislabeling. This area
also houses counting equipment, distilled water, compounding or repackaging equipment, scales,
calculators, containers, and labels.

Pharmacist Final Verification Area

The prescriptions awaiting and receiving final verification from the pharmacist reside in this area.

Processed Prescriptions Area

This area stores completed prescriptions until patient pickup. Only prescriptions that have
completed the final verification process are allowed in this area. Pharmacists place verified
prescriptions alphabetically by last name in large bins. This area can also be referred to as
“will call.”

Out Window
This is the area designated for patients to pick up completed prescriptions. Cash registers here
process payments for the verified prescriptions. Pharmacies use point-of-sale software that
allows only prescriptions verified by the pharmacist to be sold. A notification appears on the
register if a prescription is scanned that has not been verified. If this occurs, the prescription
must be returned to the pharmacist for final verification. Sometimes the pharmacy does not have
insurance information on file for a patient, so this is the time to secure and enter third-party billing
information. After adjudicating the insurance details, the pharmacy must print a new label and
the pharmacist must verify the final prescription once again. This area also contains a separate or
nearby sub-area for private consultation.

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Pharmacy Layout and Workflow in the Institutional Setting

In an institutional setting, the workflow is slightly different. The pharmacist must verify medication
orders prior to release to the nursing and health care team. The pharmacy technician should look for
the pharmacist’s signature or initials on the preparation to ensure it has been verified. Medications
waiting to be verified must be kept separately from verified ones. Some states allow for a practice
called technician check technician (TCT), which allows certified pharmacy technicians to verify
other pharmacy technicians’ work prior to release to the health care team. This practice is limited
to automated dispensing machine refills and unit dose batching. States that allow TCT have policies
in place by their state board of pharmacy to ensure patient safety. Some states are starting to allow
TCT in community retail settings, as well.

Main Dispensary Computer Stations for Pharmacist Intake

This area consists of computer stations where pharmacists receive prescription orders electronically
from the floors. Pharmacists review and validate the orders, ensuring accuracy, appropriateness, and
adherence with patient records and medication profiles.

Pullout Shelves for Technician Order Fulfillment

In this designated area, pharmacy technicians access prepackaged, individualized medications
based on pharmacist-entered orders. The shelves are organized to facilitate efficient picking of
medications, with labels printed directly from the pharmacist’s entry to ensure correct dispensing.

Ward Box Area for Final Verification and Distribution

ward boxes. Storage containers
Once medications are prepared by technicians, they are transferred to the ward boxes area. Here,
or units used to organize and
pharmacists conduct a final verification of each medication to ensure accuracy and appropriateness
dispense medications for
before packaging them into ward boxes for delivery to the respective floors or units within the specific hospital wards or units.
health care facility.

Bulk Medication Storage and Packaging Shelves

This section of the pharmacy is dedicated to storing bulk medications. Pharmacists and technicians
access these shelves to retrieve medications needed for compounding, filling prescriptions, or
replenishing stock.

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Refrigerated Medication Storage Area

Certain medications, such as those requiring refrigeration, are stored in a designated fridge area to
maintain their stability and integrity before dispensing. This ensures that temperature-sensitive
medications remain viable until they are dispensed to patients.

robot. A robot is an automated

Medication-Filling Robot system or machine designed to
The pharmacy may utilize an automated medication dispensing system or robot to prepare and assist with various tasks related
package medications efficiently. This robot fills prescriptions based on orders processed overnight to medication dispensing.
and prepares them for delivery to the floors each morning.

Aseptic Suite for IV Preparation aseptic suite. Sterile

compounding areas
In the aseptic suite, pharmacy technicians prepare sterile IV medications under controlled conditions.
or clean rooms.
After compounding, pharmacists verify each IV bag or syringe for accuracy and sterility before
distribution to patient care areas.

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Unpacking Area for Incoming Product

When pharmaceutical products are delivered from distributors, they are unpacked and
checked for accuracy and quality in the unpacking area. Items are then sorted and
stocked in the appropriate medication storage areas within the pharmacy.

Pharmacy layout and workflow in a community setting:

1. Intake area: Also called the drop-off or check-in area

2. Processing area, computer station: If a new or refill prescription is requested, the
information would be given to the entry technician to look for a new prescription
sent on the computer for lookup or to fill a refill. If a pickup was requested, the tech
would go to section 5 to look for prefilled orders.

3. Processing area, computer filling station for new prescriptions: This tech would get
information from #2 and do a double-check of the electronic prescription and the
label. They would retrieve the medication from the shelf and fill the prescription.

4. Pharmacist final verification area: The prescription would reside here for the
pharmacist’s final verification.

5. Processed prescriptions area: Verified and awaiting pickup

6. Out window: This area houses the cash register. At pickup, a prescription goes to the technician
at the register. There the technician verifies the patient with two identifiers, either name and
address or name and date of birth, and checks the prescription out, receives payment, and
receives a signature for verification.

7. Consulting area: There should be a consulting area where the pharmacist can provide education to
the patient.

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Pharmacy layout and workflow in an institutionalized setting:

⦁ Main dispensary: Pharmacists in the central pharmacy or in decentralized areas

throughout the hospital will verify medication orders entered by providers in the
electronic health record.

⦁ Pullout shelves or carousel: Prepackaged, individually wrapped medications are

stored here. After a pharmacist verifies the medication order, a label prints out so
that the technician can pull the correct medication.

⦁ Ward boxes: Filled orders go to the ward boxes area where they undergo a final
pharmacist verification and are put in the boxes to be transported to the floors.

⦁ Shelves: This is the area where bulk medications are stored and packaged to go in the
robot.

⦁ Fridge area: Refrigerated medicines are stored here before they are filled.

⦁ Robot: This part of the pharmacy is where orders are filled overnight to go to the
floors each morning.

⦁ Aseptic suite: In this area, the technician makes IVs and the pharmacist verifies
them. An anteroom outside the aseptic suite allows for proper garbing.

⦁ Unpacking area: This area is where the products are delivered from the distributor and unpacked
to be placed in the stock.

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PHARMACY INVENTORY
Maintaining inventory, both medications and supplies like vials Case Study Instructions
and labels, is essential to the pharmacy’s daily operations. If Read the following case study and use the information provided in the
a pharmacy maintains too much inventory on the shelf, the chapter to answer follow-up questions related to the scenario. Case studies
medication may expire prior to dispensing to a patient, the may have more than one part.
potential for diversion is increased, and the pharmacy will have its
capital tied up in inventory. Keeping too little inventory on the shelf
could cause delays in patient medications and a need for partial
fills. This lesson provides an overview of ordering, receiving, and Case Study: Community Pharmacy Inventory, Part 1
stocking appropriate inventory. It also covers handling expired and You are a pharmacy technician working in a busy community pharmacy. One
recalled products, drug pricing, and the pharmacy technician’s role of your primary responsibilities is to manage the pharmacy inventory, ensure
in these tasks. proper storage of medications, and handle expired or recalled products.
Additionally, you must understand the protocols for safely disposing of
medications to protect patients, staff, and the environment.

Ordering
Knowing when and how much medication to order is integral in the pharmacy. Reorder points (ROPs) Reorder points (ROPs).
and reorder quantities (ROQs) use set parameters to identify when a medication needs to be ordered The inventory level
and how much to order. The ROP is a set minimum stock level at which a medication should be at which it becomes
reordered, and the ROQ identifies how much of the medication should be ordered. Computer necessary to initiate the
replenishment of a particular
software reviews trends in a pharmacy’s orders and automatically sets these levels. The shelves or
medication or product.
bins are clearly labeled with medication descriptions, order numbers, ROPs, and ROQs. ROPs and
ROQs can be adjusted as necessary based on ordering and expiration trends.
reorder quantities (ROQs).
When ordering inventory, the pharmacy technician reviews computer-generated orders and makes The predetermined quantity
necessary edits while manually logging items to be ordered. The technician performs regular visual of a medication or product
inspections of fast movers and emergency medication shelves to assess stock levels. In the event that needs to be ordered.
of backordered or discontinued items, the technician promptly notifies the pharmacist and can try
to source the item from alternative suppliers. The technician might also print copies of submitted
orders to ensure transparency and communication about upcoming orders to other staff members so
that everyone knows what has been ordered.

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Receiving
A proper receiving system lessens the likelihood of error and improves the efficiency of the
pharmacy. A receiving system handles how medications are checked in and how the system gets
updated with inventory. The person responsible for receiving orders should be different from the
person who submitted the order to prevent drug diversion. When receiving shipments, pharmacy
technicians play a crucial role in ensuring accuracy and quality control. Pharmacy technicians
are charged with verifying the supplier’s name and address, as well as the quantity of the order
received. This information should match the purchase order. They inspect the packages for any
damage, note any observations and discrepancies, and promptly report them to the pharmacy buyer
or manager. Upon receipt, they give priority to products requiring special care, such as those with
specific temperature requirements or controlled substances, and use proper personal protective
equipment when handling hazardous medications. Technicians meticulously compare received
shipments with purchase order details, ensuring consistency for each product. They then sign
and date the invoice as the recipient. Additionally, they check expiration dates to align with the
pharmacy’s standards. Any new, discontinued, partially filled, special-ordered, or back-ordered Controlled Substance
products should be brought to the attention of pharmacists or management to prevent potential Ordering CII
inventory issues and facilitate database updates. Medications
With electronic ordering, most
pharmacies will utilize the DEA
Stocking Inventory Controlled Substance Ordering
Upon receiving and processing an order, timely stocking—adding the received inventory to the System for secure electronic
transmission of ordering CII
pharmacy stock shelves—is paramount, with close attention paid to several key aspects. Pharmacy
controlled substances.
technicians must meticulously check the expiration dates of new products against those already in
stock, employing the first in, first out (FIFO) method to prioritize dispensing items with earlier
expiration dates. first in, first out (FIFO). First
product received into stock is
During stocking, technicians should again inspect the products, noting any anomalies such as the first product used or sold.
broken seals, changes in clarity or color, or alterations in labeling; report any observations promptly
to the pharmacist. To preempt stock shortages, it is crucial to use the ROP and ROQ method aids
while walking the shelves to identify and communicate prescription patterns to the purchasing team
members. Additionally, by regularly examining stock, technicians can identify damaged products or
those subject to recalls.

Medication should be stored in well-organized alphabetical order so meds can be stocked in an efficient
manner and rotated easily so older orders are moved to the front every time new stock is added.

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Monitor Expiration Dates

In addition to ordering, receiving, and stocking medications, it is important to keep track of
expiration dates. Most pharmacies have a policy to pull medications that expire in 3 months or less
because medications can lose effectiveness or become toxic after reaching their expiration date.
Some medications, depending on the expiration, can be returned to the distributor or manufacturer
for a partial credit.

In an institutional setting, pharmacy technicians share the responsibility of monitoring expiration

dates on medications in the nursing units and automated dispensing machines. Technicians keep
records on the date and individual who checked each area. Color-coded stickers signal medications
expiring soon. They must take extra care while checking refrigerated areas for outdated medication
to ensure the temperature stays in range, and wear personal protective equipment while checking
hazardous medications for expiration dates.

Drug Pricing Primer

Understanding the basic components of drug pricing is essential for pharmacy technicians to
facilitate ordering and manage inventory effectively. One key component is the wholesale acquisition
cost, which represents the manufacturer’s list price for a drug before any discounts or rebates
are applied. Another important benchmark is the average wholesale price, which indicates the
average price at which wholesalers sell drugs to pharmacies. Note that average wholesale price is
often higher than the actual price paid due to discounts and rebates. Pharmacy technicians also
need to consider the actual acquisition cost, which reflects the price paid by the pharmacy after
factoring in discounts and rebates from wholesalers or suppliers. Additionally, understanding
maximum allowable cost is crucial as it represents the maximum reimbursement amount set by
payers for generic drugs. Pharmacies are reimbursed up to the maximum allowable cost amount
when dispensing generic medications. Manufacturers often provide rebates and discounts based
on purchasing volume or agreements, significantly impacting drug costs. Lastly, pharmacies may
negotiate contract pricing with wholesalers, manufacturers, or group purchasing organizations
for specific drugs, which can vary and influence drug acquisition costs. By comprehending these
pricing components, pharmacy technicians can effectively compare drug prices, identify cost-
saving opportunities, and optimize inventory management to maintain efficient and cost-effective
pharmacy operations.

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MEDICATION STORAGE Pharmacy Tech Tip

Medications are stored in different conditions based on the stability of the ingredients they contain. If a medication that should be
Factors that influence storage requirements are temperature, humidity, and light. Pharmacy refrigerated has been stored on a
technicians should understand where medications are stored because they often stock products, and shelf at room temperature, follow
proper storage is essential to the integrity of the products being dispensed. Information regarding these steps to address the issue.
storage requirements of medications is on the package and the product package insert. Additional Action
information can be found by contacting the manufacturer. This lesson discusses proper storage of 1. Immediately relocate the
medications and explains conversions between Celsius and Fahrenheit. improperly stored medications
to the appropriate storage area.
2. Assess the potential impact
Common Temperatures on medication efficacy due to
improper storage.
As a foundation, it is important to know what the room temperature, refrigerator temperature, and 3. Notify the pharmacist about
freezer temperature should be in a pharmacy. Room temperature is generally 20° C to 25° C or 68° F the situation and discuss any
to 77° F. Refrigerator temperature is generally 1.7° C to 7.8° C or 35° F to 46° F. Freezer temperatures necessary actions, such as
are set at −15° C or 5° F or lower. Pharmacy personnel check and document refrigerator and contacting patients who may
have received compromised
freezer temperatures twice daily to ensure that products are being appropriately stored. medications.
4. Review storage protocols with
pharmacy staff to prevent similar
Converting Between Celsius and Fahrenheit occurrences in the future.
To convert temperatures between Celsius and Fahrenheit, use one simple, basic algebraic equation: 5. Regularly inspect medication
storage areas to ensure
adherence to storage
requirements.
Review the examples below and practice converting.

Example 1: Convert 20° C to Fahrenheit. Example 2: Convert 86° F to Celsius.

Answer is 68° F. Answer is 30° C.

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Refrigeration Examples Refrigerator Temperature

In a community pharmacy setting, prescriptions awaiting pickup by patients must be stored as and Room Temperature
indicated by the manufacturer to maintain optimal expiration dating. Sublingual nitroglycerin
tablets, for example, should be dispensed in their original manufacturer’s amber bottle to protect
them from light. Nitroglycerin’s sensitivity to humidity and light underscores the importance of
proper storage to maintain its effectiveness.

Refrigeration is essential for various common medications, including latanoprost ophthalmic drops,
insulin formulations, etonogestrel/ethinyl estradiol vaginal rings, and promethazine suppositories.
Additionally, antibiotic powders for reconstitution are initially stored at room temperature until
mixed with purified water. After reconstitution, some medications require refrigeration for storage.

CHALLENGE

1. What is 25° C in Fahrenheit? 2. What is 10° C converted to 3. Convert 2° C to Fahrenheit. 1.7° C (35° F) to
A. 52° F Fahrenheit? A. 30.2° F 7.8° C (46° F)
B. 68° F A. 32° F B. 35.6° F
C. 77° F B. 41° F C. 48.7° F
D. 86° F C. 50° F D. 50.6° F
C. To convert Celsius to D. 59° F B. To convert Celsius to
Fahrenheit, you can use the C. To convert Celsius to Fahrenheit, you can use the
formula: 5F = 9C + 160 Fahrenheit, you can use the formula: 5F = 9C + 160
formula: 5F = 9C + 160

20° C (68° F) to
25° C (77° F)

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EXPIRED AND RECALLED MEDICATIONS Case Study: Community Pharmacy

The pharmacy technician bears responsibility for removing expired and Inventory, Part 2
recalled products from the shelf. The technician removes expired medications
One morning, you receive a shipment of medications from a
from stock and places them in a bin marked for expired medications. The wholesaler. As you unpack the boxes and update the inventory
technician also flags medications with expiration dates nearing and places system, you notice that the expiration date on several vials of
these medications in a separate area designated for soon-to-expire products. insulin is approaching. You know it’s crucial to rotate stock to
prevent dispensing expired medications to patients.
The pharmacy technician then discusses with the pharmacist whether
adjustments need to be made to patient prescriptions to ensure timely use of 1. What steps should you take to address this issue?
the expiring medications, updates the inventory system to reflect the expiration These are the steps you should take.
dates accurately, and monitors the inventory to identify and address expiring 1.) Immediately flag the vials of insulin with expiration dates nearing.
medications in a timely manner. This lesson covers expiration dates and recalls. 2.) Place these medications in a separate area
designated for soon-to-expire products.
3.) Inform the pharmacist about the situation and discuss

Expiration Dates
whether adjustments need to be made to patient prescriptions
to ensure timely use of the expiring medications.
During the drug approval process, the FDA works with manufacturers to determine 4.) Update the inventory system to reflect
the expiration dates accurately.
the expiration date for medications. Manufacturers then mark products with that
5.) Regularly monitor the inventory to identify and
date. When receiving products, this is an opportunity to evaluate expiration dates address expiring medications in a timely manner.
on all inventory, including the inventory currently in the pharmacy.
Pharmacy Tech Tip
Remove expired medications from the shelf per the protocols of the pharmacy
and, when storing, keep FIFO in mind. In an institutional setting, monitor If you receive a notification from the manufacturer that a
products on nursing units and in automated dispensing machines.
batch of a Class I medication has been recalled due to a
manufacturing defect, follow these steps to address the issue.
Moreover, check expiration dates on all products before dispensing to determine Action
if the prescription is likely to be used by the patient before the bottle’s expiration 1. Immediately stop dispensing the affected medication and
date. Medications can lose effectiveness or become toxic after reaching their remove it from the shelves.
expiration date. 2. Follow the pharmacist’s instructions regarding
documenting and returning the recalled products to the
manufacturer or wholesaler.
Changing Expiration Dates 3. Notify patients who have recently received prescriptions
Expiration dates can change depending on the environment in which a product for the recalled medication and advise them to return the
product for a replacement.
is stored. For example, famotidine vials for injection have a manufacturer
4. Update the inventory system to reflect the removal of the
expiration date at controlled refrigerated temperature, but once removed from the
recalled products.
refrigerator, they have a room temperature expiration date of 6 months. Insulin is
5. Stay informed about any additional instructions or
another example. In the refrigerator, insulin has a manufacturer expiration date. updates related to the recall from the manufacturer or
Once stored at room temperature, it has a shortened expiration date of 28 days. regulatory agencies.

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Removing Expired Controlled Substances

Remove expired medications from the inventory and store them in a secure area for disposal.
If an expired medication is a controlled substance, disposal requires a few extra steps. Remove
the medication from the perpetual inventory log, complete a DEA-41 form, and then dispose of
the medication. The form requires two witnesses to dispose of controlled substances. Companies
hire reverse distributors to document and dispose of expired and unwanted medications. In some
instances, credits are given to pharmacies for returning expired medications.

Medication Recalls
When the FDA receives multiple reports of adverse effects or misbranding, the agency may
determine that the product is a threat to public health. Information about adverse effects are
obtained from the FDA’s MedWatch program. Health care professionals or consumers can report
adverse effects of medications to MedWatch through an electronic form. The FDA then contacts
the manufacturer and recommends a recall. The FDA is not the only organization that can issue a
medication recall. The medication manufacturer can voluntarily recall a medication and take it off
the market. Some recalls are done at the retail level, which does not require patient notification of
the event.

The FDA classifies medication recalls in three ways, depending on the severity. Class I medication
recalls are the most serious, and Class III recalls are the least severe:

⦁ Class I: A medication product is being recalled because there is a strong chance of serious adverse
effects or death.

⦁ Class II: A medication product is being recalled because there is a temporary (but reversible)
chance of adverse effect or little chance of serious adverse effect.

⦁ Class III: A medication product is being recalled because of a problem that is not likely to cause
adverse effects.

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 PHARMACY TECHNICIAN OVERVIEW

Once a recall has been declared, the manufacturer sends a formal letter to the wholesalers, sellers,
and customers to notify them of the type of recall. The letters are clearly marked with the words,
“URGENT PRODUCT RECALL.” The letter contains important information about the recall—such as
the class of medication recall and the suspected reason. The letter clearly identifies the products
included in the recall with a description, National Drug Code, lot number, and package size. The
lot number is extremely important to identify the specific batch to which the recall relates. The
FDA then oversees a company’s recall strategy, assesses the adequacy of the company’s action, and
classifies the recall.

The pharmacy notifies the patient of the recall and specifies whether the patient will be reimbursed
for the cost or if the previous payment will be applied to the replacement medication. All
medications included in a recall must be removed from the pharmacy inventory and handled as
requested in the recall letter. Pull recalled medications from floor stock and automated dispensing
machines in hospital settings. In some instances, manufacturers want the recalled product returned
to them for inspection. Other times, the manufacturer requests that the pharmacy destroy the
recalled medication. With Class I recalls, pharmacies may notify patients to return their medication
for a refund. Media involvement can be necessary to reach patients.

CHALLENGE

1. Which classification of medication recall is characterized by a strong chance of serious adverse

effects or death?
A. Class I
B. Class II
C. Class III
D. Class IV
A. Class I medication recalls are the most serious category, indicating a strong chance of serious adverse effects
or death associated with the recalled medication. This classification prompts urgent action to remove the
product from circulation and notify wholesalers, sellers, and customers. Class II recalls involve a temporary (but
reversible) chance of adverse effects or little chance of serious adverse effects. Class III recalls involve problems
that are not likely to cause adverse effects. Class IV is not a recognized classification for medication recalls.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PHARMACY TECHNICIAN OVERVIEW

MEDICATION DISPOSAL Case Study: Community Pharmacy Inventory,

Properly disposing of medication and medication containers is the Part 3
pharmacy’s responsibility. Disposal involves employee safety, environmental
At the end of the month, you conduct a medication inventory
protection, and regulatory adherence. Pharmacies usually hire outside audit and identify several expired and discontinued medications
companies to return and properly dispose of medications. This lesson covers that need to be disposed of properly.
the proper ways to dispose of hazardous and other medications. 1. What steps should you take to address the issue?
These are the steps you should take.
1.) Gather all expired and discontinued medications for disposal.
Hazardous Substance Disposal 2.) Refer to the pharmacy’s policies and procedures for
Several federal agencies regulate the disposal of hazardous medications. medication disposal to ensure adherence to regulations.
3.) Follow the appropriate disposal methods for
United States Pharmacopeia Chapter 800 specifically addresses handling
different types of medications, such as separating
hazardous medications identified by the National Institute for Occupational hazardous medications for special handling.
Safety and Health. 4.) Document the disposal process, including the
medications disposed of and the method used.
Moreover, the Environmental Protection Agency enforces the Resource 5.) Regularly review and update the pharmacy’s medication disposal
Conservation and Recovery Act regarding hazardous medication waste protocols to align with current regulations and best practices.
disposal. The Department of Transportation regulates how hazardous
medications are transported or shipped.
Warning Label on
Hazardous medication waste is categorized in the following ways. Bottle
⦁ P-listed medications are acutely hazardous medications. Empty containers of these medications
are considered hazardous.

⦁ D-listed medications are toxic, ignitable, corrosive, or reactive. They have the potential to get into
drinking water. Toxic medications contain mercury or heavy metals. All aerosols are included in
the ignitable category. Corrosives include silver nitrate.

U-listed medications, such as many chemotherapy drugs, are toxic.

TOXIC: DISPOSE OF AS
Pharmacies are responsible for identifying and disposing of all hazardous medications in their

BIOHAZARD
facility. Most facilities have policies and procedures in place to identify the type of hazard each
medication poses and how to properly dispose of them.

For example, a label for an albuterol inhaler will have a specific mark on it to indicate it is a D-listed
ignitable hazard medication that must be disposed of in a certain color bin.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PHARMACY TECHNICIAN OVERVIEW

Controlled Substance Disposal

In adherence with the DEA, new regulations do not require a particular method of destruction
for controlled substances, so long as the destruction achieves the desired result. Pharmaceuticals
must be rendered non-retrievable in adherence with all applicable federal, state, tribal, and local
laws. Disposal of the waste must be witnessed by two pharmacists or nurses. In the community
setting, disposal can be witnessed by pharmacists, DEA or Bureau of Narcotics and Dangerous Drugs
personnel, or local law enforcement.

Patient Responsibility
Consumers are not required to follow proper disposal protocols but are encouraged to take an active
part in protecting the environment and community. Most pharmacies do not accept unwanted or
expired medications from patients for disposal, leaving patients with few options. Advise patients
and caregivers not to flush or throw away medications.

Recommend that patients make medications unattractive if they do throw them away. Solid
medications can be crushed and mixed with liquids or water in a disposable zipper storage bag.
Patients can add cat litter or coffee grounds to the mixture to deter humans or animals from
consuming. The patient can then dispose of the bag in the regular trash. Inform patients that the
DEA sponsors National Prescription Drug Take Back Days throughout the year when people can
dispose of their medications at designated disposal sites. Also explain that the patient can purchase
disposal packages at the pharmacy and mail the medications, but there is usually a cost associated
with the service.

One exception to the flushing rule is the disposal of fentanyl patches. Fentanyl patches contain
a potent opioid used for severe, long-term pain relief in patients. The product package insert
recommends that the patient flush used patches down the toilet due to the risk of accidental
exposure of others to residual medication left in the patches. Deaths from accidental exposure to
used fentanyl patches have been reported in children and pets.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PHARMACY TECHNICIAN OVERVIEW

PHARMACY REFERENCES AND RESOURCES

Access to references and resources is vital to the pharmacy department.

Reference Library
Each state board of pharmacy requires a minimum reference library to be kept in the pharmacy.
Individual states have the authority to require specific references to be printed or available online.
Some references are available as printed editions or mobile applications, while others have an
online database that is accessible with a subscription. Pharmacies can determine which additional
references are necessary for their work environment. Below is a list of useful references and the
information that can be found in each:

⦁ Clinical Pharmacology’s Drug Identifier is available for institutional and community settings.

⦁ Drug Facts and Comparisons is a print or online resource for medication monographs wherein
medication interactions can be found.

⦁ Ident-A-Drug online lists tablet and capsule identifications. It includes more than 38,000 listings.

⦁ Geriatric Dosage Handbook includes information on suggested current dosages for older
adult patients.
⦁ Martindale: The Complete Drug Reference provides information on medications in clinical
use worldwide.

⦁ Micromedex’s IDENTIDEX identifies medications by shape, color, and imprint. It is a useful

resource for law enforcement to identify medication found in the field.

⦁ ISMP Medication Safety Alert! is a newsletter published every 2 months to educate health care
workers about medication error prevention and near misses.

⦁ The Merck Manuals includes information on diagnosing and treating medical conditions.

⦁ Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) is a

comprehensive list of approved medication products with therapeutic equivalence evaluations that
are provided by the FDA. This book determines whether a generic medication is the same as a
brand-name medication. This reference is updated annually and can be accessed for free.
⦁ Pediatric and Neonatal Dosage Handbook contains information on suggested current dosages for
pediatric patients.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PHARMACY TECHNICIAN OVERVIEW

⦁ Physicians’ Desk Reference is a reprint of product package inserts published yearly.

⦁ Red Book: Pharmacy’s Fundamental Reference is useful for finding prescription and
nonprescription medication average and wholesale costs and pricing.

⦁ Safety Data Sheets explain dangers of hazardous chemicals and actions to take if exposed.

⦁ Handbook on Injectable Drugs is a print or online resource for parenteral medication compatibility
and stability. It is especially useful in the inpatient pharmacy setting.

⦁ CDC Health Information for International Travel (Yellow Book) includes health recommendations
for international travel published every 2 years. Research is available by diseases or destination.

⦁ United States Pharmacopeia—National Formulary provides access to the official standards of

the FDA. This reference aids in adherence with standards and lists new product development
and approvals.

Poison Control
Pharmacies play a critical role in medication safety by maintaining close connections with poison
control centers. Poison control centers serve as vital resources for pharmacies to consult in cases
of medication errors, adverse drug reactions, or potential poisonings. Pharmacists and pharmacy
technicians collaborate with poison control experts to provide immediate and accurate guidance
to patients and health care providers in emergencies involving medications or toxic substances.
This partnership ensures prompt intervention and appropriate management of poisoning cases,
contributing significantly to patient safety and public health. By leveraging the expertise of poison
control centers, pharmacies enhance their ability to prevent and address medication-related
incidents, ultimately safeguarding the well-being of individuals within their communities.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

OVERVIEW Federal Versus State Law: Who

Every industry has to follow the various federal, Prevails? National Drug Code
state, and local laws and regulations that
When federal and state laws address the same Every medication is required to have a
apply to that type of business, and pharmacy topic related to pharmacy practice, the more unique National Drug Code (NDC) as
practice is no exception. The laws that govern stringent of the two laws takes precedence. required by the 1972 Drug Listing Act
the profession of pharmacy help ensure administered through the FDA. The
the safety and well-being of everyone who NDC identifies the labeler, product, and
receives pharmaceutical products and services. package size.
These laws regulate the development and HIPAA and Protected Health
manufacture of pharmaceuticals. They protect Information
the pharmacists, pharmacy technicians, and
other professionals who provide these products
The primary federal law that directs pharmacy Controlled Substances Act
professionals in handling patients’ protected
and services. health information (PHI) is the Health Insurance The Controlled Substances Act (CSA)
Portability and Accountability Act (HIPAA) of 1996. of 1970 regulates the manufacture,
Regulatory agencies must be vigilant in their Pharmacy staff may not disclose any medical importation, possession, use, and
oversight of pharmacy practice, not just for the information, the medications they are dispensing, distribution of medications and
or any other personally identifiable information to substances that have the potential for
protection of everyone who dispenses, prepares,
anyone that is not providing direct medical care abuse and physical and/or psychological
and educates patients about medications, but to that patient, including treatment, payment, and dependence. It divides controlled
also for those who take prescription and over- operations. substances into five schedules according
the-counter medications and supplements. to their potential harm.

As a pharmacy technician and safe practitioner, prescription. Order for

you must have a good working knowledge of medication by a licensed
health care provider with
the laws that affect the general provision of health care services in the U.S., as well as those that
prescriptive authority.
specifically regulate pharmacy practice. It’s especially critical for you to understand how these
regulations apply directly to daily activities in a pharmacy and how to make sure you document protected health information
adherence to these regulations. (PHI). Any health information
used to identify an individual.
This chapter reviews the laws that apply to health care delivery in general, such as those from
HIPAA and OSHA. It covers the laws and regulations that govern filling, refilling, and partial filling controlled substance. Drug
of prescriptions for both non-controlled and controlled substances, including packaging and record- that has the potential for
keeping. Controlled substances require careful handling, inventory-keeping, and documentation. abuse or dependence that
is overseen by the DEA.
The information here provides extensive detail about those aspects of adherence with federal law.
This chapter also addresses reporting of fraud, waste, and abuse. Armed with these details of safe
fraud. Deliberate attempt
to accrue illicit gain from a
and legal pharmacology practice, you will be ready to provide the expert services, care, and
health care benefit program.
education your patients deserve while also practicing within legal limits.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

LAWS AND REGULATIONS FOR PHARMACY PERSONNEL Case Study Instructions

General Laws and Regulations Read the following case study and use the
information provided in the chapter to
To adhere to the laws that affect pharmacy practice, it is important to understand the differences
answer follow-up questions related to the
between statutes, regulations, and professional standards. This lesson provides a look at some scenario. Case studies may have more than
of the main laws and regulations governing pharmacy practice. It also delves into specific one part.
regulators, handling controlled substances, and diversion programs.

Overview Case Study: Controlled

Legislatures, either federal, state, or local, pass Substances, Part 1
statutes. Once passed and signed into law, agencies,
A new patient enters the pharmacy to fill
such as the Department of Health and Human Services, a prescription. The pharmacy technician
create regulations to detail, clarify, and enforce the begins to gather appropriate information
statutes. Often, statutes confer on regulatory agencies for the patient profile and glances at the
the power to create such regulations. prescription. The technician notices it is
for a controlled substance, so they begin
to think about requirements for this type
Sometimes, federal and state laws address the same topic related to pharmacy practice. If so,
of prescription and how to appropriately
the more stringent of the two laws takes precedence. For example, federal law might require scrutinize the prescription.
pharmacies to keep prescriptions for certain controlled substances on file for 2 years, while
state law requires retaining them for 5 years. In that case, a pharmacy operating in that state is
required to keep those records for 5 years.

National and/or state pharmacy associations establish professional standards, which do not have
the force of law. Nevertheless, a court of law can use these standards as evidence as to whether a
pharmacist or technician followed standard practices. These standards often take the form of a code
of ethics or list of best practices. The standards prioritize the health and safety of the patients as
well as respecting and valuing the abilities of colleagues and coworkers.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Pharmacy Practice Acts pharmacy practice act. State

law that regulates the practice
State law specific to pharmacy, usually termed the pharmacy practice act, largely governs how
of pharmacy within the state.
pharmacists and technicians practice pharmacy within the state. For example, a state’s board of
pharmacy might determine activities a technician can perform when a patient gets immunized. It
Professionalism Tip
licenses the state’s pharmacies and professionals, addresses complaints, takes disciplinary action,
and performs inspections of pharmacies for adherence to the state’s pharmacy laws and regulations. Professionalism for a pharmacy
State pharmacy boards can revoke, suspend, or place on probation the licensees they oversee. technician is defined by a
commitment to ethical conduct,
competence, and courteous
Technicians bear a responsibility to themselves, their employers, and their patients to avoid
service while ensuring patient
charges of misconduct, which can lead to legal issues, both civil and criminal, and significant trust and a high standard of care.
penalties. Activities that constitute misconduct, even if inadvertent, include dosage calculation An example of this is when a
errors, mislabeling, failure to identify expired medications, nonadherence to controlled substance certified pharmacy technician,
regulations, keeping inaccurate or insufficient records, dispensing the wrong medication, and
handles a prescription error
with transparency and prompt
breaching patient confidentiality. Beyond avoiding misconduct, it’s imperative to adhere to ethical corrective action. The pharmacy
standards that promote the best possible care for the patients. technician maintains a calm and
respectful demeanor with both
the patient and colleagues.
Federal Oversight
WARNING: BLEEDING RISK
Federal laws generally oversee the development, manufacturing, Drug warnings are specific to the medication,
and here in the black box warning is where
marketing, and distribution of medications. Some cities, counties, WARNING: POTENTIAL FOR ABUSE
you will find detailed information. These CHALLENGE
Drug warnings
warnings arelength
can vary in specific
andtodetail.
the medication,
This
and other municipalities also have regulations that affect andWARNING:
generic here in thean
text gives black
idea box
of awarning
SERIOUS is where
typical length of
you will find detailed information. These 1. Federal law requires
pharmacy practice, so all pharmacy personnel must be aware of CARDIOPULMONARY
warnings REACTIONS
can vary in length and detail. This
Drugtext
generic warnings areidea
gives an specific
of a to the medication,
typical length of
controlled substance
and adhere to federal, state, and local laws that apply to pharmacy and here in the black box warning is where you prescriptions to be kept
will find detailed information. These warnings
practice. can vary in length and detail. This generic text for 2 years, but the state
gives an idea of a typical length of passage. where the pharmacy
Pharmacists control the dispensing of medications that are is located requires
controlled substances to
potentially dangerous or have a high potential for abuse. For that
be kept for 4 years. How
reason, pharmacy practice is one of the most highly regulated professions in the U.S. The largest and long must controlled
most impactful federal regulatory agency is the Food and Drug Administration. This agency substance prescriptions
supervises the development, testing, purity, safety, and effectiveness of prescription and over-the- be maintained in this state
and why?
counter (OTC) medications, among other items. The FDA must approve medications before
The pharmacy must follow the
pharmacies can sell them in the U.S., and they must make sure they are safe when used at most stringent law that applies.
prescribed doses. Therefore, the pharmacy must
keep the controlled substance
prescription for 4 years to
meet both requirements.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Labeling for prescription medications must include official prescribing information. This is
alternatively known as a monograph, package insert, or professional labeling. Information contained
on these labels includes all relevant scientific information for the therapeutic use of the medication.
Additionally, prescription medication bottles from the manufacturer come with a “Highlight”
document attached that contains the most important information about that medication (indications
and usage, dosage and administration, adverse reactions, drug interactions). Some medications
must be dispensed with patient package inserts or “MedGuides.” These are medications that are
potentially dangerous or require very specific self-administration procedures. The FDA also requires
that retail pharmacies provide a patient package insert to every patient who receives medications
with a black box or boxed warning; these are special warnings where a pharmaceutical has
high-risk potential. The insert should state information about serious adverse reactions that are
associated with the medication.

The FDA provides a reporting program, MedWatch, through which manufacturers, health care
professionals, and consumers can report defects, adverse reactions, or any other errors related to
medications and medical products. Once the FDA analyzes the data it receives and determines that
the risks of a medication outweigh the benefits, it notifies the manufacturer of the need to remove it
from the market. For other medications that have more risks than were evident during clinical trials
but still have therapeutic benefits, the FDA issues a black box warning. black box warning. A special
warning to the consumer
Also worth noting in a more historical context of federal laws affecting pharmacy is the Pure where a high-risk potential of
Food and Drug Act of 1906, which prohibited interstate commerce of adulterated food or medicine. a pharmaceutical is present.
Adulteration means mishandling medications or food during their production, which may lead to
harm. This act had some limitations in its effect, so the 1938 Federal Food, Drug, and Cosmetic
Act was passed as a supplement, requiring manufacturers to show a medicine was safe. That act
requires appropriate warnings for medicines; it formalized the FDA as a branch of government
under the U.S. Department of Health and Human Services, determined which medications required a
prescription (legend drugs), and created labeling requirements for legend and OTC medications.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

HIPAA Adherence
The primary federal law that directs pharmacy professionals in handling patients’ protected
health information (PHI) is HIPAA. PHI is information in a person’s health files that can identify
them and that was included in the record when completing a health care service. PHI includes
anything the pharmacy staff collects, creates, or stores about a patient’s identity or health. A
patient’s health relates to the patient’s physical or mental health in the past, present, or future.
This means any information that could identify a patient (name, date of birth, telephone number,
pharmacy insurance identification number, Social Security number). HIPAA’s original provisions
allowed patients to access their own medical records and required patient consent to share those
medical records. Other provisions guard against any misuse or inappropriate disclosure of patients’
PHI. Pharmacy staff may not disclose any medical information, the medications they are dispensing,
or any other personally identifiable information to anyone that is not providing direct medical care
of that patient, including treatment, payment, and operations. The law also contains requirements
for the electronic use and transfer of medical records.

Outside of the patient or the patient’s caregiver, it is only acceptable to share information related
to medication dispensing with the prescriber’s office and the patient’s health care insurance plan
while processing payment actions. In addition, the information shared must follow the “minimum
necessary” standard: Only disclose the information the other party requires for processing the claim
or verifying the prescription. Even the technician can only access the information they need to know
to perform their job. To protect a patient’s PHI, avoid casual conversation with coworkers about
patients. Protect computer screens from public view and employees in other departments of the
retail store or health care facility.

Be discreet about conversations with patients that other customers, patients, or employees might
overhear. If unsure about sharing patient information, seek guidance from a pharmacist or
pharmacy manager before risking an illegal disclosure. Never assume it is acceptable to disclose
information to anyone who asks for it.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

HIPAA’s privacy rule affects pharmacy practice in several other important ways. Patients using
a particular pharmacy for the first time must sign an acknowledgement that pharmacy staff has
informed them of their HIPAA privacy practices. The pharmacy must keep its privacy practices and
policies stored for 6 years after their creation date or last effective date. Patients have the right to
obtain copies of their PHI, make any necessary changes or corrections, impose further restrictions
on the use of their PHI, and find out how the pharmacy has used their PHI. Improper disclosure
of PHI can result in serious penalties, including fines and jail time. Multiple violations can lead to
penalties of $250,000 and 10 years in jail. Anyone can report a HIPAA violation. Thus, discretion and
confidentiality are high priorities for technicians.

Another HIPAA tenet that applies to retail pharmacies is express prohibition on selling PHI, without
authorization, to third parties for the third party’s own marketing activities. For example, a
pharmacy may not, without the patients’ authorization, sell a list of patients to a pharmaceutical
company for that company to market its own products directly to the individuals on the list.

To help ensure adherence to HIPAA’s mandates, employers must provide training that addresses
the specific privacy and security practices that affect pharmacy operations. It is usually conducted
annually, though this frequency is not required. The training includes pharmacists, technicians,
pharmacy clerks, and anyone else who has any contact with PHI. Anyone who services computer
equipment in the pharmacy must also have HIPAA training and adhere to its mandates. Every health
care facility has a designated HIPAA privacy officer who is usually responsible for the training, and
they serve as a useful reference in case any situations related to HIPAA need clarification.

Collection, Storage, and Disposal of PHI

HIPAA mandates careful disposal of any paper that contains a patient’s PHI. Prior to disposal, PHI
should be shredded, incinerated, or destroyed so it cannot be read. It is important never to dispose
of PHI in regular waste or trash. HIPAA also mandates storing all pharmacy files and documents
containing PHI securely in a way that only allows access to authorized individuals. Employers
must monitor and update access regularly. Employers must also immediately remove access when
an employee resigns, transfers out of the department, or is terminated. Electronic records always
require protection from unauthorized access.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Transfer of Electronic Health Data

Also relevant to pharmacies, HIPAA has established standards for regulating the transfer of
electronic health data. This involves unique identifiers for all health care providers and codes for
information and transactions. Each pharmacy has a unique, 10-digit National Provider Identifier.
The staff must use it on all transactions governed by HIPAA, including claims and encounter
information; claims status; coordination of benefits and premium payment; eligibility, enrollment,
and disenrollment; payment and remittance advice; and referrals and authorizations.

HIPAA Fraud and Abuse

HIPAA also created the Health Care Fraud and Abuse Control Program to detect and investigate
fraudulent health care and insurance claims. It is important for technicians to understand that
HIPAA’s reach goes far beyond simple patient privacy practices.

CHALLENGE

1. What are some HIPAA-adherent ways to dispose of PHI?

PHI should be shredded, incinerated, or destroyed in such a manner that it cannot be read.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Laws and Regulations Pertinent to Prescription Fulfillment Case Study: Controlled Substances,
Individual state licensing boards regulate health care providers and their ability to Part 2
prescribe medications. State regulations differ regarding who has prescriptive authority
The technician continues the order entry process after
and the scope of the licensee’s practice. Typical prescribers include physicians, dentists, being initially skeptical that this may be a fraudulent
nurse practitioners, optometrists, physician’s assistants, and—in some states under prescription. The directions are, “Please take one
specific circumstances—pharmacists. Recognize the professionals who may write whole tablet by mouth two times a day.” The quantity
for the prescription is 90 tablets. The prescriber’s
prescriptions and understand the scope of practice to ensure that prescriptions are
signature is rather messy, but the first letter of the last
appropriate. For example, if a veterinarian writes a prescription for a human patient, name seems to correspond with the prescriber.
check with the pharmacist before processing. Knowledge of the area or domain of health
1. Which of the following prescription attributes
care practice for different health care providers can facilitate evaluation of prescriber should cause more suspicion that this may be a
authority. It is important to remember that this is state-specific. fraudulent prescription?
The directions are written out in an abnormally clear
manner and a quantity that is greater than a 30-
Prescription Components, Forms, and the Five Rights day supply. Earlier it was indicated that there were
two different colors of ink, which is also suspect.
A prescription is an order that conveys a prescriber’s medication treatment plan for a
patient to a pharmacist. It varies in format and requirements according to whether it
is for an inpatient in a health care facility or an outpatient who will acquire the medication
from a retail or other pharmacy. Although there is variation among states, information that
Health Care
is generally mandatory on a prescription includes the following.
Providers
⦁ Prescriber information: Prescriber information includes name, address, and phone number. 1234 Main Street
A DEA number is also required for controlled substance prescriptions. Shermer, IL 12345
1.800.555.1234
⦁ Patient’s name, address, and date of birth: Prescribers often write only the patient’s name, DEA # AS1234563
but confirm the address and date of birth either with the patient or in the pharmacy’s Name: John Doe DOB: 5/08/xx
records. Address: 12 Main , Shermer Date: 9/15/xx
⦁ Date prescribed: The month, day, and year should be written on the prescription. This
information aids in the determination of prescription expiration and potential refills. Mobic 1 - 24
15mg 1 tab PO daily (PC) 25 - 49
⦁ Medication information: Such information includes name, strength, dosage form, route, - #30 - 50 - 74
75 - 100
dose, frequency, amount to dispense, number of refills (or “no refills”), and permission for 101 - 150
generic substitution. 151+
Refill NR 1 2 3 4 5
⦁ Sig/Signa/Directions for use: This signifies the way the physician orders the patient to take
Christina Smith 9/15/xx
the medication.
Prescriber signature Date
⦁ Prescriber’s signature. Dispense as written
Brand exchange permissible

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Pharmacy staff members receive prescriptions in written form, by telephone, fax, or electronically
via computer. Prescription forms for controlled substances differ in some circumstances, as
discussed in the Controlled Substances section of this chapter.

Although they are not laws, there are standards that apply to abbreviations on prescriptions that
alert pharmacy staff to the need to clarify a prescription with a prescriber. If left unaddressed,
ambiguity could potentially lead to a medication error. Two organizations in particular, The Joint
Commission and the Institute for Safe Medication Practices (ISMP), have “Do Not Use” lists of such
abbreviations that are not recommended for use. Examples include HS (causes confusion between
half-strength and at bedtime), D/C (causes confusion between discontinue and discharge), and TIW
(unclear whether it means three times a week or three times daily). Acceptable abbreviations include
g or gm (gram), ASA (aspirin), and PO (by mouth or orally).

Other standards applicable to prescriptions components involve the use of the Five Rights of
medication administration (dispensing). This includes ensuring the right patient, medication,
strength, route, dose, and time. Two additional “Rights” added later include the right technique
and the right documentation. An example of the right technique is using the appropriate process
for compounding a sterile IV medication. The right documentation can include appropriate
documentation after a medication error takes place.

Omnibus Budget Reconciliation Act

A piece of federal legislation that applies specifically to prescription fulfillment is the Omnibus
Budget Reconciliation Act of 1990 (OBRA). It is a federal law related to pharmacists’ professional
responsibilities and the responsibility of the pharmacy in several significant ways. It is important to
note that while this law applies largely to Medicaid patients, most states have implemented its drug utilization review (DUR).
requirements for all patients. Pharmacies must keep records (patient profiles) for all medications An authorized, structured,
that Medicaid recipients use. These records help reduce the incidence of medication therapy errors ongoing review of health
due to medication duplication, allergies, medication interactions, adverse effects, and misuse or care provider prescribing,
abuse of prescribed medications. Pharmacists are to offer counseling to all Medicaid recipients about pharmacist dispensing, and
the correct use of their medications. Pharmacists are to complete prospective (prior to dispensing)
patient use of medication
to ensure patient safety.
and retrospective (periodic) drug utilization reviews (DURs). DURs are authorized, structured, ongoing
It reviews interactions,
reviews of health care provider prescribing, pharmacist dispensing, and patient use of medication.
allergies, duplicate/similar
medications, dose, and
other safety parameters.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Moreover, under OBRA and similar state laws, only pharmacists may counsel patients, but
technicians can gather information for patient records and be involved in dispensing activities.
It is important for technicians to let patients know that the pharmacist can help with explaining
instructions and answering any questions they might have. Technicians may not offer advice, but
they can read any information on the label or help find a specific OTC product within the store.

Inpatient Fulfillment
Procedures for handling medication orders in an inpatient setting are significantly different than in
outpatient pharmacies. Prescribers write prescriptions either on a medication order sheet or within
a computerized system. Electronic orders are commonly called computerized physician order entries.
Orders in an inpatient setting will require much of the same information as the outpatient setting,
but additional items like patient room number and hospital ID number are also added. Often, the
prescriber will write multiple prescriptions on the same order sheet. Prescribers are often limited
to choosing medications from the facility’s formulary—a list of medications that the facility’s
pharmacy keeps on hand. In some hospital pharmacies, the pharmacist may initiate “automatic
substitution,” replacing a non-formulary medication with one from the formulary. Always check the
policies and procedures manual for clarification and bring any questions to the pharmacist.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Prescription Refills
CHALLENGE
Technicians process refills in many of the same ways they do when
filling an original prescription. The refill process works off the original 1. How long is a prescription for a non-controlled substance
prescription. The original physical hard copy of the prescription is
valid assuming the prescription still has refills?
scanned into the computer and attached to the electronic record or A. 6 months
version of the prescription in the patient profile. This is done so that B. 30 days
the pharmacist can view the scanned image of the prescription while C. 12 months
checking the refill instead of pulling the hard copy for every refill. There D. 2 years
must be refills remaining, and the prescription must not be expired. If C. Non-controlled substance prescriptions are valid
for 12 months if they still have refills available.
there are no refills, the technician must contact the prescriber to obtain
authorization for a new prescription. Let patients know to allow time 2. Which of the following organizations publishes a list of
abbreviations that should not be used in communication
for the pharmacy to obtain this authorization, especially when they
within health care? (Select all that apply.)
make the request at times other than the prescriber’s usual business
A. The Joint Commission
hours. The technician should always cross-check the refill with the
B. MedWatch
original prescription to make sure they are preparing or dispensing the
C. United States Pharmacopeia 800 (USP 800)
right medication, dosage form, strength, and quantity. The prescription
D. ISMP
number should be the same for the original prescription and all its refills.
E. National Pharmacy Technician Association
Generally, pharmacies can refill standard prescriptions for non-controlled
A, D. ISMP publishes a list of abbreviations that are not
substances as many times as the prescriber indicates within 1 year of the recommended for use in health care. The Joint Commission
date the prescriber wrote the original prescription. publishes a list of abbreviations that are not recommended
for use in health care. MedWatch is an error reporting system
Another consideration to check is the timeline. Some patients request facilitated by the FDA. USP 800 sets quality standards for
medications. The National Pharmacy Technician Association is
refills too early. If this is the case, their health insurance plan might a national organization representing technicians’ interests.
not pay for the refill if it is more than 1 week early. Nevertheless, as
3. Which of the following are requirements for a physical
long as the prescription hasn’t expired and refills remain, the pharmacy
prescription for a non-controlled medication to be valid?
can usually provide the refill early. Insurance payment tends to be the (Select all that apply.)
limiting factor, so patients would need to pay out of pocket. The general A. DEA registry number
rule is that the patient must use 75% of what the pharmacy dispensed B. Prescriber signature
before health insurance will pay its share of the prescription cost. C. Medication name
Depending on their insurance, a patient can usually pay out of pocket for D. Quantity
any initial fill or refill.
E. Directions for use
F. Patient name
B, C, D, E, F. The prescriber signature, medication name,
quantity, directions for use, and patient name are required is
required for a valid physical prescription. The DEA number is not
required for prescriptions for non-controlled medications.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Laws Regarding Packaging and Labeling

Prescription medications, also known as “legend drugs,” arrive from the supplier in the
manufacturer’s packaging or stock bottles. This packaging has its own requirements
from the FDA, as indicated in the list below. When the pharmacy receives the package Manufacturer’s Label
from the wholesaler or manufacturer, it is stored in that packaging on the shelves. A
prescription that is later dispensed to the patient is often placed in a separate amber vial Front
with loose pills and a new label. There are specific requirements, to be discussed later in
250
®
Sample Brand
the lesson, that must be on this label, as well. mg

Generics X
Manufacturer Prescription Packaging Labels Store at room temperature

The FDA requires that all prescription medication packaging labels contain the following
IV 100 Tablets
information:

⦁ Established name and quantity of each active ingredient: Manufacturers may use a
Back
brand name if it is still under patent. If the medication is not a branded product, the
manufacturer uses the generic medication name.

⦁ Statement of new quantity: This is generally only applicable to medications requiring Generics Manufacturing
mixing or reconstituting before administration. 1234 Sample Industrial Road, Sample City NY 12345

⦁ Statement of usual dosage: This indicates the general approved dosing for the
medication.
Caution: Federal law prohibits dispensing without a prescription.

⦁ Federal legend: Medications that can only be dispensed with a valid prescription must
have an “Rx only” symbol or the following statement on the label: “Caution: Federal Side
law prohibits dispensing without a prescription.”
L1234567890
⦁ Route of administration: This lists the approved routes of administration for the EXP 12/20XX
12345-1234-01
specific product.

⦁ A federal warning if the medication is habit-forming: This generally applies to

controlled substances.

⦁ All inactive ingredients: This applies if the administration route is other than oral.

⦁ Lot number: Sometimes called a “control number,” this number marks medications as belonging
to specific batches produced by the manufacturer.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

⦁ Type of container required for dispensing: This accounts for any special dispensing procedures or
containers to avoid.

⦁ Name and place of business of manufacturer: This also includes packager or distributor if different
from manufacturer.

⦁ Expiration date: This is the last date that the medication is guaranteed to be safe and Drug facts
effective. Active ingredients in each tablet
SampleMed 300mg,pain reliever/fever reducer

⦁ Storage requirements: Prescription medications must be stored at appropriate Uses

Temporarily relieves pain and inflammation.
temperatures and in proper conditions. Warnings
Kidney warning: This product contains samplemed. Damage
⦁ Controlled substance mark: For controlled substances, the manufacturer’s label must may occur if you take
• more than 3 tablets in 12 hours
include a “C” and the Roman numeral classification the DEA has assigned to describe its • with other medications containing samplemed
• four or more alcoholic drinks within 24 hours
level of control. This symbol appears in large print on the label and is easy to see or is of ingesting this product.
overprinted in a contrasting color. Do not use
• with any medication containing samplemed.
• if you are pregnant, under a provider’s care for a serious
⦁ National Drug Code (NDC): The manufacturer of a medication assigns an NDC and places condition, or age 60 or older.
it on all medication labels. • if you have any medical conditions involving complications
of the kidney or lymphatic system.

Ask provider before use if you have

The labels on OTC medications, which are also regulated by the FDA, must include the • kidney disease
following. • liver disease
• Hodgkin’s disease, glandular fever, or tonsillitis

⦁ Product name Directions

• Do not take more than directed
• Take the minimum dose necessary for effectiveness
⦁ Name and address of manufacturer and distributor (including any re-packagers) • Adults and children over 13: take one tablet every 8 to 12 hours
while symptoms persist
• Do not exceed 3 tablets in 12 hours
⦁ Established name of all active and inactive ingredients and quantity of other ingredients
For questions or comments call 1-800-555-MEDS or visit
[Link]/FAQ
⦁ Indications for use Meds-R-Us, Sample, KS 67123 USA

⦁ Net contents

⦁ Required cautions and warnings 3 2390001441432526192 1

⦁ Name of any potentially habit-forming drug contained in formula

⦁ Adequate directions for use

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

National Drug Code

Every medication is required to have a unique NDC as required by the Drug Listing Act of 1972
administered through the FDA. The NDC identifies the labeler, product, and package size. The first
set of numbers, usually five digits, represents the labeler. The second set of digits, usually four,
represents the drug name and dose. The third set of digits, usually two, represents the package
size. The NDC is vital in appropriate insurance billing and product selection during the prescription
filling process. The barcode on a prescription bottle, which also represents the NDC, is scanned to
check appropriate medication selection for inpatient and outpatient pharmacies. The Drug Supply
Chain Security Act (DSCSA) requires the FDA to develop a tracking system to uncover and address
medications that are counterfeit, falsified, or substandard. The barcode on the packaging serves this
purpose and keeps consumers safe.

Bioequivalence
During the prescription filling process, the use of a generic medication may be preferred to a
branded medication. To determine the interchangeability of the two medications, the pharmacist
must assess bioequivalence. In almost every case, if a generic is available, that is what will be
dispensed, because it is cheaper for the patient. The FDA’s Approved Drug Products with Therapeutic
Equivalence Evaluations (Orange Book) is the primary reference for determining bioequivalence.
This reference provides bioequivalence information for prescription medications, OTC medications,
biologics, and a miscellaneous section with medications approved but not marketed, medications
for exportation, medications for the military, or discontinued medications. Ultimately, it is the
pharmacist’s responsibility to dispense bioequivalent products, but the technician should be familiar
with the Orange Book because they will be completing order entry of the prescription and then
selecting the product the pharmacy has in stock.

Prescription Labels
Many states have specific requirements about what must appear on a prescription label when
dispensing a prescription, but the following are the basic requirements put forth by the ISMP.

⦁ Name, address, and telephone number ⦁ Refills

of the pharmacy ⦁ Expiration date
⦁ Prescriber name ⦁ Medication name, strength, dosage form,
⦁ Patient name quantity dispensed, drug manufacturer,
⦁ Date prescription is filled and instructions

⦁ Prescription number ⦁ Auxiliary labels as needed

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Child-Resistant Packaging child-resistant packaging.

TLY
EW
GH Packaging required by the
R
The Poison Prevention Packaging Act of 1970 (PPPA), which the Consumer Product

C
CLOSE TI

UNS
Safety Commission enforces, requires specific child-resistant packaging for all Poison Prevention Packaging
Act of 1970 to function such

ND
prescriptions unless excluded by the PPPA, inpatient medications, or otherwise
P that 80% of children under

A
US N
requested by the prescriber or patient. This packaging is required to function such H DOW
5 years old cannot open
that 80% of children under 5 years old cannot open the container, and at least 90%
the container and at least
of adults can open the package within 5 minutes. Patients who do not wish to have
90% of adults can open the
these containers for their medications must sign a waiver. The pharmacy will update package within 5 minutes.
the patient profile with this information and keep the waiver on file. The pharmacy
might require renewal of this request periodically. Additionally, if a non-childproof
CHALLENGE
cap is used, a warning label must be affixed to the prescription bottle.
1. What medication characteristics are
Nitroglycerin sublingual tablets are a notable exception to this rule. Pharmacies must communicated in the NDC? (Select all that
dispense sublingual nitroglycerin and sublingual and chewable isosorbide in their apply.)
original, unopened containers. There are other exceptions, such as methylprednisolone A. Expiration date
(Medrol) dose packs, pancrelipase preparations, cholestyramine powder (Prevalite), B. Labeler
unit-dose potassium supplements, and unit-dose medications for inpatient use. It is C. Lot number
always good practice to check any packaging that is not child-resistant to ensure D. Product
adherence to any specific requirements. E. Trade package size
B, D, E. The labeler, product, and trade package
size are conveyed in the NDC. The expiration date

Case Study: Controlled Substances, Part 3

and lot number are not conveyed in the NDC.

2. Which of the following laws mandates

After the technician completes the patient profile, they begin the order entry that amoxicillin (Moxatag) tablets must be
process. The prescription is for oxycodone extended release (OxyContin). dispensed in child-resistant packaging?
It was written 2 days ago. The patient’s name is written in black ink, and the A. PPPA
directions are written in blue ink. There are no refills, and the prescriber is
known to the pharmacy. B. Combat Methamphetamine Epidemic Act of
2005 (CMEA)
1. Which attribute of the prescription should make you suspect that this may C. OBRA
be a fraudulent prescription?
D. DSCSA
The presence of two different ink colors indicates that
this may be a fraudulent prescription. A. The PPPA mandates that, with a few exceptions,
all prescription medications be dispensed in child-
resistant packaging. Amoxicillin tablets are not
one of the exceptions. CMEA regulates the sale
of methamphetamine precursors. OBRA requires
patient profiles, prescription counseling, and DUR.
DSCSA serves to recognize and track counterfeit,
adulterated, or substandard medications.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Laws and Regulations Related to Handling Sharps and Hazardous Substances

In 1970, the Occupational Safety Act created the Occupational Safety and Health Administration
(OSHA). OSHA helps ensure safe and healthy working conditions by setting and enforcing standards
and by providing training, outreach, education, and assistance for all workers. OSHA reminds
everyone in health care that biomedical waste is any material that can cause harm to employees and
patients.

Sharps Disposal
Sharps are objects that can penetrate a worker’s skin, such as needles, scalpel blades, and broken
glass. If blood or other potentially infectious materials contaminate these sharps and a needlestick
injury or a laceration occurs, the worker can contract infectious pathogens. Careful handling of
sharps can prevent injury and reduce the risk of infection.

A technician may be handling sharps while assisting the pharmacist with immunizations. Dispose
of sharps immediately in a rigid, specifically designated, impenetrable container that is usually red
with a biohazard symbol on it. It must be leakproof on the sides and bottom and must not allow
retrieval of its contents after disposal. Sharps disposal containers must be closable and able to stand
upright to keep the sharps and any fluids from spilling out of them. Do not overfill. Sharps disposal
containers must be readily accessible and as close as is feasible to the area where pharmacy staff
uses the sharps. It is also important that patients do not have access to these containers. sharps. Objects that can
penetrate a worker's skin,
Moreover, avoid breaking glass vials or ampules. Do not recap, bend, or remove needles from such as needles, scalpel
syringes routinely. If removal is necessary, use either a mechanical device or a one-handed blades, and broken glass.
technique, using the needle itself to pick up the cap. Then push the cap against a hard surface to
ensure a tight fit onto the device. Use safety needles whenever they are available. Clean up any
contaminated broken glass with a brush and dustpan, tongs, or forceps, not with bare hands.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Hazardous Drugs
hazardous drugs (HD).
Hazardous drugs (HD) are medications that have serious side effects during animal or human testing,
Medications that have serious
or may cause organ damage, cancer, or harm to a pregnant person. Technicians may handle
side effects during animal or
hazardous drugs if they work at an inpatient pharmacy, especially if the pharmacy provides human testing, or may cause
chemotherapy drugs to patients with cancer. Many chemotherapy agents are HD. The two main organ damage, cancer, or
regulating bodies governing the handling and disposal of HD are OSHA and USP 800. Two of USP harm to a pregnant person.
800’s main directives are that HD must be stored and prepared separately from non-HD, and HD
must be administered via a closed system transfer device. This is to protect employees and patients.
Specific garb, including special gloves and gowns, protects employees when preparing HD. Spills of
HD must be cleaned specific to the environment in which the spill occurred and placed in a HD-
specific waste receptacle, which is usually yellow. OSHA requires pharmacies to maintain, either
physically or electronically, a Safety Data Sheet for all potentially hazardous chemicals and
medicines stored and used in the workplace. Pharmacies also must have appropriate policies and
training in place for employees who handle HD. OSHA also requires appropriate disposal of biologic
material. This includes soiled gloves, paper towels, dressings, or other soft medical supplies. The
appropriate waste receptacle for biologic materials is a red bag in a box with a biohazard label on it.

CHALLENGE

1. Which of the following attributes is required for a sharps disposal container? (Select all that apply.)
A. Rigid
B. Open top
C. Leakproof
D. Biohazard symbol
E. Clear plastic
A, C, D. Sharps disposal containers should be rigid, leakproof, and have a biohazard label to identify them as
containing biomedical waste. Sharps disposal containers should not have an open top to prevent retrieval of contents
after disposal. Sharps disposal containers are usually red, but should be opaque to obscure contents once disposed.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Laws and Regulations Pertinent to Fraud, Waste, and Abuse

Health care fraud, waste, and abuse are important issues because they have the potential to
increase health care costs without benefiting patient health or outcomes. Health care fraud is the
deliberate attempt to accrue illicit gain from a health care benefit program. It is a federal crime that
can take many forms. Those who commit fraud can face legal challenges under criminal and/or
civil penalties.

Fraud
Types of health care fraud that affect pharmacy practice include submitting a false claim to an
insurer or health care payment company, using someone else’s health insurance card to obtain
coverage for prescription medications, forging or altering prescriptions, stealing and attempting
to fill someone else’s prescription, or selling personal prescriptions to others. Technicians should
report any suspicious activity of this nature to a pharmacist or manager immediately.

In terms of prescriptions themselves, a pharmacist can call the prescriber to verify a prescription’s
validity. If they suspect fraud, they can refuse to fill the prescription, alert local law enforcement,
and use the government’s reporting system. Asking to see the customer’s identification might be
enough to deter a person who has fraudulent intent. It is not always easy to detect a prescription
forgery by looking at it, but there are some common indications to look for when a customer
provides a written prescription: lack of accepted medical or pharmacy-related abbreviations, more
than one color of ink on the prescription, the appearance of a photocopied prescription, or incredibly
neat handwriting. Probably the most significant clue is a prescription that instructs the pharmacy to
dispense an unusually large amount of a medication that has abuse potential. Any visible alteration
in the quantity to dispense may be another indication of fraud.

Become familiar with the community you serve, including the prescribers. Patients who use the
pharmacy regularly are unlikely to attempt to defraud it. Notice and become familiar with the
handwriting and signatures of providers in the area who write prescriptions by hand. The sudden
appearance of new patients and new prescribers should always increase your awareness and caution
in scrutinizing these prescriptions.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Waste
Waste within the profession of pharmacy is related to inefficiencies within the system that lead to
dispensed medications going unused or unnecessary costs associated with medication dispensing.
There are many reasons for this waste. They can include patient nonadherence, dispensing a brand
name product unnecessarily, changes in medication therapy regimens, or transitions of care.
The ultimate goal should be to increase patient adherence while minimizing medication waste.
Some solutions include utilizing trial programs for certain medications or medication therapy
management to improve adherence. A technician can reduce waste by attempting to select the least
expensive medication according to the prescription (assuming a brand medication is not required)
and by helping patients improve adherence. They can help with adherence by assessing refill
history, suggesting adherence aids, or asking if there are any barriers to taking their medications as
prescribed.

Abuse
Medication abuse within health care can come in several different forms. With regard to medical CHALLENGE
billing, it can entail billing for unnecessary medical services or charging excessively for services.
1. What is wrong with
Activities such as using illegal substances, taking prescription medications differently than submitting the brand name
prescribed, or taking OTC medications in a different method than instructed or for alternative uses, medication to insurance
constitute drug abuse. All states in the U.S., except Missouri, have prescription drug monitoring while dispensing the
programs that track controlled prescription medications dispensed within that state. Pharmacies generic version?
Submitting a brand name
can use this tool to identify cases of diversion, abuse, or fraud.
product to insurance while
dispensing the generic
In that vein, and related to drug diversion, the CDC created the Opioid Rapid Response Program to version is a form of fraud.
reduce the risk of overdose deaths. Patients taking controlled substances chronically with a sudden The pharmacy will get paid
by the insurance company
discontinuation of their supply due to law enforcement action are at a high risk for overdose death
for dispensing the brand
or other negative health outcomes such as withdrawal. The Opioid Rapid Response Program works in name medication but
all 50 states and aims to minimize interruption in therapy due to health care facility closure, will incur the cost of the
cheaper generic version.
prescriber-patient relationship discontinuation, pharmacy closure, patient incarceration, and more.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Laws and Regulations Pertinent to Recordkeeping and Retention

Original copies of completed prescriptions must be filed and stored. Generally, the prescription
label is placed on the back of the original prescription and kept in a filing method where the
unique prescription number is in numerical order. Electronic prescriptions may be filed and stored
electronically. In most cases, original prescriptions, either physical or electronic, must be kept for a
minimum of 2 years. This duration may vary by state.

Pharmacies refer to patients’ records as “patient profiles.” Patient profiles are required under
OBRA and contain valuable health care information that helps pharmacists ensure proper use
of prescription medications and appropriate billing. Profiles also provide patients with records CHALLENGE
of expenditures for medications and medical supplies they can use for insurance or income tax
1. Which federal law requires
purposes. Patient profiles should contain the following information.
pharmacies to create and
⦁ Demographics (name, address, telephone numbers, date of birth, sex) maintain patient profiles?
A. CSA
⦁ Social Security number
B. CMEA
⦁ Medication or prescription history C. HIPAA
D. OBRA
⦁ Medication allergies and intolerances
D. OBRA requires pharmacies
⦁ Chronic conditions or diseases to keep patient profiles. The
CSA regulates the manufacture,
⦁ Insurance information import, possession,
use, and distribution of
⦁ Any other patient notes or preferences medications and substances
that have the potential for
abuse and physical and/or
The medication history section of a patient profile contains prescription refill history. This is useful psychological dependence.
for detecting nonadherence and checking for medication interactions. Selecting the correct profile The CMEA regulates the sale of
for each patient is critical. For example, the pharmacy might have records on several people with the methamphetamine precursors.
HIPAA requires many
same or similar names. Generally, verifying a date of birth or address will identify the correct responsibilities surrounding
patient. the security of patients’ PHI.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

CONTROLLED SUBSTANCES
There are several federal laws and regulations that direct the prescribing and dispensing of
controlled substances. Plus, each state has its own laws surrounding controlled substances.
Technicians should be familiar with the requirements controlling these heavily regulated substances
for many reasons, including public safety. This lesson covers the Controlled Substance Act (CSA) and
schedules, DEA registration, and the proper ways to fill, dispense, record, inventory, dispose of, and
otherwise oversee prescriptions for controlled substances.

Controlled Substance Act

The CSA regulates the manufacture, import, possession, use, and distribution of medications
and substances that have the potential for abuse and physical and/or psychological dependence:
controlled substances. The agency within the federal government that classifies controlled
substances and enforces the provisions of the CSA is the DEA, a branch of the Department of Justice.

CSA Schedules
Controlled substances such as opioids, narcotics, amphetamines, sedatives, and barbiturates have
significant potential for abuse. The CSA categorized drugs identified as controlled substances into
five groups or schedules. The schedules use the letter C plus Roman numerals as a symbol in their
designation of each substance’s potential for abuse or addiction.

Schedule I (C-I) includes drugs that have a high potential for abuse and have no generally
accepted medical uses. They are illegal. Providers do not prescribe them, and pharmacies do
not stock or dispense them. Examples include heroin, mescaline, peyote, and lysergic acid
diethylamide. Cannabis is a C-I drug, even though many states allow its distribution for medical or
recreational purposes.

Schedule II (C-II) includes medications that have both a medical use and a high potential for
abuse. Their use can lead to psychological and physical dependence. Examples include morphine,
methadone (Methadose), oxycodone (Oxaydo), hydromorphone (Exalgo ER), hydrocodone, fentanyl
(Duragesic), methylphenidate (Daytrana), and amphetamines.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

Schedule III (C-III) includes medications that have a medical use and have a lesser chance of abuse
than those in Schedules I and II. They have a moderate potential for physical dependence and a high
potential for psychological dependence. Examples include ketamine, acetaminophen with codeine
(Tylenol-Codeine), and anabolic steroids such as testosterone.

Schedule IV (C-IV) includes medications that have a medical use and low potential for abuse and
dependence. Examples include phenobarbital (Luminal), zolpidem (Ambien), eszopiclone (Lunesta),
tramadol (Ultram), and benzodiazepines such as lorazepam (Ativan).

Schedule V (C-V) includes medications that have a medical use, contain limited quantities of
opiates, and are used as antidiarrheals or antitussives. They have a low potential for abuse and
limited risk of dependence compared to the other schedules. Examples include diphenoxylate with
atropine (Lomotil), guaifenesin with codeine (Guaiatussin AC), pregabalin (Lyrica), and promethazine
with codeine.

CHALLENGE

1. Match the schedule classification in the right column to the correct description in the left column.
A. High potential for abuse and psychological and physical 1. C-V
dependence; accepted medical use 2. C-I
B. Low potential for abuse and dependence; accepted 3. C-III
medical use
4. C-II
C. Low potential for abuse and limited risk of dependence;
accepted medical use 5. C-IV
D. Lesser chance of abuse than C-I substances; moderate
potential for physical dependence and high potential for
psychological dependence; accepted medical use
E. High potential for abuse and psychological and physical
dependence; no accepted medical use
C-V: Low potential for abuse and limited risk of dependence; accepted medical use. C-I: High potential for abuse and
psychological and physical dependence; no accepted medical use. C-III: Lesser chance of abuse than C-I substances;
moderate potential for physical dependence and high potential for psychological dependence; accepted medical
use. C-II: High potential for abuse and psychological and physical dependence; accepted medical use. C-IV: Low
potential for abuse and dependence; accepted medical use. The DEA sets scheduling parameters for controlled
substances. C-I medications have no medical use. The potential for abuse and dependence is reduced in descending
classifications. Substances that have a high potential for abuse and psychological and physical dependence but
are accepted medical use are C-II substances. Substances with a low potential for abuse and dependence and
that are accepted for medical use are C-IV substances. Substances with a low potential for abuse and limited risk
of dependence and that are accepted for medical use are C-V substances. Substances with a lesser chance of
abuse than C-I substances and a moderate potential for physical dependence and high potential for psychological
dependence and that are accepted for medical use are C-III substances. Substances with a high potential for
abuse and psychological and physical dependence and are not accepted for medical use are C-I substances.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Laws, Regulations, and Controlled Substances

DEA Registration
The CSA mandates that anyone who manufactures, distributes, prescribes, researches, imports, DEA registry number.
exports, or dispenses controlled substances register with the DEA. Registration includes a unique Registration number issued
DEA registry number. This must accompany all prescriptions for controlled substances. When a by the DEA to prescribers,
technician receives a prescription for a controlled substance, they should check that the prescriber’s pharmacies, and manufacturers
DEA number is valid. A valid DEA number consists of two letters and seven digits, one of which is a who prescribe, dispense, and
check digit. The check digit is the last numeral of a DEA number used to corroborate the result of produce controlled substances.
the math equation applied to the first six numerals described in that section.

The first letter is a code that identifies the type of registrant and can be A, B, F, M, or X. The second
letter is the first letter of the registrant’s last name. There are some exceptions to this rule. For
example, a prescriber who changes their last name might retain their old DEA number. Take the
following steps to verify a DEA number.

⦁ Add the first, third, and fifth digits of the DEA number.

⦁ Add the second, fourth, and sixth digits, and multiply the sum by two.

⦁ Add the results of the previous two steps.

⦁ Check that the last digit of this sum is the same as the last digit of the DEA number.

For example, a prescriber whose last name is Smith has the DEA number AS4967432. The first
letter of the DEA number identifies their registrant type. The second letter is the first letter of their
last name.

⦁ The sum of the first, third, and fifth numbers is: 4 + 6 + 4 = 14.

⦁ The sum of the second, fourth, and sixth numbers is: 9 + 7 + 3 = 19. Then doubling it is:
19 × 2 = 38.

⦁ The sum of the previous two steps is: 14 + 38 = 52.

⦁ The last digit of the final sum matches the last digit of the DEA number, 2. Dr. Smith’s DEA
number is valid.

Manufacturers who produce controlled substances and pharmacies that dispense controlled
substances must register with the DEA and obtain a DEA registry number, as well.

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 Laws, Regulations, and Controlled Substances

Inpatient Pharmacies
Inpatient pharmacies and providers must follow many of the same laws regarding dispensing and
prescribing controlled substances. Pharmacies and prescribers still must obtain a DEA registry
number. One major difference is that a DEA registry number does not need to accompany a
prescription for a controlled substance in the inpatient setting. The hospital or health system keeps
the prescribers’ DEA number on file.

Prescription Verification
Upon receipt of a prescription for a controlled substance, check that all the components that the
law requires are present on the prescription. Besides the essential components of any prescription
(medication name, strength, dosage form, route, dosage, directions for use, amount to dispense), the
CSA explicitly requires the following components.

⦁ Patient’s full name and full street address

⦁ Prescriber’s name, address, telephone number, and DEA registry number (not needed in
inpatient setting)

⦁ Date the prescriber issued the prescription

⦁ Number of refills

⦁ Prescriber’s signature

Technicians are on the front line of receiving controlled substance prescriptions. Because of
the high rates of abuse of these medications’, they are often the prescriptions that are forged or
altered. Stolen prescription pads, forged physician names and DEA numbers, or altered office phone
numbers are some of the ways counterfeit prescriptions may present. The important first step if a
technician suspects a stolen, altered, or forged prescription is to immediately bring the concern to
the pharmacist.

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 Laws, Regulations, and Controlled Substances

Filling Prescriptions for Controlled Substances

The ability of certain prescribers (physician assistants, nurse practitioners, optometrists) to
write prescriptions for controlled substances varies from state to state. The category of controlled
substance or quantity prescribed may be restricted. If there are questions about the ability of a
prescriber to write for a certain controlled substance, please ask a pharmacist.

C-II
C-II prescriptions and their respective medications are the most highly regulated substances with
an accepted medical use. Refills are not allowed for C-II prescriptions, though physicians can
provide three separate prescriptions to cover a maximum 90-day supply. Generally, prescribers
write on the latter two prescriptions, “Do not fill until x date,” which is 30 and 60 days after
prescription issuance.

Emergency and Partial Refills

C-II medications may be filled on an emergency basis, but there are multiple requirements to be
met for this practice to be legal, and these requirements are generally met by the pharmacist.
Partial refills are allowed if the entire quantity is not available at the time of dispensing, but the
pharmacy must dispense the remainder within 72 hours (about 3 days). If the remainder is not
dispensed within 72 hours, the prescription expires, and the pharmacist must contact the prescriber.
In July 2016, the Comprehensive Addiction and Recovery Act was signed into law to combat the
opioid epidemic. One of the changes in the law is to permit partial fills on C-II medications
(disregarding the 72-hour rule) if requested by the patient or prescriber. In this circumstance,
partial fills are allowed if state law does not prohibit partial fills of C-II medications; the total
quantity dispensed over all partial fills does not exceed the original quantity prescribed; and the
partial fill is not dispensed later than 30 days after the original prescription was written.

CII Prescription Formats

In general, state law dictates how long a prescription for a C-II medication is valid before expiration.
Federal law allows faxing and calling in prescriptions for residents in long-term care facilities, for
hospice patients, and for parenteral narcotics from a home-infusion pharmacy. In those cases, the
prescriber must send the original prescription within 7 days. A C-II prescription can also be called or
faxed to a pharmacy to expedite a fill. However, the original prescription should be presented to the
pharmacy and compared to the telephone or faxed copy at the time of dispensing. C-II prescriptions
cannot be transferred to another pharmacy.

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 Laws, Regulations, and Controlled Substances

C-III and C-IV

Prescribers can submit C-III and C-IV prescriptions by telephone, fax, or electronically. Refills are
allowed for these medications five times within 6 months from the prescription’s date of issue.
Partial filling is allowed such that the partial quantity dispensed is written on the prescription,
and the remainder is filled within 6 months. Patients can transfer these prescriptions to another
pharmacy, but only once. If a prescription is transferred, the original pharmacy will document
and cancel that original prescription specifying that it was transferred to a receiving pharmacy.
The receiving pharmacy also notes that this is a transfer so that further transfers are not allowed.
Pharmacists handle the transfers of controlled substances.

C-V and Behind-the-Counter Products

C-V medications are often termed “exempt controlled substances.” Laws regarding the need for
a prescription and refills are often determined by state law. Some of the medications may be OTC
products that are kept behind the counter (BTC) because the federal government regulates the sale
of these products. Specifically, CMEA is a federal law that regulates retail sales of OTC products
that contain ephedrine, pseudoephedrine, or phenylpropanolamine. Individuals can use these
medications to make methamphetamine because they are chemical precursors. As a result of this
law, these products are kept BTC or in a locked cabinet, and they are subject to the following sales
restrictions.

⦁ Customers must show photo identification.

⦁ The technician must document the purchaser’s name and address, the date and time of the sale,
and the quantity sold.

⦁ The total amount of sales must not exceed 3.6 grams per day or 9 grams per 30 days.

⦁ The pharmacy must keep an electronic or bound book log of sales. Records are to be kept for
2 years, or longer if dictated by state law.

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 Laws, Regulations, and Controlled Substances

Electronic Prescriptions and Mailing Controlled Substances

The DEA grants prescribers the option to send electronic prescriptions for controlled substances,
including C-II medications. Prescribers and pharmacies must use software applications that have
been approved by the DEA. More recently, some states have enacted laws that require prescribers to
electronically prescribe controlled substances. This means pharmacy staff may not accept physical
prescriptions unless certain exclusion criteria are met according to the individual state law. In
addition, all controlled substances are allowed to be mailed as long the outer container does not
describe its contents, and the inner container is labeled with the name and address of the pharmacy.

CHALLENGE

1. Which of the following circumstances may be a sign that a controlled substance prescription has been
forged or altered? (Select all that apply.)
A. The prescription is from an out-of-state doctor.
B. The prescriber’s telephone number is handwritten on a pre-printed script pad.
C. The prescription is presented to the pharmacy 3 days after it was written.
D. A patient brings in different controlled substance prescriptions written on consecutive days.
E. A patient brings in three prescriptions for morphine that are to be filled consecutively at
30-day intervals.
B, D. Prescriptions from out-of-state doctors are legal. If there are concerns, it may be appropriate to
call the office to verify validity. Utilizing an altered or forged prescriber office number may indicate
fraudulent prescription. A slight delay from prescription origination to pharmacy presentation is
not a concern for an altered or forged prescription. Prescriptions written on consecutive days may
indicate a stolen prescription pad and thus illegitimate prescriptions. Since C-II medications cannot
be refilled, this is a legitimate way to prescribe C-II medications without monthly office visits.

2. Which of the following is the maximum amount of pseudoephedrine a patient may purchase in a day?
A. 1 gram
B. 3,600 milligrams
C. 5 grams
D. 9,000 milligrams
B. The CMEA limits daily purchase amounts for pseudoephedrine to a maximum of 3.6 grams (3,600 milligrams).

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 Laws, Regulations, and Controlled Substances

Pharmacy Obligations Under CSA

The DEA enforces specific protocols when pharmacies order, distribute, dispose of, and take
inventory of controlled substances. Orders may be sent either electronically or on paper. To order
C-II medications on paper, pharmacists must use DEA Form 222. This is a triplicate form and needs
to be signed by the pharmacist on the DEA registration or assigned power of attorney. The first copy
goes to the supplier, the second goes to the DEA, and the third stays in the pharmacy. When the
pharmacy receives the shipment, the pharmacist must note on the third copy the amount and date
they received it and retain that copy for 2 years. C-III through C-V medications do not require this
form. Another option is to use the electronic DEA Controlled Substance Ordering System (CSOS). The
system allows pharmacists to order C-II medications on an electronic Form 222 and sign with an
online certificate. The electronic system enables pharmacies to receive controlled substances more
quickly; a Form 222 is only valid for 60 days once written.

Disposal or Theft of Controlled Substances

If a pharmacy must dispose of a controlled substance, the pharmacist must fill out and submit
DEA Form 41. Medications may need to be disposed of if they are expired, damaged, or unused.
Pharmacies can dispose of them by returning them to the manufacturer, wholesaler, or a reverse
distributor service.

To report the loss or theft of a controlled substance, the pharmacist uses DEA Form 106. The
pharmacist is responsible for matters (documentation, communication) related to theft, but a
technician may be involved in information gathering, such as how many tablets of the medication
were in stock and how many were left after the theft.

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 Laws, Regulations, and Controlled Substances

Inventory of Controlled Substances Case Study: Controlled

Pharmacies must perform an inventory of controlled substances every 2 years after their initial Substances, Part 4
inventory. This helps ensure accurate and complete records of their entire stock of controlled
The technician concludes that this is most
substances. They must keep these records for 2 years at the location that appears on the DEA likely a fraudulent prescription. They stop
registration. Most pharmacies inventory their controlled substances more often than federal law the order entry process and rely on what
requires and should always have an accurate on-hand inventory. The DEA requires pharmacies to they’ve been trained to do if they have
list exact amounts of C-II substances in their inventories, but they may estimate inventories of concerns about a prescription potentially
being fraudulent.
C-III through C-V medications. When a technician fills a prescription for a C-II medication, they
update the perpetual inventory log of the medication they used with how many they removed 1. What other check can they complete with
and the remaining quantity. The pharmacist will double-check the perpetual action on the
information on the prescription to verify
the validity of the prescriber, and what
perpetual inventory log to ensure accuracy. should they do with their concern of the
fraudulent prescription?
The technician can check the validity of the
Dispensing Controlled Substances DEA registry number on the prescription.
Regardless, they should immediately relay
Physical prescriptions for C-II medications, and the subsequent record of dispensing, must be their concern and findings to the pharmacist.
filed separately from other medications. The pharmacy may file records for C-III through C-V
medications with non-controlled prescriptions if a red “C” is stamped on the prescription for
controlled substance prescriptions, or a pharmacy can create a third prescription file that separates
C-III through C-V and non-controlled substance prescriptions.

CHALLENGE
Lending Controlled Substances 1. What methods can be used to
Pharmacies may lend C-II through C-V controlled substances to one another if the following order C-II medications from a
distributor? (Select all that apply.)
criteria are met.
A. Telephone
⦁ Both pharmacies must be registered with the DEA. B. Electronically (CSOS)
⦁ A DEA Form 222 is used to document the exchange, listing the drug name, dosage form, C. Fax
and quantity. D. Paper order
B, D. Electronic ordering via CSOS and
⦁ The name, address, and DEA registry number are listed on the form, specifying which paper ordering via DEA Form 222 is
pharmacy is sending and which is receiving the medication. allowed by the CSA. Orders via telephone
and fax are not allowed by the CSA.
⦁ The total quantity transferred cannot be greater than 5% of the total dosage the sending
pharmacy receives in a calendar year. In other words, if a pharmacy receives a total of
1,000 tablets of oxycodone 5-mg tablets in a calendar year, it may not lend more than 50 tablets
(5%) to other pharmacies in that year.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

MEDICATION CLASSIFICATIONS Professionalism Tip:

Pharmacy technicians do not need to know everything about every medication the pharmacy Reliability
dispenses. They should, however, have a good overall knowledge of the most common medications
A pharmacy technician can
that patients use, what they are used for, and how patients might react to them. Technicians demonstrate reliability by
respond to simple patient questions that do not require clinical judgment and either direct patients providing consistent accuracy
to the type of products they are seeking or alert the pharmacist to the need to discuss more in their work, being punctual,
and being counted on for
complex issues. Understanding common medications—both legend and over-the-counter (OTC)—
completing tasks and resolving
and classifications, dosage forms, routes of administration, indications for use, mechanisms of issues. An example is when a
action, brand and generic names, incompatibilities, interactions, and immunizations, will help the pharmacy technician is always
technician flourish in any pharmacy setting. on time for shifts, regularly
manages medication inventory
Many websites, journal articles, and textbooks offer lists of the top 100 or 200 medications. Keep in without error, and is trusted by
a pharmacist to handle complex
mind that some of these lists change yearly or every few years, and different sources have different
insurance claim issues efficiently.
rankings of these medications. Look for the most recent date and a credible source when browsing
these lists. Learn the most common medications used by the patient population in the local area.
This lesson will list the top 10 medications prescribed. It will then cover medication classifications
by action and body system along with the concept and
use of biosimilars. The lesson will conclude by exploring Case Study Instructions
dosage forms, routes of administration, and medication
indications. Read the following case study and use the information provided in the chapter to
answer the follow-up question related to the scenario.

Top 10 Medications Prescribed

Becoming familiar with the medications that providers Case Study: Biosimilar Medications
most often prescribe is a good place to start. In
fact, many pharmacies have a shelf of “fast mover” Sima is a technician working in an independent pharmacy. A known patient presents a
prescription for insulin glargine-aglr (Rezvoglar). The patient was previously prescribed
medications. These are medications most dispensed insulin glargine (Lantus). Sima asks the pharmacist if this new prescription is the same as
from a particular pharmacy and are kept in an accessible Lantus, and they explain that this prescription is for a biosimilar product. The pharmacy
location away from the other prescription medication does not stock this specific product, but they are able to dispense an interchangeable
inventory. This improves the efficiency of the filling product, insulin glargine-yfgn (Semglee). The dose and directions are the same for this
new prescription.
process. The following table displays a top 10 list
published in a major pharmaceutical journal from 2018 1. Can insulin glargine be dispensed without a prescription?
that compiles information from multiple sources based No. Insulin glargine is a prescription-only medication (legend drug). Only insulin
regular and insulin isophane (NPH) may be dispensed without a prescription.
on number of prescriptions. This snapshot also indicates
medication classifications.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

TABLE 3.1 Top 10 Prescribed Medications in the U.S.

GENERIC NAME BRAND NAME CLASSIFICATION

Lisinopril Zestril Antihypertensive, ACE inhibitor

Levothyroxine Synthroid Thyroid hormone
Atorvastatin Lipitor Antihyperlipidemic, statin (HMG-CoA reductase inhibitor)
Metformin Glucophage Antidiabetic, biguanide
Simvastatin Zocor Antihyperlipidemic, statin (HMG-CoA reductase inhibitor)
Omeprazole Prilosec Acid reducer, proton pump inhibitor
Amlodipine Norvasc Antihypertensive, calcium channel blocker
Metoprolol Lopressor, Toprol XL Antihypertensive, beta-blocker
Acetaminophen Norco, Lortab Opioid analgesic
with hydrocodone
Albuterol Proair, Proventil, Ventolin Bronchodilator, beta-2 agonist

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

CLASSIFYING MEDICATIONS
There are multiple ways medications can be classified, but generally there are three classifications
that are used to encompass all medications. The first two classifications are relatively similar, with
some subtle differences. They are described as classifications by action. The third is classification by
body system. It is important to become familiar with the most common medication classifications
and gain a working knowledge of what common medications fit into those classifications.

Classifications by Action
The first category of classification by action is by a medication’s mechanism of action within the
body. For example, metoprolol (Lopressor, Toprol XL) is a beta-blocker. In the body, metoprolol
blocks the activity of the beta receptors, leading to decreased heart rate and blood pressure. When
the mechanism of action is not well understood, or the mechanism description is extensive, a
colloquial term, sometimes related to the chemical structure of a class of medications, stands
in for the classification. The classification of macrolides is one example of this, where the term
“macrolides” represents a class of antibiotics that share a macrocyclic lactone ring in the structure.

The second way a medication can be classified by action is through its therapeutic indication.
The therapeutic indication describes the condition or disease a medication is meant to treat. For
metoprolol, because it can treat hypertension by lowering it, it falls within the therapeutic indication
class of antihypertensive.

Just because two medications are in the same class does not mean that they are therapeutically
equivalent and interchangeable. Therapeutic equivalence means two medications:

⦁ are bioequivalent.

⦁ have the same clinical effect on the body.

⦁ have the same safety profile when used as directed on the approved labeling.

⦁ contain the same chemical compound.

⦁ are prepared in the same dosage form.

⦁ when taken at the same dose, distribute in the body at the same site of action.

The Orange Book is the reference to use when determining whether two medications are
therapeutically equivalent.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

Classification by Body System

The third classification is by the body system on which the medication exerts its effects. Metoprolol,
a beta-blocker and antihypertensive, exerts its effects on the cardiovascular system. The
cardiovascular system includes the heart and blood vessels. Some medications belong to more than
one body system classification. Furosemide (Lasix) is a loop diuretic that exerts its primary effects
within the kidney (renal system). It also has secondary cardiovascular system effects because it
treats heart failure and hypertension. Additionally, it helps reduce excess fluid from the lungs, so it
indirectly affects the respiratory system.

The following tables list common classifications with an example of each. These lists of
classifications are not all-inclusive, and classification systems are not consistent across all sources.
It’s also important to note that many medications fit into multiple classifications. The Medication
Classifications by Action table provides examples of medication classifications by action. The
Medication Classifications by Body System lists some classifications by body system.

TABLE 3.2 Medication Classifications by Action

CLASSIFICATION BY THERAPEUTIC
MECHANISM OF ACTION INDICATION GENERIC NAME BRAND NAME

ACE inhibitor Antihypertensive Captopril Capoten

Opioid receptor Opioid reversal/antidote Naloxone Narcan
antagonist
Macrolide Antibiotic Azithromycin Zithromax
Vitamin K antagonist Anticoagulant Warfarin Coumadin
Insulin Antidiabetic Insulin glargine Lantus, Toujeo, Basaglar
Benzodiazepine Anxiolytic Clonazepam Klonopin
SSRI Antidepressant Fluoxetine Prozac
Cephalosporin Antibiotic Cephalexin Keflex
5-HT3 (serotonin) Antiemetic Ondansetron Zofran
receptor antagonist
Azole Antifungal Fluconazole Diflucan

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

TABLE 3.2 Medication Classifications by Action

CLASSIFICATION BY THERAPEUTIC
MECHANISM OF ACTION INDICATION GENERIC NAME BRAND NAME

H2 blocker Acid reducer Famotidine Pepcid

Novel oral anticoagulant Anticoagulant Apixaban Eliquis
Beta-blocker Antihypertensive Metoprolol Lopressor
Bisphosphonate Bone resorption Alendronate Fosamax
inhibitor
Beta-2 agonist Bronchodilator Albuterol ProAir
Calcium channel blocker Antihypertensive Nifedipine Procardia
Corticosteroid Anti-inflammatory Prednisone Deltasone
Fluoroquinolone Antibiotic Ciprofloxacin Cipro
Estrogen Female sex hormone Estradiol Estrace
Proton pump inhibitor Acid reducer Pantoprazole Protonix
Sulfonylurea Antidiabetic Glipizide Glucotrol
Statin Antihyperlipidemic Simvastatin Zocor
Cyclooxygenase-2 Analgesic Celecoxib Celebrex
inhibitor/NSAID
Opioid receptor agonist Analgesic Oxycodone Roxicodone
Z-drug Sedative-hypnotic Zolpidem Ambien
Thiazolidinediones Antidiabetic Pioglitazone Actos
Triptan Migraine abortive Sumatriptan Imitrex

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

TABLE 3.3 Medication Classifications by Body System

CLASSIFICATION BY BODY/SYSTEM
BODY SYSTEM COMPONENTS GENERIC NAME BRAND NAME

Cardiovascular Heart and blood vessels Digoxin Lanoxin

Endocrine Glands, hormones, and Insulin glargine Lantus, Toujeo, Basaglar

receptors
Gastrointestinal Stomach, intestine, and Sucralfate Carafate
colon
Hematologic Blood and bone marrow Enoxaparin Lovenox
Immune Immune cells and Oseltamivir Tamiflu
lymphatic system
Integumentary Skin Isotretinoin Accutane
Musculoskeletal Bones, muscles, and Indomethacin Indocin
connective tissue
Nervous Brain and spinal cord Donepezil Aricept
Urinary Kidney, ureter, and Tamsulosin Flomax
bladder
Reproductive Hypothalamus, gonads, Leuprolide Lupron
uterus, and genitals
Respiratory Upper airway and lungs Salmeterol Serevent

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

Biologics and Biosimilars

Biologic medications, or biologics, are distinct from other prescription medications due to their large
and complex molecular size. Biologics are made by using living organisms (bacteria, yeast, animal
cells) rather than synthetic chemicals. It is difficult to classify biologics because they often contain
complex mixtures that are not simply characterized. All biologics are approved for safety and
efficacy by the FDA. One example of a biologic is insulin glargine, a subcutaneously administered,
injectable solution used to treat diabetes mellitus.

Biosimilars are therapeutically equivalent biologics that also undergo testing and FDA approval for
safety, effectiveness, and quality. Biosimilars are akin to generic (called biosimilar in this case)
versions of biologics, and, like generic versions of brand name (called reference product in this
case) prescription medications, they are generally less expensive. Biosimilars are produced in the
same living organism, administered the same way, utilize the same dose, and are expected to have
the same clinical benefit and side effect and adverse medication reaction profile as the reference
product. The reference product is the original product the biosimilar is based on. In the example
above, insulin glargine is the reference product, and insulin glargine-yfgn is the biosimilar. Most
biosimilar products will have four lowercase letters after the name for clarity and safety purposes.
Exceptions to this include biologics approved by the FDA before implementing this naming
convention. Biologics and biosimilars, therapeutic equivalence, or interchangeability, are determined
by the FDA and published in the Purple Book.

Pharmacies may dispense biosimilars if a provider prescribes the reference biologic if they meet two
conditions. First, the dispensed biosimilar must be interchangeable with the reference product, and CHALLENGE
second, state law must allow the substitution. “Interchangeable” is a special designation granted by
the FDA during the approval process. To identify whether products are interchangeable, the FDA 1. What is the therapeutic
indication and body system
publishes the Purple Book, which lists all biologic products, reference products, biosimilars to the classification of insulin
reference products, and whether the biosimilars are interchangeable. To continue with the example, glargine?
another biosimilar, insulin glargine-aglr, is a biosimilar to insulin glargine and is also The therapeutic indication
interchangeable to insulin glargine-yfgn. Therefore, if a patient presents a prescription for insulin is antidiabetic, and the
body system classification
glargine-yfgn, but the pharmacy only stocks insulin glargine-aglr, it is appropriate to dispense is the endocrine system.
glargine-aglr. Each state has its own laws regarding biosimilar prescribing and dispensing, so it is
important to be aware of these laws.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

MEDICATION INDICATIONS
The FDA approves medications to treat a specific disease or multiple diseases. This is specified
on the medication’s approved product labeling and is called the medication’s indication, labeled
indication, or labeled use. Medications are often used to treat diseases that aren’t FDA-approved.
This is called off-label use and is an accepted medical practice. Prescribers have the authority to
prescribe medications off-label if they feel it would benefit the patient. An example of this is the use
of ivermectin (Soolantra, Sklice, Stromectol) to treat scabies.

Common Legend Medications

It will take experience to become familiar with the indications for all the medications the pharmacy
typically dispenses, as there are thousands of prescription medications in the U.S. The following
table lists common prescription medications and their indications. The most common prescriptions
vary by location, so technicians will likely become familiar with the medications prescribed most
frequently in their locale.

TABLE 3.6 Common Medications and Indications

GENERIC NAME BRAND NAME INDICATIONS

Haloperidol Haldol Schizophrenia

Insulin glargine Lantus, Toujeo, Basaglar Type 1 and type 2 diabetes
Levothyroxine Synthroid Hypothyroidism
Hydrochlorothiazide Microzide Hypertension, edema
Lithium carbonate Lithobid Bipolar disorder
Lorazepam Ativan Anxiety
Metformin Glucophage Type 2 diabetes
Memantine Namenda Alzheimer’s disease
Methylphenidate Ritalin ADHD, narcolepsy
Montelukast Singulair Asthma, allergic rhinitis
Ondansetron Zofran Nausea, vomiting

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

TABLE 3.6 Common Medications and Indications

GENERIC NAME BRAND NAME INDICATIONS

Omeprazole Prilosec Gastroesophageal reflux disease, erosive esophagitis,

gastric ulcer
Pioglitazone Actos Type 2 diabetes
Pregabalin Lyrica Neuropathic pain, fibromyalgia
Quetiapine Seroquel Schizophrenia, bipolar disorder, depression
Metoprolol Lopressor, Toprol XL Hypertension, angina
Rosuvastatin Crestor Hyperlipidemia
Sertraline Zoloft Depression, obsessive-compulsive disorder, panic
disorder, PTSD
Sildenafil Viagra Erectile dysfunction, pulmonary arterial hypertension
Sulfamethoxazole/ Bactrim Multiple bacterial infections
trimethoprim
Tamsulosin Flomax Benign prostatic hyperplasia
Tramadol Ultram Pain
Valsartan Diovan Hypertension, heart failure
Acyclovir Zovirax Herpes and varicella infection
Acetaminophen/ Norco, Lortab Pain
hydrocodone
Allopurinol Zyloprim Gout
Alprazolam Xanax Generalized anxiety disorder, panic disorder
Amitriptyline Elavil Depression
Amlodipine Norvasc Hypertension, angina
Amoxicillin Amoxil Multiple bacterial infections
Aripiprazole Abilify Bipolar disorder, schizophrenia, depression, Tourette’s
syndrome

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

TABLE 3.6 Common Medications and Indications

GENERIC NAME BRAND NAME INDICATIONS

Atorvastatin Lipitor Hyperlipidemia

Azithromycin Zithromax Multiple bacterial infections
Lisinopril Zestril Hypertension, heart failure
Bupropion Wellbutrin Depression, smoking cessation
Cephalexin Keflex Multiple bacterial infections
Ciprofloxacin Cipro Multiple bacterial infections
Citalopram Celexa Depression
Albuterol Proair, Proventil, Ventolin Asthma
Clopidogrel Plavix Acute coronary syndrome, acute ischemic stroke
Cyclobenzaprine Flexeril Muscle spasm
Diazepam Valium Anxiety, seizure, alcohol withdrawal syndrome
Donepezil Aricept Dementia, Alzheimer’s disease
Duloxetine Cymbalta Depression, generalized anxiety disorder, neuropathic
pain, fibromyalgia
Enoxaparin Lovenox Deep venous thrombosis
Escitalopram Lexapro Depression, generalized anxiety disorder
Eszopiclone Lunesta Insomnia
Fluticasone/salmeterol Advair Asthma, COPD

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

ROUTES OF ADMINISTRATION
Medications and their respective dosage forms come in many administration routes. The route of
administration is how the medication is delivered to the body for absorption and distribution to take
place. This discussion begins with the parenteral route and then continues with the enteral route
and other common routes of administration.

Parenteral
The parenteral route of administration mainly refers to IV, IM, intradermal, and subcutaneous.
Administration of these sites relies on injection directly into the body with a needle. Many
medications used in hospitals and stocked in inpatient pharmacies are administered parenterally.
Vaccines stocked and administered in outpatient pharmacies generally utilize the IM route.
Parenteral administration benefits from rapid absorption and onset of action. The downside is that
a needle can cause mild pain and increases the risk of infection. This administration route also has
increased medication cost. Other parenteral administration routes include implants, intra-arterial
(artery), intra-articular (joint), intracardiac (heart), intraperitoneal (peritoneal cavity), intrapleural
(lining of lung), intrathecal (spinal cord), intraventricular (brain), intravesicular (bladder), and
intravitreal (eye).

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TABLE 3.4 Parenteral Routes of Administration

ROUTE-SPECIFIC
ROUTE LOCATION INFORMATION

intravenous Major veins, most often IV push for rapid

in the arms and hands, or administration or continuous
epidermis via central venous access infusion of medication
devices
dermis

hypodermis/
subcutaneous
muscle

intramuscular Deltoid, vastus Slower absorption than IV

lateralis, ventrogluteal,
epidermis dorsogluteal muscles CHALLENGE

dermis 1. Match the injection site location

in the right column to the correct
hypodermis/ parenteral route of administration in
subcutaneous the left column.
muscle A. IV 1. Under the
B. Subcutaneous skin
intradermal Top layer of skin Route used for allergy and C. Intradermal 2. Top layer of
tuberculosis testing skin
D. IM
epidermis 3. Deltoid,
vastus
dermis lateralis,
ventrogluteal,
hypodermis/ dorsogluteal
subcutaneous
muscles
muscle
4. Large veins
usually in the
subcutaneous Under the skin Slower rate of absorption arm or hand
than IM, able to be self- Under the skin: Subcutaneous. Top layer
epidermis administered (such as insulin), of skin: Intradermal. Deltoid, vastus
able to use a smaller needle, lateralis, ventrogluteal, dorsogluteal
dermis therefore is less painful muscles: IM. Large veins usually in the
arm or hand: IV. Parenteral administration
hypodermis/ routes include IV, IM, intradermal, and
subcutaneous other routes requiring needles.
muscle

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Enteral
Enteral administration usually means medications entering the body through the mouth, orally.
Tablets, capsules, solutions, and suspensions are administered orally. Enteral administration also
includes inserting a tube from the nose (nasogastric) or mouth (orogastric) to the stomach and
gastrointestinal tract to complete the absorption process. A tube called a percutaneous endoscopic
gastrostomy tube can also be placed directly to the stomach through the skin. Some also consider
buccal and sublingual lozenges and tablets to be enterally administered. These dosage forms—
dissolving between the cheek and the tongue and dissolving under the tongue, respectively—are
absorbed into the bloodstream through the mucous membranes rather than through the
gastrointestinal tract.

CHALLENGE

1. Match the enteral route of administration in the left column to the correct administration location in
the right column.
A. Sublingual 1. Mouth
B. Oral 2. Between cheek and gum
C. Buccal 3. Under tongue
Mouth: Oral. Between cheek and gum: Buccal. Under tongue: Sublingual.
There are various dosage forms administered enterally.

Other Routes of Administration

There are other routes of administration with which technicians should be familiar. Many of these
deliver medications locally rather than to the bloodstream. See the following for some additional
routes of administration.

TABLE 3.5 Non-Parenteral, Non-Enteral Routes of Administration

ROUTE LOCATION ROUTE-SPECIFIC INFORMATION

Transdermal Skin Usually applied in the form of a patch; medication travels through the skin
into the bloodstream
Topical Skin Ointments, creams, lotions, emulsions applied to skin for local effects
Inhalation Lung Gas carries medication to the lung, usually via inhaler, and has local effects

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TABLE 3.5 Non-Parenteral, Non-Enteral Routes of Administration

ROUTE LOCATION ROUTE-SPECIFIC INFORMATION

Intranasal Nose Liquid medications sprayed directly in the nostrils for either local or
systemic effects
Ophthalmic Eye Solutions, ointments, suspension, or gels applied directly to the eye for
local effects
Otic Ear Solutions or suspension applied into the ear canal for local effects
Rectal Rectum Solids (suppository), liquids, semi-solids, and aerosols administered for local
or systemic effects
Vaginal Vagina Solutions, suppositories, tablets, creams, and ointments administered for
local or systemic effects

CHALLENGE

1. Match the administration location in the right column to the correct alternative route of
administration in the left column.
A. Inhalation 1. Ear
B. Otic 2. Skin
C. Topical 3. Eye
D. Ophthalmic 4. Lung
Ear: Otic. Skin: Topical. Eye: Ophthalmic. Lung: Inhalation. See the table Non-
Parenteral, Non-Enteral Routes of Administration.

2. What is the route of administration for insulin glargine?

The route of administration for insulin glargine is subcutaneous.

3. What is the description of a biologic?

A biologic is a large, complex molecule made from a living source.

4. What is the description of a biosimilar?

A biosimilar is a biologic made by a different company using the same living organism.
A biosimilar might have slight variations in structure, but these are expected to have no
meaningful difference in safety and efficacy compared to the reference product.

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OTC Products
OTC medications are safe for use by a consumer without a prescription. They still require FDA
approval and have indications or uses listed on the product labeling. It will also take experience to
become familiar with the indications for all the OTC medications the pharmacy sells. The following
table contains many common OTC medications and their indications.

TABLE 3.7 OTC Medications and Indications

GENERIC NAME BRAND NAME INDICATIONS

Acetaminophen Tylenol Fever, pain

Alpha-galactosidase Beano Intestinal gas, bloating
Aspirin Bayer Aspirin, Bufferin, Ecotrin Inflammation, pain, fever
Benzocaine (topical liquid) Anbesol Mouth and/or gum irritation
Bismuth subsalicylate Pepto-Bismol Diarrhea, dyspepsia
Calcium carbonate Tums Indigestion, heartburn, calcium supplement
Carbamide peroxide Debrox Earwax removal
Cetirizine Zyrtec Allergic rhinitis, urticaria
Famotidine Pepcid Heartburn
Dextromethorphan Delsym Cough
Dimenhydrinate Dramamine Motion sickness
Diphenhydramine Benadryl Allergies
Docosanol Abreva Cold sores, fever blisters
Docusate Colace Stool softener
Esomeprazole Nexium Heartburn
Fexofenadine Allegra Upper respiratory allergies
Guaifenesin Mucinex Expectorant
Clotrimazole Desenex Tinea corporis (ringworm), tinea cruris (jock
itch), tinea pedis (athlete’s foot)

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TABLE 3.7 OTC Medications and Indications

GENERIC NAME BRAND NAME INDICATIONS

Ibuprofen Advil, Motrin Fever, headache, sore throat, arthritis,

menstrual pain, dental pain, musculoskeletal
pain, backache, pain due to cold and flu
Lansoprazole Prevacid Heartburn
Lidocaine (topical spray) Solarcaine Sunburn, minor cuts and burns, insect bites
Loperamide Imodium Diarrhea
Loratadine Claritin Hay fever, upper respiratory allergies
Meclizine Bonine Motion sickness, vertigo
Methylcellulose Citrucel Constipation
Minoxidil (topical) Rogaine Alopecia
Naproxen Aleve Fever, arthritis, menstrual pain, backache,
common cold, headache, toothache
Fluticasone (topical spray) Flonase Hay fever, upper respiratory allergies
Omeprazole Prilosec Heartburn
Pheniramine Naphcon-A, Opcon-A Eye itching and redness
and naphazoline
(ophthalmic spray)
Phenylephrine Sudafed PE Nasal congestion
Orthophosphoric acid, Emetrol Nausea
glucose, and fructose
Polymyxin b, bacitracin, Neosporin Infection prevention
and neomycin
Psyllium Metamucil Constipation
Permethrin Rid Head lice, scabies
Benzoyl peroxide Clearasil Acne vulgaris, rosacea

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TABLE 3.7 OTC Medications and Indications

GENERIC NAME BRAND NAME INDICATIONS

Salicylic acid Compound W Dandruff, psoriasis, seborrheic dermatitis,

removal of warts, calluses, or corns
Simethicone Gas-X Gas retention
Tetrahydrozoline Visine Eye redness, irritation
Tolnaftate Tinactin Tinea corporis (ringworm), tinea cruris (jock
itch), tinea pedis (athlete’s foot)
Camphor and menthol Icy Hot Pain
(topical)
Nicotine NicoDerm, Nicorette Smoking cessation

CHALLENGE

1. Match the OTC medication in the right column to the correct 3. Match the indication in the right column to the correct medication in
indication in the left column. the left column.
A. Head lice 1. Nicotine (NicoDerm, A. Earwax removal 2. Bismuth subsalicylate (Pepto-
B. Smoking cessation Nicorette) B. Mouth irritation Bismol)
C. Eye redness, irritation 2. Tetrahydrozoline (Visine) C. Diarrhea 3. Dextromethorphan (Delsym)
D. Warts 3. Salicylic acid (Compound W) D. Cough 4. Carbamide peroxide (Debrox)
4. Permethrin (Rid) 1. Benzocaine (Anbesol)
Nicotine (NicoDerm, Nicorette): Smoking cessation. Tetrahydrozoline Benzocaine (Anbesol): Mouth irritation. Bismuth subsalicylate (Pepto-
(Visine): Eye redness, irritation. Salicylic acid (Compound W): Bismol): Diarrhea. Dextromethorphan (Delsym): Cough. Carbamide
Warts. Permethrin (Rid): Head lice. OTC medications also have peroxide (Debrox): Earwax removal. OTC medications also have
specific indications important for technicians to know. specific indications important for technicians to know.
2. Match the indication in the right column to the correct medication in
the left column.
A. Expectorant 1. Psyllium (Metamucil)
B. Constipation 2. Meclizine (Bonine)
C. Motion sickness 3. Loratadine (Claritin)
D. Allergies 4. Guaifenesin (Mucinex)
Psyllium (Metamucil): Constipation. Meclizine (Bonine): Motion sickness.
Loratadine (Claritin): Allergies. Guaifenesin (Mucinex): Expectorant. OTC
medications also have specific indications important for technicians to know.

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Behind-the-Counter Products
Behind-the-counter medications (BTC) are OTC products that are kept behind the counter prior
to sale per state and federal law. These include cough medicine with codeine, any product with
pseudoephedrine (Sudafed, SudoGest), and regular insulin. Pharmacy staff must adhere to strict
regulations when selling these preparations. The following table contains common BTC medications.

TABLE 3.8 BTC Medications and Indications

GENERIC NAME BRAND NAME INDICATIONS

Pseudoephedrine Sudafed Nasal and sinus congestion

Fexofenadine and pseudoephedrine Allegra-D Seasonal allergic rhinitis
Loratadine and pseudoephedrine Claritin-D Cold and allergy symptoms
Codeine and guaifenesin Cheratussin AC Cough
Codeine and promethazine None Cough
Insulin regular Humulin R Diabetes
Insulin isophane (NPH) Novolin N Diabetes
Insulin regular and insulin isophane (NPH) Humulin 70/30 Diabetes

CHALLENGE

1. Which BTC medication is used to treat diabetes?

Insulin regular (Humulin R), insulin isophane (Novolin N), and combinations of the two
(Humulin 70/30) are BTC medications and have an indication for diabetes.

2. Is insulin glargine-yfgn a prescription medication (legend drug), OTC, or BTC?

Insulin glargine-yfgn is a prescription medication (legend drug). All biologic products are prescription medications.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

FREQUENTLY PRESCRIBED MEDICATIONS

This lesson contains more key classifications and details on prescribed medications. First the lesson
side effect. Unintended
reviews different name classifications of medications: chemical, generic, and brand names. It
positive or negative outcome
follows with a discussion of the risks certain medications carry alone and in combination with one
from a medication.
another, classified as side effects, adverse reactions, and contraindications. Another characteristic of
medications discussed in this lesson is whether they have been compounded. Medications that may adverse reaction. Negative
not be available commercially or in a specific dose may require compounding. This includes outcome from a medication,
nonsterile compounding, generally for non-parenteral administration, and sterile compounding for usually more serious
parenteral administration. The lesson concludes with a discussion of another classification of than a side effect.
medications: vaccines. Vaccines condition the body’s immune system to protect it against specific
pathogens. Technicians play a role in these areas and need to be knowledgeable about them.

Brand and Generic Names

Generally, medications have three different names within their nomenclature. These include a
chemical name (4’-hydroxyacetanilide), generic name (acetaminophen), and brand or trade name
(Tylenol). The chemical name describes its chemical structure. Technicians are less likely to
encounter chemical names. The generic name, or nonproprietary name, is a collaboration between
the FDA and manufacturer. Most medications also have brand names (trade or proprietary names)
that the manufacturers register or trademark to refer exclusively to their product. Some generic
medications have more than one brand name, because more than one manufacturer produces the
product. Ibuprofen, for example, is the generic name for the brand name products Advil and Motrin.
Its chemical name is (±)-2-(p-isobutylphenyl) propanoic acid. Generally, generic names appear in
lowercase letters and brand names have an initial capital letter.

Some medication products are not available as generics but only under the manufacturer’s name.
Manufacturers develop most new products under a patent. Patent protection periods last 17 to 20
years, with additional approval of 5 years if the FDA approves a new indication. Only once a patent
expires can alternative manufacturers produce and sell generic versions of the medication.

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Generics usually cost less than their brand name equivalents. Nevertheless, the FDA requires that a
generic meet the same quality standards as brand name products. Generic medication manufacturers
must demonstrate pharmaceutical equivalence and therapeutic equivalence with the brand name
medication. Pharmaceutical equivalence means same active ingredients, dosage form, route of
administration, and strength. Therapeutic equivalence means the same rate and extent of absorption
of the active ingredients into the bloodstream.

Occasionally, prescribers (or patients) might prefer brand name products over generics when they
feel it is in the patient’s best interests. Otherwise, pharmacists generally prefer to dispense generics
because they save patients money, they help keep pharmacy prices competitive, and insurance
programs often limit coverage of brand name products when there is a generic equivalent. See the
following table to become familiar with common generic medications and their brand names.

TABLE 3.9 Common Generics and Brand Names

GENERIC NAME BRAND NAME INDICATIONS

Carvedilol Coreg Hypertension, heart failure

Clindamycin Cleocin Bacterial infection
Clonidine Catapres Hypertension, ADHD
Enalapril Vasotec Hypertension, heart failure
Fenofibrate Tricor Hyperlipidemia
Fentanyl Duragesic Pain
Fluconazole Diflucan Fungal infection
Glipizide Glucotrol Type 2 diabetes
Latanoprost Xalatan Glaucoma
Losartan Cozaar Hypertension
Meloxicam Mobic Pain, osteoarthritis, rheumatoid arthritis
Pantoprazole Protonix GERD, Zollinger-Ellison syndrome
Paroxetine Paxil Generalized anxiety disorder, major depressive disorder, obsessive-
compulsive disorder, panic disorder, PTSD, premenstrual dysphoric
disorder, social anxiety disorder

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TABLE 3.9 Common Generics and Brand Names

GENERIC NAME BRAND NAME INDICATIONS

Pravastatin Pravachol Hyperlipidemia

Propranolol Inderal Hypertension, angina, cardiac arrhythmias, essential tremor, migraine
prevention, pheochromocytoma
Sitagliptin Januvia Type 2 diabetes
Spironolactone Aldactone Heart failure, ascites, hypertension, hyperaldosteronism
Sumatriptan Imitrex Migraine, cluster headache
Vancomycin Vancocin Bacterial infection
Venlafaxine Effexor Generalized anxiety disorder, major depressive disorder, panic disorder,
social anxiety disorder

CHALLENGE

1. Match the medication brand name in the right column to the correct generic medication name in the
left column.
A. Fenofibrate 1. Vancomycin
B. Vancocin 2. Effexor
C. Venlafaxine 3. Pravachol
D. Pravastatin 4. Tricor
E. Clindamycin 5. Cleocin
Vancomycin: Vancocin. Effexor: Venlafaxine. Pravachol: Pravastatin. Tricor: Fenofibrate. Cleocin: Clindamycin.
Technicians should be familiar with commonly prescribed brand name medications and their generic equivalents.

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Side Effects and Adverse Reactions

Every medication has the potential to cause side effects and adverse reactions. Though in practice
the terms are frequently used interchangeably, for this text, side effects are unintended, usually
known or expected outcomes that do not coincide with the intended therapeutic outcome. It’s
important to note that these occur when a patient is taking the usual therapeutic dosage. Side
effects may be positive or negative. The classic example of a positive side effect is the discovery
that sildenafil (Viagra) assisted with erectile dysfunction as a side effect of its intended indication
for pulmonary arterial hypertension. The key idea here is that this side effect was unintended but
not negative.

By contrast, adverse reactions are undesirable, negative outcomes of medication use, usually more
severe than negative side effects. They are sometimes dangerous and can lead to harmful effects on
the patient. These, too, are present in therapeutic dosages. An example is a hypersensitivity reaction
to sulfonamide antibiotics that can cause severe rash, hives, and airway closure. It is not uncommon
for the terms side effects, adverse reactions, and adverse drug events to be used interchangeably
depending on the setting. It’s important to weigh the severity of the reaction with the therapeutic
intent of the medication when assessing side effects or adverse reactions and continued use of
medications. If a negative side effect or adverse reaction is mild, and the benefit of taking the
medication outweighs the harm caused by the negative side effect or adverse reaction, then (if the
patient is willing) they can continue taking the medication.

See the following table for some examples of common side effects and adverse reactions.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

TABLE 3.10 Side Effects and Adverse Reactions of Commonly Used Medications
GENERIC NAME BRAND NAME SIDE EFFECTS ADVERSE REACTIONS

Acetaminophen Tylenol Skin rash Hepatotoxicity

Baclofen Lioresal Dizziness, drowsiness, Central nervous system effects,
nausea, vomiting withdrawal effects
Clindamycin Cleocin Itching, nausea, vomiting Clostridium difficile infection
Diclofenac Lofena Edema, nausea None
CHALLENGE
Hydroxychloroquine Plaquenil Retinopathy, rash, abdominal Cardiomyopathy, G6PD deficiency,
.
pain, anemia, dizziness, hypoglycemia, myopathy,
headache, fatigue neuropsychiatric effects, QT 1. Match the medication generic name in
prolongation, retinal toxicity the right column to the correct adverse
reaction in the left column.
Lisinopril Zestril Hypotension, dizziness, rash, Acute kidney injury, angioedema,
constipation, diarrhea cough, hyperkalemia A. Blood E. Peripheral
dyscrasias edema
Morphine Duramorph Rash, hypotension, nausea Opioid-induced constipation/ B. Hepatotoxicity 1. Acetaminophen
neurotoxicity/pruritis/respiratory
C. C. difficile 2. Clindamycin
depression/withdrawal
infection 3. Lisinopril
Nitroglycerin Nitrostat Headache, hypotension, None D. Acute kidney 4. Phenytoin
dizziness, dyspnea injury
5. Amlodipine
Phenytoin Dilantin Rash, nausea, constipation, Blood dyscrasias, cardiovascular Acetaminophen: Hepatotoxicity. Clindamycin:
nausea effects, central nervous system C. difficile infection. Lisinopril: Acute
effects, gingival hyperplasia, kidney injury. Phenytoin: Blood dyscrasias.
hepatotoxicity, suicidal ideation Amlodipine: Peripheral edema. It is important
to understand common side effects and
Amlodipine Norvasc Rash, abdominal pain, Peripheral edema adverse reactions that accompany medications.
nausea, fatigue, dyspnea

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

Contraindications and Medication Interactions

Contraindications are situations where a medication should not be used because the risk likely
outweighs the benefit. They exist when a patient is taking multiple medications together or has
a certain disease or condition. A medication interaction occurs when one or more medications
or substances (such as food) are taken together, and the combination affects one or more of the
medications’ intended therapeutic effects. While the pharmacist will review most contraindications
and medication interactions (and adverse effects) with the prescriber and patient, make sure to bring
any such computer alerts or patient concerns to the pharmacist. Any new prescriptions warrant
pharmacist review, especially for patients who take several medications, prescription or OTC.

Contraindications
Contraindications can be relative or absolute. Relative contraindications mean to use extra caution
because the medication has greater risk for a particular patient. Absolute contraindications are
situations where the patient should not take a medication under any circumstances. Consider these
examples: A relative contraindication is a patient taking both aspirin and warfarin (Coumadin)
together due to an increased risk for bleeding. An absolute contraindication for concomitant
medications is for a patient taking simvastatin (Zocor) doses greater than 10 mg if that patient is
also taking diltiazem (Tiazac, Cartia XT, Cardizem CD). Moreover, isotretinoin (Accutane) has an
absolute contraindication for pregnant females, and pseudoephedrine has a relative contraindication
for patients who have hypertension.

Medication Interactions
Medication interactions can lead to negative, neutral, or even positive effects on one of the
medication’s intended therapeutic purposes. Interactions can occur during absorption, distribution,
metabolism, and excretion. There can also be pharmacodynamic interactions where two different
medications have similar effects on the body, producing too much of that effect. Opioids and
benzodiazepines, for example, can both cause respiratory depression and, when given together, can
cause profound respiratory depression.

Absorption interactions generally occur in the gastrointestinal tract and alter the way the body
absorbs a medication. An example is when posaconazole (Noxafil), an antifungal, and an acid-
reducing medication (proton pump inhibitor, omeprazole [Prilosec, Zegerid]) are taken together, the
body does not absorb as much posaconazole.

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Distribution interactions occur when there are changes in protein binding in the blood (albumin)
of one medication due to competition from another medication. When valproic acid and warfarin
are administered together, valproic acid binds to proteins in the blood more, which causes more
warfarin to be in circulation and have stronger therapeutic effects. This can lead to an increase in
INR and increased risk for bleeding.

Metabolism interactions occur because medications can increase or decrease certain enzymes in the
liver that metabolize medications. For example, amiodarone (Pacerone, Nexterone) can decrease the
activity of the enzyme that metabolizes warfarin (CYP2C9, CYP3A4, and CYP1A2). This again can
lead to an increase of warfarin in the body, increased INR, and an increased risk for bleeding.

Excretion interactions take place when a medication interaction has altered the way the kidney
excretes one of the medications. An example of an excretion interaction is when aspirin inhibits the
excretion of methotrexate (Otrexup, Xatmep, Trexall) in the kidney, which can lead to methotrexate metabolite. Administration
toxicity. Note that a medication metabolite is a byproduct of the body metabolizing a medication into route to the ear.
a new material. A metabolite may have various effects like the medication, negative side effects, or
no effect at all.

CHALLENGE

1. What is altered during the excretion stage for excretion medication interactions? (Select all
that apply.)
A. Blood protein
B. Medication
C. Liver enzyme
D. Metabolite
B, D. Medications are altered during excretion medication interactions. Metabolites are altered
during excretion medication interactions. Blood proteins are involved in distribution medication
interactions. Liver enzymes are involved with metabolism medication interactions.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

Preparing Compounds
Compounding is the extemporaneous preparation of nonsterile and sterile medications. It involves
the use of raw ingredients to formulate a medication product that meets the needs of a particular
patient. The term extemporaneous in this setting describes the uniqueness of the dose and/
or dosage form and the idea that the final product is not commercially available. Some reasons
patients use compounded medications are that a manufacturer has discontinued production of a
medication, a patient has an intolerance to an ingredient of commercially available options, or
combining medications or adding flavoring to a medication may improve adherence. Examples of
compounded medications include bioidentical hormone replacement therapy with different dosages
of testosterone or estrogen compounded so that it can be applied as a cream.
standard operating procedures.
A beyond-use date is the expiration date set for a specific compounded medication and is dependent Written guidelines and criteria
on several factors as determined by United States Pharmacopeia 795 (USP 795) guidelines. Each that list specific steps for
compounding pharmacy needs standard operating procedures and a quality assurance program to different competencies.
ensure safe and effective compounded medications.

When assisting with compounding medications, always check for chemical and physical
incompatibilities by looking for clarity, particulate matter, or other unexpected changes to the final immiscibility. Occurs
product. Incompatibilities mean that the pharmacy should not dispense a compound and should when two substances are
instead investigate the cause. Physical incompatibilities include insolubility, immiscibility, not able to combine for a
coagulation, loss of water, and adsorption. Chemical incompatibilities include presence of a homogenous mixture.
precipitate, color change, odor or gas formation, decomposition, and neutralization.

Nonsterile Compounding
Nonsterile compounding refers to the environment in which the compound is prepared. Generally,
nonsterile compounds are administered non-parenterally (oral, topical, rectal). Dosage forms include
capsules, tablets, lozenges/troches, suppositories, solutions, suspensions, emulsions, ointments,
pastes, creams, gels, and powders. Nonsterile compounding standards are set and regulated by USP
795, its National Formulary (USP-NF), and each individual state’s board of pharmacy. Nonsterile
compounding requires specific equipment, such as measuring devices, weighing equipment,
containers, labels, and personal protective equipment (PPE) for employees.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

Sterile Compounding
Sterile compounding refers to preparing (mostly) parenterally administered products in a sterile
environment using aseptic technique. Aseptic technique is the process of compounding in a
controlled environment that minimizes the risk of contamination with microbes or particles.
Sterile compounds include items like IV admixtures and parenteral nutrition solutions. Because
a contaminated sterile product can cause significant harm or death, be sure to take appropriate
care with environment and preparation. The United States Pharmacopeia 797 (USP 797), Good
Manufacturing Practices from the FDA, The Joint Commission, CDC, and American Society of
Health-System Pharmacists all provide guidelines and/or regulations on sterile compounding.
Products requiring sterile compounding receive a grade on their risk of contamination. This grade
determines the storage requirements and the beyond-use date.

Sterile Environment
A sterile environment for sterile compounding preparation must be a class 100 environment (ISO 5)
or less. This means that there can be no more than 100 airborne particles, 0.5 microns or larger, in a
cubic foot of air. Pharmacies create this environment by having pharmacists and technicians work in
a laminar flow hood, vertical flow hood, or a biologic safety cabinet (BSC). The laminar and vertical
flow hoods prefilter to remove large particles in the air. That air then passes through a high-
efficiency particulate air filter that flows over the workstation, providing a sterile environment. The
difference between laminar and vertical flow hoods is the direction of continuous clean air. A BSC
is like a vertical flow hood, except clean air is pulled through vents on the bottom to protect the
employee working in the hood. BSCs are commonly used for preparing chemotherapy agents and
hazardous medications.

Sterile Equipment
Other equipment necessary for sterile compounding, and to maintain a sterile environment, includes
alcohol wipes, needles, syringes, vials, ampules, IV fluid bags, and IV tubing. Sterile compounding
requires appropriate PPE to ensure safety of the employee and the sterile product. PPE for sterile
compounding includes antiseptic hand foam, face mask, head and facial hair covers, gown, shoe
covers, and gloves. These items must also be put on (donned) and removed (doffed) in a particular
order for them and the environment to remain sterile.

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 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

Sterility and Compatibility

Sterility, or lack of microbes, is of primary concern for compounded sterile products. Sterile products tonicity. Amount of solute
are administered in such a way that they bypass many of the body’s defense mechanisms. Sterile within a solution that
products also need to have an appropriate pH to be safely administered to humans, the correct affects movement of water
tonicity, and be stored correctly. Factors that affect a compounded product’s stability and across a membrane.
compatibility include pH, temperature, light, concentration or dilution, chemical composition, time,
base solution, temperature, buffer capacity, order of mixing, filters, and plastic materials used.
Generally, a medication’s package inserts or other sterile compounding resources (Trissel’s Stability
of Compounded Formulation, King Guide to Parenteral Admixtures) report incompatibilities. It’s
important that the sterile compound is administered prior to its beyond-use date. Medications in an
IV solution admixture can degrade quickly.

CHALLENGE

1. Which environment must be kept for safe sterile compounding?

A. Class 300
B. Class 1,000
C. Class 500
D. Class 100
D. A class 100 environment, or less, is required for safe preparation of sterile compounds. A
class 300 environment is too contaminated for safe preparation for sterile compounds. A class
1,000 environment is too contaminated for safe preparation for sterile compounds. A class
500 environment is too contaminated for safe preparation for sterile compounds.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 MEDICATION CLASSIFICATIONS AND FREQUENTLY PRESCRIBED MEDICATIONS

Vaccines and Immunization Schedules antigen. Substance that elicits

A vaccine prompts the immune system to produce antibodies that target a specific antigen that is an immune response against it.
associated with a pathogen (virus, bacteria). This process is called active acquired immunity. There
are different types of vaccines. The most common types include inactivated, acellular, toxoid, and
live attenuated. Inactivated vaccines are microorganisms that have been killed (such as typhoid).
Acellular vaccines contain the part of the microorganism that causes an immune response in
humans (such as Haemophilus influenzae type B [Hib]). Toxoid vaccines contain viral toxins that an
immune response act against (such as tetanus). Live attenuated vaccines contain live
microorganisms that have been weakened sufficiently enough not to cause an infection but elicit an
immune response (such as measles).

The CDC establishes and updates immunization schedules that include vaccine recommendations
for all ages. There are schedules for birth to 18 years, including a catchup schedule and an adult
schedule. Because updates to these schedules occur annually, it is important for pharmacy CHALLENGE
professionals to check the CDC website for changes.
1. Which governing body
Pharmacists, with the support of technicians, play a major role in immunization efforts across the regulates the requirements
U.S. Pharmacists can answer questions patients may have about vaccines, recommend vaccines to for administration of
vaccines?
patients based on CDC schedule guidance, coordinate with a patient’s primary care physician on
Each state has its own
administration and documentation, and often administer vaccines at the pharmacy. The ability to regulations, implemented
administer vaccines is state-specific; a recent trend is permitting technicians to administer vaccines by the state’s board of
pharmacy, that outline the
under certain circumstances and with appropriate training. Be aware of the immunization laws in
requirements for who can
the state. administer vaccines, which
vaccines can be administered,
Technicians can assist with ordering and storing vaccines. Technicians can also collect patient and what stipulations must
be met before administration
information, such as recent illness, allergies, and history of vaccine reactions. They can also ensure
can legally occur.
that patients receive the CDC-produced Vaccine Information Statement for the vaccine they received.
This is akin to a patient education sheet they may receive with prescription medications. Side 2. What are the brand names
of insulin glargine?
effects, or adverse reactions, can occur with any vaccine. These reactions include headache, fever,
The brand names of
stomach upset, irritability in children, skin rashes, fatigue, achiness, and irritation at the insulin glargine are Lantus,
injection site. Toujeo, and Basaglar

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

PATIENT PROFILES Case Study: Prescription

All pharmacies use computer systems for inputting, storing, and outputting information. Every Drop-Off Window, Part 2
patient should have a record (or profile) in the pharmacy system. The patient profile is vitally Maria learns that Jane has filled
important to the pharmacist’s review because, without updated information, there is a risk of prescriptions at one of the pharmacy’s
medication overdose, underdose, or allergic reactions. Technicians are generally the employees other locations and that she wants to wait
receiving the prescription at drop-off, so they have the opportunity to interface with patients for the atorvastatin refill because she is out
of medication. Maria reviews Jane’s patient
to update the patient profile. This lesson covers the contents and purposes of a complete profile and learns that she and her family
patient profile. have moved closer to this pharmacy, which
is why she is refilling her prescription at this
location.
Profile Components 1. What information should Maria change
in Jane’s profile and what would be a
The following components are either required or should be included in the patient’s profile.
good follow-up question(s)?
Technicians should ensure that all of the needed information resides in the profile. Maria should update Jane’s address and
any other information that has changed
with the move, like phone numbers. One
Contact Information good follow-up question would be if Jane
is on any other medications, and if so, if
Include the patient’s full name, address, and phone number. The phone number is not required any of those medications need to be filled
but is useful if the pharmacy needs to contact the patient about information pertaining to the or refilled. Because both pharmacies are
under common ownership and use the same
prescription. This information is also used with pharmacy mobile apps and notification systems. computer system, a manual prescription
Document the phone number type: mobile, home, or work. Also, indicate how the patient prefers transfer is unnecessary. Another related
to be contacted, by phone or text, and at which number. Some pharmacies may have secure follow-up question would be if Jane has
other family members who will be filling
messaging allowing for the use of an email to contact a patient, but this is not the usual way to prescriptions at this location. Maria could
contact patients. then update their patient profiles.

Patient-Specific Information
Input the patient’s date of birth, weight, and sex assigned at birth (the notes section should contain
the sex with which the patient identifies if different from the sex assigned at birth). Accurate
demographics are important for checking dosages and appropriateness of therapy and for billing
third-party payers. Allergy information is also crucial. Document any medication sensitivities and
reactions and food or contact allergies so that the pharmacist can assess for potential interactions.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Diagnoses and Medication History processor bank identification

Request any known diagnoses or medical conditions and document them accurately in the profile. In number (BIN). A six-digit
addition, record each patient’s medication history, including current medications with the dosage, processor ID issued by
directions for use, quantity dispensed, and date dispensed. Also, account for current over-the- the National Council on
counter medications, vitamins, herbal supplements, and tobacco and/or cannabis use because there
Prescription Drug Programs
(NCPDP) that health plans
may be drug interactions.
can use to process electronic
pharmacy claims.
Preferences and Payers identification (ID) number.
The profile should also have a place for patient preferences and payer information. For example, A unique number assigned
document a preference for generic medication substitution or if the patient would prefer not to have to the insured party by the
child-resistant vial caps. insurance company.

Required third-party payer information includes the name of the insurance company, processor bank processor control number
identification number (BIN), identification (ID) number, processor control number (PCN), Rx group code, (PCN). A secondary
and person code (primary, spouse, dependent). Without this information in the patient profile, the identifier used in routing
pharmacy cannot submit claims to third-party payers for adjudication, which creates more work at
pharmacy transactions.
pickup. This is one opportunity to create a positive impression on the patient. Obtaining all the
pertinent information necessary ensures the prescription is complete and ready for the patient
promptly.

Drug-Drug Interactions
Gather all pertinent patient information and update the patient’s drug-drug interactions
(DDIs). A situation in which a
profile prior to dispensing prescriptions. The software uses this
medication affects the activity
information to cross-check medical conditions, drug-drug
of another medication when the
interactions (DDIs), and allergies with the medications being
profile two are administered together.
dispensed. It is critical to provide this information to the
medical history
pharmacist for review so they can decide if the medication can be medications
contraindications. A condition
dispensed safely. DDIs can only be identified after obtaining the allergies or factor that serves as a reason
patient’s complete medication list. With the increase in mail-order contact information to withhold a specific medical
pharmacies, many patients receive medications from multiple treatment due to the harm that
pharmacies. Ask new patients about any medications they are taking and ask about any changes in it would cause to the patient.
medications at each visit. Also update health conditions so the pharmacist can check for
contraindications.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Drug Utilization Reviews

The computer software performs drug utilization reviews (DURs) to alert prescribers of
inappropriate or unapproved medication usage. Notify the pharmacist if one of these alerts arises
when entering a prescription. This information allows the pharmacist to suggest medication therapy
changes that can be more advantageous to the patient based on age, prescribed medication usage,
dosage, and medication cost.

CHALLENGE

1. Which of the following patient information components should be part of a patient’s profile? (Select
all that apply.)
A. Patient’s full name
B. Patient’s date of birth
C. Patient’s work phone number
D. Patient’s email address
E. Patient’s spouse’s name
F. Patient’s allergies
A, B, F. The patient’s full name in their profile ensures the correct patient is selected. Have the patient’s
date of birth in their profile to help in selecting the correct patient. There may be patients who have the
same name, and the date of birth will help identify the correct patient. Have medication, food, or contact
allergies in the patient’s profile to allow the pharmacist to decide if a medication may present a problem
for the patient. Have a phone number in order to contact a patient, but it does not need to be a work
phone number. Have a way to contact the patient, but email would be unlikely as it may also present a
problem with secure messaging and patient privacy. Phone numbers are a preferred method of contact. It
is not necessary to have a patient’s spouse’s name in their profile unless the patient has requested it.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Electronic Prescriptions
Most prescriptions are sent electronically. They may be referred to as e-prescriptions, e-scripts, or e-prescribing. The secure
eRxs. The provider sends the prescription digitally, using a computer or other secure electronic electronic generation and
device, to the pharmacy via a health care network interface. The largest e-prescribing network is transmission of prescriptions.
operated by Surescripts, which processed more than 2.5 billion e-prescriptions in 2023. The
e-prescription information may automatically populate the pharmacy computer system’s data
entry fields, or it may need manual entry during prescription processing. E-prescribing can be
faster and more accurate than written or telephoned prescriptions because it minimizes the risk
Health Care
of errors due to poor handwriting, misinterpretation of abbreviations, and inaccurate
Providers
transcribing. E-prescribing expedites refills and prescription cancellations, allows convenient 1234 Main Street
information exchange between the prescriber and pharmacist, and links information from a Shermer, IL 12345
1.800.555.1234
patient’s medical file to their prescription file. Some states are now requiring either all
DEA # AS1234563
prescriptions or all controlled substance prescriptions to be processed electronically. For
Name: Jane Smith DOB: 2/4/1977
example, Minnesota requires e-prescriptions for all medications.
Address: 12 Main Street Date: 9/16/xx

Lipitor 20 mg
Written and Phone Prescriptions Disp # 30
1 - 24
25 - 49
po daily 50 - 74
Prescriptions received via the fax machine, in written form, or verbally via telephone or 75 - 100
voicemail and reduced to writing on a prescription form are scanned into the computer system 101 - 150
151+
according to the pharmacy’s policies and procedures. In most states, pharmacists must be the Refill NR 1 2 3 4 5
ones transcribing telephone or verbal prescriptions. The scanned prescription image is the
Christina Smith 9/16/xx
starting point for prescription processing and data entry. Pharmacy computer systems have a Prescriber signature Date
“data entry” queue where these prescriptions are found for processing. Both technicians and Dispense as written
Brand exchange permissible
pharmacists perform prescription data entry.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Prescription Transfers
A patient may request their prescription(s) be transferred from another pharmacy. They may do so
in person, over the telephone, or through the pharmacy’s mobile app or other digital system. The
pharmacist at the receiving pharmacy may receive the prescription information verbally and reduce
it to writing or request that the transferring pharmacy fax the prescription. The prescription is now
in a format that can be scanned into the receiving pharmacy’s computer system for processing.
If a prescription is being transferred from a different location within the same pharmacy’s
ownership, the transfer can often be done electronically because the pharmacies are using the same
computer system.

Documentation is important to ensure there are not multiple active prescriptions for the same
medication. For example, the patient might have two active prescriptions for the same medication
that were written at different times, and both are transferred. Review each of these prescriptions to
see if they are identical. If they are not, talk to the patient to confirm which prescription is current.
Make a note on the patient’s profile indicating the current prescription. Then, deactivate the other
active, but not current, prescription in the system to prevent it from being filled accidentally.

CHALLENGE

1. Sort the elements listed as either “Needed” in a prescription or “Not necessary.”

A. Date prescription was written/ordered
B. Patient name
C. Medication name
D. Prescriber name
E. DEA number
F. Prescriber signature
Needed: Date prescription was written/ordered, patient name, medication name, prescriber name, prescriber
signature; Not necessary: DEA number Necessary prescription elements include the patient’s name, address, and
date of birth. Prescriptions must have the date written, the medication ordered and its dosage, directions for use,
the quantity ordered, and the number of refills. Whether or not a generic medication can be substituted is helpful
but not required. The prescriber’s name, address, contact information, DEA number for controlled substances,
and signature are required elements. A DEA number for non-controlled prescriptions may be helpful but is not
required. The NPI may or may not be required depending on state law and insurance company policies for billing.
Technicians may come across these following elements as well—they are not required but can be added to a
patient’s profile: home, work, and mobile telephone, gender, allergies, health conditions, and insurance coverage.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

PRESCRIPTION BILLING
Patients may have prescription medication coverage through a variety of third-party programs.
Prescription coverage may be offered by private entities, such as an employer, or through a
government program, such as the federal Medicare program or state Medicaid program. Federal
Medicare and state Medicaid programs may also be contracted to private insurance companies.
A third-party program comprises the patient, the pharmacy, and the insurance company or a
Health Insurance Card
government program. These parties are involved in the coverage of payment for prescriptions.

Third-Party Payer Information

Identifying and inputting third-party payer information can be a primary and time-consuming
task when processing prescriptions. Being able to identify the pertinent information on a
third-party prescription medication card will help simplify this process. Because patients can
have several different insurance cards, they may require assistance in locating which card is
needed for processing their pharmacy claims. To complicate matters, in some cases, patients
may choose to use a prescription discount card if they do not have insurance coverage or if
their plan has a high deductible. Many pharmacies and private insurers offer prescription
discounts or savings cards. These cards also have the BIN, PCN, member IDs, and Rx group
numbers described below. These numbers are needed for the information on a claim submission to
Prescription Discount Card
be sent to the correct payer for adjudication.

⦁ Processor BIN: A six-digit number that is assigned to third-party processors for electronic routing
of transactions. This number on the insurance card helps pharmacy personnel correctly route
pharmacy claims for processing.

⦁ PCN: A secondary identifier that can be used in routing pharmacy claims. The PCN is
alphanumeric and defined by the pharmacy benefits manager or processor. The pharmacy
benefits manager or processor can differentiate between plan packages with the use of unique
PCNs. There is no registry for PCNs.

⦁ Member ID number: An ID number unique to the primary insurance holder on a plan. Most family
members under the plan will have the same ID and group number but different person codes.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

⦁ Person code: A code that identifies which household member under one plan is receiving services
and prescriptions. For example, member 01 is usually the primary cardholder, 02 is the spouse
or domestic partner, and subsequent numbers are children and other dependents in order of age
(03 is the oldest child and so on). The person code 00 also sometimes represents the primary
cardholder.

⦁ Rx group number: Identifies which specific insurance plan a member falls under. The group number
often identifies the patient’s employer.

CHALLENGE

1. Match each term with its definition.

A. PCN 2. Identifies the plan a member falls under
B. Person code 3. Number unique to the primary insurance
C. Member ID number holder
D. BIN 4. Secondary identifier used in routing claims
E. Rx group number 5. Number that tells the computer where to
send the claim for processing
1. Identifies which household member is
receiving services
Person code: Identifies which household member is receiving services, Rx group number: Identifies the plan
a member falls under, Member ID number: Number unique to the primary insurance holder, PCN: Secondary
identifier used in routing claims, BIN: Number that tells the computer where to send the claim for processing

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Third-Party Processing
Third-party processing or billing is how the pharmacy determines what portion of a prescription’s
payment will be reimbursed by the insurance company. After verifying that member information is
correct, submit the prescription information to continue processing the claim. Once the prescription
is submitted, the plan will determine the patient’s eligibility, whether the patient’s plan will cover
copay. The amount of payment
the desired prescription, the quantity allowed, and the amount of payment to the pharmacy by
to the pharmacy left to be
insurance and the insured patient (the coinsurance or copayment, also called a copay).
covered by the insured patient.

Submitting Claims
The entire pharmacy claim process is done by computer. This may Third Party Processing
be different from medical claims, which are processed on paper.
Patients receive an explanation of benefits and a bill later for those
claims. The pharmacy electronically submits a claim to the
insurance provider or a third-party claims processor. This process
takes only a few seconds, and payment from the insurance company Patient Pharmacist Insurance company
is automatically transferred to the pharmacy. This entire process
occurs using standards and electronic submission formats developed
by the National Council for Prescription Drug Programs (NCPDP).
Rejected Claims
Unfortunately, not every claim is processed this easily. Become
familiar with the various coverage limitations and the methods to
address them. Depending on the pharmacy and the issue at hand,
technicians may be responsible for contacting third-party payers
and handling coverage questions that arise.

Patient Pharmacist Insurance company

National Council for Prescription

Drug Programs (NCPDP). A not-for-
profit, multi-stakeholder forum for
developing and promoting industry
standards and business solutions that
improve patient safety and health
outcomes while decreasing costs.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Rejected Claims
If a payer rejects a claim, the pharmacy will receive a message and rejection code from the third-
party processor. The rejection message and code are standardized by NCPDP. The message can
Coinsurance and
be easy to handle, such as a days’ supply change. For example, a patient or prescriber could have Copayment
requested the medication be filled as a 90-day supply, but the processor returned with a rejection Most insurance companies pay
message saying that the claim exceeded the maximum supply of 30 days. In this case, resubmit the only a portion of the prescription
claim for a 30-day supply and inform the patient that their insurance only allows a 30-day supply to cost, and patients pay either
a coinsurance percentage or
be dispensed for this medication.
a fixed amount of copayment,
called a copay, depending on
Some messages from the processor request claim modification or additional information. Examples the medication.
include prescriptions with an invalid prescriber ID or a missing or incorrect date of birth or gender
code. Obtain this information from the prescriber or patient before resubmitting the claim for
processing. Most pharmacies have access to a third-party help desk with experts who can assist
in solving prescription claim processing issues. Call the help desk if in need of assistance when
resolving a claim processing issue.
prior authorization (PA). A
Prior Authorizations process used by some health
Other rejection codes can be more involved, and the patient may need to return to pick up the insurance companies to
medication after completing further paperwork or processing. If a rejection comes back stating that determine if they will cover
prior authorization (PA) is needed, this means the insurance company requires additional information a prescribed procedure,
from the prescriber’s office to determine if the medication will be covered. If this occurs, send the service, or medication.
PA request to the provider for completion. Most of these requests are sent to the prescriber
electronically through programs such as CoverMyMeds. Programs like CoverMyMeds are often
integrated with the pharmacy computer system so a “submit PA” field can be filled in directly from
the rejected claim. There can be times, however, when only a third-party toll-free number is
provided. Send this number to the prescriber’s office so they can call to provide any additional
information the third-party payer is requesting. Once the third-party payer receives and reviews
this information, it will approve or deny the claim. Be sure to explain this process to the patient. PA
can sometimes take several days for insurance company determinations. Let the patient know that
the pharmacy will call them when their claim is processed to ease their frustrations and assure
them they will receive their medication as soon as possible.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Formularies
Insurance providers have formularies just as some hospitals do. This means insurance companies formulary. A prescription
only pay for certain approved medications along with the approved strength, dose, and quantity. medication that is on a list
Claims can be returned stating that the medication is non-formulary and, therefore, not covered. of medications covered by
Communicate this to the pharmacist so they can evaluate if a different, covered medication is an a health care benefit plan.
available option. The pharmacist will then need to contact the prescriber to determine if they want
to prescribe a different medication. The patient may also have the option of paying cash for the
non-formulary prescription. This might not be financially possible for some people, or it may be
disallowed by some insurance programs in their contracts. There may be a prescription savings card
or discount plan available for the medication that can be found by contacting the individual
manufacturer directly or online. These programs can also be used if the patient’s medication is
covered by insurance, but the patient retains a large out-of-pocket cost. Be aware of and notify the
patient of these assistance programs. Note that manufacturer discounts are not allowed when a
patient has federal insurance such as Medicare.

Additional Information
Some federal- and state-funded programs require additional information to submit claims legally.
Periodically, third-party payers will perform on- or offsite audits of pharmacies. If audits uncover
issues, the third-party payer may assess penalties to the pharmacy, lowering the reimbursement
received for the prescription.

Payment Allocation
Patients might question why they owe specific amounts for their prescriptions, so become familiar
with the possible reasons, such as the patient having a copay for their part of the prescription cost
or having a deductible to meet before insurance starts paying.

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Tiered Copays
The patient can have a third-party payer that uses tiered copayments, meaning they have different
copays for differently classified medications. Tiers are levels determined by the insurer based
on medication usage, cost, and clinical effectiveness. If a prescribed brand-name medication is
in a higher tier, the pharmacist can check for the availability of a generic equivalent. Generic
substitutions are usually considered Tier 1 copays, which are the lowest cost to the patient.
Pharmacists can also check if there is a generic for a medication that is in the same class but not
an exact equivalent. Medication changes require authorization from the prescriber. Sometimes,
the third-party payer prefers one brand name over another. In this case, search for a formulary
online and contact the prescriber with suggestions of medications that can be less expensive for
the patient. If there is no formulary, the pharmacist can recommend another medication to the
prescriber that may fall into a lower tier and cost the patient less.

Multiple Insurance Plans coordination of benefits.

When a patient is covered by multiple insurance plans, it is important to be aware of the coordination The practice of ensuring
of benefits to determine which plan is to be billed as the primary insurance and the extent to which that insurance claims are
the other plans will contribute after the primary has been billed. The coordination of benefits helps not paid multiple times.
prevent patients from submitting one claim to multiple insurance companies. Make sure the total
amount paid for a claim does not exceed 100%.

Multiple Payers

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

When an insurance company denies a claim by stating it is not the primary insurance, contact the
patient to see if they have another insurance that should be billed first. For instance, if a patient has
Medicaid plus other insurance, Medicaid is always the payer of last resort. If they have a plan with
commercial or private insurance, that plan would be billed first, followed by Medicaid or a federally
funded program. The primary insurance plan would have to meet its legal requirements for payment
on the claim. Then, the pharmacy could bill Medicaid for any remainder of the claim.

Deductible
Adjudication Messages
deductible = $300 deductible = $300 deductible met
Decoding adjudication messages from a third-party online processor can be a 25%
time-consuming and frustrating job that requires the use of communication
skills. Not only might the patient not understand why the insurance is 100% 100%
75%
not paying the claim, but the prescriber can also be confused as to why
the medication is not covered. If a change needs to be made, communicate $150 $150 $150
with the pharmacist. The pharmacist will decide whether to contact the
prescriber. Knowing the following insurance terms, however, can help
technicians properly communicate with the patient, prescriber, and pharmacist.
Copay
⦁ Adjudication: Process of transmitting a prescription electronically to the proper
insurance company or third-party payer for approval and billing $25 copay
$25 copay
⦁ Carrier/insurer: Insurance company
$125 remainder
⦁ Processor: Company hired by the insurer to process claims $50 remainder

⦁ Claim: Request for reimbursement for products or services rendered from a $75 $150

health care provider to an insurance provider

⦁ Copayment or coinsurance: Portion of the cost of a service or product that a
patient pays out of pocket each time it is provided
⦁ Deductible: Set amount the insured pays upfront before their insurance coverage applies. In the
diagram below, the first prescription claim processed for $150 returned a patient payment of the
full $150 because the patient had not met the plan’s deductible. In the second diagram, the next
prescription claim processed for $150 also returned a patient payment of the full $150, but now
the patient has met the plan deductible of $300. When the next prescription claim is processed for
$150, the plan will pay 75% because the deductible has been met, and the plan will return a patient
payment of $37.50, which is 25% of the billed amount.
⦁ Days’ supply: Number of days a dispensed quantity of medication is prescribed for.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Durable Medical Equipment and Diabetes Supplies Claims durable medical equipment
Durable medical equipment (DME) and diabetes supplies are often processed and billed differently than (DME). Equipment that
provides therapeutic benefits
prescriptions for medications. There are federal standards that pharmacies must meet to be able to
to a patient due to medical
process and bill prescriptions for DME. For patients with Medicare, DME and diabetes supplies are
conditions or illnesses.
billed through Medicare Part B. Centers for Medicare & Medicaid Services (CMS) requires specific
information in order to reimburse for these supplies. Centers for Medicare &
Medicaid Services (CMS). A
federal program responsible
Diabetes Supplies for administering Medicare
Diabetes supplies are most commonly covered under Medicare Part and Medicaid programs.
B. Diabetes supplies include glucometers, test strips, lancets, lancing
devices, alcohol swabs, needles, and syringes. Even though these Case Study: Prescription Drop-Off Window, Part 3
claims can be submitted online for adjudication, CMS still requires Maria checks out Jane’s atorvastatin prescription from the computer
extra paperwork to prevent fraud and waste. If a prescription does not system at the prescription pickup window. Jane tells Maria that her
contain all the information required by CMS, contact the prescriber mother is being released from assisted living after recovering from a
bad fall. The provider has told Jane her mother needs a hospital bed to
to acquire it. For example, for Medicare Part B claims, CMS requires
continue her recovery at home. Jane asks Maria if the pharmacy can fill
documenting whether the patient with diabetes uses insulin or not an order for the hospital bed.
when prescriptions are being filled for glucose testing supplies. The
1. What does Maria need to consider before she answers Jane’s
prescriber must also indicate the quantity of supplies ordered and how question?
often the patient is testing. First, Maria needs to know that a hospital bed is considered DME. To fill a
prescription for DME, the pharmacy must be DMEPOS-accredited. In this
case, the pharmacy is not accredited. Because the pharmacy does not fill
DME orders, they have created a resource of nearby DME providers to help
DME their patients who need DME. Maria can let Jane know this and provide
DME includes items like canes, hospital beds, nebulizers, ostomy her with other DME providers who can help her mother. Note that if the
pharmacy is so inclined, it can file for an accreditation exemption to allow it
supplies, toilet cushions, wheelchairs, and walkers. DME comes to be enrolled in Medicare to supply DMEPOS if it meets certain criteria.
with specific billing requirements when adjudicating claims through
Medicare Part B. One main difference from billing other third-party
payers is that Medicare Part B can only receive paper claims. Some
pharmacies contract with a company that receives the pharmacy’s electronic claim and then bills
Billing for DME
Medicare with a paper claim on the pharmacy’s behalf. Reimbursement lags because this process Specific billing requirements exist
does not occur in “real time” like prescription claims. when sending claims for diabetes
supplies and DME to Medicare
Part B. Know if the pharmacy is
DMEPOS-accredited.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Billing for medical supplies under Medicare Part B entails following even more stringent guidelines
than when billing diabetes supplies. The filling pharmacy must be Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS)-accredited or have an exemption from the National
Supplier Clearinghouse to receive payment from CMS for these items. Prescribers’ orders must state
the reason for the product to be dispensed on the prescription, and additional paperwork may need
to be completed by the prescriber before the supplies can be billed. The pharmacy must keep
stringent documentation when both Medicare Part B and Part D are billed for supplies. This
information will be needed in the event of an audit. If this paperwork is not presented at the audit,
the pharmacy will be required to pay back any reimbursement they received for these claims.

CHALLENGE

1. Which of the following are considered DME? (Select all that apply.)
A. Diabetes glucose test strips
B. Nebulizers
C. Blood glucose testing meters
D. Ostomy supplies
E. Walkers
B, D, E. You answered incorrectly. DME examples include canes, hospital beds,
nebulizers, ostomy supplies, toilet cushions, wheelchairs, and walkers.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

PRESCRIBER’S DIRECTIONS, SIG CODES, AND ABBREVIATIONS

Some of the terms, codes, and abbreviations used by prescribers can look like a different language to
patients. It is one role of the technician to understand the often-used terms and interpret them in
simpler language for patients so they can secure and use medications properly. When the technician
is unsure, they should consult the pharmacist. This lesson covers decoding prescriber instructions,
including Sig codes.

Medication is only effective when the correct patient takes the correct medication in the correct
strength and dose at the correct time. Interpreting the directions from the prescriber correctly
is vital to the safety and effectiveness of the medication. Yet prescribers often write directions
in shorthand with abbreviations and symbols. The Sig (also referred to as the directions for use)
includes the route of administration, dosage, and frequency. The dosage can imply the route. The
Sig can also contain information on the length of time to continue the medication and the reason
for the medication. When this information is included on the prescription, it must also be on the
prescription label. When interpreting the Sig, do not add any other information.

Technicians must be able to interpret key words, abbreviations, and symbols when entering a
prescriber’s directions for use from a prescription. The following tables offer several examples.
Table 4.1 presents abbreviations for the routes of administration often used by prescribers. Table 4.2
provides the common abbreviations for the dosage forms. Table 4.3 summarizes dosage frequency
abbreviations, and Table 4.4 lists abbreviations that prescribers should (but sometimes do not) avoid
when writing prescriptions.

TABLE 4.1 Routes of Administration

CHALLENGE
ABBREVIATION ROUTE ABBREVIATION ROUTE

EN Each nostril PO My mouth 1. Match the abbreviation to the

correct route of administration.
IV Intravenous UD, UT As directed A. UD 1. As directed
IVPB Intravenous piggyback TOP Topically B. TOP 2. Topically
C. VAG 3. Vaginally
LOC Locally VAG Vaginally
D. IV 4. Intravenous
E. EN 5. Each nostril
CAP: Capsule, LIQ: Liquid, SUPP:
Suppository, SUSP: Suspension,
TAB: Tablet, UNG, OINT: Ointment

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

TABLE 4.2 Dosage Forms

ABBREVIATION DOSAGE FORM ABBREVIATION DOSAGE FORM

AMP Ampule PULV Powder

CAP Capsule SOL Solution
CR Cream SUPP Suppository
CHALLENGE
ELIX Elixir SUSP Suspension
1. Match the correct dosage form to
EXPECT Expectorant SYR Syrup its abbreviation.
FL Fluid TAB Tablet A. Ointment 1. CAP
B. Suppository 2. LIQ
LIQ Liquid TINC Tincture
C. Suspension 3. SUPP
LOT Lotion UNG, OINT Ointment D. Capsule 4. SUSP
E. Tablet 5. TAB
TABLE 4.3 Dosage Frequency F. Liquid 6. UNG, OINT
UD: As directed, TOP: Topically, VAG:
ABBREVIATION FREQUENCY ABBREVIATION FREQUENCY Vaginally, IV: Intravenous, EN: Each nostril

AD LIB As often as needed PM In the afternoon and evening 2. Match the correct dosing frequency to
its abbreviation.
AM Morning Q Every A. After meals F. Every night at
ASAP As soon as possible Q4H Every 4 hours and at bedtime
bedtime 1. AM
ATC Around the clock Q6H Every 6 hours B. Morning 2. ASAP
H, HR Hour QHS Every night at bedtime C. Every 4 hours 3. PC, HS
D. As soon as 4. Q4H
BID Twice daily STAT At once or immediately possible
5. QHS
NOC Night UD, UT As directed E. At once or
immediately 6. STAT
NV Nausea and vomiting W/ With AM: Morning, ASAP: As soon as possible,
PC, HS: After meals and at bedtime,
PC, HS After meals and at bedtime W/o Without Q4H: Every 4 hours, QHS: Every night at
bedtime, STAT: At once or immediately

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

There are several abbreviations that are not recommended for use because they can be easily
misinterpreted. The Joint Commission has deemed the following as unacceptable due to the
increased risk of error. Use extra care when interpreting these abbreviations on prescriptions.

TABLE 4.4 Abbreviations to Avoid

ABBREVIATION POTENTIAL MISINTERPRETATION

U (unit) 0, 4, CC
IU (international unit) 10, IV
QD (daily) QID, QOD
QOD (every other day) QID, QD
Trailing zeros on decimals Missed decimal point
Lack of leading zeros on decimals Missed decimal point
@ 2

CHALLENGE

1. Sort each abbreviation as to whether it should be avoided or can be 2. Which Sig translations are correct for the prescriber’s directions?
used. (Select all that apply.)
A. U A. Sig: 1 TAB Q4H
B. QHS B. Sig: 1 application TOP in AM and QHS
C. QD C. Sig: 2 TABs at PC, HS
D. PM D. Sig: Insert 1 TAB VAG QHS
E. QOD B, D. Because this is being used topically, it is more appropriate to say “apply”
rather than “use.” The complete Sig translation is: Apply 1 application topically
F. AM
in the morning and at bedtime. There are a number of tablet medication dosage
Abbreviation to Avoid: QOD, U, QD; Abbreviation to Use: AM, PM, QHS; forms meant to be used vaginally. This Sig translation is correct as: Insert 1 tablet
QHS for every night at bedtime, PM for in the afternoon or evening, and vaginally every night at bedtime. Q4H is every 4 hours. The correct translation
AM for in the morning are abbreviations that may be used as they are of this Sig is: Take 1 tablet every 4 hours. This Sig should be clarified. Did the
not on The Joint Commission’s list of abbreviations to avoid. U can be prescriber mean to take 2 tablets together after meals and at bedtime for a
misinterpreted as 0, 4, or CC, and its use should be avoided. QD for daily total of 8 per day? Or did the prescriber want the patient to take 2 tablets per
may be misinterpreted as QOD (every other day) or QID, which is four times day with 1 taken after a meal and the other at bedtime? Looking at the quantity
a day. QOD for every other day may be misinterpreted as QD for daily or of tablets prescribed would provide more information. For example, if there
QID for four times a day. Both QD and QOD are abbreviations to avoid. were 60 tablets prescribed, that may indicate the latter set of directions for a
30-day supply. If there were 40 tablets prescribed, that may mean the first set of
directions. In either case, call the prescriber to clarify and document accordingly.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

DISPENSING MEDICATIONS
This section brings everything from this chapter together—from creating a patient profile to
securing pharmacist prescription verification and handing an error-free prescription to the patient.
The technician plays a critical role in each step of the process. This lesson will cover and review
accessing, updating, and creating the patient profile; steps to input the prescription; guidance on
dispensing as written or generic; responding to alerts and prescription monitoring programs; and
including medication guides where required.

Inputting the Prescription

The first step in the prescription dispensing process is to create or update the patient profile. Select
the correct patient within the system by verifying each patient with two identifiers, such as the
patient’s middle initial, date of birth, address, or other patient numbers. This practice helps prevent
selecting the wrong patient who has a similar name. Because so many alerts and cross-references
occur during the processing of a prescription, make sure the patient’s profile is up to date with
demographic information, allergies, medications, medical conditions, and insurance information.

The Patient Profiles section in this chapter outlined the steps in prescription input and processing.
Review and recall the data entry steps after creating or updating the patient profile.

1. Enter the date the prescription was written. 7. Select the correct prescriber and their
address used on the prescription order.
2. Enter the NDC of the medication if it is on
the prescription; if not on the prescription, 8. Enter the correct days’ supply.
then enter the medication name and
9. Enter the method of prescription receipt:
strength, and select the correct medication
electronic, fax, written, telephone, transfer,
and strength from the options in the
or if it was generated by the pharmacy—for
computer system.
example, when administering a flu shot or
3. Determine whether the medication can be other vaccine.
substituted or not and select the correct
10. Select the correct billing option.
DAW code.
11. Process the entry.
4. Enter the quantity ordered.

5. Enter the number of refills.

6. Enter the directions for use.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Pay attention to detail when inputting information from the prescription and clarify anything that
is not perfectly clear to avoid any mistakes. The information entered into the computer is printed on
the label for the patient. This might be the only information about the prescription that the patient
has once they get home.

DAW Codes
DAW codes are a numerical set of codes created by the NCPDP that are used when filling
prescriptions to indicate substitution or requested substitutions by the prescriber, patient, and/or
insurance company. The DAW codes are listed in Table 4.5.

TABLE 4.5 DAW Codes

CODE CODE VALUE

0 No Product Selection Indicated (may also have missing values)

1 Substitution Not Allowed by Prescriber
2 Substitution Allowed - Patient Requested That Brand Product Be Dispensed
3 Substitution Allowed - Pharmacist Selected Product Dispensed
4 Substitution Allowed - Generic Medication Not in Stock
5 Substitution Allowed - Brand Medication Dispensed as Generic
6 Override
7 Substitution Not Allowed - Brand Medication Mandated by Law
8 Substitution Allowed - Generic Medication Not Available in Marketplace
9 Other

During prescription entry, the pharmacist or technician should select the correct DAW code. The
DAW code selected during data entry will be included when the prescription claim is submitted to
the insurance company. Using the correct DAW code during data entry will reduce the number of
error messages and rejections during the claim adjudication process.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

The majority of prescriptions are written using a medication’s generic name and sent with a DAW
code of 0. Generic substitution allows for a prescription written for one brand-name medication to
be filled with the same chemical that is sold under a different brand name or by the medication’s
generic name. Medication must be proven to be equivalent based on the Food and Drug
Administration’s (FDA) AB rating for it to be substituted. An AB rating means that there is adequate AB rating. A code assigned
evidence supporting the bioequivalence of the generic medication to the brand-name medication. by the FDA that indicates a
For example, an adequate equivalent for brand-name medication Prozac is generic fluoxetine. If the medication product is the
prescriber includes DAW code 0 or does not include any DAW code, then the generic medication can therapeutic equivalent, as
be used, even if the prescription is written using a medication’s brand name. For example, a demonstrated by testing, and
prescription written for the brand-name medication Cozaar that has no DAW code indicated can be
therefore substitutable, where
permitted by the prescriber.
filled with the generic medication, losartan potassium.

In most states, the law specifies that the medication be filled with the lowest-cost generic unless
specified otherwise. Insurance companies often require medications to be filled with generic
alternatives. They will pick up more of the cost of a generic medication and shift more of the cost of
a brand-name medication to the patient in the form of their copay. This is why it is important to
add the correct DAW code to each claim when submitting a claim to a processor for adjudication.

Sometimes, a prescriber will insist that a brand-name medication be

used to fill a prescription. For example, the patient may be getting
better health outcomes from a specific product, and substituting
another product may be less effective. When a prescriber wants a
particular brand of medication dispensed, they must include a DAW
code 1 on the prescription. Some pharmacies require DAW 1 codes to John Q. Smith
Rx 1234567
be confirmed with a call to the prescriber. This call is documented on Ciprofloxacin 250 mg

the prescription image during the data entry process. Even when the TAKE TWO TABLETS
BY MOUTH TWICE
DAILY FOR 14 DAYS
prescriber has used the correct DAW code 1 on the prescription and QTY 28

it is submitted correctly, the insurance plan may require additional

steps before allowing the medication to be covered. They can require
the use of a generic alternative first or PA paperwork to be completed
before covering the cost of the medication.

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

The patient may also request a particular brand product be used. An example is a patient with a dye
allergy who requires a certain brand of medication formulated without dye. In this scenario, the
technician would select a DAW code 2 during the data entry process. During medication recalls and
shortages, substitutions may occur based on what medications are available. DAW codes 3, 4, 5, and
8 may come into play.

Each insurance company decides how to use these codes and will send an error message with the
correct code to be used during claim adjudication. Documenting the correct DAW code is also
important because third-party payers audit prescriptions and if the proper code is not used, the
payer will fine the pharmacy, resulting in less reimbursement for the prescription.

CHALLENGE

1. Which is the correct DAW code to use when processing the prescription transfer for John Q. Smith’s
ciprofloxacin?
A. 0
B. 1
C. 2
D. 8
A. DAW 0 (no product selection) is indicated as notated by the pharmacist’s “no” by the DAW area on the
transfer. DAW 1 is substitution not allowed by prescriber. Here the pharmacist has clearly noted “no” by the
DAW area on the transfer. DAW 2 means substitution is allowed, but the patient requested the brand be
dispensed. Both the transferred prescription notation and product label indicate this is a generic, so DAW 2 is
not correct. DAW 8 is when substitution is allowed, and the brand medication is dispensed because the generic
is not currently manufactured, not currently distributed, or is currently unavailable in the marketplace. The
dispensed product label indicates this has been filled with the generic medication, so DAW 8 is not correct.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Payment Allocation
Patients might question why they owe specific amounts for their prescriptions, so become familiar
with the possible reasons, such as the patient having a copay for their part of the prescription cost
or having a deductible to meet before insurance starts paying.

Tiered Copays
The patient can have a third-party payer that uses tiered copayments, meaning they have different
copays for differently classified medications. Tiers are levels determined by the insurer based
on medication usage, cost, and clinical effectiveness. If a prescribed brand-name medication is
in a higher tier, the pharmacist can check for the availability of a generic equivalent. Generic
substitutions are usually considered Tier 1 copays, which are the lowest cost to the patient.
Pharmacists can also check if there is a generic for a medication that is in the same class but not
an exact equivalent. Medication changes require authorization from the prescriber. Sometimes,
the third-party payer prefers one brand name over another. In this case, search for a formulary
online and contact the prescriber with suggestions of medications that can be less expensive for
the patient. If there is no formulary, the pharmacist can recommend another medication to the
prescriber that may fall into a lower tier and cost the patient less.

Multiple Insurance Plans coordination of benefits.

When a patient is covered by multiple insurance plans, it is important to be aware of the coordination The practice of ensuring
of benefits to determine which plan is to be billed as the primary insurance and the extent to which that insurance claims are
the other plans will contribute after the primary has been billed. The coordination of benefits helps not paid multiple times.
prevent patients from submitting one claim to multiple insurance companies. Make sure the total
amount paid for a claim does not exceed 100%.

Multiple Payers

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

When an insurance company denies a claim by stating it is not the primary insurance, contact the
patient to see if they have another insurance that should be billed first. For instance, if a patient has
Medicaid plus other insurance, Medicaid is always the payer of last resort. If they have a plan with
commercial or private insurance, that plan would be billed first, followed by Medicaid or a federally
funded program. The primary insurance plan would have to meet its legal requirements for payment
on the claim. Then, the pharmacy could bill Medicaid for any remainder of the claim.

Deductible
Adjudication Messages
deductible = $300 deductible = $300 deductible met
Decoding adjudication messages from a third-party online processor can be a 25%
time-consuming and frustrating job that requires the use of communication
skills. Not only might the patient not understand why the insurance is 100% 100%
75%
not paying the claim, but the prescriber can also be confused as to why
the medication is not covered. If a change needs to be made, communicate $150 $150 $150
with the pharmacist. The pharmacist will decide whether to contact the
prescriber. Knowing the following insurance terms, however, can help
technicians properly communicate with the patient, prescriber, and pharmacist.
Copay
⦁ Adjudication: Process of transmitting a prescription electronically to the proper
insurance company or third-party payer for approval and billing $25 copay
$25 copay
⦁ Carrier/insurer: Insurance company
$125 remainder
⦁ Processor: Company hired by the insurer to process claims $50 remainder

⦁ Claim: Request for reimbursement for products or services rendered from a $75 $150

health care provider to an insurance provider

⦁ Copayment or coinsurance: Portion of the cost of a service or product that a
patient pays out of pocket each time it is provided
⦁ Deductible: Set amount the insured pays upfront before their insurance coverage applies. In the
diagram below, the first prescription claim processed for $150 returned a patient payment of the
full $150 because the patient had not met the plan’s deductible. In the second diagram, the next
prescription claim processed for $150 also returned a patient payment of the full $150, but now
the patient has met the plan deductible of $300. When the next prescription claim is processed for
$150, the plan will pay 75% because the deductible has been met, and the plan will return a patient
payment of $37.50, which is 25% of the billed amount.
⦁ Days’ supply: Number of days a dispensed quantity of medication is prescribed for.

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Electronic Alerts in Processing and Dispensing

When entering patient information into the pharmacy computer system, it can generate alerts that
require immediate attention. The pharmacy’s computer system is programmed to check for allergies,
medication interactions, duplicate therapies, contraindications, early refills, overuse, and other
related warnings. Pay attention to these warnings. For some alerts, like early refills, the technician
can act alone. For other alerts, such as DDIs, the technician should seek the pharmacist’s help in (1)
determining if the warning is valid and (2) determining the appropriate action to resolve the issue.
Heeding alerts is one of the most important steps in ensuring that the medication dispensed will be
safe for the patient.

Consider this example: A patient tells a technician that they have an allergy to an antibiotic, which
causes them stomach upset. The technician enters this into the computer as an allergy. When the
patient is prescribed another medication in that class, the computer system alerts the technician
to the allergy. The technician brings this to the attention of the pharmacist, or the pharmacist
will see an allergy alert when they are verifying data. The pharmacist questions the patient about
the allergy. The pharmacist explains to the patient that stomach upset is not a true allergy but
a medication intolerance, and the different medications being dispensed are much easier on the
stomach. This allows the patient to continue with the prescriber’s intended treatment without delay.
Medication Allergy
Selection: Sulfamethoxazole
DUR Alerts Conflict: Sulfa (sulfonamide)
Other electronic alerts provided by the computer system, such as DURs, provide a comprehensive allergy
review of a patient’s prescriptions and medication data to ensure appropriate medication decision-
Go Back
making and positive patient outcomes. These alerts may indicate, for example, inappropriate dosage,
therapy not appropriate for age, therapy contraindicated by sex, or over- or underutilization. Bring
DUR alerts to the pharmacist’s attention so they can take the appropriate action and the prescriber
DDI
can be informed of the potential interaction or risk.
Selection: Clarithromycin
Conflict: Active colchicine
prescription

Go Back

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 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

DUR alerts may be classified by their severity: mild, moderate, or severe. DUR alerts, especially
moderate or severe ones, usually require that the pharmacist document actions taken to resolve
them using DUR codes. For example, a patient with a severe allergy to sulfa medications has been
prescribed trimethoprim/sulfamethoxazole (Bactrim DS) 800 mg/160 mg. During the data entry
process, a medication allergy DUR alert occurs. The pharmacist checks the patient’s profile for
details about the sulfa allergy and learns the patient experiences severe breathing problems, itching,
and rash requiring hospitalization. The pharmacist calls the urgent care clinic prescriber to discuss
the patient’s allergy. The prescriber changes the medication to avoid a potentially severe allergic
response.

Another example is a DUR alert received on two prescriptions written for the same patient for Electronic Alerts
duloxetine extended-release (ER; Irenka, Cymbalta) 30-mg capsules and duloxetine ER 60 mg.
During the claim adjudication process, the insurance company sends a DUR alert for duplicate Pharmacy computer systems generate
electronic alerts during data entry
therapy. The pharmacist looks at the directions on each prescription. The directions on the and verification. Some alerts may be
prescription for the duloxetine ER 30-mg capsules indicate taking 1 capsule by mouth in the addressed by the technician, such as refill
morning, along with a 60-mg capsule, for a total daily dose of 90 mg. The directions on the too soon, days’ supply limits, incorrect
prescription for the duloxetine ER 60-mg capsules indicate taking 1 capsule by mouth in the billing selection, and coordination of
benefits. Other alerts must be addressed
morning, along with a 30-mg capsule, for a total daily dose of 90 mg. The pharmacist checks the and overridden by the pharmacist, such
patient’s profile and confirms they have been on both doses for many years. This was documented as DDIs, medication allergies, and over-
by the prescriber within the last year and indicated in the patient’s profile. The pharmacist then or under-use.
overrides the DUR alert noting that the prescriber has been consulted and that the prescription can
be filled as written with the prescriber’s approval. Codes, abbreviations, and messages used may
vary by different pharmacy computer systems, online networks used to process claims, and third-
party payers. Be familiar with the codes in the pharmacy’s computer system.

DDI Alerts
Other important electronic alerts that the computer system can generate are DDI or medication-
disease state interactions. Make sure that the patient’s profile is up to date so that these alerts will
be accurate. The pharmacist will need to respond to these alerts by verifying that the patient is still
taking both medications and that the disease states are still current on the computer. Sometimes,
the patient can be counseled on how to avoid the interaction and other times; the prescriber will
need to change the medication plan to prevent an adverse medication reaction.

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Prescription Monitoring Programs prescription monitoring

Prescription monitoring programs (PMPs) are state-run programs that collect and distribute data about programs (PMPs). Program
prescribing and dispensing federally controlled substances. As the individual state deems that collects and distributes
appropriate, other potentially addictive or abusable prescription medications can qualify for PMPs, data about the prescription
as well. Some pharmacies will have computer software that is linked to the PMP; this software will
and dispensation of federally
controlled substances and—
generate alerts automatically when processing controlled medication prescriptions.
as individual states deem
With other computer systems, the PMP might need to be checked as a separate step. The alerts appropriate—other potentially
generated by PMPs notify the pharmacist of potential abuse and diversion of controlled prescription
addictive or abusable
prescription medications.
medications. Document the results of the PMP check in the pharmacy computer system. State law
varies on who can access the PMP and what process is used to provide access. Be familiar with the
PMP process at the pharmacy and with the technician’s role with respect to PMPs.

Pre- and Post-Adjudication Alerts

Pre-adjudication messages alert the pharmacy about something
that might be missing from a prescription before a claim is CHALLENGE
processed. These alerts are usually set up by the pharmacy and
its software. Examples include missing or invalid NDCs, NDCs 1. Sort the adjudication message as either pre-adjudication or post-
no longer available, incorrect package size, missing days’ supply,
adjudication.
or invalid prescriber. These alerts occur during data entry before A. Incorrect package size
the prescription is moved to the prescription verification queue. B. Maximum days’ supply allowed is 30.
There are fees associated with submitting claims online, so these C. Missing or incorrect days’ supply
alerts help ensure claims are adjudicated accurately and with D. Drug-drug interaction between A and B
fewer transmittals. E. Refills not allowed. Patient must use mail-order.
Pre-adjudication: Incorrect package size, Missing or incorrect days’ supply,
Post-adjudication messaging happens after the claim has been Drug-drug interaction between A and B; Post-adjudication: Maximum days’
supply allowed is 30. Refills not allowed. Patient must use mail-order.; Pre-
processed. The claim will be returned by the third-party payer as adjudication messages occur during data entry before the prescription is
paid or denied. There can be other messages that come with these moved to the prescription verification queue. Examples include missing or
communications. If a claim is returned paid, it can also have invalid NDCs, NDCs no longer available, incorrect package size, missing days’
supply, or invalid prescriber. Post-adjudication messages occur after the claim
a message attached, such as that the patient has a deductible is processed. The claim will be returned by the third-party payer as paid or
remaining that will be applied to this prescription copay. The denied. There can be other messages that come with these communications.
third-party payer may also send a message, for example, that the The plan may only allow a 30-day supply, and this would be communicated
when a 90-day supply has been entered on a submitted claim. Some plans
patient can only get the initial fill at a retail pharmacy and the require the patient to use mail order after an initial prescription fill, and this
patient must have refills filled at a mail-order pharmacy. may be communicated when a prescription refill claim is submitted.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Labels and Medication Guides

After entering the prescription information, addressing all alerts and warnings, and the pharmacist
Take with food
verifying the information, the prescription goes into the filling queue. Most pharmacy computer
systems require the medication stock bottle be scanned. The software verifies that the scanned NDC
For external
from the stock bottle matches the NDC entered in the prescription, and it generates a label for the use only
prescription bottle. If the NDC scanned does not match, the software will issue an alert. Address the
alert and select the correct NDC to continue filling the prescription. The system can also alert the Shake well
before using
technician regarding auxiliary labels necessary for the medication, or they may be printed directly
on the prescription vial label by the software. These alerts are important for the proper use and
storage of medication and include messages like “keep refrigerated” and “take with food.”

The FDA requires medication guides or informational leaflets to accompany some medications; Case Study: Prescription
include these with patient medications. These guides provide information about specific Drop-Off Window, Part 4
medications or medication classes and are used to help patients avoid serious adverse effects. The Jane also asks Maria if a new antibiotic
FDA requires medication guides for medications and biologicals that meet the following criteria. prescription for her husband can be
transferred to this pharmacy from ABC
⦁ Information is necessary to prevent serious adverse effects: For example, taking celecoxib (Celebrex), Pharmacy where it was sent by the clinic.
naproxen (Aleve, Anaprox DS, Naprosyn), or ibuprofen (Advil, Motrin) with food to avoid Maria notifies the pharmacist, who calls
stomach bleeds. ABC Pharmacy for the prescription
and reduces it in writing on a transfer
⦁ There is a known serious side effect with a product: For example, birth defects result from taking prescription pad. Maria created John Q.
isotretinoin (Absorica, Myorisan, Zenatane) during pregnancy, or severe neutropenia from Smith’s profile when Jane first came to
taking clozapine (Clozaril, FazaClo, Versacloz). the pharmacy for her atorvastatin (Lipitor)
prescription. Maria remembered that
⦁ Medication effectiveness is dependent upon adherence to directions for use: For example, John has an allergy to penicillin.
nitrofurantoin monohydrate (Furadantin, Macrobid, Macrodantin) must be taken with food or 1. What should Maria do next?
it cannot be absorbed into the body and will not work. Maria should alert the pharmacist that John
Q. Smith is allergic to penicillin and ask
the pharmacist if there are issues with the
antibiotic prescribed. In this case, there is
a modest risk factor alert. The pharmacist
can discuss John’s allergy with him to see
if the medication presents a problem.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Durable Medical Equipment and Diabetes Supplies Claims durable medical equipment
Durable medical equipment (DME) and diabetes supplies are often processed and billed differently than (DME). Equipment that
provides therapeutic benefits
prescriptions for medications. There are federal standards that pharmacies must meet to be able to
to a patient due to medical
process and bill prescriptions for DME. For patients with Medicare, DME and diabetes supplies are
conditions or illnesses.
billed through Medicare Part B. Centers for Medicare & Medicaid Services (CMS) requires specific
information in order to reimburse for these supplies. Centers for Medicare &
Medicaid Services (CMS). A
federal program responsible
Diabetes Supplies for administering Medicare
Diabetes supplies are most commonly covered under Medicare Part and Medicaid programs.
B. Diabetes supplies include glucometers, test strips, lancets, lancing
devices, alcohol swabs, needles, and syringes. Even though these Case Study: Prescription Drop-Off Window, Part 3
claims can be submitted online for adjudication, CMS still requires Maria checks out Jane’s atorvastatin prescription from the computer
extra paperwork to prevent fraud and waste. If a prescription does not system at the prescription pickup window. Jane tells Maria that her
contain all the information required by CMS, contact the prescriber mother is being released from assisted living after recovering from a
bad fall. The provider has told Jane her mother needs a hospital bed to
to acquire it. For example, for Medicare Part B claims, CMS requires
continue her recovery at home. Jane asks Maria if the pharmacy can fill
documenting whether the patient with diabetes uses insulin or not an order for the hospital bed.
when prescriptions are being filled for glucose testing supplies. The
1. What does Maria need to consider before she answers Jane’s
prescriber must also indicate the quantity of supplies ordered and how question?
often the patient is testing. First, Maria needs to know that a hospital bed is considered DME. To fill a
prescription for DME, the pharmacy must be DMEPOS-accredited. In this
case, the pharmacy is not accredited. Because the pharmacy does not fill
DME orders, they have created a resource of nearby DME providers to help
DME their patients who need DME. Maria can let Jane know this and provide
DME includes items like canes, hospital beds, nebulizers, ostomy her with other DME providers who can help her mother. Note that if the
pharmacy is so inclined, it can file for an accreditation exemption to allow it
supplies, toilet cushions, wheelchairs, and walkers. DME comes to be enrolled in Medicare to supply DMEPOS if it meets certain criteria.
with specific billing requirements when adjudicating claims through
Medicare Part B. One main difference from billing other third-party
payers is that Medicare Part B can only receive paper claims. Some
pharmacies contract with a company that receives the pharmacy’s electronic claim and then bills
Billing for DME
Medicare with a paper claim on the pharmacy’s behalf. Reimbursement lags because this process Specific billing requirements exist
does not occur in “real time” like prescription claims. when sending claims for diabetes
supplies and DME to Medicare
Part B. Know if the pharmacy is
DMEPOS-accredited.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 PRESCRIPTION AND MEDICATION ORDER INTAKE AND ENTRY

Billing for medical supplies under Medicare Part B entails following even more stringent guidelines
than when billing diabetes supplies. The filling pharmacy must be Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS)-accredited or have an exemption from the National
Supplier Clearinghouse to receive payment from CMS for these items. Prescribers’ orders must state
the reason for the product to be dispensed on the prescription, and additional paperwork may need
to be completed by the prescriber before the supplies can be billed. The pharmacy must keep
stringent documentation when both Medicare Part B and Part D are billed for supplies. This
information will be needed in the event of an audit. If this paperwork is not presented at the audit,
the pharmacy will be required to pay back any reimbursement they received for these claims.

CHALLENGE

1. Which of the following are considered DME? (Select all that apply.)
A. Diabetes glucose test strips
B. Nebulizers
C. Blood glucose testing meters
D. Ostomy supplies
E. Walkers
B, D, E. You answered incorrectly. DME examples include canes, hospital beds,
nebulizers, ostomy supplies, toilet cushions, wheelchairs, and walkers.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

Medication Product Selection Expiration Dates

Choosing the correct medication when filling a prescription Always check expiration dates
is a critical part of safe patient care. One way to prevent before dispensing. Remove
medication errors when making medication product selections expired medications from stock.
is to understand that each medication has a unique and
permanent product code, known as the National Drug Code
(NDC). The NDC identifies the medication manufacturer, the
formulation, and the size/type of product packaging. This is
like the UPC codes for consumer goods. Each NDC is made up
of three sets of numbers. The first set of numbers indicates
the manufacturer, the second set indicates the medication
strength and dosage form, and the third set indicates the package size. In the retail or community
pharmacy setting, the process of medication product selection when filling prescriptions is critical
for ensuring patient safety and satisfaction. Technicians must verify each prescription; select
the correct medication, dosage, and quantity; and prepare it for dispensing. This process requires
attention to detail and adherence to protocols in order to prevent errors. Unlike hospital or long-
term care facilities, retail and community pharmacies typically do not employ automatic dispensing
machines, relying instead on the expertise and diligence of pharmacy technicians to manually
manage and dispense medications.

The general process for selecting the proper medication is as follows. First, the technician or
pharmacist chooses the prescribed medication from the computer database. This selection generates
a patient medication label that prints with a barcode. The barcode is used in the pharmacy to verify
that the correct medication is used in both the order entry and filling process. The barcode is
associated with the NDC of the medication to be filled. The technician then retrieves the medication
from stock and scans the barcode located on the medication.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

The barcode on the prescription label and the stock bottle need to match for the computer to allow
the prescription to continue to be filled. Every prescription label should have the NDC (even when
using a barcode system) so that the individual filling the prescription can properly identify that they
are pulling the correct medication. In other words, when manually pulling the medication from the
shelf, the NDC on the prescription label and the NDC on the stock medication bottle must match.

CHALLENGE Case Study Instructions

1. When attempting to choose the correct product to fill a prescription, which of Read the following case study and use the information
the following statements is correct? provided in the chapter to answer a follow-up question
A. The first set of numbers in the NDC represents the medication strength and related to the scenario.
dosage form.
B. The second set of numbers in the NDC indicates the package size of the
medication.
C. The NDC is not required on prescription labels if barcoding systems are used Case Study: Medicine Mix-Up
in the pharmacy.
D. The barcode on the prescription label and on the stock bottle must match for The pharmacy technician went to the stock shelf to
the prescription to be filled. retrieve the medication to be filled and pulled it. The
Accutane was on the shelf next to the Aldactone.
D. The NDC is comprised of three sets of numbers with the first set of numbers Although the prescription was for Accutane, the
indicating the manufacturer, not the medication strength and dosage form. The
technician chose Aldactone, and counted the medication
second set of NDC numbers indicate the medication strength and dosage form, not
the package size. The NDC is still required on prescription labels even if barcoding to fill the prescription. This was not the correct
systems are used in the pharmacy in order to ensure proper identification and matching medication.
of medications. When using a scanning system, the barcode on the prescription 1. What are the steps that should be taken to prevent
label and on the stock bottle must match for the prescription to be filled.
this error from happening in the future?
To reduce medication errors, follow these three steps:
1.) Double-check protocols. After filling a prescription,
have another technician or pharmacist review it before
dispensing. Always match the National Drug Code (NDC)
on the label to the stock bottle to ensure accuracy.
2.) Use technology. Implement barcode scanning
systems to verify that the medication matches the
prescription. Use electronic verification tools to reduce
human errors in selecting or transcribing medications.
3.) Create a distraction-free zone. Designate specific
areas in the pharmacy for filling and refilling prescriptions
where interruptions are minimized. Work in these areas to
stay focused and reduce the chance of making mistakes.
By following these steps, you will help create a safer
and more accurate medication dispensing process.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

PACKAGING MEDICATIONS
This lesson covers all things packaging, from maintaining the original packaging to shipping.
Pharmacy technicians play a vital role in ensuring that medications are stored and dispensed
in the proper packaging, that the medications are handled safely, and that the packaging is
labeled properly. This lesson explores the types of medications that must remain in their original
packaging; how to handle hazardous materials in the pharmacy; appropriate containers for
medications that do not remain in manufacturer packaging; package labeling, inserts, and guides;
and package shipping. The technician has a hand in many of these activities.

Original Packaging and Hazardous Materials

Pharmacy technicians play a crucial role in dispensing medications safely and in adhering to federal
and state regulations. These regulations can require maintaining original packaging and adhering
to special handling procedures for hazardous materials. Therefore, pharmacy technicians must be
thoroughly trained in recognizing and handling these packaging requirements in order to protect
patient health and safety.

Maintaining Original Packaging

There are several circumstances where manufacturers and/or federal and state rules and regulations
dictate maintaining original packaging of prescriptions when dispensing: when packaging is critical teratogenic. An agent or
to the contents, when a package contains reconstituted medication powders, or when the package factor able to disturb the
contains teratogenic medications. One such medication that should remain in manufacturer growth and development
packaging because that packaging is critical to the contents is nitroglycerin sublingual tablets. of an embryo or fetus.
These tablets need to be dispensed in the original glass packaging to ensure efficacy because this
medication can adhere to the soft plastics often used in other forms of packaging. Dabigatran also
must be dispensed in the original packaging to protect the medication from degradation and
moisture. Some medications need to be in the original packaging because the packaging contains
special instructions for the patient. This includes azithromycin (Z-Pak) or a methylprednisolone
(Medrol) dose pack, which have packaging that directs the patient how to properly use the
medication. Accutane must also be dispensed in the original packaging because of the information
provided on the packaging itself.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

Moreover, many manufacturers are opting to package medications in a manner that eliminates the
need for repackaging upon dispensing from the pharmacy. This practice serves several important
purposes. It significantly reduces the likelihood of the medication being handled inappropriately
or being exposed to unclean or unsafe environments during the repackaging process. Retaining
medications in their original containers also helps protect them from potentially harmful factors,
such as light and moisture, that can degrade their potency or stability. Furthermore, maintaining
medications in their original packaging can reduce confusion since the unique appearance of a
manufacturer’s bottle can distinguish it from others in the inventory.
Teratogenic Medications
Medications that can cause birth
Reconstituted Medication Powders defects and require special handling
include, for instance, isotretinoin,
Medication powders that need to be reconstituted also need to be dispensed in the original
finasteride, dutasteride, thalidomide, and
container. Medications that can require reconstitution include antibiotic suspensions, such as methotrexate.
amoxicillin, cephalexin, and ciprofloxacin. Reconstituted medications need to be kept in their
original packaging to ensure proper storage conditions, accurate dosing, and to retain critical
information, such as expiration dates and specific handling instructions. The original packaging
often includes essential features that help maintain the medication’s stability and effectiveness. The
packaging also provides clear instructions for pharmacy staff regarding proper reconstitution of
the medication.

Teratogenic Medications personal protective equipment

(PPE). Clothing and equipment
A teratogen is an agent that can disturb the development of an embryo or fetus. Teratogenic
worn or used to provide
medications have the potential to cause birth defects. They often require special handling
protection against hazardous
procedures and may necessitate the use of specific personal protective equipment (PPE) during substances or environments.
handling in order to mitigate risks. By minimizing the need for repackaging and by adhering to
manufacturers’ packaging standards, pharmacies can ensure adherence to proper handling protocols
and enhance overall medication safety. There are several medications that pregnant people should
avoid. These medications should be labeled in the pharmacy. Some of the more common teratogenic
medications include isotretinoin, finasteride, and dutasteride, which can be absorbed through the
skin. Pregnant individuals (and those trying to conceive) should also take care to avoid thalidomide,
methotrexate, and any chemotherapy or antineoplastic agent.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

Hazardous Materials United States Pharmacopeia

United States Pharmacopeia (USP) <800> establishes standards for safely handling hazardous materials (USP) <800>. Provides
within health care facilities, including pharmacies. Requirements include storing hazardous standards for safe handling
medications in areas with negative or normal/neutral pressure as well as conducting compounding of hazardous medications to
activities within certified biological safety cabinets or compounding aseptic containment isolators
minimize the risk of exposure.
located in separate rooms with negative pressure. Furthermore, administering hazardous
medications necessitates the use of closed-system medication-transfer devices during compounding
activities and administration procedures in order to minimize the risk of exposure. There are
guidelines for garbing that emphasize the importance of wearing appropriate PPE tailored to the
specific tasks being performed. Cleaning protocols outlined in USP <800> mandate deactivation and
disinfection using oxidizers, cleaning with germicidal detergents, and final disinfection with sterile
alcohol to ensure proper sanitation. By adhering to these standards, health care facilities mitigate
potential hazards associated with handling hazardous medications and safeguard the health and
safety of both health care workers and patients.

CHALLENGE

1. Which of the following medications must be dispensed in the original packaging to ensure its
effectiveness and protect it from degradation?
A. Ibuprofen
B. Diphenhydramine
C. Nitroglycerin tablets
D. Aspirin
C. Nitroglycerin sublingual tablets must be dispensed in the original glass packaging to
protect the medication from adhering to soft plastics and ensure its effectiveness. Ibuprofen,
diphenhydramine, and aspirin do not require special packaging considerations.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

Other Containers for Dispensing

Although some medications need to be dispensed in the original packaging, many
medications are transferred to prescription vials to be dispensed. This transfer involves
counting or pouring medications into the appropriate packaging to ensure the integrity
and proper use of the medication.

Containers are usually amber in color but can be blue or green. These colored vials protect
the medication from light. Pharmacy technicians count medications on counting trays if
they are not dispensed from a machine. When counting a medication that commonly
causes allergic reactions (or leaves a residue), it is important to clean the tray before
counting a different medication. The most common medications to cause allergic
CHALLENGE.
reactions are penicillin- and sulfa-containing medications, such as sulfamethoxazole and
sulfasalazine. Counting trays should be cleaned with isopropyl alcohol by first applying a generous 1. The technician counts a
amount of the alcohol to a clean cloth or disposable wipe and then thoroughly wiping the surface of prescription for #30 amoxicillin
the tray, ensuring all areas, especially corners and edges, are disinfected. After cleaning, the tray (which is a medication in the
penicillin class) on the counting
should be allowed to air dry completely to ensure all residual alcohol has evaporated before using it tray. What is the next step the
again. technician should take prior to
counting another prescription on
When selecting packaging for medications, consider several factors. The medication dosage form the counting tray?
plays a pivotal role. Whether it’s a capsule, tablet, liquid, or solid dictates the type of container The tray should be cleaned thoroughly
needed for proper storage and administration. The size, shape, form, and quantity of the with isopropyl alcohol because this
medication is in a medication class that
medication must align with the packaging dimensions to ensure it can adequately accommodate commonly causes allergic reactions.
the prescribed amount.

Additionally, specific medication requirements, such as dispensing in glass, protecting from light
or heat, or needing refrigeration, necessitate specific packaging considerations to maintain the
medication’s efficacy and safety.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

The choice of prescription container requires a careful assessment of these factors to ensure optimal
storage, preservation, and administration of the medication. With all of these considerations in
mind, the technician chooses the packaging that is appropriate for the medication.

Prescription vials are typically used for tablets and capsules. Vials are measured in drams, and sizes
range from 6 to 60 drams. Smaller vials, such as those holding 6 or 8 drams, are typically used for
dispensing small quantities of medications. Larger vials, such as those holding 40 or 60 drams, are
used for bulkier medications or larger quantities.

The technician chooses from ointment jars of various sizes for ointments, creams, or suppositories. CHALLENGE
Ointment jars may also be used when the pharmacy specially compounds prescriptions. Dropper
1. Medication vials are usually
bottles package solutions or liquids needed in smaller quantities. Examples include medications for measured in drams. What is the
administration in eyes or ears or to infants. Blister packaging uses a medication card that includes typical range of sizes for these
individual compartments for each tablet. vials?  
A. 1 to 10 drams
According to the Poison Prevention Packaging Act of 1970, all medications must be packaged in B. 1 to 60 drams
childproof containers unless the patient requests otherwise. Note that a blister pack is C. 6 to 60 drams
not childproof. D. 6 to 120 drams
The most common sizes
range from 6 to 60 drams.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

DISPENSING MEDICATIONS automated dispensing

Pharmacy technicians are an integral part of the prescription dispensing process. The dispensing machines (ADMs). An
process involves creating a prescription label, picking the correct medication from stock, and
automated machine that
functions to store, dispense,
counting and measuring the quantity of medication as prescribed by the provider. The pharmacy
and track commonly used
technician carries out these responsibilities under the pharmacist’s supervision. Therefore, it is the
medications. It uses biometric
pharmacy technician’s role to accurately fill and dispense a prescription as prescribed. The user identification to allow
pharmacist completes the final check and verification of the prescription. This lesson concentrates hospital staff to access
on the role of automated dispensing machines in pharmacies and then covers selecting the correct medication for patient
medications using the National Drug Code (NDC). administration. They are
in most hospital units.

Automated Dispensing Machines National Drug Code (NDC). A

Automated dispensing machines (ADMs) are used in patient unique, 10-digit, 3-segment
number used to identify
care settings, such as hospital nursing units and long-term
and report medications.
care facilities, to streamline medication administration,
improve accuracy, and enhance overall efficiency. ADMs are
cabinets with differently sized drawers and compartments
that hold medications. They are also called unit-based
cabinets, automated medication delivery systems, and
automated dispensing cabinets. To access these cabinets,
health care workers must comply with different security
(C) JONES & BARTLETT LEARNING, LLC, AN ASCEND LEARNING COMPANY
passwords or physical locks based on the requirements of the
institution and the nature of the medication contained in the
ADM. A nurse or other health care provider may be able to retrieve medications by logging onto the
computer, for instance. Each person may have a different programmed access level, via password
or fingerprint, so they can each only retrieve certain items. With automated delivery systems, the
turnaround time for medication orders has decreased dramatically. Automated Dispensing
Machines (ADMs)
Before the use of ADMs, the medication dispensing process involved several manual steps. A nurse
ADMs have greatly decreased
would send a medication order to the pharmacy, where a pharmacist would receive it and enter the
the turnaround time for
order into the system. The pharmacist would then prepare the medication, and it would be delivered medication orders because the
back to the nursing unit. This process was time-consuming and prone to delays and errors due to order can be entered in the
the multiple handoffs and manual entry involved. With the introduction of ADMs, the process pharmacy and the nurse can
became significantly more efficient.
access it through the machine.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

The medication order is now entered into the pharmacy’s computer system, which interfaces with
ADMs located within the nursing unit. The patient’s medication profile is updated in real-time,
allowing nurses to directly access and retrieve the required medication from the dispensing cabinet.
This automated process reduces preparation and delivery time, minimizes human error, enhances
convenience for nurses, and improves inventory management, ultimately leading to better patient
care and operational efficiency.

ADM Security
These machines provide a high level of security for the hospital or health care facility. The
embedded computer system tracks every individual who gains access to any medication or supply,
based on the individual’s password or biometrics marker, such as a fingerprint. Some machines
require an additional level of security to access controlled substances and items that have a high risk
of theft or misuse. Some systems dispense medications one at a time. This is referred to as unit-
dose or unit-of-use dispensing technology. This allows access only to the exact units of medication
being used, not the whole inventory. Some machines also feature compartment-specific locks and
alarms to prevent unauthorized access and tampering with controlled substances.

Pharmacists often perform random checks on the machines to make sure the inventory is correct
and that the pharmacy technician has correctly filled the medication compartments. Pharmacy
technicians stock ADMs by first verifying and gathering the required medications from the
pharmacy inventory. They check each medication for accuracy, ensuring the correct medication,
dosage, and quantity. The technician then accesses the ADM using secure login credentials. They
then choose “refill medications” on the ADM screen and scan the medication barcode to alert
the machine of which medication is being refilled. The machine will allow access only to that
compartment. The technician then places each medication in its designated compartment within
the machine, updating the system to reflect the current inventory. Throughout this process,
the technician adheres to stringent security and accuracy standards, placing only the scanned
medication into the open compartment of the machine.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

ADM Cost Savings

Automatic dispensing machines offer significant cost savings for health care facilities by enhancing
efficiency and accuracy in medication management. One of the primary ways ADMs save money
is by recouping lost charges through accurate medication dispensing and billing. ADMs provide
instant inventory usage reports, which allow pharmacy managers to see exactly how much of
each item is in stock at any given moment. This real-time tracking helps in maintaining optimal
inventory levels, avoiding overstocking, and ensuring that medications are available when needed
without excessive surplus. The system’s ability to pull historical data and determine usage rates
for any specified period is particularly beneficial for inventory control. By analyzing these reports,
pharmacy managers can make informed decisions about purchasing and restocking, which helps
in cutting down on inventory losses. This precision in inventory management reduces waste and
prevents the financial loss associated with expired or unused medications.

ADMs also contribute to savings by reducing labor costs. Traditional medication dispensing requires
significant manual effort from pharmacists and pharmacy technicians, including order entry,
medication preparation, and delivery. With ADMs, much of this process is automated, allowing
pharmacy staff to focus on more critical tasks, such as patient care and clinical duties. This
reduction in manual labor not only lowers operational costs but also enhances productivity and job
satisfaction among health care staff.

ADMs and Patient Safety

ADMs significantly enhance patient safety in multiple ways. One key feature is the creation of
individual patient profiles within the system, which allows nurses and other health care providers to
access only the medications prescribed for each specific patient. This reduces the risk of medication
errors due to lookalike or soundalike medications, ensuring that patients receive the correct
medication and dosage.

ADMs also include features that further ensure that the right medication is dispensed to the right
patient, such as barcode scanning and electronic verification. Barcode scanning involves scanning
both the medication and the patient’s identification band, which cross-references the information
with the patient’s profile in the system. This double-check process helps catch any potential errors
before the medication reaches the patient.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

Another significant way ADMs improve patient safety is by reducing medication diversion.
Diversion, the theft or misuse of medications, particularly controlled substances, is a serious issue in
health care settings. ADMs enhance security through features like user-specific access codes,
biometric authentication, and detailed audit trails that track every transaction and access attempt.
These measures make it difficult for unauthorized personnel to access medications, thereby reducing
the risk of diversion. By maintaining a secure and monitored dispensing environment, ADMs help
ensure that medications are used appropriately and safely.

CHALLENGE

1. Which of the following statements about automated dispensing machines (ADMs) is correct?
A. ADMs increase the turnaround time for medication orders by requiring nurses to send orders
directly to the pharmacy for processing.
B. ADMs track individuals accessing medications, often based on their fingerprint biometrics,
ensuring a high level of security.
C. ADMs typically dispense medications in bulk, allowing access to the entire inventory of a
particular medication.
D. ADMs do not provide historical usage data or instant inventory reports, making it difficult for
facilities to manage inventory effectively.
B. ADMs streamline the medication dispensing process by allowing orders to be entered in the pharmacy and
by enabling nurses to retrieve medications directly from the machine. ADMs utilize various security measures,
including fingerprint biometrics, to track individuals accessing medications, which ensures accountability and
enhances security within health care facilities. ADMs dispense medications one at a time or in unit doses. ADMs
provide instant inventory usage reports and historical data for effective inventory management.D. The NDC is
comprised of three sets of numbers with the first set of numbers indicating the manufacturer, not the medication
strength and dosage form. The second set of NDC numbers indicate the medication strength and dosage form,
not the package size. The NDC is still required on prescription labels even if barcoding systems are used in the
pharmacy in order to ensure proper identification and matching of medications. When using a scanning system,
the barcode on the prescription label and on the stock bottle must match for the prescription to be filled.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 Preparing and Dispensing Prescriptions

Other Containers for Dispensing

Although some medications need to be dispensed in the original packaging, many
medications are transferred to prescription vials to be dispensed. This transfer involves
counting or pouring medications into the appropriate packaging to ensure the integrity
and proper use of the medication.

Containers are usually amber in color but can be blue or green. These colored vials protect
the medication from light. Pharmacy technicians count medications on counting trays if
they are not dispensed from a machine. When counting a medication that commonly
causes allergic reactions (or leaves a residue), it is important to clean the tray before
counting a different medication. The most common medications to cause allergic
CHALLENGE.
reactions are penicillin- and sulfa-containing medications, such as sulfamethoxazole and
sulfasalazine. Counting trays should be cleaned with isopropyl alcohol by first applying a generous 1. The technician counts a
amount of the alcohol to a clean cloth or disposable wipe and then thoroughly wiping the surface of prescription for #30 amoxicillin
the tray, ensuring all areas, especially corners and edges, are disinfected. After cleaning, the tray (which is a medication in the
penicillin class) on the counting
should be allowed to air dry completely to ensure all residual alcohol has evaporated before using it tray. What is the next step the
again. technician should take prior to
counting another prescription on
When selecting packaging for medications, consider several factors. The medication dosage form the counting tray?
plays a pivotal role. Whether it’s a capsule, tablet, liquid, or solid dictates the type of container The tray should be cleaned thoroughly
needed for proper storage and administration. The size, shape, form, and quantity of the with isopropyl alcohol because this
medication is in a medication class that
medication must align with the packaging dimensions to ensure it can adequately accommodate commonly causes allergic reactions.
the prescribed amount.

Additionally, specific medication requirements, such as dispensing in glass, protecting from light
or heat, or needing refrigeration, necessitate specific packaging considerations to maintain the
medication’s efficacy and safety.

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 Preparing and Dispensing Prescriptions

The choice of prescription container requires a careful assessment of these factors to ensure optimal
storage, preservation, and administration of the medication. With all of these considerations in
mind, the technician chooses the packaging that is appropriate for the medication.

Prescription vials are typically used for tablets and capsules. Vials are measured in drams, and sizes
range from 6 to 60 drams. Smaller vials, such as those holding 6 or 8 drams, are typically used for
dispensing small quantities of medications. Larger vials, such as those holding 40 or 60 drams, are
used for bulkier medications or larger quantities.

The technician chooses from ointment jars of various sizes for ointments, creams, or suppositories. CHALLENGE
Ointment jars may also be used when the pharmacy specially compounds prescriptions. Dropper
1. Medication vials are usually
bottles package solutions or liquids needed in smaller quantities. Examples include medications for measured in drams. What is the
administration in eyes or ears or to infants. Blister packaging uses a medication card that includes typical range of sizes for these
individual compartments for each tablet. vials?  
A. 1 to 10 drams
According to the Poison Prevention Packaging Act of 1970, all medications must be packaged in B. 1 to 60 drams
childproof containers unless the patient requests otherwise. Note that a blister pack is C. 6 to 60 drams
not childproof. D. 6 to 120 drams
The most common sizes
range from 6 to 60 drams.

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 Preparing and Dispensing Prescriptions

Medication Package Labeling PATIENT INFORMATION

Pharmacy name, Sample
Labeling the medication after it has been placed in the appropriate John Q. Smith Patient name
address, and Pharmacy 987 S 2nd St,
packaging is important for proper use and administration of the phone number 1234 Main Street City KS 12345
medication. The label is usually computer-generated and has the Example, KS 12345
PRESCRIBER INFORMATION
1.800.555.1234
information required by law. This includes the following: Dr. F Wilson Prescriber’s name
Prescription NO: 1234567-12345 DISPENSED: 12/15/20XX Dispense date
⦁ Pharmacy name, address, and phone number number TAKE TWO TABLETS BY MOUTH TWICE
DAILY FOR 14 DAYS Directions
⦁ Prescription number
CIPROFLOXACIN 250 mg tablets Name, strength,
⦁ Dispense date of the prescription and dosage form
QTY: 28 REFILL: No refills of the medication
⦁ Patient name Expiration date EXPR: Use before 3/15/20XX Number of refills
⦁ Directions for use
3 2390001441432526192 1
⦁ Name, strength, and dosage form of the medication
CAUTION: Federal law prohibits transfer
of this medication to any person other
⦁ Number of refills than for whom prescribed.
⦁ Prescriber’s name

⦁ Expiration date (state specific) CHALLENGE

⦁ Name or initial of dispensing pharmacist (state 1. Labeling medication appropriately is crucial for ensuring its proper use.
specific) This label is typically computer-generated and contains legally required
information. Sort the following items into required or not required on
⦁ “Caution: Federal law prohibits transfer of this prescription labels.
medication to any person other than for whom it was A. Patient’s name G. Date the prescription was
prescribed.” (federal legend) B. Patient’s date of birth dispensed
C. Patient’s gender H. Quantity of the medication
Medications dispensed in the original packaging still dispensed
D. Federal legend
receive a pharmacy-created label. It is important I. Prescription number
to make sure the label is appropriately placed on
E. Prescriber’s name
J. Medication manufacturer
the package so that it does not conceal important F. Prescriber’s phone number
Required on Prescription Label: Patient’s name, Federal legend, Prescriber’s name, Date the
information. For example, methylprednisolone packs
prescription was dispensed, Quantity of the medication dispensed, Prescription number.
have directions for proper dosing of the medication. It is Not Required on Prescription Label: Patient’s date of birth, Patient’s gender, Prescriber’s
critical that the pharmacy-created label does not conceal phone number, Medication manufacturer, The requirements for a prescription label
include: Pharmacy name, address, and phone number; Prescription number; Dispense
this information. date of the prescription; Patient name; Directions; Name, strength, and dosage form of the
medication; Number of refills; Prescriber’s name; Expiration date (state specific); Name or
initial of dispensing pharmacist (state specific); “Caution: Federal law prohibits transfer of
this medication to any person other than for whom it was prescribed.” (federal legend).

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 Preparing and Dispensing Prescriptions

Auxiliary Labels
Auxiliary labels serve as essential educational tools for patients, complementing the information For the nose
provided on prescription labels. These labels, often brightly colored to catch the patient’s attention,
are affixed to medication containers. Pharmacies typically maintain a diverse supply of these labels,
Do not refrigerate
ensuring they have representatives from various categories readily available.

Among the most utilized categories are those pertaining to administration and route of Chew tablets
administration, such as instructions for use in the eye or ear. Dosing information, including before swallowing
indications for dose adjustments, is another crucial alert called out by auxiliary labels. Storage
instructions, such as the need for refrigeration, help patients maintain the efficacy of their
medication. Dietary restrictions, such as directions to take with food or avoid certain substances
like grapefruit, are also conveyed through these labels. Additionally, labels may highlight expiration
dates to ensure patients use medication within its potency period. Warning and cautionary
labels provide vital information about potential adverse effects or precautions, such as the risk of
dizziness. Together, these auxiliary labels play a vital role in patient education and medication
adherence.

Some medications can require several auxiliary labels and others require none. The auxiliary label
is an extension of the pharmacy label. Therefore, do not place it over the pharmacy label, where
it could hide the instructions of the prescription. Place auxiliary labels next to the prescription
label. If unsure about which labels to attach, consult the pharmacist. Auxiliary labels often print
out alongside the prescription label. Sometimes, the stock medication container itself will have
indicators, such as “refrigerate,” to inform the technician of specific storage requirements and
which auxiliary labels to apply. See Table 5-1 for common auxiliary labels.

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 Preparing and Dispensing Prescriptions

table 5.1 Commonly Used Auxiliary Labels

CLASSIFICATION COMMONLY USED AUXILIARY LABELS

Contraceptives Take as directed.

Nonsteroidal anti-inflammatory drugs (NSAIDs) Take with food.
Narcotics Do not drink alcohol, and/or drinking may increase
the effects of the drug.
Macrolide antibiotics Take on an empty stomach.
All antibiotics Take until gone.
Sulfa antibiotics May cause sun sensitivity. Take with plenty of water.
Warfarin Do not take aspirin unless prescribed.

CHALLENGE

1. Match the category with the most used auxiliary label.

A. Contraceptives 1. Do not take aspirin unless prescribed.
B. Nonsteroidal anti-inflammatory drugs 2. Take with food
(NSAIDs) 3. Take until gone.
C. All antibiotics 4. Do not drink alcohol, and/or drinking may
D. Narcotics increase the effects of the drug.
E. Warfarin 5. Take as directed.
Do not take aspirin unless prescribed: Warfarin. Take with food: Nonsteroidal anti-inflammatory drugs (NSAIDs). Take
until gone: All antibiotics. Do not drink alcohol, and/or drinking may increase the effects of the drug: Narcotics. Take
as directed: Contraceptives. Auxiliary labels offer targeted guidance to patients regarding potential adverse effects
and necessary precautions. For contraceptives, patients are typically advised to adhere strictly to the prescribed
regimen with the instruction, “Take as directed,” ensuring optimal effectiveness. Nonsteroidal anti-inflammatory drugs
(NSAIDs) are often recommended to be taken with food to minimize gastric irritation, conveyed through the label,
“Take with food.” In the case of narcotics, patients are cautioned against alcohol consumption due to the increased risk
of adverse effects, with labels warning, “Do not drink alcohol” and/or “Drinking may increase the effects of the drug.”
For all antibiotics, patients are advised to complete the prescribed course to ensure full eradication of the infection,
succinctly stated as, “Take until gone.” For patients on anticoagulant therapy (such as warfarin), the label, “Do not take
aspirin unless prescribed” serves as a crucial cautionary measure to prevent potential interactions and complications.

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 Preparing and Dispensing Prescriptions

Other Patient Guidance Requirements patient package insert

Some medications require inclusion of patient information guides, patient package inserts, or (PPI). Patient labeling that
consumer information sheets. is part of the FDA-approved
prescription medication
Medication Guides labeling. PPIs are developed
Medication guides are paper handouts that the FDA requires be given to patients taking certain
by the manufacturer, approved
by the FDA, and required to
types of medications. The medication guide is considered part of the labeling. Manufacturers are
be dispensed with specific
required to produce them and alert pharmacists of their existence. These broad-based guides
products or classes of products.
address important patient safety concerns that are particular to a specific medication or medication
class. They contain FDA-approved language, often written for the lay person, to help avoid serious
adverse events. The FDA requires that medication guides be given with prescription medications and
biological products when the agency determines that the following is true:

⦁ Precautionary information is necessary to prevent serious adverse events.

⦁ Patient decision-making should be informed by information about a known serious side effect
with a product.

⦁ Patient adherence to directions for the use of a product is essential to its effectiveness.

Many medications require medication guides when dispensed. Most pharmacy management
systems will print the medication guides automatically when the prescription is filled. Some of the
most common medication classes that require medication guides include NSAIDs, antidepressants,
ADHD/ADD medications, insomnia medications, long-acting beta-agonists (LABAs), and products
containing isotretinoin. The FDA website lists all the medications requiring medication guides.

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 Preparing and Dispensing Prescriptions

Patient Package Inserts

CHALLENGE
A patient package insert (PPI) is a more specific document that accompanies prescription
medications, providing comprehensive information beyond what is typically included on the 1. The FDA requires that
prescription label. This insert ensures that patients receive essential details about that medication’s medication guides be
given with prescription
use, potential adverse effects, interactions, and proper administration. PPIs serve as a vital medications and biological
educational tool, empowering patients with important insights into their prescribed treatments. The products when the agency
inserts often include instructions on dosage, storage conditions, warnings, and precautions, and aim determines what is true
to enhance patient understanding and promote safe and effective medication use. about that medication?
Precautionary information is
Consumer Information Sheets: Consumer information sheets are required to accompany all new necessary to prevent serious
adverse events. Patient
prescriptions. A consumer information sheet helps all consumers understand key information about decision-making should be
their prescription medicine, including how to take it, store it, and monitor improvement. It also informed by information
about a known serious side
gives information on precautions and warnings, symptoms of serious or frequent adverse events,
effect with a product. Patient
and what to do in those events. The consumer information sheet offers more general information on adherence to directions
how to appropriately use a medicine than does a package insert. for the use of a product is
essential to its effectiveness.

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 Preparing and Dispensing Prescriptions

Medication Shipping CHALLENGE

Medications must be stored during shipping according to the manufacturer’s storage guidelines.
If a medication requires refrigeration, the medication must be shipped in a container that will 1. Which statement accurately
reflects the shipping
guarantee the medication remains at the manufacturer’s storage requirements. An example of this requirements for medications
is insulin, which needs to be stored and shipped at 2.2° to 7.8° C (36° to 46° F) to ensure efficacy. that require refrigeration?
When shipping medication, follow the laws of both the state the medication is shipping from and A. Medications can be shipped
the state the medication is shipping to. This ensures compliance with all applicable regulations since in any container.
both sets of laws may have specific requirements regarding the handling, packaging, and delivery B. Medications can be shipped
of medications. with ice packs regardless of
manufacturer guidelines.
States impose various regulations on the shipping of medications to safeguard public health and C. Medications must be shipped
ensure regulatory compliance. These regulations encompass licensing requirements, mandating that in a container that meets
the manufacturer’s storage
pharmacies or medication distributors hold specific permits to ship medications within or into their
guidelines.
jurisdiction. States commonly stipulate that medications can only be shipped with a valid
D. Medications must be shipped
prescription from a licensed health care provider, with some requiring adherence to electronic in a container with a built-in
prescription protocols or stricter regulations for controlled substances. Labeling regulations are also heating system.
prevalent, dictating that shipped medications must bear essential information, such as patient C. The container must meet the
details, dosage instructions, and expiration dates to facilitate safe usage. States may mandate manufacturers recommendations for
storage guidelines. Ice packs may not
temperature control measures for certain medications, necessitating the implementation of keep the medication at the required
monitoring and control systems to maintain stability during transit. Packaging standards are temperature for as long as it takes
to ship. When shipping medications
enforced to ensure medications are adequately protected from tampering or damage throughout the
that require refrigeration, such as
shipping process. States often require pharmacies to maintain comprehensive records of shipped insulin, it is crucial to use a container
medications, including tracking information, to ensure traceability and regulatory compliance. that ensures the medication
remains within the manufacturer’s
Patient consent may be necessary for medication shipments in some states, particularly for
specified temperature range in
recurring prescriptions or automatic refills. These regulations collectively aim to uphold the order to maintain efficacy. The
integrity of medication distribution and safeguard public health. Shipping comes up more frequently container would need to stay at
refrigeration temperatures, so it
for pharmacy technicians working at mail order pharmacies. In those instances, the technician may would not require a heating system.
be involved in packaging the medication to be shipped.

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 Preparing and Dispensing Prescriptions

ENSURING THE PATIENT RECEIVES THE CORRECT MEDICATION risk evaluation and mitigation
A pharmacy technician must take measures to ensure the patients receive the correct medications, strategies (REMS). A medication
and that they adhere to all safety guidelines for that medication. This lesson covers critical safety initiative that the U.S. Food
components of pharmacy practice, including risk evaluation and mitigation strategies (REMS); elements and Drug Administration (FDA)
to assure safe use (ETASU); the distinctions between legend medications, over-the-counter (OTC) requires for certain medications
medications, behind-the-counter (BTC) medications, and supplements; the importance of pharmacist with serious safety concerns to
consultations; and the detection of prescription forgeries. These elements collectively contribute to help ensure that the benefits of
safeguarding patient health and ensuring the accuracy and appropriateness of medication the medication outweigh its risks.
dispensing. REMS and ETASU highlight the specific safety protocols required for certain high-risk elements to assure safe use
medications. Pharmacist consultations serve as a final checkpoint to confirm that patients (ETASU). Required medical
comprehend their medication regimens, reducing the likelihood of errors. Additionally, detecting interventions or other actions
prescription forgeries is essential in preventing the misuse of medications. By mastering these by health care professionals
topics, pharmacy technicians will be well-equipped to support the accurate and safe distribution prior to prescribing or
dispensing the medication.
of medications.
legend medications. A medication,
chemical, or substance that has
REMS and ETASU been approved by the FDA and
can only be distributed to patients
REMS, or risk evaluation and mitigation strategies, are risk management plans mandated by the if they have a prescription from
FDA to ensure that the benefits of certain high-risk medications outweigh their risks. The steps a licensed medical practitioner,
required by these plans can be required either before or after the medication’s approval. ETASU, or as required by federal or state
elements to assure safe use, are specific FDA-issued safety measures that health care professionals law. Also called a prescription
must follow before prescribing or dispensing these medications, ensuring safe administration [Link] medications
and monitoring. carry the federal legend: “Federal
law prohibits the dispensing of this
medication without a prescription.”
REMS
over-the-counter (OTC) .
Risk evaluation and mitigation strategies (REMS) are required risk management plans containing Medication available for purchase
risk-minimization strategies to ensure that the benefits of certain prescription medications without a prescription.
outweigh their risks. REMS allow some riskier medications to stay on the market. The FDA
can require REMS before or after approving a medication and for a single medication or a class
behind-the-counter (BTC)
of medications. REMS might entail having health care professionals and distributors follow medications. A subgroup of over-
a specific safety procedure prior to prescribing, shipping, or dispensing the medication. Each the-counter medications available
strategy prescribed by REMS has a specific safety measure unique to the safety risks associated without a prescription but kept
with a particular medication or class of medications. Table 5-2 has examples of REMS risks behind the pharmacy counter.
and requirements.

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 Preparing and Dispensing Prescriptions

table 5.2 REMS

RISK EXAMPLE REMS ACTION

Decreased white blood cell count • Regular patient laboratory work

• Prescriber and pharmacy registration with REMS to dispense
• Example: Clozapine
Serious risk associated with use • Medication guide dispensed with each fill
• Example: All antidepressants, such as sertraline
Teratogenicity • Providing the patient with information regarding contraception
• Negative pregnancy test before each fill
• Prescriber and pharmacy registration with REMS to dispense
• Example: Isotretinoin
Potentially fatal risk of • Use of a communication plan to educate providers, caregivers,
neurological toxicity with use pharmacists, and the scientific community regarding recognizing
symptoms and the actions needing to be taken
• Example: Ciltacabtagene autoleucel

Elements to Assure Safe Use

Adjunctive to REMS, elements to assure safe use (ETASU) encompass Risk Evaluation and Mitigation Strategies (REMS)
required medical interventions or actions that health care
What REMS do:
professionals must undertake before prescribing or dispensing a
• Ensure that the benefits of certain prescription medications outweigh
medication to a patient. Additionally, certain actions may also be
their risks.
necessary for patients to take in order to embark on a treatment
• Issue specific safety measures tailored to the risk of each medication.
regimen. Pharmacies, practitioners, or health care settings that
• Ensure that health care professionals and distributors follow these
dispense the medication may need to obtain special certification to
procedures prior to prescribing, shipping, or dispensing.
ensure adherence to safety protocols.

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 Preparing and Dispensing Prescriptions

Legend Medications Versus OTC, BTC, and Supplements

The pharmacy technician must understand the distinction between prescription, OTC, and BTC
medications. Prescription (legend) medications are specifically authorized by health care providers
to treat specific conditions and require careful dispensing to the intended recipient based on
individual medical needs. In contrast, OTC medications are available without a prescription but
still necessitate vigilant monitoring to avoid potential interactions or adverse effects, particularly
when administered alongside other treatments. By upholding these distinctions and prioritizing
patient well-being, technicians play a vital role in safeguarding the accuracy and appropriateness of
medication use.

Legend Medications
Legend medications, as classified by the FDA, necessitate a prescription from licensed practitioners
– such as physicians, veterinarians, dentists, physician assistants, nurse practitioners, and, in
some jurisdictions, pharmacists – for dispensing. Labeling requirements for dispensing legend
medications include the pharmacy’s name and address, a serial or prescription number, the date
of fill, and the expiration date. Additionally, the prescriber’s name, the patient’s name, directions
for use, and cautionary statements must also be prominently displayed on the medication label.
These guidelines ensure the safe and appropriate use of legend medications in accordance with
regulatory standards.

Over-the-Counter
Over-the-counter (OTC) medications, as determined by the FDA, are considered safe for common
consumer use and do not require a written prescription. These products are labeled as suitable for
self-medication, but they do come with warnings and precautions to ensure safe usage. The label for
OTC medications includes essential information, such as the product name, the name and address of
the manufacturer, the distributor, and any person or place responsible for repackaging. Additionally,
it must list all inactive and active ingredients along with their quantities, net contents, required
cautions and warnings, and the name of any potentially habit-forming medication contained in
the formula. Adequate directions for use or consumption also accompany OTC medications to
ensure proper administration or consumption by consumers. These labeling requirements aim to
inform consumers about the contents, usage, and potential risks associated with OTC medications,
promoting safe and effective self-medication practices.

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 Preparing and Dispensing Prescriptions

The pharmacy can be the most accessible place for patients to obtain health care advice, so it’s
important to know the different sections of the OTC areas to direct patients to the products
that they are seeking. If the patient is asking questions requiring clinical judgment, consult the
pharmacist. Keep in mind that there are small differences in similar-seeming OTC medications.
When assisting the patient in finding the OTC product that the pharmacist suggests, look for
that exact product. Small differences can greatly impact the effectiveness of a medication. If the
pharmacist suggests that the technician help the patient find calcium citrate, and the technician
directs that patient to calcium carbonate, the patient might not get the same absorption from the
carbonate product. These small differences can also affect safety. If the pharmacist suggested
enteric-coated 81 mg aspirin and the technician directs the patient to aspirin 81 mg chewable, this
could cause stomach irritation.

Behind-the-Counter
A third type of medication is behind-the-counter (BTC) nonprescription products that carry an
element of risk. These must be purchased from the pharmacy counter itself due to extra warnings
or a specific registration requirement the pharmacist must keep. Examples of BTC products
include cough syrups that contain guaifenesin and codeine. These are Schedule V medications
that have specific limitations on how much and how often they may be purchased. Any products
containing pseudoephedrine or ephedrine must be BTC to control the illegal compounding of
methamphetamine. Emergency contraceptives may also be BTC because they require the purchaser
to be 17 years old, have a valid ID, and be recorded by the pharmacy.

The decision to classify products as BTC is made by the FDA. There is no exhaustive public list
of BTC products. When a customer asks for a BTC product, the pharmacy technician should first
verify the customer’s identification and ensure they meet any age or purchase limits. They should
then document the transaction according to state and federal regulations, including recording the
buyer’s information and the amount purchased, and finally, consult with the pharmacist to complete
the sale.

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 Preparing and Dispensing Prescriptions

Supplements
A wide array of dietary supplements are available in the pharmacy, ranging from vitamins and
minerals to herbal products and specialty supplements designed for specific health concerns. A
pharmacy technician plays a crucial role in assisting patients with identifying the right supplements
for their needs based on the pharmacist recommendation. They can also provide information on the
different types of supplements available. Technicians can help patients understand product labels,
ensuring they choose supplements that are safe and effective for their health conditions. They also
collaborate closely with pharmacists to verify that the chosen supplements do not interact adversely
with the patient’s prescription medications. By offering this guidance, pharmacy technicians help
ensure that patients make informed decisions about their supplement use.

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 Preparing and Dispensing Prescriptions

Omnibus Budget Reconciliation

Pharmacist Consultation Act of 1990 (OBRA ’90). Law
When dispensing prescriptions to a patient, it is important to be aware of state laws regarding that changed reimbursement
counseling. The Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90) increased the need for pharmacy limits and mandated drug
technicians because it mandated that pharmacists spend time performing drug utilization reviews utilization evaluation, pharmacy/
(DURs) and offering counseling to patients. This created the need for pharmacy technicians to assist patient consultation, and
pharmacists in filling prescriptions. educational outreach programs.
drug utilization reviews
While OBRA ‘90 set a federal standard requiring pharmacists to offer counseling to Medicaid
(DURs). An authorized,
patients, individual states have generally extended these requirements to all patients and specify structured, ongoing review
additional guidelines for the content and delivery of counseling sessions. As a result, the scope and of health care provider
specifics of mandatory counseling can differ significantly from one state to another, influencing prescribing, pharmacist
how pharmacists and pharmacy technicians conduct these interactions. The pharmacy technician’s dispensing, and patient use of
role in patient counseling primarily involves supporting the pharmacist to ensure the process runs medication to ensure patient
smoothly and efficiently. This includes preparing the medications, verifying patient information, safety. It reviews interactions,
and managing the workflow to free the pharmacist’s time for counseling. Pharmacy technicians allergies, duplicate/similar
must refer detailed questions and in-depth counseling needs to the pharmacist, as mandated by law medications, dose, and
and their scope of practice. other safety parameters.

The pharmacist counseling the patient at the time of pick up is the final check in making sure the
patient receives the correct medication. Asking questions such as, “Why did the doctor prescribe
this medication for you?” can help ensure that the medication the provider intended is being taken
correctly. The pharmacist can also ask the patient to do the teach-back method when counseling.
This is where the pharmacist asks the patient to explain back to them the instructions they were
given. This ensures the patient hears the instructions correctly. Informing the patient of adverse
effects can alert the patient if a medication might not be appropriate for them.

National Healthcareer Association ExCPT Pharmacy Technician Exam (CPhT) Study Guide Focused Review
 CALCULATIONS

SYSTEMS OF MEASUREMENT CONVERSIONS metric system. The most common

This lesson presents ways to perform unit conversions between and within the metric system, system in which pharmacy
apothecary system, avoirdupois system, and household system of measurements. Within these, pharmacy
calculations are completed.
technicians will be able to effectively calculate the quantities of medication to be dispensed for a apothecary system. A mostly
given prescription, the days’ supply for the prescription, individual, and daily doses. Technicians historical system in which pharmacy
perform conversions frequently in the course of a day’s work. calculations used to be completed.
Used to determine weight and
volume. This has largely been
Basic Concepts of Algebra replaced by the metric system.
Algebra is the foundational math used for performing pharmaceutical calculations at the technician avoirdupois system. A mostly
level. Each calculation requires an equation, one or multiple variables, solving equations for the historical system used to
unknown variable, as well as the basic mathematic concepts of addition, subtraction, multiplication, determine weight in ounces and
and division. pounds. This has largely been
replaced by the metric system.
Case Study Instructions household system. A system for
Read the following case study and use the information provided in the measurement calculations that are
chapter to answer follow-up questions related to the scenario. Case studies easily completed and measurable
may have more than one part. in a household setting.

days' supply. The number of days a

prescription will last given the amount
Case Study: Pharmacy Calculations, Part 1 of medication dispensed, the amount
of each dose, and the number of
Min is working in a pharmacy as a new technician. The pharmacy is busy times per day a medication is given.
and understaffed. There has been recent staff turnover resulting from the
discovery of multiple errors. Specifically, several errors involving improper equation. A mathematical
calculation of dosage and conversion of units resulted in patients receiving statement that determines that two
incorrect quantities and improper strengths of medication. Min is new to mathematical expressions are equal
the field, has only used math skills during her program, and has not yet put to one another, symbolized with =.
these skills into practice.
variable. A symbol that represents a
value in a mathematical equation.

unknown variable. The variable

in a mathematical equation that
requires the equation to be
solved to determine its value.

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 CALCULATIONS

Metric System conversion factor. A fraction

The metric system makes scientific and industrial measurements. This system is the international that in total equals 1 but
has different units in the
standard and is the approved system for use in the pharmacy setting in the U.S. In the metric
numerator and denominator
system, there are three basic units of measurement that can be scaled larger or smaller in
in order to convert from
increments of 10. These three basic units are grams (g), which measure mass; liters (L), which
one unit to another.
measure volume; and meters (m), which measure length.
dimensional analysis. This
To make a unit of measurement in the metric system either larger or smaller, use a conversion factor is a method for solving
within dimensional analysis. These conversion factors are listed as fractions or proportions to complicated calculations that
simplify the math required for unit conversion calculations. Each conversion factor explains the requires multiple sets of ratios
quantity of one measurement that is equal to a quantity of another measurement. For example, as or proportions. This method
listed below, 1,000 mcg is equal to 1 mg, 1,000 mg is equal to 1 g, 1,000 g is equal to 1 kg, and allows for easy tracking of units.
1,000 mL is equal to 1 L.

Common Conversion Factors and Dimensional Analysis

Dimensional analysis in pharmacy is a mathematical technique that represents associations between

various units of measurement. Because the units have this association or relationship, they can
be converted to one another, between the units of measurement, utilizing the conversion factors
mentioned.

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 CALCULATIONS

Example 1 Example 2
Using dimensional analysis, convert Using dimensional analysis, convert 60 mcg/100
900 mcg/1,500 mL into mg/L. mL into g/L.

1. First, write the given information in a 1. First, write the given information in a
fraction to easily use the conversion factors. fraction to easily use the conversion factors.

2. Convert the weight from mcg to mg first. 2. Convert the weight from mcg to mg, then
Then, in the same equation, convert the convert from mg to g, then in the same
volume from mL to L. This is dimensional equation convert the volume from mL to L.
analysis. This is dimensional analysis.

3. Cross out any duplicated units because they 3. Cross out any duplicated units as these cancel
cancel each other out. each other out.

4. Solve the equation.

4. Solve the equation.

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Apothecary System 1 dram

60
The apothecary system, which has European origins, is a traditional system used by both physicians 55 5
and apothecaries. It was previously widely used in the pharmacy field but has largely been replaced 50 10
by the metric system. Currently, the apothecary system is primarily only studied for its historical ¾ dram 45 minims 15 ¼ dram
significance, but will, on occasion, be found on a prescription. The basic units for this system of
40 20
measurement include weight-based measurements (grain [gr], ounce [℥], pound [lb], minim [♏︎]) and
35 25
volume-based measurements (dram [ʒ], fluid dram [fʒ], fluid ounce [fl oz]). 30
½ dram
¼ dram = 15 minims
Household System ½ dram = 30 minims
The household system is frequently used in the U.S.; it consists of measurements that can be made ¾ dram = 45 minims
1 dram = 60 minims
with household utensils. This system is often seen in pharmacy when converting the units of
Note: a dram = 1 tsp
measurements for a dose into everyday terms. The common units of measurement for the household
system include weight-based measurements (pound [lb], ounce [oz], grain [gr]) and liquid-based
measurements (teaspoon [tsp], tablespoon [tbsp], ounce [oz], quart [qt], pint [pt], gallon [gal]). Refer
to Table 6.1 for conversion factors. 12.5 mL 2.5 tsp

TABLE 6.1 Conversion Factors: Metric, Apothecary, Household 7.5 mL 1.5 tsp
METRIC SYSTEM APOTHECARY SYSTEM HOUSEHOLD SYSTEM

N/A I (1 minim) 1 gtt 2.5 mL 0.5 tsp

1 mL N/A 20 gtt
5 mL 1 dram 1 tsp
15 mL 0.5 fl oz 1 tbsp Case Study: Pharmacy Calculations,
30 mL 1 fl oz 2 tbsp Part 2
240 mL 8 fl oz 1 cup Min receives several scripts with multiple different
units of measurement. She is familiar and
480 mL 16 fl oz 1 pt comfortable with her ability to measure quantities
based on the metric system. She has recently
960 mL 32 fl oz 1 qt received medications, however, that contain fluid
3,840 mL 128 fl oz 1 gal quantities measured in drams, and medication
strengths in grains. Min has worked with these units
in training but is nervous about her ability to convert
these units back to the metric system in practice.

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 CALCULATIONS

Example 1 Example 2
A prescription is sent to the pharmacy with the A medication is ordered for the pharmacy’s
Sig: Take 2 tsp po bid x 7 days. The pharmacy inventory, but it comes in 450-mL bottles. The
only has oral syringes in milliliters available to pharmacy staff prepackages this medication
dispense this medication. How many mL is each into 120-mL bottles for the most common
dose? therapy, which is dosed in teaspoons. How many
doses will each bottle that is prepackaged by the
1. First, determine what the dose is.
pharmacy contain?

1. First, determine which bottle is being

2. Using the conversion factor, set up a referenced for the final answer.
proportion equation.

2. What is the question asking?

3. Cross out any like units. How many teaspoons are
in the 120-mL bottle
3. Using the conversion factor for milliliters to
4. Solve the equation. teaspoons, set up a proportion equation.

Final answer: The dose is 10 mL. 4. Cross out any like units.

5. Solve the equation.

Final answer: There are 24 tsp in each

prepackaged bottle of 120 mL.

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International or Military Time

International time, often called military time, is exclusively used within the institutional health
care setting. The use of military time removes the confusion regarding dose times or the times that
events occurred because it is based on a 24-hour clock rather than the 12-hour clock (with a.m. and
p.m.) that is standard in the U.S. Military time is expressed as a four-digit number, without a colon
between hours and minutes. For example, in regular time, the time could be written as 5:00 a.m.,
but in military time, this would be expressed as 0500.

In the military clock, times between 12:59 p.m. and 12:01 a.m. differ from the 12-hour clock. On the
24-hour clock, 1:00 p.m. changes to 1300, the next hour after 1200 (12 p.m.). One trick to make the
conversion is simply adding 12. In other words, convert 5:00 p.m. to military time by calculating
5 + 12 = 17, to determine that 5 p.m. is 1700 in military time. This applies to the minutes, as well:
Carry over the minutes into the last two digits of military time: 6:43 p.m. would be 6 + 12 = 18, carry
over 43 minutes: 1843.

Note that while this is based on a 24-hour clock, there is no 2400. The clock starts at 0000, the
equivalent of midnight, or 12:00 a.m., and goes until 2359, the equivalent of 11:59 p.m.

CHALLENGE

1. Match the regular time with the equivalent military time.

A. 6:00 p.m. 1. 2100
B. 12:00 p.m. 2. 1800
C. 6:00 a.m. 3. 1200
D. 11:00 p.m. 4. 2300
E. 9:00 p.m. 5. 0600
2100: 9:00 p.m. 1800: 6:00 p.m. 1200: 12:00 p.m. 2300: 11:00 p.m. 0600: 6:00 a.m. Each of these military
times is determined by first taking the regular time and determining if it is a.m. or p.m. For a.m. times,
the colon is removed, and any necessary leading zeros are added to ensure there are four digits. For
p.m. times, the time of day has 12 added to the hour digit and the colon removed. Remember that
12:00 p.m. is still 1200 as the 24-hour clock does not start counting higher until 1:00 p.m. (1300).

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PRESCRIPTION OR MEDICATION ORDER QUANTITY

Prescriptions and medication orders will arrive at the pharmacy in a few different formats. Some frequency of dose. How
many times per day a
prescriptions or medication orders will list the frequency of the dose and the days’ supply, which
medication is taken.
leaves the total quantity to be calculated. Other prescriptions or medication orders will list the
quantity and frequency of the dose, which leaves the days’ supply to be calculated. It is also
important for technicians to know the concepts of body surface area, dilution, and alligation when Professionalism Tip: Critical
determining medication order quantity. Body surface area may be considered when calculating Thinking
medication doses to ensure accurate dosing. This measure often factors in chemotherapy
Critical thinking for a technician involves
prescriptions and medications for pediatric patients. Dilution comes into play when the strength of evaluating and analyzing information to
a product on the market is greater than the strength prescribed. The technician will use these make informed decisions, ensuring both
techniques to dilute the concentration so it matches that prescribed. Similarly, alligation comes in accuracy and patient safety. For example,
a technician who notices a discrepancy
handy when a prescribed concentration is not available but falls in between two other
in a patient’s usual medication dosage
concentrations that are on the market. The pharmacy can compound a new concentration to meet will engage their critical thinking skills to
the prescription requirements using alligation. This lesson explores and provides examples of all of consult with a pharmacist and contact the
these concepts. prescriber, which may prevent a potential
medication error.

Days’ Supply, Frequency, Quantity

When the days’ supply is included, such as, “Take 1 tablet by mouth daily for 7 days,” the total
quantity needed can be calculated by multiplying the total dose required per day (1 tablet x 1 dose
per day) by the number of days (1 tablet daily x 7 days). When the total quantity is provided, such
as “Take 1 tablet by mouth twice daily, #180”, the days’ supply can be calculated by dividing the
quantity to be dispensed (180 tablets) by the total dose per day (1 tablet x 2 doses).

Sometimes, calculating the total quantity required per dose or per day can be tricky, especially with
oral solutions and suspensions. To determine these doses, it may be easiest to set up a proportion
equation, also known as cross multiplication. Cross multiplication comes in handy with oral
solutions and suspension because the concentration (weight/volume, typically mg/mL) is known.
This is called a proportion equation because the concentration given and the concentration of the
dose must be the same because the medication is the same. This means that when the required
volume or the required weight of the medication is known, the technician can solve for the other
unknown variable.

Some examples are listed below.

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Body Surface Area

Body surface area (BSA) is sometimes used when calculating medication dosages. This is considered
to be one of the most accurate ways to calculate because it accounts for the patient’s height and
weight. The most common scenarios in which BSA calculations are used are in chemotherapy
dosing and pediatric dosing. Typically, institutions that dose medications using BSA use their
electronic medical record system to calculate body surface area and include that information in the
prescription along with dosing information. BSA values are expressed in meters squared. To find the
dose of a medication for a patient, use dimensional analysis.

Example 1 Example 2
What is the total dose to be given to this What is the total dose to be given to this
patient? patient?

⦁ Patient Information: BSA 0.43 m2 ⦁ Patient Information: BSA 0.67 m2

⦁ Ordered Dose: 100 mg/m2 ⦁ Ordered Dose: 112 mg/m2

First, set up the dimensional analysis formula. First, set up the dimensional analysis formula.
The total dose in mg is the information being The total dose in mg is the information being
requested, so mg should be placed on top. requested, so mg should be placed on top.

Cross out any like units. Cross out any like units.

Solve the equation. Solve the equation.

43 mg 75.04 mg
The total dose for this patient is 43 mg. The total dose for this patient is 75.04 mg.
Remember not to round the answer unless
specifically asked to.

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DAYS’ SUPPLY
Technicians encounter prescriptions in which they need to calculate days’ supply to ensure proper
medication adherence and billing. Recall that days’ supply means the number of days a prescription
will last given the amount of medication dispensed, the amount of each dose, and the number of
times per day a medication is given. Most prescriptions are billed through insurance, which relies on
the days’ supply to determine the cost of the medication. Days’ supply also assists with controlling Drug Enforcement Agency.
the use of medications, especially those that are likely to be abused (such as narcotics). The The federal body that
oversees the sale, purchase,
pharmacy will meet Drug Enforcement Agency regulations by ensuring the correct calculation of days’
storage, and destruction of
supply. Technicians calculate the days’ supply of all medications during the prescription dispensing
all controlled substances.
process. Consider the following examples.

Example 1
A physician writes a prescription with the Sig: 2 tabs po tid, dispense 180 tablets. What is the days’
supply for this prescription?

First, determine what the Sig means.

2 tabs po tid is the equivalent of 2 tablets by mouth three times daily.

What is the total quantity of tablets needed to fulfill one day’s worth of medication?

2 tablets per dose × 3 doses per day = 6 tablets per day

Divide the requested quantity to be dispensed by the total number of tablets needed for one day’s
worth of doses.

Final answer: This is a 30-day supply of medication.

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Example 2
A provider writes a prescription with the Sig: 1 spray each nostril bid, dispense 120 metered doses.
What is the days’ supply for this prescription?

First, determine what the Sig means.

1 spray each nostril po bid is the equivalent of 1 spray in each nostril twice daily.
What is the total quantity of metered doses needed to fulfill one day’s worth of medication?

1 spray per dose × 2 nostrils × 2 times per day = 4 metered doses per day
Divide the requested quantity to be dispensed by the total number of tablets needed for 1 day’s worth
of doses.

Final answer: This is a 30-day supply of medication.

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 CALCULATIONS

Individual and Total Daily Dosage

Always verify medication dosages whenever they appear outside expected limits or when dosing for
children or older adult patients. For certain medications or patient populations, doses are calculated
and prescriptions written for a patient’s weight, if the weight is known. Dosing is usually written as
milligrams of medication per kilogram of body weight. It may be necessary to convert from pounds
to kilograms prior to calculating the dose. A technician will know, for instance, if the prescription is
for a child because date of birth is always on the prescription.

Example 1
A patient weighs 167 lb. They have a prescription for a medication that is dosed at 20 mg/kg. How
many mg of medication should be dispensed for this patient?

First, convert pounds to kilograms.

How many pounds are in 1 kg?

1 kg = 2.2 lb
To convert pounds to kilograms, a proportion equation is needed.

Cross-multiply these to simplify the equation.

Divide both sides by 2.2 lb to isolate X.

Solve for X and round to the nearest tenth.

Partial answer: The patient weighs 75.9 kg.

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 CALCULATIONS

Now, the dose needs to be determined.

What is the standard dose of this medication?

20 mg/1 kg
Set up another proportion equation.

Cross-multiply to simplify the equation.

Divide both sides by 1 kg to isolate X.

Solve for X.

Final answer: The appropriate dose of this medication for this patient is 1,518 mg.

Example 2
A patient weighs 126 lb. They have a prescription for a medication that is dosed at 10 mg/kg. How
many mg of medication should be dispensed for this patient?

First, convert pounds to kilograms.

How many pounds are in 1 kg?

1 kg = 2.2 lb
To convert pounds to kilograms, a proportion equation is needed.

Cross-multiply these to simplify the equation.

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 CALCULATIONS

Divide both sides by 2.2 lb to isolate X.

Solve for X and round to the nearest tenth.

Partial answer: The patient weighs 57.3 kg.

Now, the dose needs to be determined.

What is the standard dose of this medication?

10 mg/1 kg
Set up another proportion equation.

Cross-multiply to simplify the equation.

Divide both sides by 1 kg to isolate X.

Solve for X.

Final answer: The appropriate dose of this medication for this patient is 573 mg.

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 CALCULATIONS

Dimensional Analysis to Calculate Pediatric Doses

Pediatric doses can be calculated using dimensional analysis. Several different formulas can be used
to calculate pediatric dosing. Clark’s rule and Young’s rule for pediatric dosing are two formulas.
Another method for calculating pediatric doses is using BSA as discussed earlier. Determining which
method to use depends upon how the provider has written the prescription. If the dose is ordered in
mg/m2, then use BSA calculations. If the dose is ordered in milligrams only, then use Clark’s rule.
Consider this example:

The pharmacy receives a dose for a baby weighing 9 lb with an order of 20 mg/kg/dose. This means
for every 1 kg the child weighs, they should receive 20 mg of the medication.

Clark’s rule uses the following formula:

Young’s rule uses the following formula:

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 CALCULATIONS

Case Study: Pharmacy Calculations, Part 3

Min has been tasked with working on dispensing prescriptions for over-the-counter (OTC) products. Part of repackaging the
OTC medications into new bottles for the prescription is verifying the dosage of each medication. Min, remembering her
classes, knows that OTC medications for children can be determined using Clark’s rule.
1. A prescription comes in for OTC children’s acetaminophen (Tylenol). The prescription calls to adjust the dose per the adult
dose of 325 mg/dose. Using Clark’s rule, what would be the correct dose for a child who weighs 67 lb?
A. 145 mg
B. 66 mg
C. 325 mg
D. 319 mg
A. 145 mg is the correct answer. This is calculated by dividing the weight in pounds by 150, then multiplying by the adult
dose: 67/150 × 325 mg = 145 mg. 66 mg is incorrect. This is obtained by first converting the weight of the patient to
kilograms. 325 mg is incorrect. This is the adult dose of the medication. 319 mg is incorrect. This is obtained by incorrectly
converting the patient’s weight from pounds to kilograms by multiplying by 2.2 instead of dividing by 2.2.

2. A child weighing 88 lb is prescribed an oral antibiotic dosed for adults at 150 mg every 12 hours. What would be the child’s
dosage?
A. 44 mg
B. 88 mg
C. 7.33 mg
D. 40 mg
B. 88 mg is the correct answer and is obtained by dividing the weight in pounds by 150 and then multiplying by the
standard adult dose. 44 mg is incorrect and is calculated by completing the correct steps but then dividing by 2 due to
the q12h statement. 7.33 mg is incorrect and is calculated by completing the correct steps but then dividing by 12 due
to the q12h statement. 40 mg is incorrect and is obtained by first converting the child’s weight into kilograms.

3. A prescription is received for a child weighing 64 lb for a medication dosed at 175 mg bid for adults. How many mg will the
child receive per day?
A. 150
B. 75
C. 68
D. 34
A. 150 is the correct answer. This is calculated by dividing the child’s weight in pounds by 150, then multiplying by the adult dose
(175 mg), then multiplying by the number of doses per day. 75 is incorrect and is obtained by forgetting to multiply by the total
number of doses per day. 68 is incorrect and is obtained by first converting the child’s weight to kilograms. 34 is incorrect and is
obtained by first converting the child’s weight to kilograms and then forgetting to multiply by the total number of doses per day.

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Dilution diluent. The substance

Dilution is a process that a pharmacy will use to compound a medication when the commercially used to dilute a compound.
Either a liquid or a solid
available strength of a product is greater than what is prescribed. When this occurs, pharmacy
that is inert. It is added to a
personnel must dilute the commercially available medication with a diluent, or solvent, in order to
preparation to reduce the initial
create the desired strength of the medication. When discussing the concentration of a medication
concentration of a product.
that is a liquid, the concentration is expressed as a percentage. When discussing the concentration
of a medication that is a mass, the concentration is expressed as weight. Below are the formulas solvent. This is another
used to determine how much diluent is needed to reach the desired concentration. term for diluent.

TABLE 6.2 Solution Dilution Acronyms

VARIABLES DEFINITION

SV stock volume
SP stock percentage concentration
SW stock weight
DV desired volume
DP desired percentage concentration
DW desired weight

Volume (only three values are needed to perform calculations with these formulas):

SV × SP = DV × DP
Amount of diluent needed = DV – SV
Weight (only three values are needed to perform calculations with these formulas):

SW × SP = DW × DP
Amount of diluent needed = DW – SW

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 CALCULATIONS

Example 1
How many milliliters of sterile water must be added to a volume of 100 mL of a 20% stock solution
to prepare a 5% dextrose solution?

First, identify the variables to be used:

SV = 100 mL, SP = 20%, DV = ?, DP = 5%

Next, write the appropriate formula and fill in the variables.

SV x SP = DV x DP
100 mL x 20% = DV x 5%
Isolate the unknown variable by dividing both sides by 5%.

Next, solve the equation to find DV.

400 mL = DV
Finally, determine how much diluent, sterile water, is required by plugging in the appropriate
variables into the diluent calculation.

Amount of diluent needed = DV – SV

Amount of diluent needed = 400 mL – 100 mL
Amount of diluent needed = 300 mL
300 mL of sterile water is necessary to create the 5% dextrose solution.

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 CALCULATIONS

Example 2
How many mg of petrolatum must be added to a weight of 250 mg of a 25% stock solution to prepare
a 12% hydrocortisone ointment?

First, identify the variables to be used:

SW = 250 mL, SP = 25%, DW = ?, DP = 12%

Next, write the appropriate formula and fill in the variables.

SW x SP = DW x DP
250 mg x 25% = DW x 12%
Isolate the unknown variable by dividing both sides by 12%.

Next, solve the equation to find DW.

520.8 mg = DW
Finally, determine how much dilutant, petrolatum is required by plugging in the appropriate
variables into the diluent calculation.

Amount of diluent needed = DW – SW

Amount of diluent needed = 5 20.8 mg – 250 mg
Amount of diluent needed = 270.8 mg
270.8 mg of petrolatum is necessary to create the 12% hydrocortisone solution.

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Alligation Generally
Alligation is a grid-method calculation used to compound a medication when the prescribed
concentration of a medication is not available, but two other concentrations are available. This
method only works when the prescribed concentration lies between the two available concentrations
of medication available. This process will be the same for weights and volumes. A situation in
which alligation would be used is if a physician ordered 200 mL of 15% potassium chloride and the
pharmacy has 20% potassium chloride and 10% potassium chloride in stock. Because the desired
15% concentration falls in between the available 20% and 10%, an alligation would be sufficient.

parts of higher
Alligation 8-Step Process % strength

There is an 8-step process for completing alligations: desired

higher % strength
strength minus lower
Step 1. Draw a tic-tac-toe board. strength
Step 2. Place the desired strength in the middle square.
total parts
Step 3. Put the higher strength solution in the top left square. desired % desired %
strength strength

Step 4. Put the lower strength solution in the bottom left square. (Use 0 if
using an inert dilutant like sterile water or petrolatum).
higher
lower % strength
Step 5. Calculate the difference between the number in the top left square strength minus desired
and the middle square. Place this calculated number in the bottom right strength
square. Always use positive numbers as the answer. Do this same calculation
parts of lower
for the bottom left number and the middle square, placing this result in the % strength
top right square.

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Step 6. Create a fraction by adding the top right and bottom right squares together to create a denominator. The bottom
common denominator. Place the top right parts of higher
number of a fraction.
% strength
number above the common denominator to
create one fraction and place the bottom
right number above the common 70
denominator to create another fraction.

Step 7. Divide out each fraction to get a total parts

45 desired %
decimal number. Multiply this decimal strength

number for each by the total volume

needed. This will give the required volume
of each solution needed to combine in order 5
to create the requested concentration of the
prescription.
parts of lower
% strength
Step 8. Check the answer to ensure
accuracy by adding the two volumes
together. They should equal the total volume.
parts of higher
% strength

CHALLENGE
70 40 1. You receive an order for 90 g of 2% hydrocortisone ointment. In
stock, you have 1% and 2.5% hydrocortisone ointment. How much of
each ointment do you need to mix together in order to fill the order?
total parts A. 1% = 60 g & 2.5% = 30 g
45 desired %
strength B. 2.5% = 60 g & 1% = 30 g
C. 1.5 = 60 g
D. 2% = 60 g
5 25 2.5% = 60 g & 1%=30 g
The allegation method to subtract, add, divide and multiply,
will yield the correct calculations to where:
parts of lower
% strength subtracting 2.5 – 2 = 0.5, 2 – 1 = 1,
then adding 1 + 0.5 = 1.5,
then dividing 90/1.5=60,
then multiplying 1 × 60 = 60 g & 0.5 × 60 = 30 g
The sum of 60 g + 30 g = 90 g of a 2% hydrocortisone
ointment (Desired amounts)

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RATIOS AND FRACTIONS Ratios

Ratios are used in pharmacy calculations in order to show how two quantities are related to one Ratios show how two quantities are
another. A ratio can be written with two numbers separated by a colon, which would read as “two related to one another. A ratio can be
is to three” and would be expressed as 2:3. Ratios can also be expressed as fractions, in which the written with two numbers separated
numerator is the first number in the ratio and the denominator is the second number in the ratio. only by a colon or can be expressed as
fractions where the numerator is the first
Ratios are necessary for pharmacy professionals to know and understand because they are used number in the ratio and the denominator
is the second number in the ratio.
frequently when compounding medications. For instance, injectable medications come either in
a powder for reconstitution or in a vial as a liquid. In either formation, the concentration of the
medication is written and understood as mg/mL or milligrams per milliliter. This is a ratio. Recall numerator. The top
finding the necessary quantity or strength of a medication in oral solutions and suspensions; medication number of a fraction.
for injection is determined in this same way with the same proportion equation, using ratios.

Example 1
A bottle of amoxicillin oral suspension is to be reconstituted to a total of 100 mL. Once reconstituted,
the concentration will be 250 mg/5 mL. How many g total will the reconstituted amoxicillin oral
suspension bottle contain?

First, set up a proportion equation.

Cross-multiply the ratios.

Divide both sides by 5 mL to isolate X.

Solve for X.

The question is requesting an answer in grams. Using the conversion factor—a fraction that can be
reversed, is used for converting from one unit system to another, and equals 1—convert milligrams
to grams to solve for the final answer.

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Final answer: 5 g of amoxicillin are in 100 mL of the suspension.

Example 2
A 500-mL bag of normal saline contains 2,000 mg of vancomycin. How many mg of vancomycin are
in 100 mL of this IV bag?

First, set up a proportion equation.

Cross-multiply the ratios.

Divide both sides by 500 mL to isolate X.

Solve for X.

Final answer: 400 mg of vancomycin are in 100 mL of this solution.

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TEMPERATURE CONVERSIONS
While Fahrenheit is the common unit for temperature in the U.S., Celsius is far more widely used,
especially in countries that also use the metric system. The metric system uses multiples of 10,
and Celsius follows suit. Sometimes in pharmacy it is necessary to convert between Fahrenheit
and Celsius units. Technician should be familiar with these conversions because the available
thermometers in medication warmers, refrigerators, and freezers may only be available in one of
these units. Many medications have temperature restrictions, and technicians are often tasked with
ensuring that medications are stored properly according to manufacturer guidelines.

Conversion Equations
There are two Fahrenheit to Celsius equations pharmacies use to convert temperatures. By plugging
in numbers, the conversion becomes simple:

C equals F minus 32, divided by 9/5.

Alternatively, because 9/5 = 1.8, C equals F minus 32, divided by 1.8.

Likewise, there are two Celsius to Fahrenheit equations for the reverse conversion:

F equals C multiplied by 9/5, plus 32.

Alternatively, because 9/5 = 1.8, F equals C multiplied by 1.8, plus 32.

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Example 1 Example 2
A medication is required to be stored between Gerald is unpacking medications that just arrived
2° C and 8° C. The pharmacy thermostat reads in the order. It’s a cold day and it is snowing
72° F. Sally wants to know if this can be stored outside. He notices the 50-mL vials of mannitol
on the shelf or if it should be stored in the have crystalized. He remembers someone told
refrigerator. Convert the pharmacy thermostat him this medication must be warm to melt the
temperature to Celsius. crystals. The packaging states these should be
stored between 20° and 25° C. Unfortunately, the
First, identify what units the current digital readout on the pharmacy’s incubator only
temperature is and what units the temperature displays the temperature in Fahrenheit. Calculate
is being converted to, then pick a formula. the range the incubator should be set to keep the
mannitol in its liquid form.

Plug the known values into the chosen formula. First, identify what units the temperature range
is in and what units the temperature is being
converted to, then pick a formula.
Solve the equation to find the temperature in
Celsius.
Plug in the first value of the known temperature
range.
Final answer: The room temperature is 22.2° C,
which exceeds the storage requirements of the
medication. This medication should be stored in Solve the equation to find the low end of the
a refrigerator. temperature range in Fahrenheit.

Plug in the second value of the known

temperature range.

Solve the equation to find the high end of the

temperature range in Fahrenheit.

Final answer: The incubator in the pharmacy

should be set between 68 ° F and 77 ° F in order
to properly store the mannitol.

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 CALCULATIONS

PERCENTAGE CALCULATIONS
Percent (%) means per 100. These numbers represent portions or parts of a whole. Decimals and
fractions can both be converted separately into percentages, and percentages can be converted into
decimals or fractions.

Here are the formulas for conversions between decimals, fractions, and percentages.

In order to convert decimals to percentage, use the equation:

To convert fractions to a percentage, place the numbers in this equation:

To change percentages to decimals, fill in this equation:

To change percentages to fractions, use this equation:

Technicians will use the conversion of a percent to a decimal and a decimal to a percent when
calculating the concentration of a medication. For example, a 0.9% sodium chloride 1,000-mL bag
means that in 1,000 mL, 0.9.% of that volume is sodium chloride and the remaining volume is
the diluent (typically sterile water for injection, though refer to any labels for the most accurate
information). The percentage of sodium chloride is the concentration of the medication in that
IV solution.

Technicians also use percentage calculations to determine such things as the percentage of a
prescription that has been filled or is remaining to be filled, or determining what percentage of
medication is still in stock in the pharmacy versus the par level. Par level refers to the periodic
automatic replenishment level, which is a set level of a medication that is expected to be kept in a
specific area at any given time.

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 CALCULATIONS

Moreover, in pharmacy, percent can be expressed in three different ways including:

⦁ Weight/Weight (g/100 g): This percentage is the number of grams of solute dissolved in 100 g of the
final product.

⦁ Weight/Volume (g/100 mL): This percentage is the number of grams of solute in 100 mL of solution.

⦁ Volume/Volume (mL/100 mL): This percentage is the number of milliliters of solute in 100 mL of
solution.

Case Study: Pharmacy Calculations, Part 4

Min, having worked at this pharmacy for quite some time now, has been tasked with inventory management.
She is reviewing the par levels for various medications and must evaluate what needs to be ordered. All the
par levels in the system alert for reorder as a percentage based on the amount on hand and the maximum
amount the pharmacy wants on hand. Min needs to be able to convert percentages to whole numbers to
determine whole numbers on hand, maximum quantities stocked, percentage of par level, and the amount of
medication she needs to order.
1. There is an alert that metoprolol succinate is running low and needs to be ordered. The medication is
currently sitting at 22.5% on hand with a maximum quantity of 1,250 tablets. Metoprolol succinate comes
in 150-count bottles. If the technician wants to get as close to the max without going over the max, how
many bottles will they need to order?
A. 6
B. 7
C. 1
D. 42
A. 6 is the correct answer. This is calculated by first determining how many tablets the pharmacy has in stock by
converting 22.5% into a decimal (0.225) and multiplying this by the total quantity the pharmacy allows to have in stock
(1,250). This number (281.25) is then subtracted from the total quantity (968.75). This is how many tablets it will require
to get back to maximum quantity. The number of required tablets is then divided by the number of tablets in the
bottles that are purchased to replenish stock (150), leaving the final number of bottles needed. However, this number
must be rounded down to not exceed the maximum number of tablets. 7 is incorrect. This is obtained by following the
correct steps, but then rounding up to the next full bottle. This will have 1,331 tablets on hand, which will be over the
1,250 max quantity allowed. 1 is incorrect and would be obtained by calculating 22.5% of 1,250 and then dividing this
by the number of tablets in the manufacturer’s bottle and rounding down. 42 is incorrect and would be obtained by
calculating 22.5% of 1,250 and then dividing this by the number of tablets in the manufacturer’s bottle and rounding up.

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 CALCULATIONS

Example 1 Example 2
A prescription requires a total quantity of 60 The inventory system for the pharmacy states
tablets in order to complete a 30-day supply that there is only 32% of the par level for
refill. The pharmacy has 28 tablets in stock, and metformin 500 mg tablets remaining on the
the pharmacist has approved a partial fill for shelf. Aaron, the pharmacy buyer, remembers
this medication. What is the percentage of the that the pharmacy restocks metformin 500 mg
prescription that has been filled? tablets to 3,000 tablets. If Aaron is able to order,
to the tablet, the missing stock, how many
First, create a fraction that represents the tablets would they order?
number of tablets dispensed to the total number
of tablets required for the prescription to be First, the percentage of remaining tablets needs
completed. to be converted to a decimal number using the
formula.

Divide the denominator by the numerator and

note the decimal that results. To find the number of remaining tablets, the
percentage as a decimal can be multiplied by the
total number of tablets Aaron should have.

Using the equation for converting a decimal to a

percentage, multiply the decimal by 100. In order to find the number of tablets it is
necessary to order, the remaining quantity can
be subtracted from the expected quantity.
Final answer: 46.7% of the prescription has been
filled.
Final answer: Aaron would need to order 2,040
tablets to bring the metformin back to par level.

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 CALCULATIONS

Example 3
Dextrose 5% Water (D5W) means there are 5 g of dextrose in 100 mL of water. An order is written
to put 4 mg of norepinephrine in 250 mL of D5W. The nurse would like to know how many g of
dextrose are in the final solution.

Final answer: There are 12.5 g of dextrose in the 250 mL bag.

Example 4
Dextrose 50% water (D50W) 50 mL is used to treat low blood sugar. D50W is typically stored on the
nursing unit in the automated dispensing cabinet for quick access. This medication is on shortage,
and the pharmacy only has D10W. The nurse manager for the unit has asked the pharmacy to stock
D10W in its place. A technician and the pharmacist are trying to decide what size D10W bag to stock
on the nursing unit. How many mL of D10W would need to be given to equal the same amount of
dextrose in 50 mL of D50W?

If 50 mL are given:

Use dimensional analysis to cancel units.

Final answer: 250 mL of D10W would need to be given to give the same number of grams of dextrose
as 50 mL of D50W.

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 STERILE AND NONSTERILE PRODUCTS, COMPOUNDING, UNIT DOSE, AND REPACKAGING

STANDARD PRECAUTIONS standard precaution. CDC

Pharmacy technicians need to know about standard precautions because they come into play when rules and procedures put
technicians are compounding medications. As discussed in Chapter 3, Medication Classifications,
in place to eliminate the
potential for a medication to
there are many reasons that pharmacies compound medications for patients: A medication may no
become contaminated with
longer be manufactured. A patient may be allergic to a component in a commercially available
microbes or particles, protect
product. A special strength or dosage form may be needed that is not commercially available. personnel from infection,
Flavorings or other additives may make a medication more palatable to the patient. and prevent infection.
There are two categories of compounding: sterile and nonsterile. Nonsterile compounding consists
bloodborne pathogen
of compounding two or more medications in a nonsterile environment. Sterile compounding is
standards. OSHA requirements
compounding (combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise
for the prevention of, and
altering a medication) two or more medications to create a sterile preparation. Guidelines for response to, exposure to
compounding nonsterile, sterile, and hazardous products are developed by the United States bloodborne pathogens.
Pharmacopeia (USP). USP <795> outlines guidelines for pharmaceutical compounding of nonsterile
preparations. USP <797> outlines guidelines for pharmaceutical compounding of sterile preparations,
aseptic technique. A series of
and USP <800> outlines guidelines for handling of hazardous medications in health care settings. steps and precautions that are
These guidelines outline requirements for training, space, facilities, equipment, cleaning, sanitizing, used to decrease the chance
hygiene, beyond-use dates, and documentation. of contamination during the
preparation of a sterile product.
When compounding medications, technicians must use standard precautions to minimize the risk of
contamination. This lesson provides an overview of these precautions and details bloodborne
pathogen standards, standards regarding bodily fluids, and vaccines. Standard Precautions
1. Hand hygiene
Overview of Standard Precautions 2. Use of PPE such as gloves,
masks, and eyewear
Although sterile and nonsterile compounding do not require patient contact, the risk of infectious
3. Respiratory hygiene/cough
items within a work area is high because there is potential for contamination. The CDC has created a
etiquette
list of standard precautions, sometimes termed “universal precautions,” for the safety of health care
4. Sharps safety
workers, including technicians. These precautions are created based on common sense practices,
risk assessments, and personal protective equipment (PPE), with the aim to stop the spread of
5. Safe injection practices such
as aseptic technique for
infection from one individual to another. Standard precautions, according to the CDC, include hand parenteral medications
hygiene, use of PPE, respiratory etiquette, appropriate patient placement, proper cleaning and
6. Sterile instruments and
disinfecting of the environment and utensils, handling textiles and laundry carefully, and following devices
safe injection practices. 7. Clean and disinfected
environmental surfaces

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Bloodborne Pathogen Standard Case Study Instructions

Likewise, the Occupational Safety and Health
Administration (OSHA) has created the Bloodborne Read the following case study and use the information
provided in the chapter to answer follow-up questions
Pathogen Standard, which creates a set of standard related to the scenario. Case studies may have more than
precautions related to exposure to bloodborne one part.
pathogens. The OSHA Bloodborne Pathogen Standard
is specifically applied to compounding any time the
skin of a pharmacy employee is broken, such as in the
event of a needle stick or contact with broken glass. Case Study: Maintaining a Sterile
Bloodborne pathogens are infectious microorganisms Compounding Environment, Part 1
in human blood that can cause disease in humans.
Stacy is the sterile compounding trainer at a large sterile and
These pathogens include, but are not limited to, nonsterile compounding lab for a long-term care pharmacy.
hepatitis B, hepatitis C, and HIV. As part of the exposure A paramount portion of her job is to maintain the sterility of
control plan for the worksite, employers must detail the lab. Part of this is carrying out protocol operations for
employee protection measures. The plan must describe the cleaning and sanitizing of lab equipment and tools. The
other is making sure that all staff maintain proper training
how an employer will use engineering and work
and adherence to standard precautions.
practice controls, personal protective clothing and
The protocols for standard precautions in her workplace
equipment, employee training, medical surveillance,
are in place to maintain safety and sterility of the
hepatitis B immunizations, and other provisions as lab environment. These precautions include proper
required by OSHA’s Bloodborne Pathogens Standard. handwashing, proper use of PPE, and how to handle
Institutions may implement other policies to prevent exposure to various fluids including unknown substances.
the dissemination of highly contagious diseases, such as
testing employees for tuberculosis or requiring certain
immunizations.

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 STERILE AND NONSTERILE PRODUCTS, COMPOUNDING, UNIT DOSE, AND REPACKAGING

Bodily Fluids amniotic fluid. Fluid

Standard precautions address contamination from bodily fluids. Bodily fluids exist and are created in the amniotic sac
surrounding a fetus.
within the body in order to assist in the body’s function. Some examples of bodily fluids include
amniotic fluid, blood, breast milk, cerebrospinal fluid, feces, pericardial fluid, peritoneal fluid, semen, cerebrospinal fluid. Clear and
synovial fluid, urine, vaginal secretions, and vomit. Bodily fluids are a threat to the sterility and watery fluid that flows in the
safety of compounded medications, and they pose a great threat to health care workers by creating a brain ventricles around the
risk for infection. The specific CDC-supported guidelines that relate to dealing with bodily fluid brain surface and spinal cord.
exposure are proper hand hygiene, use of PPE, and proper cleaning and disinfecting of the
pericardial fluid. Fluid that
environment. In all cases, the best method for ensuring a break in the spread of infection is hand
exists within the pericardial
hygiene. PPE would be used when working with bodily fluids to ensure the safety of the staff. Proper
sac surrounding the heart.
cleaning and disinfecting of the environment is essential to ensuring that no infection or pathogens
spread amongst staff or patients. When a substance is unknown or when a staff member experiences peritoneal fluid. A liquid that
a break in their skin, it should be assumed that it is hazardous and should be contained using all is made in the abdominal
standard procedures according to an institution’s policy. cavity to lubricate the surface
of the tissue that lines the
abdominal wall and pelvic
CHALLENGE
cavity and covers most of the
1. Stacy notices that a staff member has a cut on their hand. Which of the following should Stacy organs in the abdomen.
suggest the technician do first, prior to cleaning and disinfecting the flow hood?
synovial fluid. Fluid secreted
A. Wash and clean the cut.
by a thin membrane in
B. Place a bandage on the cut. synovial joints that lines
C. Disinfect the cut with 70% ISO alcohol. the joint capsule.
D. Glove the hand and ignore the cut.
A.

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 STERILE AND NONSTERILE PRODUCTS, COMPOUNDING, UNIT DOSE, AND REPACKAGING

Vaccines attenuated. Weakened.

Vaccines are another component of standard precautions. They can protect against the risks posed This occurs to live vaccines
in which live viruses exist
by exposure to infectious items, including bodily fluids and bloodborne pathogens. For instance,
to help the patient build
OSHA requires employers to offer the hepatitis B virus vaccine series to all health care workers who
immunity without causing a
might encounter or be exposed to bodily fluids on the job.
manifestation of the disease.
The hepatitis B virus vaccine is a subunit vaccine, a vaccine that contains only the parts of a virus inactivated vaccines. Vaccines
that are best stimulated within the immune system and one of the less common types of vaccines in which the virus product
available. More common are viral vaccines and bacterial vaccines. Viral vaccines that are categorized is grown in a culture and
as live and attenuated include measles, mumps, and rubella, polio, rotavirus, influenza, smallpox, then destroyed to prevent
and varicella. Inactivated vaccines include polio (injection), hepatitis A, rabies, and influenza replication and disease.
(injection). Bacterial vaccines are also available as live attenuated vaccines. The most common
toxoid. Inactivated bacterial
example of this is the typhoid vaccine. Inactivated bacterial vaccines are also called toxoids; a
vaccine in which the bacteria
common example of this is diphtheria and tetanus toxoids and pertussis vaccine (DTaP). cells have been altered
to prevent the spread of
Vaccines do not protect against all potential risks of infectious exposures. Technicians should take
disease but can still induce
other precautions, such as avoiding contact with bodily fluids, wearing PPE, and disposing of sharps
antibody production.
in puncture-resistant containers. For PPE to be effective, it must be donned and doffed appropriately
and disposed of in the correct container, as detailed more thoroughly in the Infection Control and don. To put on PPE.
Personal Protective Equipment section. doff. To take off PPE.

CHALLENGE

1. Match the vaccine with its type. 2. Which of the following is the most effective way to prevent the
A. Influenza, intranasal 1. Inactivated viral vaccine spread of infection?
B. DTaP, injection 2. Attenuated viral vaccine A. Respiratory etiquette
C. Varicella, injection 3. Toxoid vaccine B. Hand hygiene
D. Typhoid, injection 4. Attenuated bacterial vaccine C. Using PPE
E. Polio, oral D. Cleaning and disinfecting the environment
F. Influenza, injection B. Hand hygiene is the single most effective way
to prevent the spread of infection.
Inactivated viral vaccine: Influenza, injection. Attenuated viral vaccine:
Varicella, injection; Influenza, intranasal; Polio, oral; Toxoid vaccine; DTaP,
injection. Attenuated bacterial vaccine: Typhoid, injection. Attenuated viral
vaccines are the most common type of vaccine because they cover more
common diseases, and attenuated vaccines are typically more effective than
inactivated vaccines. The most common toxoid vaccine is the DTaP, and
the most common attenuated bacterial vaccine is the typhoid vaccine. The
influenza vaccine comes as both an inactivated vaccine (injection) and as an
attenuated vaccine (intranasal) depending on the route of administration.

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 STERILE AND NONSTERILE PRODUCTS, COMPOUNDING, UNIT DOSE, AND REPACKAGING

INFECTION CONTROL AND PERSONAL PROTECTIVE EQUIPMENT

One of the most effective ways to prevent infections is handwashing. Contaminated hands of
health care providers are a primary source of pathogenic spread. Proper hand hygiene decreases the
infection control. Measures
that are practiced by
proliferation of microorganisms, thus reducing infection risk and overall health care costs, length of
health care professionals
stays, and ultimately, reimbursement. As a health care worker, hand hygiene should be performed
in various facilities to lower
regularly in the sterile and nonsterile compounding processes. the risk of contamination.
Technicians should know how, when, and why handwashing is critical for infection control. Aseptic
handwashing must precede compounding anything, including sterile products, nonhazardous garbing. The process
medication preparations, and hazardous medication preparations. Garbing should immediately follow
of donning PPE.
proper aseptic handwashing. This lesson covers performing hand hygiene, donning and doffing PPE,
and using gloves.

Aseptic Handwashing
There are many chemicals one can use to perform effective handwashing, though the correct
chemical is dependent upon the established procedures outlined by the institution at which the
compounding process is occurring. Some facilities stock povidone-iodine, some stock chlorhexidine
gluconate, and others only stock antibacterial soap and water. For aseptic handwashing, choose a
chemical that is both antibacterial and antimicrobial. It is imperative to rotate the antimicrobial
cleansers to prevent antimicrobial resistance. Use an alcohol-based hand rub, such as hand sanitizer,
in between tasks, when the hands are not visibly soiled, after touching something that is potentially
contaminated, or between garbing. This alcohol-based hand rub must be allowed to dry before
continuing any tasks. To handwash properly and aseptically, follow these guidelines.

Nails and Jewelry

Remove nail polish, jewelry, and artificial nails before handwashing. Keep nails short and clean.

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Washing
Handwashing takes a minimum of 30 seconds to perform.

1. If a foot pedal is available to operate the sink, use that to turn on the warm water.
2. Wet the hands, wrists, and forearms up to the elbow with water.
3. Using circular motions, clean from the wrist to the elbow.
4. Rinse the cleanser from the hands and arms while holding hands in the upright position; this
means that the water will flow down from the fingertips to the elbow into the sink.

5. Dry hands using a lint-free, disposable paper towel.

6. Turn off the water by releasing the foot pedal.
7. In addition, do not shake the hands or arms. If at any point the hand or arms touch the sink,
restart the handwashing process. If the sink does not have a foot pedal to turn the water off, use
a lint-free, disposable paper towel to turn off the water to prevent cross contamination.
anteroom. The smaller
outer room that leads into
Garbing the buffer/clean room and
No outerwear, such as jackets or sweaters, may be worn in the compounding area. Remove these is used for garbing.
items before handwashing and garbing and store them elsewhere, along with any electronics such as line of demarcation. A line
cellphones. Garbing is to be performed in the anteroom. Many institutions have a visible line of that separates the clean
demarcation separating the entry of the compounding area that is open to anyone from the clean areas from the non-clean
anteroom area in which preparation for sterile compounding occurs. Following the handwashing areas, such as the entry to the
procedure, it is time to don PPE. The order in which garbing occurs is important because the dirtiest compounding area (non-clean)
areas should be addressed first, and the cleanest areas should be addressed last. from the anteroom (clean).

CHALLENGE

1. Stacy observed that a technician did not remove a bracelet prior to handwashing. What will Stacy
recommend for the technician to do?
A. Keep the bracelet on for now.
B. Disinfect the bracelet with 70% ISO alcohol.
C. Remove the bracelet.
D. Wash the bracelet with soap and water.
C. Guidelines stipulate best practices are to remove nail polish, jewelry, and artificial nails before handwashing.

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 STERILE AND NONSTERILE PRODUCTS, COMPOUNDING, UNIT DOSE, AND REPACKAGING

Generally, all garb, with the exception of the gown and gloves, is donned prior to handwashing.
After handwashing occurs, the gown is donned, then an alcohol-based hand rub is used, which is a
second instance of hand hygiene. Then sterile gloves are donned. Here are the details. First, apply
an alcohol-based hand rub. Then, place a bootie or shoe cover on, one foot at a time, setting each
covered foot over the line of demarcation. Use an alcohol-based hand rub again. Place a bouffant cap
on the head with a mirror to ensure all the hair is covered. Use an alcohol-based hand rub again. If
applicable, don a beard cover and reapply hand rub. Don a mask and ensure that it covers the nose
and mouth securely. Perform aseptic handwashing. Don a gown and ensure that it is fastened or
tied securely. Apply an alcohol-based hand rub again. Enter the buffer room, if applicable to the
specific compound being made. Don sterile, powder-free gloves.

When compounding is completed and PPE must be doffed, the procedure depends on the policies
of a given facility. In many instances, a facility will ask that the gown is saved until the end of the
shift unless it is soiled. If this is the case, then the gown should be removed, ensuring that no part
of the gown touches the floor. No other PPE items should be saved. PPE can be discarded in the trash
unless it is soiled with bodily fluids, in which case they should be discarded into a biohazard bin.

Gloves
Don sterile, powder-free gloves using a specific process so as not to compromise their sterility.
Begin by opening the sterile glove package on a clean surface. Do not touch the fingertips of the
gloves. Glove one hand by grabbing the inner cuff with the other hand, pulling the glove on, and
pulling the cuff over the gown. Repeat the process for the second hand while ensuring only the
sterile areas of the gloves are touched. Ensure that the gloves are well fitting and there is no excess
glove material at the fingertips. If contamination occurs (a break or violation of the sterile field) use
an alcohol-based hand rub. Examine the gloves to ensure absence of defects, holes, or tears.

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 STERILE AND NONSTERILE PRODUCTS, COMPOUNDING, UNIT DOSE, AND REPACKAGING

PRODUCT COMPOUNDING
Product compounding occurs in both sterile and nonsterile environments to produce sterile and
nonsterile compounds, respectively. Personnel must be trained in each process, and technicians
must have the supervision and final product approval of the pharmacist before dispensing any
compounded products. The sterile compounding process relies on aseptic techniques to maintain the
sterility and safety of the compound. The nonsterile compounding process does not rely on aseptic
techniques, though every effort should be made to ensure the compounded products are as clean
as possible.

Sterile Compounding
high-efficiency particulate
Many of the operating procedures and rules about the compounding environment are directed at
air (HEPA) filter. A high-
decreasing particles (dust, dirt) in the air and near the hood(s) where sterile compounds are
efficiency particulate air filter.
prepared. The hood should be located away from busy areas of the pharmacy department and in a
separate room built for sterile compounding only. Boxes and cartons will create a lot of particulate first air. The air from the HEPA
matter and should not be stored near the compounding area. The particulate matter from cardboard filter that passes over materials
boxes has the potential to clog the high-efficiency particulate air (HEPA) filter. It is important not to and is contaminant free.
block the HEPA filter because first air is the cleanest air. First air is the air pushed into the sterile IPA. Isopropyl
compounding area directly from the HEPA filter. It is the only air in which there are no particulates, alcohol used to clean many
microbes, or pathogens. Many pharmacies have a policy of assembling all the needed components of surfaces in the pharmacy.
a prescription on a cart, then wiping down the cart and supplies with sterile IPA before entering the
compounding area. Computers and printers should not be near the hood. Pens, pencils, calculators,
and paper may be necessary in the compounding room but should never be in the
compounding hood.

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Equipment and Supplies Ampule Syringes

Syringes
Syringes used for sterile compounding are clear in color and sterile. They can
be either slip tip, where the needle slides on and off, or Luer Lok, where the
needles screw onto the syringe. They are available in various sizes, from 0.5 to 60
milliliters. Use the smallest syringe necessary to measure the required volume.

Needles
Various types of needles are used for sterile compounding. Needles vary in size
by gauge and length in inches. Needles with a larger number for the gauge of
the needle have a smaller diameter, and needles with a smaller number for the
gauge have a larger diameter. Common needle gauges used range from 15 to 25 horizontal laminar flow hood.
gauge. Needle length is dependent on the application. For example, longer needles are necessary A hood used for preparing
for IM injections, and shorter needles are used for subcutaneous injections. Use filter needles when nonhazardous IV medications.
drawing up medications from ampules to filter out glass. Use vented needles to vent air in and out of direct compounding area.
medication vials when reconstituting. The 15 centimeters (6
inches) inside of the primary
Laminar Flow Hoods engineering control where
There are two types of laminar flow hoods used to compound sterile products: vertical laminar flow compounding takes place.
hoods and horizontal laminar flow hoods. Vertical laminar flow hoods are typically used to compound
compounded sterile product.
hazardous medications and involve airflow starting with the HEPA filter at the ceiling flowing down
A compounded sterile dosage
to the direct compounding area. This airflow prevents contaminated air from being blown directly
form that results from mixing
onto the compounding technician. Horizontal laminar flow hoods are used only for compounding
pharmaceutical ingredients
non-hazardous medications and consist of a HEPA filter at the back of the laminar flow hood with for patient preparation in a
air moving forward across the direct compounding area. controlled environment.
Ampules
CHALLENGE
Ampules are glass containers used to store
sterile medications. They must be broken 1. A technician has just cut themselves while breaking an ampule. Which of the following
should Stacy and the technician do to maintain a sterile environment?
prior to withdrawing medication. Use a filter
needle or straw to filter out glass shards that
A. Maintain a workflow so as not to interrupt batch processing.
would contaminate the compounded sterile B. Attend to the injury immediately and pause sterile compounding.
product. Ampules are always single- C. Re-clean and disinfect the flow hood.
dose vials. D. Bandage the cut, re-wash, and glove without cleaning and disinfecting the flow hood.
B. When a technician sustains an injury while breaking an ampule, it is crucial to prioritize
their health and safety by attending to the injury immediately and pausing sterile
compounding to prevent potential contamination of the sterile environment.

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Vials Vial Sharps Container

Vials are plastic or glass containers with rubber stoppers that store sterile liquids. There are
single-dose vials and multiple-dose vials. Single-dose vials do not contain preservatives
and must be discarded after one use. Multiple-dose vials contain preservatives and can
be used up to 28 days unless the manufacturer states otherwise. Multiple-dose vials must
always be labeled with the date opened and initials.

Isopropyl Alcohol
Sterile 70% IPA is used to sterilize supplies and surfaces in the clean room. Pre-saturated
IPA swabs sterilize the tops of vials and ports of solutions prior to injection.

Repeater Pumps
These automated compounding systems used to measure and transfer ingredients from a source
bag to another container are helpful when reconstituting powders. Automated compounding
Luer-to-Luer connector
systems are useful when mixing total parenteral nutrition bags or chemotherapy base solutions.

Empty Evacuated Containers

2
1
These empty glass vials or empty IV bags store or mix ingredients.

2
1
Luer-to-Luer Connectors
Luer-to-Luer connectors are used to transfer fluid from one syringe to another without a
needle.
Repeater pump
Syringe Caps
Syringe caps cover the top of a syringe. Syringe caps can be basic or tamper
evident (used with narcotics).

Sharps Containers
Two types of sharps containers are in the clean room. Red sharps containers
are used for needles, syringes, vials, and ampules. Yellow sharps containers
are used for all items used when compounding chemotherapy or hazardous
medications, including PPE.

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 STERILE AND NONSTERILE PRODUCTS, COMPOUNDING, UNIT DOSE, AND REPACKAGING

Aseptic Technique
To maintain a sterile environment for compounding sterile products, always use aseptic technique.
Aseptic technique plays a significant role in infection control. USP <797> guidelines set out the steps
to adhere to aseptic technique and ensure a contaminant-free environment. Here is an overview of
the guideline requirements, followed by details.

⦁ Train personnel on aseptic technique, hand hygiene, and proper garbing.

primary engineering controls.
⦁ Evaluate personnel through observation, testing, media fills, and fingertip sampling.
Another term for compounding
⦁ Monitor surface microbial contamination, temperature, and humidity. hoods that provide an ISO
Class 5 environment or better.
⦁ Review primary engineering controls (such as laminar flow hoods), especially those used for
hazardous medications.

⦁ Remodel facilities and update cleaning and disinfecting procedures.

Clean the primary engineering controls throughout the day and document the cleaning on a
handwritten or electronic log. Clean by first wiping the hood with sterile water to remove any debris
and dissolve any sugars. Then, disinfect the hood by pouring a small amount of sterile 70% IPA onto
a sterile, lint-free pad. To avoid contaminating the cleanest part of the work surface with particles
from the dirtier parts in a horizontal laminar flow hood, start by cleaning the ceiling of the hood,
followed by the sides of the hood, then the bar. Next, clean the direct compounding area and the
surrounding 15-centimeter (6-inch) zone. Be sure to wipe from the filter to the front edge of the
work surface in a broad, overlapping, side-to-side motion. Do not spray alcohol within the hood or
directly on the filter, because this can damage the HEPA filter. Any company granted the authority
to certify the primary engineering controls can do so. The frequency at which these are certified is
regulated by The Joint Commission. The Joint Commission serves as an accrediting body for hospital
systems, though accreditation is not required for a hospital to be open and running.

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USP <797> describes minimum frequency for cleaning and disinfecting compounding areas. Clean barrier isolator. Another term
laminar flow hoods and barrier isolators at the beginning of each shift, before each batch preparation, for a glove box that is in an
every 30 minutes during continuous compounding of a singly compounded sterile product, and when encapsulated compounding
contamination is suspected (such as spills or drops). Clean counters and work surfaces in the buffer cabinet with gauntlet
rooms and anterooms daily. Mop floors daily. Mops and other cleaning materials (wipers and gloves for quick use without
sponges) should be nonshedding, preferably composed of synthetic microfibers, and are not used to the need for garbing.
clean areas outside of the buffer and anterooms. The mop and mopping closet must be dedicated to
the clean room and may not be used in other areas of the pharmacy or institution. All single-use
cleaning materials should be discarded after one use. Clean walls, ceilings, and storage bins monthly
with approved cleaning agents. Clean counters, bins, and hoods with sterile 70% IPA.

Quality Assurance
Media fill testing and gloved fingertip testing are conducted for quality
media fill test. A test designed
assurance regarding compounded sterile products. The technician to promote microbial growth
must pass the initial fingertip test and media fill test prior to being to ensure that compounding
allowed to compound sterile products for human use. Ongoing testing personnel can maintain sterility.
occurs on an annual schedule or as needed. A failed media fill test
indicates a contaminated product and will prevent staff members from
continuing to compound until they complete remediation, followed by
a passing media fill test. Written and/or oral exams may be given to
ensure competency.

Media Fill Testing

A media fill test is designed for each type of risk level of compounding. Low-risk compounding
involves mixing three or fewer sterile ingredients. Medium-risk compounding involves mixing more
than three sterile ingredients. High-risk compounding involves mixing nonsterile ingredients and/ IV piggyback. Flexible
or mixing ingredients in a nonsterile environment. Commercially available media fill tests use a soy containers or bottles, usually
made of PVC, intended to be
broth inside of an IV piggyback that is intended to promote the growth of microorganisms if
placed on top of a primary IV
contaminated. Media fill tests must be completed at least every 6 months for personnel
with tube connection sets.
compounding Category 1 and 2 compounds and at least every 3 months for personnel compounding
Category 3 compounds (American Society of Health-System Pharmacists, 2023, USP <797> Key
Changes). New pharmacy staff are required to complete three media fill tests correctly.

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Gloved Fingertip Testing

To complete gloved fingertip testing, first practice preliminary procedures including hand hygiene
and garbing. Place gloved fingertips gently on the agar surface of an agar plate, which is designed
to detect the presence of microorganisms by promoting their growth. The gloved fingertip test is
incubated between 30° and 35° C (86° and 95° F) for at least 48 hours and then between 20° and 25° C
(68° and 77° F) for at least 5 additional days. After incubation, the gloved fingertip tests are read by
checking the agar plates for any signs of bacterial growth. Positive bacterial growth means that the
personnel member who performed the gloved fingertip test was unable to maintain sterility when
donning their gloves. At this point, the personnel member may repeat the gloved fingertip test or be
barred from compounding per their specific pharmacy.

Sterile Compounding Process

There are many products that are necessary to be sterile, and there are also many that do not
have this requirement. The determination that exists for whether a product is sterile lies in the
administration route. For instance, oral medication is not required to be sterile because, just like
food, oral medication is broken down by the digestive system, and the risk of infection from a
nonsterile oral product is low. Conversely, an IV bag must be sterile because this medication is
introduced directly into the bloodstream through the vein, which carries an increased risk of
infection. One route of administration that should be sterile is ophthalmic, because the eye itself is a
sterile area. If there is ever a question regarding whether a compounded product should be made in
a sterile or nonsterile environment, it is always best practice to ask.

Gather all materials needed at the hood and only compound one product at a time. Ensure all
containers are sealed with no visible signs of contamination. If a container shows signs of
contamination, document it appropriately and discard it according to facility procedures. Keep all
products within at least 15 centimeters (6 inches) of the hood on the direct compounding area. There
is often a mark within the hood that indicates the 15-centimeter (6-inch) mark. Any supplies that
are taken outside of the 15-centimeter (6-inch) zone are contaminated and must either be discarded
or wiped down with sterile 70% IPA, depending upon the item.

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Review the medication order and verify any calculations. Confirm that there are no chemical or
physical incompatibilities among ingredients. Clean the tops of the product vials and any ports with
one alcohol swab each and allow these to dry. Attach the needle to the syringe. Do not touch any bevel. The slanted part
critical site of the needle or syringe. Critical sites include the vial top, syringe tip, syringe plunger, of the needle tip where
all parts of the needles except for the cap, and fluid bag ports. Avoid blocking airflow. Remove the the opening is visible.
cover from the needle and pull back the plunger of the syringe to the desired volume. Insert the
coring. The process where
needle at a 45° angle into the vial with the bevel facing upward. This prevents coring. Inject the air part of the rubber stopper
into the vial and withdraw the desired amount of medication. Insert the appropriate amount of from the top of the vial
medication into the fluid bag or other vial as necessary. Check the final product for clarity and any is punched out from the
particulate matter or precipitation. needle and contaminates
the liquid inside of the vial.

CHALLENGE

1. A technician asks Stacy to check the calculations prior to compounding a final nonsterile solution.
Stacy checks the calculations and final volume. There is a +/- 1% error for the product’s final volume.
Will Stacy accept the final volume?
A. Yes, it is within tolerance.
B. No, it is not accurate.
A. This response is correct because a +/- 1% error for the final volume is generally considered acceptable and
falls within the acceptable tolerance range. Therefore, Stacy can accept the final volume without concern.

diluent. The substance used

To reconstitute powders inside vials, follow the above directions to draw up the diluent. The diluent to dilute a compound.
required will be listed on the medication label or in the package insert for the medication. Add the
diluent to the powder to reconstitute it by attaching a vented needle to the syringe of diluent. Insert
the syringe at a 90° angle and slowly add the diluent to the vial. Gently agitate the vial until the
medication is in solution and there is no remaining powder. Use the right diluent in IVs based on
compatibility with other ingredients. Match the appropriate tonicity to the patient’s condition. The
product package insert is vital to finding the compatible diluent. For example, the daptomycin
(Cubicin) product package insert states that it is not compatible with dextrose; it must be
reconstituted and diluted with normal saline. Fluid tonicity is classified as isotonic, hypertonic, or
hypotonic. Isotonic solutions have the same tonicity as human blood plasma. Hypertonic solutions
have a higher tonicity than human blood plasma and cause fluid to move out of the cell and the cells
to shrink. Hypotonic solutions have a lower tonicity than human blood plasma and will cause fluid
to move into the cells and possibly burst; these fluids include saline solutions less than 0.9% sodium
chloride.

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If the compound requires the use of an ampule, swirl the ampule until all the medication is in the
bottom of the vial and there is none left in the neck. Swab the neck of the ampule and break the
ampule away by applying pressure from the thumb. Using a quick and firm snapping motion, break
the ampule away from the body and the HEPA filter. To withdraw medication from an ampule, use a
filter needle or filter straw. This prevents any shards of glass from entering the final product.
Remove the filter needle and replace it with another needle prior to using the drawn-up medication.
Ampules are always single use.

Case Study: Maintaining a Sterile Compounding Environment, Part 2

Aside from sterile compounding duties, Stacy is also the lead for the nonsterile compounding part of the
pharmacy. The pharmacy dispenses and ships out blister-packed oral medications, repackaged topicals and
solutions, and also the occasional compounded nonsterile medications. Stacy oversees maintaining and
organizing all documentation relating to the compounding completed in the pharmacy.
1. Which of the following should Stacy do if one of the products in a nonsterile compound has a BUD that
expires in 60 days and the medication is for a 30-day supply?
A. Apprise the pharmacist that one of the products will expire in 60 days.
B. Consult the patient on when to dispose of any remaining product.
C. Label the final product with a 30-day expiration date.
D. Label the final product with a 60-day expiration date.
C. When one of the products in a nonsterile compound has a BUD that expires in 60 days, but
the medication is for a 30-day supply, it is important for Stacy to label the final product with a 30-
day expiration date to ensure patient safety and adherence to medication guidelines.

2. Stacy found that one of the blister packs is labeled for a different patient and not the patient who was
prescribed hydrochlorothiazide (Microzide). Which of the following will be Stacy’s next step to correct the
situation?
A. Talk with the pharmacist.
B. Talk with the dispensing technician.
C. Correct the label and notify the pharmacist.
D. Correct the label and do not notify the pharmacist.
C. In the given situation, when one of the blister packs is labeled for a different patient, it is crucial to
correct the label to ensure accurate medication dispensing and patient safety. Additionally, notifying the
pharmacist is important for proper documentation and to address any potential issues or concerns.

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Equipment and Supplies Ampule Syringes

Syringes
Syringes used for sterile compounding are clear in color and sterile. They can
be either slip tip, where the needle slides on and off, or Luer Lok, where the
needles screw onto the syringe. They are available in various sizes, from 0.5 to 60
milliliters. Use the smallest syringe necessary to measure the required volume.

Needles
Various types of needles are used for sterile compounding. Needles vary in size
by gauge and length in inches. Needles with a larger number for the gauge of
the needle have a smaller diameter, and needles with a smaller number for the
gauge have a larger diameter. Common needle gauges used range from 15 to 25 horizontal laminar flow hood.
gauge. Needle length is dependent on the application. For example, longer needles are necessary A hood used for preparing
for IM injections, and shorter needles are used for subcutaneous injections. Use filter needles when nonhazardous IV medications.
drawing up medications from ampules to filter out glass. Use vented needles to vent air in and out of direct compounding area.
medication vials when reconstituting. The 15 centimeters (6
inches) inside of the primary
Laminar Flow Hoods engineering control where
There are two types of laminar flow hoods used to compound sterile products: vertical laminar flow compounding takes place.
hoods and horizontal laminar flow hoods. Vertical laminar flow hoods are typically used to compound
compounded sterile product.
hazardous medications and involve airflow starting with the HEPA filter at the ceiling flowing down
A compounded sterile dosage
to the direct compounding area. This airflow prevents contaminated air from being blown directly
form that results from mixing
onto the compounding technician. Horizontal laminar flow hoods are used only for compounding
pharmaceutical ingredients
non-hazardous medications and consist of a HEPA filter at the back of the laminar flow hood with for patient preparation in a
air moving forward across the direct compounding area. controlled environment.
Ampules
CHALLENGE
Ampules are glass containers used to store
sterile medications. They must be broken 1. A technician has just cut themselves while breaking an ampule. Which of the following
should Stacy and the technician do to maintain a sterile environment?
prior to withdrawing medication. Use a filter
needle or straw to filter out glass shards that
A. Maintain a workflow so as not to interrupt batch processing.
would contaminate the compounded sterile B. Attend to the injury immediately and pause sterile compounding.
product. Ampules are always single- C. Re-clean and disinfect the flow hood.
dose vials. D. Bandage the cut, re-wash, and glove without cleaning and disinfecting the flow hood.
B. When a technician sustains an injury while breaking an ampule, it is crucial to prioritize
their health and safety by attending to the injury immediately and pausing sterile
compounding to prevent potential contamination of the sterile environment.

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Vials Vial Sharps Container

Vials are plastic or glass containers with rubber stoppers that store sterile liquids. There are
single-dose vials and multiple-dose vials. Single-dose vials do not contain preservatives
and must be discarded after one use. Multiple-dose vials contain preservatives and can
be used up to 28 days unless the manufacturer states otherwise. Multiple-dose vials must
always be labeled with the date opened and initials.

Isopropyl Alcohol
Sterile 70% IPA is used to sterilize supplies and surfaces in the clean room. Pre-saturated
IPA swabs sterilize the tops of vials and ports of solutions prior to injection.

Repeater Pumps
These automated compounding systems used to measure and transfer ingredients from a source
bag to another container are helpful when reconstituting powders. Automated compounding
Luer-to-Luer connector
systems are useful when mixing total parenteral nutrition bags or chemotherapy base solutions.

Empty Evacuated Containers

2
1
These empty glass vials or empty IV bags store or mix ingredients.

2
1
Luer-to-Luer Connectors
Luer-to-Luer connectors are used to transfer fluid from one syringe to another without a
needle.
Repeater pump
Syringe Caps
Syringe caps cover the top of a syringe. Syringe caps can be basic or tamper
evident (used with narcotics).

Sharps Containers
Two types of sharps containers are in the clean room. Red sharps containers
are used for needles, syringes, vials, and ampules. Yellow sharps containers
are used for all items used when compounding chemotherapy or hazardous
medications, including PPE.

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Nonsterile Compounding Process

USP <795> regulates nonsterile compounding. It details guidelines, policies, and procedures for the
physical design and maintenance of the compounding area, training requirements, hygiene and
garbing, beyond-use dates, and documentation. Gloves are required for compounding activities.
Other garb depends upon each facility’s standard operating procedures. Garb is recommended
for the protection of personnel and to minimize the risk of compounded nonsterile preparation
contamination. The garb must be appropriate for the type of compounding performed. The garbing
requirements and changing frequency must be determined and documented by the facility (USP,
2023; <795> FAQs). Nonsterile compounding differs from sterile compounding in its requirements,
which is why a different standard from USP exists. While nonsterile compounds are not expected to
be sterile, they should be compounded with cleanliness in mind.

Facilities and Equipment

The compounding area must be designated away from routine dispensing and counseling functions
and high-traffic areas of the pharmacy. The area is to be cleaned and sanitized daily and after
each use. Ensure the area is clean before starting any compounding activity. The lighting should be
tailored to the types of ingredients being compounded, as some are sensitive to light. Compounding
pharmacies have specialized equipment in the compounding area. Compounding areas and supplies
must be cleaned to prevent cross-contamination. Inspect the area and supplies before use and clean
them immediately following use. Industrial dishwashers can help with this process, if available.
Follow USP <797> and USP <795> guidelines regarding maintenance protocols to ensure their
operation matches guidelines. Some equipment requires some form of calibration prior to use.
For example, a Baxa Repeater Pump, used to transfer bulk units of liquid of equal volume, must
be calibrated to ensure that it is accurately dispensing the requested amount of fluid. Often in
nonsterile compounding, a scale is used to weigh a variety of ingredients. However, scales must be
tared prior to use to ensure the correct amount is being weighed.

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Balances Graduated Cylinders and Beakers

There are several types of balances used to Two types of graduated cylinders are used to 200

weigh pharmaceutical ingredients. Class A measure liquids. Conical graduated cylinders are 60

55

balances weigh smaller amounts of medications. wider at the top and narrower at the bottom. 150 50

Electronic balances weigh larger amounts. Brass Cylindrical graduated cylinders are uniform in
45

40

weights calibrate balances and should never be size from top to bottom and are more accurate 100 35

30
touched with ungloved hands. than conical graduate cylinders. These can be 25

made of glass or plastic and are available in a 50 20

Spatulas variety of sizes. Use the smallest graduated

15

10

Spatulas come in many sizes and materials cylinder necessary to measure the liquid. 5

(stainless steel, plastic, rubber). They are used to Beakers are cylindrical and can be used to mix
mix or transfer pharmaceutical ingredients. or melt ingredients. Ingredients are always
measured at a level on the bottom of the
Weighing Paper/Boats meniscus.
meniscus. The U shape
formed at the top of liquid in
Weighing paper or boats are used to hold
Syringes the measuring container.
pharmaceutical ingredients, protect balance
surfaces, and transfer ingredients. Syringes vary in size from 0.5 to 60 milliliters.
They transfer liquid ingredients.
Mortars and Pestles
The mortar is the container, and the pestle is Ointment Jars/Tubes and Dispensers
used to mix or grind. Mortars and pestles are Final products for patient use are dispensed
made in different sizes and materials for various in disposable plastic ointment jars, tubes, and
applications. dispensers.

Ointment Slabs Heat Sealers and Crimping Guns

Slabs are usually made of glass and provide Tubes and containers are sealed shut with heat
a surface on which to mix powders, liquids, sealers and crimping guns.
and creams. Spatulas are used to combine the
ingredients. Molds
Molds are used to shape troches,
Hot Plate suppositories, and tablets. They can be
Hot plates heat or melt ingredients. They are made of aluminum or plastic.
useful in making troches and suppositories.
Magnetic stirring rods are often used to mix
ingredients on a hot plate.

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Ingredient Standards
The raw chemical ingredients used in compounding must meet a minimum grade of purity. United
States Pharmacopoeia: National Formulary (USP-NF) is the minimum grade to be used. This purity
grade is established by USP. However, the end requirement is set by USP and the board of pharmacy
for the presiding state.

Packaging and Storage

Properly store all ingredients, medications, supplies, and formulations in the compounding area per
the manufacturers’ labeling or USP-NF requirements. Hazardous ingredients must follow USP <800>
standards. The National Institute for Occupational Safety and Health publishes a list of hazardous
ingredients annually. Included on this list are antineoplastic medications, which are those
medications that pose a reproductive risk and can cause organ toxicity or genotoxicity. All packaging
materials must be stored so they will not chemically react with any medication or ingredient. For
final packaging of nonsterile compounds, consider strength, visibility, moisture protection, ease of
use, and cost. Mark materials with the date of receipt and the date the container is opened. Rotate
stock to use the oldest products first. Maintain products at the correct temperature as indicated
on the product’s label. Additionally, some products are sensitive to light and must be stored in a
manner that protects them from light. The technician would use the appropriate packaging for a
compounded product as directed by a pharmacist or prescribed by a provider. It is not within the
scope of a technician to make this determination. Repackaging materials should not interact with
and must be compatible with the compounding ingredients. For example, some medications are not
compatible with plastic IV bags, such as lorazepam (Ativan). Be aware of ingredients that degrade
under specific conditions; place a brown protective bag over medications that are sensitive to light,
or place medications that crystallize at room temperature into warmers.

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Diluent or Base Product Selection

All IV medications are made of a base diluent. Medications that need to be reconstituted have
directions as to how much of a diluent to use. Use the right diluent in IVs based on compatibility
with other ingredients. Selecting the right diluent is one of the “two rights” that need to be
checked in the compounding process. The other “right” is selecting the right medication. Match
the appropriate tonicity to the patient’s condition. The product package insert is vital to finding
the compatible diluent. For example, the product package insert for daptomycin states that it is not
compatible with dextrose; it must be reconstituted with normal saline.

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Beyond-Use Dates beyond-use dating (BUD). The

Manufactured products have an expiration date, but compounded products have beyond-use dating date assigned to compounded
(BUD). A useful reference in the pharmacy is the Handbook on Injectable Drugs. USP <797> has prescriptions beyond which the
determined that Category 1 compounded sterile products may be assigned a BUD of a maximum of 12 compound should not be used.
hours at room temperature and 24 hours or less under refrigeration. Category 2 compounded sterile
products may be assigned a BUD of no greater than 12 hours at room temperature or no greater than Handbook on Injectable
24 hours under refrigeration. Drugs. Written by Lawrence
Trissel and primarily used
in a hospital setting. This is
a reference for information
on parenteral agents.

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Compounded Product Labeling

Label every sterile prescription appropriately. Attach the label to the bag only after adding all of the
ingredients. Sterile products should be labeled so as not to cover the volume markings on syringes
or the fluid name on IV bags. Sterile products compounded into containers that do not contain
ingredient information or unit markings should be labeled so that the final product is still able to
be visually inspected. Additionally, when able, the label should be affixed so it is flat. Labels vary in
format but always contain the following information: patient’s name and medical record number,
patient’s current room number, the medication name and strength, the IV solution the medication
is in, and the rate of infusion. Ensure the entire label is flat and easily visible without manipulating
the bag or container, and that all information is readable. Nonsterile products must be labeled so
that the final product can be used without tearing the prescription label.

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UNIT DOSE PRODUCT REPACKAGING AND LABELING

Pharmacies that provide medications for institutions like hospitals and long-term care facilities use
a dispensing process different from that of a community pharmacy. These systems help efficiently
manage inventory and provide a safe method for medication distribution within the facility.
Typically, these methods include repackaging medication into smaller packages that are easier for
the institution to use (a process called unit dosing) or into punch cards or blister packs to dispense
in long-term care facilities to help in the administration of medications to patients.

Punch Cards and Blister Packs

In this system, patient medications are packaged individually on cards for convenient administration
to minimize errors and to assist with patient adherence. These cards come in variations to
accommodate different dosing and are typically individualized for each patient. This provides
accountability for dosing and minimizes the opportunity for giving a patient the wrong medication.
The punch cards are generally dispensed in a 30-day supply of medication for these patients. Punch
or blister cards can also be made so that a patient’s morning medications are in one packet, the
afternoon medications in a second packet, and the evening medications in a third packet. This helps
with adherence to the medication schedule.

Unit Dose Systems

Unit dose systems are used in the inpatient hospital setting. With this system, medications are
individually packaged. Some facilities purchase medications packaged this way directly from the
wholesaler, while others buy medications in bulk and repackage them in unit-dose form on their
own. Appropriate labeling is necessary for all repackaged medications.

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Repackaging
Packaging influences the purity and potency of a product and is essential for maintaining a good
quality. For that reason, the process of repackaging bulk medications into unit doses must include
product identification, environmental exposure, handling, and usability.

Product identification ensures each unit is completely and precisely labeled. Being wary of
environmental exposure ensures that the selected container is resistant to and protects the product
from air, moisture, light, heat, and contamination. Handling is an important consideration because
the packaging should not be one that permits or promotes the destruction or damage of the product
when opening the packaging. Usability means ease of use so that staff members do not struggle to
open the product.

Also, technicians should follow these repackaging guidelines.

⦁ Use a clean area with adequate space isolated from regular work processes.

⦁ Repackage one medication at a time to avoid confusion and potential medication errors.

⦁ Follow procedures closely when repackaging medications to prevent environmental exposure or

contamination. Label the product with the medication name, strength, lot number, manufacturer,
expiration date, and any other relevant information.

⦁ Check ingredients and labels to verify they are correct.

⦁ Always obtain a pharmacist’s approval of repackaging work.

⦁ Maintain repackaging equipment to avoid product destruction.

⦁ Keep precise records of all repackaging work at the batch level.

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Adherence Aids in Repackaged Products

Despite precise instructions for taking medications, some patients still have difficulties adhering to
their medication regimen. The pharmacist may counsel these patients to improve their adherence.
Some adherence aids exist in repackaging to help patients take their medications more consistently
and effectively. These include dosage spoons, pill cutters, droppers, oral syringes, and dosing
planners or pill organizers.

Dosage spoons are devices that accurately measure the correct dose of medication while minimizing
spills that are possible with household spoons. Dosage spoons are a type of unit dosing, as one
dose is available per dosage spoon. Pill cutters are used to break tablets easily and cleanly when
the dose requires half-tablet dosing. Pill cutters assist with repackaging if a punch card dose
requires 0.5 or 1.5 tablets per dose, for instance. Droppers are useful when measuring small amounts
of medications. Oral syringes are beneficial for caregiver use when an accurate dose needs to be
measured. Dosing planners and pill organizers help patients stay on track with taking their daily
medications at their prescribed times.

Repackaged Products Documentation

In the instance of unit dosing, repackaged medication must be noted and logged into the
compounding log. (This is not the case for punch cards, however, as punch cards are the equivalent
of a pill bottle from any retail pharmacy.) The approving pharmacist must also sign.

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Final Product Inspection

Physical incompatibilities result in a noticeable visual change (precipitate, color, cloudiness,
gas production). An example of a physical incompatibility is mixing calcium with a phosphate-
containing electrolyte (sodium phosphate, potassium phosphate). When calcium and phosphate
are mixed, the calcium binds with the phosphate, forming a white precipitate and thus preventing
absorption of electrolytes into the body. Inspect the final compounded sterile product for
incompatibilities by holding the final product to a light box. One side of the light box is black, and
the other is white. The black side will help identify any physical incompatibilities, and the white
side will help detect if any coring occurred. Physical incompatibilities usually present as a white
precipitate that falls, and coring presents as a gray piece of rubber floating in the container. If there
is an incompatibility, notify the pharmacist immediately and discard the product.

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 STERILE AND NONSTERILE PRODUCTS, COMPOUNDING, UNIT DOSE, AND REPACKAGING

Documentation and Recordkeeping

Properly document and maintain records for all compounding activities. Documentation can be kept
with a written logbook or electronically. Master compounding formulas and recordkeeping can also
help ensure consistency when formulations are compounded more than once. Documentation is
logged by the compounder and the approving pharmacist. These documentation logs are reviewed by
board of pharmacy auditors as well as The Joint Commission auditors (and the DEA if compounding
narcotics). Depending upon the department’s policy, these can be internally audited more frequently.
There are four types of records required to be maintained in the compounding area.

⦁ Master formulation record: Contains the compounding formula and procedure with detailed
instructions and documentation of the source reference for each compound

⦁ Compounding record: Documentation of the ingredients used (including lot number, expiration
date, manufacturer, and quantity used), the steps taken to compound, and the compounding
personnel and pharmacist verification

⦁ Standard operating procedure: Detailed document with information about equipment maintenance,
equipment calibration, and handling and disposal of supplies

⦁ Ingredient record: Includes certificates of purity and safety data sheets

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

MEDICATION SAFETY AND QUALITY ASSURANCE

There are several best practices for quality assurance and medication safety.

medication error. A preventable

Medication Errors event that may cause or lead
to inappropriate medication
This lesson focuses on medication errors in the context of patient safety because medication errors
use or patient harm while the
can and do happen. Most of them, however, are preventable. Technicians need to understand when medication is in control of
and how they are most likely to occur, what steps to take when they do occur, and what best the health care professional,
practices to implement to avoid them. Many organizations study medication errors to identify patient, or consumer.
common causes and create best practices and tools pharmacies use to improve medication safety.
The Institute for Safe Medication Practices (ISMP) is a nonprofit organization devoted entirely to
preventing medication errors. ISMP has a variety of best practice tools and resources for community Best Practice Resources
and health system pharmacies. The American Society of Health-System Pharmacy (ASHP) is a
ISMP: [Link]
nonprofit association of pharmacists, technicians, and others practicing in hospitals and health
systems. ASHP has a long history of advocating for patient safety and developing best practices to • Targeted Medication Safety
Best Practices for Community
improve medication use. Creating safe medication practices begins with making medication safety a
Pharmacies 2023-2024
priority within the pharmacy and creating a safety-oriented culture. Specifically, this lesson will
• Targeted Medication Safety Best
review the common reasons behind and prevalence of errors, ways to incorporate best practices to Practices for Hospitals 2024-2025
eliminate errors, and the role of the National Institute for Occupational Safety and Health (NIOSH) in
ASHP: [Link]
implementing policies to reduce instances.
• ASHP Guidelines on Preventing
Medication Errors in Hospitals
Prevalence of Medication Errors
A meta-analysis of 81 studies from 2000 to 2020 concluded “that 1 in 30 patients are exposed
to preventable harm in medical care,“ with 3% of incidents being medication-related. Of the
preventable medication harm, 39% of the incidents were classified as mild, 40% as moderate, and
26% as severe or potentially life-threatening. Across the community, hospital, and other pharmacy
settings, a 2024 systematic review and meta-analysis found the worldwide prevalence of medication
dispensing errors was 1.6%. In 2023, Americans filled 6.9 billion prescriptions (30-day equivalent),
which would result in an estimated 110,400,000 errors, given a medication dispensing error rate
of 1.6%.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Just Culture
A supportive or just culture allows the pharmacy team to operate at its best. It encourages team
members to speak up about safety issues and feel comfortable when errors are found and must be
addressed. It is an environment where team members should learn from errors, identify causes,
and prevent recurrence. Incident reporting should focus on system improvement, not blaming
individuals for actions that may contribute to medication errors.

This is referred to as a “just culture,“ a concept that grew out of the airline industry. A just culture
is a learning culture rather than a punitive culture. In a punitive culture, the individual making an human error. Inevitable,
error is held accountable and often punished, resulting in less open error reporting and a system unpredictable, unintentional
that does not contribute to error reduction. In a just culture, individuals are empowered to monitor failure in perception,
the environment and participate in efforts that improve safety. Employees are held accountable for thought, or behavior. It is
errors, and so is the organization, with a focus on education, risk reduction, and system design.
not a behavioral choice.
Humans are fallible.
Importantly, a just culture differentiates between human error, at-risk behavior, and reckless behavior. at-risk behavior. Behavioral
Humans are fallible, and human error is not a behavioral choice. These errors may be random choices made when individuals
human errors based on an individual‘s cognition and/or influenced by stress, fatigue, distraction, lose perception of the risk
fear, dread, or other psychosocial factors. They can also be system-based errors where features in associated with those choices
the environment contribute to failure in an individual‘s cognition. An example of human error is or mistakenly believe the risk
transposing numbers of a medication dose. These errors are best managed with system redesign to to be insignificant or justified.
make the system human error-proof or error-resistant. reckless behavior. Conscious
disregard of a substantial
At-risk behaviors happen when an individual loses the perception or risk associated with a choice
and unjustifiable risk.
made or mistakenly believes the risk to be justified or insignificant. An example of at-risk behavior
is when an individual decides to scan only one item‘s barcode during the filling process, although
multiple containers are required to fill the prescription‘s correct quantity. Without scanning each
item, an incorrect medication could easily be mixed up with the correct medication. Managing at-
risk behaviors includes removing the barriers to safe behavioral choices, any rewards for at-risk
behaviors, and coaching individuals to see the risks associated with their choices.

Individuals who behave recklessly know the risk they are taking and understand it is substantial. An
example would be intentional breaches in patient confidentiality. In a just culture, reckless behavior
is blameworthy behavior resulting in disciplinary action, according to the organization‘s human
resources policies. Patient safety programs should focus on at-risk behaviors and related system
redesign. It takes a team working together to prevent medication errors.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Common Causes of Medication Errors

Addressing medication errors requires understanding how and why they occur during the
medication use process. ISMP has defined the following key elements of the medication use process.
Refer to the ISMP Medication Error Potential table.

TABLE 8.1 ISMP Medication Error Potential

ELEMENT ERROR POTENTIAL WITHIN EACH ELEMENT

Patient information • Failure to obtain patient demographic information (age, weight)

and clinical information (allergies)
• Failure to conduct drug utilization review (DUR) during data
verification
Medication information • Failure to provide accurate and usable medication information
• Mixing up order documents with incorrect products during product
verification
• Entering the wrong medication information during data entry
Communication of medication • Miscommunication between prescriber, nurse, and pharmacist
information • Inaccurate prescription transcription
• Failure to call prescriber‘s office with questions
• Duplicating medication therapy during prescribing
Medication labeling, packaging, • Look-alike, sound-alike names
and nomenclature • Confusing medication labeling and/or packaging
• Bypassing label scanning systems during dispensing
Medication storage, stock, • Poor shelf labels
standardization, and distribution • Not separating dosage forms on shelves high-risk/high-alert
medications. Medications
• Not separating look-alike, sound-alike medications, high-risk/
that bear a heighted risk of
high-alert medications, or hazardous medications
causing significant patient harm
• Lack of standardized medication concentrations when they are used in error.
Medication and device • No safety assessments for medication delivery devices or
acquisition, administration, and independent double checks
monitoring • Not providing dosage tools/devices
• Failure to use smart pumps

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

TABLE 8.1 ISMP Medication Error Potential

ELEMENT ERROR POTENTIAL WITHIN EACH ELEMENT

Environmental factors • Poor lighting

• Noise
• Interruptions
• Workload
Staff competency and education • Not focusing on appropriate education of policies and processes
for medication safety or how to protect from errors
• Failure to reconstitute medication at pick-up
Patient education and monitoring • Failure to offer counsel on medication indications, doses,
medication or food interactions, and adverse effects
Quality processes and risk • Not analyzing medication error causes
management • Not having a system of detecting and preventing errors
Medication errors can occur within any of these elements. They can occur within the various steps
in the prescription workflow, including prescription intake, order communication and transcribing,
data entry, data entry verification, dispensing, product verification, prescription pick-up, medication
administration, and patient monitoring.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Best Practices to Avoid Medication Errors Case Study: Potential Medication

Every pharmacy has a set of standards and best practices to ensure safe medication delivery. Mishap, Part 1
It is everyone‘s responsibility to follow these standards. Failure to follow policies and
Steve Whiteman, a 50-year-old male, is a regular
procedures related to medication safety could result in patient harm or death. Using best
patient at the pharmacy. He approaches the
practices within the pharmacy can lower the likelihood of medication errors. pharmacy technician, Carol, at the drop-off
window. He wants to know if he received the
Standard Protocol correct medication for treating his high blood
Use a standard protocol to verify a patient‘s identity, utilizing at least two patient identifiers pressure earlier in the week. He opens the
prescription vial he picked up and shows Carol
(patient‘s full name, date of birth) when receiving a prescription to be filled, responding round white scored tablets with the number
to patient-specific questions, providing filled prescriptions to patients at the point of sale, “25“ imprinted on one side. He says that prior
picking up medication at the inpatient pharmacy, delivering prescriptions to the patient‘s to this refill, his medication consisted of round
home and prior to administering vaccines or other treatments. Standardize the use of orange scored tablets.
the milliliter unit of measure when prescribing, dispensing, and measuring oral liquid 1. What would be a good first response to Mr.
medications and compounded medications. Whiteman? What next steps can be taken to
research the issue?
Make it part of the standard operating procedure to ask patients for updates about medication Your response may include assuring Mr. Whiteman
that this is important and that the pharmacy team
allergies and medical conditions when they arrive at the pharmacy. All patient weights
will take time to double-check the medication.
should be documented in the patient profile in kilograms, not pounds. Complete and accurate Consult with the pharmacist immediately so they
patient profiles are essential to the pharmacist‘s final verification process. Regularly select can review Mr. Whiteman’s profile, determine
what blood pressure medication he takes,
the medication from the hard copy of the prescription and not the printed label whenever check the prescription vial label against Mr.
possible. Some pharmacies scan the hard copy to be saved electronically, and others retain the Whiteman’s profile, and double-check that the
hard copy during the filling process for review. medication in the vial is what is on the label.

In the hospital setting, order floor stock on approved preprinted forms so only approved
medications are dispensed to nursing units. Concentrated electrolytes and neuromuscular blocking
agents (NMBAs) must not be dispensed as floor stock. Concentrated potassium chloride or floor stock. Approved list of
magnesium sulfate administered without dilution could cause death. NMBAs are only used when medications allowed to be
artificial respiration is available. They are segregated and stored separately from other medications. stored on a nursing unit for
These can be dangerous in the hands of unauthorized personnel. A best practice is administering all
easy access and patient use.
medication and hydration infusions via a programmable infusion pump using dose error-reduction
technology. Use standardized workflow management systems when compounding sterile
preparations.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Verify labeler
Use verification methods to ensure the medication pulled from the shelf matches the label. product code
Technology has improved the ability to compare the NDC on the label to the medication
package code
bottle. The NDC is given to each medication before it is marketed. The NDC is found NDC 12345-1234-01
on the medication bottle as an 11-digit number as well as in the form of a barcode. The Total 50
prescription label also contains the NDC. Scan and compare the medication bottle and the Sample capsules 35 mg
prescription label. If they do not match, the NDC on the label must be changed, or another Samplex
medication bottle should be selected. A prescription label should never be affixed to a
bottle containing a medication from another NDC. Not only could this cause a medication
error, but it is also fraud if the prescription is billed to an insurance company. The prescription label automated dispensing
machine (ADM). An automated
should be affixed to the vial immediately after placing the medication inside.
machine that functions to
Also, verify the expiration date on the stock bottle from which the medication is being dispensed. store, dispense, and track
Review and flag medication expiration dates at least once per month to prevent dispensing expired commonly used medications.
It uses biometric user
medication.
identification to allow hospital
In the hospital setting, when delivering medication to an automated dispensing machine on a nursing staff to access medication for
unit, verify the medication prior to placing it in the pocket. Do this by scanning the barcode on the patient administration. They
are in most hospital units.
medication and scanning the location where it will be stocked. The nurse is responsible for verifying
the correct medication, strength, route, and amounts added to the machine. Limit the variety of
medications that can be removed from the automated dispensing machine using the override
function. A pharmacist double-checks parenteral chemotherapy medication orders prior to mixing.
The nurse responsible for the patient‘s care performs a final verification. ISMP best practices call,
for example, for vincristine and other vinca alkaloids to be dispensed in a mini-bag of a compatible
solution rather than in a syringe. Prior to dispensing warfarin, a patient‘s INR is checked to ensure
proper coagulation. Hemoglobin levels are verified prior to dispensing epoetin alfa.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Ensure Accuracy
Ask the pharmacist on duty to clarify prescriptions that are illegible or need interpretation. Never
make assumptions about a medication, strength, or Sig code. Count controlled substances at least
twice to ensure accuracy. After the second count, circle and initial next to the quantity on the
prescription label. Also, use this practice for large quantities and expensive medications.

In the hospital setting, consider drawing up long-acting insulin doses in the pharmacy in patient- total parenteral nutrition
specific syringes to prevent dosing errors. Many facilities that mix total parenteral nutrition (TPN) (TPN). A method of feeding
solutions use barcode technology to set up automated compounding machines. TPN uses a 1- to that bypasses the GI tract.
6-liter IV fluid bag that contains the patient‘s nutritional needs for a 24-hour period. The technician This method is used when a
ensures the correct ingredient is attached to the correct port. The scales used to weigh the fluids person cannot or should not
pumped into the bags are calibrated at least once daily. receive feeding or fluid by
mouth. TPN solution is made
Nursing units should be inspected each month to ensure safe medication storage. Refrigerator of amino acids, dextrose,
temperatures are verified, multi-dose vials are checked for beyond-use dates, and floor stock (if water, and electrolytes.
supplied by the pharmacy) is checked for adherence and expiration dates. All opened multi-dose
vials are dated with initials and disposed of after 28 days.

Engage the Pharmacist

Alert the pharmacist to any electronic notifications—such as DUR notifications—at the time of
processing a prescription. The electronic health record will prompt a pharmacist review if a patient‘s
profile, medical history, medication history, or allergies could cause the patient harm. In a retail
setting, pharmacist counseling should be offered to patients to adhere to the Omnibus Budget
Reconciliation Act of 1990. Counseling by the pharmacist is the final opportunity to catch or prevent
a medication error at the pharmacy level. The pharmacist reviews how to take the medication and medication reconciliation.
its possible side effects during the counseling process. This allows patients to ask questions or The process of preparing a
address concerns about the medication they are picking up. Use medication reconciliation to prevent complete and accurate listing
medication errors during transitions of care between home, hospital, nursing home, and of a patient's medications
other settings. and all related medical
information, such as allergies.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

AVOIDING ERRORS The 9 Rights of

Medication
Following these “9 rights“ has been proven to minimize medication errors. Understanding these
rights is core to medication safety. These rights are broadly stated goals or desired outcomes of • Right medication
safe medication practices. Health care providers must follow the procedural rules designed by • Right dose
organizations to satisfy these rights. It is essential to focus not only on human error factors, but • Right time
also on medication use systems. A 2023 analysis of pharmacist liability claims provides insights into • Right patient
medication error types and causes. Among 187 paid claims between January 1, 2017, and December • Right education
31, 2022, the distribution of errors is shown in the Distribution of Closed Liability Claims by
• Right to refuse
Type table.
• Right route
• Right effects
TABLE 8.2 Distribution of Closed Liability Claims by Type
• Right documentation
CLAIM ERROR PERCENTAGE OF OCCURRENCE

Wrong medication 41.7

Failure to prevent sound-alike medication errors 35.9
Failure to check medication against label and actual prescription 32.1
Wrong dose/strength 21.9
Failure to prevent look-alike medication errors 11.5
Prescription given to wrong patient 7.5
Failure to consult with prescriber on question/concern 6.0
Calculation and/or preparation error 3.2

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Right Patient
The first step in the prescription intake and entry process is to select the correct patient. Verify
each patient with two identifiers, such as the date of birth and address. In the inpatient setting,
do not use a patient‘s room number as part of the verification because there may be multiple
patients in one room, or the patient could have been moved to a different room or procedural area.
This has the potential to cause an error. Many alerts and cross-references can occur during the
processing of a prescription. It is essential to ensure that the patient‘s profile is up to date with
accurate demographic information, including weight, allergies, medications, medical conditions,
and insurance.

Double verification is a best practice that helps prevent the selection of the wrong patient who has a
similar name. Double verification is used when responding to patient-specific questions, providing
filled prescriptions to patients at the point of sale, when picking up medication at the in-patient
pharmacy, prior to administering vaccines or other treatments, and when delivering prescriptions
to the patient‘s home. When a patient picks up a prescription, verify the number of prescriptions
being picked up. Prescriptions may have been bagged separately during the filling process. Some
prescriptions have special storage requirements, such as being refrigerated. Some medications are
large and must be stored in a separate location for pick-up. Verify that all demographic information
is correct and up to date. Always ask the patient to provide this information rather than supplying
it for them. Check the prescription for accuracy. Always compare the prescription number and
the patient‘s name and date of birth on the prescription label to the number and name of the
prescription in the patient‘s profile. Double-checking receipts and labels prevents the wrong
medication being given to the wrong person—especially for patients who have common names.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Right Medication
Many safety checks are in place during the dispensing process to ensure that the correct medication
is chosen. Double-checks are built into the workflow systems:

⦁ Keeping the original prescription order, label, and medication container together throughout the
dispensing process

⦁ Using bar codes to scan the medication label against the NDC ordered

⦁ Scanning prescription label and checking contents against a visual picture of what the medication
should look like

⦁ Scanning medication at pick-up/will-call window

⦁ Verifying the patient‘s date of birth against the patient record and medication label sound-alike, look-alike
medications (SALAD).
⦁ Using second data verification Medications that either sound
alike when spoken or look
Medication storage and organization in the pharmacy should minimize confusion among alike when viewed, also called
medications, with the separation of sound-alike, look-alike (SALAD) medications, high-risk/high-alert look-alike, sound-alike.
medications, and those with different routes of administration. Some medications are stored in
separate locations to prevent mix-ups. For example, NMBAs and chemotherapy medications should
be stored separately from all other medications, including medications stored in the refrigerator.
Different-colored bins can be used to identify these medications.

SALAD Names Tall Man lettering. A system of

ISMP updates and publishes a formal list of SALAD names that uses Tall using lowercase and uppercase
Man lettering to prevent a mix-up. An example of a SALAD combination letters for medication names
that uses Tall Man lettering is hydrALAZINE and hydrOXYzine. to prevent mix-ups.
Hydralazine and hydroxyzine come in similar strengths and formulations
(IV, PO) and have similar-looking bottles and vials. Each medication is
25 mg 25 mg
prescribed for different indications as determined by the prescribing
physician. Mixing up these two medications could be deadly. See the
FDA-Approved Generic Medication Names With Tall Man Letters table for
examples of SALAD Tall Man lettering.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

TABLE 8.4 FDA-Approved Generic Medication Names With Tall Man Letters
MEDICATION NAME (INCLUDING TALL MAN OFTEN CONFUSED WITH (INCLUDING TALL MAN
LETTERING) LETTERING)

amLODIPine aMILoride
buPROPion busPIRone
CeleBREX CeleXA
glipiZIDE glyburide
guanFACINE guaiFENesin
HumuLIN HumaLOG
lamoTRIgine lamivudine
oxyMORphone HYDROmorphone, oxyCODONE,OxyCONTIN
PARoxetine FLUoxetine,DULoxetine
prednisoLONE prednisone
QUEtiapine OLANZapine
traMADol trazodone
vinCRIStine vinblastine

ISMP High-Risk/
High-Alert Medications High-Alert Resources
In addition to SALAD, high-risk/high-alert medications should be flagged to be handled with
Visit ISMP’s website for
additional care to ensure the correct medication has been selected with the correct dosage. High- recommendations for high-alert
alert medications are medications that bear a heightened risk of causing significant patient medications in the following
harm when they are used in error. ISMP maintains lists of high-alert medications for acute care, settings:
community/ambulatory pharmacy, and long-term care settings. High-risk/high-alert medication • Acute care setting
examples follow in the “right dose“ discussion. • Community/ambulatory care
settings
• Long-term care setting

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Right Route
A prescription‘s route of administration should match the dosage form. For example, suppositories
are used rectally or vaginally. Ophthalmic drops are used in the eye, although some can be
administered aurally; aural drops (ear drops) should never be administered into the eye. Eye drops
are specially formulated to the pH level of the eye and are prepared aseptically, while ear drops
are not. It is critical to review an order‘s directions to ensure the right route has been selected for
the medication prescribed. Storage and organization in the pharmacy should separate medications For the ear
with different routes of administration.

Patients should receive counseling about a prescription‘s route of administration. In the retail Topical use only
setting (and occasionally in the hospital setting) medications are labeled with auxiliary labels
to identify the route of administration, if not taken orally, to prevent administration error. For
example, a ciprofloxacin ear drop will have an auxiliary label with a picture of an ear and the
words “for the ear.“ A bottle of Dakin‘s solution for wound care or benzoyl peroxide face wash
for acne will have the auxiliary label for “topical use only“ affixed to the bottle. The amount of
medication to give is dependent on the route of administration.

Technicians must be able to interpret important key words, abbreviations (called Sig codes), and The Joint Commission. A
symbols when entering a prescriber‘s directions for use from a prescription because these can be a not-for-profit organization
source of medication error. The Joint Commission publishes a list of unapproved abbreviations that that accredits health
should not be used by organizations it accredits. The ISMP also publishes a more comprehensive list care organizations.
of error-prone abbreviations. The ISMP Error-Prone Abbreviations table contains examples from the
ISMP list of error-prone abbreviations.

TABLE 8.5 ISMP Error-Prone Abbreviations

ABBREVIATION MEANING MISINTERPRETATION CORRECTION

AD Right ear OD, OS, OU (right eye, left eye, each eye) Right ear
AS Left ear Left ear
AU Each ear Each ear
OD Right eye AD, AS, AU (right ear, left ear, each ear) Right eye
OS Left eye Left eye
OU Each eye Each eye

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

TABLE 8.5 ISMP Error-Prone Abbreviations

ABBREVIATION MEANING MISINTERPRETATION CORRECTION

cc Cubic centimeters u (units) mL

o.d. or OD Once daily Right eye (can lead to oral liquid medications Daily
administered in the eye)
q.d. or QD Every day q.i.d. (especially if the period after the “q“ or the Daily
tail of the “q“ is misunderstood as an “i“)
qhs At bedtime qhr (every hour) At bedtime
q.o.d. or QOD Every other day q.d. (daily) or q.i.d. (four times daily) if the “o“ is Every other day
poorly written
U or u Unit 0 or 4 (causing a 10-fold overdose or greater— 4U Unit
seen as 40)
cc (dose might be given in volume instead of
units—4u seen as 4cc)

Right Dose
The amount of medication administered to a patient is also critical. Dose ranges for medications
HIGH
are built into pharmacy computer systems and in computerized physician order entry systems ALERT
in hospitals and clinics. In hospitals, doses are verified prior to leaving the pharmacy, but the DOUBLE
nursing staff is also responsible for verifying that the correct dose is given. High-risk/high-alert CHECK

medications require extra verification steps prior to administration to the patient. Some facilities
place high-alert medications in specialized bags with appropriate auxiliary labels to alert the
nursing staff of the potential danger. For example, an IV bag of lidocaine should have a bright red
“high-alert caution“ sticker to identify the possible danger associated with administration of the
medication. Having another nurse verify the dose of a high-alert medication prior to administration
can also help in decreasing medical errors. Both nurses are responsible for documenting the
verification of the medication administration [Link] suggests using auxiliary labels, shelf
labels, and automated alerts and standardizing the storage, dispensing, and administration of these
products. Additionally, ASHP has created a list of risk reduction strategies that have proven effective
when dosing high-risk medications (see the ISMP High-Alert Medications table).

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

TABLE 8.6 ISMP High-Alert Medications

CLASS ROUTE EXAMPLES

adrenergic agonists IV epinephrine, phenylephrine,

norepinephrine
adrenergic antagonists IV propranolol, metoprolol, labetalol
anesthetic agents general, inhaled, IV propofol, ketamine
antiarrhythmics IV lidocaine, amiodarone
anticoagulants warfarin, low molecular weight
heparin, IV unfractionated heparin
factor Xa inhibitors fondaparinux, apixaban, rivaroxaban
direct thrombin inhibitors argatroban, bivalirudin, dabigatran
etexilate
thrombolytics alteplase, reteplase, tenecteplase
glycoprotein IIb/IIIa inhibitors eptifibatide
cardioplegic solutions
chemotherapeutic agents parenteral, oral
dextrose, hypertonic, 20% or greater
dialysis solutions, peritoneal and peritoneal
hemodialysis
epidural or intrathecal medications
hypoglycemics oral
inotropic medications IV digoxin, milrinone
insulin subcutaneous, IV
moderate sedation agents IV dexmedetomidine, midazolam
moderate sedation agents for children oral chloral hydrate

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

TABLE 8.6 ISMP High-Alert Medications

CLASS ROUTE EXAMPLES

narcotics/opioids IV, transdermal, oral (liquid

concentrates, immediate-
and sustained-release)
NMBAs succinylcholine, rocuronium,
vecuronium
parenteral nutrition preparations
sterile water for injection, inhalation,
and irrigation (excluding pour bottles)
in containers of 100 mL or more
sodium chloride for injection,
hypertonic, greater than 0.9%
concentration
sulfonylurea hypoglycemics chlorpropamide, glimepiride,
glyburide, glipizide, tolbutamide

CHALLENGE

1. Which of the following is considered a high-alert medication?

A. Amoxicillin
B. Sodium chloride 0.9%
C. Warfarin
D. Losartan
C. The correct answer is warfarin. Warfarin is a blood thinner with a
narrow dosage range, and it is a high-alert medication.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Right Time
Some medications should be taken at specific times. If a dose is given 90 minutes earlier or 90
minutes later than the prescribed time, for instance, a wrong-time error has occurred. For example,
zolpidem is a sedative-hypnotic, often prescribed for use as a sleep aid; it should be administered
prior to sleep. Taking a once-daily blood pressure medication (the ACE inhibitor lisinopril) at
bedtime poses a risk for hypotension, which could lead to a patient experiencing syncope (fainting)
or dizziness. Medications for ADHD are usually taken at the start of the patient‘s day so that the
medication is effective while the patient is awake. A medication‘s dose timing depends on its
characteristics, the type and severity of infection, and the prescriber.

Right Education
Patients should be counseled by pharmacists about their medication, which provides an important
double-check in the dispensing process and gives patients needed information to use the
medication correctly. Education should include the medication‘s name, purpose, appearance, dose,
administration schedule, adverse effects, and precautions. For patients that may be pregnant
or breastfeeding (lactation), review information from the medication‘s labeling on use during
pregnancy or lactation. The FDA requires pregnancy and lactation warnings in prescription
medication labeling to assist health care providers and pregnant and/or nursing patients in
assessing benefit versus risk of taking a medication. Patients should be encouraged to double-check
their medications and call the pharmacist if there is anything unusual. If a different manufacturer is
used and the medication‘s size, shape, and/or color has changed, it is important to bring this to the
patient‘s attention. Providing patients with access to their medication profile can be helpful, as can
encouraging them to keep an updated profile available to share with all their care provides.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Right Effects
MMS enhance patients‘ understanding of appropriate medication use, increase adherence to
medication therapy, and improve the detection of adverse medication events. Medications that have medication guide. A document
a potential risk of an adverse reaction will have a black box warning. The FDA requires that a required to be dispensed with
medication guide be dispensed with them. Medication guides are paper handouts that address issues specific medications that have
specific to certain medications and medication classes. They contain FDA-approved information potential adverse reactions,
designed to help patients avoid serious adverse events by using the medication correctly. There are written in language that the
nearly 1,000 entries in the FDA-maintained Medication Guide Database. The number of medications patient can understand.
requiring a medication guide to be dispensed with them continues to grow. Examples of medications
that must have medication guides dispensed with them are in the Medications Dispensed With a
Medication Guide table.

TABLE 8.7 Medications Dispensed With a Medication Guide

MEDICATIONS REASON

SSRIs Increased risk of suicidal thoughts in adolescents;

example: fluoxetine
NSAIDs Risk of GI bleeding; example: naproxen
isotretinoin Risk of birth defects fluoroquinolones
Risk of tendinitis
eszopiclone Risk of sleep-related activities you may not
remember
metoclopramide Risk of tardive dyskinesia rosiglitazone
Risk of heart failure

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

For medications that have been identified to have an adverse risk associated with them,
manufacturers and the FDA are continually evaluating these risks versus the benefits of keeping
such medications on the market. In some cases, either the manufacturer or the FDA may determine
that the risks are significant enough to require additional product labeling for patient safety. A Risk
Evaluation and Mitigation Strategy (REMS) is recommended to ensure the benefits outweigh the
risks. An example of medication with a REMS is isotretinoin-containing medications, such as
Accutane, Claravis, or Zenatane. Isotretinoin can be used to treat severe forms of acne and, when
used properly, can have positive patient outcomes. This medication is associated with severe birth
defects if taken while pregnant, however. Patients who have prescriptions for medications
containing isotretinoin will be enrolled in the iPLEDGE program. Patients can only fill the
prescription at pharmacies that participate in iPLEDGE. The iPLEDGE program requires patients to
pledge to take a monthly pregnancy test and always use two forms of birth control. Other
medications that have REMS include transmucosal immediate-release fentanyl, buprenorphine-
naloxone (Suboxone), and dofetilide (Tikosyn). Like medication guides, the number of medications
subject to REMS continues to grow.

CHALLENGE

1. Which medication requires a medication guide to be dispensed with each prescription due to the risk
of suicidal thoughts in adolescents?
A. Fluoxetine
B. Naproxen
C. Penicillin
D. Isotretinoin
A. Fluoxetine is an SSRI with a boxed warning that requires a medication guide to be dispensed with
each prescription due to the risk of suicidal thoughts in adolescents. Naproxen requires a medication
guide to be dispensed with each prescription because of the risk of GI bleeding. Amoxicillin is an
antibiotic, but it does not have a black box warning or require a medication guide. Isotretinoin requires a
medication guide to be dispensed with each prescription due to the risk of causing birth defects.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Right Documentation
Document any issues related to a prescription or medication order and how they were resolved. For CHALLENGE
example, if the directions for a medication and the quantity ordered on a prescription do not agree 1. Which of the following are
and a follow-up call to the prescriber‘s office is made to clarify the information, document the “rights“ of medication? (Select
outcome and note who at the prescriber‘s office provided the clarification. The pharmacist should all that apply.)
document any counseling given, including information given to the patient and any questions. MMS A. Right medication
should be documented in the patient‘s profile. B. Right cost
C. Right billing
In the hospital setting, documenting medication administration is a vital part of the patient
D. Right dose
record and is done by the registered nurse or provider who performed the administration. Health
E. Right prescriber
care professionals depend on accurate documentation for many reasons. Electronic medication
F. Right education
administration records are used to track trends, ensure medications are given at the correct
G. Right day
times, and prevent a duplicate dose from being administered. If a patient‘s vital signs change,
A, D, F. The nine rights of medication
the documented information might help find a possible reason. Finally, documentation is used for are right patient, right medication,
auditing purposes. Internal and external audits depend on the information for correct billing. If a right route, right dose, right time,
right education, right documentation,
medication is not documented as given, it cannot be charged to the patient.
right effects, and right to refuse. Cost
may be an important factor in the
patient’s decision to fill a medication,
Right to Refuse but this is not a right or guarantee
to the patient. The correct billing
Patients also have an ethical and legal right to refuse care. Federal and state constitutional rights to is important so that patients are
not overcharged for medication or
privacy also protect the refusal of care. There are many reasons a patient may refuse care, and it can
charged for services that were not
be a complex decision. Competent patients have the right to refuse any medical treatment. For received, but it is not a “right.” The
example, after learning about the potential side effects of a new self-administered weight loss prescriber is not one of the “rights.”
The right time is important as some
medication, a patient decides against filling the prescription and decides to try other weight loss
medications are dependent on being
strategies instead. taken at the same time each day
or on specific days. But the “right
day” is not one of the “rights.”

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

CORRECTIVE ACTION FOR MEDICATION ERRORS continuous quality

Even with the best systems and processes in place, errors can still occur. Pharmacies have policies improvement (CQI). Process
and procedures in place for reporting medication errors. Take ownership of any medication errors,
of meeting regularly to
identify, review, and promote
near misses, or potential errors. It is important to report errors and near misses to the pharmacist
safe medication use.
or pharmacy supervisor in keeping with the pharmacy‘s policies and procedures. Organizations
should strive to have a safe and just culture where individuals feel empowered to proactively
root cause analysis. The
monitor the environment and participate in efforts that improve safety. Employees should be held
process of investigating an
accountable for errors, but so should the organization, with a focus on education, risk reduction, and error to determine the cause to
system design. prevent it from occurring again.

Continuous Quality Improvement

Continuous quality improvement (CQI) is one of the tools that pharmacies can use to identify, review,
and promote safe medication use. CQI meetings can be held monthly with key members of the
pharmacy team. Minutes should be kept and followed up on to continuously support an environment
for safe medication use. Safety strategies for SALAD, high-risk/high-alert medications, error-prone
abbreviations, double patient verification, and standardization are among the components of the CQI
process. ASHP and ISMP recommend that health systems use interdisciplinary safety teams. An
important part of CQI is risk assessment. Proactively using risk assessment tools can help
organizations identify, prioritize, and address issues that could lead to safety problems.

Root Cause Analysis

Another tool that can be used to help identify the risk of errors is root cause analysis. A root cause
analysis is used to find the cause of the problem. Risk management teams are specifically trained to
assist with this process. An action plan, a measurement strategy, and outcomes of the root cause
analysis process are used to address the root cause of the incident. This is required by The Joint
Commission within 45 days of the event or its detection. An error should never be hidden.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Communicating Errors
A discreet phrase should be used when notifying a pharmacist about a medication error, such as, “I
have an urgent matter to discuss with you.“ This way, the pharmacist knows that their attention is
needed right away without alarming patients and other staff members nearby. Discuss the errors in
an office or other private space that creates a comfortable, confidential environment.

Communication with the patient regarding the error should follow the employer policy and come
from the pharmacist in charge. Approach the error with the correct attitude and without panic
to easily manage the error and fix the problem. How errors are handled can mean the difference
between professional complaints and litigation or successful error resolution with a satisfied patient.
Any error should be addressed promptly and professionally, and the process should follow the
incident reporting policies and procedures of the facility.

The most important goal is to ensure what is best for the patient and reduce harm. Every error
should be taken seriously. Patients want to be heard. Use active listening and express empathy
with their reports and concerns using therapeutic communication. Do not make excuses or
appear otherwise dismissive, make evasive or flippant remarks, or “talk down“ to the patient.
A sincere apology for the concern, inconvenience, and situation can go a long way to successful
error resolution and patient satisfaction. Document all discussions with patients, parents/
caregivers, prescribers, or other parties, and ensure the documentation is in both the patient and
pharmacy records.
adverse drug event (ADE).
An injury resulting from
medical intervention
National Voluntary Reporting related to a medication.
In addition to internal employer error reporting, CQI, and root cause analysis, other national
voluntary reporting tools critical in addressing adverse drug events (ADEs) and adverse drug reactions adverse drug reaction
(ADR). An unexpected
(ADRs) exist. Not all medication errors result in harm. When they do, these medication errors may
reaction to a medication.
be called ADEs, which are a subset of medication errors and are defined as an injury resulting from
medical intervention related to a medication. An ADR is an unexpected reaction to a medication,
such as anaphylaxis or shortness of breath.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

These national voluntary programs use the reports gathered to educate health care providers about
error causes. The reports also allow stakeholders to develop strategies for preventing medication
errors in the future. Investigating and using information about medication safety risks and errors
that have occurred in other organizations and taking action to prevent similar errors is an ISMP best
practice. Reporting errors to national programs is important in preventing future patient harm.

ISMP National Medication Errors Reporting Program

ISMP operates the National Medication Errors Reporting Program (ISMP MERP). The ISMP MERP
was established in 1975 and is a voluntary, practitioner-based medication error reporting program.
The program‘s objectives are to:

⦁ Learn the underlying causes of reported medication errors or hazards.

⦁ Disseminate valuable recommendations to organizations to prevent future errors.

⦁ Provide guidance to the health care community, regulatory agencies, and pharmaceutical and
device manufacturers.

Errors may be reported at [Link] There are two portals: one

for health care practitioners and one for consumers. ISMP regularly analyzes reports and provides
essential information through its Safety Alert communication tools, including early warnings
when new issues are identified and addressing serious medication errors or information requiring
immediate attention by health care practitioners.

ISMP, ASHP, and members of the National Coordinating Council on Medication Error Reporting
and Prevention operate a National Alert Network (NAN). The NAN warns health care providers
through multiple national distribution channels about actual or potential medication errors that
have recently caused serious harm or death. The alerts are based on information submitted to the
ISMP MERP.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

FDA MedWatch
The FDA also has reporting programs and memoranda of understanding with ISMP, USP, and ASHP
to share publicly available information. FDA‘s program is called MedWatch. Reports are made about
medication reactions, quality issues, therapeutic failure, and product use issues. Reports can be
made for medications, devices, dietary supplements, infant formula, and cosmetics. Reporting may
be completed online at [Link] There are
portals for both health care providers and consumers. The FDA encourages the following reports.

⦁ Unexpected side effects/adverse events

⦁ Product quality problems

⦁ Preventable product use/medication errors, which can be caused by various issues (choosing the
wrong product because of look-alike labels/packaging or similar brand/generic names). Mistakes
can also be caused by difficulty with a device due to hard-to-read controls or displays, which may
cause a test result to be recorded incorrectly. CHALLENGE

⦁ Therapeutic failures (when a medical product does not seem to work as well when you switch from 1. Which of the following is a
one generic to another) national voluntary reporting
program?
The scope of the MedWatch program includes prescription and OTC medicines, biologics, medical A. FDA Drug Reaction Program
devices, combination products, nutritional products, cosmetics, and food. B. ISMP Error Alert Tool
C. Minnesota Immunization
To subscribe to these safety alerts, go to the FDA website. Database
D. FDA MedWatch
D. MedWatch is the name of the
Vaccine Reporting FDA’s safety information and
adverse event reporting program.
Vaccine error reporting is done through separate online systems: the ISMP National Vaccine Errors FDA Drug Reaction Program is not
Reporting Program (ISMP VERP) and the Vaccine Adverse Event Reporting System (VAERS). ISMP the national voluntary reporting
formed VERP in 2012 to capture the unique causes and consequences of vaccine-related errors. The program. ISMP has two reporting
programs: the ISMP MERP and
ISMP‘s analyses typically become the basis for recommendations on safe vaccine practices. VAERS is the ISMP VERP. They issue safety
a national early warning system to detect possible safety problems in U.S.-licensed vaccines. The alerts based on the information
system is co-managed by the CDC and FDA. VAERS accepts and analyzes reports of adverse events reported to help address issues
that are identified. Each state has
after a person has received an immunization. Anyone can report an adverse event to VAERS. Health an immunization reporting program
care professionals are required to report certain adverse events, and vaccine manufacturers are to document when vaccines
are given to patients. This is a
required to report all adverse events that come to their attention.
state, not a national, resource.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

WORK ENVIRONMENT
Whether in a community or hospital setting, the pharmacy department must be efficient.
Equipment, products, and workstations are located for convenience, accuracy, and speed. Smooth,
efficient workflow helps pharmacists dispense prescriptions more quickly with fewer errors.
Work flows in one direction along the prescription counter. Each part of the counter has its own
specific function.

Managing environmental factors, such as light, noise, interruptions, and workload, may lessen
errors. CQI quality checks and best practices can address these issues by ensuring adequate staffing
levels and breaks, managing workload, eliminating distractions in the dispensing process, ensuring
adequate lighting, heat, and humidity, reducing clutter, keeping the pharmacy clean and organized,
and ensuring adequate space and proper storage of medications.

Cleaning and Organization

Cleanliness and organization help minimize stress levels and prevent errors. Work areas must be
cleaned at the beginning of each shift, during workflow, and at the end of each shift. Each practice
setting has cleaning requirements specific to regulations.

In the community pharmacy setting, counting trays must be cleaned with 70% isopropyl alcohol
at the beginning of each shift, during each shift, after each shift, and after counting penicillin
and sulfonamides. Sulfonamides can sometimes be identified by the prefix sulfa- in the generic
medication name, and penicillin medications often have the suffix -cillin in the generic medication
name (see the Examples of Sulfa-Containing Medications table). This prevents cross-contamination
of medications to which patients commonly have allergic reactions. About 10% of patients who
have a penicillin allergy are at risk for cephalosporin allergy. Avoid the use of automated counting
machines when dispensing penicillin and sulfonamide medications to eliminate the risk of cross-
contamination.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

TABLE 8.8 Examples of Sulfa-Containing Medications

GENERIC NAME BRAND NAME

co-trimoxazole Septrin
sulfadiazine, sulfamethoxazole Gantanol
trimethoprim-sulfamethoxazole Bactrim, Bactrim DS, Septra, Septra DS
sulfasalazine Azulfidine EN-tabs, Azulfidine, Sulfazine
sulfisoxazole Gantrisin

In the hospital setting, the same rules apply to counting trays and automation devices used
to prepackage medications. Additional areas need specific attention, as well. The nonsterile
compounding area must be cleaned before and after each compound is prepared. If a silver
nitrate solution is made from crystals and the work area is not cleaned properly, any person who
encounters the work surface area is at risk of a silver nitrate chemical burn. The clean room has
its own cleaning schedule to ensure medications are not contaminated. The items used to clean the
clean room must be dedicated to that room. Sterile 70% isopropyl alcohol, water, bleach, and other
approved cleaning agents are used with lint-free cleaning cloths. See the Clean Room Cleaning
Schedule table for the scheduled cleaning of the clean room.

TABLE 8.9 Clean Room Cleaning Schedule

AREA CLEANING FREQUENCY

Laminar airflow hoods Beginning of shift

Every 30 minutes during batching
After a spill
Countertops Daily
Carts Daily
Floors Daily
Storage bins Monthly
Ceilings Monthly
Walls Monthly

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Quality Assurance Checks

Medication safety starts in the pharmacy and is continuously reviewed to improve patient outcomes. crash cart. A cart containing
Quality assurance checks are done on a schedule to ensure medications are handled and stored emergency medications
safely. These include regularly checking the medication inventory to remove expired or damaged used during a code and
products, checking refrigerator and freezer temperatures daily to be sure they are in the appropriate stored on facility nursing
range, and inspecting crash carts to be sure they have all needed medications and devices. units for easy access.

Outdated and Damaged Medications

In both community and hospital pharmacies, expired medications are removed from the shelf
monthly. Damaged medications are removed immediately when they are discovered. A good practice
is to identify all medications at the beginning of a calendar year that will be expiring within that
year and indicate which month they will expire. A medication‘s expiration date is on the outer label
and is typically indicated with a month and year. The expiration date is the last date in the month
perpetual inventory. An
on the label unless indicated otherwise. For example, if the medication expiration is listed as
exact record of inventory at
06/2027, the medication‘s expiration date is June 30, 2027. Expired stock should be quarantined from any given time by adding all
the rest of the inventory. Expired products are returned either to the wholesaler or a third-party orders received and removing
processor for destruction and credit. Inventory numbers should be adjusted accordingly, and all every order dispensed from
controlled medications should be documented in the perpetual inventory logs when inventory is inventory in real time.
removed from stock. Any expired controlled substances are stored in a locked, secure area until they
are returned or destroyed.

CHALLENGE

1. A medication label has an expiration date of 11/2025. What is the actual expiration date?
A. November 1, 2025
B. November 10, 2025
C. November 20, 2025
D. November 30, 2025
D. The expiration date is the last date in the month on the label. In this case, the medication
expiration is listed as 11/2025, so the medication’s expiration date is November 30, 2025. While
it may seem like 11/2025 indicates that the medication expires as soon as November 2025 starts,
the expiration date reflects the last day of the month if only a month and year are listed.

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 MEDICATION AND PATIENT SAFETY AND QUALITY ASSURANCE

Refrigerated and Frozen Medications

CHALLENGE
Refrigerators and freezers that store medications should contain a thermometer
that can be checked and logged daily to ensure inventory is stored at the appropriate 1. Match the medication or vaccine in column
temperature. The use of a smart thermometer helps with the safe storage of
A to the correct storage temperature in
column B.
temperature-sensitive medications. Smart thermometers are programmed with
A. Refrigerated 1. 2° to 8° C
safe temperature ranges for refrigerators and freezers in the pharmacy. If the insulin lispro pen 2. -13° to 14° F
temperature falls out of range, an alarm will sound, and an email or text message B. Frozen vaccine 3. 36° to 46° F
will alert a supervisor. When a refrigerator or freezer is out of range, ensure the door Comirnaty
has been shut properly, there is power to the machine, and that no one has recently C. Refrigerated
had the door open for a long time. Document the date, time, and temperature, and eyedrop
return in 1 hour to see if the temperature has returned to the normal range. If not, latanoprost
(Xalatan)
most pharmacy protocols include calling facility management and completing a
work order. Document the work order on the temperature log and follow up on its
D. Frozen medication
erythropoietin alfa
progress. In the meantime, relocate medications from the malfunctioning machine
2° to 8° C: Refrigerated eyedrop latanoprost (Xalatan).
to another refrigerator or freezer. Attach a sign on the broken machine with details −13° to 14° F: Frozen medication erythropoietin
of the work order and where the medications were relocated. Protocols also require alfa. 36° to 46° F: Refrigerated insulin lispro pen.
−25° to −10° C: Frozen vaccine Comirnaty. The
pharmacy staff to call the medication manufacturer to determine how long a
acceptable refrigerator temperature range is 2°
medication can be safely stored outside the labeled temperature. For example, the to 8° C (36° to 46° F), so column A items 1 and 3
Zostavax shingles vaccine can be stored outside the refrigerated temperature range should be matched to one of these ranges. The
acceptable freezer temperature range is −25° to
for 3 days before any quality degrades. −10° C (−13° to 14° F), so column A items 2 and
4 should be matched to one of these ranges.

2. -25° to -10° C A patient has a prescription for

Crash Carts fluconazole 150 mg, quantity 2, with directions
In hospital settings, nursing units are usually inspected monthly to ensure that to take 1 tablet by mouth immediately and 1
medications are stored properly and in a secure area. Crash carts with appropriate tablet in 72 hours. The technician is filling the
prescription. The technician looks at the box
amounts of emergency medications are located throughout the hospital and nursing
of fluconazole, and it has an expiration date of
units. Check the expiration dates of all medications on the carts monthly. After each 5/2024. Today is May 30, 2024. Can Carol use 2
use, take inventory and restock the crash cart as necessary. Controlled substances tablets to fill the prescription from this box?
should be secured in a locked cabinet away from other inventory depending on state The medication’s expiration date is May 31, 2024.
law or employer policy. Controlled substances should never be stored in a patient‘s One of the tablets could be used since the patient is
prescribed to take 1 tablet immediately. The second
room or medication cart. tablet that is due in 3 days (72 hours) will need to be
taken from a different package that has not expired.

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