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COFEPRIS Pharmacy Exam Guide

The document outlines various regulations and requirements related to the operation of pharmacies, including prescription management, medication classification, and storage conditions. It also details the responsibilities of pharmacy personnel and the legal documentation necessary for pharmacy operations. Additionally, it covers topics such as adverse reactions to medications, health licenses, and the disposal of expired medications.
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0% found this document useful (0 votes)
4 views9 pages

COFEPRIS Pharmacy Exam Guide

The document outlines various regulations and requirements related to the operation of pharmacies, including prescription management, medication classification, and storage conditions. It also details the responsibilities of pharmacy personnel and the legal documentation necessary for pharmacy operations. Additionally, it covers topics such as adverse reactions to medications, health licenses, and the disposal of expired medications.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

May 28, 2021 SICAD

(.. /[Link])
JORGE RENDON
Start (.. /[Link])
Exit. /[Link]
Exam
Assistant to the
Dispensation

Take the exam

Answer the questions and press the 'Finish Exam' button.

In the event that a prescription includes the details of several doctors,


the corresponding ones for the prescribing physician must be clearly indicated and
include:*

The seal of the clinic or institution that endorses it


Your signature and the seal of the clinic or institution that endorses it

Your name
It is not necessary to make the distinction

2. Once the special prescription is filled, it is the means by which you are
the delivery to the prescribing doctor will be notified of the delivery:*

COFEPRIS email
Email of the PHARMACOPOEIA
The prescribing doctor does not receive notification regarding this.

Only by phone

3. What legal documentation supports the operation of pharmacies without


management of controlled substances or biologicals, homeopathic pharmacies without
preparation of compounded and herbal medicines and the pharmacy without management
of controlled and biological?

Health Responsible Notice


Operating Notice
Health License
Health license and Operating notice

4. The business name and address of the original invoice for the supplies for the
health must correspond with:*

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May 28, 2021 SICAD
The personal address of the owner
The license or notice of operation of the establishment that took effect
medication
The private address of the health responsible notice of the provider
The company name and address of previous invoices

5. According to Art. 61 of the Health Supplies Regulation, what is a


vitamin medication?

Chemical substance composed of vitamin B2 for energy production


New molecule composed of fat-soluble vitamins for solubilizing in the
body fat
The product that is made up of vitamins or minerals such as:
polypharmacy, alone or in combination indicated to prevent or treat
sufferings due to deficiencies of them
Active ingredient added with water-soluble vitamins to maintain a
stable intake

6. It is an Adverse Reaction to Medications that must be reported:

Reaction that puts the patient's life at risk


Reaction that causes dizziness effects
Reaction that causes nausea effects
Reaction that causes drowsiness effects

7. Medication that corresponds to group III, according to the classification


for sale and supply:

Moclobemide
Salbutamol
Methadone
Ergotamine

8. They are some of the members of Pharmacovigilance:*

Institutional Pharmacovigilance Centers


Institutional Centers for Pharmacovigilance and Chemical Industry
Pharmaceutical
None of the above
Pharmaceutical Chemical Industry

According to Article 262 of the General Health Law, they are devices or
materials that, added or not with antiseptics or germicides, are used in
the surgical practice or in the treatment of continuity solutions,
skin lesions or its appendages:

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28/5/2021 SICAD
Sterilized materials for healing
Surgical and healing materials
Sterilized materials for surgical use
Hygienic products for the healing of wounds and injuries

10. They are products made from plant material or some derivative of it.
whose main ingredient is the aerial or underground part of a plant or
extracts and tinctures, as well as juices, resins, fatty and essential oils,
presented in pharmaceutical form, their efficacy and safety have been
scientifically confirmed:*

Homeopathic Medicines
Natural Medicines
Herbal Remedies
Herbal Medicines

11. It refers to the report concerning a patient who has developed a


clinical manifestation that is suspected to have been caused by a medication and is
done through a schematic form called Format:

Notification
Supervision
Assessment result
Verification

12. It is any substance or product, solid or semi-solid, natural or


transformed, which provides the organism with elements for its nutrition:*

Food
Nutrient
dietary supplement
Vitamins

13. They are medical devices whose designation key in the records
sanitary facilities according to their category of use is the letter 'R':

Prosthetics, orthotics, and functional aids


Surgical and healing material
Dental supplies and hygiene products
Diagnostic agent

14. According to the storage conditions of the medications and


other health supplies, to a place with a relative humidity not greater than
40% at a controlled room temperature is considered:*

Sub humid

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May 28, 2021 SICAD
Dry
Warm
Thermal

15. What does Health Control refer to?*

Education, sampling
Verification and security measures and penalties
All of the above
Set of actions, direction

16. These are some requirements that the pharmacy must meet as a minimum*

To be independent of any other legal entity, business line, or residence.


The pharmacies located inside self-service stores
They must be installed in specific areas, physically separated.
Pharmacies with a functioning notice must have a sign on the
entry, in a publicly visible place, indicating the name or business reason
social, giro and operating hours
All the above

17. Even when the pharmacy belongs to a corporate or chain, the


Standard Operating Procedures must be:

Specimens
Applied
Directed
Generals

18. If the label of a medication or health product indicates


"it must be kept in a cool place", it can be stored and distributed
in a refrigerator at a temperature that is between:

9 and 20°C
8 and 15°C
10 and 18°C
5 and 18°C

19. At this stage of assistance in the sale and supply of inputs for
the health, the pharmacy employee verifies that the prescription is not registered
as provided in the COFEPRIS portal:

Supply of medication from fraction or group III


Supply of medications from fraction or group I
Supply of medications from fraction or group II

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28/5/2021 SICAD
Supply of medications from fraction or group IV

20. It is the information that must be considered for management of


*

Most common routes of administration and usage considerations


Complete data of the laboratory that manufactures the medication
Health registration with the Secretary of Health
Trade name and concentration of the medication

21. It is part of the clothing that must be worn by the personnel working in
pharmacies

All of the above


Clean clothes suitable for their activities
Identification badge
Security team

22. How many levels of nested structures are required for the operation of VigiFlow:

The system requires 4 levels


The system requires 3 levels
The system requires 2 levels.
The system only requires 1 level.

23. In which of the following cases is it not necessary to present a medical prescription?
for the sale of vitamin medications?

A prescription is never required


When none of its components exceed the indicated daily doses
When its route of administration is parenteral
When there is no medical prescription

There are two types of prescription:

Simplified and Customized


Authorized and Exclusive
Manual and Electronics
Ordinary and Special

25. The assortment of the recipe of the medications in this fraction must
register immediately on the pharmacies portal of the website of the
COFEPRIS:

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May 28, 2021 SICAD
Fraction I
Fraction III
Fraction IV
Fraction II

26. This drug corresponds to fraction VI and can be dispensed in others


establishments that are not pharmacies:

Triazolam
Ibuprofen
Lithium carbonate
Amoxicillin

27. The recording of movements in the control books is carried out and endorsed.
with your signature by:

The pharmacy staff who made the sale


The assistant in the dispensing of medications
The owner of the pharmacy exclusively
The healthcare responsible person or the individuals authorized for that activity.

28. Homeopathic medicines must be prepared according to


the procedures:*

Established in the Regulations of Homeopathic Medicines of the


United Mexican States
Established in the operational manual for homeopathic medicines
from the Secretary of Health
Of manufacturing described in the Homeopathic Pharmacopoeia of the States
United Mexicans, in those of other countries or other sources of information
national and international science
Manufacturing described in the General Law of Homeopathic Medicines,
Allopathic and Herbalists

29. The aspects that must be taken care of in storage conditions


of medications and other health supplies are:*

Particulars, natural, light and cleanliness


Temperature
Particulars, normal, light and cleaning
General, normal, light and cleaning

30. It is the correct final disposal for expired medications.


from households:*

Destroy them and dispose of them down the drain.

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May 28, 2021 SICAD
A waste management plan authorized by SEMARNAT
Reintegrate them to the pharmacy
Throw them in the trash in a separate bag

31. According to Article 215 of the General Health Law, what are the
Nutritional Supplements?

Auxiliary products in the treatment of digestive diseases


Mix of plant nutrients
Herb-based products, plant extracts, traditional foods,
added or not added vitamins and minerals
Concentrates added 100% of vitamins and minerals

32. According to article 226 of the General Health Law, it is the legend
mandatory that must be carried by medicines and herbal remedies
fraction III:*

"Its sale or dispensing requires a medical prescription that can be filled in three
"occasions with a validity of six months" and, if applicable, "its prolonged use even in
therapeutic doses can cause dependence.
Its sale or dispensing requires a medical prescription, which will be retained in the
pharmacy" and, if applicable, "Its prolonged use even at therapeutic doses may
cause dependency.
All of the above
Its sale or dispensing requires a prescription or special permission with code of
bars which will be retained at the pharmacy.

33. It aims to guarantee the right of every person to the environment.


healthy environment and promote sustainable development through prevention
from the generation, valuation, and integrated management of waste
dangerous.

General Law for the Protection of the Environment


Federal Law for the Protection of the Environment
General Law for the Prevention and Comprehensive Management of Waste
Federal Law for the Prevention and Comprehensive Management of Waste

34. Substance or mixture of substances of natural or synthetic origin that has


therapeutic, preventive or rehabilitative effect, that occurs in the form of
pharmaceutical and identifies itself as such by its pharmacological activity,
physical, chemical, and biological characteristics:*

Medication
Herbal remedy
Input for health
Vitamin

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May 28, 2021 SICAD
35. A Health License is required for:*

Condition medications in unit doses and treatments


All of the above
Prepare, sell and supply magistral and medicinal drugs.
Acquire, sell, and supply, medications that contain
narcotics and psychotropics, blood derivatives, vaccines, toxoids, serums and
animal-origin antitoxins

36. In case of an error in the manually prepared record in the book of


antibiotic control will be necessary:*

Cancel with a diagonal or half line and write the date and signature.
Perfectly erase with special eraser for ink
Apply the corrector and overwrite by making the observation in the footnote.
Use a new sheet specifying the reason

They are toxic substances that have lost, lack, or show variation in
the characteristics to be used, transformed, or marketed
regarding the original design or production standards:*

Hazardous waste
Organic waste
Biodegradable waste
Toxic waste

They are professionals who have a professional license issued by


the competent educational authorities and that are authorized by the
Health Secretary to prescribe Class I medications in prescriptions
specials:

Doctors, Veterinarians, Dentists


Doctors, Homeopathic Doctors, Herbal Doctors
Doctors, Doctors with a specialty, Nursing Graduates
Doctors, Homeopathic Doctors, Veterinarians, Dental Surgeons

39. They are pharmaceutical products, medicines or specialties


medicinal products whose administration does not require medical authorization, since
are used by consumers on their own initiative and
*

Generic drugs
Similar medications
Expired medications
Over-the-counter (OTC) medications

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May 28, 2021 SICAD
40. These are aspects that the staff working in a pharmacy must take care of:*

Maintain safety and hygiene conditions, identify the product that


it is required and to verify its existence
Prescribe the appropriate medication for the discomfort expressed by the patient, be
respectful and courteous
Greet customers warmly and prepare injectable mixtures of
quality if the user requests them
Have a service attitude and always recommend the most effective medications.
economic

* Required fields Finish Exam

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public servants
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Participate It is the single portal of of complaints and
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and participation sfp/SFP54)
Publications
Officials citizena. Read more
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es-gobmx
Legal Framework
[Link] Data portal
National Platform open
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