PCPM101: Perspectives in Pharmacy
Module 4: Pharmacy Regulations Lesson 1: Pharmacist Licensure
Examination
Introduction
A pharmacist before being able to
The board examination is one of the last practice the profession must pass the
hurdles that a candidate must face before licensure examination as required by
he/she can practice his/her the Republic Act 10918 otherwise
profession. The purpose of a board known as the “Philippine Pharmacy
examination is to identify persons who Act”.
possess the minimum knowledge
necessary to perform tasks on the job The following are the requirements for
safely and competently. Also this applicants who will be taking the
examination ensures that candidates Pharmacists’ Licensure Examination:
meet technical, professional, and legal
standards, and protects the health, safety 1. A citizen of the Philippines or of a
and welfare of the public by assessing foreign country which has a law or
the abilities to practice competently. policy on reciprocity for the practice of
the pharmacy profession;
In this module, you will learn about the 2. Of good moral character and
requirements when applying for the reputation;
Pharmacist Licensure Examination and 3. A degree holder of Bachelor of
renewal of license, the different laws Science in Pharmacy or its
affecting the pharmacy profession, the equivalent degree conferred by an
Pharmacist Professional Ethics and the HEI in the Philippines or an institution
Philippine Practice Standards for of learning in a foreign country duly
Pharmacists (PhilPSP), and the different recognized by the CHED;
organizations both in the national and 4. Has completed an internship
international level where a pharmacist program approved by the Board,
could be affiliated. pursuant to such guidelines as may
hereinafter be promulgated, in
Learning Outcomes: consultation with the duly recognized
associations of pharmacy schools
At the end of the module you should be and the CHED.
able to:
Upon completion of the requirements, the
1. Identify the requirements in the applicant may take the licensure
processing for the Pharmacist examination usually given two times a
Licensure Examination and renewal year in places and dates designated by
of license the Professional Regulation Commission
2. Describe the different laws affecting (PRC).
the practice of pharmacy
3. Describe the Pharmacist Professional In order to be registered and licensed as
Ethics and the Philippine Practice a pharmacist, a candidate must:
Standards for Pharmacists - Obtain a general weighted average
4. Recognize the different national and of seventy-five percent (75%) with
international pharmacy organizations
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PCPM101: Perspectives in Pharmacy
no rating lower than fifty percent Lesson 2: Laws Affecting the
(50%) in any of the subjects. Pharmacy Practice
- An applicant who failed in the
licensure examination for the third The practice of pharmacy profession
(3rd) time shall not be allowed to take is regulated by the following laws in
the next succeeding examinations the country:
without having undertaken a
refresher program in a duly 1. Republic Act 10918 - “Philippine
accredited institution. The Board shall Pharmacy Act”
issue guidelines on the refresher
program requirement. It is an act regulating and modernizing
the practice of pharmacy in the
All successful candidates in the licensure Philippines. It provides for and shall
examination shall: govern the following:
- Take their oath of profession prior to • Standardization and regulation of
entering the practice of the pharmacy pharmacy education;
profession, in which he or she will be • Administration of licensure examination,
- Issued a Certificate of Registration registration and licensing of
(COR) and a pharmacists;
- Professional Identification Card • Supervision, control, and regulation of
(PIC) the practice of pharmacy in the
Philippines;
Renewal of license every 3 years and • Development and enhancement of
the requirements professional competence of
pharmacists through continuing
A PIC bearing the registration number professional development, research
and dates of its issuance and expiry, duly and other related activities;
signed by the Chairperson of the PRC, • Integration of the pharmacy profession.
shall likewise be issued to every
registrant, upon payment of the The Professional Regulatory Board of
prescribed fees. Pharmacy, under the administrative
control and supervision of the PRC, shall
- The PIC shall be renewed every three be responsible for the full implementation
(3) years, upon presentation of the of the law.
Certificate of Good Standing (COGS)
from the accredited professional 2. Republic Act 3720 - “The Foods,
organization (APO) and proof of Drugs, Devices and Cosmetics Act”
completion of the continuing
professional development (CPD) It is an act to ensure the safety and
requirements. purity of foods, drugs and cosmetics
being made available to the public by
creating the Food and Drug
Administration which shall administer
and enforce the laws pertaining thereto.
It was made into a law on June 22, 1963
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PCPM101: Perspectives in Pharmacy
and was already amended by E.O. No. packaging, and can apply to both
175 on May 22, 1987. branded and generic products;
- A drug itself or the
In the implementation of this law, it also container or labeling thereof of any
stipulated that the government shall (a) part of such drug, container or labeling
establish standards and quality measures bearing without authorization,
for food, drug, devices and cosmetic; and the trademark, trade name or other
(b) adopt measures to ensure pure and identification mark or imprint or any
safe supply of food, drug, devices and likeness to which is owned or
cosmetic in the country. registered in the Bureau of Patent,
Trademark and Technology Transfer
3. Republic Act 6675 - “The Generics (BPTTT) in the name of another
Law of 1988” natural or juridical person;
- A drug refilled in containers by
RA 6675 was made into law on unauthorized persons if the
September 13, 1988. It is an act to legitimate labels or marks are used;
promote, require and ensure the - An unregistered imported drug
production of an adequate supply, product, except drugs brought in the
distribution, use and acceptance of drugs country for personal use as confirmed
and medicines identified by their and justified by accompanying medical
generic names. records;
- A drug which contains no amount of
4. Republic Act 8203 - “Special Law on or a different active ingredient or
Counterfeit Drugs” less than eighty percent (80%) of the
It is an act known as “The Special Law on active ingredient it purports to
Counterfeit Drugs” approved September possess as distinguished from an
4, 1996. It is an act prohibiting adulterated drug including reduction or
counterfeit drugs, providing penalties loss of efficacy due to expiration.
for violations and appropriating funds
therefor. 5. Republic Act 9165 - “The
Comprehensive Dangerous Drugs Act
Counterfeit drug or medicine refers to any of 2002”
of the following:
The Comprehensive Dangerous Drugs
- Medicinal products with the correct Act of 2002 was made into law on June 7,
ingredients but not in the 2002. It is an act repealing R.A. 6425,
amounts as provided otherwise known as the “Dangerous
hereunder, wrong ingredients, Drugs Act of 1972”.
without active ingredients, with
sufficient quantity of active ingredient, A Philippine law that was created to
which results in the reduction of the safeguard the integrity of its territory
drug’s safety, efficacy, quality, and and the well-being of its citizenry
strength or purity; particularly the youth, from the
- A drug which is deliberately and harmful effects of dangerous drugs on
fraudulently mislabeled with respect their physical and mental well-being,
to identity and/or source or with fake and to defend the same against acts or
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PCPM101: Perspectives in Pharmacy
omissions detrimental to their quality, affordable drugs and
development and preservation. medicines is recognized by the state as
a primary instrument.
The government shall pursue an
intensive and unrelenting campaign 7. Republic Act 9711 - “Food and Drug
against the trafficking and use of Administration Act of 2009”
dangerous drugs and other similar
substances through an integrated It is an act strengthening and rationalizing
system of planning, implementation the regulatory capacity of the Bureau of
and enforcement of anti-drug abuse Food and Drugs (BFAD) by establishing
policies, programs and projects. The adequate testing laboratories and field
government shall however aim to achieve offices, upgrading its equipment,
a balance in the national drug control augmenting its human resource
program so that people with legitimate complement, giving authority to retain
medical needs are not prevented from its income, renaming it the Food and
being treated with adequate amounts of Drug Administration (FDA), amending
appropriate medications, which include certain sections of RA No. 3720.
the use of dangerous drugs.
It was created to have the following
The state shall also provide effective objectives of:
mechanisms or measures to re-
integrate into society, individuals who - Enhancing and strengthening the
have fallen victims to drug abuse or administrative and technical capacity of
dangerous drug dependence through the FDA in the regulation of
sustainable programs of treatment and establishments and products under its
rehabilitation. jurisdiction;
- Ensuring the FDA’s monitoring and
6. Republic Act 9502 - “Universally regulatory coverage over
Accessible Cheaper and Quality establishments and products under its
Medicines Act of 2008” jurisdiction; and
- Providing coherence in the FDA’s
Republic Act No. 9502 is an act providing regulatory system for establishments
for cheaper and quality medicines that and products under its jurisdiction.
was approved June 6, 2008.
Lesson 3: Pharmacy Professional
The general policy of this act is to protect Ethics & The PhilPSP
public health, and when the public
interest or circumstances of extreme Pharmacy Professional Ethics
urgency so require, it shall adopt
appropriate measures to promote and Professional Ethics
ensure access to affordable quality
drugs and medicines for all. • Encompass the personal, and
corporate standards of
In pursuant to the attainment of the behavior expected by professionals.
general policy, an effective competition
policy in the supply and demand of
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PCPM101: Perspectives in Pharmacy
• Every organization should have a For each practice area, the following are
code of ethics, whether or not listed:
mandated by law.
• A code has value as both an internal 1. Competency standard - describes a
guideline and an external statement of specific function to be carried out by a
corporate values and commitments. pharmacist who is deemed
professionally qualified;
Code of Ethics
2. Element - lists actions and processes
• A well-written code of conduct clarifies that are expected to be performed in
an organization’s mission, values and demonstrating a specific competency;
principles, linking them with standards
of professional conduct. 3. Performance criteria - are evaluative
• The code articulates the values the statements that specify the activities
organization wishes to foster in leaders or tasks needed to be accomplished
and employees and, in doing so, in order to carry out specific
defines desired behavior. processes;
• A code is a central guide and reference
for employees to support day-to-day 4. Evidence - consists of outputs,
decision making. outcomes, and/or examples relevant
• Encourages discussions of ethics and in achieving the competency.
compliance, empowering employees to
handle ethical dilemmas they encounter Core Competency Standards across
in everyday work. Practice Areas
Philippine Practice Standards for The following are the core competency
Pharmacists standards common in the five major
areas of pharmacy practice:
The Philippine Practice Standards for
Pharmacists (PhilPSP) was prepared by 1. Practices in a professional, legal and
the Philippine Pharmacists ethical manner
Association (PPHA) to serve as
a guidance for the desired minimum 2. Place client’s/patient’s welfare at the
standards of practice for pharmacists center of the practice
in various settings.
3. Demonstrates leadership and
The PhilPSP cover five major areas of management skills
pharmacy practice in the Philippines: a)
academic pharmacy; b) regulatory 4. Demonstrates cultural competence
pharmacy; c) manufacturing and effective communication
pharmacy; d) community, hospital and
institutional pharmacy; and e) public 5. Engages in inter professional
health pharmacy. collaboration
6. Commits oneself to continuing
professional development
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PCPM101: Perspectives in Pharmacy
Lesson 4: National and International 5. Ensures compliance to health
Pharmacy Organizations vigilance requirements
A pharmacist upon practice of the Practice Area No. 3: Manufacturing
profession can join different affiliations Pharmacy
both in the national and international
arena. 1. Participates in quality management
system
Read PDF provided for further 2. Contributes in product life cycle
discussion management
3. Maintains adequate premises and
Competency Standards per Practice equipment
Area 4. Participates in health vigilance
programs
The following are the competency
standards for each practice area: Practice Area No. 4: Community,
Hospital and Institutional Pharmacy
Practice Area No. 1: Academic
Pharmacy 1. Provides quality medicines and other
health products appropriate to the
1. Prepares students to become needs of the client/patient
professional pharmacists through 2. Compounds products in a manner
effective teaching that ensures product quality, safety
and efficacy
2. Contributes to existing body of 3. Counsels client/patient on the safe
knowledge through conduct of and judicious use of medicines and
scientific research other health products
4. Engages actively in client/patient
3. Shares technical expertise to the safety and health promotion activities
members of the community 5. Ensures business sustainability
through efficient processes and
4. Enriches teaching with additional systems
training and practice experience
Practice Area No. 5: Public Health
Practice Area No. 2: Regulatory Pharmacy
Pharmacy
1. Identifies appropriately the health and
1. Represents the organization to pharmaceutical needs of the
regulatory authorities population as well as the appropriate
2. Coordinates pertinent regulatory- interventions to address them
related marketing activities of the 2. Support activities aimed at protecting
organization and improving the health and well-
3. Participates in the development of being of the population
regulatory guidelines 3. Participates in policy and strategy
4. Ensures quality regulatory development and implementation
documentation
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PCPM101: Perspectives in Pharmacy
4. Contributes to the evidence base on
how medicines-related interventions,
programs and policies improve and
protect the health of the population
through academic and/or pharmacy
practice research
5. Ensures clinical governance and
continuous quality improvement in
service design and delivery
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