MODULE 4: PHARMACY REGULATION Flashcards by Eros Stear

A pharmacist before being able to practice the profession must pass the licensure examination as required by the R.A. 10918

PHARMACY LICENSURE EXAMINATION

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Republic Act 10918

PHILIPPINE PHARMACY ACT

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PHARMACY LICENSURE EXAM
REQUIREMENTS FOR APPLICATION
(1) A citizen of the Philippines or of a foreign country which has a law or policy on reciprocity for the practice of the pharmacy profession

Required Documents
➢Original and photocopy of the Philippine Statistics Authority-issued Certificate of Live Birth
➢Original and photocopy of the Philippine Statistics Authority-issued Marriage Certificate (for female applicant)

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PHARMACY LICENSURE EXAM
REQUIREMENTS FOR APPLICATION
(2) Of good moral character and reputation

Required Documents
➢Certification of Good Moral Character issued by any of the following: barangay, church, School of Pharmacy or employer
➢National Bureau of Investigation (NBI) Clearance

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PHARMACY LICENSURE EXAM
REQUIREMENTS FOR APPLICATION
(3) A degree holder of Bachelor of Science in Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of learning in a foreign country duly recognized by the CHED

Required Documents
➢Certified true copy of the Transcript of Records of BS Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of learning in a foreign country duly recognized by the CHED

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PHARMACY LICENSURE EXAM
REQUIREMENTS FOR APPLICATION
(4) Has completed an internship program approved by the Board, pursuant to such guidelines as may herein after be promulgated, in consultation with the duly recognized associations of Pharmacy school and the CHED

Required Documents
➢Certificate of Completion of the internship program duly signed by the dean/program head

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It is given 2x per annum
> March
> August

PHARMACISTS LICENSURE EXAM (PLE)

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PHARMACY LICENSURE EXAM
It requires:
- GWA of 75%
- No 50% in any subjects
- NB: 3rd failure = refresher course for 1 year in the school

TO BE AN RPh

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PHARMACY LICENSURE EXAM
Will be issued with:
- Certificate of Registration (COR)
- Professional Identification Card (PIC)

UPON PASSING THE PLE

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PHARMACY LICENSURE EXAM
ISSUANCE OF COR AND PIC:
- Issued to those who passes the licensure examination, subject to compliance with the requirements and payment of the prescribed fees.
- Bears the following:
+ Registration number
+ Date of issuance
+ Signature of the PRC Chairperson, Board chairperson, and Members, stamped with the seal of the Board and PRC
- Shall remain in full force and effect until suspended or revoked

CERTIFICATE OF REGISTRATION (COR)

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PHARMACY LICENSURE EXAM
ISSUANCE OF COR AND PIC:
- Bears:
+ Registration number
+ Date of issuance and expiry
+ Signature of the PRC Chairperson
- Renewal: Every 3 years; On-line renewal
- Requirements for renewal:
+ Certificate of Good Standing (COGS) from the Integrated Association of the Professional Organization (IAPO)
+ Proof of completion if the CPD requirements
+ Payments of renewal fee

PROFESSIONAL IDENTIFICATION CARD (PIC)

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LAWS AFFECTING THE PHARMACY PRACTICE
- Lapsed into Law (July 21, 2016)
- IRR: PRC Res. No. 52 s. 2017
- IRR Effectivity: 5/30/2017

R.A. 10918
PHILIPPINE PHARMACY LAW

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LAWS AFFECTING THE PHARMACY PRACTICE
- It is an act regulating and modernizing the practice of pharmacy in the Philippines. It provides for and shall govern the following
+ Standardization and regulation of pharmacy education
+ Administration of licensure examination, registration and licensing of pharmacists
+ Supervision, control, and regulation of the practice of pharmacy in the Philippines
+ Development and enhancement of professional competence of pharmacists through continuing professional development, research and other related activities
+ Integration of the pharmacy profession

REPUBLIC ACT 10918

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LAWS AFFECTING THE PHARMACY PRACTICE
- The Professional Regulatory Board of Pharmacy, under the administrative control and supervision of the PRC, shall be responsible for the full implementation of the law

REPUBLIC ACT 10918

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LAWS AFFECTING THE PHARMACY PRACTICE
- Signed into law on June 22, 1963
- Amendments:
+ E.O. No. 851 on December 2, 1982
+ E.O. No. 175 on May 22, 1987

REPUBLIC ACT 3720
THE FOODS , DRUGS, DEVICES, AND COSMETICS ACT

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LAWS AFFECTING THE PHARMACY PRACTICE
- It is an act to ensure the safety and 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 law pertaining thereto.

REPUBLIC ACT 3720

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LAWS AFFECTING THE PHARMACY PRACTICE
- This law was Signed on August 18, 2009
- Also known as ‘Food and Drug Administration act of 2009’

REPUBLIC ACT 9711
FOOD AND DRUG ADMINISTRATION ACT OF 2009

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LAWS AFFECTING THE PHARMACY PRACTICE
- It is an act strengthening and rationalizing the regulatory capacity if the Bureau of Food and Drugs (BFAD) by establishing adequate testing laboratories and field offices, upgrading it equipment, augmenting its human resource complement, giving authority to retain its income, renaming it the Food and Drug Administration (FDA)

REPUBLIC ACT 9711

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LAWS AFFECTING THE PHARMACY PRACTICE
- Signed on September 13, 1988
- Known as ‘Generics act of 1988’

REPUBLIC ACT 6675
GENERICS ACT IF 1988

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LAWS AFFECTING THE PHARMACY PRACTICE
- It is an act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names.

REPUBLIC ACT 6675

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LAWS AFFECTING THE PHARMACY PRACTICE
- Signed on September 4, 1996
- It is an act prohibiting counterfeit drugs, providing penalties for violations and appropriating funds therefor

REPUBLIC ACT 8203
SPECIAL LAW ON COUNTERFEIT DRUGS

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LAWS AFFECTING THE PHARMACY PRACTICE
- Medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, and strength or purity

COUNTERFEIT DRUG

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LAWS AFFECTING THE PHARMACY PRACTICE
- A drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products

COUNTERFEIT DRUGS

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LAWS AFFECTING THE PHARMACY PRACTICE
- A drug itself or the container or labeling thereof of any part of such drug, container or labeling bearing without authorization, the trademark, trade name or other identification mark or imprint or any likeness to which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person;

COUNTERFEIT DRUGS

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LAWS AFFECTING THE PHARMACY PRACTICE - A drug refilled in containers by unauthorized persons if the legitimate labels or marks are used - An unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records;

COUNTERFEIT DRUGS

LAWS AFFECTING THE PHARMACY PRACTICE - A drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration.

COUNTERFEIT DRUGS

LAWS AFFECTING THE PHARMACY PRACTICE - Signed on June 7, 2002 - Repealed R.A. 6425 - “Dangerous Drugs Act of 1972”

REPUBLIC ACT 9165 COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002

LAWS AFFECTING THE PHARMACY PRACTICE - A Philippine law that was created to safeguard the integrity of its territory and the well-being of its citizenry particularly the youth, from the harmful effects of dangerous drugs on their physical and mental well-being, and to defend the same against acts or omissions detrimental to their development and preservation.

REPUBLIC ACT 9165

LAWS AFFECTING THE PHARMACY PRACTICE - Signed on June 6, 2008 - Known as ‘Universally Accessible Cheaper and Quality Medicines Act of 2008’

REPUBLIC ACT 9502 UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF 2008

LAWS AFFECTING THE PHARMACY PRACTICE - The general policy of this act is to protect public health, and when the public interest or circumstances of extreme urgency so require, it shall adopt appropriate measures to promote and ensure access to affordable quality drugs and medicines for all.

REPUBLIC ACT 9502

- Encompass the personal, and corporate standards of behavior expected by professionals - Every organization should habe a code of ethics, whether or not mandated by law - A code has value as both an internal guideline and an external statement of corporate values and commitments

PROFESSIONAL ETHICS

- A well-written code of conduct clarifies an organization’s mission, values, and principles, linking them with standards of professional conduct - The code articulates the values the organization wishes to foster in leaders and employees and, in doing so, defines desired behavior

CODE OF ETHICS

- A code is a central guide and reference for employees to support day-to-day decision making - Encourages discussions of ethics and compliance, empowering employees to handle ethical dilemmas they encounter kn everyday work

CODE OF ETHICS

PHARMACY PROFESSIONAL ETHICS Resolution No. 23 (s. 2021) - Resolution Promulgating and Prescribing The Code of Ethics of the Pharmacy Profession

CODE OF ETHICS FOR THE PHARMACY PROFESSION

PHARMACY PROFESSIONAL ETHICS ARTICLE I PREAMBLE •Pharmacists are valued and recognized health professionals who are given the responsibility within the overall health system, mainly to promote safe, effective and responsible use of medicines. Together with other health professionals, they assist patients and those to whom they provide professional services to gain maximum therapeutic benefit from their medicines. As pharmacy practice is not limited to the provision of direct clinical care, pharmacists also work closely with consumers, patients, carers and other stakeholders in the discovery, development, manufacture and supply management of medicines. They perform technical and leadership roles in education, research, regulations and policy development. Pharmacists help individual, families and communities maintain good health and avoid ill health. •With these professional responsibilities, the pharmacists hereby publicly state, through this Code of Ethics, the principles that form the fundamental basis of the norms and standards in the performance of their duties and responsibilities. These basic principles based on moral obligation and virtues are established to guide the pharmacists in their relationship with and obligation to patients, consumers, carers, health professionals and other partners in particular and with the society in general

CODE OF ETHICS FOR THE PHARMACY PROFESSION

PHARMACY PROFESSIONAL ETHICS Code of Ethics for the Pharmacy Profession FOCUS AREA: The Pharmacist’s Patients and Clients 1. A pharmacist places the health and well-being of the individual and the community at the center of professional practice.

INTERPRETATION: A pharmacist commits to help individual and community to improve self-care and to maintain good health, prevent illness and make the best use of medications. A pharmacist establishes therapeutic relationship to gain trust and confidence of the clients.

PHARMACY PROFESSIONAL ETHICS Code of Ethics for the Pharmacy Profession FOCUS AREA: The Pharmacy Profession 2. A pharmacist acts with honesty, integrity and professionalism in her/his relationship with patients, carers and other stakeholders in healthcare.

INTERPRETATION: (1) A pharmacist builds a trusting relationship with patients, carers and other healthcare professionals with appropriate actions and behaviors; commits to transparency and accountability in all dealings. (2) A pharmacist abides by regulatory requirements, scientific principles, professional practice and ethical standards. A pharmacist is responsible for her/his actions and faces consequences when regulatory and scientific standards are not met. (3) A pharmacist is committed to lifelong learning to enhance professional competence. A pharmacist ensures that her/his knowledge and skills are continuously updated and upgraded. (4) A pharmacist demonstrates commitment to the development and enhancement of the profession. A pharmacist takes leadership roles and involvement in initiatives and programs that are critical to the demands of the profession as it continuously evolves

PHARMACY PROFESSIONAL ETHICS Code of Ethics for the Pharmacy Profession FOCUS AREA: Other Health Professionals 3. A pharmacist respects and collaborates with other healthcare professionals and colleagues to achieve optimal treatment outcomes for their patients and ensures continuum of care.

INTERPRETATION : A pharmacist exercises professionalism, diplomacy and tact at all times and recognizes the individual contributions and differences of the members of the team in the patient’s continuum of care.

PHARMACY PROFESSIONAL ETHICS Code of Ethics for the Pharmacy Profession FOCUS AREA: Professional Business Practices 4. A pharmacist conducts the business of pharmacy in an ethical and professional manner.

INTERPRETATION : A pharmacist conducts business practices in the best interest of the patients and clients, respects confidentiality and exercises propriety in communicating information; respects his competitors and their products and services while using her/his time and resources for legitimate business purposes.

The Board shall have the power, upon notice and hearing, to revoke or suspend the Certificate of Registration of a registered pharmacist for violation of any provision of this Code of Ethics, conviction of an offense involving moral turpitude by a court of competent jurisdiction, unprofessionalism, immorality, malpractice, incompetence, gross negligence, or imprudence in the practice of the profession in accordance with the provisions of R.A. No. 10918 and R.A. No. 8981.

CODE OF ETHICS FOR THE PHARMACY PROFESSION

This shall take effect immediately after its publication in the Official Gazette or in any newspaper of general circulation. Let a copy hereof be furnished the UP Law Center. Done this _22nd _ day of _September_, 2021 in the City of Manila, Philippines. Officer-in-charge • ANTHONY ALDRIN C. SANTIAGO Member: • ADELINA C. ROYO • MILDRED C. OLIVEROS ATTESTED: OIC, PRB Secretariat Division • ATTY. OMAIMAH E. GANDAMRA APPROVED: Chairman • TEOFILO S. PILANDO, JR. Commissioner: YOLANDA D. REYES JOSE Y. CUETO, JR

CODE OF ETHICS FOR THE PHARMACY PROFESSION

PHARMACY PROFESSIONAL ETHICS - Prepared by the Philippine Pharmacists Association, Inc. to serve as a guidance for the desired minimum standards of practice for pharmacists in various settings

PhilPSP PHILIPPINE PRACTICE STANDARDS FOR PHARMACISTS

PHARMACY PROFESSIONAL ETHICS Major areas of practice: - Academic pharmacy - Regulatory pharmacy - Manufacturing pharmacy - Community, Hospital, and Institutional pharmacy - Public health pharmacy

PhilPSP

PHARMACY PROFESSIONAL ETHICS - Describes a specific function to be carried out by a pharmacist who is deemed professionally qualified

COMPETENCY STANDARD

PHARMACY PROFESSIONAL ETHICS - Lists actions and processes that are expected to be performed in demonstrating a specific competency

ELEMENT

PHARMACY PROFESSIONAL ETHICS - Evaluative statements that specify the activities or tasks needed to be accomplished in order to carry out specific processes

PERFORMANCE CRITERIA

PHARMACY PROFESSIONAL ETHICS - Consists of outputs, outcomes, and/or examples relevant in achieving the competency

EVIDENCE

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Year Established: 1920 Composition: •Regular Members •Pharmacists •Auxiliary Members •Pharmacy students

PPhA PHILIPPINE PHARMACISTS ASSOCIATION, INC.

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Year Established: 1965 Composition: •Regular Members •Deans and Program heads of SOPs/COPs/DOPs •Associate Members •RPh faculty members •Auxiliary Members •Pharmacy students

PACOP PHILIPPINE ASSOCIATION OF COLLEGES OF PHARMACY

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Date Established: December 10,1993

CPAP COMMUNITY PHARMACISTS ASSOCIATION OF THE PHILIPPINES

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Year Established: 1986 Composition •Regulatory pharmacists representing different pharmaceutical companies

PAPPI PHILIPPINE ASSOCIATION OF PHARMACISTS IN THE PHARMACEUTICAL INDUSTRY

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Year established 1962 Composition •Hospital pharmacists working either in private and government hospitals

PSHP PHILIPPINE SOCIETY OF HOSPITAL PHARMACISTS

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Year Established: 1968 Composition •Pharmacy students enrolled in different schools of pharmacy accredited by CHED

FJCPPhA FEDERATION OF THE JUNIOR CHAPTERS OF PHILIPPINE PHARMACISTS’ ASSOCIATION

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Date established: July 14, 1962 DOHLP Composition •Hospital pharmacists in government hospitals •Food and Drug Regulation Officers of the Center for Health Development •Food and Drug Administration (all divisions) •Other DOH Facilities and affiliate members from the AFPNC, Naval and Air Force of the Philippines

DOHLP DEPARTMENT OF HEALTH - LEAGUE OF PHARMACISTS

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Founded on April 02, 2004 Composition •Pharmacists working in companies providing healthcare

IPAP INDUSTRIAL PHARMACISTS ASSOCIATION OF THE PHILIPPINES

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: PAPVI

PAPVI PHILIPPINE ASSOCIATION OF PHARMACISTS IN VETERINARY INDUSTRY

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Year established: 2010 Composition •Young pharmacists until the age of 35 y.o.

YPG PHILIPPINES YOUNG PHARMACISTS GROUP - PHILIPPINES

PHILIPPINE PHARMACY ORGANIZATIONS NATIONAL ORGANIZATIONS: - Year established : 2011 Composition • Pharmacists who handles cosmetics, health and wellness activities from different cosmetic companies

COSHWELL COSMETICS, HEALTH, AND WELLNESS PHARMACISTS ASSOCIATION, INC.

PHILIPPINE PHARMACY ORGANIZATIONS GOVERNMENT AGENCIES: - Holds the over-all technical authority on health as it is a national health policy-maker and regulatory institution.

DOH DEPARTMENT OF HEALTH

PHILIPPINE PHARMACY ORGANIZATIONS GOVERNMENT AGENCIES: - Ensure safety, efficacy, purity and quality of products that the organization is regulating through effective implementation of the national regulatory framework consistent with international best practices

FDA FOOD AND DRUG ADMINISTRATION

PHILIPPINE PHARMACY ORGANIZATIONS GOVERNMENT AGENCIES: - It was mandated to be the policy-making and coordinating agency as well as the national clearing house on all matters pertaining to law enforcement and control of dangerous drugs

DDB DANGEROUS DRUG BOARD

PHILIPPINE PHARMACY ORGANIZATIONS GOVERNMENT AGENCIES: - It is the lead anti-drug law enforcement agency, responsible for preventing, investigating and combating any dangerous drugs, controlled precursors and essential chemicals within the Philippines.

PDEA PHILIPPINE DRUG ENFORCEMENT AGENCY

PHILIPPINE PHARMACY ORGANIZATIONS GOVERNMENT AGENCIES: - A government agency attached to the Office of the President of the Philippines that covers both public and private higher education institutions as well as degree-granting programs in all post-secondary educational institutions in the country

CHED COMMISSION ON HIGHER EDUCATION

PHILIPPINE PHARMACY ORGANIZATIONS GOVERNMENT AGENCIES: - It was first created as a national government agency mandated to enforce the laws regulating the various professions.

PRC PROFESSIONAL REGULATION COMMISSION

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - A networking organization where career minded individuals exchange ideas, educate and empower one another. Members enjoy a wealth of resources and benefits that are dedicated to enhancing both their personal and professional lives.

IAHCP THE INTERNATIONAL ASSOCIATION OF HEALTHCARE PROFESSIONALS

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - A unique global alliance representing patients of all nations across all disease areas. It has 276 member organizations from 71 countries representing 50 disease areas.

IAPO INTERNATIONAL ALLIANCE OF PATIENT’S ORGANIZATIONS

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - A professional organization of Asian pharmacists. - It was founded in 1946 with its headquarters in Manila, Philippines.

FAPA FEDERATION OF ASIAN PHARMACEUTICAL ASSOCIATIONS

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - The AASP serves as a platform for the exchange of ideas and strategies in pharmacy education as well as to foster research collaborations among the member pharmacy schools in Asia.

AASP ASIAN ASSOCIATION OF SCHOOL OF PHARMACY

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - The original idea of ACCP came from Asian pharmacists who were looking for organizing a conference in which they could exchange and share ideas on the concept of clinical pharmacy.

ACCP ASIAN CONFERENCE ON CLINICAL PHARMACY

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - A non-governmental, non-political and non-religious organization that represents pharmaceutical students, pharmacy students and recent graduates from all over the world. It was founded in August 25, 1949 and it is the oldest faculty-based student organization.

IPSF INTERNATIONAL PHARMACEUTICAL STUDENT’S FEDERATION

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - The FIP is the global body representing pharmacy and pharmaceutical sciences.

FIP FEDERACION INTERNATIONALE PHARMACETIQUE/ INTERNATIONAL PHARMACEUTICAL FEDERATION

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - A specialized agency of the United Nations that is concerned with international public health - Established April 7, 1948 in Geneva, Switzerland

WHO WORLD HEALTH ORGANIZATION

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: Since its establishment, it has played a leading role in the eradication of small pox, its current priorities now are: •Communicable diseases particularly HIV/AIDS, Ebola, malaria and tuberculosis; •Mitigation of the effects of non-communicable diseases such as sexual and reproductive health, development and aging; •Nutrition, food security and healthy eating; •Occupational health; •Substance abuse; and •Driving the development of reporting, publications and networking.

WHO WORLD HEALTH ORGANIZATION

PHILIPPINE PHARMACY ORGANIZATIONS INTERNATIONAL ORGANIZATIONS: - It is responsible for the World Health Report, the worldwide World Health Survey, and the World Health Day. •The current Director-General is TEDROS ADHANOM

WHO WORLD HEALTH ORGANIZATION