Professional Documents
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Pharmacy Ethics and Jurisprudence in The Philippines
Pharmacy Ethics and Jurisprudence in The Philippines
(Must know)
Law- the sum total of rules and regulations by which a society is governed.
Sources of Law
1. Constitution
2. Statutes
3. Administrative law
4. Common law
Amendments- any change in the law can be done by passing this
Ethics- A method of inquiry that helps people to understand the morality of human behavior
The practices or beliefs of a certain group. The expected standards of moral behavior of a particular group as
described in the groups formal code of professional ethics
Pharmacy ethics- Refers to the ethical standard and issues that occur in pharmacy practice
Bioethics-Ethics as applied to human life or health
Profession- the willingness of an individual practitioner to comply with ethical and professional standard which
exceed minimum legal requirements
Pharmacist- ensure the provision of safe, effective, and quality drugs, for improved patient care and QOL
President of the Philippines- the members of the board of pharmacy are appointed by
Council of pharmaceutical education to recognize and accredit colleges and school of pharmacy in the
different universities is a function of
Board of pharmacy- to reprimand any erring pharmacist or to suspend or revoke his
certificate of registration
BFAD the minimum mandatory requirements necessary for the opening and
operation of drugstores are as prescribed by
-number of years of pharmacy practice for the pharmacist to comply as board examiner
60 days the decision of board of pharmacy in administrative cases involving pharmacist becomes final
and executor
2 -members of the board and a chairman- composition of board of pharmacy
2. Drug Trader – any establishment which is registered owner of the drug product, procures the
raw materials and packing components, and provides the production monographs, quality control
standards and procedures, but sub-contract the manufacturer of such product to a licensed
manufacturer. It may engage in distribution and/or marketing of its products.
3. Drug Distributor/Importer – any establishment that imports raw materials, active ingredients
and/or finished products for its own use or for wholesale distribution to other drug establishments
or outlets.
4. Drug Distributor/Exporter – any drug establishment that exports raw materials, active
ingredients and/or finished products to another country.
5. Drug distributor/Wholesaler – any drug establishment that procures raw materials, active
ingredients and/or finished products from local establishments n wholesale basis.
Requirements for A. Premises
Drug Outlets A signboard in front of the place of the business bearing registered name of the drugstore
A well-ventilated area not less than 15 sq.m. in floor area with concrete tile or wooden flooring
A place suitable for compounding prescription and for washing and sterilizing bottles (compulsory only
for hospital pharmacy)
A suitable and proper place for the adequate storage of drugs and biological products as specified on the
label
A suitable cabinet for keeping poisons and/or dangerous drugs
An adequate water supply
B. References/Documents
Philippine National Drug Formulary (when available)
USP/NF (latest edition)
RA 3720, RA 6675, RA 5921
Remington’s Pharmaceutical Sciences (latest edition)
Goodman and Gilman-Pharmacological Basis of Therapeutics (latest edition)
D. A full-time validly registered pharmacist physically present while drugstore is open for business
E. Others
Invoices indicating the lot number or batch number of the manufacturer’s stock
created by Margarita M. Gutierrez, RPh, MHPED
University of the Philippines Manila
Version 2015
File of prescriptions filled, consecutively numbered
Dry seal or rubber stamp containing the name and address of the drug outlet
Red and white labels indicating the name and address of drugstore
"Traditional medicine" - the sum total of knowledge, skills, and practice on health care, not
necessarily explicable in the context of modern, scientific philosophical framework, but recognized
by the people to help maintain and improve their health towards the wholeness of their being, the
community and society, and their interrelations based on culture, history, heritage, and
consciousness.
"Biomedicine" - that discipline of medical care advocating therapy with remedies that produce
effects differing from those of the diseases treated. It is also called "allopathy","western medicine",
"orthodox medicine", or "cosmopolitan medicine".
"Herbal medicines" - finished, labelled, medicinal products that contain as active ingredient/s serial
or underground part/s of plant or other materials or combination thereof, whether in the crude state
or as plant preparations.
"Natural product" - those foods that grow spontaneously in nature whether or not they are tended
by man. It also refers to foods that have been prepared from grains, vegetables, fruits, nuts, meats,
fish, eggs, honey, raw milk, and the like, without the use or addition of additives, preservatives,
artificial colors and flavors, or manufactured chemicals of any sort after harvest or slaughter.
"Traditional healers" - the relatively old, highly respected people with a profound knowledge of
traditional remedies.
"Intellectual property rights" - is the legal basis by which the indigenous communities exercise
their rights to have access to, protect, control over their cultural knowledge and product, including,
but not limited to, traditional medicines, and includes the right to receive compensation for it.
Governing Body Philippine Institute of Traditional and Alternative Health Care. - There is hereby established a
body corporate to be known as the Philippine Institute of Traditional and Alternative Health Care,
hereinafter referred to as the Institute. The Institute shall be attached to the Department of Health.
Its principal flag office shall be in Metro Manila, but it may establish other branches or offices
elsewhere in the Philippines as may be necessary or proper for the accomplishment of its purposes
created by Margarita M. Gutierrez, RPh, MHPED
University of the Philippines Manila
Version 2015
and objectives.
D. FDA ACT
(b) To ensure the FDA's monitoring and regulatory coverage over establishments and products
under its jurisdiction; and
(c) To provide coherence in the FDA's regulatory system for establishments and products under its
jurisdiction.
Director General (1) To hold in direct or indirect contempt any person who disregards orders or writs he or she
issues and impose the appropriate penalties following the same procedures and penalties provided
in the Rules of Court;
(2) To administer oaths and affirmations and issue subpoena duces tecum and subpoena ad
testificandumrequiring the production of such books, contracts, correspondence, records, statement
of accounts and other documents and/or the attendance and testimony of parties and witnesses as
may be material to the investigation conducted by the FDA;
(3) To obtain information from any officer or office of the national or local governments,
government agencies and its instrumentalities;
(5) To call on the assistance of any department, office or agency and deputize members of the
Philippine National Police or any law enforcement agency for the effective implementation of this
Act; and
(6) To exercise such powers and functions as may be necessary for the effective implementation of
this Act."
organization (1) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and
biologicals);
(3) Center for Cosmetics Regulation and Research (to include household hazardous/urban
substances); and
(2) Product Research and Standards Development Division, which shall be responsible for the
conduct of research, development of standards and regulations, compliance monitoring, and the
oversight and audit of related researches that would ensure safety, quality, purity and efficacy of
health products, as covered in this Act; and
(3) Laboratory Support Division, which shall be responsible for the conduct of research and
appropriate testa and calibration, analyses and trials of products including, but not limited to,
assays, and the conduct of oversight and/or audit of centers conducting bioavailability and
bioequivalence tests and other tests as covered by this Act. It shall likewise provide direct line
support to the centers which shall be separate and distinct per major product category that is
regulated
Other divisions (a) The Administration and Finance Office headed by the deputy director-general for
administration and finance shall have, at least, the following divisions: the Human Resource
Development Division; Property and Logistics Management Division; Human Resource
Management Division; Assets and Financial Management Division; and the Information and
Communication Technology Management Division.
(b) The Policy and Planning Office which shall be under the Office of the Director-General shall
have, at least, a training, advocacy and communications division and shall monitor the performance
of the centers for product research and evaluation and standards development.
(c) The Field Regulatory Operations Office headed by the deputy director-general for field
regulatory operations shall include, among others, all the field offices, field or satellite laboratories
and the regulatory enforcement units.
(d) The Legal Services Support Center shall provide legal services to the entire FDA and shall be
directly under the Office of the Director-General
(f) testing laboratory each in Luzon, Visayas and Mindanao, which shall have the necessary and
appropriate state-of-the-art laboratory equipment and personnel complement.
- The main testing laboratories at the central office shall be maintained and shall serve as a support
unit to the centers
- The existing laboratories in Cebu and Davao will be upgraded and transformed as quality
assurance laboratories, while another one will be established in Subic, Zambales
(g) Field Offices- The field offices shall be comprised of the following: (a) licensing, inspection
and compliance division, which shall have charge of the inspection of food, drugs and cosmetic
establishments engaged in their manufacture, importation, distribution, and sale; (b) satellite
laboratory division; and (c) administrative division.”
F. ASEAN Harmonisation
In 2015, the ten countries which form ASEAN ("Association of Southeast Asian Nations") will implement the
ASEAN Economic Community ("AEC") with the goal of creating a common economic community in Southeast Asia,
characterized by a single market and production base. The establishment of this community has the potential to
substantially change the way we do business and interact with our neighboring countries.
In order to achieve the ASEAN's objectives, there is a need to eliminate the barrier of having different laws,
regulations and standards governing goods and services. Thirteen sectors have been identified as areas of importance,
where efforts to achieve harmonization should be concentrated. The Healthcare industry, including pharmaceuticals and
other relevant products, has been particularly identified as one of these 13 sectors.
The ASEAN Pharmaceutical Product Working Group ("PPWG"), the regulatory body responsible for overseeing the
ASEAN harmonization efforts, has formally stated the following objective:
"To develop harmonization schemes of pharmaceutical regulations of the ASEAN member countries to
complement and facilitate the objective of AFTA, particularly, the elimination of technical barriers to trade posed
by these regulations, without compromising drug quality, safety and efficacy."
In terms of the registration of pharmaceutical facilities, compliance with the Pharmaceutical Inspection Cooperation
Scheme ("PIC/S") standards is the end goal of the ASEAN harmonization. Although some countries have already
enforced this, not all countries have fully adopted the PIC/S compliance requirement.
A. Generics Act
VIOLATIVE PRESCRIPTIONS
Where the generic name is not written
Where the generic name is not legible and a brand name which is legible is written
When the brand name is indicated and instructions added (such as “No substitution”) which
tend to obstruct, hinder, or prevent proper generic dispensing
What to do with VIOLATIVE PRESCRIPTIONS?
Do not fill.
Keep and report to the nearest DOH office for appropriate action
Pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the
proper prescription.
ERRONEOUS PRESCRIPTIONS
Where the brand name precedes the generic name
Where the generic name is the one in parentheses
Where the brand name is not in parentheses
What to do with ERRONEOUS PRESCRIPTIONS?
Shall be filled
Keep and report to the nearest DOH office for appropriate action
IMPOSSIBLE PRESCRIPTIONS
When only the generic name is written but is not legible
When the generic name does not correspond to the brand name
When both the generic name and the brand name are not legible
When the drug product prescribed is not registered with BFAD
What to do with IMPOSSIBLE PRESCRIPTIONS?
Shall not be filled
Keep and report to the nearest DOH Office for appropriate action
Pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the
proper prescription.
AO 63 s 1989 RULES AND REGULATIONS TO IMPLEMENT DISPENSING REQUIREMENTS UNDER
THE GENERICS ACT OF 1988
Generic dispensing: dispensing the patient’s choice from among generic equivalents (same
API, dosage form and strength)
Inform the patient of all available drug products generically equivalent to th prescribed drug.
All drug outlets shall post in a conspicuous place in their establishment a list of drug products
using generic names with their brand names.
Important “Compulsory License” is a license issued by the Director General of the Intellectual Property
definitions Office to exploit a patented invention without the permission of the patent holder, either by
manufacture or through parallel importation;
“Drug outlet” refers to drugstores, pharmacies, and any other business establishments which sell
drugs and medicines;
“Essential drugs list or national drug formulary” refers to a list of drugs prepared and periodically
updated by the Department of Health on the basis of health conditions obtaining in the Philippines
as well as on internationally accepted criteria
Amendment in the Drugs and medicines” refers to any chemical compound or biological substance, other than food,
definition of drugs intended for use in the treatment, prevention or diagnosis of disease in humans or animals,
or medicine including but not limited to:
(1) any article recognized in the official United States Pharmacopoeia-National Formulary
(USP-NF), official Homeopathic Pharmacopoeia of the United States, Philippine
Pharmacopoeia, Philippine National Drug Formulary, British Pharmacopoeia, European
Pharmacopoeia, Japanese Pharmacopoeia, Indian Pharmacopoeia, any national
compendium or any supplement to any of them;
(2) any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease in humans or animals;
(3) any article other than food intended to affect the structure or any function of the human
body or animals;
(4) any article intended for use as a component of any articles specified in clauses (1), (2),
and (3) not including devices or their components, parts, or accessories; and
(5) herbal and/or traditional drugs which are articles of plant or animal origin used in folk
medicine which are:
(i) recognized in the Philippine National Drug Formulary;
(ii) intended for use in the treatment or cure or mitigation of disease symptoms, injury or body
defects in humans;
(iii) other than food, intended to affect the structure or any function of the human body;
(iv) in finished or ready-to-use dosage form; and
(v) intended for use as a component of any of the articles specified in clauses (i), (ii), (iii), and
(iv);
AMENDMENTS >President have the power to impose maximum retail prices over any or all drugs and medicines as
TO REPUBLIC enumerated in Section 23, upon recommendation of the Secretary of the Department of Health
ACT NO. 8293,
OTHERWISE >. Drugs and Medicines Price Monitoring and Regulation Authority of the Secretary of the
KNOWN AS THE Department of Health.
INTELLECTUAL
PROPERTY >Functions and Responsibilities of the Secretary of the Department of Health.
CODE OF THE
PHILIPPINES Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to Price
Regulation,
Power to Include Other Drugs and Medicines in the List Subject to Price Regulation,
Power to Implement Cost-Containment and Other Measures,
Power to Impose Administrative Fines and Penalties,
Power to Deputize Government Entities, or
Other Powers Necessary to Implement Provisions of this Chapter, shall be immediately
operative
MAXIMUM DURATION :
RETAIL PRICE power to impose MRP over drugs and medicines shall be exercised within such period of time as
the situation may warrant as determined by the President of the Philippines. (17)
COVERAGE:
the imposition of the MRP will be at all levels of the supply chains i.e manufacturer’s price,
trader’s price, distributor’s price, wholesaler’s price and retailer’s price.
Display of Maximum Retail Price Fixed and Approved by Order of the President of the Philippines
for Drugs and Medicines Subject to Price Regulation.
F. Price Act
REPUBLIC ACT 7581
TITLE It is the act providing protection to consumers by stabilizing the prices of basic necessities and
prime commodities.
Definition of terms Basic necessities- includes rice, corn, bread, fish and drug classified essential by the DOH
Buffer fund- it is a contingent fund in the budget of the implementing agency which shall
not be used in normal or regular operations
Price ceiling- maximum price at which any basic necessities or prime commodities may be
sold to the general public
Prohibited acts Profiteering- the sale or offering for sale of any basic necessity or prime commodity at a
price grossly in excess of its true worth
A certified true copy of such record covering a period of six calendar months, duly signed by the
pharmacist or owner of the drugstore or pharmacy, shall be forwarded to the Board within fifteen
days following the last day of every June and December of each year, copy furnished the city or
municipal health officer concerned
Composition of a. DOH Secretary or representative
the Dangerous b. DOH Undersecretary or representative
Drugs Board c. Executive Director of the Dangerous Drugs Board
d. DOJ Secretary or representative
e. Department of National Defense or representative
f. DepEd Secretary or representative
Practitioner- any person who is licensed physician, dentist, chemist, med tech etc in the
Philippines
Pusher- any person who sells, trades administers etc to another or transports, broker in any
such transaction
Cultivate and culture- any act of knowingly planting, growing, raising etc planting of any
plant which is the source of dangerous drugs:
Deliver- any act of knowingly passing a dangerous drug to another, personally or otherwise
and by any means, with or without consideration
Illegal trafficking- The illegal cultivation, delivery administration etc. of any dangerous
drug or controlled precursor and essential chemical