pharmacy ethics and jurisprudence in the philippines

8/10/2019 Pharmacy Ethics and Jurisprudence in the Philippines

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created by Margarita M. Gutierrez, RPh, MHPED

University of the Philippines ManilaVersion 2015

Important Statutes Summarized(Must know)

Republic Act No. Common name Year Amendments/supplemental AOS

RA 5921 Pharmacy Law June 23, 1969 EO 174RA 9502

RA 3720 Food, Drugs and CosmeticsAct

June 22, 1963 EO 175AO 55AO 56RA 9711

RA 6675 Generics Act of 1988. September 13, 1988 AO 62AO 63RA 9502

RA 8203 Special Law on CounterfeitDrugs

July 22, 1996

RA 6425 The Dangerous Drugs Actof 1972."

April 4, 1972 RA 9165

RA 9165 Comprehensive DangerousDrugs Act of 2002"

June 7, 2002 None

RA 7432 Senior Citizen Act of 1992 April 23, 1992 RA 9257RA 9257 Expanded Senior Citizens

Act of 2003February 26, 2004 RA 9994

RA 9994 Expanded Senior CitizensAct of 2010

February 15 2010

RA 7394 Consumer Act of thePhilippines

April 13 1994

RA 7581 Price Act May 7, 1992

RA 9502 Universally AccessibleCheaper and QualityMedicines Act of 2008

June 6, 2008

RA 9711 Food and DrugAdministration (FDA) Actof 2009

August 18, 2009

RA 8423 "Traditional and AlternativeMedicine Act (TAMA) of1997."

December 9, 1997


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Pharmaceutical Ethics and Jurisprudence

I. Introduction to Pharmacy Jurisprudence and ethics

Jurisprudence- Science and philosophy of lawImportance To ensure the pharmacist decision and actions are consistent with current legal principles To protect pharmacist from liability

Law- the sum total of rules and regulations by which a society is governed. Sources of Law

1. Constitution2. Statutes3. Administrative law4. 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

ethical awareness - the ability to discern between right and wrongethical competency - the ability to engage in sound moral reasoning and consider carefully the implication ofalternative action

Pharmacy ethics- Refers to the ethical standard and issues that occur in pharmacy practice Bioethics- Ethics as applied to human life or healthProfession - the willingness of an individual practitioner to comply with ethical and professional standard whichexceed minimum legal requirementsPharmacist - ensure the provision of safe, effective, and quality drugs, for improved patient care and QOL

Ethical Principles Summarized

Ethical Principle Definition Non-maleficence To do no harmBeneficence Duty to promote goodRespecting the patient professional relationshipRespect for autonomy Respect for the individuals right to decide on issues that affect self Consent Right to be informed and to choose a course of actionConfidentiality right to give or refuse consent relative to release of privileged informationRespect for personsVeracity obligation to tell the truth, or honesty

THE PHILIPPINE PHARMACISTS ASSOCIATION CODE OF ETHICS 1. A pharmacist places the well-being of the patient at the center of professional practice.2. A pharmacist promotes the welfare of each individual in a caring and compassionate manner.3. A pharmacist serves the needs of the individual, community and society and provides health for all.4. A pharmacist respects the rights of the patients and upholds confidentiality of patients records.5. A pharmacist acts with honesty, integrity and professionalism in relationship with the patients and other

health professionals.6. A pharmacist respects the abilities, values and contributions of colleagues and other health professionals and

work with them closely to ensure better patient care.7. A pharmacist is committed to continuously enhance professional competence.


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8. A pharmacist in coordination with the government and other health professionals helps in the formulation andimplementation of health care policies, standards and programs designed for the benefit of the society.

II. Standards of Pharmacy Practice

A. Pharmacy Law Overview

REPUBLIC ACTNO.

RA 5921 (as amended by EO 174)

TITLE AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING STANDARDS OFPHRMACEUTICAL EDUCATION IN THE PHILIPPINES AND FOR OTHER PURPOSES

OBJECTIVES TO GOVERN:a. the standardization and regulation of pharmaceutical education

b. the examination for registration of graduates of schools of pharmacyc. the supervision, control and regulation of the practice of pharmacy

Composition ofCouncil ofPharmaceutical

Education

Education Secretary UP College of Pharmacy DeanHealth Undersecretary Dean (representing private pharmacy schools)BFAD Director Representative (pharmacy organizations)

PRC Pharmacy Board ChairmanPRC Board ofPharmacy

Chairman and 2 members with three-year terma. natural-born Filipino citizens

b. registered and practicing for at least ten yearsc. of good moral character and of recognized standing in the professiond. at time of appointment, not a faculty of any school offering pharmacy or f a college of

pharmacye. member of a national pharmacy organization

Candidacy forBoardExamination

Filipino citizen Of good moral character Must have completed internship requirements Graduated with degree in pharmacy

Ratings required General average of at least 75% No ratings below 50% in more than two subjects (modules) Failure to pass in three successive attempts need to attend a pre-board review course from a

duly accredited college of pharmacyPractice ofpharmacy

Prepare or manufacture, analyze, assay, preserve, store, distribute or sell any medicine, drugchemicals, cosmetics, pharmaceuticals, devices of contrivances used in pursuance thereof;

Render pharmaceutical service in any office or drug and cosmetic establishment wherescientific, technological or professional knowledge of pharmacy is applied;

Engage in teaching scientific, technological or professional pharmacy subject in a college of pharmacy;

Conduct or undertake scientific pharmaceutical research for biological and bacteriological

testings and examinationsPrerequisites forthe Practice ofPharmacy

At least 21 years of age Passed the Board Exams Holder of valid certificate of registration

Pharmacy Law commonly asked concepts and definition

A. Cipher vs Codes vs Secret Keys

Cipher Codes Secret keys


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method of secret writing thatsubstitutes other letters or charactersfor the letter intended

system of words or other systemsarbitrarily used to present words

characteristics style or symbols keptfrom the knowledge of others ordisclosed confidentially to one or few

B. Authorities to memorize

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

C. Important numbers to memorize

21 years the minimum age requirement to practice pharmacy in the Philippines5 years -the book kept for the purpose of recording the sale of violent poisons should preserved in the

period of

-ordinary prescription shall be retained by the pharmacist for a period of

-number of years of pharmacy practice for the pharmacist to comply as board examiner60 days the decision of board of pharmacy in administrative cases involving pharmacist becomes final

and executor2 -members of the board and a chairman- composition of board of pharmacy

-times board exam is given in a year960 hours complete pharmacy internship program10 days the BOP, upon receipt of formal complaint under oath against any pharmacist, shall furnish an

answer within

III. Standards for Food, Drugs, devices and cosmetics

A. Food, Drugs and Cosmetics Act summarized

REPUBLIC ACT NO.

RA 3720 (as amended by EO 175)

TITLE AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS AND COSMETICS, ANDTHE PURITY, SAFETY, EFFICACY AND QUALITY OF DRUGS AND DEVICES BEINGMADE AVAILABLE TO THE PUBLIC, VESTING THE BUREAU OF FOOD AND DRUGSWITH AUTHORITY TO ADMINISTER AND ENFORCE THE LAWS PERTAININGTHERETO, AND FOR OTHER PURPOSES

OBJECTIVES a. Establish standards and quality measures for foods, drugs and devices and cosmetics b. Adopt measures to ensure pure and safe supply of foods and cosmetics, and pure, safe,

efficacious and good quality drugs and devices in the countryc. Adopt measures to ensure the rational use of drugs and devicesd. Strengthen the Bureau of Food and Drugs

BFAD Functions To administer and supervise the implementation of this Act and other regulations pursuant tothe same

To provide for the collection of samples of food, drug and cosmetics To analyze and inspect food, drug and cosmetic To establish analytical data to serve as basis for the preparation of food, drug and cosmetic

standards, and recommend standards of identity, quality and fill of container


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14. storage conditions15. For Rx Drugs: Foods, Drugs and Devices, and Cosmetics Act prohibits dispensing without

prescription.

ADMINISTRATIVEORDER

NO. 56 SERIES 1989

TITLE REVISED REGULATIONS FOR THE LICENSING OF DRUG ESTABLISHMENTS ANDOUTLETS

Types of DrugEstablishments

1. Drug Manufacturer any establishment engaged in operations involved in the production ofdrug, including propagation, processing, compounding, finishing, filling, packing, repacking,altering, ornamenting and labeling with the end in view of storage, distribution, or sale of the

product.

2. Drug Trader any establishment which is registered owner of the drug product, procures theraw materials and packing components, and provides the production monographs, quality controlstandards and procedures, but sub-contract the manufacturer of such product to a licensedmanufacturer. It may engage in distribution and/or marketing of its products.

3. Drug Distributor/Importer any establishment that imports raw materials, active ingredientsand/or finished products for its own use or for wholesale distribution to other drug establishmentsor outlets.

4. Drug Distributor/Exporter any drug establishment that exports raw materials, activeingredients and/or finished products to another country.

5. Drug distributor/Wholesaler any drug establishment that procures raw materials, activeingredients and/or finished products from local establishments n wholesale basis.

Requirements forDrug Outlets

A. Premises 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 onlyfor 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 Remingtons Pharmaceutical Sciences (latest edition) Goodman and Gilman-Pharmacological Basis of Therapeutics (latest edition)

C. Record Books duly registered with BFAD Prescription Book Dangerous Drug Book Exempt Preparation Book Poisons Book Record Book for Selected Non-Prescription Drugs

D. A full-time validly registered pharmacist physically present while drugstore is open for businessE. Others Invoices in dicating the lot number or batch number of the manufacturers stock


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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

B. Traditional and Alternative Medicine Act (TAMA) of 1997.

REPUBLIC ACT 8423 TITLE AN ACT CREATING THE PHILIPPINE INSTITUTE OF TRADITIONAL AND

ALTERNATIVE HEALTH CARE (PITAHC) TO ACCELERATE THE DEVELOPMENT OFTRADITIONAL AND ALTERNATIVE HEALTH CARE IN THE PHILIPPINES, PROVIDINGFOR A TRADITIONAL AND ALTERNATIVE HEALTH CARE DEVELOPMENT FUND ANDFOR OTHER PURPOSES

Definition of terms " Traditional and alternative health care " - the sum total of knowledge, skills and practices onhealth care, other than those embodied in biomedicine, used in the prevention, diagnosis andelimination of physical or mental disorder.

"Traditional medicine " - the sum total of knowledge, skills, and practice on health care, notnecessarily 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, thecommunity and society, and their interrelations based on culture, history, heritage, andconsciousness.

" Biomedicine " - that discipline of medical care advocating therapy with remedies that produceeffects differing from those of the diseases treated. It is also called "allopathy","western medicine","orthodox medicine", or "cosmopolitan medicine".

" Alternative health care modalities " other forms of non-allopathic, occasionally non-indigenousor imported healing methods, though not necessarily practiced for centuries nor handed down fromone generation to another. Some alternative health care modalities include reflexology,acupressure, chiropractics, nutritional therapy, and other similar methods.

" Herbal medicines " - finished, labelled, medicinal products that contain as active ingredient/s serialor underground part/s of plant or other materials or combination thereof, whether in the crude stateor 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 oftraditional remedies.

" Intellectual property rights " - is the legal basis by which the indigenous communities exercisetheir 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 Phil ippine In stitute of Tr aditi onal and Altern ative H ealth 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 officeselsewhere in the Philippines as may be necessary or proper for the accomplishment of its purposes


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and objectives.

C. Special law on counterfeit drugs

REPUBLIC ACT RA 8203 SPECIAL LAW ON COUNTERFEIT DRUGSTITLE AN ACT PROHIBITING COUNTEREIT DRUGS, PROVIDING PENALTIES FOR

VIOLATIONS AND APPROPRIATING FUNDS THEREFORWhat arecounterfeit drugs?

a. Medicinal products with the correct ingredients but not in the amounts as provided b. Wrong ingredientsc. Without active ingredientsd. With insufficient quantity of active ingredientse. Deliberately and fraudulently mislabeled with respect to identity and/or sourcef. With fake packagingg. Container or labeling bearing without authorization the trademark, trade name or other

identification mark or imprinth. Drug product refilled in containers by unauthorized persons if the legitimate labels were usedi. An unregistered imported drug product

j. A drug which contains no amount of, or a different active ingredient, or less than eighty percent of the active ingredient it purports to possess

D. FDA ACT

REPUBLIC ACT RA 9711 TITLE AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF

THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTINGLABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTINGITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITSINCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDINGCERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, ANDAPPROPRIATING FUNDS THEREOF

objectives (a) To enhance and strengthen the administrative and technical capacity of the FDA in theregulation of establishments and products under its jurisdiction;

(b) To ensure the FDA's monitoring and regulatory coverage over establishments and productsunder 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 sheissues and impose the appropriate penalties following the same procedures and penalties providedin the Rules of Court;

(2) To administer oaths and affirmations and issue subpoena duces tecum and subpoena adtestificandum requiring the production of such books, contracts, correspondence, records, statementof accounts and other documents and/or the attendance and testimony of parties and witnesses asmay 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;


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(4) To issue orders of seizure, to seize and hold in custody any article or articles of food, device,cosmetics, household hazardous substances and health products that is adulterated, counterfeited,misbranded or unregistered, or drug, in-vitro diagnostic reagent, biologicals, and vaccine that isadulterated or misbranded, when introduced into domestic commerce pending the authorizedhearing under Republic Act No. 3720, as amended, Executive Order No. 175 (1987), and RepublicAct No. 7394, otherwise known as the Consumers Act of the Philippines;

(5) To call on the assistance of any department, office or agency and deputize members of thePhilippine National Police or any law enforcement agency for the effective implementation of thisAct; and

(6) To exercise such powers and functions as may be necessary for the effective implementation ofthis Act."

organization (1) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and biologicals);

(2) Center for Food Regulation and Research;

(3) Center for Cosmetics Regulation and Research (to include household hazardous/urban

substances); and

(4) Center for Device Regulation, Radiation Health, and ResearchDivision percenter

(1) Licensing and Registration Division, which shall be responsible for evaluating health productsand establishments as covered by this Act for the purpose of issuance of authorizations andconditions to be observed;

(2) Product Research and Standards Development Division, which shall be responsible for theconduct of research, development of standards and regulations, compliance monitoring, and theoversight and audit of related researches that would ensure safety, quality, purity and efficacy ofhealth products, as covered in this Act; and

(3) Laboratory Support Division, which shall be responsible for the conduct of research andappropriate 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 linesupport to the centers which shall be separate and distinct per major product category that isregulated

Other divisions (a) The Administration and Finance Office headed by the deputy director-general foradministration and finance shall have, at least, the following divisions: the Human ResourceDevelopment Division; Property and Logistics Management Division; Human ResourceManagement Division; Assets and Financial Management Division; and the Information andCommunication Technology Management Division.

(b) The Policy and Planning Office which shall be under the Office of the Director-General shallhave, at least, a training, advocacy and communications division and shall monitor the performanceof the centers for product research and evaluation and standards development.

(c) The Field Regulatory Operations Office headed by the deputy director-general for fieldregulatory operations shall include, among others, all the field offices, field or satellite laboratoriesand the regulatory enforcement units.

(d) The Legal Services Support Center shall provide legal services to the entire FDA and shall bedirectly under the Office of the Director-General


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(e) The FDA shall establish a Regulatory Enforcement Unit (REU) for a period not exceeding five(5) years from the effectivity of this Act. It shall be composed of at least five (5) qualified

personnel in every region who shall be directly under the control and supervision of the DeputyDirector-General for Field Regulatory Operations and shall be administratively supported by thefield offices.

Bear arms, wear official uniforms and insignias and shall be classified as law enforcementagents;

Serve and execute rulings, orders, and decisions of the Director-General of the FDA; and Execute and serve search warrants and arrest warrants issued by the courts in connectionwith violations under this Act and related laws concerning the regulation of health

products.

(f) testing laboratory each in Luzon, Visayas and Mindanao, which shall have the necessary andappropriate 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 supportunit to the centers- The existing laboratories in Cebu and Davao will be upgraded and transformed as qualityassurance laboratories, while another one will be established in Subic, Zambales

(g) Field Offices- The field offices shall be comprised of the following: (a) licensing, inspectionand compliance division, which shall have charge of the inspection of food, drugs and cosmeticestablishments engaged in their manufacture, importation, distribution, and sale; (b) satellitelaboratory division; and (c) administrative division.

E. BFAD (old FDA structure)

OFFICE ORDER No. 1 series of 1988TITLE IMPLEMENTATION OF EXECUTIVE ORDER NO. 119, REORGANIZIG THE BUREAU OF

FOD AND DRUGS, DEPARTMENT OF HEALTHOrganization 1.1 Office of the Director

1.2 Regulation Division I (Inspection and Licensing Sections)1.3 Regulation Division II (Inspection and Licensing Sections)1.4 Product Services Division1.5 Laboratory Services Division1.6 Legal, Information, and Compliance Division1.7 Administrative Division

RegulationDivision I(Outlets)

Plans, directs and supervises the implementation of rules, regulations an standard operating procedures in inspections and licensing of the following establishments:

a. retail drugstores b. hospital pharmaciesc. retail outlets for non-prescription drugsd. drug department

a. general wholesaler b. distributor/importer/exporter of finished products, which is neither a manufacturer

nor a producere. retailer of household hazardous substances

a. distributor/importer/exporter of finished food products, which is neither amanufacturer nor a producer

RegulationDivision II(Manufacturers)

Plans, directs and supervises the implementation of rules, regulations an standard operating procedures in inspections and licensing of the following establishments:

a. drug manufacturer b. drug assay laboratory


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c. drug producerd. drug department

a. importer/exporter in bulk b. distributor/importer/exporter, which is at the same time a manufacturer or producer

e. food and food products manufacturer/processorf. household hazardous substance manufacturer

F. ASEAN Harmonisation

In 2015, the ten countries which form ASEAN (" Association of Southeast Asian Nations ") will implement theASEAN 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 tosubstantially 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 andother 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 theASEAN harmonization efforts, has formally stated the following objective:

"To develop harmonization schemes of pharmaceutical regulations of the ASEAN member countries tocomplement and facilitate the objective of AFTA, particularly, the elimination of technical barriers to trade posedby these regulations, without compromising drug quality, safety and efficacy."

In terms of the registration of pharmaceutical facilities, compliance with the Pharmaceutical Inspection CooperationScheme (" 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.

IV. Ensure Affordability and Accessibility of Drugs

A. Generics Act

REPUBLIC ACT RA 6675 Generics ActTITLE AN ACT TO PROMOTE, REQUIRE, AND ENSURE THE PRODUCTION OF AN ADEQUATE

SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE OF DUGS AND MEDICINESIDENTIFIED BY THEIR GENERIC NAMES

Components of the National DrugPolicy

a. Quality Assurance of Drugs b. Rational Use of Drugs by Health Professionals and Consumersc. National Self-Sufficiency in Pharmaceuticalsd. Rationalization of the DOHs Procurement Program

AO 62 s 1989 RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING REQUIREMENTS UNDERTHE GENERICS ACT OF 1988

Generic names shell be used in all prescriptions. The generic name must be written in full but the salt or chemical form may be abbreviated. The generic name must be clearly written on the prescription immediately after the Rx symbol.


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If the brand name is written on the prescription, it should be in parentheses and be writtenunder the generic name.

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 dispensingWhat 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 patients 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.

B. Senior Citizen ActREPUBLIC ACT RA 7432 SENIOR CITIZENS ACTTITLE AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO

NATIONBUILDING, GRANT, BENEFIT, AND SPECIAL PRIVILEGES AND FOR OTHERPURPOSES

The Senior Citizen Any resident of the Philippines at least 60 years old, including those who have retired from bothgovernment offices and private enterprises, and has an income of not more than sixty thousand

pesos per annum subject to review by NEDA every three yearsBenefit related todrugs

The grant of 20% discount from all establishmentsand purchase of medicines anywhere in thecountry; provided that private establishments may claim the cost as tax credit

C. Expanded Senior Citizens Act of 2003


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REPUBLIC ACT RA 9994 Expanded SENIOR CITIZENS ACTTITLE An Act Granting Additional Benefits and Privileges to Senior Citizens, Further Amending

Republic Act No. 7432, as Amended, Otherwise Known as An Act to Maximize the Contributionof Senior citizens

AdditionalBenefits to seniorcitizens

1. The law would exempt senior citizens from the 12 percent value added tax imposed ongoods and services.- While the original senior citizens act, Republic Act 7342, gave the elderly a 20 percent

discount on goods and services, they were not exempted from the VAT, whicheffectively brought down the level of discount to only eight percent

- Now that the law has been amended, senior citizens would be able to enjoy the full 20 percent discount.

2. Indigent senior citizens will also be given a monthly stipend of P500, subject to the periodic review of Congress in coordination with the Department of Social Welfare andDevelopment.

3. In case of death of an indigent senior citizen, an amount of P2,000 will be awarded to hisor her nearest kin as death benefit assistance

4. Senior citizens may also enjoy a five percent discount on their water and electric bills onthe condition that the utilities are in the name of the senior citizen residing in thehousehold, and that the consumption for electricity and water does not exceed 100kilowatt-hours and 30 cubic meters per month, respectively.

Expandedcoverage ofdiscounts

1. medicine and essential medical supplies,2. accessories and equipment;3. fees of attending physicians;4. medical, dental and diagnostic and laboratory fees;5. fares for buses, jeepneys, taxis, AUVs, shuttle services, public railways, domestic air transportand other vessels;6. utilization of services in hotels7. restaurants and similar establishments; admission fees in cinemas, theaters and other places ofculture, leisure and amusement; and funeral and burial services

D. Universally Accessible Cheaper and Quality Medicines Act of 2008REPUBLIC ACT RA 9502TITLE AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES, AMENDING FOR THE

PURPOSE REPUBLIC ACT NO. 8293 OR THE INTELLECTUAL PROPERTY CODE,REPUBLIC ACT NO. 6675 OR THE GENERICS ACT OF 1988, AND REPUBLIC ACT NO.5921 OR THE PHARMACY LAW, AND FOR OTHER PURPOSES

Importantdefinitions

Compulsory License is a license issued by the Director General of the Intellectual PropertyOffice to exploit a patented invention without the permission of the patent holder, either bymanufacture or through parallel importation;

Drug outlet refers to drugstores, pharmacies, and any other business establishments which selldrugs and medicines;

Essential drugs list or national drug formulary refers to a list of drugs prepared and periodicallyupdated by the Department of Health on the basis of health conditions obtaining in the Philippinesas well as on internationally accepted criteria

Multisource pharmaceutical products refers to pharmaceutically equivalent or pharmaceuticallyalternative products that may or may not be therapeutically equivalent. Multisource pharmaceutical

products that are therapeutically equivalent are interchangeable

TRIPS Agreement or Agreement on Trade -Related Aspects of Intellectual Property Rights refers
http://www.philstar.com/Article.aspx?articleId=550330&publicationSubCategoryId=63http://www.philstar.com/Article.aspx?articleId=550330&publicationSubCategoryId=63http://www.philstar.com/Article.aspx?articleId=550330&publicationSubCategoryId=63http://www.philstar.com/Article.aspx?articleId=550330&publicationSubCategoryId=63


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to the international agreement administered by the WTO that sets down minimum standards formany forms of intellectual property regulation; and

Amendment in thedefinition of drugsor medicine

Drugs and medicines refers to any chemical compound or biological substance, other than food,intended for use in the treatment, prevention or diagnosis of disease in humans or animals,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, PhilippinePharmacopoeia, Philippine National Drug Formulary, British Pharmacopoeia, EuropeanPharmacopoeia, Japanese Pharmacopoeia, Indian Pharmacopoeia, any nationalcompendium or any supplement to any of them;

(2) any article intended for use in the diagnosis, cure, mitigation, treatment, or preventionof 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 folkmedicine 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 bodydefects 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);

AMENDMENTSTO REPUBLICACT NO. 8293,

OTHERWISEKNOWN AS THEINTELLECTUALPROPERTYCODE OF THEPHILIPPINES

>President have the power to impose maximum retail prices over any or all drugs and medicines asenumerated in Section 23, upon recommendation of the Secretary of the Department of Health

>. Drugs and Medicines Price Monitoring and Regulation Authority of the Secretary of theDepartment of Health.

> Functions and Responsibilities of the Secretary of the Department of Health.

Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to PriceRegulation,

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

MAXIMUMRETAIL PRICE

DURATION : power to impose MRP over drugs and medicines shall be exercised within such period of time asthe situation may warrant as determined by the President of the Philippines. (17)

COVERAGE:the imposition of the MR P will be at all levels of the supply chains i.e manufacturers price,traders price, distributors price, wholesalers price and retailers price.


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DISCOUNTS:Senior Citizens Discount and Discount for People with Disability shall continue to be honored even ifthe drug and medicines are subject to MRP (n)

Display of Maximum Retail Price Fixed and Approved by Order of the President of the Philippines for Drugs and Medicines Subject to Price Regulation.

- manufacturer, importer, distributor, wholesaler, trader, or retailer of a drug and medicineintended for sale.- printed on the label of the immediate container of the drug and medicine and theminimum pack thereof offered for retail sale with the words RETAIL PRICE NOT TOEXCEED preceding it, and UNDER DRUG PRICE REGULATION on a red strip

E. Consumer Act of the PhilippinesREPUBLIC ACT 7394 TITLE Consumer Act of the Philippines Definition of terms Creditor- a natural person who is a purchaser, lessee, recipient or prospective purchaser,

leaser or recipient of consumer product services or credit Retailer- any person engaged in in the business of selling consumer products directly toconsumers

Price tag- any device affixed to a consumer product or displayed in a consumer services forthe purpose of indicating the retail price

Standard- set of conditions to be fulfilled to ensure the quality and safety of products Corrosive- any substance which in contact with living tissue will cause destruction of

tissue by chemical action Credit card- any card, plate, coupon book, or other device existing foer the purpose of

obtaining money, property, labor, or service in credit

F. Price ActREPUBLIC ACT 7581TITLE 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 shallnot be used in normal or regular operations

Price ceiling- maximum price at which any basic necessities or prime commodities may besold to the general public

AT a (declared state of rebellion, martial law, state of calamity) otherwise declared bythe president, prices of basic commodities shall be automatically be frozen at their

prevailing price or automatic price control

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

Cartel- it is a combination of agreement between two or more persons engaged in theactivity of any basic commodity designed to artificially and unreasonably increase ormanipulate the price


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Panic buying- abnormal phenomenon where consumers buy basic necessities and primecommodities grossly in excess of their normal requirement resulting in undue shortages ofsuch goods to the prejudice of less previledge

Hoarding- it is the undue accumulation by a person or combination of persons of any basicnecessity or prime commodity beyond his or their normal inventory levels

V. Control the use of dangerous drugs

The Dangerous Drugs Act of 1972.

REPUBLIC ACT RA 6425TITLE THE DANGEROUS DRUGS ACTDangerous Drugs a. Prohibited Drug

- including opium and its active components and derivatives, such heroin and morphine; cocaleaf and its derivatives principally cocaine; alpha and beta eucaine; hallucinogenic drugs suchas mescaline, lysergic acid diethlamide (LSD) and other substances producing similar effects;Indian hemp and its derivatives; all preparations made from any of the foregoing; and otherdrugs and chmical preparations, whether natural or synthetic, with the physiological effects ofa narcotic or a hallucinogenic drug.

b. Regulated Drug- which includes self-inducing sedatives, such as secobarbital, Phenobarbital, pentobarbital,

barbital, amobarbital ad other drug which contains a salt of a derivative of a salt of barbituricacid; any salt, isomeror salt of an isomer, of amphetamine, such as Benzedrine or Dexedrine, orany drug which produces a physiological actions similar to amphetamine; and hypnotic drug,such as methaqualone, nitrazepam; or any other compound producing similar effects.

Records Requiredof Pharmacists

Every pharmacist dealing in dangerous drugs shall maintain and keep an original record of sales, purchases, acquisitions and deliveries of dangerous drugs, indicating therein the license numberand address of the pharmacist; the name, address, and license number of the manufacturer, importeror wholesaler from whom dangerous drugs have been purchased or acquired; the date ofacquisition or purchase; the name, address and class A residence certificate number of the buyer;the serial number of the prescription and the name of the doctor, dentist, veterinarian or practitionerissuing the same; and the date of sale or delivery.

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 fifteendays following the last day of every June and December of each year, copy furnished the city ormunicipal health officer concerned

Composition ofthe DangerousDrugs Board

a. DOH Secretary or representative b. DOH Undersecretary or representativec. Executive Director of the Dangerous Drugs Boardd. DOJ Secretary or representativee. Department of National Defense or representativef. DepEd Secretary or representative


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g. Department of Finance Secretary or representativeh. DSWD Secretary r representative

Comprehensive Dangerous Drugs Act of 2002"REPUBLIC ACT 9165TITLE comprehensive DD act of 2002, repealing RA 6425, as amended providing funds thereof and for

other purposesDefinition ofimportant terms

Confirmatory test- an analytic test using a device, tool or equipment with a differentchemical or physical principle that is more specific which will validate and confirm theresults of screening test.

Screening test- rapid test performed to establish potential/presumptive positive result

Practitioner- any person who is licensed physician, dentist, chemist, med tech etc in thePhilippines

Pusher- any person who sells, trades administers etc to another or transports, broker in anysuch 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 otherwiseand by any means, with or without consideration Illegal trafficking- The illegal cultivation, delivery administration etc. of any dangerousdrug or controlled precursor and essential chemical

Indian hemp- marijuana, hashish, bhang Ecstacy- methylenedioxymethamphetamine Shabu- methamphetamine hydrochloride Coddler and protector- the penalty of 12 years and one day to 20 years of imprisonment

and a fine of 100,000 pesos to 500,000 pesos shall be imposed upon any person who actsImportant numbersand facts toremember

5 years- dangerous drug prescription shall be retained by the pharmacist for the period of: 24 hours- the confiscated or seized chemicals shall be submitted to pdea forensic

laboratory for a quantitative exam within

1 year- drug test certificate issued by accredited drug testing center shall be valid for: Over 25 nmt 18- first time minor offender is one who is Triplicate- prescription for dangerous drugs Minimum of 6 months rehabilitation in a government center- the penalty imposed upon any

person apprehended or arrested for the first time, who is found to be positive for use of anydangerous drug

Both imprisonment 6-12 years and fine 50k to 200k- penalty imposed upon person arrestedfor 2 nd time, positive based on confirmatory

Possession willresult to maximum

penalty

500g- amount marijuana subject to life imprisonment to death and fine ranging from5000,000 to 10 million

50g- amount of shabu subject to life imprisonment to death and fine ranging from5000,000 to 10 million

10g amount of opium subject to life imprisonment to death and fine ranging from5000,000 to 10 million

10g- amount of heroin subject to life imprisonment to death and fine ranging from5000,000 to 10 million

Authorities NBI director- permanent consultant of dangerous drug board DDB- has the power to reclsssify, add to, olr remove any drug from list of dangerous drugs Director general- head of PDEA PDEA- serves as implementing arm of DDB DOH- monitors the treatment and rehabilitation of drug dependents and operation of drug

rehabilitation and testing center


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created by Margarita M Gutierrez RPh MHPED