Pharmacy Ethics and Jurisprudence in the Philippines

Important Statutes Summarized (Must know) Republic Act No.

Common name

Year

RA 5921

Pharmacy Law

June 23, 1969

RA 3720

Food, Drugs and Cosmetics Act

June 22, 1963

RA 6675

Generics Act of 1988.

September 13, 1988

RA 8203

Special Law on Counterfeit Drugs The Dangerous Drugs Act of 1972." Comprehensive Dangerous Drugs Act of 2002" Senior Citizen Act of 1992 Expanded Senior Citizens Act of 2003 Expanded Senior Citizens Act of 2010 Consumer Act of the Philippines Price Act Universally Accessible Cheaper and Quality Medicines Act of 2008 Food and Drug Administration (FDA) Act of 2009 "Traditional and Alternative Medicine Act (TAMA) of 1997."

July 22, 1996

RA 6425 RA 9165 RA 7432 RA 9257 RA 9994 RA 7394 RA 7581 RA 9502

RA 9711

RA 8423

Amendments/ supplemental AOS EO 174 RA 9502 EO 175 AO 55 AO 56 RA 9711 AO 62 AO 63 RA 9502

April 4, 1972

RA 9165

June 7, 2002

None

April 23, 1992 February 26, 2004

RA 9257 RA 9994

February 15 2010 April 13 1994 May 7, 1992 June 6, 2008

August 18, 2009

December 9, 1997

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Pharmaceutical Ethics and Jurisprudence I. Introduction to Pharmacy Jurisprudence and ethics Jurisprudence- Science and philosophy of law Importance  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. 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 ethical awareness- the ability to discern between right and wrong ethical competency- the ability to engage in sound moral reasoning and consider carefully the implication of alternative action 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 Ethical Principles Summarized Ethical Principle Non-maleficence Beneficence Respecting the patient Respect for autonomy Consent Confidentiality Respect for persons Veracity

Definition To do no harm Duty to promote good professional relationship Respect for the individual’s right to decide on issues that affect self Right to be informed and to choose a course of action right to give or refuse consent relative to release of privileged information 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 and implementation of health care policies, standards and programs designed for the benefit of the society.

II. Standards of Pharmacy Practice A. Pharmacy Law Overview REPUBLIC ACT NO. TITLE OBJECTIVES

Composition of Council of Pharmaceutical Education PRC Board of Pharmacy

Candidacy for Board Examination Ratings required

Practice of pharmacy

Prerequisites for the Practice of Pharmacy

RA 5921 (as amended by EO 174) AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING STANDARDS OF PHRMACEUTICAL EDUCATION IN THE PHILIPPINES AND FOR OTHER PURPOSES TO GOVERN: a. the standardization and regulation of pharmaceutical education b. the examination for registration of graduates of schools of pharmacy c. the supervision, control and regulation of the practice of pharmacy Education Secretary UP College of Pharmacy Dean Health Undersecretary Dean (representing private pharmacy schools) BFAD Director Representative (pharmacy organizations) PRC Pharmacy Board Chairman Chairman and 2 members with three-year term a. natural-born Filipino citizens b. registered and practicing for at least ten years c. of good moral character and of recognized standing in the profession d. at time of appointment, not a faculty of any school offering pharmacy or f a college of pharmacy e. member of a national pharmacy organization  Filipino citizen  Of good moral character  Must have completed internship requirements  Graduated with degree in pharmacy  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 pharmacy  Prepare or manufacture, analyze, assay, preserve, store, distribute or sell any medicine, drug chemicals, cosmetics, pharmaceuticals, devices of contrivances used in pursuance thereof;  Render pharmaceutical service in any office or drug and cosmetic establishment where scientific, 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 examinations  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 that substitutes other letters or characters for the letter intended B. Authorities to memorize

system of words or other systems arbitrarily used to present words

President of the PhilippinesCouncil of pharmaceutical education Board of pharmacyBFAD

characteristics style or symbols kept from the knowledge of others or disclosed confidentially to one or few

the members of the board of pharmacy are appointed by to recognize and accredit colleges and school of pharmacy in the different universities is a function of to reprimand any erring pharmacist or to suspend or revoke his certificate of registration the minimum mandatory requirements necessary for the opening and operation of drugstores are as prescribed by

C. Important numbers to memorize 21 years 5 years

the minimum age requirement to practice pharmacy in the Philippines -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

60 days 2

960 hours 10 days

-number of years of pharmacy practice for the pharmacist to comply as board examiner the decision of board of pharmacy in administrative cases involving pharmacist becomes final and executor -members of the board and a chairman- composition of board of pharmacy -times board exam is given in a year complete pharmacy internship program 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. TITLE

OBJECTIVES

BFAD Functions

RA 3720 (as amended by EO 175) AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS AND COSMETICS, AND THE PURITY, SAFETY, EFFICACY AND QUALITY OF DRUGS AND DEVICES BEING MADE AVAILABLE TO THE PUBLIC, VESTING THE BUREAU OF FOOD AND DRUGS WITH AUTHORITY TO ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO, AND FOR OTHER PURPOSES 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 country c. Adopt measures to ensure the rational use of drugs and devices d. Strengthen the Bureau of Food and Drugs  To administer and supervise the implementation of this Act and other regulations pursuant to the 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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BFAD Divisions

Adulterated Drugs or Devices

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Misbranded Drugs and Devices

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To issue certificate of compliance with technical requirements to serve basis for issuance of license and spot-check for compliance with regulations To levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with this Act To certify batches of antibiotic and antibiotic preparations Inspection and Licensing Division Laboratory Division If it consists in whole or part of any filthy, or decomposed substances It has been manufactured, prepared or held under unsanitary conditions It is composed of any poisonous or deleterious substances It contains any color other than a permissible one It purports to be an official drug and its strength differs from, or its safety, efficacy, quality or purity falls below the standards set forth It has been mixed or packed or substituted so as to reduce safety, efficacy, quality, strength or purity Methods, facilities or controls used do not conform to current good manufacturing practices Labeling is false or misleading It did not contain (1) the name and place of business of the manufacturer, importer, packer, or distributor, and (2) an accurate statement of the quantity of contents in terms of weight, measure or numerical count If any word or information required is not prominently placed with conspicuousness If it is for use of man and contains any quantity of narcotic or hypnotic substance It is not designated solely by a name recognized in an official compendium Unless its labeling bears (1) adequate directions for use, and (2) such adequate warnings against use It purports to be the drug the name of which is recognized in an official compendium It has been found to be a drug liable to deterioration unless its label bears a statement of precautions Its container is so made, formed or filled as to be misleading It is an imitation of another drug It is offered for sale under the name of another drug It is dangerous to health when used in dosage recommended or suggested in the labeling If it purports to be, or is represented as a drug composed wholly or partly

Important Admistrative orders ADMINISTRATIVE NO. 55 SERIES OF 1988 ORDER TITLE REQUIREMENTS FOR LABELING MATERIALS OF PHARMACEUTICAL PRODUCTS Minimum 1. Name of the product (generic name alone or with brand name) Mandatory 2. Dosage form and strength Information in 3. pharmacologic category labeling material 4. Rx symbol, in case of prescription drugs 5. Name and complete address of manufacturer and trader 6. net content 7. formulation 8. indication(s) 9. contraindication(s), precaution(s), warnings(s) 10. mode of administration/directions for use 11. batch and lot number 12. expiry/expiration date of manufacture 13. registration number

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14. storage conditions 15. For Rx Drugs: Foods, Drugs and Devices, and Cosmetics Act prohibits dispensing without prescription.

ADMINISTRATIVE NO. 56 SERIES 1989 ORDER TITLE REVISED REGULATIONS FOR THE LICENSING OF DRUG ESTABLISHMENTS AND OUTLETS Types of Drug 1. Drug Manufacturer – any establishment engaged in operations involved in the production of Establishments drug, 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 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 Drug 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 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) 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 business E. Others  Invoices indicating the lot number or batch number of the manufacturer’s 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 TITLE

Definition of terms

8423 AN ACT CREATING THE PHILIPPINE INSTITUTE OF TRADITIONAL AND ALTERNATIVE HEALTH CARE (PITAHC) TO ACCELERATE THE DEVELOPMENT OF TRADITIONAL AND ALTERNATIVE HEALTH CARE IN THE PHILIPPINES, PROVIDING FOR A TRADITIONAL AND ALTERNATIVE HEALTH CARE DEVELOPMENT FUND AND FOR OTHER PURPOSES "Traditional and alternative health care" - the sum total of knowledge, skills and practices on health care, other than those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical or mental disorder. "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". "Alternative health care modalities" – other forms of non-allopathic, occasionally non-indigenous or imported healing methods, though not necessarily practiced for centuries nor handed down from one 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 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.

Governing Body

"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. 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

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and objectives.

C. Special law on counterfeit drugs REPUBLIC ACT TITLE What are counterfeit drugs?

RA 8203 SPECIAL LAW ON COUNTERFEIT DRUGS AN ACT PROHIBITING COUNTEREIT DRUGS, PROVIDING PENALTIES FOR VIOLATIONS AND APPROPRIATING FUNDS THEREFOR a. Medicinal products with the correct ingredients but not in the amounts as provided b. Wrong ingredients c. Without active ingredients d. With insufficient quantity of active ingredients e. Deliberately and fraudulently mislabeled with respect to identity and/or source f. With fake packaging g. Container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint h. Drug product refilled in containers by unauthorized persons if the legitimate labels were used i. 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 TITLE

objectives

RA 9711 AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF (a) To enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and products under its jurisdiction; (b) To ensure the FDA's monitoring and regulatory coverage over establishments and products under its jurisdiction; and

Director General

(c) To provide coherence in the FDA's regulatory system for establishments and products under its jurisdiction. (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;

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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 is adulterated or misbranded, when introduced into domestic commerce pending the authorized hearing under Republic Act No. 3720, as amended, Executive Order No. 175 (1987), and Republic Act 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 the Philippine National Police or any law enforcement agency for the effective implementation of this Act; and

organization

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

Division per center

(4) Center for Device Regulation, Radiation Health, and Research (1) Licensing and Registration Division, which shall be responsible for evaluating health products and establishments as covered by this Act for the purpose of issuance of authorizations and conditions to be observed; (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

Other divisions

(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 (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

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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 Deputy Director-General for Field Regulatory Operations and shall be administratively supported by the field offices.  Bear arms, wear official uniforms and insignias and shall be classified as law enforcement agents;  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 connection with 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 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.”

E. BFAD (old FDA structure) OFFICE ORDER TITLE Organization

Regulation Division I (Outlets)

Regulation Division II (Manufacturers)

No. 1 series of 1988 IMPLEMENTATION OF EXECUTIVE ORDER NO. 119, REORGANIZIG THE BUREAU OF FOD AND DRUGS, DEPARTMENT OF HEALTH 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 Division 1.5 Laboratory Services Division 1.6 Legal, Information, and Compliance Division 1.7 Administrative Division 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 pharmacies c. retail outlets for non-prescription drugs d. drug department a. general wholesaler b. distributor/importer/exporter of finished products, which is neither a manufacturer nor a producer e. retailer of household hazardous substances a. distributor/importer/exporter of finished food products, which is neither a manufacturer nor a producer 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 producer d. 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/processor f. household hazardous substance manufacturer

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.

IV. Ensure Affordability and Accessibility of Drugs A. Generics Act REPUBLIC ACT TITLE

Components of the National Drug Policy AO 62 s 1989

RA 6675 Generics Act AN ACT TO PROMOTE, REQUIRE, AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE OF DUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMES a. Quality Assurance of Drugs b. Rational Use of Drugs by Health Professionals and Consumers c. National Self-Sufficiency in Pharmaceuticals d. Rationalization of the DOH’s Procurement Program RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING REQUIREMENTS UNDER THE 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 written under 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 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

AO 63 s 1989

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. 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.

B. Senior Citizen Act REPUBLIC ACT RA 7432 SENIOR CITIZENS ACT TITLE AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO NATIONBUILDING, GRANT, BENEFIT, AND SPECIAL PRIVILEGES AND FOR OTHER PURPOSES The Senior Citizen Any resident of the Philippines at least 60 years old, including those who have retired from both government offices and private enterprises, and has an income of not more than sixty thousand pesos per annum subject to review by NEDA every three years Benefit related to The grant of 20% discount from all establishments…and purchase of medicines anywhere in the drugs country; provided that private establishments may claim the cost as tax credit C. Expanded Senior Citizens Act of 2003

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REPUBLIC ACT TITLE

Additional Benefits to senior citizens

Expanded coverage of discounts

RA 9994 Expanded SENIOR CITIZENS ACT 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 Contribution of Senior citizens 1. The law would exempt senior citizens from the 12 percent value added tax imposed on goods 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, which effectively 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 and Development. 3. In case of death of an indigent senior citizen, an amount of P2,000 will be awarded to his or her nearest kin as death benefit assistance 4. Senior citizens may also enjoy a five percent discount on their water and electric bills on the condition that the utilities are in the name of the senior citizen residing in the household, and that the consumption for electricity and water does not exceed 100 kilowatt-hours and 30 cubic meters per month, respectively. 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 transport and other vessels; 6. utilization of services in hotels 7. restaurants and similar establishments; admission fees in cinemas, theaters and other places of culture, leisure and amusement; and funeral and burial services

D. Universally Accessible Cheaper and Quality Medicines Act of 2008 REPUBLIC ACT RA 9502 TITLE 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 Important definitions

“Compulsory License” is a license issued by the Director General of the Intellectual Property 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 “Multisource pharmaceutical products” refers to pharmaceutically equivalent or pharmaceutically alternative 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

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

Amendment in the definition of drugs or 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, 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 TO REPUBLIC ACT NO. 8293, OTHERWISE KNOWN AS THE INTELLECTUAL PROPERTY CODE OF THE PHILIPPINES

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

MAXIMUM RETAIL PRICE

DURATION : 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)

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

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.

created by Margarita M. Gutierrez, RPh, MHPED University of the Philippines Manila Version 2015

DISCOUNTS: Senior Citizen’s Discount and Discount for People with Disability shall continue to be honored even if the 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 medicine intended for sale. - printed on the label of the immediate container of the drug and medicine and the minimum pack thereof offered for retail sale with the words “RETAIL PRICE NOT TO EXCEED” preceding it, and “UNDER DRUG PRICE REGULATION” on a red strip

E. Consumer Act of the Philippines REPUBLIC 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 to consumers  Price tag- any device affixed to a consumer product or displayed in a consumer services for the 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 Act REPUBLIC ACT TITLE Definition of terms

7581 It is the act providing protection to consumers by stabilizing the prices of basic necessities and prime commodities.  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  AT a (declared state of rebellion, martial law, state of calamity) – otherwise declared by the 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 the activity of any basic commodity designed to artificially and unreasonably increase or manipulate the price

created by Margarita M. Gutierrez, RPh, MHPED University of the Philippines Manila Version 2015

 Panic buying- abnormal phenomenon where consumers buy basic necessities and prime commodities grossly in excess of their normal requirement resulting in undue shortages of such goods to the prejudice of less previledge  Hoarding- it is the undue accumulation by a person or combination of persons of any basic necessity 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 TITLE Dangerous Drugs

Records Required of Pharmacists

Composition of the Dangerous Drugs Board

RA 6425 THE DANGEROUS DRUGS ACT a. Prohibited Drug - including opium and its active components and derivatives, such heroin and morphine; coca leaf and its derivatives principally cocaine; alpha and beta eucaine; hallucinogenic drugs such as 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 other drugs and chmical preparations, whether natural or synthetic, with the physiological effects of a 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 barbituric acid; any salt, isomeror salt of an isomer, of amphetamine, such as Benzedrine or Dexedrine, or any drug which produces a physiological actions similar to amphetamine; and hypnotic drug, such as methaqualone, nitrazepam; or any other compound producing similar effects. 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 number and address of the pharmacist; the name, address, and license number of the manufacturer, importer or wholesaler from whom dangerous drugs have been purchased or acquired; the date of acquisition 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 practitioner issuing 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 fifteen days following the last day of every June and December of each year, copy furnished the city or municipal health officer concerned a. DOH Secretary or representative b. DOH Undersecretary or representative 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

created by Margarita M. Gutierrez, RPh, MHPED University of the Philippines Manila Version 2015

g. Department of Finance Secretary or representative h. DSWD Secretary r representative Comprehensive Dangerous Drugs Act of 2002" REPUBLIC ACT 9165 TITLE “comprehensive DD act of 2002, repealing RA 6425, as amended providing funds thereof and for other purposes Definition of  Confirmatory test- an analytic test using a device, tool or equipment with a different important terms chemical or physical principle that is more specific which will validate and confirm the results 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 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     Important numbers and facts to remember

      

Possession will result to maximum penalty

   

Authorities

    

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 acts 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 any dangerous drug Both imprisonment 6-12 years and fine 50k to 200k- penalty imposed upon person arrested for 2nd time, positive based on confirmatory 500g- amount marijuana subject to life imprisonment to death and fine ranging from 5000,000 to 10 million 50g- amount of shabu subject to life imprisonment to death and fine ranging from 5000,000 to 10 million 10g – amount of opium subject to life imprisonment to death and fine ranging from 5000,000 to 10 million 10g- amount of heroin subject to life imprisonment to death and fine ranging from 5000,000 to 10 million 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

created by Margarita M. Gutierrez, RPh, MHPED University of the Philippines Manila Version 2015

created by Margarita M. Gutierrez, RPh, MHPED University of the Philippines Manila Version 2015