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created by Margarita M. Gutierrez, RPh, MHPEDUniversity of the Philippines ManilaImportant Statutes Summarized (Must know)Republic Act No. Common name Year Amendments/ supplemental AOS RA 5921 Pharmacy Law June 23, 1969 EO 174 RA 9502 RA 3720 Food, Drugs and Cosmetics ActJune 22, 1963 EO 175 AO 55 A...

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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

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

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.

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

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

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

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

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

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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

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

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 drug, including propagation, processing, compounding, finishing, filling, packing, repacking, Establishments 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

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

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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

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

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 diffe...