Legal Pharmacy and Ethics PDF

LEGAL PHARMACY AND ETHICS ATTY. MA. RICA BELLE P. PACIENTE, RPH  REMINDER This presentation shall serve only as a supplement to your notes. Students are expected to have copies or have studied the full law as instructed during the first meeting. Copies of the law...

LEGAL PHARMACY AND ETHICS ATTY. MA. RICA BELLE P. PACIENTE, RPH  REMINDER This presentation shall serve only as a supplement to your notes. Students are expected to have copies or have studied the full law as instructed during the first meeting. Copies of the laws discussed can be found online. Hence, there might be parts that are missing in this presentation (ex: Definition of Terms) that might come out in the quiz, exam, or graded recitation. Web References: https://elibrary.judiciary.gov.ph https://lawphil.net (The Lawphil Project by The Arellano Foundation) INTRODUCTION LAW STATUTE define and regulate enacted by a legislative body composed of the the profession and congress and the senate delimit its practice SOURCES OF LAW 1. Constitution JURISPRUDENCE 2. Statutes 3. Regulatory Laws court decisions STATUTES Examples of Statutes guiding the pharmacy profession and its practice: RA 10918 – THE PHILIPPINE PHARMACY ACT RA 3720 – FOOD, DRUG, DEVICES, AND COSMETICS ACT RA 8203 – SPECIAL LAW ON COUNTERFEIT DRUGS RA 6675 – GENERICS ACT OF 1988 RA 9165 – COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002 RA 9994 – EXPANDED SENIOR CITIZENS ACT OF 2010 RA 7581 – THE PRICE ACT RA 7394 – CONSUMER ACT OF THE PHILIPPINES RA 9502 – UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF 2008 RA 9711 – FOOD AND DRUG ADMINISTRATION ACT OF 2009 RA 10912 – CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016 REGULATORY LAWS rules and regulations promulgated by government agencies to enhance enforcement and understanding of the law Examples of Regulatory Laws guiding the pharmacy profession and its practice: A.O. NO. 62, S. 1989 – RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING REQUIREMENT UNDER THE GENERIC ACT OF 1988 M.C. NO. 1, S. 1991 – REGISTRATION OF MEDICAL DEVICES AND DIAGNOSTIC REAGENTS B.C. NO. 2, S. 1997 – ACCREDITATION OF DRUG LIAISON OFFICER TO BFAD IRR RA 10918 PROFESSIONAL REGULATORY BOARD OF PHARMACY RESOLUTION NO. 52 SERIES OF 2017 THE PHILIPPINE PHARMACY ACT (Republic Act 10918) THE PHILIPPINE PHARMACY ACT Republic Act 10918 An act regulating and modernizing the practice of pharmacy in the Philippines Lapsed into law on July 21, 2016 Repealed Republic Act No. 5921, otherwise known as The Pharmacy Law ARTICLE I. GENERAL PROVISIONS OBJECTIVES Standardization and regulation of pharmacy education Administration of licensure examination, registration, and licensing of pharmacists Supervision, control, and regulation of the practice of pharmacy in the Philippines OBJECTIVES Development and enhancement of professional competence of pharmacists through continuing professional development, research, and other related activities Integration of the pharmacy profession These provisions were not part of the former Pharmacy Law or RA 5921.  SCOPE OF PRACTICE OF PHARMACY Prepare, compound or manufacture, preserve, store, distribute, procure, sell, or dispense, or both, any pharmaceutical product or its raw materials Render services, such as clinical pharmacy services, drug information services, regulatory services, pharmaceutical marketing, medication management, or whenever the expertise and technical knowledge of the pharmacist is required  SCOPE OF PRACTICE OF PHARMACY Engage in teaching scientific, technical, or professional pharmacy courses in a school or college of pharmacy Dispense pharmaceutical products in situations where supervision of dispensing of pharmaceutical products is required  SCOPE OF PRACTICE OF PHARMACY Chemical, biological or microbiological analyses and assay of pharmaceutical products, food dietary supplements, health supplements, and cosmetics Physico-chemical analyses for medical devices used in aid of administration of pharmaceutical products Not exlusive to pharmacists  SCOPE OF PRACTICE OF PHARMACY Administration of adult vaccines as approved by the Food and Drug Administration Provided, that they shall undergo the training on the safe administration of adult vaccines and management of adverse event following immunization (AEFI) for pharmacists and hold a certificate of training issued by an institution duly accredited by the Professional Regulation Commission (PRC) This provision was not a part of the former Pharmacy Law or RA 5921. Not exclusive to pharmacists  SCOPE OF PRACTICE OF PHARMACY Conduct or undertake scientific research in all aspects involving pharmaceutical products and health care Provide other services where pharmaceutical knowledge is required* These provisions were not part of the former Pharmacy Law or RA 5921. *Exclusive to pharmacists DEFINITION OF TERMS What is the Accredited Professional Organization for Pharmacists?  What is the difference between Adult Vaccines and Biopharmaceuticals?  What is the difference between a Brand Name and a Generic Name?  What is the difference between Compounding and Dispensing?  Distinguish an internship program from a refresher program. Differentiate over-the- counter medicines from Pharmacist-only OTC medicines. What are “drugs”? DRUGS pharmaceutical products that pertain to chemical compounds or biological substances, other than food, intended for use in the treatment, prevention, or diagnosis of disease in humans or animals, including: ⚬ any article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease of man or animals DRUGS ⚬ any article, other than food, intended to affect the structure or any function of the human body or animals ⚬ any article intended for use, as a component of articles, specified in clauses (1), (2) and (3), not including devices or their components, parts and accessories ⚬ Herbal or traditional drugs as defined in Republic Act No. 9502 DRUGS ⚬ Any article recognized in the official United States Pharmacopeia/National Formulary, Homeopathic Pharmacopeia of the United States of America, Philippine Pharmacopeia, Philippine National Drug Formulary, British Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, and any official compendium or any supplement to them  Define the following: 1. Adulterated Products 2.Dangerous Drugs 3.Counterfeit Products COUNTERFEIT PRODUCTS pharmaceutical products which do not contain the amounts as claimed; with wrong ingredients; without active ingredients; or with insufficient quantity of active ingredients, which result in the reduction of the products' safety, efficacy, quality, strength, or purity also refer to products that are deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products, including: COUNTERFEIT PRODUCTS ⚬ pharmaceutical product itself or the container or labeling thereof or any part of such product, container, or labeling, bearing without authorization; the trademark, trade name, or other identification marks or imprints or any likeness to that which is owned or registered in the Intellectual Property Office(IPO) in the name of another natural or juridical person COUNTERFEIT PRODUCTS ⚬ A pharmaceutical product refilled in containers bearing legitimate labels or marks, without authority ⚬ A pharmaceutical product which contains no amount of or a different active ingredient; or less than eighty percent (80%) of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration  Differentiate Online Pharmacy Services from Telepharmacy Services.  Differentiate: 1. Pharmacy Aides 2.Pharmacy Assistants 3.Pharmacy Technicians  PHARMACY PHARMACY PHARMACY AIDES ASSISTANTS TECHNICIANS assist the assist the assist in compounding pharmacists pharmacists and dispensing of different aspects of different aspects of medicines in pharmacy operation pharmacy operation community, hospital, institutional and very minimal with a minimum industrial settings or degree of degree of engaged in other independence independence activities under the or decision or decision supervision of the making making pharmacist as described in Section 39, Article IV of this Act without direct may have supervised interaction with interaction with patients patients  ARTICLE II. THE PROFESSIONAL REGULATORY BOARD OF PHARMACY PROFESSIONAL REGULATORY BOARD OF PHARMACY one (1) Chairperson two (2) Members MILDRED B. OLIVEROS ANTHONY ALDRIN C. SANTIAGO ADELINA C. ROYO MEMBER Officer-in-Charge MEMBER QUALIFICATIONS OF THE BOARD Filipino citizen and a resident for at least five (5) years; a duly registered and licensed pharmacist in the Philippines, preferably a holder of a masteral degree in Pharmacy, or its equivalent; Have been in the active practice of pharmacy for the past ten (10) years; Have not been convicted of a crime involving moral turpitude; QUALIFICATIONS OF THE BOARD Be a member in good standing of the APO for at least five (5) years, but not an officer or trustee thereof; and At the time of appointment, must neither be a member of the faculty nor an administrative officer of any school, college or university offering degree programs in pharmacy nor has any direct or indirect pecuniary interest or connection in any review center or similar institution. TERM OF THE BOARD shall hold office for a term of three (3) years from the date of appointment or until their successors shall have been qualified and appointed ⚬ reappointment: another three (3) years immediately after the expiry of their term ⚬ limitation: cannot hold office for more than two (2) terms POWERS, FUNCTIONS, AND RESPONSIBILITIES OF THE BOARD Administer and implement the provisions of this Act; Promulgate rules and regulations, administrative orders, and issuances necessary to carry out the provisions of this Act; Prepare licensure examination questions, score, and rate the examinations and submit the results thereof to the PRC POWERS, FUNCTIONS, AND RESPONSIBILITIES OF THE BOARD Recommend the issuance, suspension, revocation, or reinstatement of the COR, PIC or Special/Temporary Permits (STP) for the practice of pharmacy: Administer oaths in accordance with the provisions of this Act; Regulate and monitor the practice of pharmacy in the Philippines, adopt measures that may be deemed proper for the enhancement of the profession; POWERS, FUNCTIONS, AND RESPONSIBILITIES OF THE BOARD Promulgate and prescribe the Pharmacists' Code of Ethics, Code of Technical Standards and Guidelines for the Professional Practice of the Pharmacy Profession, in coordination with the APO; Represent the pharmacy profession in all for a involving concerns and issues related to pharmaceutical products and the practice of pharmacy; POWERS, FUNCTIONS, AND RESPONSIBILITIES OF THE BOARD Investigate cases arising from violations of this Act, the rules and regulations promulgated pursuant thereto, other Board issuances; issue summons and subpoena, and render decision thereon which shall, unless appealed to the PRC, become final and executory after fifteen (15) days from receipt of notice of judgment or decision; Delegate the hearing or investigation of administrative cases filed before the Board, except where the issue or question involves the practice of the profession POWERS, FUNCTIONS, AND RESPONSIBILITIES OF THE BOARD Conduct, through the Legal Officers of the PRC, summary proceedings on minor violations of this Act, the General Instruction to the Examinees, including the implementing rules and regulations issued by the Board, and to render summary judgment thereon which shall, unless appealed to the PRC, become final and executory after fifteen (15) days from receipt of notice of judgment or decision; Issue and promulgate guidelines on CPD, in coordination with the APO POWERS, FUNCTIONS, AND RESPONSIBILITIES OF THE BOARD Recommend the accreditation of the standardized training programs for and certifications of medical representatives or professional service representatives, pharmacy technicians, pharmacy assistants, pharmacy aides and other medicine handlers covered in Section 39, Article IV of this Act Accredit Specialty Boards of Pharmacy based on the criteria that it shall establish and prescribe SUSPENSION AND REMOVAL OF THE BOARD Gross neglect, incompetence, or dishonesty in the discharge of duty: Involvement in the manipulation, tampering, or rigging of the licensure examination, its questions or results, or both, and in the disclosure of classified and confidential information pertaining to the licensure examination; Conviction of an offense involving moral turpitude by a court of competent jurisdiction; and Unprofessional, unethical, immoral, or dishonorable conduct.  ARTICLE III. EXAMINATION, REGISTRATION, AND LICENSURE PHARMACIST LICENSURE EXAMINATION general weighted average of seventy-five percent (75%), no rating lower than fifty percent (50%)in any of the subjects ⚬ An applicant who failed in the licensure examination for the third (3rd) time shall not be allowed to take the next succeeding examinations without having undertaken a refresher program in a duly accredited institution. shall be given two (2) times a year A pharmacist will be given his/her Certificate of Registration and Professional Identification Card after taking the oath. QUALIFICATIONS FOR THE LICENSURE EXAMINATION Filipino citizen or of a foreign country which has a law or policy on reciprocity for the practice of the pharmacy profession; Has good moral character and reputation; A degree holder of Bachelor of Science in Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of learning in a foreign country duly recognized by the CHED; and Has completed an internship program approved by the Board SCOPE OF EXAMINATION Pharmacy Science and Practice Manufacturing, Quality Assurance Inorganic Pharmaceutical and Instrumentation Chemistry Pharmaceutical Calculations Organic Pharmaceutical Chemistry Drug Delivery Systems Qualitative and Quantitative Hospital Pharmacy Pharmaceutical Chemistry Clinical Pharmacy Pharmacognosy and Plant Dispensing and Medication Chemistry Counseling Pharmaceutical Biochemistry Pharmaceutical Administration and Microbiology and Parasitology Management Physical Pharmacy Public Health Biopharmaceutics Legal Pharmacy and Ethics Pharmacology and Toxicology PRACTICE THROUGH SPECIAL/ TEMPORARY PERMIT (STP) any foreign citizen who has gained entry in the Philippines for practice of pharmacy, including the following: ⚬ being a consultant in foreign-funded or assisted projects of the government; ⚬ being engaged or employed by a Filipino employer or establishment; ⚬ providing free services in humanitarian missions; ⚬ being a visiting faculty member in any field or specialty in pharmacy issued by the Board and PRC PRACTICE THROUGH SPECIAL/ TEMPORARY PERMIT (STP) The person is an internationally renowned pharmacist or expert in a field or specialty of pharmacy; The person is engaged in the provision of a professional service which is determined to be necessary due to lack of Filipino specialist or expert; and The person is required to work with a Filipino counterpart, a natural person who is a registered and licensed pharmacist. NON-REGISTRATION OF SUCCESSFUL EXAMINEES Convicted of an offense involving moral turpitude by a court of competent jurisdiction; Summarily adjudged by the Board as guilty for misrepresentation or falsification of documents in connection with the application for examination or for violation of the General Instructions to Examinees; Found guilty of immoral or dishonorable conduct by the Board; Medically proven to be addicted to any drug or alcohol by a medical or drug testing facility accredited by the government; and Declared of unsound mind by a court of competent jurisdiction. REVOKED, LOST, DAMAGED COR The Board may, upon petition, reinstate or reissue a revoked COR after the expiration of two (2) years from the date of its revocation. The Board may, in its discretion, require the applicant to take another licensure examination.  ARTICLE IV. REGULATION OF THE PRACTICE OF PHARMACY REGULATION OF PRACTICE OF PHARMACY Only duly registered and licensed pharmacists shall have the right to affix to one's name, the title "Registered Pharmacist" or "RPh". It shall be the duty of every pharmacist engaged in the practice, whether in private or under the employ of another, to display the original copy of one's COR in a prominent and conspicuous place in the drug establishment in which one is employed in a professional capacity as pharmacist. REGULATION OF PRACTICE OF PHARMACY No pharmaceutical product, of whatever nature and kind, shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public, except through a retail drug outlet duly licensed by the FDA. Prescription drugs and pharmacist-only OTC medicines shall be dispensed only by a duly registered and licensed pharmacist, except in emergency cases, where the services of a registered and licensed pharmacist are not available: Provided, That a report shall be made to the supervising pharmacist within twenty-four (24) hours after the occurrence of the emergency so that product recording in the prescription books can be done. PHARMACIST REQUIREMENT CATEGORY A pharmaceutical establishments/outlets where the direct and immediate control and supervision of a duly registered and licensed pharmacist is required, per establishment, whether in-store or online CATEGORY B Pharmaceutical establishments/outlets where the supervision and oversight of a duly registered and licensed pharmacist is required under pertinent provisions of law PHARMACIST REQUIREMENT A pharmacist working in a Category A establishment may be allowed to simultaneously work or render pharmacy services in Category B establishments, the maximum number of hours of which shall be determined, in accordance with such guidelines as may be established therefor by the Board, in coordination with the FDA, and other agencies, establishments, institutions, and regulatory bodies. CATEGORY A Pharmaceutical establishments/outlets selling or otherwise making available to the consuming public, whether owned by the government or by a private person or firm, whether sold at wholesale or retail; Establishments involved in the manufacture, importation, exportation, distribution, and sale, including the Departments/Divisions/Units of pharmaceutical laboratories, pharmaceutical manufacturing laboratories, or other establishments; Government units, first to third class municipal health units, nongovernment organizations and/or associations involved in the procurement, distribution, dispensing and storage of pharmaceutical products. CATEGORY B Retail outlets selling household remedies and OTC drugs; Satellite institutional pharmacies providing medicines solely to employees of their respective companies or dependents, or members of a duly registered organization; Fourth, fifth and sixth class municipal health units involved in the procurement, distribution, dispensing, and storage of pharmaceutical products; Institutions providing telepharmacy services; and Nontraditional outlets of pharmaceutical products. Provided, no prescription medicines and pharmacist-only OTC medicines are sold. GOVERNMENT PHARMACIST Procurement, storage, distribution, or dispensing of any pharmaceutical product in the national government and local government units shall be made only under the supervision of a duly registered and licensed pharmacist. FILLING OF PRESCRIPTIONS All prescriptions and pharmacist-only OTC medicines shall be filled, compounded and dispensed only by a registered and licensed pharmacist. Completely filled prescriptions should be surrendered to the pharmacist for recording. Partial filling of prescription less than the total quantity indicated in the prescription shall be allowed. PHYSICIAN’S SAMPLE shall not be sold to any pharmaceutical outlet or the consuming public "Sample, Not for Sale", or its equivalent, appears conspicuously on the primary and secondary' packaging It shall be unlawful to remove, erase, deface or mark the original labels of samples.  Do all drugs have “physician’s samples”? PHYSICIAN’S SAMPLE Pharmaceutical products classified as antimicrobials, including anti-TB medicines and other classifications of medicines, as may be prescribed by the FDA, shall not be given or distributed as physician’s samples. ADMINISTRATION OF ADULT VACCINES Licensed and trained pharmacists who shall administer adult vaccines shall ensure that the vaccine to be administered shall have a doctor's prescription which is not more than seven (7) days old and submit a monthly vaccination report to DOH regional offices using the prescribed form.  ARTICLE V. ACCREDITED PROFESSIONAL ORGANIZATION ACCREDITED PROFESSIONAL ORGANIZATION A pharmacist duly registered with the Board shall automatically become a member of the integrated and accredited professional organization of pharmacists. PHILIPPINE PHARMACISTS ASSOCIATION, INC. (PPhA) ACCREDITED PROFESSIONAL ORGANIZATION Membership in the integrated APO shall not be a bar to membership in other associations of pharmacists. o Young Pharmacists’ Group (YPG) o Community Pharmacists Association of the Philippines (CPAP) o Pharmaceutical and Healthcare Association of the Philippines (PHAP) o Philippine Society of Hospital Pharmacists (PSHP) ACCREDITED PROFESSIONAL ORGANIZATION The PIC shall not be renewed if the requirements for membership with the APO are not met including credit units for attendance to duly accredited CPD. 45 CPD units for every three years (RA 10912) Lifetime members (60yo and above): ₱1,500.00, one-time payment Regular members: ₱1,200.00 membership fee annually ₱700.00 for national membership ₱500.00 pesos for local membership  ARTICLE VI. VIOLATIONS, ADMINISTRATIVE SANCTIONS, AND PROCEDURES REVOCATION OR SUSPENSION OF THE CERTIFICATE OF REGISTRATION Violation of any provision of this Act, its rules and regulations, the Pharmacists' Code of Ethics, Code of Technical Standards for the Professional Practice of the Pharmacy Profession, Code of Good Governance and all other guidelines, policies and regulatory measures of the Board and/or the PRC relating to the practice of the pharmacy profession; Conviction of an offense involving moral turpitude by a court of competent jurisdiction; REVOCATION OR SUSPENSION OF THE CERTIFICATE OF REGISTRATION Unprofessionalism, immorality, malpractice, incompetence, gross negligence, or imprudence in the practice of the profession; Fraud or deceit in the acquisition of the COR, PIC or STP, or renewal thereof; Allowing the COR to be used or displayed in establishments where the pharmacist is not actually employed and practicing; REVOCATION OR SUSPENSION OF THE CERTIFICATE OF REGISTRATION Addiction to alcoholic beverages or to any habit-forming drug rendering a pharmacist incompetent to practice the profession as provided for in Section 23 hereof; Aiding or abetting the illegal practice of anon-registered and licensed person; Insanity or any mental disorder that would render the person incompetent to practice pharmacy; REVOCATION OR SUSPENSION OF THE CERTIFICATE OF REGISTRATION False, extravagant, or unethical advertisements and endorsements of pharmaceutical products, pharmaceutical outlets and establishments where the pharmacist's name or the pharmacist's professional organization and similar information, or both, are used; Manufacture, sale, offering for sale of counterfeit, spurious, substandard and falsified pharmaceutical products and committing other acts in violation of Republic Act No. 9165 and Republic Act No. 8203, otherwise known as the "Special Law on Counterfeit Drugs"; REVOCATION OR SUSPENSION OF THE CERTIFICATE OF REGISTRATION Illegal manufacture, sale, possession, dispensing of dangerous drugs and other acts in violation of Republic Act No. 9165, and other applicable laws and issuances; Committing acts in violation of Section 6 of Presidential Decree No. 881, entitled "Empowering the Secretary of Health to Regulate the Labeling, Sale and Distribution of Hazardous Substances" and Section 11 of Republic Act No. 3720, as amended; REVOCATION OR SUSPENSION OF THE CERTIFICATE OF REGISTRATION Practicing pharmacy with a suspended COR or expired PIC; Unauthorized dispensing of pharmaceutical products through unregistered online services or direct selling businesses; and Being found guilty of immoral, unprofessional, or dishonorable conduct by the Board.  ARTICLE VII. PENAL PROVISIONS  Fine = 250,000 to 500,000 Imprisonment = not less than one (1) year and one (1) day but not more than six (6) years ⚬ Commission of any act in violation of Sections 30 and 31 of this Act; ⚬ Allowing the display of one's COR in a pharmaceutical establishment where the pharmacist is not employed and practicing; ⚬ Displaying of the pharmacist's COR by pharmacy owners/operators in a pharmaceutical establishment where the pharmacist is not employed and practicing; ⚬ Dispensing or allowing the dispensing or offering for sale of prescription drugs or pharmaceutical products in a place not licensed by the FDA as a pharmaceutical outlet; ⚬ Dispensing of prescription and pharmacist-only OTC pharmaceutical products by a person other than those under the direct and immediate supervision of a duly registered and licensed pharmacist; ⚬ Allowing the dispensing of prescription and pharmacist only OTC pharmaceutical products, without the direct and immediate supervision of a duly registered and licensed pharmacist; ⚬ Compounding and dispensing not in accordance with current Good Manufacturing Practice, Good Laboratory Practice and Philippine Practice Standards for Pharmacists, and such other standards and guidelines issued by the Board; ⚬ Selling of prescription and pharmacist-only OTC drugs by manufacturers, importers, and wholesalers to unlicensed pharmaceutical outlets and other establishments; ⚬ Substituting prescription drugs which are not generically equivalent to what was on the prescription, without the consent of the prescriber or not in accordance with Republic Act No. 6675; ⚬ Forcing, coercing, or intimidating a duly registered and licensed pharmacist to compound or dispense medical and pharmaceutical products in violation of the provisions of this Act; ⚬ Preparing and compounding of pharmaceutical products in quantities greatly in excess of single therapeutic doses, without the presence and supervision of a duly registered and licensed pharmacist; ⚬ Noncompliance with the labeling requirements for dispensed medicines by a pharmaceutical outlet; ⚬ Manufacturing and selling of pharmaceutical products under fraudulent name or address, or both; ⚬ Adulterating and misbranding of pharmaceutical products; ⚬ Manufacturing and selling of unsafe, substandard and counterfeit pharmaceutical products; ⚬ Operating an unlicensed pharmaceutical outlet such as online pharmacy service or direct selling not authorized by the FDA; ⚬ Operating a Category A establishment which opens for business without a duly registered and licensed pharmacist; ⚬ Operating a Category B establishment without the supervision and oversight of a duly registered and licensed pharmacist; ⚬ Practicing pharmacy with an expired, suspended or revoked license; ⚬ Filling and refilling of prescription and pharmacist-only OTC pharmaceutical products by a person other than a duly registered and licensed pharmacist without the direct and immediate supervision; ⚬ Dispensing prescription drugs and pharmacist-only OTC drugs by rural health units without the supervision of a duly registered and licensed pharmacist; and ⚬ All other acts or omissions analogous to the foregoing.  Fine = 100,000 to 200,000 Imprisonment = not less than thirty (30) days but not more than one (1) year ⚬ Affixing of the title "RPh" by a person who is not a duly registered and licensed pharmacist; ⚬ Practicing the pharmacy profession in the Philippines without a valid COR, PIC or STP; ⚬ Non-indication of a pharmacist of his/her COR and professional tax receipt numbers in official documents requiring such information; ⚬ Refusal to display the COR of the pharmacist in a prominent and conspicuous place in the establishment and outlet where the pharmacist is employed and practicing; ⚬ Noncompliance by a duly registered and licensed pharmacist with the requirements on the filling of prescription; ⚬ Noncompliance by a duly registered and licensed pharmacist on the requirements for partially-filled prescription; ⚬ Selling of physician's samples; ⚬ Distribution of antimicrobials, including anti-TB drugs and other product classification as may be prohibited by law as physician's samples; ⚬ Removal, erasure and alteration of mark or label of physician's sample; ⚬ Use of cipher, codes, or secret keys or unusual names or terms in prescriptions; ⚬ Filling of prescriptions where cipher, codes, or secret keys or unusual names or terms are used; ⚬ Noncompliance with labeling requirements for dispensed medicines; ⚬ Noncompliance with the requirements on the keeping of record books by a pharmaceutical outlet; ⚬ Employment of personnel in a pharmacy or pharmaceutical operation without the required training and certification; ⚬ Refusal of a non-pharmacist owner/operator of a pharmaceutical outlet to undergo training and certification; ⚬ Refusal by the owner/operator to allow and require duly registered and licensed pharmacists and pharmacy support personnel to undergo CPD, training and certification; ⚬ Rendering dispensing-related services by nonpharmacists in a pharmaceutical outlet without undergoing the required training and certification; ⚬ Dispensing pharmaceutical products in medical missions without the supervision of a duly registered and licensed pharmacist;  ⚬ Noncompliance with the required training and certification of professional service; and ⚬ Violation of any provision of this Act and its rules and regulations not aforementioned above. The owner/operator of the pharmaceutical establishments/ outlets and the duly registered and licensed pharmacists/ pharmacy support personnel are jointly liable for the willful violation of any provision of this Act. THANK YOU! NEXT MEETING: Study RA 8981 and RA 10912. LEGAL PHARMACY AND ETHICS ATTY. MA. RICA BELLE P. PACIENTE, RPH  REMINDER This presentation shall serve only as a supplement to your notes. Students are expected to have copies or have studied the full law as instructed. Copies of the laws discussed are found online. Hence, there might be parts that are missing in this presentation (ex: Definition of Terms) that might come out in the quiz, exam, or graded recitation. Web References: https://elibrary.judiciary.gov.ph https://lawphil.net PRC MODERNIZATION ACT OF 2000 (Republic Act 8981) Approved on December 5, 2000 by Pres. Estrada THE PRC MODERNIZATION ACT OF 2000 Republic Act 8981 Repealed Presidential Decree 223, also known as “CREATING THE PROFESSIONAL REGULATION COMMISSION AND PRESCRIBING ITS POWERS AND FUNCTIONS” PROFESSIONAL REGULATION COMMISSION one (1) Chairperson and two (2) Members term of seven (7) years without reappointment DR. JOSE Y. CUETO, JR. ATTY. CHARITO A. ZAMORA ATTY. ERWIN M. ENAD Commissioner I Chairperson Commissioner II PROFESSIONAL REGULATION COMMISSION shall be at least forty (40) years of age COR and PIC holder, or a valid certificate of competency issued by the Commission or a valid professional license issued by any government agency familiar with the principles and methods of professional regulation and/or licensing has had at least five (5) years of executive or management experience POWERS AND FUNCTIONS OF THE COMMISSION Section 7, RA 8981 shall sit and act as a body to exercise general administrative, executive and policy-making functions of the Commission shall establish and maintain a high standard of admission to the practice of all professions and at all times ensure and safeguard the integrity of all licensure examinations POWERS AND FUNCTIONS OF THE COMMISSION Section 7(d), RA 8981. To administer and conduct the licensure examinations of the various regulatory boards; authorized to require the completion of a refresher course; approve the results of examinations and the release of the same; adopt measures to preserve the integrity and inviolability of licensure examinations; POWERS AND FUNCTIONS OF THE COMMISSION appoint supervisors and room watchers; publish the list of successful examinees; impose the penalty of suspension or prohibition from taking licensure examinations to any examinee charged and found guilty of violating the rules and regulations governing the conduct of licensure examinations; POWERS AND FUNCTIONS OF THE COMMISSION provide schools, colleges and universities, public and private, offering courses for licensure examinations, with copies of sample test questions on examinations recently conducted by the Commission and copies of the syllabi or terms of specifications of subjects for licensure examinations GUIDELINES, SECTION 7(D), RA 8981 Step 1: The University, through a duly authorized representative, must submit a written request for the issuance of sample test questions from past examinations released by the Board and the Commission. The requesting school, college or university must be offering the course for licensure examinations and must be duly accredited and/or recognized by the Commission on Higher Education (CHED). GUIDELINES, SECTION 7(D), RA 8981 Step 2: The Professional Regulatory Board (PRB) prepares a sample of five (5) questions for every subject, which shall be copied from the examination questionnaire used in the actual conduct of the examination. Q5. It is a drug which contains no amount of, or a different active ingredient, or less than 80% of the active ingredient it purports to possess. a. Counterfeit Drug b. Adulterated drug c. Both A and B d. Inactive Drug GUIDELINES, SECTION 7(D), RA 8981 Step 3: The PRB submits the sample test questions to the Office of the Chairperson, which shall be attached to the Certificate of Service within ten (10) days from the date of the release of the examination results. Step 4: The Office of the Chairperson reproduce the sample questions to be issued to the authorized representative of the requesting school, college or university within six (6) months from the date of release of the examination results. GUIDELINES, SECTION 7(D), RA 8981 The sample test questions shall contain the following phrase, which will be stamped/marked on every page thereof: "SAMPLE TEST QUESTIONS PURSUANT TO SEC. 7(d) OF R.A. NO. 8981" Name of Examination: Date of Examination:  What is the main purpose of giving sample questions to universities? GUIDELINES, SECTION 7(D), RA 8981 The sample test questions shall be released only upon payment of the prescribed fee by the requesting school, college or university. The sample test questions shall be for the exclusive use of the requesting school, college or university to give prospective examinees the idea how questions are framed only.  PRC ONLINE ACCOUNT FOR REGISTERED PROFESSIONALS PENALTIES FOR MANIPULATION AND OTHER CORRUPT PRACTICES IN THE CONDUCT OF PROFESSIONAL EXAMINATIONS  Fine = 50,000 to 100,000 Imprisonment = not less than six (6) years and one (1) day to not more than twelve (12) years manipulate or rig the licensure examination results secretly inform or make known the licensure examination questions prior to the conduct of the examination tampers with the grades in professional licensure examinations In case the offender is an officer or employee of the Commission or a member of the regulatory board, he/she shall be removed from office and shall suffer the penalty of perpetual absolute disqualification. Imposed upon the accomplices Fine = 20,000 to 49,000 Imprisonment = four (4) years and one (1) day to six (6) years Imposed upon the accessories Fine = 5,000 to 19,000 Imprisonment = two (2) years and one (1) day to four (4) years CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016 (Republic Act 10912) Lapsed into law on July 21, 2016 S. No. 2581 H. No. 6423 ; Manila Bulletin (August 01, 2016); 112 OG No. 34, 5455 (August 22, 2016) CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016 Republic Act 10912 An act mandating and strengthening the continuing professional development program for all regulated professions, creating the continuing professional development council, and appropriating funds therefor, and for other related purposes ARTICLE I. TITLE, POLICY AND DEFINITION OF TERMS CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016 to promote and upgrade the practice of professions in the country to institute measures that will continuously improve the competence of the professionals in accordance with the international standards of practice DEFINITION OF TERMS  What does “accreditation” mean? Differentiate: 1. CPD 2. CPD PROGRAM 3. CPD CREDIT UNIT  CPD CPD CPD CREDIT PROGRAM UNIT the inculcation of the set of learning the value of an advanced activities accredited amount of learning knowledge, skills and by the CPD Council that can be ethical values in a which equip the transferred to a post-licensure professionals with qualification achieved specialization or in advanced from formal, informal an inter- or knowledge, skills and or nonformal learning multidisciplinary field values in specialized setting, where in of study, for or in an inter- or credits can be assimilation into multidisciplinary accumulated to professional field of study, self- predetermined levels practice, self- for the award of a directed research directed research qualification and/or lifelong and/or lifelong learning learning  ARTICLE II. CPD PROGRAMS, COUNCILS AND SECRETARIAT CPD PROGRAM Enhance and upgrade the competencies and qualifications of professionals for the practice of their professions; Ensure international alignment of competencies and qualifications of professionals through career progression mechanisms leading to specialization/sub-specialization; Recognize and ensure the contributions of professionals in uplifting the general welfare, economic growth and development of the nation. CPD PROGRAM Ensure the development of quality assured mechanisms for the validation, accreditation and recognition of formal, nonformal and informal learning outcomes, including professional work experiences and prior learning: Ensure maintenance of core competencies and development of advanced and new competencies, in order to respond to national, regional and international labor market needs; NATURE OF CPD PROGRAMS Formal learning Nonformal learning Informal learning Self-directed learning Online learning activities Professional work experience CPD COUNCIL the body created to promote and ensure the continuous improvement of professionals, in accordance with national, regional and international standards of practice MA. GILDA SEBUA-SALJAY ANTHONY ALDRIN C. SANTIAGO ALETH THERESE DACANAY Member Officer-in-Charge Member AS OF OCTOBER 8, 2021 CPD COUNCIL MEMBERS Chairperson: A member of the PRB who is chosen by the PRB to sit on the CPD Council. Term: coterminous with his/her incumbency in the PRB First member: The president or officer of the AIPO or APO who is authorized by the Board of Governors or Trustees. Second member: The president or officer of the national organization of deans or department chairpersons of schools, colleges or universities offering the course requiring the licensure examination Term: two (2) years unless sooner replaced POWERS, FUNCTIONS, AND RESPONSIBILITIES OF THE CPD COUNCIL Ensure the adequate and appropriate provision of CPD Programs for their respective profession; Evaluate and act on applications for accreditation of CPD Providers and their CPD Programs; Monitor and evaluate the implementation of the CPD Programs; Assess and/or upgrade the criteria for accreditation of CPD Providers and their CPD Programs on a regular basis; POWERS, FUNCTIONS, AND RESPONSIBILITIES OF THE CPD COUNCIL Develop mechanisms for the validation, accreditation and recognition of self-directed learning, prior/informal learning, online learning, and other learning processes through professional work experience; Conduct researches, studies and benchmarking for international alignment of the CPD Programs; Issue operational guidelines, with the approval of the PRC and the PRB concerned; and Perform such other functions related or incidental to the implementation of the CPD. ARTICLE III. CPD PROGRAM IMPLEMENTATION AND MONITORING CPD REQUIREMENT SEC. 10. CPD as Mandatory Requirement in the Renewal of Professional License and Accreditation System for the Practice of Professions. The CPD is hereby made as a mandatory requirement in the renewal of the PICs of all registered and licensed professionals under the regulation of the PRC. Are CPD Programs the only accredited sources of CPD Credit Units? ARTICLE IV. FINAL PROVISIONS FRAUD RELATED TO CPD SEC. 16. Fraud Relating to CPD. – Fraudulent acts relating to the implementation and enforcement of this Act shall be punishable under the pertinent provisions of the Revised Penal Code, the New Civil Code and other applicable laws. In addition to the penalties prescribed in the aforementioned laws, a professional who is adjudged guilty of any fraudulent act relating to the CPD shall also be meted with the penalty of suspension or revocation of his/her PRC Certificate of Registration and/or Certificate of Specialization. FRAUD RELATED TO CPD In case of a government official or employee who is party to any fraudulent act relating to the CPD, he/she shall also be subject to the administrative penalties that may be imposed under the anti-graft laws, the Administrative Code and the Code of Conduct of Public Officials and Employees. THANK YOU! G.R. No. 156037 May 25, 2007 MERCURY DRUG CORPORATION V. SEBASTIAN M. BAKING FACTS On November 25, 1993, Sebastian M. Baking went to the clinic of Dr. Cesar Sy for a medical check- up. Dr. Sy found that respondent’s blood sugar and triglyceride were above normal levels. Dr. Sy then gave respondent two medical prescriptions – Diamicron for his blood sugar and Benalize tablets for his triglyceride. FACTS Respondent then went to Mercury Drug Corporation (Alabang Branch) to buy the prescribed medicines. However, the saleslady misread the prescription for Diamicron as a prescription for Dormicum. Thus, what was sold to respondent was Dormicum. FACTS Respondent took Dormicum on three consecutive days – November 6, 1993 at 9:00 p.m. November 7 at 6:00 a.m. November 8 at 7:30 a.m. On November 8 or on the third day he took the medicine, respondent figured in a vehicular accident. Respondent fell asleep while driving. FACTS The car he drove collided with the car of Josie Peralta. Suspecting that the tablet he took may have a bearing on his physical and mental state at the time of the collision, respondent returned to Dr. Sy’s clinic. Dr. Sy was shocked to find that what was sold to respondent was Dormicum, instead of the prescribed Diamicron. Hence, Baking filed a case for damages against the petitioner. ISSUE Whether petitioner was negligent, and if so, whether such negligence was the proximate cause of respondent’s accident RULING Yes, petitioner is negligent and the negligence was the proximate cause of the accident. Art. 2176 of the Civil Code provides whoever by act or omission causes damage to another, there being fault or negligence, is obliged to pay for the damage done. To sustain a claim based on the above provision, the following requisites must concur: (a) damage suffered by the plaintiff; (b) fault or negligence of the defendant; and, (c) connection of cause and effect between the fault or negligence of the defendant and the damage incurred by the plaintiff. RULING In this case, respondent suffer damages because the petitioner’s employee was grossly negligent in selling to respondent Dormicum, instead of the prescribed Diamicron. Considering that a fatal mistake could be a matter of life and death for a buying patient, the said employee should have been very cautious in dispensing medicines. She should have verified whether the medicine she gave respondent was indeed the one prescribed by his physician. RULING Proximate cause is defined as any cause that produces injury in a natural and continuous sequence, unbroken by any efficient intervening cause, such that the result would not have occurred otherwise. Here, the vehicular accident could not have occurred had petitioner’s employee been careful in reading Dr. Sy’s prescription. Without the potent effects of Dormicum, a sleeping tablet, it was unlikely that respondent would fall asleep while driving his car, resulting in a collision. RULING ART. 2180. The obligation imposed by Article 2176 is demandable not only for one’s own acts or omissions, but also for those of persons for whom one is responsible. xxx The owners and managers of an establishment or enterprise are likewise responsible for damages caused by their employees in the service of the branches in which the latter are employed or on the occasion of their functions. RULING When an injury is caused by the negligence of an employee, there instantly arises a presumption of the law that there has been negligence on the part of the employer, either in the selection of his employee or in the supervision over him, after such selection. The presumption, however, may be rebutted by a clear showing on the part of the employer that he has exercised the care and diligence of a good father of a family in the selection and supervision of his employee.