PHARM-AD-2023-M6-PHARMACY-REGULATION.pptx

MODULE 6: PHARMACY REGULATION REPUBLIC ACT 10918 PHILIPPINE PHARMACY ACT An Act Regulating and Modernizing the Practice of Pharmacy in the Philippines, Repealing for the Purpose Republic Act Numbered Five Thousand Nine Hundred Twenty-One (R.A. No. 5921), Otherwise Known as the Pharmacy Law PASSED IN...

MODULE 6: PHARMACY REGULATION REPUBLIC ACT 10918 PHILIPPINE PHARMACY ACT An Act Regulating and Modernizing the Practice of Pharmacy in the Philippines, Repealing for the Purpose Republic Act Numbered Five Thousand Nine Hundred Twenty-One (R.A. No. 5921), Otherwise Known as the Pharmacy Law PASSED INTO LAW: JULY 21, 2016 University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 2 REPUBLIC ACT 10918 PHARMACIST refers to a health professional who has been registered and issued a valid Certificate of Registration (COR) and Professional Identification Card (PIC) by the PRC and the Professional Regulatory Board of Pharmacy PHARMACEUTICAL OUTLETS refer to entities licensed by appropriate government agencies, and which are involved in compounding and/or dispensing and selling of pharmaceutical products directly to patients or endUniversity of San Agustin users; COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 3 REPUBLIC ACT 10918 CERTIFICATE OF REGISTRATION A COR as a pharmacist shall be issued to those who passed the licensure examination, subject to compliance with the registration requirements and payment of the prescribed fees. The COR shall bear: – the registration number – the date of its issuance – and the signatures of the Chairperson of the PRC and the members of the Board – stamped with the official seals of the PRC and of the Board – certifying that the person named therein is entitled to the practice of the profession, with all the privileges appurtenant thereto. University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 4 REPUBLIC ACT 10918 PROFESSIONAL IDENTIFICATION CARD A PIC bearing the registration number and dates of its issuance and expiry, duly signed by the Chairperson of the PRC, shall likewise be issued to every registrant, upon payment of the prescribed fees. The PIC shall be renewed every three (3) years, upon presentation of the Certificate of Good Standing (COGS) from the APO and proof of completion of the CPD requirements. University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 5 REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY AFFIXING RPh AFTER A REGISTERED PHARMACIST’S NAME. Only duly registered and licensed pharmacists shall have the right to affix to one’s name, the title "Registered Pharmacist" or "RPh". INDICATION OF INFORMATION. A pharmacist shall be required to indicate the serial numbers, the date of expiry of the pharmacist’s PIC and APO Certificate of Membership on all pertinent documents signed by him/her. University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 6 REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY Display of Certificate of Registration. 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. When employed in establishments under Category B, as defined in Section 31 of this Act, the duplicate copy of the pharmacist’s COR shall also be displayed therein. No pharmacist knowingly allow the Universityshall of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS COR to be displayed in an establishment 7 DEPARTMENT OF PHARMACY REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY PHARMACIST REQUIREMENT. Establishments/outlets which are required to employ and/or retain and maintain the professional services of duly registered and licensed pharmacists shall be classified as: ✔CATEGORY A ✔CATEGORY B University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 8 REPUBLIC ACT 10918 CATEGORY A– Pharmaceutical REGULATION OF THE PRACTICE OF PHARMACY 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, including: (1) Pharmaceutical establishments/outlets selling or otherwise making available to the consuming public prescription/ethical medicines, combination products (medical device and drugs) classified as drugs according to the primary intended mode of action, pharmacist-only OTC medicine, whether owned by the government or by a private person or firm, whether sold at wholesale or retail; (2) Establishments involved in the manufacture, importation, exportation, distribution, and sale of combination products (medical device and drugs) San Agustin classified as University drugs ofaccording to the primary intended COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS 9 DEPARTMENT OF PHARMACY mode of action; REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY (3) Departments/Divisions/Units of pharmaceutical laboratories, pharmaceutical manufacturing laboratories, or other establishments with processes involving the preparation, manufacture, assay, regulation, product research and development, quality control, repacking, importation, exportation, distribution, sale or transfer of pharmaceutical products in quantities greatly in excess of single therapeutic doses; and (4) Government units, including local government, city, first to third class municipal health units, nongovernment organizations and/or associations involved in the procurement, distribution, dispensing and storage of pharmaceutical products; University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 10 REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY CATEGORY B– Pharmaceutical establishments/outlets where the supervision and oversight of a duly registered and licensed pharmacist is required under pertinent provisions of law, including: (1) Retail outlets selling household remedies and OTC drugs as differentiated from the pharmacist-only OTC medicines; (2) Satellite institutional pharmacies providing medicines solely to employees of their respective companies or the employees’ qualified dependents, or both; or members of a duly registered organization or institution; University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 11 REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY (3) Fourth, fifth and sixth class municipal health units involved in the procurement, distribution, dispensing, and storage of pharmaceutical products; (4) Institutions providing telepharmacy services; and (5) Nontraditional outlets of pharmaceutical products: Provided, That no prescription medicines and pharmacist-only OTC medicines are sold. (6) DOH-licensed health facilities involved in the handling of medications used in clinic procedures. Clinic procedures shall include but not to be limited to minor surgery, diagnostic procedures, dialysis, cauterization and vaccination. Such health facilities shall comply with guidelines issued by the FDA University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 12 REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY The following rules on the oversight role and functions of pharmacists must be strictly complied with: 1. the supervising pharmacist must be physically present in the establishment for a minimum of two (2) hours a week. 2. The location of each establishment/outlet which the pharmacist supervises must be within the same provincial local government unit within each region. However, in the case of the National Capital Region (NCR), it shall be considered as a single unit. University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 13 REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY 3. The distance between the two farthest establishments/outlets supervised by a single pharmacist must not exceed twenty-five (25) kilometers (Km) in distance. All other establishments/outlets supervised by a single pharmacists must be within a circumferential area when plotted between the two farthest establishments/outlets. 4. A pharmacist shall be allowed to supervise a maximum of fifteen (15) establishments/outlets. 5. The supervising pharmacist shall likewise comply with the other relevant requirements as may be prescribed by the Board, in University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS 14 coordination with FDA DEPARTMENT OF PHARMACY REPUBLIC ACT 10918 REGULATION OF THE PRACTICE OF PHARMACY A pharmacist working in a Category A establishment may be allowed to simultaneously work or render pharmacy services in Category B establishments. Under this provision, simultaneous work means that a pharmacist can be employed in multiple establishments/outlets: Provided, that there is no overlap in working time. A pharmacist may be allowed to supervise a maximum of four (4) establishments/outlets classified under Category B. University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 15 COMPLIANCE WITH LEGAL REQUIREMENTS University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 16 REQUIREMENTS IN OPENING A DRUGSTORE Petition Form (notarized) Joint Affidavit of Undertaking (notarized) Tentative list of Products using Generic and Brand names Generic White Label and Red Label Rubber Stamp of Outlets Picture of drugstore with Signboard DTI Registration (for Single Proprietorship), or SEC (for Corporation or Partnership), or CDA (for Cooperative) University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 17 REQUIREMENTS IN OPENING A DRUGSTORE PHARMACIST – CERTIFICATE OF REGISTRATION – PROFESSIONAL IDENTIFICATION CARD – Valid PTR – 1 (2x2) ID Picture – Duties and Responsibilities of the pharmacist – Certificate of Attendance of Owner/Pharmacist to a FDA sponsored/accredited Seminar on Licensing of Drug Establishments and Outlets. University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 18 REQUIREMENTS IN OPENING A DRUGSTORE If the Corporate Name is different from the Business Name, secure Business Name registration with DTI If the Corporate Address is different from the Business Address, secure either Mayor's Permit or registration with DTI reflecting the Business Address. If Franchisee, submit copy of Franchise Agreement *Contract of Lease for the space occupied if not owned, or any proof of ownership if owned or notarized Certificate of Occupancy University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 19 REQUIREMENTS IN OPENING A DRUGSTORE SKETCH OF LOCATION SKETCH OF FLOOR PLAN SHOULD BE 15 SQ METER AT LEAST University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 20 REQUIREMENTS IN OPENING A DRUGSTORE Availability of Reference Materials, which are latest edition – Philippine National Drug Formulary – Remington: The Science and Practice of Pharmacy – Goodman and Gilman's: The Pharmacological Basis of Therapeutics University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 21 REQUIREMENTS IN OPENING A DRUGSTORE OTHER REQUIREMENTS: – Record books Prescription Book Senior Citizen's book PWD book. – Menu Card (Generics, MDRP, GMAP) – Generic Dispensing Flow Chart University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 22 University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 23 REQUIREMENTS IN OPENING A DRUGSTORE OTHER REQUIREMENTS Compounding Apparatus: Tablet counter Graduated Cylinder Temperature monitoring and Air conditioning appliance (optional, provided that temperature does not exceed 30 C) University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 24 REQUIREMENTS IN OPENING A DRUGSTORE RA 3720 “Food, Drug and Cosmetic Act” RA 6675 “Generics Act of 1988” RA 5921 “Pharmacy Law” RA 8203 “Special Law on Counterfeit Drug” RA 9502 "Universally Accessible Cheaper and Quality Medicines Act of 2008". Amending RA8293, RA6675, RA5921 AO # 56 s. 1989, EO # 821 Advisory Council for Price Regulation # 2009-001 (GMAP) RA 9711"Food and Drug Administration (FDA) Act of 2009". University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 25 ADVISORY COUNCIL RESOLUTION 2009-001 Government Mediated Access Prices (GMAP), also known as ADVISORY COUNCIL PRICE REGULATION RESOLUTION 2009-001, – is a mediated action made by the government to convince drug companies to lower the prices of the their products that can be acceptable in the budget of the consumers. – Almost all drugs inclusive in this were slashed into half of the original prices. Maximum Drug Retail Prices (MDRP) is a government intervention to the pharmaceutical industry to set a maximum amount of drug prices in retailing, so that no other prices shall top the allowed margin of price. University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 26 EXECUTIVE ORDER NO. 821, S. 2009 PRESCRIBING THE MAXIMUM DRUG RETAIL PRICES FOR SELECTED DRUGS AND MEDICINES THAT ADDRESS DISEASES THAT ACCOUNT FOR THE LEADING CAUSES OF MORBIDITY AND MORTALITY As a consequence of the President’s appeal to pharmaceutical companies during the process of consultation, many of these companies voluntarily undertook to reduce by at least fifty per cent (50%) the prices of sixteen (16) drugs that address diseases of public health concern originally included in the MDRP, such as hypertension, diabetes, common bacterial infections, amoebiasis (a leading cause of diarrhea), cancers (like leukemia, the number one pediatric cancer killer) and the like. I University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 27 MDR P University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 28 GMAP University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 29 PHYSICAL SET-UP OF A PHARMACY University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 30 PHYSICAL SET-UP OF A PHARMACY TYPICAL COMMUNITY PHARMACY University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 31 PHYSICAL SET-UP OF A PHARMACY University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 32 PHYSICAL SET-UP OF A PHARMACY CHAIN PHARMACIES University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 33 PHYSICAL SET-UP OF A PHARMACY University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 34 TYPICAL VS CHAIN DRUGSTORES Minimum floor area (15sqm) 1 outlet Some are airconditioned, some are not Smaller number of staff Limited availability of drug products Bigger floor area More than 1 outlet Air-conditioned Complete facilities Selling other products aside from medicines (convenient store) Offers compounding Selling of regulated/ dangerous drugs University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 35 ORGANIZATIONAL SET-UP BIG CHAIN DRUGSTORES Area Manager Branch Manager Asst. Branch Manager Officer-in-charge (supervisor) Head Pharmacist Pharmacy Assistant SMALL CHAIN Branch Manager/Owner Head Pharmacist/Supervisor/Ca shier Pharmacy Assistant/Cashier Cashier University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 36 FUNCTIONS Area Manager – Supervises all chain establishments Branch Manager – supervise all aspects of store operations Asst. Branch Manager – manage daily operation of the branch if the branch manager is not present Officer-in-charge – In charge of what is happening inside the pharmacy Head/Chief Pharmacist – The one who reads and gives the medicine needed in the prescription Pharmacist assistant – Assist the Head pharmacist Cashier – Receives the money/payment University of San Agustin COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS DEPARTMENT OF PHARMACY 37