RA 10918 otherwise know as the Philippine Pharmacy Act
I. Declared State Policy:
The State recognizes the vital role of pharmacists in the delivery of quality health care services. Thus, the pharmacists professional services shall be promoted as an indispensible component of the total health care system. II. Who are deemed to be engaged in the practice of Pharmacy: A. The following are exclusive to licensed pharmacists: 1.Preparation, compounding or manufacture, and even storage, distribution procurement, sale or dispensing of any pharmaceutical product or its raw materials 2.Clinical pharmacy services, drug information, pharmaceutical marketing, medication management 3. Teaching of pharmacy courses in schools 4.Dispensing pharmaceutical products in situations where supersivion is required 5. All other services where pharmaceutical knowledge is required. The fifth definition is a catch all provision to cover for all other instances that do not specifically fall under the enumerations B. The following are likewise engaged in pharmacy but may be undertaken by nonlicensed pharmacists, but is still however subject to other qualifications under other laws: 1.Chemical, biological or microbiological analyses and assay of pharmaceutical products, food/dietary supplements, health supplements and cosmetics 2.Physisco-chemical analyses for medical devices used in aid of administration of pharmaceutical products. 3. Administration of Adult Vaccines as approved by the FDA 4. Scientific research involving pharmaceutical products and health care. Training Pharmacy aides, and pharmacy assistants are those who assist the pharmacists in the different aspects of pharmacy operation, with very minimal degree of independence or decision making and without direct interaction with patients(Aides), or with minimum degree of independence and decision making, and may have supervised interaction with patients(assistants) Provisions on Adult Vaccines: 1. Pharmacists are required to: a. Undergo training for safe administration of adult vaccine and management of adverse events following immunization (AEFI) b. Hold a certificate of training issued by an institution accredited by the Professional Regulation Commission c. The training must form part of a higher education curriculum for pharmacists. d. Before administration, the pharmacist must ensure that the vaccine to be administered shall have a doctors prescription which is not more than 7 days old.
e. Pharmacists must submit a monthly vaccination report and AEFI report to
the DOH regional offices. 2. Adult Vaccines refer to vaccines: a. To be administered to patients aged 18 and above, such as cervical cancer, flu vaccines, pneumococcal vaccines, and other pre-exposure prophylactic vaccines. b. As defined by the Department of Health in an Administrative Issuance. III. Regulation of the Practice of Pharmacy Pharmacist Requirement: Category A Establishments/Outlets are those which are required to hire the direct and immediate control and supervision of a duly registered and licensed pharmacist, per establishment. Category B Establishments/Outlets are those which require only supervision and oversight of a duly registered and licensed pharmacist. (The FDA, in coordination with the Board, and the approval of the PRC, may add to, delete, reclassify, or modify the following list of establishments, as the need arises, in order to keep pace with the developments in the pharmacy practice.) CATEGORY A: 1. Those selling or otherwise making available to the consuming public: prescription medicines, pharmacist-only OTC medicine, combination products classified as drugs accdg. to the primary intended mode of action(medical device and drugs), 2. Those involved in that manufacture, import and export, distribution, and sale of combination products 3. Departments/Divisions/Units of establishments with the process involving the preparation, manufacture, assay, regulation, product research and development, quality control, repacking, importation and exportation, distribution, sale or transfer of pharmaceutical products, in quantities greatly in excess of single therapeutic doses. 4. Government units, including local government, city, first to third class municipal health units, non-government organizations and/or associations involved in the procurement, distribution, dispensing, cold storage. A pharmacist working under category A are allowed to simultaneously work or render pharmacy services in category B establishments. His maximum hours of work shall be determined by CATEGORY B: 1.Those selling only household remedies and OTC drugs 2. Satellite institutional pharmacies providing medicines solely to employees of their respective companies or the the dependents of such employees or both, or those with respect to a duly registered organization or institution
3.Fourth to sixth class municipal health units involved in procurement,
distribution, dispensing, and storage of pharmaceutical products. 4. Institutions providing telepharmacy services 5. Non-traditional outlets of pharmaceutical products: Provided that no prescription medicines and pharmacist-only OTC are sold. Responsibility for Quality, Safety and Efficacy of Pharmaceutical Products -Duty of the duly licensed and registered pharmacist of a pharmaceutical establishment and outlet to ensure that pharmaceutical products conform to the standards under this Act and other pertinent Rules and Regulations -Owners, managers and pharmacists-in-charge shall be held jointly responsible with these standards. Provision on Automatic Registration 1. The Certificates of Registration (COR), Special/Temporary Permits(STP), Professional Identifcation Cards (PIC) held by persons in good standing shall remain effective. 2. All Pharmacists registered prior to the effectivity of this act shall automatically be registered, but may be subject to future requirements. Display of Certificate of Registration 1. A pharmacist engaged in the practice, whether in private or as an employee, shall display the original copy of ones COR in a prominent and conspicuous place in the drug establishment. 2. When a pharmacist is employed in Category B establishments, the duplicate copy of the pharmacists COR shall be displayed therein. No Pharmacist shall knowingly allow to be displayed in an establishment where one is not actually employed as a professional pharmacist. Distinction between adulterated and counterfeit pharmaceutical products: Adulterated Pharmaceutical Products are those, following the standards of quality and purity, are unfit for human consumption. Counterfeit Pharmaceutical Products- on the other hand are those bearing misleading or fraudulent writings or marks which are enumerated in the Act. One of which is when the product contains no amount of or a different active ingredient, or less than 80% of the active ingredient it purports to possess, including reduction of efficacy due to expiration-as distinguished from an adulterated drug. Label on dispensed Medicines: Every box, bottle, or package of medicines compounded or dispensed by a pharmacist, based on prescription, the following must be indicated: (1) Name of patient; (2) generic name; (3) brand name; (4) strength; (5) expiration date; (6) directions for use; (7)Name and address of the pharmacy; (8) name of the doctor, (9)dispensing pharmacist, (10)Other requirements prescribed in the: Phil Standards for Pharmacists and Dispensing Guidelines RA 9502 Universally Accessible Cheaper and Quality Medicines Act Its implementing RRs
Other guidelines as may be promulgated by the Board.