Title
Philippine Pharmacy Act Modernization
Law
Republic Act No. 10918
Decision Date
Jul 17, 2016
Republic Act No. 10918: Philippine Pharmacy Act regulates and modernizes the practice of pharmacy in the Philippines, recognizing the important role of pharmacists in delivering quality healthcare services and aiming to develop competent and globally competitive professionals.

Questions (Republic Act No. 10918)

RA 10918, Sec. 4 defines practicing pharmacy as performing (with or without fee) activities such as preparing/compounding/manufacturing/preserving/storing/distributing/procuring/selling/dispensing pharmaceutical products or raw materials; rendering clinical pharmacy services, drug information, medication management, regulatory services, and pharmaceutical marketing when pharmacist expertise is required; teaching pharmacy courses; dispensing in supervised situations; conducting chemical/biological/microbiological analyses and physico-chemical analyses for medical devices; administering adult vaccines (subject to training and certification); conducting pharmaceutical research; and providing other services requiring pharmaceutical knowledge. Activities under Sec. 4(a), (b), (c), (d), and (i) are exclusive to licensed pharmacists.

Sec. 4(g) and Sec. 40 state that administration of adult vaccines is allowed for licensed and trained pharmacists who: (1) have undergone training on safe administration of adult vaccines and management of AEFI and hold a PRC-accredited certificate of training; (2) ensure the vaccine has a doctor’s prescription not more than seven (7) days old; (3) submit monthly vaccination reports and AEFI reports to DOH regional offices using the prescribed forms.

Sec. 3 provides that RA 10918 governs and provides for: (a) standardization and regulation of pharmacy education; (b) administration of licensure examination, registration, and licensing of pharmacists; (c) supervision, control, and regulation of pharmacy practice; (d) development/enhancement of pharmacist competence through continuing professional development (CPD), research, and related activities; and (e) integration of the pharmacy profession.

Sec. 6 creates a PRBPharm under PRC administrative control and supervision, composed of a Chairperson and two (2) members appointed by the President from lists of recommendees and nominees submitted by the PRC and the integrated and accredited professional organization (APO) of pharmacists.

Sec. 7 requires, among others: Philippine citizenship and 5-year residency; being a registered and licensed pharmacist (preferably with a masteral degree); at least 10 years active practice; no conviction involving moral turpitude; membership in good standing of the APO for at least 5 years but not an officer/trustee; and at appointment, no faculty/administrative officer in pharmacy schools and no direct/indirect pecuniary interest or connection with review centers or similar institutions.

Sec. 8 grants powers such as implementing RA 10918; promulgating rules and regulations; preparing licensure exam questions and submitting results to PRC; recommending issuance/suspension/revocation of COR/PIC/STP; administering oaths; regulating and monitoring practice including subprofessional services; prescribing Pharmacists’ Code of Ethics and technical standards; investigating violations and issuing summons/subpoenas; rendering decisions; delegating hearings (except for professional practice issues needing board member presiding); issuing guidelines on CPD; and accredit training/certifications for pharmacy technicians/assistants/aides/other medicine handlers; plus accrediting Specialty Boards in pharmacy.

Sec. 13 provides that, unless exempted, all applicants for registration for the practice of pharmacy must pass the licensure examination as provided in the Act and under Sec. 7(d) of RA 8981.

Sec. 14 requires the applicant to be a citizen of the Philippines or a foreigner from a country/state with reciprocity policy; be of good moral character and reputation; have a BS Pharmacy (or equivalent) degree from a recognized HEI/foreign institution recognized by CHED; and have completed an internship program approved by the Board.

Sec. 16 states the exam is administered two (2) times a year in places and dates designated by the PRC in the resolution providing the master schedule of all licensure exams pursuant to Sec. 7(d) of RA 8981.

Sec. 17 requires a general weighted average of at least 75%, with no rating lower than 50% in any subject. A candidate failing the exam for the third time cannot take the next succeeding exams without first undertaking a refresher program in a duly accredited institution.

Sec. 20 provides that COR remains in force until suspended or revoked, and includes the registration number, date of issuance, signatures of the PRC Chair and Board members, and PRC/Board official seals. PIC is issued upon payment of fees, bears the registration number and issuance/expiry dates, is renewed every three (3) years upon presentation of a Certificate of Good Standing from the APO and proof of CPD completion.

A foreign citizen may provide professional services within the scope of pharmacy practice (e.g., consultant in foreign-funded projects, employed by a Filipino employer, free services in humanitarian missions, or visiting faculty) only after securing an STP from the Board/PRC, and only if the person is internationally renowned, the service is necessary due to lack of Filipino specialist/expert, and the foreigner must work with a Filipino registered and licensed pharmacist counterpart.

Sec. 31(a) defines Category A as establishments requiring direct and immediate control/supervision of a duly registered pharmacist (e.g., those selling prescription/ethical medicines, pharmacist-only OTC medicines, combination products, pharmaceutical labs/manufacturing/quality control processes, and government units involved in procurement/distribution/dispensing/storage). Sec. 31(b) defines Category B as establishments requiring supervision/oversight (e.g., retail outlets for household remedies and OTC drugs excluding pharmacist-only OTC, satellite institutional pharmacies, certain municipal health units, telepharmacy institutions, and nontraditional outlets where no prescription or pharmacist-only OTC medicines may be sold).

Sec. 30 requires that prescription drugs and pharmacist-only OTC medicines be dispensed only by a duly registered and licensed pharmacist, except in emergency cases where pharmacist services are not available. In emergencies, product dispensing is allowed but a report must be made to the supervising pharmacist within 24 hours for recording in prescription books.

Sec. 37 requires that prescriptions dispensed be recorded in an appropriate system including at least patient name/address, prescriber name, generic and brand, dosage strength, quantity, and pharmacist initials. Dangerous drugs must be recorded in the Dangerous Drugs Book or equivalent system under RA 9165. Referrals (e.g., TB patients) must be recorded in a Referral Registry. Records must be kept for not less than two (2) years after the last entry and must be open to inspection by Board/FDA representatives when the pharmacy is open.

Sec. 36 requires that every box/bottle/package of pharmacist-compounded/dispensed medicines have a seal or label bearing (among others) patient name and generic name of drug; brand name (if any), strength, expiry date, directions for use; and pharmacy name/address; doctor name; dispensing pharmacist name; and other requirements under the Philippine Practice Standards for Pharmacists and Dispensing Guidelines and related laws (e.g., RA 9502). Auxiliary labels are required for dangerous drugs, external-use-only drugs, drugs with special storage/admin instructions, and others as required by law.

Sec. 39 mandates certification by appropriate government agencies after undergoing an accredited training program for persons handling pharmaceutical products other than pharmacists—this includes pharmacy owners who are non-pharmacists, medical/professional service representatives, pharmacy support personnel, pharmacy technicians, assistants, aides, and other persons performing functions in pharmacy operations. No person may render such services without undergoing a comprehensive standardized training program (with exceptions for pharmacy graduates, subject to the IRR-defined job descriptions).


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