IRR Of R.A. No. 10918 (Philippine Pharmacy Act) PDF

# IRR OF R. A. NO. 10918 (PHILIPPINE PHARMACY ACT) ## Section 3. Acts, Services or Activities Exclusive to Pharmacists: - Administration of adult vaccines as approved by the FDA. Pharmacists must undergo training on safe administration of adult vaccines and management of adverse event following im...

# IRR OF R. A. NO. 10918 (PHILIPPINE PHARMACY ACT) ## Section 3. Acts, Services or Activities Exclusive to Pharmacists: - Administration of adult vaccines as approved by the FDA. Pharmacists must undergo training on safe administration of adult vaccines and management of adverse event following immunization and hold a certificate issued by an institution duly accredited by the PRC. Safe administration of vaccines must be part of the higher education curriculum for pharmacists. - Conduct or undertaking of scientific research in all aspects involving pharmaceutical products and healthcare. The Professional Regulatory Board of Pharmacy may modify the enumerated acts, services or activities, as the need arises in consultation with PRC, to conform to the latest trends and developments in the practice of pharmacy. ## Section 6. Definition of Terms - **Act**: R. A. No. 10918, also known as "The Philippine Pharmacy Act". - **Activities Exclusive to Pharmacists**: Set of functions that require the unique expertise of the pharmacist. - **Adult Vaccine**: Cervical cancer, flu (influenza), pneumococcal, other pre-exposure prophylactic vaccines for patients aged 18 and above, and such other vaccines as defined by the Department of Health (DOH). - **Adulterated/Deteriorated Pharmaceutical Product**: Pharmaceutical product unfit for human consumption. - **Biopharmaceutical**: Pharmaceutical product used for therapeutic or for in vivo diagnostic purposes, such as vaccines, sera, and drugs derived from life forms by biotechnology. These include proteins, nucleic acids, or living microorganisms where the virulence is reduced and are used for therapeutic or for in vivo diagnostic purposes. - **Brand Name**: Proprietary name given by the manufacturer to distinguish its product from those of competitors. - **Cipher, Code, or Secret Key**: Method of secret writing, or use of characteristic style or symbol by substituting other letter/s for the letter/s intended for the purpose of misleading the consumer. - **Clinical Pharmacy Service**: Patient care provided by a pharmacist, that promote the appropriate selection and utilization of medication. - **Compounding**: Sum of processes performed by a pharmacist in drug preparation including the calculations, mixing, assembling, packaging, or labeling of a drug. - **Continuing Professional Development (CPD)**: Inculcation of advanced knowledge, skills, and ethical values in a post-licensure specialized or in an inter- or multi-disciplinary field of study. - **Cosmetics**: Substance or preparation intended to be placed in contact with the various external parts of the human body, or with the teeth and mucous membranes of the oral cavity. - **Counterfeit Pharmaceutical Product**: Pharmaceutical product which does not contain the amounts as claimed, with wrong ingredients, without active ingredients, or with insufficient quantity of active ingredients. This also refers to a product that is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging. - **Dangerous Drug**: Listed in the Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, Schedules annexed to the 1971 Single Convention on Psychotropic Substances or Annex of R. A. No. 9165, otherwise known as the "Comprehensive Dangerous Drugs Act of 2002". - **Dispensing**: Sum of processes performed by a pharmacist from reading, validating, and interpreting prescriptions; preparing; packaging; labelling; record keeping; dose calculations; and counselling or giving information, in relation to the sale, transfer or provision of pharmaceutical products. - **Drug**: Pharmaceutical product that pertains to chemical compound/s or biological substance/s, other than food, intended for use in the treatment, prevention, or diagnosis of disease in humans or animals. - **Drug Distributor/Importer/Exporter/Wholesaler**: Drug or pharmaceutical establishment that imports or exports raw materials, active ingredients and finished drug products for its own use or for wholesale distribution to other drug or pharmaceutical establishments or outlets. - **Drug Information Service**: Activity in response to a drug information request or query from healthcare professionals, organizations, committees, patients and other individuals with the goal of providing carefully evaluated, evidence-based drug information and recommendation to support medication use practice. - **Emergency Case**: Life-threatening situation where a patient needs immediate medical attention and treatment, including the occurrence of epidemic or natural calamities. - **Expiration Date**: End date when the manufacturer can guarantee that a product possesses its claimed potency, efficacy, quality, and safety. - **Filling**: Act of dispensing or providing medicines in accordance with a prescription or medication order. - **Food/Dietary Supplement**: Processed food product intended to supplement the diet that bears or contains one (1) or more of the following dietary ingredients: vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances. - **Generic Name**: Scientifically and internationally recognized name of the active ingredients. - **Good Clinical Practice (GCP)**: International ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. - **Good Distribution Practice (GDP)**: Part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout the numerous activities which occur during the distribution process. - **Good Laboratory Practice (GLP)**: Quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. - **Good Manufacturing Practice (GMP)**: System of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is concerned with both manufacturing and quality control processes and procedures. - **Good Pharmacy Practice (GPP)**: Practice of pharmacy that responds to the needs of the people who use the pharmacists' services to provide optimal evidence-based care. - **Good Regulatory Practice (GRP)**: Practice of regulation that should be clear, simple and practical for users through identified policy objectives, consistent with international standards. - **Good Storage Practice (GSP)**: Part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout its storage. - **Good Warehousing Practice (GWP)**: Part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout the warehousing. - **Handling of Pharmaceutical Products**: Range of pharmacy operations from selecting, ordering, delivery, transport, receipt, inventory of stocks, to arranging and display, compounding, storage, dispensing, provision of medication and health information to patients and/or healthcare providers and selling of pharmaceutical products. - **Health Promotion**: Process of enabling communities, patients and clients to increase control over their health by engaging in healthy behaviours to reduce the risk of developing diseases. - **Health Supplement**: Product that is used to maintain, enhance and improve the healthy function of the human body and contains one (1) or more, or a combination of the following: herbal fatty acids, enzymes, probiotics and other bioactive substances, substances derived from natural sources, including animal, plant, mineral and botanical materials, in dosage forms or in small unit doses. - **High-alert Medication**: Drug that bears a heightened risk of causing significant patient harm when they are used in error. - **Household Remedy**: Preparation containing pharmaceutical substances of common or ordinary use to relieve common physical ailments; dispensed without a prescription. - **Immunizing Pharmacist**: Certified pharmacist who administers selected vaccines for adult immunization. - **Institutional Pharmacy**: Pharmacy of institutions, organizations, and/or corporations that provide a range of pharmaceutical services exclusively to the employees and/or their qualified dependents. - **Integrated and Accredited Professional Organization (IAPO)**: Integrated and accredited professional organization of pharmacists, of which there shall be only one (1), as prescribed under Section 41, Article V of the Act. - **Internship Program**: Supervised practical experience or supervised pharmacy practice experience that is required to be completed by the pharmacy student. - **Label**: Display of written, printed, or graphic matter on the immediate container of any article. - **Labelling Material**: All labels and other written, printed, or graphic matter: (1) upon any item or any of its containers or wrappers; or (2) accompanying any such item. - **Marketing Authorization (MA)**: Official document issued by the FDA for the purpose of marketing or free distribution of a product after evaluation of its safety, efficacy, and quality. - **Marketing Authorization Holder (MAH)**: Company, corporate or legal entity in the field of pharmaceuticals in whose name the MA for a drug product has been granted. This party is responsible for all aspects of the product, including quality and compliance with the conditions of the MA. - **Medical Device**: Instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings, for one (1) or more of the specific purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment or alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy of a physiological process; supporting or sustaining life; preventing infection; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body. - **Medical Mission**: Activity conducted in normal circumstances by an individual or group of health care practitioners to provide health services outside the hospital, clinic, and health care facility premises as differentiated from humanitarian missions and relief operations which are conducted during emergency situations such as calamity, war, or natural and man-made disasters. - **Medication Error**: Preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. - **Medication Management**: Patient-centered care provided by the pharmacist to optimize safe, effective and appropriate drug therapy by ensuring the proper selection, procurement, storage, order, transcription, preparation, dispensation, administration of the drug and monitoring of the drug utilization and effect. - **Medicine**: Drug in their appropriate dosage forms, with assured quality, safety and efficacy for humans or animals, or both. - **Medical Representative/Professional Service Representative**: Represents any duly authorized manufacturer, distributor, trader, and wholesaler of pharmaceutical products and whose primary duty is to promote their products to duly-licensed health professionals. - **Non-traditional Outlet**: Licensed by appropriate government agencies to dispense over-the-counter medicines based on an approved list. - **Online Pharmacy Service**: Pharmaceutical service of a duly licensed pharmaceutical outlet done over the internet. - **Over-the-counter (OTC) Medicine**: Medicine used for symptomatic relief of minor ailments and which may be dispensed without a prescription. - **Patient Medication Counselling**: One-on-one interaction between a pharmacist and a patient, client or a caregiver to provide appropriate, understandable and relevant information about the medications prescribed and/or dispensed. - **Patient Medication Profile**: Comprehensive summary of all medications taken by a patient, including prescription, over-the-counter, health supplements and food/dietary supplements. - **Pharmaceutical Care**: Outcomes-oriented activity or intervention that requires the pharmacist to cooperate with other healthcare professionals, patients and their caregivers, and other clients in preventing, identifying and resolving any drug-related problem. - **Pharmaceutical Establishment**: Licensed by appropriate government agencies, which is involved in the manufacture, importation, exportation, repacking, and distribution of pharmaceutical products to pharmaceutical outlets. - **Pharmaceutical Manufacturer/Drug Manufacturer**: Engaged in any or all operations involved in the production of pharmaceutical products including the preparation, processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing and labeling, preparatory to their storage, sale, or distribution, except the compounding and filling of prescriptions in pharmaceutical outlets. - **Pharmaceutical Marketing**: Activity undertaken, organized, or sponsored by a pharmaceutical establishment or outlet which is directed at promoting its product. - **Pharmaceutical Outlet**: Licensed by appropriate government agencies, which is involved in compounding and/or dispensing and selling of pharmaceutical products directly to patients or end-users. This includes institutional pharmacy, Retail Outlet for Non-Prescription Drugs (RONPD), pharmacy/drugstore/farmacia/botica and hospital pharmacy. - **Pharmaceutical Product**: Drugs, medicines, biologicals, pharmaceutical and biopharmaceutical products/specialties, veterinary products, veterinary biologics and veterinary medicinal products. - **Pharmacist**: Registered and issued a valid Certificate of Registration (COR) and Professional Identification Card (PIC) by the PRC and Professional Regulatory Board of Pharmacy (Board). - **Pharmacist-only OTC Medicine**: Classified by appropriate government agencies that can be obtained only from a pharmacist, with mandatory pharmacist's advice on its selection and proper use. - **Pharmacy Aide**: Assists the pharmacist in the different aspects of pharmacy operation based on established standard operating procedures and processes, with very minimal degree of independence or decision-making and without direct interaction with patients. - **Pharmacy Assistant**: Assists the pharmacist in different aspects of pharmacy operation based on established standard operating procedures and processes, with a minimum degree of independence or decision making and may have supervised interaction with patients. - **Pharmacy Technician**: Assists in compounding and dispensing of medicines in community, hospital, institutional and industrial settings or engaged in other activities under the supervision of the pharmacist as described in Section 39, Article IV of the Act. - **Philippine Practice Standards for Pharmacists**: Established national framework for quality standards and guidelines on the practice of pharmacy that responds to the needs of the people and which requires that the pharmacists' services provide optimal and evidence-based care. - **Physician's Sample**: Medicine given to health professionals for promotional purposes only. - **Prescription Book**: Patient medication profile which can be either electronic or hard copy wherein the dispensed prescription drugs, among others, are recorded. - **Prescription/Ethical Medicine**: Medicine which can only be dispensed by a pharmacist to a patient, upon the presentation of a valid prescription from a physician, dentist, or veterinarian and for which a pharmacist's advice is necessary. - **Refilling of a Prescription**: Act of dispensing the remaining balance of medicines ordered in the prescription. - **Referral**: Process wherein the pharmacist provides consultative services, conducts preliminary assessment of symptoms and refers the patient to a physician or other healthcare professional. - **Referral Registry**: Record book maintained by pharmacists, listing the patients referred to different health facilities for further diagnosis. - **Refresher Program**: Prescribed study program of an accredited school of pharmacy or organization of colleges of pharmacy. - **Regulatory Service**: Service provided by the pharmacist to ensure the compliance of pharmaceutical products to specifications, policies, standards or laws. - **Retail Outlet for Non-prescription Drugs (RONPD)**: Pharmaceutical outlet, such as, a supermarket, convenience store and other similar retail establishment authorized to sell only identified Over-the-Counter (OTC) and household remedy products directly to the general public on a retail basis. - **Sub-professional Service**: Service provided by a person handling pharmaceutical products other than the pharmacists, such as but not limited to pharmacy owners, medical representatives, pharmacy technicians, pharmacy assistants and pharmacy aides. - **Telepharmacy Service**: Pharmaceutical service of a duly licensed pharmaceutical outlet done through the use of telephone, teleconferencing or facsimile. # Rule II: The Professional Regulatory Board of Pharmacy ## Section 1. Creation of the Professional Regulatory Board of Pharmacy: There is hereby created a Professional Regulatory Board of Pharmacy, hereinafter called the Board, under the administrative control and supervision of the PRC, to be composed of a Chairperson and two (2) members. The President of the Philippines shall appoint the Chairperson and members from a list of three (3) recommendees for each position ranked in the order of preference and submitted by the PRC from a list of five (5) nominees submitted for each position by the IAPO of pharmacists. ## Section 2. Qualifications of the Chairperson and Members of the Board: The Chairperson and Members of the Board, at the time of nomination, must: - Be citizens of the Philippines and residents thereof for at least five (5) years. - Be pharmacists in the Philippines, preferably holders of Master's Degree in Pharmacy or PhD, or their 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. - Be members in good standing of the IAPO for at least five (5) years, but not officers or trustees thereof. - Neither be, at the time of appointment, members of the faculty or administrative officers of any school, college or university offering degree programs in pharmacy nor have any direct or indirect pecuniary interest or connection in any review center or similar institution. Assessment and evaluation of nominees for the Board shall be based on the rubric to be provided by the Board, in consultation with IAPO.