RA 10918 Flashcards
Title of RA 10918
Philippine Pharmacy Act
Objectives
a) Standardization and regulation of pharmacy education;
(b) Administration of licensure examination, registration, and licensing of pharmacists;
(c) Supervision, control, and regulation of the practice of pharmacy in the Philippines;
(d) Development and enhancement of professional competence of pharmacists through continuing professional development, research, and other related activities; and
(e) Integration of the pharmacy profession.
It refers to the duly integrated and accredited professional organization of registered and licensed pharmacists, of which there shall be only one (1), as prescribed under Section 41, Article V of this Act;
Accredited professional organization (APO)
It refers to cervical cancer, flu (influenza), pneumococcal, other pre-exposure prophylactic vaccines to be administered to patients aged eighteen (18) years and above, and such other vaccines as may be defined by the Department of Health (DOH) in an administrative issuance;
Adult vaccines
It refers to pharmaceutical products unfit for human consumption
Adulterated/Deteriorated pharmaceutical products
It refer to pharmaceutical products that are used for therapeutic or for in vivo diagnostic purposes, such as vaccines, sera, and drugs derived from life forms using 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;
Biopharmaceuticals
It refers to the proprietary name given by the manufacturer to distinguish its product from those of competitors
Brand name
It refers to a method of secret writing or use of characteristic style or symbol by substituting other letter/s or character/s for the letter/s intended, for the purpose of misleading the consumer
Cipher, Code, or Secret Key
It refers to the sum of processes performed by a pharmacist in drug preparation including the calculations, mixing, assembling, packaging, or labeling of a drug: (i) as the result of a prescription or drug order by a physician, dentist, or veterinarian; or (ii) for the purpose of, or in relation to, research, teaching, or chemical analysis;
Compounding
It refers to the inculcation of advanced knowledge, skills, and ethical values in a post-licensure specialized or in an inter- or multidisciplinary field of study for assimilation into professional practice, self-directed research, and/or lifelong learning
Continuing professional development (CPD)
It refer to a substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odor, and/or protecting the body or keeping them in good condition, as defined under Republic Act No. 9711
Cosmetics
It refer to 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.
Counterfeit pharmaceutical products
It refer to those listed in the: (1) Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol; (2) Schedules annexed to the 1971 Single Convention on Psychotropic Substances; and (3) Annex of Republic Act No. 9165, otherwise known as the “Comprehensive Dangerous Drugs Act of 2002”, and its amendments
Dangerous drugs
It refers to the sum of processes performed by a pharmacist from reading, validating, and interpreting prescriptions; preparing; packaging; labeling; record keeping; dose calculations; and counseling or giving information, in relation to the sale or transfer of pharmaceutical products, with or without a prescription or medication order
Dispensing
It refer to 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
Drugs
It refer to life-threatening situations where a patient needs immediate medical attention and treatment, including the occurrence of epidemic or natural calamities
Emergency cases
It refers to the end date when the manufacturer can guarantee that a product possesses its claimed potency, efficacy, quality, and safety; after which its sale or distribution is prohibited
Expiration date
It refers to the act of dispensing or providing medicines in accordance with a prescription or medication order
Filling
It refer to processed food products intended to supplement the diet that bears or contains one (1) or more of the following dietary ingredients
Food/Dietary supplements
It refers to the scientifically and internationally recognized name of the active ingredients, as approved by the FDA pursuant to Republic Act No. 6675
Generic name
It refers to any 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
Health supplement
It refer to any preparation containing pharmaceutical substances of common or ordinary use to relieve common physical ailments and which may be dispensed without a medical prescription in original packages, bottles or containers, of which the nomenclature has been duly approved by the FDA;
Household remedies
It refer to pharmacies of institutions, organizations, and/or corporations that provide a range of pharmaceutical services, given exclusively to the employees and/or their qualified dependents
Institutional pharmacies
It refers to a supervised practical experience that is required to be completed for licensure as a registered pharmacist
Internship program
It refers to a display of written, printed, or graphic matter on the immediate container of any article
Label
It refer to 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
Labeling materials
It refers to any 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
Medical device
It refers to an activity conducted on normal circumstances of an individual or a 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 is conducted during emergency situations such as calamity, war, or natural and man-made disasters;
Medical mission
It refer to drugs in their appropriate dosage forms, with assured quality, safety and efficacy for humans or animals, or both;
Medicines
It refers to one who 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
Medical representative or professional service representative
It refer to entities licensed by appropriate government agencies to dispense over-the-counter medicines based on an approved list
Nontraditional outlets
It refer to pharmaceutical services of a duly licensed pharmaceutical outlet done over the internet;
Online pharmacy services
It refer to medicines used for symptomatic relief of minor ailments and which may be dispensed without a prescription
Over-the-counter (OTC) medicines
It refer to entities licensed by appropriate government agencies, and which are involved in the manufacture, importation, exportation, repacking, and distribution of pharmaceutical products to pharmaceutical outlets
Pharmaceutical establishments
It refer to establishments 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 manufacturers
It refers to any activity undertaken, organized, or sponsored by a pharmaceutical establishment or outlet which is directed at promoting its product
Pharmaceutical marketing
It 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 end-users
Pharmaceutical outlets
It refer to drugs, medicines, biologicals, pharmaceutical and biopharmaceutical products/specialties, veterinary products, veterinary biologies and veterinary medicinal products
Pharmaceutical products
It 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
Pharmacist
It refer to over-the-counter medicines classified by appropriate government agencies to be obtained only from a licensed pharmacist, with mandatory pharmacist’s advice on their selection and proper use
Pharmacist-only OTC medicines
It refer to persons who assist the pharmacists 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 aides
It refer to persons who assist the pharmacists 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 assistants
It refer to persons who assist 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 this Act
Pharmacy technicians
It refer to the established national framework for quality standards and guidelines of the practice of pharmacy that respond to the needs of the people who require the pharmacists’ services to provide optimal, evidence-based care as formulated by the integrated APO and approved by the Professional Regulatory Board of Pharmacy
Philippine Practice Standards for Pharmacists
It refer to medicines given to health professionals for promotional purposes only
Physician’s samples
It refer to medicines 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
Prescription/Ethical medicines
It refers to the act of dispensing the remaining balance of medicines ordered in the prescription;
Refilling of a prescription
It refers to the process wherein a pharmacist provides consultative services and conducts preliminary assessment of symptoms and refers the patient to a physician or other health care professional
Referral
It refers to the record book maintained by pharmacists, listing the patients referred to different health facilities for further diagnosis
Referral registry
It refers to a prescribed study program in an accredited school of pharmacy
Refresher program
It refer to pharmaceutical services of a duly licensed pharmaceutical outlet done through the use of telephone, teleconferencing, or facsimile
Telepharmacy services
Qualifications of the Chairperson and Members of the Board. - The Chairperson and members of the Board, at the time of nomination, must:
(a) Be a citizen of the Philippines and a resident for at least five (5) years;
(b) Be a duly registered and licensed pharmacist in the Philippines, preferably a holder of a masteral degree in Pharmacy, or its equivalent;
(c) Have been in the active practice of pharmacy for the past ten (10) years;
(d) Have not been convicted of a crime involving moral turpitude;
(e) Be a member in good standing of the APO for at least five (5) years, but not an officer or trustee thereof; and
(f) 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.
The Chairperson and members of the Board shall hold office for a term of ____ from the date of appointment or until their successors shall have been qualified and appointed.
three (3) years
They may be reappointed in the same office for another term of three (3) years immediately after the expiry of their term; Provided, That no member of the Board shall hold office for more than two (2) terms or not more than six (6) years
the first Board appointed under this Act shall hold these terms of office: the Chairperson for three () years, the first member for two () years, and the second member for one (_) year;
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The President of the Philippines may, upon recommendation of the PRC and after due process, suspend or remove the Chairperson or any member of the Board on any of the following grounds:
(a) Gross neglect, incompetence, or dishonesty in the discharge of duty;
(b) 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;
(c) Conviction of an offense involving moral turpitude by a court of competent jurisdiction; and
(d) Unprofessional, unethical, immoral, or dishonorable conduct.