RA 10918 Flashcards
Philippine Pharmacy Act
RA 10918
RA 10918
Philippine Pharmacy Act
RA 8981
PRC Modernization Act of 2000
set of functions that would require the unique expertise of the pharmacist, the absence of which would impact on health and safety
Activities Exclusive to Pharmacists
- 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 vaccine
- pharmaceutical product unfit for human consumption
- as well as those provided for in R. A. No. 3720, otherwise known as the “Food, Drug and Cosmetic Act”, as amended, and R. A. No. 9711, known as the “Food and Drug Administration Act of 2009”
Adulterated/Deteriorated Pharmaceutical Product
noxious and unintended reaction to a drug which occurs at doses normally used in humans for the prophylaxis, diagnosis or treatment of disease or for the modification of physiologic function
Adverse Drug Reaction
- pharmaceutical product used for therapeutic or for in vivo diagnostic purposes, such as vaccines, sera, and drugs derived from life forms by biotechnology.
- include proteins, nucleic acids, or living microorganisms where the virulence is reduced and are used for therapeutic or for in vivo diagnostic purposes
biopharmaceutical
proprietary name given by the manufacturer to distinguish its product from those of competitors
brand name
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, secret key
- patient care provided by a pharmacist, through pharmacologic and non-pharmacologic strategies, that promote the appropriate selection and utilization of medication to optimize individualized therapeutic outcomes, prevent diseases or achieve wellness;
clinical pharmacy service
- sum of processes performed by a pharmacist in drug preparation including the calculations, mixing, assembling, packaging, or labeling of a drug:
(1) as the result of a prescription or drug order by a physician, dentist or veterinarian, or
(2) for the purpose of, or in relation to, research, teaching, or chemical analysis;
compounding
- inculcation of advanced knowledge, skills, and ethical values in a post-licensure specialized or in an inter- or multi-disciplinary field of study for assimilation into professional practice, self-directed research, and/or lifelong learning;
continuing professional development
- 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 R. A. No. 9711;
cosmetics
- pharmaceutical product which does 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.
- product that is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products, including the following:
counterfeit pharmaceutical product
refers 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;
(3) Annex of R. A. No. 9165, otherwise known as the “Comprehensive Dangerous Drugs Act of 2002”, and its amendments;
dangerous drug
- 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, with or without a prescription or medication order;
dispensing
- 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, including the following:
drug
herbal or traditional drugs as defined in R. A. No. ______, known as the ___________________________
RA 9502
Universally Accessible, Cheaper and Quality Medicines Act
- any drug or pharmaceutical establishment that imports or exports raw materials, active ingredients and/or finished drug products for its own use or for wholesale distribution to other drug or pharmaceutical establishments or outlets. If the distributor/importer/exporter/wholesaler sells to the general public, it shall be considered a retailer;
Drug Distributor/Importer/Exporter/Wholesaler
- any 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, enhance quality of patient care, improve patient outcomes and ensure prudent use of resources
Drug Information Service
- a life-threatening situation where a patient needs immediate medical attention and treatment, including the occurrence of epidemic or natural calamities
emergency case
- 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
act of dispensing or providing medicines in accordance with a prescription or medication order;
filling
- processed food product intended to supplement the diet that bears or contains 1 or more of the following dietary ingredients: vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances
- usually in the form of capsules, tablets, liquids, gels, powders, or pills and not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines, as defined under R. A. No. 9711;
Food/Dietary Supplement
scientifically and internationally recognized name of the active ingredients, as approved by the FDA pursuant to R. A. No. 6675, otherwise known as the “Generics Act of 1988”
Generic Name
international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects
Good Clinical Practice (GCP)
that 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 Distribution Practice (GDP)
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 Laboratory Practice (GLP)
- system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use.
- concerned with both manufacturing and quality control processes and procedures;
Good Manufacturing Practice (GMP)
practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal evidence-based care;
Good Pharmacy Practice (GPP)
practice of regulation that should be clear, simple and practical for users through identified policy objectives, consistent with international standards in a sound legal and empirical basis which produces benefits that justify and minimize costs and market distortions, in consideration of its effects across society and taking into account economic, environmental and social factors
Good Regulatory Practice (GRP)
that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout its storage
Good Storage Practice (GSP)
that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout the warehousing
Good Warehousing Practice (GWP)
activities or 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, including waste disposal;
Handling of Pharmaceutical Products
process of enabling communities, patients and clients to increase control over their health and its determinants by engaging in healthy behaviours to reduce the risk of developing diseases and other comorbidities
Health Promotion
- 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 of the following:
(1) herbal fatty acids, enzymes, probiotics and other bioactive substances;
(2) substances derived from natural sources, including animal, plant, mineral and botanical materials in the form of extracts, isolates, concentrates, metabolites and synthetic sources of substances mentioned in (1) and (2).
- presented in dosage forms or in small unit doses such as capsules, tablets, powder, liquids and shall not include any sterile preparations (i.e. injectibles, eye drops)
health supplement
drug that bears a heightened risk of causing significant patient harm when they are used in error
High-alert Medication
any preparation containing pharmaceutical substances of common or ordinary use to relieve common physical ailments and which may be dispensed without a prescription in original packages, bottles or containers, of which the nomenclature and categorization have been duly approved by the FDA;
Household Remedy
a certified pharmacist who administers selected vaccines for adult immunization as prescribed under Section 40, Article 4 of the Act;
immunizing pharmacist
a pharmacy of institutions, organizations, and/or corporations that provide a range of pharmaceutical services exclusively to the employees and/or their qualified dependents;
Institutional Pharmacy
the 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;
Integrated and Accredited Professional Organization (IAPO)
a supervised practical experience or supervised pharmacy practice experience that is required to be completed by the pharmacy student prior to licensure as a pharmacist
Internship Program
a display of written, printed, or graphic matter on the immediate container of any article
Label
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
Labelling Material
an 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 (MA)
the 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. The MAH may either be a manufacturer or distributor/exporter/importer/ wholesaler;
Marketing Authorization Holder (MAH)
- 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 of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, etc. or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
- does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means, as defined under R. A. No. 9711
medical device
an 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
medical mission
any 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 error
involves the 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;
medication management
a drug in their appropriate dosage forms, with assured quality, safety and efficacy for humans or animals, or both
medicine
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/Professional Service Representative
entities licensed by appropriate government agencies to dispense over-the-counter medicines based on an approved list
Non-traditional Outlet
refers to the pharmaceutical service of a duly licensed pharmaceutical outlet done over the internet;
online pharmacy service
medicine used for symptomatic relief of minor ailments and which may be dispensed without a prescription;
Over-the-counter (OTC) Medicine
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 Counselling
a comprehensive summary of all medications taken by a patient, including prescription, over-the-counter, health supplements and food/dietary supplements;
Patient Medication Profile
any patient-centered, 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 Care
an entity licensed by appropriate government agencies, which is involved in the manufacture, importation, exportation, repacking, and distribution of pharmaceutical products to pharmaceutical outlets
Pharmaceutical Establishment
an establishment 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 Manufacturer/Drug Manufacturer
any activity undertaken, organized, or sponsored by a pharmaceutical establishment or outlet which is directed at promoting its product
Pharmaceutical Marketing
an entity 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
Pharmaceutical Outlet
drugs, medicines, biologicals, pharmaceutical and biopharmaceutical products/specialties, veterinary products, veterinary biologics and veterinary medicinal products;
Pharmaceutical Product
a health professional who has been 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
over-the-counter 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
Pharmacist-only OTC Medicine
a person who 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 Aide
a person who 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 Assistant
a person who 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
Pharmacy Technician
the 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. This Standards shall be formulated by the IAPO and approved by the Board;
Philippine Practice Standards for Pharmacists
medicine given to health professionals for promotional purposes only
Physician’s Sample
patient medication profile which can be either electronic or hard copy wherein the dispensed prescription drugs, among others, are recorded
Prescription Book
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;
Prescription/Ethical Medicine
the act of dispensing the remaining balance of medicines ordered in the prescription;
ttt
Refilling of a Prescription
the process wherein the pharmacist provides consultative services, conducts preliminary assessment of symptoms and refers the patient to a physician or other healthcare professional
referral
record book maintained by pharmacists, listing the patients referred to different health facilities for further diagnosis;
Referral Registry
prescribed study program of an accredited school of pharmacy or organization of colleges of pharmacy;
Refresher Program
service provided by the pharmacist to ensure the compliance of pharmaceutical products to specifications, policies, standards or laws;
Regulatory Service
a 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;
Retail Outlet for Non-prescription Drugs (RONPD) otherwise known as non-traditional outlet
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
Sub-professional Service
a pharmaceutical service of a duly licensed pharmaceutical outlet done through the use of telephone, teleconferencing or facsimile.
Telepharmacy Service
There is hereby created a Professional Regulatory Board of Pharmacy, hereinafter called the ________, under the administrative control and supervision of the PRC, to be composed of a Chairperson and _____ members, who shall be appointed by the President of the Philippines from a list of ____ recommendees for each position ranked in the order of preference and submitted by the PRC from a list of ____ nominees submitted for each position by the IAPO of pharmacists.
board
1 chairperson
2 members
3 recommendees
5 nominees
IAPO
Integrated and Accredited Professional Organization
2 major areas of subjects in pharmacy
pharmacy science
practice
In order to be a pharmacist, a candidate must obtain a general weighted average of ___, with no rating lower than ___ in any of the subjects.
75%
50%
The Board shall submit to the PRC the ratings obtained by each examinee within ___ working days after the last day of the examination, unless extended for just cause.
3
- shall be issued to those who passed the licensure examination, subject to compliance with the registration requirements and payment of the prescribed fees.
- shall bear the registration number, date of issuance, with the signatures of the Chairperson of the PRC and the Chairperson and Members of the Board, and stamped with the official seals of the PRC and of the Board, certifying that the person named therein is entitled to practice the profession, with all the privileges appurtenant thereto.
- shall remain in full force and effect until suspended or revoked in accordance with the Act.
- A COR as a pharmacist
