MODULE 2- SECTION 5-DEFINITION OF TERMS

Accredited professional organization (APO)

____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

Section 41, Article V

Accredited professional organization (APO) 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 ___ of this Act

Adult vaccines

____refer 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

Adulterated/Deteriorated pharmaceutical products

____refer to pharmaceutical products unfit for human consumption, following the standards of quality or purity of which, are as those stated in the United States Pharmacopeia/National Formulary and Philippine Pharmacopeia in its latest edition or any standard reference for drugs and medicines which are given official recognition as well as those provided for in Republic Act No. 3720, otherwise known as the "Food, Drug, and Cosmetic Act", as amended, and Republic Act No. 9711, known as the "Food and Drug Administration Act of 2009"

Republic Act No. 3720, otherwise known as the "Food, Drug, and Cosmetic Act"

Republic Act No. 9711, known as the "Food and Drug Administration Act of 2009"

Adulterated/Deteriorated pharmaceutical products refer to pharmaceutical products unfit for human consumption, following the standards of quality or purity of which, are as those stated in the United States Pharmacopeia/National Formulary and Philippine Pharmacopeia in its latest edition or any standard reference for drugs and medicines which are given official recognition as well as those provided for in ____ AND___

Food, Drug, and Cosmetic Act

Republic Act No. 3720

Food and Drug Administration Act of 2009

Republic Act No. 9711

Biopharmaceuticals

____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.

Biopharmaceuticals

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

_____refers to the proprietary name given by the manufacturer to distinguish its product from those of competitors

Cipher, Code, or Secret Key

____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

Compounding

____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;

(i) as the result of a prescription or drug order by a physician, dentist, or veterinarian

(ii) for the purpose of, or in relation to, research, teaching, or chemical analysis

Compounding refers to the 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)

___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

Cosmetics

____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

Republic Act No. 9711

Cosmetics 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____

Counterfeit pharmaceutical products

____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

These also refer to products that are deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products

(1) The pharmaceutical product itself or the container or labeling thereof or any part of such product, container, or labeling, bearing without authorization; the trademark, trade name, or other identification marks or imprints or any likeness to that which is owned or registered in the Intellectual Property Office (IPO) in the name of another natural or juridical person;

(2) A pharmaceutical product refilled in containers bearing legitimate labels or marks, without authority; and

(3) A pharmaceutical product which contains no amount of or a different active ingredient; or less than eighty percent (80%) of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration

Counterfeit pharmaceutical products refer to products that are 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:

Intellectual Property Office (IPO)

IPO means

less than eighty percent (80%)

A pharmaceutical product which contains no amount of or a different active ingredient; or less than ___% of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration

Dangerous drugs

____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;

(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 Republic Act No. 9165, otherwise known as the "Comprehensive Dangerous Drugs Act of 2002", and its amendments

Dangerous drugs refer to those listed in the:

Comprehensive Dangerous Drugs Act of 2002

Republic Act No. 9165

Dispensing

____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

Emergency cases

___refer to life-threatening situations where a patient needs immediate medical attention and treatment, including the occurrence of epidemic or natural calamities

Drugs

____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

Any article recognized in the official United States Pharmacopeia/National Formulary, Homeopathic Pharmacopeia of the United States of America, Philippine Pharmacopeia, Philippine National Drug Formulary, British Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, and any official compendium or any supplement to them

Drugs

Any article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease of man or animals

Drugs

Any article, other than food, intended to affect the structure or any function of the human body or animals

Drugs

Any article intended for use, as a component of articles, specified in clauses (1), (2) and (3), not including devices or their components, parts and accessories

Drugs

Herbal or traditional drugs as defined in Republic Act No. 9502

Universally Accessible Cheaper and Quality Medicines Act of 2008

Republic Act No. 9502

Expiration date

____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

Filling

____refers to the act of dispensing or providing medicines in accordance with a prescription or medication order

Food/Dietary supplements

___refer to processed food products 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 to increase the total daily intake in amounts conforming to the latest Philippine-recommended energy and nutrient intakes or internationally agreed minimum daily requirements.

Food/Dietary supplements

It usually is 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 Republic Act No. 9711

Generic name

_____refers to the scientifically and internationally recognized name of the active ingredients, as approved by the FDA pursuant to Republic Act No. 6675, otherwise known as the "Generics Act of 1988"

Generics Act of 1988

Republic Act No. 6675

Household remedies

____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

Institutional pharmacies

____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

Health supplement

____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 of the following: (1) herbal fatty adds, enzymes, probiotics, and other bioactive substances; and (2) substances derived from natural sources, induding animal, plant, mineral, and botanical materials in the form of extracts, isolates, concentrates, metabolites, synthetic sources of substances mentioned in (1) and (2).

(1) herbal fatty adds, enzymes, probiotics, and other bioactive substances

(2) substances derived from natural sources, induding animal, plant, mineral, and botanical materials in the form of extracts, isolates, concentrates, metabolites, synthetic sources of substances mentioned in (1) and (2).

Health supplement 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 of the following:

Health supplement

It is presented in dosage forms or in small unit doses such as capsules, tablets, powder, liquids and it shall not include any sterile preparations (i.e. injectibles, eyedrops)

Internship program

____refers to a supervised practical experience that is required to be completed for licensure as a registered pharmacist

Label

____refers to a display of written, printed, or graphic matter on the immediate container of any article

Labeling materials

____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

Medical device

____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 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 device

This device 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 Republic Act No. 9711

Medical mission

____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

Medicines

____refer to drugs in their appropriate dosage forms, with assured quality, safety and efficacy for humans or animals, or both;

Medical representative or professional service representative

___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

Nontraditional outlets

____refer to entities licensed by appropriate government agencies to dispense over-the-counter medicines based on an approved list

Online pharmacy services

_____refer to pharmaceutical services of a duly licensed pharmaceutical outlet done over the internet

Over-the-counter (OTC) medicines

____refer to medicines used for symptomatic relief of minor ailments and which may be dispensed without a prescription

Pharmaceutical establishments

____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 manufacturers

_____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 marketing

____refers to any activity undertaken, organized, or sponsored by a pharmaceutical establishment or outlet which is directed at promoting its product

Pharmaceutical outlets

____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 products

____refer to drugs, medicines, biologicals, pharmaceutical and biopharmaceutical products/specialties, veterinary products, veterinary biologies and veterinary medicinal products

Pharmacist

____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

- Certificate of Registration (COR)

- Professional Identification Card (PIC)

Pharmacist refers to a health professional who has been registered and issued a valid ____by the PRC and the Professional Regulatory Board of Pharmacy

PRC and the Professional Regulatory Board of Pharmacy

Pharmacist refers to a health professional who has been registered and issued a valid Certificate of Registration (COR) and Professional Identification Card (PIC) by the ___ and ___

Pharmacist-only OTC medicines

____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

Pharmacy aides

____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 assistants

_____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 technicians

____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

Section 39, Article IV

Pharmacy technicians 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 ___of this Act

Philippine Practice Standards for Pharmacists

____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

Physician's samples

____refer to medicines given to health professionals for promotional purposes only

Prescription/Ethical medicines

____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

Refilling of a prescription

_____refers to the act of dispensing the remaining balance of medicines ordered in the prescription

Referral

____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 registry

____refers to the record book maintained by pharmacists, listing the patients referred to different health facilities for further diagnosis

Refresher program

____refers to a prescribed study program in an accredited school of pharmacy

Telepharmacy services

____refer to pharmaceutical services of a duly licensed pharmaceutical outlet done through the use of telephone, teleconferencing, or facsimile