R.A. 10918 Flashcards by Marah Joy M. FLORES

Title of RA 10918

An Act Regulating and Modernizing the Practice of Pharmacy in the Philippines, Repealing for the purpose RA 5921), Otherwise knowns as the Pharmacy Law.

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What section is the objectives?

Section 3

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Philippine Pharmacy Act govern the:

Education
Licensure examination, registration of the practice of pharmacy
CPD, research, related activities
Integration of pharmacy profession

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What section is the scope of the practice of Pharmacy?

Section 4

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Prepare, compound or manufacture, preserve, store, distribute, procure, sell, or dispense, or both, any pharmaceutical product or its raw materials;

Exclusive/Non-Exclusive

Exclusive

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Render services, such as clinical pharmacy services, drug information services, regulatory services, pharmaceutical marketing, medication management, or whenever the expertise and technical knowledge of the pharmacist is required; or

Exclusive/Non-Exclusive

Exclusive

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Chemical, biological or microbiological analyses and assay of pharmaceutical products, food/dietary supplements, health supplements, and cosmetics;

Exclusive/Non-Exclusive

Non-Exclusive

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Engage in teaching scientific, technical, or professional pharmacy courses in a school or college of pharmacy;

Exclusive/Non-Exclusive

Exclusive

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Physico-chemical analyses for medical devices used in aid of administration of pharmaceutical products;

Exclusive/Non-Exclusive

Non-Exclusive

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Administration of adult vaccines as approved by the Food and Drug Administration (FDA): Provided, That they shall undergo the training on the safe administration of adult vaccines and management of adverse event following immunization (AEFI) for pharmacists and hold a certificate of training issued by an institution duly accredited by the Professional Regulation Commission (PRC); Provided further, That the safe administration of vaccines be part of
the higher education curriculum for pharmacists;

Exclusive/Non-Exclusive

Non-Exclusive

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Dispense pharmaceutical products in situations where supervision of dispensing of pharmaceutical products is required;

Exclusive/Non-Exclusive

Exclusive

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Provide other services where pharmaceutical knowledge is required.

Exclusive/Non-Exclusive

Exclusive

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Conduct or undertake scientific research in all aspects involving pharmaceutical products and health care;.

Exclusive/Non-Exclusive

Non-Exclusive

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What section is definition of terms

Section 5

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the duly integrated and accredited professional organization of registered and licensed pharmacists, of which there shall be only one

Accredited professional organization (APO)

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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

Adulterated/Deteriorated pharmaceutical products

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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

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

Brand name

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the 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

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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)

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pharmaceutical products which:
a) do not contain the amounts as claimed;
b) with wrong ingredients;
c) without active ingredients; or
d) with insufficient quantity of active ingredients, which result in the reduction of the products’ safety, efficacy, quality, strength, or purity.

Counterfeit pharmaceutical products

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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

Counterfeit pharmaceutical products

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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

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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

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the end date when the manufacturer can guarantee that a product possesses its daimed potency, efficacy, quality, and safety; after which its sale or distribution is prohibited

Expiration date

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

Filling

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

Generic name

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

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

Label

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

Medical device

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

Medicines

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

Online pharmacy services

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

Over-the-counter (OTC) medicines

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

Pharmaceutical marketing

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

Pharmaceutical products

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

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

Refilling of a prescription

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

Telepharmacy services

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

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

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

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

Pharmacy technicians

Creation of the Professional Regulatory Board of Pharmacy

Section 6

Professional Regulatory Board of Pharmacy is composed of:

Chairperson and 2 members

Section 7

Qualifications of the Chairperson and Members of the Board

Qualifications of the Chairperson and Members of the Board:

•Citizen of the Philippines 5 yrs •Duly registered & licensed pharmacist, preferable masteral •Active practitioner for 10 yrs •No crime •Good standing 5yrs •Must not be a member of administrative officer nor connection in review center

Powers, Functions, and Responsibilities of the Board

Section 8

Powers, Functions, and Responsibilities of the Board:

a) Prepare licensure examination questions, score, and rate the examinations and submit the results thereof to the PRC. b) Regulate and monitor the practice of pharmacy in the Philippines c) Promulgate and prescribe the Pharmacists' Code of Ethics, Code of Technical Standards and Guidelines for the Professional Practice of the Pharmacy Profession, in coordination with the APO d) Investigate cases arising from violations of this Act e) Issue and promulgate guidelines on CPD, in coordination with the APO

Section 9

Term of Office of the Members of the Board

Term of Office of the Members of the Board:

3 yrs of term Reappointed for 3 yrs but not more than 6 yrs

Section 11

Grounds for Suspension or Removal from Office of the Chairperson or Member of the Board

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.

Section 14

Qualifications for the Licensure Examination

Qualifications for the Licensure Examination:

a) A citizen of the Philippines or of a foreign country which has a law or policy on reciprocity for the practice of the pharmacy profession; b) Of good moral character and reputation; c) A degree holder of Bachelor of Science in Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of learning in a foreign country duly recognized by the CHED; and d) Has completed an internship program approved by the Board, pursuant to such guidelines as may hereinafter be promulgated, in consultation with the duly recognized associations of pharmacy schools and the CHED.

Documentary Requirements:

1. PSA Birth Certificate 2. PSA Marriage certificate 3. Certificate of Good Moral Character 4. NBI clearance 5. Transcript of Records 6. Certificate of completion of the Internship program 7. Other documents

Section 16

Holding of examination

Holding of Examination:

PLE given 2x a yr by PRC

Section 17

Greetings in the licensure examination

Waiting is in the licensure examination:

GWA: 75% w/ no <50% in any subjects 3x failed, take refresher program in duly accredited institution (ensure certificate of completion in refresher program) to have 3 more opportunities.

Section 19

Oath of Profession

Oath of Profession:

Oath of profession prior to entering practice of pharmacy profession

Section 20

Issuance of certificate of registration and professional identification card

COR shall bear:

Registration number Date of issuance Signatures of chairperson PRC and members of the board Stamped with official seals of the prc and of the board ... Professional identification card to be renewed every 3 yrs

Section 21

Foreign Reciprocity