LEGAL AND ETHICAL CONSIDERATION IN DISPENSING IN THE PHILIPPINES

RA 1091 - Philippine Pharmacy Act

RA 6675 - Generics Act of 1988

RA 9994 - Expanded Senior Citizen Act of 2010

RA 8203 - Special law on Counterfeit drug 

RA 9165 - Comprehensive Dangerous Drugs act of 2002 

Enumerate the Law

Prescription 

The written order and instruction of a validly registered authority for the use of a specific drug product for a specific patient 

Dispensing 

The act by a registered pharmacist of filling the prescription or a prescriber’s order

Generic Name 

Identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their officiall names as determined by FDA 

Generic Prescribing

Prescribing drugs or medicines using their generic names or generic terminology

Generic dispensing 

Dispensing the patient’s/buyer’s choice from among generic equivalent, e.g. finished pharmaceutical products having the same active ingredient, same dosage form and same strength as he prescribed drug 

RA 10918 - Philippine Pharmacy Act

An act regulating and modernizing the practice of pharmacy in hte philippines, repealing for the purpose

Pharmacy Law

RA. No. 5921 otherwise known as the

July 21, 2016

When did RA 10918 Lapsed into law?

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.

FDA

No pharmaceutical product, of whatever nature and kind, shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public, except through a retail drug outlet duly licensed by the.

emergency cases

twenty-four (24) hours after the occurrence of the emergency

Prescription drugs and pharmacist-only OTC medicines shall be dispensed only by a duly registered and licensed pharmacist, except in ____, where the services of a registered and licensed pharmacist are not available: Provided, that a report shall be made to the supervising pharmacist within_____  so that product recording in the prescription books can be done.

current Good Manufacturing Practice

Philippine Practice Standards for Pharmacists

Compounding and dispensing shall be done only by duly registered and licensed pharmacists, in accordance with_____, laboratory practice, ____and dispensing guidelines

refuse

A registered and licensed pharmacist may____ to compound, dispense or sell drugs and pharmaceutical products, if not in accordance with this Act and the abovementioned standards

Completely filled prescriptions

should be surrendered to the pharmacist for recording

Partial filling of prescription

less than the total quantity indicated in the prescription shall be allowed, subject to dispensing guidelines as provided in the immediately preceding paragraph

Physician's Sample

Pharmaceutical products given or intended to be given free to any health professional by a manufacturer or distributor or its professional service representative as part of its program or promotion shall not be sold to any pharmaceutical outlet or the consuming public.

antimicrobials, including anti-TB medicines

Physician's Sample

Pharmaceutical products classified as ______ and other classifications of medicines, as may be prescribed by the FDA, shall not be given or distributed as physician's samples

Auxiliary labels

containing special pharmacists' instructions for the patient shall be required as prescribed for dangerous drugs, external-use-only drugs, drugs with special storage and administration instructions and such other drugs as may be required by law

Dangerous Drugs Book

Republic Act No. 9165

All required information on dangerous drugs dispensed by a pharmacy shall be recorded in the ____or an equivalent recording system as required by____and other applicable laws and issuances

less than two (2) years

Recording of Patient Medication Profile

+ It shall be open for inspection by the representatives of the Board or the FDA, or both, at any time of the day, when the pharmacy is open, and must be kept for a period of not____after the last entry

tuberculosis

Referral Registry

All referrals such as ____patients undertaken by the pharmaceutical outlets shall be recorded in the ___ and shall be open for inspection by the Board, or representative of the Department of Health (DOH) or the FDA, or both, at any time of the day when the pharmacy is open, and must be kept for a period of not less than two (2) years after the last entry

REPUBLIC ACT NO. 6675

GENERICS ACT OF 1988

An act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names

September 13, 1988
Former Pres: Corazon C. Aquino

RA 6675 was approved when? and Signed by?

Essential Drugs List

In the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the ____

two (2) newspapers

The Department of Health shall publish annually in at least ____ of general circulation in the Philippines the generic names, and the corresponding brand names under which they are marketed, of all drugs and medicines available in the Philippines.

Government Health agencies and their personnel

All medical, dental, and veterinary practitioners including private practitioners 

Who shall use generic terminology?

name and country of manufacture

dates of manufacture

expiration

RA 6675

Provision on Quality, Manufacturer's Identity and Responsibility

The label of all drugs and medicines shall have the following:

RA 9994 - Expanded Senior Citizen Act of 2010

An act granting additional benefits and privileges to senior citizens, further amending republic act no. 7432, as amended, otherwise known as "an act to maximize the contribution of senior citizens to nation building, grant benefits and special privileges and for other purposes

republic act no. 7432

An act granting additional benefits and privileges to senior citizens, further amending _____, as amended, otherwise known as "an act to maximize the contribution of senior citizens to nation building, grant benefits and special privileges and for other purposes

Approved: Feb 15, 2010

Former Pres. Gloria Macapagal-Arroyo

RA 9994 is approved when and signed by?

sixty (60) years old.

RA 9994 is applicable to any resident citizen of the Philippines at least

20% discount

VAT exemption 

Give the Privileges of Senior citizen

RA 8203 - Special law on Counterfeit drugs 

An act of prohibiting counterfeit drugs, providing penalties for violations and appropriating funds therefor

Approved: September 4, 1996

Former Pres. Fidel V. Ramos

RA 8203 is approved when and signed by?

medicinal products with the correct ingredients but not in the amounts as provided

wrong ingredients

without active ingredients

Active ingredient are less than 80% of the API it purports to possess

Enumerate some characteristics of Counterfeit drug or medicine 

RA 9165 - Comprehensive dangerous durg act of 2002

An act instituting the comprehensive dangerous drugs act of 2002, repealing republic act no. 6425, otherwise known as the dangerous drugs act of 1972, as amended, providing funds therefor, and for other purposes

republic act no. 6425

dangerous drugs act of 1972

An act instituting the comprehensive dangerous drugs act of 2002, repealing _____, otherwise known as the ____, as amended, providing funds therefor, and for other purposes

Approved: June 7, 2002

Former Pres. Gloria Macapagal-Arroyo

RA 9164 is approved when?

The penalty of life imprisonment to death and a fine ranging from Five hundred thousand pesos (P500,000.00) to Ten million pesos (P10,000,000.00

For selling, trading, administration, dispensing, delivery, distribution and transportation of dangerous drugs, including any and all species of opium poppy, what is the punishment?

The penalty of imprisonment ranging from

Imprisonment:

• twelve (12) years and one (1) day to twenty (20) years

fine ranging:

• P100,000.00 to P500,000.00

For selling, trading, administration, dispensing, delivery, distribution and transportation of dangerous drugs, for any controlled precursor and essential chemical what is the penalty?

The penalty of imprisonment ranging from

Imprisonment of:

• twelve (12) years and one (1) day to twenty (20) years

Fine:

• P100,000.00 to P500,000.00

dditional penalty of the revocation of his/her license to practice

Prescribers who shall prescribe any dangerous drug to any person whose physical or physiological condition does not require the use or in the dosage prescribed what is the penalty?

Over-the-counter (OTC) medicines

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

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

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

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;

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;

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