Legal and Ethical Considerations in Dispensing Pharmacy

Philippine Pharmacy Act of 2016

RA 10918 and its IRR (Implementing Rules and Regulations)

PRC Modernization Act of 2000

RA 8981

Administrative Order No. 220 1974

adopted the World Health Organization (WHO) Guidelines on GMP for pharmaceutical and biological products

Administrative Order No. 55 1989

rules and Regulations Governing the Accreditation of Laboratories Performing HIV Testing

Administrative Order No. 56 1988

- Revised Regulations for the Licensing of Drug Establishments and Outlets which covers imported processed food products

Dispensing Prohibition

Administrative Order No. 64 1989 - prohibits the dispensing of identified Foods, Drugs, Devices and Cosmetics without prescription

Registration of Pharmaceutical Products

Administrative Order No. 67 1989 - Revised Rules and Regulations on Registration of Pharmaceutical Products

Medical Examinations for Seafarers

Administrative Order No. 85 1990 - all medical examinations of seafarers applying for STCW (Standard of Training, Certification, and Watchkeeping) Certificate shall be performed in an accredited medical clinic or hospitals

Labeling Requirements

Administrative Order No. 99 1990 - outlines new labeling requirements for pharmaceutical products containing 4 or more active ingredients

Continuing Professional Development Act

RA 10912: CPD (Continuing Professional Development) Act of 2016

Philippine Practice Standards for Pharmacist

PhilPSP

Food, Drug and Cosmetic Act

RA 3720: Food, Drug and Cosmetic Act of 1963

FDA Act

RA 9711: Food and Drug Administration (FDA) Act of 2009

Traditional and Alternative Medicine Act

RA 8423: Traditional and Alternative Medicine Act of 1997

Generics Act

RA 6675: Generics Act of 1988

Universally Accessible Medicines Act

RA 9502: Universally Accessible Cheaper and Quality Medicines Act of 2008

Price Act

RA 7581: Price Act of 1992

Consumer Act of the Philippines

RA 7394: Consumer Act of the Philippines of 1992

Expanded Senior Citizens Act

RA 9994: Expanded Senior Citizens Act of 2010

Comprehensive Dangerous Drugs Act

RA 9165: Comprehensive Dangerous drugs act of 2022

Anti-Drug Campaign Strengthening

RA 10640: An act to further strengthen the anti-drug campaign of the government, amending for the purpose Section 21 of RA 9165

Special Law on Counterfeit Drugs

RA 8203: Special Law on Counterfeit Drugs of 1996

Labeling of Hazardous Substances

PD 881: Regulate the labeling, sale and distribution of hazardous substances (1976)

Milk Code

EO 51: Milk code 1986

Salt Iodization Act

RA 8172: An act for salt iodization nationwide (ASIN) of 1995

RA 9211

Tobacco Regulation Act of 2003

Food Fortification Act

RA 8976: Philippine Food Fortification act of 2000

Pharmacy Law 5921

An act regulating the practice of pharmacy and setting standards of pharmaceutical education in the Philippines and for other purposes, which was approved on June 21, 1969.

Dispensing Definition

Under the Philippine pharmacy act of 2016 or RA10918, Dispensing refers to the sum of processes performed by a pharmacist from reading, validating and interpreting prescription; 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 prescription or medication order.

Prescription Medicines

This shall be dispensed only with a valid prescription of licensed practitioners including physician, dentists, or veterinarians.

Emergency Dispensing

This shall be dispensed only by the licensed pharmacist except in emergency cases when a pharmacist is not available.

Prescription Clarity

Prescription shall be clear and complete and shall be referred to the prescriber in case of clarification on the content by the pharmacist on duty to ensure patient medication safety.

Substitution of Medicines

Prescription shall not be substituted for other medicines, substances, or ingredients without prior consultation with and written consent of the person prescribing.

Generic Substitution

Generic substitution shall be done in accordance with RA 6675.

Pharmacist Only OTC Medicines

OTC medicines available only through pharmacist advice.

Compounding

Preparation of personalized medications by pharmacists.

Dispensing

Process of providing prescribed medications to patients.

Medication Review

Assessment of medication appropriateness and safety.

Patient Medication Counseling

Guidance on medication use and precautions.

Licensed Pharmaceutical Establishments

Authorized outlets for selling pharmaceutical products.

Category A Pharmaceutical Outlet

FDA licensed to sell prescription and POM medicines.

Pharmacist Responsibilities

Ensure safe dispensing and patient counseling.

Adverse Events Reporting

Notify FDA of medication errors or reactions.

Prescription Filling

Only pharmacists can fill prescriptions directly.

Auxiliary Labels

Additional labels for warnings on dangerous drugs.

Patient Medication Profile

Record of patient's medication history and prescriptions.

Dangerous Drugs Record

Special log for dispensing controlled substances.

Online Pharmacy Regulations

Must be licensed to operate legally.

Generics Act of 1988

Promotes affordable generic drugs in the Philippines.

Generic Dispensing

Providing patients with generic drug options.

Generic Equivalent

Drugs with identical active ingredients and dosage.

Drug Outlet Requirements

Must inform patients of available generics.

Hospital Pharmacy Policies

Patients choose between hospital or external drugs.

Prescription Book Record

Keep filled prescriptions for two years.

Dispensing Prohibited Drugs

Strict rules for handling controlled substances.

Violations by Dispensers

Failure to comply with dispensing regulations.

FDA Labeling

Generic names must be indicated on labels.

Partial Filling of Prescriptions

Allowed only for specific circumstances.

Pharmaceutical Product Safety

Ensure all products meet safety and quality standards.

Storage Practices

Guidelines for safe storage of medications.

Good Manufacturing Practice

Standards for quality in drug production.