persp laws

Ethics

The moral principles that govern a person's behavior. The
"should we?" question; Focuses on Patient welfare, integrity, confidentiality, professional competence.

Law

A system of rules created and enforced through social or
governmental institutions. The "must we?" question; Focuses on Mandatory compliance, legal consequences, standard of care.

intersection

Ethical practice often exceeds legal requirements.

Fiduciary Duty

The pharmacist's primary obligation is to the patient's well-
being.

Code of Ethics for Pharmacists

Codified by the Professional Regulation
Commission (PRC) and PPhA.

RA 10918: Philippine Pharmacy Act of 2016

The cornerstone law that modernizes the practice of pharmacy in the Philippines. It repealed the old Pharmacy Law (RA 5921).

Scope of Practice (RA10918)

Defines the acts constituting the practice of pharmacy
(e.g., drug compounding, dispensing, patient counseling, drug information, inventory control).

Licensure Examination (RA10918)

Mandates passing the national licensure exam administered by the PRC.

Continuing Professional Development (CPD)

Requires licensed pharmacists to complete CPD units for license renewal.

Pharmacy Ownership

Stipulates that a pharmacy must be owned by a Filipino citizen and managed by a licensed pharmacist.

pharmaceutical care

Emphasizes the pharmacist's role in ensuring safe and
effective drug therapy outcomes.

RA 6675 (Generics Act of 1988)

To promote, require, and ensure the use of generic terminology for drugs.

Mandatory Use of Generic Names

All government health agencies and practitioners must use
generic names in prescriptions.

dual labeling

Drug manufacturers must indicate the generic name in boldface letters and above the brand name.

Information Dissemination

Requires the conduct of information campaigns on generic drugs.

RA 9165 (Comprehensive Dangerous Drugs Act of 2002)

To safeguard the public from the dangers of dangerous
drugs through an integrated and comprehensive approach.

Custody and Dispensing

Strict regulations on the purchase, storage, dispensing, and
recording of controlled precursors and essential chemicals.

S2 license

Pharmacists and pharmacies must secure a special S2 license from the Philippine Drug Enforcement Agency (PDEA) to handle dangerous drugs.

Prescriptions Requirement

Strict rules on the validity of prescriptions (e.g., must be written in triplicate, valid for only 30 days).

Reporting

Mandatory reporting of any diversion, theft, or loss to the PDEA.

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

Strengthened the FDA as the regulatory body for health products, including drugs, cosmetics, and devices. Ensures safety, efficacy, and quality.

RA 8423 (Traditional and Alternative Medicine Act (TAMA) of 1997)

Recognizes the role of traditional and alternative medicine; pharmacists may handle approved herbal products.

RA 11223 (Universal Health Care Act)

Expands healthcare coverage; pharmacists play a role in ensuring access to affordable medicines within the national formulary.

RA 10173 (Data Privacy Act of 2012)

Mandates the protection and confidentiality of patient health information.

Professional Regulation Commission (PRC) - Board of Pharmacy

Administers licensure exams, issues licenses, and enforces the Code of Ethics.

Philippine Drug Enforcement Agency (PDEA)

Leads the enforcement of the Dangerous Drugs Act.

Food and Drug Administration (FDA)

Registers drugs, monitors safety, and licenses drug establishments.

Philippine Pharmacists Association (PPhA)

The accredited integrated professional organization (AIPO) for pharmacists. Advocates for the profession and provides CPD.

Consequences of Violations

administrative, Criminal, Civil

Administrative

Reprimand, fines, suspension, or revocation of professional license (by PRC); closure of pharmacy (by FDA/PDEA).

Criminal

imprisonment, depending on the severity of the offense
(e.g., illegal sale of dangerous drugs, falsification of records).

Civil

Liability for damages caused to a patient due to negligence or malpractice.