Legal Pharmacy and Ethics

Module 5: Legal Pharmacy and Ethics - Introduction

• Jurisprudence is a system of laws and the science of philosophy of law.
• It is crucial for pharmacists to make decisions consistent with legal principles, avoiding liability.

Ethics

• This is the science of morality with the moral principles of practice.
• It affects how people make decisions and is concerned with what is good for individuals and society.

Three Types of Law System

• There are 3: statutory, regulatory, and common law.

Statutory Law

• Passed by the Senate or Congress.
• It dictates activities and provides penalties for non-compliance, such as the Republic Acts.

Regulatory Law

• Supports statutory law and regulates/implements it using tools like Administrative Orders.

Common Law

• Based on the principle of Stare Decisis, a policy where courts stand by precedent.
• Common law covers areas evolved over 100 years of judicial decision.

Universal Principles of Biomedical Ethics

• These include autonomy, veracity, beneficence, non-maleficence, confidentiality, justice, and role fidelity

Autonomy

• Involves respecting a patient's right to choose and decide on issues affecting their life.
• It's a form of personal liberty, free from deceit or coercion.
• For example: let patients choose brands following the Generics Act (RA 6675)

Veracity

• Is the obligation to be truthful and honest with patients.
• It binds practitioners and patient in an association of truth and accuracy.
• Healthcare professionals should not withhold the whole truth, even when it causes distress.
• For example: counsel on possible adverse medication effects.

Beneficence

• It is the duty to promote what is good for the patient
• It includes acts of mercy, charity, and any actions benefiting the sick
• For example: counseling patients, encouraging them to quit smoking, doing seminars on disease prevention, and choosing the safest medication.

Non-Maleficence

• This involves ensuring treatments do not injure or harm
• "Primum non nocere" means "first, to do no harm."
• For example: Pharmacists should advise prescribers to stop harm medications and avoid dispensing adulterated products, according to RA3720.

Confidentiality

• It protects the right to privacy and requires health care professionals to protect patients' private information.
• It means safeguarding patient data, prescriptions, and medication profiles, respecting this privacy during counseling.

Justice

• Involves fairness and equal treatment.
• This means offering the same treatment options to all patients and allocating resources equally.

Role Fidelity

• Practitioners should practice faithfully within the constraints of their role

Key Pharmacy Laws

• RA 5921 (Pharmacy Law of 1969)
• RA 3720 (Food, Drug, Devices, and Cosmetics Act of 1963)
• RA 6675 (Generics Act of 1988)
• RA 7432 (Senior Citizen Act of 1992)
• RA 9257 (Expanded Senior Citizen Act of 2003)
• RA 9994 (Expanded Senior Citizen Act of 2010)
• RA 9165 (Comprehensive Dangerous Drug Act of 2002)
• RA 6425 (Dangerous Drug Act of 1972)
• RA 8423 (Traditional and Alternative Medicine Act (TAMA) of 1997)
• RA 8203 (Special Law on Counterfeit Drugs)
• RA 7394 (Consumer’s Act)
• RA 7581 (The Price Act)
• RA 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008)
• RA 9711 (FDA Act of 2009)
• RA 10918 (The Philippine Pharmacy Law)

The Philippine Pharmacy Law (RA 10918)

• This regulates and modernizes pharmacy practice
• It standardizes pharmacy education, administers licensure exams, regulates pharmacy practice in the Philippines, promotes pharmacist competence, and integrates the profession.

Scope of Pharmacy Practice

• Exclusive activities: compounding, dispensing, counseling, and teaching.
• Non-exclusive activities: physico-chemical analyses, vaccine administration (with training), and research.
• Pharmacists must adhere to current standards like Philippine Practice Standards, Good Laboratory etc..

Professional Regulatory Board of Pharmacy

• The chairperson must be a Filipino citizen, unaffiliated with any learning institutions
• Must be an APO member, RPh or MS degree holder, not convicted of a crime, and has 10 years active pharmacy practice
• The head is Ms. Adelina C. Royo, members are Ms. Mildred B. Oliveros, and Mr. Anthony Aldrin C. Santiago.
• The term is 3-6 years.
• Causes for removal include: incompetence, criminal involvement, immorality

The Board Term of Office

• Term of Office: 3 years
• Members may be reappointed by the President.

Licensure Exam Requirements

• Applicants must be Filipino, or from a country with reciprocity, has internship, is of good moral character and holds a BS Pharmacy degree.

Scope of the Exam

• Inorganic/Organic Pharmaceutical Chemistry (20%).
• Qualitative/Quantitative Pharmaceutical Chemistry.
• Pharmacognosy and Plant Chemistry/Pharmaceutical Biochemistry(15%).
• Microbiology/Parasitology (15%).
• Physical Pharmacy/Biopharmaceutics (17%).
• Pharmacology Toxicology (15%).
• Manufacturing.
• Quality Assurance/Instrumentation (15%).
• Pharmaceutical Delivery and Calculations.
• Hospital and Clinical Pharmacy(17.5%).

Pharmacist’s Rights and Responsibilities

• They can affix "RPh" behind their name.
• Display original COR conspicuously.
• Only they can fill, compound, and dispense Rx and pharmacist-only OTC medicines.
• They ensure pharmaceutical products meet safety/quality standards.
• and must maintain APO membership

Pharmacist Requirement

• Category A Establishments: requires direct pharmacist control, whether in-store or online like drugstores and hospitals
• Category B Establishments: needs pharmacist supervision as required by law.
• Category A includes pharmaceutical outlets selling prescription/ethical meds, combo products, devices and drugs, pharmacist-only OTC medicine.

The Integrated and Accredited Professional Organization

• Registered pharmacists are automatically part of the organization, receiving benefits upon payment of fees.

Philippine Pharmacists Association

• National organization is registered with the SEC, recognized by Board of Pharmacy and PRC.

Sanctions

• Upon notice and hearing, the Board holds the power to revoke/suspend the COR of a pharmacist.

Reasons for Suspension

• Violations of policies, convictions of moral turpitude, unprofessionalism, immorality, malpractice, dishonesty, abetting the illegal practice, mental disorders, false advertisements.
• Other activities include sale of counterfeit drugs, illegal manufacture, violation of labeling laws, online dispensing.

Penalties

• For the above offenses, the possible sentence is a fine (not less than ₱250,000) and/or imprisonment (1-6 years).

Penalties for Other Violations.

• A potential fine amount not less than ₱100,000 and/or imprisonment of up to 1 year may be sought.
• The owner, operator, and other staff may all be held jointly accountable for any deliberate breaches of this regulation.

The Food, Drug, Devices & Cosmetics Act (RA 3720)

• This act ensures FDDC safety, purity, efficacy, and quality, granting authority to and enforcing those laws.

Government’s Roles

• Establish standards for FDDC
• Secure safe FDDC supply.
• Ensure rational FDDC like banning drugs.
• Strengthen Food and Drug Bureau

Food and Drug Body

• It carries out the law.
• Has its place inside Health Department, under health secretary.

The FDA’s Duties

• Administer and monitor rule application.
• Collect FDDC samples.
• Analyze and check FDDC.
• Make FDDC standards for identity, cleanliness etc.
• Give compliance certification.
• Charge fees to test goods.

FDA Divisions

• Inspection and Licensing and lab sections
• Centers deal products: medications, food, cosmetics and devices, regulating their production, imports, promotion, audits, research

FDA Centers Division:

• Licensing and Registration, Research and Standards, and laboratories for testing.

FDA Administration and Finance

• This includes a human resource department, management of property, and assets and finance divisions

FDA Office

• Includes communication divisions and monitors center success in research.

FDA Field

• Field Regulatory Operations, which consists of branch offices, labs, and enforcement units.

FDA Legal

• FDA provides its entire service from its center.

Section 6

• The administrator is the leader of it
• They are picked by the Secretary, Rolando DPBO.

Section 7

• The secretary can get more workers

Chapter VI

• This chapter is on bans.

Illegal Acts

• Selling or transferring of dangerous, misbranded goods
• Doing the acts of misbranding, adulteration
• Disallowing the collection, entry, or inspection
• Faking a safety guarantee
• Spreading secrets
• Shifting labeling
• Applying items falsely
• Importing and exporting unregistered drugs

How to Report Violations

• People need to be reporting to the FDA

Fines

• Potential range of ₱5,000 up to the ₱10,000 zone

Drug Regulation Standards

• All operations must receive authorization by filing.
• Evidence will be given, showcasing drug safety.
• Also component/ingredient listing, procedures used is required.

Antibiotic Drugs

• For some drugs, a certification is granted

Violating the FDA

• Illegally sold narcotics, products from unhygienic environment

Adultered Chemicals

• Some materials could have been prepared or packed in insanitary setups.

Misbranded Materials

• Illegally labeled products are out in circulation

Violative

• A product bearing unapproved, misleading info is put up.

Report the FDA

• If you noticed any questionable activity happening, alert the FDA

List of Administrative Orders (AOs)

• AO 42: Drug regulations
• AO 4: compassion permit
• AO 27: Licensing vaccine building firm
• AO 55: Regulation of label
• AO 56: PNDF adoption.

Policy

• The rule is supposed to show what items bear standard qualities after it's all listed.
• AO 302 Reorganizing BFAD.
• AO 15 Exemption-pharmacist hour regulations.
• AO 17 Pharmacist Monitoring Hours.
• AO 62: The guidelines on prescriptions requirements
• AO 63: Dispensing requirements

Product Regulation

• AO 67: registering medicinal things.

Medical Act

• It will amend the previous acts to ensure that the law meets and exceeds the standards and requirements with health concerns.

Cheaper Medicine Act

• It means easier to afford quality medication for all

Policy

• Quality over all medication matters to those without extreme expense for the people

Construction

• Rules are applied for the safety of health standards, they support the promotion of medicine.

Price Regulations

• Only health secretaries determine how high medicine fees are, with approval needed

The Health Secretary’s Functions of RA 9502

• These were now being able to set maximum values on medicines.
• They impose fines, for all medicines, from people, or businesses.

Drugs Lists

• Drugs are classified as those which improve pregnancies/health and such, needing regulation.

Price Displays

• President determines pricing, to keep everything under the approved numbers.
• All must list product price to make purchases for affordable items

Republic Act No 8203

• It ensures legal drugs and funds the act, if someone markets counterfeit substances.

Prohibitions

• Making harmful pharmaceutical items
• Also fake substances
• Forging is illegal

List of Penalties

• Prison if rules are broken

Organization of the board

• DD Board will plan the project

The PDEA enforces the same acts

• With directors selected to push the program further