Legal Pharmacy & Ethics

Module 5: Legal Pharmacy & Ethics

• Jurisprudence is defined as a system of laws, representing the science or philosophy of laws.
• Jurisprudence ensures consistent decisions, actions, and protects pharmacists from liability by requiring knowledge of relevant laws.
• Ethics constitutes the science of morality, detailing moral principles of practice.
• Deriving from the Greek "ethos," ethics influences decisions and is concerned with individual and societal well-being. Moral philosophy.

Three Types of Law Systems

• Statutory Law is passed by the Senate or Congress, which dictates activities of persons and provides penalties for non-compliance (includes Republic Acts).
• Regulatory Law supports statutory law, created for proper regulation and implementation, including Administrative Orders, Executive Orders, Memorandum Circulars and Bureau Circulars.
• Common Law principle operates via Stare Decisis, allowing the state to decide and covers areas evolving over 100+ years of judicial decisions.

Universal Principles of Biomedical Ethics

• Autonomy entails respecting individuals' rights to make decisions affecting their lives, allowing patient choice free from deceit or coercion. Generics Act enables autonomy.
• Veracity obligates practitioners to be truthful and accurate, fostering trust even when truth causes distress, counseling of adverse effects.
• Beneficence requires healthcare team members to promote patient well-being, acting with mercy, charity and kindness. Encouraging to quit smoking.
• Non-maleficence dictates avoiding harm in treatment, embodied in the Latin phrase "Primum non nocere" first, do no harm.
• Dispensing altered or misbranded drugs to be avoided.
• Confidentiality respects privileged information, crucial for building trust in healthcare, patients have a right to consent.

Specific Acts & Laws mentioned

• RA 5921: Pharmacy Law (June 23, 1969)
• RA3720: Food, Drug, Devices, and Cosmetics Act (June 22, 1963)
• RA 6675: Generics Act (September 13, 1988)
• RA 7432: Senior Citizen Act of 1992 (April 23, 1992)
• RA 9257: Expanded Senior Citizen Act of 2003 (February 26, 2004)
• RA 9994: Expanded Senior Citizen Act of 2010 (February 15, 2010)
• RA 9165: Comprehensive Dangerous Drug Act of 2002 (June 7, 2002)
• RA 6425: Dangerous Drug Act of 1972 (April 4, 1972)
• RA 8423: Traditional and Alternative Medicine Act (TAMA) of 1997 (December 9, 1997)
• RA 8203: Special Law on Counterfeit Drugs (July 22, 1996)
• RA 7394: Consumer’s Act (April 13, 1994)
• RA 7581: The Price Act (May 7, 1992)
• RA 9502: Universally Accessible Cheaper and Quality Medicines Act of 2008 (June 6, 2008)
• RA 9711: FDA Act of 2009 (August 18, 2009)
• RA 10918: The Philippine Pharmacy Law (July 21, 2016)

RA 10918: The Philippine Pharmacy Law

• An act passed in July 21, 2016, that regulates and modernizes pharmacy practice, repealing R.A. No. 5921.

Article I: General Provisions & Objectives of RA 10918

• Standardizes and regulates pharmacy education, administers licensure, and integrates the pharmacy profession.
• Supervises/controls pharmacy practice and enhances competence via professional development and integration.

Section 4: Scope of Practice of Pharmacy

• Exclusive activities include compounding, dispensing, counseling, and teaching
• Physico-chemical and biological analyses, vaccine administration (with proper training and certification), and research are non-exclusive activities.
• Pharmacists must abide by standards like Philippine Practice Standards for Pharmacists, Good Laboratory Practice, Good Distribution Practice, Good Manufacturing Practice, and Good Clinical Practice.

Article II: The Professional Regulatory Board of Pharmacy

• Chairperson qualifications include being Filipino, unaffiliated with certain institutions, 5+ years membership in APO (PPhA), RPh or MS degree, no crime convictions, and 10+ years active practice.
• Ms. Adelina C. Royo is current chairperson. Members are Ms. Mildred B. Oliveros and Mr. Anthony Aldrin C. Santiago.
• The chairperson term lasts 3-6 years and can be suspended or removed for incompetence, crime involvement, or immorality.

Members of the Board Term of Office

• Office term is 3 years, with possible reappointment dependent on the President of the Philippines.

Article III: Examination, Registration, and Licensure

• Requirements: Filipino citizenship (or reciprocity agreement), internship, good moral character, and a Bachelor of Science in Pharmacy degree.
• Inorganic/Organic Pharmaceutical Chemistry, Qualitative/Quantitative Pharmaceutical Chemistry, Pharmacognosy/Plant Chemistry make up the scope of examination
• Pharmaceutical Biochemistry, Microbiology/Parasitology, and Physical Pharmacy are also a part of the scope of examination.
• Bio-pharmaceutics, Pharmacology/Toxicology, Manufacturing, Quality Assurance/Instrumentation, Pharmaceutical Calculations are tested with Drug Delivery Systems,
• Hospital/Clinical Pharmacy is tested, and Legal Pharmacy and Ethics are tested.

Pharmacist Licensure Examination: Important Details

• Held twice annually at PRC-designated locations as per R.A. No. 8981.
• Required: 75% general weighted average, with no subject below 50%.
• Third-time examinees must complete a refresher program before retaking, which requires certification or recommendation from university dean to take a 4th time
• Successful candidates take an Oath of Profession.

Certificate of Registration (COR) and Professional Identification Card (PIC)

• COR and PIC are issued upon meeting requirements and paying fees
• Must be 21 to receive PIC which lasts 3 years, and must be renewed.
• PIC contain: Registration number, dates of issuance/expiry, and signatures.
• Renewals every 3 years, requirements are COGS from APO and proof of 15 CPD units

Article IV: Regulation of Pharmacy Practice

• Licensed Pharmacists can use “RPh” title.
• Must display original COR in drug establishments
• The only ones who fill prescriptions (Rx) and dispense drugs.
• They ensure product safety, quality and efficacy.
• Membership must be maintained throughout practice.

Section 31: Pharmacist Establishments/Outlets

• Category A establishments require direct pharmacist control (drugstores, hospitals). Category B establishments require pharmacist supervision under laws.

Examples of A and B Categorization

• Category A includes retail of ethical Rx medicines, manufacture, or trade.
• Government and 1st-3rd class non-government organizations selling pharmaceutical products
• Category B includes Retail outlets selling household remedies and OTC drugs
• Category B also includes Satellite pharmacies for employees, municipal health units and non-traditional outlets.
• Category A pharmacists can work in Category B establishments under guidelines.

Article V: APO & PPhA

• Pharmacist automatically becomes a member of certified organizations upon registration and must receive benefits after fees are paid
• PPhA is the only integrated and accredited professional organization

Article VI: Violations, Sanctions, and Procedures

• Grounds for COR revocation/suspension of a registered pharmacist or to cancel a Sustainability and Transformation Partnerships (STP) include:
• Violations of practices & policies, and a Conviction of turpitude.
• Unprofessionalism, immorality, aiding illegal practices, fraud, deceit, addiction, and insanity.
• False advertisements, manufacturing/selling counterfeits, violating prohibited acts, and unauthorized or immoral conduct.

Penalties

• Penalties to be paid are between not less than ₱250,000.00- ₱500,000, plus 1-6 years imprisonment.
• Penalties to be paid are between not more than, ₱100,000.00-₱200,000.00, plus , 30 to 365 days in jail time to be served

Violations to be looked out for

• Owners are liable for the actions of pharmacists at establishment, with both subject to fines and suspensions.

RA No. 3720: "Food, Drugs, Devices & Cosmetics Act"

• Ensures purity and safety of items by vesting authority to the Bureau of Food and Drugs (BFAD) which is to administer rules for its enforcement

Declaration of Policies

• Government sets standards/measurements for items, proper supply, rational use, etc.

Creation of the Food and Drug Administration

• To carry out provision of this act. FDA is an agency is housed inside the Department of Health (DOH).

Powers, Duties, Responsibilities

• Administer/supervise implementation of this Act including collection of samples, testing.
• Analyze & inspect items, establish testing data to serve as a basis.
• Issuance of compliance certificates and collect fees.

Divisions of FDA Philippines

• Including inspection/licensing, laboratory which is regulated, food, cosmetics as well as devices.
• Administration, funding, field testing and legal support with regulatory enforcement.

FDA administrator info

• Led by, is head
• Appointed by the Secretary of Health

Section 7 of powers and duties

• Addressed as additional assistance for those in need

Prohibited Acts and Penalties

• Prohibition of a any false manufacturing, distributing, etc of any product labeled adulterated

Requirements for Application

• Proof that item is sound, composed well.
• List of contents, processing procedures and label sample

Certification

• Standards for providing appropriate quality of products for market

Other info

• Contains poisonous fluids and chemicals that are unauthorized.
• One must also have the capacity of identifying which item was made sound for use.

RA No. 9711

• Strengthens the Bureau of Food and Drugs (BFAD) renaming it the Food and Drug Administration (FDA).

Responsibilities of agency

• Protecting the general populations welfare and well- being.
• Creating sound items to distribute, and ensure honest operation.
• Administer the best performance

RA 3720 Director General

• To determine best help is provided to community
• Must have certification in different areas of study Both financial skill sets as well all previous mentioned

Prohibited Acts Section 11

What isn’t is the FDA approval Alter information Etc

Penalties

1-10yr prison limited 50,000−500,000-500,000−500,000 For a fine

Administrative Sanctions

Revocation of products sold Fine if P500k

Section 7 on FDA

• Possess pharmaceutical certifications Management experience also.

Section 10

-Illegal to transfer or sell non FDA approved items

RA 7581: The Price Act, Declaration of Basic Policy

• Developed to supply adequate protection for clients by managing illicit gain through set pricing.

Hoarding Defined

• This occurs if a person decides to procure items over usual requirements with zero availability for others at their disposal.

Cartel defined

• Is the grouping of producers that work cohesively to protect their personal revenue interest.

Unlawful situations and stipulations: Section 6

Disaster areas or a state of calamity are enforced with the writ of habeas corpus An area is in a state of rebellion

Conditions Warranted

• Effect if an urgent circumstance A widespread impact of illicit price

Determination of Price Ceilings

Exchange rate Costs of transports

Penalty for Acts of Illegal Price Manipulation:

Penalty of imprisonment to serve 5-15 years Also must impose a fine over 2M

Section 11

Lists all positions inside of this branch of official.

RA No. 9994

• It recognizes rights to aid any person of older age or disability

Section 2

• The provision of assistance with the government and private sector is to be sustained to increase the economic and social wellbeing to be improved

What Can Be Provided

• Tax breaks to those unable to provide sustenance at the poverty level.
• Aid on costs of medication, professional and health provisions from those in such roles. Free aid on what they do best to provide to their clients

Benefit Requirements

• Must provide info such as Passports Citizenship etc

Procedures

• Office will be established for their service

Goals of those with authority

• To aid any senior citizen to their fullest extent.

Penalties

Those not providing senior living assistance will be punished whether a 3rd party person/organization. Life-time jail time, must be of sound mind.

RA 9165: Institutions and articles

• Institutions are supported by this which implement what its best interests are. Implement methods on protecting any personal well- being and the provision of any drug dependencies with safety or sustenance and well being thought their communities.

Information provided

• Dangerous Drug Board- implements and controls illegal or illicit activity with any potential or current user.

The people in control

• The leader will serve a 6 yr shift This will include other leaders as well ranging from a 2-4yr period also. 12 members 2 regular members

Unlawful Acts & Penalties

• Harsh and brutal penalties will enforced.