Drug Development and Ethical Considerations
Core Ethical Principles
Core ethical principles
Respect for persons
Components:
(a) Autonomy- right to self determination
(b) Informed Consent- right to be informed and that participation is
voluntary
Beneficence
(a) Risk-benefit ratio- physical, psychological, and social risks must be
identified and weighed against the benefits
Justice- Selection of research subjects be fair, reflect all social classes
and racial and ethnic groups.
Phases of Pharmaceutic Research
Pre-clinical trials - determine a drugs toxic and pharmacologic effects through
in vitro and in vivo
Human clinical experimentation
Phase I - Researcher test a new drug in a small group of people to
evaluate its safety.
Phase II - Given to a larger group to see if it is effective and further
evaluate its safety.
Phase III - Given to larger group to determine its effectiveness and side
effects
Phase IV -Assess side effects associated with long term use
Clinical research study design
Independent variable - treatment
Dependent variable - clinical outcome
Selected Drug Standards
and Legislation
Selected drug standards and legislation
Drug standards
Food and Drug Administration
(a) Good manufacturing practice standards (GMP) - Pharmaceutical
manufacturers must comply with GMP to ensure that drugs are
consistently produced and controlled according to quality standards.
This includes proper facilities, equipment, and quality control
processes.
(b) Philippine National Drug Formulary (PNDF) - The PNDF is a list
of essential medicines that are considered safe, effective, and
affordable for public health. It serves as a guide for healthcare
providers in prescribing drugs and for the government in procuring
medicines.
Selected Drug Standards
and Legislation
(c) Pharmacovigilance and Post marketing Surveillance- This standard ensures
that all approved drugs are monitored for safety and efficacy even after they have
been released into the market. Manufacturers are required to report adverse drug
reactions to the FDA.
(d) Bioavailabilty and Bioequivalence Requirements - For generic drugs to be
approved, they must meet bioavailability and bioequivalence standards to ensure
Christine Genevieve B. Rivera, RM, LPT, MAN
Subject Instructor
that they are therapeutically equivalent to branded drugs. This ensures that
generics perform the same way in the body as their branded counterparts.
(e) Labeling and Packaging Standards - Drugs in the Philippines must adhere to
strict labeling guidelines, which include the proper identification of the generic
name, expiration date, batch number, dosage instructions, and warning labels.
Packaging must also ensure the integrity and stability of the drug.
Selected Drug Standards
and Legislation
Selected drug standards and legislation
Philippine Legislation
RA 3720 (Food, Drug, and Cosmetic Act)
Regulation of drug registration, manufacturing, importation, and
distribution to protect public health.
RA 6675 (Generics Act of 1988)
Promotes the use of generic medicines by mandating that generic
names must appear on all prescriptions, advertisements, and labels.
RA 9502 (Cheaper Medicines Act of 2008)
RA 9711 (FDA Act of 2009)
RA 8203 (Special Law on Counterfeit Drugs)
Selected Drug Standards
and Legislation
RA 9502 (Cheaper Medicines Act of 2008)
Aims to make quality medicines more affordable and accessible to all
Filipinos.
RA 9711 (FDA Act of 2009)
Strengthens the regulatory capacity of the Food and Drug Administration
(FDA) in ensuring the safety, efficacy, and quality of drugs and other health-
related products.
RA 8203 (Special Law on Counterfeit Drugs)
Protects public health by penalizing the manufacture, sale, and distribution
of counterfeit drugs
Combat Drug Counterfeiting
Counterfeit drugs
May contain incorrect ingredients
May have insufficient amounts of active ingredients
May have no active ingredients
May contain impurities and contaminants
May be distributed in fake packaging
Role of nurse
Consumer education
Drug Names
11
Chemical names
describes the chemical structure
EXAMPLE: N-(4-hydroxyphenyl)acetamide
4-chloro-N-furfuryl-5-sulfamoylanthranilic acid
(RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid
Generic names
the official nonproprietary name for the drug
EXAMPLE: ibuprofen, furosemide, paracetamol
Brand/trade names
Christine Genevieve B. Rivera, RM, LPT, MAN
Subject Instructor
proprietary name, is chosen by the drug company and is usually a registered
trademark
EXAMPLE: Advil, Lasix, Biogesic
Over-the-Counter Drugs
OTC drugs
Found to be safe and appropriate for use without direct supervision of health
care provider
Available without a prescription
In 2002, FDA standardized OTC labeling
Provide consumers with information
Describes benefits and risks with OTC drug
Drug Resources
Philippine National Drug Formulary (PNDF)
An official list of essential medicines recognized by the Department of Health
(DOH). It provides information on safe, effective, and affordable drugs for
healthcare providers.
Food and Drug Administration (FDA) Philippines Website
The FDA provides up-to-date drug advisories, product registrations, and recalls.
It is a valuable resource for checking the status of pharmaceutical products and
their approval for use in the [Link] Letter
Philippine Drug Enforcement Agency (PDEA)
PDEA offers information related to controlled substances, ensuring that
healthcare providers are informed about the legal use and distribution of drugs
that are subject to abuse or misuse.
MedlinePlus: [Link]/medlineplus/druginformation
Drug Resources
MIMS Philippines (Monthly Index of Medical Specialties)
A widely used drug reference guide that provides comprehensive information on
drug indications, dosing, contraindications, interactions, and side effects.
Available both in print and digital [Link] and Drug Administration (FDA)
Philippines Website
The Philippine Pharmaceutical Directory (PPD)
A reference book that provides details on drugs available in the Philippines,
including their brand names, generic names, formulations, indications, and
prices.
Drug Price Reference Index (DPRI)
Published by the Department of Health, the DPRI provides a standardized list of
drug prices to guide healthcare providers and patients on the fair price of
medications in the country.
Christine Genevieve B. Rivera, RM, LPT, MAN
Subject Instructor