Pndp And Rdu Apr 12 08

Philippine National

Drug Program and

Relevant Laws

April 12, 2008

Pia C. Campo, RPh

Presentation Outline

I. Philippine National Drug Program and Rational Drug Use (RDU)

A. Relevant Terminologies

B. PNDP Framework and Rational Drug Use

C. Relevant Laws (Republic Acts)

II. PharmacologyA. Pharmacodynamics

B. Pharmacokinetics

C. Drugs

Relevant Terminologies

Drug� Chemical: diagnosis, attenuation, treatment/cure, or prevention of

disease� Produce only quantitative changes in the behavior of cells i.e., drugs

increase or decrease the:� magnitude,

� frequency, and

� duration of the normal activities of cells

� Never produce qualitative changes in cell behavior short of producing death of the cell, e.g., � a nerve cell cannot be made to contract

� a muscle cell cannot be made to secrete saliva


� Drug Product/Form

� Finished product containing the active ingredient with or without other inactive ingredients

� Dosage form

� Release active ingredient/s where they are intended

� Easier administration

� Patient acceptance

� Solid, liquid, gas, or combination of 2 or more

e.g., tablet, capsule, IV, syrup, etc.


� Generic Name/Terminology

�Scientifically & internationally recognized

active ingredient

�Official generic name by BFAD

�E.g.

� Paracetamol

� Mefenamic acid

Generic drug – a drug where patent has expired thus any company may produce it (patent: exclusive rights to produce a product).


� Chemical Name

� Chemical structure of

the drug

� Complete identification

of the compound

� E.g.

� Para-acetylaminophenol(Paracetamol)


Trade Name

� Business name

� Trademarks

� Brand names

� E.g.

� Biogesic – Paracetamol

� Garamycin opthalmic – Gentamycin sulfate

� Cozaar – Losartan potassium

PN

DP

Fra

mew

ork

(P-Q

-R-S

-T)

PE

OP

LE

EM

PO

WE

RM

EN

T

QUALITY ASSURANCE

RATIONAL DRUG USE

SELF-RELIANCE IN

DRUG MANUFACTURING

TAILORED PROCUREMENT

From Rational Drug Use (RDU) to HTA

Generics Act of 1988

-Generic prescribing

-Generic substitution

Early 90s: EO 49 Align procurement

w/PNDF

Problems w/RDU:

• Weak regulatory implementation, marketing, & comm. strategy

• Aggressive industry marketing

• Restricted decision-making opportunities for doctors

Creation of National

Drug Committee�

PNDF: Essential Drug

List

Middle 90’s: Evidence-based Medicine �Health Technology Assessment (HTA)

Consequences:

• Clinical practice guidelines

• Increasing use & importance of dis/incentives for prescribers (public & private sectors)

Middle 90’s: Evidence-based Medicine

HEALTH TECHONOLOGY

ASSESSMENT (HTA) PRACTICE

Relevant Laws

� RA 6675: Generic Drugs Act (1988)

� RA 8423: Traditional and Alternative Medicine Act (1997)

� RA 9165: Dangerous Drugs Act of 2002

RA 6675: Generic Drugs Act (1988)

� Generic name for essential drugs and promotional incentives

� Exclusive use of generic name in the manufacture, marketing, and sales of drugs and medicines

� Generic prescribing (brand name optional)

� Generic substitution

� Drug label: name and country of manufacture, dates of manufacture and expiration

� Medical, dental, veterinary: public & private sectors

Cheap Medicines Act contains a contested provision w/c has been withdrawn:

generic name only in prescribing drugs.

RA 8423: Traditional & Alternative

Medicine Act (TAMA 1997)

� Improve delivery of quality & delivery of health services

� Traditional and alternative health care & delivery system

� Indigenous societies: use of traditional medicine � acknowledgment & financial share



� Biomedicine� Scientifcally accepted� Allopathy/Western Medicine/Regular Medicine/Conventional

Medicine/Mainstream Medicine/Cosmopolitan Medicine

� Traditional and alternative health care� Other than those embodied in biomedicine

� Traditional medicine� Recognized by the people, not necessarily by the scientific

community � Based on culture, history, heritage, and consciousness



Herbal medicines� finished, labeled medicinal

products

� active ingredient/s: aerial or underground part/s of plant or other materials, or in combination (crude state or as plant preparations)

� may contain excipients but not combined with chemically-defined active substances



Natural product

� foods that grow spontaneously (tended or untended) in nature

� foods prepared from grains, vegetables, fruits, nuts, meats, fish, eggs, honey, raw milk, and the like

� without the use or addition of additives, preservatives, artificial colors and flavors, or manufactured chemicals of any sort after harvest or slaughter



� Alternative health care

modalities

� other forms of non-allopathic,

occasionally non-indigenous or imported healing methods

� e.g. chiropractic, acupressure, acupuncture, nutritional therapy,

reflexology massage

RA 9165: Dangerous Drugs Act (2002)

� Repealed RA 6425: DDA of 1972

� Provisions were added for drug education (focus on schools), rehabilitation

� Fines and penalty were increased: life imprisonment to death

� Provisions include how drugs can be reclassified

References:

Department of Health – Republic of the Philippines. (2006). Health policies and laws. Retrieved April 1, 2008 from http://www.doh.gov.ph/health_policies_laws/republic_act

Department of Pharmacology and Experimental Therapeutics –Boston University. (2007). Glossary of terms and symbols used in pharmacology. Retrieved April 1, 2008 from http://www.physpharm.fmd.uwo.ca/psc/resources/frame.ihtml?www=http://www.bumc.bu.edu/www/busm/pharmacology/Programmed/framedGlossary.html

Hartigan-Go, K. (2001) Rational drug use: from HTA to Policy the Philippine perspective. Retrieved April 1, 2008 from http://www.philhealth.gov.ph/qa/htaconference2004/download/HTA%20Day%201/PLENARY%20I/3%20RDU%20-%20Philippine%20Experience_GO.pdf

McKenry, L. M. and Salerno, E. (1998). Pharmacology in nursing, (20th ed.). USA: Mosby.

Economy & Finance

Pndp And Rdu Apr 12 08