pndp and rdu apr 12 08
TRANSCRIPT
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
Relevant Terminologies
� 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.
Relevant Terminologies
� 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).
Relevant Terminologies
� Chemical Name
� Chemical structure of
the drug
� Complete identification
of the compound
� E.g.
� Para-acetylaminophenol(Paracetamol)
Relevant Terminologies
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
RA 8423: Traditional & Alternative
Medicine Act (TAMA 1997)
� 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
RA 8423: Traditional & Alternative
Medicine Act (TAMA 1997)
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
RA 8423: Traditional & Alternative
Medicine Act (TAMA 1997)
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
RA 8423: Traditional & Alternative
Medicine Act (TAMA 1997)
� 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.