THE PHILIPPINE EXPERIENCE IN IMPLEMENTING ESSENTIAL DRUGS PROGRAMME: Problems encountered and future

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THE PHILIPPINE EXPERIENCE
IN IMPLEMENTING
ESSENTIAL DRUGS PROGRAMME
Problems encountered
and future plans
Prof. Estrella Paje-Villar, M.D.
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PHILIPPINE NATIONAL DRUG FOMULARY (PNDF) OR
ESSENTIAL DRUGS LIST
A basic component of the National Drug Policy
which seeks to bring about the availability of
safe, effective and quality drugs at affordable
cost
An important step to rationalize drug production,
distribution, procurement and consumption
Mandated by RA 6675 otherwise known as the
Generics Act of 1988
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PROCESS OF PNDF FORMULATION
Consultations and Participatory
1. National Formulary Committee (NFC) formerly
National Drug Committee (NDC) makes draft list
based on specific criteria using inputs from WHO,
NDIC, DOH, PMA, PSECP, other specialty and
subspecialty societies, pharmaceutical industry
and latest Philippine Health Statistics. 2.
Distribution of NFC draft list to resource
persons and experts through the Deans of Medical
Schools and Specialty and Subspecialty Societies,
for written reactions/comments/position paper
based on evidence gathered. 3. Series of
deliberation meetings with resource persons/
experts for further discussion and presentation
of evidence 4. Submission of final NFC draft list
to the Secretary of Health for
final approval.
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CRITERIA FOR PNDF DRUG SELECTION
1. Efficacy, safety and quality 2. Relevance to
diseases found in the Philippines 3. Preferential
factors for therapeutically equivalent drugs 3.1
Favorable benefit/ risk ratio 3.2 Thoroughly
investigated and extensive clinical
experience 3.3 Favorable pharmacokinetic
properties
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CRITERIA FOR PNDF DRUG SELECTION
3.4 Stability under anticipated local
conditions 3.5 Cost-effectiveness and/ or
reliable local manufacturing
facilities 4. Formulated as single active
ingredient. FDC drugs must satisfy requirements
of AO 96 s1990
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CRITERA FOR DELETION OF DRUGS FROM PNDF
1. A more effective or equally effective but less
toxic drug becomes available 2. In the light of
new developments, the therapeutic efficacy is
found to be unsatisfactory or questionable 3.
Toxicity/ suspected toxicity, potential for abuse
or dangerous drug interactions prove to outweigh
its therapeutic value
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CRITERA FOR DELETION OF DRUGS FROM PNDF
4. The drug has fallen into disuse and is no
longer available 5. The drug is no longer
deemed cost-effective to other therapies 6. A
fixed dose combination drug which does not
satisfy the requirement of AO s1990
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CRITERIA FOR INCLUSION OF ADDITIONAL DRUGS
1. Essential for the prevention and treatment of
conditions not adequately covered in the current
PNDF edition 2. More effective and/ or less toxic
than a drug listed for the same indication 3. As
effective and safe and of lower cost than a drug
listed for the same indication. 4. Essential for
a specific DOH health program/ project
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All interested parties proposing inclusion or
deletion of any drug in the PNDF are required to
submit an evidence table to justify the proposal.
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EVIDENCE TABLE shall include
1. Title/ author/ year/ journal 2. Study
design 3. Participants description 4.
Intervention
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EVIDENCE TABLE shall include
5. Results/ outcome 5.1 Events (including
adverse events) 5.2 Treatment group -
number of events - total number of
patients 5.3 Control Group - number of
events - total number of patients 6. Grade
of evidence
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PROBLEMS ENCOUNTERED
1. Devolution of health services to the local
governments without supervision from DOH 2.
Limited dissemination of PNDF vol. I and vol.
II 3. Resistance of physicians specially from the
private sector to what they claim is a
restrictive list 4. Aggressive promotion of
drugs by pharmaceutical companies 5. Aggressive
advertisement of OTC drugs
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PROBLEMS ENCOUNTERED
6. Concern about the quality of drugs in the
market 7. Weak support from the professional
organizations 8. Weak monitoring and
implementation inadequate BFAD manpower to
monitor drug outlets 9. No enforcement of law and
penalty for violators 10. Waning commitment of
leaders and NGOs
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STEPS/ STRATEGIES TAKEN TO ADDRESS PROBLEMS
1. AO 51 s1988 on implementing guidelines for
DOH compliance with RA 6675 (Generics Act of
1988) 2. AO 107 s2000 reconstituting and
strengthening of Therapeutics Committees 3.
Philippine Commission on Audit - non-approval of
procurement of drugs outside of PNDF 4. EO 49
s1993 mandating all government institutions to
use PNDF as basis for drug procurement 5.
Philippine Health Insurance Corporation (Phil
Health) Memo Circular 29 s1999 to all
accredited professionals and
institutional providers
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PLANS FOR THE FUTURE
1. Regular more frequent updating of PNDF vol. I
and vol. II 2. Wider dissemination of PNDF
vol.I and vol.II 3. Strict implementing of the
provisions of EO 49 s1993 in the devolved
hospitals and private hospitals. 4. Strict
implementation of Phil Health Memo Circular 29
s1999
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PLANS FOR THE FUTURE
5. Seminar/ workshops and other forms of
education campaign 6. Integration of Essential
Drug Concept in school curricula 7. Promote
social climate and social responsibility among
the community on the availability of quality and
affordable drugs/ medicines
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Thank You