Transcript A PRESENTATION ON NATIONAL DRUG POLICY AND SUPPLY …

A PRESENTATION
ON
NATIONAL DRUG POLICY AND SUPPLY CHAIN SRATEGIES
BY
JOYCE UGWU MRS
Deputy Director, Drug & Vaccine Development,
Federal Ministry Of Health, Abuja.
16TH APRIL 2008
INTRODUCTION
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First edition of NDP was adopted and
published in 1990 to address the
inadequacies in drug availability, supply and
distribution.
The NDP is a documentation of govt’s
commitment on drug issues of the country
It is the bedrock of all pharmaceutical
activities of the country.
BACKGROUND TO THE NDP
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Ineffective system of drug administration and control
Inadequate funding of drug supply and control
activities
High dependence on foreign sources for finished
drug products pharmaceutical raw mat., reagents
and finished products.
Inadequate facilities for storage, transportation and
distribution of drugs
Poor selection and procurement practices
Poor performance of drug suppliers
Background cont’d
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Involvement of unqualified people on
procurement and distribution and sale of
drugs
Poor capacity utilisation of the local drug
Manufacturing companies
Poor R&D activities, out comes and poor
input into pharmaceutical manufacturing
etc.
CURRENT CHALLENGES
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Self sufficiency in local production of essential drugs
Dev.strategy to ensure that 75% of essential drug
needs of the country is met by local production by
the year 2008.
Establishment of an effective drug procurement
system.
Evolving a well ordered drug distribution system.
Harmonizing and updating of drug legislation
Challenges cont’d
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Ensuring effective drug regulation and control
Entrenchment of and commitment to rational
use of drugs at all levels of health care
Development of viable R&D to support local
pharmaceutical industry
Harnessing the nations medicinal plant
resources.
Challenges cont’
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Develop plans for production pharm. raw
materials especially.
Develop plans for increased production of
ACTs and ARVs.
Make proposal for the development of the
petrochemical industry as a means of
obtaining pharm. raw materials.
Development of a national Pharmacopoeia
GOALS & OBJECTIVES
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To make available at all times to the Nigerian
populace adequate supplies of drugs that
are affordable, safe and of good quality
To ensure rational use of such drugs
To stimulate increased local production of
essential drugs
GOALS & OBJs CONT’D
NDP is to:
 Ensure efficient & effective drug mgt. in the
system.
 Ensure access to safe & good quality drugs (in
order to achieve MDGs 4 & 5.
 Strengthen Administrative, Legislative &
Regulatory
controls of importation, procurement, storage,
distribution, supply, sale and use of drugs.
Goals cont’
To promote pharmaceutical research and
development of raw materials for production ,
compounding & formulation of pharmaceutical
products.
 Promote research on herbal remedies and
integrate those found to be safe and
efficacious into the health care system.
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CHANGES SO FAR
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Establishment of NAFDAC
Establishment of NIPRD
Dev. EDL / NDF
Establishment of well over 150 local drug
manufacturing companies.
The involvement of Developmental Partners
e.g JSI, USAID etc
HOW POLICY IS OPERATIONALISED
BY STAKEHOLDERS:
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The FDS(FMOH) has the secretariat of the NDP.
Role includes:
Dissemination , Dev. of necessary guidelines,
Training, capacity building, M&E.
NAFDAC, PCN ensure regulatory aspect eg
Inspection , Registration etc. to ensure good quality
and efficacy of drugs as well as good pharmacy
practice.
NIPRD deals with the R&D aspect
How policy is operationalized by
stakeholders:
Procurement : The various Health programs
Procure drugs individually ie fragmentation of
procurement.
HIV/AIDS --ARVs
RBM
---ACTs
TB
---- Anti TB and OIs
Etc
1. HIV/AIDS programme
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Adult ARV Committee oversees selection of ARVs
ARVs are Procured (Adult and Paed) and stocked at FMC,
distributed to treatment sites by distribution agents.
National Guidelines on both Adult and Paed. ART
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1st edition 2004. Reviewed biannually.
Review of 1ST edition has been concluded by 2006. awaiting
printing.
Standard is WHO & review depends on WHO recommendation
based on treatment outcomes eg. Stavudine is almost being
replaced by zidovudine.
2.
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Roll Back Malaria
Malaria Case Management Committee MCMC
oversees drug selection for ACTs
Selection is in line with the National Anti Malaria
Policy developed in Line with WHO recommendation
ACTs purchased, stocked at FMC , distributed to the
facilities. Allocation system is applied in this case
Policy is supposed to be reviewed biannually based
on WHO recommendation.
Last reviewed in 2004
3.
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TB/Leprosy programme
Policy document is Worker Manual
Has List of anti TB/ drugs approved by a
committee set up by FMOH and WHO. List of
drugs is adapted from WHO guidelines
Committee Membership is drawn from FMOH
WHO ,ILEP partners ie GLRA, TLM, NLR.
USAID and others.
TB/Leprosy cont’d.
Workers Manual is supposed to be reviewed
every 3 years. Last edition was in 2004
 Review is on going, treatment outcome plays
Vital role e.g programme is planning to shift
from Ethambutol 400mg/ Isoniazid 150mg to
Rifampicin 150mg/Isoniazid 75mg
combination for continuation phase of
category 1 case because of high failure rate
with Ethambutol/Isoniazid combination.
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6.0 SUPPLY CHAIN STRATEGIES IN
THE NDP: TARGETS OF THE NDP
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Rational Drug Selection
Proper Quantification of Drug needs at all
levels of health care delivery.
Good & Effective procurement Practices.
Assurance of quality of drugs at all levels.
Appropriate warehousing &storage facilities.
Proper costing.
6.0
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SUPPLY CHAIN STRATEGIES
IN NDP. CONT’
Effective Distribution Of drugs.
Promotion of Local drug manufacturing.
Appropriate legislation
Product registration
Research & Development
Human resource development
Inventory Control
6.0. SUPPLY CHAIN STRATEGIES IN
THE NDP. Cont’
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Enabling environment
International cooperation & Donor
collaboration.
Proper accountability
Rational use of Drugs
Monitoring & Evaluation
SUPPLY CHAIN STRATEGIES IN
THE NDP. Cont’
Section 6.1
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Product selection
objectives:
Revised Essential Drugs List (EDL) listed by generic
or International Non-Proprietary Name (INN)
EDL updated every 4 yrs by EDL Review Committee
EDL used for procurement prescribing & dispensing
EDL used for production of STGs and National Drug
Formulary
Section 6.2:
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Quantification &
Procurement Criteria
Quantification by the Pharmacy Department (i.e. the Food &
Drug Services Dept of the Federal Min of Health)
Restricted to drugs registered in Nigeria and on the EDL
Open & transparent by competitive tender with the advice of
the Pharm Dept. Giving preference to local industry
Ensure drugs supplied are of good quality
Bulk purchase to ensure low prices.
Quality assessment before distribution
Section 6.5: Drug Warehousing and
Storage objectives:
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Ensure stock security
Maintenance of quality of drugs throughout
shelf life
Suitably located, constructed and equipped
storage facilities at every level of drug
distribution system.
Expired or deteriorated stock officially
destroyed within 6 months
Drug Warehousing objs cont’d
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FMS shall have QC labs
Regular checks on drugs
Appropriate cool and cold storage facilities in
the medical stores
Professional skill of the Pharmacist is
required for efficient operation of a drug store
i.e. Pharmacists should be in charge of drug
stores at all levels (Federal, State, LGA).
Section 6.5 & 6.6:
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Inventory Control
Central computerized inventory control
systems in the central stores at all levels
Computerization of inventory control systems
in hospital pharmacies and clinics
Section 6.6: Distribution Measures
Drug distribution, supply, sale and dispensing shall
be under the control of pharmacists
 All drugs purchased or donated to governments
channeled through CMS
 Adequate security provided for storage areas and
particularly for narcotic drugs
 Drug distribution channel shall be
Manufactures/ Importers – Wholesalers – Retailers.
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Section 6.7:
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Rational Product Use
Objectives
Up-to-date STGs and National Formulary
Prescribing by INN or generic names
Drug and Therapeutic Committees
established in all tertiary and secondary
health care institutions
Establishment of diagnostic services
appropriate to the level of care.
Section 6.15:
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Quality Assurance
GMP Monitoring by regulatory authorities to
ensure compliance with quality assurance
provisions.
Establishment of QC labs in strategic locatn’
Universities with appropriate facility to join in
assessment of drug quality.
Appropriate packaging by manufacturers to
ensure quality and stability of products.
Section 6.13 & 6.17:
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Enabling
Environment
Continue to strengthen NAFDAC,PCN for
enhancement of regulatory environment
Introduction of adverse drug reaction
reporting system (Pharmacovigilance) etc.
Section 6.24: International Cooperation &
Donor Collaboration
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Establishment and maintenance of
appropriate channels of communication
between drug regulatory and law
enforcement authorities
Use of diplomatic channels for exchange of
information on sub-standard and counterfeit
drugs in international commerce
Promoting the training of personnel and
human resource development.
Section 6.25: Monitoring, Evaluation &
Drug Mgt Information Systems
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Setting up of a National Drug Policy
Monitoring and Evaluation Unit in the FMOH
Institutionalising of drug management
information systems as a basis for deriving
drug management and other relevant
information for taking decisions
Monitoring of effect of TRIPS on Nigeria’s
access to Essential Medicines.
CONCLUSION
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The NDP has almost all the strategies
needed to develop a holistic logistics system
strategic plan for the country ( with stake
holders’ input).
We can improve on existing structures for the
strengthening of the system and invariably
enhance outcome.
THE END
THANK YOU