a presentation on national drug policy and supply chain strategies by joyce ugwu mrs deputy...
TRANSCRIPT
A PRESENTATION
ON
NATIONAL DRUG POLICY AND SUPPLY CHAIN STRATEGIES
BY
JOYCE UGWU MRS
Deputy Director, Drug & Vaccine Development,
Federal Ministry Of Health, Abuja.
16TH APRIL 2008
INTRODUCTION
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
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
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
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
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’
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
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.
CHANGES SO FAR
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:
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
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
– 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. 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. 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.
6.0 SUPPLY CHAIN STRATEGIES IN THE NDP: TARGETS OF THE NDP
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 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’
Enabling environment International cooperation & Donor
collaboration. Proper accountability Rational use of Drugs Monitoring & Evaluation
SUPPLY CHAIN STRATEGIES IN THE NDP. Cont’
Section 6.1Product 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: 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:
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
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: 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.
Section 6.7: 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: 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: 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
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
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
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