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A PRESENTATION ON NATIONAL DRUG POLICY AND SUPPLY CHAIN SRATEGIES BY JOYCE UGWU MRS Deputy Director, Drug & Vaccine Development, Federal Ministry Of Health, Abuja . 16 TH APRIL 2008. INTRODUCTION.

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A PRESENTATIONONNATIONAL DRUG POLICY AND SUPPLY CHAIN SRATEGIESBY JOYCE UGWU MRSDeputy Director, Drug & Vaccine Development, Federal Ministry Of Health, Abuja.16TH APRIL 2008

introduction
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
SUPPLY CHAIN STRATEGIES IN THE NDP. Cont’

Section 6.1 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 quantification procurement criteria
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
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
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
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
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
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
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
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
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
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
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
THE END

THANK YOU