National Drug Policy and Supply Chain Strategies, April 16, 2008

							             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 6.1          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

   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




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