INTRODUCTION

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

2. 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.

3. 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

4. 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.

5. 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

6. 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.

7. 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

8. 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

9. 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.

10. 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.

11. 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

12. 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

13. 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

14. 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.

15. 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

16. 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.

17. 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.

18. 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.

19. 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

20. 6.0. SUPPLY CHAIN STRATEGIES IN THE NDP. Cont’ • Enabling environment • International cooperation & Donor collaboration. • Proper accountability • Rational use of Drugs • Monitoring & Evaluation

21. 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

22. 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

23. 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

24. 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).

25. 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

26. 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.

27. 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.

28. 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.

29. 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.

30. 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.

31. 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.

32. 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.

33. THE END THANK YOU