A PRESENTATION ON NATIONAL DRUG POLICY AND SUPPLY CHAIN STRATEGIES BY JOYCE UGWU MRS Deputy Director, Drug & Vaccine Development, Federal Ministry Of Health, Abuja. 16 TH 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 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 – 1 st edition Reviewed biannually. – Review of 1 ST edition has been concluded by 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