national drug policy

NATIONAL DRUG POLICY

DHANYA.O.G2010-09-114

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

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 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.

GOALS & OBJECTIVES

To make available at all times at adequate level , affordable rate , good quality and in safely manner

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. 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.

HOW POLICY IS OPERATIONALISED BY STAKEHOLDERS:

FEDERAL MINISTRY OF HEALTH (FMOH) has the secretariat of the NDP

Role includes: Dissemination , Dev. of necessary guidelines, Training,

capacity building, M&E.National Agency for Food and Drug Administration and

Control (NAFDAC), PCN(Primary Care Network ) ensure regulatory aspect eg. Inspection , Registration etc.

to ensure good quality and efficacy of drugs as well as good pharmacy practice.

National Institute for Pharmaceutical Research and Development ( NIPRD )-deals with the R&D aspect

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.

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

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’

Product selection

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(standard treatment

guidelines) and National Drug Formulary

Quantification & Procurement Criteria

Quantification by the Pharmacy Department (i.e. the Food & Drug Services Dept of the Federal Min of Health)

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

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

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

Inventory Control

Central computerized inventory control systems in the central stores at all levels

Computerization of inventory control systems in hospital pharmacies and clinics

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(case management committee)

Adequate security provided for storage areas and particularly for narcotic drugs

Drug distribution channel shall be Manufactures/ Importers – Wholesalers – Retailers.

Rational Product Use

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.

Quality Assurance

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.

Enabling Environment

Continue to strengthen NAFDAC,PCN for enhancement of regulatory environment

Introduction of adverse drug reaction reporting system (Pharmacovigilance) etc.

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.

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 access to Essential Medicines.

THE END

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