A REVIEW

On

NATIONAL DRUG POLICY

By

EKEOCHA, LAWRENCE EJIKE

COURSE: HEALTH POLICY PLANING AND MANAGEMENT

COURSE CODE: MPH 822

LECTURED

By

PROF OSEMWOTA
 A REVIEW ON NATIONAL DRUG POLICY
INTRODUCTION
National drug policy refers to the way in which a country regulates the availability, quality and
use of drug. It is aimed at improving the health of the people. Drug includes any substance or mixture of
substances manufactured, sold or advertised for use in the diagnosis, treatment, mitigation or prevention
of any disease disorder, abnormal physical state, or the symptoms thereof, in man or in animals;
restoring, correcting or modifying organic functions in man or in animals; disinfection, or the control of
vermin, insects or pests; or contraception.
The National Drug Policy (NDP) came into inception in 1990. Its objectives were geared
towards annihilating inadequacies in drug availability, supply and distribution which were a product of
an ineffective system of drug administration and control; Inadequate funding of drug supply and drug
control activities; High dependence on foreign sources for finished drug products, pharmaceutical raw
materials, reagents and equipment; Inadequate facilities for storage, transportation and distribution of
drugs; Poor selection and procurement practices; The involvement of unqualified persons in
procurement, distribution and sale of drugs; Poor performance of drug suppliers to public health care
institutions; and Lack of government involvement to provide safe, efficacious and good quality drugs to
meet the health needs of Nigerians. Some important development recorded after its commencement
includes the following: Publication of an Essential Drugs List (EDL) and a National Drug Formulary
(NDF); the establishment of a statutory agency with responsibility for drug administration and
control(National Agency for Food and Drugs Administration and Control, NAFDAC), and; The
introduction of drug registration procedures.
NDP Focuses more on local production of essential drugs, develop an effective drug
procurement system, create a standard drug distribution system, functional, efficient and effective drug
legislation, The effective control of drug advertisement and promotion, The entrenchment of and
commitment to rational use of drugs at all levels of health care, and drug research and development.
Policy revision gives a platform for assessment and improvement of areas which requires urgent
attention and therefore requires judicial implementation to achieve it set goals.

GOALS AND OBJECTIVES OF THE NATIONAL DRUG POICY

The goals of the national drug policy banks on providing safe, effective, affordable and standard
drugs such that theses drugs are easily accessible to the Nations populace when needed. The goal is also
aimed at optimizing local production of essential drugs. The objectives of the policy are to ensure
efficient and effective drug management in the public and private sectors; To ensure access to safe,
effective, affordable and good quality drugs at all levels of health care on the basis of health needs; To
promote the rational use of drugs by prescribers, dispensers and consumers; To increase local drug
manufacture/production and promote export; To ensure that all drugs in the national drug distribution
system are safe, efficacious, effective and of good quality; To strengthen administrative, legislative, and
regulatory controls of the importation, manufacture, procurement, storage, distribution, supply, sale and
use of drugs; To promote research on herbal remedies and integrate those found to be safe and
efficacious into the health care system; To promote pharmaceutical research and development of raw
materials for the production, compounding and formulation of pharmaceutical products, as well as
operational research for the effective implementation of the National Drug Policy; and To enlist
government commitment at all levels for the achievement of the goals and objectives of the National
Drug Policy.
 TARGET OF THE NATIONAL DRUG POLICY
Targets are important measures aimed at monitoring and evaluating the implementation of the
drug policy. Targets are set towards achieving:- Total adherence to the use of the Essential Drugs List in
public health institutions Production of National Standard Treatment Guidelines (STGs) for all levels of
the health care system; adherence to good drug procurement practices in the public sector;
Entrenchment of a rational and properly structured drug distribution system in the private sector
targeted publication of prices of essential drugs; Availability of adequate drug storage conditions in the
public and private health care sectors; Proper disposal of expired, deteriorated and sub-standard drugs in
all health care facilities; Establishment of appropriate storage and quality control laboratories at
designated ports of entry and export of drugs Establishment of fully equipped and adequately staffed
laboratories in strategic locations of the country for more effective quality assurance of drugs and
pharmaceutical products in Nigeria; Establishment in every public health care delivery institution at the
federal, state, and local government levels properly operated drug revolving fund schemes with distinct
bank accounts, transparent drug procurement procedures and mechanisms to check diversion of the fund
for other purposes; Total compliance with national guidelines on drug donations; Increase in local
production capacity; increase awareness of the concept of rational use of drugs by prescribers,
dispensers and consumers; Inclusion of the Rational Use of Drugs Concept and the National Drug
Policy Issues in the curricula of all health professional schools and continuing education programmes;
increased adherence to the rational use of narcotics and antimicrobials; Institutionalization of functional
Drugs and Therapeutics Committees and drug information centers in secondary and tertiary health
facilities; Publication of a list of all medicines in the Nigerian market in three categories, namely
prescriptions only, pharmacy only, and general sale; Awareness of appropriate self-medication practices
by the population; Establishment of well-equipped national and zonal pharmaco-vigilance centers and
achievement of reporting of adverse drug reactions; Total compliance of all drug promotion and
information with national regulations; Annual publication of registered drugs; Provision of funds to
satisfy to research needs; Publication of a Nigerian Pharmacopoeia, incorporating a list of effective
herbal medicines; Enactment of a reviewed and harmonized drug legislation in Nigeria;
Commencement of harmonization of drug laws in the ECOWAS sub-region; Full integration of the drug
management aspects of all Ministry of Health programmes; 60% compliance with the use of EVDL,
VDF, SVTG in veterinary practice.

THE NATIONAL DRUG POLICY IMPLEMENTATION STRATEGIES

The strategies for implementation of the drug policy focuses on effective drug management
processes, such as rational drug selection, proper quantification of drug needs at all levels of health care
delivery and effective procurement practices; assurance of high quality of drugs at all levels, appropriate
storage, cost effectiveness and proper and distribution of drugs, promotion of local drug manufacture,
appropriate legislation, product registration, research and development, human resources development,
monitoring and evaluation, accountability and rational use of drugs by health workers and consumers.
To ensure satisfactory policy implementation, there is need for government at all level to employ the
expertise of personnel (such as the Pharmacists) equipped with the technical-know-how to carry out its
functions. The tools employ in the implementation of NDP includes Procurement Of Drugs, Selection
Of Drugs, Drug Revolving Fund Scheme, Pricing Policy, Drug Storage, Drug Distribution, Rational
Drug Use, Regulations For Prescribing And Dispensing Drugs, Pharmacovigilance, Drug Information
And Promotion, Drug Financing And Affordability, Research And Development, Drug Research And
Development And Operational Research, Herbal And Other Traditional Remedies, Human Resources
Development, Control Of Veterinary Drugs, Donated Drugs, Local Drug Production, Registration Of
Drugs, Patents, International Cooperation, Monitoring And Evaluation.
The selection process is a strategy that aims at the creation of a national list of drugs
rationally chosen to satisfy the health care needs of the majority of the population. To this
effect a revised Essential Drug List is published by the Federal Ministry of Health and
made available to health professionals, state and local governments, primary, secondary
 and tertiary health institutions. The Essential Drug List Review Committee is mandated to
update the list every four years, making Suggestions for amendment writing on a
prescribed form to the Federal Ministry of Health, justifying each suggested amendment.
New drugs are only added to the list if sufficient scientific and clinical data are available
to show that they offer distinct advantages over existing ones. Drugs on the list for which
information becomes available that they no longer have a favorable risk/benefit ratio are
to be withdrawn and replaced with safer alternatives. This List is necessary for the
procurement of drugs and their application in the public sector; prescribing drugs in the
public sector; drug information to health care providers; the production of Standard
Treatment Guidelines and a National Formulary; reimbursements on drugs in the National
Health Insurance Scheme.
The procurement process is a major determinant of the safety, efficacy, quality,
affordability and availability of drugs. Its objective is to provide drugs on the basis of
relevant information, need and available resources. The criteria hover within the premises
of Government adherence to good pharmaceutical procurement practices in the public
sector; restriction to drugs registered in Nigeria and on the Essential Drugs List;
Procurement by International Non-Proprietary Names (INN) or generic names only, the
public sector; implementation by openness, transparency and competition; patronization
of locally manufactured drugs; accurate quantification of drug and; quality assessment
before distribution to dispensing units. As stated in NDP, under procurement of drugs,
there is need, to consult the pharmacy Department for advice, before the procurement
process is carried out. The pharmacy department is also saddled with the task of carrying
out qualitative assessment.
The Drug Revolving Fund Scheme is a very effective strategy for ensuring uninterrupted
drug supply in the health care delivery system. The objective is aimed at providing
effective and transparent fund management; Provision of adequate capital for the
procurement of required drugs; Ensuring strict accountability for the drugs provided in the
system; Empowering the head of the pharmacy department of the health institution as the
custodian of drugs to the institution.
The objective of price policy is to ensure affordability of drugs in public health
institutions.
The drug storage strategy is geared towards ensuring stock security and the maintenance
of the quality of drugs throughout their shelf life. Therefore Suitably located, constructed
and equipped storage facilities are to be made available by the government at every level
of the drug distribution system, in both public and private sectors which should be
overseen by Pharmacists. Central Medical Stores and stores in both public and private
health care facilities are to be properly managed to avoid expiration and deterioration of
shelved drugs. However, any stock of expired or deteriorated drugs should be officially
destroyed within six months; Central Medical Stores should have Quality Control
Laboratories for quality assessment of drugs, inventories are to be taken; need for the
installation of a temperature regulating system in the stores, to keep the temperature at
20oC for the sustenance of the shelf life of drugs. In respect of vaccines and biological
products they shall provide appropriate cold storage for the maintenance of the shelf life
of such vaccines and products; Government at all levels shall ensure the establishment of
central computerized inventory control systems in the central stores for effective drug
management; and Government shall encourage the computerization of private drug stores
for effective inventory control.
Drug distribution involves the Control and Registration of drug distribution activities.
Two channels of drug distribution are identified which are private sector channel of drug
distribution and public sector channel of drug distribution. The former, shows a flow from
the manufacturers or importers to the wholesalers and retailers. While the later, shows a
flow from the purchase point to the Central Medical Stores. Control measures are to be
tackle using an inventory control system also providing adequate security for storage
areas, particularly, narcotic drugs.
 The rational use of drugs requires that patients receives medications appropriate for their
clinical needs in doses that meet their own requirements for an adequate period of time
and at the lowest cost to them and their community(WHO). According to the policy, the
requirements for rational drug use are that the right drugs should be used for the right
indications in the right dose and dosage form for the right duration. Factors that result in
irrational use of medicine cut across the healthcare system, prescribers, dispensers,
patients and the community at large. The objective of rational prescribing is to ensure that
drugs are prescribed rationally. In this case the policy seeks to address the prescriber and
state the need for the prescriber to be updated with the current drug information. The
policy, also, introduces the need for the prescription of drugs using their International
Non-Proprietary Names (INN) or generic names and the appropriation of health care
facilities and diagnostic services. The policy on rational dispensing aims to ensure that
patients receive adequate information on the use of dispensed drugs in order to derive the
desired benefits. Drug information is intended to provide unbiased, scientifically
validated drug information to promote rational prescribing, dispensing and use. The
policy is also aimed ensuring that all health personnel involved in the diagnosis,
prescription and dispensing of drugs, as well as consumers, receive adequate theoretical
and practical training in rational drug use. Drugs and therapeutics committees through this
policy are set to ensure that drugs are prescribed rationally.
Legislation is the instrument by which the implementation of a drug policy is given a legal
basis by statutorily defining the various strategies for achieving the objectives of the
policy. It also defines the qualifications, duties, privileges, and obligations of individuals,
organizations, institutions, and other bodies concerned with the implementation of the
various strategies of the policy, and provides for sanctions in the event of violations. For
the effective implementation of legislation, there is need to review and update the relevant
laws regularly, in consultation with relevant stakeholders, in order to achieve the desired
objectives.
Effective inspection of drug products and manufacturing facilities is critical to ensuring
the quality, safety and efficacy of drugs. It is also necessary in order to ensure compliance
with the statutory requirements relating to the storage, supply, distribution and sale of
drugs, etc.
A substantial proportion of drugs consumed in Nigeria are imported, while the export of
drugs from the country is insignificant. The National Drug Policy seeks to promote
self-reliance in national drug consumption, as well as, the contribution of the local
pharmaceutical industry to the national economy through exportation. The overall
objective is to ensure that the import and export activities in regard to drugs are effectively
regulated so that all products, whether imported or exported, meet the required standards
of quality, safety and efficacy.
The aim of quality assurance of a drug product is to ensure that the drug provided to the
patient is safe, efficacious and of good quality. The process of quality assurance begins
from the manufacturer and continues to the point of administration of the drug to the
patient. Compliance with Good Manufacturing Practices (GMP) is an important
component of quality assurance.