The maiden National Drug Policy (NDP) for Nigeria was adopted and launched in 1990 against the background of inadequacies in drug availability, supply and distribution resulting from various factors, such as:
• 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; an
• Lack of political will to provide safe, efficacious and good quality drugs to meet the health needs of Nigerians.
The policy was formulated with laudable goals and objectives intended to address the unsatisfactory situation at that time. Its adoption was seen as a positive development by observers. After over a decade of its adoption and implementation, some modest progress has been recorded. These include the 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, and the introduction of drug registration procedures. However, much more still remains to be done in many areas, such as the realisation of self-sufficiency in local production of essential drugs, the establishment of an effective drug procurement system, evolving a well-ordered drug distribution system, the harmonisation and updating of 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 etc. The revision of the Policy presents an excellent opportunity for formulating new strategies, for consolidating achievements in areas where progress has been recorded, and addressing those areas that call for more positive action. It is hoped that with judicious implementation of the revised policy, as laid out in the accompanying implementation plan, the Nigerian people will have sustainable access to safe, efficacious and good quality drugs.
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;
GOALS OF THE NATIONAL DRUG POLICY
The goals of the policy shall be to make available at all times to the Nigerian populace adequate supplies of drugs that are effective, affordable, safe and of good quality; to ensure the rational use of such drugs; and to stimulate increased local production of essential drugs.
OBJECTIVES OF THE NATIONAL DRUG POICY
The objectives of the policy are:
i. To ensure efficient and effective drug management in the public and private sectors;
ii. To ensure access to safe, effective, affordable and good quality drugs at all levels of health care on the basis of health needs;
iii. To promote the rational use of drugs by prescribers, dispensers and consumers;
iv. To increase local drug manufacture/production and promote export;
v. To ensure that all drugs in the national drug distribution system are safe, efficacious, effective and of good quality;
vi. To strengthen administrative, legislative, and regulatory controls of the importation, manufacture, procurement, storage, distribution, supply, sale and use of drugs;
vii. To promote research on herbal remedies and integrate those found to be safe and efficacious into the health care system;
viii. 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
ix. To enlist government commitment at all levels for the achievement of the goals and objectives of the National Drug Policy.
TARGETS OF THE NATIONAL DRUG POLICY
The implementation of the NDP shall be directed towards accomplishing the following targets:
- Establishment of a National Drug Policy Monitoring and Evaluation Division in the Food and Drugs Services Department of the Federal Ministry of Health by the year 2005;
- Total adherence to the use of the Essential Drugs List in public health institutions by 2008;
- Production of National Standard Treatment Guidelines (STGs) for all levels of the health care system by 2006 and 80% adherence by 2008;
- 80% adherence to good drug procurement practices in the public sector by 2008;
- Entrenchment of a rational and properly structured drug distribution system in the private sector by 2008;
- 90% of targeted publication of prices of essential drugs by 2005;
- Availability of adequate drug storage conditions in 80% of the public and private health care sectors by 2008;
- Proper disposal of expired, deteriorated and sub-standard drugs in 60% of public and private care health facilities by 2008;
- Establishment of appropriate storage and quality control laboratories at designated ports of entry and export of drugs by 2005;
- Establishment of three new fully equipped and adequately staffed laboratories in strategic locations of the country for more effective quality assurance of drugs and pharmaceutical products in Nigeria by 2005;
- Establishment in every public health care delivery institution at the federal, state, and local government levels by the end of 2005, 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 by 2008;
- Increase in local production capacity to a level where 70% of total output satisfies at least 60% of national drug requirements of essential drugs while the balance is exported by 2008;
- 80% awareness of the concept of rational use of drugs by prescribers, dispensers and consumers by 2006; and 60% adherence by prescribers and dispensers by 2008;
- 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 by 2006;
- 80% adherence to the rational use of narcotics and antimicrobials in the country by 2008;
- xvii. Institutionalization of functional Drugs and Therapeutics Committees and drug information centres in 60% of secondary and tertiary health facilities by 2007;
- xviii. Publication of a list of all medicines in the Nigerian market in three categories, namely prescriptions only, pharmacy only, and general sale by 2005;
- Awareness of appropriate self-medication practices by 40% of the population by 2008.
- Establishment, by 2006, of well-equipped national and zonal pharmacovigilancecentres and achievement of 40% reporting of adverse drug reactions by 2008;
- Total compliance of all drug promotion and information with national regulations by 2005;
- Annual publication of registered drugs by 2004 and thereafter;
- Provision of funds to satisfy a minimum of 70% of research needs by 2006;
- Publication of a Nigerian Pharmacopoeia, incorporating a list of effective herbal medicines by 2005;
- Enactment of a reviewed and harmonised drug legislation in Nigeria by 2006;
- Commencement of harmonisation of drug laws in the ECOWAS sub-region by 2006;
- Full integration of the drug management aspects of all Ministry of Health programmes by 2005; and
- 60% compliance with the use of EVDL, VDF, SVTG in veterinary practice by 2008.
STRATEGIES FOR IMPLEMENTING THE NATIONAL DRUG POLICY
The strategies that shall be used to implement the National Drug Policy shall focus 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. Others shall include assurance of quality of drugs at all levels, appropriate storage, proper costing and effective distribution of drugs, promotion of local drug manufacture, appropriate legislation, product registration, research and development, human resources development, monitoring and evaluation. Furthermore, the strategies shall emphasize proper accountability and rational use of drugs by health workers and consumers.
In view of the fact that these activities are purely technical, government at all levels - federal, state and local governments, shall be required to employ pharmacists and other relevant personnel to ensure satisfactory implementation of the Policy.
SELECTION OF DRUGS
The objective of the drug selection process is to have a national list of drugs rationally chosen to satisfy the health care needs of the majority of the population. Such a list shall be revised regularly and shall form the basis of drug selection by primary, secondary and tertiary public health-care institutions. In this regard, the Federal Government shall take the following steps:
i A revised Essential Drugs List shall be published by the Federal Ministry of Health and made available to health professionals, state and local governments, primary, secondary and tertiary health institutions.
ii Drugs included on the list shall:
• be listed using generic or International Non-Proprietary Names (INN)
• be based on the health needs of the majority of the population
• have substantial safety and risk/benefit ratio with sufficient accumulated scientific data
• be registered by the national drug regulatory authority
iii As much as possible, formulations containing more than one active ingredient shall be avoided, unless one or more of the following criteria are met:
• the clinical condition justifies the use of more than one drug in a fixed combination, or
• two or more pharmacologically active ingredients are synergistically active in a product, or
• patient compliance is enhanced by the combination.
iv. When two or more drugs are therapeutically equivalent or several drugs are available for the same indication, preference shall be given to products with the:
• most scientific research and clinical data
• most favorable pharmacokinetic properties
• best cost advantage
• best patient compliance
• most stable pharmaceutical dosage form for which appropriate storage facilities exist.
v. The Essential Drugs List Review Committee shall update the list every four years.
vi. Suggestions for amendment shall be made in writing on a prescribed form to the Federal Ministry of Health, justifying each suggested amendment. New drugs shall only be 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 shall be withdrawn and replaced with safer alternatives.
vii. The Essential Drugs List shall be used for:
• The procurement of drugs and their use 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.
PROCUREMENT OF DRUGS
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. To address the situation, the following criteria shall be adhered to:
i. Government shall be committed to good pharmaceutical procurement practices in the public sector;
ii. Procurement of drugs shall be restricted to drugs registered in Nigeria and on the Essential Drugs List;
iii. Procurement in the public sector shall be by International Non-Proprietary Names (INN) or generic names only;
iv. Procurement at all levels shall be by open, competitive tender and shall be conducted in a transparent manner with the advice of the Pharmacy Department. To encourage local drug manufacture, preference shall be given to the purchase of locally manufactured drugs;
v. Procurement shall be based on accurate quantification of drug requirements by the Pharmacy Department;
vi. Procurement and receipt procedures shall ensure that drugs supplied are of good quality;
vii. In order to keep prices low and undertake adequate quality assessment, drugs, shall as much as possible, be purchased in bulk;
viii. Drugs procured at all levels shall be subjected to quality assessment before distribution to dispensing units.
DRUG REVOLVING FUND SCHEME
The Drug Revolving Fund Scheme is a very effective strategy for ensuring uninterrupted drug supply in the health care delivery system. Experience from several health institutions in the country, however, has shown that its advantages have not been apparent due to a variety of reasons, including the following:
• poor management,
• misapplication of the Fund,
• purchasing of drugs at exorbitant prices,
• lumping of the proceeds of the Fund into a general account, and
• non-reimbursement of the cost of drugs for exempted patients.
Consequently, the Drug Revolving Fund Scheme shall be strengthened at all levels of government through:
i. Establishment of a DRF committee in every health institution for an effective and transparent fund management;
ii. Provision of adequate capital for the procurement of required drugs;
iii. Maintenance of a separate account for the DRF scheme, which shall be used exclusively for drug purchasing;
iv. Ensuring strict accountability for the drugs provided in the system by supplying them on a “cash-and-carry” basis;
v. Empowering the head of the pharmacy department of the health institution as the custodian of drugs to the institution and making him a required signatory to the DRF account; and
vi. Provision of appropriate training for the DRF personnel.
Experience in recent years has shown that drugs have been procured at much higher prices in public health institutions than in private retail pharmacies. Even within the public sector, there are wide variations in the prices of the same drugs from one institution to another. Therefore, to ensure affordability of drugs in public health institutions, government shall establish necessary mechanisms to guarantee that drug supply to patients shall cost less than in the private sector.
6.5 DRUG STORAGE
The objectives of drug storage shall be to ensure stock security and the maintenance of the quality of drugs throughout their shelf life.
Government shall ensure that suitably located, constructed and equipped storage facilities will be available at every level of the drug distribution system, in both public and private sectors.
The efficient and successful operation of a drug storage and distribution system requires the professional skills of pharmacists. Therefore, pharmacists shall be in charge of the drug stores operated by federal, state and local governments as well as in the private sector.
In addition, the following measures shall be implemented:
- Central Medical Stores and stores in both public and private health care facilities shall be properly managed to ensure that drugs do not expire or deteriorate on the shelf. However, any stock of expired or deteriorated drugs shall be officially destroyed within six months;
- Central Medical Stores shall have Quality Control Laboratories where basic tests shall be undertaken to determine the quality of drugs received or supplied.
- Regular checks on the quality of stored drugs shall be undertaken to ensure that they do not deteriorate under storage conditions;
- Public and private sector establishments shall put adequate mechanisms in place to ensure that the temperature in all drug storage facilities is maintained at not more than 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 computerised inventory control systems in the central stores for effective drug management; and
- Government shall encourage the computerisation of private drug stores for effective inventory control.
Rational drug distribution channels shall be promoted in both public and private sectors. In this regard the following measures shall be enforced by the Federal Government:
- Drug distribution, supply, sale and dispensing shall be under the control and supervision of pharmacists at all levels;
- Government shall ensure that drug manufacturing, wholesaling and retailing activities are registered as distinct enterprises;
- The channel for private sector drug distribution shall flow from manufacturers or importers to wholesalers and retailers;
- Government shall ensure that drug supplies to public health facilities will be based on expressed need and, in the main, shall be from the Central Medical Stores;
- Government shall ensure that all drugs purchased or donated to governments at all levels are channelled through the Central Medical Stores;
- Government shall establish inventory control systems, including computerisation, in all hospital pharmacies and clinics for effective inventory control. These shall be linked to a central computerised inventory control system in the Central Medical Stores;
- Adequate security shall be provided for storage areas, and, in particular, for narcotic drugs;
- Drugs distributed in the country shall, at least, be labelled in English;
- Government shall create incentives for pharmacists to establish practices in rural areas in order to promote rational drug distribution and use. Professional associations and regulatory bodies involved in health care shall encourage their members to establish professional practices in rural areas to complement government efforts in promoting greater access to and rational use of drugs.
RATIONAL DRUG USE
The requirements for rational drug use are that the right drugs shall be used for the right indications in the right dose and dosage form for the right duration. Rational drug use as an essential element of a National Drug Policy seeks to avoid the all-too-frequent problems of under- and over-prescription, inappropriate prescription, and the use of new, expensive drugs when equally effective, well-tried, safe and cheaper alternatives are available. Concerted efforts shall be made by government at all levels to promote rational drug use through:
EDUCATION AND TRAINING
The objective is to ensure 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. It will, therefore, be necessary to take the following initiatives:
i Promote the teaching of the concepts of rational drug use in pharmacy, medical, nursing and veterinary schools;
ii. Teach communication skills in pharmacy, medical, nursing and veterinary schools to promote rational prescribing and dispensing; and
iii. Develop educational strategies and programmes directed at the public on appropriate use of drugs.
6.7.2 Rational Prescribing:
The objective is to ensure that drugs are prescribed rationally. Consequently,
i. Up-to-date Standard Treatment Guidelines and a National Formulary shall be made available to all prescribers according to the level of care;
ii. Prescribing shall be by International Non-Proprietary Names (INN) or generic names; and
iii. At health care facilities, diagnostic services appropriate to the level of health provided so as to improve the accuracy of diagnosis.
The objective of rational dispensing shall be to ensure that patients receive adequate information on the use of dispensed drugs in order to derive the desired benefits to them. In this regard the following shall be put in place:
i. Dispensing shall only be carried out on duly licensed premises;
ii. The minimum information requirement on the label of a dispensed medicine shall be the following:
Name of patient,
Generic name of dispensed drug,
Strength of the drug,
Dosage instruction in symbols or words as may be appropriate,
Duration of treatment
Date of dispensing, and
The name of the institution where the drug was dispensed;
iii. The patient shall be counselled on the use of dispensed drugs, in a conducive environment suitable for effective communication; and
iv. Dispensing shall be carried out in a suitable container that will be childproof and ensure the stability of the drug dispensed.
DRUG INFORMATION SERVICES
Drug information is intended to provide unbiased, scientifically validated drug information to promote rational prescribing, dispensing and use. In this respect, therefore, the following measures shall be taken:
i Drug information units shall be established in all public health institutions.
ii The drug information units/centres shall, at all times, be suitably equipped and provided with up-to-date reference materials and equipment, including computers, and internet access, to guarantee the acquisition and dissemination of current and accurate drug information.
DRUGS AND THERAPEUTICS COMMITTEES
Drugs and Therapeutics Committees are institutionalised mechanisms for promoting, implementing and monitoring the concept of rational drug use in health care institutions. Therefore, the following measures shall be taken:
i Drugs and Therapeutics Committees (DTCs) shall be established in all tertiary and secondary health care institutions;
ii Membership of such committees shall comprise representatives of the pharmaceutical, nursing, medical, and administrative services of the institution; and
iii A DTC shall, among other duties, be responsible for:
• the selection of drugs for use in the institution, based on the National Essential Drug List,
• the accurate estimation of pharmaceutical requirements for the hospital,
• monitoring of the use of therapeutic guidelines and overall drug utilisation, and
• monitoring of the rational use of drugs in the institution.
Self-medication is especially useful in any situation where access to health care facilities is limited. It can offer the advantage of providing quick and effective relief that does not require medical attention, thereby relieving pressure on medical personnel and freeing them to devote more time to serious problems. However, it could lead to inappropriate use of drugs, delay of proper diagnosis and the delivery of effective treatment. It could also lead to drug misuse and abuse. In order to obtain the benefits of self-medication while avoiding its risks, the following steps shall be taken:
- A list of drugs that can be sold without prescription and used for the short-term relief of symptoms, without prior medical consultation and precise diagnosis, shall be drawn up and published by government;
- Such listed drugs shall satisfy the criteria for the selection of essential drugs, be effective for their condition of use, and have a wide margin of safety;
- The list shall be reviewed from time to time in the light of experience and available new information;
- iv. Information on, and the labelling and promotion of drugs, meant for self-medication, shall conform to laws and regulations set out for such categories of drugs;
- v. Health education to the public on appropriate self-medication shall be provided through the use of print and electronic media, and other communication methods.
Experience has shown that some donated drugs have often not been relevant to the emergency situation for which they were donated or for the disease pattern, or for the level of care that was available. They may sometimes be unknown to local health professionals and patients and may not comply with locally agreed policies and standard treatment guidelines; they may even be harmful. In the light of this experience, the following measures shall be taken;
- All drug donations for use in the country shall be processed through the Federal Ministry of Health as a clearing house to ensure compliance with the guidelines for drug donations.
- Donated drugs shall among other things be required to:
- be registered for use, both by the Drug Regulatory Authority of the donor country and in Nigeria,
- have at least twelve months remaining shelf life after arrival in the country, and
- be labelled in English to include its international non proprietary or generic name; and
- The Federal Ministry of Health shall put in place an adequate machinery for monitoring the distribution of donated drugs. In an emergency, the Federal Ministry of Health, in collaboration with National Emergency Management Agency (NEMA), shall immediately establish a co-ordinating body to assess and inform donors about national needs, approve donations, and co-ordinate their receipt and distribution.
MONITORING AND EVALUATION
The success of the National Drug Policy would depend on how well its provisions are implemented. Mechanisms shall, therefore, be put in place for monitoring, measuring and evaluating the Policy’s performance and impact, and for identifying possible problems and evolving effective strategies to address them. In this regard government shall ensure:
- The setting up of a National Drug Policy Monitoring and Evaluation Unit in the Federal Ministry of Health, to measure progress in the implementation of the policy and to run a national evaluation scheme;
- Compilation of indicators for monitoring the National Drug Policy as an integral part of the Nation al Health Information System, and evaluating these indicators at all levels of health care at the local, state and federal governments;
- Institutionalizing of drug management information systems as a basis for deriving drug management and other relevant information for taking decisions on the National Drug Policy;
- Close monitoring of the effects of international trade agreements on Nigerians’ access to essential drugs; and
- Undertaking of a full evaluation of the National Drug Policy every three
|CIDA||Canadian International Development Agency|
|DFID||Department for International Development|
|DIC||Drug Information Centre|
|DRA||Drug Regulatory Authority|
|DRF||Drug Revolving Fund|
|DTC||Drugs and Therapeutic Committee|
|ECOWAS||Economic Community of West African States|
|EDL||Essential Drugs List|
|EVDL||Essential Veterinary Drugs List|
|FMOH||Federal Ministry of Health|
|GMP||Good Manufacturing Practices|
|INN||International Non-Proprietary Names|
|LGA||Local Government Area|
|MDCN||Medical and Dental Council of Nigeria|
|NAFDAC||National Agency for Food and Drug Administration and Control|
|NCN||Nursing Council of Nigeria|
|NDF||National Drug Formulary|
|NDLEA||National Drug Law Enforcement Agency|
|NDP||National Drug Policy|
|NEMA||National Emergency Management Agency|
|NIMR||National Institute for Medical Research|
|NIPRD||National Institute for Pharmaceutical Research and Development|
|NPI||National Programme on Immunisation|
|NUC||National Universities Commission|
|OTC||Over the Counter|
|PCN||Pharmacists’ Council of Nigeria|
|PMG-MAN||Pharmaceutical Manufacturing Group of the Manufacturing Association of Nigeria|
|PPMVL||Patent and Proprietary Medicine Vendors Licence|
|RMRDC||Raw Materials Research and Development Council|
|SMOH||State Ministry of Health|
|STG||Standard Treatment Guidelines|
|SVTG||Standard Veterinary Treatment Guidelines|
|TRIPS||Trade Related Aspects of Intellectual Property Rights|
|UNICEF||United Nations Children’s Fund|
|UNIDO||United Nations Industrial Development Organisation|
|UNODCCP||United Nations Office for Drug Control and Crime Prevention|
|USAID||United States Agency for International Development|
|VCN||Veterinary Council of Nigeria|
|VDF||Veterinary Drug Formulary|
|VRI||Veterinary Research Institute|
|WHO||World Health Organisation|