Pharmaceuticals make an important contribution to global reductions in mortality and morbidity. However, making drugs available to people and ensuring their safe, effective and rational use is often not without its accompanying problems. The emergence of National Drug Policies (NDPs) in the second half of the 20th century was a positive concept for achieving optimal availability and use of drugs. The policies have often been initiated with the support of the World Health Organisation as well as other bilateral and multilateral agencies and non-governmental organisations. NDPs have provided a framework for coordinating activities in the sector involving public, private, NGOs, donors and other stakeholders by specifying the goals, their relative importance and the main strategies for attaining them.
Following years of long planning and discussions among various stakeholders, Ghana launched its first national drugs policy in 1999 to serve as a reference guide for national pharmaceutical development. The specified goal of the policy was "to make essential drugs available and accessible to the population; to ensure the safety, efficacy and the quality of drugs and their rational use by prescribers, dispensers and consumers". The components of the policy included drug selection and registration, drug procurement, local manufacture and drug storage and distribution. It also dealt with issues involving rational drug use, drug advertising and human resource development as well as drug financing, quality assurance, and traditional herbal medicines among others.
The policy specified a number of strategies for achieving the above goal. For example it sought to improve the supply of essential drugs in the public sector by increasing the drug budget and specifying the introduction of cost sharing and allocation of more resources to underserved populations and areas. It also spelt out procedures for drug procurement, supply and local manufacture. The policy was also formulated with an inherent flexibility to accommodate future developments and changes with the overall vision of attaining health for the entire population of Ghana. The following constitute a brief appraisal of some of the key components.
Drug legislation and regulation
The enactment of appropriate legislation and introduction of regulations to provide legal basis is necessary to make NDP enforceable. Such legislation specify the various actors and their responsibilities in the system regarding those who can produce, or import pharmaceuticals as well as the range of prescribers, sellers and the type of products they can sell. It also specifies various institutions for monitoring and enforcing regulations and ensures product quality, safety and efficacy. The legislative models and structures in Ghana however, indicate that:
• Laws and regulations have been difficult to enforce due to lack of capacity and limited logistics.
• Penalties and sanctions have not been used.
There is therefore a need to review existing regulations and amend operations to make them adaptive to local realities and make them enforceable. The situation calls for a well organized and trained inspection unit and a system of quality control.
Drug selection, registration and supply
The selection of essential drugs that are safe, of high quality and effective and their proper registration are important components of NDPs. Since the essential drugs concept was introduced by the WHO in the late seventies, many countries have adopted it as a core component of their national drug supply system. The Ministry of Health of Ghana published its list of essential drugs with therapeutic guidelines in 1988. Since then the document has undergone reviews in response to new knowledge on drugs and diseases as well as changes in the epidemiology of disease in Ghana. The fourth editions of the Essential Drugs List (EDL) and the Standard Treatment Guidelines (STG) were published in 2000. The target of bi-annual review of the Standard Treatment Guidelines and the Essential Drugs List has not been achievable. However, a review of the procedure for selecting drugs for the Essential Drugs List was put into effect in the year 2000. This resulted in the selection of drugs based on evidence that they are the most appropriate for treating health problems in the country. While the application of the list in the public sector is commonly adhered to, in the private sector any drug registered by the Food and Drugs Board may be used.
Drug registration and licensing are therefore important tools of drug selection in Ghana's NDP. Apart from quality, safety and efficacy, other important regulatory aspects include drug advertisements, standards of practice for drug outlets, post-marketing surveillance and pharmacovigilance. The Ghana National Drugs Programme has funded activities in both FDB and the Pharmacy Council to improve on these factors including the establishment of a National Pharmacovigilance Centre. The preponderance of imported pharmaceutical products has on occasion resulted in the procurement of substandard products. A well-established and functioning laboratory for the FDB or identification of local laboratories to carry out quality assessment of products is needed.
Procurement
Ghana has a state system for procurement in the public sector. A functioning Procurement Unit is now established for the health sector resulting in improvement in procurement procedures. In the procurement of pharmaceuticals, the use of international competitive bidding has resulted in good prices for the sector. Manuals on procurement procedures have been developed and nationwide training on their use conducted. Systems for quantification of drugs and inventory management however need improvement. There is also the need to upgrade the skills of trained staff in implementing standard operating procedures prepared for the management of medicines, supplies and equipment.
Local Manufacture
The growth and capacity of local pharmaceutical production is still marginal. Local manufacture has also been weighed down by the free market policy of the government and lack of tax exemptions for raw materials thereby adversely affecting production and competition.
Drug Distribution
Drug distribution has improved essentially as a result of decentralisation of the health service and the revolving drug fund concept. The role of the Central Medical Stores in drug supply is yet to be fully clarified. A comprehensive distribution arrangement to move pharmaceutical products and other medical supplies from the medical stores to the service points is a major bottle neck to access to these items.
Rational drug use
The rational use of drugs is one of the major objectives of every drug policy. In Ghana, the recognition of the role of various health professions in achieving this objective has led to the establishment of a clinical pharmacy training programme, workshops for health personnel in various institutions and retraining of chemical sellers. The interventions introduced to improve the use of medicines have resulted in some gains including a reduction in the average number of drugs prescribed per out-patient encounter from 4.6 to 3.7. In addition, the proportion of out-patients receiving antibiotics and injections have reduced from 54% and 38% to 42% and 33% respectively. However, as in most developing countries, inadequate control of drug promotion and drug dispensing by untrained prescribers has left a wide gap in the promotion of rational use of drugs. In general, while several activities have been carried out to promote rational prescribing and dispensing in the public sector, a lot remains to be done in the private sector. An important factor that hinders rational use of drugs is the lack of unbiased objective drug information. Through the Ghana National Drugs Programme an Information Resource Centre has been established to deal with this particular aspect of use of medicines for both health providers and clients.
Public education in rational drug use to provide individuals and communities with information and skills on appropriate, safe and judicious use have also lagged behind. Additional focused programmes also need to be carried out in both public and private sectors.
Financing drugs
The main challenge of drug policy is how to ensure stable and adequate financing. The public health care services in most countries of sub-Saharan Africa was characterised by state finance during the immediate postcolonial period. However, economic difficulties have compelled the introduction of user charges in recent years. The goal of this has been to maximize resources for drugs by ensuring continuous supply at low prices in order to improve economic accessibility. In Ghana mechanisms to increase economic accessibility has led to plans to implement health insurance and encourage generic prescribing. The drug policy has to date been unable to address abuses and problems associated with government suggested exemptions for specified groups of people who are considered incapable of paying for drugs at public health institutions.
Drug Pricing
Ghana has a long tradition of innovation and reform in the organization and delivery of its health services. The planned introduction of the National Health Insurance Fund (NHIF) follows earlier efforts to decentralize health service and drug management. The NHIF will replace the cash-and-carry system for financing health services medicines while maintaining local facility autonomy in managing their revolving drug funds (RDF). This autonomy increased local management's discretion over drug procurement and pricing, within clear guidelines. These guidelines state that public facilities should buy first from the public sector and should mark up at a fixed 10 percent margin for Regional Medical Stores (RMS) and for Service Delivery points (SDPs). The MOH/Ghana Health Service (GHS) has been receiving reports of non-compliance with these guidelines within the public sector. RMS and SDPs have reportedly increased their procurement from the private sector while the considerable variation in drug prices indicate margins in excess of 10 percent. More therefore needs to be done to regulate retail margin.
Traditional Medicines
The role of traditional medicines and traditional medicine practitioners in the health care delivery system is recognised and the Traditional and Alternate Medicines Directorate of the Ghana Health Service has been established. Efforts are directed at bringing all traditional medicine practitioners under one national organisation; preparing guidelines for standards of practice and ethics, and a training manual for the profession. The Centre for Scientific Research into Plant Medicine and other research institutions like the Noguchi Memorial Institute for Medical Research continue to evaluate herbal medicines. The Food and Drugs Board has instituted a procedure for the registration of herbal products. The Traditional and Alternate Medicines Directorate will have to build the needed capacity to enable it forge links with partners and also exercise its mandate to ensure that traditional medicine products are safe, efficacious and of good quality.
Monitoring, evaluation and research
The need for routine monitoring of the NDP to evaluate its impact at regular intervals is also essential for the success of NDP. The institutional framework for monitoring the NDP in Ghana has, however, been inadequate.
Research to improve health services and health care include baseline studies of the pharmaceutical sector covering rational drug use, procurement and financing of drugs and Knowledge, Attitudes, Beliefs and Practices (KABP) studies on rational use of medicines in Ghana. The latter was geared towards the design of appropriate and effective strategy for meaningful information, education and communication on rational drug use. However, no research on the development of new products has been conducted.
This edition of the NDP differs from the earlier one in some significant respects. The current one incorporates an implementation plan to ensure that responsible organisations and individuals appropriately tackle all issues raised in the NDP. This edition also deals with intellectual property rights as contained in the Trade Related Aspects of Intellectual Property Rights agreement (TRIPS). It also covers local production of antiretroviral drugs necessitated by the importance of HIV/AIDS in the disease profile of the country. It is envisaged that the changes and improvements in content to this edition will accommodate the new challenges in the pharmaceutical environment in Ghana.
