Medical products, vaccines, infrastructures and equipment
A well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost effectiveness, and their scientifically sound and cost-effective use.
To achieve these objectives, the following are required:
- national policies, standards, guidelines and regulations that support policy;
- information on prices, international trade agreements and capacity to set and negotiate prices;
- reliable manufacturing practices and quality assessment of priority products;
- procurement, supply, storage and distribution systems that minimize leakage and other waste;
- support for rational use of essential medicines, commodities and equipment, through guidelines, strategies to assure adherence, reduce resistance, maximize patient safety and training.
Major components of the medicines market are shown in the figure.
This section on Medical products, vaccines, infrastructures and equipment is structured as follows:
The Ministry of Health has promulgated a new National Pharmaceutical Policy 2011 which aims at positively contributing to improving the health of the Swazi population by ensuring equitable access to, and rational use of efficacious, high quality essential medicines, and medical supplies and devices at affordable cost particularly for vulnerable populations.
The department is headed by the Chief Pharmacist who is responsible for organizing and directing all pharmaceutical activities in the country as well as formulating and providing policy advice and guidance to the Ministry of Health. Other functions include ensuring regular medicine supply to the public sector, technical supervision of national referral and regional hospitals and the overall implementation of the Swaziland National Pharmaceutical Policy.
The office of the Chief Pharmacist also plays the role of regulatory authority, an unsatisfactory situation which requires the urgent creation of a formal regulatory body. The limited administrative capacity of the national pharmaceutical services poses high inefficiency risks in the inefficiency risks in the management and control of pharmaceutical services.
The Pharmacy Act of 1929 which has been in use in the country is outdated. It does not provide for the licensing of pharmaceutical outlets, medicine scheduling and regulatory functions such as inspection and medicine registration. In the absence of a regulatory body, pharmaceutical personnel are registered by the Medicines and Dental Council, licensing of premises is not done. A new Pharmacy Bill and a new Medicines and Related Substances Control Bill are being drafted. They provide for the establishment of a Pharmacy Council and a Medicines Regulatory Authority.
The Central Medical Stores (CMS) is responsible for the procurement, storage and distribution of all medicines and medical supplies and devices to all government, parastatal and mission hospitals, clinics and health centres. CMS storage space is still inadequate even after the extension of the old warehouse (about 3500 cubic meters), just enough for 6 months’ supply. This requires more frequent procurement and over burdens the existing inventory system. Nine additional storage and dispensing facilities have been constructed. Most medicines are imported from outside the country particularly from South Africa.
Procurement is in principle restricted to items on the Swaziland National Essential Medicines List. However revision of the list is seldom done and there are more items from outside the list being requested. Record keeping and stock management both at the CMS and health facilities require improvement. A national quantification exercise for medicine requirements has been instituted and needs to be strengthened. There are no established quality assurances procedures for pharmaceuticals imported into or manufactured in the country. There is no medicine inspectorate, registration, adverse reaction monitoring and pharmaco-vigilance.
A Pharmaceutical product quality control laboratory was established in 1993 within the CMS premises. The laboratory is currently not operational due to lack of qualified staff, equipment and resources. Quality control and monitoring of medicines is therefore not done. There are no mechanisms for monitoring medicine use by health workers and the general public mainly due to lack of the necessary tools, staff and resources. Standard Treatment Guidelines have been recently developed and their implementations are being rolled out. Current prescribing and dispensing practices need to be rationalized and streamlined through the development of various rational medicine use tools and staff training.
There is no policy on traditional and complementary medicine (s) but their use is wide spread in the country. Patients often visit a traditional health practitioner and a health care facility for the same illness. There are no mechanisms for collaboration with traditional health practitioners, to ensure the efficacy of their preparations. There is a need to encourage collaboration between traditional health practitioners and health workers and establish mechanisms for monitoring their activities in the community.