(2003; 67 pages)
Malaria accounts for a large part of the disease burden in poor countries, causing over a million deaths a year. With 90% of the deaths occurring in Africa, malaria presents a serious health and socio-economic challenge. Effective drug treatment continues to be a critical element of any strategy to control malaria. There have been widespread reports of antimalarial drug resistance in the African region at a time when globally the development of resistance is said to exceed the pace at which new antimalarial drugs are being developed.1
In many settings, antimicrobial therapy is usually complicated not only because of microbial drug resistance but also patient-related factors, such as poor adherence to therapy, drug side-effects, such as vomiting, which lead to under-dosage, drug interactions and individual variations. Therapeutic failure also occurs due to pharmaceutical failure resulting from poor quality of products, instability of products, which leads to deterioration of their quality before they reach the patient, or the use of counterfeit products. Several WHO-sponsored studies have demonstrated significant instability of products such as ergometrine,2,3 and other essential medicines, during transport by sea, and also during road transport inland.4,5
The problem of counterfeit drugs is well recognized within the African region as well as in other parts of the developing world.6 It prompted WHO/EDM to facilitate the Joint Project on Counterfeit Drugs which, among other activities, generated guidelines for developing measures to combat counterfeit drugs.7
It should also be noted that pharmaceutical products of poor quality might contribute to the emergence of resistance. This is because when patients are treated with poor-quality drugs, resulting in low bioavailability, it leads to drug under-dosage, which promotes the development of resistance. It is therefore important to consider product quality when dealing with the problem of antimalarial resistance.
Treatment failure, ascribed to resistance, may also be due to low quality, yet in most countries the quality of antimalarials is rarely independently verified, and the local capacity for independent drug quality assurance is worst where the disease burden is the highest. Although malaria-endemic countries carry out drug resistance monitoring in accordance with the WHO protocol,8 there are no data linking these treatment failures, i.e. drug resistance level with product quality.
As part of the WHO Roll Back Malaria effort, and the on-going activities of the Essential Drugs and Medicines Policy Department to improve access and promote rational use of good quality essential medicines, a preliminary, exploratory meeting of experts and others concerned, was held in Geneva in October 1998. The meeting concluded that poor quality of antimalarials posed a problem to malaria control, and therefore to public health, especially in countries where there is little or no drug regulatory infrastructure. It was also proposed to set up a technical network of regional experts, with a primary focus on access to quality antimalarials.
There was a need to clarify the nature and magnitude of the problem of quality and consequently how it could be specifically addressed. As a prelude to a comprehensive study on the quality of antimalarials in African countries and the complex issues that might be involved, it was decided to carry out a pilot study in selected countries. It was hoped that this would provide an indication of the nature and gravity of the problem. The study results would then guide the design of intervention strategies.