The WHO 'Roll Back Malaria Project': planning for adverse event monitoring in Africa.

Artemisinin combination therapies (ACTs) have been recommended for the treatment of malaria in countries where there is widespread resistance to commonly used antimalarial drugs. Several sub-Saharan African countries are, therefore, in the process of introducing ACTs in their malaria drug policies. However, there is limited information about the safety of ACTs outside South East Asia, where their use has been well documented. As with all other new medicinal compounds, the monitoring of a drug's safety or 'pharmacovigilance' is important, especially in areas where co-morbid conditions, such as HIV/AIDS, malnutrition and tuberculosis, are common. Because in most malaria endemic countries, particularly Africa, there are no pharmacovigilance programmes in place, it has been suggested that the introduction of ACTs offers an opportunity for these countries to put drug safety monitoring systems in place. Backed by the WHO Roll Back Malaria department and other international cooperating partners, five African countries, which are in the process of introducing ACTs (Burundi, Democratic Republic of the Congo, Mozambique, Zambia and Zanzibar), have drawn up action plans to introduce pharmacovigilance in their health sector. It is planned that once the safety monitoring of antimalarials has been established, these activities can then be extended to cover medicinal compounds used in other public health programmes, such as HIV/AIDS, tuberculosis and the immunisation programmes. This article looks at the rationale for pharmacovigilance, the process of setting up monitoring centres and the challenges of implementing the project in the region.