Drug Policy Change Project in Uganda: Artemisinin-based Combination Therapy

Situation:

Drug resistance of the malaria parasite to antifolates (e.g. pyrimethamine) and chloroquine is widespread and means new combinations of antimalarials are now used to treat uncomplicated malaria. Drug combinations delay further transmission of resistant parasites by increasing cure rates and inhibiting formation of gametocytes. Atovaquone/proguanil and mefloquine have been used previously against multidrug resistant falciparum malaria, however resistance to each was reported very soon after introduction. Most currently WHO and RBM recommended drug combinations are variants of artemisinin combination therapy (ACT). Fast acting artemisinin compounds are combined with a drug of longer half-life from a different class, such as lumefantrine or amodiaquine. Efforts are going into establishing the evidence base for decisions and timing of antimalarial policy change and implementation.

Response:

This programme concerns efforts to improve understanding of the interface between evidence and policy development, to make antimalarial drug policy change more active and timely. Objectives are: to document and identify the factors influencing drug policy development at different stages of the policy change process; to describe and analyse the roles of policy makers and stakeholders; to develop an approach and a set of tools for promoting consensus- building among stakeholders. Uganda changed its first line drug from Chloroquine (CQ) to CQ + Sulphadoxine pyrimethamine (SP) in 2000. However, further efficacy studies carried out in 2002-2004 showed increasing average resistance to CQ + SP combination of 21.4%, while resistance to amodiaquine + SP and Amodiaquine + Artesunate to be 5.4% and 1.8% respectively. However an efficacy study of artemether – lumefantrine (Coartem) showed no clinical failure in 28 days. With these results Uganda has changed its policy and adopted Coartem as its first line drug to manage uncomplicated malaria and quinine for complicated malaria treatment. Planning for this policy change has been ongoing since 2004 and implementation was originally planned for 2005. Support for this change is being funded by the GFATM. These funds will also support the supply management system and training staff in pharmaceutical management. This is part of a Drug Policy Change Project, funded by DFID and includes a feasibility study on using ACT in Home Based Management, training health workers, managing the documentation, drug procurement, guidelines and improving diagnosis (RDTs).

The Malaria Consortium and partners support the Ugandan Ministry of Health and National Malaria Programme to implement the national change to ACT including assisting in finalizing the policy, writing case management guidelines, running dissemination workshops and training health workers. The work has also included assessing Rapid Diagnostic Tests to facilitate accurate diagnosis of malaria and carrying out an evaluation in the availability of first and second line antimalarials at health facilities. After successfully completing this initial survey, the Malaria Consortium is now involved in developing and implementing commercial strategies for providing ACT in Uganda. More specifically, conducting a field assessment of phasing in ACT to home based management in Kiboga District, Uganda.

Points to note:

A drug policy change was clearly required in Uganda in 2000 because of the rise of drug resistance to first line drugs chloroquine and sulphadoxine/pyrimethamine. The change in policy has to cover not only drugs used in first line treatment in hospitals, but also in home based management and intermittent preventive treatment. The higher costs of ACTs will be managed by the GFATM, but governments have to be aware that policy will be needed to drive the change.

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Photo: Malaria Consortium