Evaluation of adverse drug reactions to artemisinin-based combination therapy in a Nigeria University Community

Purpose : The study was carried out to evaluate the incidence of adverse reactions to antimalarial drugs among residents of a Nigeria university community with a focus on arte- misinin-based combination therapy (ACT). Specifically; the profile of use; and the reporting culture of people with respect to experienced reactions were noted. Method : Ques- tionnaires were administered to respondents at the university health centre between November 2006 and January 2007. Information on demographic characteristics; nature of experienced adverse reactions and the most frequently used ACT; among other questions; were collected. Descriptive statistics and Fisher's Exact test were used to evaluate the distribution of respondent's opinion. Result: The study achieved a response rate of 86. The results revealed that 210 (70.0) of respondents said they had used artemisinin-based combination drugs while 134 (44.7) said they used artemisinin derivatives alone as monotherapy for malaria treatment. Artesunate plus amodiaquine 94 (31.3) as a co-packaged product was the most commonly used ACT. Incidence of the experienced adverse reactions to ACT was reported to be generally mild and well tolerated. Conclusion : Efforts to improve the use of ACT in the management of acute uncomplicated P. falciparum malaria is recommended. Furthermore; an effective mechanism to improve reporting of adverse effects of ACT is also recommended

Pharmacovigilance of antimalarial treatment in Africa: is it possible?

"Pharmacovigilance; defined as ""the science and activities relating to the detection; assessment; understanding and prevention of adverse effects or any other possible drug related problem""; is increasingly being recognized in Africa. Many African countries have simultaneously adopted artemisinin derivative based combination therapy (ACT) as first-line treatment for uncomplicated malaria; offering an opportunity to assess the safety of these drugs when used widely. While ACTs appear to be safe and well-tolerated; there is little experience with these medicines in Africa; outside clinical trials. Pharmacovigilance for ACTs and other combination treatments in Africa is essential. Malaria transmission intensity is high and antimalarial medicines are used frequently. Presumptive treatment of fever with antimalarials is common; often in the absence of a confirmed diagnosis; using drugs obtained without a prescription. Informal use of antimalarial drugs may increase the risk of incorrect dosing; inappropriate treatment; and drug interactions; which may impact negatively on drug safety. Furthermore; the administration of antimalarial treatments in patients with a concomitant illness; including HIV/AIDs; tuberculosis and malnutrition; is a concern. African countries are being encouraged to establish pharmacovigilance systems as ACTs are rolled out. However; pharmacovigilance is difficult; even in countries with a well-developed health care system. The rationale for pharmacovigilance of antimalarial drugs is discussed here; outlining the practical challenges and proposing approaches that could be adopted in Africa."