Abstract
BackgroundThe National Malaria Control Programme in Senegal, introduced since 2006, artemisinin-based combination therapy (ACT administration) for the treatment of uncomplicated malaria cases. In this framework, an anti-malarial pharmacovigilance plan was developed and implemented in all public health services. This study investigated the occurrence of Adverse Drug Events (ADEs) after ACT.MethodsThe study was conducted between January 2007 and December 2009. It was based on spontaneous reports of ADEs in public health facilities. Data on patient demographic characteristics, dispensing facility, adverse signs and symptoms and causality were collected from a total of 123 patients.ResultsThe age range of these patients was six months to 93 years with a mean of 25.9 years. Of the reported symptoms, 46.7% were related to the abdomen and the digestive system. Symptoms related to the nervous system, skin and subcutaneous tissue, circulatory and respiratory systems and general symptoms and signs were 7%, 9.7%, 3.5% and 31.3%, respectively. Causality results linked 14.3% of symptoms to Falcimon® (Artesunate-Amodiaquine) with certainty. Effects were classified as mild and severe in 69.1% and 7.3% of cases respectively while 23.6% were serious. All patients with serious ADEs were hospitalized. One death was reported in a patient who had taken 24 pills at once.ConclusionThese results confirm the need to develop and implement pharmacovigilance systems in malaria endemic countries in order to monitor the safety of anti-malarial treatments.
Highlights
The National Malaria Control Programme in Senegal, introduced since 2006, artemisinin-based combination therapy (ACT administration) for the treatment of uncomplicated malaria cases
Socio-demographic characteristics Between 1st January 2007 and 31st December 2009, a total of 123 patients with Adverse Drug Events (ADEs) related to ACT were reported
Sixty seven percent of the notifications were gathered from public health posts while district hospitals reported 30.1% of the ADEs
Summary
The National Malaria Control Programme in Senegal, introduced since 2006, artemisinin-based combination therapy (ACT administration) for the treatment of uncomplicated malaria cases. In developing countries the incidence of adverse events in the general population is under-recognized [4], because the post-marketing drug surveillance systems are barely functional in most of the endemic countries, which explains why these countries have a low level of case reporting [5]. In most of these countries, lack of expertise and resources present barriers to a functional pharmacovigilance system. A lack of consistency across proposals in what was defined and reported as pharmacovigilance demonstrated the need for stronger efforts to advance the role and effectiveness of pharmacovigilance activities to support malaria control and prevention programmes
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