Safety monitoring of artemisinin combination therapy through a national pharmacovigilance system in an endemic malaria setting

Malaria Journal

Research

Sylla Thiam¹  Patrick Gatonga¹  Jean-Louis Ndiaye²  Oumar Gaye²  Babacar Faye²  Ndella E Diallo²  Moussa Thior³  Ibrahima Diallo³  Medoune Ndiop³  Fatou Ba Fall³  Mamadou L Diouf³  Mame B Diouf³ 

[1] African Medical and Research Foundation, Nairobi, Kenya;Department of Parasitology, Medical Faculty, Université Cheikh Anta Diop, Dakar, Senegal;National Malaria Control Programme, Dakar, Senegal;

关键词: Pharmacovigilance;    Malaria;    ACT;    Senegal;   

DOI  :  10.1186/1475-2875-12-54

 received in 2012-10-30, accepted in 2013-01-17,  发布年份 2013

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© Thiam et al; licensee BioMed Central Ltd. 2013