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

The 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 service...

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Bibliographic Details
Published in:	Malaria journal Vol. 12; no. 1; p. 54
Main Authors:	Thiam, Sylla, Ndiaye, Jean-Louis, Diallo, Ibrahima, Gatonga, Patrick, Fall, Fatou Ba, Diallo, Ndella E, Faye, Babacar, Diouf, Mamadou L, Ndiop, Medoune, Diouf, Mame B, Gaye, Oumar, Thior, Moussa
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 05-02-2013 BioMed Central
Subjects:	Adolescent Adult Aged Aged, 80 and over Antimalarials Antimalarials - adverse effects Antimalarials - therapeutic use Artemisinins - adverse effects Artemisinins - therapeutic use Case management Child Child, Preschool Complications and side effects Drug dosages Drug therapy Drug therapy, Combination Drug Therapy, Combination - adverse effects Drug Therapy, Combination - methods Drug-Related Side Effects and Adverse Reactions - epidemiology Endemic Diseases Female Health aspects Health facilities Health services Humans Infant Malaria Malaria - drug therapy Malaria - epidemiology Male Middle Aged Monitoring systems Patients Pharmacovigilance Population Public health Senegal - epidemiology Workers Young Adult Senegal
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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 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. The 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. The 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. These results confirm the need to develop and implement pharmacovigilance systems in malaria endemic countries in order to monitor the safety of anti-malarial treatments.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1475-2875 1475-2875
DOI:	10.1186/1475-2875-12-54