Pharmacovigilance of Anti Malarial Drugs in Resources Poor Country: Safety Monitoring of ACT in Senegal

Pharmacovigilance of anti malarial drugs in resources poor country: safety monitoring of ACT in Senegal S Thiam (1)*; JL Ndiaye (2); I Diallo (3), F.B. Fall (3), N.E. Diallo (2); B Faye (2); ML Diouf (3); PM Thior (3); O. Gaye (2). Abstract The National Malaria Control Program in Senegal, under its new guidelines for malaria treatment, has introduced since 2006, Artemisinin-based Combination Therapy (ACT) for the treatment of uncomplicated malaria cases. In this framework an antimalarial pharmacovigilance plan was developed and implemented in all health districts in Senegal. This study reports and analyzes Adverse Drug Reactions (ADRs) collected in health facilities after antimalarial treatment. This study was conducted between 1st January 2007 and 31st December 2009 where Artesunate-Amodiaquine (ASAQ) was the first line treatment. It was based on spontaneous reports of ADRs after ACT treatment in public health facilities. A total of 123 patients with ACT treatment- related adverse events were enrolled. The mean age of patients was 25.9 years. Most of cases (77.8%) were reported by nurses in heath posts and health centres. Two hundred and twenty seven (227) symptoms were reported. Gastrointestinal disorders (46.7%) and General state alteration signs (31.3%), were the most frequently symptoms observed. Imputability shown that 12.3% of ADRs were linked to ASAQ . Effects were classified banal in 76.6% of cases. However 22.8% of reported cases have been admitted in hospitalization and one death was reported in a patient who had taken 24 pills of ASAQ at once. These results confirm the need to develop and implement a successfully pharmacovigilance system in endemic countries in order to monitor the safety of antimalarial treatments. Furthermore this system should involve the community level given the fact that people living in malaria areas can receive more than one treatment a year. Words count: 252