| アブストラクト | INTRODUCTION: Seasonal malaria chemoprevention (SMC) by mass administration of sulfadoxine pyrimethamine + amodiaquine (SPAQ) reduces the burden of malaria in children aged 3-59 months. The occurrence of adverse drug reaction (ADR) may affect the success of this intervention. There are few studies of SMC adverse event surveillance in sub-Saharan Africa, particularly in Burkina Faso, a highly endemic country. Our main objective was to characterize the ADRs reported during SMC campaigns in Burkina Faso. Secondly, we evaluated the performance of the pharmacovigilance integrated into the SMC program in order to support safe administration of SMC. METHOD: This was a retrospective descriptive study of SMC individual case safety reports recorded in VigiBase(R) in Burkina Faso from 2014 to 2021. We used the P-method for the analysis of preventable serious adverse drug reactions and WHO criteria for assessing the performance of pharmacovigilance integrated into the SMC program. RESULTS: A total of 1,105 SMC individual case safety reports were registered in VigiBase(R) for 23,311,453 doses of SPAQ given between 2014 and 2021. No pharmacovigilance signal was detected. The number of serious cases was 101, of which 23 (22.8%) were preventable. In 38.1% of children, the occurrence of ADRs led to discontinuation of SMC treatment. Vomiting was the most frequently reported adverse drug reaction (48.0%). The proportion of children whose treatment was discontinued due to vomiting was 42.7%, while the proportion of treatment discontinuation for other ADRs was 32.8% (p = 0.01). The SMC program contributed at 46.2% to the national pharmacovigilance database. The reporting rate was 0.03 per 1,000 exposed children in 2021. The median completeness score of the ICSRs was 0.7 (IQR: 0.5-0.7), and the median time to register the ICSRs in VigiBase(R) was 204 (IQR: 143-333) days. CONCLUSIONS: Post-drug administration vomiting may interfere with the purpose of SMC. Measures to manage this adverse drug reaction should be taken to improve the success of the SMC program. Based on the information on reporting time and reporting rate, spontaneous reporting should be supported by active surveillance, including cohort event monitoring, in Burkina Faso. |
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| ジャーナル名 | Sante publique (Vandoeuvre-les-Nancy, France) |
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| 投稿日 | 2024/1/4 |
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| 投稿者 | Ouoba, Joel; Lankoande-Haro, Sougrimani; Fofana, Souleymane; Nacoulma, Aminata P; Kabore, Lassane; Sombie, Issiaka; Rouamba, Toussaint; Kirakoya-Samadoulougou, Fati |
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| 組織名 | Institut superieur des sciences de la sante, universite Nazi-Boni,;Bobo-Dioulasso, Burkina Faso;Agence nationale de regulation pharmaceutique, ministere de la Sante,;Ouagadougou, Burkina Faso;Service de pharmacovigilance et pharmacie clinique, Centre hospitalier;universitaire Souro-Sanou, Bobo-Dioulasso, Burkina Faso;Laboratoire Sciences du medicament, Institut superieur des sciences de la sante,;universite Nazi-Boni, Bobo-Dioulasso, Burkina Faso;Unite de formation et de recherche en sciences de la sante, universite;Joseph-Ki-Zerbo, Ouagadougou, Burkina Faso;African Group Organized for Research and Actions in Health (AGORAH), Ouagadougou,;Burkina Faso;Organisation ouest-africaine de la sante, Bobo-Dioulasso, Burkina Faso;Unite de recherche clinique de Nanoro, Institut de recherche en sciences de la;sante, Centre national de recherche scientifique et technologique, Ouagadougou,;Centre de recherche en epidemiologie, biostatistique et recherche clinique, Ecole;de sante publique, Universite libre de Bruxelles, Bruxelles, Belgique |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38172043/ |
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