| アブストラクト | INTRODUCTION: Pharmacovigilance (PV) in sub-Saharan Africa relies on passive surveillance but underreporting of adverse events (AEs) by health care professionals (HCPs) is a major challenge. A PV enhancement project was implemented to address this in Cote d'Ivoire. OBJECTIVE: To improve safety surveillance of medicines through PV training and mentoring of HCPs in selected health care facilities (HCFs). METHODS: This collaborative project between national PV stakeholders, GSK, and PATH was implemented from September 2018 to February 2020 in Abidjan region, Cote d'Ivoire. Trained PV focal points provided training and regular mentoring of HCPs. Key performance indicator (KPI) categories for AE reporting were the volume of AE reports, efficiency of report transmission and data entry, quality of reports, and quality of the central (Vigilance Unit) response to AE reports. RESULTS: Overall, 1427 HCPs at 91 HCFs were trained. In the 8 months before implementation, 33 AE reports were received versus 85 after 3 months and 361 after 18 months of implementation (71 [83.5%] and 278 [77.0%], respectively, from Abidjan). The KPIs with the highest proportions were: AE reports received centrally (100%), complete AE reports (69.0%), AE reports entered into the local PV database within 48 h (99.6%), and AE reports entered into the global database, VigiBase (86.7%). Report notification within 72 h, causality assessment, and serious AE reporting had proportions below 20%; feedback to reporters was provided for only 0.4% of reports. CONCLUSION: Regular PV trainings and mentoring improved AE reporting in Cote d'Ivoire but further enhancement is required to improve passive safety surveillance. |
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| ジャーナル名 | Drug safety |
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| 投稿日 | 2023/11/15 |
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| 投稿者 | Mendoza, Yolanda Guerra; Jusot, Viviane; Adou, Felix; Ota, Martin; Elenge, Diego Mpia; Begum, Tasim; Mdladla, Nkululeko; Menang, Olga; Yavo, Jean Claude; Kamagate, Mamadou |
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| 組織名 | GSK, Wavre, Belgium.;GSK, Wavre, Belgium. viviane.x.jusot@gsk.com.;Autorite Ivoirienne de Regulation Pharmaceutique (AIRP), Abidjan, Ivory Coast.;GSK Consumer Healthcare, Warren, NJ, USA.;ViiV Healthcare, Johannesburg, South Africa.;PATH, Geneva, Switzerland.;Service de pharmacologie clinique, UFR-sciences medicales Bouake, universite;Alassane-Ouattara, Abidjan, Ivory Coast. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37966696/ |
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