| アブストラクト | Background: Monitoring of adverse drug reactions (ADRs) to antimicrobials is important, as they can cause life-threatening illness, permanent disabilities, and death. We assessed country-wide ADR reporting on antimicrobials and their outcomes. Methods: A cross-sectional study was conducted using individual case safety reports (ICSRs) entered into the national pharmacovigilance database (VigiFlow) during 2017-2021. Results: Of 566 ICSRs, inconsistent reporting was seen, with the highest reporting in 2017 and 2019 (mass drug campaigns for deworming), zero reporting in 2018 (reasons unknown), and only a handful in 2020 and 2021 (since COVID-19). Of 566 ICSRs, 90% were for antiparasitics (actively reported during mass campaigns), while the rest (passive reporting from health facilities) included 8% antibiotics, 7% antivirals, and 0.2% antifungals. In total, 90% of the reports took >30 days to be entered (median = 165; range 2-420 days), while 44% had <75% of all variables filled in (desired target = 100%). There were 10 serious ADRs, 18 drug withdrawals, and 60% of ADRs affected the gastrointestinal system. The patient outcomes (N-566) were: recovered (59.5%), recovering (35.5%), not recovered (1.4%), death (0.2%), and unknown (3.4%). There was no final ascertainment of 'recovering' outcomes. Conclusions: ADR reporting is inconsistent, with delays and incomplete data. This is a wake-up call for introducing active reporting and setting performance targets. |
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| ジャーナル名 | International journal of environmental research and public health |
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| 投稿日 | 2022/3/26 |
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| 投稿者 | Thomas, Fawzi; Abiri, Onome T; Komeh, James P; Conteh, Thomas A; Bah, Abdulai Jawo; Kanu, Joseph Sam; Terry, Robert; Abrahamyan, Arpine; Thekkur, Pruthu; Zachariah, Rony |
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| 組織名 | National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown;02717, Sierra Leone.;College of Medicine & Allied Health Sciences, University of Sierra Leone,;Freetown 02717, Sierra Leone.;Institute of Global Health and Development, Queen Margaret University, Edinburgh;EH21 6UU, UK.;National Disease Surveillance Program, Directorate of Health Security and;Emergencies, Ministry of Health and Sanitation, Freetown 02717, Sierra Leone.;UNICEF, UNDP, World Bank, WHO Special Programme for Research and Training in;Tropical Diseases (TDR), 1211 Geneva, Switzerland.;Tuberculosis Research and Prevention NGO (TB-RPC), Yerevan 0014, Armenia.;Centre for Operational Research, International Union against Tuberculosis and;Lung Disease, 75001 Paris, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35328953/ |
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