ArticleInternational journal of environmental research and public health2022
Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017-2021): A Wake-Up Call to Improve Reporting.
Article in International journal of environmental research and public health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The trial behind it
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Who cites it
8 citing papers in PubMed, 14 citations in OpenAlex.
- Trends and Patterns of Adverse Drug Reaction Reporting in Sierra Leone: A Retrospective Analysis of VigiFlow Data (2008-2022).Pharmacoepidemiology and drug safety · 2026Article
- Quality and Timeliness of Pharmacovigilance Reporting in Malawi: A Cross-Sectional Analysis of Individual Case Safety Reports.Drug, healthcare and patient safety · 2026Article
- Article
- Capacity Assessment of the National Medicines Regulatory Authority in a Low -Income Country.Therapeutic innovation & regulatory science · 2024Article
- A retrospective analysis of the pharmacovigilance data registry in a tertiary teaching hospital in Jordan.Journal of pharmaceutical policy and practice · 2024Article
- Adverse Events Following Immunization with Novel Oral Polio Vaccine Type 2, and the Experience and Challenges of Reporting in Sierra Leone.Drug, healthcare and patient safety · 2024Article
- Quality of Reporting of Adverse Drug Reactions to Antimicrobials Improved Following Operational Research: A before-and-after Study in Sierra Leone (2017-2023).Tropical medicine and infectious disease · 2023Article
- Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database.Antibiotics (Basel, Switzerland) · 2023Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 4 countries.
Funding
Abstract
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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Registered trials
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