Drug, healthcare and patient safety · 2026
Quality and Timeliness of Pharmacovigilance Reporting in Malawi: A Cross-Sectional Analysis of Individual Case Safety Reports.
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Chiumia Francis Kachidza, Chimimba Frider T, Chirambo Evans Chimayi, Manja Ian Peter, Chadza Theophilus Rolland, Kantchilala Wilfred, Mchenga Peter, Nyirongo Happy Magwaza, Mkanda Wyson Mbewe, Khuluza Felix
Аннотация
BACKGROUND: Adverse events related to use of medicinal products are among the significant causes of morbidity and mortality. Quality of adverse event reports is essential for safety risk management. We therefore analyzed trends, timeliness and completeness of individual case safety reports (ICSRs) at a regional pharmacovigilance (PV) centre in Malawi.
METHODS: This was a cross-sectional study involving data extraction from ICSR reports that were submitted from 2017 to 2024. The data included patient demographics, adverse events, suspected products and reporter details. ICSR completeness was assessed using the vigiGrade® tool.
RESULTS: The PV centre received a total of 1,057 ICSRs during the targeted period. These included 940 (88.9%) ADR and 117 (11.1%) AEFI cases. Most of the ADRs were serious (56.1%, n=527) while most of the AEFIs were not serious (58.1%, n=68), p<0.001. Highest reporting rates were recorded in 2022. Most of the ADR cases were related to Isoniazid (16.6%, n=156), followed by tenofovir/lamivudine/dolutegravir (14.5%, n=136). For the AEFIs, most cases were related to pneumococcal conjugate (22.2%, n=26), followed by pentavalent vaccine (21.4%, n=25). The median vigiGrade score for the ADRs was 0.7 (95% CI: 0.7-0.9; IQR: 0.57-1). This was significantly lower (P<0.001) as compared to the AEFIs with a median score of 1 (95% CI: 1-1; IQR: 0.7 -1). There was no significant difference in transmission time between ADR and AEFI reports, p=0.106. The median duration for transmission of ADR reports was 19.5 days (95% CI: 17-21 days; IQR: 6-56 days), while the median time AEFI report transmission was 8 days (95% CI: 3-30.9 days; IQR: 1-156 days).
CONCLUSION: The study highlights poor quality and delayed reporting of adverse events. This may hinder safety signal detection, proper regulatory decision making and compromise patient safety. Strengthening digital reporting mechanisms would enhance quality reporting and streamline timely data flow.
METHODS: This was a cross-sectional study involving data extraction from ICSR reports that were submitted from 2017 to 2024. The data included patient demographics, adverse events, suspected products and reporter details. ICSR completeness was assessed using the vigiGrade® tool.
RESULTS: The PV centre received a total of 1,057 ICSRs during the targeted period. These included 940 (88.9%) ADR and 117 (11.1%) AEFI cases. Most of the ADRs were serious (56.1%, n=527) while most of the AEFIs were not serious (58.1%, n=68), p<0.001. Highest reporting rates were recorded in 2022. Most of the ADR cases were related to Isoniazid (16.6%, n=156), followed by tenofovir/lamivudine/dolutegravir (14.5%, n=136). For the AEFIs, most cases were related to pneumococcal conjugate (22.2%, n=26), followed by pentavalent vaccine (21.4%, n=25). The median vigiGrade score for the ADRs was 0.7 (95% CI: 0.7-0.9; IQR: 0.57-1). This was significantly lower (P<0.001) as compared to the AEFIs with a median score of 1 (95% CI: 1-1; IQR: 0.7 -1). There was no significant difference in transmission time between ADR and AEFI reports, p=0.106. The median duration for transmission of ADR reports was 19.5 days (95% CI: 17-21 days; IQR: 6-56 days), while the median time AEFI report transmission was 8 days (95% CI: 3-30.9 days; IQR: 1-156 days).
CONCLUSION: The study highlights poor quality and delayed reporting of adverse events. This may hinder safety signal detection, proper regulatory decision making and compromise patient safety. Strengthening digital reporting mechanisms would enhance quality reporting and streamline timely data flow.