Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting

Fawzi Thomas, Onome T. Abiri, James P. Komeh, Thomas A. Conteh, Abdulai Jawo Bah, Joseph Sam Kanu, Robert Terry, Arpine Abrahamyan, Pruthu Thekkur and Rony Zachariah
Additional contact information
Fawzi Thomas: National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone
Onome T. Abiri: National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone
James P. Komeh: National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone
Thomas A. Conteh: National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone
Abdulai Jawo Bah: College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone
Joseph Sam Kanu: College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone
Robert Terry: UNICEF, UNDP, World Bank, WHO Special Programme for Research and Training in Tropical Diseases (TDR), 1211 Geneva, Switzerland
Arpine Abrahamyan: Tuberculosis Research and Prevention NGO (TB-RPC), Yerevan 0014, Armenia
Pruthu Thekkur: Centre for Operational Research, International Union against Tuberculosis and Lung Disease, 75001 Paris, France
Rony Zachariah: UNICEF, UNDP, World Bank, WHO Special Programme for Research and Training in Tropical Diseases (TDR), 1211 Geneva, Switzerland

IJERPH, 2022, vol. 19, issue 6, 1-12

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.

Keywords: SORT IT; operational research; VigiBase; health system strengthening; universal health coverage (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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