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.

Background: The quality of pharmacovigilance data is important for guiding medicine safety and clinical practice. In baseline and follow-up studies after introducing interventions to improve the quality of reporting of Individual Case Safety Reports (ICSRs) in Sierra Leone, we compared (a) timeliness and completeness of reporting and (b) patient outcomes classified as ‘recovering’. Methods: Baseline (January 2017–December 2021) and follow-up (June 2022–April 2023) studies of ICSRs in the national pharmacovigilance database. Interventions introduced following recommendations from the baseline study included: updating standard operating procedures and guidelines, setting performance targets follow-up of patient outcomes, and training. Results: There were 566 ICSRs in the baseline study and 59 in the follow-up study. Timelines (reporting < 30 days) improved by five-fold (10% at baseline to 47% in follow-up). For the completeness of variables in ICSRs (desired threshold ≥ 90%),this was 44% at baseline and increased to 80% in the follow-up study. ‘Recovering’ outcomes reduced from 36% (baseline study) to 3% (follow-up study, p < 0.001). Conclusions: Significant improvements in timeliness, completeness, and validation of ICSRs were observed following operational research in Sierra Leone. While enhancing pharmacovigilance and patient safety, this study highlights the important synergistic role operational research can play in improving monitoring and evaluation systems.