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

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.

Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database

“…Another possible reason was that the healthcare system and workers were impacted heavily by the pandemic, which left them with less time and priority to report. A cross-sectional descriptive study conducted using the VigiFlow pharmacovigilance database in Sierra Leone between 2017 and 2021 found that the number of ICSRs was the highest in 2017 and 2019 (336 and 218 cases, respectively) [ 39 ]. Moreover, a decrease in reporting was noticed in 2020 (8 cases); however, this reduction continued into 2021 (3 cases), unlike in our study.…”

“…Moreover, a decrease in reporting was noticed in 2020 (8 cases); however, this reduction continued into 2021 (3 cases), unlike in our study. The increase in reporting in 2017 and 2019 was explained by the mass medication programs during that period [ 39 ].…”

Analysis of individual case safety reports of spontaneous reporting in adverse drug reaction monitoring centre at a tertiary care hospital

“…At the national level of pharmacovigilance, Vigiflow-an online safety data management system facilitates the standardized collection, processing, and sharing of ICSR data for analysis. 5…”

Adverse Drug Reactions Awareness Among Sample of People in Northern Region, Saudi Arabia

“…Death and perpetual disabilities can be caused by adverse drug reactions. It is important to recognize such reactions because they warn of future risks from a particular drug[s] and may require precautionary measures, treatment, dosage changes, or Cancellation of drug license [4,5]. Our purpose of the study to investigates the level of drug reaction awareness among the public in northern Saudi Arabia.…”