Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017-2021): A Wake-Up Call to Improve Reporting.
Int J Environ Res Public Health
; 19(6)2022 03 10.
Article
in English
| MEDLINE | ID: covidwho-1765706
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Drug-Related Side Effects and Adverse Reactions
/
COVID-19
/
COVID-19 Drug Treatment
Type of study:
Observational study
/
Randomized controlled trials
Limits:
Humans
Country/Region as subject:
Africa
Language:
English
Year:
2022
Document Type:
Article
Affiliation country:
Ijerph19063264
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