Quality of Reporting of Adverse Drug Reactions to Antimicrobials Improved Following Operational Research: A before-and-after Study in Sierra Leone (2017-2023).
Trop Med Infect Dis
; 8(10)2023 Oct 09.
Article
em En
| MEDLINE
| ID: mdl-37888598
ABSTRACT
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Trop Med Infect Dis
Ano de publicação:
2023
Tipo de documento:
Article