Quality of reporting of adverse drug reactions to antimicrobials improved following operational research: A before-and-after study in sierra leone (2017-2023)

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) timelines...

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Published in:Tropical medicine and infectious disease 2023-10, Vol.8 (10), p.1-9
Main Authors: Conteh, Thomas A, Thomas, Fawzi, Abiri, Onome T, Komeh, James P, Kanu, Abdulai, Kanu, Joseph Sam, Fofanah, Bobson Derrick, Thekkur, Pruthu, Zachariah, Rony
Format: Article
Language:English
Subjects:
Administration
Anti-infective agents
Brief Report
Clinical outcomes
Data processing
drug safety
Drugs
Elevator pitch
Evaluation
health systems strengthening
Medical research
Medicine, Experimental
operational research
Operations research
Patients
Pharmacovigilance
Quality control
Safety measures
Side effects
SORT IT
VigiBase
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Summary: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 're- covering'. 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.
ISSN:2414-6366
2414-6366
DOI:10.3390/tropicalmed8100470