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Improving the data quality of spontaneous ADR reports: a practical example from Malta

Authors :
Marta Zuccarelli
Benjamin Micallef
Dianne Butler
Anthony Serracino-Inglott
John-Joseph Borg
Source :
Expert Opinion on Drug Safety. 21:253-268
Publication Year :
2021
Publisher :
Informa UK Limited, 2021.

Abstract

Background Adverse drug reaction (ADR) reporting rates and high-quality data within case summary reports are crucial to detect emerging safety concerns and implement regulatory action. In this study we aimed to improve the data quality and reporting rates of ADR reports in Malta through a series of national activities. Research design and methods Between April 2018 and July 2019, we carried out the following activities: i) a review of wholesale dealers ADR reporting forms; ii) a series of educational workshops targeting physicians and pharmacist; iii) a quality system audit of the Authority's ADR management process. Results Twelve wholesaler dealer forms were reviewed, and 155 improvements were identified. Incident reporting forms modified to capture ADRs had the most opportunities for improvement. Five workshops were organised and a total of 62 physicians and 22 pharmacists attended. Although feedback from participants was positive, in our case, an increase in reporting was not observed following the workshops. The quality system audit resulted in the introduction of the "four-eye principle" to the Authority's ADR management process. Conclusions The implementation of such activities is expected to contribute to the overall pharmacovigilance systems in Malta and our experience could benefit other entities involved in spontaneous ADR reporting.

Details

ISSN :
1744764X and 14740338
Volume :
21
Database :
OpenAIRE
Journal :
Expert Opinion on Drug Safety
Accession number :
edsair.doi.dedup.....6064c6c5d7e9f2c0148d76d1295d7e8e
Full Text :
https://doi.org/10.1080/14740338.2022.1993820