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

Expert Opin Drug Saf

Medicines Authority, Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann, Malta.

Published: February 2022

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 pharmacists; 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 organized and in total 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.

Download full-text PDF

Source
http://dx.doi.org/10.1080/14740338.2022.1993820DOI Listing

Publication Analysis

Top Keywords

adr reporting
12
data quality
8
spontaneous adr
8
adr reports
8
reporting rates
8
reporting forms
8
physicians pharmacists
8
quality system
8
system audit
8
authority's adr
8

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!