期刊
EXPERT OPINION ON DRUG SAFETY
卷 22, 期 2, 页码 165-174出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/14740338.2022.2108398
关键词
Pharmacovigilance; COVID-19; drug regulation; health authority; Middle East; adverse event reporting
The preparedness and performance of national pharmacovigilance systems in 14 Arab countries were impacted by COVID-19. There are significant differences in the preparedness and performance of national pharmacovigilance centers among participating countries. Improving digital infrastructure could be a useful tool to minimize the impact of the pandemic on pharmacovigilance activities.
Background Pharmacovigilance (PV) activities were affected by COVID-19. Therefore, several health authorities around the world have issued guidelines and practices to ensure that PV activities are maintained and continued during the pandemic. This study aimed to assess the impact of COVID-19 on the preparedness and performance of national PV systems in 14 Arab countries. Research design and methods This was a cross-sectional study that was conducted between July and October 2020. National PV centers in 18 Arab countries were invited to participate in this study. Descriptive analysis was used to summarize and present the results of this study. Results Responses were obtained from 14 (77.8%) countries. Adverse events reporting was the main PV activity that was covered by PV guidelines and practices. National guidelines and practices covered other PV activities in 8 (57.14%) of the participating countries. Performance and practices of national PV centers vary considerably among participating countries during the pandemic. Conclusion The findings highlight the differences in preparedness and performance of different national PV centers in participating Arab countries. Improving digital infrastructure among participating countries could serve as a useful tool to minimize the impact of the pandemic on PV activities.
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