Pharmacovigilance regulatory actions by National Pharmacovigilance
centres in fourteen Middle Eastern Countries following COVID-19 Pandemic
Abstract
Background. Globally, pharmacovigilance activities were affected by
COVID-19. Therefore, several competent health authorities around the
world, including several countries in the Middle East, have issued
guidelines and practices to ensure that pharmacovigilance activities are
maintained and continued during the pandemic. Objective. The aim of this
study was to assess the impact of COVID-19, preparedness and performance
of national pharmacovigilance systems in participating countries during
COVID-19 pandemic. Methods. This was a cross- sectional study that was
conducted between July and October 2020. National pharmacovigilance
centres in 18 Arab countries in the Middle East 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%) Arab countries. Ten of participating countries (71.4%)
have either specific national PV guidelines or local PV practices during
the COVID-19 pandemic. 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
centres vary considerably among participating countries during the
pandemic. Conclusion. The findings highlight the differences in
preparedness and performance of different national PV centres in
participating Middle Eastern countries. Improving digital infrastructure
among participating countries could serve as a useful tool to minimize
the impact of the pandemic on PV activities.