Trends in adverse drug reaction reporting in eight selected countries after the implementation of new pharmacovigilance regulation in 2012: a joinpoint regression analysis

This study shows the significant upward trends in overall ADR reporting not only in the countries that implemented consumer ADR reporting systems after the 2012 EU pharmacovigilance legislation but also in countries that had consumer reporting systems before 2012. Moreover, significant downward trends in the ratios of HCP-to-consumer ADR reporting were documented for all EU countries, confirming increasing consumers' involvement in ADR reporting. Further, larger scale studies with the involvement of more countries are needed to better understand the trends in ADR reporting, and multifaceted interventions are warranted to be installed to enhance ADR reporting.