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

ABSTRACT:

Background and purpose

Underreporting of adverse drug reactions (ADRs) remains to be a challenge in modern health care. Major reforms in the EU pharmacovigilance system in 2012 introduced the legal basis for consumers to report suspected ADRs. This study was designed to determine trends in overall ADR reporting, the ratio of health care professional (HCP)-to-consumer ADR reporting, and the ratio of serious-to-nonserious ADR reporting for an 11-year period in the selected non-EU and EU countries that had implemented systems for consumers' reporting before the 2012 EU pharmacovigilance legislation and those that did not have.

Materials and methods

The national competent authorities of 15 countries (11 EU countries, former EU member the UK, Australia, Canada, and the USA) were

SUBMITTER: Masiliuniene G 

PROVIDER: S-EPMC12398448 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature