Diverse pharmacovigilance jurisdiction-The right way for global drug safety?

Abstract

Purpose: The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities.

Methods: Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope.

Results: The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates.

Conclusions: ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.

Keywords: Adverse drug reaction reporting; Canada; China; Czech Republic; Japan; Legislation; Pharmacovigilance; United Kingdom; United States.