Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries

Abstract

Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries. Fifteen countries (eight Western countries and seven Asian countries) were purposively selected. A questionnaire survey was distributed to national pharmacovigilance authorities in those countries. Nine countries (five Western countries and four Asian countries) returned the questionnaire. A review of the websites of national pharmacovigilance centres was conducted. The proportion of patient reports in the selected Western countries ranged from 57.83% to 14.37%, while it was accounted for less than 1% in the selected Asian countries. Currently, patients in all nine countries can report adverse drug reactions online via a website. The number of clicks from the national pharmacovigilance website to reach the online reporting form range from one to five clicks. Countries with higher patient reporting rates seemed to share the following characteristics; provision of feedback, engagement with patient organizations, and implementation of several activities to raise the awareness of the general public on the importance of pharmacovigilance. To increase the number of patient reports, the strengths of each country’s system should be adopted.