Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports.

ABSTRACT:

Introduction

Adverse event reporting patterns vary between countries, reflecting differences in reporting culture, clinical practice and underlying patient populations. Japan collects about 60,000 domestic adverse event reports yearly and shares serious reports with the World Health Organization (WHO) Programme for International Drug Monitoring in VigiBase, the WHO global database of individual case safety reports. Understanding these reports in the global context can be helpful for regulators worldwide and can aid hypothesis-generation for Japanese-specific vulnerabilities to adverse drug reactions.

Objective

The objective of this study was to explore differences in the reporting of adverse events between Japan and other countries.

Methods

vigiPoint is a method for d

SUBMITTER: Wakao R 

PROVIDER: S-EPMC6858382 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature