Efforts for Pharmacoepidemiological Drug Safety Assessments Utilizing Electronic Healthcare Databases

Abstract

Pharmaceuticals and Medical Devices Agency (PMDA) has assessed drug safety primarily based on the traditional information such as spontaneous adverse drug reaction reports and post-marketing surveillance results. To overcome the limitation on this approach and to strengthen post-marketing drug safety measures, many efforts has been taken in PMDA in the past several years and are described in this article. Launched in 2009 by PMDA, MIHARI Project-Medical Information for Risk Assessment Initiative aims to establish a new framework for pharmacoepidemiological drug safety assessments utilizing electronic healthcare databases. In this project, many pilot studies have been conducted to characterize the databases including claims data, hospital information system data and Diagnosis Procedure Combination data. Based on many findings and experiences from the pilot studies, a new framework for drug safety assessments was formally implemented in 2014. In 2011, another project called as “MID-NET^®” was launched to develop a new system to actively analyze diverse electronic healthcare data from multiple hospitals in Japan for post-marketing drug safety measures. Studies on data quality and analytical validations including various pilot studies are currently conducted toward full-scale operation of MID-NET^® in 2018. PMDA will continue our challenges to promote public health through these activities.