<b>5．Practical Use of Medical Database for Risk Management Plan (RMP)</b> / 薬剤疫学

ABSTRACT

The notification of RMP was released in 2012 and has been adapted for new drug submission since 2013. However, most cases are usual post-marketing surveillance studies. According to the ICH E2E guideline, various risk managements could be possible, especially using medical database. Recently, large database has been developed. There are two kinds of database, hospital information system including electronic medical records, and claim data. Activities of using medical database in Japan, US, and Europe are various. Based on FDA amendment acts, FDA launched Sentinel Initiative in 2008 and REMS works effectively. The Mini-Sentinel and OMOP published Common Data Model respectively. FDA also released guidance for pharmacoepidemiologic studies using electronic health data. In Europe, RMP has been implemented in 2005 and about 36% are epidemiologic studies. ENCePP which was established in 2006 provides register of pharmacoepidemiologic and pharmacovigilance studies, checklist for protocols and guide on methodological standards in pharmacoepidemiology. In Japan, PMDA provides guideline for pharmacoepidemiologic studies using medical database. Also, “MID-NET” which is the standardized medical database has been developed. As a notable activity, PMDA has conducted pilots as MIHARI project and itʼs quite promising.