Neurological Therapeutics
Online ISSN : 2189-7824
Print ISSN : 0916-8443
ISSN-L : 2189-7824
 
New PMDA initiative for safety measures based on electronic medical records
Yoshiaki Uyama
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2016 Volume 33 Issue 2 Pages 273-275

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Abstract

Pharmaceuticals and Medical Devices Agency (PMDA) has been working to establish a framework for pharmacoepidemiological (PEpi) drug safety evaluation in MIHARI Project (Medical Information for Risk Assessment Initiative) since FY 2009. In this project, PEpi studies utilizing electronic medical records (EMRs) database such as claim, DPC and Hospital Information System have been conducted for quantitative risk evaluation of a drug. Recently, a new initiative to establish large–scale HIS database called as Medical Information Database Network (MID–NET) has been started. In this way, a marked progress on drug safety evaluation based on EMRs has been made recently and further progress on this area will be needed for promoting a proper use of drugs based on scientific evidences.

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© 2016 Japanese Society of Neurological Therapeutics
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