2015 Volume 5 Issue 3 Pages 235-243
Pharmaceuticals and Medical Devices Agency (PMDA) has evaluated the safety of drugs primarily relying on the traditional information such as spontaneous adverse drug reaction (ADR) reports or post-marketing surveillance results, etc. ADR reports have contributed to safety assessment by PMDA, but have some limitations such as underreporting, incomplete and a lack of denominator. Consequently, for further reinforcement and enhancement of safety measures, the PMDA has launched the MIHARI (“Medical Information for Risk Assessment Initiative”) Project in the second mid-term plan (FY 2009 to FY 2013) to develop a new safety assessment framework of quantitative evaluation using electronic health records (EHRs). The PMDA is applying this framework into a real situation of risk management of drug safety in the third mid-term plan (FY 2014 to FY 2018). In addition, the PMDA has started to develop a new database system (MID-NET) in collaboration with Ministry of Health, Labour and Welfare (MHLW) and 10 selected collaborative medical institutions.In the MID-NET system, EHRs (including ordering data and laboratory test data) and medical claims data are converted and integrated into databases in each institution. To utilize these databases, users including the PMDA are supposed to send “data extraction script set” from “the data center” to these institutions. Each institution accepts the script set and sends the output results back to the data center, which will then be summarized and analyzed by the user. The PMDA has been working to validate the integrity of the MID-NET system for full implementation in 2018. The MID-NET system is expected to allow users to conduct quantitative safety assessments and to take more effective safety measures.
