W-03: Full Scale Implementation of Medical Information Database Network (MID-NET®) of 23 Hospitals for Drug Safety Assessment.
Poster Presenter
Sono Sawada
Epidemiologist
Pharmaceuticals and Medical Devices Agency (PMDA) Japan
Objectives
Establishing MID-NET® as a highly reliable and valuable database for post-marketing drug safety assessment.
Method
Reliability of MID-NET® was examined in various aspects including system validation, data quality and study feasibility. Regulatory framework to accept the study data has also been established by revising Ministerial Ordinance (Good Post-marketing Study Practice (GPSP)).
Results
Japan PMDA (Pharmaceuticals and Medical Devices Agency) has actively worked with 10 cooperative organizations (23 hospitals) and Ministry of Health and Labour and Welfare to establish MID-NET® toward full-scale implementation for post-marketing drug safety assessment. MID-NET® includes various types of data including order entry data (prescription, lab results, disease classifications etc.) and other medical procedures. Reliability of the system was verified by assessing error messages and validating application tools with different independent methods. High data quality in terms of consistency between original data and data stored in MID-NET® was confirmed by implementing quality management system. Pilot studies revealed that data from patients with broader backgrounds (age, gender, medical history, etc) are available for analysis and risks of adverse events induced by a drug can be objectively examined, especially for the events defined with a laboratory test result. Revised GPSP which created a new category for database utilization study as one of post-marketing studies was published in October 2017 and will be enforced in April 2018, resulting in a formal announcement to accept pharmacoepidemiological study results based on secondary use of real world data. Related guidelines such as “Basic principles on the utilization of health information databases for Post-Marketing Surveillance of Medical Products” and “Basic principles on planning of post-marketing studies” were also published.
Conclusion
MID-NET® will be made available to various users including pharmaceutical companies and academia in addition to PMDA and cooperative hospitals in 2018. Data corresponding to approximately 4 million patients are expected to be available in early 2018. MID-NET® is highly reliable and valuable database and can be utilized for conducting post-marketing studies more efficiently in Japan. It is expected that pharmacoepidemiological study results based on MID-NET® can be included as a part of documents for reexamination application in Japan in the near future.
