To strengthen safety measures for medicines and other products, the Ministry of Health, Labour and Welfare will develop a medical information database using electronic medical records and other data over three years from 2011. On 26 May, it announced the healthcare institutions selected through an open call, including the Tokushukai Group.

The medical information database infrastructure project aims ultimately to build a database covering approximately ten million people. Its initial three-year objective is to use epidemiological methods to improve drug safety. The project will be undertaken jointly by the Ministry, the Pharmaceuticals and Medical Devices Agency (PMDA), and participating healthcare institutions. A budget of ¥740 million has been secured for fiscal 2011.

At present, adverse drug reactions are reported as individual cases, rather than as epidemiological data on populations. Without knowing how many people received a medicine, it is impossible to determine the incidence of adverse reactions. It is also difficult to distinguish effects of the underlying disease from adverse drug reactions. The project aims to address these issues and enable epidemiological analysis.

Each participating institution will anonymise information from electronic medical records, order entry systems for tests and prescriptions, medical fee claims and laboratory results in a form that permits linkage, creating a database for evaluating medicines. Challenges include standardising the ways patients' clinical symptoms are recorded. PMDA will prepare protocols for epidemiological studies and analysis, and participating institutions will send the data required for those studies to PMDA.

Launching with seven university hospitals and three hospital groups

Sixteen hospitals and four groups applied by the 25 April deadline. Seven university hospitals were selected: Tohoku, Chiba, Tokyo, Hamamatsu University School of Medicine, Kagawa, Kyushu and Saga. The three selected groups were the Kitasato University and Kitasato Institute affiliated hospitals, the NTT hospital group and the Tokushukai Group.

Since November 2009, Tokushukai Information System, Inc. (TIS) has led efforts to standardise medical information across Tokushukai. President Katsuhiko Ozaki welcomed the project: “We hope it will clarify the national approach to standardising medical information, including clinical data. By participating, we believe Tokushukai can further advance standardisation across the Group in line with that approach.”

The Group will begin at ten hospitals: Matsubara Tokushukai Hospital, Nozaki Tokushukai Hospital, Kishiwada Tokushukai Hospital and Yao Tokushukai General Hospital in Osaka; Uji Tokushukai Hospital in Kyoto; Nagoya Tokushukai General Hospital; Fukuoka Tokushukai Hospital; Chigasaki Tokushukai General Hospital in Kanagawa; Sapporo Tokushukai Hospital; and Tokyo Nishi Tokushukai Hospital. It plans eventually to expand to 66 hospitals.

Source: Tokushukai Newspaper, 27 June 2011, No. 780