Kaori Yamada1, Maori Itoh1, Yoshiaki Fujimura2, Michio Kimura3, Koichiro Murata4, Naoki Nakashima5, Masaharu Nakayama6, Kazuhiko Ohe7, Takao Orii8, Eizaburo Sueoka9, Takahiro Suzuki10, Hideto Yokoi11, Chieko Ishiguro1, Yoshiaki Uyama1. 1. Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan. 2. Head Office, Tokushukai Information System Incorporated, Osaka, Japan. 3. Department of Medical Informatics, Hamamatsu University Hospital, Shizuoka, Japan. 4. Department of Radiology, Kitasato University Hospital, Kanagawa, Japan. 5. Department of Advanced Information Technology, Kyushu University Hospital, Fukuoka, Japan. 6. Medical Informatics, Tohoku University Graduate School of Medicine, Miyagi, Japan. 7. Department of Healthcare Information Management, The University of Tokyo Hospital, Tokyo, Japan. 8. Department of Pharmacy, NTT Medical Center Tokyo, Tokyo, Japan. 9. Department of Laboratory Medicine, Saga University Hospital, Saga, Japan. 10. Department of Medical Informatics, Chiba University Hospital, Chiba, Japan. 11. Department of Medical Informatics, Kagawa University Hospital, Kagawa, Japan.
Abstract
PURPOSE: To examine the potential role of Medical Information Database Network (MID-NET® ), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies. METHODS: The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark® ) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions. RESULTS: The pilot studies were successfully conducted and demonstrated the value of MID-NET® in postmarketing drug safety assessments. In particular, the ability to utilize laboratory test results as objective clinical indicators is a major advantage of this database. Potential limitations include a relatively small sample size and a lack of patient-level data linkages among hospitals. CONCLUSIONS: MID-NET® was confirmed to be a valuable database for postmarketing drug safety assessments. The use of laboratory test results to define clinical outcomes may allow more objective and accurate analyses to be conducted. These studies furthered our understanding of the characteristics of MID-NET® , including its advantages and limitations.
PURPOSE: To examine the potential role of Medical Information Database Network (MID-NET® ), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies. METHODS: The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark® ) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions. RESULTS: The pilot studies were successfully conducted and demonstrated the value of MID-NET® in postmarketing drug safety assessments. In particular, the ability to utilize laboratory test results as objective clinical indicators is a major advantage of this database. Potential limitations include a relatively small sample size and a lack of patient-level data linkages among hospitals. CONCLUSIONS: MID-NET® was confirmed to be a valuable database for postmarketing drug safety assessments. The use of laboratory test results to define clinical outcomes may allow more objective and accurate analyses to be conducted. These studies furthered our understanding of the characteristics of MID-NET® , including its advantages and limitations.