2013 Fiscal Year Final Research Report
The effectiveness of risk communication regarding drug safety information: A nationwide survey by the Japanese public health insurance claims data
| Project/Area Number |
23590213
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical pharmacy
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| Research Institution | Nagoya City University |
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Principal Investigator |
TOHKIN Masahiro 名古屋市立大学, 薬学研究科(研究院), 教授 (00270629)
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| Project Period (FY) |
2011 – 2013
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| Keywords | ナショナルレセプトデータベース / 副作用 / 医療機器等安全性情報 |
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| Research Abstract |
We evaluated the effectiveness of warning letters published by pharmaceutical regulatory agencies in Japan on communication of drug safety and risk by quantitative analysis of the national health insurance claims database (NHICD). We then explored what factors may have affected risk communication. The implementation rate of the hepatitis virus-monitoring test was only 1.6% of all MTX-administrated RA patients, with little difference before and after the official announcement by warning letter. The implementation rates of inpatient hepatitis B virus or hepatitis C virus monitoring in hospitals equipped with drug information management room (DIMR) and drug safety information management systems (DSIMS) were higher than those in hospitals without these systems. Thus, DIMRs and DSIMS efficiently transmit medication safety information.
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[Journal Article] Evaluation of two Japanese regulatory actions using medical information databases : a 'Dear Doctor' letter to restrict oseltamivir use in teenagers, and label change caution against co-administration of omeprazole with clopidogrel2014
Author(s)
Hanatani T, Sai K, Tohkin M, Segawa K, Antoku Y, Nakashima N, Yokoi H, Ohe K, Kimura M, Hori K, Kawakami J, Saito Y
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Journal Title
J Clin Pharm Ther
Volume: (Epub ahead of print)
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[Journal Article] Significant association between hand-foot syndrome and efficacy of capecitabine in patients with metastatic breast cancer2012
Author(s)
Azuma Y, Hata K, Sai K, Udagawa R, Hirakawa A, Tohkin M, Ryushima Y, Makino Y, Yokote N, Morikawa N, Fujiwara Y, Saito Y, Yamamoto H
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Journal Title
Biol Pharm Bull
Volume: 35(5)
Pages: 717-24
Peer Reviewed
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