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 |
Section | 一般 |
Research Field |
Medical pharmacy
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Research Institution | Nagoya City University |
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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Project Status |
Completed (Fiscal Year 2013)
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Budget Amount *help |
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2013: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2012: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Fiscal Year 2011: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
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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 / 医薬品・医療機器等安全性情報 / 安全性情報 |
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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Report
(4 results)
Research Products
(40 results)
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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)
Related Report
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[Journal Article] A whole-genome association study of major determinants for allopurinol-related Stevens-Johnson syndrome and toxic epidermal necrolysis in Japanese patients. Pharmacogenomics J.2013
Author(s)
Tohkin M, Kaniwa N, Saito Y, Sugiyama E, Kurose K, Nishikawa J, Hasegawa R, Aihara M, Matsunaga K, Abe M, Furuya H, Takahashi Y, Ikeda H, Muramatsu M, Ueta M,
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Journal Title
Pharmacogenomics J.
Volume: 13
Pages: 60-9
Related Report
Peer Reviewed
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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
Related Report
Peer Reviewed
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[Journal Article] Significant association between hand-foot syndrome and efficacy of capecitabine in patients with metastatic breast cancer.2012
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
Pages: 717-24
Related Report
Peer Reviewed
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[Presentation] 日本人における抗てんかん薬誘因性SJS/TEN とHIAタイプとの相関解析2013
Author(s)
杉山永見子,鹿庭なほ子,高橋幸利,古谷博和,村松正明,木下茂,造田泰誠,黒瀬光一,頭金正博,前川京子,矢上晶子,安部正通,外囲千恵,上田真由美,池田浩子,池揮善郎,松永佳世子,相原道子,斎藤嘉朗
Organizer
日本薬学会第133年会
Place of Presentation
横浜
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