2021 Fiscal Year Final Research Report
Development of a new review algorithm for off-label use in cancer chemotherapy
| Project/Area Number |
19K10530
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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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| Review Section |
Basic Section 58010:Medical management and medical sociology-related
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| Research Institution | Gifu University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
村上 啓雄 岐阜大学, 医学部附属病院, 特任教授 (50273149)
鈴木 昭夫 岐阜大学, 医学部附属病院, 准教授 (80775148)
谷口 泰弘 岐阜大学, 大学院医学系研究科, 准教授 (90359737)
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| Project Period (FY) |
2019-04-01 – 2022-03-31
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| Keywords | 抗がん薬 / 適応外使用 / 特定機能病院 / 審査 |
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| Outline of Final Research Achievements |
Although all anticancer drugs were reviewed at 69% of Special Functioning Hospitals, there is a concern that the remaining 31% of institutions may have limited and inadequate reviewThe fact that a certain percentage of disapproval decisions existed indicates that proper review is being conducted A small number of institutions made disapproval decisions after considering ethical and social background, cost, patient prognosis, and availability of family members and other supporters.
In order to make decisions that include social background, it is desirable to have a multidisciplinary panel such as a HEC(Health Care Ethics Committee, Hospital Ethics Committee), rather than a committee consisting of only physicians and pharmacists.
Although off-label use has been shifted from the discretion of physicians to management by hospitals, there is no nationally uniform, quality-assured management method for off-label use, and a quality-assured management method needs to be established.
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| Free Research Field |
医療管理学、医事法、生命倫理
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| Academic Significance and Societal Importance of the Research Achievements |
特定機能病院は法令により医薬品等の適応外使用については病院としての管理がされている。ハイリスク薬である抗ガン薬の事前の審査状況について全国調査を実施した。審査項目は公的に定められておらず、各病院での差異が判明した.
倫理・社会的背景、費用、患者の予後、家族等の支援者の有無等を検討し不承認とした少数の施設がある。社会的背景を含む判断が行うには医師・薬剤師のみの委員会ではなく臨床倫理委員会のように多職種からなる合議体が望ましい。これまで医師の裁量による適応外使用から病院での管理に移行されたが、全国統一的な質が保証された適応外使用の管理方法はなく、質が担保された管理方法の構築が求められる。
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