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題 名 | 實證藥學面面觀=Legal and Social Aspects of Pharmaceutical Evidence-Based-Medicine |
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作 者 | 王惠珀; | 書刊名 | 藥學雜誌 |
卷 期 | 31:4=125 2015.12[民104.12] |
頁 次 | 頁2-8 |
分類號 | 418.1 |
關鍵詞 | 實證藥學; 藥品智慧財產權; 藥事法第40條之1及之2; 藥品三同政策; Hatch-Waxman Amendments; Generic Drug Law; |
語 文 | 中文(Chinese) |
中文摘要 | 爾來,健保用藥的爭議浮上媒體,成為社會熱門議題。媒體及民間發聲團體對利 益導向的藥品爭戰不求甚解,以訛傳訛,亂象浮現,讓吃藥這件事變得極其複雜,顯 示台灣的藥學仍停留在產品管理的思維,尚未進入二十一世紀以實證藥學 (evidencebased- medicine) 為思維的管理層次。社會追求永續須行之以道,本文旨在闡述實證藥 學的定義、科學上的立論基礎、法規 (邏輯) 的意涵、管理學上的應用、以及在藥事 經濟學上的詮釋。 |
英文摘要 | The transformation of pharmaceutical regulation from product management of medicine to risk management in medication is a global trend. This conceptual change, initiated by the International Conference of Harmonization, is fundamentally judged with the term evidencebased- medicine (EBM). Using Hatch-Waxman Amendments (Drug Price Competition and Patent Term Restoration Act, 1984 USA) as an example, this article described how the pharmaceutical regulatory body of Taiwan adopted the concept of evidence-based-medicine to form the Generic Drug Law. The implementation, the difficulties encountered during the implementation, and the pharmaco-economic impacts is discussed. |
本系統中英文摘要資訊取自各篇刊載內容。