月旦知識庫
  1. 熱門:
 
首頁 臺灣期刊   法律   公行政治   醫學   財經   社會學   教育   其他 大陸期刊   核心   非核心 DOI文章
查看詳細全文
篇名
藥品仿單標示外使用(Off-Label Use)
並列篇名
The Off-Label Use of Drugs
作者 許杏如林梅芳
中文摘要
藥品仿單(package insert)係附隨於藥品包裝內的使用說明書,其內容經過衛生主管機關的評估及確認後,刊載有關藥品之療效及安全性資料。藥品仿單標示外使用(off-label use)係指醫師開立處方未遵照藥品仿單之指示說明內容,如使用藥品未依仿單所載之適應症、劑量、患者群、給藥途徑或劑型等。藥品off-label use 在臨床治療是一個常見的處方類型,其存在之原因主要在於藥品仿單刊載內容過於限縮,提供之資訊不夠完整,其次是藥商怠於申請仿單變更。雖然off-label use 於臨床治療具有其重要性且不可或缺,然其中存有疑慮之處,則在於off-label use 之安全性及有效性脫逸衛生主管機關之確保,該如何控管其風險?是值得探討的議題!
英文摘要
The package inserts (label) accompanying with prescription drug packages outline the drug’s efficacy and safety informations, which have been reviewed and confirmed by the Department of Health. Off-label use refers to the prescription of a registered drug for a use that is not included or disclaimed in the package insert. Examples include use in a different indication, dose, patient population, route, or dosage form that is not approved by regulatory authorities. Prescribing drugs off-label is common in the medical community and some reasons can be attributed to the popularity of off-label uses. First package inserts usually do not show complete information of drug uses; second, drug manufacturers are not willing to obtain approval for off-label uses; and the last is off-label uses are essential for optimal patient care. It is admitted that off-label uses are necessary for clinical treatments, but several doubts also arise from that. Off-label drug uses create special risks, which do not arise when drugs are used in manners that are approved by Department of Health. Which measures should be taken to control the risks? The issues mentioned above need further discussion.
起訖頁 70-74
關鍵詞 仿單仿單標示外使用說明義務告知後同意Package insertOff-label useDuty of disclosureInformed consent
刊名 台灣醫學  
期數 201101 (15:1期)
出版單位 臺灣醫學會
該期刊-上一篇 癌症末期患者群集性症狀診治的新進展
該期刊-下一篇 醫療事故損害賠償之規範目的及法律原則
 

新書閱讀



最新講座


優惠活動




讀者服務專線:+886-2-23756688 傳真:+886-2-23318496
地址:臺北市館前路28 號 7 樓 客服信箱
Copyright © 元照出版 All rights reserved. 版權所有,禁止轉貼節錄