藥品仿單標示外使用(Off-Label Use)

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！

關鍵字

仿單；仿單標示外使用；說明義務；告知後同意

並列摘要

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.

並列關鍵字

package insert ； off-label use ； duty of disclosure ； informed consent

國際替代計量

藥品仿單標示外使用(Off-Label Use)

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