藥品仿單標示外使用（Off | 合法藥品大搜索

藥品仿單（packageinsert）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 ...

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 specia...