| 摘要: | 為確保藥品安全性及有效性，藥品必須經衛生主管機關審核並發給許可證才能於市面販售。在仿單中藥品劑量、用法、適應症範圍內，是經過主管機關審查後確認具有安全性及有效性。但因為各種原因，醫師常會以標示外使用（off-label use）方式處方藥品。關於off-label use之法律性質與合理範圍、使用標準等，我國相關法律規範不明確，而醫界、學界、法界彼此間存有歧異。
國內關於off-label use之研究文獻已討論單一藥品、法律定性、責任、藥害救濟補償，或對於醫師進行問卷調查。本論文以質性訪談瞭解臨床現象及醫師態度，發現與結論如下：一、Off-label use在國內法律上應為有條件合法之醫療行為，並非人體試驗或使用新藥。二、受訪醫師認為off-label use有其存在之必要，但也有安全上的疑慮。三、受訪醫師對於off-label use合法性認知不一，期望能有明確規則可循。四、合理的Off-label use類型，應可有條件納入藥害救濟給付範圍。五、國內主管機關應改進申請及統一適應症之機制。
Drugs cannot be lawfully marketed until drug authority has examined their safety and effectiveness. The drug authority has only approved the doses, methods of use, and indications listed in the drug labels. But physicians often prescribe off-label use for various reasons. The law in Taiwan concerning off-label use is not clear. The lawfulness, reasonable scope and prescribing standards of off-label use are sometimes disputed, and medical and legal professionals have conflicting opinions.
The existing literature on off-label use in Taiwan has studied issues of liability and compensation, or surveyed physicians’ prescribing behavior from quantitative perspective. The research focuses on the attitudes of clinicians in Taiwan and has five conclusions. First, off-label use should follow Taiwan guideline of medical treatment without the need to do human experiments or follow the regulations for new drugs. Second, off-label use is sometimes necessary, but it does have some risks from clinicians’ view. Third, many clinicians still have no clear ideas about the legality of off-label use, and the government should promulgate clear legal rules as soon as possible. Forth, the Taiwan Drug relief system has to change and compensate some types of off-label use. Five, the drug authority should improve the system of registration and unification for drug indications. |
