Criminal Liability of Off-Label Use

• Main Authors: Liao, Ya Yu, 廖雅郁
• Other Authors: Hsu, Heng Da
• Format: Others
• Language: zh-TW
• Published: 2015
• Online Access: http://ndltd.ncl.edu.tw/handle/60794345404443510532

碩士 === 國立政治大學 === 法學院碩士在職專班 === 104 === After marketing approval, the labels of on drug packages should outline the indications for use, dosage, administrative directions, and safety information. The use of drug could expand over time. Off-label use, which means prescribing an approved drug for a use that is not claimed in the product information, is common in medical practice, especially for some serious or rare diseases. Since there is no regulation for off-label use , a number of clinical , legal and ethical issues arise. According to Taiwan Drug Relief Foundation for Drug Hazards’ statistics regarding the rejected reasons by foundation from 1030 application cases 1999 to 2015. The 2nd reason for unapproved cases is off-label use which is around 23% of total unapproved cases. This shows current criteria for drug relief is quite not fit in real world practice. Medicine is intended to save patients’ lives and to help patients reach renewed health. During the process of treatment, the risk versus benefit profile beyond the original product approval should first be taken into consideration. In Taiwan, the department of health provides an guidance regarding off-label use, ex: The necessity of informed consent before prescribing off-label products. Do physicians need to follow the duty of informed consent whiling prescribing a drug which is off-label use? There should be a guidance to follow in this regard. This study has established the principles and flow chart of off-label use. We suggest that some amendments to the laws are necessary, including setting up the scope of the duty of disclosure.