超药品说明书用药及其国际经验与思考_胡偌碧.pdfVIP

热点追踪 Hot Topics 超药品说明书用药及其国际经验与思考 1 2 2* 胡偌碧 ，徐春敏 ，赵志刚 1.北京大学医学部基础医学院，北京 100083； 2.首都医科大学附属北京天坛医院药剂科，北京 100050 [摘要] 药品说明书是具有法律效力的用药指导文件，但药学是由实践而产生的科学，这就决定了药品说明书一定会滞后于临 床实践，临床上对某些特殊患者的诊治需要超药品说明书用药。本文对超药品说明书用药的定义、分类、产生原因、风险及 国际经验做一综述并提出相关建议。超药品说明书用药虽具有一定的合理性，也符合国际惯例，但也可以引发政策法规、用 药安全等方面的一系列问题，存在较大的风险，临床应充分权衡利弊，谨慎、循证使用。我国在超药品说明书问题的政策完 善方面与美国存在一些差距，我国应进一步完善、充实相关政策法规，促进医药事业的发展。 [关键词] 超药品说明书用药；产生原因；风险；国际经验 [中图分类号] R951 [文献标识码] A [文章编号] 1672-2809(2012)02-0006-05 IIntroduction and International Experience of Unlicensed and Offntroduction and International Experience of Unlicensed and Off--label Drug Useslabel Drug Uses 1 2 2* HU Ruo-bi , XU-Chun-min ，ZHAO Zhi-gang 1.School of basic medical science, Peking University, Beijing 100191,China; 2.Department of pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing 100050,China [[Abstract] Package insert medication is legally binding guidancAbstract] e documents, but medicine is a science arising from the practice, which determines the package insert will lag behind the clinical practice, patients with clinical diagnosis and treatment of some special instructions that require unlicensed and off-label drug uses. This article introduces the basic information (definition, classification) of unlicensed and off-label drug uses and reviews the reasons, risks, and international experience arose from unlicensed and off-label drug uses in order to promote safe and reasonable drug uses. Although the existence of unlicensed and off-label drugs uses has its rationality, and it has been accepted by some countries, it may cause some problems related to drug safety, laws and regulations. To further reduce the gap between China and the United States in the policies of unlicensed and off-label drug uses, we should improve relevant policies on unlicensed and off-label drug uses in order to promote the development of medicine and dru