我国超说明书用药现象探析-中国药房.PDF

我国超说明书用药现象探析 ＊ 陈永法 ，黄 丽（中国药科大学国际医药商学院，南京 211198） 中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2013）13-1162-03 DOI 10.6039/j.issn. 1001-0408.2013.13.04 摘 要 目的：为规范我国超说明书用药行为提供对策参考。方法：依据相关文献及资料对超说明书用药的定义，对我国目前超 说明书用药行为进行界定、分类，分析我国超说明书用药现象普遍存在的原因、该行为的积极意义及潜在风险，提出相关对策。结 果与结论：界定超说明书用药即是指药品使用的适应证、给药方法或剂量不在官方批准的说明书用法之内。目前我国超说明书用 药行为包括扩大适应证用药、超剂量用药、改变用药方法和给药途径、超适用人群用药4类。导致超说明书用药现象普遍存在的 主要原因是儿童、孕妇用药品缺乏上市后临床试验数据，医药企业违规促销，新增适应证缺乏相应权益保障等。为规范超说明书 用药行为，建议制订超说明书用药管理办法和规定，加大对制药企业虚假促销的处罚力度及规范医师执业行为。 关键词 药品说明书；超说明书用药；适应证；原因分析；合理用药 Exploration of Off-label Drug Use in China CHEN Yong-fa ，HUANG Li （School of International Pharmaceutical Business ，China Pharmaceutical University ， Nanjing 211198，China ） ABSTRACT OBJECTIVE ：To provide reference for the regulation of off-label drug use in China. METHODS ：Based on the defi- nition of off-label drug use in literatures and materials ，the definition and classification of off-label drug use were introduced ，and the reason ，positive effects and risks of off-label drug use were analyzed to put forward relevant countermeasures. RESULTS CONCLUSIONS ：Off-label drug use means indication ，route of administration and dose beyond package insert issued by authority. Off-label drug use behaviors include expanding drug use for indication ，over-dosage drug use ，changing the method of drug use and route of administration ，drug use beyond applicable people. The lack of clinical data of drugs for children and pregnant wom- en ，the violated promotion of pharmaceutical companies and the lack of benefit protection of new indication all lead to the populari- ty of off-label drug use. Thus ，it is very important to formulate administrative regulations for off-label drug use ，to severely punish the pharmaceutical companies that promote off-label drug use illegally and to standardize the physicians ’behaviors in order to regu-