美法两国对超说明书用药监管对策及其借鉴启示  

Supervision strategies on off-label drug use in America and France and its enlightment

作　　者：郭俊荣 张方[1] GUO Jun-rong;ZHANG Fang(School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China;The Clinical Center of Pharmacy Department, PLA General Hospital, Beijing 100853, China)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016 [2]解放军总医院药学部临床药学中心,北京100853

出　　处：《中国药物应用与监测》2019年第1期46-49,共4页Chinese Journal of Drug Application and Monitoring

基　　金：辽宁省教育厅服务地方项目(2017WFW05)

摘　　要：超说明书用药在国内外比较常见,对其监管显得尤为重要。本文通过查阅文献对美、法两国超说明书用药监管策略进行分析,旨为我国超说明书用药监管对策提供参考。法国对超说明书用药采用"临时使用建议"策略,旨在通过对超说明书用药患者建立患者监测框架和数据收集,确保超说明书用药的安全性和有效性。美国采取对制药企业严禁促销手段进行超说明书用药的监管,设立多渠道参考超说明书用药信息来源,监测医师处方行为,以避免不合理的超说明书用药。参考美、法两国对超说明书用药的监管对策,结合我国国情建议我国首先应出台超说明书用药的相关法律,设立国家级超说明书用药评审委员会,规范医院内部超说明书用药操作流程,对超说明书用药患者进行密切追踪并监测数据,将超说明书用药的风险降至最低。Off-label drug use is common at home and abroad, and their supervision is particularly important. The literature investigation was adopted by analyzing the supervision methods for off-label drug use in France and the United States and the supervision recommendations for off-label drug use for our country were put forward. The temporary recommendations for use (TRU) strategy for off-label drug use was adopted in France, which aims to ensure the safety and effectiveness of off-label drug use by establishing the framework of monitoring and data collection for patient. The United States adopted a ban on prohibiting the promotion of off-label drug use by pharmaceutical companies, established multi-channel reference sources for off-label drug use, and monitored physician prescribing practices to avoid unreasonable off-label drug use. China should first introduce the relevant laws of off-label drug use, set up a national-level drug review board to supervise the use of drugs, standardize the operation flow of off-label drug use in hospitals, and closely monitor patients with off-label drug use, and monitor data to minimize harm.

关 键 词：超说明书用药 监管对策 美国 法国 

分 类 号：R95[医药卫生—药学]