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“药品说明书之外的用法”相关问题研究
引用本文:李延敏,杨悦.“药品说明书之外的用法”相关问题研究[J].中国药房,2010(37):3469-3471.
作者姓名:李延敏  杨悦
作者单位:沈阳药科大学工商管理学院,沈阳市110016
摘    要:目的:为规范我国"药品说明书之外的用法"提供参考。方法:介绍"药品说明书之外的用法"的定义及引发的问题,分析美国有关"药品说明书之外的用法"的监管和研究进展。结果与结论:"药品说明书之外的用法"可能导致用药安全、药品监管、医疗保险、企业宣传等方面的一些问题。我国可借鉴美国针对"药品说明书之外的用法"的相关举措,通过建立监管机构、行业协会、医护人员三位一体的合作模式,来规范我国市场上"药品说明书之外的用法"的使用。

关 键 词:药品说明书之外的用法  监管  研究  进展

Study on Relevant Issues of Drug Usage beyond Dispensatory
LI Yan-min,YANG Yue.Study on Relevant Issues of Drug Usage beyond Dispensatory[J].China Pharmacy,2010(37):3469-3471.
Authors:LI Yan-min  YANG Yue
Institution:(School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract:OBJECTIVE: To provide references for the standardization of drug usage beyond dispensatory in China. METHODS: The definition of drug usage beyond dispensatory was introduced as well as related cases caused by it. The relevant supervision and study progresses of drug usage beyond dispensatory in America were analyzed. RESULTS CONCLUSIONS: Drug usage beyond dispensatory may cause several problems, such as the safety of drug use, drug administration, health insurance and corporation propaganda. We should learn the relevant actions of America and standardize the utilization of drug usage beyond dispensatory in the market by establishing the trinity cooperation model of regulatory authority, industry associations and medical personnel.
Keywords:Drug usage beyond dispensatory  Supervision  Study  Progress
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