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风险最小化行动计划在中药注射剂风险控制中的应用
引用本文:李泮海,田月洁,黄传海,冯巧巧,黄琳,谢彦军.风险最小化行动计划在中药注射剂风险控制中的应用[J].中国药物警戒,2010,7(8):469-472.
作者姓名:李泮海  田月洁  黄传海  冯巧巧  黄琳  谢彦军
作者单位:山东省药品不良反应监测中心,山东,济南,250013
摘    要:概述了风险最小化行动计划和中药注射剂的安全现状,论述了实施风险最小化行动计划对降低中药注射剂使用风险的必要性和可行性。通过探讨中药注射剂生产企业实施风险最小化行动计划的内容,以期为降低中药注射剂使用风险提供一种新方法,加强我国的中药注射剂风险控制手段,提高中药注射剂生产企业履行风险管理责任主体的意识和责任。

关 键 词:中药注射剂  风险最小化行动计划  风险控制  方法

Implementation of Risk Minimization Action Plan to Reduce Risks of Traditional Chinese Medcine Injections
LI Pan-hai,TIAN Yue-jie,HUANG Chuan-hai,FENG Qiao-qiao,HUANG-lin,XIE Yan-jun.Implementation of Risk Minimization Action Plan to Reduce Risks of Traditional Chinese Medcine Injections[J].Chinese JOurnal of Pharmacovigilance,2010,7(8):469-472.
Authors:LI Pan-hai  TIAN Yue-jie  HUANG Chuan-hai  FENG Qiao-qiao  HUANG-lin  XIE Yan-jun
Affiliation:(Shandong Center for ADR monitoring,Shandong Jinan 250013,China)
Abstract:The risk minimization action plans(RiskMAP) and security status of the Traditional Chinese Medicine(TCM) injections were reviewed.The necessity,feasibility and content of the implementation of RiskMAP to reduce TCM injections risks were discussed,to provide a new method to reduce TCM injections risks and to improve the responsibility and ability of TCM injection manufacturers for risk control.
Keywords:traditional Chinese medicine(TCM) injections  risk minimization action plan(RiskMAP)  risk control  method
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