我国省级药品不良反应监测机构模式研究  

Research on the Mode of Adverse Drug Reaction Monitoring at the Provincial Level in China

作　　者：谢金洲[1] 周勇[1] 田月洁[1] 黄传海[1] 陈易新[2] 

机构地区：[1]山东省药品不良反应监测中心,山东济南250013 [2]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药物警戒》2009年第1期8-12,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的调研我国省级药品不良反应监测工作的现状,分析存在的问题及发展趋势,提出省级药品不良反应监测机构建立模式的思路。方法采取文献检索、实地调研和信函调研相结合的方法,调查我国省级药品不良反应监测模式现状,分析不同模式的特点、优势与不足。结果我国省级药品不良反应监测模式尚处于探索阶段,独立设置和挂靠其他单位是省级药品不良反应监测机构目前的两种主要模式,而两种模式中又根据运作形式分为多种类型。结论省级药品不良反应监测机构挂靠其他单位的模式,不利于其长期稳定发展;纳入行政管理是省级药品不良反应监测机构设置的理想模式,独立设置是现阶段的主要发展趋势。Objective To investigate the state of adverse drug reaction（ADR） monitoring at the provincial level in China, analyze the development trend of the mode of ADR monitoring at the provincial level. Methods With the method of information retrieval field investigation and letter investigation,we made the research on the mode of ADR monitoring at the provincial level in China. We analyzed the characteristics、advantages and shortages of different modes. Results The mode of ADR Monitoring at the provincial level is still at the exploratory stage. Independent and affiliated to other institutions are currently two main modes, and which had been divided into many types. Conclusion The mode of affiliated to other institutions is not conducive to the long-term stable. It＇s practicable to affiliated to administrative department. At this stage ,independent is the main trend of the mode of ADR monitoring at the provincial level.

关 键 词：药品不良反应 监测 省级 模式 研究 

分 类 号：R954[医药卫生—药学]