近年我国药品不良反应报告与监测总体情况分析

目的了解我国近年来药品不良反应报告的现状,找出存在的问题,为加强药品不良反应报告和监测管理提出建议。方法收集2010~2014年连续5年国家药品不良反应监测年度报告,采用内容分析、二次分析、对比分析等方法对药品不良反应报告情况进行了探讨。结果我国药品不良反应报告的数量逐年增加,新的和严重的药品不良反应数量较少;药品不良反应报告主体是医疗机构,药品生产经营企业的报告比例较低,抗感染药品的药品不良反应仍居首位。结论加强药品不良反应报告管理依然是业内关注的重要问题之一。建议:提高新的、严重的不良反应报告率;强化药品生产、经营企业药品不良反应报告工作;重视抗感染药品的不良反应;促进药品不良反应的信息共享。

Analysis of the current situation of adverse drug reaction reporting and monitoring in China

Objective To analyze the current situation of adverse drug reaction(ADR)reporting in China ,to find out the existing problems ,and to proposed suggestions on ADR reporting and monitoring management .Methods The 2010‐2014 national ADR monitoring annual reports were collected .The content analysis ,secondary analysis and comparative analysis methods were adopted to evaluate the reports .Results The annual number of ADR reports was increased year by year .Nevertheless ,new and serious ADRs were still accounted for a small proportion .Reports were mainly from medical institutions ,with low proportion from drug manufacturers .Adverse anti‐infection reaction reports always top in quantity among various drugs .Conclusions It is still an es‐sential issue to strengthen the management of ADRs reports .Our suggestions are as follows :the new and serious ADR reporting rate should be increased .Reports from the drug manufacturers and trading enterprises should be encouraged .Anti‐infective drugs ADRs should be used with care .Information sharing of ADRs should be promoted .