我院药品不良反应/事件报告填报质量分析与评价

目的:了解我院医务人员自愿呈报的药品不良反应/事件(ADR/ADE)报告的质量。方法:采取系统抽样法,分别从我院2004-2009年每年报告中抽取100份,共计600份;运用EpiData3.02软件录入数据、SPSS15.0软件统计分析数据。结果:我院ADR/ADE报告总体填报质量不高,0～4级报告分别为25.50%、3.83%、4.67%、47.67%、18.33%;问题主要表现为部分信息缺失或填写不规范,关联性评价不准确等。经我院ADR监测小组修订后报告质量有较大幅度提高。结论:临床应高度重视ADR/ADE报告质量,努力发现存在问题,适时进行干预,逐步提高ADR/ADE报告利用价值。

Quality Analysis and Evaluation of Adverse Drug Reactions or Adverse Drug Events in Our Hospital

OBJECTIVE： To investigate the quality of adverse drug reaction （ADR） or adverse drug event （ADE） spontaneously reported by medical staff in our hospital. METHODS ： 600 reports were selected in our hospital from 2004- 2009 by means of systematic sampling method, input by EpiData 3.02 software, and analyzed by SPSS 15.0 software. RESULTS： The quality of the reports was not good, reports at 0-4 levels accounted for 25.50%, 3.83%, 4.67%, 47.67% and 18.33%, respectively. There were several problems about them, such as some information missing, nonstandard reporting and illogical causality assessment. There was a big improvement in quality of reports after modification of the experts by our ADR monitoring team. CONCLUSION： It is suggested that we should strengthen ADR/ADE monitoring, find out problems and timely disposal so as to improve the utilization value ofADR/ADE reoorts.