江苏省2005年《药品不良反应/事件报告表》质量分析

The quality analysis of ADR reports of year 2005 in Jiangsu province

目的分析药品不良反应报告表质量,为深入开展药品不良反应监测工作及行政管理提供依据。方法按照国家药品不良反应监测中心所定标准,对江苏省2005年药品不良反应报告表的填写质量和报告时限进行分析和评价。结果17773份报告表中,0级报告表241份,占报告表总数的1.35%;1级0份;2级117份,占总数的0.66%;3级17415份,占总数的97.99%;4级0份。超过报告时限的报告表有1632份,占总数的9.18%。结论从填写完整性和报告时限性上都反映出药品不良反应报告质量有待提高。

Objective To provide imformation for ADR monitoring and drug Administration, the quality of ADR reports were analyzed. Method The quality and report time of ADR reports from Jiangsu province in 2005 were analyzed using the classification evaluation standard of ADR report in National Center. Result Among 17 773 ADR reports, 241 reports are at grade 0, 117 reports at grade 2, 17 415 reports at grade 3, account for 1.35%, 0.66% and 97,99%, respectively. And 1 632 reports are not reported in time limit, account for 9.18%. Conclusion The quality of ADR reports should be improved in mtegrality and reporting time limit.