我院近3年药品不良反应报告表质量分析

Quality analysis of adverse drug reactions reported in recent 3 years

目的分析评估我院近3年来药品不良反应(adverse drug reactions,ADR)报告质量状况。方法根据《药品不良反应报告和监测管理办法》及"药品不良反应/事件报告表"规范分级标准,对我院512份ADR报告质量进行分析,包括报表的规范性、完整性、加分项的正确率分析,同时对ADR的上报科室和上报类型进行了统计。结果我院ADR报告表数量逐年上升,报表的完整性和规范性亦呈逐年上升趋势,主要是一般的不良反应,但总体报告表的质量仍偏低,主要体现在完整性不高。且ADR报表大部分由所在科室的临床药师上报,主要集中于抗生素和中成药注射液。结论 ADR上报应提高规范性、完整性及正确率。发挥临床药师的专业优势是提高ADR报告表质量的一个重要因素。

Objective To evaluate the quality of adverse drug reactions（ADR）in our hospital over the past 3 years.Methods According to the ＂Drug Adverse Reaction Report and Monitoring Management＂, ＂Drug Adverse Reaction/Event Report Form＂ grading standards,512 cases of ADR reports were collected and analyzed.The correctness analysis of the normalization integrity,as well as the ADR reporting departments and the type of ADRs were also collected.Results The number of ADR reports in our hospital increased year by year,the normalization and integrity were increased too,but the quality of the report form was still low overall because of the low integrity.The majority of the ADRs were reported by the clinical pharmacists,antibiotics and traditional Chinese medicine injections were the most frequently reported.Conclusion Normalization and integrity should be improved in our hospital,the professional advantage of clinical pharmacists is an important factor in improving the quality of ADR reports.