西安市医疗机构医务人员药品不良反应报告的质量分析  

Quality of adverse drug reaction reports submitted by health care professionals in Xi′an

作　　者：刘均[1] 杨世民[1] 冯变玲[1] 赵君[1] 刘花[1] 黄海燕[1] 

机构地区：[1]西安交通大学医学院药学系,西安710061

出　　处：《西北药学杂志》2012年第3期263-266,共4页Northwest Pharmaceutical Journal

基　　金：2011年度国家食品药品监督管理局政策研究课题

摘　　要：目的评价2008年至2010年西安市医疗机构上报的药品不良反应(adverse drug reaction,ADR)报告表的质量。方法根据《"药品不良反应/事件报告表"规范分级标准》和《WHO药品不良反应病例报告分级标准》对报告表的完整性进行评价;对报告表的基本信息缺项进行统计;评估新的和严重的ADR病例报告比例以及报告表提交的时效性等。结果护士填报的报告表完整性3或4级的占72.29%,显著低于医生和药师(分别为95.01%和98.52%);报告表基本信息的缺失主要存在于患者病历号/门诊号(30.55%)、联系方式(23.55%)以及药品商品名(8.19%);药师报告的新的和严重的ADR病例构成比显著高于医生和护士;护士在ADR发生后超过3个月才上报的比例最低(2.29%),其次是医生和药师(分别为4.16%和8.30%)。结论不同专业医务人员对ADR的关注角度以及对报告过程的掌握程度并不一致,应该采取各种措施有针对性地提高药品不良反应报告表的质量。Objective To evaluate the quality of adverse drug reaction（ADR） reports submitted by health care professionals in Xi′an from January 2008 to December 2010.Methods The documentation grade of the ADR reports,the missing essential information elements in reports,the seriousness of the ADRs reported,and the time taken to report an ADR were analyzed and compared between physicians,pharmacists and nurses.Results According to ＂The Specification Ranking Standard of ADR/ADE＂ issued by the SFDA,significantly lower proportion of reports from nurses was received in documentation grade 3 or 4 than that from physicians and pharmacists.There were still some missies of essential information elements in the reports,such as medical records（miss rate=30.55%）,contact number（23.55%）,brand name（8.19%）.The proportion of new and serious ADR in the reports of pharmacists was significantly higher than that of physicians and nurses.Pharmacist reporters took a significantly longer time than physicians and nurses to report their reactions.Conclusion The quality of ADR reports submitted by health care professionals is diverse due to the professional backgrounds.Positive measures should be adopted to improve the efficiency of ADR reporting.

关 键 词：药品不良反应报告 分级标准 质量评价 医疗机构 

分 类 号：R969.3[医药卫生—药理学]