上海市不同专业医务人员药品不良反应报告质量分析

Quality Analysis of the Adverse Drug Reactions Reports from Shanghai Healthcare Professionals

目的研究不同专业医务人员药品不良反应自愿报告情况及医务人员对药品不良反应及其报告制度的认知情况。方法收集2006年1月至2007年12月上海市药品不良反应报告数据库中医务人员的报告数据,导入ACCESS软件,用EXCEL统计分析报告情况及质量。结果本组资料中,来自医师的报告占总报告数的65.87%,高于药师(26.13%)和护士(8.00%)。根据世界卫生组织(WHO)和我国质量分级标准,医务人员ADR报告的级别99%以上达到3级,但报告的基本信息存在缺失,如病历号缺失率高于10%、联系方式高于5%。2006年,医师、药师、护士上报的新的和严重的药品不良反应分别为3.54%、4.20%、5.85%,2007年分别为5.55%、6.33%和12.28%。关联性评价中,护士的评价与市中心的评价一致比例最高。结论医务人员对药品不良反应关注的角度和报告技术要点的掌握并不一致,要提高对药品不良反应的监测效率,必须调动和发挥医务人员的积极性,持续不断地进行教育和培训。

Objective To study the voluntary reports of adverse drug reaction （ADR） reported by dif- ferent healthcare professionals and their cognition to the ADR reporting system. Methods Reports submitted by doctors, pharmacists and nurses from Shanghai ADR database in 2006 and 2007 were imported to ACCESS and statistic by EXCEL and analyze the quality of the ADR reports. Results The portion of reports from doctors is 65.87%, higher than those from pharmacists （26.13 %） and nurses（8.00 %）. More than 99% of ADR reports achieved documentation grade 3 according to the documentation grading scheme developed by WHO information elements in the reports, such as medical and China. There are still some missing essential records （loss rate 〉10%） and the way of contacts （loss rate〉5%）. The portions of new and serious ADR. in the reports of doctors, pharmacists and nurses are 3.54%, 4.20%, 5.85% in 2006, and 5.55%, 6.33%, 12.28% in 2007 respectively. The highest propo- rtion of ADR reports in which reporters＇ causality assessments in line with center＇was found in nurse. Conclusion The quality of ADR reports by healthcare professionals are diverse in level and view due to the professional backgrounds. To improve the efficiency of ADR monitoring, we should encourage all professional medical staff for their contribution.