107例严重药品不良反应/事件报告分析

Analysis of 107 reports of serious adverse drug reaction/event

目的:了解严重药品不良反应/事件(ADR/ADE)上报情况和特点,为提高报表的上报率、填报和评价水平提供参考。方法:对某医院2009–2015年收集的严重ADR/ADE报告数据进行回顾性统计分析。结果:107例严重ADR/ADE中,上报国家药品不良反应监测系统36例(33.64%),未上报71例(66.36%);老年患者(≥60岁)41例(38.32%);口服给药途径67例次(57.76%);抗微生物药引发严重ADR/ADE 50例次(36.23%);皮肤及其附件损害87例(70.73%)。结论:加强对严重ADR/ADE的监测工作,提高报告质量,减少漏报及误报率,确保临床安全、有效、合理用药。

Objective: To investigate the report situation and characteristics of serious adverse drug reactions/events (ADRs/ADEs) of a hospital, and to provide reference for improving the quality of reports. Methods: ADRs/ADEs collected by a hospital from 2009 to 2015 were analyzed statistically and retrospectively. Results: In a total of 107 serious ADRs/ADEs, 36 cases (33.64%) were forwarded to the national adverse reaction monitoring center, while 71 cases (66.36%) were not. The elderly patients (41 cases,38.32%) had the highest incidence of serious ADRs/ADEs. Oral route (67 cases, 57.76%) was the main route of administrations.Most of serious ADRs/ADEs (50 cases, 36.23%) were induced by antimicrobial drugs. About 87 cases (70.73%) involved skin and appendage damage. Conclusion: Attention should be paid to strengthen training of medical staff to improve the quality of reporting and decrease the rate of false positives and false negatives, in order to promote safe, effective and rational use of drugs.