台湾高雄长庚医院药品不良反应通报案例分析

Analysis of ADR Cases in Kaohsiung Chang Gung Memorial Hospital in Taiwan

目的:建立专属台湾高雄长庚医院病患之安全数据库及建立本土用药数据,以提供相关药物警讯给各医疗相关单位参考。方法:藉由院内网络设置之"药品不良反应(ADR)通报及回复系统",以回溯性方式收集2006～2008年之ADR通报案例并进行统计、分析。结果:此期间之通报案例共1129件,且逐年增加。通报的来源以药师最多(61.82%),其次为医师(34.90%)和护理师(3.28%)。通报个案的性别分布为男性58.02%、女性41.98%。可疑药品依药理分类排名分析,最常见的为抗菌药(31.09%)、中枢神经用药(22.76%)、循环系统用药(21.35%)。在可疑药品导致的临床症状方面,最主要的为皮肤及其附件症状(45.70%)、消化系统症状(10.45%)、循环系统症状(10.01%)。通报案例的严重度分析,轻度50.13%,中度49.07%,严重0.80%。医师对ADR的处理方式,以停药最多(占40.83%),其次为停药并投予解药(占30.56%)。结论:药师希望将ADR通报业务,从个案通报、评估、确认、分析、追踪外,再加上自动警示系统的使用,能提升为主动预防。藉此能降低可预期性的ADR发生率,以维护病患的用药安全。

OBJECTIVE：To set up the database for safety of patients and medication in Kaohsiung Chang Gung Memorial Hospital（CGMH）,and to provide pharmaceutical warning for medical institutions.METHODS：Based on ADR Reporting and Responding System,ADR cases were collected from 2006 to 2008 retrospectively and analyzed statistically.RESULTS：A total of 1 129 cases were included and the number of ADR cases increased year by year.Most of ADR cases were reported by pharmacists（61.82%）,followed by physicians（34.90%） and registered nurses（3.28%）.Of 1 129 ADR cases,58.02% were male and 41.98% were female.31.09% of ADR cases were induced by antibacterial agents,22.76% drugs acting on central nerve system,21.35% drugs acting on circulatory system.Main clinical manifestations were symptoms of skin and its appendants（45.07%）,digestive system（10.45%） and circulatory system（10.01%）.Among 1 129 ADR cases,there were mild ADR cases of 50.13%,medium ADR cases of 49.07% and severe ADR cases of 0.80%.According to the disposal ways,40.83% stopped taking medicine and 30.56% were additionally given antidote.CONCLUSION：Pharmacists expect to transform ADR reporting into active prevention of ADR by case report,evaluation,identification,analysis,follow-up and automatic warning system.The incidence of predictable ADR can be reduced to guarantee the safety of drug use.