广东省三级医疗卫生机构《药品不良反应/事件报告表》报告质量调查

Evaluation of the Quality of 《Adverse Drug Reaction/Event Report Form》 Reported by Threetier Medical Institutions of Guangdong Province

目的分析2006年广东省三级医疗机构《药品不良反应/事件报告表》的填写质量及主要问题所在。方法采取随机抽样方法中的抽签法,以广东省51家三级医疗机构自2006年1月1日～12月31日所上报的所有类型为一般的药品不良反应/事件报告表为样本总量,抽取10%的报告表作为样本,进行质量评价与分析。结果报表分数在80分以上的为386份,占总数的78.33%;其中扣分点主要集中于不良反应时间变化、不良反应分析、评价意见等项目。结论广东省三级医疗机构《药品不良反应报告表》的总体质量较高,但有不少集中出现的质量问题,可针对集中质量问题对医务人员进行培训等方法进一步提高报告质量。

Objective To test the quality of 《Adverse drug Reaction/Event Report Form》 in 2006 reported by three-tier medical institutions of Guangdong province and find the key issue. Methods We use lotting method （belonging to random sampling method）. The samples are 《Adverse Drug Reaction/Event Report Form》（all types of the forms are general） reported by 51 three-tier medical institutions in Guangdong province from January to on December 2006. We draw 10% of the samples, then estimate the quality and analysis. Results The statement score counts to 386 in 80 sepa-rately above statements, accounting for 78.33% of total amount; mistakes that happened concentrate on the following items： adverse reaction respond time variety, analysis, evaluation opinion etc. Conclusion Totally the quality of 《Adverse Drug Reaction/Event Report Form》 reported by the three-tie medical institutions of Guangdong province is fine, but still a few quality problems appears. According to the above results, the professional adverse drug reaction（ADR） monitoring department can elevate the quality of 《Adverse Drug Reaction/Event Report Form》 reported by medical departments by training.