基于多中心回顾性研究设计触发器筛查药物不良事件

Designing Trigger Tools to Assess Adverse Drug Events (ADEs) Based on a Multi-center, Retrospective Study

关键词:  药物不良事件  触发器  过度抗凝  过度镇静  药物警戒

Key words:  adverse drug events (ADEs)  trigger tool  over-coagulation with warfarin  over-sedation with opioid medication  underreporting  surveillance

摘要:

目的 研究以触发器作为筛查药物不良事件（ADEs）信号的可行性。方法 选择浙江省3家三级医院的2015年住院患者作为研究对象，设计潜在过度抗凝触发器（使用华法林且国际标准化比值≥6）、潜在阿片类药物过度使用触发器（纳洛酮作为阿片类药物导致过度镇静的信号），删除重复和假阳性ADEs，并与医院不良事件呈报数据进行比对。结果 过度抗凝触发器和过度镇静触发器分别触发39例次和11例次潜在的ADEs，通过手工检索确认过度抗凝触发器触发了9例次ADEs[阳性预测值（positive predictive value，PPV） 23.1%]，而过度镇静触发器触发了4例次ADEs（PPV 36.4%）。未发现严重的华法林导致的过度抗凝或阿片类药物导致的过度镇静ADEs没有上报，但几乎所有的ADEs（12/13）未通过医院的自发系统上报。结论 通过设计用药事件触发器有助于有效改善ADEs漏报。

Abstract:

OBJECTIVE To improve the ADEs reporting by developing medication event trigger tools to detect ADEs.METHODS The present study was a multi-center, retrospective study in 3 tertiary teaching hospitals in Zhejiang province in 2015. Patients were monitored using electronic trigger tools designed to detect patients with over-anticoagulation[Using laboratory test results of International Normalized Ratio (INR) values ≥ 6 if warfarin was concurrently prescribed] or potential opioid overdose (administration of naloxone as a signal of over-sedation caused by opioid analgesics). Case note review removed the duplicates and the false positive ADEs. And medical incident reports were also reviewed. RESULTS The INR ≥ 6 electronic trigger identified 39 potential ADEs and the naloxone electronic trigger identified 11 potential ADEs. The available case note review identified 9 ADEs for the INR ≥ 6 trigger[positive predictive value (PPV) was 23.1%] and 4 ADEs (PPV 36.4%) for the naloxone trigger. No serious ADEs over-coagulation with warfarin and over-sedation with opioid medication were newly discovered using the trigger tools. Nearly all of the ADEs (12/13) discovered by the trigger tools had not been voluntarily reported to the hospital's event reporting program. CONCLUSION It's showed that the trigger tools is useful to discover ADEs that has not been voluntarily reported or evaluated. Incorporating electronic trigger tools with prescription and laboratory test data can improve the detection of ADEs, and potentially lead to methods to avoid underreporting them.