基于中国医院药物警戒系统建立地高辛不良事件主动监测电子触发器
Establish triggers for active monitoring of digoxin adverse events based on the China hospital pharmacovigilance system
林璐 1詹陆川 1刘晓琦 1刘菊娥 1王来友 1曾颖 1赖伟华1
作者信息
- 1. 南方医科大学附属广东省人民医院,广东省医学科学院药学部,广东 广州 510000
- 折叠
摘要
目的 基于中国医院药物警戒系统(CHPS)探索建立地高辛药品不良事件(ADE)主动监测电子触发器.方法 通过查阅文献、药品说明书和不良反应数据库等,拟定地高辛ADE电子触发器初始条目;采用德尔菲(Delphi)专家调查法,对电子触发器条目进行修订;利用某三甲医院使用地高辛的住院患者病历进行回顾性审查,计算电子触发器的阳性预测值(PPV),并与医院不良事件自发上报数据进行比对.结果 初拟地高辛ADE电子触发器条目18项,经德尔菲法调查和讨论后,利用CHPS系统集成建模工具,将16项电子触发器条目设置成主动监测方案,其中实验室指标 4项、解毒剂2项、临床症状7项、干预措施 3项,电子触发器总体PPV为29.37%(79/269).电子触发器检出并经人工审核确定的真阳性ADE病例41例,检出率为13.67%(41/300),而不良反应监测系统同期自发上报率为0.结论 基于CHPS建立的电子触发器可有效用于主动监测医疗机构ADE,增强监测敏感性,提高不良反应上报率.
Abstract
Objective To establish electronic triggers for active monitoring of digoxin adverse drug event(ADE)based on the China Hospital Pharmacovigilance System(CHPS).Methods The initial electronic triggers of digoxin ADEs were prepared by referring to literature,drug instructions and ADR databases.Using Delphi method,the trigger items are revised;the medical records of hospitalized patients treated with digoxin in a Grade-Ⅲ hospital were retrospectively reviewed,and the positive predictive value(PPV)of the trigger was calculated and compared with the spontaneous reporting of adverse events in the hospital.Results There were 18 electronic triggers for digoxin ADE initially proposed.After investigation and discussion by Delphi method,16 triggers were set into active monitoring schemes using CHPS integrated modeling tool,including 4 laboratory indicators,2 antidotes,7 clinical symptoms and 3 intervention measures.The overall PPV of triggers was 29.37％(79/269).There were 41 true positive ADE cases detected by electronic triggers and confirmed by manual audit,the detection rate was 13.67％(41/300),however,the spontaneous reporting rate of adverse reaction monitoring system was 0.Conclusion The electronic triggers based on CHPS can be effectively used to monitor ADEs actively in medical institutions,enhance the monitoring sensitivity and improve the reporting rate of adverse reactions.
关键词
地高辛/药品不良事件/主动监测/全面触发工具/中国医院药物警戒系统/不良反应报告率Key words
digoxin/adverse drug event(ADE)/active monitoring/Global Trigger Tool/China Hospital Pharmacovigilance System/adverse reaction report rate引用本文复制引用
基金项目
广东省药理学会专项基金(GYLY2021003)
出版年
2024
NETL
NSTL
万方数据