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

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.

Key words: digoxin, adverse drug event (ADE), active monitoring, Global Trigger Tool, China Hospital Pharmacovigilance System, adverse reaction report rate