信息化药物警戒系统用药风险防范研究20年

Clinical pharmacy practice and research focusing on medication risk prevention based on information-based pharmacovigilance system for 20 years

目的 为临床药师围绕用药安全风险防范开展药学服务提供参考。方法 介绍临床药师基于药学实践的特点和需求,依托信息化监测研究技术开展系列的药品不良反应(ADR)自发报告和药品不良事件(ADE)主动监测研究。结果 临床药师依托ADR自发报告平台,深入参与诊疗工作,提高了临床ADR监测水平。依托自发报告信息库海量数据,利用数据挖掘方法分析抗感染药物ADR发生特点,为临床提供抗感染药物安全信息。依托ADE主动监测平台,从初期的万古霉素、替加环素等单药ADE主动监测基于全部用药的条件下药源性血小板减少症、药源性低纤维蛋白原血症等风险预测模型建立,开展系列基于真实世界研究的ADE主动监测。结论 信息化药物警戒系统为专科临床药师开展临床药学实践和研究提供了良好的平台支撑,提升了临床药学服务效能。

Objective To provide reference for clinical pharmacists in conducting pharmaceutical services focusing on preventing medication safety risk.Methods The clinical pharmacists in Medical Supplies Center of Chinese PLA General Hospital carried out a series of researches of adverse drug reaction(ADR)spontaneous reports and adverse drug events(ADE)active monitoring based on the characteristics and needs of pharmaceutical practice and informationized pharmacovigilance system.Results Relying on the platform of ADR spontaneous reports,the clinical pharmacists deeply participated in the diagnosis and treatment work,thus improving the level of ADR monitoring.Based on the massive data of spontaneous reporting database,the characteristics of anti-infective drug ADR were analyzed by using data mining method,and the safety information of anti-infective drug was provided for clinician.Relying on the ADE active monitoring platform,the clinical pharmacists carried out a series of real-world studies,ranging from the initial active monitoring of single drug ADE,such as vancomycin and tegecycline,to establish risk prediction models for drug-induced thrombocytopenia and drug-induced hypofibrinogenemia under full-drug conditions.Conclusion Informationized pharmacovigilance system provides a solid platform for clinical pharmacists to carry out clinical pharmacy practice and research to enhance the efficiency of clinical pharmacy service.