国家基本药物(化药部分)风险管理平台的建立

The Establishment of Risk Management System for National Essential Drugs

目的:全面总结分析国家基本药物说明书、不良反应报告和文献信息,建立药物风险管理平台,实现药物风险评估,为群众安全用药提供参考依据。方法:文献调研,信息收集整理,数据比较,统计计算,网络平台搭建。结果:收集并分析国家基本药物原研厂最新英文说明书、中文说明书、不良反应报告和文献等信息,开发国家基本药物风险管理平台。结论:国家基本药物风险管理平台提供了药物说明书差异性的比较、药物安全信息检索和药物风险评估等功能,为群众用药安全提供帮助。

Objective：To establish the drug risk management system to realize the evaluation of drug risk and also provide a reference for safe medication by fully concluding and analyzing drug instructions,adverse drug reaction reports and literatures of national essential drugs.Methods：Literatures were investigated and collected;drugs＇ information were processed;their data were compared;drugs＇ ADR ratio was counted and calculated;and a Web platform was constructed. ResultS：The latest version instructions of national essential drugs,including English and Chinese drug instructions,ADR reports and literatures,were gathered and analyzed.A valuating method for drug safely was created and the risk management system of national essential drugs（RMSNED） was established.Conclusion：The RMSNED provided such functions as the comparison of drug instructions,retrieval of drugs＇ safety information and evaluation of drugs risk for the safe medication assistance.