儿童用药安全现状及政策研究与思考  

Research and Reflection on Situation and Policy of Pediatric Medication Safety

作　　者：金丹 田春华[2] 杨月明 王瑜歆 马辉 

机构地区：[1]辽宁省药械审评与监测中心,沈阳110003 [2]国家食品药品监督管理局药品评价中心,北京100045 [3]辽宁省药品认证中心,沈阳110003

出　　处：《中国药事》2015年第4期427-431,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:对儿童用药安全现状和国内外儿童用药相关政策进行分析研究,对促进儿童用药安全提出思考和建议。方法:通过文献研究方法,结合儿童相关药品不良反应数据,概述国内外儿童用药相关政策和措施,提出思考和建议结果与结论:我国出台了政策、指南等促进儿童用药的研究、使用,但仍存在儿童专用品种不足、不合理使用等现象。建议推进法规政策、指南的执行和落实,提高儿童药品临床使用的规范性,加强儿童用药安全性监测和评价工作,保障儿童用药安全。Objective： To analyze the current situation of pediatric drugs as well as laws and regulations on pediatric medication at home and abroad, so as to put forward some suggestions to promote pediatric medication safety. Methods：In accordance with the literature research and data of adverse reactions related to pediatric drugs, laws and regulations on pediatric medication at home and abroad were summarized, and thoughts and suggestions were provided for China to formulate relevant policies and measures. Results and Conclusion： China has introduced policies and guidelines about pediatric medication, but some problems still exist such as insufifcient varieties of medicines, irrational drug and so on. It is suggested that China should improve the execution and implementation of policies and guidelines, the standardization of pediatric drug use, and strengthen the monitoring and evaluation for pediatric drug safety to ensure pediatric medication safety.

关 键 词：儿童用药 现状 安全 监测 

分 类 号：R969.3[医药卫生—药理学]