摘要
目的论述开展儿童药物警戒工作的重要性、特征以及方法,探索儿童用药药物警戒模式。方法根据欧洲药品管理局发布的儿童用药药物警戒指南,分析儿童用药的特征。结果儿童用药不良事件潜在发生率不低于成人,而且,儿童用药的不良反应特征与成人相比有差异。结论应结合我国儿童用药不良反应监测工作现状,建立科学的儿童用药不良反应监测模式。
Objective To expound the importance, characteristics and practice of pharmacovigilance of medicines used in pediatric population and discuss its working model. Methods The characteristics of pediatric medication were analyzed using ＂Guideline on Conduct of Pharmacovigilance for Medicines Used by the Pediatric Population＂ released by EMEA as a reference. Results The rate of occurrence of ADRs in pediatric population is no lower than that in adults and ADR characteristics in pediatric population are different from those in adults. Conclusion China should establish the working model for pharmacovigilance of medicines used in pediatric population according to the current status of ADR monitoring system.
出处
《中国药事》
CAS
2013年第6期557-560,共4页
Chinese Pharmaceutical Affairs
关键词
儿童用药
药物警戒
工作模式
pediatric medication
pharmacovigilance
working model
