我国药品生产企业不良反应术语认知及使用现状调查研究  

Recognition ad Application Status of Adverse Drug Reaction Terminologies

作　　者：马丹华[1,2] 王玲[3] 孙骏[1,4] 李明[1,5] 刘红亮[3] 

机构地区：[1]江苏省药品不良反应监测中心,南京210002 [2]上海理工大学,上海200237 [3]国家食品药品监督管理局药品评价中心,北京100045 [4]南京中医药大学,南京210023 [5]中国药科大学,南京210009

出　　处：《药学与临床研究》2017年第4期369-372,共4页Pharmaceutical and Clinical Research

摘　　要：目的:对我国药品生产企业有关《世界卫生组织药品不良反应术语集》(WHOART)和《国际医学用语词典》(Med DRA)的认知度以及术语集应用现状等进行调研,为Med DRA在我国药品不良反应监测中广泛应用的可行性提供参考。方法:通过调查问卷对全国155家药品生产企业进行调查研究。结果:分别有56.77%、68.39%的企业正确选择WHOART、Med DRA术语集的结构及收录范围;92.25%的企业认为日常监测过程中术语集需要持续更新;有2.58%的企业非常了解Med DRA的企业收费标准。结论:企业对不良反应术语的认知度有限,应定期接受术语集的培训;企业认为从术语集的结构、术语数量及持续更新看,Med DRA更适合我国药品安全性监测工作;国家监管机构需统筹考虑企业使用Med DRA的费用问题。Objective： To provide a reference for the feasibility of widespread use of Medical Dictionary for Regulatory Activities （MedDRA） in drug adverse reaction monitoring, drug manufactures recognition and application status of World Heahh Organization Adverse Reaction Terminology （WHOART） and MedDRA terminology have been investigated. Methods： A questionnaire investigation was applied to 155 drug manu- factures. Results： There were 56.77% and 68.39% of the companies understood the structure and scope of WHOART and MedDRA terminology correctly, respectively. There were 92.25% of the companies agreed that terminology should be updated continuously in drug adverse reaction monitoring. And there were 2.58% of the companies knew the MedDRA subscription fees very well. Conclusion： As the limited aware- ness of drug adverse reaction terminology, companies should receive regular training. Based on the structure of terminology, the number of terms and continuous updates, companies think MedDRA is more appropriate for drug safety monitoring in China. National regulators should comprehensively consider the MedDRA subscriptions fees.

关 键 词：药品不良反应 WHOART MED DRA 认知度 

分 类 号：R95[医药卫生—药学]