药品不良反应报告数据共享平台的建设及对风险沟通的思考  

Construction of the Data Sharing Platform of Adverse Drug Reaction Reporting and Thinking on Risk Communication

作　　者：王玲[1] 黄玲 

机构地区：[1]国家药品不良反应监测中心,北京100045 [2]北京秦脉医药咨询有限责任公司,北京100044

出　　处：《中国药物警戒》2014年第9期536-541,546,共7页Chinese Journal of Pharmacovigilance

摘　　要：目的为促进我国药品安全信息的有效沟通和利用提供参考。方法介绍、分析监测系统数据共享平台的建设和应用,对比研究国内外信息公开相关方法和实践,为加强我国安全信息交流、风险沟通提出建议。结果与结论目前我国实行药品不良反应报告制度,药品安全信息管理遵循公开原则。数据共享平台的建设和应用在ADR报告数据共享方面取得了新的进展。风险沟通是药品风险管理的重要环节,应借鉴国外先进经验和技术方法,健全我国药品安全信息公开发布机制;规范药品安全信息发布的内容、形式、程序,保障信息的权威性、规范性、时效性;加强信息利用,为指导临床合理用药发挥重要作用。Objective To provide references for the promotion of effective communication and use of drug safety in-formation in China. Methods The construction and the application of the data sharing platform of monitoring system were introduced and analyzed, the comparative study on the related methods and practices of information disclosure at home and abroad were carried out. Suggestions on improving the exchange of drug safety information and risk communication in China were made. Results and Conclusion At present, ADR reporting system, principle of drug safety information openness have been carried out in China. The construction and the application of the data sharing platform in ADR data sharing made a new progress. Risk communication is an important link of the drug risk management, the government departments should learn some experiences from those advanced countries. It is suggested to perfect drug safety information public issue mechanism, standardize drug safety information dissemination content, form and process, ensure the authority, standardization and timelines of information and enhance information utilization to play an important role on guiding clinical rational use of drug.

关 键 词：药品不良反应 监测系统 数据共享平台 风险沟通 

分 类 号：R994.11[医药卫生—毒理学]