药品不良反应报告真实性的影响因素与措施探讨  

Discussion on the Influence Factors and Measures on Authenticity of Adverse Drug Reaction Reports

作　　者：温润龙 李亮华 罗万婷 

机构地区：[1]广东中山市药品不良反应监测中心,中山528437

出　　处：《中国药事》2015年第8期885-888,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:通过对药品不良反应报告表真实性影响因素的分析,探讨如何提高报告表的质量。方法:分析药品不良反应报告表真实性的重要性以及真实性核查的具体方法,并从行政、制度、观念等方面系统地讨论影响报告表真实性的因素,探讨相应的对策措施。结果与结论:药品不良反应报告表的真实性是报表质量的重要基础,应通过完善法制建设、建立损害补偿制度与管理制度、加强宣传培训等措施,保证报告表真实,为药品风险监测提供科学依据。Objective： To analyze the factors that affect the authenticity of adverse drug reaction reports, so as to explore measures to improve the quality of reports. Methods： The importance of the authenticity of adverse drug reaction reports and the specific method of authenticity verification were analyzed. The influence of authenticity of reports from the aspects of administrative, system and concept were systematically discussed. And finally, the corresponding methods to solve the problems were provided. Results and Conclusion： The authenticity of adverse drug reaction reports is an important basis for the quality control. We should improve the legal construction, the establish compensation system and management system, and strengthen the publicity and training, so as to ensure the authenticity of the report and provide a scientific basis for the drug risk monitoring.

关 键 词：药品不良反应 报告表 真实性 影响因素 

分 类 号：R95[医药卫生—药学]