中国药品安全综合评价指标体系研究  

The study for comprehensive evaluation indicators of drug safety in China

作　　者：尚鹏辉 刘佳[2] 刘继同[3] 江滨[4] 杨莉[3] 颜江瑛[1] 许嘉齐[1] 邱琼[1] 詹思延[3] 

机构地区：[1]国家卫生和计划生育委员会,北京100044 [2]国家食品药品监督管理总局药品评价中心,北京100045 [3]北京大学公共卫生学院,北京100191 [4]北京大学药学院,北京1001915

出　　处：《中国卫生政策研究》2013年第10期41-47,共7页Chinese Journal of Health Policy

摘　　要：目的:尝试建立药品安全综合评价指标体系。方法:采用文献综述、专家会议和定性访谈的方法。结果:首先采取文献综述的方法,系统收集中文数据库、英文数据库、中文网站和英文网站的相关信息,以系统整理和归纳药品风险,并在此基础上提出了药品安全综合评价备选指标。而后经专家会议和定性访谈等多种方法收集、整理、筛选和补充,最终确立了药品安全综合评价指标,共包括4个一级指标,13个二级指标和69个三级指标。结论与建议:为了进一步完善指标评价体系,建议进一步收集和整理药品质量管理规范检查资料;分部门分类别统计药品抽验结果;逐步开展医疗机构合理用药管理的检查和信息整理;提高对医疗机构处方评价资料的整理和利用;逐步开展公众合理用药调查工作;稳步推动药品不良反应哨点监测工作。Objective ：To establish comprehensive evaluation indicators of drug safety in China. Methods： The research includes literature review, expert discussion, and qualitative interview methods. Results： This study ana- lyzed the major impact factors for drug safety and confirmed the major evaluation content by literature review. After being demonstrated by experts, we obtained a comprehensive evaluation frame about drug safety. With this evaluation frame, the evaluation indicators were collected, screened, supplied and ascertained by literature review, expert meet- ing, qualitative interview, and questionnaire survey methods. This study established a comprehensive evaluation indi- cator system for drug safety in China. This system consisted of four first-class indicators, 13 second-class indicators, and 69 third-class indicators. Conclusion and Suggestion ： To improve the evaluation indicator system, this paper recommended that collecting and collating information on pharmaceutical quality management standard inspection;sub-sector sub-category statistical drug testing results; gradual development of medical institutions to drug management and information collation; prescription evaluation of medical institutions to improve check rational the collation of information and use ; gradual development of public rational drug investigation ; and steadily pushing sentinel surveil- lance of adverse drug reactions work.

关 键 词：药品安全 综合评价 评价指标 

分 类 号：R951[医药卫生—药学]