| 引用本文：尚鹏辉,刘佳,刘继同,等.中国药品安全综合评价指标体系研究[J].中国卫生政策研究,2013,6(10):41-47 |
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| 中国药品安全综合评价指标体系研究 |
| 投稿时间：2013-05-28 修订日期：2013-10-09 PDF全文浏览 HTML全文浏览 |
| 尚鹏辉1, 刘佳2, 刘继同3, 江滨4, 杨莉3, 颜江瑛5, 许嘉齐5, 邱琼5, 詹思延3 |
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 100191
5. 国家食品药品监督管理总局 北京 100053 |
| 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。 |
| 关键词:药品安全 综合评价 评价指标 |
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| The study for comprehensive evaluation indicators of drug safety in China |
| SHANG Peng-hui1, LIU Jia2, LIU Ji-tong3, JIANG Bin4, YANG Li3, YAN Jiang-ying5, XU Jia-qi5, QIU Qiong5, ZHAN Si-yan3 |
1. National Health and Family Planning Commission, Beijing 100044, China
2. Center for Drug Evaluation, China Food and Drug Administration, Beijing 100045, China
3. Peking University School of Public Health, Beijing 100191, China
4. Peking University School of Pharmaceutical Sciences, Beijing 100191, China
5. China Food and Drug Administration, Beijing 100053, China |
| Abstract: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 analyzed 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 meeting, qualitative interview, and questionnaire survey methods. This study established a comprehensive evaluation indicator 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 check rational drug management and information collation; prescription evaluation of medical institutions to improve the collation of information and use; gradual development of public rational drug investigation; and steadily pushing sentinel surveillance of adverse drug reactions work. |
| Key words:Drug safety Comprehensive evaluation Evaluation indicator |
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