目的 药品追溯标准规范是药品信息化追溯体系建设的重要组成部分,是强化追溯信息互通共享的重要基础。为统一药品追溯体系建设各参与方对药品追溯标准规范的认识和理解,推进后续标准规范的实施和应用。方法 研究药品追溯标准的在我国的实现基础和国际有关情况,提出我国药品追溯标准规范体系,包括总体标准、应用标准、数据标准和交换标准四大类,阐释10个药品追溯标准规范在整个标准规范体系中的分类和位置,分别对10个标准的主要内容做出了解释,并将10个标准按照其适用范围进行了分类。结果与结论 通过对药品追溯标准内容的解析,结合对标准实施和应用的实际情况,提出了完善药品追溯标准体系的问题及对策,为药品追溯体系建设各参与方共同建设药品追溯体系、构建药品追溯全生命周期数据链提供了指导和支持。
Abstract
OBJECTIVE Drug traceability standards and norms are an important part of the drug information traceability system construction, and basis for strengthening the traceability information sharing. To unify the understanding of relevant parties on the standards, further promote the implementation and application of standards. METHODS This paper studies the implementation basis of drug traceability standards in China and relevant international situations, puts forward China's drug traceability standard specification system, including four categories: overall standards, application standards, data standards and exchange standards, explains the classification and position of 10 drug traceability standards and specifications in the whole standard specification system, and explains the main contents of the 10 standards respectively. The 10 standards are classified according to their scope of application. RESULTS AND CONCLUSION Through the analysis of the content of drug traceability standards, combined with the actual situation of the implementation and application of those standards, this paper puts forward the problems and solutions to improve the drug traceability standard system, which provides guidance and support for all participants in the construction of drug traceability system to jointly build the drug traceability system and build the whole life cycle data chain of drug traceability.
关键词
药品追溯标准规范 /
药品信息化追溯体系 /
标准规范体系
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Key words
drug traceability standard /
drug information traceability system /
standard system
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中图分类号：
R197.39
F203
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参考文献
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脚注
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基金
国家药品监督管理局药品监督管理项目资助(20133812)
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