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将两个标准剂型术语进行对齐:美国国家医学图书馆的 RxNorm 和欧洲药品质量管理局(EDQM)的欧洲药品质量和医疗保健。

Alignment of two standard terminologies for dosage form: RxNorm from the National Library of Medicine for the United States and EDQM from the European Directorate for the Quality in Medicines and Healthcare for Europe.

机构信息

Division of Clinical Informatics, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.

European Institute for Innovation through Health Data (I-HD), UNICOM Innovation Action; Department of Medical Informatics, Ghent University, Ghent, Belgium.

出版信息

Int J Med Inform. 2022 Sep;165:104826. doi: 10.1016/j.ijmedinf.2022.104826. Epub 2022 Jun 27.

Abstract

BACKGROUND

There is currently no system that aligns pharmaceutically equivalent medicinal products across nations, creating obstacles to transnational medication prescribing and medical research. EDQM has been internationally recognized as the leading system in systematic pharmaceutical product descriptions. RxNorm is a critical terminology based in the US and used widely in applications internationally that would benefit from alignment with EDQM-based dosage form descriptions.

GOAL

Demonstrate a method for alignment of RxNorm dosage forms with EDQM terminologies and with EDQM dosage forms. Describe obstacles and advantages of such an alignment for ultimate application in calculating universal Pharmaceutical Product Identifiers.

METHODS

A pharmaceutical sciences student and a clinical pharmacology expert in dosage forms used definitions supplied by RxNorm and EDQM technical documentation to align the 120 RxNorm dose forms to EDQM-based dosage form description terms. The alignment of RxNorm to EDQM was then used to fit the RxNorm dose forms into an ontology based on EDQM.

RESULTS AND CONCLUSIONS

The alignment of RxNorm and EDQM requires further validation but provides a potential method of establishing interoperability between the two terminologies without cumbersome manual reclassification. There remain ambiguities within each dosage form nomenclature that create obstacles to integrating medication databases rooted in EDQM and RxNorm into a single worldwide database.

摘要

背景

目前没有一个系统可以在国家之间统一药物等效性的药品,这给跨国药物处方和医学研究带来了障碍。EDQM 已被国际公认为系统药物产品描述的领先系统。RxNorm 是一个基于美国的关键术语,在国际上得到了广泛应用,将其与基于 EDQM 的剂型描述相匹配将从中受益。

目标

展示一种将 RxNorm 剂型与 EDQM 术语和 EDQM 剂型对齐的方法。描述这种对齐对于最终应用于计算通用药物产品标识符的障碍和优势。

方法

一名药学专业学生和一名剂型临床药理学专家使用 RxNorm 和 EDQM 技术文档中提供的定义,将 120 种 RxNorm 剂型与基于 EDQM 的剂型描述术语对齐。然后,将 RxNorm 与 EDQM 对齐,以便将 RxNorm 剂型纳入基于 EDQM 的本体中。

结果和结论

RxNorm 和 EDQM 的对齐需要进一步验证,但提供了一种在不进行繁琐手动重新分类的情况下建立这两个术语之间互操作性的潜在方法。在每个剂型命名法中仍然存在歧义,这给将基于 EDQM 和 RxNorm 的药物数据库集成到一个全球范围内的单一数据库带来了障碍。

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