WHODrug Global：经过验证并定期更新的标准化药品信息编码词典

doi:10.19803/j.1672-8629.20250092

摘要/Abstract

摘要： WHODrug Global（以下简称“WHODrug”）药品信息词典旨在便于临床试验中的药物编码,并发现上市后监测中的药物相关问题,从而支持有效安全的药物开发与使用。WHODrug 由瑞典基金会乌普萨拉监测中心（Uppsala Monitoring Centre,UMC）开发、维护和更新,其收录的药品信息包含产品名、活性成分及其他信息,如药品上市许可持有人、销售国家、药物剂型和规格,并提供中英文版本。所有相关药物都使用结构化的字母数字代码（即WHODrug 药物代码）进行链接,使产品名和包括国际非专利药名在内的活性部分连接起来。WHODrug中的药物使用解剖学治疗学及化学分类编码（ATC）进行分类,以便对具有一个或多个共同属性的药物进行聚集及标准化分组。WHODrug的不同层级信息用于探索药物或药物类别与不良事件之间的关系。在临床试验和上市后安全监测中使用WHODrug,可确保标准化药物命名的准确性,并且利于更便捷的全球信息交换。国际标准化组织的医药产品鉴定（Identification of Medicinal Product, IDMP）及药品识别符（Pharmaceutical Product Identifiers, PhPID）正被添加到WHODrug中。为满足来自制药行业、学术界和监管机构WHODrug用户的需求,WHODrug需要不断更新以保障其在全球范围内的全面性和有效性。本文通过介绍WHODrug实践中的应用、数据结构、结构的应用及其产品组合的其他用途,以期支持有效安全的药物开发与使用。

关键词: WHODrug, 药品编码, 临床试验, 上市后安全监测, 信号检测, 药品不良事件, 药物警戒, 标准化药物分组

Abstract: The WHODrug Global (WHODrug in short) medicinal information dictionary aim to facilitate the coding of medications in clinical trials as well as identification of medication-related problems in post-marketing surveillance, and thereby supporting the development and usage of effective and safe medications. WHODrug is a product provided by the Swedish foundation Uppsala Monitoring Centre (UMC). WHODrug contains individual product names, active ingredients and additional information such as marketing authorisation holder, country of sale, pharmaceutical form and strength, available in an English and a Chinese version. All related medications are linked using a structured WHODrug alphanumeric code, connecting product names and variations of the ingredient with the active moiety of the active ingredient s, including the International Nonproprietary Name (INN). Medications in WHODrug are classified using the ATC system and clustered into Standardised Drug Groupings, to allow for grouping of medications with one or more properties in common. The different information levels in WHODrug are used to explore the relationship between a medication or a class of medications and an adverse event. Using WHODrug in clinical trials and post-marketing safety work enables the use of accurate standardised medication nomenclature and other information that supports easier global information exchange. The ISO standards for Identification of Medicinal Products (IDMP) global Pharmaceutical Product Identifier (PhPID) is currently being added to WHODrug Global. To meet the demands of WHODrug users from the pharmaceutical industry, academia and regulatory authorities, it is essential to keep the dictionary comprehensive, validated and constantly updated on a global scale. This article introduces the application of WHODrugin practice, its data structure and applications of the structure, as well as uses of other products within the product portfolio, with the aim of supporting the effective and safe development and use of drugs.

Key words: WHODrug, Drug Coding, Clinical Trial, Post Marketing Surveillance, Signal Detection, Adverse Drug Event, Pharmacovigilance, Standardised Drug Groupings

中图分类号:

R952
R994.11

STRESE Sara, LAGERLUN DOlof, 沈玲, AHNFELT Emelie, 岳群英, FLADVAD Malin. WHODrug Global：经过验证并定期更新的标准化药品信息编码词典[J]. 中国药物警戒, 2025, 22(10): 1194-1200.

STRESE Sara, LAGERLUND Olof, SHEN Ling, AHNFELT Emelie, YUE Qunying, FLADVAD Malin. WHODrug Global: a Validated, Regularly Updated and Standardised Drug Dictionary for Medicinal Information Coding[J]. Chinese Journal of Pharmacovigilance, 2025, 22(10): 1194-1200.

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