Uppsala Monitoring Centre, Box 1051, 751 40, Uppsala, Sweden.
Ther Innov Regul Sci. 2020 Sep;54(5):1116-1122. doi: 10.1007/s43441-020-00130-6. Epub 2020 Feb 20.
The WHODrug medicinal information dictionary is a worldwide source of global medicinal information with the aim to facilitate the coding of medications in clinical trials as well as identification of medication-related problems when monitoring patient safety, thereby supporting the development and usage of effective and safe medications. WHODrug contains individual trade names, active ingredients and additional information such as marketing authorisation holder, country of sale, pharmaceutical form and strength. All related medications are linked using a structured WHODrug alphanumeric code, connecting trade names and variation of the ingredient with the active moiety of the ingredient. 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 built-in data structure and the classification of medications in WHODrug facilitate various ways of aggregating medications for identification and analysis of possible adverse drug reactions. The different information levels in WHODrug are used to explore the relationship between a medication or a class of medications and an adverse event. By using WHODrug in clinical trials and post-marketing safety, accurate and standardised medication information can be achieved globally and allow easy information exchange. To meet the demands of WHODrug users from the pharmaceutical industry, academia and regulatory authorities, it is relevant to keep the dictionary comprehensive, validated and constantly updated on a global scale.
世界卫生组织药物信息字典是一个全球性的医学信息资源,旨在促进临床试验中药物的编码以及监测患者安全时药物相关问题的识别,从而支持有效和安全药物的开发和使用。WHODrug 包含个别商品名、活性成分和其他信息,如营销授权持有人、销售国家、药物形式和强度。所有相关药物都使用结构化的 WHODrug 字母数字代码链接,将商品名和成分的变化与成分的活性部分连接起来。WHODrug 中的药物使用 ATC 系统进行分类,并聚类为标准化药物分组,以便将具有一个或多个共同特性的药物分组。内置的数据结构和 WHODrug 中药物的分类促进了各种药物的汇总方式,以识别和分析可能的药物不良反应。WHODrug 中的不同信息级别用于探索药物或一类药物与不良事件之间的关系。通过在临床试验和上市后安全中使用 WHODrug,可以在全球范围内实现准确和标准化的药物信息,并允许轻松进行信息交流。为了满足制药行业、学术界和监管机构对 WHODrug 用户的需求,保持字典全面、经过验证并在全球范围内不断更新是很重要的。