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Ther Innov Regul Sci. 2020 Sep;54(5):1116-1122. doi: 10.1007/s43441-020-00130-6. Epub 2020 Feb 20.

WHODrug: A Global, Validated and Updated Dictionary for Medicinal Information.

Therapeutic innovation & regulatory science

Olof Lagerlund, Sara Strese, Malin Fladvad, Marie Lindquist

Affiliations

  1. Uppsala Monitoring Centre, Box 1051, 751 40, Uppsala, Sweden. [email protected].
  2. Uppsala Monitoring Centre, Box 1051, 751 40, Uppsala, Sweden.

PMID: 32078733 PMCID: PMC7458889 DOI: 10.1007/s43441-020-00130-6

Abstract

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.

Keywords: Adverse event; Clinical trial; Drug coding; Patient safety; Pharmacovigilance; Standardised Drug Groupings (SDG)

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