Definition

A standardized reference database (such as WHODrug) used to consistently code and classify drug names, substances, and formulations across adverse event reports.

Example

A patient reports taking 'Tylenol.' Using WHODrug dictionary, this is coded to the generic name 'Paracetamol' with ATC code N02BE01, enabling consistent analysis.

Regulatory source

WHO Drug Dictionary, ICH E2B(R3)

Common mistakes

Not updating to the current version of the drug dictionary, missing new medications or formulation changes.

Inspector question

What drug dictionary do you use and how often do you update it? How do you handle drugs not found in the dictionary?

Related terms