WHO DDE's hierarchical product coding system, its range of powerful analytical tools, and its extensive global coverage make it a valued means of interpreting and reporting medicinal product information.
The Uppsala Monitoring Centre (UMC) WHO Drug Dictionary Enhanced (WHO DDE) is the most comprehensive and actively used drug coding reference work in the world. The information it contains helps ensure that clinical trial data as well as safety data is accurately coded, analysed, interpreted and reported.
"WHO DDE is easily accessed online via UMC’s WHO Drug Dictionary Browser."
Most critically, WHO DDE meets the expressed need for a consistent drug dictionary and exact terminology when coding concomitant medications to accelerate submissions to national regulatory authorities.
The statement below from the FDA’s Center for Drug Evaluation and Research (CDER) shows the importance it puts on CROs and sponsors communicating drug data in a standard form. The center further notes the value of using a common dictionary and exact terminology across clinical trials and throughout the following submissions: concomitant medications, procedures, indications, study drug names, and medical history.
If, for example, a sponsor or regulatory authority receives data in which dictionary conventions have not been followed, e.g. due to misspellings, automated processes for analyzing this data may not be possible. This reduces the efficiency of the review process.
"It is strongly preferred that a consistent drug dictionary (for example, the WHO Drug Dictionary) terminology be used for coding of the concomitant medications."
From the CDER Common Data Standards Issues Document (Version 1.1/December 2011).
WHO DDE contains codes for identifying drug names and evaluating medicinal product information, including active ingredients and therapeutic uses. Each medicinal product has a drug code as well as a unique Medicinal Product ID with key attributes (e.g. country, Marketing Authorization Holder, pharmaceutical form and strength). WHO DDE also reveals a product’s Anatomical and Therapeutic use as well as its Chemical class using the ATC classification system.
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"WHO DDE improves the collection, analysis, understanding and reporting of clinical data. CROs and sponsors can communicate data in a standard and consistent form." |
Standardized Drug Groupings (SDGs), which are cross-classification drug lists based on pharmacological class or metabolism, are also included as a feature for WHO DDE. These can be used to identify drug-drug interactions on individual case safety reports (ICSRs), finding alternative causes of adverse events, or identifying drugs that may interfere with the result of a clinical trial (please see SDG product information below for further details).
WHO DDE’s hierarchical product coding and classification systems, its range of powerful analytical tools, together with its extensive coverage in countries where trial data is collected, are of great value. They promote the correct and complete coding, interpretation and evaluation of concomitant medications in clinical trials and safety data. The classification systems like ATC and SDGs enhance aggregation of statistics in analysis and reporting.
WHO DDE is continuously updated to adapt its contents to the ever-changing clinical landscape; novel drug types, revised regulatory requirements, trials conducted in new countries, etc. New categories, country-specific therapy traditions and names are added on a regular basis.
New product names and substances are added quarterly. The December 1, 2012 version of the WHO Drug Dictionary Enhanced now contained over 2 million (2 021 870) Medicinal Products with specified information and data from more than one hundred countries around the world, including 263 451 unique Medicinal Product names. UMC also releases quarterly updates of SDGs.
Recent additions to the dictionary family include the Drug Dictionary China (DDC) and Cross Reference Tool (CRT) Japan expansions for the Asian region. Product information for these products can be found below. Further expansion of the UMC Drug Dictionaries is expected in the future.
To make coding easier and more time efficient, take part of the latest quarterly updates in the WHO DDE and upgrade from WHO Drug Dictionary to WHO Drug Dictionary Enhanced. For more information and assistance contact sales@umc-products.com
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