Standardised Drug Groupings (SDGs) simplify the creation of medications of interest and protocol violation lists and can be used, for example, to identify possible drug-drug interactions.
Subscribers to the Uppsala Monitoring Centre (UMC) WHO Drug Dictionary Enhanced (WHO DDE) have many uses for the dictionary’s unique coding system for medicinal products, their active substances and their therapeutic effects. To make clinical studies powerful, awareness of the concomitant medication taken by the participants is very important.
Which drugs may interact with the study substance?
Do they hide or distort the measurements and endpoints of the study protocol?
Which concomitant drugs indicate that patients have concomitant conditions not recorded elsewhere, conditions that may be relevant for interpreting the study result?
In drug safety surveillance, users can code and analyse concomitant medications as well as identify possible drug-drug interactions with the help of SDGs.
Inclusion/exclusion lists are created by investigators as part of the study protocol to monitor medication taken by patients during a trial. These lists can also be re-used in future studies.
Creating and maintaining the lists is, however, time consuming, and the risk that relevant drugs recently entered in WHO DDE are missed when updating them is always present. To harmonise the use of these lists, UMC has taken on the responsibility to maintain and quality assure their up-versioning, and has made them available under the name Standardised Drug Groupings (SDGs).
SDGs are cross-classifications of drugs, generally listed according to either the drug’s pharmacological class or its metabolism. Most are divided into sub-groups (see overleaf). Each SDG is prioritized by the user community, developed by experts in the pharmaceutical industry, and peer-reviewed by counterparts in related fields.
To make SDGs as transparent as possible, each contains a definition, a description of what it contains, and how it has been compiled. Furthermore, since SDGs are maintained by UMC, new drugs are added as soon as they are included in WHO DDE.
UMC first made SDGs available in 2010 and has expanded and updated the lists quarterly since then. In March 2012, 130 SDGs, including subgroups, were available. New SDGs are added with every March release of WHO DDE.
SDGs are available free of charge to all WHO DDE users. For details of how to subscribe to WHO DDE, contact UMC at sales@umc-products.com
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