As of January 2012, DailyMed (http://dailymed.nlm.nih.gov/) featured labels for over 32,000 drug products submitted to the FDA. These labels are a rich source of drug safety intelligence, but their free text format and inconsistent terminology use make them difficult to interrogate or use with other applications.

BioWisdom’s Metawise enabled the identification of key medical terms as well as the creation of assertional metadata. Approximately 380,000 assertions were curated from 5000 DailyMed labels. They describe the side effects, black box warnings and laboratory tests for over 700 medicinal products, including highly-prescribed and black box warning-containing drugs. The data were originally built as a decision support tool for a US government agency and the approach was presented at the 2011 OpenTox conference in Munich (click for poster and presentation).

These data have now been integrated into SIP, allowing complex questions to be answered such as:

• Which laboratory tests should be considered when prescribing ACE inhibitors?
• Which black box warnings occur in medicines that list haemolytic anaemia as an adverse event?

The DailyMed data further enhances SIP’s content, particularly in the area of clinical adverse drug effects. The drug label information also benefits hugely from the SIP search interface, with a wide range of summary and dashboard views, querying against a rich collection of synonyms and taxonomic “tags” and chemical structure searches. Example summary views for the questions listed above are presented in Figure 1.

Figure 1: A list of the most common laboratory tests for drugs of the ACE inhibitor pharmacological class (left image), and the most frequent boxed warnings in drugs for which haemolytic anaemia is an adverse event (right image). Data were generated in approximately 5 minutes.

As always, please contact us if you need more information, or would like to comment on BioWisdom’s Safety Intelligence Program content and application.