Monitoring Medical Literature for Drug Safety

Jul 20, 2016
Kari Blaho-Owens

Vice President, Account Management - Pharmacovigilance

Monitoring of medical literature for safety signals and adverse events is critical to both veterinary and human PV.

I would like to share with you some learnings from a session at last month’s DIA Annual Conference in Philadelphia regarding this topic. And more specifically, the pilot project between FDA, the National Library of Medicine (NLM) and National Institute of Health (NIH). This project explored the results of a query system to extract literature citations that were relevant to adverse drug events (ADE) by leveraging existing PubMed/MEDLINE indexing terms.

In FDA’s presentation, PubMed was chosen for its wealth of information; nearly 23 million citations covering almost every area of the regulatory drug life cycle. The citations are global in nature and between 2 and 4000 are added daily. A rich environment to search for AEs, indeed.

But what are the most efficient methods and how do you sift through such vast amounts of information?

FDA CDER began by creating a subset of potential ADE citations from search criteria:

  • clinical relevant drugs,
  • unique drug manifestations,
  • unique ADE pairs and citations, a subset to search for relevant ADE was created.

Important to remember is that there are PubMed citations that have not yet been MeSH indexed. So setting up auto-alerts by leveraging simple drug name, restriction in time period and managing the query by filtering to focus retrieval of new and emerging information was compiled with more traditional methods above.

FDA’s results workflow seemed optimal by managing the search strategy, saving the search in PubMed (MyNCBI cubby) and then reviewing on a regular cadence. Auto alerts on emerging articles that have not been MeSH compiled can be sent weekly for review and combined with traditional articles that are already indexed. This result gave FDA the most robust output.

 

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