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In evidence based medicine it is expected that the most up-to-date data are being used to support decision making. Unfortunately, that is not currently the case.

Key components of drugs' safety profiles, reports that are being filed to the FDA after a drug is approved, are not being used by the healthcare system because the data is very difficult to access, and once accessed, very difficult to interpret. In order to properly monitor post-marketing safety of a drug, a significant amount of time needs to be spent working with the FDA Adverse Event Reporting System (FAERS) dataset and standardizing the output.

FAERS dataThe FDA states that relational database programming ability is needed to extract FAERS information. Once the complicated process of extracting the data is completed, the user will quickly see that searching and gleaning insight from what has been reported is extremely difficult and arduous.FAERS data is unstructured with no standardized reporting lexicon for drug names and doses. Looking at the example of Lipitor, there are over 700 different names in FAERS due to misspellings, generic vs. branded reports, and the use of ex-US brand names.

This is a flawed process that cannot be properly monitored by most industry participants, especially busy healthcare providers. As a result prescription decisions are being made without consideration of all of the data.

Evidence based medicine, without access to all of the evidence

In his Bad Science blog, Ben Goldcare discusses the problem of withheld clinical trial results. In a recent post he says, "Doctors (and patients, and researchers, and payers, and the public) need access to all the results, of all the trials, on all the uses, of all the treatments currently being prescribed, in order to make informed decisions about which is best."

We agree, and we adamantly add "all post-marketing safety data" to this list.

Our previous post by Brian, Without ROI Big Data in Healthcare is Doomed focused on the importance of making information valuable and providing a clear-cut ROI. In order to make post-marketing safety data valuable, it not only needs to be accessible, but also actionable.

We have some ideas on that as well; Although not ready to announce anything to the blogosphere, please contact us or keep watching this space for some exciting announcements soon.


Related Read: The Apple iPhone Announcement: It is Only The Second Most Exciting Product Release This Week


Promoting patient safety and providing client ROI are the driving motivations for everything we are doing at AdverseEvents, and making the information from FAERS accessible is the backbone to reducing the cost burden that lies at the heart of the issue we are working to solve.


Related Read: Logic. Software. Drug Safety?


Post FDA approval drug safety whitepaper - Download Now

Jim Davis

Jim Davis

Executive Vice President

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Topics: FDA, FAERS

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.