Last week Brian Overstreet wrote a post discussing the State of Drug Safety Systems, in which we revealed the increasing reports appearing in FAERS. After processing the full year 2014 data we found that over a 5 year period the number of reports submitted into FDA Adverse Event Reporting System (FAERS) rose by approximately 71%, resulting in roughly 900,000 primary suspect adverse event reports submitted in 2014.

This number should shock you.

While the general consensus has evolved regarding the value of FAERS, there are still some of you that view it with negative connotations. You think of it as an “antiquated” system that reeks of underreporting and bias. You probably still thought the Weber Effect  was a thing. And you probably think that yearly case reports came nowhere close to 900,000.

900,000 case reports that most people have never seen. 900,000 case reports that represents the largest trove of drug side effects data available, anywhere.

When we introduce our platform to formulary decision makers, they are blown away by what we are able to accomplish with what they previously thought was “bad” data. After walking them through the volume of case reports and the analytics that we are able to put on top of those reports it is clear to them that this is not the FAERS that they were taught to shun.

FAERS is a highly usable and actionable database that in the right hands can save the healthcare systems billions of dollars and dramatically improve patient outcomes.

But the problem remains that access to clean data and powerful analytics often takes the back seat to profits and immediate cost savings.

As a fellow drug safety advocate, you can play a role in making sure all safety aspects of prescription drugs are considered prior to their prescription. Let your voice be heard by taking the simple step of asking CMS to strengthen the Medicaid drug benefit within managed care programs, by making regular reviews of FAERS data a component of improving patient safety and reducing systemic costs. More data, more analysis – the safer the prescription drug market will be. Deadline for comments is July 25. Will you take action?

To let your voice be heard, contact CMS


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Jim Davis

Jim Davis

Executive Vice President

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Jim Davis

Written by Jim Davis

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