The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Brian Overstreet

Recent Posts

Canada’s March Toward Mandatory Reporting of Adverse Events by Providers

Posted by Brian Overstreet on July 14, 2017

Canada has long had a more open system for reporting and searching adverse drug events.  They provide an easy to use online form for healthcare providers and consumers to make direct reports, which contrasts significantly to the cumbersome reporting form provided by FDA here in the U.S.   They provide a web-based search tool that enables anyone to search through adverse event reports submitted to Health Canada.  Nothing like that exists from FDA in the U.S.

Now comes word that Canada is taking a step toward something that we’ve long believed to be a crucial factor in improving and increasing adverse event reporting – requiring reporting from healthcare providers. 

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Topics: FDA, adverse drug event reporting, Canada

Failure to Warn: The Week in Drug Safety News

Posted by Brian Overstreet on June 9, 2017

It’s been a very busy week for many of us.  School’s finishing up for the kids here in California (no snow days here!), the annual ACSO conference was in full swing, the Warriors are up 3-0 in the NBA finals, and the media coverage of the Comey hearing has been non-stop.

With everything else going on, we wanted to make sure to draw your attention to some significant drug safety reporting over the past week, as we wouldn’t want to be accused of “failing to warn”!  

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Topics: Drug Safety

2016 FDA Adverse Event Reporting System (FAERS) Data: An Infographic

Posted by Brian Overstreet on April 21, 2017

FDA released the fourth quarter of Adverse Event Reporting System (FAERS) data on Thursday March 16th.  By Monday March 20th, our team had run the data through our proprietary RxFiler optimization process and the de-duplicated, cleaned, and properly cataloged data were onto our Evidex platform and ready for use by our clients.

For the fourth quarter, we processed 310,222 new unique case reports, which brought the total new unique case reports for 2016 to 1,253,464.

While a full analysis of our Q4 findings is still pending, it’s clear that the sheer volume of case reports continues to grow rapidly. 

Our infographic below provides some key details:

 

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Topics: FAERS

Using FAERS to Determine Medical Costs – a Payer Perspective

Posted by Brian Overstreet on March 31, 2017

We're happy to have a guest writer on the RxView blog this week, Alan Lukazewski, RPh – Director of Clinical Pharmacy at WEA Trust

WEA Trust is a not-for-profit health insurer serving Wisconsin public employers, their staffs and families.  In my role as Director of Clinical Pharmacy, I manage pharmacy benefits for WEA Trust, including prior authorization management, clinical program design, and specialty pharmacy management.  Within those areas, I focus attention on adverse drug event detection and prevention, especially in older adults. 

Last year, we partnered with Advera Health on a unique project to determine whether we could use data from the FDA Adverse Event Reporting System (FAERS) to determine total medical costs for a particular class of medicines.  Previously, Advera Health published a study detailing their methodology for calculating medical costs from FAERS data, but this would be the first study to pair FAERS data with specific claims data to determine downstream medical costs.

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Topics: FAERS, RxCost, AMCP

Calculating the Reporting Rate of Adverse Events in FAERS – A New Methodology

Posted by Brian Overstreet on March 24, 2017

It’s been an exciting week for drug safety with articles in both USA Today and FiercePharma examining the five-fold rise in reporting of serious adverse events into FDA’s Adverse Event Reporting System over the past twelve years.  We were thrilled to see Advera Health featured prominently in both of those articles.

Despite the significant reporting increase, limitations in the use of FAERS data for post-market surveillance remain.  One of the biggest limitations is that not all adverse events are reported.  As a spontaneous (i.e., voluntary) reporting system, it’s simply not possible for every adverse event to be recorded.  This is different from a controlled clinical trial where all adverse events and outcomes are recorded.

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Topics: FAERS, Clinical Trials, Clinical Evidence

Make Hair Great Again - The Real Reason for FDA Reform

Posted by Brian Overstreet on March 3, 2017

A personal note:  About a month ago, we published a blog post titled Drug Safety Progressives.  While 99.9% of the readers understood that this wasn’t a political statement, we did get hit with some great trolling that accused us of, among other things, pushing “Alt-Left Propaganda on a Left Wing Socialist website.”  How or why someone reached that conclusion is beyond me.  Regardless, I’m dedicating today’s blog post to those 0.1% of our readers who troll for an internet fight.  I’m confident that the rest of you will enjoy it too.

We know that with the fake news circulating these days, you may have missed the most important breaking story concerning President Trump in February.  That’s right, he’s taking something to maintain that famous hair – Propecia.

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Topics: Drug Safety, FDA

A Big Data Stumble in Healthcare

Posted by Brian Overstreet on February 24, 2017

This week marked the annual HIMSS Conference.  HIMSS, Healthcare Information and Management Systems Society, is the big annual gathering of IT firms trying to market their wares into healthcare systems, pharmaceutical companies, and health insurers.

While usually a time for big partnerships, acquisitions, deployments, and new client wins, this year’s HIMSS kicked off in a rather inglorious manner.  On Sunday news broke that world-renowned cancer center MD Anderson had discontinued their partnership with IBM Watson.  After a string of big wins by the Watson team, this appeared to be the first – and certainly the largest – setback.

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Topics: Big Data

Advera Health Partners with APCER Life Sciences to Connect Drug Safety to Health Outcomes

Posted by Brian Overstreet on January 26, 2017

We were very excited this Monday to announce a new partnership with APCER Life Sciences, a global provider of safety, medical, regulatory, and technology services to the pharmaceutical industry.  Working with the dedicated professionals at APCER will enable us to expand our reach into the safety and pharmacovigilance departments at pharmaceutical companies globally. 

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Topics: Drug Safety, Health Outcomes

Will 2017 Be The Year of Drug Safety?

Posted by Brian Overstreet on January 12, 2017

On this past Sunday’s 60 Minutes, astronomer Mike Brown made a bold prediction – that within three years the scientific community would identity a new, large 9th planet located in the outermost area of our solar system.  Even more astonishing was how certain he was about that prediction, “I would say at this point, I am certain….that’s a rare thing to say – for a prediction for a scientist.  And I’m willing to say it.”  Mike Brown has some credibility in this area, as he’s the guy who figured out that Pluto wasn’t a planet after all.  Maybe it’s his own guilt over breaking every school-kid’s heart that’s driving his prediction, but both his prediction and his certainty really fascinated me.  If you haven’t watched the report, I’d urge you to do so (link is here).

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Topics: Drug Safety

Looking Ahead - Drug Safety in 2017

Posted by Brian Overstreet on December 16, 2016

As 2016 winds down, am I the only one who feels exhausted? 

Between pharma-bro inspired drug pricing madness, a political season that felt like a Bravo reality TV show, and Leicester City robbing my beloved Tottenham Hotspur of their first shot at a Premiere League championship in a very long time, I think John Oliver summed up this year best in this video.

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Topics: Drug Safety, Clinical Evidence, Evidex

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