The RxView Blog

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

Advera Health Analytics, Inc.

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

Happy (Drug Safety Data) Independence Day

Posted by Jim Davis on June 30, 2017

First, our sincere apologies about the lack of regular posts recenlty. It's been busy times here at Advera and rather than put out posts just to put them out, we have made the decision to scale back our publishing schedule to make sure we can deliver the quality insight that our readers deserve.

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Topics: Pharmacovigiance 2.0

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

How is Evidex Different from Traditional Signal Detection Software?

Posted by Jim Davis on May 26, 2017

When first talking with drug safety departments, we often get asked how our platform is different than systems that they already have in place. The key difference between traditional signal detection software and a drug safety evidence aggregation platform comes down to the types of data they each support, the flexibility in which those data are supported, and the much broader use cases available through an evidence aggregation platform.

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Topics: Drug Safety, Pharmacovigiance 2.0

Post-Marketing Drug Safety and Pharmacovigilance Is Now More Important Than Ever

Posted by Jim Davis on May 12, 2017

If you read this blog, you probably follow the world of drug safety closely. So I’m sure you saw the JAMA article, and the resulting coverage by the main stream media, that was authored by Downing, et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

If you haven’t had a chance to read the study yet, the results demonstrated that a third of every drug approved from 2001-2010 was subject to post-marketing action by FDA.  Even more alarming was the finding that drugs with accelerated approval by FDA during this period were twice as likely to be subject to label changes or warnings after approval. 

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Topics: Post Approval Data, Pharmacovigiance 2.0

Pharmacovigilance 2.0 – Let Freedom Ring in Philadelphia!

Posted by Jim Davis on April 28, 2017

Next week, May 3rd and 4th, will mark a big moment for Advera Health. Our Chief Product Officer Bob Kyle and I will be attending the World Drug Safety Congress in Philadelphia. The moment will be big, not because we are exhibiting for the first time (we are), or because we are demonstrating significant advances in drug safety data (we are), or even because I’m a huge fan of the Philadelphia Eagles (I am) and Bob has always dreamed of imitating Rocky and running the 72 stone steps before the entrance of the Philadelphia Museum of Art (he hasn’t).

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Topics: Pharmacovigilance, Pharmacovigilantes, Pharmacovigiance 2.0, World Drug Safety Congress

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

Evidex Alerts After 3 Months: What We’ve Learned

Posted by Bob Kyle on April 7, 2017

It has now been one full quarter since we launched Evidex Alerts, the service which keeps our clients on top of the latest Drug Label Changes, Regulatory Alerts and Clinical Safety Data in real-time.   Evidex Alerts have been a smashing success and our clients have openly thanked us making this information easier to follow.  One client in particular was amazed at how well we untangle the mess that is a drug label and pull out the important pieces of information that they need to know, when they need to know it.

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Topics: FAERS, Clinical Trials, Label Change, Clinical Evidence

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

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