The RxView Blog

Happy (Drug Safety Data) Independence Day

jim@adverahealth.com (Jim Davis) — Fri, 30 Jun 2017 15:00:00 GMT

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.

Failure to Warn: The Week in Drug Safety News

brian@adverahealth.com (Brian Overstreet) — Fri, 09 Jun 2017 15:00:00 GMT

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”!

How is Evidex Different from Traditional Signal Detection Software?

jim@adverahealth.com (Jim Davis) — Fri, 26 May 2017 15:00:00 GMT

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.

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

jim@adverahealth.com (Jim Davis) — Fri, 12 May 2017 15:00:00 GMT

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.

Pharmacovigilance 2.0 – Let Freedom Ring in Philadelphia!

jim@adverahealth.com (Jim Davis) — Fri, 28 Apr 2017 15:00:00 GMT

Next week, May 3^rd and 4^th, 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).

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

brian@adverahealth.com (Brian Overstreet) — Fri, 21 Apr 2017 15:00:00 GMT

FDA released the fourth quarter of Adverse Event Reporting System (FAERS) data on Thursday March 16^th. By Monday March 20^th, 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:

Evidex Alerts After 3 Months: What We’ve Learned

bob@adverseevents.com (Bob Kyle) — Fri, 07 Apr 2017 14:30:00 GMT

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.

Using FAERS to Determine Medical Costs – a Payer Perspective

brian@adverahealth.com (Brian Overstreet) — Fri, 31 Mar 2017 15:00:00 GMT

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.

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

brian@adverahealth.com (Brian Overstreet) — Fri, 24 Mar 2017 11:30:00 GMT

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.

Efficacy vs. Effectiveness - The Role of Pharmacovigilance

jim@adverahealth.com (Jim Davis) — Fri, 17 Mar 2017 15:00:00 GMT

I'm pleased to introduce Jill Notte, Director of Global Marketing, APCER Life Sciences, who authored this week's post.

As a marketing communications professional in the pharmaceutical industry, I try to choose my words carefully in everything I write. The field of drug safety, where I have spent the past 15 years of my career, is particularly choosy about its terms. Words have precise definitions, and so we say, for example, that an event is “suspected” when we haven’t yet confirmed whether it is “unexpected” or “serious.”