The RxView Blog

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

Advera Health Analytics, Inc.

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. 

Read More

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).

Read More

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:

 

Read More

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.

Read More

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.

Read More

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.

Read More

Topics: FAERS, Clinical Trials, Clinical Evidence

Efficacy vs. Effectiveness - The Role of Pharmacovigilance

Posted by Jim Davis on March 17, 2017

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.”

Read More

Topics: Pharmacovigilance, Pharmacovigilantes, Pharmacovigiance 2.0

ICER Underestimates Adverse Event Rates and Costs for Multiple Sclerosis Medications

Posted by Jim Davis on March 10, 2017

 

On March 6th ICER released their final Evidence Report on Multiple Sclerosis medications. The conclusion was that every MS medication, except for Lemtrada, do not provide enough value to justify their prices. As with every ICER report that is released, the pharmaceutical manufacturers refute the findings and tout their R&D expenses and the very real burden of bringing life saving drugs to markets.

I’m not looking to start a debate on the merits of either ICER’s or the manufacturers’ arguments in this post. Taking my position on the fence, I can say that I believe ICER provides a valuable, independent view into value, but at the same time pharmaceutical companies should expect to be able to be reasonably compensated for their efforts.

Read More

Topics: Multiple Sclerosis

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.

Read More

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.

Read More

Topics: Big Data

Subscribe to Email Updates