August 25, 2017

Case Studies: Signal Detection Utilizing FDA Adverse Event Reporting System (FAERS) Data

One of the key benefits of a drug safety evidence aggregation platform is the data source flexibility it provides. Historically, smaller organizations have put off automating aggregate signal detection on FDA Adverse Event Reporting System (FAERS) data to avoid the cost and time commitment needed to implement traditional signal detection software. And those organizations that do have traditional software installed, have typically limited use to specific functional areas within drug safety and “expert” users, making FAERS data and analytics hard to access. An evidence aggregation platform makes these data and the related analytics easy and provides for a robust source of insight.

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August 4, 2017

What happens when a Safety Signal contradicts Clinical Trial data?

Last month, FDA released their quarterly watch list of ongoing drug safety concerns. My colleague Jim wrote a blog post on some of the major talking points around the update, not on the drugs or the risks themselves, but general pharmacovigilance themes. Our post this week focuses on one of the risks that was specifically discussed by FDA on the SGLT-2 class of diabetes drugs. The SGLT-2's had triggered a safety signal for nephrolithiasis (aka kidney stones). Evidex RxSignal analysis had also predicted this safety signal for most of these SGLT-2 drugs, with many of the signals being triggered more than a year prior to this alert.

However, unlike the 12 other safety issues in this same alert, the FDA quickly determined that despite the safety signal shown in the postmarketing data, “no action is necessary at this time, based on available information”. In other words, the FDA does not believe that kidney stones should be disclosed as a risk to the labels of these medications.

Why did the FDA make this determination so quickly? What information did the FDA use?

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July 21, 2017

FDA Releases Q1 2017 Drug Safety Watch List: It’s Boring and That’s Good

Earlier this month FDA quietly published a quarterly update to their publicly available “watch list” of ongoing drug safety concerns. The updates are based on Q1 2017 FDA Adverse Event Reporting System (FAERS) data. You can download a copy of our recent Evidex Alert, covering the new additions, clarifications, and “all clears” so I won’t get into the details in this post. However, it is worth noting that there were fourteen unique drugs, or in some cases entire classes of drugs, that were included in the update. Many of the drugs have been on market for quite a long time and otherwise would be considered to have a well established safety profile. For 8 of the 11 alerts that could be signaled for (3 of the alerts were AEs that were already labeled for), Advera Health’s RxSignal early warning system did its job and picked up on the signal. The remaining alerts either weren't on a RxSignal eligible adverse event, meaning it wasn't a serious event that the FDA typical takes action on, but there was noticable elevated reporting as defined by reporting odds ratios (ROR). 

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July 14, 2017

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

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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June 9, 2017

Failure to Warn: The Week in Drug Safety News

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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May 12, 2017

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

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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April 28, 2017

Pharmacovigilance 2.0 – Let Freedom Ring in Philadelphia!

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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April 21, 2017

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

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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March 31, 2017

Using FAERS to Determine Medical Costs – a Payer Perspective

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 theFDA 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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March 24, 2017

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

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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