The RxView Blog

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

Advera Health Analytics, Inc.

FAERS Thee Well - Drug Safety Excitement with FDA Dashboard

By Brian Overstreet on October 6, 2017

It’s been an exciting week in the normally staid world of drug safety.  

Last Thursday, FDA launched a public dashboard for FAERS (the FDA Adverse Event Reporting System).  We’ve been calling on FDA to do this for years, so we were quite excited to read the news and take the new dashboard out for a spin.

Apparently, a lot of others were just as excited.  The site almost immediately stopped working and stayed that way for most of Friday. 

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Topics: FDA, FAERS

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

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, FAERS

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

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

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 Evidence

Using FAERS to Determine Medical Costs – a Payer Perspective

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 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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Topics: FAERS, Managed Care, Evidex

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

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 Evidence

Using FAERS Data and Clinical Evidence to Compare HER2+ Antagonists

By Andrea Demakas on February 9, 2017

Recently, Advera Health released a comparative safety report of the HER2+ Antagonists. In this drug review, we analyzed FDA Adverse Event Reporting System (FAERS) and clinical trial data to better understand how the drugs in this class stacked up.

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Topics: FAERS, Clinical Evidence, Drug / Indication Information

Why Does Adverse Event Reporting to FAERS Continue to Accelerate?

By Brian Overstreet on October 20, 2016

faers_growth.pngSeventy two hours after 2016 Q2 FDA Adverse Event Reporting System (FAERS) data were publicly released by FDA, our RxFilter® process had it standardized and loaded into the Evidex platform.  Based on the volume of data in Q2, it looks like we’re well on the way to yet another record year of adverse events reported into FAERS. 

Here is a chart of new case reports (including our estimate for full year 2016).  Note that these numbers are based on a clean dataset; de-duplicated, primary suspect cases only).

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Topics: FAERS

Honest Salespeople Aren’t Dead

By Andrea Demakas on June 24, 2016


I’m writing this in the lobby of a car dealership, waiting for my vehicle to get serviced. I brought a couple of sales books with me so I could utilize the 2 hour wait. I recently took on the added role of part-time sales rep within Advera Health as I have experienced successful case studies first-hand through being our client-facing Product Specialist over the past two years: I’ve built relationships with our existing clients, received their feedback on our data tools & analytics to see how they’ve implemented the information, and witnessed how our Evidex platform has become an integral part of their workflow.

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Topics: FAERS, Managed Care, Evidex

A Crystal Ball for FDA Action: How we Validated RxSignal

By Dr. Keith Hoffman on March 11, 2016

We are pleased to report that our latest major publication, “A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports” was released this week in the esteemed journal “Drug Safety.”  It was published as an online-first feature and will also appear in the April copy of the print version of Drug Safety.

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Topics: FDA, FAERS, Evidex

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