December 1, 2017

Analysis of a FDA Safety Signal: DPP-4's and Rhabdomyolysis

Recently the FDA published the Q2 2017 version of Potential Signals of Serious Risks / New Safety Information as identified by the FDA Adverse Event Reporting System (FAERS).

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November 22, 2017

Evidex Goes Global - VigiBase Drug Safety Data Access

Last week we announced the addition of VigiBase global safety data to the Evidex platform. VigiBase is the unique global database of individual safety reports collected from over 110 countries by the World Health Organization. It totals over 15 million adverse event reports since 1968 and is administered by the Uppsala Monitoring Centre in Sweden.

This is an exciting development for our company, for our clients, and for the drug safety community at large.

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November 10, 2017

An Analysis of Adverse Events Associated with Endothelin Receptor Antagonists (ERAs) using FAERS

Advera Health released a new functionality framework in Evidex this week called Custom Analytics. The goal of Custom Analytics is to provide Evidex users an easy way to perform complex queries across all of the clinical, spontaneous and other real-world data included in the Evidex platform and to return a filtered set of specific information. 

We have launched Custom Analytics with a Custom Drug-Adverse Event Analysis search function. With the Custom Drug-Adverse Event Analysis, users can easily filter case reports by specific drug combinations, demographic, and descriptive information, create customized MedDRA queries with multiple preferred terms, and calculate Reporting Odds Ratios (RORs).

The best part? It's simple to use.

Let's demonstrate the power of Custom Analytics through a case study, analyzing adverse events associated with endothelin receptor antagonists (ERAs) using the FDA Adverse Event Reporting System (FAERS) data. 

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October 6, 2017

FAERS Thee Well - Drug Safety Excitement with FDA Dashboard

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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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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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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October 20, 2016

Why Does Adverse Event Reporting to FAERS Continue to Accelerate?

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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March 11, 2016

A Crystal Ball for FDA Action: How we Validated RxSignal

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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