The RxView Blog

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

Advera Health Analytics, Inc.

Social Media Monitoring for Pharmacovigilance and Drug Safety

By Jim Davis on February 2, 2018

It is now well established that the rapid expansions of the internet and computing power have opened up the use of social media and Internet forums for pharmacovigilance. These sources contain untapped, albeit noisy, safety and benefit information. As noted in Social Media Listening for Routine Post-Marketing Safety Surveillance, published in the journal Drug Safety, methods exist to reduce noise and make the data suitable for post-marketing safety surveillance. However, the use of these data to date have been constrained by limitations in how to best implement novel methods without disrupting traditional signal detection management and evaluation work flow.

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Topics: Pharmacovigiance 2.0

2018- The Year of Next Gen Drug Safety and Pharmacovigilance 2.0

By Brian Overstreet on January 19, 2018

We have a tradition in the RxView blog of starting each new year by asking if the year ahead will be “The Year of Drug Safety” or “The Year of Healthcare Technology”. We typically lay out a few thoughts on why the year ahead has the potential to be a big year.

This year feels different. Maybe it’s the incredible bull market that has inflated our confidence or the fact that my colleague Jim Davis feels that it is a foregone conclusion that the Philadelphia Eagles will finally win the Super Bowl (sorry Jim, that’s ridiculous!). Or perhaps it’s the fact that our client roster keeps growing, Evidex keeps getting more valuable to our users every day, and key industry opinion leaders are confirming that our vision is THE path forward. Whatever the reason, I’m willing to be a bit bolder this year.

2018 WILL BE the year that the pharmacovigilance industry embraces the next generation of drug safety data, analytics, and software; What we call Pharmacovigilance 2.0.

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Topics: Pharmacovigiance 2.0, Company News, Drug Safety

Top Free Drug Safety Downloads of 2017

By Jim Davis on December 29, 2017

Happy Holidays! In what many describe as the most exciting countdown of the year, here are the top free downloads from Advera Health for 2017!

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Most Popular Drug Safety Articles of 2017

By Jim Davis on December 22, 2017

Happy Holidays! As another year comes to a close we share with you our most popular blog posts of 2017. Enjoy!

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

By Jim Davis on December 1, 2017

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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Topics: Clinical Evidence, Drug / Indication Information, Evidex, FAERS

Evidex Goes Global - VigiBase Drug Safety Data Access

By Brian Overstreet on November 22, 2017

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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Topics: FAERS, Evidex, Pharmacovigiance 2.0, VigiBase

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

By Jim Davis on November 10, 2017

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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Topics: Clinical Evidence, FAERS, Pharmacovigiance 2.0, Company News

Santa Rosa Wildfires - A Very Tough Week at Advera Health

By Brian Overstreet on October 20, 2017

Santa Rosa, California in Sonoma County is where we live and work.  It's probably best known for its world class wines, restaurants, and hotels.

Last week, we made global news for a much different reason.

Starting early in the morning on Monday Oct 9, a series of wildfires tore through the city of Santa Rosa and the surrounding areas. By the end of the week, thousands of homes and commercial buildings had burned, more than 40 people had died, and another 50+ remained missing. For a county with a total population less than 500,000 and fewer than 200,000 housing units, the effect on our home town has been devastating.

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Topics: Company News

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

Dear FDA, There is No Single Truth Standard

By Jim Davis on September 29, 2017
FDA needs to think of itself as an information curator, rather than an arbiter of information, FDA Commissioner Scott Gottlieb told attendees of the National Academy of Sciences’ workshop on the impact of real-world evidence ( RWE) on Tuesday, September 19th. Further stating, where a single truth standard is secured to a fixed orthodoxy”. 
 
If only it were that easy. 
 
A single truth standard sounds great in a world where patients are homogeneous, human biology is fully understood, and motivated trial sponsors don’t design studies to hit specific goals. 
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Topics: FDA, Real World Evidence

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