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. 

Read More

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. 
Read More

Topics: FDA, Real World Evidence

How Pharmacovigilance Departments Can Work Smarter, Act Bigger

By Jim Davis on September 15, 2017

Most pharmacovigilance departments are resource constrained. Whether its human capital, budget, or both, the drug safety specialists within pharmaceutical companies are being asked to do a whole lot with very little.

Read More

Topics: Pharmacovigiance 2.0

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

By Jim Davis on August 25, 2017

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.

Read More

Topics: Pharmacovigiance 2.0

What happens when a Safety Signal contradicts Clinical Trial data?

By Bob Kyle on August 4, 2017

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?

Read More

Topics: FDA, Clinical Evidence, Evidex

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

By Jim Davis on July 21, 2017

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). 

Read More

Topics: FDA, Evidex, Pharmacovigiance 2.0

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. 

Read More

Topics: FDA, FAERS

Happy (Drug Safety Data) Independence Day

By Jim Davis on June 30, 2017

First, our sincere apologies about the lack of regular posts recenlty. It's been busy times here at Advera and rather than put out posts just to put them out, we have made the decision to scale back our publishing schedule to make sure we can deliver the quality insight that our readers deserve.

Read More

Topics: Pharmacovigiance 2.0

Failure to Warn: The Week in Drug Safety News

By Brian Overstreet on June 9, 2017

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”!  

Read More

Topics: Drug Safety

How is Evidex Different from Traditional Signal Detection Software?

By Jim Davis on May 26, 2017

When first talking with drug safety departments, we often get asked how our platform is different than systems that they already have in place. The key difference between traditional signal detection software and a drug safety evidence aggregation platform comes down to the types of data they each support, the flexibility in which those data are supported, and the much broader use cases available through an evidence aggregation platform.

Read More

Topics: Drug Safety, Pharmacovigiance 2.0

New Call-to-action

Subscribe to Email Updates