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).
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.
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.
Topics: Pharmacovigiance 2.0
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”!
Topics: Drug Safety
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.
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.
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).
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:
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.
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 the FDA 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.