Wow, it’s the end of February. I’m sure I’m not the only one who feels that the first two months of 2018 have flown by. Advera Health’s engineering, product, and analyst teams have been hard at work. Evidex’s back-end data architecture has been enhanced to keep up with our growing library of datasets and to ensure the analytics layered on all of the data are efficient and fast to meet client demands.Read More
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.Read More
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).Read More
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.Read More
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
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
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
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.Read More
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).Read More
I'm pleased to introduce Jill Notte, Director of Global Marketing, APCER Life Sciences, who authored this week's post.
As a marketing communications professional in the pharmaceutical industry, I try to choose my words carefully in everything I write. The field of drug safety, where I have spent the past 15 years of my career, is particularly choosy about its terms. Words have precise definitions, and so we say, for example, that an event is “suspected” when we haven’t yet confirmed whether it is “unexpected” or “serious.”Read More