#5: 2018- The Year of Next Gen Drug Safety and Pharmacovigilance 2.0



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. READ MORE


Wow! We made some big predictions at the start of the year... and NAILED them! Not only did the Philadelphia Eagles WIN THE SUPER BOWL (!!!!!) but Pharmacovigilance 2.0 seemed to really come into its own. 


#4: Can Modern Analytics be Forced into Traditional Pharmacovigilance Workflow Tools?



Modern pharmacovigilance departments today do more than process and review ICSRs. They are involved in the entire lifecycle of a drug, providing vital data points and analysis that inform everything from clinical trial design to commercial planning to post-market safety surveillance. In order to perform well, pharmacovigilance and safety science teams require access to an array of data and the analytics to make sense of those data. The insights gained from unique combinations of clinical and real world data drive signal detection, epidemiological research, and evidence generation, all of which support organization-wide decisions.

The problem is that drug safety insights are hard to obtain and teams often get caught in a "paralysis by analysis" trap. READ MORE


The title was a bit of rhetorical question, the obvious answer is "no". Complex data integrations and modern analytics can't sit on top of traditional workflow tools. In a data-first world, those workflow tools need to be built in and around the data and analytics that drive decision making.


#3: The Evolution of Pharmacovigilance Software



I recently wrote an article for PharmExec called Pharmacovigilance Software is Having its “Salesforce” Moment. It discusses how the market for pharmacovigilance software is starting to catch up to other verticals through disruption by technological innovation. I argue that the barriers that were in place such as drug safety’s role as a cost center and the difficulty of accessing data are breaking down. And the result is that there are now choices in the pharmacovigilance software market that weren’t available just a few years ago.

After re-reading the article, I think there is an important, key point that got lost and could use further definition. The concept of the evolution of software from a “system of record”, to a “system of engagement”, to a “system of intelligence”, and why that evolution is so important. READ MORE. 


The theme of software evolution and how pharmacovigilance analytics is a revenue driver has truly resonated with our current and prospective clients. Helping PV to break out of the cost center, low value area of the curve is something the entire industry will continue to work towards in 2019 and beyond. 


#2: Depression as a Drug Side Effect: A Quick FAERS Analysis



A study published Tuesday in the Journal of the American Medical Association found that people who take at least one of the 200 drugs that list depression as a side-effect are, in fact, more likely to be depressed. The study, which included 26,192 adults who participated in the National Health and Nutrition Examination Survey, does not prove a causal effect, but the association is striking. 

Below are screen shots taken directly from Evidex that highlight analysis on depression, as a drug adverse event. READ MORE.


The JAMA study on depression as as drug side effect highlights the important work that pharmacovigilance professionals do on a daily basis. More work needs to be done to better understand the association. 

#1: Social Media Monitoring for Pharmacovigilance and Drug Safety



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.


The popularity of this post shows that methods for incorporating social media monitoring into pharmacovigilance workflow is still an open question in many researchers' minds. The partnership created between Advera and Booz Allen is key to enabling the industry to implement social media monitoring into pharmacovigilance workflows. 

Topics: Pharmacovigiance 2.0

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.