In recent years, the rapid development of “big data analytics” has created a surge within pharmaceutical companies to leverage data from the entire value chain to drive actionable insights. Although other departments within pharmaceutical companies have long been focused on utilizing data driven insights, modern pharmacovigilance departments are just starting to fully incorporate a data-and-analytics-first approach to signal detection, validation, and management.

In talking with current and prospective clients around Advera Health's partnership with Booz Allen's Epidemico social media monitoring data, we get asked a lot about not only the validity of the process Booz Allen goes through to cut through the "noise", but also about the value social media monitoring has for post-marketing drug safety surveillance and pharmacovigilance. In addition to highlighting the primer we put together, we also refer those interested to the numerous academic publications on the topic. Three core publications that Booz Allen has conducted in collaboration with regulators and industry serve as a starting point, and below is a summary of key points and links to the full publications. 

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. 

Modern pharmacovigilance departments today do more than process and review ISCRs. 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.

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.

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.

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.

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!

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

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).