The RxView Blog

In addition to asking questions around the value and validity of using social media monitoring for pharmacovigilance, we also often get questions around our thoughts on whether social media data are inherently biased. When I brought this question to the Booz Allen Epidemico data team, they educated me on the three dimensions of bias that come from different drug safety datasets: Patient reported outcomes, seriousness, and completeness. The graphic below shows how those three dimensions differ across social media, clinical trials, spontaneous reports, and EHR records.

One of the biggest fears that pharmacovigilance professionals have when it comes to using social media is that amount of work that it will create. How will you be able to take the time needed to "clean" the data and get it fit for analysis? Machines can be trained to identify posts with drug-adverse event combinations, but it is more difficult for them to be able to ensure the post is an accurate representation of an adverse event. Thus, Booz Allen's Epidemico team uses human curation to provide the most accurate data.

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. 

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.

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.

Last week we announced the addition of VigiBase global safety data to the Evidex platform. VigiBase is the unique global database of individual safety reports collected from over 110 countries by the World Health Organization. It totals over 15 million adverse event reports since 1968 and is administered by the Uppsala Monitoring Centre in Sweden.

This is an exciting development for our company, for our clients, and for the drug safety community at large.

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. 

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.