The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

What's Driving Pharmacovigilance Technology Acquisition?

By Jim Davis on July 13, 2018

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.

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Topics: Pharmacovigiance 2.0

The Value and Validity of Social Media Monitoring in Pharmacovigilance

By Jim Davis on June 29, 2018

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. 

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Topics: Pharmacovigiance 2.0

Can Modern Analytics be Forced into Traditional Pharmacovigilance Workflow Tools?

By Jim Davis on March 27, 2018

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.

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Topics: Pharmacovigiance 2.0

Social Media Monitoring for Pharmacovigilance and Drug Safety

By Jim Davis on February 2, 2018

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.

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Topics: Pharmacovigiance 2.0

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

By Brian Overstreet on January 19, 2018

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.

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Topics: Drug Safety, Pharmacovigiance 2.0, Company News

Evidex Goes Global - VigiBase Drug Safety Data Access

By Brian Overstreet on November 22, 2017

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.

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Topics: FAERS, Evidex, Pharmacovigiance 2.0, VigiBase

An Analysis of Adverse Events Associated with Endothelin Receptor Antagonists (ERAs) using FAERS

By Jim Davis on November 10, 2017

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. 

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Topics: FAERS, Clinical Evidence, Pharmacovigiance 2.0, Company News

How Pharmacovigilance Departments Can Work Smarter, Act Bigger

By Jim Davis on September 15, 2017

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.

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Topics: Pharmacovigiance 2.0

Case Studies: Signal Detection Utilizing FDA Adverse Event Reporting System (FAERS) Data

By Jim Davis on August 25, 2017

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.

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Topics: Pharmacovigiance 2.0

FDA Releases Q1 2017 Drug Safety Watch List: It’s Boring and That’s Good

By Jim Davis on July 21, 2017

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). 

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Topics: FDA, Evidex, Pharmacovigiance 2.0

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