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.
Santa Rosa, California in Sonoma County is where we live and work. It's probably best known for its world class wines, restaurants, and hotels.
Last week, we made global news for a much different reason.
Starting early in the morning on Monday Oct 9, a series of wildfires tore through the city of Santa Rosa and the surrounding areas. By the end of the week, thousands of homes and commercial buildings had burned, more than 40 people had died, and another 50+ remained missing. For a county with a total population less than 500,000 and fewer than 200,000 housing units, the effect on our home town has been devastating.
Topics: Company News
It’s been an exciting week in the normally staid world of drug safety.
Last Thursday, FDA launched a public dashboard for FAERS (the FDA Adverse Event Reporting System). We’ve been calling on FDA to do this for years, so we were quite excited to read the news and take the new dashboard out for a spin.
Apparently, a lot of others were just as excited. The site almost immediately stopped working and stayed that way for most of Friday.
Canada has long had a more open system for reporting and searching adverse drug events. They provide an easy to use online form for healthcare providers and consumers to make direct reports, which contrasts significantly to the cumbersome reporting form provided by FDA here in the U.S. They provide a web-based search tool that enables anyone to search through adverse event reports submitted to Health Canada. Nothing like that exists from FDA in the U.S.
Now comes word that Canada is taking a step toward something that we’ve long believed to be a crucial factor in improving and increasing adverse event reporting – requiring reporting from healthcare providers.
It’s been a very busy week for many of us. School’s finishing up for the kids here in California (no snow days here!), the annual ACSO conference was in full swing, the Warriors are up 3-0 in the NBA finals, and the media coverage of the Comey hearing has been non-stop.
With everything else going on, we wanted to make sure to draw your attention to some significant drug safety reporting over the past week, as we wouldn’t want to be accused of “failing to warn”!
Topics: Drug Safety
FDA released the fourth quarter of Adverse Event Reporting System (FAERS) data on Thursday March 16th. By Monday March 20th, our team had run the data through our proprietary RxFiler optimization process and the de-duplicated, cleaned, and properly cataloged data were onto our Evidex platform and ready for use by our clients.
For the fourth quarter, we processed 310,222 new unique case reports, which brought the total new unique case reports for 2016 to 1,253,464.
While a full analysis of our Q4 findings is still pending, it’s clear that the sheer volume of case reports continues to grow rapidly.
Our infographic below provides some key details:
We're happy to have a guest writer on the RxView blog this week, Alan Lukazewski, RPh – Director of Clinical Pharmacy at WEA Trust.
WEA Trust is a not-for-profit health insurer serving Wisconsin public employers, their staffs and families. In my role as Director of Clinical Pharmacy, I manage pharmacy benefits for WEA Trust, including prior authorization management, clinical program design, and specialty pharmacy management. Within those areas, I focus attention on adverse drug event detection and prevention, especially in older adults.
Last year, we partnered with Advera Health on a unique project to determine whether we could use data from theFDA Adverse Event Reporting System (FAERS) to determine total medical costs for a particular class of medicines. Previously, Advera Health published a study detailing their methodology for calculating medical costs from FAERS data, but this would be the first study to pair FAERS data with specific claims data to determine downstream medical costs.
It’s been an exciting week for drug safety with articles in both USA Today and FiercePharma examining the five-fold rise in reporting of serious adverse events into FDA’s Adverse Event Reporting System over the past twelve years. We were thrilled to see Advera Health featured prominently in both of those articles.
Despite the significant reporting increase, limitations in the use of FAERS data for post-market surveillance remain. One of the biggest limitations is that not all adverse events are reported. As a spontaneous (i.e., voluntary) reporting system, it’s simply not possible for every adverse event to be recorded. This is different from a controlled clinical trial where all adverse events and outcomes are recorded.