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).
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.
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.
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:
It has now been one full quarter since we launched Evidex Alerts, the service which keeps our clients on top of the latest Drug Label Changes, Regulatory Alerts and Clinical Safety Data in real-time. Evidex Alerts have been a smashing success and our clients have openly thanked us making this information easier to follow. One client in particular was amazed at how well we untangle the mess that is a drug label and pull out the important pieces of information that they need to know, when they need to know it.
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.
Recently, Advera Health released a comparative safety report of the HER2+ Antagonists. In this drug review, we analyzed FDA Adverse Event Reporting System (FAERS) and clinical trial data to better understand how the drugs in this class stacked up.