We are pleased to report that our latest major publication, “A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports” was released this week in the esteemed journal “Drug Safety.” It was published as an online-first feature and will also appear in the April copy of the print version of Drug Safety.
There was an interesting article in the October 2014 issue of Pharmacy Practice News called A Life Preserver for the Flood of Boxed Warnings, which discussed research conducted by Christine M. Cheng, PharmD from First DataBank, Inc. (FDB) (JAMA Intern Med 2014 Aug 15), about the increase in FDA Boxed Warnings since 1996. She found that out of 522 novel therapeutics, about one third were affected by a boxed warning, with many of them being implemented after the drug reached market. The research noted that the median time from approval to first post-market boxed warning was 4.2 years.
Happy New Year!
While you were hopefully enjoying a restful holiday break, the AdverseEvents analyst and tech staff were chained to their desks working on new product developments and data improvements for our AdverseEvents Explorer platform.
One of those that I’m most excited about is an improvement to our RxSignal tool. RxSignal is an algorithmic program whose primary goal is to identify approved drugs that we believe are likely to come under FDA review for safety related issues. A couple of months ago we published a list of twenty-eight of those drugs. Since then, the FDA has issued a safety warning on one of them (Onfi) and we continue to monitor the rest for changes and updates.
This week we went live with our newest analytic, RxSignal. For more information about our methodology, take a look at this brief video.
In short, RxSignal makes drug safety information predictable through a statistical signaling model that provides preemptive alerts to potential FDA communications and actions.
We have identified 28 drugs that have an “active” RxSignal, meaning that we believe these 28 drugs are likely to lead to FDA action. The following 5 drugs are on the list.
I attended a very interesting webinar today entitled, Combating Alert Fatigue: New Best Practices, put on by the folks at Wolters Kluwer Health / Medi-Span / Lexicomp / Dr. Howard Strasberg. As the title suggests the premise was to go over “best practices” for managing all of the alerts that are being triggered on drugs and continuously flashed in front of docs, pharmacists, and other key stakeholders that are making important prescribing decisions.
I certainly agree that there is an overwhelming number of alerts. And I agree that there needs to be processes in place by institutions to ensure that they are being seen.
Its easy if you try.
If you are not familiar, FDA Safety Alerts are meant to update consumers and practitioners about new side effects that have emerged in post-marketed use and were previously not found, or disclosed, on the drug’s safety label. FDA Safety Alerts can take many forms. Most are warnings about a new side effect with appropriate label change, but more serious Alerts can lead to, and include Black Box warnings and product withdrawals and recalls.