As director of the hospitalist program at University of Utah Healthcare and the medical director of the University of Utah Health Care Thrombosis Service, Robert Pendleton, MD, closely monitored the progress of the anticoagulant dabigatran as it marched toward regulatory approval in the U.S. Developed by Boehringer Ingelheim and marketed as Pradaxa, the drug is a big deal.
“We were sort of primed and poised and anticipating that dabigatran would be approved,” Dr. Pendleton says. The FDA approved dabigatran in October for stroke prevention in nonvalvular atrial fibrillation patients. It is the first new oral anticoagulant approved in 50 years and the first of three drugs expected to mount a challenge to the longtime standard of care, warfarin (Coumadin).
When Dr. Pendleton’s hospital got ready to add the drug to its formulary, though, the process had to slow down. The hospital wasn’t quite ready for dabigatran.
“The first thing we did is sent out an institution-wide survey to get some understanding of baseline knowledge of practitioners who might be prescribing dabigatran … and found an enormous educational need,” Dr. Pendleton explains, but “most people who we anticipated would have been prescribing dabigatran, such as our cardiologists, had a very poor understanding of the clinical data and the drug itself.”
So University of Utah Healthcare developed an education plan for providers, made resources available so that providers could easily get information about the drug, and developed institutional guidelines on appropriate use, how they would handle off-label uses, and managing urgent situations. The drug was added to the formulary in February, and the change has been working out well, with “an exponential increase in prescribing,” Dr. Pendleton says.
The challenges at University of Utah Healthcare are being experienced—or probably soon will be—by hospitalists around the country as new oral anticoagulants become available for use. Experts say hospitalists need to take a keen interest in the new drugs, given the large number of CVT, VTE, atrial fibrillation, and other patients who are at an increased risk of clotting.
Most hospitalists see anticoagulated patients on a daily or weekly basis, experts say. Dr. Pendleton estimates that if you include patients who are on a preventive dose (e.g. to prevent DVT), as many as 80% or more of HM patients use anticoagulants.
“The first thing we did is sent out an institution-wide survey to get some understanding of baseline knowledge of practitioners who might be prescribing dabigatran … and found an enormous educational need.”–Robert Pendleton, MD, University of Utah Health Care Thrombosis Service
“Anticoagulants are dangerous and they are often a bit tricky to use,” says Gregory Maynard, MD, MSc, SFHM, chief of the Division of Hospital Medicine at the University of California at San Diego, where he has won awards for their DVT prevention program. “If you look at the top three or four adverse drug events that occur, usually warfarin is one of those. … It’s common, it’s a safety issue, it’s tricky to use—all of those things add up to something that hospitalists need to pay attention to.”
New Options, New Challenges, New Costs
Dabigatran, which inhibits thrombin, is part of a new anticoagulant parade, along with rivaroxaban (Xarelto) and apixaban, both of which inhibit Factor Xa. They offer patients attractive anticoagulant options that, unlike warfarin, don’t require blood draws for monitoring every few weeks. The new options also omit the lengthy list of drug and food contraindications of warfarin.
But questions about the ability to reverse bleeds while patients are on the new drugs, as well as concerns about their costs, are forcing hospitalists to evaluate carefully. So far, dabigatran is the only one approved in the U.S., and only for one indication.