July 13, 2015

How 'the most dangerous drug in America' is making its way through nursing homes

Daily Briefing

An analysis of federal data finds tens of thousands of nursing home residents are ending up in the hospital after suffering serious injuries—and even death—while taking the anticoagulant drug Coumadin or its generic form warfarin, Charles Ornstein reports for ProPublica.

Background on Coumadin

Coumadin was developed in the 1940s by researchers at the Wisconsin Alumni Research Foundation, and doctors began prescribing the drug to humans, including President Dwight Eisenhower, in the 1950s. At the time, Coumadin was seen as a "breakthrough" for individuals with heart issues stemming from blood clots, such as pulmonary embolisms, abnormal health rhythms, and deep vein thrombosis, Ornstein writes.

Warfarin: A cardiovascular 'game-changer'

However, the drug can interact poorly with particular foods and medications, especially antibiotics. As such, people who take the drug are subject to regular blood tests to determine how long it takes for blood to clot. If a patient is given too high a dose, he or she could begin to bleed uncontrollably, but too low of a dose could lead to life-threatening blood clots.

Coumadin in nursing homes

In 2013, about 2.4 million seniors and individuals with disabilities filled at least one prescription for warfarin through Medicare Part D, while about 280,000 people were prescribed its brand-name counterparts, Coumadin or Jantoven. Further, nearly one in six of the nation's 1.3 million nursing home residents take anticoagulants, and it is likely the majority use Coumadin or its generic, Ornstein says.

Over the past several years, many individuals living in nursing homes have experienced severe injuries from the drug. For example:

  • A 2007 peer-reviewed study in the American Journal of Medicine found that about 34,000 life-threatening or serious events related to the drug occur annually in in nursing homes;
  • A 2011 New England Journal of Medicine report estimated the drug resulted in about 33,000 emergency hospitalizations among elderly Americans between 2007 and 2009—more than double the amount of insulin, which accounted for the second-most hospitalizations; and
  • A ProPublica analysis found that between 2011 and 2014, 165 nursing home residents were hospitalized or died from errors involving the drug.

Rod Baird, president of Geriatric Practice Management, says, "It's an insidious problem" and—because it's so easy to prescribe the wrong dosage—"Coumadin is the most dangerous drug in America."

And with preventing adverse events related to the drug requiring constant vigilance and coordination between multiple providers, nursing homes are the "perfect setup for bad things happening," says Jerry Gurwitz, chief of geriatric medicine at the University of Massachusetts Medical School.

Despite the statistics—and a study by Quest Diagnostics last year that found the drug had the desired effect just slightly over half the time—Coumadin has received little scrutiny from federal regulators. While some nursing homes are fined with "immediate jeopardy" citations or threatened with closure if they do not take swift action to remedy issues, most are not fined and instead are asked to correct the issues and implement remedial policies, according to the ProPublica analysis.

Nursing home report card: Eleven states get an 'F'

How regulators could help

In 2014, HHS determined Coumadin was one of the drugs most frequently found on the "adverse drug events" list and CMS announced it would work more diligently with nursing homes to prevent such events.

But some long-term care organizations say regulators need to do more to work with the nursing home industry to alter its practices rather than simply alleviating problems at facilities on a case-by-case basis.

And some doctors say they are hesitant to prescribe Coumadin—opting instead to prescribe newer anticoagulants like Eliquis, Xarelto, and Pradaxa, which do not require regular blood testing or avoidance of specific foods—although they do not have antidotes for uncontrollable internal bleeding, as Coumadin does.

Yet regulators need to keep in mind that many patients do need anticoagulants, argues Cheryl Phillps, SVP of public policy and advocacy at LeadingAge. "It may be distorting a little bit to look at the immediate jeopardy outcomes [cited by regulators] without looking at the overall population that's on it and needs to be on it," she says, noting, "In fact, to not put people on blood thinners is a huge risk and in many cases malpractice" (Ornstein, ProPublica, 7/12).

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