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Stop misusing antipsychotics for seniors

Original source:

July 13, 2012

A nurse from my mother's nursing home calls to ask if it's OK to put her on a new drug. Just a low dose to calm her, the nurse assures me.

I agree, thinking the nurse is an expert and probably knows best. And I've seen my mother's mood change dramatically for the worse as the day wanes, a phenomenon in dementia patients called "sundowning."

The drug the nurse administers is the antipsychotic Risperdal. I later find out that the FDA has issued its strongest safety caution -- known as a "black box warning" -- against using this drug and similar antipsychotics in elderly dementia patients because they pose an increased risk of death, stroke, seizures and diabetes.

"They're not supposed to be used to control dementia-related so-called bad behavior," Richard Mollot, executive director of the Manhattan-based Long Term Care Community Coalition, told me. "A lot of family members are being told 'we need to calm down your loved one' when in fact this is not appropriate care for people with dementia."

A report this month by the inspector general of the Department of Health and Human Services found that 99 percent of nursing home records show a failure to follow federal safety and quality guidelines for the use of antipsychotics, suggesting drug misuse is widespread and enforcement lax. But along with heightened scrutiny by HHS, a recent government crackdown against drug companies for illegally marketing antipsychotics is providing a ray of hope that this could change.

Introduced in the 1990s, these "second-generation" antipsychotics have largely replaced drugs created in the 1950s to treat schizophrenia, in part because the newer medicines have been considered safer, with fewer troubling side effects. Almost 40 percent of nursing-home residents with dementia received the drugs in 2010, according to the Center for Medicare and Medicaid Services. Partly as a result, antipsychotics are now the top-selling class of pharmaceuticals, with yearly revenue of about $14.6 billion -- despite their approval for only about 1 percent of the population.

The federal Nursing Home Reform Act of 1987 established "the right to be free of unnecessary and inappropriate physical and chemical restraints" -- but the government has failed to enforce this. In fact, as a campaign against physical restraints has all but eradicated them over the past two decades, chemical restraints have become more entrenched -- even as the issue has been hotly debated in Congress.

"The way antipsychotic drugs are used in nursing homes is a form of elder abuse," Patricia McGinnis, executive director of California Advocates for Nursing Home Reform, told the Senate Special Committee on Aging in 2010. "Instead of providing individualized care, many homes indiscriminately use these drugs to sedate and subdue residents." The largest study of the use of such antipsychotics, conducted by Harvard Medical School and published earlier this year, found that elderly dementia patients using them are almost twice as likely to die as those on a placebo. David Graham, associate director of the Food and Drug Administration's Office of Drug Safety, has estimated that 15,000 elderly people die in nursing homes every year as a result of the off-label prescription of these antipsychotics.

Last year, a report by the inspector general found that 88 percent of successful Medicare payment claims for antipsychotics were for nursing-home residents with dementia, despite the documented risk of death, and 22 percent of patients were on the drugs for too long or at too high a dose, violating federal rules on unnecessary drug use. The report condemned nursing homes' failure "to comply with federal regulations designed to prevent overmedication."

Fifty-one percent of the claims in the study didn't meet the government's Medicare reimbursement rules -- but were paid anyway. This means the Medicare system is shelling out hundreds of millions a year to pay for these drugs, with taxpayers footing the bill. If nothing changes, costs will explode over the next two decades as 10,000 baby boomers a day become eligible for Medicare.

No enforcement action was taken as a result of the report, the inspector general's office said, because the data were drawn from a random nationwide sample and weren't sufficient to establish patterns at particular nursing homes.

Beyond their physical risks, antipsychotics are problematic because they not only suppress dementia patients' agitation, they wipe out pleasurable emotions, too. "They turn people into zombies," Mollot says.

Patients on these drugs sleep a lot. Now it's clear to me why my mother would be in bed by 6 p.m. at the nursing home, while since moving back home and stopping the drug, she often stays up watching classic movies past 9. Though the government hasn't gone after nursing homes, it has recently won four big settlements against drug giants for illegally marketing antipsychotics. Last year, Eli Lilly and Pfizer paid the largest criminal fines in U.S. history -- $515 million and $1.3 billion, respectively -- for deceptive promotion. In a case in Arkansas last April, Johnson & Johnson was fined $1.1 billion for misleading doctors about Risperdal's risks.

Meanwhile, a federal case is pending against Johnson & Johnson for allegedly paying millions in kickbacks to Omnicare, the nation's largest long-term-care pharmacy, to recommend Risperdal for nursing-home patients.

In another promising reform initiative, the Center for Medicare and Medicaid Services has launched a campaign against antipsychotic use in nursing homes, with the goal of reducing it by 15 percent by 2013 through alternatives such as increased staffing and better pain management.

Yet, though commendable, these efforts have done little so far to change practices on the ground level for a population that has no time to spare.

I recently asked my mother if she still gets pleasure out of life, even though in the past year, she has gone from being independent to relying on a full-time caretaker for all her basic needs. She replied, "Absolutely!"

All elderly deserve that chance. But until nursing homes face greater scrutiny and sanctions, our elderly will continue to languish in chemical restraints.

Karen Angel is a freelance writer based in New Paltz.