Off-label use to control behavior seems to be part of the 'culture' at some centers, one study finds
MONDAY, Jan. 11 (HealthDay News) -- Many Americans in nursing homes still get powerful antipsychotic medications, despite recent attempts by the U.S. government to rein in the practice, two new studies show.
The practice can control problem behaviors, but can also threaten physical health. Since the U.S. Food and Drug Administration instituted a "black box" warning in 2005, one study found a 19 percent decrease in the prescription of atypical antipsychotics in elderly people with dementia. But the researchers found that in 2008, antipsychotics still represented 9 percent of all prescriptions in this group.
"The  safety warning pertained to an increased risk of death among individuals using these drugs, so the public health ramifications of use of these drugs in elderly people with dementia, often in nursing homes, which we consider a vulnerable population, is concerning," said Dr. E. Ray Dorsey, an assistant professor of neurology at the University of Rochester Medical Center and lead author of one of the studies in the Jan. 11 issue of the Archives of Internal Medicine.
Antipsychotics, developed to treat psychiatric conditions such as bipolar disorder and schizophrenia, are widely used "off label" to control difficult behavior in elderly people with dementia.
Indeed, Dorsey said he suspects that the vast majority of the use documented in his research is "off label."
In the United States, no antipsychotics are approved to calm behavior, although one such drug, risperidone (Risperdal), is approved for that indication in Canada. Black box warnings are rare for off-label use.
"There's a real disconnect between the evidence and the prescribing patterns," said Becky A. Briesacher, co-author of the second study, also in the Jan. 11 issue of Archives, and an associate professor of medicine at the University of Massachusetts Medical School in Worcester.
Briesacher's study concluded that seniors who were admitted to nursing homes that already had high rates of prescribing antipsychotics were more likely to get these drugs as well, indicating that an "organizational culture" may be driving the trend.
But according to Dr. Davangere Devanand, director of geriatric psychiatry at the New York State Psychiatric Institute and Columbia University College of Physicians and Surgeons in New York City, there's little else to control aggression and agitation.
"The only medications that have been shown to work are antipsychotics, but the problem is they have side effects so you get into a situation where it may work in some patients but it may cause some significant side effects in some patients. It's a balance," he said.
Dorsey's study looked mainly at atypical antipsychotic drug use -- meaning second-generation drugs. Clozapine, the first atypical antipsychotic, was introduced in the United States in 1989 and later was followed by risperidone, olanzapine and paliperidone, according to background information with the study.
The researchers looked at the number of times the subject of antipsychotics was brought up during doctors' office visits.
Between the beginning of January 2003 and March 2005, these mentions accelerated at a rate of 34 percent per year, 16 percent among elderly patients with dementia.
In the year after the advisory was issued, mention of atypical drugs dropped 2 percent overall and 19 percent among the dementia population. The declines were evident within one month of the warning.
And by 2008, antipsychotic use among this older population decreased more than 50 percent.
It's not clear if that drop was "enough," or if the drugs are still being overprescribed, said Dorsey.
"Whether or not 19 percent is an appropriate decrease or not is uncertain," he said. "We can say that atypical antipsychotics are commonly prescribed, they have no indication for this use and there is limited evidence for their efficacy," he added.
Devanand said "overuse" is difficult to define. "I don't think we have any way to know what overuse is. No one knows what the use should be," he said.
The second study found that almost one-third of residents in nursing homes were prescribed antipsychotics and that one-third of that number did not have dementia or psychosis.
Newly arrived residents were more likely to receive this type of drug if they were in a nursing home that routinely prescribed such drugs, suggesting that organizational culture and not patients are driving the trend.
"If you enter a nursing home that has a higher proportion of people on antipsychotics, you are also likely to be put on antipsychotics," Briesacher said.
The U.S. National Institute of Mental Health has more on mental health medications.
SOURCES: Becky A. Briesacher, Ph.D., associate professor, medicine, University of Massachusetts Medical School, Worcester, Mass.; E. Ray Dorsey, M.D., assistant professor, neurology, University of Rochester Medical Center, Rochester, N.Y.; Davangere Devanand, M.D., director, division of geriatric psychiatry, New York State Psychiatric Institute and Columbia University College of Physicians and Surgeons, New York City; Jan. 11, 2010, Archives of Internal Medicine
All rights reserved