Drug overuse threatens nursing home residents

Routine prescribing of powerful medications occurs too often, our investigation finds

Published: December 2010

Ongoing federal warnings

More than five years after the Food and Drug Administration warned that drugs routinely prescribed to nursing-home residents posed serious threats, including an increased risk of death, inappropriate use remains high, according to a recent analysis by the American Society of Health-System Pharmacists (ASHP). The project is part of a CR Best Buy Drugs ongoing investigation of medication prescribed "off-label."

The drugs in question, atypical antipsychotics, are approved by the FDA to treat bipolar disorder and schizophrenia. But they're frequently used off-label to control agitation, aggression, hallucinations, and other behavioral symptoms in elderly patients with Alzheimer's disease or other forms of dementia. There are no FDA-approved drugs to treat these behavioral symptoms, but doctors can legally prescribe any drug for any reason they deem appropriate.

But those medications—such as aripiprazole (Abilify); olanzapine (Zyprexa); quetiapine (Seroquel); and risperidone (Risperdal and generic)—pose substantial risks, especially to older people, that include diabetes, movement disorders (some permanent), pneumonia, stroke, weight gain, and even sudden cardiac death.

"There is limited evidence for the efficacy of these medications and evidence of significant safety risks," says E. Ray Dorsey, M.D., an associate professor of neurology at the Johns Hopkins University School of Medicine. "In addition, many of the people receiving them have limited capacity to weigh the risks and benefits of taking them."

According to FDA estimates, the rate of death among elderly dementia patients with behavioral problems who received antipsychotics was about 4.5 percent over the course of a typical 10-week controlled trial, compared with about 2.6 percent for a placebo group. This prompted the FDA to require black-box warnings—the strongest type—to be added to the labeling of atypical antipsychotic medications in 2005. The FDA broadened the warning in 2008 to include the labels on "typical" or older antipsychotics, including chlorpromazine (only available as a generic now) and haloperidol (Haldol and generic).

What measures should you try first?

In a study published in the 2010 Archives of Internal Medicine, researchers found that the use of antipsychotics often began during a patient's first week in a nursing home. That suggests that behavioral interventions—the treatment of choice—are used minimally, if at all.

"The patient is scared and upset in a strange environment, and the caregiver may lack training in how to respond," explains Kenneth Brubaker, M.D., a geriatrician and board member of the American Medical Directors Association (AMDA), a group of health professionals who work in nursing homes and assisted living facilities.

"I would advocate that a family member be present as much as possible during the adjustment period, because that's the patient's only contact with reality," says Brubaker. "Having frequent phone conversations between patient and family help, as do looking through family photo albums together or compiling a DVD of the patient's life story to remind them of the past."

Frontline caregivers—who deal directly with residents with dementia-related behavioral problems—often have limited skills in using such approaches, Brubaker says. At those nursing homes, according to Brubaker, agitated new residents are likely to be quieted with antipsychotic drugs in lieu of family photos.

Pattern of continued use

Despite the FDA's warnings, antipsychotic use in patients with dementia continues. In 2006, a year after the black-box warning, 28 percent of long-term nursing home residents received antipsychotics—both atypicals and older ones as well—according to a 2009 study in the journal Health Affairs. The use of these drugs was up 7 percent for both approved and off-label uses since 1999, and there were large increases among dementia patients with nonaggressive behavior, as well as those without any reported behavioral symptoms. Antipsychotic use in those two groups was 40 percent and about 23 percent, respectively.

"In those cases, relatively little in the way of severe behavioral symptoms, such as aggression, was recorded by staff," says Stephen Crystal, Ph.D., lead author of the study and director of the Center for Health Services Research on Pharmacotherapy, Chronic Disease Management and Outcomes at Rutgers University. "Often only milder symptoms were reported, like wandering or resisting care. The data do not show cautious, selective use of these drugs."

And Crystal adds that when life-threatening risks are taken into account, "the rates of use that we continue to see following the black-box warning, especially among residents for whom severe symptoms were not recorded, are reason for concern." He also notes that in practice, the medications are often used for longer periods than those tested in trials, yet relatively little is known about the long-term risks.

But a 2009 study from Great Britain, published in The Lancet medical journal, found a significantly increased risk of mortality in Alzheimer's patients who were randomly assigned to continue taking antipsychotic medication for 12 months compared with those who were switched to a placebo: The probability of survival was 70 percent in the antipsychotic treatment group versus 77 percent in the placebo group. Moreover, the difference in mortality widened after the first year: 24-month survival was 46 percent in the antipsychotic group vs. 71 percent in the placebo group; at 36-months, the survival rate was 30 percent vs. 59 percent, respectively.

In a 2010 study that looked at how often antipsychotics were prescribed in nursing homes, 29 percent of the newly admitted residents received them in 2006, with no documented indication in nearly a third of those cases. "That's a problem, because documentation helps prevent using these drugs inappropriately to sedate patients whom the staff is having trouble managing," says Becky Briesacher, Ph.D., an associate professor of medicine at the University of Massachusetts Medical School and an author of the study, which was published in Archives of Internal Medicine.

Recent data from the U.S. Department of Health and Human Services indicate that antipsychotic use remains prevalent, with 26 percent of nursing home residents in Medicare or Medicaid-certified homes receiving them in the second quarter of 2010. Figures like that are troubling. "For patients who try to climb out the window or who act aggressively toward other residents and staff, antipsychotics may have to be considered," Dorsey says. "But that kind of psychotic behavior is unlikely to be present in one out of every four patients."

Drug risks probably outweigh the benefits

A 2006 analysis of 15 trials of atypical antipsychotics used to treat symptoms of dementia or Alzheimer's found that aripiprazole and risperidone offered small benefits that were limited by intolerable side effects. A 2008 Cochrane review of 16 trials concluded that olanzapine reduced aggression and that risperidone decreased aggression and psychosis, but both were associated with serious complications.

The National Institute of Mental Health funded a recent trial of 421 patients with Alzheimer's-related aggression, agitation, or psychosis and found that olanzapine, quetiapine, and risperidone were more effective than a placebo. But between 15 percent and 24 percent of the patients stopped taking the medication because of adverse or intolerable side effects, such as sedation, confusion, weight gain, and movement disorders, compared with 5 percent of those in the placebo group. The authors concluded that the side effects outweighed the advantages.

The risks and side effects of atypical antipsychotics include:

Premature death. According to the FDA's analyses of 17 placebo-controlled trials, older patients with dementia who took atypical antipsychotic drugs were almost twice as likely to die from heart failure, sudden cardiac arrest, pneumonia, and other causes compared with those who did not take the drugs.

Strokes and ministrokes. Older adults with dementia treated with certain atypical antipsychotics might be at greater risk of having a ministroke or stroke. Call a doctor immediately if the patient seems to speak slowly or with difficulty, or experiences sudden dizziness, weakness or numbness of an arm or leg, drowsiness, or difficulty swallowing.

Weight gain and increased cholesterol and blood sugar levels. The combination, including elevated levels of cholesterol and triglycerides, can increase the risk of a heart attack or stroke. And weight gain plus the increase in blood sugar levels also increase the risk of type 2 diabetes.

Movement disorders. Repetitive, involuntary movements of the face, tongue, and other parts of the body—particularly in elderly women—can become permanent.

Neuroleptic malignant syndrome. A rare but potentially life-threatening reaction marked by high fever, sweating, rigid muscles, and unstable blood pressure.

Low blood pressure. Can cause dizziness, light-headedness, and fainting—especially when standing up suddenly after lying down—which could increase the risk of falls.

Sedation. That can lead to increased falls and interfere with the efforts of elderly people to socialize and participate in activities.

Confusion and worsened cognitive function. Cognitive test scores declined in patients with Alzheimer's disease or dementia who took atypical antipsychotics in a meta-analysis of 15 randomized, placebo-controlled trials.


What's the alternative?

Because the risks of the drugs are so serious, our medical consultants suggest that it's always best to try other solutions first:

Look for an underlying cause. Disturbed behavior in people with dementia can stem from constipation, infection, hearing or vision problems, poor sleep, unaddressed pain, and many other easily overlooked conditions. Patients should have a thorough examination and a review of all current medications—combinations of which can also cause confusion and agitation in older adults.

Use behavioral interventions. "Often something in the environment is frightening the patient, who responds with self-protective, combative behavior," says Gary J. Kennedy, M.D., director of geriatric psychiatry at the Montefiore Medical Center in New York City. "The first step is to modify the environment or the caregiver's approach so the patient feels safer." That may involve giving warnings before touching the patient, providing a predictable routine, or covering mirrors if the patient misperceives a stranger in them. Daily exercise, music, massage or a favorite snack can be calming, while activities and social contact may ease agitation caused by boredom, Kennedy says. The National Institutes of Health and the Alzheimer's Association offer other tips on ways to ease disturbing behavior.

Consider other medication. Drugs that are approved to slow cognitive decline in dementia—donepezil (Aricept and generic); galantamine (Razadyne and generic); rivastigmine (Exelon); and memantine (Namenda)—might also take the edge off behavioral disorders, though they carry some risks as well, especially when used by very ill patients. See our Best Buy Drugs report on drugs to treat Alzheimer's disease for more detailed information on those medications. Newer antidepressants, such as generic citalopram (Celexa and generic) or fluoxetine (Prozac and generic), might be effective for dementia patients who have a history of depression or show signs of apathy and irritability.

What precautions can you take?

Because the risks of the drugs are so serious, our medical consultants suggest they should be considered only if patients are at risk of hurting themselves or others, and even then, only if other measures have failed and you fully understand the risks and limited benefits. Before doing so, it's essential to take the following precautions:

Get screened for risks. Patients should be screened for risk factors that could lead to a heart attack or stroke, including high blood pressure and cholesterol levels, and their weight should be monitored. The drugs should be used with caution by elderly people who have had a recent heart attack or who have heart disease, high cholesterol, or diabetes, or if they are prone to problems with blood clotting.

In addition, the drugs might cause serious complications for people who have a low white blood cell count. Also make sure that a fasting blood sugar test and complete blood count are done to assess the risk of infection, and a thyroid test should be done to check for thyroid underactivity, which can mimic certain aspects of dementia. In addition, consider the risk of aspiration pneumonia caused by breathing foreign materials into the lungs, such as foods, liquids, vomit, or saliva. Finally, have the doctor check for other chronic diseases, such as decreased liver or kidney function, which could increase the risk of adverse effects with atypical antipsychotics.

Get monitored. During treatment, patients should be monitored closely for side effects and changes in medical conditions and alertness. If symptoms don't improve in four to six weeks, a different drug should be substituted. Treatment should be evaluated for dosage reduction or discontinuation within six months after symptoms are stabilized and every six months after. 

Bottom line. Atypical antipsychotics might reduce behavioral disorders in elderly people with dementia but at the cost of significant safety risks. Our advice: Talk with your doctor about all available treatments for the patient's behavioral problems, including approved drugs for dementia. If underlying causes have been fully explored and behavioral interventions fail to control serious symptoms, consider atypical antipsychotics only after their risks and benefits have been thoroughly explained to you. 

How to protect a loved one from antipsychotic misuse in a nursing home

Photo: Andrea Fischman

Reserve your rights. When a patient is admitted, a family member typically signs a form that gives the nursing home permission to provide necessary care, including medication. "So many facilities may put the patient on an antipsychotic without the family's knowledge," says Brubaker. But medications that are not approved for the patient's condition and that carry a black-box warning merit a discussion with family members about potential risks and benefits, and consent should be obtained first, according to treatment guidelines. "When you sign that permission you can say, 'If you're considering using an antipsychotic, I want to be informed first,'" Brubaker says. "If they won't honor that, it's a red flag."

Offer to help. Some families report feeling pressured by nursing home staff members to consent to antipsychotic use for a newly admitted patient. "You can refuse, but the facility will say, 'We can't care for them,'" Brubaker explains. "Instead you should say, 'I'd rather come in and stay with my mother until I get her settled down.' If they say you can't, it's another red flag."

Stay informed. If the person being cared for requires an antipsychotic, follow his or her treatment by attending the nursing home's quarterly team meetings—to which relatives are normally invited. "That's a good time to get a full report and ask if your family member is being monitored for side effects and taking the lowest possible dosage," Brubaker says. You can also talk with a manager, or ask when the doctor will be making rounds at the nursing home and call at that time. 

Editor's Note:

These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

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