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New Report Concludes Nursing Homes Needlessly Drugging Residents
30% of nursing home residents receive at least one antipsychotic, yet many have no clinical indication for the drug's use.

Older adults in nursing homes are being giving antipsychotic drugs they don’t need, sometimes with deadly consequences.

These drugs include Seroquel, Risperdal, Haldol and other drugs approved to treat symptoms of schizophrenia and other mental disorders. But these drugs can cause dangerous side effects, including diabetes, abnormal limb and body movements, seizures, rapid heart beat and death. So it’s essential to use them with caution. But it appears the drugs are being widely used simply to make nursing home residents easier for staff to manage.

Seroquel, for example, may be efficacious in treating schizophrenia, but carries an increased risk of diabetes pancreatitis in patients taking the drug. The FDA has warned of diabetes risks from Seroquel and the labeling has been changed to reflect the risk. Seroquel is also associated with hyperglycemia, pancreatitis, ketoacidosis, certain cardiac events, and death.

At a hearing before Congress, FDA drug safety expert Dr. David Graham was asked about concerns he may have about drugs still on the market. Dr. Graham testified that “I would pay careful attention to antipsychotic medications. ... The problem with these drugs are that we know that they are being used extensively off-label in nursing homes to sedate elderly patients with dementia and other types of disorders... But the fact is that it increases mortality perhaps by 100 percent. It doubles mortality. So I did a back-of-the-envelope calculation on this and you have probably got 15,000 elderly people in nursing homes dying each year from the off-label use of antipsychotic medications.... With every pill that gets dispensed in a nursing home, the drug company is laughing all the way to the bank."

Older adults newly admitted to nursing homes with high rates of antipsychotic prescribing in the previous year are far more likely to receive antipsychotic agents, according to a new report in the January 11 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Of these treated patients, many had no identified clinical indication for the drugs.

Yong Chen, M.D., M.H.S., of the University of Massachusetts Medical School, Worcester, and colleagues assessed antipsychotic prescribing among 16,586 residents newly admitted to 1,257 nursing homes in 2006. They computed each facility's antipsychotic prescription rates based on 2005 prescribing patterns and analyzed whether these rates, along with individual characteristics, were associated with the likelihood of new residents receiving antipsychotic prescriptions.

About 30 percent (4,818) of new residents in the study received at least one antipsychotic medication in 2006, of whom 32 percent (1,545) did not have dementia, psychosis or any other clinical indication for this therapy. "Residents newly admitted to nursing homes with the highest prescribing rates were 1.37 times more likely to receive an antipsychotic medication relative to those in the nursing homes with the lowest prescribing rates," the authors write. "The influence of the facility-level prescribing rate was most apparent in residents without psychosis, who have the weakest indication for antipsychotic medication use."

The increase in medication use may reflect the increasing proportion of nursing home residents diagnosed with psychoses, the authors note. "However, residents diagnosed as having schizophrenia, bipolar disorder or aggressive behavioral symptoms of dementia accounted for only a small proportion of antipsychotic medication use," they continue. "In addition, we found that 16.4 percent of residents who had no clinical indication for antipsychotic therapy (no psychoses and no dementia) received antipsychotic medication."

The study suggests that organizational culture at some nursing homes may encourage the prescribing of antipsychotics, the authors note. "Future research is needed to determine why such a prescribing culture exists and whether there are adverse health consequences as a result of our observed facility-level antipsychotic prescribing rate," they conclude. "This study may also inform future policies to target nursing homes with high antipsychotic prescribing rates to improve quality of care for nursing home residents."

But awareness of this problem is not new. It has been identified in the past and it seems little has changed.

Use of antipsychotic drugs like Risperdal and Seroquel to control dementia patients has continued to rise in recent years, despite the Food and Drug Administration's (FDA) "black box" warning labels that these drugs can increase the risk of death for elderly dementia sufferers. In 2007, about 30% of nursing home residents were on antipsychotic drugs, according to the Centers for Medicare & Medicaid Services (CMS), most of them on newer, atypical antipsychotics. Federal law strongly discourages nursing homes from physically restraining unruly patients, but federal health-care programs such as Medicaid pay for drugs that may help calm aggressive behavior and agitation associated with Alzheimer's.

In 2005, Medicaid spent $5.4 billion on atypical antipsychotic medicines—more than it spent on any other drug class, including antibiotics, AIDS drugs, or high blood pressure. Atypical antipsychotics are approved for schizophrenia and bipolar disorder, but in what is known as "off label" use—use not approved by the FDA for FDA-approved medications—doctors often prescribe the drugs to dementia patients. The widespread use of antipsychotics among the elderly has begun to draw criticism from regulators, researchers, lawmakers, and the nursing-home industry.

The $122 billion nursing-home industry has moved toward large, often understaffed, institutions where use of psychotropic drugs is rising. According to CMS, nearly 21% of nursing-home patients who don't have a psychosis diagnosis are on antipsychotics. A 2005 study found antipsychotics were prescribed not only for psychosis, but for depression, confusion, memory loss, and feelings of isolation. Last year, CMS instituted new guidelines to limit the use of antipsychotics; however, it's still easier for nursing homes to get reimbursed for giving patients extra pills than it is for hiring extra staff.

An Alzheimer's patient often cannot refuse antipsychotic drugs, says Cynthia Rudder, of the Long-Term Care Community Coalition. "You are basically quieting them against their will and it is absolutely horrendous," she says. Family members can object to the use of such drugs, but risk having their relative discharged for unruly behavior.

This practice has been challenged in a very small number of isolated cases. For example, in California this past year, arrests were made of a nurse, physician, and a pharmacist of a nursing home for "forcibly administering" psychotropic medications for their own convenience, rather than for their patients' therapeutic interests, actions that are alleged to have resulted in the deaths of three residents. But unfortunately, criminal charges are rare.

"These people maliciously violated the trust of their patients, by holding them down and forcibly administering psychotropic medications if they dared to question their care," Attorney General Brown said of the case. "This is appalling behavior, which amounts to assault with a deadly weapon."

It is illegal for drug makers to promote off-label uses, but doctors may prescribe medications as they see fit.

AstraZeneca recently agreed to pay $520 million to settle two federal investigations and two whistleblower lawsuits regarding its illegal promotion of the antipsychotic Seroquel for unapproved uses.

Other pharmaceutical companies have also attracted scrutiny for marketing drugs for unapproved uses. Last month, the Arkansas attorney general filed suit against Johnson & Johnson and two of its units, claiming, among other things, that they "engaged in a false and misleading campaign" to promote its antipsychotic drug Risperdal to geriatric patients.

Earlier this year, Eli Lilly & Company paid $1.4 billion over its illegal marketing of Zyprexa, another antipsychotic drug.