As more of the elderly crowd into nursing homes, a new report from Consumer Reports Health finds risky drugs are being misused to sedate patients.  

Sales of atypical antipsychotics have been rising steadily from $8.4 billion in 2003 to $14.6 billion in 2009 -- outperforming sales for drugs to treat such common conditions as depression, heartburn, high cholesterol and hypertension.  

"Our analysis indicates that the use of these drugs in confused or demented patients in nursing homes is usually not warranted," said John Santa, M.D., M.P.H., director of the Consumer Reports Health Ratings Center.  "The benefits are fairly limited and risks are significant, especially in this population. Once again, we have an all too painful illustration of the pharmaceutical drug industry's blockbuster drug model seeking out inappropriate and risky uses for their drugs."

The report, by the American Society of Health-System Pharmacists and Consumer Reports Best Buy Drugs (BBD), is part of a continuing investigation of drugs prescribed by doctors "off-label."

The authors of the report analyzed scores of studies on the use of atypical antipsychotics, officially approved by the Food and Drug Administration (FDA) to treat bipolar disorder and schizophrenia, but frequently used "off-label" to control agitation, aggression, hallucinations, and other symptoms in elderly patients with Alzheimer's disease or other forms of dementia.  There are no FDA approved drugs for these uses but doctors can legally prescribe any drug they deem appropriate.

Increased risks

However these medications pose significant, increased risks -- including diabetes, sudden cardiac death, movement disorders, pneumonia, stroke, and weight gain -- especially to older people.  During a three-month period in 2010, 26 percent of nursing home residents received antipsychotics, according to recent data collected by the Department of Health & Human Services (HHS).Furthermore, research suggests that behavioral interventions, the treatment of choice, are employed minimally, if at all, in some nursing homes.

"This is a warning to spouses, adult children, and other family members of nursing home patients that potent drugs are being used to manage these patients, exposing them to very serious risks.  It's up to all concerned -- from the family to the front line care givers in the nursing home to the physicians -- to try alternative measures to decrease the need for these potent drugs," said Santa. 

Such alternatives include the use of music, massage, reviewing family photo albums, frequent phone conversations with family members, distraction techniques, and medications approved to slow cognitive decline in dementia or some of the newer antidepressants.  

Danger signs

Black box warnings from the FDA have been landing in doctors' mailboxes for more than five years, warning that powerful atypical antipsychotics can pose serious health risks, including increased risk of death.  The warnings, which began in 2005, were prompted by evidence that the rate of death in elderly dementia patients who received antipsychotics was about 4.5 percent during the course of a 10-week controlled trial, compared to about 2.6 percent in the placebo group, according to FDA estimates. 

"The FDA's black box warning system is well-intended but the escalated use of these powerful and risky drugs suggests that the system is not working," said Santa.

Tips for consumers

There are several steps that consumers can take to avoid antipsychotic misuse in nursing homes:

  • Reserve your rights.  When a patient is admitted to a nursing home, the family typically signs a form granting permission to provide necessary care, including medication.  But medications that are not approved for the patient's diagnosis and that carry a black box warning merit a discussion with family members about potential risks and benefits, and consent should be obtained, according to the treatment guidelines.  Family members who sign the permission should clearly note that if the facility is considering the use of an antipsychotic, to please inform the family first.  If a nursing home won't honor that request, then that's a red flag.
  • Offer to help.  Some families report feeling pressured by nursing homes to consent to an antipsychotic on behalf of a newly admitted patient.  If a facility refuses to care for the patient without the use of a major sedative, then the family might offer to help by asking if they can come in and stay for a while until the patient is settled.   Again, if the nursing home resists, it might be another red flag.
  • Stay informed.  If the person being cared for requires an antipsychotic, follow treatment details by attending the nursing home's quarterly team meetings, to which a relative is normally invited.  That can provide a good opportunity to ask if the patient is being monitored for side effects and taking the lowest possible dosage, which is optimal. Family members can also ask to speak to the manager or ask to be notified when the doctor will be making rounds at the home.