In April 2017, AARP highlighted the misuse of psychotropic drugs, including antipsychotics, in nursing homes. Their report revealed that these extremely strong drugs are still used as restraints, given without the patient’s or guardian’s consent, and have led to a high number of fatalities.

AARP also investigated this issue three years ago in 2014. Their study found that as many as one in five patients in 15,500 nursing homes are still given antipsychotics for behavior management and dementia-related symptoms. Despite the Centers for Medicare & Medicaid Services’ efforts to reduce over-prescription since, you and your loved one should know your rights.

Off-Label Use

upset elderly manPrescribing antipsychotics for behavioral modification is one of the biggest red flags. Whether for the elderly, adults or children, the FDA has not yet approved such off-label use. Although doctors can legally recommend drugs for off-label use, drug companies cannot. Unfortunately, drug companies were the primary pushers of Risperdal and other atypical antipsychotics for use as behavioral restraints.

The most high-profile example is the $2.2 billion fine Johnson & Johnson received in 2013 for criminal and civil charges. Prior to this case, the drug manufacturer had marketed Risperdal to nursing homes without FDA approval and further compensated physicians and pharmacies who recommended the drug for this purpose. Yet, even though this case came to a resolution, doctors in nursing homes continue to use antipsychotics specifically for this purpose.

However, the FDA has not approved this drug for restraint and behavioral modification. It also carries a black box warning specifying that the elderly and patients with Alzheimer’s or dementia should not take these drugs, as they may trigger agitation, anxiety, confusion and even death.

Giving Consent

The use of antipsychotics in nursing homes requires informed consent, either by the patient or guardian managing that individual’s care, because of the off-label use and black box warning.

Unfortunately, as AARP emphasized in both of its reports, that does not always happen. One patient had been given antipsychotics to manage aggression, wandering or other behavioral issues, and family members only became informed when that individual was transferred.

Further contributing to this concerning issue is the lack of staff training. Certified nursing assistants (CNAs) are often administering the drugs instead of doctors, who may be off-site. Particularly at understaffed facilities, CNAs must manage twice the number of patients and receive minimal on-the-job instruction.

Who Receives Antipsychotics?

A report from the Office of the Inspector General of the Department of Health and Human Services found that up to 83 percent of all nursing home residents may have been prescribed an antipsychotic with or without approval. Yet, the typical patient tends to have dementia and, based on various statistics, anywhere from one-third to as many as 68 percent of residents living with this condition may have been given an antipsychotic for symptom management.

CMS’ Efforts

Following up on multiple studies, the CMS started working in 2012 to decrease antipsychotic prescriptions across homes receiving federal funding. As of 2016, use at these facilities has declined 30 percent – right in line with the organization’s goals. In Connecticut, prescriptions dropped 33 percent from 2011 to 2016, although about 17.5 percent of state homes continue to use them.

What other options would homes have? Based on the CMS’ National Partnership to Improve Dementia Care, facilities’ staffs are being encouraged to take non-pharmacologic and person-centered approaches to reduce aggression and monitor patients whose medications have since been withdrawn.

Side Effects

In 2007, the FDA Office of Surveillance and Epidemiology pointed to one troubling statistic: As many as 15,000 elderly people per year are dying in homes from off-label antipsychotic use.

Since 2005, the FDA’s black box warning has included an increased mortality risk for the elderly. For this demographic, the drug may also be associated with:

  • A sudden loss of independence
  • Over-sedation or lethargy
  • Confusion
  • A higher-than-average incidence of respiratory infections
  • Higher stroke risks
  • Agitation, anger and excessive screaming
  • Hitting
  • Pacing
  • Delusions
  • Wandering
  • Insomnia
  • Decreased appetite

Has a nursing home prescribed you or a loved one antipsychotics for off-label purposes? Trantolo & Trantolo understands that you put your trust in the facility’s care and the use of harmful drugs violates that trust. If you believe you have a case concerning antipsychotic usage in nursing homes, contact our attorneys today for more information.