Off-Label Antipsychotic Use: Not Just a Nursing Home Problem

Providers continue to prescribe potentially harmful antipsychotic (AP) medications to older adults with dementia, putting them at increased risk of adverse health events such as stroke and death

Antipsychotics are prescription drugs approved by the US Food & Drug Administration (FDA) to treat psychosis, including delusions and hallucinations, as well as schizophrenia, bipolar disorder, Tourette syndrome, and Huntington’s disease, among other conditions. These drugs are not approved to treat symptoms of dementia, such as aggression and agitation. Nevertheless, antipsychotics are sometimes prescribed off-label (an unapproved use of an FDA-approved drug) to dementia patients.

Such off-label use is particularly concerning given that the FDA requires antipsychotics to include a warning that there is an increased risk of death when used in elderly patients with dementia-related psychosis. This is called a “black box” warning (see example below).

While decades-long efforts to reduce antipsychotic use among dementia patients living in nursing homes are showing some success, less attention has been given to the practice outside nursing homes. In fact, an  AARP Public Policy Institute report released today shows that rates of antipsychotic use among older adults with dementia living in the community increased by 6%, from 12.6% to 13.4%, between 2012 and 2015. Meanwhile, antipsychotic use reportedly dropped by over 30% among nursing home residents with dementia over this same time period.

This research analyzed insurance claims data from the OptumLabs® Data Warehouse, a comprehensive, longitudinal, real-world data asset with de-identified lives across claims and clinical information. Our report is based on a sample of Medicare Advantage beneficiaries ages 65 and older with dementia living in any location other than a nursing home, including assisted living facilities.

Our findings indicate that policymakers should consider expanding efforts to reduce the off-label use of antipsychotic drugs among elderly dementia patients to include those living in the community. Preventing such use will benefit patients and augment ongoing efforts by reducing the number of patients who begin using antipsychotic drugs prior to entering a nursing home.