It’s a Matter of Patient Safety: Reducing the Off-Label Use of Antipsychotic Medications in Long Term Care

By Lauri St. Ours

Director of Governmental & Legislative Affairs, Washington Health Care Association

Over 5 million Americans are living with Alzheimer’s disease and other dementias according to the Alzheimer’s Association. The impact of this national health epidemic is startling. One in three seniors dies with some form of dementia.  In Washington State, one in ten seniors suffers from the disease; at this time, nearly 100,000 Washington citizens are living with dementia. ^[1]

The disease process is often protracted and difficult, with behaviors such as aggression, agitation, confusion, and depression common among those with dementia. Physicians and other health care prescribers have used antipsychotic medications to control behaviors. While there may be a small benefit for a limited number of individuals with dementia, there is a great risk of adverse events with this approach.

In 2005, the Food and Drug Administration (FDA) issued a warning related to the use of atypical antipsychotic drugs with patients with dementia. In a study of over 5,000 patients, the risk of mortality was over one and half times more likely in those with dementia. The specific causes of these deaths were mostly due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).^[2]   This advisory led to an overall reduction in use of about five percent, but despite the use of “black box” warnings (the most stringent advisory message from the FDA), the significant use of antipsychotics continued.

In 2011, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) reported that 88% of a 2007 sample of 1.4 million Medicare claims for newer antipsychotic drugs for older adult nursing home residents was associated with a dementia diagnosis.^[3] The federal government’s interest in this issue goes beyond the matter of patient safety and into the area of health care costs. Claims for elderly nursing home residents reached $309 million during the study period.

As a result of the OIG report, the Centers for Medicare and Medicaid Services (CMS) launched a nursing facility quality initiative that included a goal to decrease the off-label use of antipsychotics by 15% by December 2012.  This effort echoes the national goal of the American Health Care Association, and the statewide goal of the Washington Health Care Association, two organizations that represent the skilled nursing sector. Washington is ahead of the nation in terms of reduction efforts. Since 2011, state providers have steadily decreased the use of these medications; the current level of use stands at about two percent in short stay nursing home residents. Washington providers are ahead of the nation in abating off-label use of antipsychotic medications with long stay residents, as well. Since 2011, the state has seen a 3% reduction in the use of such medications.

The effort to abate off label use of antipsychotics continues today. In our state, the Washington Health Care Association continues to work with and educate providers about patient-centered care approaches designed to alleviate behavioral challenges in patients with dementia. The State Long Term Care Ombudsman Program has also made this issue a priority, and has a resource list available for those who are working on this initiative.

Here is the good news: CMS formed the National Partnership to Improve Dementia Care in 2014, with a goal to improve patient care and outcomes through the use of individualized, person-centered care approaches. The first goal of a 15% national reduction in antipsychotic medication use for the treatment of dementia in skilled nursing homes was achieved in 2015.

CMS hopes to further reduce the use of unnecessary antipsychotic medications in nursing homes and to begin to address this issue in other care settings. The Partnership has set new goals of a 25% reduction by the end of 2015, and 30% by the end of 2016.

While the federal government has a vested financial interest in the outcome, the impact on patient safety cannot be overstated. National and state partnerships are leading to better care and, thus, better outcomes for dementia suffers.

Unfortunately, these resources aren’t necessarily as readily available to home caregivers, or to those caregivers in other settings. Thus, it is imperative that all health care providers, regardless of sector, understand what’s at risk with the off-label use of antipsychotic medications.

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[1] Alzheimer’s Association, 2014 Alzheimer’s Disease Facts and Figures, Alzheimer’s & Dementia, Volume 10, Issue 2.

[2] FDA Public Health Advisory, 11 April 2005 “Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances”

[3] Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents, U.S.

Daniel R. Levinson, Inspector General May 2011