The warning, written in bolded letters and placed in a black-bordered box at the front of the labeling for all antipsychotic drugs, couldn't be starker:
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS...
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. [DRUG NAME] is not approved for the treatment of patients with dementia-related psychosis.
The Food and Drug Administration initially required the inclusion of this warning on the labels of all newer "atypical" antipsychotic drugs (for example, Abilify [aripiprazole], Risperdal [risperidone] and Zyprexa [olanzapine]) in 2005. In 2008, the agency expanded this requirement to the labels of all older "conventional" antipsychotics (for example, Haldol [haloperidol] and Thorazine [chlorpromazine]).
Nevertheless, despite these long-standing, glaring warnings, physicians continue to prescribe antipsychotic drugs to too many elderly patients with dementia. A report by the U.S. Government Accountability Office (GAO) released in January documented the scope of the problem: In 2012, about a third of older adults receiving care in nursing homes for more than 100 days were treated with an antipsychotic medication. In addition, among the 1.2 million older adults enrolled in Medicare Part D who were diagnosed with dementia and living outside of nursing homes (for example, in assisted-living facilities or at home), 170,000 (14 percent) were prescribed one of these drugs.
The GAO report acknowledged that the U.S. Department of Health and Human Services (HHS) has taken several actions to reduce the use of antipsychotic medications in nursing home patients, but it criticized HHS for doing nothing to rein in the misuse of these drugs in elderly dementia patients in other settings.
Elderly dementia patients commonly display agitation, aggression, delusions or other disruptive behaviors (1). For many assisted-living facilities and nursing homes, use of antipsychotic drugs -- sometimes called "chemical restraint" -- is viewed as an easier, cheaper substitute for having qualified staff with the training and expertise needed to respond to these behavioral problems.
A solution to this problem is well within reach: Evidence from at least one well-designed study has shown that a training and support program that teaches nursing home staff individual patient-centered behavioral management techniques can dramatically reduce the use of antipsychotic drugs in nursing home residents with severe dementia (2). The same type of training likely would work just as well in other settings.
The continued misuse of dangerous antipsychotic medications in elderly dementia patients -- one of the most vulnerable groups of individuals in this country -- represents a collective failure of federal, state and local government agencies; advocates for the elderly; professional health care organizations; and individual health care providers. Until this failure is addressed, family members of elderly patients with dementia must take proactive steps to protect their loved ones from being exposed to antipsychotic drugs. These steps could include:
• Monitoring the patient's prescription drug regimen.
• If the patient is prescribed an antipsychotic drug, speaking to the prescribing physician about using alternative interventions, such as appropriate behavioral management interventions, and if the physician refuses, seeking another health care provider.
• If necessary, moving the patient to a different long-term care facility that has the resources and staff to deliver patient-centered behavioral management techniques shown to be effective.
1.) Andrews GJ. Managing challenging behavior in dementia: A person centred approach may reduce the use of physical and chemical restraints. BMJ. 2006; 332(7544):741.
2.) Fossey J, Ballard C, Juszczak E, et al. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial. BMJ. 2006; 332(7544):756-761.