Oct. 8, 2015

Antipsychotic Drug Use in Elderly Patients with Dementia

The Centers for Medicare & Medicaid Services (CMS) and the CMS National Partnership to Improve Dementia Care in Nursing Homes have set a new goal to achieve a 25 percent reduction in antipsychotic drug use within nursing homes by the end of 2015, with a 30 percent reduction by the end of 2016. Eleven states met the previous 2012 goal to reduce antipsychotic drug use within nursing homes by 15 percent.

A Black Box warning was released by the U.S. Food and Drug Administration (FDA) in 2005, which notified health care professionals that patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death. The Black Box warning was based on a review of 17 placebo-controlled trials showing a 1.6 to 1.7 times greater increase in death with the use of atypical antipsychotics compared with the placebo group¹. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (pneumonia) in nature. Additional studies have found the increased risk of death is similar between conventional and atypical antipsychotics.

Atypical antipsychotics are associated with significant weight gain and metabolic changes, such as hyperlipidemia and an increased risk of diabetes. Conventional antipsychotics are additionally associated with movement disorders such as akathisia, Parkinsonism and dystonia. Side effects may be more prominent in elderly patients, as they may have altered metabolism of medications due to physiologic changes. The long half-lives of some antipsychotics are also concerning, as patients may experience prolonged lethargy and sedation. Patients and/or caretakers should be aware of the risks of taking an antipsychotic prior to initiating therapy. Baseline weight, blood glucose level and lipid panels should be established and then monitored when a patient begins taking an antipsychotic.

Despite the FDA Black Box warning, a U.S. Department of Health and Human Services Office of Inspector General (OIG) report released in 2011 showed 88 percent of atypical antipsychotic drug claims in nursing homes were for patients with dementia². The report also showed 83 percent of atypical antipsychotic drug claims were for non-FDA labeled indications (off-label indications).

In addition to the antipsychotic reduction targets, CMS is surveying nursing facilities that dispense antipsychotics for: chemical restraints, unnecessary drugs, quality of care, standards of care, physician review and drug regimen review. CMS regulations state that each nursing home resident’s drug regimen must be free from unnecessary drugs that are used in excessive doses for excessive durations, without adequate monitoring and indications for their use, or in the presence of adverse consequences. Besides increased CMS scrutiny, law firms are also becoming increasingly aggressive in their liability claims against nursing homes. A variety of claims against nursing facilities are being attributed to the use of antipsychotics, including: tardive dyskinesia, gynecomastia, diabetes, pancreatitis, neuroleptic malignant syndrome, suicide, cardiovascular events and death.

Blue Cross and Blue Shield of Oklahoma (BCBSOK) is using the GuidedHealth^® clinical rules platform to review claims data that it receives to help identify members who have had a claim for an anti-dementia medication and who also have a recent pharmacy claim for an antipsychotic drug. Prescribing physicians of these identified members are sent informational letters on a quarterly basis to help increase awareness and promote patient safety.

¹Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA. 2005; 294:1934–1943.
²Department of Health and Human Services. Office of Inspector General. (May 2011) Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents. OE-07-07-00150.

GuidedHealth is a registered trademark of Prime Therapeutics LLC (Prime), a pharmacy benefit management company. BCBSOK contracts with Prime to provide pharmacy benefit management and other related services. BCBSOK, as well as several other Blue Cross and Blue Shield Plans, has an ownership interest in Prime. BCBSOK makes no endorsement, representations or warranties regarding GuidedHealth. If you have any questions about this product or services, you should contact Prime Therapeutics directly.

The information mentioned here is for informational purposes only and is not a substitute for the independent medical judgment of a physician. Physicians are instructed to exercise their own medical judgment. Pharmacy benefits and limits are subject to the terms set forth in the member’s certificate of coverage which may vary from the limits set forth above. The listing of any particular drug or classification of drugs is not a guarantee of benefits. Members should refer to their certificate of coverage for more details, including benefits, limitations and exclusions. Regardless of benefits, the final decision about any medication is between the member and their health care provider.