The number of deaths associated with using antipsychotic drugs in dementia patients may be higher than previous estimates. The mortality rate for use of one high-dose antipsychotic, for example, was found in a new study to be four times greater than previous studies had discovered.
“Prescribing a medication that increases mortality risk seems contrary to the tenet “First, do no harm,” wrote authors from the University of Michigan and the VA Center for Clinical Management Research in the latest study published Wednesday in JAMA Psychiatry.
All of the high- and low-dose antipsychotics evaluated were linked to increased death rates when compared to patients not given the drugs, but the risk increased along with the dose. The rates include a 3.8% increased mortality risk among patients prescribed haloperidol; 3.7% increased risk for risperidone; 2.7% for olanzapine; and 2% risk for quetiapine, according to the findings.
Major concerns about antipsychotics have been raised in recent years due to continued overprescribing of the drugs for off-label purposes. Most are Food and Drug Administration-approved for patients with schizophrenia, but they have widely been used off-label to manage aggression, agitation and other behaviors in elderly dementia patients.
Besides mortality, the team also evaluated the “number needed to harm,” or the number of patients who would need to receive treatment before one death would occur. They found that for every 26 patients treated with haloperidol, there was one additional death within six months that would not have been expected to occur had those patients not received the drug. For every 50 patients taking quetiapine, one unnecessary death might occur over six months.
“At this point, I think providers are very aware of the risks of using these medications,” said Dr. Donovan Maust, an assistant professor of psychiatry at the University of Michigan and lead researcher of the new study. Persistent use, despite warnings, speaks to how distressing and potentially dangerous the behaviors can be, he said. “It also speaks to the fact that providers feel that they have few other tools to help address these behaviors.”
Federal and other initiatives have focused intently on encouraging nursing homes to find alternative means of managing dementia patients, due to the riskiness of the drugs. Some facilities found they could achieve success by making adjustments to the nursing home environment, like eliminating loud noises that led to increased aggression or reducing the brightness of lights that prevented patients from sleeping well.
Maust said reimbursement incentives also could help with rates. “But a nondrug behavioral intervention is precisely the type of 'cognitive' (nonprocedural) service that is difficult to deliver in traditional, fee-for-service care models,” he said.
The retrospective analysis used 90,786 Veterans Health Administration records of patients 65 and older who received antipsychotics or an antidepressant between October 1998 and September 2009.
Recent studies also have pointed to a need to expand focus beyond just nursing homes. Internists, family medicine physicians, psychiatrists and neurologists wrote more than 80% of the prescriptions for antipsychotics for older adults with dementia in 2012, according to a report released earlier this month. More than 90% of every medication group in the new JAMA Psychiatry study was not associated with a nursing home stay in the prior year, the study found.
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