By Matthew Malamud
Many elderly nursing home residents with dementia are prescribed atypical (or second-generation) antipsychotic drugs despite the increased risk of death that these medications pose, federal investigators have found.
According to a report released last month by the Department of Health and Human Services (HHS) Office of the Inspector General (OIG), 88 percent of reimbursement claims submitted to Medicare for atypical antipsychotic drugs prescribed for nursing home residents during a six-month review period (January to June 2007) were for residents diagnosed with dementia. These drugs carry a black box warning stating that they pose an increased risk of death in elderly patients with that condition.
The OIG also found that 83 percent of claims were for the treatment of off-label conditions, and 76 percent were for the treatment of off-label conditions and dementia. Doctors can prescribe FDA-approved drugs for off-label uses, but the agency’s required black box warning specifically points out that antipsychotic drugs are not approved for the treatment of dementia-related psychosis.
“Government, taxpayers, nursing home residents, as well as their families and caregivers should be outraged—and seek solutions,” HHS Inspector General Daniel Levinson said in a statement following the release of the report. “It is of great concern that so many nursing home residents are prescribed these drugs in the first place.”
Steven Levin, a Chicago attorney who represents plaintiffs in nursing home cases, said nursing homes often use atypical antipsychotic drugs as chemical restraints “because it’s easier to control the patient and requires fewer staff. However, nursing homes should never use antipsychotic drugs for the purpose of convenience.”
Levin’s firm recently represented two nursing home residents who suffered acute kidney failure resulting from dehydration while taking the antipsychotic drug Seroquel. One resident died and the other suffered a brain injury. Dehydration is a known side effect of the drug.
“Our anecdotal evidence suggests that when the resident is placed on these drugs, something bad happens,” he said. “Attorneys should never ignore the role that these types of drugs might play in cases involving nursing home neglect.”
Levin said attorneys representing clients injured by antipsychotic drugs should investigate whether the nursing home appropriately assessed the need for the drugs, monitored the resident’s behavior while on the medication, and discontinued it if adverse effects occurred.
The use of antipsychotic drugs in nursing homes drew Congress’s attention in 2007, when FDA epidemiologist David Graham testified that as many as 15,000 nursing home residents die every year from the off-label use of these medications. Sen. Charles Grassley (R-Iowa) asked the OIG to investigate prescriptions of the drugs for residents with off-label conditions and dementia.
While the report does not speculate about why nursing homes give residents antipsychotic drugs for off-label conditions, Levinson noted that there’s substantial evidence that pharmaceutical companies’ marketing tactics may play a role. He cited recent settlements between the federal government and drugmakers to resolve allegations that they illegally promoted the drugs for off-label uses.
Of the eight FDA-approved atypical antipsychotic drugs, the three most commonly prescribed in nursing homes are Astra Zeneca’s Seroquel, Johnson & Johnson’s Risperdal, and Ely Lilly’s Zyprexa.