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Thursday December 1, 2011
Industry Headlines:
Gov't Inspector Says Penalties Needed to Curb Use of Psychiatric Drugs in Nursing Homes
(11/30/11 Associated Press) By Matthew Perrone
Government inspectors told lawmakers Wednesday that Medicare officials need to do more to stop
doctors from prescribing powerful psychiatric drugs to nursing home patients with dementia, an
unapproved practice that has flourished despite repeated government warnings.
So-called antipsychotic drugs are designed to help control hallucinations, delusions and other abnormal
behavior in people suffering from schizophrenia and bipolar disorder, but they're also given to hundreds of
thousands of elderly nursing home patients in the U.S. to pacify aggressive behavior related to dementia.
Drugs like AstraZeneca's Seroquel and Eli Lilly's Zyprexa are known for their sedative effect, often putting
patients to sleep.
But the drugs can also increase the risk of death in seniors, prompting the Food and Drug Administration
to issue multiple warnings against prescribing the drugs for dementia. Antipsychotics raise blood sugar
and cholesterol, often resulting in weight gain.
An inspector for the U.S. Department of Health and Human Services told the Senate Committee on Aging
that the federal government's Medicare program should begin penalizing nursing homes that
inappropriately prescribe antipsychotics, according to written testimony obtained by the Associated Press.
The Centers for Medicare and Medicaid Services provides health coverage to nearly 80 million senior,
poor or disabled Americans.
HHS Inspector General Daniel Levinson proposed that Medicare force nursing homes to pay for drugs
that are prescribed inappropriately, and potentially bar nursing homes that don't use antipsychotics
appropriately from Medicare.
A report by Levinson's office issued in May found that 83 percent of Medicare claims for antipsychotics
were for residents with dementia, the condition specifically warned against in the drugs' labeling. Fourteen
percent of all nursing home residents, nearly 305,000 patients, were prescribed antipsychotics. The HHS
Inspector General's office Medicare claims during a 2007 six month period.
Doctors are permitted to prescribe drugs for off-label uses, though it is illegal for drug companies to
promote uses that haven't been cleared by the FDA. In recent years several pharmaceutical companies
have paid huge fines to the Department of Justice in cases involving off-label marketing of antipsychotics.
In January 2009, Eli Lilly & Co. Inc. agreed to plead guilty and pay $1.4 billion for illegal promotion of
Zyprexa, including marketing to nursing home doctors. The company told its sales representatives to use
the slogan "5 at 5," to persuade doctors that giving 5 milligrams of the drug at 5 p.m. would make
dementia patients sleep through the night.
AstraZeneca PLC has paid nearly $600 million in two separate settlements with federal and state
prosecutors over alleged off-label promotion of its drug Seroquel.
 

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