Print“Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there's ample evidence that some drug companies aggressively marketed their products towards such populations, putting profits before safety.”
Nursing homes are often using powerful antipsychotics for unapproved uses and almost always with patients suffering from dementia, despite the fact these drugs warn of an increased risk of death in these patients, a new government report finds.
The report from the U.S. Department of Health and Human Services Inspector General comes in response to a request from Senator Charles Grassley, R-Iowa, to investigate the use of atypical antipsychotics in elderly patients in nursing homes and the cost to Medicare.
“Nursing home residents are getting antipsychotic drugs for dementia, not psychoses,” Grassley said. “No one seems to have a good handle on whether the patients are benefiting from these medicines or whether they’re being prescribed drugs that don’t help and might even harm them. The government needs to do a better job of protecting nursing home residents from unnecessary drugs.”
The report found that for the six months ending June 30, 2007, 83 percent of the time nursing homes residents over 65 received atypical antipsychotics it was for uses not approved by the U.S. Food and Drug Administration. Additionally, 88 percent of these patients suffered from dementia, even though these drugs carry the harshest FDA warning that their use has an increased risk of death for these patients.
The report found that the Centers for Medicare & Medicaid Services paid out $116 million it shouldn’t have for these drugs during the six months period studied as 51 percent of Medicare claims for atypical antipsychotic drugs failed to comply with Medicare reimbursement criteria. In those cases the drugs were either not used for medically accepted indications or there was not adequate documentation showing the nursing home administered the drug to the resident.
“Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there's ample evidence that some drug companies aggressively marketed their products towards such populations, putting profits before safety,” wrote Daniel Levinson, inspector general of the Department of Health and Human Services. “Government, taxpayers, nursing home residents, as well as their families and caregivers should be outraged - and seek solutions.”
Levinson says that while the report didn't explore the pharmaceutical industry’s role in the high rate of off-label use of these drugs in elderly nursing home patients, he noted that HHS had been engaged in a series of lawsuits and settlements over drugmakers improper promotion of these drugs to doctors and nursing homes.
Eli Lilly pled guilty to criminal charges associated with illegally marketing its drug Zyprexa, including to doctors that treat elderly nursing home patients. Bristol-Meyers Squibb, AstraZeneca and Pfizer settled government allegations that they improperly promoted their antipsychotic drugs for unapproved uses. And federal prosecution is pending against Johnson & Johnson for allegedly paying millions of dollars in kickbacks to induce Omnicare, the nation's largest long-term care pharmacy, to recommend the use of Risperdal in treating nursing home patients, many of whom had dementia, Levinson says. The Wall Street Journal reported prosecutors are seeking around $1 billion from the company to settle the charges.
May 13, 2011
http://www.burrillreport.com/article-nursing_homes_use_of_antipsychotics_on_elderly_raises_concerns.html
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