Some patients with dementia can behave in ways that caregivers find difficult: They hit, they yell. Sometimes, they get prescribed anti-psychotics.
The Food and Drug Administration says that such off-label uses are risky — people taking them are more likely to die. A new report from the Government Accountability Office recommends steps for reducing their use.
Marketing efforts for these non-approved uses have drawn fire from federal prosecutors. In 2013, Johnson & Johnson paid more than a billion dollars in federal fines for improperly marketing its anti-psychotic drug Risperdal. In March of this year, a Chicago psychiatrist pleaded guilty to accepting $600,000 in kickbacks from another drug-maker.
Not all adoption is illicit, says Dan Mendolson, CEO of Avalere, a health-care consultancy.
“A lot of the demand is driven by the patients’ families,” he says. “These are effective drugs, and the reason why they’re so widely prescribed is because they work beautifully.”
However, they may eclipse other, safer alternatives, says Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins University.
“There are certainly some settings where clinicians and patients and family members are between a rock and a hard place,” Alexander says. “But I don’t think it’s fair to say that there aren’t other options. And I don’t think it’s fair to say that patients are breaking down the doors, trying to access these therapies.”
The Department of Health and Human Services has been attempting to reduce the use of these drugs in nursing homes. Today’s report looks at their use with patients in other settings.