Monday, October 23, 2017

The Latest in Off-Label Prescriptions for Dementia Patients: "The Little Red Pill"

My thanks to my colleague Dermot Groome for pointing me to the CNN investigative series on "The Little Red Pill Being Pushed on the Elderly." The prescription drug in questions is Nuedexta, approved to treat PseudoBulbar Affect or PBA, a "disorder marked by sudden and uncontrollable laughing or crying." (Perhaps you have seen commercials for treatment of PBA with actor Danny Glover effectively portraying the disorder).   

According to the CNN report:

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.
 
Concerns about unnecessary prescription, side effects (including a higher incidence of falls), and federal reimbursements for cost are raised by critics:
 
Nuedexta is approved by the Food and Drug Administration (FDA) to treat anyone with PBA, including those with a variety of neurological conditions such as dementia. But geriatric physicians, dementia researchers and other medical experts told CNN that PBA is extremely rare in dementia patients; several said it affects 5% or less. And state regulators have found doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta to treat patients whose confusion, agitation and unruly behavior make them difficult to manage.
 
 
"There has to be a diagnosis for every drug prescribed, and that diagnosis has to be real ... it cannot be simply made up by a doctor," said Kathryn Locatell, a geriatric physician who helps the California Department of Justice investigate cases of elder abuse in nursing homes. "There is little to no medical literature to support the drug's use in nursing home residents (with dementia) -- the population apparently being targeted."
The article notes that Medicare pays for much of the use of this drug in the nursing home setting, and as we've been reported before on other off label prescriptions of  medications, federal regulators have the power to investigate and sanction improper use (not just off-label use) under the False Claims Act and similar anti-fraud regulations.  

http://lawprofessors.typepad.com/elder_law/2017/10/the-latest-in-off-label-prescriptions-for-dementia-patients-the-little-red-pill-.html

Cognitive Impairment, Dementia/Alzheimer’s, Elder Abuse/Guardianship/Conservatorship, Ethical Issues, Medicare, Science, Statistics | Permalink

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