Pharmaceutical Company Marketed Drug to Nursing Home Residents with Dementia and Alzheimer’s Not Approved for that Purpose by FDA
Providing medications like Nuedexta to residents with dementia and Alzheimer’s disease for off-label use (not approved for those purposes by the FDA) may result in fraud and the submission of a false claim.
Compliance Perspective – Unapproved FDA Drugs
Policies/Procedures: The Compliance and Ethics Officer with the Administrator, Medical Director, Director of Nursing, and Consultant Pharmacist will evaluate policies and procedures involving pharmaceutical review of medications prescribed for residents.
Training: The Compliance and Ethics Officer with the Director of Nursing will ensure that staff are trained to respond in a timely manner to concerns about medications that may be prescribed inappropriately to residents and the need for a medication regimen review of a resident’s medications.
Audit: The Compliance and Ethics Officer should personally conduct an audit of residents’ medications to determine if the drug Nuedexta has been prescribed and the indications for its use.
After an investigation by the U.S. Department of Justice (DOJ), a pharmaceutical company faces significant financial penalties for marketing Nuedexta—a drug only approved by the federal government for use in treating a rare condition known as pseudobulbar affect (PBA)—to nursing home patients with dementia and Alzheimer’s disease.
Medical experts have indicated that while PBA can occur in residents with neurological issues like dementia, it is not a common for this group of individuals.
It is reported that state regulators found instances where doctors improperly diagnosed some nursing home residents with PBA to support their prescribing Nuedexta to treat patients with diagnoses that made them difficult to manage, e.g., confusion, agitation, and unruly behavior. Regulators found in one California nursing home that 46 of the facility’s 162 resident had been placed on Nuedexta after the facility’s psychiatrist had been paid to speak to the employees in favor of the drug by the pharmaceutical company.
Medicare Part D prescription drug funding has underwritten much of the cost for Nuedexta. In 2016, the Medicare program spent $200 million—up more than 600% since 2012.
It is not clear what areas the DOJ will be focusing on, but the marketing tactics that have been identified appear to cross ethical lines and indicate that the pharmaceutical salespeople have involved themselves inappropriately in prescribing decisions. Salespeople are not to have access to private patient records without the patient’s consent, and they are not to promote the use of drugs outside the uses that have been approved by the Federal Drug Administration (FDA).
