FDA Issues Warning About Suspicious Prescribing Activity in Senior Homes

It was a medication released in 2011 for the treatment of a neurological condition but is now being used, or so say its critics, as a chemical restraint for aggressive and behaviorally disturbed nursing home patients. So concerned about the way this drug is being prescribed that earlier this week, the Food and Drug Administration (FDA) issued a warning about suspicious prescribing activity at senior care facilities across the country. The drug we are writing about is Nuedexta.

Over the last few years, television commercials have provided the public with information on a condition known as Pseudobulbar Affect, or PBA. PBA causes uncontrollable crying and/or laughing that happens suddenly, frequently and often out of context to the situation that is present. Nuedexta is the medication approved for treating this condition.However, the “little red pill” has now come under fire for off label uses and questionable prescribing practices.

When you go to Google and type in Pseudobulbar Affect, one of the first results comes from Avanir, the company that manufactures Nuedexta. Avanir's webpage states that “almost 2 million people in the US with neurologic conditions or traumatic brain injury who have PBA, over 7 million people in the US have symptoms that may suggest PBA."

A graphic on the home page also reports the percentage of people with the below listed conditions "exhibit symptoms of PBA":

• 48% with Traumatic Brain Injuries

• 39% with Alzheimer’s/Dementia

• 28% suffering a stroke

• 46% with Multiple Sclerosis

• 50% with ALS (Lou Gehrig’s Disease)

• 24% with Parkinson’s

Critics of Avanir and their marketing practices for Nuedexta say these numbers are greatly exaggerated.

In a CNN report in late 2017, geriatric physicians, dementia researchers and other

medical experts said that PBA is extremely rare in dementia patients, many saying it is less than 5 percent. Despite this, 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.

Further, the maker of Nuedexta has been implicated in aggressively targeting frail and elderly nursing home residents for this drug, according to the CNN report.

When prescribed for PBA, the medication is covered under Medicare Part D, allowing the drug’s maker to show millions of dollars in annual sales from nursing facilities. However, insurance providers have voiced concerns about the dramatic rise in the diagnosis of PBA among the elder population, especially those in nursing homes.

In 2012, Blue Cross/Blue Shield sent a letter of concern to the FDA claiming that Avanir was misrepresenting the drug as being safe for use among these patients. “We believe that the manufacturer appears to be marketing Nuedexta far beyond the scope of the clinical evidence,” the company stated in the letter.

This was followed by complaints submitted from doctors, nurses and other medical professionals in nursing facilities. According to CNN, one specific complaint from an employee at a nursing home cited the pressure tactics of a salesperson from Avanir.

“The person who submitted the complaint also described how they had overheard a salesperson -- clearly but cleverly -- promoting the drug for unapproved uses, which is illegal. This representative, the complaint said, would try to draw nurses’ attention to a document listing PBA symptoms by placing snacks like Slim Jims next to it. The hope was that the nurses would then identify potential candidates to prescribe the drug.”

In March of this year, the Centers for Medicare and Medicaid Services (CMS) issued a memo to insurance providers asking them to monitor prescriptions for Nuedexta in order to insure that the medication was being prescribed as intended. The memo stated clearly that the drug was approved solely to treat PBA and Part D insurers were “legally required to make sure this was happening”.

The CNN report stated that two large Part D providers, CVS and Priority Health, had previously voiced concerns about the increase in PBA diagnoses and scripts written for Nuedexta and put safeguards in place requiring a prior authorization process occur before the drug would be provided. These providers had reason to believe that Nuedexta was being used off label for other presenting issues.

The makers of the drug protested the prior authorization requirement and went about finding ways to circumvent this process. As part of the CNN investigation, internal emails were obtained from Avanir showing that the sales force coached doctors and facility employees on how to fight for Medicare coverage of the drug if it was initially refused, with representatives celebrating when prior authorizations were lifted by specific insurance companies.

Despite the insurance concerns and medical professionals issuing warnings about the off-label use of the drug, it continued to be prescribed in record numbers - along with questionable marketing practices.

News reports highlighted some of the concerns:

• In a Los Angeles nursing home in 2017, regulators found that more than a quarter of its residents -- 46 of 162 -- had been placed on Nuedexta, noting that a facility psychiatrist had given a talk about the drug to employees. This psychiatrist was a paid speaker for Avanir.

• At another facility in Southern California, an employee admitted to inspectors that a resident had been given a diagnosis of PBA to "somehow justify the use" of Nuedexta, even though its intended purpose was to control the resident's "mood disturbances" and yelling out.

• In Ohio, a doctor paid by Avanir has come under government investigation for allegedly receiving kickbacks for prescribing the drug and fraudulently diagnosing patients with PBA in order to secure Medicare coverage -- though the doctor has denied any wrongdoing.

Exactly what harm does off-label prescribing do to the patient who may indeed benefit from Nuedexta's ability to tamp down aggression?

According to Lon Schneider, director of the University of Southern California's California Alzheimer's Disease Center, there is plenty to be concerned about, including problems stemming from potential interactions between Nuedexta and other powerful medications intended to treat problematic behaviors.

Schneider cites one report filed by a nurse practitioner in 2015 detailing the rapid decline of an 86-year-old Alzheimer's patient after Nuedexta was added to the psychotropic medications she took including Zoloft (an antidepressant), Xanax (an antianxiety drug) and Risperidone (an antipsychotic). Nuedexta had been prescribed to treat PBA and "weeping with underlying Alzheimer's dementia."

Almost immediately, the nurse practitioner stated, the woman experienced weakness and fatigue to the point that she was barely able to talk and was described as being "almost unresponsive."

The dose of Nuedexta was increased, and her symptoms worsened. The drug was discontinued about a week later, but she failed to recover. She remained unable to eat or drink and her kidneys failed -- ultimately leading to her death.

"The patient seemed to be doing fine," the nurse practitioner wrote, "until she was placed on Nuedexta." It is important to point out, however, that Nuedexta was not found to be responsible for her passing.

So just what is Neudexta?

You may be surprised to know that Nuedexta is a combination of two relatively inexpensive generic drugs:

• Dextromethorphan – a chemical found in over the counter cough suppressants like Robitussin and Cepacol Lozenges, and;

• Quinidine - an antiarrhythmic medication prescribed for abnormal heart rhythms such as atrial fibrillation, atrial flutter, and ventricular arrhythmias such as paroxysmal ventricular tachycardia (Quinidine products do contain a blackbox warning).

In the past, this combination was available from compounding pharmacies and cost less than $1.00 per pill. Today, one Nuedexta tablet costs as much as $12.60 a pill with Medicaid Part D providers paying a hefty share of the bill. This is also a part of the problem.

Attorney Connelly practices in the area of elder law. This area of law involves Medicaid planning and asset protection advice for those individuals entering nursing homes, planning for the possibility of disability through the use of powers of attorney for the both health care and finances, guardianship, estate planning, probate and estate administration, preparation of wills, living trusts and special or supplemental needs trusts. He represents clients primarily in the states of Rhode Island, Connecticut and the Commonwealth of Massachusetts. He was certified as an Elder Law Attorney (CELA) by the National Elder Law Foundation (NELF) in 2008. Attorney Connelly is licensed to practice before the Rhode Island, Massachusetts, Connecticut, and Federal Bars.