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The FDA Cites Nuedexta Misuse in Some Nursing Homes - Part 2



In last week’s blog, we looked at the issues associated with the over-prescribing of the drug Nuedexta for Pseudobulbar Affect (PBA) in nursing homes. We also discussed why this has led to a warning from the FDA about off-label prescribing. In this blog, we’ll look at some of the reasons off-label prescribing is problematic and why some critics say this drug is being used as a chemical restraint in some senior care facilities.

As pointed out last week, the number of scripts written in nursing homes for Nuedexta has risen dramatically – as have the diagnosis of PBA in residents with dementia and other neurological disorders. From a financial stand point, the increase in prescriptions for Nuedexta is costing Medicare millions of dollars annually.

According to new pricing data regarding Nuedexta, the website Good Rx states that the average retail price of the drug is just over $1,160 for a month’s supply with co-pays of Part D providers varying by plan. Pricing data provided by First Databank shows that the medication can cost as much as $12.60 a pill. That can add up to more than $9,000 a year, though the amount a patient actually pays depends on factors including individual insurance coverage. Medicare Part D spending on the drug averaged $3,400 per patient in 2015.


But if a resident really needs this medication for PBA, why shouldn’t it be provided?

This, according to many medical professionals and the FDA, is the problem – there appears to be a correlation between the diagnosis of PBA and residents with histories of aggressive behaviors. Nuedexta, according to medical providers, can help control these acting out activities and has raised the suspicions of the FDA.

So what’s the problem?

First, Nuedexta has been approved solely for treatment of PBA. Although many medications have been approved for off label use, Nuedexta is not one of them. The FDA states that doctors are skirting this issue by giving residents with dementia and aggressive behaviors a PBA diagnosis to allow for the use of this medication. In plain words, the major issue here is the concern that Nuedexta is being used as a chemical restraint.

Let’s discuss what this means.

A chemical restraint is defined as the use of any drug to restrict a person’s


movement or freedom. This type of restraint is used for the sole purpose of sedating an individual. In many cases, a chemical restraint refers to the use of psychotropic drugs such as sedative and anti-anxiety (benzodiazepines) medications. The FDA reports that roughly 15,000 nursing home resident deaths each year result from unnecessary anti-psychotic use.

The classes of medications used to control a patients mood, behaviors and thinking fall under three areas:

Antipsychotics

Antipsychotics can be most commonly associated with chemical restraint. There are several classes of antipsychotics which may be used as chemical restraint, including atypical antipsychotics and typical, or classic antipsychotics. Common antipsychotic drugs include droperidol, haloperidol, risperidone, and olanzapine. In certain cases, antipsychotics may cause life-threatening heart conditions.

Benzodiazepines

Benzodiazepines are a class of drug that can help alleviate conditions such as anxiety, seizure disorders, muscle tension, panic attack symptoms, and insomnia. Studies show that benzodiazepines are effective for controlling agitation and sedating an individual. The most common types of benzodiazepine for agitation control are lorazepam and midazolam.

Dissociative Anesthetics

Dissociative anesthetics are a type of hallucinogen that distorts the patient’s perceptions of sound and sight. They also tend to dissociate or detach individuals from their self and environment. Dissociatives work by blocking or reducing brain signals between the conscious mind and other parts of the brain. They are less commonly used than drugs such as antipsychotics and benzodiazepines.

Where does Nuedexta fall within these classes of drugs?

One of the active ingredients, Dextromethorphan (DXM or DM) is a drug of the morphinan class with sedative, dissociative and stimulant properties (at higher doses). Morphinan is the prototype chemical structure of a large chemical class of psychoactive drugs which consist of opiate analgesics, cough suppressants, dissociative hallucinogens and others.

The other ingredient, Quinidine, is a pharmaceutical agent that acts as a class I anti-arrhythmic agent in the heart. Quinidine also has off-label uses as well.

Many medical professionals who work with the elderly say Nuedexta is a safer alternative to antipsychotics, benzodiazepines and dissociative anesthetics – and providers say that like it or not, aggressive behaviors associated with dementia need to be managed in the best interest of all concerned.

Unfortunately, there exists no FDA approved drugs for treating dementia related agitation and in the past, other companies have been penalized for off-label use of drugs to deal with this problem.

In 2012, Abbott Laboratories, Inc. pleaded guilty to illegally marketing Depakote, an


anti-convulsant, in nursing homes as a way to control aggressive dementia residents. The drug had only been approved for treating seizures, bi-polar disorders and migraine headaches and as a result, the company was forced to pay a total of $1.6 billion in civil and criminal penalties.

But according to a CNN report, the FDA warnings and past legal problems for other pharmaceutical companies have not deterred the makers of Nuedexta from marketing their product to nursing homes – and not just to doctors.

They cited one case of a nursing home director at a facility in Alameda, California. In emails sent to an aggressive client’s son, the director threatened to discharge the resident due to her physical acting out unless the behavior was brought under control.

In one email, the director suggested using Nuedexta to help control the outbursts. She cited the fact that she had seen it help other aggressive dementia residents without the “dangers and side effects of an antipsychotic.”

The problem was, the director was not a medical doctor.

When confronted about recommending a medication in an email, she stated, "I've seen it just work wonders with people, it was the only intervention I could come up with. We needed to do something not only for her own benefit, but also for the people around her."


Television commercial marketing Nuedexta and its uses. Critics say that the number of people with PBA is greatly exaggerated and nothing more than a marketing ploy to increase the drug maker's bottom line. However, medical professionals are pushing back on this claim and see Nuedexta as a way to help control the agitation of residents with dementia.

There is no doubt that providers need help controlling aggressive residents. In fact, physical interventions can also prove harmful to elderly residents. But according to those investigating the use of Nuedexta, this is more about the bottom line of the drug company rather than the well-being of the residents and the staff.

This claim, according to CNN, is backed up by the fact that of all the complaints made about inappropriate prescribing of this drug nationally, 40 percent were from Southern California where the drug company’s corporate offices are and according to former employees, the hotbed of where aggressive marketing tactics emanate.

One complaint, which came out of the Montrose Healthcare Center near Los Angeles, stated that three nursing home residents were given Nuedexta without a prescription in 2015. It was family members who discovered this and contacted state regulators.


An investigation found that the nursing staff had decided on their own to use this medication on residents that they felt had exhibited symptoms of PBA. Just how did they obtain the medication? It appears that two of the nurses had attended a sales seminar about Nuedexta and were given a doctor’s sample prescription to obtain the medication. The Center stated that disciplinary action was taken against the nurses.

Closer to home, St. Vincent’s Healthcare and Rehab Center in New Jersey was cited by regulators in 2017 when it was found that six residents were prescribed Nuedexta in the absence of PBA symptoms. The facility stated it “changed its policies” to prevent such an abuse from happening again.

As we wrote before, the overwhelming majority of nursing homes and those providing services to seniors are professional, ethical and meet or exceed state and federal requirements. However, with a rapidly aging population in America and the increasing need for programs and people to provide services to this group, the door is open to unscrupulous providers -- and make no mistake about it, they will walk in.

In next week’s blog, we will examine the problems associated with the use of medications as chemical restraints and what dishonest and unethical providers could do with these drugs without the appropriate oversight.

If you have a loved one in a nursing facility, make sure you know what medications are being used and why they are being used. Should you suspect abuse, neglect or the misuse of medications, contact Connelly Law Offices at 855-724-9400 for guidance or contact your state's Department of Elderly Affairs Office.

Attorney RJ Connelly III 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.


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