Nuedexta Off-Label Fraud

Neudexta Off-Label Fraud

I stumbled into this article a while ago regarding Nuedexta off-label fraud for behavioral issues involving dementia patients in long term care facilities. It makes me sad and frustrated. I’d like to make a couple of points.

Nuedexta Off-Label Evidence in Dementia

The evidence of Nuedexta being beneficial in this patient population for the off-label use is scant to non-existent. Here’s the major study I could find on the evidence of using it in dementia patients: Effect of Dextromethorphan-Quinidine on Agitation in Patients With Alzheimer Disease Dementia: A Randomized Clinical Trial.

The trial involved around 200 patients. Most of the patients were actually outpatients, not institutionalized patients. On the risk side of the equation, there was double the number of falls in the Nuedexta group compared to placebo and nearly double “serious adverse events” versus placebo.

The study did show mild, statistically significant efficacy in reducing agitation and aggression scores. The real-world, clinical significance of the change in scores can certainly be debated.

The cost of Nuedexta is insane. This cash price of this medication is over one-thousand dollars per month. Couple that fact with adverse drug reactions, interactions, lack of data in the nursing home population and we essentially don’t know how meaningful the reductions in the agitation/aggression scale is, it is no wonder why the Beers Criteria has specifically mentioned this medication as having limited efficacy and should be used with caution.

Why You Need a Pharmacist on the team?

Among many other reasons for having a pharmacist on the team, this fraud case represents another example. Much like The Pharmacist series on Netflix, we can be another set of eyes to ensure that the patient’s best interests are taken care of.

Consultant pharmacists are a medication expert and a voice of reason in long term care facilities. CMS has made the recommendation (but not mandated) that consultant pharmacists should be independent of the dispensing pharmacy and if you work in a nursing home, I think you should understand why that independence is important. I’m biased, but having an independent voice, separate from the sale of pharmaceuticals is ideal to avoid any possibility of a conflict of interest when it comes to selecting medication therapy and attempting to stop polypharmacy.

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  1. Emilee

    Very interesting article, thank you

  2. kirk seale

    Thank you, Eric, for bringing this study to our attention.
    I once had a sales rep come into my long term care facility, according to the nursing staff the sales rep stated that this medication was safe and had no contraindications and NO drug interactions and could be used to treat dementia patients for behavioral problems. after a quick research on my part I was able to convince the director of nursing and the medical director that this was not true.
    In reviewing the package insert, I discovered that this medication is contraindicated in heart failure, which is very common in long term care. Also concerning was drugs that can affect QT interval changes and metabolized by CYP2D6. the package insert list examples as thioridazine or pimozide both not commonly used today. However, as Eric mentioned in his post, there are several medications, commonly used in long term care patients, that are metabolized by CYP2D6 that can be affected by this medication.

    • Eric Christianson

      Thanks for sharing!


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Written By Eric Christianson

May 20, 2020

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