Nuedexta 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.