New Legislation on Antipsychotic Drugs?

There have been concerns raised for several years about the off-label use of antispychotic drugs in people living with various forms of dementia. But things got kicked into high gear last November 30th with HHS Inspector General Daniel Levinson’s report to Congress. CMS promptly took up the charge and has been working diligently to reduce such prescribing in nursing homes.

Over the past year, CMS has set a goal for homes to try to reduce their off-label antipsychotic use by 15% by the end of 2012. They will be releasing a new educational video series, “Hand In Hand” to all nursing homes this fall, and are working on a variety of educational initiatives for all stakeholders. Also, a National Dementia Initiative met in DC this past June to detail recommendations for a more person-centered approach to dementia, with a white paper being written for Congress as we speak.

AHCA took up the 15% reduction charge as a goal for their member homes, and last week NCAL proposed a similar goal for their assisted living communities by the end of 2013. (I’m still waiting to hear something from LeadingAge–anyone??)

Now the US Senate has raised the bar, introducing a bipartisan bill that would charge HHS to require informed consent before prescribing antipsychotic drugs to nursing home and assisted living residents. The bill would also establish monthly report cards on each home’s use of the drugs. (S. 3604)

Co-sponsor Richard Blumenthal (D-Conn) did not mince words. He called such drug prescribing “Elder abuse–plain and simple….chemical restraint as pernicious and predatory as unnecessary physical restraint.” Herb Kohl (D-Wis) added, “Despite the black box warnings and numerous multi-billion dollar settlements levied against pharmaceutical manufacturers for illegal off-label marketing, we continue to see an alarming number of dementia patients in nursing home and assisted living facilities being prescribed antipsychotics off-label…” Chuck Grassley (R-Iowa) is the third sponsor.

Strong talk, and it is laudable that the government is taking a stand on this issue, because a major barrier to medication reduction among providers is the belief that the regulators might penalize them for trying new approaches. As a member of the CMS Advisory Panel for these efforts, I can attest to the breadth and depth of their new initiatives.

Of course I will add a few comments of my own:

First, as I have mentioned previously here, the big secret is that this is not merely a problem with nursing homes, or even long-term care. The little data I have seen (including some of my own) shows that there is much, if not more, inappropriate prescribing happening in the community. Informal care partners are often ill-equipped to help their loved ones at home with minimal support. The fact that many community physicians do not have geriatric expertise is a likely factor as well.

Second, education is the key to success. Those who provide care will not be able to successfully reduce medication use unless they know how to care differently. New approaches to care are not intuitive and fly in the face of many of the common “truisms” about dementia, so both learning and “un-learning” are critical components.

Third, such re-education is not simply a “one-off” process – it requires repetition through hands-on tutelage to change patterns of care.  We must all recognize that there will be a learning curve, and we need to support those who may not immediately create significant reduction in drug use, but who are working conscientiously toward that goal.

Fourth, the process of “culture change” is vital to any successful approach. While I am not particularly fond of that somewhat vague and misused term, it should be understood that in order to change our approach to care, we must transform operations to align with that new philosophy, or it is doomed to failure.

To this end, my new Eden course, “Dementia Beyond Drugs” was specially designed to link a person-centered, “experiential” approach to the transformational steps necessary to create sustainable results.

Lastly, culture change is for everyone, not just nursing homes. That means that families need to be educated, and regulators need to continue to evolve their processes to support this new philosophy. (One area of great need here is negotiating acceptable risk to enhance quality of life, which too often is regulated on the side of surplus safety.) And our reimbursement system–which incentivizes illness and invasive care, as opposed to a relationship-based, non-pharmacologic approach–needs a big overhaul.

Legislation + education + culture change = success. Unlike Meat Loaf’s claim, two out of three won’t cut it.

About Dr. Allen Power

G. Allen Power, MD is Eden Mentor at St. John’s Home in Rochester, NY, and Clinical Associate Professor of Medicine at the University of Rochester. He is a board certified internist and geriatrician, and is a Fellow of the American College of Physicians / American Society for Internal Medicine.
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8 Responses to New Legislation on Antipsychotic Drugs?

  1. Beverley Laubert says:

    Great equation. As we work on reduction, we’re watching physical restraints to make sure they don’t increase. As always, our advocacy theme in Ohio is Expect Excellence. No more status quo. Thanks for this post!

    • Dr. Allen Power says:

      Thanks for the comment, Beverley, and for your important caution about restraints. Back in the “old days”, when we removed our physical restraints, we were puzzled by the increase in falls we saw. Then we realized that we were adding more psychotropic drugs as we took away the restraints. Once we cut the drugs back, the falls declined. Could the reverse happen with our new drug-reduction efforts? Absolutely, if we’re not careful!

  2. Rachel Main says:

    Goal to reduce antipsychotic use by 15%- this is wonderful. I’m wondering, has anyone set any benchmarks? Reduce antipsychotic use to less than 10%? 5%? Does it vary by setting? Skilled Nursing vs. Assisted Living vs. Memory Care?
    Thank you!

    • Dr. Allen Power says:

      I think the initial goal is to start everyone on the road to reduction, regardless of how high their baseline use might be. I think there is probably a reluctance to set target numbers, due to varying populations. The CMS initiative was directed at nursing homes, though it’s great to see other levels of care stepping up, because the problem exists across all of these environments.

      My personal feeling is that the setting should not affect the final target goal, because if the medications are being used in a way that does not support well-being and fulfill unmet needs, then the type of environment should not be a justification for more pills.

      There are currently nearly 150 nursing homes that are not using any antipsychotic drugs, so I think it is very reasonable to set long-term goals quite low in most populations.

  3. Ann Catlin says:

    I’m glad to see this issue gaining attention and am wondering if there are specific recommendations regarding alternatives. I teach care professionals and massage therapists how to use an approach called Compassionate Touch in dementia care as a non-pharmacological tool to decrease agitated behaviors and pain. There is a growing body of evidence in the effective use of massage for these issues and contributes one solution to reducing anti-psychotic meds for behaviors.

    • Dr. Allen Power says:

      Thanks for your comment Ann. There are many practices that can be helpful in calming distress, including therapeutic touch, aromatherapy, programmed music, etc. However, in spite of the benefits we have often seen, I do not see them as the solution, in and of themselves, but rather as tools that we can use.
      I believe our primary goal is not to relieve distress, but to enhance well-being, which gets much closer to the root of the person’s distress. I think most distress comes from the loss of one’s ability to maintain their own level of well-being. The tools we use can be helpful in this regard, but they must not simply be chosen from a laundry list of “things to try”; they must be person-directed, tied into one’s individual history and meaningful for that individual. And they will only provide lasting benefit when given in combination with a larger effort to see the whole person and to transform the care environment, 24/7, to support that person’s well-being.

  4. Nate Payne says:

    I’m doing a little late-life education for my MSN which gives me a captive audience as long as I have evidence to back my verbosity. Can anyone point me to any clinical practice guidelines relating to the off-label use of anti-psychotics in our target population. This will be peer reviewed so there is enormous potential for influence among students and educators alike but I need published evidence-based research to back it. I appreciate any guidance you can give.

    Nate Payne

    • Dr. Allen Power says:

      Hi Nate. Unfortunately, the research out there is not very strong and shows risks that often outweigh the benefits. These drugs remain non-FDA approaved for dementia with a black box warning for excess mortality risk. There are some guidelines out there, notably from the Centers for Medicare/Medicaid Services, as well as guidelines from the American Psychiatric Association. I personally don’t agree with any of them, and feel that they are way too “loose”, but that’s about all we have.
      The real problem is people being stuck in the paradigm that what is needed is a pill. That’s where my book and accompanying course come in–teaching people other ways of looking at dementia and distress that create well-being and remove the need for medications.

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