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Dear Dr. Jeff

Antipsychotics, Dementia, Dilemma
September 13, 2011



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Dear Dr. Jeff:

I’ve heard that the federal government’s powerful Office of Inspector General came out with a report saying that skilled nursing facilities are still grossly overadministering antipsychotic drugs to our residents. In my state, California, the department of public health is initiating its own "complaint investigations" when any SNF resident receives two or more antipsychotic medications. Are we really doing such a bad job?

Dr Jeff responds: The use of antipsychotic medications for nursing home residents is controversial, with people on the two sides of the issue too seldom listening to each other. And as with so many medical issues touching nursing homes, much of the discussion is based on evidence obtained from patients quite different from those we care for.

There is nothing new about governmental agencies weighing in on the practice of medicine in nursing homes. Skilled nursing facilities all operate according to volumes of regulations born of the Omnibus Budget Recognition Act of 1987 (OBRA-87). The regulations flowing from the law have often been based on expert recommendations from the Institute of Medicine.

In the late 1980s, OBRA-87’s restrictions on psychotropic drugs were not considered the most controversial or difficult effect of the law. Most howls from nursing homes back then centered on the goal of eliminating physical restraints, which were considered a standard of care in American nursing homes (although already largely eliminated in England and many other countries). But as the decades passed, physical restraints largely disappeared. Now it may or may not be the turn of antipsychotics.

The OBRA-87 recommendations on psychotropic drugs remain unique in federal law by laying out the appropriate diagnoses and dosages for medications. But after 25 years, these recommendations still represent the opinions of many experts.

The new report from the OIG was based on the review of Medicare Part B and Part D claims made for atypical antipsychotics during the first 6 months of 2007, not on chart reviews. It is important to remember that the study period came 2 years after the Food and Drug Administration mandated a "black box" warning about atypical antipsychotics for dementia patients. The black boxes were extended to typical antipsychotics after the study period, in 2008.

It is also important to recognize that the prevalence of antipsychotic use in nursing homes has been declining since at least 2003, even before the studies demonstrating their potential risks.

Among the OIG’s findings was that 22% of the Medicare claims were for psychotropic medications not administered in accordance with the OBRA-87 standards. That is, they were given in excessive doses or for excessive periods of time or without a reported diagnosis.

Although many of these claims may have been justified through appropriate chart notes, the likelihood exists that many orders were in violation of OBRA-87 regulations.

All About Alternatives

If the Inspector General (am I the only person who thinks of the play by that name or the 1949 Danny Kaye movie whenever I hear this title?) had stopped there, no one would really have argued that nursing homes should be routinely violating federal law. But the report went on to note the extensive use of these medications for "off-label" indications, including use known to increase the risk of cardiovascular death.

The existence of off-label prescribing seems to have come as a surprise to the OIG. It is certainly no surprise to any health professional. The prescribing of medications for uses other than those approved by the FDA is so routine in American medicine that the only surprise is that anyone would be surprised.

The practice is both legal and necessary, given our peculiar system of drug development and approval. Indeed, nearly all the pharmaceuticals administered to our frail seniors have never been tested for efficacy or safety in this population, and certainly never in the combinations that many residents receive.

Meanwhile, those with an ironic bent must enjoy the advertisements for psychotropic medications in geriatric journals, obviously placed (wink-wink) where docs caring for mentally frail elderly residents will read them and consider their use. Even the OIG has admitted that there is actually no medication that has been approved by the FDA to treat the behavioral complications of dementia, which are so prevalent in nursing homes.

Where is this new antimedication push coming from if, in fact, there is really nothing new about antipsychotics for dementia and few available alternatives to the occasional use of these drugs? It is too simple to blame it all on penny-pinching and nannying bureaucrats and lawmakers in Washington.

Rather, there is a rising tide of expert opinions questioning the use of many medications in psychiatry. I would encourage everyone to read the two-part article–book review by Marcia Angell, MD, in the June 23 and July 14, 2011, editions of the New York Review of Books titled "The Epidemic of Mental Illness: Why?" (available online at www.nybooks.com/articles/archives/2011).

Although I disagree with some portions of Dr. Angell’s essay, it is a well-written and carefully researched attack on much of psychopharmacology as currently practiced. This is not some conspiracist, but a former editor of the New England Journal of Medicine questioning the widespread use of psychotropic medications and even the underlying disease definitions in DSM-4 and DSM-5.

Expert opinion is clearly shifting. For instance, there is no scientific basis for administering medications that decrease neurotransmitter levels in the brains of patients already suffering from decreased neurotransmitters.

Two years ago, I was quoted in the Wall Street Journal saying that using antipsychotics to treat the behavioral complications of dementia is like hitting the television set on the side to improve the picture. For readers too young to remember televisions with vacuum tubes and wire connections that could sometimes benefit from a good whack, what I meant is that it was a common activity based on frustration rather than any understanding of the complex mechanisms that are producing the problem.

Antipsychotics are used to treat unsafe behaviors in nursing home patients because they sometimes work and other options may be very limited. For many dementia residents, the real black box is not the FDA warning but rather the mind, whose inner workings are a complete mystery.

Underlying Problems

Dementia experts are well aware that dementia behaviors are "about something" and not simply involuntary, random behaviors generated by a damaged brain. When it is possible to understand the behavior, the treatment of choice is to deal with the underlying problem. This requires extensive time from multiple staff members, for which insurers don’t want to pay.

The agitated dementia resident who is refusing care and striking out at staff members might be in pain or severely constipated or nauseated; have an untreated infection; be delirious from medications or electrolyte imbalance, or simply be confused and frightened. Ideal treatments might be as varied as analgesics, laxatives, medication withdrawal, antacids, cholinesterase inhibitors, antibiotics, music therapy, a stuffed animal, or a specialized activity program for diversion. When these work, they are wonderful.

Unfortunately, it is often extremely difficult to understand some behaviors. Indeed, the inability to manage a dementia patient in the community may be what led to institutional care. It is unlikely that the interdisciplinary team can immediately identify underlying problems and develop care strategies to stop the behavior immediately. If consulted, a psychiatrist would probably introduce an antipsychotic without hesitation.

Many people who advocate improved quality of life for nursing home residents are at the forefront of the movement against psychotropic drugs. Yet anyone who has cared for a demented resident swept up in uncontrolled rage or fear must recognize the suffering that represents.

Where is the dignity in spending your declining years screaming, scratching staff and spitting at them, or cowering in fear? Surely these emotions are worthy of palliation, particularly for a confused resident who is unable to control his or her behaviors and lacks all insight into what is going on.

I believe that after a reasonable effort to identify the underlying causes of seemingly psychotic behavior has failed, the resident who is truly suffering deserves a trial of one or more psychotropic medications in cautious doses. Unfortunately, the highest risk period for cardiac events or sudden death is in the first month or two of use. There are no medications without side effects or that shouldn’t be used with caution.

Many other medications commonly used in nursing homes are much less effective and more dangerous than atypical antipsychotics. On the other hand, don’t expect miracles. The most successful studies of antipsychotics demonstrate efficacy rates of about 40% at 3 months.

These may be inadequate drugs, but sometimes they are all we have.CfA

Displaying results 1 to 2 out of 2
 

Robert Merrill

Friday, 03/23/12 09:04

I am a part time Medical Director in three Nursing facilities. In addition to a family practice, I provide care for approximately 50 NF patients. It is a challenge to find the time to investigate every possible cause of a behavioral outburst. This issue directly impinges on the manpower shortage in NF's, not only of physician coverage but of appropriately trained nurses and CNA's. That, in turn, is directly related to money....it's the tip of the iceberg.

 

Tony Chicotel from CANHR

Friday, 09/23/11 16:52

Dr. Jeff, thank you for focusing on the issue of misusing antipsychotics on nursing home residents with dementia. As one of the advocates for improved quality of life you mentioned, I thought I would point out that we share a tremendous amount of common ground.

I take issue with the notion that antipsychotic use in nursing homes has been declining. In 2003, 27.2% of all nursing home residents received an antipsychotic at least once a week. In 2010, that number is 26.2%, a negligible decrease, especially considering the increased mortality risks that were not widely known in 2003.

I think we can all agree that antipsychotics should only be used as a last resort after all practical non-pharmacological interventions have been tried and failed. But there is plenty of evidence that nursing homes can and do commit to providing person-centered care. In California, forty nursing homes do not administer an antipsychotic to any residents while more than 150 facilities have rates of use less than ten percent. Other nursing homes, Like Beatitudes in Phoenix and Cobble Hill in New York, have embraced non-pharmacological dementia care to great fanfare and managed not only to stay in business but to thrive.

We all want nursing home residents with dementia to have the highest quality of life possible and most agree that a least medicating approach can help lead them there. The key is facility commitment to this approach. If anything, the OIG report you cited supports the notion that the commitment is lacking in many facilities. We have much more work to do.

 
 

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