Monday, April 30, 2018

Health Affairs Blog Targets "Never-Ending Misuse of Antipsychotics in Nursing Homes"

I'm always interested in articles about the use -- misuse? -- of antipsychotic medications for older adults.  Therefore I was eager to read the recent post on the Health Affairs Blog by David Introcaso entitled The Never-Ending Misuse of Antipscyhotics in Nursing Homes. The article begins:

In response to a generic question about post-market drug surveillance posed during a February 2007 House Energy and Commerce Committee hearing, Dr. David Graham, then associate director of science and medicine in the Food and Drug Administration’s (FDA’s) Office of Surveillance and Epidemiology, stated: “I would pay careful attention to antipsychotic medications. … The problem with these drugs are that we know that they are being used extensively off label in nursing homes to sedate elderly patients with dementia … . It is known that the drugs don’t work in those settings. … But the fact is, is that it increases mortality perhaps by 100 percent. It doubles mortality. So I did a back-of-the-envelope calculation on this and you probably got 15,000 elderly people in nursing homes dying each year from the off-label use of antipsychotic medications for an indication that FDA knows the drug doesn’t work. This problem has been known to FDA for years and years and years.”

I've highlighted in bold the words that are the focus of my interest:  "It is known that the [antipsychotic] drugs don't work in those settings."  No citation to authority here - and it is the authority for this statement that I would like to see.  Is there a study of the use of antipsychotic drugs showing they "don't work" for dementia patients?  What does it mean "not" to work?  Is all "use" a "misuse" for patients who "only" have dementia?

I ask because I saw my father struggle at home for several years with dementia.  As the disease robbed him of the ability to understand where he was and why he couldn't remember things, he sometimes became aggressive.  He was still very strong.  His doctor tried various mild anti-anxiety drugs, but they seemed to interact with his blood pressure issues (and perhaps his other medications).  He would sometimes swing between aggressive behavior and losing consciousness.  Finally his doctor suggested a very small dose of an antipsychotic.  My mother was desperate for help at the time -- and thus, Dad started on the drug. This is an example of "off label" use.  I was worried, and said so, because I knew the associated concerns about increased mortality for those with dementia.  I looked for specific studies of risk versus benefit and frankly, all I could find were records showing the ratio of deaths for individuals with dementia who also were taking an antipsychotic drug.  Mere correlation is not necessarily evidence of causation. What I was looking for was a careful study of risk versus benefit.   

Over time I saw that the small dose did "work" for this one individual, my father.  He wasn't "knocked out."  He wasn't "docile."  He wasn't "asleep all the time" -- typical of the accusations that are often made about misuse of antipsychotics.  What we did see was that he was much less likely to strike out an arm or push someone hard when he was frustrated (and yes, he was still frustrated).   The small dose did not interfere with his blood pressure or the other medications he was taking.  Perhaps most importantly, he continued to live at home for many more months. Eventually it was appropriate to wean him off the antipsychotic altogether.  

One anecdotal account is not evidence.  But the fact that there reportedly continues to be "widespread"use of antipsychotic drugs by the elderly means there could be some very real need for  safe, effective alternatives. Behavioral health approaches are important, but those too can have limits in effectiveness.  I'd certainly like there to be "good" studies of the use of these drugs and any drug that might be able to help a person suffering from dementia live a less tormented life.  Not zoned out and not asleep all the time, but also not likely to harm themselves or those who on a daily basis are trying to help them live as normally as possible.

Cognitive Impairment, Consumer Information, Dementia/Alzheimer’s, Ethical Issues, Federal Statutes/Regulations, Health Care/Long Term Care, Science | Permalink


They "don't work," i.e., there's no evidence they do work, i.e., treat the causes of dementia nor the progression thereof - made evident by the FDA black box warning.

Posted by: david introcaso | May 2, 2018 7:25:12 AM

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