Black box (not so) indirectly to a pine box?

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psychwhy

Simply disillusioned
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I am asking this, not as a geropsychologist, but at one whose father has just suffered a precipitous decline into dementia.

During a telephone conference, I was rather put off by the nurse practitioner leading the meeting casually dismissing my question about the black box warnings about utilizing atypical antipsychotics for elders with dementia. Later, speaking to the attending psychiatrist, he more gently said this was a "quality vs. quantity of life issue."

His comment got me thinking -- and I realize the sensitivity of asking this question -- are physicians "ignoring" the warning because most negative outcome of using these meds with elders may not be so negative after all?

We've come a long way from reflexively chemically restraining people into a stupor. Have we turned an evolutionary corner in this particular situation where bypassing a contraindication actually is more compassionate to the individual (and the surviving family)?

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I am asking this, not as a geropsychologist, but at one whose father has just suffered a precipitous decline into dementia.

During a telephone conference, I was rather put off by the nurse practitioner leading the meeting casually dismissing my question about the black box warnings about utilizing atypical antipsychotics for elders with dementia. Later, speaking to the attending psychiatrist, he more gently said this was a "quality vs. quantity of life issue."

His comment got me thinking -- and I realize the sensitivity of asking this question -- are physicians "ignoring" the warning because most negative outcome of using these meds with elders may not be so negative after all?

We've come a long way from reflexively chemically restraining people into a stupor. Have we turned an evolutionary corner in this particular situation where bypassing a contraindication actually is more compassionate to the individual (and the surviving family)?

We use these drugs because the drug companies tell us what to prescribe. They are way over used and their alleged superiority is dubious at best.
 
There's no good answer. Non-pharmacologic interventions do some good, but lots of people don't have access, and they can't be used "PRN"

Every drug class that does any good has significant drawbacks in this pop'n.
What should we do, not treat the problem?

I haven't stopped using atypicals, but I'm using more typicals in tiny doses and trying clonidine. Most neurologists I've talked to seem very comfortable continuing the atypicals.
 
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I appreciate the responses but apparently my attempt at subtlety has been too successful.

I'm asking -- Given that the atypicals have been connected to increased mortality in elders with dementia, is that outcome included as part of the rationale for prescribing?

Yes, hopefully there is a reduction in psychotic symptomlogy.
But does it cross any presciber's mind that a "fortunate" side effect might be that the individual may not live as long suffering with dementia?
 
There was not much difference in typicals vs atypicals in the studies. AFAIR, all-cause mortality was 3 times as great with antipsychotics as a whole, regardless of being typicals or atypicals, at least in patients over 65 with dementia (Was it only alzheimers?).

So there has to be a strong reason to continue them beyond merely being an aggitated patient. Switching to depakote and similar is an option, and I have had good luck with that so far.

But the more we learn about atypicals, the worse they look. It is NOT like using an SSRI (even they have their problems). I feel the era of atypicals as crowd control is coming to an end. I am paying lots attention to the black box in this case.

The black box suffered tremendously from the SSRI warning, making it seem ridiculous, but in this case, it matters.
 
But does it cross any presciber's mind that a "fortunate" side effect might be that the individual may not live as long suffering with dementia?

Yep, I completely missed your point.
My answer:
No, it didn't. But now it will. Thanks for THAT:scared:
 
I'm asking -- Given that the atypicals have been connected to increased mortality in elders with dementia, is that outcome included as part of the rationale for prescribing?

That's a pretty horrible way to shorten someones life. Increased morbidity as well as mortality....... I certainly hope that's not the case.
 
My condolences if your father is experiencing some symptoms of dementia.

Given that the atypicals have been connected to increased mortality in elders with dementia, is that outcome included as part of the rationale for prescribing?

I certainly hope a doctor would do so. I have recommended antipsychotics to demented patients, but did so when the benefit outweighed the risk. E.g. a demented patient who is throwing items at staff, is paranoid & agitated, threatening staff etc. The risk of danger to the patient (not even considering the staff) is far higher to the patient vs the risk of death from an antipsychotic.

If a practitioner were to not take the black box warning into consideration, that IMHO would be a violation of the standard of care. Blackbox warnings as far as I know in all 50 states should be considered as part of the standard of care (I'm only throwing geography into this because standard of care is often times defined by a local geographical standard).

Take this into consideration. Physical restraints cause death in about 1% of those restrained. That's higher than the mortality caused by antipsychotics use in demented patients. That's not considering the morbidity (broken bones, cuts, bruises, etc) with physical restraints which is far higher than 1%.

In cases where the demented patient is dangerous enough to justify restraints, there's pretty much no question that the benefit of an antipsychotic outweighs the risks because the alternative--restraints already has a good data pool on its level of morbidity & mortality that exceeds that of antipsychotics on demented patients. However in patients that are very difficult to manage that do not meet justifiable grounds for restraint--this is a grey area that will lead to some debate and several differing opinions. In cases such as that, and assuming the person lacks capacity (e.g. a patient who is not responding to verbal redirection, causing some disruption on the unit, but not in a dangerous manner), I recommend to call the patient's guardian or next of kin or someone with power of attorney of the situation, appraise them of the situation, warn them of the risks & benefits of an antipsychotic, and ask them if they would allow an antipsychotic be prescribed, or would like other interventions attempted.

Any person diagnosed with early signs of dementia IMHO should be advised by their doctor of the prognosis, and have that person pre-plan what type of care will be given to them when they lose capacity to make their own medical decisions. Unfortunately, during my experience in CL psychiatry, I've rarely seen patients with such end of life planning. In fact, I've seen a few doctors recommend an antipsychotic to a patient they diagnosed as having dementia when that patient didn't even meet DSM criteria for dementia, nor was showing any signs of danger, in fact were showing no symptoms of dementia. (This was very frustrating for me because I'd spend several hours trying to clear up why they were diagnosed with dementia in the first place, which is very difficult given the medical floor attending often times did not make the diagnosis, and the PCP starts playing defensive medicine when you call them up and ask for a justification of dementia when that patient scored a perfect 30/30 on the MMSE & has no symptoms of dementia).

I would though for the safety of the health care providers & patient detail the grey area I mentioned above, and discuss this with the patient, so that patient could pre-plan what type of management they would like. This will make life much easier not only for the health care provider, but for the patient & their loved ones should that patient eventually reach a point where they are very difficult to manage.

But does it cross any presciber's mind that a "fortunate" side effect might be that the individual may not live as long suffering with dementia?
It may. This is often times a typical USMLE question--a patient has a terminal illness and has high intensity chronic pain. The question is something to the effect of--the only dosage of opioid strong enough to treat the pain may be life threatening. Do you administer the medication?
This question is pretty complicated, and quite complex. Some patients may while having capacity have clear mandated instructions requesting their doctor to take more drastic & life threatening actions. Others may not. If any actions were taken by a doctor that could lead to a loss of life or morbidity that was within the realm of reason--that doctor should take some precautions--as I mentioned above, or perhaps an ethical committee consult or 2nd opinion.
 
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Whopper said it in a long stretch.

The true reason atypicals are used in the elderly is that your options are limited and the patient is a danger to others (or in some bad cases the patient is annoying the staff).

It's a question of... can the staff and the demented patient at the nursing home / hospital live with each other. Take into account that demented patients (even without delirium on board) can suffer many delusions, hallucinations, and agitation.

So what are you going to do if that 70 year old man keeps tossing things around and punching staff when they come to give him his insulin? They work him up and make sure it's not delirium. Alright, so it's not delirium.... now what are you going to do about the psychotic symptoms after you changed his nurse the third time this week? Haldol? Then you have to worry about EPS symptoms... which is a nightmare in an elderly cause cogentin/benadryl can put them in delirium. You certainly don't want to push addictive benzos on them (at least the ethical docs) cause that also can put them into delirium.

The answer is your favorite medications.....the atypicals.

And that is why atypicals are used in dementia of the elderly.
 
We use these drugs because the drug companies tell us what to prescribe. They are way over used and their alleged superiority is dubious at best.

I know it's sexy to bag on every new drug out there, but this is just a false sweeping statement.

Typicals, in many cases, are not compatible with the myriad medical problems that elderly have. Since you're a pharmacist, I don't have to go into detail on this, as it would be a long treatise.

It's not that physicians are 'ignoring' the fact that there are black box warnings in this scenario. The FDA takes pieces of data, and make decisions based on it. In many cases, this data is later revised, improved upon, or the clinical rationale superscedes the warning itself. Not satisfied with limiting psychiatrists' ability to treat the elderly demented agitated patient with atypicals, they extended it to most antipsychotics: http://pn.psychiatryonline.org/cgi/content/full/43/14/1.

Other useful clinical points, such as the fact that agitation in the demented itself carries a morbidity rate, are not discussed or included in the warning. Unfortunately, this becomes fodder for lawyers looking to make money off the hapless physician attempting to treat these patients who otherwise may endanger the entire therapeutic milieu with dangerous behavior.
 
Other useful clinical points, such as the fact that agitation in the demented itself carries a morbidity rate, are not discussed or included in the warning. Unfortunately, this becomes fodder for lawyers looking to make money off the hapless physician attempting to treat these patients who otherwise may endanger the entire therapeutic milieu with dangerous behavior.

Well put, O Digital Ruler.

Just in case anyone didn't read the article 'Sazi linked,
"The lesson for clinicians is that these drugs carry certain liabilities, including potentially lethal consequences," Lieberman said. Although the increase in risk is small, it is important to individual patients. Nonetheless, he acknowledged that physicians have very limited options in treating dementia-related psychosis and related behavioral symptoms.

No antipsychotics have been approved for treating psychosis or agitation in elderly patients with dementia. In fact, no drug has been approved for these symptoms. Laughren also emphasized that the black-box warning is not a contraindication, and clinicians still have the option of using these drugs for dementia patients at their discretion.

In a white paper released in July 2007, the American College of Neuropsychopharmacology (ACNP) reviewed clinical evidence and found that "clinicians, patients, and caregivers are left with unclear choices of treatment for dementia patients with psychosis and/or severe agitation," which often "cause considerable caregiver distress and hasten institutionalization of patients."

Despite the risks associated with antipsychotic drugs, "there is insufficient evidence to suggest that (ANY) psychotropics other than antipsychotics represent an overall effective and safe, let alone better, treatment choice for psychosis or agitation in dementia," said the white paper.
 
I think you underestimate the power of the Pharmaceutical industry. I see it every day. These drugs are over used. I don't maintain they should never be used. The number of in patients that receive these is minuscule compared to the number of out patients prescriptions written for atypicals. You really think we need to spend nine billion dollars a year in the US for these agents? I would assume that almost all of that is off label unapproved use.

This article, while dealing with children as opposed to seniors, shows the way too cozy relationship between psychiatrists and the drug makers.

This one is real doozy.....

Dr. Carlat's Blog....

Following the Script: How Drug Reps Make Friends and Influence Doctors




If that is not enough to make you take a minute to think about the relationship between doctors and drug companies, just remember this:
If we put horse manure in a capsule, we could sell it to 95% of these doctors.
Harry Loynd, Former President, Parke Davis and Company
 
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I think you underestimate the power of the Pharmaceutical industry. I see it every day. These drugs are over used. I don't maintain they should never be used. The number of in patients that receive these is minuscule compared to the number of out patients prescriptions written for atypicals. You really think we need to spend nine billion dollars a year in the US for these agents? I would assume that almost all of that is off label unapproved use.

This article, while dealing with children as opposed to seniors, shows the way too cozy relationship between psychiatrists and the drug makers.

This one is real doozy.....

Dr. Carlat's Blog....

Following the Script: How Drug Reps Make Friends and Influence Doctors




If that is not enough to make you take a minute to think about the relationship between doctors and drug companies, just remember this:
Harry Loynd, Former President, Parke Davis and Company

Old Timer, you are 100% correct... but in the elderly with dementia with psychotic features, there are two sides to the coin. Agitation is a symptom that we are not scaling on paper in dementia.

You are defintely correct to also be concerned how easy it is to call the agitation secondary to dementia. I noticed how the IM physicians are quick to neglect delirium causes and call it dementia agitation. There is no solution for this, you will never see anyone aim and hit correctly even 50% of the time. How can they when the spectrum of etiology for agitation in the demented elderly is HUGE. Even the joke UTI that you would never treat in the young is a big factor in the elderly.
 
Old Timer, you are 100% correct... but in the elderly with dementia with psychotic features, there are two sides to the coin. Agitation is a symptom that we are not scaling on paper in dementia.

You are defintely correct to also be concerned how easy it is to call the agitation secondary to dementia. I noticed how the IM physicians are quick to neglect delirium causes and call it dementia agitation. There is no solution for this, you will never see anyone aim and hit correctly even 50% of the time. How can they when the spectrum of etiology for agitation in the demented elderly is HUGE. Even the joke UTI that you would never treat in the young is a big factor in the elderly.

I don't want to downplay the difficulty in treating patients exhibiting signs of agitation along with dementia. I am also not trying to say there are really good choices in these patients. I watched my grandfather suffer from that when all they had was Haldol and a posey. All I am trying to point out is the information we have on the safety and efficacy of these agents for these conditions is limited at best.

Physicians and pharmacists need to be aware these affects and should be monitoring weight & glucose levels in these patients.
 
I think you underestimate the power of the Pharmaceutical industry. I see it every day. These drugs are over used. I don't maintain they should never be used. The number of in patients that receive these is minuscule compared to the number of out patients prescriptions written for atypicals. You really think we need to spend nine billion dollars a year in the US for these agents? I would assume that almost all of that is off label unapproved use.

This article, while dealing with children as opposed to seniors, shows the way too cozy relationship between psychiatrists and the drug makers.

This one is real doozy.....

Dr. Carlat's Blog....

Following the Script: How Drug Reps Make Friends and Influence Doctors




If that is not enough to make you take a minute to think about the relationship between doctors and drug companies, just remember this:
Harry Loynd, Former President, Parke Davis and Company


damn this guy only makes 140k a year from his private practice? I will hope that he only has that practice part time, and spends the other half making an income at tufts...
 
When I took part in a teleconference and asked the meeting leader (who I didn't know was a nurse practitioner) about the black box warning, I felt she rather dismissively ignored the question with a comment along the lines of "everything comes with a black box warning."

A few days later, when I spoke to my father's attending psychiatrist (he had been out-of-town during the teleconference), he was much more candid calling it a "quantity vs. quality of life" issue.

My father was diagnosed with Parkinson's Disease eight years ago. When I saw him last, sadly, over 6 months ago, he had some confusion (and increasing agitation later in the day), but we still were able to hold a reasonably lucid conversation.

A couple of weeks ago (in a sad coincidence, my parents' 47th wedding anniversary), he became aggressive toward my mother, trying to shove her out of the way in an attempt to leave their apartment.

He was emergently hospitalized that night on a gero-psychiatric unit where he is today. Given his presentation and rapid progression to paranoid delusions, visual hallucinations, confabulation, loose associations, memory retrieval problems -- the whole package -- it was hypothesized he more likely was suffering from Dementia from Lewy Bodies. However, given its accelerated progression, the underlying cause was immaterial -- stabilization does not seem likely; his treatment plan is more likely to be palliative care.

The day after I visited my father, there was an article circulated about how the manufacturers of Seroquel (one of my father's medications) had deliberately hid adverse information and openly sought to find surreptitious ways to encourage its off-label use. (Did they borrow Big Tobacco's playbook?) Also that day, an article about the first legal assisted suicide in Washington state. The confluence of these two articles together led me to my original question.

My father's psychiatrist also called saying they were going for the "last resort" and adding Depakote for mood stabilization, including that they expected that my father would not survive a year.

For the record, both my mother and I -- knowing the man my father was -- morally have no problem with my father being "black boxed." Frankly, if I had the means, I would not wait for a potential adverse effect.

They call a dementia demise the "long goodbye."
Is there any purpose served by prolonging that farewell -- Hippocrates notwithstanding?
 
When I took part in a teleconference and asked the meeting leader (who I didn't know was a nurse practitioner) about the black box warning, I felt she rather dismissively ignored the question with a comment along the lines of "everything comes with a black box warning."

A few days later, when I spoke to my father's attending psychiatrist (he had been out-of-town during the teleconference), he was much more candid calling it a "quantity vs. quality of life" issue.

My father was diagnosed with Parkinson's Disease eight years ago. When I saw him last, sadly, over 6 months ago, he had some confusion (and increasing agitation later in the day), but we still were able to hold a reasonably lucid conversation.

A couple of weeks ago (in a sad coincidence, my parents' 47th wedding anniversary), he became aggressive toward my mother, trying to shove her out of the way in an attempt to leave their apartment.

He was emergently hospitalized that night on a gero-psychiatric unit where he is today. Given his presentation and rapid progression to paranoid delusions, visual hallucinations, confabulation, loose associations, memory retrieval problems -- the whole package -- it was hypothesized he more likely was suffering from Dementia from Lewy Bodies. However, given its accelerated progression, the underlying cause was immaterial -- stabilization does not seem likely; his treatment plan is more likely to be palliative care.

The day after I visited my father, there was an article circulated about how the manufacturers of Seroquel (one of my father's medications) had deliberately hid adverse information and openly sought to find surreptitious ways to encourage its off-label use. (Did they borrow Big Tobacco's playbook?) Also that day, an article about the first legal assisted suicide in Washington state. The confluence of these two articles together led me to my original question.

My father's psychiatrist also called saying they were going for the "last resort" and adding Depakote for mood stabilization, including that they expected that my father would not survive a year.

For the record, both my mother and I -- knowing the man my father was -- morally have no problem with my father being "black boxed." Frankly, if I had the means, I would not wait for a potential adverse effect.

They call a dementia demise the "long goodbye."
Is there any purpose served by prolonging that farewell -- Hippocrates notwithstanding?

The angel of death is knocking on the door and what you need is a big hug my friend. I wish you wisdom. :(
 
Psychwhy,

I'm so sorry for what your family is experiencing, and the fear/confusion your father may be experiencing.

I have never heard any provider state, imply, joke, or in any other way suggest that there is a "benefit" in the increased risk of stroke/death for elders taking antipsychotics. If anyone thinks of it this way, they've kept it well hidden.
 
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