Published by Dr. Al Power, Changing Aging Contributor on January 5, 2015
Al Power is a geriatrician, author, musician, and an international educator on transformational models of care for older adults, particularly those living with changing cognitive abilities. You can follow his speaking schedule at http://www.alpower.net/gallenpower_schedule.htm
Recently, a friend who works in long-term care wrote to ask if I had any formal guidelines for prescribing antipsychotic drugs to people living with dementia. She and her colleagues are very supportive of the approaches I teach, but they are frustrated by medical professionals who simply write the order for one of these drugs without discussing the situation with staff, elders, or family members. She wondered what protocol(s) I felt should be followed.
Excellent question, We have guidelines here in the U.S., both from the Federal government and from various professional organizations. But as I implied in my December 10th post, these guidelines have holes a doctor can drive a med cart through. I believe we need to raise the bar in order to influence a change of habit in many professionals.
In spite of all of my talks and writings about avoiding these medications, I have never sat down to write any formal prescribing guidelines of my own; so I told my friend I would give this some thought and answer her via a considered blog post. Here we are, in a two-part response. I will use Part 1 to make some preliminary comments about the issue, and Part 2 for some actual guideline suggestions.
First, I truly believe that doctors who continue to prescribe these drugs with little or no discussion or reflection are woefully behind in their education. We now have a pile of evidence attesting to their low efficacy and high risk when given to people living with various forms of dementia.
Many professionals using these drugs may also be concerned about their potential liability if they do not prescribe them. In other words, if Mrs. Jones gets upset and falls down or strikes another person, will I get sued? Is my medical license on the line?
Putting aside the obvious point that there is no risk-free environment, let’s look at where the bulk of liability truly rests. These drugs have never been approved for use in dementia; in fact, the FDA has given them a black box warning, due to the risk of excess mortality and morbidity in this population. A doctor prescribing a drug for an unapproved use—with such a severe warning attached to the labeling—runs a much greater liability risk from an untoward side effect of the drug than from not using it.
I can attest to the reality of this liability risk. Since the 2010 release of Dementia Beyond Drugs, I have received several phone calls or emails each year from lawyers or family members who are suing doctors and nursing homes for giving antipsychotics to their loved ones, and who want me to testify at their trials. (I don’t have time or interest to get into that line of work, so please do not ask.) I am not familiar with other nations’ liability climates, but several years ago the makers of one antipsychotic drug paid a multi-million dollar class action settlement in Canada because of excess morbidity/mortality resulting from the drug.
When I give my talks, a question often arises in some form or other: “Are you saying that antipsychotics should never be used in people living with dementia?” or else, “What would you have us do when a true crisis emerges where there is imminent danger of harm?”
The answer is a bit complex, but my reply usually goes something like this:
When I was working full-time in the nursing home in the early 2000s, caring for an average of 100 people living with dementia; before I had an inkling of writing a book or had formulated my thoughts on the subject; before I had an effective way to teach better approaches to my co-workers; before our organization had moved far down the culture change path; and when many co-workers were still convinced that these drugs were often useful; even then, my antipsychotic use hovered around 5-7% .
This was at a time when the national average for people in nursing homes with a diagnosis of dementia was closer to 35%. (Remember that the CMS figures look lower because they report overall usage—among people with and without dementia.) As a result of what I have learned since writing my first book, I truly believe that any living environment can eventually reduce their usage to near 0%, with the occasional rare exception.
The key word here is eventually; most organizations are not at the point today where they have the knowledge and infrastructure to fully support people’s well-being. Some crises are bound to occur and they may feel backed into a corner. So there will necessarily be a learning curve and a progressive reduction. But our current situation should not be considered our endpoint. There are over 150 U.S. nursing homes whose antipsychotic rate is 0%, and we should all strive to create communities where we can safely get as close to that number as possible.
Here is why this is so important: Even for those who subscribe to a purely biomedical view of dementia, the model does not support the use of these drugs. They were developed for use in schizophrenia, where dopamine activity is increased, causing hallucinations and delusions. Their primary action in that disorder is achieved by blocking dopamine activity.
But no form of dementia involves heightened dopamine activity; in fact many people, including those with Lewy body dementia, have decreased dopamine activity. So dopamine-blocking drugs not only have no chemical rationale, they also are particularly toxic for such people.
People who seem quieter on these medications are usually experiencing the effects of sedation. Even when the person doesn’t appear sedated, there are subtle but important effects on alertness and general cognition that are often recognized only when the drug is removed and a marked improvement is noted.
And what of those cases where a person physically assaults another? That certainly is a potentially dangerous event that would seem to warrant some sort of response. But think of all of the different ways that assault can occur in our society—from muggings to schoolyard bullying, spousal abuse, or fraternity hazing. Not one of the aforementioned examples represents a situation where the solution would be an antipsychotic drug. So why do we think it’s the proper response for dementia??
The answer is: our biomedical model teaches us that dementia is a disease and the brain changes have caused the person’s actions. Therefore some sort of medical therapy must be the answer. But then how do we explain the many situations that have successfully resolved through non-drug approaches? Our biomedical model has no answers for that either.
(In my books, I also forward the radical notion that most people with dementia who are characterized as “delusional” or “hallucinating” are mislabeled, and/or do not have a condition that is likely to respond to this type of drug. I will leave a more detailed discussion of that issue to a future blog post.)
In most living environments as they exist today, care partners will occasionally find themselves in a situation that truly presents some potential for harm, and may have no choice at that moment but to use a sedating medication to defuse the crisis. But that is not a long-term solution; it is merely a Band-Aid for a situation that we have not yet gained the knowledge to prevent or solve in other ways.
Therefore, the use of an antipsychotic in such situations should always be accompanied by a plan of action that explores what can be done over the next several days to weeks, so that the medication can be eventually withdrawn. And it nearly always can be withdrawn successfully, once an infrastructure for well-being can be created.
In Part 2, I will share my ideas for some specific guidelines—a sort of “twelve-step program.” Except it may not be exactly twelve steps—I haven’t written them yet. Stay tuned.
Article written by Dr. Al Power, ChangingAging Contributor
Published by Dr. Al Power, ChangingAging Contributor on January 8, 2015
In Part 1 of this post, I listed several preliminary comments and concerns regarding the use of these drugs. I continue to maintain that antipsychotics are “the physical restraints of the 21st century,” meaning that their use should become the rare exception, once we have navigated the same type of learning curve.
But given the reality that most people are not currently equipped with the knowledge and resources to implement other solutions, there will be times when the use of medication may need to be considered. So here are some guidelines for those along the journey who have not yet created the infrastructure for an anti-psychotic-free environment. As I implied in Part 1, these guidelines will be more specific and restrictive than others published to date.
First the Standard Disclaimer: “The following recommendations are my own; they do not reflect current national or state guidelines, nor do they represent the positions of any medical or other professional organizations.” Okay? Here we go, in italics, to give it gravitas…
The use of an antipsychotic medication in a person living with dementia could be considered in the following situations:
1. A person with evidence of an ongoing underlying psychiatric disorder (such as schizophrenia, major depression with psychosis, or bipolar disorder with mania) who needs antipsychotic therapy for that condition. Comment: Some psychiatric conditions may stabilize or resolve, in which case long-term use would not be necessary.
2. A person with true, ongoing, and disturbing delusions or hallucinations (usually as a consequence of delirium) that are not easily resolved through adjustment of medications or treatment of underlying illness. Comments: Most expressions that are characterized as delusional or hallucinatory are incorrectly labeled and are actually misinterpretations of the environment due to memory loss and changes in one’s perception of verbal and non-verbal communication. True delusions are also repetitive and persist over time. Also, note the qualifying term “disturbing,” which means these feelings must be disturbing to the person in question (as opposed to family members or care staff). Expressions that do not cause undue distress for the individual do not need to be medicated. True hallucinations—outside of schizophrenia—are more often visual, and are usually the result of drug toxicity or other acute illness; therefore, attention to the underlying cause is the primary response. (An exception is Lewy body dementia; but the mechanism here is damage to the nerves of the visual cortex. Antipsychotics are largely ineffective for this illness and potentially dangerous. Also, most people with LBD have been given anti-Parkinson drugs for their rigidity—these are the most hallucinogenic drugs we prescribe, and usually of little benefit for this condition—so those drugs should be tapered or stopped as our first response.)
1. A person who presents an imminent and ongoing danger to oneself or others, for whom no readily available means to defuse the situation can be found. Comment: If an altercation occurs and our subsequent intervention restores calm, this is not a sufficient reason for an antipsychotic. There must be a reasonably high risk of recurrence of the potentially dangerous situation in the short term to justify starting sedating medication.
2. Severe and persistent anxiety that poses a significant threat to health and well-being, for which other approaches have proven ineffective. Comment: Significant threats may include inability to eat or other measurable effects on health. Antipsychotics do not usually help this situation, but may provide some degree of sedation until more effective approaches (such as antidepressants and/or non-drug approaches to well-being) can be optimized. Also, keep in mind that a common cause of restlessness is akathisia—a condition of severe motor restlessness that is a side effect of antipsychotic drugs; this is often misinterpreted as agitation and can result in an increase in the antipsychotic dose, thus producing more harm.
3. The following are not indications for antipsychotic use: calling out, and other repetitive verbalizations, insomnia, attempts to stand, walk, or exit a building, expressions of anger, mild to moderate anxiety, and most cases of striking out during care. Expressions of suspicion do not constitute paranoia that justifies antipsychotic treatment unless they are persistent and delusional, not explainable by environmental, verbal, and nonverbal signals, and significantly interfere with the person’s health.
The following protocol should be followed whenever antipsychotic drugs are ordered:
1. The person must be examined by a medical professional within 72 hours of any order for antipsychotics (including an increase in dose).
2. A note in the medical record reflecting the appropriate aforementioned criterion should justify the decision to order the drug.
3. Informed consent for the medication must be obtained within 72 hours. The person receiving the medication should be approached first for consent, and if that person is found to lack capacity for such consent, the health care proxy or designated surrogate would need to sign. A diagnosis of dementia or an abnormal cognitive test is not sufficient to presume lack of capacity in this regard.
4. A team meeting must be held (with the medical professional in attendance) within 1 week of the start of the medication to discuss the situation in detail and outline a plan to identify and support unmet needs or minimize other triggers. The team should meet regularly to update progress and amend the plan as needed.
5. All of the aforementioned criteria for drug use (except #1) should be considered indications for short-term antipsychotic use only. A schedule for regular reviews with an attempt to taper the medication should be devised after the initial meeting.
6. Every subsequent medical visit must include a review the use of the medication and must follow current guidelines for evaluation of potential physical, cognitive, or laboratory abnormalities as a result of the drug. Any new abnormality should trigger a consideration of more rapid removal of the drug.
7. If the situation persists after a reasonable period of time while using a stable medication dosage, the antipsychotic drug is considered ineffective and should be stopped. If the person’s initial symptoms were due to underlying drug toxicity or delirium, the antipsychotic drug should be stopped when the underlying condition is under control. Comment: I am continually amazed at how often one of these drugs is prescribed, and even though the situation doesn’t improve, the drug is simply continued month after month. There is no other drug that we would continue using in the face of a lack of benefit (except for other drugs used for Alzheimer’s!).
Keep in mind that these criteria should be adapted to all living environments; remember that the inappropriate use of antipsychotic drugs is much higher in the community than it is in nursing homes!
I will expand upon my comments about hallucinations and delusions in a future post.
I hope that as the learning curve progresses and we make further progress in eliminating these drugs, these criteria could be tightened up even further. This is my first shot at writing such recommendations. Feel free to share your feedback. I may or may not amend them as time goes on.
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.
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.
Treating Dementia with Anti-Psychotic Drugs: Is the Tide Turning?
About ten years ago, a friend (“Samuel”) called me to discuss his frustration over his mother’s care in a nursing home. His beloved mother was dealing with dementia, and the nursing home was dealing with mom by sedating her. Samuel somehow knew this treatment wasn’t really the right thing for her, and he was convinced his mother was being zapped into a psychotropic fog to make her “easier to deal with.” In trying to convince the facility’s staff — and his family — to consider other approaches, Samuel encountered only resistance, hostility, and finally the threat of legal action against him — by his own sister! He now says, several years after his mother’s death, that struggling alone against the drug /sedation issue — knowing in his bones that it wasn’t the best thing for his mother — was as difficult and gut-wrenching as the experience of seeing her slowly, gradually, slipping away. Samuel appears to have been ON to something. In 2009, Eli Lilly and Company, the American drug company behemoth, agreed to pay almost $1.5 billion in fines for marketing Zyprexa as a treatment for dementia and Alzheimer’s. While that drug had been approved to treat schizophrenia, the FDA never gave the green light for the drug giant to pitch Zyprexa as a treatment for dementia. The Department of Justice described the penalty as “the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution.” That hefty fine pales in comparison to what “Big Pharma” stands to lose if doctors and facilities around the world STOP using anti-psychotic drugs to “treat” dementia. Until anything like that happens, the drug companies have pockets deep enough to engage the finest lobbyists to press their case on Capitol Hill, and to hire the slickest marketing firms to make everyone — patients, doctors, caregivers — believe they simply cannot manage without their products. One of the strongest, clearest voices advocating a new way forward belongs to Dr. Al Power, author of the book Dementia Beyond Drugs: Changing the Culture of Care. The author recaps his position as a guest contributor on the LiLY (not the drug company) Forum Blog:
For many years, it has been a standard practice in the traditional nursing home to respond to distress in people with dementia by using psychiatric medications, especially antipsychotic drugs. There are several problems with this approach.
The first problem is that these drugs are not particularly effective in eliminating the distress. They may quiet a person, but this occurs primarily through sedation, which can stifle growth and engage management.
A second problem is that we are discovering many serious side effects from these drugs. In addition to the well-known problems of lethargy, gait imbalance, movement disorders, and poor food and fluid intake, we now know that there is an increased risk of weight gain, diabetes, pneumonia, and strokes. Worse still is that these drugs have been shown to significantly increase mortality in people who take them.
Doctors are aware of these risks, but they use the drugs because there are no better pills available. But what if the best answer isn’t a pill?
In our medical model approach we make an important mistake: We see the behavioral expression as a problem instead of a symptom. Consider this: a person with pneumonia will often develop a bad cough. The cough is a symptom of the pneumonia. But if the doctor thinks the cough is the problem, she will only treat the person with cough syrup. This might quiet the cough for a while, but eventually the person will get worse, because nothing was done for the real problem—the pneumonia.
Behavioral expressions are the same way. Studies show that these expressions are almost always a symptom of a larger need that is not being met by the care environment. If we only see the person’s distress as the problem, we will treat it (usually with sedating medication), while not addressing the underlying need.
This is why most people on medication in a dementia ward may look quieter, but are not truly calm, happy, or engaged with their environment. We have only sedated the behavior without meeting their real needs. In doing so, we have found a solution which is staff-centered, but not person-centered, and ultimately causes more harm than good.
Therefore, when we see a person in distress, our primary goal should be to try and find out what his unfulfilled needs are, and then adjust the care environment to meet them. The “Eden Alternative” believes that there are seven indicators of well-being, which can be experienced by people regardless of their cognitive or functional limitations. These seven “domains” of well-being are:
Identity: Having a life story that is well-known to our care partners;
Connectedness: Having a feeling of belonging in our living environment;
Security: Feeling safe in our environment and trusting our care partners;
Autonomy: Having choice in many aspects of our daily life;
Meaning: Engaging in activity that reflects our individual needs and values;
Growth: The ability to continue to develop to our best potential; and
Joy: No explanation necessary!