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Managing Residents on Psychoactive Drug Therapy - PowerPoint PPT Presentation


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Larry W Lawhorne, MD Professor and Chair, Dept of Geriatrics Boonshoft School of Medicine Wright State University Dayton OH. Everything is complicated. If that were not so, life and poetry and everything else would be a bore. Poet Wallace Stevens. Dementia-Associated

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slide1

Larry W Lawhorne, MD

Professor and Chair, Dept of Geriatrics

Boonshoft School of Medicine

Wright State University

Dayton OH

slide2

Everything is complicated.

If that were not so, life and

poetry and everything else

would be a bore.

Poet Wallace Stevens

slide3

Dementia-Associated

Behavioral Symptoms:

Why are recognition, assessment,

treatment, and monitoring so

complicated?

slide5

One in a continuing series of nationally representative sample surveys of U.S. nursing homes.

  • Conducted1973-1974 and repeated in 1977, 1985, 1995, 1997, 1999, and 2004.
  • Provides basic information about nursing homes, the services provided, their staff, and their residents.
slide6

Prevalence of dementia: 52.58%

> 77% Female

> 56% ≥85 years of age

> 97% non-Hispanic; 88% White

  • Antipsychotic medications were taken by 32.88% of residents with dementia

http://www.cdc.gov/nchs/nnhs.htm

slide7

More residents received atypical agents (31.63%) than typical agents (1.75%).

  • Males with dementia more likely than females with dementia to receive antipsychotic agents .
  • Atypical antipsychotic use increased with dependence in decision-making ability, indicators of depressed mood and behavioral symptoms.
slide8

The odds of receiving atypical antipsychotic treatment increased with the diagnosis of schizophrenia, bipolar mania and anxiety among dementia patients.

  • The likelihood of receiving atypical antipsychotic agents decreased with increasing dependence for out-of-bed mobility.
slide9

I am not a geriatric psychiatrist but know when to call one

  • I believe in the value of the IDT
  • I believe in the importance of observations by and suggestions from direct care staff and families
  • I believe in the utility of Clinical Process Guidelines
  • I receive no pharmaceutical support
slide10

Evaluating dementia-associated behaviors that are distressing, disturbing or disruptive.

  • Considering the role of antipsychotic drugs for these behavioral symptoms.
  • Comparing care for chronic medical conditions with care for degenerative neuropsychiatric disorders.
slide11

Evaluating dementia-associated behaviors that are distressing, disturbing or disruptive.

  • Considering the role of antipsychotic drugs for these behavioral symptoms.
  • Comparing care for chronic medical conditions with care for degenerative neuropsychiatric disorders.
slide12

Surveyor view…

  • Provider view…
  • Different versions of the truth?
slide13

Are these different versions of the truth or do they reflect a lack of a “coherent language” to represent the benefits and risks of atypical antipsychotics (AAPs) for residents with dementia-associated behavioral symptoms?

slide14

How valid and valuable is the existing “evidence” as presented in articles in peer-reviewed journals on efficacy and safety of AAPs for the indications listed in Appendix PP of the CMS State Operations Manual?

slide15

Dementing illnesses with associated behavioral symptoms

  • Medical illnesses or delirium with manic or psychotic symptoms and/or treatment-related psychosis or mania (e.g., thyrotoxicosis, neoplasms, high-dose steroids)
slide16

Diagnosis alone is not sufficient to begin a drug; at least one of the additional criteria must also be met:

  • Symptoms are caused by mania or psychosis.
  • Behavioral symptoms present a danger to resident or others.
  • Symptoms are severe enough that resident is experiencing inconsolable or persistent distress, significant decline in function, and/or substantial difficulty receiving necessary care.
slide17

Diagnosis alone is not sufficient to begin a drug; at least one of the additional criteria must also be met:

  • Symptoms are caused by mania or psychosis.
  • Behavioral symptoms present a danger to resident or others.
  • Symptoms are severe enough that resident is experiencinginconsolable or persistent distress, significant decline in function, and/or substantial difficulty receiving necessary care.
slide18

Antipsychotics may be helpful in the treatment of distressing symptoms at the end of life.

  • A drug such as haloperidol may be used for hiccups, nausea and vomiting associated with cancer or cancer chemotherapy, or adjunctive therapy at end of life as long as rationale is well documented.
slide20

AAPs are used to treat dementia-associated behavioral symptoms in nursing facility residents.

  • Agree
  • Disagree
  • Neither agree nor disagree
slide21

AAPs are over-used in the treatment of dementia- associated behavioral symptoms in nursing facility residents.

  • Agree
  • Disagree
  • Neither agree nor disagree
slide22

AAPs are used more in the U.S. than in Canada, UK or France to treat dementia- associated behavioral symptoms in nursing facility residents.

  • Agree
  • Disagree
  • Neither agree nor disagree
slide23

The effectiveness of AAPs in treating dementia-associated behavioral symptoms in nursing facility residents is over-rated.

  • Agree
  • Disagree
  • Neither agree nor disagree
slide24

The danger of AAPs in treating dementia- associated behavioral symptoms in nursing facility residents is over-stated.

  • Agree
  • Disagree
  • Neither agree nor disagree
slide26

By looking at the list of authors on a paper and glancing at the title, one can often predict the conclusion:

  • If authors A,B, and C are listed, then AAPs are safe and effective…if not effective, then certainly beneficial.
  • If authors D,E, and F, then AAPs are ineffective, dangerous, and not at all beneficial .
slide27

By looking at the list of authors on a paper and glancing at the title, one can often predict the conclusion:

  • If authors A,B, and C are listed, then AAPs are safe and effective…if not effective, then certainly beneficial.
  • If authors D,E, and F, then AAPs are ineffective, dangerous, and not at all beneficial .
slide28

Authors D, E, and F accuse authors A,B, and C of being pawns of the drug industry and marketing dangerous drugs to vulnerable older adults on the basis of corrupt research.

slide29

Authors A, B, and C say that authors D, E, and F are not clinician scientists who gather and analyze hard data but rather nihilistic academics who respond to sentinel events and sentimentality while riding a wave of public opinion opposed to nursing facilities and the medicalization of aging.

slide30
The following slides are not in your handout but can be obtained by email as described at the end of the presentation.
slide31

Low-dose, once-a-day olanzapine and risperidone appear to be equally safe and equally effective in the treatment of dementia-related behavioral disturbances in residents of extended care facilities.

slide32

In an elderly NH population, there was no evidence that short-term use (median 13.1 weeks) of atypical antipsychotic agents was associated with the onset or worsening of diabetes.

slide33

Preliminary evidence indicates that atypical antipsychotics such as quetiapine (Seroquel) may result in QoL improvements.

  • The inclusion of systematic QoL measures in future clinical trials is imperative in order to provide evidence to enable the clinician to make informed judgments regarding the potential benefits or risks of pharmacologic treatment for individual patients.
slide34
CATIE-AD Trial

(Schneider et al. NEJM 2006)

slide35

No differences in efficacy between

placebo and the atypical antipsychotics olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) in treating psychosis, aggression, and agitation in dementia.

slide36

Rates of drug discontinuation due to adverse effects ranged from 5% for placebo to 24% for olanzapine.

  • Overall, 82% of the patients stopped taking their initially assigned medications during the 36-week period of the trial.
slide37

During treatment of nursing home residents with dementia with antipsychotics, the severity of most behavioral problems continues to increase in most patients, with only one out of six patients showing improvement.

  • After withdrawal of antipsychotics, behavioral problems remained stable or improved in 58% of patients.
slide38

A Public Health Advisory released on 4/11/2005 states that the FDA has “determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality.”

slide39

15 of 17 placebo controlled trials performed with olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), or quetiapine (Seroquel) in elderly demented patients with behavioral disorders showed numerical increases in mortality in the drug-treated group compared to the placebo-treated patients.

slide40

Total of 5106 patients.

  • 1.6-1.7 x increase in mortality.
  • Specific causes of deaths due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).
slide41

Conventional antipsychotics are associated with a higher risk of all-cause mortality than atypical agents. It seems advisable that they are not used in substitution for atypical antipsychotics among nursing home residents with dementia even when short-term therapy is being prescribed.

slide42

Residents were at increased risk of death simply by being admitted to a facility with a higher intensity of antipsychotic drug use, despite similar clinical characteristics at admission.

slide43

The fundamental problem in the testing and use of AAPs for dementia-associated behavioral symptoms is the lack of a “coherent language” to represent the benefits and risks of the drugs.

  • “Coherent language” means a set of words, phrases, and descriptors that makes sense for all stakeholders…researchers, clinicians, residents, families, caregivers, policy makers, and even providers and surveyors.
slide48

Were behaviors characterized in

enough detail (onset, trigger, nature,

intensity, duration, frequency,

consequences, and other relevant

information)?

slide49

Was there documentation that

justified why the behavior was

considered problematic?

slide50

Was there timely recognition of

problematic behavior?

slide51

Were specific behaviors identified

for which a medication or other intervention was provided?

slide52

Was the current medication regimen

reviewed as a potential source of

problematic behavior?

slide53

If a plausible cause was not found

readily in someone with an acute

behavior change, were fluid and

electrolyte imbalance, acute infection,

pain, or other potential causes

considered?

slide54

“The resident is restless and repeatedly gets up, walks to the window, mutters something about her son coming home from work, wringing her hands, and asking for someone to help her.”

  • She is not eating and drinking because of the behavioral symptoms and is at risk for dehydration.
slide55

Known medical and neuropsychiatric conditions

Infection or new medical or neuropsychiatric condition

Side effect of medication

Something suggesting pain

Environmental factors

Social or spiritual issues

slide56

Adverse effect of a drug, especially an

antimuscarinic or anticholinergic

  • Delirium associated with an acute medical

condition, such as UTI, dehydration, or upper respiratory infection

  • Chronic medical condition, osteoarthritic

or ischemic pain

  • Cognitive symptoms, such as frustration

from memory problems

slide57

Unmet physical needs (hunger, toileting)

  • Unmet psychological needs caused by separation from spouse or family (such as when a spouse is hospitalized or placed in a nursing home)
  • Environmental precipitants (noise, crowded conditions, strangers in the home)
  • Unsophisticated care-giving
slide58

Everything is complicated.

If that were not so, life and

poetry and everything else

would be a bore.

Poet Wallace Stevens

slide59

Was there an attempt to identify

categories of cause(s) of any

problematic behavior, OR explain why

causes could or should not be sought?

slide60

Was a plausible explanation offered

as to how it was determined that

certain causes were the most likely

reason for the behavior?

slide61

Were specific goals and objectives

identified for managing behaviors?

slide62

Were appropriate individuals

consulted in planning the management

of problematic behavior?

slide63

Was cause-specific management

used OR an explanation why it was

not feasible or not provided?

slide64

Was a rationale documented for

the specific choice of interventions?

slide66

N = 81 residents; Intervention: consciousness-raising, educational sessions, and clinical follow-up; 6-month study

  • Measures: discontinuations and dose reductions of antipsychotics, use of other psychotropics and restraints, frequency of disruptive behaviors, and stressful events experienced by nursing staff and personal care attendants.
  • Results: Substantial reduction in the number of residents receiving antipsychotics and decrease in the frequency of disruptive behaviors.

Int J Geriatr Psychiatry. 2008 Jun;23(6):574-9

slide68

Was there some documented

explanation, in conjunction with a

physician, for the dose, frequency, and

duration of medication treatments?

slide69

Because of their risk of causing side effects, medications prescribed for problematic behaviors should be used

for specific indications, at the lowest effective dose, and for the shortest possible period of time.

slide70

Were the individual’s behavior and

related causes monitored and

treatment adjusted accordingly?

slide71

A systematic approach and descriptive documentation help the staff to see more clearly the outcomes of treatment, to measure the results more objectively, and to determine if modifications are necessary or appropriate.

Continued on next slide

slide72

Underlying causes of problematic behavior may resolve, or the resident’s condition may change over time. Periodic monitoring is part of a systematic approach to care.

  • Lack of anticipated response to treatment requires reevaluation of approaches.
slide73

Were the risks for significant

complications and problems related to

interventions identified and

addressed?

slide74

Were possible significant adverse

drug reactions (ADRs) or other

complications of psychoactive

medications considered?

slide78

Early trials used the words “effective” and “efficacious” prominently and the word “benefit” never appeared.

  • Later studies almost all spoke to “benefits” or to the “beneficial” impact of treatment with Aricept.
slide79

Effectiveness is determined by short-term, observable measurements, e.g., blood pressure readings in hypertension studies, scores on tests of cognition in dementia studies, or the NPI (Neuropsychiatric Inventory) in studies on Atypical Antipsychotics.

slide80

Benefit is much more difficult to measure and can be influenced by marketing, spin, advertising, repeating the same things over and over even if they may not be true…and hope.

slide81

Doctors, families, and others need to realize that effective drug treatment may require years to show benefit

slide91

For medical conditions such as hypertension, diabetes or cancer, the health sciences developed reasonable expertise in diagnosis and staging before developing expertise in treatment.

  • For dementia-associated behavioral symptoms, we are trying to develop diagnostics, staging, and interventions all at the same time.
slide92

1. Dementia-associated behavioral symptoms occur across all settings of care, and we do not manage them well.

2. Non-drug approaches are under-utilized but translating these approaches from studies conducted by researchers invested in them into our every day work is hard.

slide93

3. AAPs are probably over-utilized or at least not always prescribed for the right resident, at the right time, at the right dose, for the right reason, and for the right length of time.

4. On the other hand, AAPs probably are both effective and beneficial for some residents with dementia-associated behavioral symptoms.

slide94

5. One way to identify residents with dementia-associated behavioral symptoms who are most likely to benefit from AAPs and to administer them as safely as possible is to follow a systematic approach such as the one outlined in the Michigan Department of Community Health Clinical Process Guideline on Behavior Management and Antipsychotic Medication Prescribing.

slide96

Available since the mid-1950\'s.

  • Some of the more commonly used medications include:

> Chlorpromazine (Thorazine)

> Haloperidol (Haldol)

> Perphenazine (generic only)

> Fluphenazine (generic only).

slide97

Aripiprazole (Abilify)

  • Clozapine (Clozaril)
  • Olanzapine (Zyprexa)
  • Quetiapine (Seroquel)
  • Risperidone (Risperdal)
  • Ziprasidone (Geodon, Zeldox)
slide99

Alcohol or benzodiazepine

withdrawal

  • No alcohol or benzodiazepine

withdrawal

  • A benzodiazepine,

e.g., oxazepam (Serax)

  • Antipsychotics
slide100

Mild to moderate dementia

  • Moderate to severe dementia
  • Cholinesterase inhibitors, e.g., donepezil (Aricept)
  • Memantine (Namenda) and a cholinesterase inhibitor
slide101

Delusions, hallucinations, or

physical aggression

  • Impulsivity
  • Two or more symptoms of low

mood

  • Difficulty sleeping
  • Begin or raise dose of antipsychotic
  • An anticonvulsant
  • An SSRI
  • Low-dose trazodone (Desyrel)
slide102

No drug specifically addresses wandering, hoarding, or

resistance to care, behaviors that are particularly frustrating

to caregivers.

slide103

Many drugs are sedating and increase the risk of falling and injury; antipsychotic use is off-label for dementia and carries significant and possibly lethal adverse effects.

slide104

Managing the behavioral symptoms of dementia requires attention to the environmental and psychosocial

context in which they occur, as well as to comorbidities and potential adverse drug effects.

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