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Managing Residents on Psychoactive Drug Therapy

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Larry W Lawhorne, MD Professor and Chair, Dept of Geriatrics Boonshoft School of Medicine Wright State University Dayton OH * It is often possible to target ... – PowerPoint PPT presentation

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Title: Managing Residents on Psychoactive Drug Therapy


1
  • Larry W Lawhorne, MD
  • Professor and Chair, Dept of Geriatrics
  • Boonshoft School of Medicine
  • Wright State University
  • Dayton OH

2
Everything is
complicated. If that were not so, life and
poetry and everything else would be a
bore. Poet Wallace Stevens
3
  • Dementia-Associated
  • Behavioral Symptoms
  • Why are recognition, assessment,
  • treatment, and monitoring so
  • complicated?

4
  • New slides from the National Nursing Home Survey

5
  • 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.

6
  • Prevalence of dementia 52.58
  • gt 77 Female
  • gt 56 85 years of age
  • gt 97 non-Hispanic 88 White
  • Antipsychotic medications were taken by 32.88 of
    residents with dementia
  • http//www.cdc.gov/nchs/nnhs.htm

7
  • 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.

8
  • 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.

9
  • 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

10
  • 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.

11
  • 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.

12
  • Surveyor view
  • Provider view
  • Different versions of the truth?

13
  • 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?

14
  • 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?

15
  • 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)

16
  • 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.

17
  • 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.

18
  • 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.

19
  • Show of hands.

20
  • AAPs are used to treat dementia-associated
    behavioral symptoms in nursing facility
    residents.
  • Agree
  • Disagree
  • Neither agree nor disagree

21
  • AAPs are over-used in the treatment of dementia-
    associated behavioral symptoms in nursing
    facility residents.
  • Agree
  • Disagree
  • Neither agree nor disagree

22
  • 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

23
  • The effectiveness of AAPs in treating
    dementia-associated behavioral symptoms in
    nursing facility residents is over-rated.
  • Agree
  • Disagree
  • Neither agree nor disagree

24
  • The danger of AAPs in treating dementia-
    associated behavioral symptoms in nursing
    facility residents is over-stated.
  • Agree
  • Disagree
  • Neither agree nor disagree

25
  • need better research untainted by a sponsors
    funding or a researchers biases!

26
  • 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 effectiveif not effective, then
    certainly beneficial.
  • If authors D,E, and F, then AAPs are ineffective,
    dangerous, and not at all beneficial .

27
  • 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 effectiveif not effective, then
    certainly beneficial.
  • If authors D,E, and F, then AAPs are ineffective,
    dangerous, and not at all beneficial .

28
  • 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.

29
  • 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.

30
  • The following slides are not in your handout but
    can be obtained by email as described at the end
    of the presentation.

31
  • 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.

32
  • 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.

33
  • 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.

34
  • CATIE-AD Trial
  • (Schneider et al. NEJM 2006)

35
  • 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.

36
  • 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.

37
  • 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.

38
  • 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.

39
  • 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.

40
  • 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).

41
  • 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.

42
  • 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.

43
  • 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
    stakeholdersresearchers, clinicians, residents,
    families, caregivers, policy makers, and even
    providers and surveyors.

44
  • requires ongoing respectful dialogue!

45
  • The Michigan Department of Community Health

46
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47
create a situation where there is always
complete agreement or consensus.
48
  • Were behaviors characterized in
  • enough detail (onset, trigger, nature,
  • intensity, duration, frequency,
  • consequences, and other relevant
  • information)?

49
  • Was there documentation that
  • justified why the behavior was
  • considered problematic?

50
  • Was there timely recognition of
  • problematic behavior?

51
  • Were specific behaviors identified
  • for which a medication or other intervention was
    provided?

52
  • Was the current medication regimen
  • reviewed as a potential source of
  • problematic behavior?

53
  • 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?

54
  • 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.

55
  • 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

56
  • 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

57
  • 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

58
Everything is
complicated. If that were not so, life and
poetry and everything else would be a
bore. Poet Wallace Stevens
59
  • Was there an attempt to identify
  • categories of cause(s) of any
  • problematic behavior, OR explain why
  • causes could or should not be sought?

60
  • Was a plausible explanation offered
  • as to how it was determined that
  • certain causes were the most likely
  • reason for the behavior?

61
  • Were specific goals and objectives
  • identified for managing behaviors?

62
  • Were appropriate individuals
  • consulted in planning the management
  • of problematic behavior?

63
  • Was cause-specific management
  • used OR an explanation why it was
  • not feasible or not provided?

64
  • Was a rationale documented for
  • the specific choice of interventions?

65
  • Everybody advocates non-drug but difficult

66
  • 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 Jun23(6)574-9

67
  • We are initiating the following interventions
    because

68
  • Was there some documented
  • explanation, in conjunction with a
  • physician, for the dose, frequency, and
  • duration of medication treatments?

69
  • 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.

70
  • Were the individuals behavior and
  • related causes monitored and
  • treatment adjusted accordingly?

71
  • 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

72
  • Underlying causes of problematic behavior may
    resolve, or the residents 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.

73
  • Were the risks for significant
  • complications and problems related to
  • interventions identified and
  • addressed?

74
  • Were possible significant adverse
  • drug reactions (ADRs) or other
  • complications of psychoactive
  • medications considered?

75
  • Is there a difference?

76
  • Producing result causing a result, especially
    the desired or intended result

77
  • Promoting or enhancing well-being
  • Advantageous

78
  • 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.

79
  • 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.

80
  • 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 trueand hope.

81
  • Doctors, families, and others need to realize
    that effective drug treatment may require years
    to show benefit

82
An Intervention can be Beneficial Not Beneficial
Effective X
Not Effective
83
An Intervention can be Beneficial Not Beneficial
Effective X
Not Effective
84
An Intervention can be Beneficial Not Beneficial
Effective
Not Effective X
85
An Intervention can be Beneficial Not Beneficial
Effective
Not Effective X
86
Blood Pressure Treatment Beneficial Not Beneficial
Effective Clinical trial evidence to support.
Not Effective
87
Cholesterol-lowering drugs for residents with terminal condition on Hospice Beneficial Not Beneficial
Effective Expert opinion and consensus support.
Not Effective
88
Music therapy for residents with dementia Beneficial Not Beneficial
Effective
Not Effective Expert opinion and consensus
89
Antipsychotics for dementia associated behavioral symptoms Beneficial Not Beneficial
Effective Authors A,B, and C
Not Effective Authors D, E and F
90
Antipsychotics for dementia associated behavioral symptoms Beneficial Not Beneficial
Effective It depends
Not Effective on the resident!
91
  • 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.

92
  • 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.

93
  • 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.

94
  • 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.

95
  • For an electronic version of the updated
    PowerPoint presentation, email me at
  • larry.lawhorne_at_wright.edu

96
  • Available since the mid-1950's.
  • Some of the more commonly used medications
    include
  • gt Chlorpromazine (Thorazine)
  • gt Haloperidol (Haldol)
  • gt Perphenazine (generic only)
  • gt Fluphenazine (generic only).

97
  • Aripiprazole (Abilify)
  • Clozapine (Clozaril)
  • Olanzapine (Zyprexa)
  • Quetiapine (Seroquel)
  • Risperidone (Risperdal)
  • Ziprasidone (Geodon, Zeldox)

98
(No Transcript)
99
  • Alcohol or benzodiazepine
  • withdrawal
  • No alcohol or benzodiazepine
  • withdrawal
  • A benzodiazepine,
  • e.g., oxazepam (Serax)
  • Antipsychotics

100
  • Mild to moderate dementia
  • Moderate to severe dementia
  • Cholinesterase inhibitors, e.g., donepezil
    (Aricept)
  • Memantine (Namenda) and a cholinesterase inhibitor

101
  • 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)

102
  • No drug specifically addresses wandering,
    hoarding, or
  • resistance to care, behaviors that are
    particularly frustrating
  • to caregivers.

103
  • 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.

104
  • 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.

105
  • Evidence for the efficacy of antidepressants for
    depression
  • in dementia is limited.
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