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)

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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.