Transcript To Pill or Not to Pill – That is the question… (But what

Bruce Gerlich, R.Ph.
Consultant Pharmacist
Omnicare
6 December 2012
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Describe the risks and benefits of
antipsychotic use for residents in LTC
facilities
Understand CMS quality measures on the use
of antipsychotic medications in the LTC
setting
Identify and recognize behaviors that may be
a form of communication of a resident’s
unmet needs
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The men and women who mistake:
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Roommate for a punching bag
Another resident’s bed for a toilet
Person feeding him/her as trying to poison
Another resident for a long-dead spouse
The men and women who
◦ Won’t eat, don’t sleep, lose weight, fall, hit, bite,
scratch, scream day and night, have pain, won’t get
out of bed, cough, have chronic diarrhea, bleed,
vomit, always feel bad, just want to die, can’t sit
still, etc. etc.
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Mortality Risk in Elderly Dementia Patients May
Rise With Newer Antipsychotics
Antipsychotics Increase Risk for Stroke in Elders
Psych Drugs Linked to MI Risk in Dementia
Again, Higher Mortality with Antipsychotics in
Patients with Dementia
Rapid Serious Adverse Events with Antipsychotics
in Dementia
Antipsychotics Linked to Increased Risk for
Hyperglycemia in Older Patients with Diabetes
Antipsychotics Increase Risks for Sudden Cardiac
Death
MEDICATIONS TO CONTROL BEHAVIOR
GOOD OR BAD?
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Antipsychotic medications
1954/55 – Thorazine first to be used
Within a decade, millions received it
Helped change the face of psychiatric
institutionalization
As with all remarkable new drugs(cortisone,
beta-blockers, antibiotics) in each decade,
overenthusiastic expectations and relative
minimization of risks
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Antipsychotic effect takes 3-7 days to start working
Very sedating medication so acute effect is most
likely due to sedating effect not antipsychotic effect
In RCTs, recipients do a little bit better than placebo
but the effect beyond 3 months is unclear
Not everyone who receives the meds improve
A large number of people getting the placebo
improve
The net effect is that 10 to 20 people out of 100 who
receive the medication improve due to the medication
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“For every 100 patients with dementia treated
with an antipsychotic medication, only 9 to
25 will benefit and 1 will die”
◦ Drs Avorn, Choudhry & Fishcher
Harvard Medical School
◦ Dr Scheurer
Medical University of South Carolina
◦ Source: Independent Drug Information Service (IDIS)
Restrained Use of antipsychotic medications:
rational management of irrationality. 2012
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Wandering*
Disrobing
Persistent disruptive vocalization (swearing, offensive comments,
yelling/screaming)*
Restlessness/ repeated attempts to unsafely arise from chair or
climb out of bed*
Inappropriate urination/defecation
Hiding/hoarding
Eating inedibles
Annoying repetitive activities, including “exit seeking”
Climbing into bed with other residents
Sleep disturbance, diurnal reversal*
Pushing wheelchair-bound residents
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* may be related to pain or discomfort
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Organization Year Country Recommendations regarding
antipsychotic use in dementia
ASCP 2011 USA - 2nd Line: “Only for the duration needed, and at the lowest
effective dose”
APA 2007 USA -2nd Line: “Recommended for the treatment of psychosis and
agitation in dementia”
AGS 2011 USA - 2nd Line: “May be needed for treatment of distressing
delusions and hallucinations”
NICE 2006 UK- 2nd Line: “Risk benefit analysis should occur prior to use”
CCSMH 2006 Canada 2nd Line:“Atypical antipsychotics should only be used if
there is marked risk, disability or suffering associated with the symptoms”
EFNS 2007 Europe- 2nd Line:“Antipsychotics, conventional as well as
atypical,
may be associated with significant side effects and
should be used with caution”
◦ American Society of Consultant Pharmacists, position statement, 2011
◦ Ageing Res Rev. 2012 Jan;11(1):78-86
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Schizophrenia
Bi-polar Disorder
Irritability associated with Autistic Disorder
(Aripiprazole & Risperidone)
Treatment Resistant Depression (Olanzapine)
Major Depressive Disorder (Quetiapine)
Tourettes (Orap)
When prescribed to a patient without an FDA
approved diagnosis; the prescription is considered as
an “off-label use”, which is allowed by FDA and
Medical Boards
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Dementia with behavior difficulties
Agitation
Abusive, violent
Wandering
Acute Delirium
Obsessive-compulsive disorder
Psychotic symptoms (e.g. hallucinations,
delusions) with neurological diseases
◦ Parkinson’s disease
◦ Stroke
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Issued in 2005
Warning: Increased Mortality in Elderly
Patients with Dementia-Related Psychosis
Elderly patients with dementia-related
psychosis treated with antipsychotic drugs
are at and increased risk of death. [Name of
Antipsychotic] is not approved for the
treatment of patients with dementia-related
psychosis.
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Off-label use of antipsychotics in nursing
facility residents are associated with an
increase in:
Death
Hospitalization
Falls & fractures
Venothrombolic events
Conventional antipsychotics are worse than
atypical antipsychotics
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Not indicated or approved to treat most behavior
symptoms in absence of underlying psychiatric
disorder
Not part of person-centered care
Oversedated people, cause a “zombie-like” state
Used for convenience of staff, in place of
adequate staffing
Limited benefits, major risks
Major increase in mortality risk
Cause strokes, MIs, hyperglycemia
Very expensive
 2011: OIG investigations
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OIG report
◦ Reviewed 600 medical records
◦ Medicare claims data for Part B and Part D and MDS data from
January 1st to July 31st, 2007 was used to identify payments for
atypical antipsychotic drug use for elderly nursing home residents
Major Findings
14% of elderly nursing home residents had Medicare
claims for atypical antipsychotic drugs
Off-label conditions accounted for 83% of these claims
Over ½ of the Medicare claims for antipsychotic drugs for
elderly nursing home resident were incorrect
Medicare reimbursement criteria was not met for 726,000
of the 1.4 million claims
22% of the atypical antipsychotic drugs were not
administered in accordance with CMS standards
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No FDA-approved treatment for agitation associated
with dementia. The strongest and most consistent
evidence for efficacy in severe dementia-related
agitation/aggression is for the atypical antipsychotics
Alternatives to antipsychotics may be effective for
certain target behaviors, but are not as well-studied.
Evaluate comorbid illness(s) and complex drug
regimens before selecting alternative drug therapy
for BPSD
Optimal treatment usually includes individualized
non-drug interventions and adjustment of
expectations
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Aripiprazole, Olanzapine, and Risperidone had a small but
statistically significant effect (12 – 20%) when compared to
placebo
Quetiapine did not have a statistically significant effect
Antipsychotics led to an average change/difference on the
NeuroPsychiatric Inventory (NPI) of
◦ 35% from a patient’s baseline
◦ 3.41 point difference from placebo group
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(note: a 30% change and 4.0 difference is the minimum threshold
needed for a clinically meaningful result)
No conclusive evidence was found regarding the comparative
effectiveness of different antipsychotics
Source: JAMA 306:1359-69 2011; Meta-analysis 38 RCTs in
dementia
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Residents should have drug regimens that are free of
unnecessary drugs defined as
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There in an excessive dose including duplicate therapy
There is an excessive duration of being on the drug
There is inadequate monitoring of the drug
There is inadequate indication for the use of the drug
There are adverse consequences
A combination of the reasons above
Specific conditions for antipsychotic drugs
◦ The facility must ensure that residents have not used
antipsychotics previously, are not given these drugs unless
the drug therapy is necessary, and recorded in the clinical
record
◦ In an effort to decrease the use of antipsychotics residents
must receive gradual dose reduction and alternate
therapies, unless they are counter-
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Anxiety
Depressive symptoms
Persistent physical aggression
Manic-like symptoms
Persistent and distressing delusions or
hallucinations
Sleep disturbance, initial or middle insomnia
Sexually inappropriate behavior
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Dementia – behaviors can respond to
cholinesterase inhibitors (Aricept, Exelon, etc)
and Namenda
Treat depression if present – can be manifested
by confusion, forgetfulness, anxiety, insomnia,
etc – SSRIs (Lexapro, Celexa, Zoloft are preferred)
For acute behavioral problems when resident is
violent and a danger to themselves and others –
may consider short term use of antipsychotic
medications and rule out possible causes
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Antipsychotic medications are only marginally
effective
Have a high incidence of side effects:
increase fall risk, EPS
Have an overall increased in cardiovascular
death (CVA, MI) than those that do not use
these agents
Can be helpful in a small percentage of our
population
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Risperidone has the most evidence supporting
efficacy in BPSD
◦ There are no FDA-approved medications for BPSD at
this time
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No consensus among experts in the field
• Patient selection and monitoring is essential
 Antipsychotics are 2nd line
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Only use drug therapy if behaviors cause severe
distress or immediate risk of harm
Always determine if behavior is a method of
communication beforeassuming physiologic
change
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CMS is making the reduction of off-label use
of antipsychotic medications a national
priority
Don Berwick, Director of CMS has asked
professional associations to work together
and with CMS to reduce the off-label use of
antipsychotic medications in nursing homes
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Improve dementia care by
◦ Rethinking overall approach
◦ Using standard techniques
◦ Using more nonpharmacological interventions in
prevention and management
◦ Prudent and limited use of antipsychotic
medications
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Allegedly, more to follow
◦ What should that be?
“Distressed behavior” is behavior that
reflects individual discomfort or
emotional strain. It may present as
crying, apathetic or withdrawn
behavior, or as verbal or physical
actions such as: pacing, cursing,
hitting, kicking, pushing, scratching,
tearing things, or grabbing others.
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CMS developed a national partnership to
improve dementia care and optimize
behavioral health.
◦ By improving dementia care and person-centered,
individualized interventions for behavioral health in
nursing homes, CMS hopes to reduce unnecessary
antipsychotic medication use in nursing homes and
eventually other care settings as well.
◦ While antipsychotic medications are the initial
focus of the partnership, CMS recognizes that
attention to other potentially harmful medications
is also an important part of this initiative.
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…. [CMS] is considering reviving the specific citation
for antipsychotic use to encourage more scrutiny, but
is concerned that homes will instead use other
sedating drugs that can also be harmful.
“One of the things we want to do is to make sure that
surveyors are looking out for a prescribing shift. Did
a person get taken off of an antipsychotic and simply
put on an antidepressant or antianxiety agent
instead?’’
Alice Bonner PhD, RN CMS Director, Division of
Nursing Homes
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Lazar K, Carrol M. “A rampant prescription, hidden
peril"; The Boston Globe, 4/29/12.
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In some cases, persons with dementia may have behavioral
expressions that indicate they are trying to communicate their
needs (with brain dysfunction that prevents this communication
from being effective in expressing a need or distress).
In other cases, behaviors may be symptoms of underlying
medical issues such as delirium or medication side effects, or
psychiatric symptoms.
Surveyors will be looking to see that a systematic and
comprehensive process was followed that not only includes
medical or clinical aspects, but also assesses whether or not the
nursing home provided tools, resources and staff training on
person centered care practices and environmental modification,
whether families are engaged in dementia care, whether there is
adequate staff, and other organizational issues.
reference:CMS
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The team may discuss specific cases in order to determine
the optimal dose and duration of therapy.
Input from the nursing assistants, nurses, social workers,
therapists, family and other caregivers working closely
with the resident is essential.
Input from all three shifts and weekend caregivers is also
important in “telling the story.”
Surveyors will look at communication between shifts,
between nurses and practitioners or prescribers.
Surveyors will also look at whether medications
prescribed by a covering practitioner in an urgent situation
are reevaluated by the primary care team.
Surveyors will look at whether or not other
psychopharmacologicals are prescribed if/when
antipsychotic medications are discontinued or reduced
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It may be helpful to refocus on the bigger
picture –
share resources on dementia care principles:
– www.nhqualitycampaign.org
Remind leadership that focusing on each
individual resident and using a careful,
systematic process to evaluate his/her needs is
what surveyors will be looking for (not the
antipsychotic rate in the facility)
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Experiencing the world in a different way
What are “behaviors”?
◦ Medical symptoms?
◦ Predictable human responses to the situation
perceived?
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Key questions to ask:
◦ What is this person trying to tell me?
◦ What is distressing this person?
◦ What does he or she need to be in well-being?
are often a rational attempt to
cope with circumstances that
do not make sense to a
resident with dementia
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Everyone brings their own baggage with them
Personality tendencies
Life experiences
Relationships
Past roles
Education
Religious beliefs
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become complacent by
assuming that behaviors are
caused by dementia and that
nothing except medicating the
resident can be done
Absenteeism
 Staff turnover
 Decreased productivity
 Increased desire to use
chemical and/or
 physical restraints
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 REASONS
FOR BEHAVIORS
RULE THESE OUT!!!
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health care professionals
and families believe
(1) dementia “behaviors” are
abnormal & need to be treated
(2) antipsychotics medications
are effective
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Infection
Congestive heart failure
Respiratory distress
Fracture
Cerebrovascular accident
Myocardial infarction
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. Seating/positioning
. Diagnoses that may lead to:
chronic pain
. Past history of pain
. Indicators of pain
◦ Resistance to care
◦ Non-verbal sounds
◦ Verbal complaints of pain
◦ Protective body movements or postures
. Routine rather than PRN pain medication
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Some estimates reveal residents with
dementia spend 60-80% of their time
with nothing to do.
It is during this unstructured time that
most disturbing behaviors occur.
Residents are often seeking stimulation,
movement, or comfort which leads to be
"needs-driven dementia compromised
behaviors"
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Creative ways to deliver foods
◦ Finger foods
◦ Fanny pack
Give drink every time person passes
◦ Hydration cart
◦ Popsicles/push pops
Pack calories into foods resident will eat
Medication administration-Med Pass,Ensure
. Bladder assessment
◦ Type of incontinence identified
◦ Individualized plan
 . Bowel patterns
◦ Opportunities to sit on the toilet
◦ Adequate fiber and fluids in diet
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Sleep hygiene
◦ What is the resident’s usual pattern?
◦ Noise
◦ Lighting
◦ Temperature
◦ Oral care
◦ Type of mattress, pillow, blankets
◦ Usual hours of sleep
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Anticholinergic medications
 Diphenydramine; hydroxyzine;
cyclobenzaprine
Benzodiazepines
 Lorazepam; alprazolam; diazepam;
 Clonazepam
Psychotropics
Anticonvulsants
 phenytoin
Corticosteroids- prednisone
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No role for PRN only antipsychotic medications
Evaluate the need for continuing antipsychotics
at admission & those on very low doses
Evaluate need for antipsychotics started on
residents during the evening/night shift or over
the weekend
Look at discontinue or gradual dose reduction for
residents on medications for greater than 12
weeks (3 months), particularly those with no
change in dose or frequency
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RCTs comparing low dose to placebo show
Risperidone to be minimally effective
Olanzapine to be not effective
Aripiprazole and Quetiapine unknowns as low dose
not tested
RCTs for withdrawal of medication show no
difference in outcomes between placebo and
continued medication
About 75% remain off the drug after the trial
Less than 25% need to be restarted on the medication
Placebo group (drug withdrawal) have fewer adverse
events
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Phase II: steps that will take longer to implement but need to be
started now
Focus on implementing programs to minimize the off-label use
of antipsychotics by promoting
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Strategies
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Non-pharmacologic strategies to manage individuals with dementia
Changes to how we view dementia behaviors as attempts to
communicate unmet needs
Staff training on interacting with individuals with dementia
Adopt policy on minimal use of medications with dementia residents
Educate families about this policy
Implement consistent assignment
Compare facility off-label antipsychotic use to others
Learn from other facilities
Inappropriate antipsychotic
prescribing is only one part of a
complex problem
 Need systematized culture change
around dementia care and the use
of medications to treat behavioral
and psychiatric symptoms of
dementia (BPSD)
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Nonpharmacologic Interventions
• First-line therapy for BPSD
• Ideally, non-pharmacologic interventions should
be:
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Targeted
Tailored
Individualized
Flexible
Adaptable
Multi-component
• Not all individuals will respond positively to
interventions
 VA-ESP Project #05-225, 2011
 Health Technol Assess. 2006;10(26):iii,ix-108
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Family and friends
Sleep habits
Childhood experiences
Occupation
Significant events
Favorite foods
Spiritual beliefs
Unique characteristics
Daily routine
Likes and dislikes
Life achievements
Hobbies
Communication preferences
Physical functioning
Sensory capabilities
Decision-making capacity
Alzheimer’s Association, Dementia Care Practice Recommendations for Assisted Living
Residences and NursingHomes, 2006.
http://www.alz.org/national/documents/brochure_dcprphases1n2.pdf
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Ground Rules:
We cannot change the person
Try to accommodate behavior not control it
We can change our behavior or the physical
environment
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Check with the doctor
 Is there an underlying medical reason?
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Behavior has a purpose
◦ What need is the person trying to meet with their
behavior?
 Family Caregiver Alliance, Caregiver’s Guide to
Understanding Dementia Behaviors, 2004
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Ground Rules:
All behavior is triggered !!!!!
The key to changing behaviors is disrupting the
patterns that we create
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What works today, may not tomorrow
◦ Be creative and flexible with your strategies
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Get support from others
Support groups, community resources,
training
 Family Caregiver Alliance, Caregiver’s Guide to
Understanding Dementia Behaviors, 2004
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Routine
Caregiver
Room
Roommate
Number of visitors
Medications
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• Physical discomfort
 Illness or medication
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• Overstimulation
 Loud noises or busy environment
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• Unfamiliar surroundings
 New places or inability to recognize home
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• Complicated tasks
 Difficulty with activities or chores
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• Frustrating interactions
 Inability to communicate effectively
Alzheimer’s Association, Behaviors–How to respond when
dementia causes unpredictable behaviors, 2012
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Attachment
Inclusion
Occupation
Identity
Comfort
◦ Kitwood T. Dementia reconsidered: The person
comes first. London: Open University Press; 1997
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Remain flexible, patient, and calm
Explore pain as a trigger
Respond to the emotion, not the behavior
Don’t argue or try to convince
Use memory aids
Acknowledge requests and respond to them
Look for the reason behind each behavior
Don’t take the behavior personally
Share your experiences with others
 Alzheimer’s Association, Behaviors–How to respond when
dementia causes unpredictable behaviors, 2012
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If you were a mother, what would you do if you were not
allowed to leave the building to pick up your children
after school?
If you couldn’t remember how to put on a sweater,
what would you do if someone just handed it to you?
If you couldn’t remember what time dinner is, what
would you do if you were hungry?
EMPATHY IS KEY!!!!!!!!
 Gould E. Understanding Behavioral Symptoms in
Dementia. NASMHPD Panel Presentation, August 2012
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What did you do to try and figure out why the
resident was doing <fill in the blank>?
What is resident trying to communicate to us
about their <fill in blank>?
What is reason for resident doing <fill in
blank>?
Unacceptable answer (Dementia or sundowning)
What did you try before requesting
medications?
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www.ascp.com
www.amda.com
Detailed clinical practice guideline on
dementia
www.nhqualitycampaign.org
– Multiple resources and links to other
organizations, training materials
[email protected]
CMS staff can put you in touch with state
coalition leads
and state-level resources
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Dealing with residents with dementia and
behavioral problems IS A COMPLEX ISSUE WITH
NO ONE ANSWER!!!
Behaviors happen for a reason and are a form of
communitcation for the elderly with dementia
related illnesses
Eliminating antipsychotic medications takes
patience, diligence and a TOTAL team approach
Whether we like it or not antipsychotic
medications will not disappear but can be
dramatically reduced…..