Practical Steps in
Reducing Psychotropic
Medications
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Michael A. Lutz RPh, CGP Asst. Director of Clinical
Services Green Tree Pharmacy

Dawn Conaty RN, BSN, Field Nurse Consultant
Heritage Enterprises
CMS Initiative
5/30/2012
CMS National Partnership to Improve Dementia
Care: Rethink, Reconnect, Restore
CMS Initiative
15%
406,300 vs. 345,355 = 60,945 fewer residents receiving
antipsychotics
610 fewer deaths due to treatment each year
CMS Initiative
Where are we today?
Nationally Long-stay nursing home residents 2011Q4 = 23.9%
Nationally Long-stay nursing home residents 2014Q3 = 19.2%
19.7%
National Statistical Results
CMS initiative.
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Illinois Long-stay nursing home residents 2011Q4 = 25.7%
Illinois Long-stay nursing home residents 2014Q3 = 23.54%
8.4%
Illinois Statistical Results
CMS Initiative
Where are we today?
Illinois
State Ranking 49 of 51
National Comparison
Future Reductions
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New goal of a 25 percent reduction by the
end of 2015
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30 percent reduction by the close of 2016
using the prior baseline rate (fourth quarter
of 2011)
F329 (Unnecessary Drugs)
1. Each resident’s drug regimen must be free from unnecessary
drugs. An unnecessary drug is any drug when used:
(i) In excessive dose (including duplicate therapy); or
(ii) For excessive duration; or
(iii) Without adequate monitoring; or
(iv) Without adequate indications for its use; or
(v) In the presence of adverse consequences which indicate the dose
should be reduced or discontinued; or
(vi) Any combinations of the reasons above.
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2 Antipsychotic Drugs. Based on a comprehensive
assessment of a resident, the facility must ensure that:
(i) Residents who have not used antipsychotic drugs are
not given these drugs unless antipsychotic drug therapy is
necessary to treat a specific condition as
diagnosed and documented in the clinical record; and
(ii) Residents who use antipsychotic drugs receive gradual
dose reductions, and behavioral interventions, unless
clinically contraindicated, in an effort to discontinue these
drugs.
INTENT: §483.25(l) Unnecessary drugs
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Each resident’s entire drug/medication regimen be managed and monitored
to achieve the following goals:
The medication regimen helps promote or maintain the resident’s highest
practicable mental, physical, and psychosocial well-being, as identified by
the resident
Each resident receives only those medications, in doses and for the
duration clinically indicated to treat the resident’s assessed condition(s);
Non-pharmacological interventions (such as behavioral interventions) are
considered and used when indicated, instead of, or in addition to,
medication;
Clinically significant adverse consequences are minimized; and
The potential contribution of the medication regimen to an unanticipated
decline or newly emerging or worsening symptom is recognized and
evaluated, and the regimen is modified when appropriate.
NOTE: This guidance applies to all categories of medications including
antipsychotic medications.
Why is this important?
Resident health and safety
death rate, BG, stokes, lipids
Survey deficiency
 CMS Chief Medical Officer Patrick
Conway, M.D., confirmed in the fall that
the Five Star system would start including
antipsychotics measurements in 2015.
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Indications for Use:
A. Conditions Other than Dementia
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An antipsychotic medication should generally be used only for the following conditions/diagnoses
as documented in the record and as meets the definition(s) in the Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition, Training Revision (DSM-IV TR) or subsequent
editions):
Schizophrenia
Schizo-affective disorder
Schizophreniform disorder
Delusional disorder
Mood disorders (e.g. bipolar disorder, severe depression refractory to other therapies and/or with
psychotic features)
Psychosis in the absence of dementia
Medical illnesses with psychotic symptoms (e.g., neoplastic disease or delirium) and/or treatment
related psychosis or mania (e.g., high-dose steroids)
Tourette’s Disorder
Huntington disease
Hiccups (not induced by other medications)
Nausea and vomiting associated with cancer or chemotherapy
B. Behavioral or Psychological Symptoms of Dementia (BPSD)
Behavioral or Psychological
Symptoms of Dementia (BPSD)
There is no one code fits all for
BPSD, however, depending on the
specific situation the majority of the
time 294.11 and 294.21 will be the
code of choice
Diagnosis alone does not warrant the use of
antipsychotic medications.
The following criteria are also met:
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The behavioral symptoms present a danger to the
resident or others
AND one or both of the following:
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The symptoms are identified as being due to mania or
psychosis (such as: auditory, visual, or other
hallucinations; delusions, paranoia or grandiosity); OR
Behavioral interventions have been attempted and
included in the plan of care, except in an emergency.
Inadequate Indications for
Antipsychotics
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Insomnia
Wandering
Restlessness
Impaired memory
Mild anxiety
Poor self-care
Unsociability
Fidgeting
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Nervousness
Uncooperativeness (e.g.
refusal of or difficulty
receiving care)
Inattention/indifference to
surroundings
Verbal expressions
and/or behaviors that do
not present danger to the
resident or to others
Non-pharmacologic approaches
Exercise
 animal-assisted therapy
 aroma therapy
 music therapy
 light therapy
 massage/touch therapy
 TENS
 Multisensory stimulation
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Antipsychotic Medications
First generation (conventional) agents, e.g.
• chlorpromazine (Thorazine)
• fluphenazine (Prolixin)
• haloperidol (Haldol)
• loxapine (Loxitane)
• mesoridazine (Serentil)
• molindone (Moban)
• perphenazine (Trilafon)
• thioridazine (Mellaril)
• thiothixene (Navane)
• trifluoperazine (Stelazine)
Second generation (atypical) agents, e.g.
• asenapine (Saphris)
• aripiprazole (Abilify)
• clozapine (Clozaril)
• iloperidone (Fanapt)
• lurasidone (Latuda)
• olanzapine (Zyprexa)
• paliperidone (Invega)
• quetiapine (Seroquel)
• risperidone (Risperdal)
• ziprasidone (Geodon)
Antipsychotic medications may be considered for elderly residents with dementia but only after
medical, physical, functional, psychological, emotional psychiatric, social and environmental
causes have been identified and addressed.
PRN antipsychotic usage
Additional Criteria:
Acute Situations/Emergency
When an antipsychotic medication is being initiated or used to treat an
emergency situation (i.e., acute onset or exacerbation of symptoms or
immediate threat to health or safety of resident or others) related to one
or more of the aforementioned conditions/diagnoses, the use must
meet the above criteria and all of the following additional requirements:
1.
The acute treatment period is limited to seven days or less; AND
2.
A clinician in conjunction with the interdisciplinary team must
evaluate and document the situation within 7 days to identify
Pharmacist involvement
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Identify maximum daily dosage, appropriate DX, documentation to
support AP, BTS, etc.,
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Letter sent from pharmacy about CMS-specific DX & max daily dose
(not in all homes, yet)
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Safe reductions (longer on AP = longer for reduction)
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AIMS-must be proficient History dictates otherwise
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Assess risk to resident: first determining whether there is an underlying
medical, physical, functional, psychosocial, emotional, psychiatric, or
environmental cause of the behaviors
Surveyor Interview Encouraged
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Surveyors are strongly advised to speak
with the practitioner/prescriber and/or
consultant pharmacist in cases where an
antipsychotic medication is prescribed for
an elderly resident with dementia.
Risks
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Sedation
Postural Hypotension
Cardiac Arrhythmia
Sudden Cardiac Death
Falls
CVA
“FDA Black Box Warnings Regarding Atypical Antipsychotics in
Dementia provides, “Elderly patients with dementia-related psychosis
treated with atypical antipsychotic drugs are at increased risk of death
compared to placebo.”
Monitoring: Antipsychotics May be Considered
Unnecessary When in the Presence of Side Effects
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Anticholinergic effects
Akathisia (internal restlessness)
Neuroleptic malignant syndrome
Delirium, hypertensive crisis, raised WBC, raised CPK,
rhabdomyolysis
Falls
Lethargy/Excessive sedation
Parkinsonism
Tardive dyskinesia (repetitive, involuntary, purposeless movements)
Increased total cholesterol and triglycerides
Increased blood sugar
Orthostatic hypotension
Cardiac arrhythmias
Cerebrovascular event (stroke, TIA in elderly with dementia)
Monitoring Recommendations
 Obesity
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American Diabetes Association Recommends
 Weight check at baseline, then 4,8, and 12 weeks after starting
therapy or changing therapy--and then every 3 months.
 Diabetes
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Fasting glucose and blood pressure should be checked at baseline,
12 weeks, and then at least annually.
 Lipids
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Should be checked at baseline, 12 weeks, then every 5 years if
normal.
Boxed warnings
INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated
with antipsychotic drugs are at an increased risk of death.
A risk of death in drug-treated patients of between 1.6 to
1.7 times the risk of death in placebo-treated patients
[cardiovascular (e.g. heart failure, sudden death) or
infectious (e.g. pneumonia) in nature].
Agency for Healthcare
Research and Quality (AHRQ)
11,950 Strokes Annually!
Agency for Healthcare
Research and Quality (AHRQ)
Why was the AP medication started?
Insomnia
 Agitation
 Anxiety
 Aggression
 Obsessive, repetitive behavior
 Depression
 Etc.
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Before initiating medication
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What is person communicating through their
behavior
Reasons for the person’s behavior that led to
the initiation of the medication;
What other approaches and interventions were
attempted prior to the use of the antipsychotic
medication;
Was the family or representative contacted prior
to initiating the medication;
Hand-in-Hand CMS program
The problem is an
expression of an un-met
need – a communication
that challenges you to
understand.
Behavior is Communication!
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Pain?
Bathroom or UTI?
Hungry?
Boredom?
Too much stimulation?
Life style change (use social service & relate to nursing) shift worker
Labs: B12, UA
Nursing home routine…start at 5am (resident-centered care)
Algorithm: MDS 3.0 Patient Level
Report AP patient review flowchart
BPSD Treatment Algorithm
Reduced Yesterday and Treatment
Failure Today?
Generic Name
Brand Name
Half-Life
Aripiprazole
Abilify
75 hours
Ziprasidone
Geodon
7 hours
Risperidone
Risperdal
20 hours
Quetiapine
Seroquel
6 hours
Olanzapine
Zyprexa
30 hours
Monitoring of all
Psychopharmacological agents
 Review
continued need at least quarterly
 Document rationale for continuing
 Resident’s
target symptoms
 Effects of the medication(s)
 Benefit
vs. Risk
 Changes
in resident’s function
 Medication-related adverse drug reactions
 AIMS
test (evaluation) [Abnormal
Involuntary Movement Scale]
Cholinesterase Inhibitors
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Donepezil (Aricept)
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Galantamine (Razadyne)
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Rivastigmine (Exelon)
Glutamate (NMDA)
Receptor Antagonist
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Memantine (Namenda)
Selective Serotonin Reuptake
Inhibitors (SSRIs)
Citalopram (Celexa)
 Escitalopram (Lexapro)
 Fluoxetine (Prozac)
 Paroxetine (Paxil)
 Sertraline (Zoloft)
 Vilazodone (Viibryd)
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Other Clinically Useful Antidepressants
Bupropion (Wellbutrin)
 Desvenlafaxine (Pristiq)
 Duloxetine (Cymbalta)
 Mirtazapine (Remeron)
 Trazodone (Desyrel)
 Venlafaxine (Effexor)
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Mood Stabilizers
Carbamazepine (Tegretol)
 Lamotrigine (Lamictal)
 Oxcarbazepine (Trileptal)
 Valproic Acid (Depakote)
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Anxiolytics
Short Acting
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Alprazolam (Xanax)
Lorazepam (Ativan)
Oxazepam (Serax)
Temazepam (Restoril)
Long Acting
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Chlordiazepoxide
(Librium)
Clonazepam (Klonopin)
Clorazepate (Tranxene)
Diazepam (Valium)
Flurazepam (Dalmane)
Antipsychotic GDR
Documentation of Clinical
Contraindication
Gradual Dose Reduction (GDR)
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Stepwise dose reduction used to determine if
symptoms, conditions, or side effects can be
managed by a lower dose or if the medication
can be discontinued
Determines benefit and appropriate dose
Necessary even when condition has improved or
stabilized
Often the only way to determine continued
benefit and need by the resident
GDR-Antipsychotics
GDR required for use of antipsychotics,
unless clinically contraindicated
 Attempted within the 1st year of
admittance to the facility or initiation of an
antipsychotic by the facility in 2 separate
quarters, with at least 1 month in between
attempts
 After the 1st year, a GDR must be
attempted annually
 Also: ADs, AAs, mood stabilizers
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GDR-Sedative/hypnotics
For as long as a resident remains on a
sedative/hypnotic that is used routinely and
beyond the manufacturer's
recommendations for duration of use the
facility should attempt to taper the
medication quarterly unless clinically
contraindicated.
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Example Note:
Clinically Contraindicated
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Resident has had recurrent behaviors with
previous dose reduction (date). Behaviors are
aggressive (explicitly what are they and how
often do they or did they occur) in nature and do
not allow for assisted self-care (which care is
affected) essential for this resident’s well-being.
Resident is without side-effects of therapy and
these continue to be monitored per facility
protocol.
Benefit > Risk.
Clinically Acceptable Withdrawal
Reduce gradually
 Never more than 50% of dose Q2weeks
 The longer the medication prescribed, the
slower the withdrawal
 Reduction to quickly leads to emergence
of symptoms (drug withdrawal ≠ BPSD)
Clinically Acceptable Withdrawal
BPSD symptoms are often temporary
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When stable, reduce
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Reduce Q3months
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Most patients do not worsen behaviorally
GDR: BPSD
Clinical Contraindication
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Behavioral and Psychological Symptoms of
Dementia (BPSD):
- Target symptoms return or worsen after
most recent GDR attempt AND
- Clinical reasoning is documented by the
physician explaining why a GDR would be
inappropriate at that time
GDR: Psychiatric Conditions
Clinical Contraindication
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Psychiatric Conditions (≠ BPSD):
- Continued use is within current practice
guidelines and the physician has
documented why a GDR attempt would be
inappropriate OR
- Symptoms returned or worsened during most
recent GDR attempt and the physician has
documented why a GDR would be
inappropriate at that time
How
to start reducing
antipsychotics in your facility
How to start reducing antipsychotics in
your facility
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Educate your staff
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Educate your physicians
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Educate your resident and family
How to pick a PIP team
Choose a leader for this team
It could be
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Administrator
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Director of Nursing
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MDS Coordinator
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Floor Nurse
Choose members of the team
It could be
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C.N.A. from each shift
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Floor nurses
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Housekeeping
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Dietary
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SSD
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Activities
4 major components to F329
1) The diagnosis and indication for use is correct
2) If antipsychotic is being used for BPSD that the
maximum daily dose is not exceeded.
3) The behavior tracking is being done.
4) If behaviors are not present that gradual dose reduction
is being initiated.
Different approaches
(initially: low-hanging fruit)
Getting rid of PRN meds that have not
been used in 60 days
 When attempting a reduction start
conservatively.
 Focus on smaller groups initially.
 Review BTS for those with little/no
behaviors
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Different approaches
(initially: low-hanging fruit)
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Review potential admission paperwork.
 admitted
on an antipsychotic medication, the
facility must re-evaluate the use of the
antipsychotic medication at the time of
admission and/or within two weeks of
admission (at the time of the initial MDS
assessment) and consider whether or not the
medication can be reduced (tapered) or
discontinued).
Root Cause Analysis
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Determine “contributing” cause(s) = a factor that,
if corrected would not prevent a recurrence, but
is significant enough to fix
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Determine “root” cause(s) = the most basic
condition that if corrected, prevents recurrence
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Using 5 Why’s or the Fishbone diagram
Using Fishbone- Group into categories of causal factors:
Human factors - communication
Human factors – fatigue/staffing
Environment/Equipment
Rules/Policies/Procedures
Information management
Culture
Model for Improvement- Identify Manageable Change based
upon outcome of RCA
Model for Improvement
Thinking Part
Doing Part
What are we trying to
accomplish?
How will we know that a
change is an improvement?
What change can we make that
will result in improvement?
Act
Plan
Study
Do
Pilot Facilities Data
Facility A Facility B Facility C Facility D Facility E
Q2-2014
23.9
23.1
19.4
27.4
21.4
Q3/2014
19.2
19.7
5.9
25.8
18.9
Q4/2014
21.9
14.5
3.2
17.9
19.9
Pilot Facility’s Data
30
25
20
Q2-2014
Q3/2014
15
Q4/2014
10
5
0
facility A
Facility B
Facility C
Facility D
Facility E
Case study #1
A
resident is in the hospital with UTI
and fracture hip with repair. Looking
at admitting to your facility for rehab
and home. The admitting orders
include pain med, antibiotic, and
Seroquel 25mg for insomnia. The
Seroquel was start in the hospital.
1) Is the diagnosis appropriate?
No
2) Is the Seroquel under recommended daily
dose?
Yes
Approach:
 Ask
the hospital not to order the
Seroquel upon discharge to the
facility. Monitor resident’s insomnia
and reasons for insomnia.
1)
2)
3)
Pain control
New environment
Urine issues
Case study #2
 Resident
has dx of stroke,
cardiac issues, dementia.
Resident needs assistance
with all ADL’s. Resident is on
Risperdal 0.5mg BID for
agitation.
1)Is the diagnosis appropriate?
No
2) Under recommended daily dose?
Yes
3) What behavior is showing?
Hitting staff during cares
4) What is the approach the staff is taking during
cares?
Approach:
 Look
at frequent position
changes, pain, activities.
Case study #3
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Resident is on hospice for failure to thrive.
Resident has dementia, poor appetite with
weight loss. History of osteoarthritis and
compression fractures. Attempts to get out
of bed and out of wheelchair. Resident
was put on Seroquel 100mg BID for
anxiety.
1)Is the diagnosis appropriate?
No
2) Under recommended daily
dose?
No
Approach:
 Look
at frequent position
changes, pain, activities.
Dementia Residents that require
Antipsychotic med
-Document!
-Document!
-Document!
Try gradual dosage reduction again.
QUESTIONS??