Pharmacy Northern Region Update 2013

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Pharmacy Northern
Region Update 2013
Doug Englebert, R.Ph.
608-266-5388
[email protected]
August 28, 2013
What is Being Cited in NH?
F329 - Unnecessary Drugs
120
2
1
1
0
100
2
80
3
4
60
40
20
2
9
2
0
0
24
31
2005
2006
0
0
1
63
69
63
58
2007
2008
2009
2010
110
112
2011
2012
0
Level 4
Level 3
Level 2
Level 1
OIG Findings


Fourteen percent of elderly nursing home
residents had Medicare claims for atypical
antipsychotic drugs
Eighty-three percent of Medicare claims for
atypical antipsychotic drugs for elderly
nursing home residents were associated with
off-label conditions; 88 percent were
associated with the condition specified in the
FDA boxed warning
OIG Findings


Fifty-one percent of Medicare atypical
antipsychotic drug claims for elderly nursing
home residents were erroneous, amounting
to $116 million
Twenty-two percent of the atypical
antipsychotic drugs claimed were not
administered in accordance with CMS
standards regarding unnecessary drug use in
nursing homes
OIG Recommendations


Assess whether survey and certification
processes offer adequate safeguards against
unnecessary antipsychotic drug use in
nursing homes
Explore alternative methods beyond survey
and certification processes to promote
compliance with Federal standards regarding
unnecessary drug use in nursing homes
F329- Unnecessary DrugsSurvey Considerations

Each resident’s medication regimen must be
free from unnecessary medications. An
unnecessary medication is any medication
when used:
–
–
–
–
–
In excessive doses (including duplicate therapy); or
For excessive duration; or
Without adequate monitoring; or
Without adequate indication for use; or
In the presence of adverse consequences which indicate
the dose should be reduced or discontinued
Psychotropic Drug Use
QI/QM Data
Prevalence of Antipsychotic Use in Absence of Psychotic or
Related Conditions
25
20.7
20 18.2
19.8
17.6
19.3
17.1
18.6
16.3
18.5
16.1
15
WI Overall
National Overall
10
5
0
2006
2007
2008
2009
2010
QI/QM Data
Prevalence of Antipsychotic Use in Absence of Psychotic
or Related Conditions: High Risk
Residents who exhibit both cognitive impairment and behavior problems on most recent
assessment
50
44.1
42.5
41.7
39.6
45
39.4
40 45
41
46.2
37.8
35
36.7
30
25
20
15
10
5
0
2006 2007 2008 2009 2010
WI
National
QI/QM Data
Prevalence of Antipsychotic Use in Absence of
Psychotic or Related Conditions: Low Risk (Residents
who are not high risk)
18
16
14
17.2
14.2
16.5
13.7
16.2
13.5
15.6
12.5
15.6
12.9
12
10
WI
National
8
6
4
2
0
2006
2007
2008
2009
2010
Dr. Gifford-Focus 2012
Dr. Gifford: Focus 2012
DX Code Not Enough*



14
The behavioral symptoms present a danger to the
resident or others
– AND one or both of the following:
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
Protecting and promoting the health and safety of the people of Wisconsin
Emergency


15
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 and address
any contributing and underlying causes of the acute
condition and verify the continuing need for an
antipsychotic medication
Protecting and promoting the health and safety of the people of Wisconsin
Emergency

16
3. If the behaviors persist beyond the emergency
situation, pertinent non-pharmacological
interventions must be attempted, unless clinically
contraindicated, and documented following the
resolution of the acute psychiatric event
Protecting and promoting the health and safety of the people of Wisconsin
Enduring Condition

17
In addition, before initiating or increasing an
antipsychotic medication for enduring
conditions, the target behavior/s must be
clearly and specifically identified and
documented. Monitoring must ensure that
the behavioral symptoms are…
Protecting and promoting the health and safety of the people of Wisconsin
Enduring Condition

18
Not due to a medical condition or problem
(e.g., pain, fluid or electrolyte imbalance,
infection, constipation, medication side effect
or polypharmacy) that can be expected to
improve or resolve as the underlying
condition is treated or the offending
medication(s) are discontinued; AND
Protecting and promoting the health and safety of the people of Wisconsin
Enduring Condition

19
Not due to environmental stressors alone
(e.g., alteration in the resident’s customary
location or daily routine, unfamiliar care
provider, hunger or thirst, excessive noise for
that individual, inadequate or inappropriate
staff response), that can be addressed to
improve the symptoms or maintain safety;
AND
Protecting and promoting the health and safety of the people of Wisconsin
Enduring Condition

20
Not due to psychological stressors alone (e.g.,
loneliness, taunting, abuse), anxiety or fear
stemming from misunderstanding related to his or
her cognitive impairment (e.g., the mistaken belief
that this is not where he/she lives or inability to find
his or her clothes or glasses, unaddressed sensory
deficits) that can be expected to improve or resolve
as the situation is addressed; AND
Protecting and promoting the health and safety of the people of Wisconsin
Enduring Condition

21
Persistent. In this case, there must be clear
documented evidence in the medical record that the
situation or condition continues or recurs over time
(persists) and that other approaches that have been
attempted have failed to adequately address the
behavioral/psychological symptoms and that the
resident’s quality of life is negatively affected by the
behaviors/symptoms as described above
Protecting and promoting the health and safety of the people of Wisconsin
Antipsychotic Review:
Dementia Cliff Notes

Is the dementia behavior
–
–
–
–
Persistent?…No… then inadequate indications
Harmful?…No… then inadequate indications
And…
Have other treatable causes been ruled
out?…No… then inadequate indications
Have Non-Pharm interventions been
attempted?…No…then indications
Protecting and promoting the health and safety of the people of Wisconsin
New Admission

23
This PASRR screening (F285) should
provide pertinent information including
appropriate clinical indications for the use of
an antipsychotic
Protecting and promoting the health and safety of the people of Wisconsin
New Admission

24
For residents who do not require PASRR
screening and are admitted on an
antipsychotic medication, the facility must reevaluate 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
Protecting and promoting the health and safety of the people of Wisconsin
Monitoring

Effectiveness
–
–

Adverse Consequences
–
25
Changes to other psychopharmacological
medications or other antipsychotic medications
Qualitative/Quantitative
Anticholinergic, diabetes, TD, hypotension
Protecting and promoting the health and safety of the people of Wisconsin
Monitoring

Effectiveness
–
–

Adverse Consequences
–
26
Changes to other psychopharmacological
medications or other antipsychotic medications
Qualitative/Quantitative
Anticholinergic, diabetes, TD, hypotension
Protecting and promoting the health and safety of the people of Wisconsin
Dr. Gifford-Focus 2012
Dr. Gifford-Focus 2012
Gradual Dose Reduction


29
No Changes
However, emphasis on new admissions
evaluation sooner for potential tapering or
dose reduction
Protecting and promoting the health and safety of the people of Wisconsin
F329

GDR-Antipsychotics
–
–
GDR must be attempted in 2 separate quarters (1
month between) within 1st year of being
medicated or admitted on the antipsychotic
After 1st year, taper on annual basis
Clinically Contraindicated

Behavioral symptoms related to dementia
–
–
The resident’s target symptoms returned or
worsened after the most recent attempt at a GDR
within the facility; and
The physician has documented the clinical
rationale for why any additional attempted dose
reduction at that time would be likely to impair the
resident’s function or increase distressed
behavior.
Clinically Contraindicated

To treat a psychiatric disorder other than
behavioral symptoms related to dementia
–
The continued use is in accordance with relevant
current standards of practice and the physician
has documented the clinical rationale for why any
attempted dose reduction would be likely to impair
the resident’s function or cause psychiatric
instability by exacerbating an underlying
psychiatric disorder; OR
Clinically Contraindicated

To treat a psychiatric disorder other than
behavioral symptoms related to dementia
–
The resident’s target symptoms returned or
worsened after the most recent attempt at a GDR
within the facility and the physician has
documented the clinical rationale for why any
additional attempted dose reduction at that time
would be likely to impair the resident’s function or
cause psychiatric instability by exacerbating an
underlying medical or psychiatric disorder.
Dr. Gifford: Focus 2012
F329 New Update Summary



35
Emphasis that antipsychotics not approved
for dementia, have high risk, and often are
ineffective for dementia behaviors
Emphasis on assessing for adequate
indications: DX Code not enough
New Admission Assessment and Evaluation
Protecting and promoting the health and safety of the people of Wisconsin
New Procedures/Tools for
Surveyors
Appendix P-Sample Selection


Goal: Insure a resident with dementia and
antipsychotics is in the sample for ALL
surveys
Task 1: Off-Site Prep
–
–
37
Facility is flagged at 75th percentile for either of
the two antipsychotic quality measures.
During off-site prep a sample of residents with
these flags will be included
Protecting and promoting the health and safety of the people of Wisconsin
Appendix P-Sample Selection

Task 2: Entrance
–
–
38
Ask for list of residents with diagnosis of dementia
and who have received or are receiving or have
PRN orders for antipsychotic medications in the
last 30 days
If facility has residents with dementia ask for
policies for dementia care and use of
antipsychotic medications
Protecting and promoting the health and safety of the people of Wisconsin
Appendix P-Sample Selection


39
For 75th percentile flagged facilities compare
pre-selected residents to facility list of
residents with dementia on antipsychotics
within last 30 days
Make sure pre-selected off-site includes one
of these residents. If not, then exchange or
add resident. Exchanged or added residents
should have similar flagged QMs
Protecting and promoting the health and safety of the people of Wisconsin
Appendix P-Sample Selection

40
For facilities that did not flag make sure there
is at least one resident from the facilityprovided list of residents with dementia and
on antipsychotic medications in the phase 1
sample. If not, exchange a resident from the
facility-provided list to the phase I sample.
The resident exchanged should have like or
similar QM’s.
Protecting and promoting the health and safety of the people of Wisconsin
Investigation of Selected Resident

F309-Dementia Checklist
–
–
–
–
41
Goal is to evaluate dementia care provided in the
facility
Checklist is a way to systematically review
When pieces of the system are broken other tags
may be cited
When the system is broken or pieces are broken
and it leads to the resident not receiving care to
meet care needs, then F309 is cited
Protecting and promoting the health and safety of the people of Wisconsin
Dementia Care Checklist






42
Assess and Identify Underlying Cause of
Dementia Behaviors (F272)
Care Planning (F279)
Care Plan Implementation (F282)
Care Plan Monitoring and Revision (F280)
Quality Assurance (F520)
Did the facility provide…to highest
practicable (F309)
Protecting and promoting the health and safety of the people of Wisconsin
Focus of Interventions

Indications
–





Persistent, Harmful, Other Causes Ruled Out
Start via a telephone order
Premonitor: Trends (Watchful Waiting)
Drug Review prior to start?
Line List?
Stop Order Review?
Informed Consent
Act 281

WI Stats. 50.08 requiring written informed
consent before administration of a
psychotropic medication to a nursing home
resident who has degenerative brain disorder
Chapter 50 Informed Consent
Components




Definitions
General Requirement
Exceptions
Documentation Requirement
Degenerative Brain Disorder

WI Stats 55.01 (1v) "Degenerative brain
disorder" means the loss or dysfunction of an
individual's brain cells to the extent that he or
she [an individual] is substantially impaired in
his or her ability to provide adequately for his
or her own care or custody. Wis. Stats. 55.01
(1v)
Degenerative Brain Disorder

Examples:
–
–
–
–
Alzheimer’s Dementia
Lewy Body Dementia
Frontal Lobe Dementia or
Pick’s Disease
Psychotropic Medication

“Psychotropic medication" means an
antipsychotic, an antidepressant, lithium
carbonate, or a tranquilizer. Wis. Stats. 50.08
(1)(d)
Boxed Warning




Only psychotropic medications with a boxed
warning…commonly called black box
Not all psychotropic medications have black
box
All antipsychotics. All Antidepressants.
Lithium
Not all sedative hypnotics or anxiolytics
Boxed Warning

Is there a list?

http://blackboxrx.com/
Exceptions

Orders for medications by facilities off of the
premises of the nursing home
Resources

Flow Sheet: Decision Maker
–

http://www.dhs.wisconsin.gov/publications/p0/p00
336.pdf
Informed Consent Forms
–
http://www.dhs.wisconsin.gov/forms1/F2/MedBran
dName.htm
Med Pass Changes
Med Pass Task 5E



55
Effective immediately
Only complete a single med pass with a
minimum of 25 medication opportunities
You can go over 25 but not under
Protecting and promoting the health and safety of the people of Wisconsin
Med Pass Task 5E




56
Watch and document ALL of the resident’s
medications being administered
Do not stop the observation in the middle of
a resident’s medication pass
Stopping a potential medication error
Drugs by protocol/OTC Formulary
Protecting and promoting the health and safety of the people of Wisconsin
Med Pass Task 5E
57

Make sure if multiple staff complete the task
all observations are included for one
calculation of the med error rate

Review New Form
Protecting and promoting the health and safety of the people of Wisconsin
Med Pass Task 5E

G Tube Review
Do Not Crush Resource
MDI Review
Omeprazole Review

S&C memo:



http://www.cms.gov/Medicare/Provider-
Enrollment-andCertification/SurveyCertificationGenInfo/Downloads/Surveyand-Cert-Letter-13-02.pdf
58
Protecting and promoting the health and safety of the people of Wisconsin
Questions
Doug Englebert
608-266-5388
[email protected]
dhs.wisconsin.gov
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