pharmacy northern region update 2013 doug englebert, r.ph. 608-266-5388
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Pharmacy Northern Region Update 2013
Doug Englebert, R.Ph.
608-266-5388
Douglas.englebert@dhs.wisconsin.gov
August 28, 2013
F329 - Unnecessary Drugs
24 31
63 69 63 58
110 112
00
49
1
0
1
0
0
2
1
2
023
2
0
20
40
60
80
100
120
2005 2006 2007 2008 2009 2010 2011 2012
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 Drugs-Survey 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
QI/QM DataPrevalence of Antipsychotic Use in Absence of Psychotic or Related Conditions
18.2
20.7
17.6
19.8
17.1
19.3
16.3
18.6
16.1
18.5
0
5
10
15
20
25
2006 2007 2008 2009 2010
WI OverallNational Overall
QI/QM DataPrevalence 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
45
44.1
46.2
42.5
41
41.7
36.7
39.6
37.8
39.4
05
101520253035404550
2006 2007 2008 2009 2010
WI
National
QI/QM DataPrevalence of Antipsychotic Use in Absence of
Psychotic or Related Conditions: Low Risk (Residents who are not high risk)
14.2
17.2
13.7
16.5
13.5
16.2
12.5
15.6
12.9
15.6
0
2
4
6
8
10
12
14
16
18
2006 2007 2008 2009 2010
WI
National
DX Code Not Enough*
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 14
Emergency
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 15
Emergency
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 16
Enduring Condition
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 17
Enduring Condition
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 18
Enduring Condition
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 19
Enduring Condition
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 20
Enduring Condition
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 21
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
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 23
New Admission
For residents who do not require PASRR screening and are 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
Protecting and promoting the health and safety of the people of Wisconsin 24
Monitoring
Effectiveness– Changes to other psychopharmacological
medications or other antipsychotic medications– Qualitative/Quantitative
Adverse Consequences– Anticholinergic, diabetes, TD, hypotension
Protecting and promoting the health and safety of the people of Wisconsin 25
Monitoring
Effectiveness– Changes to other psychopharmacological
medications or other antipsychotic medications– Qualitative/Quantitative
Adverse Consequences– Anticholinergic, diabetes, TD, hypotension
Protecting and promoting the health and safety of the people of Wisconsin 26
Gradual Dose Reduction
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 29
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.
F329 New Update Summary
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 35
Appendix P-Sample Selection
Goal: Insure a resident with dementia and antipsychotics is in the sample for ALL surveys
Task 1: Off-Site Prep– 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 37
Appendix P-Sample Selection
Task 2: Entrance– 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 38
Appendix P-Sample Selection
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 39
Appendix P-Sample Selection
For facilities that did not flag make sure there is at least one resident from the facility- provided 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 40
Investigation of Selected Resident
F309-Dementia Checklist– 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 41
Dementia Care Checklist
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 42
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?
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
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 Task 5E
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 55
Med Pass Task 5E
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 56
Med Pass Task 5E
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 57
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-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-02.pdf Protecting and promoting the health and safety of the people of Wisconsin 58
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