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Steps to Success
Eliminating Off-Label Use
of Antipsychotics
Regulatory Aspects
F309- Review of Care and Services for a Resident with Dementia
F329 – Unnecessary Meds
Margie Huguet, RN, MCSDHH Health Standards Section
Long Term Care Supervisor
Objectives:1. Discuss the requirements for
appropriate use of antipsychotics in dementia only residents (F309 – Quality of Care & F329 – Unnecessary Meds).
CMS S&C: 13-35-NHInterpretive Guideline Revisions
F309 Quality of CareReview of Care and Services for a
Resident with Dementia
F309- Review of Care and Services for
a Resident with Dementia
F309 – Quality of CareCare and Services for a Resident with Dementia
Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable
physical, mental, and psychosocial well-being,
in accordance with the comprehensive assessment and plan of care.
Refer to handout for F309
F309- Review of Care and Services for
a Resident with Dementia
Person-Centered Care
F309- Review of Care and Services for
a Resident with Dementia
Behavioral Interventions individualized approaches (including
direct care and activities) provided as part of a supportive
physical and psychosocial environment directed toward understanding,
preventing, relieving, accommodating a resident’s distress
or loss of abilities.
F309- Review of Care and Services for
a Resident with Dementia
Behavioral or Psychological Symptoms of Dementia (BPSD)
Behavior or other symptoms in individuals with dementia that cannot be attributed to a specific medical or psychiatric cause.
Specific Guidance for Antipsychotic Use and residents with BPSD.
7F309- Review of Care and Services
for a Resident with Dementia
Dementia & Behavioral Health
8F309- Review of Care and Services
for a Resident with Dementia
Care Process for a Resident with DementiaA. Recognition and AssessmentB. Cause Identification and DiagnosisC. Development of Care PlanD. Individualized Approaches and
TreatmentE. Monitoring, Follow-up and OversightF. Quality Assessment and Assurance
F309- Review of Care and Services for
a Resident with Dementia
A. Recognition and Assessment Collecting detailed information
Past life experiences Description of behaviors Preferences Oral health Presence of pain Medical conditions Cognitive status Medications
10F309- Review of Care and Services
for a Resident with Dementia
Knowing the Whole Person How communicates physical needs such as
pain, discomfort, hunger or thirst, as well as emotional and psychological needs such as
frustration or boredom; or a desire to do or express something that he/she cannot articulate;
Usual and current cognitive patterns, mood and behavior, and whether these present a risk to the resident or others;
How displays personal distress such as anxiety or fatigue.
11F309- Review of Care and Services
for a Resident with Dementia
Knowing the Whole BehaviorConducting a Behavior AssessmentSpecific description of behaviorPotential underlying causeDurationIntensityPrecipitating eventsEnvironmental triggers, etc…Related factors such as appearance & alertness
12F309- Review of Care and Services
for a Resident with Dementia
B. Cause Identification and Diagnosis
Use the information collected to identify potential causes Looking to see if a REVERSIBLE CAUSE
Physical Functional Psychosocial Environmental Interactions with others Etc…
13F309- Review of Care and Services
for a Resident with Dementia
Steps to Eliminate Off-Label Antipsychotic Use
Step 6QI Closest to the Resident
Track and Trend and Care PlanRefer to Handout for Process
©B&F Consulting 2015www.BandFConsultingInc.com
16©B&F Consulting 2015
www.BandFConsultingInc.com
17
Track and
Trend
©B&F Consulting 2015www.BandFConsultingInc.com
Step 2 – C. Development of Care Plan
The care plan should reflectBaseline and ongoing details of common behavioral expressions and expected response to interventions;
Specific goals for and monitoring of all interventions for effectiveness in responding to target behaviors/expressions of distress;
F309- Review of Care and Services for
a Resident with Dementia
C. Development of Care PlanFor any medications indication/rationale for use, specific target behaviors and expected outcomes, dosage, duration, monitoring for efficacy and/or adverse consequences and plans for GDR if an antipsychotic medication is used.
F309- Review of Care and Services for
a Resident with Dementia
Changing the Culture of Care Planning
TRADITIONAL PERSON CENTERED
Staff know you by ‘diagnosis’
Staff have personal relationship with resident & family
Staff write the care plan based on what they think is best for your diagnosis
Resident, family, and staff develop a care plan that reflects what the resident desires for him/herself
Interventions are based on standards of practice per diagnosis.
Unique interventions which meet the need of that resident.
Care Plan is written in the third person.
Care plan is written in the first person “I” format.
Changing the Culture of Care Planning
TRADITIONAL PERSON CENTERED
Care plan attempts to fit the resident into the facility routine.
Care plan identifies the resident’s lifelong routine and how to continue in the nursing home.
Nursing Assistants are not part of ID Team.
Nursing Assistants are a very valuable part of IDT and present at each care plan conference.
The Care Plan is scheduled to fit facility convenience.
The Care conference is scheduled at resident and family convenience.
Traditional Care Plan“Innovations in Quality of Life – Pioneer Network”Problem Goal Interventions
Resident wanders due to Dementia.
Resident will not wander into other resident rooms through the next care planning meeting.
Redirect resident to appropriate areas of facility.
Teach resident not to enter rooms with sashes across door.
Encourage resident to sit in lounge and other common areas.
Praise for cooperation.
Person Centered Care Plan“Innovations in Quality of Life – Pioneer Network”
Problem
Goal Interventions
I need to walk.
I will continue to walk freely throughout my home.
After I eat breakfast and get dressed, I want to walk with staff.
I will accompany you anywhere. I like to help while we are together. I can fold linen and put things away
with you. I do not like to nap. If weather permits, please walk
outside with me. I like to keep walking in the evening
until I go to bed. I sit when I am tired; don’t fuss over
asking me to sit.
D. Individualized Approaches/Treatment Implementing Care Plan
Staffing & Staff Training Quantity of Staff & Quality of Staff
Familiarity with the residents (consistent staffing)
Staff competency in the skills and techniques Staff Training in the care of individuals with
dementia and related behaviors Involvement of the Medical Team Monitoring and follow-up to ensure
effectiveness of care plan interventions Revisions to care plan as needed.
F309- Review of Care and Services for
a Resident with Dementia
NON-PHARMACOLOGICAL APPROACHES TO
REDUCING THE USE OF ANTIPSYCHOTICS
Presented byWanda Raby Spurlock, DNS, RN-BC, CNE,
FNGNAProfessor, Southern University and A&M College
School of Nursing
Non-pharmacological approaches Think about the PERSON
Think about the PROBLEM behavior
Select a type of intervention
PERSONALIZE the intervention
26
Revised by M. Smith (2005) from M. Smith & K.C. Buckwalter (1993), “Acting Up and Acting Out: Assessment and Management of Aggressive and Acting Out Behaviors,” The Geriatric Mental Health Training Series, for the Hartford Center of Geriatric Nursing Excellence, College of Nursing, University of Iowa.
Non-pharmacological approaches Algorithm for Treating BPSD (handout)
Interventions fall into 3 major categories:1. Adjust care giver approaches2. Change the environment3. Use evidence-based interventions
27
Revised by M. Smith (2005) from M. Smith & K.C. Buckwalter (1993), “Acting Up and Acting Out: Assessment and Management of Aggressive and Acting Out Behaviors,” The Geriatric Mental Health Training Series, for the Hartford Center of Geriatric Nursing Excellence, College of Nursing, University of Iowa.
https://www.youtube.com/watch?v=vk4wcLK9nTc
CMS S&C: 13-35-NHInterpretive Guideline Revisions
F329 – Unnecessary Medications
Antipsychotic Medications
F329- Unnecessary MedicationsAntipsychotic Medications
Is the antipsychotic medications being used as a:
OR A SUBSTITUTE FOR A HOLISTIC APPROACH (F309)?
F329- Unnecessary MedicationsAntipsychotic Medications
§483.25(l) Unnecessary Drugs - F329 Part 1. General (all classifications of meds)
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.
F329- Unnecessary MedicationsAntipsychotic Medications
§483.25(l) Unnecessary Drugs - F329 “Part 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.
F329- Unnecessary MedicationsAntipsychotic Medications
F329- Unnecessary MedicationsAntipsychotic Medications
Psychosis in the Absence of Dementia
What was CMS thinking? prevent diagnosis of psychosis NOS used to justify
antipsychotic medication…
could psychosis be related to symptoms of dementia and non-pharmacolgical approaches if tried been effective…
B. Behavioral or Psychological Symptoms of DementiaAntipsychotic medications:
are only appropriate for elderly residents in a small minority of circumstances
Carry a FDA Black Box Warning
↑ risk of death in elderly patients treated for dementia-related psychosis
35F329- Unnecessary Medications
Antipsychotic Medications
BPSD - Indications for Use - Elderly residents with Dementia Considered and Prescribed only after:
Medical, physical, functional, psychological, emotional, psychiatric, social and environmental causes have been identified and addressed.
Prescribed at: the lowest possible dosage for the shortest period of time
Subjected to: gradual dose reduction and re-review
F329- Unnecessary MedicationsAntipsychotic Medications
§483.25(l) Unnecessary Drugs - F329BPSD - “Inadequate Indications for Use”
wandering poor self-care restlessness impaired memory mild anxiety insomnia inattention or
indifference to surroundings
inattention or indifference to surroundings
sadness or crying alone that is not related to depression or other psychiatric disorders
fidgeting nervousness uncooperativeness (e.g.
refusal of or difficulty receiving care).
Antipsychotic medications in persons with DEMENTIA should not be used if the only indication is one or more of the following:
F329- Unnecessary MedicationsAntipsychotic Medications
BPSD - Indications for Use - Elderly residents with Dementia The behavioral symptoms present a danger to
the resident or others
AND one or both of the following:
1. The symptoms are identified as being due to mania or psychosis (such as: auditory, visual, or other hallucinations; delusions, paranoia or grandiosity);
OR
2. Behavioral interventions have been attempted and included in the plan of care, except in an emergency.
38F329- Unnecessary Medications
Antipsychotic Medications
BPSD - Indications for Use Elderly residents with Dementia A diagnosis alone without substantiating
information in the record is not necessarily justification for the use of a medication.
For example: Adding a diagnosis of schizophrenia next to an
order for an antipsychotic when there is no supporting documentation that substantiates the diagnosis, does not meet the regulatory requirement regarding indication for use.
F329- Unnecessary MedicationsAntipsychotic Medications
BPSDAcute Situations/Emergency1. The acute period is limited to 7 days or less;
AND
2. A clinician with IDT must evaluate/document situation within 7 days to identify /address contributing and underlying causes of the acute conditions and verify the continuing need
3. If behaviors persist, pertinent non-pharmacological interventions must be attempted, unless clinically contraindicated, and documented following the resolution of the acute psychiatric event.
BPSDEnduring Conditions Antipsychotic medications may be used
to treat an enduring (i.e., non-acute; chronic or prolonged) condition, if the clinical condition/diagnosis meets the criteria discussed earlier.
Target behaviors must be clearly and specifically identified and documented.
BPSD - Enduring Conditions Before initiating or increasing
Monitor behavior symptoms to ensure the behavioral symptoms are not due to:
Medical condition or problem…; and Environmental stressors alone…; and Psychological stressors alone…; and Persistent…
BPSD - New Admissions If resident newly admitted/readmitted on an
antipsychotic medication and the resident diddid require a PASRR screen, the facility is responsible for:
Preadmission screening, andObtaining physician’s orders for the
resident’s immediate care
This PASRR screening (F285) should provide pertinent information including appropriate clinical indications for the use of an antipsychotic.
BPSD - New Admissions If resident newly admitted/readmitted on an
antipsychotic medication and the resident did not did not require a PASRR screen, the facility must re-evaluate the
use of the antipsychotic medication at the time of admission and/or within 2 weeks of admission and
consider whether or not the medication can be reduced (tapered) or discontinued.
BPSD - Antipsychotic Dosage Treatment should begin at the lowest
possible dose to improve the target symptoms being monitored.
Start low – go slow…
Steps to Eliminate Off-Label Antipsychotic Use
Step 5
Train Staff on Why and How to Reduce Antipsychotics
©B&F Consulting 2015www.BandFConsultingInc.com
State Licensing Requirement
State Licensing Requirement
The initial dementia-specific training required within 90 day of employment must have curriculum approval.
The annual dementia training does not require the department’s approval.
49F309- Review of Care and Services
for a Resident with Dementia
50
Joanne Rader
F309- Review of Care and Services for
a Resident with Dementia
https://www.youtube.com/watch?v=PUZFqERMeE8
10 Steps to Eliminate Off-Label Antipsychotic Use
1. Establish A Leadership Team
2. Review CMS Survey Guidance to Understand Why and How
3. Analyze MDS CASPER Resident Level Quality Measure Report to Identify Target Population and Coding Errors
4. Triage: Review Why Each Resident is Receiving Antipsychotics and Take Care of Easy-to-Act-On Situations
5. Train Staff on Why and How to Reduce Antipsychotics
6. QI Closest to the Resident – Track and Trend and Care Plan
7. Engage Physicians, Prescribers, Consultant Pharmacist
8. Engage Families9. Update your policies,
procedures and forms 10. Sustain and Spread
©B&F Consulting 2015www.BandFConsultingInc.com
Available Toolkits - FREE Eliminating Off-Label Use of Antipsychotic – A 10 Step
Guide for Nursing Homes Developed by B&F Consulting for the LA Dementia Partnership
Workgroup Project & Funded by CMS CMP funds (handout)
A Toolkit for Improving Dementia Care in Nursing Homes - Clinical Consideration of Antipsychotic Management
Developed by AHCA/NCAL Quality Initiative – Antipsychotic Management Toolkit
Archived Webinar (June 24) training on how to use this Toolkit presented by eQHealth Solutions
Promoting Positive Behavioral Health: A Non-pharmacological Toolkit for Senior Living Communities http://www.nursinghometoolkit.com
You Can Do It!