steps to success eliminating off-label use of antipsychotics regulatory aspects f309- review of care...

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



Person-Centered Care



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.



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



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



A. Recognition and Assessment Collecting detailed information

Past life experiences Description of behaviors Preferences Oral health Presence of pain Medical conditions Cognitive status Medications



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.



Knowing the Whole BehaviorConducting a Behavior AssessmentSpecific description of behaviorPotential underlying causeDurationIntensityPrecipitating eventsEnvironmental triggers, etc…Related factors such as appearance & alertness



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…



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

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Track and

Trend


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;



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.



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.



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

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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)?


§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.


§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.


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


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


§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:


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


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.


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


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.

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Joanne Rader



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


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!

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