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Clare I. Hays, MD, CMD

Review regulatory background for current CMS emphasis on antipsychotics

Understand the risks and (limited) benefits of antipsychotic medications

Review non pharmacologic management of Review non-pharmacologic management of patients with dementia

Begin to develop a plan for anti-psychotic reduction in your facility

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F329 Unnecessary Drugs

F428 D (M di ti ) R i R i F428 Drug (Medication) Regimen Review

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Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used:In excessive doseFor excessive durationFor excessive durationWithout adequate monitoringWithout adequate indication for useIn the presence of adverse consequences

AntipsychoticsResidents 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 medical recordResidents who use antipsychotic drugs receive

gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs

Gradual Dose ReductionConsiderations Specific to AntipsychoticsIn 1st year must attempt GDR in 2 separate quarters

(with 1 month between attempts)After 1st year GDR attempted annuallyContraindicated if target symptoms returned or

worsened or MD documents clinical rationale for why any additional attempted dose reduction would impair resident’s function or increase distressed behaviorContraindicated for specific psychiatric disorder

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Thorough evaluation of medication regimen of resident required

Promote positive outcomes and minimizing adverse consequences associated with medicationmedication

Collaborate with other members of the IDT

Treatment of psychotic disorder, e.g. schizophrenia

Treatment of psychotic symptoms (e.g. delusions, hallucinations) associated with other conditions (e g Alzheimer’s Disease orother conditions (e.g. Alzheimer s Disease or delirium)

Treatment of behavioral and psychological symptoms associated with dementia (BPSD), when these symptoms present a risk of harm to the resident or others

Black Box Warning Issued in 2004 for atypicals; expanded to include all antipsychotics in 2008Elderly with dementia related psychosis treatedElderly with dementia-related psychosis treated

with these drugs are at increased risk for death compared to placebo

Consistent across all antipsychotics Relative risk=1.6-1.7

Jeste et al, Neuropsychopharmacology 2008; 33:957-70.

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Sedation Postural Hypotension Falls Extrapyramidal (Parkinsonism, tremor,

k thi i )akathisia) Cerebrovascular (Stroke) Mortality, predominantly infection and cardiac Metabolic side effects (weight gain, DM,

hyperlipidemia)

The resulting emphasis on reducing the inappropriate prescribing of antipsychotic drugs

for elderly nursing home residents

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14% of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs304,983 of 2.1 million NH residents20% of all claims for atypicals for all Medicare20% of all claims for atypicals for all Medicare

beneficiaries17% of NH residents with claims had claims for

more than one atypical

83% of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions

88% were associated with the condition 88% were associated with the condition specified in the FDA boxed warning (dementia with psychosis or behavioral symptoms)

51% of Medicare atypical antipsychotic drug claims for elderly nursing home residents were erroneous (did not comply with Medicare reimbursement criteria), amounting to $116 millionto $116 millionNot used for medically accepted indications as

supported by the compendiaNot documented as having been administered to

the elderly nursing home residents

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22% of the atypical antipsychotic drugs claimed were not administered in accordance with CMS standards regarding unnecessary drug use in nursing homes ($63 million)42% of those claimed drugs did not comply with42% of those claimed drugs did not comply with

CMS standards for more than one reason

22% of antipsychotic prescriptions in nursing homes are problematicProblem per CMS Standards % Claims

Excessive Dose 10.4 %Excessive Dose 10.4 %

Excessive Duration 9.4%

Without Adequate Indication 8.0%

Without Adequate Monitoring 7.7%

In the Presence of Adverse Effects 4.7%

Cost ~$116 million

Facilitate access to information necessary to ensure accurate coverage and reimbursement determinations. Recommended including diagnosis on claim but CMS did

not concur (no requirement on Rx; no industry standard) Assess whether survey and certification processes

offer adequate safeguards against unnecessary q g g yantipsychotic 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.

Take appropriate action regarding the claims associated with erroneous payments identified in the sample.

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CMS Initiative—Surveyor Training•Raise awareness of antipsychotic misuse•Improve regulatory oversight•Train NH workers on non-drug treatments for aggressive and agitated dementia behaviors

A CMS nursing home resident report found that almost 40 percent of nursing home patients with signs of dementia were receiving antipsychotic drugs at some point in 2010, even though there was no diagnosis of psychosis

Multiple federal investigations/lawsuits involving drug companies and marketing of antipsychotics todrug companies and marketing of antipsychotics to nursing homes

Failure of a proposed amendment meant to curb the “off-label” use of antipsychotic drugs to control elderly residents with dementia

Involves federal and state agencies, advocacy groups, and caregivers at nursing homes and other eldercare facilities.

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National Goal--Reduce use of antipsychotic drugs in nursing home residents by 15 percent by the end of 2012. “Just a start”

Enhanced training— “Hand in Hand” Increased transparency facility antipsychotic Increased transparency—facility antipsychotic

rates to be on Nursing Home Compare then updated quarterly

Alternatives to antipsychotics— “non-pharmacologic alternatives”

CMS will report the percent of long-stay nursing home residents who are on an anti-psychotic drug

And, CMS will report the percent of short-stay residents who are started on an anti-psychotic drug after being admitted to a nursing home

Alabama’s Opportunity for Improvement

Reporting Period 4/1/2011-12/31/2011

07/1/2011-3/31/2012

Average for all reporting nursing 27.3% 27.6%

Reducing Antipsychotic Medications

homes- AL

Average for all reporting nursing homes- US

23.9% 23.9%

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Problem Behavior MisinterpretationAmnesia (loss of memory)

Repeats questions often, misplaces objects

“frustrating”“paranoid”

Apraxia (loss of ability to coordinate learned

t )

Cannot use utensils, dress, use toilet

“won’t eat”“uncooperative”

movements)Aphasia (inability to speak or understand)

Cannot follow directions or engage in coversation

“quiet”“uncooperative”“agitated”

Agnosia Cannot recognize faces, familiar places, or objects

“frightened”“combative”“wandering”“steals others’ belongings”

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Describe Decode Design interventiong Do it Decide if intervention was successful

Social Services Activities Nursing Nursing Direct Care Staff Medical Director, Attending Physicians, NPPs Dietary Staff Ancillary Staff

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How does staff address behavioral responses by persons withpersons with dementia in your facility?

Person-centered care Consistent assignment Increased exercise or time outdoors Environment

R d l d h do Reduce glare and shadowso Reduce noiseo Reduce clutter

Monitoring and managing acute and chronic pain

Planning individualized activities

Look for unmet needso Hunger, thirsto Too hot, too coldo Tiredo Boredo Overstimulatedo Paino Toileting

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Rule out reversible causes prior to using a drug Try non-drug management strategies first Clearly document target symptoms Justify use of an antipsychoticSymptom must present danger to self or others or cause:Symptom must present danger to self or others or cause:

o Inconsolable or persistent distresso A significant decline in functiono Substantial difficulty receiving needed care

Consider impact of side effects If the drug doesn’t help, stop it

Aggressive behavior (especially physical) Hallucinations (if distressing) Delusions (note: memory problems are often

mistaken for delusions, e.g. thinks someone stealing lost items)stealing lost items)

Severe distress

Wandering Unsociability Poor self-care Restlessness Nervousness, fidgeting, mild anxiety Impaired memory Uncooperativeness, “resistance to care” without

aggressive behavior Inattention or indifference to surroundings Verbal expressions or behaviors that do not

represent a danger to the resident or others

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The use of antipsychotics in nursing facility residents should include:An appropriate indication for useA specific and documented goal of therapyOngoing monitoring of the resident to evaluate g g g

effectiveness in achieving the therapy goal and the development or presence of adverse effects from the medicationUse of the medication only for the duration needed,

and at the lowest effective dose

List of all residents with antipsychotic medication

Confirm diagnosis. Eliminate Schizophrenia, Bipolar, Tourette’s, Huntington’s.

Confirm target symptoms look for specific Confirm target symptoms…look for specific evidence of delusions, hallucinations, severe symptoms. Use behavior management program/social services.

Find those without appropriate diagnosis/symptoms and work on those first

Review baseline data

Pull your own dataU d d h Understand the numbers

Follow regularly

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Get Medical Director on board Utilize pharmacy consultant Make sure Medical Director communicates

with attending physicians and NPPs who write ordersorders.

Physicians must document WHY—must show risk/benefit assessment done

More frequent review of all patients on antipsychotics

“We want our loved ones with dementia to receive the best care and the highest quality

of life possible,” Acting Admin. Marilyn Tavenner.