ANTIPSYCHOTIC DRUG USE IN

SKILLED NURSING

FACILITIES

Rhonda Anderson, RHIA

President

AHIS, Inc.

Antipsychotic Use in the Headlines

May 27, 2008 – JAMA and Archives Journals– “Short-term Use Of Antipsychotics In Older Adults

With Dementia Linked To Serious Adverse Events.”– http://

jama.ama-assn.org/content/300/4/379.short?citedby=yes&legid=jama;300/4/379

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Antipsychotic Use in the Headlines -2

2009- American Journal of Geriatric Pharmacotherapeutics- “There is a statistically significant increase in antipsychotic drug prescriptions from 16.4% in 1996 to 25.9% in 2006. Higher utilization rates were found in nursing homes that were for-profit, had lower Medicare reimbursement rates, and had lower levels of competition. “– Reference www.medscape.com/medline/abstract/19616182

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Antipsychotic Use in the Headlines -3

January 2010 – Archives of Internal Medicine– University of Massachusetts Medical School Study

(Y. Chen, MD)–More than 1/3 of nursing home residents were

prescribed an antipsychotic without clinical indication.

– Residents in NHs with the highest prescribing rates were 1.37 times more likely to receive antipsychotic medication.• http://archinte.jamanetwork.com/article.aspx?articleid=48

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Antipsychotic Use in the Headlines -4

2009 – Eli Lilly pled guilty and paid $ 1.4 billion to the federal government for allegedly targeting doctors who worked in NHs and assisted living facilities to prescribe olanzapine off-label to patients with dementia

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Antipsychotic Use in the Headlines -5

2011 – Health and Human Services OIG Report– 14% of all nursing home residents with Medicare

had claims for antipsychotics– 88% of the atypical antipsychotics prescribed off-

label were for dementia.– http://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf

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Definition – Psychotropic

Exerting an effect on the mind, capable of modifying mental activity; said especially of drugs (Dorland’s).

Having an altering effect on perception or behavior. Used especially of a drug (The American Heritage Medical Dictionary).

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Definition – Psychotherapeutic

Drugs that are prescribed for their effects in relieving symptoms of anxiety, depression, or other mental disorders (Mosby’s Medical Dictionary).

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What are Psychotherapeutic Medications?

Antipsychotics – typical and atypical– Haldol, Seroquel,

Risperdal, etc…

Anticonvulsants– Tegretol, Depakote,

etc…

Antidepressants– Celexa, Lexapro, etc…

Sedative‐Hypnotic– Ativan, Xanax, etc…

Others– Beta‐blockers, alpha 1‐

2, Provera, etc…

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The Proper Indications for Use

Antipsychotics– Psychotic behavior:

Auditory or Visual Hallucinations, delusional thinking

Anticonvulsants– Poor impulse control:

Aggressive behavior or mood disorder

Antidepressants– Depression or mood

disorder

Sedatives‐Hypnotics‐Benzodiazepines– Insomnia or Anxiety

Others– Sexually aggressive,

temper outburst, impulsive behavior

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DSM‐IV Diagnosis

SchizophreniaSchizo‐affective

disorderDelusional disorderPsychotic mood

disorders (including mania and depression with psychotic features)

Acute psychotic episodes

Brief reactive psychosis

Atypical psychosisTourette's disorderHuntington's disease

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Organic Mental Syndromes

Delirium, dementia & amnesic & other cognitive disorders w/ associated psychotic and/or agitated behaviors that have been quantitatively & objectively documented. This documentation is necessary to assist in:– Assessing whether the resident's behavioral

symptom requires some form of intervention;– Determining whether the behavioral symptom is

transitory or permanent.12

Organic Mental Syndromes -2

Delirium, dementia & amnesic & other cognitive disorders (cont.)– Relating the behavioral symptom to other events in

the resident's life to learn about potential causes (e.g., death in the family, adhering to the resident's customary daily routine);

– Ruling out environmental causes (e.g., excessive heat, noise, overcrowding);

– Ruling out medical causes (e.g., pain, constipation, fever, infection).

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Dementia with Behavior Disturbance

According to the AHCA– 1st line treatment for residents who do not present

immediate danger to themselves or others should be non-pharmacologic;

–While no drugs are approved by the FDA for the treatment of behavioral symptoms in older adults with dementia, if pharmacotherapy is deemed appropriate use the most appropriate agent and the lowest effective dose, for the shortest amount of time;

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Dementia with Behavior Disturbance -2

According to the AHCA– Response to therapy should be monitored and

documented frequently and evaluated for gradual dose reduction, tapering or discontinuation.

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Meanwhile in CA… SB 303 Veto Message…..

…“My Administration is concerned about the inappropriate use of psychotherapeutic medications, especially antipsychotics, in skilled nursing facilities. One recent study concluded that over half of the residents receiving antipsychotic therapy were being treated outside the current Center for Medicare and Medicaid Service guidelines.

I have instructed my Department of Public Health to identify providers that may be inappropriately prescribing these medications and thereby posing a threat to the health and safety of residents in skilled nursing facilities. If the department’s analysis indicates that such inappropriate prescribing behavior is occurring and recommends statutory changes in this area, I ask the Legislature to immediately seek changes to correct it.”

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Regulatory Information

In response to concerns expressed by the Senate Special Committee on Aging, the Office of Inspector General (OIG) studied the extent to which psychotropic drugs are being used in nursing homes as inappropriate chemical restraints.

The OIG found that, in general, these drugs are being used appropriately.

Where there are problems, they are related to inappropriate dosage, chronic use, lack of documented benefit to the resident, and unnecessary duplicate drug therapy.

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“CDPH/ DHCS AntipsychoticCollaborative” Is Born

CDPH and DHCS mine data to identify Medi-Cal residents who receive one or more antipsychotic medications.

CDPH invests consultant pharmacist resources to conduct “complaint” visits at targeted facilities in these District Office Areas:– Chico, Daly City, East Bay, Fresno (Modesto

only), Sacramento, San Diego, San Jose, Santa Rosa/Redwood Coast

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Collaborative “Target” Criteria

Residents currently prescribed either:– Two antipsychotic medications concurrently

OR– One (or more) antipsychotic medication(s) with a

primary diagnosis of Alzheimer’s or dementia with or without a co-existing diagnosis of serious mental illness (SMI)

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Definition of Unnecessary Drug Use

Each resident’s drug regimen must be free from unnecessary drugs which is any drug used:– In excessive dose (including duplicate drug therapy);– For excessive duration;– Without adequate monitoring;– Without adequate indications for its use;– In the presence of adverse consequences which indicate the dose

should be reduced or discontinued;– Any combination of the above reasons;– When a resident receives duplicate drug therapy, an evaluation

should be completed for accumulation of the adverse effects. 20

Justification for Drug Use OutsideGuidelines

Medical Provider’s progress note indicating that the dosage, duration, indication & monitoring are clinically appropriate and why they are clinically appropriate.

Carefully considered the RISK/BENEFIT to the resident.

A medical or psychiatric consultation and ongoing evaluation.

Evaluations (e.g., Geriatric Depression Scale) confirming the medical provider’s judgment that use of a drug outside the guidelines is in the best interest of the resident. 21

Be Proactive In Your Facility

What can you do?– Open transparent communication with patients and

their family/responsible parties (RP);– Education (patient/family/RP/staff);• Use your local resources (ALZ association);

– Therapeutic communication with medical providers;– Ask “is this going to improve the quality of the

residents life?”;– Interdisciplinary team meetings (IDT).

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IDT Meetings

Should include:– Nursing staff that knows the resident;– Physical therapy;– Dietary;– Social Services;–Medical staff if they are available;– Psychiatrist MD/NP, Psychologist, etc.;– Review every resident’s chart that is using a

psychotherapeutic medication at least Quarterly.23

Informed Consent

Who is responsible for obtaining the informed consent?– The medical provider who ordered the medication

(only physician for antipsychotics).

Nursing responsibility is per facility policy– Obtain verification of informed consent; via

physician orders and or a form.

Flow Chart Admin #4030

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“Antipsychotic Collaborative”Outcomes

Focus on informed consent – EXPECT SURVEYORS TO SCRUTINIZE.

Consultant pharmacist services.Nursing services- care planning and monitoring.Pharmacist “Fair Market Value”.

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DHCS Weighs In…

August 2011 – The Department of Health Care Services (DHCS) adds a “Code I Restriction” for all antipsychotic medications available on the Contract Drug List (CDL) for Fee-For-Service Medi-Cal beneficiaries.

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DHCS Weighs In…-2

After October 1, 2011, all antipsychotic medications listed on the CDL will include the following restriction: “Restricted to … Federal Drug Administration (FDA) – approved indications for those beneficiaries residing in Skilled Nursing Facilities only.”– http://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull

/ph201108r.asp#al

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Justification

Documentation of:–Medical provider, nursing, or other health

professional indicating that the resident is being monitored for adverse consequences or complications of the drug therapy;

– GDR attempts and outcomes (including MDS documentation) showing the resident's subjective or objective improvement or maintenance of function while taking the medication.

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Justification -2

Documentation showing:– The resident's decline or deterioration has been

evaluated by the interdisciplinary team to determine whether a particular drug, a particular dose, or duration of therapy may be the cause;

–Why the resident's age, weight, or other factors would require a unique drug dose or drug duration, indication, or monitoring.

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Guidelines for Use of AntipsychoticDrugs

Long‐term care centers must ensure, based on a comprehensive assessment of the resident, the following:–When an antipsychotic drug has not been used in the

past, it is not given unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record. Antipsychotic drugs should not be used unless the clinical record documents that the resident has a specific Diagnosis????

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DPH Focuses on InformedConsent

DPH Informed Consent All Facilities Letter (AFL) Issuances:– January 7, 2011 – Obtaining informed consent for preexisting

orders;– April 12, 2011 – Q&A Document

http://www.cdph.ca.gov/certlic/facilities/Documents/LNC-AFL-11-31.pdf

Key is educating acute hospital re: need for informed consent verification.

Facility documentation verifying that informed consent has been obtained by the M.D.

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Regulations of Interest

Frequency Cited in 2011– F Tag 329- Unnecessary Drugs (28%);– F Tag 425- Pharmacy Procedures (25%);– F Tag 431- Labeling of Drugs ( 32%);– F Tag 481- Professional Standards of Quality ( 24%).

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What Surveyors Evaluate

CDPH Antipsychotic Survey Tool July 2012 Medications used are routinely monitored

(therapeutic effects, ADR, side effects) according to manufacturer’s specifications or standards of practice.

Necessary labs, weights, VS are taken and recorded.

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What Surveyors Evaluate -2

Doses are appropriately titrated up or down for an elderly person, including planned dose reduction.

Resident with renal/hepatic impairment has appropriate dose adjustment and.

Whether there is an association between Rx and recently identified symptoms/condition change such as fall/recurrent falls, decline in ADLs or decreased sensorium/increased somnolence.

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What To Do From Here?

Run a list of all residents on antipsychotics.Identify what MDS indicates re: ability to make

decisions.Review MDS what states re: Behaviors &

Beh./Psych Medications.Review the Admission information re: who

signed the resident into the facility.Determine the resident’s capacity from the H&P.

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Determine Resident on Antipsychotics and Psychotherapeutic Drugs

Determine if antipsychotic and the resident has approved discussion with other family members (if resident has capacity). -id. Where they plan to document.

Acute Hospital – Resident admitted from Acute– Do records show if informed consent obtained?– Acknowledgement of informed consent by

appropriate party.

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Verification by Physician

Verification by the attending physician that informed consent obtained was provided to the resident and/or family (depending on capacity).

Facility’s verification may also include documentation of red box warnings and information the facility wishes to provide.

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Your Action Plan

List:– – – – –

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