Practical Steps in Reducing Psychotropic Medications Michael A. Lutz RPh, CGP Asst. Director of Clinical Services Green Tree Pharmacy Dawn Conaty RN,

Practical Steps in Reducing Psychotropic

Medications

Michael A. Lutz RPh, CGP Asst. Director of Clinical Services Green Tree Pharmacy

Dawn Conaty RN, BSN, Field Nurse Consultant Heritage Enterprises

CMS Initiative5/30/2012

CMS National Partnership to Improve Dementia Care: Rethink, Reconnect, Restore

CMS Initiative

15%406,300 vs. 345,355 = 60,945 fewer residents receiving

antipsychotics

610 fewer deaths due to treatment each year

CMS InitiativeWhere are we today?

Nationally Long-stay nursing home residents 2011Q4 = 23.9%

Nationally Long-stay nursing home residents 2014Q3 = 19.2%

19.7%National Statistical Results

CMS initiative.

Illinois Long-stay nursing home residents 2011Q4 = 25.7% Illinois Long-stay nursing home residents 2014Q3 = 23.54%

8.4%Illinois Statistical Results

CMS InitiativeWhere are we today?

Illinois

State Ranking 49 of 51

National Comparison

Future Reductions

New goal of a 25 percent reduction by the end of 2015

30 percent reduction by the close of 2016 using the prior baseline rate (fourth quarter of 2011)

F329 (Unnecessary Drugs)

1. 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.

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.

INTENT: §483.25(l) Unnecessary drugs

Each resident’s entire drug/medication regimen be managed and monitored to achieve the following goals:

The medication regimen helps promote or maintain the resident’s highest practicable mental, physical, and psychosocial well-being, as identified by the resident

Each resident receives only those medications, in doses and for the duration clinically indicated to treat the resident’s assessed condition(s);

Non-pharmacological interventions (such as behavioral interventions) are considered and used when indicated, instead of, or in addition to, medication;

Clinically significant adverse consequences are minimized; and The potential contribution of the medication regimen to an unanticipated

decline or newly emerging or worsening symptom is recognized and evaluated, and the regimen is modified when appropriate.

NOTE: This guidance applies to all categories of medications including antipsychotic medications.

Why is this important?

Resident health and safety

death rate, BG, stokes, lipids

Survey deficiency CMS Chief Medical Officer Patrick

Conway, M.D., confirmed in the fall that the Five Star system would start including antipsychotics measurements in 2015.

Indications for Use: A. Conditions Other than Dementia

  An antipsychotic medication should generally be used only for the following conditions/diagnoses

as documented in the record and as meets the definition(s) in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Training Revision (DSM-IV TR) or subsequent editions):

Schizophrenia Schizo-affective disorder Schizophreniform disorder Delusional disorder Mood disorders (e.g. bipolar disorder, severe depression refractory to other therapies and/or with

psychotic features) Psychosis in the absence of dementia Medical illnesses with psychotic symptoms (e.g., neoplastic disease or delirium) and/or treatment

related psychosis or mania (e.g., high-dose steroids) Tourette’s Disorder Huntington disease Hiccups (not induced by other medications) Nausea and vomiting associated with cancer or chemotherapy 

B. Behavioral or Psychological Symptoms of Dementia (BPSD)

Behavioral or Psychological Symptoms of Dementia (BPSD)

There is no one code fits all for BPSD, however, depending on the specific situation the majority of the time 294.11 and 294.21 will be the

code of choice

Diagnosis alone does not warrant the use of antipsychotic medications.

The following criteria are also met: 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.

Inadequate Indications for Antipsychotics

Insomnia Wandering Restlessness Impaired memory Mild anxiety Poor self-care Unsociability Fidgeting

Nervousness Uncooperativeness (e.g.

refusal of or difficulty receiving care)

Inattention/indifference to surroundings

Verbal expressions and/or behaviors that do not present danger to the resident or to others

Non-pharmacologic approaches

Exercise animal-assisted therapy aroma therapy music therapy light therapy massage/touch therapy TENS Multisensory stimulation

Antipsychotic Medications First generation (conventional) agents, e.g.

• chlorpromazine (Thorazine)

• fluphenazine (Prolixin)

• haloperidol (Haldol)

• loxapine (Loxitane)

• mesoridazine (Serentil)

• molindone (Moban)

• perphenazine (Trilafon)

• thioridazine (Mellaril)

• thiothixene (Navane)

• trifluoperazine (Stelazine)

Second generation (atypical) agents, e.g.

• asenapine (Saphris)

• aripiprazole (Abilify)

• clozapine (Clozaril)

• iloperidone (Fanapt)

• lurasidone (Latuda)

• olanzapine (Zyprexa)

• paliperidone (Invega)

• quetiapine (Seroquel)

• risperidone (Risperdal)

• ziprasidone (Geodon)

Antipsychotic medications may be considered for elderly residents with dementia but only after medical, physical, functional, psychological, emotional psychiatric, social and environmental

causes have been identified and addressed.

PRN antipsychotic usageAdditional Criteria:

Acute Situations/Emergency

When an antipsychotic medication is being initiated or used to treat an emergency situation (i.e., acute onset or exacerbation of symptoms or immediate threat to health or safety of resident or others) related to one or more of the aforementioned conditions/diagnoses, the use must meet the above criteria and all of the following additional requirements:

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

Pharmacist involvement Identify maximum daily dosage, appropriate DX, documentation to

support AP, BTS, etc.,

Letter sent from pharmacy about CMS-specific DX & max daily dose (not in all homes, yet)

Safe reductions (longer on AP = longer for reduction)

AIMS-must be proficient History dictates otherwise

Assess risk to resident: first determining whether there is an underlying medical, physical, functional, psychosocial, emotional, psychiatric, or environmental cause of the behaviors

Surveyor Interview Encouraged

Surveyors are strongly advised to speak with the practitioner/prescriber and/or consultant pharmacist in cases where an antipsychotic medication is prescribed for an elderly resident with dementia.

Risks Sedation Postural Hypotension Cardiac Arrhythmia Sudden Cardiac Death Falls CVA

“FDA Black Box Warnings Regarding Atypical Antipsychotics in Dementia provides, “Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared to placebo.”

Monitoring:  Antipsychotics May be Considered Unnecessary When in the Presence of Side Effects

Anticholinergic effects Akathisia (internal restlessness) Neuroleptic malignant syndrome Delirium, hypertensive crisis, raised WBC, raised CPK,

rhabdomyolysis Falls Lethargy/Excessive sedation Parkinsonism Tardive dyskinesia (repetitive, involuntary, purposeless movements) Increased total cholesterol and triglycerides Increased blood sugar Orthostatic hypotension Cardiac arrhythmias Cerebrovascular event (stroke, TIA in elderly with dementia)

Monitoring Recommendations

Obesity American Diabetes Association Recommends

Weight check at baseline, then 4,8, and 12 weeks after starting therapy or changing therapy--and then every 3 months.

Diabetes Fasting glucose and blood pressure should be checked at baseline,

12 weeks, and then at least annually.

Lipids Should be checked at baseline, 12 weeks, then every 5 years if

normal.

Boxed warnings

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

A risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients [cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature].

Agency for Healthcare Research and Quality (AHRQ)

11,950 Strokes Annually!

Agency for Healthcare Research and Quality (AHRQ)

Why was the AP medication started?

Insomnia Agitation Anxiety Aggression Obsessive, repetitive behavior Depression Etc.

Before initiating medication

What is person communicating through their behavior

 Reasons for the person’s behavior that led to the initiation of the medication;

 What other approaches and interventions were attempted prior to the use of the antipsychotic medication;

 Was the family or representative contacted prior to initiating the medication;

Hand-in-Hand CMS program

The problem is an expression of an un-met need – a communication

that challenges you to understand.

Behavior is Communication!    Pain? Bathroom or UTI? Hungry? Boredom? Too much stimulation? 

Life style change (use social service & relate to nursing)  shift worker Labs: B12, UA

Nursing home routine…start at 5am (resident-centered care)

Algorithm:  MDS 3.0 Patient Level Report  AP patient review flowchart

BPSD Treatment Algorithm

Reduced Yesterday and Treatment Failure Today?

Generic Name Brand Name Half-Life

Aripiprazole Abilify 75 hours

Ziprasidone Geodon 7 hours

Risperidone Risperdal 20 hours

Quetiapine Seroquel 6 hours

Olanzapine Zyprexa 30 hours

Monitoring of all Psychopharmacological agents

Review continued need at least quarterly Document rationale for continuing

Resident’s target symptomsEffects of the medication(s)

Benefit vs. RiskChanges in resident’s function Medication-related adverse drug reactions

AIMS test (evaluation)   [Abnormal Involuntary Movement Scale]

Cholinesterase Inhibitors

Donepezil (Aricept)

Galantamine (Razadyne)

Rivastigmine (Exelon)

Glutamate (NMDA) Receptor Antagonist

Memantine (Namenda)

Selective Serotonin Reuptake Inhibitors (SSRIs) Citalopram (Celexa) Escitalopram (Lexapro) Fluoxetine (Prozac) Paroxetine (Paxil) Sertraline (Zoloft) Vilazodone (Viibryd)

Other Clinically Useful Antidepressants

Bupropion (Wellbutrin) Desvenlafaxine (Pristiq) Duloxetine (Cymbalta) Mirtazapine (Remeron) Trazodone (Desyrel) Venlafaxine (Effexor)

Mood Stabilizers Carbamazepine (Tegretol) Lamotrigine (Lamictal) Oxcarbazepine (Trileptal) Valproic Acid (Depakote)

AnxiolyticsShort Acting

Alprazolam (Xanax) Lorazepam (Ativan) Oxazepam (Serax) Temazepam (Restoril)

Long Acting

Chlordiazepoxide (Librium)

Clonazepam (Klonopin) Clorazepate (Tranxene) Diazepam (Valium) Flurazepam (Dalmane)

Antipsychotic GDR Documentation of Clinical

Contraindication 

Gradual Dose Reduction (GDR)

Stepwise dose reduction used to determine if symptoms, conditions, or side effects can be managed by a lower dose or if the medication can be discontinued

Determines benefit and appropriate dose Necessary even when condition has improved or

stabilized Often the only way to determine continued

benefit and need by the resident

GDR-Antipsychotics GDR required for use of antipsychotics,

unless clinically contraindicated Attempted within the 1st year of

admittance to the facility or initiation of an antipsychotic by the facility in 2 separate quarters, with at least 1 month in between attempts

After the 1st year, a GDR must be attempted annually

Also: ADs, AAs, mood stabilizers

GDR-Sedative/hypnotics For as long as a resident remains on a

sedative/hypnotic that is used routinely and beyond the manufacturer's recommendations for duration of use the facility should attempt to taper the medication quarterly unless clinically

contraindicated.

Example Note: Clinically Contraindicated

Resident has had recurrent behaviors with previous dose reduction (date). Behaviors are aggressive (explicitly what are they and how often do they or did they occur) in nature and do not allow for assisted self-care (which care is affected) essential for this resident’s well-being. Resident is without side-effects of therapy and these continue to be monitored per facility protocol.

Benefit > Risk.

Clinically Acceptable Withdrawal

Reduce gradually Never more than 50% of dose Q2weeks The longer the medication prescribed, the

slower the withdrawal Reduction to quickly leads to emergence

of symptoms (drug withdrawal ≠ BPSD)

Clinically Acceptable Withdrawal

BPSD symptoms are often temporary

When stable, reduce

Reduce Q3months

Most patients do not worsen behaviorally

GDR: BPSD Clinical Contraindication

Behavioral and Psychological Symptoms of Dementia (BPSD):- Target symptoms return or worsen after

most recent GDR attempt AND- Clinical reasoning is documented by the

physician explaining why a GDR would be inappropriate at that time

GDR: Psychiatric ConditionsClinical Contraindication

Psychiatric Conditions (≠ BPSD):- Continued use is within current practice

guidelines and the physician has documented why a GDR attempt would be inappropriate OR

- Symptoms returned or worsened during most recent GDR attempt and the physician has documented why a GDR would be inappropriate at that time

How to start reducing antipsychotics in your facility

How to start reducing antipsychotics in your facility

Educate your staff

Educate your physicians

Educate your resident and family

How to pick a PIP teamChoose a leader for this team

It could be Administrator

Director of Nursing

MDS Coordinator

Floor Nurse

Choose members of the teamIt could be

C.N.A. from each shift

Floor nurses

Housekeeping

Dietary

SSD

Activities

4 major components to F329

1) The diagnosis and indication for use is correct

2) If antipsychotic is being used for BPSD that the maximum daily dose is not exceeded.

3) The behavior tracking is being done.

4) If behaviors are not present that gradual dose reduction is being initiated.

Different approaches(initially: low-hanging fruit)

Getting rid of PRN meds that have not been used in 60 days

When attempting a reduction start conservatively.

Focus on smaller groups initially. Review BTS for those with little/no

behaviors

Different approaches(initially: low-hanging fruit)

Review potential admission paperwork.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).

Root Cause Analysis

Determine “contributing” cause(s) = a factor that, if corrected would not prevent a recurrence, but is significant enough to fix

Determine “root” cause(s) = the most basic condition that if corrected, prevents recurrence

Using 5 Why’s or the Fishbone diagram

Using Fishbone- Group into categories of causal factors:Human factors - communicationHuman factors – fatigue/staffingEnvironment/EquipmentRules/Policies/ProceduresInformation managementCulture

Model for Improvement- Identify Manageable Change based upon outcome of RCA

What are we trying toaccomplish?

How will we know that achange is an improvement?

What change can we make that will result in improvement?

Model for Improvement

Act Plan

Study Do

Thinking Part

Doing Part

Pilot Facilities Data

Facility A Facility B Facility C Facility D Facility E

Q2-2014 23.9 23.1 19.4 27.4 21.4

Q3/2014 19.2 19.7 5.9 25.8 18.9

Q4/2014 21.9 14.5 3.2 17.9 19.9

Pilot Facility’s Data

facility A Facility B Facility C Facility D Facility E0

5

10

15

20

25

30

Q2-2014Q3/2014Q4/2014

Case study #1

A resident is in the hospital with UTI and fracture hip with repair. Looking at admitting to your facility for rehab and home. The admitting orders include pain med, antibiotic, and Seroquel 25mg for insomnia. The Seroquel was start in the hospital.

1) Is the diagnosis appropriate?

No

2) Is the Seroquel under recommended daily dose?

Yes

Approach:

Ask the hospital not to order the Seroquel upon discharge to the facility. Monitor resident’s insomnia and reasons for insomnia.

1) Pain control

2) New environment

3) Urine issues

Case study #2

Resident has dx of stroke, cardiac issues, dementia. Resident needs assistance with all ADL’s. Resident is on Risperdal 0.5mg BID for agitation.

1)Is the diagnosis appropriate?

No

2) Under recommended daily dose?

Yes

3) What behavior is showing?

Hitting staff during cares

4) What is the approach the staff is taking during cares?

Approach:

Look at frequent position changes, pain, activities.

Case study #3

Resident is on hospice for failure to thrive. Resident has dementia, poor appetite with weight loss. History of osteoarthritis and compression fractures. Attempts to get out of bed and out of wheelchair. Resident was put on Seroquel 100mg BID for anxiety.

1)Is the diagnosis appropriate?

No

2) Under recommended daily dose?

No

Approach:

Look at frequent position changes, pain, activities.

Dementia Residents that require Antipsychotic med

-Document!

-Document!

-Document!

Try gradual dosage reduction again.

QUESTIONS??