Bruce Gerlich, R.Ph. Consultant Pharmacist Omnicare 6 December 2012.

Bruce Gerlich, R.Ph.Consultant Pharmacist

Omnicare6 December 2012

Describe the risks and benefits of antipsychotic use for residents in LTC facilities

Understand CMS quality measures on the use of antipsychotic medications in the LTC setting

Identify and recognize behaviors that may be a form of communication of a resident’s unmet needs

The men and women who mistake:◦ Roommate for a punching bag◦ Another resident’s bed for a toilet◦ Person feeding him/her as trying to poison◦ Another resident for a long-dead spouse

The men and women who◦ Won’t eat, don’t sleep, lose weight, fall, hit, bite,

scratch, scream day and night, have pain, won’t get out of bed, cough, have chronic diarrhea, bleed, vomit, always feel bad, just want to die, can’t sit still, etc. etc.

Mortality Risk in Elderly Dementia Patients May Rise With Newer Antipsychotics

Antipsychotics Increase Risk for Stroke in Elders

Psych Drugs Linked to MI Risk in Dementia Again, Higher Mortality with Antipsychotics in

Patients with Dementia Rapid Serious Adverse Events with

Antipsychotics in Dementia Antipsychotics Linked to Increased Risk for

Hyperglycemia in Older Patients with Diabetes Antipsychotics Increase Risks for Sudden

Cardiac Death

MEDICATIONS TO CONTROL BEHAVIORGOOD OR BAD?

Antipsychotic medications 1954/55 – Thorazine first to be used Within a decade, millions received it Helped change the face of psychiatric

institutionalization As with all remarkable new drugs(cortisone,

beta-blockers, antibiotics) in each decade, overenthusiastic expectations and relative minimization of risks

Antipsychotic effect takes 3-7 days to start working Very sedating medication so acute effect is most

likely due to sedating effect not antipsychotic effect In RCTs, recipients do a little bit better than placebo

but the effect beyond 3 months is unclear Not everyone who receives the meds improve A large number of people getting the placebo

improve The net effect is that 10 to 20 people out of 100

who receive the medication improve due to the medication

“For every 100 patients with dementia treated with an antipsychotic medication, only 9 to 25 will benefit and 1 will die” ◦ Drs Avorn, Choudhry & Fishcher

Harvard Medical School ◦ Dr Scheurer

Medical University of South Carolina ◦ Source: Independent Drug Information Service

(IDIS) Restrained Use of antipsychotic medications: rational management of irrationality. 2012

Wandering* Disrobing Persistent disruptive vocalization (swearing, offensive

comments, yelling/screaming)* Restlessness/ repeated attempts to unsafely arise from chair or

climb out of bed* Inappropriate urination/defecation Hiding/hoarding Eating inedibles Annoying repetitive activities, including “exit seeking” Climbing into bed with other residents Sleep disturbance, diurnal reversal* Pushing wheelchair-bound residents

* may be related to pain or discomfort

Organization Year Country Recommendations regarding antipsychotic use in dementia ASCP 2011 USA - 2nd Line: “Only for the duration needed, and at the

lowest effective dose” APA 2007 USA -2nd Line: “Recommended for the treatment of

psychosis and agitation in dementia” AGS 2011 USA - 2nd Line: “May be needed for treatment of distressing delusions and hallucinations” NICE 2006 UK- 2nd Line: “Risk benefit analysis should occur prior to

use” CCSMH 2006 Canada 2nd Line:“Atypical antipsychotics should only be used

if there is marked risk, disability or suffering associated with the symptoms” EFNS 2007 Europe- 2nd Line:“Antipsychotics, conventional as well as

atypical, may be associated with significant side effects and should be used with caution”

◦ American Society of Consultant Pharmacists, position statement, 2011◦ Ageing Res Rev. 2012 Jan;11(1):78-86

Schizophrenia Bi-polar Disorder Irritability associated with Autistic Disorder

(Aripiprazole & Risperidone) Treatment Resistant Depression (Olanzapine) Major Depressive Disorder (Quetiapine) Tourettes (Orap)

When prescribed to a patient without an FDA approved diagnosis; the prescription is considered as an “off-label use”, which is allowed by FDA and Medical Boards

Dementia with behavior difficulties Agitation Abusive, violent Wandering Acute Delirium Obsessive-compulsive disorder Psychotic symptoms (e.g. hallucinations,

delusions) with neurological diseases ◦Parkinson’s disease ◦Stroke

Issued in 2005 Warning: Increased Mortality in Elderly

Patients with Dementia-Related Psychosis Elderly patients with dementia-related

psychosis treated with antipsychotic drugs are at and increased risk of death. [Name of Antipsychotic] is not approved for the treatment of patients with dementia-related psychosis.

Off-label use of antipsychotics in nursing facility residents are associated with an increase in:

Death Hospitalization Falls & fractures Venothrombolic events Conventional antipsychotics are worse than

atypical antipsychotics

Not indicated or approved to treat most behavior symptoms in absence of underlying psychiatric disorder Not part of person-centered care Oversedated people, cause a “zombie-like” state Used for convenience of staff, in place of

adequate staffing Limited benefits, major risks Major increase in mortality risk Cause strokes, MIs, hyperglycemia Very expensive

2011: OIG investigations

OIG report ◦ Reviewed 600 medical records ◦ Medicare claims data for Part B and Part D and MDS data from

January 1st to July 31st, 2007 was used to identify payments for atypical antipsychotic drug use for elderly nursing home residents

Major Findings 14% of elderly nursing home residents had Medicare

claims for atypical antipsychotic drugs Off-label conditions accounted for 83% of these claims Over ½ of the Medicare claims for antipsychotic drugs

for elderly nursing home resident were incorrect Medicare reimbursement criteria was not met for

726,000 of the 1.4 million claims 22% of the atypical antipsychotic drugs were not

administered in accordance with CMS standards

No FDA-approved treatment for agitation associated with dementia. The strongest and most consistent evidence for efficacy in severe dementia-related agitation/aggression is for the atypical antipsychotics

Alternatives to antipsychotics may be effective for certain target behaviors, but are not as well-studied.

Evaluate comorbid illness(s) and complex drug regimens before selecting alternative drug therapy for BPSD

Optimal treatment usually includes individualized non-drug interventions and adjustment of expectations

Aripiprazole, Olanzapine, and Risperidone had a small but

statistically significant effect (12 – 20%) when compared to placebo

Quetiapine did not have a statistically significant effect Antipsychotics led to an average change/difference on the

NeuroPsychiatric Inventory (NPI) of ◦ 35% from a patient’s baseline ◦ 3.41 point difference from placebo group (note: a 30% change and 4.0 difference is the minimum threshold needed for a clinically meaningful result)

No conclusive evidence was found regarding the comparative effectiveness of different antipsychotics

Source: JAMA 306:1359-69 2011; Meta-analysis 38 RCTs in dementia

Residents should have drug regimens that are free of unnecessary drugs defined as ◦ There in an excessive dose including duplicate therapy ◦ There is an excessive duration of being on the drug ◦ There is inadequate monitoring of the drug ◦ There is inadequate indication for the use of the drug ◦ There are adverse consequences ◦ A combination of the reasons above

Specific conditions for antipsychotic drugs ◦ The facility must ensure that residents have not used

antipsychotics previously, are not given these drugs unless the drug therapy is necessary, and recorded in the clinical record

◦ In an effort to decrease the use of antipsychotics residents must receive gradual dose reduction and alternate therapies, unless they are counter-

Anxiety Depressive symptoms Persistent physical aggression Manic-like symptoms Persistent and distressing delusions or

hallucinations Sleep disturbance, initial or middle insomnia Sexually inappropriate behavior

Dementia – behaviors can respond to cholinesterase inhibitors (Aricept, Exelon, etc) and Namenda

Treat depression if present – can be manifested by confusion, forgetfulness, anxiety, insomnia, etc – SSRIs (Lexapro, Celexa, Zoloft are preferred)

For acute behavioral problems when resident is violent and a danger to themselves and others – may consider short term use of antipsychotic medications and rule out possible causes

Antipsychotic medications are only marginally effective

Have a high incidence of side effects: increase fall risk, EPS

Have an overall increased in cardiovascular death (CVA, MI) than those that do not use these agents

Can be helpful in a small percentage of our population

Risperidone has the most evidence supporting efficacy in BPSD◦ There are no FDA-approved medications for BPSD at

this time No consensus among experts in the field

• Patient selection and monitoring is essential Antipsychotics are 2nd line

Only use drug therapy if behaviors cause severe distress or immediate risk of harm

Always determine if behavior is a method of communication beforeassuming physiologic change

CMS is making the reduction of off-label use of antipsychotic medications a national priority

Don Berwick, Director of CMS has asked professional associations to work together and with CMS to reduce the off-label use of antipsychotic medications in nursing homes

Improve dementia care by◦ Rethinking overall approach◦ Using standard techniques◦ Using more nonpharmacological interventions in

prevention and management◦ Prudent and limited use of antipsychotic

medications Allegedly, more to follow

◦ What should that be?

“Distressed behavior” is behavior that reflects individual discomfort or emotional strain. It may present as crying, apathetic or withdrawn behavior, or as verbal or physical actions such as: pacing, cursing, hitting, kicking, pushing, scratching, tearing things, or grabbing others.

CMS developed a national partnership to improve dementia care and optimize behavioral health.◦ By improving dementia care and person-

centered, individualized interventions for behavioral health in nursing homes, CMS hopes to reduce unnecessary antipsychotic medication use in nursing homes and eventually other care settings as well.

◦ While antipsychotic medications are the initial focus of the partnership, CMS recognizes that attention to other potentially harmful medications is also an important part of this initiative.

…. [CMS] is considering reviving the specific citation for antipsychotic use to encourage more scrutiny, but is concerned that homes will instead use other sedating drugs that can also be harmful.

“One of the things we want to do is to make sure that surveyors are looking out for a prescribing shift. Did a person get taken off of an antipsychotic and simply put on an antidepressant or antianxiety agent instead?’’

Alice Bonner PhD, RN CMS Director, Division of Nursing Homes

Lazar K, Carrol M. “A rampant prescription, hidden peril"; The Boston Globe, 4/29/12.

In some cases, persons with dementia may have behavioral expressions that indicate they are trying to communicate their needs (with brain dysfunction that prevents this communication from being effective in expressing a need or distress).

In other cases, behaviors may be symptoms of underlying medical issues such as delirium or medication side effects, or psychiatric symptoms.

Surveyors will be looking to see that a systematic and comprehensive process was followed that not only includes medical or clinical aspects, but also assesses whether or not the nursing home provided tools, resources and staff training on person centered care practices and environmental modification, whether families are engaged in dementia care, whether there is adequate staff, and other organizational issues.

reference:CMS

The team may discuss specific cases in order to determine the optimal dose and duration of therapy.

Input from the nursing assistants, nurses, social workers, therapists, family and other caregivers working closely with the resident is essential.

Input from all three shifts and weekend caregivers is also important in “telling the story.”

Surveyors will look at communication between shifts, between nurses and practitioners or prescribers.

Surveyors will also look at whether medications prescribed by a covering practitioner in an urgent situation are reevaluated by the primary care team.

Surveyors will look at whether or not other psychopharmacologicals are prescribed if/when antipsychotic medications are discontinued or reduced

It may be helpful to refocus on the bigger picture –

share resources on dementia care principles: – www.nhqualitycampaign.org Remind leadership that focusing on each

individual resident and using a careful, systematic process to evaluate his/her needs is what surveyors will be looking for (not the antipsychotic rate in the facility)

Experiencing the world in a different way What are “behaviors”?

◦ Medical symptoms? ◦ Predictable human responses to the situation

perceived? Key questions to ask:

◦ What is this person trying to tell me? ◦ What is distressing this person? ◦ What does he or she need to be in well-being?

are often a rational attempt to cope with circumstances that do not make sense to a resident with dementia

Everyone brings their own baggage with them

Personality tendencies Life experiences Relationships Past roles Education Religious beliefs

Don’t become complacent by assuming that behaviors are caused by dementia and that nothing except medicating the resident can be done

Absenteeism Staff turnover Decreased productivity Increased desire to use chemical and/or

physical restraints

REASONS FOR BEHAVIORS

RULE THESE OUT!!!

Most health care professionals and families believe (1) dementia “behaviors” are abnormal & need to be treated (2) antipsychotics medications are effective

Infection Congestive heart failure Respiratory distress Fracture Cerebrovascular accident Myocardial infarction

. Seating/positioning . Diagnoses that may lead to: chronic pain . Past history of pain . Indicators of pain

◦ Resistance to care◦ Non-verbal sounds◦ Verbal complaints of pain◦ Protective body movements or

postures . Routine rather than PRN pain medication

Some estimates reveal residents with dementia spend 60-80% of their time with nothing to do.

It is during this unstructured time that most disturbing behaviors occur. Residents are often seeking stimulation, movement, or comfort which leads to be "needs-driven dementia compromised behaviors"

Creative ways to deliver foods◦ Finger foods◦ Fanny pack

Give drink every time person passes◦ Hydration cart◦ Popsicles/push pops

Pack calories into foods resident will eat Medication administration-Med Pass,Ensure

. Bladder assessment◦ Type of incontinence identified◦ Individualized plan

. Bowel patterns◦ Opportunities to sit on the toilet◦ Adequate fiber and fluids in diet

Sleep hygiene◦ What is the resident’s usual pattern?◦ Noise◦ Lighting◦ Temperature◦ Oral care◦ Type of mattress, pillow, blankets◦ Usual hours of sleep

Anticholinergic medications Diphenydramine; hydroxyzine;

cyclobenzaprine Benzodiazepines

Lorazepam; alprazolam; diazepam; Clonazepam

Psychotropics Anticonvulsants

phenytoin Corticosteroids- prednisone

No role for PRN only antipsychotic medications Evaluate the need for continuing antipsychotics

at admission & those on very low doses Evaluate need for antipsychotics started on

residents during the evening/night shift or over the weekend

Look at discontinue or gradual dose reduction for residents on medications for greater than 12 weeks (3 months), particularly those with no change in dose or frequency

RCTs comparing low dose to placebo show Risperidone to be minimally effective

Olanzapine to be not effective Aripiprazole and Quetiapine unknowns as low dose

not tested RCTs for withdrawal of medication show no

difference in outcomes between placebo and continued medication

About 75% remain off the drug after the trial Less than 25% need to be restarted on the

medication Placebo group (drug withdrawal) have fewer adverse

events

Phase II: steps that will take longer to implement but need to be started now

Focus on implementing programs to minimize the off-label use of antipsychotics by promoting ◦ Non-pharmacologic strategies to manage individuals with

dementia Changes to how we view dementia behaviors as attempts to

communicate unmet needs Strategies

◦ Staff training on interacting with individuals with dementia ◦ Adopt policy on minimal use of medications with dementia residents ◦ Educate families about this policy ◦ Implement consistent assignment ◦ Compare facility off-label antipsychotic use to others

Learn from other facilities

Inappropriate antipsychotic prescribing is only one part of a complex problem

Need systematized culture change around dementia care and the use of medications to treat behavioral and psychiatric symptoms of dementia (BPSD)

Nonpharmacologic Interventions• First-line therapy for BPSD

• Ideally, non-pharmacologic interventions should be:◦ Targeted◦ Tailored◦ Individualized◦ Flexible◦ Adaptable◦ Multi-component

• Not all individuals will respond positively to interventions

VA-ESP Project #05-225, 2011 Health Technol Assess. 2006;10(26):iii,ix-108

• Family and friends • Sleep habits • Childhood experiences • Occupation • Significant events • Favorite foods • Spiritual beliefs • Unique characteristics • Daily routine • Likes and dislikes • Life achievements • Hobbies • Communication preferences • Physical functioning • Sensory capabilities • Decision-making capacity

Alzheimer’s Association, Dementia Care Practice Recommendations for Assisted Living Residences and NursingHomes, 2006. http://www.alz.org/national/documents/brochure_dcprphases1n2.pdf

Ground Rules: We cannot change the person

Try to accommodate behavior not control it We can change our behavior or the physical environment

Check with the doctor Is there an underlying medical reason?

Behavior has a purpose◦ What need is the person trying to meet with their

behavior? Family Caregiver Alliance, Caregiver’s Guide to

Understanding Dementia Behaviors, 2004

Ground Rules: All behavior is triggered !!!!!

The key to changing behaviors is disrupting the patterns that we create

What works today, may not tomorrow◦ Be creative and flexible with your strategies

Get support from others Support groups, community resources,

training Family Caregiver Alliance, Caregiver’s Guide to

Understanding Dementia Behaviors, 2004

. Routine. Caregiver. Room. Roommate. Number of visitors. Medications

• Physical discomfort Illness or medication

• Overstimulation Loud noises or busy environment

• Unfamiliar surroundings New places or inability to recognize home

• Complicated tasks Difficulty with activities or chores

• Frustrating interactions Inability to communicate effectively

Alzheimer’s Association, Behaviors–How to respond when dementia causes unpredictable behaviors, 2012

• Attachment • Inclusion • Occupation • Identity • Comfort

◦ Kitwood T. Dementia reconsidered: The person comes first. London: Open University Press; 1997

• Remain flexible, patient, and calm • Explore pain as a trigger • Respond to the emotion, not the behavior • Don’t argue or try to convince • Use memory aids • Acknowledge requests and respond to them • Look for the reason behind each behavior • Don’t take the behavior personally • Share your experiences with others

Alzheimer’s Association, Behaviors–How to respond when dementia causes unpredictable behaviors, 2012

If you were a mother, what would you do if you were not allowed to leave the building to pick up your children after school?

If you couldn’t remember how to put on a sweater, what would you do if someone just handed it to you?

If you couldn’t remember what time dinner is, what would you do if you were hungry?

EMPATHY IS KEY!!!!!!!! Gould E. Understanding Behavioral Symptoms in

Dementia. NASMHPD Panel Presentation, August 2012

What did you do to try and figure out why the resident was doing <fill in the blank>?

What is resident trying to communicate to us about their <fill in blank>?

What is reason for resident doing <fill in blank>?

Unacceptable answer (Dementia or sun-downing)

What did you try before requesting medications?

www.ascp.com www.amda.com Detailed clinical practice guideline on

dementia www.nhqualitycampaign.org – Multiple resources and links to other

organizations, training materials [email protected] CMS staff can put you in touch with state

coalition leads and state-level resources

Dealing with residents with dementia and behavioral problems IS A COMPLEX ISSUE WITH NO ONE ANSWER!!!

Behaviors happen for a reason and are a form of communitcation for the elderly with dementia related illnesses

Eliminating antipsychotic medications takes patience, diligence and a TOTAL team approach

Whether we like it or not antipsychotic medications will not disappear but can be dramatically reduced…..