Bruce Gerlich, R.Ph. Consultant Pharmacist Omnicare 6 December 2012 To Pill or Not to Pill – That is the question… (But what are the answers?) Bruce Gerlich, R.Ph. Consultant Pharmacist Omnicare 6 December 2012

objectives 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

Our Daily Encounters 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.

THE HEADLINES 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

TO PILL ???? MEDICATIONS TO CONTROL BEHAVIOR GOOD OR BAD?

Looking Back……. 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

Effectiveness in Dementia 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

Net effectiveness “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

“Normal” Behaviors Associated with Degenerative Dementias Generally Unresponsive to Psychoactive Medications 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

Atypical Antipsychotics – Consensus? 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

FDA approved diagnoses 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

Common Off-label uses 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

FDA Black Box Warning 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.

FDA Black Box Warning

Associated with adverse outcomes 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

Attention on 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 2011 OIG report Major Findings 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

Treatment of Dementia-Related Behaviors 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

Effectiveness in Dementia is weak Meta-Analysis (JAMA 2011) 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

F-Tag associated with off-label use F-Tag 329: Unnecessary Drugs 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-

Behavioral Symptoms that May Respond to Pharmacologic Intervention Anxiety Depressive symptoms Persistent physical aggression Manic-like symptoms Persistent and distressing delusions or hallucinations Sleep disturbance, initial or middle insomnia Sexually inappropriate behavior

Treat disease states appropriately 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

BOTTOM LINE 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

Key Points 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

Reducing these agents What does the Government say? (CMS)

National Priority 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

Current National Initiative CMS 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?

CMS definition of behavior “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 National Partnership to Improve Dementia Care 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 …. [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.

What will Surveyors be Looking for? 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

What should I advise my nursing home – they are asking how to “reduce our rate of antipsychotic use…” 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 – What should I advise my nursing home – they are asking how to “reduce our rate of antipsychotic use…” 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)

Dementia re-examined 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?

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

Behavior is in the “Eye of the Beholder” Everyone brings their own baggage with them Personality tendencies Life experiences Relationships Past roles Education Religious beliefs

Dementia is not the cause of every behavior Don’t become complacent by assuming that behaviors are caused by dementia and that nothing except medicating the resident can be done

Effects of behaviors on staff Absenteeism Staff turnover Decreased productivity Increased desire to use chemical and/or physical restraints

REASONS FOR BEHAVIORS RULE THESE OUT!!!

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

Acute change in condition – WHAT HAPPENED??? Infection Congestive heart failure Respiratory distress Fracture Cerebrovascular accident Myocardial infarction

Pain/discomfort . 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

Boredom 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"

Hunger/thirst 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

Elimination needs . Bladder assessment ◦ Type of incontinence identified ◦ Individualized plan . Bowel patterns ◦ Opportunities to sit on the toilet ◦ Adequate fiber and fluids in diet

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

Medication side effects Anticholinergic medications Diphenydramine; hydroxyzine; cyclobenzaprine Benzodiazepines Lorazepam; alprazolam; diazepam; Clonazepam Psychotropics Anticonvulsants phenytoin Corticosteroids- prednisone

SO WHAT CAN WE DO???!!!

Immediate steps to reduce antipsychotics 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

Evidence based for Discontinuing Meds at lowest dose 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

Strategies to reduce use of antipsychotics in nursing facilities 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

The choices medicine?

Eliminating Antipsychotics ≠ Better Dementia Care 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)

Training Staff – what should they be thinking about? 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

Learn About the Person – What’s the story? • 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

Responding to Behaviors 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

Responding to Behaviors (II) 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 Change . Routine . Caregiver . Room . Roommate . Number of visitors . Medications

Behavior is Communication! • 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

What Does a Person with Dementia Need? • Attachment • Inclusion • Occupation • Identity • Comfort Kitwood T. Dementia reconsidered: The person comes first. London: Open University Press; 1997

Quick Tips for Responding to Behaviors • 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

What would you do… EMPATHY IS KEY!!!!!!!! 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

Questions to ask for new Rxs 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?

What if I don’t have a lot of geriatric training or experience? www.ascp.com www.amda.com Detailed clinical practice guideline on dementia www.nhqualitycampaign.org – Multiple resources and links to other organizations, training materials DNH_BehavioralHealth@cms.hhs.gov CMS staff can put you in touch with state coalition leads and state-level resources

summary 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…..