To Pill or Not to Pill – That is the question… (But what are the answers?)

1. 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

2. 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

3. 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.

4. 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

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

6. 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

8. 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

9. 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

10. “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

11. 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

12. 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

13. 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

14. 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.

15. FDA Black Box Warning

16. 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

17. Attention on Antipsychotics • Not indicated or approved to treat most behavior • symptoms in absence of underlying psychiatric • disorder • Not part of person-centered care • Oversedatedpeople, 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

18. OIG Report 2011 • 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

19. 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

20. 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 • Quetiapinedid 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

21. 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-

22. 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

23. 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

24. 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

25. 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

26. Reducing these agentsWhat does the Government say?(CMS)

27. 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

28. Current National InitiativeCMS • 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?

29. 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.

30. CMS National Partnership toImprove 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.

31. 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.

32. 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

33. What should I advise my nursing home – theyare asking how to “reduce our rate ofantipsychotic 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 psychopharmacologicalsare prescribed if/when antipsychotic medications are discontinued or reduced

34. What should I advise my nursing home – theyare asking how to “reduce our rate ofantipsychotic 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)

35. 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?

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

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

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

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

41. REASONS FOR BEHAVIORS RULE THESE OUT!!!

42. 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

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

44. 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

45. 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"

46. 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

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

48. 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

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

50. SO WHAT CAN WE DO???!!!