Presentation on theme: "Bruce Gerlich, R.Ph. Consultant Pharmacist Omnicare 6 December 2012"— Presentation transcript:
1Bruce 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 PharmacistOmnicare6 December 2012
2objectivesDescribe the risks and benefits of antipsychotic use for residents in LTC facilitiesUnderstand CMS quality measures on the use of antipsychotic medications in the LTC settingIdentify and recognize behaviors that may be a form of communication of a resident’s unmet needs
3Our Daily Encounters The men and women who mistake: Roommate for a punching bagAnother resident’s bed for a toiletPerson feeding him/her as trying to poisonAnother resident for a long-dead spouseThe men and women whoWon’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.
4THE HEADLINESMortality Risk in Elderly Dementia Patients May Rise With Newer AntipsychoticsAntipsychotics Increase Risk for Stroke in EldersPsych Drugs Linked to MI Risk in DementiaAgain, Higher Mortality with Antipsychotics in Patients with DementiaRapid Serious Adverse Events with Antipsychotics in DementiaAntipsychotics Linked to Increased Risk for Hyperglycemia in Older Patients with DiabetesAntipsychotics Increase Risks for Sudden Cardiac Death
5TO PILL ????MEDICATIONS TO CONTROL BEHAVIOR GOOD OR BAD?
6Looking Back……. Antipsychotic medications 1954/55 – Thorazine first to be usedWithin a decade, millions received itHelped change the face of psychiatric institutionalizationAs with all remarkable new drugs(cortisone, beta-blockers, antibiotics) in each decade, overenthusiastic expectations and relative minimization of risks
8Effectiveness in Dementia Antipsychotic effect takes 3-7 days to start workingVery sedating medication so acute effect is most likely due to sedating effect not antipsychotic effectIn RCTs, recipients do a little bit better than placebo but the effect beyond 3 months is unclearNot everyone who receives the meds improveA large number of people getting the placebo improveThe net effect is that 10 to 20 people out of 100 who receive the medication improve due to the medication
9Net 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 & FishcherHarvard Medical SchoolDr ScheurerMedical University of South CarolinaSource: 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 MedicationsWandering*DisrobingPersistent disruptive vocalization (swearing, offensive comments, yelling/screaming)*Restlessness/ repeated attempts to unsafely arise from chair or climb out of bed*Inappropriate urination/defecationHiding/hoardingEating inediblesAnnoying repetitive activities, including “exit seeking”Climbing into bed with other residentsSleep disturbance, diurnal reversal*Pushing wheelchair-bound residents* may be related to pain or discomfort
11Atypical Antipsychotics – Consensus? Organization Year Country Recommendations regardingantipsychotic use in dementiaASCP 2011 USA - 2nd Line: “Only for the duration needed, and at the lowesteffective dose”APA 2007 USA -2nd Line: “Recommended for the treatment of psychosis andagitation in dementia”AGS 2011 USA - 2nd Line: “May be needed for treatment of distressingdelusions 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 andshould be used with caution”American Society of Consultant Pharmacists, position statement, 2011Ageing Res Rev Jan;11(1):78-86
12FDA approved diagnoses SchizophreniaBi-polar DisorderIrritability 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
13Common Off-label uses Dementia with behavior difficulties Agitation Abusive, violentWanderingAcute DeliriumObsessive-compulsive disorderPsychotic symptoms (e.g. hallucinations, delusions) with neurological diseasesParkinson’s diseaseStroke
14FDA Black Box Warning Issued in 2005 Warning: Increased Mortality in Elderly Patients with Dementia-Related PsychosisElderly 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.
16Associated with adverse outcomes Off-label use of antipsychotics in nursing facility residents are associated with an increase in:DeathHospitalizationFalls & fracturesVenothrombolic eventsConventional antipsychotics are worse than atypical antipsychotics
17Attention on Antipsychotics Not indicated or approved to treat most behaviorsymptoms in absence of underlying psychiatricdisorderNot part of person-centered careOversedated people, cause a “zombie-like” stateUsed for convenience of staff, in place of adequate staffingLimited benefits, major risksMajor increase in mortality riskCause strokes, MIs, hyperglycemiaVery expensive2011: OIG investigations
18OIG Report 2011 OIG report Major Findings Reviewed 600 medical recordsMedicare 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 residentsMajor Findings14% of elderly nursing home residents had Medicare claims for atypical antipsychotic drugsOff-label conditions accounted for 83% of these claimsOver ½ of the Medicare claims for antipsychotic drugs for elderly nursing home resident were incorrectMedicare reimbursement criteria was not met for 726,000 of the 1.4 million claims22% of the atypical antipsychotic drugs were not administered in accordance with CMS standards
19Treatment 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 antipsychoticsAlternatives 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 BPSDOptimal treatment usually includes individualized non-drug interventions and adjustment of expectations
20Effectiveness in Dementia is weak Meta-Analysis (JAMA 2011) Aripiprazole, Olanzapine, and Risperidone had a small but statistically significant effect (12 – 20%) when compared to placeboQuetiapine did not have a statistically significant effectAntipsychotics led to an average change/difference on the NeuroPsychiatric Inventory (NPI) of35% from a patient’s baseline3.41 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 antipsychoticsSource: JAMA 306: ; Meta-analysis 38 RCTs in dementia
21F-Tag associated with off-label use F-Tag 329: Unnecessary Drugs Residents should have drug regimens that are free of unnecessary drugs defined asThere in an excessive dose including duplicate therapyThere is an excessive duration of being on the drugThere is inadequate monitoring of the drugThere is inadequate indication for the use of the drugThere are adverse consequencesA combination of the reasons aboveSpecific conditions for antipsychotic drugsThe 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 recordIn an effort to decrease the use of antipsychotics residents must receive gradual dose reduction and alternate therapies, unless they are counter-
22Behavioral Symptoms that May Respond to Pharmacologic Intervention AnxietyDepressive symptomsPersistent physical aggressionManic-like symptomsPersistent and distressing delusions or hallucinationsSleep disturbance, initial or middle insomniaSexually inappropriate behavior
23Treat disease states appropriately Dementia – behaviors can respond to cholinesterase inhibitors (Aricept, Exelon, etc) and NamendaTreat 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
24BOTTOM LINE Antipsychotic medications are only marginally effective Have a high incidence of side effects: increase fall risk, EPSHave an overall increased in cardiovascular death (CVA, MI) than those that do not use these agentsCan be helpful in a small percentage of our population
25Key PointsRisperidone has the most evidence supporting efficacy in BPSDThere are no FDA-approved medications for BPSD at this timeNo consensus among experts in the field• Patient selection and monitoring is essentialAntipsychotics are 2nd lineOnly use drug therapy if behaviors cause severe distress or immediate risk of harmAlways determine if behavior is a method of communication beforeassuming physiologic change
26Reducing these agents What does the Government say? (CMS)
27National PriorityCMS is making the reduction of off-label use of antipsychotic medications a national priorityDon 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
28Current National Initiative CMS Improve dementia care byRethinking overall approachUsing standard techniquesUsing more nonpharmacological interventions in prevention and managementPrudent and limited use of antipsychotic medicationsAllegedly, more to followWhat should that be?
29CMS 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.
30CMS 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.
31CMS…. [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 HomesLazar K, Carrol M. “A rampant prescription, hidden peril"; The Boston Globe, 4/29/12.
32What 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
33What 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
34It 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:–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)
35Dementia 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?
36Behaviors…are often a rational attempt to cope with circumstances that do not make sense to a resident with dementia
37Behavior is in the “Eye of the Beholder” Everyone brings their own baggage with themPersonality tendenciesLife experiencesRelationshipsPast rolesEducationReligious beliefs
38Dementia 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
42Primary 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
43Acute change in condition – WHAT HAPPENED??? InfectionCongestive heart failureRespiratory distressFractureCerebrovascular accidentMyocardial infarction
44Pain/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
45BoredomSome 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"
46Hunger/thirst Creative ways to deliver foods ◦ Finger foods ◦ Fanny packGive drink every time person passes◦ Hydration cart◦ Popsicles/push popsPack calories into foods resident will eatMedication administration-Med Pass,Ensure
47Elimination needs . Bladder assessment ◦ Type of incontinence identified◦ Individualized plan. Bowel patterns◦ Opportunities to sit on the toilet◦ Adequate fiber and fluids in diet
48Sleep issues Sleep hygiene ◦ What is the resident’s usual pattern? ◦ Noise◦ Lighting◦ Temperature◦ Oral care◦ Type of mattress, pillow, blankets◦ Usual hours of sleep
49Medication side effects Anticholinergic medicationsDiphenydramine; hydroxyzine; cyclobenzaprineBenzodiazepinesLorazepam; alprazolam; diazepam;ClonazepamPsychotropicsAnticonvulsantsphenytoinCorticosteroids- prednisone
51Immediate steps to reduce antipsychotics No role for PRN only antipsychotic medicationsEvaluate the need for continuing antipsychotics at admission & those on very low dosesEvaluate need for antipsychotics started on residents during the evening/night shift or over the weekendLook 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
52Evidence based for Discontinuing Meds at lowest dose RCTs comparing low dose to placebo show Risperidone to be minimally effectiveOlanzapine to be not effectiveAripiprazole and Quetiapine unknowns as low dose not testedRCTs for withdrawal of medication show no difference in outcomes between placebo and continued medicationAbout 75% remain off the drug after the trialLess than 25% need to be restarted on the medicationPlacebo group (drug withdrawal) have fewer adverse events
53Strategies to reduce use of antipsychotics in nursing facilities Phase II: steps that will take longer to implement but need to be started nowFocus on implementing programs to minimize the off-label use of antipsychotics by promotingNon-pharmacologic strategies to manage individuals with dementiaChanges to how we view dementia behaviors as attempts to communicate unmet needsStrategiesStaff training on interacting with individuals with dementiaAdopt policy on minimal use of medications with dementia residentsEducate families about this policyImplement consistent assignmentCompare facility off-label antipsychotic use to othersLearn from other facilities
55Eliminating Antipsychotics ≠ Better Dementia Care Inappropriate antipsychotic prescribing is only one part of a complex problemNeed systematized culture change around dementia care and the use of medications to treat behavioral and psychiatric symptoms of dementia (BPSD)
56Training Staff – what should they be thinking about? Nonpharmacologic Interventions• First-line therapy for BPSD• Ideally, non-pharmacologic interventions should be:TargetedTailoredIndividualizedFlexibleAdaptableMulti-component• Not all individuals will respond positively to interventionsVA-ESP Project #05-225, 2011Health Technol Assess. 2006;10(26):iii,ix-108
57Learn 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 capacityAlzheimer’s Association, Dementia Care Practice Recommendations for Assisted Living Residences and NursingHomes,
58Responding to Behaviors Ground Rules:We cannot change the personTry to accommodate behavior not control itWe can change our behavior or the physical environmentCheck with the doctorIs there an underlying medical reason?Behavior has a purposeWhat need is the person trying to meet with their behavior?Family Caregiver Alliance, Caregiver’s Guide to Understanding Dementia Behaviors, 2004
59Responding to Behaviors (II) Ground Rules:All behavior is triggered !!!!!The key to changing behaviors is disrupting the patterns that we createWhat works today, may not tomorrowBe creative and flexible with your strategiesGet support from othersSupport groups, community resources, trainingFamily Caregiver Alliance, Caregiver’s Guide to Understanding Dementia Behaviors, 2004
60. Routine . Caregiver . Room . Roommate . Number of visitors Change. Routine. Caregiver. Room. Roommate. Number of visitors. Medications
61Behavior is Communication! • Physical discomfortIllness or medication• OverstimulationLoud noises or busy environment• Unfamiliar surroundingsNew places or inability to recognize home• Complicated tasksDifficulty with activities or chores• Frustrating interactionsInability to communicate effectivelyAlzheimer’s Association, Behaviors–How to respond when dementia causes unpredictable behaviors, 2012
62What Does a Person with Dementia Need? • Attachment• Inclusion• Occupation• Identity• ComfortKitwood T. Dementia reconsidered: The person comes first. London: Open University Press; 1997
63Quick 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 othersAlzheimer’s Association, Behaviors–How to respond when dementia causes unpredictable behaviors, 2012
64What 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
65Questions 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?
66What if I don’t have a lot of geriatric training or experience? Detailed clinical practice guideline on dementia– Multiple resources and links to other organizations, training materialsCMS staff can put you in touch with state coalition leadsand state-level resources
67summaryDealing 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 illnessesEliminating antipsychotic medications takes patience, diligence and a TOTAL team approachWhether we like it or not antipsychotic medications will not disappear but can be dramatically reduced…..