Considerations For Reducing and Eliminating Antipsychotic Medications for Behaviors in Elderly Patients

Considerations For Reducing and Eliminating Antipsychotic Medications for Behaviors in Elderly Patients David Lawless PharmD, MBA Pharmacoeconomics Washington State University Graduated and began practice in 1998 Regional Clinical Director for WA, ID, MT and Northern WY Summary of Clinical experience Learning Objectives 1. Describe key features of the boxed warning for antipsychotics 2. Identify history and current regulations related to the use of antipsychotic medications in Long Term Care Facilities for the treatment of behavioral symptoms of dementia; 3. Define the types of distressed behaviors usually associated with dementia; 4. Discuss non-pharmacologic approaches to distressed behaviors in residents with dementia; 5. Discuss Strategies for increasing safety and ultimately insuring compliance with appropriate antipsychotic utilization 1

Omnibus Budget Reconciliation Act of 1987 In 1986, a blue ribbon panel, selected by the Institute of Medicine (IOM) completed a report titled Improving the Quality of Care in Nursing Homes This report made it clear for the first time that quality of life carries equal weight to quality of care. Congress used the findings in this report to create The Omnibus Reconciliation Act of 1987 (OBRA '87), [2] which changed the quality of care of nursing home residents across America, by mandating enforceable minimal quality of care standards for long term care facilities. At the time of OBRA '87's landmark passage, nursing homes were viewed by the American public as institutions plagued with abuse and neglect, places without dignity and respect. The release of the IOM report substantiated the need to establish higher standards for nursing homes. Why Are We Focusing On This? A hot topic : Office of the Inspector General (OIG) Report (May 2011) 83% of Medicare claims (2007 data) for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions; 88% were associated with the condition specified in the FDA boxed warning As a result of the OIG report, the use of antipsychotics for off-label conditions (e.g., behaviors associated with dementia) will be an area of increased scrutiny for nursing home surveyors American Medical Directors Association response (May 2011) - AMDA.. acknowledges that psychotropic drug use remains a challenge in this setting and continues to make this a priority issue. Currently, the organization has many educational efforts to reduce and even eliminate the inappropriate use of these medications Why Are We Focusing On This? (cont d) American Health Care Association (AHCA) Talking Points document (May 2011) - we agree that the number of patients using antipsychotic drugs in nursing facilities should be less, and that more efforts need to be done to look at how to manage dementia patients with behavior problems without medications 2

Why Are We Focusing On This? (cont d) Senate Special Committee on Aging Hearing, 11/30/11 Title of meeting- Overprescribed: The Human and Taxpayers Costs of Antipsychotics in Nursing Homes Statements from Senator Herb Kohl: - While antipsychotic drugs have been approved by the FDA to treat an array of psychiatric conditions, numerous studies have concluded that these medications can be harmful when used by frail elders with dementia who do not have a diagnosis of serious mental illness. In fact, the FDA issued 2 black box warnings citing increased risk of death when these drugs are used to treat elderly patients with dementia. Improper prescribing not only puts patients health at risk, it also leads to higher health costs. ANTIPSYCHOTIC SAFETY CONCERNS The Antipsychotic Boxed Warning ALL antipsychotics carry the following Boxed Warning specifically addressing their use in patients with dementia-related psychosis: Warning: 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. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drugtreated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. DRUGNAME is not approved for the treatment of patients with dementia-related psychosis. 3

Selected Additional Antipsychotic Warnings Common to ALL antipsychotics: Neuroleptic malignant syndrome (can be fatal) Tardive dyskinesia (highest among elderly, especially women) Common to ALL atypical antipsychotics Hyperglycemia (can be fatal) Orthostatic hypotension (can lead to falls) Seizures (Alzheimer s disease can lower seizure threshold) Dysphagia (can lead to aspiration pneumonia) Leukopenia, neutropenia, and agranulocytosis Potential for cognitive and motor impairment Common to aripiprazole, olanzapine and risperidone Cerebrovascular adverse events, including stroke (can be fatal) Other Important Antipsychotic Adverse Effects Sedation (can lead immobility and pressure ulcers, or limited mobility with dizziness, balance issues, and falls) Clinical worsening, suicidality, and unusual changes in behavior, especially in first few months of therapy and with dosage changes (increases or decreases) Hyperlipidemia Dizziness Fatigue Increases in liver enzymes A Telling Story: Length of Antipsychotic Package Inserts Risperdal - 43 pages Seroquel - 51 pages Zyprexa - 49 pages Many of these pages are related to adverse effects of these drugs! As a comparison: Coumadin (warfarin) - 21 pages Digoxin- 16 pages Methotrexate- 16 pages Amiodarone- 21 pages Duragesic - 26 pages Pradaxa - 13 pages 4

What Is A Behavior? A form of communication A reaction to frustration or boredom A reaction to stimuli (internal- e.g., pain, constipation; external- e.g., sounds, physical surroundings, people) A sign of an underlying condition (e.g., depression, insomnia) Common Neuropsychiatric Symptoms Associated With Dementia In April, 2011, the American Geriatrics Society published A Guide to the Management of Psychotic Disorders and Neuropsychiatric Symptoms of Dementia in Older Adults 3, which identifies the following common symptoms associated with dementia: psychotic symptoms (hallucinations, delusions)- 20% of patients depressive symptoms (sadness, anxiety, irritability)- up to 40% of patients apathy manic-like behavioral syndromes (disinhibition, intrusiveness, hyperactivity) agitation or aggression (up to 80% of patients) 3 American Geriatrics Society. A Guide to the Management of Psychotic Disorders and Neuropsychiatric Symptoms of Dementia in Older of Dementia in Older Adults. April 2011. Available at http://www.americangeriatrics.org/; accessed 8/3/2011 What Are The Symptoms Of Agitation Walking aimlessly, pacing Psychomotor agitation/general restlessness (which could be akathisia, a movement side effect from antipsychotic drugs) Repetitive actions (dressing/undressing) Sleep disturbances Excessive worrying (e.g., about toileting, etc.) 2 AMDA Multidisciplinary Medication Management Manual, American Medical Directors Association, March 2011 5

Evaluating Problematic Behavior: The ABC s 2 A- what are the Antecedents of the behavior? communication emotional environmental physical task B- what is the Behavior? anxiety and/or depression psychosis-related agitation C- what are the Consequences of the behavior 2 AMDA Multidisciplinary Medication Management Manual, American Medical Directors Association, March 2011 Approaches To Behavioral Symptom Management 2 : More Alphabet Soup D- describe the behavior R- reasons for the behavior N- nonpharmacologic approach O- order medication as last step 2 AMDA Multidisciplinary Medication Management Manual, American Medical Directors Association, March 2011 General Approach For Residents with Dementia: Approach Is Almost Everything Display a positive, comforting demeanor (smile, calm/nonthreatening voice and body language; praise often) Treat resident with respect Be aware of resident s need for personal space, and historical way of doing things ( my way ) Care must be individualized 6

Nonpharmacologic Approaches to Behavior Management 4 Examples of nonpharmacologic treatment categories and strategies: Sensory- music therapy, massage, light therapy Environmental- adequate space, reduction in disruptive stimuli Behavioral- positive reinforcement, redirection, avoid reality orientation Communication- use short sentences, give adequate time for response, awareness of non-verbal communication 4 Omnicare 2011 Geriatric Pharmaceutical Care Guidelines, Behavioral Symptoms Associated with Dementia monograph Nonpharmacologic Approaches to Agitation 2 Avoid confrontation Remove environmental triggers Create calm, quiet environment (offer gentle help) Structure daily routine Address pain, discomfort Use aromatherapy Use scheduled or prompted toileting 2 AMDA Multidisciplinary Medication Management Manual, American Medical Directors Association, March 2011 Pharmacologic Approaches For Distressed Behaviors: General 2 Minimize anticholinergic load Maximize response to non-pharmacologic interventions - the effectiveness of many nonpharmacologic interventions is enhanced when the patient has a higher degree of cognition. Consider using agents approved to treat Alzheimer s disease (acetylcholinesterase inhibitors, memantine) to maximize patients cognition and thus their response to nonpharmacologic behavioral interventions. Optimize treatment of comorbid conditions (e.g., pain, constipation) Treat depression and anxiety 2 AMDA Multidisciplinary Medication Management Manual, American Medical Directors Association, March 2011 7

Management of Neuropsychiatric Symptoms of Dementia: Some Key Points 3 Medication treatment of behavioral disturbances of dementia is of limited efficacy and should be used only after environmental and nonpharmacologic techniques have been implemented No psychoactive medication prescribed to treat neuropsychiatric symptoms of dementia should be continued indefinitely, and attempt at drug withdrawal should be made regularly (e.g., every 3-6 months) The goal (of treatment) is reduction, rather than elimination, of the distressing behavior 3 American Geriatrics Society. A Guide to the Management of Psychotic Disorders and Neuropsychiatric Symptoms of Dementia in Older Adults. April 2011. Available at http://www.americangeriatrics.org/; accessed 8/3/2011 The Facility (Nursing) Burden of Antipsychotics! Monitoring For Adverse Consequences (from F329: Unnecessary Drugs) Anticholinergic effects Akathisia Neuroleptic malignant syndrome Cardiac arrhythmias Falls Lethargy Increase in total cholesterol and triglycerides Parkinsonism Blood sugar elevations (including diabetes mellitus) Orthostatic hypotension Stroke Tardive dyskinesia (routine AIMS or DISCUS tests) Excessive sedation [Documentation, documentation, documentation] Behavioral Tracking Importance and Elements Identify Target Behavior/Trigger prior to medication start Track SPECIFIC behaviors (ideally for several days prior to medication starts) Continually monitor quantitatively per shift for behavioral episodes as well as care planned interventions, outcome and any side effects noted Discussion relating to CNA reporting to Nursing and who fills out the behavioral tracking forms 8

F309 - **New Section** Review of Care and Services for a Resident with Dementia Begins by stating: Use this guidance for a resident with dementia. If the resident is receiving one or more psychopharmacological agents, also review the guidance at F329, Unnecessary Drugs. Keys to Recognition and Management Individualized interventions (including direct care and activities) Person-Centered or Person-Appropriate Care Activities should be relevant to the specific needs, interests, culture, background, etc. of the individual for whom they are developed and medical treatment should be tailored to an individual s risk factors, current conditions, past history, and details of any present symptoms. Proper description of Behavioral or Psychological Symptoms of Dementia (BPSD) Therapeutic Interventions or Approaches Caregivers and practitioners are expected to: understand or explain the rationale for interventions/approaches monitor the effectiveness of those interventions/approaches provide ongoing assessment as to whether they are improving or stabilizing the resident s status or causing adverse consequences. Identifying the frequency, intensity, duration and impact of behaviors, as well as the location, surroundings or situation in which they occur may help staff and practitioners identify individualized interventions or approaches to prevent or address the behaviors. In many situations, medications may not be necessary; staff/practitioners should not automatically assume that medications are an appropriate treatment without a systematic evaluation of the resident. Therapeutic Interventions or Approaches Examples of suggested ideas to prevent BPSD include (but are not limited to): Arranging staffing to optimize familiarity with the resident (e.g., consistent caregiver assignment); Identifying and applying knowledge of lifelong patterns, preferences, and interests for daily activities to enhance quality of life and individualize routine care; Understanding that the resident may be responding predictably given the situation or surroundings (e.g., being awakened at night in his/her bedroom by unfamiliar staff); and Matching activities for a resident with dementia to his/her individual cognitive and other abilities and the specific behaviors in that individual based on the assessment. 9

Medication Use in Dementia (From F309) It has been a common practice to use various types of psychopharmacological medications in nursing homes to try to address [BPSD] without first determining whether there is an underlying medical, physical, functional, psychosocial, emotional, psychiatric, or environmental cause of the behaviors. Common complications of antipsychotics: Movement disorders Falls Hip Fractures Cerebrovascular accidents and transient ischemic events Increased risk of death (BLACK BOX WARNING) Resident and/or Family/Representative Involvement CMS expects that the resident and family/representatives, to the extent possible, are involved in helping staff to understand the potential underlying causes of behavioral distress and to participate in the development and implementation of the resident s care plan. How have you involved them in discussions about: Potential approaches to address behaviors? Potential risks and benefits of psychopharmacological medications (including boxed warnings)? Expected duration of use of a medication? Use of individualized approaches? Plans to evaluate the effects of treatment? Pertinent alternatives? Necessity of informed consent The Care Process Overview A. Recognition and Assessment B. Cause Identification and Diagnosis C. Development of Care Plan D. Individualized Approaches and Treatment E. Monitoring, Follow-up and Oversight F. Quality Assessment and Assurance (QAA) 30 10

The Care Process Overview A. Recognition and Assessment The resident s record should reflect comprehensive information about the person including, but not limited to: Past Life Experiences Medications Description of Behaviors Cognitive Status and Related Abilities Resident Record Personal Preferences (e.g., food, music, daily routine) Medical Conditions Oral Health Presence of Pain 31 The Care Process Overview A. Recognition and Assessment How do they communicate pain? Discomfort? Hunger? Thirst? Frustration? Boredom? Anxiety? Fatigue? staff should specifically describe the behavior (including potential underlying causes, onset, duration, intensity, precipitating events or environmental triggers, etc.) and related factors (such as appearance and alertness) in the medical record with enough detail of the actual situation to permit cause identification and individualized interventions Describing the details and possible consequences of resident behaviors helps to distinguish expressions such as restlessness or continual verbalization from potentially harmful actions such as kicking, biting or striking out at others. This description alone does not suggest that a specific intervention is or is not indicated; Noting that the resident is generally violent, agitated or aggressive does not identify the specific behavior exhibited by the resident. Noting instead that the resident responds in crowded, busy group activities by yelling or throwing furniture reflects not only a potential safety issue but should result in the resident being provided alternative activities to meet his/her needs. 32 The Care Process Overview B. Cause Identification and Diagnosis Identify possible risk and casual/contributing factors for behaviors: Co-existing medical or psychiatric conditions (e.g., pain, constipation, etc.) Uncontrolled pain is known to cause or contribute to changes in mood/behavior Adverse drug effects (e.g., anticholinergic side effects) Significant changes in physical, mental, or psychosocial status must immediately consult with the resident s physician If two or more areas of decline or improvement are noted, a Significant Change in Clinical Status Assessment (SCSA) should be considered 33 11

The Care Process Overview B. Cause Identification and Diagnosis If medical causes are ruled out, consider: Boredom; lack of meaningful activity or stimulation during customary routines and activities; Anxiety related to changes in routines such as shift changes, unfamiliar or different caregivers, change of (or relationship with) roommate, inability to communicate; Care routines (such as bathing) that are inconsistent with a person s preferences; Personal needs not being met appropriately or sufficiently (e.g., hunger, thirst, bowels); Fatigue/Disturbance in sleep pattern Environmental factors (e.g., noise could lead to discomfort or delusions) Mismatch between the activities or routines selected and the resident s cognitive and other abilities to participate in those activities/routines. 34 The Care Process Overview C. Development of Care Plan Each individual care plan must: Be specific to the resident Involve the resident and family/representative The care plan should include: Common behavioral expressions and expected responses to interventions Certain behavior may be anticipated and sometimes may be preventable based on understanding the underlying causes and possible triggers for each individual. Goals for monitoring of all interventions Any medications - In certain cases, residents may benefit from the use of medications. Indication/rationale for use Duration Care Planning for Medications Must Include: Specific target behaviors and expected outcomes Monitoring for efficacy and/or adverse consequences Dosage Plans for gradual dosage reduction (GDR) when applicable 35 The Care Process Overview C. Development of Care Plan Questions to ask if a psychopharmacological medication is initiated or continued: What was the person trying to communicate through their behavior? What were the possible 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? Was the medication clinically indicated and/or necessary to treat a specific condition and target symptoms as diagnosed and documented in the record? Was the medication adjusted to the lowest possible dosage to achieve the desired therapeutic effects? Were gradual dose reductions planned and behavioral interventions, unless clinically contraindicated, provided in an effort to discontinue the medication? Was the interdisciplinary team, including the primary care practitioner, involved in the care planning process? How does the staff monitor for the effectiveness and possible adverse consequences of the medication? 36 12

The Care Process Overview D. Individualized Approaches and Treatment Identify and document specific target behaviors, expressions of distress and desired outcomes Implement appropriate, individualized, person-centered interventions and document the results Communicate and consistently implement the care plan, over time and across various shifts Staffing and Staff Training 37 The Care Process Overview D. Individualized Approaches and Treatment Staffing There must be sufficient numbers of staff to consistently implement the care plan Quantity (direct care and supervisory) Quality (to meet the needs of the resident s assessments and care plan) Strive to staff in a way that optimizes familiarity with residents Assess for caregiver stress Staff Training Must demonstrate competency in skills and techniques necessary to care for the resident s needs as identified through resident assessments, and as described in the plan of care Nursing Assistants must have: Performance review (at least every 12 months) Regular in-service education based on the outcome of the reviews Training in care of individuals with dementia and related behaviors (initially after being hired and annually) 38 The Care Process Overview E. Monitoring, Follow-up and Oversight The interdisciplinary team (IDT) should: review a resident s progress toward defined goals, adjust interventions as needed Identify when care objectives are met When concerns are identified related to effectiveness or potential or actual adverse consequences of a resident s medication regimen, staff must notify the physician and the physician must respond and, as necessary, initiate a change to the resident s care 39 13

The Care Process Overview F. Quality Assessment and Assurance (QAA) The medical director and the quality assessment and assurance committee can help the facility evaluate existing strategies for coordinating the care of a resident with dementia and ensure that facility policies and procedures are consistent with current standards of practice. The QAA oversight should include: resident care policies and how they are monitored for implementation Staff training (including nursing, dietary, therapy or rehabilitation staff, social workers) on how to communicate with and address behaviors in residents with dementia Ensuring sufficient staff to implement the care plan for residents with dementia, so that medication is not used instead of pertinent non-pharmacological interventions, unless clinically contraindicated Analysis of data collected to monitor the pharmacological and non-pharmacological interventions used Monitoring responses to the issues and concerns identified through the consultant pharmacist medication regimen review 40 F329 483.25 Unnecessary Drugs Table 1 Revisions for Antipsychotic Medications Antipsychotics Indications for Use A. Conditions Other Than Dementia Schizophrenia Schizo-affective disorder Schizophreniform disorder Delusional disorder Mood disorders (e.g. bipolar disorder, etc.) Psychosis in the absence of dementia Medical illnesses with psychotic symptoms and/or treatment related psychosis or mania Tourette s Disorder Huntington disease Hiccups (not induced by other medications) Nausea and vomiting associated with cancer or chemotherapy 42 14

Antipsychotics Indications for Use (continued) B. Behavioral or Psychological Symptoms of Dementia (BPSD) Antipsychotic medications are only appropriate for elderly residents in a small minority of circumstances (unless the antipsychotic is prescribed to treat previously diagnosed mental illness such as schizophrenia or possibly other conditions listed [in A.]). 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. Antipsychotic medications must be prescribed at the lowest possible dosage for the shortest period of time and are subject to gradual dose reduction and re-review. 43 Inadequate Indications for Antipsychotic Use Wandering Poor self-care Restlessness Impaired memory Mild anxiety Insomnia Inattention or indifference to surroundings Fidgeting Sadness or crying alone that is not related to depression or other psychiatric disorders Nervousness Uncooperativeness (e.g. refusal of or difficulty receiving care) 44 Criteria for Use of An Antipsychotic All of the [preceding] highlight conditions/diagnoses where antipsychotic medications may possibly be appropriate, but diagnoses alone do not warrant the use of an antipsychotic unless 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. Acute Situations/Emergency 1) Use must be limited to 7 days or less 2) A clinician with the IDT must evaluate and document the situation within 7 days to identify and address any contributing and underlying causes of the acute condition and verify the continuing need for an antipsychotic medication. 3) If the behaviors persist beyond the emergency situation, pertinent non-pharmacological interventions must be attempted, unless clinically contraindicated, and documented following the resolution of the acute psychiatric event. 45 15

Criteria for Use of An Antipsychotic (continued) Enduring Conditions (i.e., non-acute; chronic or prolonged condition) Before initiating or increasing an antipsychotic medication for enduring conditions, the target behavior/s must be clearly and specifically identified and documented. Monitoring must ensure that ALL 4 of the following are TRUE about the behavioral symptom: 1) Not due to a medical condition or problem (e.g., pain, medication side effect, etc.) that would improve or resolve if treated/the offending medication(s) are discontinued; 2) Not due to environmental stressors alone (e.g., alteration in the resident s customary location or daily routine, unfamiliar care provider, hunger or thirst, excessive noise for that individual, inadequate or inappropriate staff response) 3) Not due to psychological stressors alone (e.g., loneliness, taunting, abuse), anxiety or fear stemming from misunderstanding related to his or her cognitive impairment (e.g., the mistaken belief that this is not where he/she lives or inability to find his or her clothes or glasses, unaddressed sensory deficits) that can be expected to improve or resolve as the situation is addressed; 4) Persistent as documented in the medical record, the situation or condition continues or recurs over time (persists) and that other approaches that have been attempted have failed to adequately address the behavioral/psychological symptoms and that the resident s quality of life is negatively affected by the behaviors/symptoms as described above 46 Beyond CMS An Industry-wide Consensus The American Geriatrics Society (AGS) Medication treatment of behavioral disturbances of dementia is of limited efficacy and should be used only after environmental and nonpharmacologic techniques have been implemented No psychoactive medication prescribed to treat neuropsychiatric symptoms of dementia should be continued indefinitely, and attempt at drug withdrawal should be made regularly (e.g., every 3-6 months) The goal (of treatment) is reduction, rather than elimination, of the distressing behavior The American Medical Directors Association (AMDA) The use of antipsychotic medications should be limited to treating dementia-related behaviors that are unresponsive to conservative management and done only after thoughtful evaluation, identification of appropriate indications, and considerations of the benefits and risks involved. The goal of using antipsychotic medications, as with any psychopharmacological medications, is to address behavioral or mood symptoms and/or their underlying causes while preserving or enhancing function and quality of life. If the medication causes excessive or unwanted sedation or impairs function and diminishes quality of life, then its use may not be appropriate and should be reconsidered. Prescribing an antipsychotic medication, except in an emergency, should be done only after an attempt to determine if there are other environmental or medical factors causing these types of symptoms, and after taking appropriate actions when other causes are suspected (e.g., treating a urinary tract infection or providing medication for arthritis pain). 47 New Admissions (**New Section of F329**) For residents who do not require PASRR [Pre-Admission Screening and Resident Review] and are admitted on an antipsychotic, the facility MUST re-evaluate the use of the antipsychotic medication at the time of admission and/or within 2 weeks of admission (at the time of the initial MDS assessment) AND consider whether or not the medication can be reduced (tapered) or discontinued. 48 16

Daily Dose Thresholds for Antipsychotics Used for BPSD Generic Name Maximum Total Dosage per day First Generation or Typical Agents Generic Name Maximum Total Dosage per day Second Generation or Atypical Agents chlorpromazine (Thorazine) 75 mg aripiprazole (Abilify) 10 mg fluphenazine (Prolixin) 4 mg clozapine (Clozaril) 50 mg haloperidol (Haldol) 2 mg olanzapine (Zyprexa) 5 mg (previously 7.5 mg) loxapine (Loxitane) 10 mg quetiapine (Seroquel) 150 mg molindone (Moban) 10 mg risperidone (Risperdal) 2 mg perphenazine (Trilafon) 8 mg ziprasidone (Geodon) ** thioridazine (Mellaril) 75 mg paliperidone (Invega) ** thiothixene (Navane) 7 mg asenapine (Saphris) ** trifluoperazine (Stelazine) 8 mg iloperidone (Fanapt) ** lurasidone (Latuda) ** Higher doses warrant closer review for adverse effects and risk/benefit evaluation. * = Due to additional boxed warnings of QTc prolongation, its use should be avoided ** = no studies have been conducted or have results available to assess the drug s safety or efficacy in older adults with dementia. 49 Monitoring and Effectiveness Monitor for: ongoing effectiveness potential adverse consequences Evaluate the use of any other psychopharmacological medications (e.g. mood stabilizers, benzodiazepines) being given to the resident. Surveyors should investigate further in cases where: more than one antipsychotic agent has been prescribed, OR where an antipsychotic has been discontinued and a medication such as a mood stabilizer has been added. After initiating or increasing the dose of an antipsychotic, the behavioral symptoms must be reevaluated periodically (at least during quarterly care plan review, but often more frequently, depending on the resident s response to the medication) to determine: the effectiveness of the antipsychotic AND the potential for reducing or discontinuing the dose based on target symptoms AND any adverse effects or functional impairment. 50 Potential Adverse Consequences of Antipsychotics Category General Cardiovascular Metabolic Neurologic Specific Adverse Consequences Anticholinergic Effects (see Table II), falls, excessive sedation Cardiac arrhythmias, orthostatic hypotension total cholesterol, triglycerides, unstable or poorly controlled blood sugar, weight gain Akathisia, parkinsonism, tardive dyskinesia, neuroleptic malignant syndrome, stroke, transient ischemic attack If the antipsychotic medication is identified as probably causing or contributing to adverse consequences as identified above, the facility must act upon this. In some cases, the benefits of treatment will still be considered to outweigh the risks or burdens of treatment, so the medication may be continued; however, the facility and prescriber must document the rationale for the decision and also that the resident, family member or legal representative is aware of and involved in the decision to continue the medication. 51 17

Actual Case Study: Mrs. S Mrs. S is an 87 year-old resident of a facility who decided to really focus on non-pharmacologic approaches to dementia-related behaviors. She has diagnoses of Alzheimer s disease, depression, and arthritis. Her current medications include: -citalopram 10 mg QD for depression -Seroquel 25mg AM and HS for combative behaviors -Acetaminophen 1000mg TID PRN pain (which she rarely received) During the facility s review of her behaviors, she was noted to have 4 episodes of combativeness in the past month, 2 in the morning during AM care and dressing, and 2 around 9PM when receiving help with getting ready for bed. The activities coordinator noted that she did not seem to actively participate in morning exercise activities, but did participate in similar activities in the afternoon Actual Case Study: Mrs. S (cont d) Her nursing assistant said that Mrs. S often grunted and groaned when she helped her get dressed in the morning, but that she seemed to be most combative when a turtleneck top was chosen to be worn that day. Considering this information and the fact that she has a diagnosis of arthritis, the team checked and verified that she had not received any acetaminophen in the mornings, and decided to ask her physician if a routine dose could be tried each morning for a month. Nursing assistants were asked not to dress her in a turtleneck during that period as well. Upon review the following month, Mrs. S was noted to have no episodes of combative behavior in the mornings, but that she had 3 episodes around bedtime. The care team then asked her physician if the AM dose of Seroquel could be discontinued on a trial basis, and that the AM dose of acetminophen be continued routinely. Actual Case Study: Mrs. S (cont d) Upon review the following month, there were no noted episodes of AM combativeness after the discontinuation of Seroquel, and her nursing assistant noted that she appeared to moan and groan less often upon dressing and AM care. Excited about these results, the team now wanted to address the PM Seroquel. The nursing assistants that usually cared for Mrs S. in the evenings noted that she often liked to listen to music after dinner, and look at family photo albums. The team asked this nursing assistant to attempt to offer to turn on some music during any episodes of PM combativeness, and also offer to look at a photo album with her after getting dressed for bed. This approach was successful, with only 1 minor episode of combativeness over the next month. 18

Actual Case Study: Mrs. S (cont d) The team then asked her physician if for a trial discontinuation of her PM Seroquel dose, which occurred. While occasional episodes of AM and PM combativeness still occur, the nursing assistants state that they can handle it, and are very engaged and excited about their success with Mrs. S, and want to try it on other residents. The nursing assistants were brought into the facility s next Quarterly Quality Assurance Meeting and asked to explain what they had been able to accomplish with Mrs. S, and were applauded by all for their success, which was very rewarding for them. Mrs. S remains off of her antipsychotic to this day SUMMARY Antipsychotics present significant safety risks to elderly residents with dementia, and as such should generally be reserved for those patients with distressing psychotic symptoms (delusions, hallucinations) or aggressive behavior that presents a danger to self or others Non-antipsychotics (e.g., antidepressants) should be attempted initially for other behaviors for which non-pharmacologic interventions have not been optimally effective The goal should be to use these medications infrequently and discontinuation of these drugs whenever possible. Shortest duration and lowest dose possible. Additional Actual Case Studies Upon entering facility I was asked to review Mr X. Facility was concerned about an increase in sexual inappropriate behaviors relating to touching staff inappropriately. Zyprexa 7.5mg BID was initiated 15 days prior and behaviors continued despite antipsychotic therapy. Discussion with nursing staff as well as therapy and nursing assistants all verified the concern with inappropriate staff contact when approaching the patient. Where do we go from here? 19

Additional Actual Case Studies 42 YO patient I was asked to review for escalating behaviors. Resident currently received Haldol 10mg BID, Risperdal 4mg BID and Zyprexa 20mg QHS. No other medications on board. His most recent behavior was related to aggressive behaviors associated with staff and other residents and had recently thrown a metal chair through a window. Where do we go next? Additional Actual Case Studies 89 YO female patient with history of AFIB, AD, and DM2 with the following medications on board: Haldol 2mg BID, digoxin 250mcg daily, warfarin 2mg daily, lasix 40mg daily, lisinopril 2.5mg daily, sliding scale insulin with humalog and no regular coverage. Celexa 10mg was recently started due to symptoms of depression significant for emotional lability and the haldol was initiated due to decreased cognition, impaired memory, disoreintation and striking at staff during cares. I was asked to review the resident due to the recent medication changes and suggest alternatives to the Haldol for behavioral management. Where do we go from here? 20