Advisory Council April 2019 Meeting Presentation: Inappropriate Antipsychotics Use

04/29/2019

ADVISORY COUNCIL ON ALZHEIMER'S RESEARCH, CARE, AND SERVICES

Monday, April 29, 2019

Printer Friendly Version in PDF Format (11 PDF pages)

 

Inappropriate Use of Antipsychotics for People with Dementia in Community Settings

Anita Everett, MD, Director, Center for Mental Health Services
Matthew L. Goldman, MD, MS, Policy Fellow
Substance Abuse and Mental Health Services Administration
U.S. Department of Health and Human Services

Agenda

  1. Background
  2. Community Considerations
  3. Principles of Care
    1. Assessment
    2. Goals of Care
    3. Care Plan: Non-Pharmacologic Interventions
    4. Care Plan: Pharmacologic Treatment
    5. Monitoring and Reassessment
    6. Preventing Caregiver Burnout
  4. Resources

I. Background

  • Behavioral manifestations of dementia are common
  • Agitation and aggression can be dangerous for both the person as well as caregivers
  • Behavioral modification should be first-line for challenging behaviors
  • However, people with dementia are often inappropriately prescribed sedating medications such as antipsychotics
  • Can result in significant harm (increased stroke risk and overall mortality); should be used only when clinically indicated

Ballard CG, Waite J, Birks J. Atypical antipsychotics for aggression and psychosis in Alzheimer's disease. Cochrane Database Syst Rev [Internet] 2006 [cited 2018 Nov 8];(1). Available from: http://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003476.pub2/abstract
Deb S, Kwok H, Bertelli M, et al. International guide to prescribing psychotropic medication for the management of problem behaviours in adults with intellectual disabilities. World Psychiatry Off J World Psychiatr Assoc WPA 2009;8(3):181-6.
Gill SS, Bronskill SE, Normand S-LT, et al. Antipsychotic drug use and mortality in older adults with dementia. Ann Intern Med 2007;146(11):775-86.

History of Federal Actions to Address Antipsychotic Prescribing for Dementia

2008
  • FDA issues an advisory and black box warning
  • "The treatment of behavioral disorders in elderly patients with dementia with ... antipsychotic medications is associated with increased mortality."
2011
  • National Alzheimer's Project Act signed into law, establishes Advisory Council coordinated by ASPE
2011
  • HHS Office of Inspector General issues report, "Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents" [oei-07-08-00150]
  • Found that 14% of elderly nursing home residents had Medicare claims for second generation antipsychotic drugs, and 88% of those were prescribed for dementia.
2012
  • CMS launches National Partnership to Improve Dementia Care in Nursing Homes
2015
  • Government Accountability Office issues report, "Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings" [GAO-15-211]
  • "Among Medicare Part D enrollees with dementia living outside of a nursing home [in 2012], about 14 percent were prescribed an antipsychotic," compared to about one third of older adults with dementia who had spent more than 100 days in a nursing home.

II. Community Considerations

  • The majority of efforts through the National Partnership have focused on antipsychotic use in nursing homes
  • However, many people living with dementia are in community settings such as their own homes, group homes, assisted living facilities, and other congregate settings
    • Often receive health care services through Medicare, Medicaid, or both
    • Medications often prescribed by primary care providers who are required to regularly review and complete medication lists
    • Subset of Medicaid beneficiaries enrolled in home and community based services (HCBS) programs
      • Required to have a person-centered plan to address individual needs, including any challenging behaviors associated with dementia or other cognitive impairment

U.S. Department of Health and Human Services. Guidance to HHS Agencies for Implementing Principles of Section 2402(a) of the Affordable Care Act: Standards for Person-Centered Planning and Self-Direction in Home and Community-Based Services Programs [Internet]. 2014. Available from: https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf

Overall, therapeutic approaches in community settings, including medication utilization, are less monitored and regulated than in nursing homes and hospital settings and therefore need special attention to ensure safe and appropriate prescribing practices.

III. PRINCIPLES of Care

  • Given the complexities of working with older adults and people with disabilities, the following general principles should be considered in developing and implementing an actionable person-centered care plan for each individual.
    • Assessment
    • Goals of Care
    • Care Plan: Non-Pharmacologic Interventions
    • Care Plan: Pharmacologic Treatment
    • Monitoring and Reassessment
    • Preventing Caregiver Burnout

PRINCIPLES -- Assessment

  • Behavioral symptoms should be carefully assessed based on:
    • Underlying disorder(s) and disease stage
    • Possible contributing factors such as medication regimen, time of day, environmental stressors and unmet needs
  • Behavioral manifestations of dementia must be distinguished from other potential and treatable causes
  • Medical causes include:
    • Delirium due to infection, electrolyte disturbances, constipation, pain, sleep disturbance, sensory impairment, polypharmacy, etc.
  • Underlying cause should be treated
  • Psychiatric comorbidities include:
    • Depression, anxiety and psychosis (e.g. paranoid delusions, auditory or visual hallucinations)
  • First identify and address environmental stressors using family interventions and environmental modifications
  • SSRIs are typically safe as first-line treatment for depression and anxiety disorders in combination with non-pharmacologic care
  • For active psychosis, treatment depends on underlying condition
    • Older adults with established primary psychotic disorders are cared for differently than those who manifest psychosis as part of a late-life disorder, given that the balance between benefit and risk of antipsychotic treatment is different.

Krause M, Huhn M, Schneider-Thoma J, Rothe P, Smith RC, Leucht S. Antipsychotic drugs for elderly patients with schizophrenia: A systematic review and meta-analysis. Eur Neuropsychopharmacol [Internet] 2018 [cited 2018 Oct 1];Available from: http://www.sciencedirect.com/science/article/pii/S0924977X18308198
Lyketsos CG, Colenda CC, Beck C, et al. Position statement of the American Association for Geriatric Psychiatry regarding principles of care for patients with dementia resulting from Alzheimer disease. Am J Geriatr Psychiatry Off J Am Assoc Geriatr Psychiatry 2006;14(7):561-72.

PRINCIPLES -- Goals of Care

  • Review the benefits and risks of all interventions
  • Include non-pharmacologic approaches as first line
  • Consider safe short- and long-term interventions
  • Informed consent is necessary and should include the person and a legal representative when needed, as well as friends and caregivers
  • Address issues such as communication preferences, use of technology, work or volunteer status, finances, housing, and advanced care planning

Azermai M, Petrovic M, Elseviers MM, Bourgeois J, Van Bortel LM, Vander Stichele RH. Systematic appraisal of dementia guidelines for the management of behavioural and psychological symptoms. Ageing Res Rev 2012;11(1):78-86.

PRINCIPLES -- Care Plan: Non-pharmacologic approaches for behavioral disturbances

  • Non-pharmacologic treatments should be considered as first-line interventions before considering medications
  • Each behavior should be clearly identified
  • Teach staff to look for antecedents and causes and to respond consistently
  • Consider the use of a behavior tracking chart
  • Team review of behavior with modeling a culture of curiosity about the behavior rather than blaming or labeling
  • Care should be tailored to the individual with a person-centered, multidisciplinary approach that addresses relevant psychosocial aspects of care
  • Results of certain approaches such as music therapy, aroma therapy, massage, and multisensory stimulation are broadly inconclusive but may be very safe and beneficial for some individuals
  • The American Association of Geriatric Psychiatry's principles of care for people with dementia recommends:
    • Maximize current abilities and function; avoid demanding or challenging tasks
    • Maintain a routine schedule
    • Create a positive and familiar environment
    • Engage in activities that are important to the person
    • Employ positive behavioral management strategies
  • Principles of applied behavior analysis include:
    • Evaluating the behavior using the Antecedent-Behavior-Consequence (ABC) Model
    • Avoiding or reducing experiences that trigger behaviors
    • Promoting alternative behaviors with positive phrasing, praising desired behaviors, relaxation techniques, distraction, and tangible reinforcers

Brosnan J, Healy O. A review of behavioral interventions for the treatment of aggression in individuals with developmental disabilities. Res Dev Disabil 2011;32(2):437-46.
Scales K, Zimmerman S, Miller SJ. Evidence-Based Nonpharmacological Practices to Address Behavioral and Psychological Symptoms of Dementia. The Gerontologist 2018;58(suppl_1):S88-102.
Health Resources and Services Administration. Training Curriculum: Alzheimer's Disease and Related Dementias, Supplemental Module 5, Addressing Behaviors in Dementia [Internet]. 2017 [cited 2018 Dec 19]. Available from: https://bhw.hrsa.gov/grants/geriatrics/alzheimers-curriculum

PRINCIPLES -- Care Plan: Pharmacologic treatment for severe behavioral disturbances

  • Antipsychotic medications are only indicated as a last resort if aggression, agitation or psychotic symptoms cause severe distress or an immediate risk of harm to the individual or others
  • The side effect profile of antipsychotics should be aligned with patient risk:
    • Second generation antipsychotics may cause metabolic syndrome and weight gain, which should be avoided in an overweight person with diabetes.
    • People with Parkinson's disease and Lewy Body Dementia frequently have hallucinations but are at high risk of side effects of antipsychotics, which should therefore be avoided whenever possible.
  • The American Psychiatric Association's "Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis in Patients with Dementia" recommends the following principles:
    • Antipsychotic medications should be avoided when possible
    • If indicated, dosage should be started as low as possible with modest increases only when necessary
    • Second generation antipsychotics are preferable over first generation antipsychotics due to more favorable side effect profiles
    • Medications should be discontinued if no clinical benefit is observed
    • Discontinuation may need to be considered for those who experience side effects even if there is improvement in behavioral symptoms
    • Taper should be attempted for ALL patients within 4 months of treatment with close monitoring

Krause M, Huhn M, Schneider-Thoma J, Rothe P, Smith RC, Leucht S. Antipsychotic drugs for elderly patients with schizophrenia: A systematic review and meta-analysis. Eur Neuropsychopharmacol [Internet] 2018 [cited 2018 Oct 1];Available from: http://www.sciencedirect.com/science/article/pii/S0924977X18308198
Yohanna D, Cifu AS. Antipsychotics to Treat Agitation or Psychosis in Patients With Dementia. JAMA 2017;318(11):1057-8.
Sheehan R, Hassiotis A. Reduction or discontinuation of antipsychotics for challenging behaviour in adults with intellectual disability: a systematic review. Lancet Psychiatry 2017;4(3):238-56.
de Kuijper G, Evenhuis H, Minderaa RB, Hoekstra PJ. Effects of controlled discontinuation of long-term used antipsychotics for behavioural symptoms in individuals with intellectual disability. J Intellect Disabil Res JIDR 2014;58(1):71-83.

PRINCIPLES -- Monitoring and Reassessment

  • All people with dementia should be periodically reassessed to determine if antipsychotics are needed as part of the person-centered care plan
  • Antipsychotics prescribed for behaviors resulting from delirium--a common practice without clear efficacy--should be reconsidered following resolution of the delirium and should not be continued long-term
  • It is generally not appropriate to replace an antipsychotic with an alternate class of medication such as a benzodiazepine or mood stabilizer for the purpose of sedation given the risks of major side effects (e.g. falls, cognitive decline, and delirium)
  • If an antipsychotic medication is prescribed, vital signs and side effects should be monitored closely:
    • Common side effects can include sedation, dizziness, postural hypotension and confusion which can increase the risk of falls
    • Extrapyramidal symptoms (e.g. tardive dyskinesia, Parkinsonism) are common in people with dementia and should be monitored with standardized tools (e.g. Abnormal Involuntary Movement Scale or the Dyskinesia Identification System: Condensed User Scale)
    • Antipsychotic medications may lower the seizure threshold and induce seizure activity in this population, particularly those with existing seizure disorders or other accumulated brain injury related to falling, atrophy or other changes.

Declercq T, Petrovic M, Azermai M, et al. Withdrawal versus continuation of chronic antipsychotic drugs for behavioural and psychological symptoms in older people with dementia. Cochrane Database Syst Rev [Internet] 2013 [cited 2018 Nov 8];(3). Available from: http://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD007726.pub2/abstract
Bloechliger M, Rüegg S, Jick SS, Meier CR, Bodmer M. Antipsychotic drug use and the risk of seizures: follow-up study with a nested case-control analysis. CNS Drugs 2015;29(7):591-603.
Burry L, Mehta S, Perreault MM, et al. Antipsychotics for treatment of delirium in hospitalised non-ICU patients. Cochrane Database Syst Rev 2018;6:CD005594.
Rochon PA, Vozoris N, Gill SS. The harms of benzodiazepines for patients with dementia. CMAJ. 2017;189(14):E517-E518. doi:10.1503/cmaj.170193

PRINCIPLES -- Preventing Caregiver Burnout

  • Symptoms of stress and burnout are common among both paid and unpaid caregivers of people with dementia
  • It is important to link caregivers to services and supports, including:
    • Education and training
    • Counseling
    • Respite care
  • The effect of antipsychotics for people with dementia on caregiver burnout is not known

Thomas P, Lalloué F, Preux P-M, et al. Dementia patients caregivers quality of life: the PIXEL study. Int J Geriatr Psychiatry 2006;21(1):50-6.
White P, Edwards N, Townsend-White C. Stress and burnout amongst professional carers of people with intellectual disability: another health inequity. Curr Opin Psychiatry 2006;19(5):502-7.
Mason A, Weatherly H, Spilsbury K, et al. A systematic review of the effectiveness and cost-effectiveness of different models of community-based respite care for frail older people and their carers. Health Technol Assess Winch Engl 2007;11(15):1-157, iii.

Summary

  • Behavioral manifestations of dementia are common and require careful assessment and management
  • Physical and psychiatric causes of behavioral symptoms should be identified and treated accordingly
  • Goals of care should be discussed when dementia results in behaviors that endanger the individual or their caregivers
  • A clear person-centered care plan should be made with specific behavior modification strategies
  • Non-pharmacologic approaches to care should always be attempted first unless clinically contraindicated, including:
    • Helping individuals maintain a routine schedule
    • Avoiding demanding or challenging tasks
    • Engaging in activities that are important to the person
    • Focusing on creating a positive environment
  • If antipsychotics are required for behaviors that are dangerous to the individual or to others:
    • Risks and benefits should be discussed with individuals and family or other legal representatives to obtain informed consent
    • Second generation antipsychotics are preferred, though potential side effects must be considered in the context of each individual
    • Dosage should be started as low as possible with modest increases only when clinically indicated
    • Symptoms and side effects should be monitored closely
    • Medications should be discontinued through tapering when necessary if side effects outweigh potential benefits, or if no clinical benefit is observed
    • Taper should be attempted for all patients within 4 months of treatment with close monitoring

Considerations for NAPA Recommendations

  • Action 2.D.1: Explore dementia care guidelines and measures
    • Consider expanded use of quality metrics focused on antipsychotic prescribing in dementia (e.g. NQF 2111)
  • Action 3.D.1: Monitor, report and reduce inappropriate use of antipsychotics in nursing homes
    • Consider expanding action to include people living outside of nursing home settings

Additional Resources

Questions and Discussion

SAMHSA's mission is to reduce the impact of substance abuse and mental illness on America's communities.

Anita Everett, MD, Director, Center for Mental Health Services
Anita.Everett@samhsa.hhs.gov

Matthew L. Goldman, MD, MS, Policy Fellow
Matthew.Goldman@samhsa.hhs.gov

http://www.samhsa.gov

1-877-SAMHSA-7 (1-877-726-4727) -- 1-800-487-4889 (TDD)


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