Karl Steinberg, MD, CMD President, Stone Mountain Medical Associates, Inc.

1. Reducing Unnecessary Antipsychotic Use in Dementia Residents:Prescriber/Medical Director Perspective Karl Steinberg, MD, CMD President, Stone Mountain Medical Associates, Inc. Medical Director, Kindred Village Square/Life Care Center of Vista Past President, CALTCM Editor-in-Chief, Caring for the Ages (AMDA) August 21, 2013

2. Tessa & Josie

3. What antipsychotic use is necessary?? • 42 CFR 483.25 (l)(2) Antipsychotic Drugs. Facility must ensure that— • (i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and • (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

4. What antipsychotic use is necessary?? When an antipsychotic medication is being initiated or used to treat an emergency situation: • 1. The acute treatment period is limited to ≤7 days • 2. A clinician in conjunction with the IDT must evaluate and document the situation within 7 days to identify and address contributing and underlying causes of the acute condition and verify continuing need. • 3. If behaviors persist, pertinent non-pharmacological interventions must be attempted, unless clinically contraindicated, and documented following the resolution of the acute psychiatric event.

5. What antipsychotic use is necessary?? • Antipsychotics are the drug of choice for delirium, although it is off-label • Antipsychotics are approved and effective for bipolar disorder (mania) • Some antipsychotics are approved and effective for refractory major depressive disorder • According to CMS, appropriate for Huntington’s and Tourette’s but not for bipolar

6. What else works? Evidence? • No drug approved for BPSD/agitation of dementia • Antipsychotics clearly carry significant risks and benefit in this population. • Clinician’s availability to explain risks and benefits is of key importance • Non-pharmacological interventions can be helpful, although evidence is limited • Systematic Review 2011 done for Veterans Affairs • Less than 20 good studies (see next slide) • No magic bullet • Resident-specific, individualized strategy can work

7. What else works? Evidence? • Reminiscence Therapy: No support • Simulated Presence Therapy: No support • Validation Therapy: Insufficient evidence • Acupuncture: No quality evidence of benefit or harm • Aromatherapy: Insufficient evidence • Light Therapy: Some beneficial effect on agitation and nocturnal restlessness, but poor quality. Insufficient evidence to support its use. • (Hand) Massage and Touch: May have beneficial effect • Music Therapy: Limited evidence, may be of benefit • Snoezelen (Multi-Sensory Stimulation): Insufficient evid.

8. What else works? Evidence? • TENS: Insufficient evidence • Animal-assisted therapy: Potential for benefit but no rigorous evidence • Exercise: Improvement in sleep and other parameters but no consistent effect on behavior ____________________________________________ • Wandering: Exercise, Walking not helpful. Tracking devices, alarms, motion detectors effective. • Agitation: some benefit in some studies from hand massage, aromatherapy, thermal bath, calming music

9. Opportunity • Despite poor evidence, there may be justification to try non-pharmacological efforts to targeted and carefully selected NH residents • Anecdotally—definite improvement in some residents • Opportunity to develop and carry out better studies • CALTCM stands ready to lead the effort for the collaborative to study this issue if funding available

10. From British Columbia (Canada) • Risperidoneis the only atypical antipsychotic medication approved for the short-term treatment of aggression or psychosis in patients with severe dementia. Other drugs have been shown effect as well • Despite the modest efficacy, the significant increase in adverse events suggests that neither Risperidonenor Olanzapineshould be used routinely to treat residents with aggression or psychosis unless there is marked risk or severe distress.Best Practice Guideline for Accommodating and Managing Behavioural and Psychological Symptoms of Dementia in Residential Care (Province of British Columbia, 2012)

11. From British Columbia (Canada) • Key considerations: • Carefully weigh the potential benefits of pharmacological intervention versus the potential for harm. • Recognize that the evidence base for drug therapy is modest. • (Number needed to treat that ranges from 5-14) • Engage the resident/family/substitute decision-maker in the health care planning and decision-making process. • Obtain consent for health care treatment from the appropriate decision-maker before administering antipsychotic medication. • Regularly review the need (or not) for ongoing antipsychotic therapy for BPSD and trial withdrawal. • Continue non-pharmacological interventions by tailoring them to individuals Best Practice Guideline for Accommodating and Managing Behavioural and Psychological Symptoms of Dementia in Residential Care (Province of British Columbia, 2012)

12. From British Columbia (Canada) • Table 2- Examples of BPSD Usually not Amenable to Antipsychotic Treatment • wandering • vocally disruptive behaviour • inappropriate voiding • hiding and hoarding • inappropriate dressing /undressing • eating inedible objects • repetitive activity • tugging at seatbelts • pushing wheelchair bound residentsBest Practice Guideline for Accommodating and Managing Behavioural and Psychological Symptoms of Dementia in Residential Care (Province of British Columbia, 2012)

13. From British Columbia (Canada) • Table 2- Examples of BPSD Usually not Amenable to Antipsychotic Treatment • wandering • vocally disruptive behaviour • inappropriate voiding • hiding and hoarding • inappropriate dressing /undressing • eating inedible objects • repetitive activity • tugging at seatbelts • pushing wheelchair bound residents Best Practice Guideline for Accommodating and Managing Behavioural and Psychological Symptoms of Dementia in Residential Care (Province of British Columbia, 2012)

14. “Inadequate” Indications for Antipsychotic Medications • wandering • poor self-care • restlessness • impaired memory • mild anxiety • insomnia • inattention or indifference to surroundings From Guidance to Surveyors (F309) • sadness or crying alone (unrelated to other dx) • fidgeting • nervousness • uncooperativeness (resistiveness to care, refusal to take meds, etc.)

15. Prescriber Engagement is Critical • Experienced, Engaged Medical Director is a huge benefit in Antipsychotic Reduction • CMD demonstrated to improve quality indicators • Can help communicate with other prescribers • Can help update Policies & Procedures, especially around informed consent • Psychiatrist can also help, especially one who does not automatically feel obligated to prescribe! • Needs to be included in care plan/IDT meetings • Mention this explicitly, a survey focus

16. Summary • Antipsychotics are not always poison • Risperidone, olanzapine probably best for BPSD • Nonpharmacologic measures are always preferred, if they work! Individualize, be creative • Your CNAs may have the best ideas • We need more research on these interventions • Consider other kinds of medication • Especially Pain Meds • Insist on prescriber involvement and active engagement, and document in IDT/CPs