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Psychotropic Medications Broad term encompassing any medication used to influence mood, mental status or behavior CMS guidelines break them into four categories: - Anti-psychotics - Anti-anxiety agents - Hypnotics - Antidepressants Additional important categories – Cognitive enhancers – Mood stabilizers 1 QI Domains And Psychoactive Medications Skin Care Accidents Behavioral/Emotional Problems Quality of Life Psychotropic Drug Use QI Domains Physical/ Functioning Clinical Management Cognitive Patterns Nutrition/Eating Infection Control Elimination/ Incontinence 2 Paradigm for Comprehensive Assessment Dementia Frontal lobe impairment Delirium Medical illness Psychotic disorder Affective disorder Anxiety disorder Cognitive enhancers Mood Stabilizers Antipsychotics Antidepressants Anxiolytics Personality disorder Environment/stressors 3 Acetylcholinesterase Inhibitors (AChI) Aricept (donepezil) – Start: 5 mg qhs x 4 – 6 wks, then Increase to 10 mg qhs Exelon (rivastigmine) – Start: 1.5 mg bid w/ meals x 2 - 4 wks – Target dose 6 mg bid, titrate 1.5 mg q 2 - 4 weeks Reminyl (galantamine) – Start 4 mg bid – Target dose is 24 mg qd – Titrate by 4 mg bid increase q 4 weeks Treatment goal is to titrate to the highest dose tolerated 4 ACHI Treatment Effects Initial improvement may be seen @ 2 - 4 weeks At 26 wks: Approximately 20% of mild/mod pts will have significant cognitive improvement Approximately 80% will remain above baseline for function for 6-10 months Cost vs benefit analysis ongoing Watch for significant sudden decline when stopped Initial data indicates delay in NH placement >20 months in those with 4 years of donepezil use 5 Memantine Marketed in Germany since 1982 for “Organic Brain Syndrome” and spasticity Approved as Namenda in October 2003 for “moderate to severe” Alzheimer’s Disease No significant food interaction, i.e., can be administered without regard to meals Interactions with highly protein-bound drugs unlikely No interactions with acetylcholinesterase inhibitors Slide courtesy of: Schneider L. Geriatrics. 2003(Aug);Suppl 6 Memantine Study Results Memantine treatment was associated with less decline vs. placebo on: – Global, CIBIC-plus – Cognition, Severe Impairment Battery – Function, ADCS-ADL outcome measures Patients switched from placebo to Memantine showed significant improvement relative to projected decline Memantine treatment resulted in reductions in caregiver time, institutionalisation rate and total costs compared to the placebo group Memantine was well-tolerated with dropout rates and side effects rates similar or lower than placebo 7 Paradigm for Comprehensive Assessment Dementia Frontal lobe impairment Delirium Medical illness Psychotic disorder Affective disorder Anxiety disorder Cognitive enhancers Mood Stabilizers Antipsychotics Antidepressants Anxiolytics Personality disorder Environment/stressors 8 Frontal Lobe Impairment: Pharmacologic Management Antipsychotics – Conventionals – Atypicals Risperidone Olanzapine Quetiapine Ziprasidone Mood stabilizers – Carbamazepine – Divalproex sodium – Lithium – Topiramate – Gabepentin Benzodiazepines Aripiprazole 9 Mood Stabilizers These pathways transmit gamma-aminobutyric acid (GABA). Lower levels of GABA associated with aggressive animal behavior. NH study of 56 agitated elderly patients given Carbamazepine had significant improvement in agitation and decreased staff time needed. Newer anticonvulsants advantageous due to improved side effect profile but have few good clinical studies 10 Mood Stabilizers: carbamazepine divalproex sodium gabapentin lithium topiramate (Tegretol) (Depakote) (Neurontin) (Lithium) (Topimax) 11 Mood Stabilizers Their role is uncertain at present No need to monitor serum/blood levels for Lamictal or Topimax Behavior effects can be seen at low serum levels The role of multiple mood stabilizers concurrently remains uncertain Documentation on the working diagnosis and monitoring of benefits and side effects remains important 12 Divalproex Study in Dementia Randomized, double-blind, placebo-controlled trial1 N=172 NH residents met criteria for secondary mania Target dose 20 mg/kg/day in 10 days N=100 completers Statistically significant improvement on CMAI score Consistent with antiagitation, not antimanic effects Study suspended due to side effects (sedation) Follow-up indicated with lower doses/slower titration 1. Tariot et al, 2000 13 Divalproex in Elderly Mania / Dementia Cohen-Mansfield Agitation Inventory (Total Scores) 0 Placebo * -2 Mean Change -4 from -6 Baseline -8 * * Divalproex * * (SE=2.72) -10 (SE=2.65) -12 -14 -16 0 7 14 21 28 35 42 Days *p<0.05 for group differences Tariot et al,142001 Valproate Summary Clinical effects similar to Carbamazepine risk of drug interaction SE profile More definitive controlled trial underway Current clinically recommendations –Initial dose 125-250 mg bid with 125-250 q 5d –Usual range 500 - 1,250 mg/d –Usual level 40-90 µg/ml –Clinical response more important than serum level 15 Paradigm for Comprehensive Assessment Dementia Frontal lobe impairment Delirium Medical illness Psychotic disorder Affective disorder Anxiety disorder Cognitive enhancers Mood Stabilizers Antipsychotics Antidepressants Anxiolytics Personality disorder Environment/stressors 16 OBRA Guidelines: Antipsychotics Use only if patients exhibit symptoms that impair functioning or cause danger to themselves or others, and/or interfere with provision of care Agitated behavior is an insufficient reason to use an antipsychotic medication (i.e. must be psychotic or aggressive) Considered unnecessary if initiated as treatment in the absence of documentation of the approved indications – Use requires approved diagnosis and symptoms Stoudemire A. Gen Hosp Psych. 1996;18:77-94 The Long Term Care Survey.ACHA 17 Accepted Diagnosis for Antipsychotic Use in LTC 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Schizophrenia Schizo-affective Disorder Delusional Disorder Psychotic Mood Disorder Acute Psychotic Episodes Brief Reactive Psychosis Schizophreniform Disorder Atypical Psychosis Tourettes Disorder Huntington’s Disease Organic Mental Syndromes IF certain criteria are met 18 Treatment with Antipsychotics Requires: 1. Quantitative and Objective Documentation that: a) The behavior requires intervention b) You determined if the behavior is permanent or transitory c) The behavior has been evaluated for possible social or situational causes d) Environmental causes have been ruled out e) Medical causes have been ruled out 2. The symptoms are persistant 3. Not caused by preventable reasons 19 Treatment with Antipsychotics Requires: Organic Mental Syndromes with associated psychotic and/or agitated behaviors defined by: a) Specific Behaviors (biting, kicking, extreme fear, etc) that have been quantified AND present a danger to themselves or others (including staff) b) Continuous crying out, screaming or pacing if quantified and cause a functional impairment or actually interfere with the staff’s ability to provide care c) Psychotic symptoms (AH, VH, PI, delusions) that are not dangerous but cause distress or an impairment in functional capacity 20 Antipsychotics Should NOT be used if: the following symptoms are the ONLY criteria Wandering Poor self-care Anxiety/Restlessness Impaired memory Uncomplicated Depression Unsociability Fidgeting Nervousness Uncooperativeness Agitation without any danger to resident or others 21 Antipsychotic Medication Guidelines F-tag 330: Use only as necessary to treat a specific condition as diagnosed & documented in the clinical record F-tag 331: Gradual dose reductions & behavioral interventions, unless clinically contraindicated, are required in an effort to discontinue these drugs Currently, only IM Zyprexa is approved by the FDA for the treatment of acute agitation in dementia Usually reserved for dangerous or very distressed psychotic symptoms such as aggression, delusions or hallucinations 22 Antipsychotic Medication Guidelines The cause of the psychosis indicates the treatment duration: – For psychosis as a symptom of dementia, stabilizing behavior may take as long as 12 weeks and may require treatment for at least several months and up to a year – For Schizophrenia, antipsychotic treatment is lifelong although the dose may decrease with age – For Bipolar illness, antipsychotics are used during acute mania or long term to prevent relapse – For psychotic depression, antipsychotics are typically needed for a few months in addition to a longer term antidepressant – For delirium, antipsychotics are needed for a few days to a few weeks (even after medical problem is cleared) 23 Antipsychotics “Typicals” – Haldol (haloperidol ) – Thorazine (chlorpromazine) – Many others “Atypicals” – – – – – – Clozaril (clozapine) Risperdal (risperidone) Zyprexa/Zydis (olanzapine) Seroquel (quetiapine) Geodon (ziprasidone) Abilify (aripiprazole) 24 Atypical Antipsychotics and Increased Stroke Risk Data from four International studies revealed increased incidence of CVA & TIA in Risperidone treated pts 1 In 2003, the FDA changed the Risperdal label warning that the use of Risperidone dementia patients has an increased risk of stroke Currently a similar label is pending for Zyprexa Perhaps increased stroke risk is a “class effect” Stroke risk should be included in the risk/benefit assessment 1. Web site address http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/advisory/industry/risperdal 25 Antipsychotics: Summary Atypicals are effective in the management of psychosis in the elderly In elders, atypicals offer improved safety and tolerability compared with conventional agents Differences in tolerability/side effect profiles between atypicals impact treatment selection It is critical to evaluate for Parkinson’s symptoms before choosing the atypical to avoid worsening motor symptoms. 26 Paradigm for Comprehensive Assessment Dementia Frontal lobe impairment Delirium Medical illness Psychotic disorder Affective disorder Anxiety disorder Cognitive enhancers Mood Stabilizers Antipsychotics Antidepressants Anxiolytics Personality disorder Environment/stressors 27 28 Treatment of Major Depression There is no ‘good reason’ for depression to ever go untreated Start low, go slow, but go! Strive for maximum recovery/function – Compare GDS or Cornell Treat the sleep disturbance initially then change to a prn after 2-3 wks The dose that gets them well, keeps them well Continue for 6-12 months or perhaps even lifelong…? 29 Common Antidepressants SSRI’s – Fluoxetine (Prozac) – Paroxetine (Paxil) – Sertraline (Zoloft) – Citalopram (Celexa) – Escitalopram (Lexipro) SNRI’s – Bupropion (Wellbutrin) – Mirtazapine (Remeron) – Venlafaxine (Effexor) – Trazodone (Desyrel) too sedating to treat depression 30 Depression Therapy TCA’s vs. SSRI’s vs. SNRI’s Select the drug based on target symptoms and the side effects wanted, for example – Dep. + anorexia – mirtazapine – Dep. + lethargy – activating antidepressant – Dep. + constipation – sertraline – Dep. + psychosis - cymbiax Insomnia can be effectively treated with the addition of Trazodone, Ambien, or Sonata 31 32 Paradigm for Comprehensive Assessment Dementia Frontal lobe impairment Delirium Medical illness Psychotic disorder Affective disorder Anxiety disorder Cognitive enhancers Mood Stabilizers Antipsychotics Antidepressants Anxiolytics Personality disorder Environment/stressors 33 Anxiolytic Therapy Guidelines F-tag 329: Guidance to Surveyors – Short-acting & maximum doses indicated – Behavioral monitoring charts needed Does not indicate how to monitor – Gradual dose reduction al least twice within one year before can conclude dose reduction is clinically contraindicated per regulations 34 Anxiolytic Therapy Guidelines Indications for use: - other reasons for the distress have been considered & eliminated - use results in maintenance/improvement of resident’s functional status - reduction must be attempted by 4 months - specific diagnoses (anxiety disorder, organic mental syndromes, panic disorder, anxiety in concert with another psychiatric disorders) 35 Anxiolytic lorazepam alprazolam oxazepam buspirone temazepam klonzepam (Ativan) (Xanax) (Serax) (BuSpar) (Serax) (Klonopin) 0.25 – 2.0 mg /d 0.25 – 1.5 mg / d 7.5 – 30 mg / d 10 – 45 mg / d 0.25 -3.0 mg / d 36 Benzodiazepines Minimal efficacy data Sedating Further inhibit learning and memory Ataxic gait is episodic - difficult to assess Associated with falls Paradoxical disinhibition possible Avoid long acting benzodiazepines in the elderly 37 Anxiety Disorder: Treatment Short-acting benzodiazepines – sedating, inhibit learning, increases fall risk Trazodone – check orthostatic BP and Pulse Buspirone? If paranoid or psychotic component, consider Atypicals Consider antidepressants, may need empiric trial 38 Insomnia - Hypnotics F-tag 329: Unnecessary drugs: GTS Address “sleep hygiene” issues Daily dose 10 or more continuous days requires documentation of necessity for maintenance or improvement of functional status. Maximum hypnotic dosages Dose reduction attempts at least 3 times within 6 mo. before declaring further reductions are contraindicated. 39 Insomnia – Hypnotics - 2 Trazodone 25-200 mg @hs Mirtazepine (Remeron) 7.5-45 mg @hs Short-acting benzodiazepine Zolpidem (Ambien) 5-10 mg @hs Zalepion (Sonata) 5-10 mg @hs Melatonin 3 mg @ 6 pm 40 Remember, Psychotherapy Can Also Help Some Residents Summary Distressed behaviors are only symptoms Unless urgent, a complete assessment to determine/develop a working diagnoses should guide the long term treatment approach. Consider nonpharmacologic management in every case. Monitor treatment benefits: MMSE, GDS, FAST, Cornell dementia in depression scale, Behave AD, Cohen Mansfield Agitation Inventory Optimal care requires teamwork, education, and respect. 42