Disclosure Statement. Nursing Facility Regulations and Psychotropic Medication Use. Learning Objectives (Cont) Learning Objectives

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1 Nursing Facility Regulations and Psychotropic Medication Use Jeffrey C. Reist PharmD, BCPS College of Pharmacy The University of Iowa December 2010 Disclosure Statement I, Jeffrey Reist, PharmD, BCPS do not have any financial interests or relationships with any manufacturers of products or providers of services I might be discussing in my presentation. I have no financial relationships with any of the companies supporting this educational event. I will not discuss any pharmaceuticals, medical procedures, or devices that are investigational or unapproved for use by the FDA. Learning Objectives List the medication related nursing facility (NF) regulations Define the term unnecessary medication in the context of NF regulations List common medication classes specifically mentioned in NF regulations Learning Objectives (Cont) Evaluate a NF resident s medication regimen for potential unnecessary medications and make appropriate recommendations to maintain adherence with NF regulations Develop an appropriate monitoring plan for psychotropic medications Medication Related NF Regulations Pharmacy Services (F425 and F431) Drug Regimen Review (DRR) (F428) Unnecessary Medications (F329) Medication Errors (F332 and F333) Pharmacy Services in NF Pharmacist to oversee all aspects of medication use Dispensing, storage, administration and disposal Quality improvement initiatives Controlled substance accountability Emergency medication availability 1

2 Drug Regimen Review (DRR) Must be done monthly by consultant pharmacist Review all medication regimens to promote positive outcomes and minimize adverse drug events Report findings to Director of Nursing and attending physician Findings must be acted upon DRR Goals Assess for attainment of goals of therapy Assure appropriate monitoring Identify potential medication related causes of symptoms or changes in condition Behavior change or cognitive decline Falls/dizziness Constipation/diarrhea/GI bleeding Sedation/depression/change in function Unnecessary Medication Regulation: General Each resident s drug regimen must be free from unnecessary drugs Defined as any drug when used. in excessive dose (or duplicative therapy) for excessive duration without adequate monitoring in the presence of adverse consequences So. ANY DRUG can be considered an unnecessary drug! Medications Specifically Mentioned Antipsychotics Sedative/hypnotics Psychopharmacological Medications Defined by how medication is used or what it is being used to treat Unnecessary Medications: Antipsychotics Based on a comprehensive assessment of a resident, the facility must ensure that: 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 clinic record 2

3 Unnecessary Medications: Antipsychotics (cont) AND Residents who use antipsychotic drugs receive gradual dose reductions and behavior interventions unless clinically contraindicated in an effort to discontinue these drugs Antipsychotics Use Two basic categories of use Psychiatric diagnosis such as i.e. Schizophrenia, bipolar, etc Dementia type illnesses with associated behavioral symptoms i.e. Alzheimer s disease Intended use will dictate some of requirements of regulations Antipsychotic Use Criteria In addition to diagnosis, clinical condition must include at least one of the following Symptoms due to mania or psychosis i.e. hallucinations or paranoia Behaviors present a danger to themselves or others Symptoms result in persistent distress, decline in function or ability to receive care Before Antipsychotic Use Must rule out that behaviors not due to Medical problem pain, hypoxia, dehydration, etc Environmental stressors Change in location, hunger, thirst, noise level, etc Psychological stressors Loneliness, abuse, anxiety Antipsychotics-Target Behaviors When used for behaviors associated with dementia, target behaviors must be monitored Daily every shift Objective and quantitative (i.e. hitting 3x during day shift) Avoid subjective (i.e. agitation all day) Antipsychotics-Monitor for Adverse Effects Anticholinergic effects/sedation/lethargy Dry mouth, constipation, dizziness, confusion Parkinsonism/ Akathisia/ dystonia Tremor, shuffling gait, restlessness Orthostatic hypotension and falls Metabolic syndrome (newer agents especially) Cardiac arrhythmias-sudden death Tardive Dyskinesia 3

4 Antipsychotics-Daily Dose Max Antipsychotics-Duration chlorpromazine 75mg fluphenazine 4 mg haloperidol 2 mg perphenazine 8 mg thioridazine 75mg thiothixine 7 mg trifluoperazine 8mg aripiprazole clozapine olanzapine quetiapine risperdone 10mg 50mg 7.5mg 150mg 2mg Unless clinically contraindicated, must have periodic gradual dose reduction (GDR) Antipsychotic Gradual Dose Reduction (GDR) Required unless clinically contraindicated Within the first year in which a resident is admitted on or after the facility initiated an antipsychotic medication, GDR must be attempted in two separate quarters (with at least one month between attempts) After first year, a GDR must be attempted annually Antipsychotic GDR Contraindicated If used for symptoms related to dementia And resident s target symptoms return or worsen after the most recent attempt at GDR AND Physician has documented the clinical rational for why additional attempts would likely impair resident s function or increase distressed behavior Antipsychotic GDR Contraindicated When used to treat a psychiatric disorder other than behavioral symptoms related to dementia (i.e. schizophrenia or bipolar) if Continued use is in accordance current standards of practice and physician has documented clinical rational OR Target symptoms returned or worsened after the most recent attempt at GDR within NF and physician has documented clinical rational Unnecessary Medications: Sedative/Hypnotics Any medication used to treat insomnia Use should be preceded/accompanied by non-pharmacological interventions Exceptions include Short-term use for procedures Dental, etc During initiation of treatment for depression or pain until symptoms identified and treated 4

5 Before Sedative/Hypnotic Use: Rule Out Environmental factors Heat, cold, light, or noise Caffeine or other medications Inadequate physical activity Facility routines/provision of care Underlying conditions Pain, HF, COPD, restless leg, urinary frequency Sedative/Hypnotics: Prior to Initiation Good sleep hygiene initiated Individualize the sleep and wake times to accommodate resident s wishes Treat any underlying condition Address any environmental contributing factors Evaluate for stimulating medications Sedative/Hypnotic Monitoring Efficacy Improvement in sleep or sleep quality Reduction in nocturnal awakening Adverse effects Falls Morning hang-over Confusion Forgetfulness Sedative/Hypnotic Daily Dose Max Benzodiazepines estazolam lorazepam oxazepam temazepam 0.5mg 1 mg 15mg 15mg Non-benzodiazepines eszopiclone 1 mg ramelteon 8 mg zaleplon 5 mg zolpidem IR 5 mg zolpidem CR 6.25mg Sedative/Hypnotics to Avoid Serious side effects and/or long duration of action: diphenhydramine hydroxyzine chloral hydrate flurazepam triazolam quazepam barbiturates Sedative/Hypnotic: Duration Short-term use Non-daily use If routine use beyond manufacturer s recommendation of use a gradual dose reduction (GDR) is required 5

6 Sedative/Hypnotic GDR For as long as a resident remains on a sedative/hypnotic that is used routinely and beyond manufacturer s recommendation for duration of use, GDR attempt should be made quarterly unless clinically contraindicated Sedative/Hypnotic GDR Contraindicated Continued use is accordance with relevant current standards of practice AND physician has documented clinical rationale for why GDR would impair resident s function or cause psychiatric instability OR Target symptoms returned or worsened after most recent GDR attempt within NF and physician documented clinical rationale Unnecessary Medications: Psychopharmacological Defined as medications used to Manage behavior Stabilize mood Treat a psychiatric disorder Referred to as other than antipsychotic and sedative hypnotic Broader definition from previous regulations-more medications included Psychopharmacological Medications Include Anxiolytics Benzodiazepines Buspirone* Antidepressants* Anticonvulsants* Antidepressants* *not previously regulated Psychopharmacological Medications Exempted indications Neuromuscular syndromes (cerebral palsy, tardive dyskinesia, restless leg syndrome or seizure disorder) Long-acting BZD when use to taper from shortacting BZD Symptom relief in end-of-life situations Anxiolytics When used for delirium, dementia and other cognitive disorders, the associated behaviors must: Be quantitatively and objectively documented Be persistent Not be due to preventable or correctable reasons (i.e. meds, other DX or environment) Cause significant distress or dysfunction to self or danger to self or others 6

7 Anxiolytics: Monitoring Efficacy Use must result in maintenance or improvement of mental, physical or psychosocial well-being Reflected in MDS or other assessment tools Behaviors objectively and quantitatively documented Adverse Effects Vary by class Anxiolytics: Benzodiazepines Short-acting agents preferred in geriatric patients due to less accumulation Adverse Effects Falls Confusion Sedation Forgetfulness Benzodiazepine Max Daily Doses Anxiolytics: Do Not Use chlordiazepoxide clorazepate diazepam dlonazepam alprazolam oxazepam lorazepam 20 mg 15 mg 5 mg 1.5 mg 0.75 mg 30 mg 2 mg Diphenhydramine Hydroxyzine Anxiolytic: Buspirone Treat as any other anxiolytic for monitoring and GDR No listed Max Daily Dose Antidepressants Listed both under Anxiolytics and alone under psychopharmacological medications Are subject to GDR when used for behavior or mood stabilization OR to treat other psychiatric disorder Monitoring of use for all indications 7

8 Antidepressants: Monitoring Efficacy monitoring for anxiety Target behaviors objectively and quantitatively documented Efficacy monitoring for mood or other psychiatric indication Improvement of symptoms as well as worsening of symptoms and suicidal behavior Antidepressants: Monitoring Adverse Effects Sedation or stimulation Dizziness/falls Suicidal ideation Orthostatic hypotension Hyponatremia (SSRIs) Nausea/anorexia (SSRI) Weight gain (TCA) Serotonin syndrome (SSRIs especially with other serotonergic medications-tramadol, St. Johns Wort) Anticonvulsants Subject to GDR if used to manage behavior, stabilize mood or treat psychiatric disorder Exempted from GDR if used for neuropathic pain, prevention or migraines or seizure disorder Anticonvulsant: Monitoring Efficacy for behavior stabilization Target symptoms Objectively and quantitatively documented Serum concentrations available for some agents but not useful for efficacy determination Anticonvulsant: Monitoring Adverse effects Liver dysfunction Anemia Skin rash Dizziness/ataxia/falls Lethargy Blurred vision Confusion/interfere with concentration Psychopharmacological GDR Required unless clinically contraindicated Within the first year in which a resident is admitted on or after the facility initiated an psychopharmacological medication, GDR must be attempted in two separate quarters (with at least one month between attempts) After first year, a GDR must be attempted annually 8

9 Psychopharmacological GDR Contraindicated Continued use is accordance with relevant current standards of practice AND physician has documented clinical rationale for why GDR would impair resident s function or cause psychiatric instability OR Target symptoms returned or worsened after most recent GDR attempt within NF and physician documented clinical rationale. References State Operations Manual Appendix PP Guidance to Surveyors for Long Term Care Facilities. CMS Website available at: ap_pp_guidelines_ltcf.pdf Accessed 9/24/2010 9

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