Friend or Foe? Review of the Regulations & Benefits: Risk Profiles of the Benzodiazepines

Friend or Foe? Review of the Regulations & Benefits: Risk Profiles of the Benzodiazepines

Program Learning Objectives At the conclusion of the activity, participants should be able to: Have a basic understanding of the new CMS regulations as they apply to psychoactive/bzds Know the classes of benzodiazepines Have a working understanding of the pharmacology and pharmacodynamics of benzodiazepines Consider the benefits of BZDs in LTC: risk/benefit profile

OBRA 1987 Ombudsman Budget and Reconciliation ACT Purpose to improve standards of care and establish the rights of the elderly First initiative to address the use of psychoactive medication in LTC Residents

State Operations Manual (SOM) Better known as F-tags Guidance to surveyors Full rewrite went into effect November 2017 Included a renumbering and expansion of F-tags Over 700 pages of regulations

National Partnership to Improve Dementia Care in Nursing Homes Implemented 2012 Resulted in a relative risk reduction of 27% to an absolute rate of 17.4% 2015 established the Five Star Quality Rating System which ranks LTC Facilities for incidence and prevalence of antipsychotic meds

Updated Report on CMS National Partnership to Improve Dementia Care in LTC In 2015, 37 national surveys were analyzed 65% cited F309 70% cited F329 57% cited F309/F329 F428 also cited G level cited 7.5%

Prevalence of Antipsychotic Use from 2014-2015 USE Rank Reduction NJ 13.00% 3 28 % NY 15.75% 17 26 % PA 16.66% 26 25 % CT 17.45% 32 33 % HI 7.63% 1 38.7% LA 22.21% 51 25.1%

Epidemiology of Nursing Home Residents In 2012, the federal government began a program to reduce the use of antipsychotics in nursing homes Since the inception, the use of these agents has dropped by about a third 2012 - estimated 23.9% 2017 - estimated 15.7 % CMS has called for an additional 15 % reduction by 2019

Antipsychotic and Benzodiazepine Use Among Nursing Home Residents National Nursing Home Survey Cross sectional analysis of LTC (n=12090) Benzodiazepine and antipsychotic use based on Behavior l diagnosis Antipsychotic use (26%), among which (40%) had no appropriate indication Benzodiazepine use (13%), among which (42%) had no appropriate indication Highest inappropriate use was among residents with dementia and depression and Medicaid residents

American Geriatric Society BEERS List 2015 BEERS list from the American Geriatric Society is representative of potentially inappropriate medication use in older adults Last updated 2015; newest version due Fall 2018 Identifies 40 problematic medications Based upon quality of evidence (moderate) and strength (strong) of recommendations for the following: BZD short acting - alprazolam, lorazepam, temazepam, estazolam, oxazepam and triazolam BZD long acting - chlordiazepoxide, clorazepate, clonazepam, diazepam, and flurazepam Recommendations are to avoid with exception of seizure disorders, REM sleep disorders, ETOH withdrawal and severe generalized anxiety disorders

CMS Regulations State Operations Manual F-Tags full rewrite went into affect November 28, 2017 Psychoactive medication related F-Tags: F757: Unnecessary Medications F758: Psychotropic Medications

F-TAG Cross Walk Tag Title New Old Unnecessary Drug F-757 F-329 Unnecessary F-758 F-329 Psych/PRN

Unnecessary Medications - F757 Each resident shall be free of unnecessary drugs as evidenced by: Excessive dose Excessive duration Without adequate monitoring Without adequate indications for use Or in the presence of adverse consequences, indicating the dose should be lowered or discontinued

Psychotropic Medication - F758 Any drug that affects brain activities associated with mental processes and behavior. These drugs include but are not limited to: antipsychotic; 1 st, 2 nd generation antidepressants anti-anxiety hypnotic

Key Elements of Non-Compliance Failure to attempt a GDR unless clinically contraindicated Using psychotropic medications in the absence of an approved diagnosis PRN psychotropic medications used for more than 14 days without a documented clinical rationale Failure to implement non-pharmacological approaches in an attempt to reduce or discontinue a psychotropic med Extending a PRN psychotropic medication, other than an antipsychotic, beyond 14 days without a documented rationale and a specific duration

GDR (Gradual Dose Reduction) Within the first year, the facility must attempt a GDR in two separate quarters (with at least one month between attempts) unless clinically contraindicated After the first year, an annual GDR must be attempted unless clinically contraindicated Clinical Contraindicated means: -Dementia: if target symptoms worsen after most recent reduction or if physician has documented why further reduction would impair residents function or increase distress -Psychiatric Diagnosis: continued use in accordance with current standards of practice or target symptoms worsen after the most recent reduction in the facility and the physician has documented the clinical rationale for continued use

Diagnosis Drift Use of multiple medications within the same class for a different diagnosis increases the risk of adverse consequences o Lexapro depression o Trazodone sleep

PRN Orders for Psychotropics PRN psychotropic medications may be prescribed for dose adjustments, acute symptoms, or in an emergency When psychotropics (excluding antipsychotics) are PRN, the following apply: All initial PRN orders are limited to 14 days New orders must be written to extend the PRN if the prescriber believes it is appropriate The prescriber must document clinical rationale for extending the time and specify a duration of use PRN regulation also applies to hospice residents

PRN Orders for Antipsychotics PRN orders limited to 14 days Order cannot be extended unless the prescriber directly examines the resident and assesses their condition and documents the benefit of continuing The improvement of the residents symptoms must be well documented

Benzodiazepines The first BZD was created in 1955: Chlordiazepoxide (Librium) In 2013, there were 112 million prescriptions for BZDs, making them the #1 prescribed psychoactive medication o o Major clinical advantage: rapid onset, high efficacy, low toxicity Indication/Use: hypnotic, anxiolytic, anticonvulsant, myorelaxant, amnesic

Benzodiazepines BZDs bind to receptors with different affinity Lipid solubility Protein binding Molecular size T ½ life Potency Metabolism

Benzodiazepine Pharmacology BZDs act on GABA(gamma amino butyric acid) receptors GABA is the most common neurotransmitter in the CNS GABA is inhibitory and this reduces excitability of neurons and thus a calming effect on the brain 3 GABA receptors are A, B and C, BZDs act on GABA-A receptors BZDs act on chloride ion channels and hyperpolarize the cell and thus account for inhibitory effect on the CNS

Age Related Pathological Changes CNS, kidneys and liver decompensate with age CNS: dendritic synapses decrease, neurons are replaced glial cells Hepatic metabolism: prolonged clearance CYP 450-3A4 Renal function: declines at rate 1% per year after 40 The clinical impact is noted with amnesia, sedation, drowsiness and motor impairment

High Potency BZD Alprazolam High potency, 0.25mg-0.5mg TID. Max dosing 4mg /day (anxiety) Protein binding 80% T 1/2: 6-26h No active metabolites Renal excretion

High Potency BZD Clonazepam Both GABA-A and Serotonin agonist Dosing 0.25mg- 0.5mg twice daily max dose 1-4mg/day Protein binding 85% T ½ : 18-50 h No active metabolite Renal excretion Low lipid solubility

High Potency BZD Lorazepam Dosing up to 10mg/day Protein binding 85% T ½ : 10-20 h No active metabolite Renal excretion

Medium Potency BZD Diazepam Dosing: 2-4mg two-four times daily. Max dose 30mg/day Protein binding 98% Active metabolite: desmethyl diazepam (40-120h), oxazepam (5-15h) and temazepam (8-15h) Renal excretion

Adverse Drug Reactions (ADR) Cognitive impairment: sedation, drowsiness, dizziness and motor dysfunction Amnesia Disinhibition Delirium CNS toxicity

Considerations for Use of BZDs in the LTC Setting Diagnosis Age Comorbidities Target organ function: Renal/Hepatic Treatment Behaviors Risk/Benefit Analysis

Nursing Home Action Plan Goals Better care and lower costs Prevention and population health Expanded health care coverage Enterprise excellence

Principles of Action Enhance consumer awareness and assistance Strengthen surveys processes, standards and training Improve enforcement activities Promote quality improvement Create strategic approaches through partnership

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REFERENCES CMS.gov