Transcript Effective and Appropriate Use of Psych

Dr. Cynthia Hadfield, Pharm.D.
Director of Pharmacy for Employee, LTC & Retail Pharmacies
Lead Clinical Pharmacist, Geriatric Specialist
Citizens Memorial Healthcare
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Dr. Hadfield has no financial, other
relationship or other support from the
pharmaceutical industry
Dr. Hadfield will be discussing off-label use
of Psychoactive medications and other
medications
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Prescribing of a medication for a condition other
than its FDA approved indication
Common practice allowed by FDA and Medical
boards and often appropriate and beneficial
FDA approval expensive
>50% Cancer Drugs used off label
All Anti-psychotic use for Behavioral and
psychological Symptoms of Dementia (BPSD) in
USA is off-label
◦ Risperdal is approved in Canada
◦ OIG report 2011—83% Antipsychotic use off label
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Outline CMS Regulations and initiatives related to
use of Antipsychotics
Understand how Antipsychotics work and why
they can cause serious side effects
Understand how Anti-anxiety and Hypnotic
medications work and related side effects
Understand effects and side effects of
Antidepressants and Anticonvulsants
Understand how analgesics and other main
classes of medications affect cognition and
behaviors
Strategies to ensure safe and effective use of
Psychoactive medications in Long Term Care and
how to reduce Psychoactive medication use rates
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CMS reports by late 2014 nursing homes in the US
had achieved a 19.4% reduction in Antipsychotic use
>30,000 fewer residents on Antipsychotics
All but 8 states have met or exceeded 15% reduction
target
Missouri Antipsychotic rate was25.5% in 2nd quarter
of 2011 but rose to 26.1% in 4th Quarter of 2011,
then dropped to to 20.7% in the 4th Quarter of 2014
◦ 5.43% percentage point decrease, which translates to a
20.8 “% change”
◦ Excludes individuals with Schizophrenia, Tourette’s and
Huntington’s disease
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CMH LTC overall rate is13% (11% if Schizophrenia,
Tourette’s and Huntington’s Excluded)
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CMS and national organizations that are actively
participating in the Partnership, recently
announced an updated goal to achieve 30%
reduction in the use of Antipsychotic medications
nationally, no later than the end of CY2016
Feb 2015 CMS added two measures of
Antipsychotic use (one for long stay residents
and one for short stay) to the algorithm that is
used to calculate each nursing home’s Five Star
Rating System on CMS Nursing Home Compare
website
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Chlorpromazine (Thorazine)
Fluphenazine
Haloperidol (Haldol)
Loxapine
Mesoridazine
Molindone
Perphenazine
Promazine
Thioridazine (Mellaril)
Thiothixine
Trifluperazine
Triflupromazine
Typical
(first generation / conventional)
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Asenapine (Saphris)
Aripiprazole (Abilify)
Clozapine (Clozaril)
Iloperidone (Fanapt)
Lurasidone (Latuda)
Olanzepine (Zyprexa)
Paliperidone(Invega)
Quetiapine (Seroquel)
Riperidone(Risperdal)
Ziprasidone(Geodon)
Atypical
(second generation)
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Psychotic symptoms (hallucinations, delusions) linked
to abnormal dopamine release and function in the
brain
Antipsychotic Medications block Dopamine receptors
in the brain causing dopamine to have less effect
Older Antipsychotics (Typical) not particularly
selective and also block dopamine receptors in other
areas of the brain including the nigrostriatal pathway
responsible for movement
Newer Antipsychotics (Atypical) developed to be more
selective but still have the same side effects
• also affect serotonin receptors
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The “why” behind all of the regulations!
General: anticholinergic effects , falls, sedation
Cardiovascular: arrhythmias, orthostatic
hypotension
◦ Perform orthostatic blood pressures every shift for the
first week and again with dose increases
◦ ECG recommended with older agents
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Metabolic: Increase in total cholesterol and
triglycerides, unstable or poorly controlled blood
sugar, weight gain
◦ Fasting lipid profile and fasting blood glucose / A1c
(prior to treatment, at 3 months, then annually)
◦ Weight, BMI waist circumference
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Esophageal dysmotility /Aspiration
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Lowers seizure threshold
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Neuroleptic malignant syndrome (NMS)
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Mental status changes
Muscle rigidity
Fever
Impaired temperature regulation
Worsened by heat exposure, dehydration and medications
with anticholinergic properties
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Extrapyramidal Symptoms (EPS)
◦ Pseudo parkinsonism
◦ Acute dystonic reactions
 Dose related
 Higher risk in males and younger patients
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Akathesia
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Tardive Dyskinesia
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 Inability to stay still, restlessness, feeling of crawling out of
one’s skin
 Irreversible
 Tongue and facial movements
Abnormal Involuntary Movement Scale (AIMS) test
recommended prior to treatment then every 3
months while on antipsychotic
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Sternest warning from FDA that a medication can cary
and still remain on the US market
Indicating serious side effects or life threatening risks
Thioridazine (Mellaril)
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All Antipsychotics
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◦ QTC prolongation
◦ Dose related
◦ Should be avoided and reserved for patients with
Schizophrenia who have failed other antipsychotics
◦ Elderly patients with dementia-related psychosis are at
increased risk of death
 Cardiovascular (stroke, heart failure, sudden death)
 Infectious (pneumonia)
 Issued in 2005
◦ Careful consideration of Risk versus Benefit
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Schizophrenia
Bipolar Disorder
Treatment Resistant Depression
(Olanzapine, Aripirazole )
Major Depressive Disorder (Quetiapine)
Tourettes (Pimozide)
ICU Delirium (Quetiapine)
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Emphasis on Person Centered Care, especially for
residents with dementia
Same diagnosis and dosage limits
Guidelines are just more defined
Bottom line: If resident has dementia, the facility
must:
◦ Do everything possible to manage behaviors without
medication
◦ If medication is used, more than one person had better
put a lot of thought into the selection of the medication
◦ Continual monitoring & documentation of the residents’
behaviors, medical conditions, social situation
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Schizophrenia
Huntington’s Disease
Tourette’s Disorder
Schizo-affective disorder
Schizophreniform disorder
Delusional Disorder
Moods Disorders
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Psychosis in the absence of dementia
Hiccups (not induced by other medications)
Nausea and vomiting associated with cancer or chemotherapy
Medical illnesses with psychotic symptoms
 Bipolar
 Severe depression refractory to other therapies and/ or with psychotic
features
 Neoplastic disease
 Treatment related psychosis (high dose steroids)
 Delirium
BPSD
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Behavior or Psychological Symptoms of Dementia
(BPSD)
Also referred to as “Neuropsychiatric Symptoms”
Describes behavior or other symptoms in
individuals with dementia that cannot be
attributed to a specific medical or psychiatric
cause
◦ Agitation, Aberrant Motor behavior, Anxiety, Elation,
Irritability, Depression, Apathy, Disinhibition, Delusions,
Hallucinations, sleep and appetite changes
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NOT included in the defining criteria of dementia
in the current classifications
“Dementia with Behaviors” is the closest ICD code
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Diagnosis alone does NOT warrant the use of an
Antipsychotic
Identify the specific behavior
Document all of the non- medication
interventions tried and how they worked
◦ Must also be included in the care plan
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Describe how the behavior poses a threat to the
resident or to others
Describe how the behavior seriously impairs the
resident’s quality of life
Identify the behavior as related to mania or
psychosis (hallucinations, delusions, paranoia,
grandiosity)
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Wandering
Confusion
Agitation
Uncooperative
Resisting care
Nervousness
Restlessness
fidgeting
Indifference
unsociability
Poor self care
Depression
Impaired memory
Insomnia
Crying out (occasional)
Yelling or screaming (occasional)
Cannot Use
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Spitting, Biting, pinching
Kicking, Punching
Scratching, Slapping
Extreme fear
Frightful distress
Inappropriate Sexual Behavior
Continuous pacing
Finger painting feces
Throwing objects
Purposeful vomiting
Purposeful B/B inappropriately
Tripping, Ramming, Pushing others
Head banging
Self inflicted injuries
Hallucinations
Delusions
Paranoia
Continuous and extreme crying out,
yelling, screaming
Can Use
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CNAs & CMTs should document every shift
Charge Nurses should document a
meaningful summary once per week
Document before and after a PRN is
administered
Interdisciplinary team document every care
plan
Consultant Pharmacist: at least every quarter
Physician: every month
Document more often when behaviors occur
or when medication is changed
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Documentation reminder comes up whenever
an Antipsychotic Medication is ordered.
CNAs document behaviors every shift for
residents on Antipsychotics.
Charge nurses complete detailed
Antipsychotic Medication Documentation
every week for residents on an Antipsychotic
Weekly behavior documentation is done by
both CNAs and Charge nurses for residents
on any psychoactive medication
Acute onset or exacerbation of symptoms
 Immediate threat to health or safety of
resident or others
 Acute treatment is limited to 7 days
AND
Clinician and interdisciplinary team must
evaluate and document the situation within 7
days to identify and address any contributing
and underlying causes of the acute condition
and verify the continuing need for
antipsychotic medication
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Encourage Prescribers to only prescribe a one
time dose for emergencies
Limit PRN Antipsychotic orders to residents who
occasionally exhibit very psychotic and
dangerous behavior
Only allow Charge nurse to administer PRN
Antipsychotics
◦ Only after all non-medication and other medication
interventions have been tried and failed
◦ Extensive documentation before and after dose
administered
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Team follow up after each dose administered to
confirm positive response and continued need
for PRN dose
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Facility is responsible for pre-admission
screening for mentally ill and intellectually
disabled individuals AND obtaining physicians
orders for resident’s immediate care.
This screening (F285) should provide diagnosis
for Antipsychotic use
Other residents admitted on Antipsychotic must
have use evaluated at time of admission and / or
within 2 weeks of admission (initial MDS)
◦ Consider dose reduction or discontinuance of
Antipsychotic
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Anticholinergic Medications
Antiparkinson’s Medications
Benzodiazepines
Alcohol (including withdrawal)
Cardiac Medications (especially digoxin)
Corticosteroids
Opioid Analgesics
Stimulants
Any medication can cause a psychiatric side
effect in an individual patient
◦ always note new medications (even antibiotics and OTCs)
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Antihistamines
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Muscle Relaxants
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Urinary agents (Antimuscarinics)
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GI antispasmodics
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Tricyclic Antidepressant
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Antiparkinson Agents
◦ Hydroxyzine, diphenhydramine
◦ Cyclobenzaprine, Tizanidine
◦ Oxybutynin
◦ Dicyclomine, Atropine
◦ Amitriptyline, Doxepin
◦ Benztropine, Trihexyphenidyl
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Control pain which is a
major cause of anxiety,
irritability and behavior
problems
Anti-anxiety effect
Help with shortness of
breath a major cause
of anxiety in COPD
patients
Improved quality of life
BENEFITS
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Sedation
Confusion
Falls
Insomnia
Hallucinations (visual)
Constipation
Urinary retention
POTENTIAL SIDE EFFECTS
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Significantly increase with age
Generalized Anxiety Disorder (GAD)
◦ Diffuse constant anxiety and worry for >6 months
90% of presentations of late-life anxiety accounted for by Generalized
Anxiety Disorder(GAD) or a specific phobia
10% are Obsessive-compulsive (OCD), post-traumatic Stress (PTSD) and
panic disorders
Increasing frailty, medical illness, and losses can contribute to feelings of
vulnerability, fear and can reactivate anxiety disorders
Agoraphobia (fear of being trapped in a place from which escape might be
difficult)
◦ Afraid of being alone and unable to get help
◦ Fear of leaving home
◦ Fear of falling
Rule out underlying causes
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Angina, arrhythmia, MI, Stroke
Diabetes, low calcium, hyperthyroidism
PUD, Pancreatic cancer, UTI
Anemia, low blood sugar, low potassium, low
sodium
COPD, Pneumonia, Pulmonary Embolism
Delirium, Dementia, hearing and visual
impairment,
Parkinson’s, Seizures, brain cancer
PAIN
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Bronchodilators, Steroids, Theophylline
Nasal decongestants, Antihistamines
Caffeine
Nicotine; benzodiazepine or alcohol withdrawal
Opioid analgesic withdrawal
Thyroid medication, Estrogen
Digoxin
Calcium channel blockers, alpha-blockers, betablockers
Levodopa
GAD
Phobia
PTSD
OCD
First Line
SSRI, SNRI,
Buspirone
SSRI
SSRI, TCA
SSRI
Second Line
TCA
SNRI
SNRI
SNRI
Third Line/
Adjunct
Benzodiazepine
Benzodiazepine
Benzodiazepine,
Divalproex,
Clonidine
Benzodiazepine,
Gabapentin
Adapted from Cassidy, K.L., Rector, N.A. et al.
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SSRIs generally safest and most effective
◦ Celexa, Lexapro, Zoloft, Prozac, Luvox, Paxil
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Many residents also have depression
May take up to 6 – 8 weeks to see full benefit at
any given dose
Nausea, diarrhea, tremor, increased anxiety can
occur for the first few weeks
◦ Start with low dose
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Use of benzodiazepine in the short term may be
beneficial
◦ Remember to get stop date
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Mechanism of Action unknown
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Most Common Adverse Effects
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Dose: 5 mg BID, increase by 5mg/day every 2-3
days as needed up to 20-30mg/day
◦ High affinity for serotonin receptors
◦ Moderate affinity for dopamine receptor
◦ Does NOT affect benzodiazepine-GABA receptors
◦ Dizziness
◦ Headache
◦ Nausea
◦ Maximum dose: 60 mg /day
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Not as effective on a PRN basis but is sometimes
acceptable to use PRN
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Alprazolam (Xanax)
Lorazepam (Ativan)
Temazepam (Restoril)
Oxazepam (Serax)
Triazolam (Halcion)
Estazolam
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Short Acting
Clonazepam (Klonopin)
Diazepam (Valium)
Chlordiazepoxide
(Librium)
Clorazepate
Flurazepam
Quazepam
Chlordiazepoxide –
Amitriptyline
ClidiniumChlordiazepoxide
(Librax)
Long Acting
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Sedation
Respiratory depression
Hypotension, dizziness
Falls, Fractures
Disinhibiting
Akathesia, Ataxia, weakness
Amnesia, headache
Increased Risk of Dementia
◦ Prospective Population based study in France
◦ 1063 men & women, free of Dementia and did not start taking
benzodiazepines until at least the 3rd year of follow-up
◦ 15 year follow up
◦ 50% increase in the risk of Dementia for patients that ever used a
benzodiazepine versus those who never used
Long acting agent should NOT be used unless shorter acting
medication has failed
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Sleep cycle deteriorates with age
Hypnotics provide minimal improvements on
sleep latency and duration with high risk of
adverse events
Underlying causes for insomnia should always
be addressed prior to starting medication
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Environmental (light, noise, temperature)
Physical (Pain, shortness of breath)
Medications (including caffeine intake)
Persons life long sleep habits
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FDA labeled for Insomnia
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Lorazepam (Ativan)
Oxazepam
Estazolam
Temazepam (Restoril)
 7.5mg – 15 mg Capsules QHS
 Hard to dose reduce because 7.5 mg capsules are more
expensive
◦ Triazolam (Halcion)----NOT RECOMMENDED
 Short half-life
 Increased risk of anterograde amnesia
 Inability to create new memories
◦ Alprazolam (Xanax)-off label
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Consider using same benzo for insomnia that is
being used for anxiety to minimize polypharmacy
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Zolpidem (Ambien & Ambien CR, Intermezzo
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5-10 mg (max 10mg) of immediate release
6.25-12.5 extended release
Zolpimist Spray – 5 mg / actuation
Should only be administered when patient is able to stay in bed a full night
Intermezzo- 1.75 or 3.5 mg SL tab for middle of night (>4 hrs left)
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Zaleplon (Sonata)
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Eszopiclone (Lunesta)
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◦ 5 mg-20 mg at bedtime (max. 10 mg in geriatrics) for 7-10 days
◦ High fat meals prolong absorption
◦ 1-3 mg (2 mg max for geriatrics)
◦ Do NOT take with or immediately after a high fat meal
Rapid onset and should be administered when resident is already
in bed and having difficulty sleeping
Withdrawal can occur with abrupt discontinuance
Chronic use >90 days NOT recommended
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Abnormal thinking & behavior
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Worsen depression
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CNS depression
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◦ Decreased inhibition, aggression, agitation,
hallucinations
◦ Suicidal ideation
◦ Impairment of physical and mental capabilities
◦ Respiratory depression (caution with COPD & apnea)
Sedation, Delirium
Falls, Fractures
Angioedema and anaphylaxis
Complex sleep-related behavior
◦ Driving, making phone calls, preparing food while asleep
with no memory
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Trazodone
◦ Unlabeled but common use
◦ 25 mg – 150 mg at bedtime
 less than antidepressant dose of up to 600mg /day in
divided doses
◦ Orthostatic hypotension & Syncope
◦ QT prolongation & tachycardia (less than SSRIs)
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Mirtazapine (Remeron)
◦ 7.5-15 mg QHS
◦ Also helpful with appetite
◦ Higher doses actually are less sedating and less
effective for sleep and appetite
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Not recommended due to Anticholinergic side
effects and adverse effect on sleep
architecture
Diphenhydramine (Benadryl)
◦ In Tylenol PM
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Hydroxyzine (Atarax, Vistaril)
◦ Safely used for anxiety in younger adults
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For a resident with allergies and anxiety
consider Cetirizine (Zytrec) 5-10mg QHS
◦ Active metabolite of hydroxyzine with slightly less
anticholinergic effect
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Increase the amount of Serotonin available in the
Brain
Citalopram (Celexa), Escitalopram (Lexapro),
Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline
(Zoloft), Fluvoxamine (Luvox)
Most also FDA approved for Anxiety
Adverse Effects:
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EPS (movement disorders)
Hypernatremia (low sodium)
GI upset, nausea, GI bleeding
Tremor, headache
Decreased libido, sexual dysfunction
Insomnia or somnolence
Suicide (in early treatment, younger patients)
Serotonin Syndrome
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Results from too much Serotonin in the brain
Often occurs when more than one medication that increases
serotonin
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SSRIs (Prozac, Zoloft, Celexa etc…)
SNRIs (Cymbalta, Effexor)
Tramadol (Ultram)
Buprenorphine (Butrans patch)
Dextromethorphan (Robitussin DM)
Buproprion (Wellbutrin, Zyban)
Buspirone (Buspar)
Anti –Migraine medicines (Triptans – Amerge, Zomig)
TCAs (Amitriptyline, Nortriptyline)
Lithium
Ondansetron (Zofran)
St. John’s Wart, Ginseng
Or agents that impair metabolism of serotonin
◦ Linezolid (Zyvox), IV Methylene blue
◦ Marplan, Nardil (MOAI antidepressants)
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Mental Status Changes
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Hallucinations
Agitation, increased anxiety
Delirium
Coma
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Autonomic Instability
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Neuromuscular changes
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GI Symptoms
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◦ Tachycardia
◦ Labile blood pressure
◦ Diaphoresis, fever
◦ Tremor
◦ Rigidity
◦ Myoclonus
◦ Nausea / vomiting
Seizures, coma, death
Anxiety, Ankle clonus, agitation and tremor most common signs
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Tricyclic Antidpressants
 Amitriptyline (Elavil), Imipramine (Tofranil)
 Nortriptyline (Pamelor), Desipramine (Norpramin)
 Side Effects:Hypotension, sedation, cardiac arrhythmias
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Duloxetine (Cymbalta)
◦ Approved for anxiety
◦ Approved for fibromyalgia, diabetic neuropathy, chronic
pain
◦ Nausea, dry mouth, dizziness
◦ Hypertension
◦ Reduce dose if CrCl 30-60ml/min and contraindicated if
CrCl <30 ml/min
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Lithium
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More commonly used in Bipolar patients
Narrow therapeutic index drug
Adversely effects renal function and is cleared renaly
High risk of toxicity with dehydration and with medications that
affect sodium excretion (ACEIs, diuretics, NSAIDs)
Anticonvulsants
◦ Divalproex (Valproic acid, Depakote)
 Most commonly used for behaviors in seniors
 Better tolerated than other mood stabilizers in older adults
◦ Carbamazepine (Tegretol)
 Lots of monitoring required: cbc, thyroid, LFTs
◦ Lamotrigine (Lamictal)
◦ Gabapentin (Neurontin)
◦ Topiramate (Topamax)
helpful in patients that need to lose weight
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Side effects:
Sedation, confusion, falls,
 Nausea,
 Low sodium, pancreatitis, low platelets, high ammonia
levels
Monitoring:
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CBC, Platelets, Liver function at baseline and every 6 months.
Monitoring
Serum levels for carbamazepine and valproic acid (every 6-12
months depending on dose)
Maintain on minimum effective dose
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Seizure disorders
Bipolar disorder
Chronic pain
Neuropathic pain
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Diabetic neuropathy
Post-herpetic neuralgia
Trigeminal neuralgia
Post-Stroke pain
Restless Leg Syndrome
Watch for Polypharmacy with Gabapentin for
neuropathic pain
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Antipsychotics
◦ Within the first year of admission or initiating of medication, attempt GDR
during two separate quarters (with at least one month between attempts)
◦ Then at least annually thereafter
◦ Semi-annually if dementia with no behaviors
◦ More Aggressive Protocol: Consider GDR every quarter until behaviors
emerge
◦ Limit PRN use to 1x doses or to 10 days when titrating routine doses
Anti-Anxiety, Antidepressants, Anticonvulsants
◦ Within the first year of admission or initiating of medication, attempt GDR
during two separate quarters (with at least one month between attempts)
◦ Then at least annually thereafter
◦ If used for pain dose reduction not recommended unless side effects
Hypnotics
◦ Manufacturer Guidelines considered
◦ Attempt Quarterly
GDRs May be clinically contraindicated if target symptoms
returned or worsened after dose reduction or physician has well
documented rationale
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How long it took to titrate to therapeutic dose and
residents history of depression or anxiety
Inherent physical dependence /withdrawal properties
of the medication
Dosage forms available, price, whether or not tablets
can be split
Number of different psychoactive medications
resident is on and set priorities based on symptoms
Is the resident experiencing side effects
◦ FALLS
◦ WEAKNESS
◦ TREMORS
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Behavioral health Committee or team
◦ Consultant Pharmacist, Psychologist, Medical Director,
Administrator, D.O.N.
◦ Activities, Therapy, Social services
◦ Direct care staff (Nurses, RMTs, CNAs)
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Meet at least monthly to discuss dementia
patients, residents on antipsychotics or
residents with problematic behavior issues
◦ Look for underlying causes of behavior
 Pain, medication side effects, metabolic conditions,
psychosocial factors
◦ Consider gradual dose reductions
◦ Ensure supportive documentation

Educate Nursing Staff (including CNAs) regarding
the use of Psychoactive Medications
◦ Which medications work for which symptoms
◦ Side effects to monitor
◦ Diagnosis and specific behaviors that must be
documented to justify / support the use of the
medication

Consider implementing policy / Process
◦ No single nurse allowed to call and request and
antipsychotic
◦ Psychoactive medications started by on-call physicians
be reevaluated promptly by the behavior team
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Advanced Copy: Dementia Care in Nursing Homes: Clarification to Appendix P
State Operations Manual (SOM) and appendix PP in the SOM for F309-Quality of
Care and F329-Unnecessary Drugs. Accessed online August 2013 at:
http://surveytraining.cms.hhs.gov
Billioti de Gage, S.,Begaud, B., Bazin, F. et al. Benzodiazepine Use and Risk of
Dementia Prospective Population Based Study. BMJ. Accessed online Sept. 2013 at:
http//www.medscape.com/viewarticle/771934.
Cassidy, k.L., Rector, Neil A. The Silent Geriatric Giant: Anxiety Disorders in Late
Life. Geriatrics and Aging. 2008;11(3):150-156
Cerejeira, J., Lagarto, and Mukaetova-Ladinska, E.B., Behavioral and Psychological
Symptoms of Demetia. Published online 201 May 7. frontiers in Neurology.
Guide to the Management of Psychotic Disorders and Neuropsychiatric Symptoms
of Dementia in Older Adults. October 2012. Accessed online Sept. 2013 at:
http://dementia.americangeriatrics.org/GeriPsych_index.php
Policy Statement. Use of Antipsychotic Medications in Nursing Facility Residents.
Accessed online Sept. 2013 at: www.ascp.com
The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American
Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication
Use in Older Adults. JAGS 2012. Accessed online September 2013 at:
www.americangeriatrics.org
Lexicomp online drug information: www.online.lexi.com