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Medication Friend or Foe - Jennifer Hardesty
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Medications: Friend or Foe?
The role of medications in both causing and curing
behavior and cognition problems
Jennifer Hardesty, PharmD, FASCP
Director of Clinical Services, Remedi SeniorCare
Jennifer.Hardesty@RemediRx.com
Could These Behaviors Be a Result of a Medication?
Altered Cognition
Confusion
Aggression
Negative Behaviors
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Objectives
To identify various medications that can
contribute to cognitive impairment and
behavioral symptoms in the older individual.
To educate on appropriate interventions to
address behavioral/cognitive problems in the
elderly.
To review the implications these medications and
resultant behaviors have in relation to regulatory
guidance.
Risk vs. Benefits of Medications
Medications can cause problems, even if used correctly!
MEDICATION BENEFITS
• When used correctly, medications can lead to:
• Better life quality
• Healthier life
• Longer life
MEDICATION RISKS
• Unwanted or unexpected effects may occur
• Mild adverse effect:
• upset stomach
• dry mouth, nausea
• Serious adverse effects:
• organ damage
• coma
• CNS adverse effects:
• Sedation
• Confusion
• Agitation/aggression
• Psychosis
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Organic Causes of Cognitive/Behavior Changes
Medical Conditions:
• Infections:
• UTI
• Pneumonia
• Sepsis
• Stroke, hemorrhage
• Metabolic derangements:
• electrolytes
• dehydration
• hyper/hypoglycemia
• hyper/hypothyroid
• hypoxia
• CV disease:
• hypotension
• MI
• hypertensive crisis
Psychiatric Disorders
• Dementia
• Depression
• Anxiety
• Schizophrenia
• Psychosis
DementiaDementia is progressive deterioration in
Intellectual function
Memory/Recognition
Language
Executive
function/skilled motor
activities
Visuospatial ability
leading to a
decline in the
ability to perform
activities of daily
living.
Changes in Behavior &
Activity Level
• Isolation/ social withdrawal/
Decreased interest
• Difficulty with decision
making
• Problems concentrating
• Unexplained anger
• Anxiety
• Aggression/Agitation
• Sleep difficulties
• Changes in appetite
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Psychiatric Disorders
Depression
• Symptoms include
either a depressed
mood or loss of
interest, PLUS:
• Weight Changes,
sleep changes
• Behavior that is
agitated or slowed
down.
• Fatigue
• Thoughts of
worthlessness or
extreme guilt
• Problems
concentrating or
making decisions
• Thoughts of death or
suicide
• The person's
symptoms are a cause
of great distress or
difficulty in functioning
at home, work, or
other important areas.
Anxiety
• Excessive anxiety and
worry about a variety
of events and
situations.
• Struggle to gain
control, relax, or cope
with the anxiety and
worry
• Feeling wound-up,
tense, or restless
• Easily fatigued or
worn-out
• Concentration
problems
• Irritability
• The symptoms cause
"clinically significant
distress" or problems
functioning in daily life.
Schizophrenia
• Delusions
• Hallucinations
• Disorganized speech
• Grossly disorganized or
catatonic behavior
• Negative symptoms:
• low levels of interest
• motivation
• mental activity
• social drive
• speech
Psychosis
• Psychosis can be a
symptom of mental
illness, but it is not a
mental illness in its
own right
• hallucinations or
delusional beliefs
• personality changes
• disorganized thinking
• unusual or bizarre
behavior
• impairment in activities
of daily living
Causes of Cognitive Changes
OrganicCauses
Dementia
Psychiatric
Disorders
Depression
Anxiety
Schizophrenia
IatrogenicCauses
Predictable drug side
effects
Alcohol or illicit drug
intoxication
Medications-Adverse
Drug event
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Iatrogenic Causes
From outside influences
Alcohol/drug
intoxication
or withdraw
Poisons
Anesthesia
• Sedation
• Confusion
• Agitation
Sensory
deprivation/E
nvironment
Medications
• Numerous CNS
side effects
Adverse Drug Reactions
Any noxious, unintended, and undesired effect of a drug which occurs at
doses used in humans for prophylaxis, diagnosis or therapy
Adverse Drug Reactions (ADRs)
36% of all reported adverse drug events involve an elderly patient
Elderly are at Greater Risk for ADR’s:
• Multiple chronic diseases
• Multiple prescribers
• Multiple medications
• Types of medications prescribed
• Under-representation in clinical trials, particularly those over age 75
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Preventable Adverse Drug Events
Incidence of ADRs in high risk seniors (=>5 Rxs)
• 35% experienced ADR
• 95% of ADRs were predictable
• 63% required MD intervention
• 11% required hospitalization
Psychoactive drugs and anticoagulants are the most common medications
associated with preventable adverse drug events
-oversedation, confusion, hallucinations, delirium, falls and bleeds
Signs / Symptoms of Delirium:
• Restlessness, agitation
• Memory deficit
• Drowsiness, poor attention span
• Wandering
• “Picking” at the air/clothes...
• Hallucinations
Types of delirium:
• Hyperactive delirium: agitation, anxiety state
• Hypoactive delirium: lethargy, excess somnolence, sluggish
• Mixed delirium: symptoms of both
Medications = Most common causes of delirium
22-39% of all cases
Drug-Induced Delirium
A clinical state characterized by an acute, fluctuating change in mental status,
with inattention and altered levels of consciousness.
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Prevalence of Delirium in the Elderly
Common in hospitalized older adults:
Emergency 10% - 30%
Post-operatively up to 50%
Cardiac Surgery 17 - 73%
Post Hip Fracture 35% - 65%
General Medicine 11% - 26%
Known Dementia 32% - 89%
Course: Can be quite variable
Prevalence:
Typical: 10-12 days
Range: 1-8 weeks
Lasting > 30 days: 15%
Increased Risk: Longer LOS, LTC
Risk factors for Delirium
Risk factors include:
• Advanced old age
• Underlying dementia
• Functional impairment
• Multiple medical problems
• Polypharmacy
• Renal impairment
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Dementia, Depression, and Delirium
Depression Dementia Delirium
Onset Usually within a
period of weeks
Slow, insidious, over
a period of
months/years
Abrupt, may be
within hours or
days
Symptoms Pervasive sadness
or loss of pleasure,
plus somatic signs
Gradual decline in
functioning,
including recent
memory loss and
word finding
difficulty
Fluctuation in
consciousness
and attention
Possible
hallucinations,
delusions,
disorientation
Course Episodic, treatable,
resolvable
Progressive,
manageable
Treatable, usually
resolvable
Facility
Staff
Nurse
Family
Pharmacist
MD/NP
Resident
Consultant
TEAMWORK is needed to help identify and
resolve cognitive and behavioral problems!
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Case Study: AD
AD is an 89 year old woman residing in your SNF for 2 weeks. She is
recovering from knee replacement surgery. Two days ago she was not
communicating as clearly as usual with nursing staff, and after further
investigation was found to have a UTI.
PMH:
• Mild dementia • DM Type 2
• HTN, CHF • Osteoporosis
• S/P knee replacement
Current medications include:
• HCTZ 25mg QD • Digoxin 0.25mg QD
• Lisinopril 20mg QD • Metoprolol XL 50mg QD
• Tolterodine LA 4mg QD • Amitriptyline 25mg HS for restless legs
• Cipro 500 mg BID x 10 days • Metformin 500mg BID
• Zolpidem 5mg HS prn sleep • Diphenhydramine 50mg PRN itchy rash
Today she is acting very confused and does not recognize her son who visits
in the morning. She does claim to see her husband and speaks with him while
she is in her room, although he had passed away several years ago.
Can you assess this situation?
Drugs Associated with Adverse Cognitive Effects
“Medicine sometimes snatches away health, sometimes gives it.”
~Ovid, Tristia
"Any symptom in an elderly patient should be considered
a drug side effect until proved otherwise.”
J Gurwitz, M Monane, S Monane, J Avorn
Brown University Long-term Care Quality Letter 1995
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Can you name any medications that may
cause cognition or behavior problems?
Medications Associated with Cognitive Impairment
‘ACUTE CHANGE IN MS’
Initial Drug Class
A Antiparkinsonian drugs
C Cardiovascular drugs
U Urinary incontinence drugs
T Theophylline
E Emptying drugs
C Corticosteroids
H H2-blockers
A Antimicrobials
N NSAIDs
G Geropsychiatric drugs
E ENT drugs
I Insomnia drugs
N Narcotics
M Muscle relaxants
S Seizure drugs
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Anti-Parkinsonian Drugs
Anti-Parkinson’s drugs, besides causing psychotic symptoms, have also been linked to
mood symptoms, even at therapeutic doses.
Levodopa:
About 5% of patients
develop delirium
from the use of this
drug
Cognitive symptoms
occur in up to 60%
of patients
• Isolated hallucinations
while maintaining a clear
state of consciousness
• Abnormal dreaming and
sleep disturbances may
be early signs
Selegiline, dopamine
agonists,
amantadine:
Visual hallucinations,
delusions,
depression
Anticholinergics:
(eg, trihexyphenidyl,
benztropine):
confusion and
delirium
Cardiovascular Drugs
Antiarrhythmics
Disopyramide :
Fatigue,
nervousness,
confusion
Digoxin
Confusion,
delirium,
hallucinations,
anxiety
Antihypertensives: (5-10%
incidence in normal population)
Beta-Blockers: Depression, delirium,
confusion, psychosis
Clonidine: Depression, delirium,
psychosis, hallucinations
Methyldopa: May exacerbate depression
or anxiety in elderly patients
Amiodarone: long half-life may promote
prolonged confusion or memory
problems
Diuretics: can cause fluid and/or acid-
base imbalances, which can result in
confusion, especially in the postoperative
patient
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Urinary Incontinence Agents
oxybutnin, tolterodine, trospium, etc.
Elderly have increased sensitivity to anticholinergic effects,
resulting in:
• Confusion/Delirium
• Xerostomia
• Constipation
• Urinary Retention
Anticholinergic drugs have been linked to
memory impairment, changes in consciousness,
and even decreases in ADLs/IADLs
Anticholinergic Drugs
• Total burden of anticholinergic drugs may determine
the development of delirium, rather than any single
agent.
• The total burden of anticholinergic medications is the
sum of the anticholinergic activity of all the drugs
a patient is consuming.
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Medications with anti-cholinergic properties
Antidepressants
Amitriptyline
Desipramine/Imi
pramine
Doxepin
Antipsychotics
Olanzapine
Clozapine
Antihistamines
Diphenhydramin
e
Hydroxyzine
Meclizine
OTC
antihistamines
Prochlorperazin
e
Scopolamine
Narcotics
Urinary
Incontinence
Oxybutynin
Toleterodine
Muscle Relaxants
Cyclobenzaprine
Carisoprodol
Others
Ipatropium
Captopril
Furosemide
Nifedipine
Cimetidine/Ranit
idine
Theophylline
Warfarin
Glycopyrrolate
Theophylline
Adverse effects usually occur in high dose or overdose
situations:
• Insomnia
• Anxiety
• Agitation
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Emptying Drugs (GI Drugs)
GI antispasmodics
• Dicyclomine
• Hyoscyamine
Metoclopramide
Confusion, lethargy, delirium, hallucinations (rare)
High risk of cognitive toxicity due to:
• High anticholinergic activity
• Dopaminergic activity
Symptoms occur in approximately 18% of patients on
high doses of corticosteroids
Corticosteroids can induce mental status changes
Corticosteroids
Risks include:
• Use of high-dose steroids (> 80 mg/day of prednisone)
• Long duration of use
• Abrupt discontinuation
Appear as a variety of mental status changes:
• depressive symptoms
• manic symptoms
• paranoid-hallucinations
• psychosis
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H-2 Receptor Blockers
Cimetidine is most common offender
• Confusion
• Depression
• Delusions/Psychosis
• Aggression or Mania
Predisposing factors include:
• High doses, older age
• Pre-existing psychiatric illness
• Poor renal function
• Simultaneous treatment with psychotropic medications
Cimetidine, ranitidine, famotidine
Risk factors include sepsis, renal impairment, high
doses
Antimicrobials
Cephalosporins/Penicillins:
• Delusions,hallucinations, agitation, confusion
Aminoglycosides:
• Confusion, hallucinations
Fluoroquinolones
• Confusion, agitation, depression, hallucinations, paranoia,
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NSAIDs
Aspirin toxicity:
Delirium is the major manifestation
Indomethacin:
Depression and delirium
Naproxen/Ibuprofen:
Disturbances in memory and concentration (low risk; usually occurs
at high doses).
Celecoxib:
Confusion, anxiety
Geropsychiatric Drugs
Antidepressants
• Tricyclic Antidepressants: (Amitriptyline,
Imipramine)
• Delirium, disorientation, and memory
impairment
• Highly anticholinergic properties
• Fluoxetine
• Long half-life of drug
• Anxiety, sleep disturbances, and increasing
agitation
• Venlafaxine
• Nervousness, Agitation
Antidepressant
Medication
Anticholinergic
Activity
Amitriptyline 4
Trimipramine 4
Doxepin 3
Imipramine 3
Nortriptyline 2
Phenelzine 2
Tranylcypromine 2
Selegiline 2
Desipramine 1
Paroxetine 1
Duloxetine 1
Venlafaxine 1
Mirtazapine 1
Citalopram 0
Escitalopram 0
Fluoxetine 0
Fluvoxamine 0
Sertraline 0
Bupropion 0
Trazodone 0
Lexicomp Drug Information Handbook, 2008
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Anxiolytics
Long-acting benzodiazepines (diazepam, chlordiazepoxide, flurazepam, chlordiazepoxide)
• Long half-life in elderly patients (often several days)
• Produce prolonged sedation and increase risk of falls and fractures
Short- and intermediate-acting benzodiazepines preferred
All benzodiazepines have been associated with:
• impaired learning of verbal and visual information
• immediate and delayed memory
• psychomotor performance
Geropsychiatric Drugs
Antipsychotics
• Sedation
• Confusion
• Delusions
• Personality Changes
• Traditional and some newer antipsychotics possess
anticholinergic properties
Lithium
• May impair memory and psychomotor performance
• Sedation and confusion
• Associated with the development of delirium at high serum levels
Geropsychiatric Drugs
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1st Generation Antihistamines (diphenhydramine, brompheniramine )
• Potent anticholinergic effects
• Sedation
• Constipation
• Confusion
Anticholinergic OTC Medications:
• Cough/cold products with antihistamines
• Sleep aids
Oral Decongestants (pseudoephedrine, phenylephrine)
• Anxiety, nervousness, hallucinations
ENT Drugs
Insomnia drugs
Sedative-hypnotics (zolpidem/zaleplon)
• Confusion
• Abnormal thinking
• Behavior changes
• Aggression/agitation
• Hallucinations
Barbiturates (secobarbital, pentobarbital)
• Confusion, agitation, hallucinations
• Cause more adverse effects than other sedative or hypnotic drugs
Tylenol-PM (diphenhydramine)
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Untreated pain itself can cause delirium
Narcotics
Drugs
• Meperidine:
– Accumulation of normeperidine, a neurotoxic substance
– fluctuations in levels of awareness, confusion, disorientation,
hallucinations, delusions
• Pentazocine:
– Causes confusion and hallucinations more commonly than
other narcotic drugs
• Opioids
– Probably the most important cause of delirium in postoperative
patients
– Renal impairment = accumulation of metabolites
Withdraw effects
Muscle Relaxants
Muscle Relaxants
• Cyclobenzaprine, methocarbamol, carisoprodol metaxalone
Anticholinergic adverse effects:
• Sedation
• Confusion
• Weakness
• Hallucinations
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All anticonvulsants can affect cognition, even in the
presence of therapeutic drug levels
Seizure Drugs
Phenytoin
• Confusion, mood changes, lethargy at high serum levels
• In elderly patients with low albumin, a therapeutic level of phenytoin may also
be toxic.
Carbamazepine
• Sedation
• Confusion
Valproic Acid:
• Nervousness,
• Confusion, abnormal thinking
Topiramate:
• Memory impairment and confusion
• Cognitive and motor slowing
Others
Diabetes medications
• Reversible and irreversible brain damage secondary to hypoglycemia
• Chlorpropamide- long half-life in elderly patients and could cause
prolonged hypoglycemia
Herbal Products
• St. John's Wort mania, anxiety
• Melatonin confusion, sedation
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Medication-Related Problems Can Occur at ANY Time!
When Are Medication-Related Problems
Most Likely to Occur?
• New drug is added
• Change of dose (higher or lower)
• Drug discontinued
• With alcohol or illicit drugs
• Taking multiple sedating drugs or CNS active drugs
Case Study: AD
AD is an 89 year old woman residing in your SNF for 2 weeks. She is
recovering from knee replacement surgery. Two days ago she was not
communicating as clearly as usual with nursing staff, and after further
investigation was found to have a UTI.
PMH:
• Mild dementia • DM Type 2
• HTN, CHF • Osteoporosis
• S/P knee replacement
Current medications include:
• HCTZ 25mg QD • Digoxin 0.25mg QD
• Lisinopril 20mg QD • Metoprolol XL 50mg QD
• Tolterodine LA 4mg QD • Amitriptyline 25mg HS for restless legs
• Cipro 500 mg BID x 10 days • Metformin 500mg BID
• Zolpidem 5mg HS prn sleep • Diphenhydramine 50mg PRN itchy rash
Today she is acting very confused and does not recognize her son who visits in
the morning. She does claim to see her husband and speaks with him while she
is in her room, although he had passed away several years ago.
What Medications Could be Contributing?
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What medications could contribute to her confusion?
HCTZ 25mg QD
Digoxin 0.25mg QD
Lisinopril 20mg QD
Metoprolol XL 50mg QD
Tolterodine LA 4mg QD
Amitriptyline 25mg HS for restless legs
Cipro 500 mg BID x 10 days
Metformin 500mg BID
Zolpidem 5mg HS prn sleep
Diphenhydramine 50mg PRN itchy rash
Resource for Appropriate and
‘Inappropriate’ Medication Therapy
http://www.cms.hhs.gov/manuals/downloads/som107ap_pp_guidelines_ltcf.pdf
F329: Unnecessary Drugs
TABLE I: MEDICATION ISSUES OF PARTICULAR RELEVANCE
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Managing Cognitive and Behavioral Problems
Investigating the Cause!
Organic Disorders
• Dementia
• Psychiatric
Disorders
• Depression
• Anxiety
• Schizophrenia
• Psychosis
Iatrogenic Problems
• Adverse Drug
Events
• Delirium
Managing Drug-Related Delirium & CNS- Related
Adverse Drug Events
Basic principles:
– Identifying and treating/removing acute precipitants
– Supportive and restorative care
– Controlling disruptive behaviors with a minimum of
chemical or physical restraint
Non-pharmacological Management
Provide general supportive measures:
• Avoid restraints
• Encourage familiar faces for reassurance
• Low stimulation - avoid excessive noise
• Provide orientation (calendar, clock)
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When control is needed to prevent harm and to allowWhen control is needed to prevent harm and to allow
evaluation and treatment,
psychotropic medications
may be required.
Pharmacological Management
Indications for pharmacologic treatment:
• Aggression
• Risk of harm to self or others
• Hallucinations
• Inconsolable or Persistent Distress
(e.g., fear, continuously yelling, screaming, end-of-life distress, or crying);
• Significant decline in function
Must seek the underlying cause of distressed behavior
before or while treating the symptom
Pharmacological Management
Prescribing Principles:
• Use a SINGLE medication
• Start with a low dose.
• Choose a drug with low anticholinergic activity
• Stop the medication as soon as possible
• Continue to use Non-Pharmacological interventions
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Acute Situations/Emergency
“Acute onset or exacerbation of symptoms, or immediate threat
to health or safety of resident or others”
• Acute treatment period limited to 7 days
• Clinician and IDT must reevaluate and document situation within 7 days,
and define continuing need
• Non-drug therapies are attempted beyond the emergency period
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-
Regions-Items/Survey-and-Cert-Letter-13-35.html
Part of all medication treatment = Non-pharmacological approaches
Non-Drug Therapy Requirements
Examples of non-pharmacological interventions may include:
• Identifying, addressing, and eliminating or reducing underlying causes of
distressed behavior
• Developing interventions that are specific to resident’s interests, abilities,
strengths and needs
• Minimize distractions or overstimulated environment
• Using sleep hygiene techniques and individualized sleep routines
• ↑ exercise or therapy
• Massage, hot/warm or cold compresses
• Enhancing the taste and presentation of food
• Music therapy
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Pharmacological Management
When control is needed to prevent harm and to allow evaluation and
treatment, psychotropic medications may be required.
Indications for pharmacologic treatment:
• Aggression
• Agitation
• Risk of harm to self or others
• Hallucinations
• Inconsolable or Persistent Distress
(e.g., fear, continuously yelling, screaming, distress associated with end-of-life,
or crying);
• Significant decline in function
Must seek the underlying cause of distressed behavior before or while treating
the symptom.
Behavioral symptoms must be reevaluated periodically to determine the
effectiveness of the antipsychotic and the potential for reducing or discontinuing
Requirements for Enduring Use of Antipsychotics
Target behavior must be clearly and specifically identified and
monitored objectively and qualitatively
Ensure the behavioral symptoms are:
A. Not due to a medical condition or problem that can be expected to improve or resolve
B. Persistent or likely to reoccur without continued treatment; and
C. Not sufficiently relieved by non-pharmacological interventions; and
D. Not due to environmental stressors that can be addressed to improve the psychotic
symptoms or maintain safety
E. Not due to psychological stressors or anxiety or fear stemming from misunderstanding
related to his or her cognitive impairment
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Inadequate Indications for Antipsychotic Use:
• Wandering
• Poor self-care
• Restlessness
• Impaired memory
• Mild anxiety
• Insomnia
• Unsociability
• Inattention or indifference to surroundings
• Fidgeting/Nervousness
• Uncooperativeness;
• Verbal expressions or behavior that do not represent a danger
to the resident or others
CMS State Operations Manual: Antipsychotics Usage
New Admissions to Skilled Nursing Facility
When a resident is admitted to a SNF from hospital/ community
and are already on an antipsychotic:
• Facility must re-evaluate antipsychotic medication at the time of admission
and/or within two weeks of admission
• PASRR screening (F285) - evaluation for mental illness and/or intellectual
disability
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Investigator’s Review of Medication Management
Surveyors are instructed to review the clinical record to
determine if it reflects the following elements:
• Indication
• Non-pharmacological interventions
• Dose
• Duration
• Tapering/Gradual Dose Reduction documentation
• Monitoring and reporting for efficacy and adverse consequences
• Adverse consequence identification, evaluation, and actions by
physician and facility
Surveyor Investigation- Areas of Focus
• PRN orders for antipsychotic medications
• Describe how the facility provides individualized care and
services for residents with dementia
• Provide policies related to the use of antipsychotic
medications in residents with dementia
• Resident/families/representatives involvement
• Identify and document specific target behaviors
• Communicate consistently
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CMS State Operations Manual: Medication Management
Medication Management Process:
• All drugs implicated!
• Enhanced focus on :
• Medications as cause for change in condition
• Need for Medication Reviews in response to changes in condition
• Enhanced interdisciplinary teamwork
• Enhanced care process
• Personal responsibility
• Need to document process
Medication Management
Medication management should support and promote:
1. Evaluating resident for underlying causes of signs/symptoms
2. Use of non-drug interventions
3. Selection of medications based on benefits vs. risk for individual
residents
4. Selection and use of medication in doses and duration individual
resident
5. Monitoring of medications for efficacy and adverse consequences*.
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Adverse Consequences: Identification
Medication review should be performed if resident has experienced a change in condition:
Weight loss or gain
Behavioral changes/ mental status changes
Bleeding or bruising
Bowel dysfunction
Dehydration/electrolyte imbalance
Dysphagia
GI bleed
Headaches or non-specific pain
Rash or itching
Respiratory changes
Sedation, insomnia, sleep changes
Seizures
Urinary retention or incontinence
How Can I Remember All of This?
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Your Pharmacy Provider Service Team
• Pharmacists
• Technicians
• Nurses
• Consultant Pharmacists
• Account Managers
Facility
Staff
Nurse
Family
Pharmacist
MD/NP
Resident
Consultant
TEAMWORK is needed to help identify and
resolve cognitive and behavioral problems!
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References
Jennifer Hardesty, PharmD, FASCP
Director of Clinical Services, Remedi SeniorCare
Jennifer.Hardesty@RemediRx.com
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