Download Omnicare Diabetes Health Management Program

Polypharmacy and Avoidng The Use of High
Risk Medications
June 13, 2014
Kristin Kim, RPh
Omnicare Consultant
Pharmacist
Omnicare
Learning Objectives
At the completion of this program, the participant will be
able to:
1. State an appropriate definition of polypharmacy;
2. Define the term “unnecessary medications” and
describe the risks associated with their use;
3. List specific modifiable and non-modifiable risk
factors for polypharmacy;
4. Outline approaches and strategies for making drug
therapy more appropriate; and
5. Determine necessary modifications to complex
medication regimens involving common conditions
seen in the long-term care setting.
Polypharmacy Facts
 A study of 3000 nursing home residents found a rate
of 1.89 adverse drug events per 100 resident months.
Overall, 51% of the events were judged to be
preventable, with fatal, life-threatening, or serious
events more likely to be preventable than less severe
events. Most errors occur in the prescribing and
monitoring phases of medication use.
 Other studies indicate that from 30 – 64% of nursing
home residents experience an adverse drug event.
 Risk factors for developing adverse drug events have
been identified and some are modifiable
Gurwitz JH, Field TS, Avorn J, et al. Incidence and preventability of adverse drug events in nursing homes. Am J Med 2000;
109(2): 870-94.
Patient Safety at the Clinical Interface: Preliminary Meeting Summary. Organized by the Agency for Healthcare Research and
Quality for the Quality Interagency Coordination Task Force. November 30, 2000.
Field TS, Gurwitz JH, Avorn J et al. Risk factors for adverse drug events among nursing home residents. Arch Intern Med
2001;161(13):1629-34.
The Poly-definitions of Polypharmacy
 Bushardt et al. reviewed articles between
January 1997 and May 2007 that clearly
define the word “polypharmacy”
 24 different definitions were identified but two
predominated


“the presence of six or more concurrent
medications”
“use of at least one potentially inappropriate drug”
Bushardt R, Massey EB, Simpson TW, et al. Polypharmacy: misleading, but manageable. Clin Interventions in Aging 2008;
3(2):383-389.
So How to Define Polypharmacy?

A continued and growing health concern where more
medications are prescribed than are warranted
clinically

Polypharmacy should not be a quota on the number
of medications prescribed concurrently
For some residents, 1 medication may be too much and
for others 15 medications may not be enough.

The goal is to provide the right number of
medications and identify opportunities to eliminate
unnecessary or potentially harmful drugs while
adding drugs needed to assure optimal therapeutic
outcomes.
Risks of Unnecessary Drug Use
 F329 specifically identifies the following risks:





Medication interactions
Depression
Confusion
Immobility
Falls and related hip fractures
CFR 483.25(I), Unnecessary Drugs
F329 - What is an Unnecessary Drug?
 According to F329
“Each resident’s drug regimen must be free from
unnecessary drugs. An unnecessary drug is any
drug when used:
(i) In excessive dose (including duplicate therapy);
or
(ii) For excessive duration; or
(iii) Without adequate monitoring; or
(iv) Without adequate indication for its use; or
(v) In the presence of adverse consequences
which indicate the dose should be reduced or
discontinued; or
(vi) Any combinations of the reasons above.”
CFR 483.25(I), Unnecessary Drugs
Intent of F329
To help promote or maintain the resident’s highest
practicable mental, physical, and psychosocial wellbeing:





Use only those medications, in doses and for the
duration clinically indicated to treat the resident’s
assessed condition(s);
Non-pharmacological interventions are considered and
used when indicated, instead of, or in addition to,
medication
Clinically significant adverse consequences are
minimized; and
The potential contribution of the medication regimen to
an unanticipated decline or newly emerging or
worsening symptom is recognized and evaluated, and
the regimen is modified when appropriate
CFR 483.25(I), Unnecessary Drugs
CMS Definitions
 Excessive dose
 Duplicate therapy
 Excessive duration
Definitions – “Excessive dose”
“the total amount of any medication (including duplicate therapy)
given at one time or over a period of time that is greater than the
amount recommended by the manufacturer’s label, package
insert, current standards of practice for resident’s age and
condition, or clinical studies or evidence-based review articles
that are published in medical and/or pharmacy journals and that
lacks evidence of:





A review for the continued necessity of the dose;
Attempts at, or consideration of the possibility of, tapering a
medication; and
A documented clinical rationale for the benefit of, or necessity for,
the dose or for the use of multiple medications from the same
pharmacological class.”
“Factors influencing the appropriateness of any dose include the
resident’s clinical response, possible adverse consequences,
and other resident and medication-related variables”
CFR 483.25(I), Unnecessary Drugs
Definitions – “Duplicate therapy”
 “Multiple medications of the same
pharmacological class/category or any
medication that substantially duplicates a
particular effect of another medication that
the individual is taking.”
 “Duplicate therapy is generally not indicated,
unless current clinical standards of practice
and documented clinical rationale confirm the
benefits of multiple medications from the
same class or with similar therapeutic
effects.”
CFR 483.25(I), Unnecessary Drugs
Definitions – “Excessive duration”

“Many conditions require treatment for extended
periods, while others may resolve and no longer
require medication therapy.”

“The medication is administered beyond the
manufacturer’s recommended time frames or facilityestablished stop order policies, beyond the length of
time advised by current standards of practice, clinical
practice guidelines, clinical studies or evidencebased review articles, and/or without either evidence
of additional therapeutic benefit for the resident or
clinical evidence that would warrant continued use of
the medication”
CFR 483.25(I), Unnecessary Drugs
Risk Factors for Polypharmacy
NONMODIFIABLE
MODIFIABLE
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Multiple prescribers

Multiple pharmacies

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High-risk medications
Number of medications
Diet
Multiple ingredient products
Failure to order drugs with
knowledge of drug effects,
interactions, doses, and
adverse effects
Failure to monitor drug
therapy appropriately


Age
Recent hospitalization
Underlying medical
conditions
Gender - male
New resident to nursing
home
Gurwitz JH et al. Incidence and preventability of
adverse drug events in nursing homes.
Am J Med 2000;109:87-94.
Gupta S et al. Polypharmacy among nursing home
geriatric Medicaid recipients. Ann Pharmacother
1996;30:946-50.
Field TS et al. Risk factors for adverse drug events
among nursing home residents. Arch Intern Med
2001;161:1629-34.

Costly Consequences of Polypharmacy
In U.S. nursing homes in 1995


$3 billion dollars were spent on medications
At least $4 billion dollars were spent on drug related
problems

For every $1 dollar spent on drugs, $1.33
is spent managing the complications of
drug therapy!!!
Without consultant pharmacist services,
drug-related problems would be estimated
at $7.6 billion dollars

Bootman JL, Harrison DL, Cox E. The health care cost of drug-related morbidity and mortality in nursing facilities.
Arch Intern Med 1997;157:2089-96.
Hospital Discharges
 A review of 384 frail older VA patients revealed
44% of patients had one or more unnecessary
medications upon hospital discharge




38.2% received a medication without an appropriate
indication for use
18.5% evidenced lack of efficacy
7.6% received therapeutic duplication
The most common categories of unnecessary drug
use were gastrointestinal, CNS, and therapeutic
nutrients and minerals
Hajjar ER, Hanlon JT, Sloane RJ et al. Unnecessary drug use in frail older people at hospital discharge.
JAGS 2005; 53: 1518-1523.
Most Common Preventable Adverse
Drug Effects

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Neuropsychiatric
Falls
Hemorrhage
Gastrointestinal
Extrapyramidal/TD
Anorexia/weight loss
Metabolic/endocrine
Cardiovascular
28.8%
19.9%
14.4%
11.1%
7.1%
5.8%
4.4%
4.0%
Field TS et al. Risk factors for adverse drug events among nursing home residents.
Arch Intern Med 2001;161:1629-34.
Most Commonly Implicated Drug Classes
in Preventable Events
Opioids
Antipsychotics
Antibiotics/anti-infectives
Anticonvulsants
Antidepressants
Nutrients/supplements
Odds Ratio*
6.6 (2.3-19.3)
4.0 (2.2-7.3)
3.0 (1.6-5.8)
2.2 (1.1-4.5)
2.0 (1.1-3.5)
0.27(0.14-0.50)
*(95% Confidence Interval)
Field TS et al. Risk factors for adverse drug events among nursing home residents.
Arch Intern Med 2001;161:1629-34.
Fifteen Most Commonly Prescribed
Potentially Inappropriate Drugs
1)
2)
3)
4)
5)
6)
7)
Alprazolam
Lorazepam
Amitriptyline
Nifedipine
Promethazine
Oxybutynin
Fluoxetine
8) Cyclobenzaprine
9) Temazepam
10) Indomethacin
11) Amiodarone
12) Hydroxyzine
13) Diphenhydramine
14) Metaxalone
15) Naproxen
Bushardt R, Massey EB, Simpson TW, et al. Polypharmacy: misleading, but manageable. Clin Interventions
in Aging 2008; 3(2):383-389.
F329 and Antipsychotic Use
 Analysis of antipsychotic use by 693,000
Medicare nursing home residents revealed:


28.5% of doses were deemed excessive
32.2% lacked appropriate indications for use
 Castle et al. in June 2009 found that within
nursing homes, antipsychotic usage
increased from 16.4% in 1996 to 25.9% in
2006
CFR 483.25(I), Unnecessary Drugs
Castle NG, Hanlon JT, Handler SM. Am J Geriatr Pharmacother. 2009;7:143–150
Additional Concerns with Antipsychotics
 “Boxed Warning” on all antipsychotics, citing
increased mortality when used in elderly
patients with dementia-related psychosis
 Numerous serious adverse effects, including
stroke, diabetes, extrapyramidal symptoms,
neuroleptic malignant syndrome, etc.
 Even short-term use (e.g., 30 days) of
antipsychotic therapy has been associated
with serious adverse events, including death
Ray WA, Chung CP, Murray KT, et al. NEJM 2009; 360:225-35.
Schneider LS, Tariot PN, Dagerman KS, et al. CATIE-AD. NEJM 2006; 355:1525-38.
Castle NG, Hanlon JT, Handler SM. Am J Geriatr Pharmacother. 2009;7:143–50
Discontinuation of Antipsychotics

Within the dementia
antipsychotic
withdrawal (DART-AD)
trial, 64 patients (out of
128 total patients
receiving
antipsychotics) were
randomized to receive
placebo for 12 months
Time point
Probability of
Survival: AP v.
placebo
12 months
70% v. 77%
24 months
46% v. 71%
36 months
30% v. 59%
Only 7 patients (10.9%) required re-initiation
of an antipsychotic after the 12 month trial
was completed
Ballard C, Hanney ML, Theodoulou M, et al. DART-AD: long-term follow-up of a randomised
placebo-controlled trial. Lancet. 2009; 8(2):151-7.
A Quick Focus on Falls
 Falls are the primary reason for:


injury-related hospitalizations (85% of total)
More than 40% of nursing home
admissions
 About 40% of nursing home residents
fall annually
 Several commonly used medications
have been implicated with falls
Messinger-Rapport B and Dumas LG. Falls in the nursing home: a collaborative approach. Nurs Clin N Am 44(2009): 187-195.
Woolcott JC, Richardson KJ, Wiens MO, et al. Meta-analysis of the impact of 9 medication classes on falls in edlerly persons.
Arch Intern Med. 2009; 169(21): 1952-1960.
The Impact of Medications on Falls
Medication Class
“Antihypertensives”
β-blockers
Fall Risk (odds ratio)
1.24
1.01
Diuretics
Antidepressants
Antipsychotics
1.07
1.68
1.59
Sedative-hypnotics
Benzodiazepines
NSAID’s
1.47
1.57
1.21
Opioid narcotics
0.96
Woolcott JC, Richardson KJ, Wiens MO, et al. Meta-analysis of the impact of 9 medication classes on falls in edlerly persons.
Arch Intern Med. 2009; 169(21): 1952-1960.
Appendix PP Table 2 – Medications with
Significant Anticholinergic Properties

Antiparkinson Medications
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

meclizine
Scopolamine
“Other medications not listed
here that have anticholinergic
properties”
chlorpromazine
clozapine
olanzapine
thioridazine
Urinary Incontinence

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

cyclobenzaprine
dantrolene
orphenadrine
Antivertigo Medications


Antipsychotic Medications
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
amantadine
benztropine
biperiden
trihexphenidyl
Muscle Relaxants

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
oxybutynin
probantheline
solifenacin
tolterodine
trospium
Phenothiazine Antiemetics


prochlorperazine
promethazine
Possible side effects from anticholinergic medications include confusion or decreased cognition,
lightheadedness, blurred vision, constipation, dry mouth, and difficulty urinating.
CFR 483.25(I), Unnecessary Drugs
Appendix PP Table 2 – Medications with
Significant Anticholinergic Properties

Antihistamine (H-1
Blockers)

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
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
chlorpheniramine
cyproheptadine
diphenhydramine
hydroxyzine
Antidepressants

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
amitriptyline
amoxapine
clomipramine
desipramine
doxepin
imipramine
nortriptyline
protriptyline
paroxetine

Cardiovascular Medications

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


digoxin
disopyramide
furosemide
nifedipine
Gastrointestinal Medications

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belladonna
chlordiazepoxide
cimetidine
clidinium
dicyclomine
diphenoxylate with atropine
hyoscyamine
propantheline
ranitidine
Possible side effects from anticholinergic medications include confusion or decreased cognition,
lightheadedness, blurred vision, constipation, dry mouth, and difficulty urinating.
CFR 483.25(I), Unnecessary Drugs
Approaches to Helping Make Drug
Therapy Appropriate
 ARMOR
 STOPP
 START
ARMOR
(Assess Review Minimize Optimize Reassess)

Assess



total number of medications
Use of medications with higher rates of adverse
outcomes (e.g., β-blockers, psychotropics, pain
medications, Beers Criteria medications)
Review

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
drug-drug interactions
drug-disease interactions
impact on functional status
benefits versus risk of therapy (e.g., weight changes,
bladder changes, skin changes, etc)
Minimize (non-essential medications)


lack of clear indication
risk outweighs benefits
Haque R. ARMOR: A tool to evaluate polypharmacy in elderly persons. Ann LTC 2009; 17(6): 26-30.
ARMOR (continued)
(Assess Review Minimize Optimize Reassess)

Optimize

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
eliminate duplication or redundancy
adjust renally or hepatically cleared medications
adjust oral hypoglycemics based on target blood sugar
and A1c
gradual dosage reductions for psychotropics
adjust Beta-blockers based on heart rate response
adjust warfarin based upon target INR and potential
interactions
adjust phenytoin based upon free phenytoin
concentrations
Haque R. ARMOR: A tool to evaluate polypharmacy in elderly persons. Ann LTC 2009; 17(6): 26-30.
ARMOR (continued)
(Assess Review Minimize Optimize Reassess)

Reassess

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


vitals at rest and during activity
functional status
cognitive status
clinical status
medication compliance
Haque R. ARMOR: A tool to evaluate polypharmacy in elderly persons. Ann LTC 2009; 17(6): 26-30.
STOPP – Screening Tool of Older People’s
potentially inappropriate Prescriptions
 65 categories of potentially inappropriate
prescribing in persons aged 65 years or older
(33 categories more than Beers’ Criteria)
 Compared to Beers’ Criteria, STOPP
identified:


336 potentially inappropriate medicines (PIMs)
affecting 247 patients (35%) compared to 226 PIMs
affecting 177 patients (25%)
a significantly higher proportion of patients
requiring hospitalization due to a PIM-related
adverse event (91% v. 48%)
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008 46(2): 72-83.
Gallagher P and O’Mahony D. STOPP: Application to acutely ill elderly patients and comparison with Beers’ criteria. Age and
Ageing 2008: 1-7.
STOPP – Examples of Potentially Inappropriate
Prescribing NOT in the Updated Beers’ Criteria
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Thiazide use with history of gout
Long-term NSAID or colchicine for
chronic treatment of gout where
there is no contraindication to
allopurinol
Diltiazem or verapamil with NYHA
III or IV HF
Aspirin with history of PUD without
gastroprotection
TCA with glaucoma, prostatism or
hx of urinary retention
Long-term (>1 month)
antipsychotic use as a hypnotic
Diphenoxylate, loperamide, or
codeine for diarrhea of unknown
cause or severe infective
gastroenteritis
PPI for PUD at full therapeutic
dosage for > 8 weeks

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
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


Beta-blockers in those with
frequent hypoglycemic episodes
Theophylline monotherapy for
COPD
Systemic corticosteroids instead of
inhaled corticosteroids for
maintenance of moderate-severe
COPD
Long-term corticosteroid as
monotherapy for RA or OA
Benzodiazepine, antipsychotic,
vasodilator, or long-term opiate
use in those with recurrent falls
Long-term powerful opiates (e.g.,
fentanyl) as first-line therapy for
mild-moderate pain)
Long-term NSAID use for mildmoderate OA joint pain
Any duplicate drug class
prescription
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008 46(2): 72-83.
Gallagher P and O’Mahony D. STOPP: Application to acutely ill elderly patients and comparison with Beers’ criteria. Age and
Ageing 2008: 1-7.
STOPP – Screening Tool of Older People’s
potentially inappropriate Prescriptions
 Most commonly observed PIMs
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
Long acting benzodiazepines or tricyclic
antidepressants with a contraindication
Prolonged use of first generation antihistamines
Medications that increase falls in patients already
known to be prone to falling (e.g.,
benzodiazepines, antipsychotics, vasodilators)
Inappropriate use of NSAIDs and opioids
Duplicate therapy (e.g., 2 ACE Inhibitors, 2
NSAIDs, 2 SSRIs, 2 antiplatelet therapies)
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008 46(2): 72-83.
Gallagher P and O’Mahony D. STOPP: Application to acutely ill elderly patients and comparison with Beers’ criteria. Age and
Ageing 2008: 1-7.
START – Screening Tool to Alert doctors to
the Right Treatment
22 categories of “errors of omission” – absence of
prescribing appropriate treatment despite the
absence of any contraindications
A prospective, consecutive cohort of 600
hospitalized, elderly patients

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
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Mean age 77.9 years (17% were 85 years or older)
Median number of medications was 5
347 patients (57.8%) had one or more appropriate
medicines omitted where no contraindication existed

Probability of omission increased:


with age (OR 1.0512 for those 65-84 years compared to OR
2.08 in those 85 years and older)
Female gender (OR 2.29)
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008 46(2): 72-83.
Barry PJ, Gallagher P, Ryan C, et al. START – an evidence-based screening tool to detect prescribing omissions in elderly
patients. Age and Ageing 2007; 36:632-638.
START – Top 5 Omitted Drugs
 Top 5 Indicated but Omitted drugs

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


Statins in symptomatic cardiovascular
disease
Bisphosphonates with long term
corticosteroid treatment
ACE Inhibitors in CHF
Statins in diabetics with
hypercholesterolemia
ACE Inhibitors with prior history of MI
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008 46(2): 72-83.
Barry PJ, Gallagher P, Ryan C, et al. START – an evidence-based screening tool to detect prescribing omissions in elderly
patients. Age and Ageing 2007; 36:632-638.
START – Other Categories of Omissions

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
Warfarin in the presence of chronic A-Fib (or aspirin when warfarin was
contraindicated)
Aspirin with a documented history of coronary, cerebral, or peripheral
vascular disease OR diabetes with well controlled blood pressure
Calcium and vitamin D for osteoporosis
Routine inhaled beta-agonist or anticholinergic in mild to moderate
asthma or COPD
Routine inhaled corticosteroid in moderate-severe asthma or COPD
ACE Inhibitors in diabetics with overt proteinuria or microalbuminuria
Antidepressant therapy in the presence of “clear-cut” depressive
symptoms
Levodopa/carbidopa in Parkinson’s with definite functional impairment
Antihypertensive therapy in clearly defined hypertension
Fiber supplementation in chronic, symptomatic diverticular disease with
constipation
PPI in the presence of chronic severe GERD
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008 46(2): 72-83.
Barry PJ, Gallagher P, Ryan C, et al. START – an evidence-based screening tool to detect prescribing omissions in elderly
patients. Age and Ageing 2007; 36:632-638.
POLYPHARMACY
What leads to polypharmacy?
Both patient and physician factors result in over-prescribing of drugs. Patient factors including communicating that a
prescription medicine is expected. Also, not reporting all currently used medicines or symptoms that might be drug
induced can result in duplicate prescriptions or treating drug effects with additional drugs.
Strong predictors of polypharmacy include seeing multiple physicians and using multiple pharmacies,
which can lead to incomplete knowledge by physicians of all drugs taken.
How can polypharmacy be prevented?
 Document a desired measurable outcome for each medication prescribed-Assess outcomes (e.g. improved
incontinence) at each office visit. Discontinue medications that do not achieve the desired outcome.
 Take comprehensive medication histories- Include over-the-counter drugs, vitamins, minerals, and herbal
preparations.
 Ask patients/families to bring in all medications to physician and hospital visits and upon admission to
the nursing home- Continuously review the need for each medication.
 Conduct a Drug Assessment- Are there multiple prescribers? Is the person compliant or non-compliant? Are
medications being administered correctly?
 Have the patient keep a list of all medicines taken- Provide patients with medication profile cards personally.
They will consider it important if you do.
 Determine if the drug is producing adverse effects- Do not assume symptoms are due to natural ageing
problems. Consider all drugs as potential causes.
 Assess the benefit to risk ratio of drug treatment -Is a drug with potential side effects in the elderly being
considered for a relatively minor complaint?
 Avoid prescribing a drug to treat adverse effects of other drugs.
 Consider use of combination drug (two or more drugs in one pill) products only where appropriate to
reduce cost or improve drug adherence..
 Limit the use of PRN medications.
Principles of Medication Safety
Medication safety spans all phases of the
medication use process including prescribing,
transcribing, dispensing, administration, and
monitoring of medications. Failure at any step
along the medication use continuum can
result in a failed therapeutic response,
toxicity, and unnecessary expense.
General Guidelines for Preventing
Medication Therapy Problems
Evaluate elderly patients thoroughly.
• Manage medical conditions without drugs as often as possible.
• Know the pharmacology of the drug being prescribed and how it might
adversely interact with other drugs.
• Consider how the clinical status of each patient could influence the
pharmacology and effectiveness of the drug(s).
• Be sensitive to potential barriers to compliance (e.g., impaired cognitive
function, diminished vision and hearing, cultural barriers)
• For drugs or their active metabolites that are renally eliminated, make
appropriate age-related adjustments in dosages.
• If there is a question about drug dosage, start small and increase
gradually.
• Use drug blood concentrations to monitor potentially toxic drugs used
frequently in the elderly.
• Monitor elderly patients frequently for compliance, drug effects and
toxicity.
Kane, R. L., Ouslander, J. G., & Abrass, I. B. (1994). Essentials of clinical geriatrics. New York: McGraw-Hill. p. 373.
Medication Appropriateness Checklist
Hanlon JT, Schmader KE et al. J Clin Epidemiol 1992 ;45 :1045
Fitzgerald LS, Hanlon JT et al. Ann Pharmacother 1997 ;31 :543-8.
Schmader KE. Hanlon JT. Pieper CF et al. Am J Med 2004;116(6):394-401.
Questions That May Help Improve
Drug Use


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









Has the disease state resolved that the drug was originally
prescribed for?
Are non-pharmacological interventions being used or are there
alternative non-drug options that could be tried?
Is there another drug more effective for the disease?
Is there an equally effective, lower-cost drug available?
Have treatment goals been achieved?
Are there any adverse effects to the medication observed?
Are 2+ drugs of the same class/pharmacological action being used?
Are there any drug-drug or drug-disease interactions?
Is there a lower effective dose of the medication?
Are any medications dosed more than 2 times per day?
Are there any adherence / compliance concerns noted?
Should the dosage be adjusted based on age, renal, or liver status?
Has there been any recent change in IADL or ADL status?
Bushardt R, Massey EB, Simpson TW, et al. Polypharmacy: misleading, but manageable. Clin Interventions
in Aging 2008; 3(2):383-389.
Discontinuing Medications
 In a study of 124 ambulatory elderly,
undergoing 238 drug discontinuations, 26%
experienced an adverse drug event related to
drug discontinuation
 Most common problems occurred with stopping
cardiovascular or CNS drugs
 88% were attributed to exacerbation of
underlying disease
 80% of drug discontinuations were NOT
restarted
 36% resulted in hospitalization
Graves T, Hanlon J, Schmader K. Adverse events after discontinuing medications in elderly outpatients.
Arch Intern Med 1997;157:2205-10.
Improving Drug Efficiency
 Look for once daily and extended-release
formulations to decrease the number of
administration times and minimize peak to
trough variation in serum concentrations
 Consider use of combination drug products in
replacement of the two individual components
 Evaluate if the dose can be decreased to
minimize the likelihood of adverse events
without compromising efficacy
 Assure that optimal monitoring strategies are
in place to evaluate therapeutic success and
potential toxicity
Application to Common Conditions








Alzheimer’s
Asthma/COPD
Behavioral Problems
Benign Prostatic
Hyperplasia
Chronic Kidney
Disease
Depression
Diabetes Mellitus
GERD










Heart Failure
Hypertension
Insomnia
Lipid Disorders
Osteoporosis
Pain Syndromes
Seizure Disorder
Stroke
Urinary Incontinence
Weight Loss/Anorexia
Application to Common Conditions –
Alzheimer’s Disease
Scenario
Why is this Potentially
Inappropriate?
Acetylcholinesterase inhibitors
(donepezil, galantamine, or
rivastigmine) + anticholinergic
agents
Pharmacological
antagonism and deleterious
effects on cognition
Acetylcholinesterase inhibitors
with benzodiazepines
Worsening cognition related
to additive CNS adverse
effects
Acetylcholinesterase inhibitors
with cardiac conduction disorder
Increased risk of cardiac
conduction abnormalities
CFR 483.25(I), Unnecessary Drugs
Arch Intern Med 2003;163:2716-24
Am J Geriatr Psych 2003;11:458-461
Application to Common Conditions –
Asthma or COPD
Scenario
Why is this Potentially
Inappropriate?
Monotherapy with short-acting β2–
agonist or theophylline
Possible need for a controller
(e.g., long acting bronchodilator)
Inhaled corticosteroid or β2-agonist
+ combination long-acting β2agonist/corticosteroid
Duplicate therapy
Non-cardioselective β-blocker with
asthma or COPD
Risk of increased bronchospasm
Routine systemic corticosteroid for
moderate-severe COPD
Exposure to long-term side
effects; safer alternatives
Benzodiazepine, sedative-hypnotic
or opioid with severe COPD
Drug-induced respiratory
suppression
CFR 483.25(I), Unnecessary Drugs
http://www.nhlbi.nih.gov/guidelines/asthma/index.htm
Arch Intern Med 2003;163:2716-24
http://www.thoracic.org/sections/copd/index.html
Application to Common Conditions –
Behavioral Problems
Scenario
Why is this Potentially
Inappropriate?
Duplicate anxiolytics, hypnotics,
antipsychotics, antidepressants
Additive CNS effects
Daily dose of
psychopharmacological medication
exceeding thresholds established in
F329 - Table 1
Exposure to excessive dose
increases risk of adverse
consequences
Antipsychotic + anticholinergic (e.g., “Cascade effect” –treating
benztropine)
drug-induced side effect
Metoclopramide + antipsychotic
CFR 483.25(I), Unnecessary Drugs
Arch Intern Med 2003;163:2716-24
Increased risk of abnormal
involuntary movements
Application to Common Conditions –
Benign Prostatic Hyperplasia
Scenario
Why is this Potentially
Inappropriate?
Doxazosin or terazosin for
BPH alone (without
hypertension)
Anticholinergic agents +
alpha-blockers (tamsulosin or
alfuzosin) or 5-alpha receptor
inhibitors (dutasteride or
finasteride)
Safer alternatives
available
Arch Intern Med 2003;163:2716-24
Increased risk of urinary
retention
Application to Common Conditions –
Chronic Kidney Disease
Scenario
Why is this Potentially
Inappropriate?
Metformin with CKD
Increased risk of lactic
acidosis
Increased risk of
worsened kidney function
NSAIDS with CKD
Any renally eliminated drug
(e.g., Low molecular weight
heparins)
CFR 483.25(I), Unnecessary Drugs
Arch Intern Med 2003;163:2716-24
Potential need for
adjusting dose based
upon renal function
Renal Adjustment of Selected
Medications










Acyclovir
Amantadine
Chlorpropamide
Ciprofloxacin
Colchicine
Gabapentin
Glyburide
Memantine
Meperidine
Nitrofurantoin








Probenecid
Propoxyphene
Ranitidine
Rimantidine
Spironolactone
Sulfamethoxazole /
trimethoprim
Triamterene
Valacyclovir
- This list is not all inclusive of medications that
require renal dosing
Hanlon JT, Aspinall SL, Semla TP, et al. Consensus Guidelines for Oral Dosing of Primarily Renally
Cleared Medications in Older Adults. J Am Geriatr Soc. 2009 Feb;57(2):335-40.
Application to Common Conditions –
Depression
Scenario
Why is this Potentially
Inappropriate?
Benzodiazepine, β-blocker, or Possible drug-induced
sympatholytic +
depression
antidepressants
SSRI or SNRI + tramadol, St. Increased risk of
John’s Wort, linezolid, or
serotonin syndrome
another serotonergic
antidepressant
CFR 483.25(I), Unnecessary Drugs
Arch Intern Med 2003;163:2716-24
Application to Common Conditions –
Diabetes Mellitus
Scenario
Why is this Potentially
Inappropriate?
2 or more oral antidiabetics and
A1C>8%
Could be better controlled with
insulin therapy
Oral corticosteroids or atypical
antipsychotics + insulin or oral
antidiabetic agents
Increased risk of hyperglycemia
Β-blocker with frequent episodes
of hypoglycemia
Risk of masking hypoglycemic
manifestations
Fluoroquinolone with diabetes
Increased risk of hypo- or
hyperglycemia
Feldman PD, Hay LK, Deberdt W, et al. Retrospective cohort study of diabetes mellitus and antipsychotic treatment in a geriatric
population in the United States. J Am Med Dir Assoc 2004;5:38-46.
ADA. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care 2004;27:596-601.
CFR 483.25(I), Unnecessary Drugs
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008 46(2): 72-83.
Application to Common Conditions –
GERD
Scenario
Why is this Potentially Inappropriate?
PPI + H2 antagonist therapy
(H2RA)
Duplicate therapy
Metoclopramide for GERD
Increased risk of tardive dyskinesias
Calcium channel blocker with
GERD
Decreased esophageal sphincter
tone
NSAIDs with GERD
Less GI toxic analgesic alternatives
may be appropriate
PPI on admission or prolonged
use without GERD symptoms
Medication without supporting
indication
Arch Intern Med 2003;163:2716-2724
CFR 483.25(I), Unnecessary Drugs
Application to Common Conditions –
Heart Failure
Scenario
Metformin with HF
NSAIDS, pioglitazone, or
rosiglitazone with HF
Digoxin > 0.125 mg / day
without a diagnosis of atrial
fibrillation
Why is this Potentially
Inappropriate?
Increased risk of lactic
acidosis
Increased risk of fluid
retention / HF
exacerbation
Increased risk of digoxin
toxicity
CFR 483.25(I), Unnecessary Drugs
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008
46(2): 72-83.
Arch Intern Med 2003;163:2716-2724
Application to Common Conditions –
Heart Failure (continued)
Scenario
Calcium channel blockers or
antiarrhythmics with HF
ACEI/ARB + K+ supplements
or K+ sparing diuretics
(spironolactone or
eplerenone)
Two loop diuretics
Why is this Potentially
Inappropriate?
Negative inotropic effect
Increased risk of
hyperkalemia
Increased risk of
electrolyte imbalance
CFR 483.25(I), Unnecessary Drugs
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008
46(2): 72-83.
Application to Common Conditions –
Hypertension
Scenario
Why is this Potentially
Inappropriate?
Increased blood pressure
due to fluid retention
NSAIDs or pioglitazone or
rosiglitazone +
antihypertensives
Verapamil + anticholinergics Additive anticholinergic
effects
Reserpine > 0.25 mg/day
Increased risk of depression,
impotence, sedation, and
orthostatic hypotension
CFR 483.25(I), Unnecessary Drugs
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol Ther. 2008
46(2): 72-83.
Arch Intern Med 2003;163:2716-2724
Application to Common Conditions –
Hypertension (continued)
Scenario
Why is this Potentially
Inappropriate?
Methyldopa, clonidine,
doxazosin, terazosin
Better options available
for the elderly
CNS stimulants,
decongestants, or
erythropoiesis stimulating
agent with hypertension
Increased blood pressure
4 or more concurrent
antihypertensives
increased cost and
potential for adverse
consequences
Arch Intern Med 2003;163:2716-2724
CFR 483.25(I), Unnecessary Drugs
Application to Common Conditions –
Insomnia
Scenario
Why is this Potentially
Inappropriate?
Decongestants, theophylline,
methylphenidate, MAOIs,
SSRIs with insomnia
Daily dose or duration of
sedative-hypnotic exceeds
thresholds established in
F329 - Table 1
May cause or worsen
insomnia
CFR 483.25(I), Unnecessary Drugs
Arch Intern Med 2003;163:2716-24
Excessive dose and/or
duration
Application to Common Conditions –
Lipid Disorders
Scenario
Why is this Potentially
Inappropriate?
Cholestyramine + other medications Reduced absorption of other
meds (administer them 1 hour
before or 4 hours after)
Statin but not at LDL/triglyceride
goal
CFR 483.25(I), Unnecessary Drugs
NCEP/ATPIII JAMA 2001;285:2486
Potential need for dosage
increase
Application to Common Conditions –
Osteoporosis
Scenario
Why is this Potentially
Inappropriate?
Diagnosis of osteoporosis without
therapy
Increased risk of falls/fracture
Bisphosphonate use in a bed-bound
patient (unable to remain upright)
Increased risk of esophageal
damage
Use of two or more active therapies
Duplicate therapy without
proven benefit
Drugs associated with falls
Increased fall risk
Active therapy without calcium and
Vitamin D
Benefit only established with
combining calcium and vitamin
D with active therapy
CFR 483.25(I), Unnecessary Drugs
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol
Ther. 2008 46(2): 72-83.
Application to Common Conditions –
Pain Syndromes
Scenario
Propoxyphene
Acetaminophen doses >
4 g / day
Meperidine
Opioid use without bowel
regimen
Arch Intern Med 2003;163:2716-2724
CFR 483.25(I), Unnecessary Drugs
Why is this Potentially
Inappropriate?
Few analgesic advantages
with increased adverse effects
Increased risk of
hepatotoxicity
Increased risk of confusion
and decreased efficacy at
typical doses
Increased risk of severe
constipation
Application to Common Conditions –
Pain Syndromes
Scenario
Why is this Potentially
Inappropriate?
Psychopharmacological drug
Possible evidence of
initiated for new onset behavior untreated pain
3 or more analgesics
Duplicate therapy
Frequent use of PRN in the
absence of scheduled
analgesics
Suggestive of untreated
pain
Arch Intern Med 2003;163:2716-2724
CFR 483.25(I), Unnecessary Drugs
Application to Common Conditions –
Seizure Disorder
Scenario
Why is this Potentially
Inappropriate?
Antipyschotics, bupropion,
fluoroquinolones, meperidine,
metoclopramide, promethazine,
prochlorperazine, tramadol, or
tricyclic antidepressant with seizure
disorder or use of anticonvulsants
Lowered seizure threshold
Long-term anticonvulsant therapy at Re-evaluate seizure history /
very subtherapeutic doses and
indication (excessive duration
serum concentrations
of prophylaxis?)
CFR 483.25(I), Unnecessary Drugs
Arch Intern Med 2003;163:2716-2724
Application to Common Conditions –
Stroke
Scenario
Why is this Potentially
Inappropriate?
Warfarin and use of a LMWH
beyond the establishment of a
therapeutic INR
Increased risk of bleeding
Any 2 of the following: warfarin,
aspirin, clopidogrel, prasugrel, oral
corticosteroids, or NSAIDs
Increased risk of bleeding
Extended warfarin use for VTE
prophylaxis in the absence of A-Fib
Potentially excessive duration
(refer to CHEST guidelines)
CFR 483.25(I), Unnecessary Drugs
Gallagher P, Ryan C, Byrne S, et al. STOPP and START – consensus validation. Int J Clin Pharmacol
Ther. 2008 46(2): 72-83.
Application to Common Conditions –
Urinary Incontinence
Scenario
Why is this Potentially
Inappropriate?
Late-day/evening
administration of diuretics
Increased risk of
nocturnal falls
OAB medications (e.g.,
oxybutynin ER, tolterodine,
etc.) + anticholinergic
medications
Decreased urinary flow
and increased risk of
urinary retention
CFR 483.25(I), Unnecessary Drugs
Arch Intern Med 2003;163:2716-24
Application to Common Conditions –
Weight Loss / Anorexia
Scenario
Why is this Potentially
Inappropriate?
Acetylcholinesterase inhibitor, Potential drug-induced
digoxin, fluoxetine or CNS
weight loss
stimulants + megesterol,
cyproheptadine, oxandrolone
or mirtazapine
Arch Intern Med 2003;163:2716-24
Summary
 Polypharmacy is not a new concept
 All drug therapy must be individualized
to the individual patient
 Consultant pharmacists contribute
valuably to the healthcare team caring
for the elderly by assuring that drug
therapy is appropriate
References










67
American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society
Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc
2012; DOI: 10.1111/j.1532-55415.2012.03923.x
Beers MH, Ouslander JG, Rollingher I, et al. Explicit criteria for determining inappropriate medication
use in nursing home residents. Arch Intern Med 1991;151:1825-32.
Beers MH. Explicit criteria for determining potentially inappropriate medication use by the elderly. An
Update. Arch Intern Med 1997;157:1531-6.
Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate
medication use in older adults: results of a US consensus panel of experts. Arch Intern Med
2003;163:2716-24.
State Operations Manual: Appendix PP. Guidance to Surveyors for Long Term Care Facilities, F329
Unnecessary Drugs, Table 1. rev 1-7-2011.
Humana, Aetna, Envision, Windsor/CRK Pharmacy Quality Alliance. Use of High-Risk Medications in
the Elderly (HRM), Quality Measure, 2013.
Proposed 2014 CMS Quality Measures. available at: http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/QualityMeasures/Downloads/Eligible-Providers-2014-ProposedEHR-Incentive-Program-CQM.pdf
Clinical Pharmacology, Elsevier/Gold Standard, Copyright 2013, available at:
http://clinicalpharmacology-ip.com accessed 5-28-2013.
Tapering Recommendations for Medications Commonly Used in the Elderly. Clinical Tools, Geriatric
Pharmaceutical Care Guidelines®, Omnicare, Inc., Cincinnati, OH; 2014.
Fox C, Richardson K, Maidment ID, et al. Anticholinergic medication use and cognitive impairment in
the older population: the Medical Research Council Cognitive Function and Ageing Study. JAGS
2011;59:1477-83.
Potentially
Inappropriate High
Risk Medications
June 2014
Learning Objectives
 At the completion of this activity, the
1. identify regulatory and legislative requirements
participant
will be able to:
affecting
high risk medications;
2. state mechanisms by which high risk
medications are potentially inappropriate in
persons older than 65 years of age; and
3. select appropriate monitoring actions and
clinical alternatives to high risk medications.
69
Regulatory and Legislative Intersection
Centers for Medicare
and Medicaid
Services
State Operations Manual
Appendix PP
Skilled Nursing
Facility
3
Centers for Medicare
and Medicaid
Services
Medicare Prescription Drug,
Improvement and
Modernization Act of 2003
Part D Drug
Plan
Appendix PP Table 2 – Medications with
Significant Anticholinergic Properties

Antiparkinson Medications




amantadine
benztropine
trihexphenidyl
Muscle Relaxants






cyclobenzaprine
dantrolene
orphenadrine
Antivertigo Medications


meclizine
scopolamine












Antipsychotic Medications
chlorpromazine
clozapine
olanzapine
thioridazine
Urinary Incontinence
oxybutynin
propantheline
solifenacin
tolterodine
trospium
Phenothiazine Antiemetics
prochlorperazine
promethazine
Possible side effects from anticholinergic medications include: confusion or decreased cognition,
lightheadedness, blurred vision, constipation, dry mouth, and difficulty urinating.
CFR 483.25(I), Unnecessary Drugs
71
Appendix PP Table 2 – Medications with
Significant Anticholinergic Properties
Antihistamine (H-1 Blockers) 















chlorpheniramine
cyproheptadine
diphenhydramine
hydroxyzine
Antidepressants
amitriptyline
amoxapine
clomipramine
desipramine
doxepin
imipramine
nortriptyline
protriptyline
paroxetine













Cardiovascular Medications
digoxin
disopyramide
furosemide
nifedipine
Gastrointestinal
Medications
belladonna
chlordiazepoxide
cimetidine
dicyclomine
diphenoxylate with atropine
hyoscyamine
propantheline
ranitidine
Possible side effects from anticholinergic medications include confusion or decreased cognition,
lightheadedness, blurred vision, constipation, dry mouth, and difficulty urinating.
CFR 483.25(I), Unnecessary Drugs
72
Anticholinergic Burden in Older
Persons
Death
Increasing
Anticholinergic
Burden Cognitive Score
Cognitive Decline
(↓ MMSE Score)
Delirium
73
Pharmacy Quality Alliance –
Use of High Risk Medications in the
Elderly
PQA
• Develops and implements quality performance
measures
• Measures are adopted by CMS as performance ratings
for Medicare Part C and Part D plans
2013
• Use of High Risk Medications in the elderly
• % of patients ≥ 65 years who receive 2 or more
prescription fills for a high-risk medication during the
measurement period.
HRM
• American Geriatrics Society 2012 Updated Beers
Criteria for Potentially Inappropriate Medication Use in
Older Adults
Pharmacy Quality Alliance, http://pqaalliance.org/images/uploads/files/HRM%20Measure%202013website.pdf
7
Potentially Inappropriate Medications
Antiarrhythmic Agents
disopyramide
Multaq (dronedarone)
Antidepressants
amitriptyline
imipramine
clomipramine
trimipramine
doxepin > 6 mg/day
Antidiabetic Agents
chlorpropamide
glyburide
Antiemetic
metoclopramide
trimethobenzamide
Antihypertensive Agents
clonidine (oral only)
nifedipine IR
doxazosin
prazosin
guanfacine
reserpine > 0.1 mg
guanabenz
terazosin
methyldopa
Antimuscarinic / Anticholinergic Agents
benztropine (oral only)
oxybutynin IR
dicyclomine
trihexyphenidyl
hyoscyamine
Antihistamine
Antipsychotics, Conventional (oral only)
brompheniramine
carbinoxamine
chlorpheniramine
clemastine
cyproheptadine
75
dexchlorpheniramine
dimenhydrinate
diphenhydramine
doxylamine
hydroxyzine
fluphenazine
thioridazine
haloperidol
trifluoperazine
loxapine
thiothixene
mesoridazine
Potentially Inappropriate Medications
(continued)
Barbiturates
amobarbital
pentobarbital
butabarbital
phenobarbital
butalbital
secobarbital
mephobarbital
Endocrine
desiccated thyroid
somatropin
(growth hormone)
Estrogens* (oral and transdermal only)
esterified estrogen
Premphase
Estradiol
Prempro
Vasodilators
ergoloid mesylates
isoxsuprine
Other Agents
Premarin
Narcotic Analgesics
76
Skeletal Muscle Relaxants
carisoprodol
metaxolone
chlorzoxazone
methocarbamol
cyclobenzaprine
orphenadrine
Stroke Prevention
dipyridamole IR
ticlopidine
megestrol
meperidine
Sedative-Hypnotics
chloral hydrate
zaleplon > 90 days
Lunesta (eszopiclone)
zolpidem > 90 days
> 90 days
meprobamate
pentazocine
digoxin > 0.125 mg/day
nitrofurantoin > 90 days
spironolactone > 25
mg/day
Mechanism, Suggested Monitoring and Potential Alternatives
SELECTED HIGH RISK
MEDICATIONS
77
Analgesics for Pain
Indomethacin (Indocin)
Ketorolac (Toradol)
Meperidine (Demerol)
HRM
Mechanis
m
Monitoring
Alternative(s)
Indomethacin
GI Bleeding,
ulcers
Blood in stool;
vomiting
blood/”coffee
grounds”
Acetaminophen 650 mg
three times daily
OR
Meloxicam 7.5 mg/day
with a proton pump
inhibitor
Confusion,
seizures
Break-through
pain, mental status
changes
Acetaminophen 650 mg
three times daily
OR
Tramadol 25 mg100/day
Ketorolac
Meperidine
78
Weight Loss
Megestrol acetate
Megace ES
HRM
Mechanism
Monitoring
Alternative(s)
Megestrol
acetate
High risk of
causing blood
clots
Weight gain,
Lower
extremities for
warm, swollen
area
Patients with underlying
depression may benefit
from mirtazapine 15 mg at
bedtime.
Megace ES
79
First Generation Antihistamines
Brompheniramine, Dexchlorpheniramine
Carbinoxamine, Chlorpheniramine
Clemastine, Cyproheptadine
Diphenhydramine
Doxylamine
Hydroxyzine, Hydroxyzine pamoate
Triprolidine
HRM
Mechanism
Sedating
Anticholinergi
Antihistamine c
s
80
Monitoring
Alternatives
Confusion, dry
mouth,
constipation,
dizziness, falls
Loratadine 10 mg/day for
seasonal allergy and itching.
Buspirone 5 mg twice daily for
anxiety
Cardiovascular Agents – Blood
Pressure
Clonidine
Nifedipine IR
Lisinopril
Losartan
Methyldopa
Reserpine > 0.1 mg/day
HRM
Mechanism
Monitoring
Alternative(s)
Clonidine
CNS side effects,
bradycardia,
hypotension,
myocardial ischemia
Lying to sitting and
sitting to standing
BP, mental status
changes, heart rate
Lisinopril 2.5
mg/day
Losartan 25
mg/day
Nifedipine
IR
Methyldopa
Reserpine
81
CNS side effects,
bradycardia
Cardiovascular Agents – Blood
Pressure
Doxazosin
Prazosin (Minipress)
Terazosin
82
First-line
Antihypertensive
HRM
Mechanism
Monitoring
Alternative(s)
Doxazosin
Prazosin
Terazosin
Orthostatic
hypotension
Sitting to standing
blood pressure,
dizziness, falls
For Blood Pressure
Lisinopril 2.5 mg/day
Losartan 25 mg/day
Doxazosin
Terazosin
Orthostatic
hypotension
Sitting to standing
blood pressure,
dizziness, falls
For Benign Prostatic
Hyperplasia
Tamsulosin 0.4 mg/day
Cardiovascular Agents
Disopyramide (Norpace)
Dronedarone (Multaq)
Digoxin > 0.125 mg/day
83
HRM
Mechanism
Monitoring
Alternatives
Disopyrami
de
Potent negative
inotrope
Anticholinergic
Worsen heart failure
Confusion, dry mouth,
constipation, dizziness,
falls
Contact physician for
alternative antiarrhythmic
Dronedaron
e
Worse outcomes
in atrial fibrillation
with heart failure
SOB, fluid accumulation,
fatigue
Contact physician for
alternative antiarrhythmic
if appropriate
Digoxin >
0.125 mg
Arrhythmias,
anorexia,
nausea, color
vision changes
Heart rate and rhythm, GI
side effects, visual
changes
Digoxin doses ≤ 0.125
mg/day
Anti-nauseant/Anti-emetic
Medications
Promethazine and
combination products
Ondansetron
Trimethobenzamide
84
HRM
Mechanism
Monitoring
Promethazine
Anticholinergic Confusion, dry
mouth,
constipation,
dizziness, falls
Trimethobenzamid
e
Extrapyramida
l effects
AIMS Testing
Alternative(s)
Ondansetron 4 mg twice
daily up to a Max Daily
Dose – 24 mg/day
Gastrointestinal Antispasmodics
Belladonna alkaloids
Clidinium-chlordiazepoxide
Dicyclomine
Hyoscyamine
Propantheline
Scopolamine
85
Loperamide for diarrhea
Lactulose or
Polyethylene glycol
(Miralax) for constipation
Diabetes Mellitus
• Chlorpropamide
Long-acting • Glyburide
Sulfonylurea
Mechanism
• Prolonged hypoglycemia
• Inappropriate antidiuretic hormone secretion
• Glipizide 5 mg/day up to 20 mg/day
• Glimepiride 1 mg/day up to 8 mg/day
Alternatives • Basal insulin with scheduled prandial insulin as needed
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Muscle Relaxants
Carisoprodol (Soma)
Chlorzoxazone (Parafon Forte)
Cyclobenzaprine (Flexeril, Amrix)
Methocarbamol (Robaxin)
Metaxalone (Skelaxin)
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HRM
Mechanism
Monitoring
Alternatives
Muscle
Relaxants
Anticholinergi
c
Confusion, dry
mouth,
constipation,
dizziness, falls
Tizanidine 4 mg/day up to 36
mg/day for spasticity
Insomnia – Non-Benzodiazepines
HRM
Mechanism
• Eszopiclone (Lunesta)
• Zaleplon (Sonata)
• Zolpidem (Ambien, Ambien CR)
• Sedation, dizziness, falls
• Effects similar to benzodiazepines in the
elderly
• Melatonin 2 – 3 mg at bedtime
Alternative
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Insomnia - Barbiturates
Amobarbital
Butalbital
Butabarbital
Melatonin 2 – 3 mg at
bedtime if for insomnia
Mephobarbital
Pentobarbital
Phenobarbital
Secobarbital
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Phenytoin 300 mg/day
if for seizures
Nitrofurantoin
HRM
• Nitrofurantoin
• Used > 90 day (PQA Measure)
• Pulmonary toxicity, peripheral neuropathy
• Ineffective if CrCl < 60 mL/min
Mechanism
• Suppressive therapy for UTIs not recommended
• Choose antibiotic based on culture and sensitivity
Alternative(s)
CrCl = creatinine clearance; PQA = Pharmacy Quality Alliance; UTIs = urinary tract infection
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Tricyclic Antidepressants – For Pain
or Depression
Amitriptyline
Chlordiazepoxide-amitriptyline
Clomipramine
Doxepin > 6 mg/day
Imipramine
Perphenazine-amitriptyline
Trimipramine
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Nortriptyline or
gabapentin for
neuropathic pain
Escitalopram (Lexapro) for
depression
Estrogens – Oral and Transdermal
HRM
• Estrogen oral, patches, topical gels, sprays
• With or without progestins (Premphase,
Prempro)
• Potential to cause breast/endometrial cancer
• Lack of cardiovascular protection
Mechanism • Increase risk of blood clots
• Premarin Vaginal Cream
• Estrace Vaginal Cream
Alternatives
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General Guidance on
Discontinuation
Many medications can be discontinued abruptly without
adverse consequences.
e.g. estrogens, antihistamines, oxybutynin, megestrol
Most medications with central nervous system properties
must be tapered then discontinued.
e.g. tricyclic antidepressants, insomnia meds, barbiturates,
muscle relaxants, anticonvulsants, clonidine, tramadol
Some medications should be tapered to reduce the risk of
worsening a patient’s condition.
e.g. antipsychotics, antidepressants
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Summary
High Risk Medications
High risk of clinical adverse consequences for residents , i.e., falls, declines in ADLs
Regulated by CMS - Declining Payment by Part D Plans
Increased risk of survey citation for F-329 Unnecessary Drugs
Increased facility cost for non-covered high risk medications
Safer and More Appropriate Alternatives Exist
Some alternatives may be priced higher
than high risk medication
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Reduction in risk of toxicity and adverse
events results in fewer hospitalizations