Transcript Warfarin Therapy – Improving INR Control

Avoiding Inappropriate
Medication Use In Older
Adults
Jason Stein, MD
Emory Reynolds Faculty Scholar
Emory Hospital Medicine Service
Scope of the Problem
If medication related problems were ranked as
a disease by cause of death it would be the:
5th leading cause of death in the U.S.
Updating the Beers Criteria
Demographic Trends:
the Elderly
DEMOGRAPHIC TRENDS
 20th century
– U.S. population < 65 tripled
– U.S. population > 65 increased by factor of 11
 grew from 3.1 million (1900) to 33.2 million (1994)
 Will more than double by middle of 21st century
– to 80 million people, with most of this growth b/t 2010-30.
Hobbs, FB, Damon BL. Sixty-Five Plus in America. Current Population Reports, Special Studies, P23–P190. Washington,
DC: US Department of Commerce, Economics, and Statistics Administration, Bureau of the Census; 1996.
National Center for Health Statistics. Health, United States, 1999 With Health and Aging Chartbook. Hyattsville, MD: US
Department of Health and Human Services, National Center for Health Statistics; 1999. DHHS Pub. No. (PHS) 99–1232.
Educational Trends:
the Elderly
Educational Trends:
High School Diploma
Education = closely related to lifetime
economic status
 1970: 28%
 1998: 67%
 2030: 83%
Education = associated with better
health and lower risk of disability than
those with low levels of educational
attainment
Bachelor’s Degree
 1998: 15%
 2030: 24%
Education ~ more activist health care
(or higher) consumers, more demanding of the
health care system (speculation about
better-educated elderly baby boomers)
American Association of Retired People (AARP) and Administration on Aging (AOA), US Department of Health and Human Services. Profile of
Older Americans. 1999.
Hobbs, FB, Damon BL. Sixty-Five Plus in America. Current Population Reports, Special Studies, P23–P190. Washington, DC: US Department of
Commerce, Economics, and Statistics Administration, Bureau of the Census; 1996.
National Center for Health Statistics. Health, United States, 1999 With Health and Aging Chartbook. Hyattsville, MD: US Department of Health and
Human Services, National Center for Health Statistics; 1999. DHHS Pub. No. (PHS) 99–1232.
Health Trends:
the Elderly
Health Trends:
 79% of persons > 70 have at least one of the 7
chronic conditions most common among elderly:
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–
–
Arthritis
Hypertension
Diabetes mellitus
Heart disease
Stroke
Respiratory disease
Cancer
Hobbs, FB, Damon BL. Sixty-Five Plus in America. Current Population Reports, Special Studies, P23–P190. Washington,
DC: US Department of Commerce, Economics, and Statistics Administration, Bureau of the Census; 1996.
National Center for Health Statistics. Health, United States, 1999 With Health and Aging Chartbook. Hyattsville, MD: US
Department of Health and Human Services, National Center for Health Statistics; 1999. DHHS Pub. No. (PHS) 99–1232.
Functional StatusTrends:
the Elderly
Functional Status Trends:
 Functional disability increases with age
 Functional disability is associated with chronic
disease
 majority < 85 yo have no difficulty in ADLs or
instrumental activities of daily living (iADLs)
– 72% of those 65 – 74 yo
– 53% of those 75 - 84 yo
 majority > 85 do report difficulty
– 78% !!
Hobbs, FB, Damon BL. Sixty-Five Plus in America. Current Population Reports, Special Studies, P23–P190. Washington, DC: US Department of
Commerce, Economics, and Statistics Administration, Bureau of the Census; 1996.
National Center for Health Statistics. Health, United States, 1999 With Health and Aging Chartbook. Hyattsville, MD: US Department of Health and
Human Services, National Center for Health Statistics; 1999. DHHS Pub. No. (PHS) 99–1232.
Hospital Diagnosis Trends:
the Edlerly
Discharge Diagnosis Trends:
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Heart Disease Leading discharge diagnosis
Account for > 25% of all hospital discharges
Heart Disease + Stroke
among men and women > 85
Malignant neoplasms
Pneumonia
Bronchitis
American Association of Retired People (AARP) and Administration on Aging (AOA), US Department of Health and Human Services. Profile of
Older Americans. 1999.
Hobbs, FB, Damon BL. Sixty-Five Plus in America. Current Population Reports, Special Studies, P23–P190. Washington, DC: US Department of
Commerce, Economics, and Statistics Administration, Bureau of the Census; 1996.
National Center for Health Statistics. Health, United States, 1999 With Health and Aging Chartbook. Hyattsville, MD: US Department of Health and
Human Services, National Center for Health Statistics; 1999. DHHS Pub. No. (PHS) 99–1232.
Prescription Medication Trends:
the Elderly
Prescription Medication Trends:
 80% of elderly use > 1 prescription medication
 93% of elderly with low functional status
(dependent for 3-5 ADLs) use > 1 prescription
medication
– Medicate beneficiaries spend more out-of-pocket for prescription medications than
physician care, vision services, and medical supplies combined.
– Medicare beneficiaries spend more than 5x more on prescription drugs than for
outpatient and inpatient hospital care combined
American Association of Retired People (AARP) and Administration on Aging (AOA), US Department of Health and Human Services. Profile of
Older Americans. 1999.
Hobbs, FB, Damon BL. Sixty-Five Plus in America. Current Population Reports, Special Studies, P23–P190. Washington, DC: US Department of
Commerce, Economics, and Statistics Administration, Bureau of the Census; 1996.
National Center for Health Statistics. Health, United States, 1999 With Health and Aging Chartbook. Hyattsville, MD: US Department of Health and
Human Services, National Center for Health Statistics; 1999. DHHS Pub. No. (PHS) 99–1232.
The Elderly and
Hospital Medicine
Differential diagnosis of every problem in a geriatric
patient includes a drug side effect
Inappropriate Medication
definition: “inappropriate” medication
→ greater potential to harm than benefit
patient
May be due to:
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Lack of proven effect
High likelihood of ADE
Potential for severe ADEs
High potential for interaction with another drug or class of drugs
Chutka D, Takahashi P, Hoel R. Inappropriate Medications in Elderly Patients. Mayo Clin Proc. 2004;
79:122-139.
Use of Inappropriate Medications
 Evidence: physicians often prescribe medications
with increased potential of harm to elderly patients
 Evidence: physicians treat certain conditions
aggressively despite patient’s age and functional
status
 Evidence: adverse reactions up to 7x more
common in 70-79 yo compared with 20-29 yo
 Evidence: Increasing number of meds increase
risk of serious drug interaction
Chutka D, Takahashi P, Hoel R. Inappropriate Medications in Elderly Patients. Mayo Clin
Proc. 2004; 79:122-139.
Adverse Drug Events (ADEs)
definition: “adverse drug event”
→ when injury or illness occurs as a result of drug
use
Majority of occur in older adults – likely d/t 3
primary reasons:
 increased polypharmacy (# medications = single most
important factor)
 altered pharmacodynamics/kinetics (75% of geriatric
adverse drug effects occur at manufacturer
recommended doses)
 increased prevalence of disease with advancing age
Polypharmacy
definition: “polypharmacy”
→ >5 medications
 Increases risk of drug interactions (which likely
contributes to increased adverse effects in older adults)
 Increases complexity and cost of medication regimens
Why Consider the Elderly?
 Quantity of the Elderly
– Demographics
 Quality of the Elderly
– Age Related Physiological Changes
– Other Age Related Factors
 Multiple medical conditions
 Multiple medications
Why Consider the Elderly?
ADEs, drug-drug interactions, and drug toxicities are
more likely in elderly patients due to:
 Age related changes in pharmacokinetics
 Age related changes in pharmacodynamics
 Reduced organ reserve capacity (tends to increase the
severity of ADEs)
 Multiple medical conditions
 Number of medications taken
Chutka D, Takahashi P, Hoel R. Inappropriate Medications in Elderly Patients. Mayo
Clin Proc. 2004; 79:122-139.
The Elderly: Pharmacokinetics
Body composition changes:
 body fat (relative)
 lean body mass
 decreased total body water
 Changes in drug distribution, metabolism, and
elimination increases susceptibility to ADEs (but minimal
changes in absorption)
 Water soluble medications: concentrations increased at
any given dose relative to younger adults
 Fat soluble medications: half-lives prolonged
The Elderly: Pharmacodynamics
Elderly more sensitive so greater drug effects
(both beneficial and adverse) may occur at a
given serum level relative to younger adults.
e.g. altered pharmacodynamics with aging include opiates,
benzodiazepines, warfarin, and theophylline
The Elderly and
Medication Compliance
Altered Compliance
 Under-utilization (taking less than prescribed dose frequency
or strength)
 Over-utilization (taking more than prescribed doses)
 Enforced Adherence
The Elderly and
Medication Compliance
Under-utilization
(taking less than prescribed dose frequency or strength)
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Common and increases with polypharmacy
Associated with complex dosing regimens
Associated with expensive medications
May be “appropriate” if due to drug side effects
May occur if difficulty obtaining or taking drugs (e.g.,
functional impairments, cognition, dexterity, vision
problems)
The Elderly and
Medication Compliance
Over-utilization
(taking more than prescribed doses)
 Occurs often in patients with cognitive impairment
 Increases the potential for adverse drug events
 Suspect if medication refills needed early, too frequently
The Elderly and
Medication Compliance
Enforced Compliance
 Occurs when administering an “assumed” outpatient
dose (when in fact patient has not been taking that
dose)
 Common occurrence in hospital or nursing home setting
 High potential for overdose/adverse drug effects
Elderly Patients and
Hospital Medicine
Risk Factors
 Hospitalized patients with lower admission MMSE
scores may have higher rates of ADEs
 More newly prescribed inpatient medications
Frequency
 1 in 6 hospitalized elderly patients (>70 yo) may
experience an ADE
Inevitable?
 Over half of ADEs are potentially preventable
Gray S, Sager M, Lestico M, Jalaluddin M. Adverse Drug Events in Hospitalized Elderly.
Journ of Gerontology. 1998; 1: M59-M63.
Elderly Patients and
Hospital Medicine
ADEs and Functional Decline
 50% of hospitalized patients who experience an
ADE deteriorate in ADL function during the
hospitalization (25% of non-ADE patients)
Gray S, Sager M, Lestico M, Jalaluddin M. Adverse Drug Events in Hospitalized Elderly.
Journ of Gerontology. 1998; 1: M59-M63.
Elderly Patients and
Hospital Medicine
Which Drug Can We Eliminate to Make the
Problem Go Away?
 No single drug accounts for a high % of ADEs
 But there are high risk drug classes (those most often
a/w preventable ADEs) → meds with CNS effects:
 narcotics
 sedatives
 antidepressants
54%
Gray S, Sager M, Lestico M, Jalaluddin M. Adverse Drug Events in Hospitalized Elderly.
Journ of Gerontology. 1998; 1: M59-M63
Elderly Patients and
Hospital Medicine
LOS and Costs
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In one study 60/190 ADEs preventable
Additional LOS assoc with ADE=2.2 d
Additional cost assoc with ADE=$3,244
Based on cost data and incidence of ADEs:
 estimated annual attributable cost to in a 700 bed teaching
hospital was…
$5.6 million (attributable to all ADEs)
$2.8 million (attributable to preventable ADEs)
Bates D, Spell N, Cullen D, et al. The Costs of Adverse Drug Events in Hospitalized Patients.
JAMA. 1997; 277(4): 307-311.
Elderly Patients and
Hospital Medicine
Scope of the Problem
 As many as 30% of hospital admissions of elderly patients are due
to ADEs
 35% of ambulatory older adults experience an ADE (29% require health care
services: physician, ED, or hospitalization)
 Symptoms of ADEs in elderly can be:
 non-specific, or
 subtle
confusion, falls, hip fractures, functional decline, poor PO
intake, urinary retention, or constipation
 Temptation is to “treat” an ADE with another drug
Chutka D, Takahashi P, Hoel R. Inappropriate Medications in Elderly Patients. Mayo Clin Proc. 2004;
79:122-139.
Identifying the Medications to Avoid for
Elderly Patients:
Beers Criteria – the Why
How do we formulate Clinical Guidelines?
 Controlled studies
 Systematically review the evidence-based
literature
Beers Criteria – the Why
What if # of controlled studies is limited?
 For “Medication Use in Elderly Patients” that’s the
problem – elderly excluded from many studies
 One approach is to ask the opinion of those
considered experts
– Consensus Criteria
– Types of Bias this introduces
– Recognize the Bias…and Move On
Consensus Criteria for Medication
Use in Older Adults – 2 such sets
1)
2)
Beers Criteria
Canadian Criteria
Beers Criteria – the What
 “Criteria” = Statements:
– Specific medications (or classes of medications)…
 Should generally be avoided in any person > 65yo
 Should not be used routinely > 65 yo with a specific medical
condition
 Risk for ADE too high when safer alternative exists
– Problematic in excessive dosages
– Problematic in extended duration of use (when initially
intended for limited time)
Beers Criteria – the How?
 The process – Delphi Method
– Analysis Concurrent with Data Collection
 1) Literature Review -> 1st Questionnaire
 2) Experts complete 1st Questionnaire
 3) Analysis of 1st Questionnaire -> 2nd Questionnaire
 4) Experts complete 2nd Questionnaire (Using
Feedback Provided by Investigators - allowed to see
answers from 1st Questionnaire plus Face-to-Face
discussion)
Delphi Method
 Set of procedures for formulating group judgment
for subject matter where precise info is lacking
 Procedures consist of obtaining individual answers
to pre-formulated questions, e.g. by questionnaire
 Iterating questionnaire one or more times where
information feedback b/t rounds is carefully
controlled by exercise manager
Delphi Method
 Taking as the group response a statistical
aggregate of the final answers
 Leads to increased accuracy of group
responses more often than not
Who Were the Experts?
 12 of them (13 in 1991, 6 in 1997)
 “nationally recognized experts in geriatric
care, clinical pharmacology, and
psychopharmacology”
What Made Them “Experts?”
 Published extensively
 Senior academic rank
 Represented acute care, long-term care,
and community practice setting
 Geographically diverse
 12 of 16 invited experts completed all
rounds of survey (dropout, intention to survey)
Response Standardization
 Likert Scale
– Rate agreement or disagreement with a
statement from
 <1> strongly agree
 <3> expresses equivocation
 <5> strongly disagree
Response Open-ended
 If expert didn’t feel qualified to reply, could
opt not to answer
 If expert wanted to add own statement
provision for that
(this is good because…)
Literature Review
 4 Investigators -> 1st questionnaire from
systematic review of the literature:
– Identified literature published in English 1/199412/2000 analyzing medication use in older
adults living in the community and living in NH’s
 Note: did not include medication use in hospitals
Literature Review
 Searched MEDLINE using terms:
– Adverse drug reactions
– Adverse drug events
– Medication problems
– Medications and elderly
Literature Review
 Hand searched & identified additional references
from bibliographies of relevant articles
 All panelists invited to add references to the
literature review
Literature Review-> 1st Questionnaire
 Each publication was reviewed by 2 (of the 4)
principal investigators
 Each investigator used a table to outline:
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Study design
Sample size
Medications reviewed
Summary of results and key points
Quality, type, and category of medication addressed
Severity of drug related problem
1st Questionnaire
 Experts Respond
– Parts 1 and 2 reviewed 1997 criteria
– Parts 3 and 4 new for 2002
 Part 3 – Medications Independent of Disease or
Condition
 Part 4 – Medications Considering Disease or
Condition
– Provision for Expert to add open-ended input (44)
1st Questionnaire Analyzed
 Building the 2nd Questionnaire – Trashing
Questions
– Calculated mean rating (Likert 1-5)
– Calculated corresponding 95% CI for each
“statement or dosing question”
 Where lower limit of the 95% CI was > 3 those
statements & dosing questions were excluded
 Included statements & dosing questions whose
upper limit of 95% CI < 3
1st Questionnaire
 Building the 2nd Questionnaire – Adding Questions
– Any statement added by an expert in the openended included in 2nd Questionnaire
2nd Questionnaire
 Experts received it 10 days before meeting
face-to-face
 Opportunity to reconsider own responses
– After given information on their previous
answers plus anonymous answers of other
experts
Severity Rating
 Potential medication problems
 5 point scale
Results
 Final Criteria
– Table 1
 48 individual medications (or classes) to avoid in
older adults
– Table 2
 20 diseases or conditions plus medications to avoid
– Table 3
 Sensitivity of the Process Poor?
Example
Questionnaire #1
Ativan in dose of 3mg is safe
1
Strongly Agree
3
Equivocal
5
Strongly Disagree
Example
Questionnaire #2
Ativan dose of 3mg is excessive
(11/12 Other Panelists
Strongly Disagreed)
1
Strongly Agree
3
Equivocal
5
Strongly Disagree
Critiques of this Method
 Simplistic – misses other prescribing problems
such as underuse or interactions of drugs in older
patients
 Limiting – clinical judgment
 Lack of prospective, controlled studies that show
criteria make a difference in outcomes
 May not reflect best practice for the oldest old (sig
> 65 yo)
 Same limitations previously documented regarding
use of Delphi technique
Beers Criteria – Valid?
 Studies have shown the Beers Criteria to be useful
in decreasing problems in older adults (15-19)
 Adopted by CMS in July 1999 for NH regulation
 An independent review of scientific literature found
evidence to support most of the Beers
designations
Chutka D, Takahashi P, Hoel R. Inappropriate Medications in Elderly Patients. Mayo Clin Proc. 2004; 79:122-139.
Improving the Care You Deliver to
Hospitalized Elderly
Many challenges facing those prescribing meds to
elderly patients…
 If inappropriate medication use is to be reduced…
– Avoid inappropriate medications altogether
– Use inappropriate medications wisely
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Only for appropriate reasons
Discontinue when no longer providing benefit
Dose appropriately
Monitor closely
Chutka D, Takahashi P, Hoel R. Inappropriate Medications in Elderly Patients. Mayo Clin Proc.
2004; 79:122-139.
General Principles of Medication
Prescribing for Older Patients
 Start doses low and increase slowly as
needed (“start low and go slow”)
 Keep regimens to the bare minimum
number of medications
 Use medications with simpler dosing
regimens (daily or twice-daily preferred)
General Principles of Medication
Prescribing for Older Patients
 Educate patients regarding drug indications
(and routinely include this information on the prescription)
 Be aware of all medications, prescription and
nonprescription, that patient may be taking.
 D “brown bag” review when patient brings all medications
(prescription and nonprescription) to hospital
General Principles of Medication
Prescribing for Older Patients
 Review drugs regularly
– consider discontinuing agents of uncertain benefit
 Be alert for potential drug–drug and drug–disease
interactions
 Differential diagnosis of every problem in a geriatric patient
includes a drug side effect
We Don’t Communicate Well
 14% of patients and physicians had complete congruence
regarding medication regimen
 70% of patients took > 1 med that…
– the physician was unaware of, or
– the physician thought the patient was taking but actually
was not
Bikowski RM, Ripsin CM, Lorraine VL. Physician-patient congruence regarding
medication regimens. J Am Geriatr Soc. 2001;49:1353-7
Case #1:
79 yo male admitted to your service in from ED with vomiting
and altered mental status. Illness started 3 days ago with
nausea and abdominal pain. Associated headache.
He lives alone. It is July and he acknowledges mosquito
bites while mowing his lawn recently.
PMH: CAD, CHF
Meds:
1.
2.
3.
4.
5.
6.
Coumadin 4mg qday
Lasix 60mg qd (doubled from 30mg qd)
Digoxin 0.25mg qday
Lisinopril 30mg qday
Vitamin E 400 IU qday
MVI qday
Case #1:
Medication history: regimen mostly unchanged for
last 10 years. However, lasix dose increased
one week ago for mildly decompensated CHF.
What is most likely?
A) Hepatic congestion from right HF
B) Viral gastroenteritis
C) West Nile Virus encephalitis
D) Digoxin toxicity
Case #1:
Medication history: regimen mostly unchanged for
last 10 years. However, lasix dose increased
one week ago for mildly decompensated CHF.
What should you suspect is going on?
A) Hepatic congestion from right HF
B) Viral gastroenteritis
C) Ileus
D) Digoxin toxicity
Case #1
 Digoxin toxicity in the elderly
– General: malaise, fatigue
– GI: anorexia, nausea, vomiting, diarrhea
– Neuro: headache, dizziness, confusion, delirium
 Elderly patients frequently manifest
neuropsychiatric findings
 Risk factors for dig toxicity: decreased renal
function, hypoK, hypoMg