Transcript There*s A Pill For That (But should my patient be on it?) A Review of

There’s A Pill For That
(But should my patient be on it?)
A Review of Tools for the Evaluation of
Optimal Prescribing in Geriatric Patients
Marilyn N. Bulloch, PharmD, BCPS
Assistant Clinical Professor
Harrison School of Pharmacy, Auburn University and
Adjunct Assistant Professor, University of Alabama-Tuscaloosa
School of Medicine
[email protected]
Objectives
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Describe pharmacokinetic and
pharmacodynamic changes in the geriatric
patient that impact medication use
Define suboptimal prescribing
Evaluate clinical tools for assessing
appropriate use of medications in the elderly
patient
Geriatric Medication Discourse
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Heterogenous patient population
Variation in physiological status
Co-morbidities
Lack of evidence-based medicine
Communication
Compliance
Self-medication
Variables Impacting Medication Effects
Figure 1. Klotz U. Drug Met Rev 2009;41:58
Age-Related Physiologic Changes
Adapted from: Nolin TD et al. Figure 6-1, 2009
Pharmacokinetic Changes
Absorption
↑ Gastric pH
↓ GI motility
↑ Gastric
emptying
↓ GI blood
flow
↓ Absorption
surface
Distribution
↓ Lean
muscle mass
↑ Body fat
↓ Body water
↓ Albumin
↓ Cardiac
output
Metabolism
↓ Enzyme
activity
↓ Liver mass
↓ Liver
blood flow
Elimination
↓ GFR
↓ Kidney
blood flow
↓ Renal
tubular
function
Klotz U. Drug Met Rev 2009;41:67-76
Corsonello et al. Cur Med Chem 2010;17:571-84
Pharmacodynamic Changes
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Changes at receptor site
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↓ number of receptors
Altered effects at receptor or post-receptor levels
causing changes in end-organ response
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↓ sensitivity at receptor site
Diminished or exaggerated pharmacologic response
Altered reflex response
Altered neurotransmitters
Hormonal changes
Changes in mental status
Corsonello et al. Cur Med Chem 2010;17:571-84
Chaurasia et al. J Indian Aca Geri 2005;2:82-88
What is “Suboptimal Prescribing”
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Overuse - polypharmacy
Inappropriate prescribing
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Medications where risk > benefit
Disagrees with accepted medical standards
Underutilization
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Omitted but necessary
Hanlon et al. J Am Geriatr Soc 2001;49:200-209
Implicit versus Explicit Tools
Implicit Criteria
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Use published literature
and patient information
Influenced by clinical
knowledge, experience,
and judgment
May be time consuming
Patient focus
Explicit Criteria
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Developed from:
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Published literature
Expert opinion
Consensus techniques
Require little/no clinical
judgment
High reliability and
reproducibility
Medication or disease
focus
Shelton et al. Drugs Aging 2000;16:437-450
The Beers List
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Beers Criteria for Potentially Inappropriate
Medication Use in Older Adults
Explicit list of medications, doses, and durations
that should be avoided in geriatric patients
Developed from expert consensus through
extensive literature review
For all patients ≥ 65 years old
Adopted by CMS in 1999 for nursing home
patients
The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
Beers et al. Arch Intern Med 1991;151:1825-1832
Beers Criteria 2012 Updates
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Partnership with American Geriatrics Society
Three Categories – 53 medications or classes
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Medications to avoid in any patient ≥ 65 years
Medications to avoid in patients ≥ 65 years with
certain diseased or syndromes
Medications to be used with caution in patients ≥ 65
years ***NEW***
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Formally potentially inappropriate medications
Sufficient # plausible reasons for use in certain individuals
Potential for misuse or harm substantial: extra caution in use
The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
Beers Criteria 2012 Updates
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Organization
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Major therapeutic class or organ system
Rationale
Recommendation
Quality of Evidence
Strength of Recommendation
19 medications or classes removed
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Examples: Ferrous sulfate, stimulant-laxatives
The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
Beers Criteria
New medications to avoid in any older adult
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Glyburide
Megestrol
Sliding scale insulin
Anitiparkinson agents:
benztropine,
trihexypehidyl
Scopolamine (except
palliative care)
Alpha1 blockers:
prazosin, terazosin
Metoclopramide
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Antiarrhythmic drugs (1a,
1c, III) – as 1st line
Dronedarone
Spironolactone >25mg/day
Phenobarbital
Nonbenzodiazepine
hypnotics
All non-COX selective
NSAIDs
Aspirin > 325 mg/day
The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
Beers Criteria
New medications to avoid in certain diseases
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Heart failure: thiazolidineones, cilostazol, dronedarone,
non-dihydropyridine calcium channel blockers, NSAIDs
Syncope: acetylcholinesterace inhibitors, alpha1 blockers, olanzapine
Seizures/epilepsy: olanzapine, tramadol
Delirium: TCAs, anticholinergics, benzodiazepines, corticosteroids,
H2-receptor antagonists, meperidine
Dementia/cognitive impairment: H2-receptor antagonists, zolpidem
Falls/fracture history: SSRIs, antipsychotics
Parkinson disease: all antipsychotics (except quetiapine and
clozapine), promethazine, prochlorperazine
CKD stage IV-V: triamterene
Urinary incontinence: estrogen
BPH: inhaled anticholinergics
The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
Beers Criteria
Medications to Be Used With Caution
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Aspirin for primary prevention of cardiac events in
patients ≥ 80 years
Dabigatran in patients ≥ 75 years or CrCl <30 mL/min
Prasugrel in patients ≥ 75 years
Vasodilators in patients with syncope
SIADH/hyponatremia
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Agents- antipsychotics, carbamazepine, carboplatin, cisplatin,
mirtazapine, SNRIs, SSRIs, TCAs, vincristine
The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
McLeod Criteria
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Developed by Canadian consensus expert panel
38 practices involving medications grouped as cardiovascular,
psychotropic, analgesics, and miscellaneous
3 categories of inappropriate prescribing in geriatrics
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Inclusion Criteria
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Drugs contraindicated due to unacceptable risk-benefit ratio
Drugs causing drug-drug interactions
Drugs causing drug-disease interactions
Clinically significant ↑ risk of serious ADEs
More/equally effective & less risky alternatives available
Prescribing practice occurs often enough that prescribing change could
↓ morbidity in geriatrics
Rating of clinical importance:1 (not significant) to 4 (highly significant)
Provides alternative therapy recommendations
McLeod et al. Can Med Assoc J 1997;156:385-391
IPET
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Improving Prescribing in the Elderly Tool: “Canadian Criteria”
Developed for inpatients utilizing McLeod Criteria
List of 14 most common prescribing errors in
routine clinical practice that should be avoided.
Not based on physiological symptoms
Does not address omission
Weighted towards cardiovascular, psychotropic, and
NSAID use
Errors
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Avoidance of beta blockers in heart failure
Avoidance of benzodiazepines with long half-lives under any
circumstance
Naugler et al. Can J Clin Pharmacol 2000;7:103-107
STOPP & START
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Developed by expert consensus panel for Ireland and
United Kingdom
Criteria arranged according to relevant physiological systems
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Cardiovascular
Central Nervous System
Gastrointestinal
Respiratory
Musculoskelatal
Urogenital (STOPP only)
Endocrine
Specific criteria: analgesics, drugs that affect geriatrics who fall,
duplicate drug class therapy
Gallagher et al. Clin Pharm Ther 2011;89:845-854
Gallagher et al. Int J Clin Pharm Ther 2008;45:72-83
Rynn et al. Ann Pharmacother 2009;43M157e1-3
STOPP & START
STOPP
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Screening Tool of Older Person’s
Prescriptions
Addresses potentially inappropriate
medications
65 rules or criteria
Each criteria given concise
explanation
Most criteria related to drug-drug or
drug-disease interactions
Sets maximum doses for digoxin
(125 mcg) and aspirin (150 mg)
Other criteria address: indication,
place in therapy, duration of use,
Defines renal failure as GFR 20-50
mL/min
START
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Screening Tool to Alert
doctors to the Right
Treatment
Addresses potential errors of
omission or underutilization
22 rules or criteria
Lists medication therapy that
should be utilized in patients
with specific medical
conditions
Gallagher et al. Clin Pharm Ther 2011;89:845-854
Gallagher et al. Int J Clin Pharm Ther 2008;45:72-83
Rynn et al. Ann Pharmacother 2009;43M157e1-3
Prescribing Indicators Tool
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Developed using 50 most frequently prescribed medications and
medical conditions in Australia
Incorporates risk vs. benefit, co-morbidities, life expectancy, quality of
life, and patient preferences.
48 indicators
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18 address avoidance of medications in specific disease states/conditions
19 concern use of recommended treatment
4 involve medication monitoring
4 concern drug interactions [ 3 specific interactions; 1 addresses any
interactions]
1 involves changes in medication within 90 days
1 concerns smoking
1 addresses vaccination
Not rated by severity
Basger et al. Drugs Aging 2008;25:777-793
ACOVE Quality Indicators
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Assessing Care of Vulnerable Elders
Applied to community-dwelling geriatrics
Developed by expert panel via literature review
Quality indicators [QI] that measure quality of
care in vulnerable elderly patients across the
continuum of care
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Disease states
Care coordination
End-of-life
Hearing loss
Medication use
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Hospital care and surgery
Operative care
Screening and prevention
Undernutrition
Shrank et al. JAGS 2007;55:S373-S382
Knight et al. Ann Intern Med 2001;135:703-710
ACOVE Quality Indicators
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Medication Use QI - 20
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Address medication reconciliation, drug regimen
reviews, education, drug avoidance, monitoring,
and risk reduction
4 additional QIs regarding NSAIDs and aspirin
75 additional QI regarding medication initiation,
adjustments, and discontinuations
4 addition medication-related QI
Shrank et al. JAGS 2007;55:S373-S382
Knight et al. Ann Intern Med 2001;135:703-710
HEDIS
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Health Plan Employer Data & Information Set
Use of high-risk medications in the elderly
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Originally created by expert panel in 2003 for the
National Committee on Quality Assurance
Classified Beers List into 3 categories :
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Always avoid
Rarely Appropriate
Some Indications
“Always Avoid” and “Rarely Appropriate” included
Pugh et al. J Manag Care Pharm 2006;12:537-545
Gray et al. J Manag Care Pharm 2009;15:568-571
Medication Appropriateness Index
Domain
Weight
1. Is there an indication for the drug?
3
2. Is the medication effective for the condition
3
3. Is the dosage correct?
2
4. Are the directions correct?
2
5. Are the directions practical?
1
6. Are there clinically significant drug-drug interactions?
2
7. Are there clinically significant drug-disease interactions?
2
8. Is there unnecessary duplication with other drugs?
1
9. Is the duration of therapy acceptable?
1
10. Is this drug the least expensive alternative compared with
others of equal utility?
1
Min = 0 = Completely appropriate
Max = 18 = Completely inappropriate
Hanlon et al. J Clin Epidemiol 1992;45:1045-1051
Samsa et al. J Clin Epidemiol 1994;47:891-896
Holmes HM et al. Arch Int Med 2006;166:605-609
O’Mahony D, et al. Age Ageing 2008;37:138-41
Time Until Benefit Model
Figure 3. Holmes et al. Arch Intern Med 2006;166:605-608
Good Palliative-Geriatric
Practice Algorithm
Garfinkel et al. Arch Intern Med 2010;170:1648-1654
The ARMOR Tool
A
Assess
Total # of medications &
certain medicine groups with
potential for adverse outcomes
Beers Criteria
Analgesics
Beta Blockers
Antidepressants Antipsychotics Psychotropics
Vitamins
Supplements
R
Review
Potential for
Interactions: drug, disease, pharmacodynamic
Functional status impact
Subclinical ADRs
Drug benefit vs. primary body function
M
Minimize
Nonessential medications
Lack evidence for use
Risk outweigh benefit
High potential for negative impact on function
O
Optimize
Address
Duplication & redundancy
Renal and hepatic dosing
Gradual dose ↓ for antidepressants
Adjust drugs : oral hypoglycemics (HbA1c),
beta blockers (heart rate, pacemakers), warfarin
(INR), phenytoin (free phenytoin level)
R
Reassess
Heart rate, blood pressure, and O2 saturation
Functional, cognitive, and clinical status
Medication compliance
Haque R. Ann Long-Term Care 2009;17:26-30
Drug Burden Index
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Measures total exposure to medications with
anticholinergic and/or sedative properties
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If both: classified as anticholinergic
Higher DBI associated with impaired
physical function
Each additional unit of drug burden is equivalent to 3
additional physical comorbidities
Does not adequately address risk versus benefit
Does not incorporate PK/PD changes
Assumes a linear dose relationship
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Castelino et al. Drugs Aging 2010;27:135-148
Drug Burden Index
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D – daily dose of medication
δ – minimum efficacious daily dose approved
by Food & Drug Administration
Total drug burden – sum of the drug burden of
all anticholinergic or sedative medications the
patient is exposed to
Castelino et al. Drugs Aging 2010;27:135-148
There’s A Pill For That
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Should my patient be on it?
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Many tools were developed by small panels
Most tools have only been evaluated in
limited clinical studies
Tools do not replace clinical judgment
Questions?