There’s A Pill For That (But should my patient be on it?) A Review of Tools for the Evaluation of...
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Transcript of There’s A Pill For That (But should my patient be on it?) A Review of Tools for the Evaluation 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, BCPSAssistant Clinical ProfessorHarrison School of Pharmacy, Auburn University and
Adjunct Assistant Professor, University of Alabama-Tuscaloosa School of Medicine
Objectives 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 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
Dosing regimenPlasma
Concentration in plasma
Concentration at site of action Effect
Pharmacokinetics
Pharmacodynamics
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;41:67-76Corsonello et al. Cur Med Chem 2010;17:571-84
Pharmacodynamic Changes Changes at receptor site
↓ number of receptors Altered effects at receptor or post-receptor levels
causing changes in end-organ response ↓ 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;17:571-84Chaurasia et al. J Indian Aca Geri 2005;2:82-88
What is “Suboptimal Prescribing” Overuse - polypharmacy Inappropriate prescribing
Medications where risk > benefit Disagrees with accepted medical standards
Underutilization Omitted but necessary
Hanlon et al. J Am Geriatr Soc 2001;49:200-209
Implicit versus Explicit ToolsImplicit Criteria
Use published literature and patient information
Influenced by clinical knowledge, experience, and judgment
May be time consuming Patient focus
Explicit Criteria
Developed from: 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 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 Partnership with American Geriatrics Society Three Categories – 53 medications or classes
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*** 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 Organization
Major therapeutic class or organ system Rationale Recommendation Quality of Evidence Strength of Recommendation
19 medications or classes removed 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 Glyburide Megestrol Sliding scale insulin Anitiparkinson agents:
benztropine, trihexypehidyl
Scopolamine (except palliative care)
Alpha1 blockers: prazosin, terazosin
Metoclopramide
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 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
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
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 Developed by Canadian consensus expert panel 38 practices involving medications grouped as cardiovascular,
psychotropic, analgesics, and miscellaneous 3 categories of inappropriate prescribing in geriatrics
Drugs contraindicated due to unacceptable risk-benefit ratio Drugs causing drug-drug interactions Drugs causing drug-disease interactions
Inclusion Criteria 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 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
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 Developed by expert consensus panel for Ireland and
United Kingdom Criteria arranged according to relevant physiological systems
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;89:845-854Gallagher et al. Int J Clin Pharm Ther 2008;45:72-83Rynn et al. Ann Pharmacother 2009;43M157e1-3
STOPP & STARTSTOPP
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 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;89:845-854Gallagher et al. Int J Clin Pharm Ther 2008;45:72-83Rynn et al. Ann Pharmacother 2009;43M157e1-3
Prescribing Indicators Tool 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
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 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
Shrank et al. JAGS 2007;55:S373-S382Knight et al. Ann Intern Med 2001;135:703-710
Hospital care and surgery Operative care Screening and prevention Undernutrition
Disease states Care coordination End-of-life Hearing loss Medication use
ACOVE Quality Indicators Medication Use QI - 20
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-S382Knight et al. Ann Intern Med 2001;135:703-710
HEDIS Health Plan Employer Data & Information Set Use of high-risk medications in the elderly
Originally created by expert panel in 2003 for the National Committee on Quality Assurance
Classified Beers List into 3 categories : Always avoid Rarely Appropriate Some Indications
“Always Avoid” and “Rarely Appropriate” included
Pugh et al. J Manag Care Pharm 2006;12:537-545Gray et al. J Manag Care Pharm 2009;15:568-571
Medication Appropriateness Index
Hanlon et al. J Clin Epidemiol 1992;45:1045-1051Samsa et al. J Clin Epidemiol 1994;47:891-896Holmes HM et al. Arch Int Med 2006;166:605-609O’Mahony D, et al. Age Ageing 2008;37:138-41
Evaluator Rating• Appropriate (Weight x 0)• Marginally appropriate (Weight x 0.5)• Inappropriate (Weight x 1)
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 appropriateMax = 18 = Completely inappropriate
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 ToolA Assess Total # of medications & certain
medicine groups with potential for adverse outcomes
Beers Criteria Analgesics Beta Blockers Antidepressants Antipsychotics PsychotropicsVitamins Supplements
R Review Potential for Interactions: drug, disease, pharmacodynamic Functional status impactSubclinical ADRsDrug benefit vs. primary body function
M Minimize Nonessential medications Lack evidence for useRisk outweigh benefitHigh potential for negative impact on function
O Optimize Address Duplication & redundancyRenal and hepatic dosingGradual dose ↓ for antidepressantsAdjust drugs : oral hypoglycemics (HbA1c), beta blockers (heart rate, pacemakers), warfarin (INR), phenytoin (free phenytoin level)
R Reassess Heart rate, blood pressure, and O2 saturationFunctional, cognitive, and clinical statusMedication compliance
Haque R. Ann Long-Term Care 2009;17:26-30
Drug Burden Index Measures total exposure to medications with
anticholinergic and/or sedative properties 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
Castelino et al. Drugs Aging 2010;27:135-148
Drug Burden Index
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 Should my patient be on it?
Many tools were developed by small panels Most tools have only been evaluated in
limited clinical studies Tools do not replace clinical judgment
Questions?