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 mjn0004@auburn.edu
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 Heterogeneous patient population Communication Variation in physiological status Co-morbidities Compliance Self-medication Lack of evidence-based medicine
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 Distribution Metabolism Elimination Gastric ph GI motility Gastric emptying GI blood flow Absorption surface Lean muscle mass Body fat Body water Albumin Cardiac output Enzyme activity Liver mass Liver blood flow 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 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 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
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 Tools Implicit Criteria Explicit Criteria Use published literature and patient information Developed from: Published literature Influenced by clinical knowledge, experience, and judgment May be time consuming Patient focus 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 Criteria 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 from 13 experts through extensive literature review For all patients 65 years old except hospice and palliative care ***NEW*** 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 Organization Major therapeutic class or organ system Rationale Recommendation Quality of Evidence Strength of Recommendation The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
Beers Criteria 2015 Updates Five 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 Formally potentially inappropriate medications Sufficient # plausible reasons for use in certain individuals Potential for misuse or harm substantial: extra caution in use Drug-Drug Interactions ***New*** Medications to avoid or have dose reduced with varying levels of kidney function ***New*** The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
Beers Criteria 2015 Updates Companion article best way to use and not use the Beers Criteria Removals from 2012 Nitrofurantoin if CrCl < 60 ml/min Recommendation to avoid long-term use still in place Antiarrhythmics drugs as 1 st line treatment for atrial fibrillation Changes from 2012 Nonbenzodiaepine receptor agonists avoid regardless of duration of use Further clarification on what a sliding-scale insulin regimen is. Additions PPIs > 8 weeks without justification. The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. J Am Geriatr Soc 2012;60:616-630
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;12:537-545 Gray et al. J Manag Care Pharm 2009;15:568-571
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
O Mahony et al. Age and Ageing. 2015;44:213-218 Gallagher et al. Clin Pharm Ther 2011;89:845-854 Gallagher et al. Int J Clin Pharm Ther 2008;45:72-83 STOPP & START Developed by expert consensus panel for Ireland and United Kingdom in 2008 Version 2 published December 2014 Version 2 Panel 19 experts in Geriatric medicine and pharmacotherapy 13 European countries
STOPP & START Process Each panelist commented on 2008 criteria Each panelist proposed new criteria Literature search for all criteria Panelists able to review literature Online Delphi validation Likert scale (0= don t know, 1= strongly agree to 5 = strongly disagree) Retained criteria with median value of 1 or 2 3 additional drafts with same process O Mahony et al. Age and Ageing. 2015;44:213-218
STOPP Screening Tool of Older Person s Prescriptions Addresses potentially inappropriate medications 80 Criteria in the form of a statement Arranged according to relevant physiological systems Other criteria categories Indication none (EBM), duplication, duration Drugs that increase risk of falls in older adults Analgesics Antimuscarinic/anticholinergic drug burden ( 2) Each criteria given concise explanation and references Most criteria related to drug-drug or drug-disease interactions Others place in therapy, indication, monitoring requirements Sets maximum doses for digoxin (125 mcg) and aspirin (160 mg) O Mahony et al. Age and Ageing. 2015;44:213-218 Gallagher et al. Clin Pharm Ther 2011;89:845-854 Gallagher et al. Int J Clin Pharm Ther 2008;45:72-83
START Screening Tool to Alert doctors to the Right Treatment Addresses potential errors of omission or underutilization 34 criteria Arranged according to relevant physiological systems Other types of criteria analgesics, vaccines Explanation not provided References listed with each criteria O Mahony et al. Age and Ageing. 2015;44:213-218
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 Disease states Care coordination End-of-life Hearing loss Medication use 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 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-S382 Knight et al. Ann Intern Med 2001;135:703-710
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 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?