Marilyn N. Bulloch, PharmD , BCPS Assistant Clinical Professor

1. 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

2. 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

3. Geriatric Medication Discourse • Heterogenous patient population • Variation in physiological status • Co-morbidities • Lack of evidence-based medicine • Communication • Compliance • Self-medication

4. Variables Impacting Medication Effects Figure 1. Klotz U. Drug Met Rev 2009;41:58

5. Age-Related Physiologic Changes Pharmacokinetics Pharmacodynamics Adapted from: Nolin TD et al. Figure 6-1, 2009

6. Pharmacokinetic Changes Klotz U. Drug Met Rev 2009;41:67-76 Corsonello et al. Cur Med Chem2010;17:571-84

7. 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 Chem2010;17:571-84 Chaurasia et al. J Indian Aca Geri 2005;2:82-88

8. 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 GeriatrSoc2001;49:200-209

9. Implicit versus Explicit Tools Implicit Criteria Explicit Criteria Developed from: Published literature Expert opinion Consensus techniques Require little/no clinical judgment High reliability and reproducibility Medication or disease focus • Use published literature and patient information • Influenced by clinical knowledge, experience, and judgment • May be time consuming • Patient focus Shelton et al. Drugs Aging 2000;16:437-450

10. 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 GeriatrSoc 2012;60:616-630 Beers et al. Arch Intern Med 1991;151:1825-1832

11. 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 GeriatrSoc 2012;60:616-630

12. 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 GeriatrSoc 2012;60:616-630

13. 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 GeriatrSoc 2012;60:616-630

14. 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 GeriatrSoc 2012;60:616-630

15. 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 GeriatrSoc 2012;60:616-630

16. 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

17. 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 ClinPharmacol2000;7:103-107

18. 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 Ther2011;89:845-854 Gallagher et al. Int J Clin Pharm Ther2008;45:72-83 Rynn et al. Ann Pharmacother 2009;43M157e1-3

19. STOPP & START STOPP 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 • 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 Gallagher et al. Clin Pharm Ther2011;89:845-854 Gallagher et al. Int J Clin Pharm Ther2008;45:72-83 Rynn et al. Ann Pharmacother 2009;43M157e1-3

20. 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

21. 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

22. 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

23. 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

24. Medication Appropriateness Index • Evaluator Rating • Appropriate • (Weight x 0) • Marginally appropriate (Weight x 0.5) • Inappropriate (Weight x 1) Hanlon et al. J ClinEpidemiol 1992;45:1045-1051 Samsa et al. J ClinEpidemiol1994;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 Min = 0 = Completely appropriate Max = 18 = Completely inappropriate

25. Time Until Benefit Model Figure 3. Holmes et al. Arch Intern Med 2006;166:605-608

26. Good Palliative-Geriatric Practice Algorithm Garfinkel et al. Arch Intern Med 2010;170:1648-1654

27. Haque R. Ann Long-Term Care 2009;17:26-30

28. 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

29. 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

30. 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

31. Questions?