Geriatric Pharmacotherapy: ACOVE Indicators Module Development by Lynne E. Kallenbach M.D.

1. Geriatric Pharmacotherapy:ACOVE IndicatorsModule Development by Lynne E. Kallenbach M.D.

2. Objectives • Address issues of medication use in vulnerable older adult population - Physiologic changes with aging - Adverse drugs effects & polypharmacy • Identify specific quality indicators for medication management in older adults • ACOVE indicators

3. ACOVE Indicators • Assessing Care of Vulnerable Elders (ACOVE) from RAND Health/collaborators • 236 if/then indicators in 4 domains • 43 indicators re: pharmacologic care: • Medication Quality Indicators - Prescribing indicated medications - Avoiding inappropriate medications - Education, continuity, and documentation - Medication monitoring

4. What does this mean for us? • As residents proceed through training, awareness of quality indicators is critical - Intended for betterment of patient care - On individual level, may be tied to re-imbursement - On institutional level, may be tied to accreditation &/or public perception of your hospital

5. What does this mean for us? • Nearly all primary care and specialty physicians will have contact with older adults, and many will write prescriptions for them • Many of these medications can have unintended consequences

6. Why Geriatric Pharmacotherapy Is Important • Now, people age 65+ are 13% of US population, buy 33% of prescription drugs • By 2040, will be 25% of population, will buy 50% of prescription drugs Adapted from Geriatrics Review syllabus 6th edition teaching slides

7. Pharmacokinetics • Absorption • Distribution • Metabolism • Elimination • Altered by changes in body make-up • Decreased lean mass, relatively increased fat

8. Aging and Absorption • Actual amount absorbed not changed • Peak concentrations may be altered • May be affected by co-morbid conditions or other medications or vitamins

9. Aging and Volume of Distribution •  body water  lower Vd for hydrophilic drugs •  fat stores  higher Vd for lipophilic drugs •  plasma protein (albumin)  higher percentage of drug that is unbound (active)

10. Aging and Metabolism • Metabolism may be reduced because: • Decrease in liver blood flow, size, mass - liver is the most common site of drug metabolism • But cannot easily estimate effect of these changes • Phase II pathways generally preferable for older patient

11. Aging and Elimination(or you and your kidney) •  kidney size •  renal blood flow •  number of functional nephrons •  renal tubular secretion Lower glomerular filtration rate

12. Serum Creatinine Does Not = Clearance •  lean body mass  lower creatinine production & glomerular filtration rate (GFR) • Estimation for CrCl with Cockcroft Gault equation

13. Pharmacodynamics • Definition:Intensity & time course of the effect of a drug • Examples: • Benzodiazepines may cause more sedation and worse psychomotor performance in older adults. • Older patients may experience higher levels of morphine with longer pain relief

14. Decreased homeostatic reserve • Impacts ability to tolerate medications • Postural hypotension • Fluid and electrolyte problems • Response to hypoglycemia • Temperature/sweating regulation

15. Medication Use Issues with Multiple Prescriptions (and OTCs…herbals…etc)

16. What is polypharmacy? “As older patients move through time, often from physician to physician, they are at increasing risk of accumulating layer upon layer of drug therapy, as a reef accumulates layer upon layer of coral.” Jerry Avorn, MD From Gurwitz J. Arch Intern Med Oct 11, 2004

17. General types of medication-related problems • Unnecessary drug • Not prescribing new needed Rx • Contraindicated drug • Dose too low or too high • Adverse drug event • Nonadherence • From Williams CM, Am Fam Phys Nov 15, 2002

18. Medications Accounting for Most ADEs in Older Adults • Cardiovascular medications • Psychotropic medications • Anticoagulants • Antibiotics • NSAIDS • Anti-seizure medications (JAGS 2004;52:1349-1354 and NEJM 2003;348:1556-64)

19. The Extent of Injuries From Medications ADEs are responsible for 5% to 28% of acute geriatric hospital admissions • Adapted from Geriatric Review Syllabus 6th edition, teaching slides JAGS 1997;45:945-948 JAGS 1996;44:194-197 Am Pharm Assoc 2002;42:847-857

20. Multiple Medications • Complexity of regimen reduces adherence • Drug interactions • Adverse drug reactions contribute to hospitalization in 25% of persons ≥ 80 yr • Drug-induced problems can mimic geriatric syndromes • Prescribing cascade phenomenon • Williams CM, Am Fam Phys Nov 15, 2002

21. Prescribing Cascade • Misinterpretation of an adverse drug reaction as a symptom of another condition prescribing of another Rx • Important to ask about ALL medications, not just the prescription ones • Example: • Persons receiving a cholinesterase inhibitor had >50% increase risk for subsequent anticholinergic drug for incontinence Gill et al. Arch Intern Med 2005, April 11

22. Characteristics of Older Adults with Medication-related Problems • 85 years and older • 6 or more active chronic conditions • Estimated creat clearance < 50 ml/min • Low body weight • Nine or more medications • More than 12 doses of medication daily • Previous adverse drug reaction • From Williams CM, Am Fam Phys 2002, adapted from Fouts, Consult Pharm, 1997

23. “And now, for the rest of the story….” • Under-utilization of effective therapies in older adults is widespread

24. “Polypharmacy: A New Paradigm for Quality Drug Therapy in the Elderly” • Under-use of beneficial Rx in older adults • ACE-I in CHF • Anticoagulants in Afib • Antiresorptive Rx in osteoporosis • Disease management guidelines often favor more than one Rx for a condition • Gurwitz J. Arch Intern Med 2004, Oct 11 • “And an ARB makes nine: polypharmacy in patients with heart failure” • Clev Clinic J Med Aug 2004

25. Potentially Inappropriate Medication Use

26. Inappropriate Medications in Older Adults: “Beers List” • “potentially or generally inappropriate” • “suboptimal prescribing” • Overall risks outweigh potential benefits • May be ineffective and/or poorly tolerated • May be justified in some circumstances • Controversial • expert opinion • Limited evidence-base for many drugs

27. Beer’s List: Two Groups of Drugs • Unconditionally inappropriate • Generally best avoided regardless of circumstances • Some are considered more high risk than others • Conditioned upon disease state or dose • May only be inappropriate in specific context

28. Beer’s List Selected Highlights: 1997 • Propoxyphene (but not included in Rx review guidelines for NH) • Indomethcin, phenylbutazone, pentazocine • Digoxin above 0.125 mg except for atrial arrythmia • Muscle relax/antispasmodics, including ditropan • Flurazepam • Amitriptyline & combinations; doxepin • Dipyridamole • Meperidine • Ticlopidine • GI antispasmodics • Nonprescription and many Rx antihistamines • Methyldopa • Chlordiazepoxide, diazepam

29. Updates to Beer’s List in 2003 (selected additions since 1997)

30. 2003: selected conditionally inappropriate by disease state

31. High Potential for Severe ADEs Amitriptyline Chlorpropamide Digoxin > 0.125 mg/day Disopyramide GI antispasmodics Meperidine Methyldopa Pentazocine Ticlopidine High Potential for Less Severe ADEs Antihistamines Diphenhydramine Dipyridamole Ergot mesylates Indomethacin Meperidine, oral Muscle relaxants Potentially Inappropriate Medications for Older Persons

32. Medication Appropriateness Index • Another formalized assessment tool - based on evaluation of 10 criteria indication effectiveness dosage expense duration duplication drug-disease interaction drug-drug interaction directions correctness directions practicality

33. Approach to the Older Patient with Multiple Medications

34. Approach to Multiple Medications • Brown bag med review at least annually • Including herbals and OTCs • Determine clinical indication for each • Motto “One disease, one drug, once daily” • Avoid the prescribing cascade • Eliminate drugs without benefit or indication • Substitute less toxic drugs where able • From Carlon JE, Geriatrics, 1996; 51:26-30

35. Regulatory Scrutiny • Mandated drug review already in LTC • Provider profiling increasingly common • Pay for performance models • Patient satisfaction monitoring • Increasing use of electronic records

36. ACOVE Indicators • Medication Quality Indicators - Prescribing indicated medications - Avoiding inappropriate medications - Education, continuity, and documentation - Medication monitoring

37. Higashi, T. et. al. Ann Intern Med 2004;140:714-720 Medication Quality Indicators, Number of Eligible Patients, and Pass Rates

38. ACOVE Indicators • Hospital indicators - All vulnerable older adults should not be prescribed a medication with strong anticholinergic side effects if alternatives are available - If a vulnerable older adult is prescribed a new drug, THEN the prescribed drug should have a clearly defined indication documented in the chart

39. ACOVE Indicators • Ambulatory indicators - All vulnerable older adults should not be prescribed a medication with strong anticholinergic effects if alternatives are available - If a vulnerable older adults is prescribed a new drug, THEN the patient (or caregiver) should receive education about the purpose of the new drug, how to take it, and the expected side effects or important adverse reactions

40. ACOVE Indicators • Ambulatory indicators, cont’d - If a vulnerable older adult is prescribed a new drug, THEN the prescribed drug should have a clearly defined indication documented in the record - Every new drug that is prescribed to a vulnerable older adult on an ongoing basis for chronic medical condition should have a documentation of response to therapy within 6 months

41. ACOVE Indicators • Ambulatory indicators, cont’d - If a vulnerable older adult is newly started on a diuretic, THEN serum potassium and creatinine levels should be checked within 1 month of initiation of therapy - If a vulnerable older adult is prescribed a thiazide or loop diuretic, THEN s/he should have electrolyte levels checked at least yearly - If a vulnerable older adult is newly started on an ACE inhibitor, THEN serum potassium and creatinine levels should be checked within 1 month of the initiation of therapy

42. ACOVE Indicators • Ambulatory indicators, cont’d - If a vulnerable older adult is prescribed warfarin, THEN an INR should be determined within 4 days after initiation of therapy - If a vulnerable older adult is prescribed warfarin, THEN an INR should be determined at least every six weeks

43. Principles of Prescribing for Older Patients : the Basics • Start low, go slow • Avoid starting 2 drugs at the same time • Is it necessary? • Has the patient been educated about the drug and its potential side effects? • Is the drug being appropriately monitored?

44. “The patient, treated on the fashionable theory, sometimes will get well in spite of the medicine.” Thomas Jefferson 1807

45. Additional References • Barber N, Bradley C et al. “Measuring the appropriateness of prescribing in primary care: are current measures complete?” Journal of Clinical Pharmacy and Therapeutics, 30; 533-539. • Blackstone K and Cobbs E, co-editors, Geriatric Review Syllabus 6th ed. Teaching slides • Curtis L, Ostbye T et al. “Inappropriate Prescribing for Elderly Americans in a Large Outpatient Population,” Archives of Internal Medicine, Vol. 164: 1621-1625, Aug 9, 2004. • Fick D, Cooper J et al. “Updating the Beers Criteria for Potentially Inappropriate Medication Use for older Adults,” Archives of Internal Medicine, Vol. 16: 2716-2724, Dec 8 2003. • Field T, Gurwitz J et al. “Risk Factors for Adverse Drug Events Among Older Adults in the Ambulatory Setting,” Journal of the American Geriatrics Society, 52:1349-1354, Aug. 2004. • Gandhi T, Weingart S et al. “Adverse Drug Events in Ambulatory Care,” New England Journal of Medicine, 34;6, 1556-1564 April 17, 2003. • Higashi R, Shekelle P et al. “The Quality of Pharmacologic Care for Vulnerable Older Patients,” Annals of Internal Medicine, 140; 714-720, 2004. • Hajjar E, Hanlon J et al. “Unnecessary Drug Use n Frail Older People at Hospital Discharge,” Journal of the American Geriatrics Society, 53:15181523, 2005. • Steinman M,Landefeld C et al. “Polypharmacy and Prescribing Quality in Older People,” Journal of the American Geriatrics Society, 54:1516-1523, Oct. 2006. • Willcox S, Himmelstein D, and Woolhandler S. “Inappropriate Drug Prescribing for the Community Dwelling Elderly,” JAMA, Vol. 272, No. 4: 292-296, July 27, 1994. • Williams C, “Using Medications Appropriately in Older Adults,” American Family Physician, Vol. 66, No. 10: 1917-1924, Nov. 15, 2002.