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Pharmacologic Debridement: More Does Not Equal Better

Pharmacologic Debridement: More Does Not Equal Better. Jacob B. Blumenthal, MD, FACP Baltimore Geriatrics Research, Education and Clinical Center/VAMC University of Maryland School of Medicine Baltimore, MD jblument@grecc.umaryland.edu Nicole J. Brandt, PharmD, CGP, BCPP, FASCP

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Pharmacologic Debridement: More Does Not Equal Better

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  1. Pharmacologic Debridement: More Does Not Equal Better Jacob B. Blumenthal, MD, FACP Baltimore Geriatrics Research, Education and Clinical Center/VAMC University of Maryland School of Medicine Baltimore, MD jblument@grecc.umaryland.edu Nicole J. Brandt, PharmD, CGP, BCPP, FASCP Peter Lamy Center on Drug Therapy and Aging University of Maryland, School of Pharmacy Baltimore, MD nbrandt@rx.umaryland.edu

  2. …but… • Unlike Dick the Butcher • ”The first thing we do, let's kill all the lawyers” • Not: medications are bad • Rather, suggesting need for judicious use and continuous re-litigation Henry VI William Shakespeare

  3. Outline • Demographics • Aging and Multimorbidities • Polypharmacy and ADR’s • Age-related changes • Pharmacodynamics (absorption, clearance) • Body Composition • What are we doing? Whose standard? • Bad Drugs: Beer’s List, HEDIS High Risk Meds • Semper Vigilentes – Med Review as a SOP

  4. The Demographic Imperative • Population Explosion • Where we are: • Over 65 years old: 12.9% of population • Over 75: 6.1% 18,766,000 • Where we’re going US Census Bureau

  5. Prevalence of Multimorbidities Arch Intern Med. 2002;162(20):2269-2276. doi:10.1001/archinte.162.20.2269

  6. …which influence prognosis Risk for Mortality in Frail Elders Risks: Male = 2 points CHF = 3 points Age >85 = 3 points Carey EC et al. JAGS 2008;56:68–75.

  7. Nonetheless, Demographically… • Compression of Morbidity Fries, 1982

  8. The Search for Clinical Decision Making Tools • Large heterogeneity  difficult to find applicable studies • “No index…prospectively tested and found to be accurate in a large diverse sample…no study was completely free from potential sources of bias. Testing of transportability was limited, raising concerns about overfitting and underfitting. These factors limit a clinician's ability to assess the accuracy of these indices across patient groups that differ according to severity of illness, methodology of data collection, geographic location, and time.” • The Controversy • How far can we extrapolate data for this population? • To what extent can we base clinical practice on biologic plausibility in the absence of clinical trail data?

  9. Importance of Multimorbidity Brendan Smialowski (NY Times) • Over 50% of older adults have 3+ chronic conditions • Increased risk of: • Death • Institutionalization • Increased utilization of healthcare resources • Decreased quality of life • Higher rates of adverse effects of treatment or interventions • Almost all existing “guidelines” have single disease focus • Best approaches to decision-making and clinical management of older adults with multimorbidity remain unclear

  10. Prevalence of Polypharmacy… Qato et al JAMA 2008: 300(24): 2867-2878

  11. Treatment Complexity & Feasibility • Difficult to define a uniform threshold for treatment complexity and feasibility • Influenced by • Treatment regimen • Older adult’s unique characteristics • Barriers to assessing complexity and feasibility • Time-consuming • Lack of necessary training

  12. Drugs are not benign Kongkaew C, et al. Annals of Pharmacotherapy 2008; 42:1017-1025 Budnitz et al. N Engl J Med 2011;365:2000-12. Beers MH. Arch Internal Med. 2003 ~100,000 emergency hospitalizations/year due to adverse drug events (ADEs) 10.7% of hospital admissions in older adults “If medication related problems were ranked as a disease, it would be the fifth leading cause of death in the US!”

  13. Pharmacokinetics Change with Age • Absorption • Other drugs, nutrition, gastric emptying • Distribution • ↑adipose/↓lean, water • Binding/Localization • ↓albumin • Biotransformation • ↓Hepatic Clearance (some drugs), great variability • Elimination • ↓GFR …and diminished homeostatic reserve

  14. Need for Balance Risk… Rane A, Lindh JD. Hum Genomics Proteomics 2010

  15. …mitigated by other meds…. Rane A, Lindh JD. Hum Genomics Proteomics 2010

  16. Need for Balance Benefit… Rane A, Lindh JD. Hum Genomics Proteomics 2010

  17. Need for Balance Benefit…all of it! Rane A, Lindh JD. Hum Genomics Proteomics 2010

  18. Need for Balance Is the effect statistically and/or clinically significant? % event-free Is there a wide variation in time to benefit, or by subgroups? TIME

  19. Diabetes Mellitus • Drug withdrawal study in 17 nursing homes in patients with HbA1c <6: safe to discontinue all oral meds, and stop or reduce insulin ADA Standards of Medical Care in Diabetes 2012. Sjoblom P. Diabetes Res Clin Prac 2008; 82:197-202. Less stringent control reasonable in those with a long history of diabetes, limited life expectancy, or comorbid conditions

  20. Top Five Problematic Medication Classes leading to ED • Hematologic • Endocrine agents • Cardiovascular agents • Central Nervous System Agents • Anti-infective Oral Hypoglycemic 67% Oral Antiplatelet Warfarin Insulin Budnitz et al. N Engl J Med 2011;365:2000-12.2

  21. …including time to benefit Proportion in the PROSPER Trial with CHD Death, Non-Fatal MI, or Stroke PROSPER. Lancet 2002; 360: 1623–30.

  22. Osteoporosis 50% reduction in risk of fracture over a 3 year period 1.2% absolute risk reduction for fractures in 3 years bisphosphonate % fracture-free placebo Time to benefit 9 to 18 mos Median life expectancy: 2.7- 4.7 years Prevention of osteoporotic fracture Benefits possibly similar in men, but data is extrapolated from studies of women TIME National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis, 2009

  23. No “best” approach to either communicate prognosis nor effect “optimal” clinical decision making • Guidelines lack adequate ways to assess prognosis • Published prognosis measures have limited generalizability • Overwhelming to evaluate prognosis • Uncertainty in how to use prognostic measures in clinical practice

  24. Consider patient preferences… • Influenced by the way risk information is presented to the patient • Multimorbidity patients face more preference-based and complex decisions • Eliciting preferences may make clinical management more time-consuming

  25. …and patient capabilities • Medication Management Capacity • Drug Regimen Unassisted Grading Scale (DRUGS) • Edelberg HK, Shallenberger E, Wei JY. Medication management capacity in highly functioning community-living older adults: detection of early deficits. J Am Geriatr Soc. 1999 May;47(5):592-6. • Hopkins Medication Schedule (HMS) • Carlson MC, Fried, LP, Xue QL, et al. Validation of the Hopkins Medication Schedule to Identify Difficulties in Taking Medications Journal of Gerontology: Feb 2005;60A,2: Health Module 217-223 • Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE) • Orwig D, Brandt N, Gruber-Baldini, A. Medication Management Assessment for Older Adults in the Community. The Gerontologist 2006;46:661-668

  26. PUTTING IT ALL TOGETHER…

  27. Inappropriate Prescribing • Methods to Look at Inappropriate Prescribing e.g.: • American Geriatrics Society 2012 Beer’s Criteria • STOPP (Screening Tool of Older Persons’ potentially inappropriate Prescriptions) • START (Screening Tool to Alert doctors to the Right Treatment) • Clinical Judgment Hamilton HJ. Inappropriate Prescribing and adverse drug events in older people. BMJ Geriatrics (2009). Accessed at www.biomedcentral.com/1471-2318/9/5 Bergert FW, Conrad D, Ehrenthal EJ et al. Pharmacotherapy Guidelines for the aged by family doctors for the use of family doctors. Inter J Clin Pharm Ther (2008) 46:600-616.

  28. HISTORY AND DEVELOPMENT OF THE AGS 2012 BEERS CRITERIA

  29. Mark H Beers, MD • 1954-2009 • “ A ballet-dancing opera critic who hiked the Alps and took up rowing after diabetes cost him his legs” • MD, University of Vermont • First medical student to do a geriatrics elective at Harvard‘s new Division on Aging • Geriatric Fellowship, Harvard • Faculty, UCLA/RAND • Co-editor, Merck Manual of Geriatrics • Editor in Chief, Merck Manuals

  30. Beers Criteria: History and Utilization • Original 1991 – Nursing home pts • Updates • 1997: All elderly; adopted by CMS in 1999 for nursing home regulation • 2003: Era of generalization to Med D, then NCQA, HEDIS • 2012: Further adoption into quality measures

  31. Specific Aims AGS 2012 Beers Criteria Specific aim – update 2003 Beers Criteria using a comprehensive, systematic review and grading of evidence Strategy: • Incorporate new evidence • Grade the evidence • Use an interdisciplinary panel • Incorporate exceptions

  32. Method Framework • Expert panel • 11 members • IOM 2011 report on guideline development • Includes a period for public comment • Literature search

  33. Panel Members Nonvoting Panelists Robert Dombrowski, PharmD (CMS) David Nau, PhD (PQA) Bob Rehm (NCQA) AGS Staff Christine Campenelli Elvy Ickowicz, MPH Others Sue Radcliff (research) Susan Aiello, DVM (editing) • Co-chairs • Donna Fick, PhD • Todd Semla, MS, PharmD • Panelists (voting) • Judith Beizer, PharmD • Nicole Brandt, PharmD • Catherine DuBeau, MD • Nina Flanagan, CRNP,CS-BC • Joseph Hanlon, PharmD, MS • Peter Hollmann, MD • Sunny Linnebur, PharmD • Stinderpal Sandhu, MD • Michael Steinman, MD

  34. Method • Literature search: ADE, inappropriate drug use, med errors, polypharmacy x age/human/English 25,549 citations 12/1/2001 – 3/30/2011 19,044 excluded 6,505 prelim review 4238 excluded 2,267 reviewed by co-chairs Additional searches, additions 844 excluded 2169 reviewed Additional searches, additions 258 included in evidence tables

  35. Method • Survey to panel to rate (strong agreestrong disagree) • 2003 Beers meds • New additions • Ratings tallied, shared with panel, 2 rounds of consensus • In-person: review survey draft and lit search • 4 groups reviewed lit, selected citations • Evidence tables prepared, rated quality of evidence and strength of recommendation • Final group consensus

  36. Designations of Quality and Strength of Evidence: ACP Guideline Grading System, GRADE Quality • High Evidence • Consistent results from well-designed, well-conducted studies that directly assess effects on health outcomes (2 consistent, higher-quality RCTs or multiple, consistent observational studies with no significant methodological flaws showing large effects) • Moderate Evidence • Sufficient to determine effects on health outcomes, but the number, quality, size, or consistency of included studies, generalizability, indirect nature of the evidence on health outcomes (1 higher-quality trial with > 100 participants; 2 higher-quality trials with some inconsistency, or 2 consistent, lower-quality trials; or multiple, consistent observational studies with no significant methodological flaws showing at least moderate effects) limits the strength of the evidence • Low Evidence • Insufficient to assess effects on health outcomes because of limited number or power of studies, large and unexplained inconsistency between higher-quality studies; important flaws in design or conduct, gaps in the chain of evidence • Or lack of information on important health outcomes

  37. Designations of Quality and Strength of Evidence: ACP Guideline Grading System, GRADE Strength of recommendation • Strong: • Benefits clearly > risks and burden OR risks and burden clearly > benefits • Weak: • Benefits finely balanced with risks and burden • Insufficient: • Insufficient evidence to determine net benefits or risks

  38. AGS 2012 BEERS CRITERIACLINICAL HIGHLIGHTS & EVIDENCE

  39. Need for Updates or New Criteria • Continuous arrivals of new drugs on the market1 • Older formulations unavailable in European formularies2 • Only 12-21% of the medications identified are being used by older adults3 • Tangible benefit to patients in terms of clinical outcomes2 Fick D, Cooper J, Wade W, et al. Arch Intern Med 2003;163:2716-2724 1 Hamilton H, Gallagher P, Ryan C, Arch Intern Med 2011;171(11):1013-1019 2 Rudolph J, Salow M, Angelini M et al. Arch Inern Med 2008; 168 (5): 508-513 3

  40. Beers Criteria- 3 Main Tables • Table 2: Medications or medication classes that should be avoided in persons 65 years or older • Table 3: Medications that should not be used in older person known to have specific medical diseases or conditions. • Table 4: Medications that should be used with caution

  41. Beers Criteria: Overall Results • A total of 53 medications or medication classes, which are divided into three tables. • Constructed and organized by: • major therapeutic classes and • organ systems

  42. Beers Criteria: Table 2 Results • 34 potentially inappropriate medications/classes to avoid in older adults independent of diagnoses or conditions. • Notable mentions: • Sliding Scale Insulin • Antipsychotics for Behavioral Health issues associated with dementia • Non benzodiazepine Hypnotics • Megestrol

  43. Sliding Scale Important to look at during transitions in care due to the fact that PO Diabetes meds are stopped when they are admitted and typically have insulin protocols in place.

  44. Antipsychotics Timely addition with the increased focus on safety and efficacy in patients on these medications especially within the nursing home setting.

  45. Non Benzodiazepine Hypnotics

  46. Megestrol

  47. Beers Criteria: Table 3 Notables

  48. Beers Criteria: Table 3 Notables

  49. Beers Criteria: Table 4 Notable Mentions

  50. Limitations • Older adults often under-represented in drug trials potentially underestimating medication related problems/evidence grading. • Does not comprehensively address the needs of palliative and hospice care patients • Does not address other types of potential potentially inappropriate medications • e.g.: • dosing of primarily renally eliminated medications, • drug-drug- interactions

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