Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults

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2 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults Dr. Janice Hoffman, PharmD, CGP, FASCP Dr. Sam Shimomura, PharmD, CGP, FASHP Western University of Health Sciences College of Pharmacy October 2016

3 Disclosure Dr. Janice Hoffman has no conflict of interest to disclose. Dr. Sam Shimomura has no conflict of interest to disclose.

4 Pharmacist Learning Objectives Describe the physiological changes that occur in aging and how that may affect pharmacokinetics State at least three principles to consider when prescribing or recommending drug therapy for older adults Apply Beer s Criteria to patient cases

5 Pharmacy Technician Learning Objectives Identify the key physiological changes that occur in aging. List three characteristics of medications that meet the Beer s Criteria. Identify from patient cases at list 3 medications that are potentially not appropriate in the elderly according to Beer s Criteria.

6 Physiological changes with aging

7 Pharmacotherapy Pharmacotherapy in elderly is complicated by multi-factorial issues Age related physiologic changes Presence of multiple chronic disease states Cognitive changes Physical disabilities Patients desire vs. ability to comply to recommended medications

8 Change in Disease States Increased prevalence of disease Difficulty in differentiating often subtle adverse effects from the disease Drug-Disease Interaction or Exacerbation Anticholinergic drugs BPH Constipation Alzheimer s Disease Confusion Benzodiazepines Depression Dementia Gait

9 Aging Effects on the Body 2 Functional Systems Sensory Losses Oral Health Status GI Function Metabolism CV Function Functional Changes Reduced sense of taste, smell, sight, hearing, touch Xerostomia - dry mouth caused by hyposalivation Dentures and periodontal problems Hypochlorhydria Constipation Decreased glucose tolerance 15-20% decline in resting metabolic rate Blood vessels become less elastic and total peripheral resistance increases : cholesterol peak ~60 y.o. : total cholesterol & LDL continue to rise until ~70 y.o. 9

10 Question # 1 If Sally is 97 years old woman who is not eating well which of the following changes from aging may be contributing? A. Increase in drooling or hypersalivation to accommodate dentures B. Blood vessels become more elastic causing weakening in the legs C. Loss in sensory functions (smell, taste and sight) D. Increased gastric motility causing her to feel full faster

11 Changes in Absorption 1 Most oral drugs are absorbed via passive diffusion No major changes in bioavailability of drug due to age-related physiologic changes Decreased first-pass effect (e.g. Morphine, propranolol) results in : increased bioavailability higher plasma concentrations

12 Transdermal Absorption 1 skin hydration surface lipids peripheral circulation keratinization Outcome: Possible absorption from a transdermal patch

13 GI Absorption 1 gastric emptying rate intestinal motility intestinal blood flow and surface area gastric acid output - gastric ph Outcome: No significant change in quantity absorbed Time to onset or peak may be delayed

14 IM absorption 1 muscle mass peripheral circulation connective tissue Outcome: possible Intramuscular absorption

15 Distribution 1 Physiologic Changes in total body water Volume of distribution of hydrophilic drugs is in lean body mass (Scr will be ) in body fat Volume of distribution of lipophilic drugs is in albumin

16 Protein Binding Changes 1 serum albumin protein affinity binding alpha 1- acid glycoprotein Outcome: Increased free fraction of highly protein-bound medications

17 Question # 2 We find out that Sally our 97 years old patient is not eating well due to her Depression. Which of the following physiologic complications may occur? A. Increase in body fat will lead to larger distribution of hydrophilic drugs B. Decrease in albumin will lead to more free drug and more adverse effects C. Decrease stomach acid will lead to more drug being absorbed D. Increased absorption from a transdermal patch

18 Metabolism 2 Liver is the major organ for metabolism : Aging leads to: hepatic mass hepatic blood flow Decreased phase-i metabolism (oxidation) clearance half life of drug Side effects (e.g.. Diazepam, theophylline, quinidine, alprazolam) Phase II metabolism (conjugative) Less affected by age (e.g.. Lorazepam, oxazepam) CYP 450 activity limited changes

19 Aging and CYP Activity 2 Decreased Decreased or Unchanged Increased CYP 1A2 CYP 2C19 CYP 2A CYP 2C9 CYP 3A4 CYP 2D6 Cusack. Am Geriatr Pharmacother 2004: 2:274:

20 Other metabolic Influences 2 Factor Smoking Alcohol Drugs Diet Malnutrition Frailty Result Enzyme Induction Enzyme Induction Enzyme Induction/Inhibition Variable Enzyme Inhibition if severe Enzyme Inhibition 20

21 Renal Excretion 1 Physiologic Changes Renal blood flow GFR creatinine clearance (CrCl) Tubular secretion function Stable serum creatinine due to muscle mass Outcome: CrCl by 50% between age despite maintained SCr of 1.0 mg/dl.

22 Clinical Application of Renal Changes 1 Clinical Effects: half life of renally excreted drugs concentration of renally excreted drugs Significant for narrow therapeutic index Aminoglycosides Anticoagulants Primary goal: prevent toxicity

23 Question # 3 We also find out that our 97 year old patient smokes a pack of cigarettes daily and drinks 2 glasses of wine with dinner every night. How will these lifestyle choices affect her medications? Select the BEST answer A. Decrease renal elimination of her medications B. Contribute to liver enzyme Induction increasing hepatic elimination of her medications C. Enhance topical absorption of transdermal patches increasing adverse effects D. Decreased GI ph ( more acidic) increasing oral absorption of her medications

24 Pharmacodynamics Alterations in sensitivity to drugs with age Receptor sensitivity to: benzodiazepine, warfarin, opioids side effects Receptor sensitivity to beta-blockers Baroreceptor sensitivity Orthostatic hypotension with vasodilators, tricyclic antidepressants, antihypertensives Outcome: FALL risk 1

25 Etiology for Altered Pharmacodynamics Receptor changes in number of some receptors (β receptors) Altered reserve capacity Homeostatic changes Increased sensitivity to drug therapeutic & adverse effects Increased co-morbid diseases Increased drug interactions from polypharmacy 1

26 Pharmacodynamics Outcomes Antipsychotic agents - risk of Tardive Dyskinesia and psuedoparkinsonism (receptor sensitivity) sensitivity to anticholinergics increased side effects sensitivity to warfarin risk of bleeding renin and aldosterone levels response to ACE-I NSAID, ACE-I, K+ sparing diuretics risk of hyperkalemia 1

27 Pharmacogenomic Issues The genes you are born with are the genes you die with B. Williams USC No apparent changes during adult lifespan Possible decreased in CYP 3A4 and CYP 2A6 Fast and slow metabolizers (ethnicity) N-acetyltransferase activity Slow acetylators (autosomal recessive) 1

28 Applying these principles to patients Clinical response = PK + PD + Individual variance??? (Brad Williams USC professor)

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30 Beers Criteria History Dr. Mark Howard Beers with a team from Harvard, looked at prescriptions and case files for 850 residents of nursing homes around Boston. Researcher s found that sedatives, antidepressants and antipsychotic drugs often caused confusion or even physical tremors in patients. The teams finding were published in The Journal of the American Medical Association in 1988.

31 Beer s Criteria History This Boston study led to establish a list of drugs with known side effects on elderly. In the year 1991,this list of drugs was published known as Beers Criteria. Consist of Potentially Inappropriate Medications (PIM) for use in older adults

32 2012 AGS Beers update used the following criteria: Incorporated new evidence on currently listed PIMs and evidence from new medications or conditions not addressed in the 2012 update. Incorporated 2 new areas of evidence on drug-drug interactions and dose adjustments based on kidney function for select medications. Grade the strength and quality of each PIM statement based on level of evidence and strength of recommendation. 6

33 Goal of 2015 AGS Beers Criteria Improve care of older adults By reducing their exposure to Potentially Inappropriate Medications (PIM). Provide the evidence to support the PIM 8

34 Beers Criteria Exclusion Age less than 65 Hospice & Palliative care Inclusion Age 65 and older Intended for use in ambulatory, acute, and institutionalized setting of care in the United States. Modified Delphi method was used to systematically review and grade the evidence.

35 New ADDED changes in 2015 update Drug-Drug Interactions Effects of drug-drug interactions Renal Adjustment for drug Previously marked as avoid Clarification of drugs from 2012 list

36 Table 2 Beer s Potentially Inappropriate Medication(PIM) in Elderly : 2015 update Additions to Table 2 PIM PPI s for duration > 8 weeks Deletions to Table 2 PIM Anti-arrhythmic drugs (Class 1a,1c, III except amiodarone) as first-line treatment for atrial fibrillation Desmopressin Trimethobenazmide *Independent of Diagnoses or Condition 10

37 Table 3 Beer s in Elderly : 2015 update (Drug-drug and Drug-Disease Interactions) Medication ADDED to Table 3 Falls and fractures- Opioids REMOVED Chronic Constipation- Entire criterion Insomnia- Armodafinil & Modafinil Lower urinary tract- Inhaled anticholinergic drugs Dementia or cognitive impairment- Eszopiclone & Zaleplon Delirium- Antipsychotics 10 37

38 Table 5: Potentially clinically important Drug-Drug Interactions that should be avoided in older adults 10 Object Drug and Class Interacting drug and class Risk Rationale Recommendation Quality of Evidence Strength of recommendation Antidepressant (i.e., TCAs and SSRIs) 2 other CNS-active drugs Increased risk of falls Avoid total of 3 CNS-active drugs Moderate Strong Antipsychotic 2 other CNS-active drugs Increased risk of falls Avoid total of 3 CNS-active drugs Moderate Strong Hypnotics 2 other CNS-active drugs Increased risk of falls Avoid total of 3 CNS-active drugs High Strong 39

39 Table 5: Potentially clinically important Drug-Drug Interactions that should be avoided in older adults 10 Object Drug and Class Interacting drug and class Risk Rationale Recommendation Quality of Evidence Strength of recommendation Corticosteroids (po/iv) NSAIDs Increased risk of peptic ulcer/gi bleeding Avoid; if not possible provide GI protection Moderate Strong Lithium ACEIs Increased risk of toxicity Avoid, monitor lithium conc. Moderate Strong Warfarin Amiodarone Increased risk of bleeding Avoid when possible; Monitor INR Moderate Strong 40

40 Table 6: Non-Anti-Infective medications to AVOID or dose REDUCE in impaired kidney function in > 65 years 10 Medication Class/ Medication Creatinine Clearance (ml/min) Cardiovascular/Hemostasis Amiloride <30 Potassium Sodium Rationale Recommendation Quality of Evidence Avoid Moderate Strong Apixaban <25 bleeding Avoid Moderate Strong Dabigatran <30 bleeding Avoid Moderate Strong bleeding Reduce dose Strength of Recommendation Edoxaban <30 or >95 Avoid Moderate Strong 41

41 Table 6: Non-Anti-Infective medications to AVOID or dose REDUCE in impaired kidney function in > 65 years 10 (cont. 2) Medication Class/ Medication Creatinine Clearance (ml/min) Cardiovascular/Hemostasis Rationale Recommendation Quality of Evidence Strength of Recommendation Enoxaparin <30 bleeding Reduce dose Moderate Strong Fondaparinux <30 bleeding Avoid Moderate Strong Rivaroxaban bleeding Reduce dose Moderate Strong Spironolactone <30 Potassium Avoid Moderate Strong Triamterene <30 Potassium Sodium Avoid Moderate Strong 42

42 Table 6: Non-Anti-Infective medications to AVOID or dose REDUCE in impaired kidney function in > 65 years 10 (cont. 3) Medication Creatinine Clearance (ml/min) Rationale Recommendation Quality of Evidence Strength of Recommendation Central Nervous System and Analgesics Duloxetine <30 GI adverse effects Gabapentin <60 CNS adverse effects Levetiracetam 80 CNS adverse effects Avoid Moderate Weak dose Moderate Strong dose Moderate Strong Pregabalin <60 CNS adverse effects dose Moderate Strong Tramadol <30 CNS adverse effects Immediate release: dose ER: Avoid Low Weak 43

43 Question #4 Which of the following medications according to the Beer s Criteria Update 2015 should be absolutely be AVOIDED in an elderly patient with a CrCl < 30 ml/min due to risk of complications? A. Spironolactone due to risk of decreased potassium B. Apixaban due to increased risk of bleeding as C. Tramadol ER due to risk of increased CNS side effects D. Risperdone due to increased risk of Tardive Dyskinesia

44 Stakeholders and Star Ratings In 2007 star rating were created by CMS to help beneficiaries select insurance plans Plans were rated based on HEDIS scores, CMS Outcome scores and CMS data A 5-point scale - 5 = excellent and one was poor CMS met with 15 pharmacy associations, pharmacy benefit management companies and pharmacy chains in 2013 Outcomes: If health plans collaborate with community improved star ratings 45

45 Active Learning: Case Studies Please work in groups of MAX 6 people Refer to separate sheets on table 46

46 Case # 1 A 94yo female admitted to SNF s/p ORIF R hip 3 days ago. BP 104/68 HR 52 RR 18 Temp 98 She has no allergies and on the following medications: 1. Metoprolol XL 50mg po daily (HTN/Afib) 2. Amlodipine 5mg po daily in AM (HTN) 3. Furosemide 20mg + KCL 10mEq daily PRN ankle swelling 4. Atorvastatin 10mg po qhs (Hyperlipidemia) 5. Levothyroxine 50mcg daily AM (Hypothyroid) 6. Omeprazole 20mg po daily (GERD) 7. Metformin 500mg po daily AM (Diabetes Type II) 8. Enoxapirin 30mg SQ daily x 14 days 8. ASA 81mg po daily (CVA prevention) 9. Calcium w/ Vit D 1000mg BID (Osteoporosis) 10. Hydrocodone/APAP 7.5/750mg 1-2 tabs q4 hrs PRN mod pain 11. Morphine 2mg po q4h PRN severe pain 12. Oxybutynin 5mg BID PRN incr urination 13. Lorazepam 0.5mg q4h PRN anxiety 14. Temazepam 7.5mg qhs PRN sleep 15. Risperidone 0.5mg HS + q4h PRN agitation (screaming at hospital) 47

47 Question #5 Which of the following medications that is on the Beer s Criteria can easily be discontinued? A. Metoprolol XL B. Omeprazole C. Metformin D. Risperidone PRN

48 Case #1 Target #1 1. What meds could would be considered Potentially Inappropriate Medications according to the Beer s Criteria? 49

49 Case #1 Target #2 2. What labs should be monitored? 50

50 Case #1 Target #3 3. What potential drug-drug interactions exist in her medication regimen?

51 Case #1 Target #4 4. What ADR would you be concerned about? 52

52 Case #1 5. How should Antipsychotics be used in SNF? What are their risks vs. their benefits?

53 References 1. Cusack. Am Geriatr Pharmacother 2004: 2:274: O Mahoney&Woodhouse. Pharmacol Ther 1994;61: Resnik B, Pacala JT Beers Criteria. J AM Geriatr Soc; 2012; 60: DOI /j Beers, MH. Explicit criteria for determining potentially inappropriate medication use by the elderly. An update. Arch Intern Med 1997; 157: Fick DM, Cooper JW, Wade WE et al. Updating the Beers Criteria for Poteintally Inappropriate Medication Use in Older Adults: Results of consensus panel of experts. Arch Intern Med 2003; 163: The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. AGS updates Beers Criteria for potentially inappropriate medication use in older adults. J AM Geriatr Soc; 2012; 60: Steinmen, MA, Beizer, JL, DuBeau, CE, et al. How to Use the American Geriatrics Society 2015 Beers Criteria-a Guide for Patients, Clinicians, Health Systems, and Payors. J AM Geriatr Soc; 2015; 63: e1-e7 8. The American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J AM Geriatr Soc; 2015; 63: McCormick WC. American Geriatrics Society response to letter to the editor from Marc S. Berger Misuse of Beers Criteria July J. Am Geriatr. 2014; 62(12): AGS Beers Criteria and Evidence Tables. Published 2015 Accessed Hanlon JT, et al. Alternative medications for medications in the use of high-risk medications in the elderly and potentially harmful drug-disease interactions in the elderly quality measures. J Amer Geriatr Soc 2015;63:e8-e18 54

54 Acknowledgements Thank you to Aida Oganesyan, PharmD Brad Williams PharmD Azin Keyvani, PharmD Candidate 2017 Mariam Khachatryan, PharmD 55

55 Session Code: 1. Write down the course code. Space has been provided in the daily program-at-aglance sections of your program book. 2. To claim credit: Go to before December 1, 2016.