NAVIGATING THE BEERS CRITERIA: BALANCING MEDICATION SAFETY AND EFFICACY IN THE GERIATRIC PATIENT KIMBERLY GRANT, PHARM.D.

Transcription

1 NAVIGATING THE BEERS CRITERIA: BALANCING MEDICATION SAFETY AND EFFICACY IN THE GERIATRIC PATIENT KIMBERLY GRANT, PHARM.D.

2 DISCLOSURE STATEMENT I, the speaker, have no relative financial relationships to disclose.

3 LEARNING OBJECTIVES At the conclusion of this presentation, the audience will be able to: 1. Identify updates made to the American Geriatrics Society (AGS) Beers Criteria for Potentially Inappropriate Medication Use in Older Adults 2. Recommend alternatives to medications not recommended for use in the older adult 3. Identify supporting research and rationale for Beers recommendations 4. Discuss the role of the pharmacist to improve patient safety and wellness in the geriatric population

4 BACKGROUND: PIM Potentially Inappropriate Medication (PIM) Risk > Benefit The Beers Criteria is the most cited resource in regards to PIMs Beers List/Criteria. American Society of Consultant Pharmacists. Online. Available at: Hanlon JT, et al. Geriatric Pharmacotherapy and Polypharmacy. Brocklehurst s Textbook of Geriatric Medicine. 2010:

5 BACKGROUND Two-thirds of those over age 65 use 3 or more prescription drugs a month 42% of older adults have at least one medication filled that meets the requirement of a Potentially Inappropriate Medication (PIM) NSAIDs Sulfonylureas Estrogens Use of PIMs is associated with poor outcomes Falls Increased confusion Increased mortality The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012;60: National Center for Health Statistics. Health, United States, 2011: With Special Feature on Socioeconomic Status and Health. Hyattsville, MD

6 BACKGROUND Medication-related problems in community-dwelling seniors cost over $177 billion per year Hospital admission: $121.5 billion Long-term care admissions: $32.8 billion Physician costs: $13.8 billion Emergency department visit costs: $5.8 billion Estimated Annual Cost of Medication Related Problems. American Society of Consultant Pharmacists Available at: Ernst F. R., A. J. Grizzle. Drug-related morbidity and mortality: updating the cost-of-illness model. J Am Pharm Assoc 2001;41:192 9.

7 BACKGROUND Up to 25% of hospital admissions in the elderly may be drug-related ~16 % due to adverse drug reactions (ADRs) 5-11% due to therapeutic failures 1-9% due to adverse drug withdrawal effect (ADWEs) Hanlon JT, et al. Geriatric Pharmacotherapy and Polypharmacy. Brocklehurst s Textbook of Geriatric Medicine. 2010: Cahir C, Fahey T, Teeling M, Teljeur C, Feely J, Bennett K. Potentially inappropriate prescribing and cost outcomes for older people: a national population study. Br J Clin Pharmacol. 2010;69: Abstract

8 BACKGROUND: AGE RELATED CHANGE Pharmacokinetics Absorption Distribution Metabolism Excretion Pharmacodynamics Homeostatic Regulation Disease States Body Weight Adherence

9 BACKGROUND: AGE RELATED CHANGES Liver Decrease in size Decrease in blood flow Kidneys Decrease in mass Decrease in secretory function Decrease in blood flow Decrease in filtration rate Image available at:

10 BACKGROUND: AGS BEERS CRITERIA The American Geriatrics Society (AGS) first released The Beers List in 1991 under the direction of Dr. Mark Beers Consensus list of potentially inappropriate medications for long-term care facility residents Incorporated into CMS (Centers for Medicare & Medicaid Services ) Interpretive Guidelines in 1999 Beers List/Criteria. American Society of Consultant Pharmacists. Online. Available at:

11 BACKGROUND: AGS BEERS CRITERIA Who is included? Age 65 Excludes palliative care Excluded hospice care

12 BACKGROUND: AGS BEERS CRITERIA TIMELINE The Beers List is first released CMS adopts Beers Criteria AGS assumes responsibility for Beers Update Added new PIMS Added strength and 6 panelists quality ratings Added PIMS Medications to avoid Maximum dose 12 panelists Drug-disease interactions Drugs with safer alternatives Beers List/Criteria. American Society of Consultant Pharmacists. Online. Available at:

13 BACKGROUND: AGS BEERS CRITERIA Literature search August 1, July 1, 2014 Reviewed by 13 member interdisciplinary panel of geriatric experts 1,188 citations were chosen for full panel review Focusing on adverse drug events or adverse drug reactions AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

14 BACKGROUND: AGS BEERS CRITERIA 2015 Update: Literature search August 1,2011- July 1, 2014 Systematic reviews Meta-analyses Randomized controlled trials Observational studies 1,188 citations were chosen for full panel review AGS members also contributed evidence: 342 studies, 49 RCT, 233 other publications

15 2015 UPDATES AGS BEERS CRITERIA

16 AGS BEERS CRITERIA 2015 Update Added guidance on renally-dose adjusted medications Added section regarding drug-drug interactions Enhanced section regarding drug-disease interactions Incorporated new evidence for listed Potentially Inappropriate Medications (PIMS) Companion guide article AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

17 AGS BEERS CRITERIA: RENAL DOSING RECOMMENDATIONS 2015 update provides drugs to be avoided or dose-adjusted according to renal function Not to be utilized as a comprehensive list Anti-infectives are not included Adapted from published consensus guidelines organized by two Beers panelists +/- some medications AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS Hanlon JT, Aspinall SL, Semla TP et al. Consensus guidelines for oral dosing of primarily renally cleared medications in older adults. J Am Geriatr Soc 2009;57:

18 AGS BEERS CRITERIA: RENAL DOSING RECOMMENDATIONS Estimated Cockcroft-Gault Estimated MDRD Hanlon JT, et al. Geriatric Pharmacotherapy and Polypharmacy. Brocklehurst s Textbook of Geriatric Medicine. 2010:

19 AGS BEERS CRITERIA: RENAL DOSING RECOMMENDATIONS Drugs to avoid in reduced renal function Drugs Amiloride < 30 Colchicine Duloxetine <30 Fondaparinux <30 Probenecid <30 Spirinolactone <30 Tramadol (ER) <30 Triamterene <30 Estimated CrCl (ml/min) Drugs NOACS Apixaban <15 Dabigatran <30 Edoxoban <30 Rivaroxaban <30 Est CrCl (ml/min)

20 Drugs Est CrCl (ml/min): ADJUST Est CrCl (ml/min): AVOID Amiloride 30-50: Administer ½ normal dose < 30 (or SCr > 1.5 mg/dl, or BUN >30mg/dL) Apixaban (SCr 1.5 mg/dl + 80 yo or BW 60 kg <15 AGS Cimetidine BEERS CRITERIA: RENAL <50: Administer DOSING ½ of normal dose RECOMMENDATIONS Colchicine <30: Monitor for adverse effects <10 Dabigatran P-gp inhibitor: 75 mg BID <30: *75 mg BID based upon PK data Edoxaban 30-50: 30 mg once daily (Mft labeling): DVT, PE, Afib. <30 or >95 Enoxaparin <30 * Not FDA approved in dialysis Famotidine <50: Administer 50% of normal dose or increase interval (q36h or q48h) Fondaparinux 30-50: Administer 50% of normal dose or heparin <30 Gabapentin Levetiracetam Pregabalin Ranitidine <60: Increase dosing interval <80: Reduce dose <60: Dosing chart based on indication <50: Administer 150 mg q24h Rivaroxaban 30-50: 15 mg once daily (A.fib) <30 Spirinolactone 30-50: Maximum dose 25 mg daily <30 Tramadol <30: Increase dosing interval to q12h (IR) <30 Avoid (ER) Triamterene <30

21 QUESTION 1 For a patient with a creatinine clearance = 36mL/min using a total daily dose of 900 mg of gabapentin, which choice would represent a safe and effective dose of gabapentin? A. 300 MG TID B. 300 MG BID C. 400 MG BID D. 400 MG QAM MG QPM E. 500 MG QAM MG QPM

22 CASE EXAMPLE: GABAPENTIN Gabapentin Seizures Diabetic neuropathy Neuropathic pain Restless legs syndrome Anxiety Dosing recommendations >60 ml/minute 300 to 1,200 mg 3 times daily ml/minute 200 to 700 mg twice daily ml/minute 200 to 700 mg once daily <15 ml/minute Reduce daily dose in proportion to creatinine clearance Dialysis Dose based on CrCl plus a single supplemental dose of 125 to 350 mg (given after each 4 hours of hemodialysis) LexiComp Online

23 CASE EXAMPLE: GABAPENTIN Resident receiving Gabapentin 300 mg BID for anxiety. (Estimated CrCl ~ 36 ml/min) Increased behaviors noted Increase gabapentin 300 mg TID Resident experiences 3 falls within 2 weeks

24 CASE EXAMPLE: GABAPENTIN Increase the dose, not the interval Total daily dose = 300mg mg mg= 900 mg Recommend gabapentin 400 mg in the morning and 500 mg at bedtime.

25 AGS BEERS CRITERIA: RENAL DOSING RECOMMENDATIONS Dosing of primarily renally cleared anti-infectives Drug Est CrCl (ml/min) Maximum Dosage Acyclovir <10 Amantadine < mg q8h 800 mg q12h 100 mg qd 100 mg q48h 100 mg q7d Ciprofloxacin < mg q24h Nitrofurantoin <30 Avoid Valacyclovir < mg q12h 1000 mg q24h 500 mg q24h Hanlon JT et al., JAGS 2009;57: AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

26 AGS BEERS CRITERIA: RENAL DOSING RECOMMENDATIONS Narrow therapeutic range drugs: renal elimination is impaired with age Aminoglycosides Digoxin Lithium Methotrexate Vancomycin AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

27 AGS BEERS CRITERIA: DRUG-DRUG INTERACTIONS Drug-drug interactions associated with harmful outcomes included in 2015 update Excluding anti-infectives Described as selective and not comprehensive Highlight drug-drug interactions studied specifically in the elderly population AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

28 AGS BEERS CRITERIA: DRUG-DRUG INTERACTIONS Drug Interacting drug(s) Effect Management Lithium ACE inhibitors, Loop diuretics Increased lithium toxicity Decrease ACE or Loop dose Minimize therapy changes Monitor serum lithium 4-6 weeks after change Theophylline Cimetidine Ciprofloxacin Increased theophylline toxicity Change interacting drug therapy Anticipate change and decrease theophylline dose Warfarin NSAIDs Antibiotics Increased bleeding Switch Acetaminophen for NSAID Increase INR monitoring Decrease warfarin dose AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

29 CASE EXAMPLE: WARFARIN Increased INR = Increased bleeding risk Aspirin NSAIDs: Ibuprofen, Naproxen Antibiotics: Sulfamethoxazole-trimethoprim, Ciprofloxacin Decreased INR = Decreased effectiveness Rifampin Colestyramine Herbal supplements: St. John s wort Dietary supplements

30 AGS BEERS CRITERIA: DRUG-DRUG INTERACTIONS Drug Interacting Drug(s) Effects Management Benzodiazepines CYP3A4 Inhibitors Increased risk of hip fracture Use shorter-acting BZDs Calcium channel blockers Macrolides (excluding azithromycin) Increased risk of hypotension Increased monitoring Medication alternatives Digoxin Amiodarone Macrolides Verapamil Increased risk of digoxin toxicity Increased monitoring Appropriate dosing Phenytoin SMX/TMP Increased risk of phenytoin toxicity Antibiotic choice Increased monitoring Sulfonylureas SMX/TMP Macrolides Quinolones Hypoglycemia Alter therapy Patient education Tamoxifen Paroxetine Breast cancer Medication choice Hines LE, Murphy J. AJGP 2011; 9:364-7 AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

31 QUESTION 2 Which of the following choices represents a safe therapeutic alternative to lorazepam in a patient with dementia displaying sundowning behaviors? A. Temazepam 15 mg QHS PRN B. Melatonin 3 mf QHS C. Acetaminophen/diphenhydramine 1 tablet QHS D. Quetiapine 12.5 mg QHS PRN

32 CASE EXAMPLE: BENZODIAZEPINES Resident admitted following hospitalization for UTI receiving Ciprofloxacin 250 mg every 12 hours x 5 days. Resident has had increased confusion and wandering with baseline dementia. Lorazepam 0.5 mg every 6 hours PRN is ordered. Lorazepam 0.5 mg given at 2:39 am Resident falls at 4:30 am Lorazepam at 5:00 pm Resident falls at 7:25 pm

33 AGS BEERS CRITERIA: DRUG-DRUG INTERACTIONS Drug Interacting drug(s) Effect Management ACE/ARB Potassium supplements Increase in K+ Medication alternatives Alpha-1 blockers (peripheral) Loop diuretics Increase in urinary retention Medication alternatives Anticholinergic Anticholinergic Increased confusion Medication alternatives Antiplatelet NSAID Warfarin Increased bleeding Medication alternatives Increased monitoring (INR) Corticosteroid NSAID Increased bleeding Limit duration of use Medication alternatives CNS medications 2+ CNS medications Increase in falls Medication alternatives Falls prevention measures

34 AGS BEERS CRITERIA: DRUG-DISEASE INTERACTIONS Disease Drug Delirium/Dementia Anticholinergics, BZDs, H2 Blockers, Steroids Falls/Fractures AED, Antipsychotic, BZD, Opioids, SSRI, TCAs Heart Failure CCBs (non-dihydropyridine, Cilostazol, Dronedarone, Glitazones, NSAIDs Insomnia Amphetamines, Caffeine, Decongestants, Methylphenidate, Modafinil, Theophylline LUTS (Lower urinary tract symptoms) Anticholinergics Parkinson s Disease Antipsychotics (except clozapine), Metoclopramide Peptic Ulcer Disease NSAIDs Seizures Antipsychotics, Bupropion Syncope ACHE inhibitors, Alpha blockers, Antipsychotics, TCAs Urinary Incontinence Alpha blockers, Estrogen

35 AGS BEERS CRITERIA 2015 PIMS CHANGES Nitrofurantoin in individuals with creatinine clearance <30 ml/min Amiodarone as first-line treatment for Atrial fibrillation Nonbenzodiazepine and benzodiazepine hypnotics and consider duration of use Sliding scale insulin Proton-pump inhibitors beyond 8 weeks without justification for use Desmopressin for treatment of nocturia or nocturnal polyuria AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

36 NITROFURANTOIN Historically warned against use if creatinine clearance < 40 ml/min In 2003 warning was changed to < 60 ml/min 4 studies between included patients with poor renal function Recently, 3 retrospective trials have looked at nitrofurantoin use in presence of impaired renal functioning : hospitalized patients CrCl <50 ml/min vs. > 50 ml/min : outpatient women CrCl 50 ml/min : large retrospective review women > 65 yo median CrCl ~ 69 ml/min Oplinger M, Andrews CO. Nitrofurantoin contraindication in patients with a creatinine clearance below 60 ml/min: looking for evidence. Ann Pharmacother. 2013;47: Bains A, Buna D, Hoag NA. A retrospective review assessing the efficacy and safety of nitrofurantoin in renal impairment. Can Pharm J. 2009;142: Geerts AFJ, Eppenga WL, Heerdink R, et al. Ineffectiveness and adverse events of nitrofurantoin in women with urinary tract infection and renal impairment in primary care. Eur J Clin Pharmacol. 2013;69: Singh N, Gandhi S, McArthur E, et al. Kidney function and the use of nitrofurantoin to treat urinary tract infections in older women. CMAJ Jun 16;187(9): doi: /cmaj Epub 2015 Apr 27.

37 2015 PIMS CHANGES Avoid nitrofurantoin in individuals with creatinine clearance <30 ml/min Long term use in suppression therapy should still be avoided Irreversible pulmonary fibrosis Liver toxicity Peripheral neuropathy AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

38 NITROFURANTOIN Utilize appropriate antibiotic stewardship Suppression therapy? Guidelines for Antimicrobial Treatment of Acute Uncomplicated Cystitis and Pyleonephritis in Women. Infectious Disease Society of America. 2011; 52;52:e03-e120.

39 2015 PIMS CHANGES Avoid amiodarone as first-line treatment for Atrial fibrillation Dronedarone Disopyramide Digoxin AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS Hon-Chi L, Huang KT, Win-Kuang S. Use of antiarrhythmic drugs in elderly patients. J Geriatr Cardiol Sep; 8(3):

40 ANTIARRHYTHMICS IN THE ELDERLY Increased risk of drug-drug interactions Age-related changes in ADME processes Individualize use Device therapy Anticoagulation Ablation

41 2015 PIMS CHANGES Avoid non-benzodiazepine and benzodiazepine hypnotics without consideration of duration of use Diagnosis/ behavior intended to be treated Half-life/Metabolism Pharm versus Nonpharm AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS

42 2015 PIMS CHANGES Avoid use of sliding scale insulin Refers to use of short-acting or bolus insulin Does not apply to titration schedules

43 2015 PIMS CHANGES Avoid use of proton-pump inhibitors beyond 8 weeks without justification for use Bone loss Fracture Clostridium difficile infection (CDI) Image available at:

44 RISK FACTOR: PPI USE Recommendations & Rationale IDSA No recommendation other well controlled studies have suggested this association is the result of confounding with underlying severity of illness and duration of hospital stay. FDA Use lowest dose & shortest duration of therapy as appropriate to the condition being treated The role of PPI use cannot be definitively ruled out in these reviewed reports the weight of evidence suggests a positive association between the use of PPIs and C. difficile infection and disease Beers Avoid use of proton-pump inhibitors beyond 8 weeks without justification. Multiple studies and 5 systematic reviews and meta-analyses support an association between PPI exposure and CDI, bone loss, and fractures. Cohen et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol 2010; 31(5): FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs). February 8, Available online at: American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS 2015.

45 HOW TO UTILIZE THE BEERS CRITERIA? PRACTICE APPLICATION

46 APPLICATION OF BEERS CRITERIA Improve medication selection Decrease number of adverse drug events Improve quality of care Cost avoidance

47 RESOURCES Companion article AGS igeriatrics Educational materials National Library of Medicine s Medline Plus

48 2015 COMPANION ARTICLE

49 KEY PRINCIPLES TO APPLICATION Medications are potentially inappropriate Caveats are listed Understand the rationale Balance safer options: nonpharmacologic versus pharmacologic Starting point Provide access Steinman 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. JAGS. 2015;63: e1-e7.

50 KEY PRINCIPLES TO APPLICATION Clinical Health System Payor Journal of the American Geriatrics SocietyVolume 63, Issue 12, pages e1-e7, 8 OCT 2015 DOI: /jgs.13701http://onlinelibrary.wiley.com/doi/ /jgs.13701/full#jgs13701-fig-0002

51 APPLICATION Any symptom in an older adult is a medication side effect until proven otherwise

52 PRACTICE CASE An 89 yof is admitted to your facility following a hospitalization due to overall deconditioning and an episode of acute kidney injury. The patient has been living alone in a 2-story home, but has a large, supportive family. Her family claims she has a past history of frequent falls. Serum creatinine = 1.06 mg/dl Potassium = 5..2 Sodium = 139 Vital signs= 119/64 (80) Weight = 167 pounds Height= 65 inches Past medical history: CHF Diabetes- type II Hypothyroidism Gout Atrial fibrillation Hypertension Hyperlipidemia Osteopenia DJD Hx. Heart attack Hx. Breast cancer Medication list: Allopurinol 100 mg BID Aspirin 81 mg chewable QD Digoxin mg QD Diltiazem CD 120 mg QD Levothyroxine 100 mcg QAM Metformin 500 mg QAM Metoprolol tartrate 50 mg BID Pantoprazole 40 mg QD Simvastain 20 mg QHS Rivaroxaban 20 mg QPM

53 CASE QUESTIONS 1-3: Which medication(s) would warrant discontinuation according to the 2015 Beers Criteria? A. Aspirin 81 mg B. Digoxin mg C. Pantoprazole 40 mg D. Metformin 500 mg

54 CASE QUESTIONS 1-3 According to the 2015 Beers Criteria, Rivaroxaban 20 mg QPM is an appropriate choice for treating this patient s atrial fibrillation? True or false?

55 CASE QUESTIONS 1-3 The nursing staff reports that your patient has been eating <25% of her meals during the past few days and doesn t want to eat in the dining room with the other residents. She also declined activities yesterday. Are there any medications that could be contributing to this behavior?

56 THANK YOU