NAVIGATING THE BEERS CRITERIA:
BALANCING MEDICATION SAFETY AND EFFICACY IN THE
GERIATRIC PATIENT KIMBERLY GRANT, PHARM.D.
DISCLOSURE STATEMENT
I, the speaker, have no relative financial relationships to disclose.
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
BACKGROUND: PIM
Potentially Inappropriate Medication (PIM)
Risk > Benefit
The Beers Criteria is the most cited resource in
regards to PIMs
Hanlon JT, et al. Geriatric Pharmacotherapy and Polypharmacy. Brocklehurst’s Textbook of Geriatric Medicine. 2010:880-885.
Beers List/Criteria. American Society of Consultant Pharmacists. Online. Available at: https://www.ascp.com/articles/beers-list-criteria
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
National Center for Health Statistics. Health, United States, 2011: With Special Feature on Socioeconomic Status and Health. Hyattsville, MD. 2012 http://www.cdc.gov/nchs/data/hus/hus11.pdf
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;60:616-631.
http://www.americangeriatrics.org/files/documents/beers/2012BeersCriteria_JAGS.pdf
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
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.
Estimated Annual Cost of Medication Related Problems. American Society of Consultant Pharmacists. 2014. Available at: https://www.ascp.com/articles/about-ascp/ascp-fact-sheet
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. 2010:880-885.
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;69:543-552. Abstract
BACKGROUND: AGE RELATED CHANGE
Pharmacokinetics
Absorption
Distribution
Metabolism
Excretion
Pharmacodynamics
Homeostatic Regulation
Disease States
Body Weight
Adherence
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: http://www.news-medical.net/image.axd?picture=2009%2f12%2fch3_liver.jpg
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: https://www.ascp.com/articles/beers-list-criteria
BACKGROUND: AGS BEERS CRITERIA
Who is included?
Age ≥ 65
Excludes palliative care
Excluded hospice care
BACKGROUND: AGS BEERS CRITERIA TIMELINE
1991 1997 1999 2003 2012 2015
The Beers List is
first released AGS assumes responsibility for Beers
Update CMS adopts Beers Criteria
• 6 panelists
• Added PIMS
• Medications to avoid
• Maximum dose
• 12 panelists
• Drug-disease interactions
• Drugs with safer alternatives
• Added new PIMS
• Added strength and
quality ratings
Beers List/Criteria. American Society of Consultant Pharmacists. Online. Available at: https://www.ascp.com/articles/beers-list-criteria
BACKGROUND: AGS BEERS CRITERIA
Literature search August 1, 2011- 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. 2015.
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
2015 UPDATES AGS BEERS CRITERIA
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. 2015.
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
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;57:335–340. AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS. 2015.
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. 2010:880-885
AGS BEERS CRITERIA: RENAL DOSING RECOMMENDATIONS
Drugs to avoid in reduced renal function
Drugs Estimated CrCl
(mL/min)
Amiloride < 30
Colchicine 10-29
Duloxetine <30
Fondaparinux <30
Probenecid <30
Spirinolactone <30
Tramadol (ER) <30
Triamterene <30
Drugs Est CrCl
(mL/min)
Apixaban <15
Dabigatran <30
Edoxoban <30
Rivaroxaban <30
NOACS
AGS BEERS CRITERIA: RENAL DOSING RECOMMENDATIONS
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 15-25 (SCr ≥ 1.5 mg/dL + ≥ 80 yo or BW ≤ 60 kg <15
Cimetidine <50: Administer ½ of normal dose
Colchicine <30: Monitor for adverse effects <10
Dabigatran 30-50 + 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 <60: Increase dosing interval
Levetiracetam <80: Reduce dose
Pregabalin <60: Dosing chart based on indication
Ranitidine <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
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 + 500 MG QPM
E. 500 MG QAM + 400 MG QPM
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
30-59 mL/minute 200 to 700 mg twice daily
15-29 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. 2016.
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
CASE EXAMPLE: GABAPENTIN
Increase the dose, not the interval
Total daily dose = 300mg + 300 mg + 300 mg= 900 mg
Recommend gabapentin 400 mg in the
morning and 500 mg at bedtime.
AGS BEERS CRITERIA: RENAL DOSING RECOMMENDATIONS
Dosing of primarily renally cleared anti-infectives
Drug Est CrCl (mL/min) Maximum Dosage
Acyclovir 10-29
<10
800 mg q8h
800 mg q12h
Amantadine 30-59
15-29
<15
100 mg qd
100 mg q48h
100 mg q7d
Ciprofloxacin <30 500 mg q24h
Nitrofurantoin <30 Avoid
Valacyclovir 30-49
10-29
<10
1000 mg q12h
1000 mg q24h
500 mg q24h
Hanlon JT et al., JAGS 2009;57:335–340
AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS. 2015.
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. 2015.
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. 2015.
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. 2015.
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
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. 2015.
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
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
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
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
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. 2015.
NITROFURANTOIN
Historically warned against use if creatinine clearance < 40 mL/min
In 2003 warning was changed to < 60 mL/min
4 studies between 1958-1971 included patients with “poor” renal function
Recently, 3 retrospective trials have looked at nitrofurantoin use in presence of impaired renal functioning
1. 2009: hospitalized patients CrCl <50 mL/min vs. > 50 mL/min
2. 2013: outpatient women CrCl 50 mL/min
3. 2015: 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;47:106-111.
Bains A, Buna D, Hoag NA. A retrospective review assessing the efficacy and safety of nitrofurantoin in renal impairment. Can Pharm J. 2009;142:248-252.
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;69:1701-1707.
Singh N, Gandhi S, McArthur E, et al. Kidney function and the use of nitrofurantoin to treat urinary tract infections in older women. CMAJ. 2015 Jun 16;187(9):648-56. doi: 10.1503/cmaj.150067. Epub 2015 Apr 27.
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. 2015.
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.
2015 PIMS CHANGES
Avoid amiodarone as first-line treatment for
Atrial fibrillation
Dronedarone
Disopyramide
Digoxin
Hon-Chi L, Huang KT, Win-Kuang S. Use of antiarrhythmic drugs in elderly patients. J Geriatr Cardiol. 2011 Sep; 8(3): 184-194
AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS. 2015.
ANTIARRHYTHMICS IN THE ELDERLY
Increased risk of drug-drug interactions
Age-related changes in ADME processes
Individualize use
Device therapy
Anticoagulation
Ablation
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. 2015.
2015 PIMS CHANGES
Avoid use of sliding scale insulin
Refers to use of short-acting or
bolus insulin
Does not apply to titration schedules
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: http://www.nps.org.au/medicines/digestive-system/indigestion-reflux-and-stomach-ulcer-medicines/heartburn-and-reflux-medicines/for-health-professionals/pharmacology
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): 431-455.
FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs). February 8, 2012. Available online at: http://www.fda.gov/drugs/drugsafety/ucm290510.htm#hcp
American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS 2015.
HOW TO UTILIZE THE BEERS CRITERIA? PRACTICE APPLICATION
APPLICATION OF BEERS CRITERIA
Improve medication selection
Decrease number of adverse drug events
Improve quality of care
Cost avoidance
RESOURCES
Companion article
AGS iGeriatrics
Educational materials
National Library of Medicine’s Medline Plus
www.nlm.nih.gov/medlineplus/druginformation.html
www.nursinghometoolkit.com
www.hospitalelderlifeprogram.org
2015 COMPANION ARTICLE
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.
KEY PRINCIPLES TO APPLICATION
Clinical
Health System
Payor
Journal of the American Geriatrics SocietyVolume 63, Issue 12, pages e1-e7, 8 OCT 2015 DOI:
10.1111/jgs.13701http://onlinelibrary.wiley.com/doi/10.1111/jgs.13701/full#jgs13701-fig-0002
APPLICATION
“Any symptom in an older adult is a
medication side effect until proven
otherwise”
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
Medication list:
• Allopurinol 100 mg BID
• Aspirin 81 mg chewable QD
• Digoxin 0.125 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
Past medical history:
•CHF
•Diabetes- type II
•Hypothyroidism
•Gout
•Atrial fibrillation
•Hypertension
•Hyperlipidemia
•Osteopenia
•DJD
•Hx. Heart attack
•Hx. Breast cancer
CASE QUESTIONS 1-3:
Which medication(s) would warrant discontinuation according to the 2015 Beers
Criteria?
A. Aspirin 81 mg
B. Digoxin 0.125 mg
C. Pantoprazole 40 mg
D. Metformin 500 mg
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?
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?
THANK YOU
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