navigating the beers criteria: balancing medication safety...

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



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



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.


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 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.


Estimated Cockcroft-Gault

Estimated MDRD

Hanlon JT, et al. Geriatric Pharmacotherapy and Polypharmacy. Brocklehurst’s Textbook of Geriatric Medicine. 2010:880-885


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


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.


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


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.


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



Narrow therapeutic range drugs: renal elimination is impaired with age

Aminoglycosides

Digoxin

Lithium

Methotrexate

Vancomycin


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



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


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


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


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


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


(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


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


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


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


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.

http://www.fda.gov/drugs/drugsafety/ucm290510.htm#hcp

http://www.fda.gov/drugs/drugsafety/ucm290510.htm#hcp

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

http://www.nlm.nih.gov/medlineplus/druginformation.html

http://www.nursinghometoolkit.com/

http://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

navigating the beers criteria: balancing medication safety...

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