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AGS UPDATED 2015 BEERS CRITERIA FOR POTENTIALLY INAPPROPRIATE MEDICATION USE IN OLDER ADULTS Disclosures Conflict of Interest Dr. Beizer is an author and editor for LexiComp, Inc. Dr. Brandt is a consultant for Omnicare, Centers for Medicare and Medicaid Services, and University of Pittsburgh and a Section Editor for the Journal of Gerontological Nursing and received a grant from Econometrica. Dr. Fick is a paid consultant for SLACK Inc., is an editor for the Journal of Gerontological Nursing, and has current R01 funding from the National Institutes of Health and the National Institute of Nursing Research. Dr. Linnebur is a consultant for Colorado Access and Kindred Healthcare. Dr. Semla serves on the AARP Caregiver Advisory Panel, is an editor for Lexi-Comp, and is a consultant for Omnicare. Dr. Semla’s wife holds commercial interest in AbbVie (at which she is also an employee), Abbott, and Hospira. Dr. Semla receives honoraria from the AGS for his contribution as an author of Geriatrics at Your Fingertips and for serving as a section editor for the Journal of the American Geriatrics Society and is a past president and chair of the AGS Board of Directors. Dr. Steinman is a consult for Iodine.com, a web start-up company. Author Contributions All panel members contributed to the concept, design, and preparation of the manuscript. Sponsor’s Role AGS staff participated in the final technical preparation and submission of the manuscript. Objectives Understand commonly used medications that should be avoided in the elderly. Understand how to use the 2015 Beer’s list in clinical decision making. 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, Univ of Vermont First med 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 Original Purpose 1991 Original Beers Criteria Evaluate inappropriate Rx used in NH residents in “common” situations, but under “certain circumstances” might be appropriate (e.g., using amitriptyline to treat pt with both Parkinson’s disease and depression) Clinical research on use of Potentially Inappropriate medications (PIMs) QA/QI Education of students, residents Beers Criteria: History and Utilization Original 1991 – Nursing home pts Updates 1997 2003 2012 All elderly; adopted by CMS in 1999 for nursing home regulation Era of generalization to Med D, then NCQA, HEDIS First AGS Updated Beers Criteria Released, Further adoption into quality measures 2015 AGS Beers Criteria Update Specific aim: Update 2012 Beers Criteria using a comprehensive, systematic review and grading of evidence Strategy – same as 2012: 1. Incorporate new evidence 2. Grade the evidence 3. Use an interdisciplinary panel 4. Incorporate exceptions 2015 AGS Beers Criteria Update What’s New Two New Tables 1. Drug-Drug Interactions Table 2. Renal Dosage Table Two New Companion Pieces 1. How to Use Paper 2. Beers Alternatives 2015 AGS Beers Criteria Update What’s New 1. New Drugs – Table 2 1. PPI’s > 8 weeks without justification 2. Desmopressin for treatment of nocturia or nocturnal polyuria 2. New Drugs – Table 3 1. Eszopiclone and zaleplon added to list of drugs to avoid in dementia or cognitive impairment 2. Opioids added to list of drugs to avoid in patients with history of falls Intent of the AGS 2015 Beers Criteria Goals: Improve care by ↓ exposure to PIMS Educational tool Quality measure Research tool Method Framework Expert panel • 13 members Followed IOM 2011 recommendations on guideline development • Includes a period for public comment Literature search Evidence tables prepared, rated quality of evidence and strength of recommendation Panel Members Co-chairs • Donna Fick, PhD, RN, FAAN • Todd Semla, MS, PharmD Panelists (voting) • • • • • • • • • • • Judith Beizer, PharmD Nicole Brandt, PharmD Catherine DuBeau, MD Jerome Epplin, MD Nina Flanagan, CRNP,CS-BC Joseph Hanlon, PharmD, MS Peter Hollmann, MD Rosemary Laird, MD, MHSA Sunny Linnebur, PharmD Satinderpal Sandhu, MD Michael Steinman, MD Nonvoting Panelists • Robert Dombrowski, PharmD (CMS) • Woody Eisenberg, MD (PQA) • Erin Giovannetti (NCQA) AGS Staff • Elvy Ickowicz, MPH • Mary Jordan Samuel Others • • • • Sue Radcliff (research) Susan Aiello, DVM (editing) Gina Rocco (research) Jirong Yue (research) Assembling the Evidence SEARCH TERMS: ADE, inappropriate drug use, med errors, polypharmacy x age/human/English Initial Search (8/1/2001-7/1-2014) n=27,467 citations Records reviewed by co-chairs n=3,387 Records Screened by Full Panel (n=1,188 citations) Studies Used to create Evidence Tables (n=342) Designations of Quality and Strength of Evidence: ACP Guideline Grading System, GRADE QUALITY OF EVIDENCE GRADING—USING GRADE High Evidence Moderate Evidence Low Evidence Designations of Quality and Strength of Evidence: ACP Guideline Grading System, GRADE STRENGTH OF RECOMMENDATION—HOW DID WE DO THIS? Strong Benefits clearly outweigh harms, adverse events, and risks – or – harms, adverse events, and risks clearly outweigh benefits. Weak Benefits finely balanced with harms, adverse events, and risks. Insufficient Evidence inadequate to determine net harms, adverse events, and risks. Not included in Beer’s List Drugs with risks not unique to elderly • Purpose is for PIMs specific to elderly Drugs used with patients in the hospice and palliative care setting Tables Table 2 – PIM list (with some selective caveats) Table 3 – PIMs due to Drug – Disease/Syndrome Interaction Table 4 – Medications to be used with caution Table 5 – Non-Anti-infective Drug-Drug Interactions Table 6 – Non-Anti-Infective Medications that should be avoided or have dosage reduced with varying levels of kidney function Table 7 – Drugs with strong anticholinergic properties Table 8 – Medications Moved or Modified Table 9 – Medications Removed Table 10 – Medications Added Table 2. Drugs to Avoid (except if…) Organ System or TC or Drug Rationale Recommend. Quality of Evidence Strength of Recommend. Nitrofurantoin Pulmonary and hepatic toxicity, peripheral neuropathy; Lack of efficacy <30 mL/min Avoid long term suppression; avoid if CrCl <30 mL/min Low Strong Antipsychotics (conventional or atypical) Increase CVA risk; increased cognitive decline and mortality in dementia Avoid unless danger to self/others and non pharm has failed Moderate Strong Insulin, sliding scale Hypoglycemia risk Avoid Moderate Strong Chlorpropamide Glyburide Hypoglycemia risk Avoid High Strong Table 2. Drugs to Avoid (except if…) Organ System or TC or Drug Rationale Benzodiazepines Short and long acting Recommend. Quality of Evidence Strength of Recommend. Risk cognitive Avoid effects and injury (fall/MVA); may be appropriate, eg EtOH withdrawal Moderate Strong Megestrol Minimal effect on Avoid weight; risk of thrombotic events and death Moderate Strong Proton –pump inhibitors Risk of C. diff infection, bone loss and fractures High Strong Moderate Strong Avoid use for >8 weeks unless high-risk Non-COX NSAIDs, GI bleeding; Avoid chronic oral Protection w/ PPIs use or misoprostol Table 2. Drugs to Avoid (except if…) Organ System or TC or Drug Rationale Recommend. Quality of Evidence Strength of Recommend. Non Benzodiazepines Hypnotic s (“z” drugs) Risk cognitive effects and injury (fall/MVA); same ADE as benzo’s Avoid Moderate Strong Estrogens with or Carcinogenic w/o progestin potential, lack of efficacy in dementia/CV disease prevention Avoid oral and topical patch. Vaginal cream and tablets safe and effective for vaginal symptoms Oral and Oral and patch: high patch: strong Vaginal crm/tab: moderate Vaginal crm/tab: weak Muscle Relaxants Ineffective at tolerated doses, antichol, falls Avoid Moderate Strong Table 3. Drug-disease/syndrome Interactions Disease or Syndrome Drug Rationale Recomm. Quality of Evidence Strength of Recomm. Syncope AChEIs Peripheral αblockers Tert. TCAs Orthostatic hypotension or bradycardia Avoid α- blockers: High TCAs, AChEIs, antipsych: Moderate AChEIs, TCAs: Strong CNS stimulant effects Avoid Moderate Strong Chlorpromazine Thioridazine Olanzapine Insomnia Oral decongestants Stimulants Theobromines α- blockers, antipsych.: Weak Table 4. Use with Caution Drug Rationale Recommend Quality of Evidence Strength of Recommend Dabigatran Risk of bleeding; lack of evidence of efficacy if CrCl < 30mL/min Use with caution if >75 years old or if CrCl <30mL/min Moderate Strong Drugs linked to SIADH/ Hyponatremia (eg SSRI, TCA, CBZ, antipsychotics) May exacerbate or cause SIADH/ hyponatremia; monitor sodium level Use with caution Moderate Strong Previous Drugs to Avoid Dropped from 2015 AGS Beers Criteria DRUGS Antiarrhythmic drugs (Class 1a, 1c, III except amiodarone) Trimethobenzamide Rationale • New evidence suggests that rhythm control is just as good as rate control. • For treatment of apomorphine-induced nausea; evidence did not support its inclusion Mesoridazine • Off market in US Chloral hydrate • Off market in US Previous Disease and Syndrome Interactions Dropped from 2015 AGS Beers Criteria DRUGS Rationale Chronic Constipation • Syndrome is not applicable primarily to older adults. Lower Urinary Tract – Inhaled anticholinergic drugs • Evidence no longer compelling for inclusion Table 5. 2015 AGSBeers Criteria for Potentially Clinically Important Non-anti-infective Drug– Drug Interactions That Should Be Avoided in Older Adults Object Drug and Class Interacting Drug and Class Risk Rationale Recommendation Quality of Strength of Evidence Recommendation ACEIs Amiloride or triamterene Increased risk of Avoid routine use; hyperkalemia reserve for patients with demonstrated hypokalemia while taking an ACEI Moderate Strong Anticholinergic Anticholinergic Increased risk of Avoid, minimize cognitive number of decline anticholinergic drugs (Table 7) Moderate Strong Antidepressants (ie, ≥2 other CNSTCAs and SSRIs) active drugsa Increased risk of Avoid total of ≥3 CNS- Moderate Strong falls active drugsa; minimize number of CNS-active drugs Antipsychotics Increased risk of Avoid total of ≥3 CNS- Moderate Strong falls active drugsa; minimize number of CNS active drugs ≥2 other CNSactive drugsa Table 5, continued Object Drug and Class Interacting Drug and Class Benzodiazepines and ≥2 other CNS-active nonbenzodiazepine, drugsa benzodiazepine receptor agonist hypnotics Corticosteroids, oral NSAIDs or parenteral Lithium Lithium Opioid receptor agonist analgesics Risk Rationale Recommendation Quality of Evidence Increased risk of Avoid total of ≥3 CNS- High falls and active drugsa; fractures minimize number of CNS active drugs Avoid; if not possible, Moderate provide gastrointestinal protection Strong Avoid, monitor Moderate lithium concentrations Loop diuretics Increased risk of Avoid, monitor Moderate lithium toxicity lithium concentrations ≥2 other CNS-active Increased risk of Avoid total of ≥3 CNS- High drugsa falls active drugsa; minimize number of CNS drugs Strong ACEIs Increased risk of peptic ulcer disease or gastrointestinal bleeding Increased risk of lithium toxicity Strength of Recommendati on Strong Strong Strong Table 5, continued Object Drug and Class Interacting Drug and Class Peripheral, Alpha-1 Loop diuretics blockers Theophylline Cimetidine Warfarin Amiodarone Warfarin NSAIDs Risk Rationale Recommendation Quality of Evidence Strength of Recommendation Increased risk of urinary incontinence in older women Increased risk of theophylline toxicity Increased risk of bleeding Increased risk of bleeding Avoid in older women, unless conditions warrant both drugs Avoid. Moderate Strong Moderate Strong Avoid when possible; Moderate monitor INR closely Avoid when possible; High if used together, monitor for bleeding closely Strong Strong Table 6. 2015 American Geriatrics Society Beers Criteria for Non-Anti-Infective Medications That Should Be Avoided or Have Their Dosage Reduced with Varying Levels of Kidney Function in Older Adults Medication Class and Medication CrCL, mL/min, at Which Action Required Cardiovascular or hemostasis Amiloride <30 Rationale Recommendation Quality of Strength of Evidence Recommend ation Increased potassium Avoid and decreased sodium Increased risk of Avoid bleeding Moderate Strong Apixaban <25 Moderate Strong Dabigatran <30 Increased risk of bleeding Avoid Moderate Strong Edoxaban 30–50 <30 or >95 Increased risk of bleeding Reduce dose Avoid Moderate Strong Enoxaparin <30 Increased risk of bleeding Reduce dose Moderate Strong Fondaparinux <30 Increased risk of bleeding Avoid Moderate Strong Table 6, continued Medication Class CrCL, mL/min, at and Medication Which Action Required Rivaroxaban 30–50 <30 Spironolactone Triamterene <30 <30 Rationale Recommendation Quality of Evidence Increased risk of bleeding Reduce dose Avoid Moderate Strength of Recommenda tion Strong Increased potassium Increased potassium and decreased sodium Avoid Avoid Moderate Moderate Strong Strong Avoid Moderate Weak Reduce dose Moderate Strong Central nervous system and analgesics Duloxetine <30 Gabapentin <60 Increased gastrointestinal adverse effects (nausea, diarrhea) CNS adverse effects Levetiracetam ≤80 CNS adverse effects Reduce dose Moderate Strong Pregabalin <60 CNS adverse effects Reduce dose Moderate Strong Tramadol <30 CNS adverse effects Immediate release: reduce dose Extended release: avoid Low Weak Table 6, continued Medication CrCL, mL/min, at Class and Which Action Medication Required Gastrointestinal Rationale Recommendation Quality Strength of of Recommendati Evidence on Cimetidine <50 Mental status changes Reduce dose Moderat Strong e Famotidine <50 Mental status changes Reduce dose Moderat Strong e Nizatidine <50 Mental status changes Reduce dose Moderat Strong e Ranitidine <50 Mental status changes Reduce dose Moderat Strong e Colchicine <30 Gastrointestinal, neuromuscular, bone marrow toxicity Reduce dose; monitor for Moderat Strong adverse effects e Probenecid <30 Loss of effectiveness Avoid Hyperuricemia Moderat Strong e Key Principles on How To Use the Beers Criteria Medications in the Beers Criteria are potentially inappropriate, not definitely inappropriate. Read the rationale and recommendations statements for each criterion. The caveats and guidance listed there are important. Understand why medications are included in the Beers Criteria, and adjust your approach to those medications accordingly Optimal application of the Beers Criteria involves identifying potentially inappropriate medications, and where appropriate offering safer non-pharmacologic and pharmacologic therapies Key Principle on How To Use the Beers Criteria continued.. The Beers Criteria should be a starting point for a comprehensive process of identifying and improving medication appropriateness and safety Access to meds in the Beers Criteria should not be excessively restricted by prior authorization and/or health plan coverage policies The Beers Criteria are not equally applicable to all countries Uses of the Beers Criteria in Clinical Care Quality Prescribing Patient-centered Patient-specific goals Tolerance for deviation from EBM care guidelines Requires system-level approaches Quality Performance Measurement Population-centered Benchmark goals Less tolerance for deviation from EBM care guidelines Requires system-level approaches Beers Criteria only Part of Quality Prescribing Quality prescribing includes • Correct drug for correct diagnosis • Appropriate dose (label; dose adjustments for comorbidity, drug-drug interactions) • Avoiding underuse of potentially important medications (e.g., bisphosphonates for osteoporosis) • Avoiding overuse (e.g., antibiotics) • Avoiding potentially inappropriate drugs • Avoiding withdrawal effects with discontinuation • Consideration of cost Perceived Barriers to Appropriate Prescribing Polypharmacy, can’t review such a long list “Best” drugs may cost too much Worrying about drug interactions if making drug changes Time involved Difficulty communicating with pt’s other prescribing clinicians Lack of knowledge re Beers Lack of therapeutic alternatives Patient unwillingness to change Discomfort changing a med another clinician prescribed Ramaswamy R et al, J Eval Clin Pract 2011 What are the challenges of using them in clinical care? All of the above perceived barriers RN/Family Request Lack of Tested Non Drug Alternatives Multiple prescribers Risk of drug is less than risk of condition Palliative Care and other special cases and populations Take homes Don’t let the perfect be the enemy of the good Beers PIMs are only part of appropriate prescribing Target initiatives to high prevalence/high severity meds (based on local data, where possible) Stopping meds should be done with same consideration as starting Beers Criteria = Patient-centered care Limitations Evidence base available What’s not covered • Therapeutic duplication Special populations within geriatrics Search strategy - missed information Summary: AGS 2015 Beers Criteria Beers Criteria have come a long way since 1991 Are explicit criteria supported by evidence-based literature Guidelines for identifying medications whose risks>benefits in older adults Not meant to supersede clinical judgment or individual patient values or needs AGS Beers Criteria Resources Criteria • AGS Updated Beers Criteria • How-to-Use Article • Alternative Medications List Coming Soon! • Updated Beers Criteria Pocket Card • Updated Beers Criteria App Public Education Resources for Patients & Caregivers • AGS Beers Criteria Summary • 10 Medications Older Adults Should Avoid • Avoiding Overmedication and Harmful Drug Reactions • What to Do and What to Ask Your Healthcare Provider if a Medication You Take is Listed in the Beers Criteria • My Medication Diary - Printable Download • Eldercare at Home: Using Medicines Safely - Illustrated PowerPoint Presentation www.americangeriatrics.org Facebook.com/AmericanGeriatricsSociety Twitter.com/AmerGeriatrics linkedin.com/company/american-geriatrics-society