An Evidence-Based Algorithm for Deprescribing Diabetes Medications
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2019 MICNP Conference 3/23/2019 An Evidence-Based Algorithm for Deprescribing Diabetes Medications Caroline Trapp, DNP, ANP-BC, CDE, FAANP, DiplomateACLM Director of Diabetes Education and Care Physicians Committee for Responsible Medicine Washington, DC 1 Disclosure of Financial Conflicts of Interest for Caroline Trapp • None • Nada • Zip • Zero • Not a bit • Not an iota • Not a hint 2 1
2019 MICNP Conference 3/23/2019 Objectives 1. Describe the risks of antihyperglycemic medication use in elderly patients with type 2 diabetes. 2. Discuss appropriate use of an algorithm to safety deprescribe certain medications. 3 NPs and Rxs – A reasonable effort to prevent complications of T2DM 4 2
2019 MICNP Conference 3/23/2019 What 3 classes of medications for T2DM can cause hypoglycemia? • Insulin • Sulfonylureas • Meglitinides 5 Hypoglycemia 6 3
2019 MICNP Conference 3/23/2019 Severe Hypoglycemia - 20191 • Impaired cognition • Coma and physical function • Falls • Depression and • MVI or other injury reduced quality of life • ER visits and • Confusion, delirium hospitalizations • Loss of • Major cardiovascular consciousness events (within 3 • Seizure months – VADT)2 • Death 1. ADA Diabetes Care 2019;42(Suppl.1)S61-70 2. Davis SN et al. Diabetes Care 2018; doi:10.2337/dc18-1144 7 Repeated episodes of hypoglycemia: • Hypoglycemia Unawareness • Dementia ADA Diabetes Care 2019;42(Suppl.1)S61-70 8 4
2019 MICNP Conference 3/23/2019 • Serious hypoglycemia: a national public health issue.1-2 • Defined as requiring third-party assistance.3 • Any reading
2019 MICNP Conference 3/23/2019 Tight control – the holy grail of diabetes management 11 Factors to consider with A1c target • Age • Life expectancy • Comorbid conditions • Duration of diabetes • Risk of hypoglycemia • Motivation and adherence • Quality of life • Patient satisfaction 12 6
2019 MICNP Conference 3/23/2019 Approach to the Management of Hyperglycemia more A1C less Patient/Disease Features 7% stringent stringent Risks associated with hypoglycemia & other drug adverse effects low high Disease Duration newly diagnosed long-standing Life expectancy long short Important comorbidities absent Few/mild severe Established vascular complications absent Few/mild severe Patient attitude & expected treatment efforts highly motivated, adherent, less motivated, nonadherent, excellent self-care capabilities poor self-care capabilities Resources & support system readily available limited American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 13 Choosing Wisely Avoid using all Among non-older medications other than adults, …using metformin to achieve medications to achieve A1c
2019 MICNP Conference 3/23/2019 New Guidelines! March 6, 2018, American College of Physicians 15 Qaseem et al. Ann Intern Med.2018;168:569-576. 16 8
2019 MICNP Conference 3/23/2019 American College of Physicians • Five large-scale international trials. • Problems with major guidelines. • Evidence does not support using medications to aggressively lower A1c for most patients. • Greater use of lifestyle interventions – A1c reduction with lifestyle is SAFE! And Effective! – #1: Discuss benefits and harms, individualize care. – #2: A1c range of 7-8% for most patients. – #3: No target A1c for frail elderly: treat symptoms only. 17 Not without controversy… 18 9
2019 MICNP Conference 3/23/2019 There is agreement re: need to use less in older adults. How? 19 Deprescribing.org 20 10
2019 MICNP Conference 3/23/2019 21 22 11
2019 MICNP Conference 3/23/2019 Besides hypoglycemia, are there other reasons to deprescribe? 23 Polypharmacy 29.4% of elderly patients have been prescribed 6 or more concurrent drugs. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2546482/ 24 12
2019 MICNP Conference 3/23/2019 COST Over the past 11 years, insulin prices have increased 197%. Herman et al. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4886177 http://care.diabetesjournals.org/content/42/Supplement_1/S90 25 The Miracle of Insulin 26 13
2019 MICNP Conference 3/23/2019 Unforseen Risks of Specific Medications Consider: Troglitizone – Off the market 2000 Insulin inhalation – Off the market 2007 Exenatide and sitagliptin – concerns re: pancreatitis Rosiglitazone – FDA restricted access due to cardiovascular risks May 2011 Pioglitazone – FDA linked to bladder cancer June 2011 Cartoon by permission of Dan Piraro, creator of Bizarro, Bizarro.com 27 Opportunity Costs vs. Gains Costs: • John Abrahamson, MD: “A prescription is a missed opportunity to empower the patient to change lifestyle.” Gains: • Lifestyle changes get at the underlying problem(s). 28 14
2019 MICNP Conference 3/23/2019 Meet Debbie, RN A1c 6.6% 2013 29 Circulation. 2017;135:180-195. DOI: 10.1161/CIRCULATIONaha.116.022622. 30 15
2019 MICNP Conference 3/23/2019 “Glycemic control [with medication] had no effect on mortality or clinically relevant complications.” Makam & Nguyen. Circulation. 2017;135:180-195. DOI: 10.1161/CIRCULATIONaha.116.022622 31 32 16
2019 MICNP Conference 3/23/2019 The reported benefits of tight control (UKPDS) Retinopathy 29% ↓ per 0.9% A1c drop Neuropathy 19% ↓ ‘’ ‘’ Nephropathy 33% ↓ ‘’ ‘’ Nonfatal MI 15% ↓ per 1% A1c drop Makam, AN & Nguyen OK. Circulation.2017;135:180-195. DOI:10:1161/CIRCULATIONAHA.116.022622 33 What outcomes were studied? Outcomes Risk Reduction Retinopathy 29% ↓ per 0.9% A1c drop Neuropathy 19% ↓ ‘’ ‘’ Nephropathy 33% ↓ ‘’ ‘’ Nonfatal MI 15% ↓ per 1% A1c drop Reported Outcomes: Surrogate, not Meaningful • Progression of retinopathy on exam, vs. loss of vision • Loss of reflexes or sensation, vs. symptomatic neuropathy or amputation • Microalbuminuria vs. kidney failure requiring dialysis • Non-fatal MI vs. stroke or death from CV disease Circulation.2017;135:180-195. DOI:10:1161/CIRCULATIONAHA.116.022622 34 17
2019 MICNP Conference 3/23/2019 Can you spot the surrogate marker? 35 36 18
2019 MICNP Conference 3/23/2019 % drop, compared to what? Outcomes Relative Risk Reduction Retinopathy 29% ↓ per 0.9% A1c drop Neuropathy 19% ↓ ‘’ ‘’ Nephropathy 33% ↓ ‘’ ‘’ Nonfatal MI 15% ↓ per 1% A1c drop Circulation.2017;135:180-195. DOI:10:1161/CIRCULATIONAHA.116.022622 37 ADVANCE Study: Benefit of intensive control NEPHROPATHY 20% relative risk reduction; 1.1% absolute risk 1 in 100 people reduction in 5 years did not • 4.1% (intensive develop control) nephropathy • 5.2% (standard treatment) 38 19
2019 MICNP Conference 3/23/2019 Figure 6. Conceptual model for classifying hemoglobin A1c distribution among US adults with diabetes, NHANES, 2011-2012 Makam & Nguyem. Circulation. 2017;135:180-195. DOI: 10.1161/CIRCULATIONaha.116.022622. 39 Lending a Hand to Patient with Type 2 Diabetes: A Simple Way to Communicate Treatment Goals Erlich DR, Slawson DC, Shaughnessy AF. Am Fam Phys 2014;89(4):257-258 40 20
2019 MICNP Conference 3/23/2019 How do we best advise patients when: • Guidelines for clinical targets are not in agreement. • We are exhorted to aggressively use medications to fix “uncontrolled” diabetes. • Quality measures look at intermediate measures (e.g. A1c); prevention of hypoglycemia or other adverse outcome(s) are usually not measured. 41 Evidence-based medicine framework for clinical decision making. a Estimated on the basis of age, comorbidities, and functional status. b Includes an individual’s lifestyle, social support, financial circumstances, and workload capacity. Anil N. Makam, and Oanh K. Nguyen Circulation. 2017;135:180-195 Copyright © American Heart Association, Inc. All rights reserved. 42 21
2019 MICNP Conference 3/23/2019 STEPS Mnemonic 1. How safe is the drug for various patient populations? 2. Is the drug well tolerated or do its adverse effects cause patients to stop taking it? 3. Has the drug been shown to be effective for various patient populations? 4. How will the price of the drug affect adherence? 5. Will addition of this drug be simple or difficult for various patient populations? 43 Management of Hyperglycemia in T2DM ADA, 2018 44 22
2019 MICNP Conference 3/23/2019 2019 Glucose-lowering medication in type 2 diabetes: overall approach. American Diabetes Association Diabetes Care 2019;42:S90-S102 ©2019 by American Diabetes Association 45 How not to choose 46 23
2019 MICNP Conference 3/23/2019 47 48 24
2019 MICNP Conference 3/23/2019 Medication Sample Closet and Refrigerator If all you have is a hammer, everything looks like a nail. 49 50 25
2019 MICNP Conference 3/23/2019 K.I.S.S.* Keep It Simple, Sister! 51 Safest Intervention? Lifestyle Medications 52 26
2019 MICNP Conference 3/23/2019 Treat the Cause Deprescribing medications, while prescribing evidence-based lifestyle intervention(s), may lead to prevention or remission of type 2 diabetes. 53 Plant-Based Dietary Pattern • Whole grains • Vegetables • Beans, Peas, Lentils • Fruit • Water (not cow’s milk) • Small amounts of nuts and seeds • Vitamin B12 The Power Plate – Physicians Committee for Responsible Medicine 54 27
2019 MICNP Conference 3/23/2019 Debbie, RN, 2017 55 A plant-based dietary pattern is recommended by: • American Association of Clinical Endocrinologists (2018) • American Diabetes Association (2010-2019) • Canadian Diabetes Association • Canada Food Guide (2019) • Dietary guidelines of Sweden, Brazil, Germany, Qatar, the Netherlands, Denmark, Finland, Iceland, Norway & Sweden • USDA Dietary Guidelines Advisory Committee (2015) • American Institute for Cancer Research (2009) 56 28
2019 MICNP Conference 3/23/2019 Acceptability A Plant-Based Diet has been found to be highly acceptable in diverse populations with various disease states. Trapp C, Barnard ND, et al. A plant-based diet for type 2 diabetes: scientific support and practical strategies. Diabetes Educ. 2010;36:33-48. 57 Plant-Based Dietary Pattern: Significant Benefits Beyond Diabetes* • Acne • Appendicitis • Hypertension • Arthritis • Irritable Bowel Disease • Atherosclerosis (CMS, • Multiple Sclerosis 2014) • Osteoporosis • Cancer (WHO, 2015) • Renal Insufficiency/CKD • Constipation • Stroke • Erectile Dysfunction • Weight Control • High Cholesterol *More information: NutritionMD.org and NutritionFacts.org 58 29
2019 MICNP Conference 3/23/2019 https://www-ncbi-nlm-nih-gov.proxy.lib.umich.edu/pubmed/29659968 59 Easy. Delicious! Affordable. 60 30
2019 MICNP Conference 3/23/2019 “Cross Titrate*” Up-prescribe Plants De-prescribe Meds 1. Assess interest. 1. Identify medications that 2. Assess diet (typical can become too strong with meals, likes and diet change. dislikes, etc.) 2. Identify medications that 3. Basic instruction (plan patient would most like to some meals) discontinue. 4. Resources (Pt and 3. Discuss known benefits Family) and risks, establish priorities, and document 5. Referrals discussion. 4. Determine targets for BP, lipids, A1c/glucose. * Term from Michelle McMaken, MD 5. Schedule follow ups. 61 Special Considerations • Hypoglycemia: Patients on insulin or sulphonylureas • Hypotension • Anticoagulants (warfarin) • Add Vitamin B12 (recommended with plant-based diet, and/or over the age of 50, and/or metformin) 62 31
2019 MICNP Conference 3/23/2019 What to do with those de-prescribed drugs? Do Not Flush!!! Find a local program: search “drug disposal/takeback.” Last resort: mix with wet cat litter or used coffee grounds and put in sealed container in trash. 63 Summary – Type 2 Diabetes • Prevention of hypoglycemia is a greater priority than tight control, especially in elderly patients. • Patients on SFUs, meglitinides or insulin should be regularly assessed for reduction or discontinuation (see deprescribing.org). Hypoglycemia s&s, prev. and tx should be regularly reviewed. • Medication might be reserved for patients who are symptomatic and unwilling or unable to make lifestyle changes. • A plant-based dietary pattern over any medication offers benefits beyond glycemic control and is a safe, affordable and an acceptable option that may be offered to all patients. • Nurse practitioners should resist calls to intensify treatment, in favor of patient-centered care and shared decision making. 64 32
2019 MICNP Conference 3/23/2019 Resources 65 66 33
2019 MICNP Conference 3/23/2019 21-Day Vegan Kickstart (Free!) 21DayKickstart.org App Website 67 https://nutritionguide.pcrm.org 68 34
2019 MICNP Conference 3/23/2019 Coding/Billing • E & M Codes (99212-99215) (document: “>50% of time spent on counseling & education”) • ICD-10 Codes – Type 2 Diabetes (e.g.E11.65 w/hyperglycemia) Plus Z codes (help to explain the time spent) – Dietary counseling and surveillance Z71.3 – Inappropriate diet and eating habits Z72.4 – Long Term Insulin Use Z79.4 69 PreventionOfDisease.org Sat. May 18 – Mon. May 20, 2019 70 35
2019 MICNP Conference 3/23/2019 July 25-27, 2019 71 Be a joyful NP! 72 36
2019 MICNP Conference 3/23/2019 Cartoon used with permission of Dan Piraro 73 37
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