5/15/2018 DISCLOSURE OBJECTIVES. FLORIDA HOSPITAL ORLANDO Not for profit organization Acute care medical center 1,368 licensed beds BACKGROUND

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1 DISCLOSURE PHARMACIST DIRECTED MANAGEMENT OF GLUCOCORTICOID INDUCED HYPERGLYCEMIA AT A LARGE COMMUNITY HOSPITAL Jill Zaccardelli, PharmD PGY1 Pharmacy Resident Florida Hospital Orlando Jill.Zaccardelli@flhosp.org Florida Residency Conference Tampa, FL May 17 th, 2018 The following individuals have nothing to disclose concerning possible financial or personal relationships with commercial entities (or their competitors) that may be referenced in this presentation Primary Investigator o Jill Zaccardelli, PharmD Project Advisors and Co Investigators o Nicholas Edmonds, PharmD o Dennis Dubovetsky, PharmD, BCPS 96 FLORIDA HOSPITAL ORLANDO Not for profit organization Acute care medical center 1,368 licensed beds OBJECTIVES 1 Review literature regarding treatment of glucocorticoid induced hyperglycemia Internal Medicine Division o 7 patient care units o Multidisciplinary collaboration 2 3 Describe the study treatment protocol Discuss the impact of protocol implementation on glycemic management Increased insulin resistance and glucose production Mechanisms Inhibition of insulin production and secretion 64% with hyperglycemia (>40 Prevalence mg/day prednisone) 56% in patients without diabetes Infection, poor wound healing, dehydration Risks Marker of poor clinical outcome and mortality Perez A, et al. J Diabetes. 2014;6(1):9 20. Donihi AC, et al. Endocr Pract. 2006;12(4): Umpierrez GE, et al. J Clin Endocrinol Metab. 2002;87(3): Onset (hrs.) Prednisone Methylprednisolone Draznin B. American Diabetes Association; Wallace MD, et al. Ann Pharmacother. 2017;[Epub ahead of print]. Duration (hrs.) Dexamethasone NPH insulin

2 Article Design Results Dhital 2012 Seggelke 2011 Grommesh 2016 Retrospective, NPH vs. glargine (basal), prednisone, N=120 RCT, basal bolus +/ NPH, IV methylprednisolone, cystic fibrosis and transplant, N=20 RCT, basal bolus correction +/ NPH protocol, N=61 Similar glycemic control Lower insulin doses in NPH group Lower pre prandial BG in NPH group Similar fasting BG and insulin doses Mean BG lower with NPH on day 3 Similar insulin doses AMERICAN DIABETES ASSOCIATION (ADA) 2018 LOE A Insulin for treatment of persistent hyperglycemia (BG >180 mg/dl) Goal BG mg/dl for most noncritically ill patients Strongly discourage sole use of sliding scale insulin LOE C Lower goals, such as mg/dl, may be appropriate for selected patients while avoiding significant hypoglycemia Dhital SM, et al. Endocr Pract. 2012;18(5): Seggelke SA, et al. J Hosp Med. 2011;6(3): Grommesh B, et al. Endocr Pract. 2016;22(2): BG = blood glucose LOE = level of evidence ADA. Diabetes Care. 2018;41(1):S1 S PURPOSE Determine if implementation of a pharmacist directed protocol for glucocorticoid induced hyperglycemia improved glycemic control compared to standard care STUDY PROTOCOL Diabetes, prediabetes, A1c >6.5%, BG >180 mg/dl Basal bolus 0.4 units/kg Correction Scale Home regimen (weight, insulin if appropriate TDD) No history of diabetes, Correction scale BG <180 mg/dl If BG >180 mg/dl: o NPH 5 units administered with glucocorticoid o NPH 10 units if diabetes and weight >100 kg or insulin TDD >100 units/day TDD = total daily dose STUDY PROTOCOL PHARMACIST ROLE BG (mg/dl) NPH Adjustment When Dosing Steroid <100 Discontinue NPH Adjust basal/prandial insulin accordingly NPH Adjustment When Weaning Steroid Discontinue NPH Adjust basal/prandial insulin accordingly No change Change by same % as steroid adjustment >180 Increase NPH by 5 units with each steroid dose Decrease NPH by ½ of steroid change Daily Report Review chart for pertinent history Apply inclusion/exclusion criteria Glycemic Control Evaluate insulin history Assess glucocorticoid regimen Utilize Evaluate BG and glucocorticoids daily Contact provider with recommendations

3 STUDY OBJECTIVES STUDY DESIGN Primary Objective o Mean BG during glucocorticoid administration Secondary Objectives o Mean BG on day 1, 2, 3, and 4 o Percent of BG in defined ranges o Mean insulin doses o Number of insulin dose adjustments o Length of hospital stay Retrospective cohort, single center IRB approved for quality improvement Statistics o 39 patients per group to meet 80% power o Continuous variables: t test o Categorical variables: Pearson chi square Oct 2017 Mar 2018 Mar 2016 o adherence o Two tailed alpha 0.05 Sep POPULATION PATIENT SELECTION Inclusion Criteria o Age >18 years o Glucocorticoid administration for >48 hours o BG >180 mg/dl o Internal medicine unit Exclusion Criteria o Type 1 diabetes o Gestational diabetes o Critically ill o GFR <30 ml/min/1.73 m 2 o Pancreatectomy o Insulin pump o Tube feeds or parenteral nutrition o Hepatic disease o Acute psychiatric condition 19 Excluded 63 patients screened Glucocorticoid <48 hours: N=2 BG <180: N=10 Critically ill: N=1 GFR <30: N=1 Tube feed/tpn: N=1 Hepatic disease: N=1 Psychiatric: N=1 Provider declined: N=2 N= patients screened N= Excluded Glucocorticoid <48 hours: N=38 Non IM unit: N=28 Type 1 diabetes: N=2 Critically ill: N=1 GFR <30: N=20 Tube feed/tpn: N=3 Hepatic disease: N=3 Lack of BG: N=30 Admission <48 hours: N= DEMOGRAPHICS Age (years, mean + SD) Race (% white) Gender (% female) BMI (kg/m 2, mean + SD) Diabetes diagnosis (%) A1c (%, mean + SD) Insulin use (%) Insulin TDD (units, mean + SD) Mean BG (mg/dl, mean + SD) DEMOGRAPHICS GLUCOCORTICOIDS Respiratory indication (%) Duration (days, mean + SD) Total dose in prednisone equivalent (mg, mean + SD) SD = standard deviation

4 Blood Glucose (mg/dl) Blood Glucose Results p=0.138 p=0.014 p=0.007 p=0.025 p=0.06 Overall Day 1 Day 2 Day 3 Day 4 RESULTS Blood Glucose (mg/dl, %) Length of stay (days, mean +SD) < < < > > RESULTS Insulin Dose (units/day, mean +SD) Insulin Dose Adjustments (mean +SD) Basal Bolus NPH Correction Basal Bolus NPH Correction PROTOCOL ADHERENCE Regimen Adherence (%) Basal bolus 81 NPH 89 Correction 93 Adjustments 91 Pharmacist recommendations accepted: 108/113 = 96% CONCLUSION based treatment was associated with reduced mean BG and a greater percentage of BG within goal No differences in safety parameters Successful pilot implementation of pharmacist based service ADA Consensus Statement Improved glycemic control for hospitalized patients Development of protocols and algorithms APPLICATION Strengths Results consistent with existing literature Standardized protocol for real world application Multidisciplinary approach Limitations Retrospective design Single site Variable follow up duration Requirement for recommendation acceptance by providers protocol deviations ACE/ADA Task Force. Diabetes Care. 2006;29:

5 ACKNOWLEDGEMENT SELF ASSESSMENT QUESTION Project Advisors and Co Investigators o Nicholas Edmonds, PharmD o Dennis Dubovetsky, PharmD, BCPS Project Collaborators o Pradeep Vangala, MD o Mary Gaines, RN, MSN Residency Program Director o Kristie Zappas, PharmD, BCPS (AQ ID) Which of the following statements is true regarding the use of NPH insulin for glucocorticoid induced hyperglycemia? A. NPH insulin should be administered once daily, since it has a duration of action around 24 hours B. NPH insulin has an onset and duration of action that closely mimic the hyperglycemia profile of intermediate acting glucocorticoids C. NPH insulin should replace prandial insulin coverage as part of a daily insulin regimen D. NPH insulin should only be administered to patients with a history of diabetes SELF ASSESSMENT QUESTION Which of the following statements is true regarding the use of NPH insulin for glucocorticoid induced hyperglycemia? A. NPH insulin should be administered once daily, since it has a duration of action around 24 hours B. NPH insulin has an onset and duration of action that closely mimic the hyperglycemia profile of intermediate acting glucocorticoids C. NPH insulin should replace prandial insulin coverage as part of a daily insulin regimen D. NPH insulin should only be administered to patients with a history of diabetes REFERENCES 1. Perez A, Jansen Chaparro S, aigi I, Berna Lopez MR, Minambres I, Gomez Huelgas R. Glucocorticoid induced hyperglycemia. J Diabetes. 2014;6(1): Wallace MD, Metzger NL. Optimizing the treatment of steroid induced hyperglycemia. Ann Pharmacother. 2017;[Epub ahead of print], doi: / Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002;87(3): Donihi AC, Raval D, Saul M, Korytkowski MT, DeVita MA. Prevalence and predictors of corticosteroid related hyperglycemia in hospitalized patients. Endocr Pract. 2006;12(4): Draznin B. Managing diabetes and hyperglycemia in the hospital setting. American Diabetes Association; Dhital SM, Shenker Y, Meredith M, Davis DB. A retrospective study comparing neutral protamine Hagedorn insulin with glargine as basal therapy in prednisone associated diabetes mellitus in hospitalized patients. Endocr Pract. 2012;18(5): Seggelke SA, Gibbs J, Boris Draznin. Pilot study of using neutral protamine Hagedorn insulin to counteract the effect of methylprednisolone in hospitalized patients with diabetes. J Hosp Med. 2011;6(3): Grommesh B, Lausch MJ, Vannelli AJ, et al. Hospital insulin protocol aims for glucose control in glucocorticoid induced hyperglycemia. Endocr Pract. 2016;22(2): American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care. 2018;41(1):S1 S ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association consensus statement on inpatient diabetes and glycemic control. Diabetes Care. 2006;29: PHARMACIST DIRECTED MANAGEMENT OF GLUCOCORTICOID INDUCED HYPERGLYCEMIA AT A LARGE COMMUNITY HOSPITAL Jill Zaccardelli, PharmD PGY1 Pharmacy Resident Florida Hospital Orlando Jill.Zaccardelli@flhosp.org Florida Residency Conference Tampa, FL May 17 th,