7/22/2018. Team approach directed by the Department of Pharmacy for management of anemia and bone mineral disorder in chronic dialysis patients

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Bartholomew Manning
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1 Team approach directed by the Department of Pharmacy for manment of anemia and bone mineral disorder in chronic dialysis patients Disclosure Statement The authors of this presentation have research support from Keryx Pharmaceutical Inc. The terms of this arrangement have been reviewed and approved by Western Institutional Review Board in accordance with its policy and objectivity in research. St. Mary s Medical Center (SMMC) and Palm Beach Children s Hospital, West Palm Beach, FL Lofti, M. MD Medical Director for Dialysis, Chief of Nephrology at SMMC Lefkowitz S., RPh, MS, Director of Pharmacy Kung M., PharmD, Research Pharmacist Learning Objectives Learning Objectives For Pharmacists Identify the challenges that End St Renal Disease (ESRD) patients face, which compromise their quality of life (QoL) Describe the expanding role of clinical pharmacists in a Chronic Dialysis Center setting that can improve patients care and QoL Explain the collaborative team approach to optimize care of ESRD patients in anemia and/or bone mineral disorder Discuss how the use of ferric citrate may improve phosphate control, stabilize patients hemoglobin (Hgb) levels, reduce the us of erythropoietin stimulating nts (ESAs) (darbepoetin) and decrease the us of intravenous (IV) iron For Pharmacy Technicians Identify the challenges that End St Renal Disease (ESRD) patients face, which compromise their quality of life (QoL) Understand the treatment of anemia and bone mineral disorder for ESRD patients in the Chronic Dialysis Center Understand how the proper medications manment in ESRD patients can improve their therapeutic outcomes and quality of life Challenges ESRD Patients Face Primary Challenges Chronic dialysis patients face multiple clinical challenges in conjunction with numerous medications Dialysis patients admit to medication non adherence due to the difficulties of their conditions and issues with their medications. For example, excessive amounts, cost, side effects, frequent dose adjustments, and regimen complexity The mean rates of non adherence among this population are being reported as high as 67% 5 Secondary Challenges ESRD patients receive care from multiple providers at multiple locations. Their rigorous dialysis schedule makes managing comorbidities challenging and patients often have increased complication rates and emergency healthcare utilization rates A Different Dialysis Center SMMC Schwartz Dialysis Center is a free standing dialysis facility on the hospital s campus that works with a multidisciplinary team. Most dialysis facilities are independent for profit organizations. There are 371 dialysis facilities 9 in the state of Florida alone The community standard for dialysis facilities is to have a director, several technicians, and a nursing staff. No clinical pharmacist is present Dr. Lotfi, the Medical Director for Dialysis and Chief of Nephrology at SMMC, along with another nephrologist, coordinate the care for hemodialysis patients, 20 peritoneal dialysis patients, along with any patients requiring acute dialysis The majority of dialysis patients at SMMC experience comorbidities such as hypertension, diabetes, dyslipidemia, and human immunodeficiency virus (HIV) / 1

The Multidisciplinary Team Members of the multidisciplinary team include two nephrologists, nursing staff, a clinical pharmacist, technicians, a social worker, and a dietician Every month, the team

pharmacist doses ESAs, IV iron, and doxercalciferol using protocols approved by pharmacy and therapeutics committee Nursing staff and technicians administer drugs, evaluate vitals, and alert the

The social worker assists patients with resolving any financial and logistical issues they have Collaborative Team Work The Department of Pharmacy has taken the initiative of medication manment at

mineral disorder (BMD) manment Establishing policies and procedures based on Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines 6 for clinical pharmacists guiding the dosing of the

Switched epoetin alfa to darbepoetin Collaborative Team Work Cont 2015 Compared data collected from the Schwartz dialysis center from 2013 to 2015: Number of patients with Hgb level 9.

5 mg/dl increase from 72% to 91% 2016 During a hospital wide survey, Joint Commission on Accreditation of Health Organization (JCAHO) acknowledged the pharmacy involvement showed provided positive

2 The Multidisciplinary Team Members of the multidisciplinary team include two nephrologists, nursing staff, a clinical pharmacist, technicians, a social worker, and a dietician Every month, the team meets to reassess patients care plans, discuss patients needs and issues, review current guidelines, clinical studies, and recommendations The nephrologists leads and coordinates the team while the pharmacist doses ESAs, IV iron, and doxercalciferol using protocols approved by pharmacy and therapeutics committee Nursing staff and technicians administer drugs, evaluate vitals, and alert the nephrologists of new situations that arise The dietician provides a monthly dietary assessment to the patient Paying for dialysis and a patient s care can be a complex and difficult task. The social worker assists patients with resolving any financial and logistical issues they have Collaborative Team Work The Department of Pharmacy has taken the initiative of medication manment at the Schwartz Dialysis Center in order to meet the challenges that chronic dialysis patients face 2012 Expanding the role of the pharmacist in the Schwartz Dialysis Center to improve anemia and bone mineral disorder (BMD) manment Establishing policies and procedures based on Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines 6 for clinical pharmacists guiding the dosing of the erythropoietin stimulating nt (ESA), intravenous (IV) iron therapy and doxercalciferol dosing Implementing Centers of Medicare and Medicaid Services (CMS) standards for optimal patient outcomes 2013 Switched epoetin alfa to darbepoetin Collaborative Team Work Cont 2015 Compared data collected from the Schwartz dialysis center from 2013 to 2015: Number of patients with Hgb level 9.5 mg/dl decrease from 28.99% to 8.33% Number of patients with Hgb level 9.5 mg/dl increase from 72% to 91% 2016 During a hospital wide survey, Joint Commission on Accreditation of Health Organization (JCAHO) acknowledged the pharmacy involvement showed provided positive value to the dialysis patients Submitted a pharmacy initiated clinical study at the Schwartz Dialysis Center using ferric citrate, a new phosphate binder, with the objective to observe and evaluate if our professional intervention would: improve phosphate control normalize fluctuations of Hgb levels reduce IV iron requirements reduce ESA utilization Collaborative Team Work Cont 2017 Patient enrollment in the clinical study begins. The pharmacist reviews and reconciles patients medications, obtains patients quality of life (QoL) data, and titrates the phosphate ferric citrate to establish a phosphate level of mcg/ml Clinical pharmacists increased participation in the multidisciplinary meetings at the dialysis center to provide better patient care 2018 Working on a etelcalcetide, a IV calcimimetic, dosing guideline in conjunction with pharmacy and therapeutics committee, and Dr. Lofti The Agency for Health Care Administration (AHCA) during an annual review stated all requirements for the dialysis center and the pharmacy component have been met with no deficiencies noted End St Renal Disease Medications Dosing Protocols at SMMC ESA (darbepoetin), Intravenous iron (sodium ferric gluconate), and Doxercalciferol 2017 Schwartz Dialysis Center Continuous Quality Improvement (CQI) Indicators for Anemia Goals based on CMS Standards : 83.5% patient with Hgb>10 g/dl Normal Range: Male Hgb g/dL, Female g/dL Protocol target Hgb: maintain at g/dl Protocol target TSAT: 30% Indicators for Mineral Bone Disease Goals based on CMS Standards: 88.2% patient with PO 4 <7 mg/dl; 96.8 % patient with Calcium 10.2mg/dL; 50% patient with PTH pg/mL Protocol target Corrected Calcium 10.2 mg/dl Protocol target Phosphorus (PO 4 ) level mg/dL Protocol target Parathyroid Hormone (PTH) pg/ml 2

Ferric Citrate Study: Patient Screening Ferric Citrate Study: Current Status Active Enrolled Off Study 19 (61%) 12 (39%) Screened Patients 101 (100%) Not Enrolled Refused 18 (26%) Did not meet

3 Ferric Citrate Study: Patient Screening Ferric Citrate Study: Current Status Active Enrolled Off Study 19 (61%) 12 (39%) Screened Patients 101 (100%) Not Enrolled Refused 18 (26%) Did not meet eligibility criteria 52 (74%) Low Phosphorus/patients Mental Does not speak do not require binder Issues/Nursing Home English Reasons 1) Did not like AE 25 (48%) 9 (17%) 6 (12%) profile 2) Reluctant to Other (Cancer, change their Parathyroidectomy, Life expectancy <1 year Iron Allergies medications Bariatric Surgery, Moved) Data collection is ongoing and all trends are based on preliminary data Expected active phase completion: March 2019 Expected follow up completion: March 2020 Out of 19 active patients 5 patients are identified as successful 6 patients required ferric citrate dose reduction due to diarrhea or constipation. 4 of these patients maintain phosphate levels at target ( mg/dl) Data for 8 patients is too early for interpretation 5 (10%) 3 (6%) 4 (8%) Study Demographics Study Demographics Cont Study Summary 67% of study patients are 60 years of A significant portion, 22%, is 36 years of Overall, mean study patient is 52 82% of study patients use Medicaid and Medicare 13% do not have any payer available Study patients are majority African American Study Demographics (N=31) Ethnicity Caucasian 6 (19%) African American 22 (71%) Hispanic or Latino 3 (10%) Age (years) (16%) (6%) (6%) (3%) (12%) (24%) (18%) >67 3 (9%) Payer Uninsured 4 (13%) Medicaid/HMO 3 (10%) CCPD/Medicare 2 (7%) Medicare 20 (65%) Commercial 2 (7%) National Demographics 10 Ethnicity White 61.73% African American 30.68% Asian 5.58% American Indians 1.09% Hispanic 16.91% Age Below 21 years of 1.51% From 22 to 44 years of 15.28% From 45 to 64 years of 44.30% From 65 to 74 years of 22.61% Age 75 years or more 16.28% Protocol is begin patients on 2 tabs of ferric citrate TID w/meals If phosphate is >5.5mg/dL, increase dose by 1 tab per day If phosphate is >7mg/dL, increase dose by 2 tabs per day. Max dose is 12 tabs/day 58% of patients remained at the starting dose, with 14% increasing the dose Dosing titration is limited by high incidence of gastrointestinal (GI) upset being reported Clinical Laboratory Trends Goal N=31 YES Number (%) NO Number (%) Achieved Target TSAT: 30 % 26 (84%) 5 (16%) Achieved Target Hgb: maintain at g/dl 19 (61%) 12 (39%) Achieved Goal: patients with Hgb>10 g/dl 23 (74%) 8 (26%) Achieved Goal: patients with PO 4 <7 mg/dl 16 (52%) 15 (48%) Achieved Target Corrected Calcium: 10.2 mg/dl 30 (97%) 1 (3%) All preliminary data is based on the last reported visit from the patient, post pharmacist intervention While we are currently seeing a positive trend, more time and data is needed to make any conclusive statements Clinical Laboratory PO4 & Hgb Values of Hemodialysis Patients The primary outcome of the study was to control PO4 by maintaining a value of mg/dL Secondary outcome included anemia control, which is measured by Hgb values 10 12g/dL and a reduction of fluctuations in values Since November 2017, CMS has changed the standards for PO4 to <7mg/dL and Hgb to >10g/dL 3

4 Clinical Laboratory PO4 Values of Hemodialysis Patients Laboratory PO4 Parameter Mean ± SD P value Control (1 mo. prior to study) 6.6 ± 1.6 Visit 1 (n=31) 6.5 ± Visit 2 (n=29) 6.2 ± Visit 3 (n=28) 6.4 ± Visit 4 (n=23) 6.5 ± * Visit 1=Day 30±15 days; Visit 2=Day 60±15 days; Visit 3=Day 90±15 days; Visit 4=Day 120±15 days) It was shown that baseline (visit 1 month prior to study start) mean serum phosphorus was lower when comparing to the visit 4 group Although not statistically significant, the mean serum phosphorus decreased slightly with a mean PO4 range of 6.6 ± 1.6 mg/dl at baseline to 6.5 ± 2.1 mg/dl at visit 4, which is consistent with other phosphate binders available Clinical Laboratory PO4 Values of Hemodialysis Patients and Adherence Laboratory PO4 Parameter Non-adherent Adherent Mean ± SD Mean ± SD Serum phosphorus Visit 1* 6.8 ± ±.9 Serum phosphorus Visit ± ± 1.5 Serum phosphorus Visit 3* 7.5 ± ± 1.5 Serum phosphorus Visit 4* 8.0 ± ± 1.2 *P < 0.05 is considered as statistically significant; Visit 1=Day 30±15 days; Visit 2=Day 60±15 days; Visit 3=Day 90±15 days; Visit 4=Day 120±15 days The analysis here using the independent samples t test shows a statistically significant decrease in mean serum phosphorus among adherent patients Low adherence is associated with higher serum phosphorus levels We note that future studies may involve pharmacist efforts to characterize patients who are at high risk for non adherence to develop customized interventions to improve patient health outcomes Comparison of Secondary Outcomes: Control Group vs. Post Intervention Visits 1, 2, and 3 Outcome (N=29) Control Group (1 month prior to study start) Post Intervention Visit 1 Post Intervention Visit 2 Post Intervention Visit 3 Mean TSAT (%) * Mean IV Iron (mg/month) Mean ESA Dose (mcg/week) $ $ * $ * $ $ $ * $ $ Mean Hemoglobin (g/dl) Mean PTH * P < 0.05 is considered as statistically significant; Visit 1=Day 30±15 days; Visit 2=Day 60±15 days; Visit 3=Day 90±15 days Data Summary Study is ongoing. All data is preliminary and all information is descriptive A trend of improvement in PO4 values from baseline to the last 3 patient visits is seen. This improvement was found to not be statistically significant We can infer that the main reason we do not see a larger improvement in PO4 values is due to non adherence When we compare adherent to non adherent patients, the PO4 values are on aver below the target of 7mg/dL and are statistically significant for patients that are adherent Based on patient responses, the largest limitation in adherence is regimen complexity and GI upset A reduction in ESA us (baseline of 179.5mcg/week & $ to mcg/week & $ at visit 3) was noted and found to be statistically significant A reduction in IV iron us (baseline of 413.8mg/month & $57.93 to 282.6mg/month & $39.56 at visit 3) was noted and found to be statistically significant Dialysis Patient Quality of Life Questionnaire Scores (N=21) As shown, scores for the physical and mental component of the QOL questionnaire increased over time, but these findings were not statistically significant Although preliminary in nature, this is promising data as the literature reflects QOL scores of 38 and below for this highly impaired population The QoL questionnaire was developed by QualityMetric Inc. to quantify the health related quality of life of ESRD patients The questionnaire was given upon enrollment as a baseline measure and then again 30 days or more thereafter Study Challenges Non adherence to treatment plan due to complexity of the medication regimen and GI side effects Due to the fragmented nature of care for ESRD patients, patients may receive care at other facilities and their records are not up to date The nature of the stand alone dialysis facility led to periodic interface issues with Cerner (Lab system) and Renasen (dialysis electronic order system). This resulted in miscommunications and increased the work load for the pharmacy team Limited patient population due to the dialysis center being a stand alone unit 4

Conclusion/Objective Summary References The ESRD patients face many challenges due to complications of the disease and the complexity of the treatment Team approach directed by the department of

5 Conclusion/Objective Summary References The ESRD patients face many challenges due to complications of the disease and the complexity of the treatment Team approach directed by the department of pharmacy showed improvement in anemia control and reductions in ESA and IV iron utilization The pharmacy initiated study provided an opportunity for the clinical pharmacists to improve the medication manment in the Schwartz Dialysis Center For the study subjects who tolerated ferric citrate and were compliant to the regimen, this medication might be a good option to control phosphorus and reduce fluctuations in Hgb Quality of life has slightly improved and the data collection is still ongoing Patients expressed satisfaction with the pharmacist s involvement in their medication manment 1. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease.. Kidney International Supplements. 2012;2(4): doi: /kisup Kidney Disease: Improving Global Outcomes (KDIGO) CKD MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease Mineral and Bone Disorder (CKD MBD). Kidney Int Suppl. 2017;7:1 59. Kidney International Supplements. 2009;7(3). doi: /j.kisu Centers for Disease Control and Prevention. National Chronic Kidney Disease Fact Sheet, Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; Kidney Failure (ESRD) Causes, Symptoms, & Treatments. American Kidney Fund, American Kidney Fund, Inc., 2018, failure/#complications_of_kidney_failure. 5. Schmid H, Hartmann B, Schiffl H. Adherence to prescribed oral medication in adult patients undergoing chronic hemodialysis: A critical review of the literature. European Journal of Medical Research. 2009;14(5): / X National Kidney Foundation. KDOQI clinical practice guideline for hemodialysis adequacy: 2015 update. Am J Kidney Dis. 2015;66(5): doi 7. Hynicka, Lauren. The Forgotten Organs: Complications with the Kidney Manment of Bone Metabolism and Disease in Chronic Kidney Disease. Webinar. FreeCE, b b941858c01f. 8. Obrador GT, Pereira B. Epidemiology of chronic kidney disease. Wolters Klover. Available from: chronic kidney disease. 9. Shinkman R. The Big Business of Dialysis Care. NEJM Catalyst. big business of dialysis care/. Published June 9, Accessed July 2, Kidney Disease Statistics for the United States. National Institute of Diabetes and Digestive and Kidney Diseases. information/health statistics/kidney disease. Published December 1, Accessed July 2, Acknowledgements Questions? Renata Masimova, PharmD, Dialysis Pharmacist and data acquisition Jacqueline Waddell, RPh., Operations Manr Colette Isner, PharmD, Informatics Pharmacist and Regulatory Affairs Annesha White, PharmD, MS, PhD, Assistant Dean for Assessment, UNT System College of Pharmacy, Associate Professor Department of Pharmacotherapy All of the pharmacy staff at St. Mary s Medical Center All of the staff at the Schwartz Dialysis Center Kristin Solberg, Joseph Pinner, and Ronnie Knudsen, PharmD Candidates 2019 Breaking Through the Challenges of Patient Care! 5

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