Albumin stewardship for fluid replacement in plasmapheresis Kamarena Sankar, Pharm.D. PGY-1 Resident Pharmacist Holmes Regional Medical Center Disclosure Statement
.These individuals have nothing to disclose concerning possible financial or personal relationships with commercial entities (or their competitors) that may be referenced in this presentation:
.Kamarena Sankar, Pharm.D. .Jay Pauly, Pharm.D. .Michael Sanchez, Pharm.D. Presentation Objective
.Understand the post-implementation safety and cost data of an Albumin Stewardship Initiative for fluid replacement in plasmapheresis Background
.Definition: Plasmapheresis is removal of a patient’s own plasma .Varies between patients .This also removes potentially harmful substances: .Immunoglobulin .Autoantibodies .Immune complexes .Monoclonal paraproteins .Protein-bound toxins
Hollie M. Reeves Br J Haematol. 2014;164.3:342-351. Indications
Guillain-Barré Syndrome, ANCA glomerulonephritis, Myasthenia Gravis, Autoimmune Encephalitis, Renal First-Line Transplantation, Thrombotic Thrombocytopenic Purpura (TTP)
Cryoglobinemia, Familial Hypercholesterolemia, Second-Line Multiple Sclerosis
Role Not Heparin-induced Thrombocytopenia (HIT), Nephrogenic Established Systemic Fibrosis
Ineffective or Psoriasis, Dermatomyositis/Polymyositis Harmful
J Schwartz. J Clin Apher. 2016;31.3:149-338. Background
.Fluid Replacement during plasmapheresis: .Necessary to avoid hypotension .Institution practice: .Albumin 5% 3,000 mL .IV room processing time .Multiple manipulations .High cost
J Schwartz. J Clin Apher. 2016;31.3:149-338. Background Literature
.Yamada (2017) .Albumin in combination with normal saline .5:1, 4:1, 5:2, 1:1 .3 patients, 12 procedures .No blood pressure differences .Albumin only fluid replacement .Albumin-normal saline combination replacement .McCullough (1982) .Options for fluid replacement .Normal saline .Albumin
Chisa Yamada. J Clin Apher. 2017;32.1:5-11. J McCullough. Vox Sang. 1982;43:270-295. Albumin Stewardship Initiative
.Switch from 3 liter albumin 5% fluid replacement to 1:1 combination fluid replacement .1.5 liter albumin 5% + 1.5 liter normal saline .Purpose: .Decrease patient exposure to albumin .Decrease IV room processing time of plasmapheresis fluid replacement .Increase efficient use of albumin .Effective: February 1st, 2018 Study Purpose
.Evaluate the safety of using combination fluid replacement during plasmapheresis compared to conventional albumin-only fluid replacement Outcomes
.Determine difference in net blood pressure change during plasmapheresis in pre-implementation vs post-implementation groups .Determine cost savings of plasmapheresis initiative Study Design Single-Center, Retrospective Study, Inpatients and Outpatients
Included patients who had Excluded patients who received TPE plasmapheresis ordered with less than 1 hour documented blood pressures
1 Dose 31 Patients
Pre - Implementation Post-Implementation 2/1/2017 – 4/30/2017 2/1/2018 – 4/30/2018
17 Patients 14 Patients 104 Doses 81 Doses
Age, Gender, Net SBP Change, Net DBP Change, Indication Baseline Characteristics
Pre Post (n = 17 (n = 14 patients) patients) 76% 64% Female (%) p = 0.46 (n = 13) (n = 9) Average Age 60.23 64 p = 0.77 Myasthenia Gravis 3 patients 3 patients TTP 2 patients 1 patient P-ANCA(+)/ANCA/Vasculitis 2 patients 1 patients Multiple Sclerosis 2 patients 1 patient Autoimmune Encephalitis 2 patients - Chronic Inflammatory Demyelinating 1 patient 2 patients Polyneuritis Baseline Characteristics Baseline Characteristics Pre Post Implementation Implementation Significance Mean Mean (n = 99 doses) (n = 69 doses)
Pre Procedure 129 135 p = 0.07 SBP
Post Procedure 127 124 p = 0.31 SBP
Pre Procedure 67 71 p < 0.05 DBP
Post Procedure 69 68 p = 0.80 DBP Results – Net BP Change
Pre Implementation Post Implementation N = 104 Doses N = 81 Doses Significance Mean of Range Mean of Range Net Change (Min, Max) Net Change (Min, Max)
SBP -2.12 (-45, 43) -10.80 (-95, 33) P < 0.05 (mmHg)
DBP 1.76 (-35, 39) -2.77 (-57, 43) P < 0.05 (mmHg) Results – Clinically Significant Hypotension*
Pre Post Implementation Implementation Significance N = 104 Doses N = 81 Doses
Hypotension Post 1 patient 4 patients Plasmapheresis (1 DBP) (2 SBP, 2 DBP) p = 0.10 Normotension Post 103 patients 77 patients Plasmapheresis
*Defined as SBP < 90 or DBP < 45 Results – Cost Savings
Cost Pre Post Savings Wholesale Acquisition Cost over 3 month study $50,202.88 $20,389.32 $30,420.6 period
Number of Doses 104 81 Cost Per Dose $482.72 $251.72 $231.00 Conclusion
.Significant difference in net blood pressure change when combination fluid replacement is compared to albumin only fluid replacement during plasmapheresis .No significant difference in clinically relevant hypotension between groups .Continued monitoring of initiative is necessary .Collaborate with Nephrology to decide which patients may need conventional albumin fluid replacement Limitations and Future Directions
.Limited sample size .3 months .Patients with multiple doses may confound data .Difference in baseline characteristics .Pre Procedure DBP .Single center, retrospective .Consider matching patients .Indication, Weight, Age, Gender, Number of Doses .Anecdotal Reports .Delayed Effect Analysis Self-Assessment Question
Indications for plasmapheresis used in the pre and post-analysis included the following, except: A. Myasthenia Gravis B. Guillain Barre Syndrome C. Autoimmune Encephalitis D. Hypoalbuminemia References
1. Reeves, Hollie M., and Jeffrey L. Winters. "The mechanisms of action of plasma exchange." British Journal of Haematology164.3 (2014): 342-351. 2. Schwartz J et al. "Guidelines on the Use of Therapeutic Apheresis in Clinical Practice–Evidence‐Based Approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue." Journal of Clinical Apheresis 31.3 (2016): 149-338. 3. McCullough, J., et al. "What are the established clinical indications for therapeutic plasma exchange and how important is the choice of replacement fluid for efficacy of therapeutic plasma exchange in these situations?." Vox Sanguinis 43 (1982): 270-295. 4. Yamada, Chisa, et al. "Report of the ASFA apheresis registry on muscle specific kinase antibody positive myasthenia gravis." Journal of Clinical Apheresis 32.1 (2017): 5-11. Albumin stewardship for fluid replacement in plasmapheresis Kamarena Sankar, Pharm.D. PGY-1 Resident Pharmacist Holmes Regional Medical Center