Disclosures. Objective (NRHS) Self Assessment #2

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1 Development and Implementation of a Protocol for Reversing the Effects of Anticoagulants for Use in a Community Hospital Samantha Sepulveda, Pharm.D. PGY1 Pharmacy Resident Norman Regional Health System Disclosures Authors of this presentation have the following to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation: Samantha Sepulveda: Nothing to disclose 2 Norman Regional Health System (NRHS) Norman Regional Porter & HealthPlex campuses 513 licensed beds Acute care community hospital with full range of services Objective State the recommendations for vitamin K antagonist reversal according to the CHEST guidelines. 3 4 Self Assessment #1 According to the CHEST guidelines, which of the following is the best approach for reversing the effects of warfarin in a non urgent situation without bleeding and with an INR of 6.2? a. Vitamin K 2.5mg PO b. Vitamin K 5mg SC c. Vitamin K 10mg PO d. Vitamin K 10mg IV 5 Self Assessment #2 A patient presents with an intracranial hemorrhage while on warfarin. What is (are) the recommended strategy(s) for reversing the coagulopathy? I. Vitamin K IV II. FFP III. rfviia IV. 4 Factor PCC a. I only b. II and III c. I and IV d. I, II, and IV 6

2 Anticoagulants Introduction Important therapy for patients who have experienced or are at risk for thrombosis Substantial risk involved with use High alert medications according to Institute for Healthcare Improvement (IHI) Increased bleed time Delay to urgent/emergent procedures Reversal Use Indicated for patients with Active bleeding Need for invasive procedures Elevated INRs (>10) who are asymptomatic Potential complications Increased risk of thrombosis Warfarin resistance Patient cost 7 CHEST 2012; 141(2)(Suppl):e44S e88s 8 Anticoagulant Reversal Agents Vitamin K Promotes production of vitamin K dependent clotting factors VII, IX, X, and II Clotting Factors Reversal Agent 3Factor PCC (PCC3) 4 Factor PCC (PCC4) Activated PCC (apcc) rfviia Clotting Factor(s) Replaced II, IX, X (inactivated) II, IX, X, VII (inactivated) II, IX, X (inactivated) VII (activated) VII (activated) Factor Xa Inhibitors Direct Thrombin Inhibitor PCC Prothrombin Complex Concentrate, rfviia Recombinant Factor VIIa Am J Health Syst Pharm. 2013; 70: Oral Anticoagulant Vitamin K antagonist: Warfarin (Coumadin ) Direct thrombin inhibitor: Dabigatran (Pradaxa ) Factor Xa inhibitor: Rivaroxaban (Xarelto ) Apixaban (Eliquis ) Reversal Strategies Recommended Reversal Agents 1. Vitamin K (PO/IV) 2. PCC4 3. apcc 4. PCC3 5. rfviia 6. FFP 1. apcc Activated charcoal 2. PCC4 Hemodialysis 1. PCC4 Activated charcoal 2. apcc 3. PCC3 Condition INR above therapeutic range but < 5.0; no significant bleed INR 5.0 but < 10.0; no significant bleed Warfarin Reversal CHEST Recommended Intervention Lower dose or omit dose Minimally elevated No dose reduction may be required Hold next one or two doses Increased bleed risk Give vitamin K 1 2.5mg PO Rapid reversal required Give vitamin K 5mg PO (allow 24 h for INR reduction) INR still high Additional vitamin K (1 2mg PO) Monitor INR more frequently Resume at lower dose when INR is therapeutic Am J Health Syst Pharm. 2013; 70: , CHEST 2012; 141(2)(Suppl):e44S e88s 11 CHEST 2012; 141(2)(Suppl):e44S e88s, CHEST 2008; 133(suppl):160s 98s 12

3 Condition INR 10.0; no significant bleeding Serious bleeding at any elevation of INR Life threatening bleeding Warfarin Reversal Monitor INR more frequently Resume when appropriate at lower dose when INR is therapeutic CHEST 2012; 141(2)(Suppl):e44S e88s, CHEST 2008; 133(suppl):160s 98s CHEST Recommended Intervention Hold warfarin therapy & give higher dose of vitamin K 2.5 5mg PO (allow h for INR reduction) Hold warfarin therapy & give vitamin K 10mg by slow IV infusion Supplement with FFP, PCC, or rviia depending on level of urgency Vitamin K can be repeated q12h, if necessary Hold warfarin therapy & give FFP or PCC supplemented with vitamin K 10mg by slow IV infusion Repeat if necessary depending on INR 13 Purpose NRHS has limited, non comprehensive policies regarding anticoagulant reversal agents Adherence to published guidelines and literature was unknown Development of policy and procedures to define and guide pharmacologic anticoagulant reversal at NRHS Implementation of procedures focusing on compliance with published guidelines and literature 14 Endpoint Goals Successful education of pharmacy staff and physicians on: Anticoagulation reversal recommendations per current CHEST guidelines Recommended routes of vitamin K administration Formalized hospital wide policy for anticoagulant reversal approved by the Pharmacy and Therapeutics Committee Methods Phase One Initial data collection and evaluation Phase Two Education Development and implementation of order set and policy Phase Three Follow up data collection and evaluation Methods Methods IRB approved retrospective chart review April 1, 2014 thru May 31, patient charts reviewed 43 Included 31 Excluded Inclusion Criteria Age 18 years Anticoagulant use Anticoagulant reversal agent given at NRHS Exclusion Criteria Age < 18 years No anticoagulant use 17 Data collection included Reversal agent Indication for reversal Anticoagulant and indication Adherence to guidelines and literature based indications for reversal INRs and other monitoring parameters Hospital cost of reversal agent 18

4 Number of Patients Anticoagulants Reversed (n = 43) Coumadin Xarelto Eliquis Pradaxa Anticoagulants Results INR Prior to Reversal (n = 42) 14% 14% INR < 2 INR 2 5 INR 5 10 INR > 10 29% 43% 19 Indications for Reversal (n = 43) Elevated INR GI Bleed Other Bleed Surgery LHC Other Procedure Anemia Number of Patients 5 7 Results Reversal Agent Necessary (n = 43) 12% 88% YES NO 20 Appropriate Reversal Use (n = 43) 23% Results YES NO Reversal Agent Use by Route of Administration (n = 83) 11% 5% 11% 19% Vitamin K PO Vitamin K SC Vitamin K IV Vitamin K IM Physician Education Physician meetings Reviewed CHEST guidelines regarding vitamin K use Recommended routes of administration PO and IV Urged compliance with the guidelines 77% 54% PCC Article in NRHS Pharmacy newsletter, The Script Protocol Development Gained support for vitamin K policy Automatic conversion of vitamin K IM to SC Development of a vitamin K antagonist order set Pharmacy staff and physician education once approved Future Directions Completion and implementation of The policy with approval from Pharmacy and Therapeutics Committee The order set with approval from physicians Additional education for pharmacy staff and physicians Follow up data collection and evaluation 23 24

5 Self Assessment #1 According to the CHEST guidelines, which of the following is the best approach for reversing the effects of warfarin in a non urgent situation without bleeding and with an INR of 6.2? a. Vitamin K 2.5mg PO b. Vitamin K 5mg SC c. Vitamin K 10mg PO d. Vitamin K 10mg IV 25 Self Assessment #2 A patient presents with an intracranial hemorrhage while on warfarin. What is (are) the recommended strategy(s) for reversing the coagulopathy? I. Vitamin K IV II. FFP III. rfviia IV. 4 Factor PCC a. I only b. II and III c. I and IV d. I, II, and IV 26 Development and Implementation of a Protocol for Reversing the Effects of Anticoagulants for Use in a Community Hospital Samantha Sepulveda, Pharm.D. PGY1 Pharmacy Resident Norman Regional Health System

6 Development and Implementation of a Protocol for Reversing the Effects of Anticoagulants for Use in a Community Hospital. Samantha Sepulveda Norman Regional Health System Norman, Oklahoma References 1. Ageno W, Gallus AS, Wittkowsky A, et al. Oral Anticoagulant Therapy. Antithrombotic Therapy and Prevention of Thrombosis,9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST 2012; 141(2)(Suppl):e44S e88s. 2. Ansell J, Hirsh J, Hyle KE, et al. Pharmacology and management of the vitamin K antagonists. Antithrombotic and Thrombolytic Therapy, 8 th ed. American College of Chest Physicians Evidence- Based Clinical Practice Guidelines. CHEST 2008; 133(suppl):160s-98s. 3. Nutescu EA, Dager WE, Kalus JS, et al. Management of bleeding and reversal strategies for oral anticoagulants: Clinical practice considerations. Am J Health-Syst Pharm. 2013; 70: Suggested Reading 1. Crowther M A, Douketis J D, Schnurr T, e t al. Oral vitamin K lowers the international normalized ratio more rapidly than subcutaneous vitamin K in the treatment of warfarin associated coagulopathy. A randomized, controlled trial. Ann Intern Med. 2002; 137 (4):251-4.

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