Truth or Dare: Optimizing the Safety of Target Specific Oral Anticoagulants

Transcription

1 Truth or Dare: Optimizing the Safety of Target Specific Oral Anticoagulants Kelly M. Rudd, Pharm D, BCPS, CACP Clinical Pharmacy Specialist Network Coordinator of Anticoagulation Services Bassett Medical Center Cooperstown, New York

2 Pathogenesis 300,000 first-time cases of DVT occur in the United States every year % have an inherited thrombophilia 40-50% of proximal DVTs become PEs 10% of symptomatic PEs become fatal within 1 hour of symptom onset Mortality greatly increases if not therapeutically anticoagulated in the first 24 hours. Circulation. 2003;107:I-22-I-30 doi: /01.CIR

3 Phases of anticoagulation for VTE With the approval of TSOACs this increases options and potentially eliminates need to bridge with parenteral agent Chest 2012;141;e419S-e494S DOI /chest

4 Target Specific Oral Anticoagulants (TSOACs) Also called Novel Oral Anticoagulants (NOACs) Inhibit free & clot bound Xa/IIa = decreased clot propagation & growth

5 Your version of the truth is all that matters. -James D Arcy, Cloud Atlas

6 Some of the places we can go wrong Initiation Wrong Dose Drug-drug & Drug-disease Interactions Suboptimal Drug Maintenance No monitoring (yes, that s right ) Drug-drug & Drug-disease Interactions Transitions of Care Are we stopping/starting correctly?

7 Indications & Dosing

8 Indications & Dosing

9 Biostatistics: 101

10 Biostatistics: 101 Could we be over/under dosing 36% of our patients???

11 FDA Labeled Dose Adjustments

12 Clinically Studied Dose Adjustments

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16 Safety & Efficacy Comparison Truth : Rivaroxaban in non-inferior to warfarin in the acute phase, no statistical difference in clinical or major bleeds. Dabigatran is inferior to warfarin in the acute phase & non-inferior to warfarin in chronic phase after 3 months of initial anticoagulation therapy, with less clinically significant bleeding.

17 EINSTEIN Trail open label; randomized, non-inferiority trial The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:

18 RE-COVER Trail single/double dummy; randomized, non-inferiority trial The RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:

19 Meta-Analysis of TSOACs vs. Warfarin Van der Hulle T, et al. Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta-analysis. J Thrombosis and Haemostasis, :

20 Meta-Analysis of TSOACs vs. Warfarin Van der Hulle T, et al. Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta-analysis. J Thrombosis and Haemostasis, :

21 RE-LY TTR Analysis Wallentin L. Efficacy and safety of dabigatran compared with warfarin at different levels of INR control for stroke prevention in A. Fib: an analysis of the RE-LY Trial. Lancet. DOI: /S (10)

22 Adapted from iforumrx.org/index.php?q=node/47, Author Deborah A. Sturpe, PharmD, BCPS

23 Food For Thought ISMP Newsletter. January 10, Volume 18. Issue 1.

24 Some of the places we can go wrong Initiation Wrong Dose Drug-drug & Drug-disease Interactions Suboptimal Drug Maintenance No monitoring (yes, that s right ) Drug-drug & Drug-disease Interactions Transitions of Care Are we stopping/starting correctly?

25 Transitions of Care How do you safely start and stop these anticoagulants Around procedures For changing between agents And how do you mitigate these risks?

26 Discontinuation precautions

27 Safety Around Procedures

28 Transitions between Anticoagulants

29 Transitions of Care How do you safely start and stop these anticoagulants Around procedures For changing between agents And How do you mitigate these risks?

30 Applying Research to Practice

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32 PATIENT-CENTRIC CROSS-SETTING MEDICATION MANAGEMENT of ANTICOAGULANTS 32

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35 Change in Practice Identify patients on any anticoagulant: Determine if the right medication given for the right condition Insure there is NO interruption in AC therapy Confirm patients insurance will pay for prescribed therapy Provide a comprehensive discharge summary addressing all components of AC therapy

36 Critical Information Next Provider of Care Upon discharge, provide the following information to next care setting: Patient demographics Dietary habits (i.e. vegetarian, other) Fall risk score, include history of falls, other pertinent past medical history Diagnosis or indication for anticoagulation (AC) therapy If new to AC therapy, start date Date/time/dose of last dose given Date/time/dose of the next dose due Duration of therapy? Provide a stop/end date for all agents prescribed Warfarin only Target INR (goal or range) Next INR due Last 2-3 INR results Name and contact information of the provider managing AC have patient schedule the appointment prior to leaving the facility 36

37 AC Forum Consensus Statement 37

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39 Vicky Agramonte, RN, MSN Project Manager (518) ext 115 IPRO CORPORATE HEADQUARTERS 1979 Marcus Avenue Lake Success, NY IPRO REGIONAL OFFICE 20 Corporate Woods Boulevard Albany, NY

40 Integration of Improvement Efforts

41 Questions? Comments? Discussion?