Andrew Stoessel, PharmD PGY-1 Pharmacy Practice Resident Jackson Memorial Hospital

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1 Andrew Stoessel, PharmD PGY-1 Pharmacy Practice Resident Jackson Memorial Hospital

2 Objectives Discuss rationale in analyzing prescribing practices for direct oral anticoagulants Outline current prescribing practices and common errors associated with direct oral anticoagulants Identify the role of the clinical pharmacist in anticoagulation with direct oral anticoagulants

3 Direct Oral Anticoagulants (DOACs) Directly inhibit thrombin or activated factor X Faster onset/offset of action as compared to Vitamin-K antagonist therapy (Warfarin) Do not require overlap Routine monitoring not required Currently, only dabigatran has an approved antidote

4 DOACs Indications Deep vein thrombosis treatment Pulmonary embolism treatment Non-valvular atrial fibrillation Postoperative deep vein thrombosis prophylaxis Apixaban (Eliquis ) Rivaroxaban (Xarelto )

5 DOACs Apixaban (Eliquis ) JMH formulary agent Rivaroxaban (Xarelto ) Non-formulary: Restricted to continuation of home therapy Dabigatran (Pradaxa ) Non-formulary: Restricted to continuation of home therapy Edoxaban (Savaysa ) Non-formulary: Restricted to continuation of home therapy

6 DOAC Prescribing Errors Paucity of data related to DOAC prescription errors 2014 study analyzing rivaroxaban and dabigatran 28% of orders had an error based on indication 26% of orders had an error in dosing 2015 retrospective analysis of apixaban, rivaroxaban, and dabigatran 39% of patients prescribed inappropriate dose based on indication and renal function

7 Rationale Retrospective analysis at JMH demonstrated a number of issues with DOACs Inappropriate indication Inappropriate dose Drug interactions Overlap with parenteral anticoagulants Targeting DOAC orders could serve as a screening method to correct errors prior to verification

8 Objective To measure the impact of a criteria-based, clinical pharmacist-driven DOAC order review service on the quality of anticoagulation in patients receiving DOACs

9 Methodology Logistics Upon receipt of a DOAC medication order, central pharmacy paged the clinical pharmacist Clinical pharmacist reviewed the order and either approved or denied the order If order was denied, appropriate therapy was recommended Standardized protocol for evaluation Indication, dose, renal function, drug interactions, overlap with other anticoagulants Orders identified via pager between 7AM - 9PM and retrospective reports for overnight hours

10 Outcomes Primary goal Identify the number and type of errors prevented by clinical pharmacist review Secondary goals Collect data on specific dosing errors Develop targeted education for prescribers and pharmacists

11 Demographics Demographics Apixaban (n=172) Rivaroxaban (n=53) Dabigatran (n=14) Average age (range) 64 (24-95) 65 (22-95) 70 (55-79) Male (%) 105 (61) 34 (64) 6 (43) Female (%) 67 (39) 19 (36) 8 (57) Top 3 prescribing services (%) Private physicians (39.5) Private physicians (32.1) Cardiology (28.6) Hospitalists (17) Hospitalists (24.5) Hospitalists (21.4) Medicine (24) Medicine (18.9)

12 Indications Apixaban N=172 Rivaroxaban N=53 Dabigatran N=14 Atrial Fibrillation/Flutter 84 (49) 16 (30) 10 (71.4) DVT/PE 76 (44) 32 (60) 4 (28.6) DVT/PE prophylaxis 4 (2.3) 4 (7.5) 0 (0) Unknown 7 (4.1) 1 (2) 0 (0) Valvular Atrial Fibrillation 1 (0.6) 0 (0) 0 (0)

13 Interventions Intervened (%) Apixaban (n=172) Rivaroxaban (n=53) Dabigatran (n=14) Yes 67 (39) 22 (41.5) 6 (43) Accepted 62 (92.5) 18 (81.8) 5 (83) Not accepted 5 (7.5) 4 (18.2) 1 (17) No 105 (61) 31 (58.5) 8 (57)

14 Apixaban Interventions N=67 Overlap 36% Dose 31% Consult 12% Drug 12% Major DDI 9%

15 Rivaroxaban Interventions N=22 Consult 4% Overlap 14% Dose 32% Drug 41% Major DDI 9%

16 Dabigatran Interventions N=6 Overlap 17% Major DDI 33% Dose 50%

17 Role of the Clinical Pharmacist Verify and ensure correct dosing and indication Assess renal function and verify correct dosing Ensure that there is no overlap with parenteral anticoagulants Education

18 Conclusion Pharmacists have a key role in ensuring the appropriate prescribing of DOAC medications Overlap of DOAC medications with parenteral anticoagulants is prevalent Prescribers will benefit from education and familiarity with DOAC medication indication and dosing

19 Limitations Active pharmacist intervention during the second half of the study period All DOAC medications were not equally represented Did not follow patients throughout the course of hospitalization

20 Future Plans Prospective surveillance of all DOAC medication orders will be continued Follow up for clinical outcomes of the study patient population Potential creation of a full time anticoagulation stewardship position

21 Learning Assessment True/False: Overlap therapy with parenteral anticoagulant is required when transitioning to DOACs True/False: DOACs have a faster onset/offset of action as compared to Vitamin-K antagonist therapy True/False: Pharmacists may have a vital role in verifying and ensure correct dosing and indication for DOACs

22 References Gómez-Outes A, Suárez-Gea ML, Lecumberri R, Terleira-Fernández AI, Vargas- Castrillón E. Direct-acting oral anticoagulants: pharmacology, indications, management, and future perspectives. Eur J Haematol. June Larock A-S, Mullier F, Sennesael A-L, et al. Appropriateness of prescribing dabigatran etexilate and rivaroxaban in patients with nonvalvular atrial fibrillation: a prospective study. Ann Pharmacother. 2014;48(10): Mekaj YH, Mekaj AY, Duci SB, Miftari EI. New oral anticoagulants: their advantages and disadvantages compared with vitamin K antagonists in the prevention and treatment of patients with thromboembolic events. Ther Clin Risk Manag. 2015;11: Simon J, Hawes E, Deyo Z, Bryant Shilliday B. Evaluation of prescribing and patient use of target-specific oral anticoagulants in the outpatient setting. J Clin Pharm Ther. May 2015.

23 Andrew Stoessel, PharmD PGY-1 Pharmacy Practice Resident Jackson Memorial Hospital

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