1. Antithrombotic Stewardship: A Multidisciplinary Approach to Improve Antithrombotic Therapy
David Reardon, PharmD BCPS
September 18th, 2015
Tri-State Health-System Pharmacy Summit

2. Disclosures
David Reardon has received consulting fees from Boehringer Ingelheim

3. Pharmacist Objectives
Compare and contrast anticoagulation management services and anticoagulation stewardship programs
Identify areas of target for anticoagulation stewardship programs
Describe interdisciplinary approaches to improving anticoagulation utilization and decreasing costs

4. Technician Objectives
Identify potential technician roles in an anticoagulation stewardship
Describe medication reconciliation approaches to improve anticoagulant use

5. Anticoagulation
Arterial and venous thromboemobolism is a leading cause of morbidity/mortality in the US
In 2007, 4.2 million American age 18 and older received at least one anticoagulant
27.9 million prescriptions filled
$905.2 million spent
Kirley K et al. Circ Cardiovasc Qual Outcomes. 2012;5:615-21
Beauregard KM et al. Agency for Healthcare Research and Quality. October 2009

6. Anticoagulation Percentage
Beauregard KM et al. Agency for Healthcare Research and Quality. October 2009

7. Anticoagulation Percentage
Kirley K et al. Circ Cardiovasc Qual Outcomes. 2012;5:615-21

8. A Need for Change
Percentage
Budnitz DS, et al. NEJM. 2011;365:

9. Anticoagulation Management Services (AMS)
Provide a specialized service in one area
Warfarin management
Improved therapeutic efficacy and decrease in adverse events
Decrease in total treatment costs
Cost avoidance
Biscup-Horn PJ, et al. J Thromb Thrombolysis. 2008,25:129
Padron M, et al. J Pharm Pract. Epub ahead of print

10. Antithrombotic Stewardships Programs (ASP)
Inpatient-focused program
Incorporate principles of AMS
Focus on transitions of care
Patient education and follow up
Design, implement, and enforce institutional protocols
Determine areas of improvement
Medication use evaluations (MUE)
Formulary review
High risk patient populations
Expose gaps in therapy management
Padron M, et al. J Pharm Pract. Epub ahead of print
Reardon, et al. J Thromb Thrombolysiss. 2015;40:379-82

11. Identifying Targets Institution specific Attainable results
High cost medications (IV direct thrombin inhibitors, anti-platelets, NOACs)
MUEs
Determine appropriateness of utilization and off-label use
Medication frequently associated with adverse events
Attainable results
Realistic short and long-term goals
Reardon, et al. J Thromb Thrombolysiss. 2015;40:379-82

12. Potential Targets Management of heparin-induced thrombocytopenia (HIT)
Minimize costs of expensive IV therapies such as direct thrombin inhibitors (DTIs)
Initiate non-heparin anticoagulation quickly
Transition to long-term therapy
Improve vitamin K administration
Dosing of anticoagulation in patients with mechanical circulatory support devices (i.e. ventricular assist device, total artificial heart)
High risk patient population
Require highly skilled management
Oversight of anticoagulation in patients receiving extracorporeal membrane oxygenation (ECMO)
Reardon, et al. J Thromb Thrombolysiss. 2015;40:379-82

13. Getting the Key Players Together
ASP
Pharmacy
Hematology
Hospital Leadership ?
Blood Bank
Lab

14. Hospital Leadership Quality Assessment and Process Improvement
Ensure The Joint Commission National Patient Safety Goals met
Improve patient care and decrease re-admissions
Business plans and funding
Approve more FTE support
Provide top-down support
Enforcement of clinical initiatives
Wide-spread communication to those affected by change

15. Pharmacy Specialized training in antithrombotic management
Warfarin management clinics
Inpatient heparin management services
Budgetary motivation
Structure for management
Pharmacy clinical services
Medication reconciliation
Medication reconciliation technicians
Pharmacy and Therapeutics Committee
Collaborative Drug Therapy Management

16. Physician Champion Hematology/Cardiology/Internal Medicine
Physical champions
Serve as medical director of ASP
Write and review protocols and guidelines
Have “skin in the game”
Proper diagnosis and therapy utilization reduces unnecessary workload
Improved patient follow up and outcomes

17. Lab Proper utilization of resources
Decrease in time performing unnecessary tests
Ability to fast-track results
Protocol and guideline development

18. Blood Bank Reversal strategies and agents
Protocol and guideline development
Blood products
Clotting factors

19. Multidisciplinary approaches
Buy in from key stakeholders
Identification of areas for improvement
Assigning specific tasks to create ownership
Determine physical champion(s)

20. Tactics for Success Formulary Restriction
Authorization for use
Limited indications for use
Order entry restriction
Audit with Intervention and Feedback
Prospective vs. retrospective
Education
Grand rounds, orientation, patient care rounds
Clinical pathways and guidelines
Proper diagnosis, treatment, and discharge planning
Drew. J Manag Care Pharm. 2009;15:S18-23

21. Pharmacist Activities
Dosing and reviewing antithrombotics in designated patient populations
Drug-drug interactions
Hepatic/renal dysfunction
Daily progress notes
Stewardship rounds
Patient monitoring and laboratory follow up
Protocol and guideline development
Committee participation
ASP progress updates to hospital leadership
Research and publication
Student and resident precepting

22. Management of HIT: Target Identified
Fiscal year 2013 DTI costs: $1,087,647 directly associated with HIT
Improper diagnosis
Dogmatic approach to diagnosis
Not “believing” laboratory data
Prolonged transition
Unsure of long-term plan
Perceived barriers of fondaparinux therapy
Reardon, et al. J Thromb Thrombolysiss. 2015;40:379-82

23. Management of HIT: Action Plan Created
Update institutional guideline for HIT Management
Easy to use 4Ts scoring sheet
Appendix with rationale behind guideline
Clinical surveillance of anti-heparin PF4 antibody and serotonin release assays
Follow up after DTI initiation
Pharmacist-written note in medical record
Reviewed with Hematology attending
Recommendations for therapy
Ability to stop therapy
Targeted educational activities
Senior physicians and their teams
Reardon, et al. J Thromb Thrombolysiss. 2015;40:379-82

24. DTI Use in HIT 782 patients evaluated 592 patients included
152 patients excluded
259 post-ASP patients
333 pre-ASP patients

25. Bivalirudin Cumulative Use in HIT Patients by Month
Expenditure in Millions of Dollars
Months
Reardon, et al. J Thromb Thrombolysiss. 2015;40:379-82

26. Changes in HIT Treatment Costs
 Variable
All Patients
N=592
Pre-ASP
n=333
Post-ASP
n=259
Cost of fondaparinux, dollars
$28,772.78
$4,159.92
$24,612.86
Cost of DTI, dollars
$423,142.70
$266,689.40
$156,453.30
Total drug cost of DTI and fondaparinux, dollars
$451,915.48
$270,849.32
$181,066.16
Cost data: $784.56/vial of bivalirudin, $198.57/vial of argatroban, $346.66/syringe of fondaparinux.
Decrease in duration of DTI therapy in patients with suspected or diagnosed HIT pre- vs. post-ASP (4.07 vs days, p=0.01)

27. Barriers to Implementation and Success
Time devotion and funding
Disrupting the “status quo”
Protocol and guideline adherence
Pharmacist vs. physician-driven service
Lack of specific “antithrombotic-trained” pharmacists
Drew. J Manag Care Pharm. 2009;15:S18-23

28. Questions?