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

Disclosures David Reardon has received consulting fees from Boehringer Ingelheim

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

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

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

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

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

A Need for Change Percentage Budnitz DS, et al. NEJM. 2011;365:2002-12

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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. 2.86 days, p=0.01)

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

Questions?