Lindsey Lindsey, PharmD
Emergency Medicine Pharmacy Resident
Grady Memorial Hospital
Atlanta, Georgia
Disclosure information not submitted.
Elaina Etter, PharmD
PGY-2 Critical Care Pharmacy Resident
Grady Memorial Hospital
Atlanta
Disclosure information not submitted.
Christopher Morrison, BCCCP, PharmD, FNCS
Pharmacist
Grady Memorial Hospital, United States
Disclosure information not submitted.
Marjorie Curry, PharmD, BCOP
Pharmacist
Grady Health System, United States
Disclosure information not submitted.
Katleen Chester, BCCCP, PharmD, BCGP
Pharmacist
Grady Health System, United States
Disclosure information not submitted.
Title: 4-Factor PCC Dosing in Patients on DOAC or Warfarin: Support for a Fixed-Dose Protocol
Introduction: Four-factor prothrombin complex concentrate (PCC (Kcentra®)) is indicated for urgent reversal of warfarin patients with acute major bleeding. Direct oral anticoagulant (DOAC) use has become increasingly prevalent for prophylaxis and treatment of venous and arterial thrombotic events. Data is emerging for use of high cost PCC as a fixed dose for reversal of both warfarin and DOACs. This quality improvement project compared PCC doses administered for warfarin and DOAC reversal at a large academic trauma hospital to dosing using a fixed dose PCC protocol. The impact of the fixed dose protocol on cost avoidance was also evaluated.
Methods: This single-center retrospective medication record review evaluated patients with an order for PCC between May 1, 2018 and June 30, 2021. Documentation of PCC administration was required for inclusion. Patients were excluded if PCC was used for coagulopathies not associated with an oral anticoagulant. For cost analysis, 100 mg vial costs $1870, $1.87 per unit was utilized to calculate total cost. Currently, warfarin dosing is INR dependent and DOAC reversal is 25-50 mg/kg. The fixed dose protocol standardizes dosing to 2000 units for DOAC reversal and 1500 units for warfarin reversal for central nervous system (CNS) bleed, INR >7.5 or > 100 kg, other indications for reversals are dosed at 1000 units. The primary objective is to compare current actual units of PCC to recommended fixed dosing.
Results: Overall, 223 PCC administrations were reviewed, 177 were included in the final evaluation with 77 patients on warfarin and 100 patients on a DOAC. The median dose of PCC used for DOAC reversal was 25 mg/kg with a mean dose of 2000 units. The mean INR was 4.5 for those requiring reversal on warfarin and the mean PCC dose was 2500 units. The cost was $428,230 for 229,000 units in the DOAC group, per fixed dose protocol estimated cost was $377,740 and 202,000 units. Warfarin reversal total cost was $362,780 for 194,000 units, per fixed dose protocol, estimated was $191,675 for 102,500 units.
Conclusion: The mean dose for DOAC reversal was the am as the recommended fixed dose protocol. He mean dose for warfarin reversal was 2500 units where the fixed dose protocol recommends 1500-1000 units. The fixed dose protocol would reduce cost and decrease the mean dose by half.