On-label compared to off-label four-factor prothrombin complex concentrate use: a retrospective, observational study.

BACKGROUND: Four-factor prothrombin complex concentrate (4F-PCC) is US Food and Drug Administration approved for the urgent reversal of coagulation factor deficiency induced by a vitamin K antagonist complicated by acute major bleeding or in situations in which invasive procedures are urgently needed. Although recent evidence suggests the superiority of 4F-PCC over plasma for on-label indications, the off-label use of 4F-PCC has not been rigorously studied. STUDY DESIGN AND METHODS: Eighty-nine patients receiving 4F-PCC at a single institution from July 2016 to December 2017 were retrospectively analyzed. Two cohorts, "On-Label" and "Off-Label" uses of 4F-PCC, were evaluated, comparing patient characteristics, blood utilization, and clinical outcomes including in-hospital mortality. RESULTS: Patients receiving 4F-PCC for off-label reasons (n = 46) were younger and sicker compared to those receiving 4F-PCC for on-label reasons (n = 43). Notably, the mortality rate for off-label use was approximately twofold greater than the mortality rate for on-label use (26 of 46 [56.5%] vs. 12 of 43 [27.9%]; p = 0.006). Patients receiving 4F-PCC for off-label reasons received more units per patient of each blood component than their on-label counterparts. The average cost estimate per patient for 4F-PCC was similar (approx. $4300) in each cohort. CONCLUSION: 4F-PCC is an effective but expensive treatment option for those requiring urgent reversal of vitamin K antagonist-induced coagulopathy. However, providers should be conscious of the high costs and questionable efficacy when using 4F-PCC off-label.

Implementing a Health System-wide Patient Blood Management Program with a Clinical Community Approach.

BACKGROUND: Patient blood management programs are gaining popularity as quality improvement and patient safety initiatives, but methods for implementing such programs across multihospital health systems are not well understood. Having recently incorporated a patient blood management program across our health system using a clinical community approach, we describe our methods and results. METHODS: We formed the Johns Hopkins Health System blood management clinical community to reduce transfusion overuse across five hospitals. This physician-led, multidisciplinary, collaborative, quality-improvement team (the clinical community) worked to implement best practices for patient blood management, which we describe in detail. Changes in blood utilization and blood acquisition costs were compared for the pre- and post-patient blood management time periods. RESULTS: Across the health system, multiunit erythrocyte transfusion orders decreased from 39.7 to 20.2% (by 49%; P < 0.0001). The percentage of patients transfused decreased for erythrocytes from 11.3 to 10.4%, for plasma from 2.9 to 2.2%, and for platelets from 3.1 to 2.7%, (P < 0.0001 for all three). The number of units transfused per 1,000 patients decreased for erythrocytes from 455 to 365 (by 19.8%; P < 0.0001), for plasma from 175 to 107 (by 38.9%; P = 0.0002), and for platelets from 167 to 141 (by 15.6%; P = 0.04). Blood acquisition cost savings were $2,120,273/yr, an approximate 400% return on investment for our patient blood management efforts. CONCLUSIONS: Implementing a health system-wide patient blood management program by using a clinical community approach substantially reduced blood utilization and blood acquisition costs.