Implementation of an off-label recombinant factor VIIa protocol for patients with critical bleeding at an academic medical center.

Abstract

To describe the development of a pharmacy driven off-label recombinant factor seven (rFVIIa) protocol by a multi-disciplinary team for critical bleeding. A multi-disciplinary team made up of members from several critical care and surgical departments within the hospital were formed and charged with developing a standardized approach to how rFVIIa would be used for critical bleeding in an academic medical center. Groups represented on the multi-disciplinary team included clinical pharmacy, emergency medicine, pulmonary, hematology, cardiothoracic surgery, trauma, neurosurgery, and vascular surgery physicians. A pharmacist driven off-label rFVIIa protocol was developed and implemented for the use in those patients with critical bleeding. The protocol was based on the available literature and local expert opinion. Through the use of this protocol a significantly smaller average dose of rFVIIa is now being used when compared to those patients treated prior to the new protocol (47.5 vs. 62.2 mcg/kg, p = 0.036) while all-cause mortality was not significantly altered (35 vs. 48.8%, p = 0.057). An effective and safe pharmacy driven protocol was implemented by a multi-disciplinary team for rFVIIa as seen by providing a significantly lower average dose of rFVIIa while not sacrificing for overall patient mortality.