Evaluation of Recombinant Factor VIIa Off-Label Use at an Acute Care Hospital with Established Guidelines for Use

Abstract

Purpose: At present, there are a scarcity of data available evaluating off-label prescribing patterns of recombinant factor VIIa (rFVIIa), pharmacoeconomic impact, and patient outcomes in clinical practice in an acute care setting with guidelines in place to influence prescribing practices. The primary objective of this study was to retrospectively evaluate the off-label usage and prescribing patterns of rFVIIa at a large acute care hospital with established rFVIIa guidelines. Results: During the study period, a total of 199 patients were ordered rFVIIa, of which 181 (91%) received at least one dose of rFVIIa for an off-label use (n5181). Refractory bleeding and intracerebral hemorrhage were the 2 leading uses for rFVIIa, accounting for 30% (n 5 54) and 29% (n 5 51) of all uses, respectively. Overall, the mean number of doses per patient for all uses was 1.79. The mean number of doses per patient by non-FDA-approved use was highest in patients with cardiac surgery and refractory bleeding. The total yearly acquisition of rFVIIa for the study institution has decreased from 5.25 mcg/patient-day in 2005 to 2.52 mcg/patient-day in 2009. Conclusion: The findings are encouraging and support the impact that education of pharmacy, nursing, and physician staff along with guideline development may have on off-label rFVIIa usage. Further research evaluating the impact of rFVIIa guidelines and/or order sets is warranted.