A system of tools to promote development, communication, and education of off-label medication use policy

Period of Performance: 09/15/2016 - 03/31/2017


Phase 1 SBIR

Recipient Firm

Vasanta Health Science, LLC
Principal Investigator


Project Summary/Abstract Pharmacy and Therapeutic (P&T) Committees within healthcare organizations are challenged in developing off-label use policies for two main reasons: 1) Examples of effective internal policies that have been developed at other organizations are generally not available for guidance, and 2) little evidence-based research has been done on factors that lead to optimized off-label use of these key pharmaceuticals. Vasanta Health Science LLC (VHS) proposes the production of online administration, communication, education and dissemination tools that will support P&T committees within healthcare organizations in the development of their internal off-label use policies. The project proposed in this application is the conduct of Research & Development (R&D) necessary to accrue proprietary evidence as to the specific internal policies (and other hospital- and provider-level factors) that impact the off-label use of recombinant factor 7a (rFVIIa, trade name NovoSeven® by Novo Nordisk). The specific aims of Phase I of this project are: 1) to determine what hospital-level factors are associated with use vs. no use of off-label rFVIIa in a sample of US hospitals in three states, 2) to determine what factors are associated with decreased levels of use among a nationwide sample of hospitals and provider specialties who report using off-label rFVIIa, 3) to identify best practices for developing policy to mitigate or eliminate off-label rFVIIa use and, 4) to develop a prototype of an online platform that will provide the appropriate communication and educational tools. Page 1