Vasanta Health Science LLC — Department of Health and Human Services SBIR Phase I: FDA

Description

Project Summary Abstract Pharmacy and Therapeutic Pandamp T Committees within healthcare organizations are challenged in developing off label use policies for two main reasons Examples of effective internal policies that have been developed at other organizations are generally not available for guidance and 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 Pandamp 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 andamp Development Randamp 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 a rFVIIa trade name NovoSeven by Novo Nordisk The specific aims of Phase I of this project are 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 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 to identify best practices for developing policy to mitigate or eliminate off label rFVIIa use and to develop a prototype of an online platform that will provide the appropriate communication and educational tools Page Project Narrative Due to lack of research findings on best practices healthcare organizations face challenges when developing off label use policies for key medications This project proposes Phase I funding to support Randamp D that will determine best practices for the internal organizational regulation of the off label use of key pharmaceuticals such as rFVIIa a medication that is expensive and compromises patient safety when used off label The ultimate aim is to develop online software that provides communication and education to healthcare organizations to promote the appropriate off label use of key drugs and that assists with the internal development of optimal off label use policies This project will serve the public good by improving patient safety and decreasing healthcare costs Page