SBIR/STTR Research Award
A system of tools to promote development, communication, and education of off-label medication use policy
Award amount
$147,980Program and phase
SBIR · Phase IAward year
2016Award details
- Awarding agency
- Department of Health and Human Services
- Branch
- Food and Drug Administration
- Recipient company
- Vasanta Health Science LLC
- Proposal award date
- 2016-09-15
- Contract end date
- 2017-03-31
- UEI
- Not reported
- Solicitation number
- PA15-269
- Topic code
- FDA
Research abstract
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
Technology keywords
Not reported
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