Novo 7 Study

Goal: Determine how to mitigate use of off-label Novo 7 in US hospitals.

UF Health <$10k Current Project / Health Policy 2012

Objective
To make evidence-based recommendations to US hospitals on how to mitigate or eliminate their off-label use of recombinant factor VIIa (Novo 7 ®).
Impact
  • rFVIIa (Novo 7®) was approved for use by the US FDA in 1999 to stop bleeding in certain hemophiliacs.  It has never been approved for use in the general population.
  • Many clinicians thought Novo 7 might help stop bleeding in the general population, such as trauma patients, or people bleeding uncontrollably during cardiovascular surgery.
  • Since 1999, clinicians have used Novo 7 on the general population.  This is called “off-label” use.
  • The makers of Novo 7 have not encouraged off-label use (except possibly in the military), but they have not actively discouraged it, either.  This is probably because it costs $10,000 per dose, and the company making it improves their finances when Novo 7 is used off-label.
  • Up to 2012, clinicians and scientists studied Novo 7’s effect when used off-label.  In 2012, the Cochrane Collaboration determined that there are adverse effects (clots) when used off-label, and said it should not be used this way.
  • But 97% of the use of Novo 7 in the US remains off-label.  This use is supported by Medicaid DSH payments, thus putting a strain on hospital finances, and putting patients at risk.
  • The aim of the Novo 7 Study is to make evidence-based recommendations to US hospitals so they can mitigate or eliminate off-label use of Novo 7 to both protect their patients as well as be more fiscally responsible.
Company Role
This has been an ongoing line of research in collaboration with Dr. Agnes Aysola, now Medical Director of the Coagulation Laboratory and the Transfusion Medicine Department at UF Health in Jacksonville, FL.
Publications
Grantwriting
  • Assisted with grant submissions to UF Health internal funding mechanisms.
  • SBIR application recently awarded by FDA to develop policy portal for hospitals to use for guidance.
Pilot Study
  • Developed pharmacist questionnaire in REDCap.
  • Working with research assistant to gather Novo 7 usage information via questionnaire from pharmacy leaders in Florida’s inpatient pharmacies.

 

Related Publications
Aysola AE, Wahi MM, McKelvey RP, Gerdik CR. Research on patient safety for off-label use of recombinant factor VIIa. American Journal of Health-system Pharmacy, 2015, 72(8):600-602.

  • This letter sets forth a new perspective toward research approaches to studying recombinant factor VIIa (Novo 7).
  • In 2012, an updated Cochrane Review established that using Novo 7 to stop bleeding in non-hemophiliacs represented a threat to patient safety. Off-label use of Novo 7 should not take place.
  • Nevertheless, researchers keep studying off-label use of Novo 7.
  • Novo 7 costs approximately $10,000 per dose, so it is very expensive as well as a patient safety risk when used off-label.
  • Instead of studying indications for off-label uses of Novo 7, researchers should instead begin to study how to mitigate or eliminate off-label use of Novo 7 at healthcare institutions.
  • Currently, there is almost no peer-reviewed, evidence-based scientific literature to guide healthcare leaders on how to mitigate or eliminate the dangerous and wasteful practice of off-label Novo 7 use. We propose to fill this gap in the literature through our research.

Leadership is key clinical skill for hospital pharmacist

  • This article describes one pharmacist’s journey to mitigating off-label Novo 7 use at her institution.

 

Photos courtesy of Monika Wahi, ReytanBrokenSegue and Jkgroove.  Page updated January 8, 2017.