Drug safety is a growing concern for pharmaceutical companies as abuse and misuse of prescription medications becomes increasingly widespread. This is especially true for opioid analgesics and other medications with a high potential for abuse and addiction.

As companies grapple with the stringent requirements of the United States Food & Drug Administration (FDA), approval of new products often hinges on the development of comprehensive risk management plans.

Inflexxion provides thought leadership, tailored solutions, and effective intervention programs in support of all
facets of pharmaceutical risk management.
 
Effective risk management begins with carefully designed data gathering systems that monitor real world behaviors, and provide reliable product-specific abuse rates.
A validated and scientifically-based signal detection system helps minimize false-positive or false-negative signals.
Thirdly, field investigation procedures are engaged to confirm signals detected in specific areas.
Finally, effective interventions are used to minimize abuse rates in high-risk areas. The process begins again with constant surveillance to monitor new signals or measure the efficacy of a particular intervention.




 

Inflexxion’s in-house teams of medical and behavioral health scientists and software engineers help pharmaceutical companies leverage existing technologies and develop custom solutions that support:

   

risk management plans for new pharmaceutical products seeking FDA approval
    pre- and post-marketing pharmacovigilance programs

Through the generous support of the National Institutes of Health and industry partners, Inflexxion has developed and tested a number of tools, products, and services for companies that research, manufacture and market opioid pain medications and other therapeutic agents with potential abuse problems. 
 

an award-winning continuing education resource for physicians, nurses, psychologists and pharmacists dedicated to the safe and effective treatment of patients with pain, used by more than 7,000 health practitioners nationwide.

a robust online resource that
helps patients and health consumers better understand and effectively manage their chronic pain, while learning proper use of their prescription medication.
the SOAPP® (Screener and Opioid Assessment for Patients with Pain)
is a patient level risk management tool that helps clinicians assess the relative risk of medication misuse among patients.
 
 
 
NAVIPPRO (National Addictions Vigilance
Intervention & Prevention Program) is an Internet-based drug abuse surveillance
system that enables pharmaceutical companies to detect changes in prescription opioid abuse patterns.
 
developed with support from the National Institute on Drug Abuse (NIDA), Inflexxion’s new drug-focused component of
the myStudentBody® suite is a part of Endo Pharmaceuticals’ PROMISE Initiative, and will help minimize the inherent risk of abuse and misuse of some prescription medications among college students.