OR WAIT null SECS
Opioid abuse detected by program that may be useful in REMS and post-market surveillance
A recently published study concerning the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) finds that the program succeeded in capturing patient opioid abuse data, as well as discerning differences among patient subpopulations, products, and geographic locations. A major component of NAVIPPRO—the Addiction Severity Index-Multimedia Version (ASI-MV) Connect—captured data revealing that 12% of 42,000 patients admitted to 265 treatment centers reported abuse of at least one prescription opioid analgesic product in the 30 days prior to beginning substance abuse treatment.
The announcement comes fast on the heels of an FDA disclosure that it will require a risk evaluation and mitigation strategy (REMS) for opioids. “The FDA announcement of a common REMS for extended-release opioids highlights the need for science-based pharmaceutical risk management,” says Simon Budman, Ph.D., CEO of Inflexxion Inc., a Newton, MA developer of behavioral change programs intended to reduce health-related risks and improve clinical outcomes.
Budman and coauthors published results of the NAVIPPRO study in the December issue of Pharmacoepidemiology and Drug Safety. NAVIPPRO is a risk-management program for post-marketing surveillance of Schedule II and III medications. The program, available to drugmakers by subscription, monitors indicators of adverse drug events on an active, ongoing basis. It provides a continuous, real-time, national data stream that assesses pharmaceutical abuse by patients entering substance abuse treatment by collecting product-specific, geographically-detailed information. The program was developed by Inflexxion with grants from the National Institute on Drug Abuse.
NAVIPPRO enables subscriber companies to track the abuse of all branded and generic prescription opioids in real-time and against a standard metric, according to Inflexxion. It also provides tools for mitigating risk, including empirically tested programs that help clinicians and patients better understand the safe use of opioids.
Although NAVIPPRO targets Schedule II and III medications, Budman notes that some of its elements have broader applicability and may be of interest to the makers of drugs other than opioids. “Companies are being pushed by FDA to have better REMS in place,” he says.