Welcome to the NAVIPPRO Signal.
This newsletter is aimed at helping risk management professionals understand and meet the challenges of developing effective risk evaluation and mitigation strategies.
We hope this issue of NAVIPPRO Signal is useful. If you have any questions about NAVIPPRO or our research, please feel free to contact us.
Sincerely,
The NAVIPPRO team
NAVIPPRO® Solution Helps Fulfill Elements of U.S. Government’s Action Plan to Reduce Prescription Drug Abuse
On April 19, the Obama Administration announced its plan to reduce prescription opioid abuse across the country in, “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” [PDF]. In support of the action plan, the Food and Drug Administration (FDA) also announced a required Opioids Risk Evaluation and Mitigation Strategy (REMS) making it mandatory for manufacturers of long-acting and extended-release opioids to provide funding for educational programs to healthcare providers and patients to learn about the risks and benefits associated with opioid use.
NAVIPPRO® (National Addictions Vigilance Intervention and Prevention Program) aligns with the administration’s strategies to reduce the growing epidemic currently facing the Nation as prescription opioid abuse soars to record levels. “Inflexxion is proud to offer a comprehensive pharmaceutical risk management program that can help the government meet the goals of the action plan for reducing our Nation’s fastest-growing drug problem, prescription opioid abuse,” says Simon Budman, PhD, CEO, and founder of Inflexxion, Inc.
A key element of the action plan calls for increased education about safe and appropriate use of opioids for clinicians and patients. In support of the action plan, the Food and Drug Administration (FDA) is requiring an Opioids Risk Evaluation and Mitigation Strategy (REMS) making it mandatory for manufacturers of long-acting and extended-release opioids to provide funding for educational programs to healthcare providers, as well as materials healthcare providers can use when consulting with patients about the risks and benefits associated with opioid use. NAVIPPRO’s educational components meet the FDA’s need for opioid education with PainEDU.org and painACTION.com; both are non-promotional, free online educational programs that cover every area which the FDA requires of an educational program.
“For the past several years, PainEDU and painACTION have been providing medication safety education to healthcare professionals and the public, so these programs are uniquely positioned to help meet the FDA’s Opioid REMS educational recommendations,” states Kevin Zacharoff, MD, VP of Medical Affairs at Inflexxion. “Our educational offerings have been developed and tested with support from the National Institutes of Health and are being used by pharmaceutical companies as part of their risk management and REMS plans.”
painACTION offers the public a variety of educational articles and tools on using opioids safely including information on the appropriate use, secure storage and disposal of opioids. PainEDU.org, which currently has over 35,000 subscribers and is adding over 1,100 new subscribers each month, offers healthcare providers education about pain assessment, safe and appropriate use of opioids, and opioid risk management tools.
“As a healthcare provider and educator, I find PainEDU.org invaluable for my education as well as the education of the primary care providers that I work with. Combined with the companion website for patients, painACTION.com, it is the first thing that I suggest to healthcare providers who want to know more about safe and effective pain management,” commented Ilene Robeck, MD, a pain and addiction specialist who works at the Veterans Administration Medical Center in Bay Pines, Florida.
Inflexxion’s opioid risk management tools include the Screener and Opioid Assessment for Patients with Pain (SOAPP®) which helps predict which patients, being considered for long-term opioid therapy, may be at future risk for misuse or abuse of opioid pain medication. SOAPP is part of the clinical guidelines for the American Pain Society/American Academy of Pain Medicine, Utah Department of Health, and the Berkshire Health System Pain Care Resource Manual. Inflexxion’s Current Opioid Misuse Measure (COMM)® helps identify whether a patient, currently on long-term opioid therapy, may be exhibiting aberrant behaviors associated with misuse of opioid medications. The SOAPP and COMM are both part of the Canadian National Regulatory Guidelines for Safe and Effective Use of Opioids. PainEDU.org also offers a variety of case-based pain management accredited Continuing Education (CE/CME) courses to healthcare providers, including physicians, nurses, psychologists, and pharmacists.
A second component of the Obama administration’s action plan to reduce prescription opioid abuse involves assessment and metrics. NAVIPPRO surveillance components consist of data streams that can provide the much needed assessment and metrics through its tracking and monitoring. The system includes data from the ASI-MV® Connect, which is being used in more than 500 substance abuse treatment centers across the country, and data from WISTM Internet Monitoring and Internet Surveys.
NAVIPPRO surveillance streams and educational offerings give government agencies and pharmaceutical companies a powerful tool for prescription drug abuse surveillance and related public health efforts such as the ones outlined in the government’s action plan.
To learn more about how NAVIPPRO can fulfill your REMS and risk management activities, contact us.
About NAVIPPRO
The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a public health-oriented risk management solution that integrates the four key components of an effective Risk Evaluation and Mitigation Strategy (REMS): national, real-time, product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.
NAVIPPRO began in 2001 with a series of grants from the National Institute on Drug Abuse (NIDA). In 2005, Endo Pharmaceuticals became the founding industry sponsor of NAVIPPRO and in 2006 Alpharma Pharmaceuticals LLC. (now King Pharmaceuticals, Inc.) became the second industry founder. Since that time, Shire Development, Inc. has joined in supporting the program, including providing founding sponsorship for the CHAT component. With NIDA’s continued support of ongoing research and product development, NAVIPPRO is constantly evolving to meet our goal of advancing public health.
- NAVIPPRO® Solution Fulfills Elements of U.S. Government’s Action Plan to Reduce Prescription Drug Abuse
- About NAVIPPRO
- NAVIPPRO
- Surveillance
- Signal detection
- Signal verification
- Prevention & intervention
- DETER Model
- About Inflexxion
Contact
Contact us to find out how we can assist you with your risk evaluation and mitigation strategy planning.
Subscribe
Join the NAVIPPRO Signal mailing list.
Support
The NAVIPPRO team gratefully acknowledges the support of the NIH, King Pharmaceuticals, Inc., Endo Pharmaceuticals, and Shire Development, Inc.in the development of NAVIPPRO.
The NAVIPPRO team gratefully acknowledges the support of the NIH, King Pharmaceuticals, Inc., Endo Pharmaceuticals, and Shire Development, Inc. in the development of NAVIPPRO.
The contents of this newsletter are for informational purposes only and are not intended to be a substitute for professional medical advice, diagnosis or treatment. Reliance on any information provided in this newsletter is at your own risk.
You should consult your physician or other qualified health provider if you have questions about a medical condition. If you think you have a medical emergency, call your doctor or 911 immediately.
©2011 Inflexxion, Inc. All rights reserved.
