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
FDA to unveil proposal for class–wide opioid REMS
On July 22-23, 2010, the FDA will hold a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committees, to discuss Risk Evaluation and Mitigation Strategies (REMS) for extended–release and long–acting opioid analgesics. At the meeting, the FDA plans to present a proposal for a class–wide opioid REMS, and will ask for feedback from the advisory committees and public on the components of that proposal.
Details, including information on how to participate in the discussion, are available on the FDA website.
NAVIPPRO team presents research at CPDD 2010
Last week, members of the NAVIPPRO team presented research at the 2010 College on Problems of Drug Dependence (CPDD). Following is a list of our presentations. If you would like to be sent a copy of a poster, click on the link next to the title:
- Identification of Internet discussion aimed at defeating abuse deterrent formulations — McNaughton, E.C., Cassidy, T.A., Butler, S.F., Budman, S.H., Whalley, E. Request a copy
- Internet–based post–marketing surveillance of newly marketed opioid analgesics — Brownstein, J.S., McNaughton, E.C., Cassidy, T.A., Budman, S.H., Butler, S.F. Request a copy
- Abuse Deterrent Adjusted Measurement Model (ADAMM™): adjusting for local prescription opioid availability and local use of heroin — Black, R.A., Budman, S.H., Cassidy, T.A., Butler, S.F. Request a copy
- How accurate are estimates of community abuse made by local key informants? — Budman, S.H., Cassidy, T.A., Lioy, K., Butler, S.F. Request a copy
- Route of administration patterns across extended release prescription opioid products — Butler, S.F., Cassidy, T.A., Budman, S.H. Request a copy
- Prescription opioid abuse in adult and adolescent substance abuse treatment center populations: early findings from CHAT™ (Comprehensive Health Assessment for Teens) — Dailey, T., Cassidy, T.A., Butler, S.F., Budman, S.H. Request a copy
- Drug life cycle situation awareness: a novel approach to signal detection and post–marketing surveillance of prescription drugs — Cassidy, T.A., Butler, S.F., Budman, S.H. Request a copy
- Internet survey to explore methods for collecting street price of prescription opioids — Weiss, M., Wood, M., Cassidy, T.A., McNaughton, E.C., Butler, S.F. Request a copy
- Non–fatal overdose among people who abuse prescription opioids — Green, T.C., Cassidy, T.A., Budman, S.H., Butler, S.F. Request a copy
Study uncovers gender differences in risk factors for aberrant prescription drug use
Inflexxion researchers have conducted extensive research to identify risk factors for engaging in aberrant prescription drug use. Drs. Simon H. Budman and Stephen F. Butler recently collaborated on a study led by Robert N. Jamison, Ph.D., which identified gender differences in these risk factors among chronic pain patients who had been prescribed opioids for pain.
“Our analysis showed the drug misuse by women is motivated more by emotional issues and psychological distress while in men this behavior usually stems from problematic social and behavioral problems that lead to substance abuse,” said Dr. Jamison, a clinical psychologist at Harvard′s Brigham and Women′s Hospital, in a news release.
“Further, women who misuse pain drugs are more likely to admit to being sexually or physically abused or have a history of psychiatric or psychological problems.”
Results of the study are published in the April 2010 issue of The Journal of Pain (Vol. 11, No. 4). If you would like to review an author’s copy, please feel free to contact us.
Canada issues guidelines for safe and effective use of opioids for non–cancer pain
Canada′s National Opioid Use Guideline Group (NOUGG) has released a new national set of guidelines, the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non–Cancer Pain, to provide Canada′s health care providers with clear, evidence–based guidance regarding the use of opioids to safely manage patients with chronic non–cancer pain.
The NOUGG guidelines have 24 practice recommendations to assist clinicians who are initiating opioid therapy, conducting an opioid trial, and/or monitoring long–term opioid therapy. In addition, the guidelines incorporate practice tools and other resources to support opioid prescribing practices for this specific patient group. These include the Screener and Opioid Assessment for Patients with Pain–Revised Version (SOAPP®–R) and the Current Opioid Misuse Measure (COMM)®.
Developed by Inflexxion, the SOAPP is a brief, paper–and–pencil self–report tool that enables health care providers to assess the risk of addiction in patients being considered for opioid therapy. The COMM is a complementary tool for identifying whether a patient, throughout the course of long–term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.
The SOAPP has been shown to be a highly sensitive instrument. In a recent study comparing the sensitivity of a semi–structured clinical interview and three screening tools, researchers found the highest sensitivity for the clinical interview and the SOAPP, followed by the Opioid Risk Tool (ORT) and the Diagnosis, Intractability, Risk, and Efficacy inventory (DIRE) (Pain Medicine, Volume 10, Issue 8, pages 1426–1433).
The release of the Canadian guidelines follows publication last year of ground–breaking evidence–based guidelines for use of chronic opioid therapy in non–cancer pain patients in the U.S., developed jointly by the American Pain Society and the American Academy of Pain Medicine. These guidelines also highlight the utility of the SOAPP and COMM tools.
An article introducing Canada′s new guidelines is published in the Canadian Medical Association Journal.
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.
- FDA to unveil proposal for class–wide opioid REMS
- NAVIPPRO team presents research at CPDD 2010
- Study uncovers gender differences in risk factors for aberrant prescription drug use
- Canada issues guidelines for safe and effective use of opioids for non–cancer pain
- 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.
©2010 Inflexxion, Inc. All rights reserved.
