August/September 2010 | ISSUE 18
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
Rejection of FDA’s opioid REMS plan highlights the need for timely, product-specific data on opioid use
On July 23, an advisory panel voted 25-10 against the FDA’s proposal for a class-wide Risk Evaluation and Mitigation Strategy (REMS) for extended-release opioid medications. While much of the media coverage of the vote has focused on the panel’s concerns about the educational components of the program, panel members also expressed significant concerns regarding the proposed metrics for evaluating the REMS.
“A major flaw is that I heard almost nothing about data collection,” said John Farrar, M.D., Ph.D., Senior Scholar and Associate Professor of Epidemiology at the University of Pennsylvania Center for Clinical Epidemiology and Biostatistics. “A global measure of how many patients die may not completely reflect the situation. Understanding where people get their pain medications is especially important, because it tells us where to focus our efforts.”
Several panel members noted that government data sources in the FDA proposal lack product-specific data, and are not sufficiently timely. For example, there is a year and 9-month lag for the emergency room data that SAMHSA collects; data are collected for only a small number of states; and the data are not product-specific, and so would not distinguish, for instance, between immediate- and extended-release opioid medications. There is an even longer lag-time for the data collected through the Treatment Episode Data Set (TEDS); the most recent data report available is from 2008.
Thomas Kosten, M.D., Professor of Psychiatry/Addiction at Baylor College of Medicine, further noted that there was scant discussion of data sources that provide timely and/or product-specific information, such as NIDA’s “Monitoring the Future” survey.
“I wouldn’t want us to lose track in all of this that there are surrogate measures, which is the drug abuse data,” he said. “This tends to be a much earlier marker than deaths, and if you have data for particular compounds, you can usually pick up trends over time, if nothing else than to identify which drug is problematic as compared to another.”
Simon H. Budman, Ph.D., President & CEO of Inflexxion, Co-founder NAVIPPRO, spoke at the meeting to discuss metrics for evaluating the proposed REMS.
“We need to go beyond measuring changes in knowledge; we need to measure changes in behavior,” said Dr. Budman. He noted that the NAVIPPRO data streams include product-specific substance abuse data collected from nearly 500 treatment centers across the U.S., representing 200,000 cases to date, uploaded at a rate of 1,500 cases per week, and available in near real-time.
Citing data from NAVIPPRO, Dr. Budman observed that of all substance abuse admissions reported through the program, 15.4% have abused one or more prescription opioid, and of those abusing an opioid medication, 58.3% abused one or more extended-release preparation. Those admitted for treatment reported getting these medications primarily through three sources: 1) their own prescription, 2) their friends or family members, or 3) dealers.
“Some drug sources may be impacted by an effective class-wide REMS,” said Dr. Budman. “We believe that an effective REMS would show changes in the first two areas quite rapidly.”
Dr. Budman concluded by reiterating that while it is crucial to measure changes in provider and patient knowledge, it is incredibly important to measure behavior, and in a timely manner. “We cannot wait three years to get TEDS data to see if a program is working,” he said.
FDA officials acknowledged the importance of using the appropriate metrics to monitor the impact of any REMS program. Responding to panel members’ call for a pilot program to bolster the evidence base for the proposed REMS, Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research (CDER), stated, “To the extent that we’re able to develop meaningful metrics that would allow us to see how well a program is working, [the REMS] can function in a way as a pilot program, because it can be broadened, or extended or made tighter depending on the results of that assessment.”
To learn more about NAVIPPRO, visit the NAVIPPRO website.
For more information on the FDA’s proposal for a class-wide opioid REMS, follow the links to the meeting agenda, questions, and briefing materials that include the proposed REMS.
Agenda [PDF]
Questions [PDF]
Briefing materials [PDF]
Research update: painACTION.com proves to be a useful tool for people with chronic back pain
Every component of NAVIPPRO is scientifically developed and tested, and our research team regularly publishes the results in peer-reviewed journals.
Following is the abstract from an article published in the July 2010 issue of Pain Medicine (Vol. 11, Issue 7, pages 1044-1058), entitled “painACTION-Back Pain: A Self-Management Website for People with Chronic Back Pain.” The abstract summarizes the results of a study of the painACTION program, one of the prevention and intervention programs incorporated in NAVIPPRO.
Objective. To determine whether an interactive self-management Website for people with chronic back pain would significantly improve emotional management, coping, self-efficacy to manage pain, pain levels, and physical functioning compared with standard text-based materials.
Design. The study utilized a pretest–posttest randomized controlled design comparing Website (painACTION-Back Pain) and control (text-based material) conditions at baseline and at 1-, 3-, and 6-month follow-ups.
Participants. Two hundred and nine people with chronic back pain were recruited through dissemination of study information online and at a pain treatment clinic. The 6-month follow-up rates for the Website and control groups were 73% and 84%, respectively.
Measurements. Measures were based on the recommendations of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials and included measures of pain intensity, physical functioning, emotional functioning, coping, self-efficacy, fear-avoidance, perceived improvement with treatment, self-efficacy, and catastrophizing.
Results. Compared with controls, painACTION-Back Pain participants reported significantly: 1) lower stress; 2) increased coping self-statements; and 3) greater use of social support. Comparisons between groups suggested clinically significant differences in current pain intensity, depression, anxiety, stress, and global ratings of improvement. Among participants recruited online, those using the Website reported significantly: 1) lower "worst" pain; 2) lower "average" pain; and 3) increased coping self-statements, compared with controls. Participants recruited through the pain clinic evidenced no such differences.
Conclusions. An online self-management program for people with chronic back pain can lead to improvements in stress, coping, and social support, and produce clinically significant differences in pain, depression, anxiety, and global rates of improvement.
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.
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Rejection of FDA’s opioid REMS plan highlights the need for timely, product-specific data on opioid use
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Research update: painACTION.com proves to be a useful tool for people with chronic back pain
- About NAVIPPRO
- NAVIPPRO
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- DETER Model
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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.
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