Tufts Health Care Institute Program on
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November 9 — 10, 2006 Pharmaceutical companies marketing abusable therapeutic agents are generally required by the FDA to propose and implement risk management programs (RMPs) to maximize the benefit and minimize the risks associated with the specific product. RMPs generally consist of elements such as label changes, education of both clinicians and patients, surveillance and other epidemiologic approaches, adverse events monitoring, clinician guidance systems, etc. Little information about the nature of such programs has been made public, and there has not been a single public description of the effectiveness of any opioid risk management effort that we are aware of. The few public discussions of such programs have made it clear that the FDA’s goals of bringing risk management into the 21st century, as articulated in three recent guidance documents, are far from being met. The conference reviewed the types of risk management programs that are available, discussed approaches to measuring their effectiveness, described available evidence of the effectiveness of such programs, and generated recommendations for best practices not only in risk management, but in measurement and accountability for the results.
Overview of Meeting Goals and Objectives Elements of a Guidance Document for Abuse-Deterrent Opioid Formulations Painless Politics: Strategies for Building Congressional Support for Abuse-Deterrent Opioid Formulations Concurrent Workgroup Breakouts Group 1: Benchtop Assessment of Extractability Group 2: Pre-Clinical Abuse Liability Group 3: Analgesic Clinical Trials: Measuring Abuse Liability Group 4: Human Abuse Liability Studies Group 5: Human Alcohol Interaction Studies Group 6: Epidemiologic Studies Group 7: Policy, Advocacy, Legislative Agenda Deliverables and Draft Citizens' Petition
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2011 Tufts Health Care Institute •
Boston, MA 02111 •
(617) 636-1000 |
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The mission of the Tufts Health Care Institute Program on Opioid Risk Management is to address challenges in the development and utilization of opioid analgesics, by engaging a multidisciplinary group of stakeholders focused on optimizing the benefits of opioid for pain management, and minimizing their risks, including abuse and diversion.