Citizens Petition
- Sustaining Partners
May 2012-
The Search for an Ideal Analgesic
June 2011-
Pharmacotherapy for Prescription Opioid Addiction
March 2011-
Advancing Safe Opioid Prescribing through Prescriber Training and Behavior Change
June 2010-
Payer Issues Related to Prescription Opioid Monitoring and Abuse
March 2010-
The role of Dentists in Preventing Opioid Abuse
July 2009-
Risk Evaluation and Mitigation Strategy for Prescription Opioids
April 2009-
Prescription Monitoring Research Update
November 2008-
Co-ingestion of Alcohol with Prescription Opioids
June 2008-
The Role of Urine Drug Monitoring in Pain Management
March 2008-
Sources of Diverted Prescription Opioids
September 2007-
Understanding the Types of Opioid Abusers
March 2007-
Responding to Signals of Opioid Abuse
November 2006-
Development of Abuse Deterrent Formulations
September 2006-
Best Practices in Opioid Risk Management
October 2005-
Opioid Abuse Resistance
March 2005-
Opioid Risk Management

Tufts Health Care Institute Program on
Opioid Risk Management

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.

November 9 — 10, 2006
Guidelines for the Development of Abuse-Deterrent Opioid Formulations

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.


Executive Summary

November 2006

Overview of Meeting Goals and Objectives
Nathaniel Katz, MD, MS Presentation >>

Elements of a Guidance Document for Abuse-Deterrent Opioid Formulations
What makes a good Guidance Document for use by the FDA

Cynthia McCormick, MD Presentation >>

Painless Politics: Strategies for Building Congressional Support for Abuse-Deterrent Opioid Formulations
Andrea Barthwell, MD Presentation >>

Concurrent Workgroup Breakouts

Group 1: Benchtop Assessment of Extractability
Robert Bianchi, PhD Presentation >>

Group 2: Pre-Clinical Abuse Liability
William Schmidt, PhD Presentation >>

Group 3: Analgesic Clinical Trials: Measuring Abuse Liability
Bruce Rounsaville, MD Presentation >>

Group 4: Human Abuse Liability Studies
Sandra Comer, PhD Presentation >>

Group 5: Human Alcohol Interaction Studies
Ed Sellers, MD Presentation >>

Group 6: Epidemiologic Studies
Edgar Adams, ScD Presentation >>

Group 7: Policy, Advocacy, Legislative Agenda
Andrea Barthwell, MD Presentation >>

Deliverables and Draft Citizens' Petition
Nathaniel Katz, MD, MS Presentation >>


2008 Tufts Health Care Institute •   Boston, MA 02111 •   (617) 636-1000