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Project Title:

Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
PIN: IOM-HSP-16-05        

Major Unit:

Health and Medicine Division

Sub Unit: Board on Health Sciences Policy

RSO: Ford, Morgan

Subject/Focus Area: Health and Medicine; Policy for Science and Technology


Project Scope
The Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine will convene an ad hoc committee to develop a report that will inform the U.S. Food and Drug Administration (FDA) as to the state of the science regarding prescription opioid abuse and misuse, including prevention, management, and intervention, and to provide an update from the 2011 Institute of Medicine (IOM) report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, which includes a further characterization of the evolving role that opioid analgesics play in pain management.  The report additionally will make recommendations on the options available to FDA to address the prescription opioid overdose epidemic, from both the individual and public health perspectives, and to otherwise further advance the field.

Specifically, the committee's report will:

-Provide an update on the state of the science of pain research, care, and education since the 2011 IOM report and characterize the evolving role of opioid analgesics in pain management.

-Review the available evidence on best practices with regard to safe and effective pain management, including practices to reduce opioid abuse and misuse, including an assessment of possible barriers to implementation of those best practices by prescribers and patients.

-Characterize the epidemiology of prescription opioid abuse and misuse, to include an assessment with regard to patient characteristics (such as indication, acute versus chronic pain; formulation, immediate-release versus extended-release; duration of use; and dose) and approaches to address the problem (such as approval of abuse-deterrent opioids, FDA communication strategies, prescription drug monitoring programs, and state or local policies) and review the available evidence on differences in pain experiences and treatment effectiveness across subpopulations.

-Given the state of the available data, identify important research questions to be addressed to assist FDA in meeting the goal of further developing a framework for opioid review, approval, and monitoring that balances individual need for pain control with considerations of the broader public health consequences of opioid abuse and misuse.

-Given the state of the available data, identify additional actions FDA and others should consider now, with a particular focus on those actions the FDA can undertake, to balance the needs of pain patients and the need to address opioid misuse and abuse. Areas of particular focus include:
-FDA actions to be taken as a part of development, review and approval, and safe use of pain medicines, such as development of a formal method to incorporate the broader public health impact of opioid abuse in future FDA approval decisions regarding opioids; the development of non-opioid pain medicines to treat severe pain; the development of abuse-deterrent opioids; the incorporation of prevention strategies into safe opioid prescribing, including modification of the standard opioid indication statements; the development of medicines for medication assisted treatment for patients with opioid use disorder; the development of medicines to treat opioid overdose; the education of prescribers and patients about safe use of pain medications; and the education of prescribers and patients about appropriate medication storage and disposal.
-Actions by prescribers, professional societies, and government agencies (local, state, and federal).

This study is sponsored by the U.S. Food and Drug Administration. The start date for the project is 03/25/2016. The committee's report will be issued in summer 2017.


 
Project Duration: 18 months    

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Committee Membership
Committee Membership

Meetings
 Meeting 1 - 07/06/2016
 Meeting 2 - 09/22/2016
 Meeting 3 - 11/03/2016
 Meeting 4 - 12/14/2016
 Meeting 5 - 01/23/2017
 Meeting 6 - 03/27/2017

Reports

Reports having no URL can be seen
at the Public Access Records Office