Recently, the United States Food and Drug Administration (FDA) announced a public workshop to discuss mandatory prescriber education for opioids, reconsidering the need for mandatory opioid prescriber education through the Opioid Analgesic (OA) Risk Evaluation and Mitigation Strategy (REMS). The public workshop will be held virtually on October 13, 2021 from 1:00 pm ET to 5:00 pm ET and October 14, 2021, from 1:00 pm ET to 4:05 pm ET.
The two-day public workshop, “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis,” is an opportunity for stakeholders to provide input on aspects of the current opioid crisis that might be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS. The dynamics of the opioid and substance abuse crisis have shifted significantly since the Opioid Analgesic REMS was initially implemented and new opportunities may have emerged for improving prescriber education.
The public workshop is being convened by the Duke-Margolis Center for Health Policy and is supported by a cooperative agreement between the FDA and Duke-Margolis. A second public workshop is expected to gather input on additional issues associated with a move to mandatory prescriber education under a REMS, such as operational and technical issues and what would be included in the mandatory prescriber education.
Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), noted that the workshop is “the beginning of an important series of discussions with a broad group of stakeholders as the agency explores the value of mandatory opioid prescriber education on the appropriate use of opioids, the risks of opioid abuse and misuse and the treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers.”
Dr. Cavazzoni also noted that “Although many public and private entities have independently implemented their own education programs and other interventions to encourage safe and effective prescribing practices for opioid analgesics, there is no consistent education that all prescribers are required to take about the safe use of opioid medicines. Therefore, these programs likely differ with regard to content, focus and duration.”
Agenda Topics
Topics to be discussed include:
How could mandatory prescriber education through a REMS improve appropriate opioid prescribing, pain management, and the treatment of opioid use disorder?
Please specifically discuss the value of such a system in light of existing continuing education requirements, the wide array of available educational programs (including currently available OA REMS educational offerings), and other interventions by Federal Agencies, States, healthcare systems, retail pharmacies, payers, pharmacy benefit managers, and other public and private organizations. Could mandatory education under a REMS make prescriber education more consistent, efficient, and effective?
Please specifically discuss how a mandatory REMS educational program could address the needs for prescriber education on the overprescribing of opioids for acute pain.
Please specifically discuss how a mandatory REMS educational program could address the needs for prescriber education on the treatment of opioid use disorder.
What are the important core competencies, knowledge gaps, clinical challenges, or misunderstandings among practitioners that could be addressed through mandatory education under a REMS to help improve patient outcomes and mitigate the current crisis?
Please comment specifically on any key knowledge gaps or core competencies related to screening, diagnosis, or treatment of opioid use disorder or substance use disorder that should be incorporated into mandatory education for opioid prescribers.
If FDA were to implement a mandatory prescriber education program, please discuss what appropriate program goals might be. How could we measure the impacts of such a program and determine whether it is meeting its goals?
Regarding the implementation of such a mandatory REMS educational system:
Please discuss challenges you foresee in the implementation of a mandatory REMS educational system.
What can we learn about the implementation of prescriber education from existing educational programs in pain management, in opioid risk reduction, and in the treatment of opioid use disorder?
What could be unintended consequences of mandatory opioid prescriber education through a REMS and are there ways to identify and address them?
Registration
To register for the public workshop, click here. While registration is free, you must register by 4:05 PM ET on October 14, 2021.
Additionally, the workshop will be recorded and the recording will be made available after the workshop here.
Comments
If you are interested in submitting electronic or written comments, you may do so no later than December 3, 2021.
To submit a comment with confidential information that you do not wish to be made publicly available, you must submit your comments as a written/paper submission with two copies. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments, while the second copy will have the claimed confidential information redacted/blacked out and will be made available for public viewing.