Strictly Clinical
  • FDA Weighs Mandatory Education for Opioid Providers

    Earlier this month, the United States Food and Drug Administration (FDA) announced a public workshop to discuss mandatory prescriber education for opioids. The virtual two-day public workshop, “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis,” will be held 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 workshop, being convened by the Duke-Margolis Center for Health Policy, is supported by a cooperative agreement between the FDA and Duke-Margolis.

    Why now?

    According to FDA, the dynamics of the opioid and substance abuse crisis have shifted significantly since the Opioid Analgesic REMS was initially implemented and that “new opportunities may have emerged for improving prescriber education.”

    The number of prescriptions dispensed for opioid analgesics has been steadily declining from a peak of 84 prescriptions per 100 residents in 2012 to 43 prescriptions per 100 residents in 2020, according to agency data. Yet, despite this dispensing decrease, opioid overdoses and opioid-involved deaths are higher than ever, with opioids often seen in combination with other substances such as cocaine, methamphetamine, and benzodiazepines.

    This rise has been driven primarily by a surge in overdose deaths initially involving heroin and then illicitly manufactured fentanyl and fentanyl analogues. Although these overdose deaths largely involve illicit substances, FDA notes that many users of illicit opioids are initially exposed to opioids through nonmedical use of prescription opioids. Further, prescription opioids were involved in more than 16,000 fatal overdoses per year as of 2020 — higher than the number seen at the peak of opioid analgesic dispensing in 2012.

    Seeking standardization

    Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), explained 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.”

    While acknowledging the opioid provider training which many institutions have already established, Dr. Cavazzoni notes that “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.”

    What’s on the agenda?

    While a final agenda has yet to be released, the FDA has announced that topics will allow stakeholders to provide input on:

    • How could mandatory prescriber education through a REMS improve appropriate opioid prescribing, pain management, and the treatment of opioid use disorder?
    • Could mandatory education under a REMS make prescriber education more consistent, efficient, and effective?
    • 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?
    • If FDA were to implement a mandatory prescriber education program, what might appropriate program goals be? How could we measure the impacts of such a program and determine whether it is meeting its goals?
    • What challenges do 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?

    A second subsequent public workshop is expected to be convened by FDA 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.

    Signing up and weighing in

    To register for the public workshop, click here.  While registration is free, those wishing to attend must register by 4:05 PM ET on October 14, 2021. Registered participants will receive instructions on how to access the live webcast of the virtual event, as well as technical system requirements, in advance of the workshop.

    The workshop will also be recorded, and the recording will be made available after the workshop here.

    Further, the agency is soliciting feedback from workshop attendees by early December. Attendees interested in submitting comments either online or in writing may do so no later than December 3, 2021.

    The workshop’s agenda, additional materials and any other updates will be posted to the Duke-Margolis website as they become available.

    Dr. Cavazzoni concludes, “Opioid addiction and abuse remain a serious public health crisis and addressing it is among the FDA’s highest priorities. We will continue to explore new approaches that allow us to confront the crisis head-on.”