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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
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concerns about continued opioid analgesic prescribing to vulnerable populations, such as children and adolescents following common dental and minor surgical procedures.
Despite this decline in opioid analgesic dispensing, overall opioidinvolved overdose deaths have risen sharply since 2012, with opioids often seen in combination with other substances such as cocaine, methamphetamine, and benzodiazepines.4 5 This rise has been driven primarily by a surge in deaths initially involving heroin and then illicitly manufactured fentanyl and fentanyl analogues. Although these overdose deaths largely involve illicit substances, many users of illicit opioids are initially exposed to opioids through nonmedical use of prescription opioids.6 Moreover, as of 2020, prescription opioids were involved in more than 16,000 fatal overdoses per year,7 higher than the number seen at the peak of opioid analgesic dispensing in 2012.8
Against this background of a complex and intensifying crisis, FDA is reconsidering the need for mandatory prescriber training through a REMS and seeks input from stakeholders about the aspects of the opioid crisis that mandatory training through such a REMS could potentially mitigate. In light of the many available education programs and the lack of a nationwide standard, FDA is exploring the value of a single source for education on the appropriate use of opioids, on the risks of opioid abuse and misuse, and on the treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers.
Review. 2021 Pain Medicine, doi: 10.1093/pm/
pnab244.
4 National Institute on Drug Abuse, Overdose Death Rates. 2021 Available at: https
www.drugabuse.gov/drug-topics/trends-statistics/
overdose-death-rates accessed August 20, 2021.
5 Mattson C.L., L.J. Tanz, K. Quinn, et al, Trends and Geographic Patterns in Drug and Synthetic Opioid Overdose DeathsUnited States, 2013
2019. Morbidity and Mortality Weekly Report, 2021 706:202207.
6 Compton, W.M., C.M. Jones, and G.T. Baldwin, Relationship Between Nonmedical PrescriptionOpioid Use and Heroin Use. New England Journal of Medicine, 2016 374:154163.
7 Ahmad, F.B., L.M. Rossen, and P. Sutton, Provisional Drug Overdose Death Counts.
National Center for Health Statistics, 2021.
Available at: https www.cdc.gov/nchs/nvss/vsrr/
drug-overdose-data.htm accessed 8/20/2021.
8 National Institute on Drug Abuse, Overdose Death Rates. January 29, 2021. Available at:
https www.drugabuse.gov/drug-topics/trendsstatistics/overdose-death-rates.

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II. Topics for Discussion at the Public Workshop 1. How could mandatory prescriber education through a REMS improve appropriate opioid prescribing, pain management, and the treatment of opioid use disorder?
a. 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?
b. Please specifically discuss how a mandatory REMS educational program could address the needs for prescriber education on the overprescribing of opioids for acute pain.
c. Please specifically discuss how a mandatory REMS educational program could address the needs for prescriber education on the treatment of opioid use disorder.
2. 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?
a. 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.
3. 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?
4. Regarding the implementation of such a mandatory REMS educational system:
a. Please discuss challenges you foresee in the implementation of a mandatory REMS educational system.
b. 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?
5. What could be unintended consequences of mandatory opioid prescriber education through a REMS

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and are there ways to identify and address them?
Although not specifically discussed at this Public Workshop, FDA is interested in obtaining input on additional issues, including:
a. The continuing education delivery approaches, methods, and information technology platforms that should be considered to maximize the acceptability and effectiveness of mandatory prescriber education.
b. Any technological advances since 2012 that would make the delivery of mandatory training more efficient and reduce burden on the healthcare system.
III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following website: http
events.constantcontact.com/register/
event?llr=4fyj4myab&oeidk=a07eifbycns fd5b6b1f. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.
Registration is free. Persons interested in attending this public workshop must register by 4:05 p.m. Eastern Time on October 14, 2021. Registrants will receive confirmation when they have been accepted. Registered participants will be sent technical system requirements in advance of the event.
We recommend that you review these technical system requirements prior to joining the virtual public workshop. The workshop will be recorded, and the recording will be available after the workshop at https
healthpolicy.duke.edu/events/fdapublic-workshop-opioid-prescribereducation.
There will be live closed captioning for this event. If you need other special accommodations due to a disability, please contact Michie Hunt see FOR
FURTHER INFORMATION CONTACT no later than October 4, 2021, or the DukeMargolis Center for Health Policy at margolisevents@duke.edu.
FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
Dated: September 2, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119437 Filed 9821; 8:45 am BILLING CODE 416401P

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