[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50541-50543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0951]


Reconsidering Mandatory Opioid Prescriber Education Through a 
Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis; 
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Reconsidering 
Mandatory Opioid Prescriber Education Through a Risk Evaluation and 
Mitigation Strategy (REMS) in an Evolving Opioid Crisis.'' Convened by 
the Duke-Margolis Center for Health Policy and supported by a 
cooperative agreement between FDA and Duke-Margolis, the purpose of the 
public workshop is to give stakeholders an opportunity to provide input 
on aspects of the current opioid crisis that could be mitigated in a 
measurable way by requiring mandatory prescriber education as part of a 
REMS. We expect interested stakeholders to include healthcare 
providers, healthcare professional associations, pharmacists, pharmacy 
benefit managers, public and private insurers, patient organizations, 
Federal and State Agencies, providers of continuing education for 
healthcare professionals, and the public. A second public workshop is 
being planned to solicit input on additional issues associated with a 
move to mandatory prescriber education under a REMS, such as 
operational and technical issues related to such a system and what 
should be included in potential mandatory prescriber education.

DATES: The public workshop will be held on October 13, 2021, from 1 
p.m. to 5 p.m. Eastern Time and October 14, 2021, from 1 p.m. to 4:05 
p.m. Eastern Time. Submit either electronic or written comments on this 
public workshop by December 3, 2021. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: Due to the impact of the COVID-19 pandemic, these meetings 
will be held virtually to help protect the public and limit the spread 
of the virus.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before December 3, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 3, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0951 for ``Reconsidering Mandatory Opioid Prescriber 
Education Through a Risk Evaluation and Mitigation Strategy (REMS) in 
an Evolving Opioid Crisis.'' Comments filed and received in a timely 
manner (see ADDRESSES) will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. 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. The

[[Page 50542]]

second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Michie Hunt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6153, Silver Spring, MD 20993, 301-796-
3504, michie.hunt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    As FDA continues to work to address the opioid crisis, we are 
reconsidering our current efforts to ensure prescriber education 
regarding opioids is being delivered in a way that is as efficient and 
effective as possible. As a part of this work, we are revisiting 
whether there is a need for a mandatory form of prescriber education 
linked to the prescribing of opioids. In 2012, FDA approved the 
Extended Release/Long Acting (ER/LA) Risk Evaluation and Mitigation 
Strategy (REMS), at the core of which was a requirement that sponsors 
of ER/LA opioid analgesics make an education program available for 
healthcare providers who prescribe ER/LA opioid analgesics (e.g., 
physicians, nurse practitioners, and physician assistants). The goal of 
the ER/LA opioid analgesic REMS was to reduce serious adverse outcomes 
resulting from inappropriate prescribing, misuse, and abuse of ER/LA 
opioid analgesics while maintaining patient access to pain medications. 
The adverse outcomes of concern included addiction, unintentional 
overdose, and death.
    While developing the REMS requirements, FDA considered whether the 
education should be made mandatory for prescribers but decided against 
making mandatory education a REMS requirement at the time. This was due 
to concerns about placing an undue burden on the healthcare delivery 
system, in part because the implementation of mandatory education 
through the REMS might have required a restricted distribution system. 
It is possible that given technological advances in the intervening 
years, including broader implementation of e-prescribing for controlled 
substances, there might be ways to lessen the burden associated with a 
restricted distribution system, including potential negative impact on 
patients who need opioids for pain management.
    When the REMS was put in place in 2012, instead of mandatory 
education, FDA required that ER/LA opioid manufacturers make the 
training available to prescribers at no or nominal cost and that the 
training be accessible in a variety of different formats. FDA also 
recommended that the training be offered for continuing education (CE) 
credit. The REMS as implemented requires the training to conform to a 
blueprint (available at https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_analgesic_2018_09_18_FDA_Blueprint.pdf) developed by FDA 
that contains a high-level outline of the core educational messages to 
be included in the CE programs developed under the REMS. The initial 
education program included general and product-specific information 
about the ER/LA opioid analgesics; information on proper patient 
selection for use of these drugs; guidance for safely initiating 
therapy, modifying dosing, and discontinuing use of ER/LA opioid 
analgesics; guidance for monitoring patients; and information for 
counseling patients and caregivers about the safe use of these drugs.
    After reviewing existing requirements and considering Advisory 
Committee recommendations obtained in 2016 about the ER/LA REMS, in 
2018 FDA expanded the REMS to include both immediate release (IR) 
opioid analgesics and ER/LA opioid analgesics intended for use in an 
outpatient setting. The content of the blueprint was redesigned to 
contain principles of appropriate pain management, including the use of 
alternatives to opioids for the treatment of pain; the basic elements 
of addiction medicine; and the neurobiology, identification, and 
management of opioid use disorder. The blueprint currently does not 
include principles for managing opioid use disorder, including 
treatment with buprenorphine. The revised Opioid Analgesic (OA) REMS 
also expanded the prescriber audience and requires that the OA 
manufacturers make training available to all members of the healthcare 
team involved in the management of patients with pain, including nurses 
and pharmacists. As with the ER/LA REMS, training under the OA REMS is 
voluntary.
    Cumulatively, from February 28, 2013, through May 15, 2021, there 
have been 354,949 completers of REMS CE from the ER/LA REMS and the OA 
REMS. For context, there were approximately 1 million prescribers of 
opioid analgesics in 2019. In addition, 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 nationwide 
standard. Therefore, these programs likely differ with regard to 
content, focus, and duration.
    Following the creation and expansion of the REMS and other efforts, 
including the introduction of the Centers for Disease Control and 
Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain in 
2016,\1\ the estimated number of opioid analgesic prescriptions 
dispensed per capita in the United States has been steadily declining 
from a peak of 84 prescriptions per 100 residents in 2012 to 67 
prescriptions per 100 residents in 2016; and 52 prescriptions per 100 
residents in 2018. The rate dropped to 43 prescriptions per 100 U.S. 
residents in 2020, reflecting levels not seen since the early 1990s (44 
prescriptions per 100 U.S. residents in 1992).\2\ Despite this decrease 
in dispensing, multiple studies have reported patients received more 
opioid analgesic tablets than needed following surgical procedures. 
FDA's systematic review of studies published prior to 2019 showed that 
in articles reporting on the prescribing of excess tablets, 25 percent 
to 98 percent of the total tablets prescribed were reported to be 
excess, with most studies reporting that 50 percent to 70 percent of 
tablets went unused.\3\ There are also

[[Page 50543]]

concerns about continued opioid analgesic prescribing to vulnerable 
populations, such as children and adolescents following common dental 
and minor surgical procedures.
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    \1\ Dowell, D., T.M. Haegerich, and R. Chou, ``CDC Guideline for 
Prescribing Opioids for Chronic Pain--United States, 2016''. JAMA, 
(2016) 315(15):1624-1645.
    \2\ IQVIA Institute, ``National Prescription Audit'' extracted 
March 2021, U.S. Census Bureau.
    \3\ Mallama, C.A., C. Greene, A.A. Alexandridis, et al. 
``Patient-Reported Opioid Analgesic Use After Discharge From 
Surgical Procedures: A Systematic Review.'' (2021) Pain Medicine, 
doi: 10.1093/pm/pnab244.
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    Despite this decline in opioid analgesic dispensing, overall 
opioid-involved 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\
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    \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 Deaths--
United States, 2013-2019.'' Morbidity and Mortality Weekly Report, 
(2021) 70(6):202-207.
    \6\ Compton, W.M., C.M. Jones, and G.T. Baldwin, ``Relationship 
Between Nonmedical Prescription-Opioid Use and Heroin Use.'' New 
England Journal of Medicine, (2016) 374:154-163.
    \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/trends-statistics/overdose-death-rates).
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    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.

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 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=a07eifbycnsfd5b6b1f. 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/fda-public-workshop-opioid-prescriber-education.
    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 Duke-Margolis 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. 2021-19437 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P


