Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis; Public Workshop; Request for Comments, 50541-50543 [2021-19437]
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Lauren K. Roth,
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Policy.
[FR Doc. 2021–19436 Filed 9–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0951]
lotter on DSK11XQN23PROD with NOTICES1
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.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
SUMMARY:
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Jkt 253001
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 DukeMargolis, 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,
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50541
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
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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
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-201509-18/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:
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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
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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 eprescribing 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 productspecific 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,
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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
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
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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 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 PrescriptionOpioid 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/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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50543
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: https://
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. 2021–19437 Filed 9–8–21; 8:45 am]
BILLING CODE 4164–01–P
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, [email protected].
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: https://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
[email protected].
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