[Federal Register Volume 85, Number 215 (Thursday, November 5, 2020)]
[Notices]
[Pages 70637-70639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24542]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1561]
Evaluating the Effect of the Opioid Analgesics Risk Evaluation
and Mitigation Strategy Education Program on Prescribing Behaviors and
Patient Outcomes--Exploring the Path Forward for Assessment; Public
Workshop; Issues Paper; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: As part of the work by the Federal Government to address the
opioid crisis, the Food and Drug Administration (FDA or the Agency) is
announcing the following public workshop entitled ``Evaluating the
Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy
Education Program on Prescribing Behaviors and Patient Outcomes--
Exploring the Path Forward for Assessment.'' The purpose of the public
workshop is to obtain scientific input on methods to evaluate the
Opioid Analgesics Risk Evaluation and Mitigation Strategy (OA REMS)
education program. To assist in the workshop discussion, FDA is making
available an issues paper that provides a brief overview of the REMS
background and challenges with evaluating the REMS education
intervention.
DATES: The public workshop will be held virtually and broadcast via
webcast only on December 11, 2020, from 9 a.m. to 5 p.m., Eastern Time.
Submit either electronic or written comments on this public workshop by
February 11, 2021. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this public workshop via an
online teleconferencing platform.
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 February 11, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 11, 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-2020-N-1561 for ``Evaluating the Effect of the Opioid Analgesics
Risk Evaluation and Mitigation Strategy Education Program on
Prescribing Behaviors and Patient Outcomes--Exploring the Path Forward
for Assessment; Public Workshop; Issues Paper; Request for Comments.''
Received comments, those filed 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 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: Paul Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4462, Silver Spring, MD 20993-0002, 301-796-9029,
OAREMS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[[Page 70638]]
I. Background
On July 9, 2012, FDA approved a REMS for extended-release and long-
acting (ER/LA) opioid analgesic medications (ER/LA REMS). The ER/LA
REMS required that prescriber training in the form of accredited
continuing education (CE) be made available to health care providers
who prescribe ER/LA opioid analgesics.
On May 3 and 4, 2016, FDA convened a joint meeting of the Drug
Safety and Risk Management (DSaRM) Advisory Committee and the
Anesthetic and Analgesic Drug Products (AADP) Advisory Committee to
discuss whether the ER/LA REMS assured safe use of these products,
whether it was not unduly burdensome to patient access to the drugs,
and whether it (to the extent practicable) minimized the burden to the
health care delivery system (see the Federal Register of March 14, 2016
(81 FR 13372)). FDA also sought input from the committees on effective
short- and long-term approaches for measuring the success of the ER/LA
REMS in reducing serious outcomes resulting from inappropriate
prescribing, misuse, and abuse of ER/LA opioid analgesics. Committee
members suggested that a study to assess specific prescribing behaviors
and patient outcomes before and after prescriber completion of a REMS-
compliant CE, or a study comparing prescriber behavior and patient
outcomes for prescribers who completed an educational activity with
prescriber behavior and patient outcomes for those who did not, would
be useful to evaluate the effect of the ER/LA REMS. The DSaRM and AADP
Advisory Committees, however, struggled with how to define
appropriateness of prescribing.
Based on recommendations from the 2016 joint advisory committee
public meeting, FDA required a modification to the ER/LA REMS to: (1)
Include all opioid analgesics (immediate-release, ER, and LA) intended
for outpatient use that were not included in another REMS; (2) expand
the educational blueprint to encompass broad pain management concepts;
and (3) train other members of the health care delivery team involved
in the management of patients with pain. The current REMS, the OA REMS,
was approved on September 18, 2018 (https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17).
The central component of the OA REMS is a voluntary CE program for
all health care providers, including nurses and pharmacists, who are
involved in the management of patients with pain (in addition to
doctors and others who prescribe these products). Under the OA REMS,
the application holders of affected products are meeting this
requirement by providing educational grants to accredited CE providers
who develop and offer the training. A variety of formats (e.g.,
didactic, case-based, interactive, multimedia, adaptive) and settings
(live, webinar, internet) have been used to provide these educational
activities (https://opioidanalgesicrems.com/RpcUI/home.u). The OA REMS
also includes a patient counseling guide to assist prescribers in
properly counseling patients on their responsibilities for using these
medicines safely and to provide patients with additional written
instructions as needed (see https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_Patient_Counseling_Guide.pdf). The labeling
for opioid analgesics includes a product-specific one-page Medication
Guide to be given to patients each time they are dispensed their opioid
analgesic medicine.
The goal of the OA REMS is to educate prescribers and other health
care providers (including pharmacists and nurses) on the treatment and
monitoring of patients with pain. The education provided through the
REMS program is based on the FDA Blueprint (https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_FDA_Blueprint.pdf). Through better
education, the health care team will have an improved understanding of
how to manage pain and the role of opioid analgesics, as well as
nonpharmacologic and non-opioid analgesics, in pain management. The
education will also provide information about the risks of opioids and
use of other therapies. This information is intended to assist health
care providers in reducing adverse outcomes of addiction; unintentional
overdose; and death resulting from inappropriate prescribing, abuse,
and misuse. The REMS aims to accomplish this goal by:
1. Ensuring that training based on the FDA Blueprint is effective
in educating prescribers and other health care providers involved in
the treatment and monitoring of patients in pain (including pharmacists
and nurses) about recommended pain management practices and the
appropriate use of opioid analgesics.
2. Informing patients about their roles and responsibilities
regarding their pain treatment plan, including the risks of opioid
analgesics and how to use and store them safely, as outlined in the
Medication Guides and Patient Counseling Guide for opioid analgesics
(see Opioid Analgesic REMS page on the Approved Risk Evaluation and
Mitigation Strategies (REMS) website, available at https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17).
The REMS-compliant CE content, based on the FDA Blueprint, includes
information on the following:
The fundamental concepts of pain management, including
definitions and mechanisms of pain;
how to assess patients in pain and identify risk factors
for abuse and addiction;
the range of therapeutic options for managing pain,
including nonpharmacologic approaches and pharmacologic (non-opioid and
opioid analgesics) therapies;
how to integrate opioid analgesics into a pain treatment
plan tailored to the needs of the patient;
how to safely and effectively manage patients on opioid
analgesics in the acute and chronic pain settings, including initiating
therapy, titrating, and discontinuing the use of opioid analgesics;
how to counsel patients and caregivers about the safe use
of opioid analgesics, including proper storage and disposal;
how to counsel patients and caregivers about the use of
naloxone for opioid overdose;
when referral to a pain specialist is appropriate;
the fundamental elements of addiction medicine; and
how to identify and manage patients with opioid use
disorder.
The workshop will focus primarily on the evaluation of the effect
of REMS CE on prescriber behavior and patient outcomes, which is one
component of the OA REMS assessment plan. The OA REMS assessment plan
also includes:
Evaluations of the distribution of letters to health care
providers, professional societies, and licensing boards;
the status of grants and descriptions of CE programs
awarded;
the number of CE activity completers;
audits of activities;
the overall pain/opioid CE landscape;
surveillance and monitoring related to opioid analgesic
use, misuse, abuse, overdose, addiction, and death;
an evaluation of drug utilization patterns;
an evaluation of CE completers' knowledge; and
[[Page 70639]]
an evaluation of patient experiences around pain
management and an evaluation of patient knowledge.
The OA REMS assessment plan also includes an evaluation of the
effect of REMS-compliant CE on prescriber behavior and patient
outcomes. FDA has been in discussion with the application holders on
possible study designs and approaches to measure the effect of the OA
REMS-compliant CE on prescriber behaviors and patient outcomes, and a
number of challenges have been identified, including but not limited
to:
how to define and measure good pain management practices
and key patient outcomes related to pain management and opioid safety
and
How to isolate an effect of REMS-compliant CE given all of
the other drivers of prescribing behavior and patient outcomes (e.g.,
widespread availability of other education programs, opioid analgesic
prescribing limits, required checks of prescription drug monitoring
programs)
II. Topics for Discussion at the Public Workshop
On December 11, 2020, FDA will hold a public scientific workshop
entitled ``Evaluating the Effect of the Opioid Analgesics Risk
Evaluation and Mitigation Strategy Education Program on Prescribing
Behaviors and Patient Outcomes--Exploring the Path Forward for
Assessment.'' The main objective of the workshop is to discuss three
major topics. The three major topics are as follows:
1. Specific, measurable outcomes that might demonstrate that the
REMS training based on the FDA Blueprint is effective in educating
prescribers and other health care providers (including pharmacists and
nurses) involved in the treatment and monitoring of patients in pain
about recommended pain management practices and the appropriate use of
opioid analgesics.
2. The feasibility of conducting a study to specifically evaluate
the effect of OA REMS-compliant CE on prescriber behavior and patient
outcomes amidst the numerous concomitant strategies to combat the
opioid crisis at the Federal, State, and local levels. This discussion
will include, for example, what effect size might be reasonable to
expect to result from a one-time completion of a CE program and whether
there are methods (e.g., study design, data sources, metrics) that
could isolate and identify the effect that REMS-compliant CE has on
prescriber behavior and patient outcomes. Participants may also be
asked to discuss:
Whether a pilot study would be informative and, if so,
what features of the pilot study would be key;
which types of stakeholders might be well-positioned to
conduct such a study;
how a single study might evaluate the varying formats of
CE activity; and
reasonable timing for outcome evaluation relative to
completion of a CE activity.
3. Whether there might be suitable alternative study approaches to
better understand the influence of CE, more broadly, on pain management
practice and patient outcomes, if a study to directly measure the
impact of REMS-compliant CE is thought to be infeasible.
FDA has developed an issues paper entitled ``Methods for Evaluating
the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS).''
This issues paper provides a brief overview of the REMS background and
challenges with evaluating the REMS education. The issues paper can be
found on the internet at https://www.fda.gov/drugs/news-events-human-drugs/opioid-analgesics-rems-study-workshop-12112020.
Panelists are expected to include individuals with expertise in
dissemination and implementation science, public health, health
services research, pharmacoepidemiology, program evaluation, and CE.
Public participation and comment are encouraged.
III. Participating in the Public Workshop
Registration: To register for the public workshop, send an email to
OAREMS@fda.hhs.gov by 11:59 p.m. Eastern Time on November 30, 2020.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
Registration is free.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin, and will select and notify participants by December 2, 2020. All
requests to make oral presentations must be received by the close of
registration on November 30, 2020. If selected for presentation, any
presentation materials must be emailed to Paul Tran (see FOR FURTHER
INFORMATION CONTACT) no later than December 4, 2020. No commercial or
promotional material will be permitted to be presented or distributed
at the public meeting.
Streaming Webcast of the Public Workshop: This public workshop will
be webcast. Additional information will be made available regarding
accessing the webcast 2 days before the public workshop at https://www.fda.gov/drugs/news-events-human-drugs/opioid-analgesics-rems-study-workshop-12112020.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/drugs/news-events-human-drugs/opioid-analgesics-rems-study-workshop-12112020.
Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24542 Filed 11-4-20; 8:45 am]
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