[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]
BILLING CODE 4164-01-P


