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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 FDAs 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, 2404027500.
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, 3017963504, 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.
FDAs 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 PainUnited States, 2016. JAMA, 2016
31515:16241645.
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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