FDA Seeks Public Comment on Info Collection: Reconsidering Mandatory Opioid Prescriber Education Through Risk Evaluation and Mitigation Strategy in Evolving Opioid Crisis

WASHINGTON, Sept. 11 -- The U.S. Department of Health and Human Services' Food and Drug Administration proposed a 90-day public comment period starting on Sept. 9, 2021, on an information collection entitled "Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis."

A notice was published in the Federal Register by Lauren K. Roth, Acting Principal Associate Commissioner for Policy.

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 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 opioid-involved overdose deaths have risen sharply since 2012, with opioids often seen in combination with other substances such as cocaine, methamphetamine, and benzodiazepines.[45] 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.

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.

Footnotes

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.

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).

[FR Doc. 2021-19437 Filed 9-8-21; 8:45 am]

BILLING CODE 4164-01-P

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Complete text: https://www.federalregister.gov/documents/2021/09/09/2021-19437/reconsidering-mandatory-opioid-prescriber-education-through-a-risk-evaluation-and-mitigation

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