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Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

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Extended-release, long-acting (ER/LA) and immediate-release (IR) opioid analgesics, such as hydrocodone, oxycodone, and morphine, are powerful pain-reducing medications that have both benefits as well as serious risks. The FDA has determined that a REMS is necessary for all opioid analgesics intended for outpatient use to ensure that the benefits of these drugs continue to outweigh the risks. The Opioid Analgesic (OA) REMS, approved on September 18, 2018, is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose, and deaths due to prescription opioid analgesics.

The OA REMS requires that education be made available to all health care providers (HCPs) who are involved in the management of patients with pain, including nurses and pharmacists. To meet this requirement, drug companies with approved opioid analgesics provide unrestricted grants to accredited continuing education providers for the development of education courses for HCPs based on the 2018 version of FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (also referred to as the “FDA Blueprint”). The FDA believes that all HCPs involved in the management of patients with pain should be educated about the fundamentals of acute and chronic pain management, including the risks and safe use of opioids, and the diagnosis and management of opioid use disorders. Therefore, when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight.

The OA REMS does not require that prescribers or other HCPs take REMS education. However, Section 1263 of the Consolidated Appropriations Act of 2023, otherwise known as the Medication Access and Training Expansion (MATE) Act, requires new or renewing Drug Enforcement Administration registrants to have completed a total of at least 8 hours of training on opioid or other substance use disorders, as well as the safe pharmacological management of dental pain. The continuing education (CE) provided through the OA REMS may be used to satisfy, in part, requirements of the MATE Act, as noted in SAMHSA’s Recommendations for Curricular Elements in Substance Use Disorders Training. The OA REMS education is made available to prescribers and other HCPs at little or no cost and in a variety of formats. Prescribers and other HCPs can access the education through the OA REMS Home Page.

The OA REMS education implements part of the FDA Overdose Prevention Framework, which includes the priority to support primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing. Through the OA REMS education, FDA aims to reduce unnecessary and/or inappropriate exposure to opioids by ensuring HCPs are properly informed about appropriate prescribing recommendations, identification of abuse by individual patients, and treatment for patients with opioid use disorders.

OA REMS Update

On April 3, 2023, FDA issued a letter requiring all manufacturers of opioid analgesics dispensed in outpatient settings to submit a proposed modification to the OA REMS. The manufacturers will be required to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. The FDA expects to take action on this modification to the OA REMS in 2024. Concurrent with the OA REMS modification, FDA is publishing an updated 2023 version of the FDA Blueprint in advance of the REMS modification action so CE providers selected in the 2024 CE grant cycle can begin developing educational materials and activities to align with the 2023 FDA Blueprint. Revisions to the FDA Blueprint include but are not limited to: additional information on safe disposal options, updated statistics on the public health crisis involving opioid use disorder and overdoses, and updates to the terminology commonly used to describe substance abuse and misuse (generally replaced with the term “nonmedical use”) and addiction (generally replaced with the term “substance use disorder” and/or “opioid use disorder”).

Additional Resources

Background and Historical Information

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