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fda.gov

FDA Opioid Analgesic REMS prescriber education

Also: ER/LA Opioid Analgesic REMS (2012-2018) · Opioid Analgesic REMS (2018-) · FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers

Since July 2012 the FDA has required makers of extended-release/long-acting opioids, and since September 2018 makers of immediate-release outpatient opioids too, to fund accredited continuing education for prescribers and other clinicians built on an FDA "Blueprint". Courses are voluntary for clinicians; manufacturers also fund patient counseling guides.

Years
2012–now
Country
United States
Topic
Opioids
Asks people to
StartStop
Strategy
Policy pairedSelf efficacy
Channel
Clinical settingEventsWebsite
Audience
Clinicians
Prescribers of opioid analgesics; from 2018 also pharmacists, nurses and other clinicians involved in treating and monitoring patients with pain.

Evidence

ProcessUnknown

Review of 9,739 pages of FDA documents (Heyward 2020): FDA aimed for 60% of ER/LA prescribers to complete REMS-adherent CE between 2012 and 2016; 27.6% (88,316 of 320,000) had by 2016. Five years in, neither FDA nor manufacturers could say whether the REMS reduced inappropriate prescribing or improved outcomes, because the assessments used self-selected surveys, lacked controls and never linked CE receipt to prescribing.

Sponsor (who paid)

  • U.S. Food and Drug Administration Federal government, requires the program and writes the Blueprint
  • Opioid analgesic manufacturers (REMS Program Companies) Industry, funders, through unrestricted grants to accredited CE providers

Credits (who made it)

Not recorded yet.

Related campaigns

Sources

  1. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) (FDA) sponsor
  2. Heyward J, Olson L, Sharfstein JM et al. Evaluation of the ER/LA Opioid Prescribing REMS Program by the FDA: A Review. JAMA Intern Med 180(2):301-309 evaluation · 2020 · DOI 10.1001/jamainternmed.2019.5459 · PMID 31886822
  3. Alford DP et al. SCOPE of Pain: An Evaluation of an Opioid Risk Evaluation and Mitigation Strategy Continuing Education Program. Pain Med 2016 evaluation · 2016 · DOI 10.1111/pme.12878 · PMID 26304703

Research notes

Clinician-facing program. Discovered 2026-10-22 for #17 (clinician-campaigns pass). FDA page fetched 2026-10-22: OA REMS approved 18 September 2018; courses based on the 2018 Blueprint (search results mention 2023 and 2026 Blueprint revisions, not opened). The ER/LA REMS approval date (July 2012) comes from the Heyward review and contemporaneous coverage; not re-checked on an FDA page. No agency credits: courses are made by many accredited CE providers (e.g. Boston University SCOPE of Pain). Taxonomy gap: no "continuing-education" channel; mapped to events/website. Procurement search 2026-10-22: the REMS education is paid for by the REMS Program Companies (manufacturers), not by FDA, so it does not appear in federal award records. The RPC's 12-month assessment report (FDA, https://www.fda.gov/media/124910/download, opened via Wayback) says an outside vendor ran the prescriber letter distribution and another helped with the prescriber survey, without naming them, and its grant RFA tells CE providers to 'Contact Polaris Grant Coordinator' at grants@er-la-opioidrems.com, so a firm called Polaris administered the education grants (company not identified). The courses themselves are made by accredited CE providers funded by unrestricted RPC grants. FDA's own spending on prescriber education is research, not the program: MITRE 'REMS prescriber education innovation development', 2021-2022, USD 1.0M (https://www.usaspending.gov/award/CONT_AWD_75F40121F80450_7524_75FCMC18D0047_7530) and Brillient Corp. 'Prescriber education on the recognition and treatment of opioid use disorders', 2022-2024, USD 484,313. Evaluation sources added 2026-10-22 (citation snowballing / helpline pass): Alford 2016; evidence level and outcome unchanged. Reuse terms checked 2026-10-23 by an AI research pass for #47; not yet reviewed by a person.

Record cases/fda-opioid-analgesic-rems.json, updated 2026-10-23· Link to this campaign