There were many suggestions on how to improve the current REMS education program, mostly revolving around making the program more individualized. The REMS itself is much like a blueprint, guiding prescribers on how to use opioids in their patients, according to Mary Lynn McPherson, a pain and palliative care pharmacist and the director of graduate studies in palliative care at University of Maryland Center to Advance Chronic Pain Research. “[The REMS] was absolutely one-size-fits-all. Don’t just have a blueprint [for REMS]. You have to have a plan that meets the needs of your learners,” she added. 

There could also be targeted education, as Kathy Chappell, Senior VP of Accreditation, Certification, Measurement, Credentialing Research, Quality Management, and APRN Initiatives for the American Nurses Credentialing Center suggested. “Address the individual outliers, those prescribers who are not in compliance with what the clinical practice guideline is, as opposed to a one-size-fits-all education model.” An individualized approach could target those prescribers that need a little push in changing their practices, possibly by utilizing one-on-one coaching, as suggested by Blake Fagan, co-director of office-based opioid treatment services at the Mountain Area Health Education Center, who has been involved with providing mandatory opioid education through North Carolina. 

Another resource to target education is utilizing the state prescription drug monitoring program (PDMP) to identify the high prescribers. “We should be using the data that we have at our fingertips to make the interventions,” said Elyse Powell, state opioid coordinator for the North Carolina Department of Health and Human Services. 

The material presented should also be new and relevant to the prescriber’s specialty, not covering the same information across the board, according to Theresa Campo, VP of Education and Accreditation at the American Association of Nurse Practitioners. These improvements to the REMS education program will hopefully drive more prescribers to complete the education and change their practices accordingly.

Panelists also discussed some challenges that may surface with a mandatory REMS education program. Anuradha Rao-Patel, physician member of the North Carolina Medical Board, said that prescribers could stop prescribing altogether to try and lower opioid prescriptions, as she has seen in some areas in North Carolina. This could in turn limit access to pain management medications that are truly needed for certain populations. Bobby Mukkamala, chair of the American Medical Association Board of Trustees and chair of the AMA Substance Use and Pain Care Task Force shared this sentiment and described a scenario such as the one in Flint, Michigan, where a significant number of African American patients with sickle cell disease reside. These patients need opioids to manage their pain and if prescribers have not completed their mandatory education, there may be issues with access in a population that is already disproportionately affected when it comes to health equity and access to appropriate pain care.

Targeted education programs in lieu of mandatory REMS could mitigate these challenges and specifically focus on those prescribers who are not following guidelines or are high opioid prescribers. Graham McMahon, President and CEO of the Accreditation Council for Continuing Medical Education, voiced concerns that mandating the REMS opioid prescribing education could create a lot of “resistance and cynicism” that would take away from “creating a fertile ground where people are going to absorb information, be curious about it…and actually grow and change.” 

In the end, many of the panelists seemed to be in favor of opioid prescribing education that is individualized to the prescriber and their specialty, instead of a one-size-fits-all federally mandated REMS program.


Margolis-FDA Convening: Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Crisis. Workshop summary. US Food and Drug Administration. October 14, 2021. Accessed November 8, 2021.