The CME Coalition has submitted public comments on the Food and Drug Administration's (FDA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (OA REMS) program to highlight the essential role of continuing medical education (CME) in educating prescribers and other health care providers on the treatment and monitoring of patients with pain. The central component of the OA REMS is a voluntary CME program for all health care providers who are involved in the management of patients with pain, including doctors and others who prescribe these products.
Under the OA REMS, manufacturers of impacted products are meeting this requirement by providing educational grants to accredited CME providers who develop and offer the training. As a result, CME providers have demonstrated a strong track record of providing these educational activities through a variety of formats and settings. During the pandemic, our CME providers have accommodated live in-person courses to online courses both live and archived, to ensure that healthcare providers are up to date on the most recent blueprint.
Key Updates to the Program
Among the most important developments in the REMS program in recent years is the addition of immediate-release (IR) opioids used in the outpatient setting that are not already covered by another REMS program. In comments submitted in 2016, the CME Coalition encouraged the Extended-Release and Long-Acting (ER/LA) Opioid Analgesic REMS program, while emphasizing that IR opioids are even more likely to be abused and therefore, much more difficult to manage. We believe the FDA's updated Blueprint, which includes IR opioids, will more effectively support national efforts to address the misuse and abuse of prescription opioid analgesics.
Further, we applaud the FDA for adopting our 2016 recommendation that CME should not be limited to prescribers, and instead be extended to all health care providers who participate in the treatment and monitoring of pain, including pharmacists and nurses.
Program Recommendations
In our letter, the CME Coalition emphasized that FDA should consider standardizing the REMS process, while allowing more flexibility in content. The strength of CME is that it can produce myriad educational activities that are targeted to physicians based on their professional practice gaps, individualized needs, and stages of learning and change. Added flexibility will allow prescriber education to better address individual prescribers’ educational and practice needs.
Additionally, we suggested that the effectiveness of REMS can also be measured in terms of how successfully it promotes access to education and draws the attention of the medical profession to a problem. Further, rather than requiring the whole three to six hours of content outlined in the Blueprint, the letter contends counting credit hours towards a goal of three hours of REMS education should be considered. This would align OA REMS to most state requirements and allow for further customization towards specific audiences.
Key Updates to the Program
Among the most important developments in the REMS program in recent years is the addition of immediate-release (IR) opioids used in the outpatient setting that are not already covered by another REMS program. In comments submitted in 2016, the CME Coalition encouraged the Extended-Release and Long-Acting (ER/LA) Opioid Analgesic REMS program, while emphasizing that IR opioids are even more likely to be abused and therefore, much more difficult to manage. We believe the FDA's updated Blueprint, which includes IR opioids, will more effectively support national efforts to address the misuse and abuse of prescription opioid analgesics.
Further, we applaud the FDA for adopting our 2016 recommendation that CME should not be limited to prescribers, and instead be extended to all health care providers who participate in the treatment and monitoring of pain, including pharmacists and nurses.
Program Recommendations
In our letter, the CME Coalition emphasized that FDA should consider standardizing the REMS process, while allowing more flexibility in content. The strength of CME is that it can produce myriad educational activities that are targeted to physicians based on their professional practice gaps, individualized needs, and stages of learning and change. Added flexibility will allow prescriber education to better address individual prescribers’ educational and practice needs.
Additionally, we suggested that the effectiveness of REMS can also be measured in terms of how successfully it promotes access to education and draws the attention of the medical profession to a problem. Further, rather than requiring the whole three to six hours of content outlined in the Blueprint, the letter contends counting credit hours towards a goal of three hours of REMS education should be considered. This would align OA REMS to most state requirements and allow for further customization towards specific audiences.
| FDA REMS Comments - February 2021 |
