The CME Coalition has submitted public comments on the Food and Drug Administration's (FDA) reconsideration of mandatory opioid prescriber education through a risk evaluation and mitigation strategy (REMS) to urge the FDA to consider the full scope and ramifications of implementing such a requirement. While the CME Coalition respects required education, we agree with the vast majority of presenters at the FDA's meeting on this subject who believe that required Opioid REMS is not a workable solution to the opioid crisis.
"Specifically, we are concerned that a mandatory opioid REMS program could create a tremendous bottleneck at pharmacy counters across the country. Requiring pharmacy personnel to confirm that the prescribing clinician has met the mandatory opioid REMS education requirements could create massive delays in receiving necessary medications as pharmacists would now be tasked with carrying out a burdensome verification process. This could exhaust time and resources that could be otherwise used to deliver critical patient care services."