Academy Stresses Need for REMS-related CME to Remain Voluntary at FDA Meeting

July 31, 2013 02:09 pm Matt Brown

During a recent public meeting seeking input on the issues and challenges surrounding the standardization and assessment of risk evaluation and mitigation strategies( (REMS), the FDA heard from multiple stakeholders, including health care providers, drug manufacturers, prescribers and vendors, as well as from standards development organizations such as the AAFP.

[Prescription bottle with medication spilling out]

Ann Karty, M.D., medical director of the AAFP's Division of Continuing Medical Education, delivered a presentation on REMS requirements that pertain specifically to extended-release and long-acting (ER/LA) opioids and also represented the Academy on a discussion panel.

Karty said the FDA needs to continue prescriber involvement when determining whether and how risks posed by certain classes of drugs and biologics will be mitigated. Because the REMS for ER/LA opioids is the first to involve a specific CME component, it "serves as a sort of case study," she said.

The AAFP supports prescriber education on many topics, including patient safety, but when it comes to ER/LA opioids, the AAFP also focuses on appropriate pain management and maintaining patient access. According to Karty, if REMS-related CME was mandatory for prescribers, the overall continuing professional development of physicians, which includes a variety of information and procedural skill acquisition, could be diluted.

Story Highlights
  • The FDA recently held a public meeting seeking input on the issues and challenges surrounding the standardization and assessment of the agency's risk evaluation and mitigation strategies (REMS).
  • The AAFP presented information on REMS requirements that pertain to extended-release and long-acting opioids, stressing the importance of ensuring that the educational components of the REMS for these products remain voluntary for physicians.
  • Family physicians are encouraged to participate in voluntary REMS-specific CME to demonstrate the specialty's ability to mitigate risks of pharmacologic and biologic agents identified by the FDA through education and self-regulation.

"I explained that REMS CME needs to be voluntary for prescribers, not mandatory," Karty told AAFP News Now after the meeting. "(Physicians and other medical professionals) really need to keep patient outcomes in mind, and if the FDA is planning to include CME in their risk evaluation and mitigation strategies for products going forward, (the agency needs) to have a good reason for it." Ultimately, she noted, mandating CME to prescribe specific drugs could have an impact on patient access to those medications.

Asked in the question-and-answer session after her meeting presentation why she so strongly stressed the need for prescriber education to remain voluntary, Karty said mandatory CME has the potential to create a significant amount of confusion for physicians.

"Physicians, on average, have multiple licenses in multiple states, each of which may have different requirements," she said. "So, for example, you have a physician who has two to four different licenses, many of which have different CME credit requirements that may or may not be reciprocal from state to state.

"You also have to consider those folks practicing in states that are already required to have topic-specific CME to maintain their license, as well as requirements for board certification," Karty said. "On top of that, with the consideration by the FDA regarding recommendations for additional REMS-specific CME to be able to prescribe certain drugs, you can see how it gets confusing.

"If you start adding more requirements, sooner or later, there is the potential that some people will not participate," she said. "And then, for example, you'll have a critical-access physician who isn't able to meet the requirement and, suddenly, nobody in that region can prescribe a certain drug, thereby cutting off patient access."

Karty said she thinks some form of prescriber education -- whether formal CME or not -- will continue to be a component of REMS going forward.

"As long as it continues to be an ongoing conversation, we are on the right track," she said, referring to discussions with the FDA during public forum sessions. "In the meantime, family physicians need to participate in (REMS-specific CME) as it becomes available, because that will demonstrate to the FDA that we can self-regulate.

"Participation is the current metric by which we are going to be judged by the FDA, so the continued recommendation is that physicians engage when presented the opportunity."

According to Kathy Marian, M.Ed., AAFP manager of CME standards and outcomes, REMS-specific CME to address the FDA blueprint for ER/LA opioids( will be available during the 2013 AAFP Scientific Assembly in San Diego, Sept. 24-28, with online CME launching in late October.