The Alliance for Continuing Education in the Health Professions annual conference in January included a session on on risk evaluation and mitigation strategy, or REMS, for long-acting and extended-release opioids. Now required by the Food and Drug Administration, these are of high interest to many CME providers (78 percent of those in the audience intended to do education) and many of these would like to also use commercial support to do REMS (50 percent said they plan to apply for grants for REMS). Session leaders included the Accreditation Council for Continuing Medical Education’s Chief Executive Murray Kopelow, MD; Theresa Toigo, RPh, with the FDA’s Center for Drug Evaluation and Research; and Pamela Mason, BS, CCMEP, FACME, director, Medical Education Grants Office, AstraZeneca.
Mason talked about concerns the pharmaceutical companies have when it comes to REMS, such as:
-How will CME providers get the intended audience to participate? Will offering CME credit be enough of a draw?
-REMS focuses on safety and risk issues, which is important, but does not encompass an equally important issue: how to prescribe the products appropriately.
-Because REMS are so product-specific, how do they fit into the certified CME model?
-There is concern about accuracy, since the ’s Standards for Commercial Support won’t let pharma control the content.
-What will be appropriate to measure? to report on?
-What about pharmacists, who also play a big role in managing these types of drugs?
Kopelow said many of these issues are moot if accredited providers follow the same policies and procedures they would for any other accredited activity for validating content, resolvingconflicts of interest, and other requirements. Evaluation, assessment, and measurement are already part of what you do, he said. “The accreditors have looked at all the elements, and we haven't found anything you shouldn't be part of.”
They also said there was a working group of 14 pharmaceutical companies that would be serving as a single source of commercial support for these REMS, with a Web-based granting system. They already have a draft RFP completed and are awaiting the release of the final blueprint.
Kopelow on REMS
caught up with Kopelow after the meeting to learn more of the ACCME’s perspective on REMS. When asked what the most important message he would like people to take away from accredited CME’s potential role in REMS, he said, “The most compelling thing about REMS is that CME has been identified as a significant strategic asset to the varying elements of the system that is trying to address this public health issue. It remains to be seen what impact accredited CME can have, but we’re very optimistic that the FDA has incorporated accredited continuing medical education into the REMS model.”
He added that when he and Peter Vlasses, PharmD, executive director, American Council For Pharmacy Education, first proposed the use of accredited continuing education in REMS to an FDA advisory committee in July 2010, their position was that accreditation requirements already ask providers to focus on designing activities that address professional practice gaps, and providers already know how to identify the needs that underlie these gaps.
But the involvement of industry in the discussions and planning of the overall REMS was first thought by some to be a barrier to including accredited CE in the process, Kopelow acknowledged. However, he added, “One of the positive outcomes of this process is that accreditors, credit systems, the FDA, and the commercial supporters have been able to work cooperatively and respectfully in service of the public health imperatives involved.
He said there were three important messages to take away:
1. REMS is not a special-use case. There is no safe harbor—all the usual expectations apply, including those surrounding the role of industry as a commercial supporter.
2. The professional practice gaps are being identified by the FDA through the blueprint.
3. The providers still need to ascertain what the needs are that underlie those professional practice gaps.
Also, he said, remember that accredited providers can design and deliver an activity that addresses the issues in the FDA’s blueprint without it being commercially supported, and that many organizations have already been working on this subject area for years. “They don’t have to wait for anybody,” he said. “Once the blueprint is available, they can develop educational activities. They’re not required to take commercial support to do it.”
MM suggested to Kopelow that, while there is no ACCME requirement that prohibits providers from developing product-specific content or centering an activity on a single topic, providers still tend to be cautious, to the point of paranoia at times, to ensure that their content covers as many products and treatment options as possible to avoid the potential for the perception of bias.
Kopelow said that this concern stems from when the FDA first was looking at what educational features could be indicative of promotion. At one end of the spectrum were activities focused on a single product or topic. At the other end, he said, the one that seemed more balanced and less likely to hold the potential for bias, were activities that included a disease process or a management goal and covered multiple products. It’s still important to maintain that balance and avoid bias, especially when an activity is commercially supported, Kopelow stressed.
“But we have to remember that the content for REMS continuing education begins with the FDA. The FDA tells the producer of a drug in a class that accounts for a majority of substance abuse, deaths, and inappropriate prescriptions that it is in the public interest to educate prescribers on the proper use and potential harm of that drug. To dilute that education [by discussing other products] would not be in the public interest. That’s a message I’d like CME providers to hear—that the public interest has been identified by the FDA, and that’s what we have to laser in on. We don’t want old misperceptions to get in the way.”
The PARS Project
During the session, Kopelow also mentioned that the ACCME’s Program and Activity Reporting System can play a role in REMS. As he explained, prior to 2010 accredited providers gave aggregate data to the ACCME on how many CME activities they produced, how many attended, etc.
Beginning in 2010, accredited providers were asked to enter data, activity by activity, into PARS, so the database now contains the title, number of physicians and nonphysicians who attended, whether the activity was designed to change competence, performance, or patient outcomes, and whether changes in competence, performance, or patient outcomes were evaluated, in addition to activity type, date, directly or jointly sponsored, hours of instruction, and whether or not commercial support was received.
“The FDA wants the Industry Working Group to report information to fulfill the drug companies’ obligations,” Kopelow said. “That information—the content being covered, the type of changes that are evaluated—is or will be in PARS. We could add a field that asks if this was a REMS activity, and then a couple of fields that describe what kind of learner the activity is designed for and what element of the blueprint is being addressed. These additional fields would be optional.
"Providers already have to enter most of this data; now if they’re asked in the supporter’s grant to produce this additional information, the PARS database is available to take that burden off of the providers’ shoulders. We can export the data from PARS and give it to the working group to create reports, or we can do it ourselves. That’s a process in development.”
He added that PARS’ adaptability means it has potentially a huge number of uses. “For example you could add another field on what competency the activity is addressing, and we’d have a database to support maintenance of certification. Another attribute of the PARS database is that we can capture and report the scope of the whole ACCME-accredited CME enterprise. One of the things we may be able to say to the FDA is how much of the education addressing the REMS blueprint is commercially supported and how much is being done without commercial support.”
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