As we noted last week, Murray Kopelow, M.D., M.S., Chief Executive and Secretary for the Accreditation Council for Continuing Medical Education (ACCME) gave a presentation at a Joint Meeting of the Anesthetic and Life Drugs Advisory Committee (ALSDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM), hosted by the Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER).
Dr. Kopelow spoke to participants by highlighting how continuing medical education (CME) would be an extremely useful and tremendous tool to help educate physicians and health care providers regarding opioid use. Specifically, his comments focused on how “CME can be used as the keystone to controlling a tough drug overuse/abuse situation.”
In addressing the audience, Dr. Kopelow discussed the size and scope of the 2009 data from ACCME regarding the number of activities, hours of instruction, and number of physician and non-physician participants. These numbers indicate the size and impact effective CME programs can have across the nation.
Dr. Kopelow also recognized that CME is used as a “bridge to quality,” and that accredited CME is “linked to practice and focused on quality gaps.” Additionally, he noted how CME uses:
– Practice-based needs;
– Matches content to the learner’s scope of the practice; and
– Measures change in competence or performance or patient outcomes as part of the process.
The ACCME Chief Executive also acknowledged that continuing education is “effective in assisting professionals to modify and improve their practice” because the overwhelming majority of such programs used evidence based methods. Dr. Kopelow further discussed the importance of using CME to focus on practice gaps, where health care providers need more education about issues such as opioid use.
He also explained to members of the audience how CME can address gaps in quality and practice because of the various formats and methodologies it uses to bring physicians up to date on the latest treatments and breakthroughs. For example, CME does not just consist of lecturing to thousands of participants. It includes small, focused and interactive groups, which use self-assessment and reflection, along with hands-on experience to gain new knowledge and data, and to overcome system obstacles.
With these established tools and methods, Dr. Kopelow noted that the role of CME is to overcome the challenges of overuse of opioids by using the intervention of predisposing (prepare for change); the challenge of under use through enabling (link new to what a learner is already doing, in practice); and the challenge of misuse by reinforcing care through reminders and feedback.
To achieve these goals, Dr. Kopelow pointed to the updated accreditation criteria and standards for commercial support that ACCME uses to ensure the independence and integrity of CME activities. On this topic in particular, Dr. Kopelow showed support of these measures from Deputy Director of the National Institutes of Health (NIH), Raynard S. Kington, M.D. Ph.D., who applauded ACCME for their efforts to provide additional guidance for ensuring research independence and a free flow of scientific exchange, while safeguarding accredited CME from commercial influence.”
Dr. Kington also noted that ACCME’s vigilance in this “important matter contributes to the best practices of unbiased information-sharing and will benefit, ultimately, the health of the American public.”
In recognition of this support, Dr. Kopelow noted that the purpose of accredited CME is aligned with the goals of the final report of the FDA Prescriber Education Working Group. In particular, he noted that the ACCME Task Force on Competency and the Continuum from 2004 and the Working Group 2010 report both believe that CME can be used to optimize practitioner performance and improve patient outcomes. To that effect, Dr. Kopelow used various slides to show how numerous criteria in the ACCME Task Force align with the goals of FDA’s 2010 Working Group report.
Another aspect of addressing opioid use that Dr. Kopelow presented was ways to address the context of the problem. He noted how factors such as administration, professional and educational environment, public pressure and economic incentives can all adversely impact how physicians treat patients with opioids. He also discussed that changes in practice can also be dependent on social and cultural forces such as group norms, professional regulation and environmental factors such as location, and demographics setting. Consequently, accredited CME programs are able to tailor programs specifically to help provide the necessary training to overcome such factors.
He included a section on how the standards for commercial support should not act as a barrier to providing CME. Instead, he noted how the standards are used to ensure that providers cannot receive guidance either nuanced or direct, on the content of the activity or on who should deliver that content. Moreover, he explained how the primary purpose of the standards is to ensure independence and that the programs underlie professional practice gaps.
Dr. Kopelow also talked about President Obama’s 2010 National Drug Control Policy to show that “increasing healthcare providers’ knowledge of screening and brief intervention of techniques through medical schools” can be done effectively through continuing education programs. He also noted how this policy recognizes the need for primary care physicians and other healthcare providers to “learn how to recognize and intervene in patients’ early stage substance abuse.”
Additionally, Dr. Kopelow recognized that the policy also focuses on the need of federal agencies that support their own healthcare systems to “increase using CME” for their prescribers on proper prescribing and disposal.” Accordingly, to expand the number of physicians and other healthcare providers trained to recognize an overdose, the drug policy calls for continuing education programs and state licensing and accreditation bodies to provide CME programs that will address these gaps in care.
Consequently, to carry out this policy and initiative effectively, Dr. Kopelow asserted that accredited CME providers can “produce specific CME to support CPD on proper use,” These providers could also evaluate or measure effectiveness and facilitate change and data. These responsibilities for CME providers are important because although “there is no single intervention available for universally shaping practice patterns and promoting quality improvement, CME is one of the most effective ways of doing so. As a result, Dr. Kopelow concluded his presentation by asserting that ACCME accredited continuing education is and can be a strategic asset to Risk Evaluation and Mitigation Strategy (REMS).
Despite his presentation and others on the usefulness of CME for REMS, the Advisory Committee voted 25 to 10 that the FDAs proposed REMS for long-acting (LA) and extended-release (ER) opioids is too weak. As a result, panel members urged the FDA to “put some teeth into the plan,” since the proposal “basically sets the bar pretty low by calling for a Medication Guide, a voluntary education program for prescribers, patient education materials for prescribers to use voluntarily with patients, and a timetable for the assessment of the effectiveness of the REMS in reducing serious adverse outcomes.”
To make the plan stronger, panel members “not only want the LA/ER opioid REMS strengthened; they recommended immediate-release opioids be included as well. They also want a registration program for prescribers and pharmacists, either administered by the DEA or the FDA or both, whichever is easier and faster.
While some see this as a setback, it appears likely that the FDA will go forward with some type of REMS program. According to one FDA official that the “panel was sidetracked by focusing on the non-medical use or inappropriate use or pill mills.” They noted that FDA has decided to go through with the current REMS proposal according because “the panel blurred the line about what the actual discussion topic for the meeting was – medical use of opioids.”
Regardless, there is a strong need for more medical education on the proper use opoids for pain treatment. The proceedings further exposed an educational gap between, optimal treatment and current treatment practice.