Life Science Compliance Update

February 21, 2018

ACCME Releases Report Highlighting 2017 Successes


The Accreditation Council for Continuing Medical Education (ACCME) recently released a new report, Transforming Continuing Medical Education Together: 2017 Highlights from the Accreditation Council for Continuing Medical Education. The inaugural year-in-review report showcases the efforts of the ACCME and the continuing medical education (CME) community to leverage the power of education to respond to the changing healthcare environment. 

The report aims to celebrate the CME community’s initiatives to drive meaningful change for educators, clinicians, and ultimately patients, including: 

  • The Menu of Criteria for Accreditation with Commendation which represents the CME community’s vision of the future of education. From engaging with students, patients, and teams to tackling population and public health issues, CME providers that meet these criteria demonstrate the capacity of education to address healthcare challenges. 
  • Expanded opportunities for physicians to participate in education that counts for multiple requirements, thus reducing burdens and allowing clinicians more flexibility in choosing education that meets their needs, as a result of collaborations between accreditors, certifying boards, and educators. 
  • Freedom and flexibility in employing blended, new, and innovative approaches to education through the alignment of ACCME/American Medical Association requirements. 
  • Collaborations with other organizations, including the nursing and pharmacy accreditor colleagues to initiate a new IPCE credit mark that identifies education designed to improve team collaboration and patient care, helping to increase recognition for interprofessional continuing education (IPCE).
  • Increased engagement with healthcare leaders to promote the value of CME as a strategy to fulfil institutional and health system priorities.
  • Becoming a model of accreditation standards for other CME systems and providers around the world.

The report also describes the ACCME’s commitment to supporting the CME community. With its new annual meeting and online learning portal, as well as other educational offerings, the ACCME aims to build a community of practice that assists CME professionals in achieving their full potential. 

The ACCME published Transforming Continuing Medical Education Together as part of its efforts to build visibility for the CME community and communicate the value of accreditation and accredited CME.  

Graham McMahon, MD, MMSc, ACCME President and CEO said, “The CME community has much to be proud of. We look forward to continuing our work together, as we fulfill our shared aspiration to enhance education, drive improvements in clinician and team performance, and—most important—to optimize care for the patients we all serve.”  

February 02, 2018

FDA REMS Blueprint on Opioids Finalized


On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” The Blueprint includes educational messages for health care providers involved in the treatment and monitoring of patients with pain. It also includes information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (non-opioid analgesic and opioid analgesic).  This REMS represents a major upgrade from the current ER-LA Opioid REMS and includes all Opioid Manufacturers.

Ever since the Opioid Policy Steering Committee was established the FDA has been working to evaluate different policy efforts to combat the emergency. According to FDA Commissioner Dr. Scott Gottlieb, “At the FDA, we believe one of our key roles in addressing the opioid epidemic is to reduce new addiction. We’re exploring ways we can reduce exposure to opioids through our influence on prescribers, particularly through our Risk Evaluation and Mitigation Strategy (REMS) authorities. We’re also actively exploring how we can use changes in packaging as a way to give providers better options for tailoring how much they prescribe to the clinical need. This is especially true when it comes to immediate release formulations of opioid drugs like Vicodin and Percocet, which are typically meant for short-term use.”

The Blueprint aims to educate health care providers on safe opioid practices, as well as current Federal and state regulations, national guidelines, and professional organization and medical society guidelines on treating pain and prescribing opioids.

The Blueprint begins with an overview on pain management, including intelligence behind the need for comprehensive pain education, definitions and mechanisms of pain, and how to assess patients in pain.

From there, it goes on to help providers learn how to create a pain treatment plan, customized to the needs of the individual patient and including the types of therapies planned, the goals of treatment, and an explanation of the patient and prescriber roles and responsibilities. It further notes that if HCPs encounter potential barriers to managing patients with pharmacologic and/or nonpharmacologic treatment options, such as lack of insurance coverage or inadequate availability of certain HCPs who treat patients with pain, attempts should be made to address these barriers. The overall treatment approach and plan should be well documented in the patient record, including written agreements and informed consent/patient provider agreements that reinforce patient-provider responsibilities and avoid punitive tones.

The section about creating a pain treatment plan includes sections that outline: components of an effective treatment plan, general principles of nonpharmacologic approaches, general principles of pharmacologic analgesic therapy, managing patients on opioid analgesics, and a primer on addiction medicine.

FDA is making the FDA Blueprint, which will be approved as part of the Opioid Analgesic REMS, available on the REMS@FDA Website (, where it will remain posted for use by CE providers as they develop the CE materials and activities. A list of the REMS-compliant CE activities supported by unrestricted educational grants from the opioid analgesic companies to accredited CE providers will be made available when the Opioid Analgesics REMS is approved.

Other FDA Actions

On the same day the FDA released the new Blueprint, the Agency also hosted a meeting entitled, “FDA’s Opioid Policy Steering Committee – Prescribing Intervention – Exploring a Strategy for Implementation,” where various stakeholders spoke about the Agency’s Risk Evaluation and Mitigation Strategy (REMS) authority and how to improve safe use of opioid analgesics.

In the Press Announcement that accompanied these moves by the FDA, Commissioner Gottlieb wrote, “I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse. If you’re selling a drug with the potential for abuse and misuse through an online website, you’re no longer in the business of selling widgets, or books. You have a social contract to take voluntary steps to help address public health challenges.”

Gottlieb encouraged stakeholders to participate in this ongoing process by submitting electronic or written comments to the docket until March 16, 2018.

January 30, 2018

CME Continues to Evolve for Providers and Practitioners


Several articles about continuing medical education (CME) were recently published in the Journal of the American Medical Association (JAMA). One article discussed the importance of regulatory alignment with the boards while the other discussed the proposed CME pyramid.

CME Pyramid

Medical education is an evolving field and as of late, there has been an increased focus on addressing professional practice gaps – the gaps between what physicians are doing and what they should be doing. Therefore, an outcomes framework has been proposed in the form of a pyramid that provides perspective on how addressing these practice gaps may be accomplished.


According to the article, “[t]he pyramid is based on 7 levels of outcomes that are associated with the decisions of a clinician to participate in learning, to engage in learning, to use what he or she learned, and, at the summit, the effects of learning on patients and community. CME has traditionally been focused on learning (level 3) and in some cases on competence (level 4), which is similar to the “shows how” level of the pyramid in which a learner demonstrates to a teacher that he or she can do what has been learned.”

The article further notes, “It could be argued that if CME contributes to improving patient health on a broad front, such that many patients and many diseases are affected, then community health, that is, population health, must necessarily improve,” which is the impetus behind the push for all physicians and health care providers to be current on their education and continue learning for the benefit of their patients.

Cultural differences also plays a role in practice gaps and an analysis of health care in different countries shows how evident cultural differences are and that gaps in knowledge happen in developed countries like the United States and the United Kingdom.

The article also notes, however, that improvement cannot be achieved by CME alone, but will require the involvement of many different organizations. For example, this year the Centers for Medicare & Medicaid Services is proposing completion of an accredited CME program directed at performance or quality improvement. This Clinical Practice Improvement Activity must address a quality or safety gap that is supported by a needs assessment. The proposal has been endorsed by the Accreditation Council for Continuing Medical Education, which is now collaborating with the American Board of Medical Specialties to facilitate the integration of CME and maintenance of certification.

The CME pyramid works to bring each of the individual groups together to create a comprehensive solution to physician and provider education.  

Innovation through Regulatory Alignment

The President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), Graham McMahon, MD, MMSc, and the Vice President for Medical Education at the American Medical Association (AMA), Susan Skochelak, MD, co-authored a piece published in JAMA on how to promote innovation through the regulatory framework. The article discussed the collaboration between the ACCME and the AMA to establish and credit CME activities in an attempt to support clinicians and developing learning opportunities.

The authors discussed the way the two groups collaborated on a strategy “to more closely align the 2 organizations’ requirements, simplify the system, and eliminate any barriers (perceived or real) that would constrain innovation in educational delivery. To develop their approach, the organizations convened listening sessions with various groups (including staff, volunteers, and leadership from accredited organizations and state medical societies), gathering feedback from physicians and educators about how to reconstruct the system to better support the evolution of CME.” It was through this process that a joint construct was formed.

“As part of the alignment, the AMA simplified and reduced its learning format requirements. There were previously specific requirements for 7 formats; now, there are specific requirements for only 3 formats: enduring materials, journal-based CME, and performance improvement CME. In addition, the requirements for these 3 format types were simplified, so that learning is prioritized. For example, the familiar posttests can be replaced with a self-reflective statement about what has been learned and how the learner plans to change; the outcome measure for a quality improvement effort can be locally determined.”

This flexibility will help physicians and CME providers alike learn more and be able to achieve more through CME.

To that end, the ACCME, in collaboration with the Accreditation Council for Pharmacy Education and the American Nurses Credentialing Center, created the first joint accreditation system to facilitate interprofessional continuing education. This program can serve as a model for accreditors in the health professions for developing systems that promote and facilitate team-based education by removing barriers between professions and expanding the delivery of interprofessional continuing education to facilitate measurable improvements in team performance.

McMahon and Skochelak noted that the success of this construct and the continuing success of CME is going to mean continuing evolution – including identifying needs and gaps in CME and adopting approaches that reflect “the same innovative spirit and nimbleness” expected of educational providers.


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