Education Is First Line in Combating the Opioid Crisis

By Thomas Sullivan and Kaitlin Fallon, JD

Since 2012, CME providers from across the country have responded to the opioid crisis by educating thousands of U.S.-based clinicians on the safe use of long-acting/extended release opioids through the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (“FDA Blueprint”).1

FDA REMS Hearing Focuses on CME
In May 2016, the Food and Drug Administration (FDA) held a Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC),2 where a range of stakeholders discussed results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). The FDA sought feedback from the committees regarding if this REMS with Elements to Assure Safe Use (ETASU) actually assures safe use, does not unduly burden patient access to drugs and minimizes the overall burden to the healthcare delivery system.

FDA Staff Presentations
Several FDA staff members were in attendance and made presentations.3 Janet Woodcock, MD, director at the Center for Drug and Evaluation Research (CDER) at the FDA, kicked off the two-day meeting by outlining the goals of the REMS program and the importance of educating prescrib­ers on safe opioid use. She noted that physicians have been urged and trained over the course of the past 20 years to respond more aggressively to a patient’s pain and most are not currently trained in the multimodal approach. As such, prescriber education (REMS) is a major part of the FDA’s approach to prevent opioid abuse and addiction.

Terry Toigo, associate director of Drug Safety Operations at CDER, noted although many stakeholder comments supported prescriber education, comments were divided as to whether such education should be mandatory.4 Suggestions at that stage of the meeting recommended that safe use, storage and disposal of opioid medications, pain management, benefits and risks of opioid treatment be included, and that if education was mandated, REMS certification should be linked to DEA registration to maximize participation, minimize cost and streamline the prescription process. It was also suggested that less restrictive elements should be implemented first to determine if they are effective in mitigating risk while preserving access.

The FDA worked with the Accreditation Council for Con­tinuing Medical Education (ACCME), and other accredit­ing bodies and CE providers, in an attempt to ensure that CE programs would comply with the REMS while also being compliant with ACCME accreditation criteria and standards for commercial support.

Two CDER employees followed up, discussing ER/LA REMS background, history, authority and a general over­view.5 Cynthia LaCivita, PharmD, noted that there is no national registry that tracks which providers have completed the REMS training and that having such a registry may offer a clearer picture of the program’s total impact.

REMS Program Committee
Paul Coplan, ScD, MBA, presented on REMS design and implementation.6 He noted that REMS had two main components: communication (e.g., dear prescriber letter, call center, website) and education and training (e.g., patient education and continuing education for prescribers). He discussed the one-page medication guide distributed by pharmacists to their patients when opioids were dispensed and part of product labelling. The guide is a tool for patient education and focused on the proper storage and taking of ER/LA opioids and how to prevent abuse, addiction and overdose.

Marsha Stanton, PhD, RN, discussed continuing education activities, primarily design and results. She discussed the fact that REMS is focused on accredited education,7 noting that it offers in-depth learning and helps fulfill general CME requirements of various state licensure boards. When talking about CME training, Stanton noted that the FDA blueprint is the roadmap and that CME providers can use the blue­print to create activities such as print, live lecture, interactive discussions and internet options that are longer than three hours, with pre-test and periodic evaluations throughout the educational activities.

According to Stanton, 29 audits were performed from March 2014 through February 2015; all audits met require­ments for content, accuracy and assessment.8 Nine audits had non-content-related observations (i.e., failure to promi­nently display financial disclosure, all of which were reme­diated). To develop CME, providers submit grant proposals to REMS Program Companies (RPC), who provides grants. CME providers determine course content: Medication man­ufacturers cannot participate in content development.

Laura Wallace, MPH, presented on lessons learned.9 She noted there were more than 800 REMS-compliance CME courses, all of which had a consistent message, positive ratings by completers, and resulted in generally good knowledge of safe opioid prescribing. The RPC recommended to: (a) enhance communication through the improvement of the REMS CME website and a planned launch of awareness campaign; (b) expand CME to include the extended healthcare team; (c) revise the FDA blueprint to reflect evolving stakeholder input and feedback (i.e., include tools to manage risks, condense content, utilize case studies, address other topics in pain management, etc.); (d) tie training, if required, to DEA registration; and (e) harmonize federal course content.

NIH Presentation
Wilson Compton, MD, MPE, deputy director of the National Institute on Drug Abuse at the National Institutes of Health (NIH), presented on various state and federal efforts.10 He noted that heroin and prescription painkiller abuse tends to be more common in particular areas (e.g., the Southwest, the Northeast, and rural areas). He also noted there is some overlap between people who are on Medicaid and those who abuse opioids. As such, Compton stated Medicaid and individual state budgets tend to shoulder the burden of those patients when they are sick; however, as more people become eligible for Medicaid through federal law, that burden will continue to grow. It will therefore be important for states to create individual plans for combating this epidemic, while working to fit their individual plan in with a larger, federal plan for all providers.

Compton noted that doctors and other clinicians should know what prescriptions have been given to their patients by other practitioners. He supports that such information should be included in the patient’s electronic healthcare records and accessible through a Prescription Drug Monitoring Program (PDMP) that provides immediate information. As of Feb. 1, 2016, all states except Missouri had authorized PDMPs, 34 states allowed the sharing of PDMP data with other states’ PDMPs, and 13 states require prescribers to check the PDMP. He also noted that most states require CME for licensure, but fewer require pain/opioid specific education. Another theme in NIH presentation was the need for more education on Naloxone as an antidote for opioid overdoses.

The Collaborative for REMS Education (CO*RE), an organization comprising 13 partners that supports learner-focused education as an agent for change, suggested that the use of accredited CME continue by using well-established, widely accepted, uniform measures to track performance outcomes and evaluate overall success and safeguards against content bias. They also suggested that IR/SA opioids be included, as well as all appropriate healthcare team members. Finally, CO*RE noted that opioid efforts and processes should be streamlined, as an already onerous reporting and tracking burden should not be made more complex.12

FDA Advisory Recommendations – Questions
The FDA had several questions for stakeholders to ponder, including what the impact of the ER/LA Opioid Analgesics REMS on patient access to opioid analgesics is, and provide examples; whether the scope of the current FDA blueprint is sufficient and, if not, what needs to be added or deleted from the blueprint; whether the current Medication Guide and Patient Counseling Documents are sufficient and, if not, what needs to be added or deleted; and whether or not a REMS for the immediate release (IR) opioid analgesics should be required to ensure their benefits outweigh their risks.13

ACCME Presentation
Graham McMahon, CEO of ACCME, outlined how mandatory CME is often not effective in changing clinical practice and called for continuing education to be voluntary for physicians who prescribe opioids. He noted that the ACCME is committed to facilitating the development and delivery of REMS-compliant accredited CME and that the ACCME has participated in prior FDA meetings and other events related to REMS, clarified ACCME policy for various stakeholders, developed resources for CME providers, and conducted the audits required by the FDA. The ACCME recommends that the blueprint be revised to focus on high-level messages regarding risks and safety without serious restriction on CME providers’ ability to tailor education.14

CME Coalition Comments
The CME Coalition, a Washington-based organization comprising numerous CME professionals and stakeholders, believes that CME is critical to the success of the REMS program, noting there have been numerous studies done as to the effectiveness of CME. Over the course of 39 systematic reviews published between 1977 and 2014, it was confirmed that CME “can more reliably change health professionals’ knowledge and competence than their performance and patient health outcomes.”15

As such, the Coalition believes that the FDA should con­sider standardizing the REMS process, while allowing more flexibility in content. Flexibility found in CME courses allows prescriber education to better address individual pre­scribers’ educational and practice needs.16

Conjoint Committee on Continuing Education
The CCCE noted that this should be treated as a quality improvement activity: plan, do, study, act and repeat. Further, the CCCE argues that educating practice teams is critical: Chronic care management is not the sole responsibility of the prescriber — it is a team effort. As such, all team members should be given the opportunity to participate in CME.17

During the two-day conference, the FDA heard more than 30 different presentations. Emerging as an underlying theme, CME courses are working to change practice, but there is still much work to be done.

Where Do We Go from Here?
Interestingly, ER/LA opioid prescription rates dropped for the period of the REMS 2012-2015. As such, it is important to continue a REMS program, especially one that includes CME programs.

The REMS program, in combination with the FDA and accredited CME providers, serves as a model of cooperation in helping to address public health issues. It is encouraging that the FDA sees CME as a valuable tool in combating the opioid epidemic. CME providers have created hundreds of hours of pain education programs and delivered them to hundreds of thousands of physicians. One idea is that, perhaps, instead of requiring all three to six hours of content outlined in the blueprint, counting credit hours toward a goal of three hours of REMS education should be considered.

Special thanks to the 37 member companies of the REMS program committee who have funded this effort to educate America’s physicians on the FDA Blueprint. Without their support, none of this would have been possible.


  3. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501048.pdf
  4. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501048.pdf
  5. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501048.pdf
  6. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501050.pdf
  7. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501050.pdf
  8. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501050.pdf
  9. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501050.pdf
  10. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501049.pdf
  11. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501049.pdf
  12. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501049.pdf
  13. CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ UCM501045.pdf
  14. Comments_FDA__REMS_Public_Advisory_Committee_Meeting_2.pdf
  15. rems_-_comments_to_fda.pdf
  16. rems_-_comments_to_fda.pdf
  17. Letter from Conjoint Committee on Continuing Education to Robert M. Califf, dated April 19, 2016.


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