RPC REQUEST FOR (CE GRANT) APPLICATIONS (RFA)

RPC REQUEST FOR (CE GRANT) APPLICATIONS (RFA) Overview Information Sponsoring Organization Opioid Analgesic REMS Program Companies (RPC) RFA Title* RFA Code OA 090618 RFA Goal Opioid Analgesic: Risk Evaluation and Mitigation Strategy (REMS) The goal of this RFA is to support high-quality REMS-compliant accredited (as defined by the applicable accrediting organization(s)) continuing medical education or continuing education (CE) designed to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of opioid analgesics while maintaining patient access to pain medications. The mechanism by which this is intended to occur is by educating healthcare providers (HCPs), based on U.S. Food and Drug Administration (FDA) REMS goals. Such education will be based solely on the FDA s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (revised FDA Blueprint or Blueprint https://www.regulations.gov/contentstreamer?documentid=fda- 2017-D-2497-0683&attachmentNumber=1&contentType=pdf)with the goal to optimize both knowledge acquisition and the translation of that knowledge into practice. Successful proposals should detail educational initiatives that include but are not limited to the following components: Clearly define the intended audience including rationale for how it was designated, why the applicant believes this is a new audience or, if not a new audience, how the proposed educational activity(ies) and efforts will be more successful in attracting HCPs to complete the REMS-compliant accredited CE. Identify novel partners who will assist in attracting HCPs to and encouraging completion of the activities (e.g., state licensing boards, integrated delivery networks, managed care organizations, accountable care organizations). Specifically describe the unique/innovative nature of the proposed educational design/format (e.g., adaptive learning/personalized education and/or traditional CE delivery methods) and how it fills a void considering currently available live and online activities (e.g., electronic activities for mobile utilization or engaging print formats). Page 1 of 31

RFA Elements Essential to Meet REMS- Compliant Accredited CE Requirements Educational design of proposed CE activities must incorporate all of the requirements for REMS-compliant accredited CE training: All activities within each educational activity must cover the revised FDA Blueprint elements contained within the updated document. Each activity must include an assessment that covers all sections of the revised FDA Blueprint. Grant applications should provide options that are intended to increase the likelihood of learners completing the entire assessment. The RPC encourages the collection of outcomes data as requested by the FDA and developed independently of the RPC. Consideration will be given to CE providers who demonstrate methods to measure retention of information. Please reference the related MedBiquitous specification for a full list of REMS-related definitions currently under revision by the MedBiquitous Metrics Working Group (Appendix A). For CE providers requesting grant support for the assessment period, provide the following information: Moore s level of outcome the activity is designed to impact CE format (live, webinar, etc.) Duration of activity for live or webinar activities Average time to complete for internet/enduring activities Education methods and tools (case-based, multimedia, didactic, interactive, adaptive, etc.) The educational activities are subject to independent audit by external auditors from a CE accrediting body not involved in the creation, production, or completion of educational content or delivery method/platform. This audit is intended to occur prior to learners encountering the activity, and as such, CE providers conducting CE under RPCsupported grants agree to submit all materials to their accrediting body at least 45 days before the activity start date. RPC-supported CE providers agree to provide documentation to the RPC in which a medical expert independent of but chosen by the CE provider, attests that the activity meets the REMS-compliant accredited CE requirements. This requirement, intended to assure that all RPC-supported activities are fully REMS-compliant, applies to all activities, regardless of whether or not the activity is selected for audit by one of the Accrediting Bodies. The activities must be conducted in accordance with the standards for accredited CE set by the appropriate specialty accrediting body or bodies, Page 2 of 31

FDA- Requested Demographic Information including but not limited to the following, ACCME, AAFP, AANP, AAPA, ACPE, ADA, ANCC, and AOA. The FDA has requested that RPC-supported CE providers collect learnerlevel data for those individuals who complete REMS-compliant accredited CE activities. The FDA would like for CE providers to collect the following standard CE learner data for the Opioid Analgesic REMS: 1. Geographic location State of primary practice 2. Prescribers I have an individual registration with the DEA to prescribe controlled substances (CS) I am authorized to prescribe controlled substances under an institutional (hospital/clinic) DEA registration 3. Profession a. Physician b. Advanced practice nurse (e.g., APRN, CNS, NP, DNP, CRNA, CNMW, other) c. Physician Assistant d. Dentist e. Podiatrist f. Nurse g. Pharmacist h. Optometrist i. Psychologist j. Other health care professional k. Other 4. Practice area a. Which best describes your practice area? i. Addiction ii. Anesthesiology iii. Critical Care iv. Dentistry v. Emergency vi. Family Medicine vii. Geriatric viii. Hematology ix. Hospice and/or Palliative Care x. Internal Medicine xi. Neurology xii. Obstetrics/Gynecology xiii. Oncology xiv. Ophthalmology xv. Pain xvi. Pediatric xvii. Physical Medicine and Rehabilitation xviii. Psychiatry xix. Surgery Page 3 of 31

1. General surgery 2. Orthopedic surgery 3. Other surgical specialty xx. Urology xxi. Other xxii. N/A b. Do you perform surgical procedures? (yes/no) 5. Length of time learner has been in practice a. Trainee (e.g., student, intern, resident, fellow) b. <5 years post training c. 6-10 years d. 11-15 years e. 16-20 years f. 21+ years Key Dates RFA Posted: June 29, 2018 Application Due Date: 11:59pm ET September 10, 2018 Award Notification Date: Q4 2018 RFA Document Grant applicants should submit applications in MS Word. Parameters Submission Link Questions on RFA? Grant applications must be submitted via the Grant Management System (GMS), which will be accepting new grant applications in response to this RFA beginning on June 29, 2018. The GMS may be accessed by way of the RPC website at www.er-la-opioidrems.com via the right side link, Continuing Education Provider Information. For this specific RFA, the appropriate RFA code is 090618. Please contact the Grant Coordinator: Phone: 1-800-376-9756; Email: grants@er-la-opioidrems.com Table of Contents Section 1: Scope of the Problem and Background on the Opioid Analgesic REMS... 5 Section 2: Funding Opportunity and Award Information... 8 Section 3: Applicant Eligibility Criteria... 9 Section 4: RFA Submission Information...10 Section 5: Grant Appliation Review Citeria...10 References...21 Appendix A: Medical Education Metrics Definitions...23 Appendix B: Key Learnings and Challenges as Reported by CE Providers...24 Appendix C: Current Listing of the RPC Member Companies...25 Page 4 of 31

Section 1: Scope of the Problem and Background on the Opioid Analgesic REMS The Intersection of Dual Public Health Issues The nation is facing competing public health issues: the need to adequately treat a large number of Americans with acute and chronic pain and a crisis of prescription opioid abuse. Described in the 2011 report by the National Academies of Science, Engineering, and Medicine (NASEM), Relieving PAIN in America, A Blueprint for Transforming Prevention, Care, Education, and Research, 100 million Americans suffer from common chronic pain conditions; fewer than half of Americans undergoing surgery report adequate pain relief; and 60% of Americans visiting the emergency department with acute painful conditions receive analgesics. It is critical that HCPs are knowledgeable about the risks associated with opioid analgesics as they pertain to their patients as well as from a public health perspective. The data continue to show problems associated with prescription opioid analgesics. In 2016, over 63,632 Americans died from drug poisonings, and of these, approximately 66% or 42,249 deaths involved illicit and/or prescription opioids, likely driven by illicitly manufactured fentanyl. 1 Based on the 2016 National Survey on Drug Use and Health (NSDUH), an estimated 11.5 million Americans aged 12 or older misused a prescription pain reliever in the past year with hydrocodone, oxycodone, and codeine products being the most commonly reported. 2 The most common source of pain relievers in the 2016 NSDUH was a friend or relative (53%). A physician s prescription was the second most common source, reported by approximately 35% of respondents. 2 It is critically important that HCPs have all the information they need to properly treat their patients and safely manage their pain. It is also critical for HCPs to understand when opioid analgesics may be an appropriate treatment and how to implement best practices to ensure their patients safety. A 2017 report by NASEM, Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use, describes the challenges of providing adequate pain management and calls for the establishment of comprehensive pain education materials and curricula for HCPs. 2 Having broad knowledge about how to manage patients with pain can create the opportunity for HCPs to consider all options for pain management, including nonpharmacologic and non-opioid pharmacologic options, and to reserve opioids for when non-opioid options are inadequate and when the benefits of the opioids are expected to outweigh the risks. This information can also aid HCPs in identifying and intervening when encountering obstacles that may reduce access to nonpharmacological and non-opioid medication options. Fully informed HCPs can help contribute in national efforts to address opioid addiction and reduce opioid misuse and abuse. Page 5 of 31

Opioid Analgesic REMS and the RPC The Opioid Analgesic REMS is designed to ensure that the benefits of opioid analgesics outweigh the risks (in patients whose clinicians have determined opioid analgesics to be an appropriate treatment option). The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of opioid analgesics while maintaining patient access to opioids, non-opioid pain medications, and non-pharmacologic treatments. Adverse outcomes of concern include addiction, unintentional overdose, and death. 3 The FDA determined that a shared system was to be implemented for all extended-release / long-acting products within this drug class. On September 27, 2017, the FDA formally notified holders of new drug applications and/or abbreviated new drug applications for immediaterelease / short-acting opioid analgesic products that those products are now included in the Opioid Analgesic REMS. A component of this REMS is the provision of REMS-compliant accredited CE to educate HCPs on the treatment of pain. RPC-supported REMS-compliant accredited CE will be provided through accredited continuing education activities supported by independent educational grants from the RPC. For a current listing of the RPC member companies, please reference Appendix C. The FDA has developed a revised Blueprint, which is posted on the FDA website for use by accredited CE providers to develop the actual CE activities. In order to be considered REMScompliant (and eligible for RPC support), CE activities must include all elements of the revised FDA Blueprint, available at: (https://www.regulations.gov/contentstreamer?documentid=fda- 2017-D-2497-0683&attachmentNumber=1&contentType=pdf) Desired Outcomes and FDA Expectations of RPC-Supported REMS Education The desired outcome of the Opioid Analgesic REMS-compliant CE is to increase understanding of appropriate patient assessment and HCP practices, as well as provide other information that can help reduce misuse, abuse, and overdose deaths associated with opioid analgesics. Education that is focused on the expected results outlined below should result in HCPs incorporating into their practice such processes that can assist in seeking to ensure that the benefits of opioid analgesic medications outweigh the risks. The expected results of the REMS-compliant accredited education, as described by the FDA in the revised FDA Blueprint introductory section, are that HCPs of opioid analgesics will be evaluated on the following: The fundamental concepts of pain management, including definitions and mechanisms of pain How to assess patients with pain, and to identify potential risk factors for abuse and addiction The range of therapeutic options for managing pain, including nonpharmacologic approaches and pharmacologic (non-opioid and opioid analgesics) therapies Page 6 of 31

How to integrate opioid analgesics into a pain treatment plan individualized to meet the needs of the patient How to safely and effectively manage patients on opioid analgesics in the acute and chronic pain settings, including initiating therapy, titrating, and discontinuing use of opioid analgesics, if appropriate and necessary How to counsel patients and caregivers about the safe use of opioid analgesics, including proper storage and disposal How to counsel patients and caregivers about the use of naloxone for opioid overdose When referral to a pain specialist is appropriate The fundamental elements of addiction medicine How to identify and manage patients with opioid use disorder In addition, HCPs will gain an understanding of current information about safe opioid practices and about current federal and state regulations, national guidelines, and professional organization and medical specialty guidelines on treating pain and prescribing opioids. HCPs will also become familiar with the use of naloxone and with the importance of its availability for use by patients and caregivers both in the community and in the home. 2 In order to be REMS-compliant, and therefore eligible for educational grant support from the RPC, the educational activity(ies) and material(s) must address all elements of the revised FDA Blueprint. While this represents FDA s overall expectation for RPC-supported CE activities, successful proposals should translate such expectation into accredited CE-compliant objectives and outcomes. Key Learnings and Challenges Since the inception of REMS-compliant accredited CE activities in early 2013, CE providers have been accruing information on both REMS CE challenges, as well as key learnings. In the interests of optimizing REMS education for learners and achieving the REMS education goals, CE providers have worked collaboratively to share this information within the CE community and with all Opioid Analgesic REMS stakeholders. Highlights of key learnings and challenges can be found in Appendix B. Definitions and Clarifications As part of the REMS, the FDA identified HCPs as the intended audience for the REMS CE. Accredited REMS-compliant CE definitions were developed and finalized by the MedBiquitous Metrics Working Group, which included representation from accreditors, national CE provider organizations, CE providers, the FDA, the RPC, and other REMS CE-related stakeholders. For a full list of definitions, please reference the related MedBiquitous specification on REMS-related definitions developed by the MedBiquitous Metrics Working Group, which can be found in Appendix A. The revised FDA Blueprint and additional information on REMS-compliant accredited CE can be found on the FDA s website at https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm163647.htm. Page 7 of 31

Section 2: Funding Opportunity and Award Information Anticipated Number of Awards Award Budget Award Project Period The number of grants awarded in 2018 will be dependent on the number/quality of grant applications. Awards may be provided for various CE delivery methods/platforms, including adaptive learning / personalized CE learning modalities and/or traditional CE delivery methods, that fully address the REMS requirements, revised FDA Blueprint, and the ability of the CE provider(s) to engage HCPs. Budgets should be consistent with the realistic total number of opioid analgesic learners that the CE provider estimates will successfully complete REMS-compliant accredited CE activities. Consideration will be given to grant applications that are costeffective, collaborative, and provide innovative educational activities or platforms, and that minimize redundancies in development costs and leverage potential synergies. CE providers may propose budget models with multiple levels of support, which would enable the RPC to review and potentially award funds for a subset of activities. Note: The RPC will ONLY support budget proposals, in which providers submitting proposals must be prepared to comply with any requirements that become relevant/arise with regards to Transparency Reports and Reporting of Physician Ownership Interests provisions of the Social Security t 1128G (42 U.S.C. 1320a-7h) (Physician Payment Sunshine Act). CE providers must ensure that grant funds from the RPC will not be used for payments associated with the provision of food, beverages, travel, or lodging for meeting participants. CE providers will be responsible for the awareness of and must abide by applicable state-specific reporting requirements. Because of the need to report ongoing progress to the FDA, the RPC expectations are: The initial activity(ies) within the proposed training must begin within three months of signing the Letter of Agreement (LOA). Unless otherwise noted in the original proposal, all activity(ies) should be completed no later than December 31, 2019. Note: The RPC will accept applications from CE providers to extend grant support for currently funded activities and/or for new proposed activities, provided that the content adheres to the Page 8 of 31

Other Award Information revised FDA Blueprint. Based on the number of applications received, it is the intent of the RPC to complete the application review process and notify selected grantees during Q4 of 2018. To optimize the learning opportunities, the RPC intends to fund multiple accredited CE providers and educational partners with different, yet complementary, initiatives. Consideration will be given to grant applications that propose high-quality, creative activities that will enable achievement of education outcomes. Grant applicants must demonstrate how the proposed accredited CE will fully meet or exceed the requirements for REMS compliance. The proposed activity(ies) must be cost-effective for the scope of the proposal, and satisfy the RFA criteria outlined in Section 4. Section 3: Applicant Eligibility Criteria The applicant must be an accredited provider who will serve as the provider of record for the proposed activities. The applicant must be accredited to provide CE by a national specialty Accrediting Body, including but not limited to the following, ACCME, AAFP, AANP, AAPA, ACPE, ADA, ANCC and AOA, or equivalent accrediting body, or by an official state accrediting agency, and must demonstrate that its organization is in good standing at the time of submission. The applicant should provide rationale for the design and implementation of adaptive learning/personalized CE or other innovative, interactive, engaging, multimodal educational activities. The development of electronic activities for mobile devices or the implementation of adaptive learning education are examples of innovation. Effective communication skills, as evidenced by solid partnerships and collaborations, are highly valued. Page 9 of 31

Consideration should be given to whether or not your audiences have been previously engaged by you and/or other RPC-supported CE providers. Completing the REMS-compliant accredited CE means that learners have minimally: received information/instruction that covers all elements of the revised FDA Blueprint completed an assessment of learning that covers all sections of the revised FDA Blueprint and meets the CE provider s criteria for passing Note: Refer to Key Learnings and Challenges (Appendix B) when estimating the number of learners planned to complete the REMS-compliant accredited CE. Qualifications of CE Provider and Partners Needs Assessment 5,6,7 Educational Design/Methods 8,6,9,10,11,12,13,14 Your grant application should include a detailed explanation of how the applicant calculated the estimated number of learners that prescribe opioids, specifically the number of HCPs that are anticipated to register to take your education and the number of learners that are planned to complete your education. Attention should be given to identifying and describing novel partnerships/coalitions across professional, governmental, and/or healthcare organizations that can achieve broad reach, engagement, and impact. Consider the inclusion of such groups as, accountable care organizations, integrated delivery networks, state licensing boards, and group health organizations, etc. Your needs assessment should be specific to the audiences and should determine the goals of the activities, ensuring the content of the educational material is relevant and adapted to the needs and clinical practice circumstances of the learners. Ensure that the proposed educational design/methods fill a void, considering currently available REMS-compliant accredited live and online activities (for example, electronic activities for mobile devices, engaging print format), and/or utilize adaptive learning or personalized education that will encourage completion and promote participation in activities. Content is delivered using evidence-based methods and Page 19 of 31

multiple formats including, but not limited to, audio, visual, case discussions, role plays, print materials and other features of active learning and problem-based learning approaches, to guide learners in reflection and application of new knowledge to their practice settings. Activities should be innovative and creative in nature, motivating learners to participate and complete activities, including the requisite learning assessment inherent to REMS-compliant CE. Formats in which learners receive content over time, should be delivered in digestible chunks or modules, in ways that optimize learning. Knowledge Transfer 15 Principles from the field of implementation science are incorporated into overall learning activities to address barriers to the application of the knowledge conveyed in the activity(ies). Application of REMS-compliant outcomes measures of knowledge, competence, performance, etc. Interprofessional Education 11,16 Valid and Reliable Outcome Measures 11,17,18 Budget Marketing Plan for CE Activities Facilitates interprofessional education and educational activities, particularly for HCPs practicing in settings in which care is delivered by multidisciplinary teams. Evidence for the validity and reliability of CE evaluation and outcome assessment methods. Consideration will be given to grant applications that integrate assessments throughout the educational activity (versus waiting until the end of the entire activity) to optimize HCP completion. Reasonable cost per learner given the proposed educational activities (see Section 2 above) Detailed marketing strategy outlining for how audiences will be reached, including new audiences, activities and methods; how audiences will be motivated to participate in the educational activity and engaged to complete all components of the educational activity; and how to meet the education CE provider s criteria for passing. Page 20 of 31

References 1. CDC Newsroom. Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 29 Mar. 2018, www.cdc.gov/media/releases/2018/p0329-drug-overdose-deaths.html. 2. FDA. revised and updated Blueprint Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain FDA static link: https://www.regulations.gov/contentstreamer?documentid=fda-2017-d-2497-0683&attachmentnumber=1&contenttype=pdf 3. ER/LA Opioid Analgesics REMS document (FDA Approved, June 2015). http://www.fda.gov/downloads/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ UCM311290.pdf 4. Bonnie, Richard J., et al. PAIN MANAGEMENT AND PRESCRIPTION OPIOID: Balancing Individual and Societal Risks and Benefits. Edited by National Academies Press, NATIONAL ACADEMIES PRESS, 2017. 5. Bordage, G., B. Carlin, and P. E. Mazmanian. Continuing Medical Education Effect on Physician Knowledge Effectiveness of Continuing Medical Education: American College of Chest Physicians Evidence-Based Educational Guidelines. CHEST Journal 135, no.3_suppl (2009): 29S 36S. 6. Moore, D. E., J. S. Green, and H. A. Gallis. Achieving Desired Results and Improved Outcomes: Integrating Planning and Assessment Throughout Learning Activities. Journal of Continuing Education in the Health Professions 29, no. 1 (2009): 1 15. 7. Jamison R.N., Sheehan K.A., Scanlan E., Matthews M., Ross E.L. Beliefs and attitudes about opioid prescribing and chronic pain management: Survey of primary care providers. Journal of Opioid Management. 2014 Nov-Dec;10(6):375-82..2014. 8. MedBiquitous Medical Education Metrics Definitions http://medbiq.org/mems/definitions. Accessed January 2017. 9. Bloom, B. S. Effects of Continuing Medical Education on Improving Physician Clinical Care and Patient Health: a Review of Systematic Reviews. International Journal of Technology Assessment in Health Care 21, no. 3 (2005): 380 385. 10. Chiauzzi, E., K. J. Trudeau, K. Zacharoff, and K. Bond. Identifying Primary Care Skills and Competencies in Opioid Risk Management. Journal of Continuing Education in the Health Professions 31, no. 4 (2011): 231 240. 11. Van Hoof, T. J., and T. P. Meehan. Integrating Essential Components of Quality Improvement into a New Paradigm for Continuing Education. Journal of Continuing Education in the Health Professions 31, no. 3 (2011): 207 214. 12. Institute of Medicine. Redesigning Continuing Education in the Health Professions. National Academies Press, 2010. 13. Légaré F., Freitas A., Thompson-Leduc P., Borduas F., Luconi F., Boucher A., Witteman H.O., Jacques A. The majority of accredited continuing professional development activities do not target clinical behavior change. Academic Med. 2015 Feb;90(2):197-202[1] 14. Squires J.E., Sullivan K., Eccles M.P., Worswick J., Grimshaw J.M. Are multifaceted interventions more effective than single-component interventions in changing health-care professionals' behaviours? An overview of systematic reviews. Implement Sci. 2014 Oct 6;9:152. 15. Ratanawongsa, N., P. A. Thomas, S. S. Marinopoulos, T. Dorman, L. M. Wilson, B. H. Ashar, J. L. Magaziner, R. G. Miller, G. P. Prokopowicz, and R. Qayyum. The Reported Validity and Reliability of Methods for Evaluating Continuing Medical Education: a Systematic Review. Academic Medicine 83, no. 3 (2008): 274 283. 16. Sargeant, J., F. Borduas, A. Sales, D. Klein, B. Lynn, and H. Stenerson. CPD and KT: Models Used and Opportunities for Synergy. Journal of Continuing Education in the Health Professions 31, no. 3 (2011): 167 173. Page 21 of 31

17. Marinopoulos SS, Dorman T, Ratanawongsa N, Wilson LM, Ashar BH, Magaziner JL, MillerRG, Thomas PA, Prokopowicz GP, Qayyum R, Bass EB. Effectiveness of Continuing MedicalEducation. Evidence Report/Technology Assessment No. 149 (Prepared by the Johns HopkinsEvidence-based Practice Center, under Contract No. 290-02-0018.) AHRQ Publication No.07-E006. Rockville, MD: Agency for Healthcare Research and Quality. January 2007. 18. Price, D. W., E. K. Miller, A. K. Rahm, N. E. Brace, and R. S. Larson. Assessment of Barriers to Changing Practice as CME Outcomes. Journal of Continuing Education in the Health Professions 30, no. 4 (2010): 237 245. Page 22 of 31

Appendix A: Medical Education Metrics Definitions Medical Education Metrics provides a standard XML format for accredited CE outcomes data, including data related to the FDA Opioid Analgesic REMS training. Please reference the related MedBiquitous specification for a full list of REMS-related definitions developed by the MedBiquitous Metrics Working Group. As of June 29, 2018, the definitions currently under consideration are as follows: Individual The participant has an individual registration with the DEA to prescribe controlled substances. Institutional The participant is authorized to prescribe controlled substances under an institutional (hospital/clinic) DEA registration. None The participant is not authorized to prescribe controlled substances. CE providers are encouraged to reference the MedBiquitous website periodically for updates: https://www.medbiq.org/mems/definitions Page 23 of 31

Appendix B: Key Learnings and Challenges as Reported by CE Providers While there are currently more than 75 different REMS approved by the FDA, the Opioid Analgesic REMS represents the first use of accredited CE to fulfill a REMS training requirement. REMS CE Learner Challenges: REMS-compliant CE requirements are daunting to busy HCPs: Substantial investment of time (2-3 hours) required Relatively low REMS awareness, as well as uncertainty about what REMS is contributes to lack of motivation for HCPs to complete REMS-compliant accredited CE While HCPs are well-aware of the patient safety/public health issues related to opioids, the term REMS itself is not particularly meaningful to HCPs - Available opioid education that competes with REMS-compliant accredited CE activities CE Provider Challenges with REMS-Compliant Accredited CE The prescriptive nature of REMS-compliant accredited CE, as well as the fact that there is presently no way for knowledgeable clinicians to demonstrate evidence of prior learning/competence, reduces learners incentive to complete REMS-compliant CE Concurrent non-rems-compliant opioid-related CE that targets the same audience as the REMS-compliant accredited CE programs The reduction in the numbers of HCPs prescribing opioids may limit the number of HCPs interested in completing REMS-compliant accredited CE The activities include a greater-than-usual number of registration questions required of REMS activity participants, which contributes to the length of activities. Competing activities from other agencies (e.g., CDC, NIDA, state medical societies) is a challenge resulting in confusion on the part of clinicians, and dilutes the number of potential REMS participants In some states, there are very specific state education requirements, which HCPs are more likely to complete to meet state requirements Low REMS awareness, coupled with the time investment required, demands a strategic, innovative approach to attracting opioid prescribers to complete REMScompliant CE. Innovative partnerships with professional organizations, malpractice insurance companies, health systems, institutional credentialing bodies, etc. may increase awareness of REMS CE, engage learners to participate, and may increase the likelihood that participants will successfully complete the full activity Acknowledgement of completion and receipt of a certificate that may increase the likelihood of learners successfully completing the full activity Page 24 of 25