Abstract
Background: The Collaborative for REMS (Risk Evaluation and Mitigation Strategy) Education (CO*RE) includes 13 organizations that provide REMS Program Companies (RPC) grant-supported accredited education on extended-release and long-acting (ER/LA) opioid therapy. This report summarizes results of a survey designed to investigate the impact of participant criteria and to better understand the roles and preferences of continuing medical education/continuing education (CME/CE) participants. Methods: In April 2015, the authors made an online survey available to an estimated 10,000 clinicians who had completed a CO*RE CME/CE activity since 2013. The purpose of the survey was to (1) examine possible reasons learners may underreport prescribing status, (2) investigate ways in which learners engage in nonprescribing roles relevant to reducing adverse patient outcomes, and (3) determine the acceptability of a potential test-based learning tool that allows participants with mastery to test out in lieu of participating in 2- to 3-hour education. Results: Findings revealed that there was little confusion or reluctance by learners to answer questions about Drug Enforcement Administration (DEA) licensing and whether they prescribed opioids in the past year. REMS “prescriber” education covers opioid management responsibilities that are distributed among team members who play critical nonprescribing roles in reducing serious adverse outcomes from both ER/LA and immediate-release (IR) opioids. Seventy-three percent of study participants would favor a test-based learning tool should future circumstances warrant it. Conclusion: The authors concluded the likelihood of underreporting is small, but there is an opportunity to clarify license and prescribing questions; opioid management responsibilities are distributed among nonprescribing team members who play roles in reducing adverse outcomes from both ER/LA and IR opioids, who would therefore benefit from REMS education; and clinicians favor a test-based learning tool, should future circumstances warrant it. These findings could have implications for planning future ER/LA opioid REMS curriculum and for setting and interpreting training goals for the US Food and Drug Administration's (FDA) ER/LA opioid REMS program.
Introduction
In April 2011, the Office of National Drug Control Policy (ONDCP) released a comprehensive action plan in the Obama Administration's Epidemic: Responding to America's Prescription Drug Abuse Crisis. 1 In support of the plan, in July 2012 the US Food and Drug Administration (FDA) announced a Risk Evaluation and Mitigation Strategy (REMS) whose goal was “to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics while maintaining patient access to pain medications.” 1 , 2 The REMS required manufacturers of extended-release and long-acting (ER/LA) opioids to work together to ensure training is provided to prescribers of these medications, 3 , 4 in accordance with an FDA Blueprint for Prescriber Education (“FDA Blueprint”) 5 of core messages. In response, 23 companies formed the REMS Program Companies (RPC) consortium to support independent educational grants for accredited continuing medical education/continuing education (CME/CE) activities covering topics such as assessing patients, initiating/modifying/discontinuing therapy, managing ongoing therapy, and counseling patients and caregivers on safe and proper use.5
The Collaborative for REMS Education (CO*RE), made up of 13 partner organizations (see Acknowledgments), promotes evidence-based, outcome-oriented, and interprofessional education related to the comprehensive management of pain, addiction, and their comorbidities. CO*RE Partners represent 750,000 clinicians, including primary care and specialty physicians, nurse practitioners, and physician assistants. A recipient of RPC grants, CO*RE has delivered over 500 CME/CE activities (in person and online) since 2013, providing education to more than 170,000 clinicians across the United States in accordance with the FDA Blueprint.
To date, the RPC has completed 4 annual grant cycles.
3
The FDA set the goal of 160,000 of the approximately 320,000 US ER/LA opioid active prescribers to complete the education by the end of the second year.
6
In order to be counted toward this goal, the learner must complete the education and answer participant criteria questions indicating that they
are currently licensed by the DEA to prescribe Schedule 2 and/or Schedule 3 drugs
7
and have prescribed ER/LA opioids within the past year.
After 3 years, 157,493 people completed the ER/LA opioid training nationally, but only 66,219 officially counted toward the FDA's training goal. 8 , 9 CO*RE-provided activities mirror this pattern: although 89,996 completed the education through May 2016, only 29,373 (33%) learners counted toward the goal.
We suggest that the current participant criteria exclude many health care professionals who are key to safe opioid use: nonprescribing clinical practice staff, those caring for patients on opioids prescribed by another clinician, those unsure of their recent prescribing history, those who will prescribe in the near future, and those that prescribe immediate-release (IR) opioids. In addition, the constricted definition helps to explain the shortfall in meeting the FDA's training goal. Our collaboration constructed a survey to better contextualize past and potential future CO*RE REMS CME/CE participants by exploring 3 key issues: Do they misinterpret or hesitate to answer the questions about license and prescribing status, which would lead to underreporting? To what extent do they engage in roles beyond prescribing ER/LA opioids that are relevant to reducing serious adverse outcomes? Do they favor a potential test-based learning tool that allows participants with mastery to test out in lieu of participating in 2- to 3-hour education?
Methods
Design
The study tool was an online survey. Survey development occurred through a series of 20 qualitative telephone interviews recruited by e-mail from CO*RE Partners. The interviews informed survey item development, ensured appropriate response choices, and helped to refine survey language and terminology. Interviewees included 14 physicians, 3 advanced practice nurses (APNs), and 3 physician assistants (PAs) practicing in a variety of primary care and pain specialty settings. Approximately half the interviewees were recent CO*RE activity participants (less than 1 month prior) and half participated 2 to 6 months prior.
This study was done to provide insight and context surrounding clinician participation in an educational program rather than a research study guided by research questions. Therefore, the study plan was not submitted for an institutional review board review. Nevertheless, the study procedures were in compliance with the recommended human participation protection practices. Participation in the study was voluntary. To protect the confidentiality of the data, the project team treated any study-related documents as confidential. The study report as well as this article includes aggregate data, and neither study participants nor their clinical settings were identified. All interview and survey subjects were presented a brief informed consent statement to which they agreed before participating.
Study participants
CO*RE Partners made the online survey available to an estimated 10,000 target audience members (physicians, APNs, and PAs). Because we used e-mail and a posted link to deliver the survey, we cannot be specific about its total reach. To ensure geographic representation and improve generalizability, ResearchNow, a commercial research panel provider, recruited an additional 211 survey respondents matching target audience criteria.
Measures
Each of the 27 survey items corresponded to at least 1 of the 3 study issues. Survey items are available in Supplemental Material.
Procedure
We used QuestionPro as our survey platform. 10 CO*RE Partners sent e-mail invitations to their membership during a 6-week period in April to May 2015. The final data set was downloaded for analysis using simple descriptive statistics.
Results
A total of 1247 surveys were completed, 121 of which were excluded (completion in an unacceptably short duration [<3 minutes] or response straightlining), leaving 1126 surveys for analysis. For those CO*RE organizations who only delivered the survey via e-mail, and could therefore calculate a response rate, the average was 11.4%. Because CO*RE Partners are professional membership organizations with similar structures, we believe 11.4% is a reasonable estimate of the response rate among all survey recipients.
Demographics
Respondents included 43% physicians, 50% APNs, and 7% PAs or “other” (see Table 1). Most reported they are licensed by the Drug Enforcement Administration (DEA) to prescribe Schedule 2 and/or Schedule 3 drugs.
Survey respondent demographic data.
Key Issue 1
Nearly all (98%) physicians indicated that they were very comfortable or comfortable answering the licensing question (see Table 2). Of respondents (n = 30) who were somewhat uncomfortable or very uncomfortable, the majority indicated that they were unsure how to answer the question, providing open-text responses such as: “I have a DEA (number) but do not know the categories,” and “Current changes have left me uncertain of what I now can prescribe or not.” Most were comfortable with the prescribing questions too. Ten of 30 respondents who were somewhat uncomfortable or very uncomfortable indicated that the question is not applicable to their practice. Open-text responses indicated reasons why they do not prescribe, not discomfort with the question.
Survey responses.
See Table 3 for additional Key Issue 2 results.
Key Issue 2
Respondents care for patients who are prescribed opioids by another clinician (Table 2). Clinicians who would not “count” as a current ER/LA opioid prescriber, in fact, play a significant role in managing patients on opioid therapy (Tables 2 and 3). Seventy-nine percent counsel patients about safe use, 55% discuss opioid therapy with colleagues, 24% recommend opioid therapy to the prescribing clinician, 10% consult with other clinicians on appropriate therapy, and 7% give presentations on pain management with opioid therapy. Other responses (n = 67) include mention of working in a pain clinic, tapering patients off opiates, reviewing opioid use in long-term care, counseling caregivers about signs of adverse events, and monitoring prescription history. Additionally, whereas 42% of respondents have prescribed an ER/LA opioid, 77% have prescribed an IR opioid, in the past year; out of all 478 ER/LA opioid prescribers, 474 report that they also prescribed an IR opioid in the past year (Table 1).
Roles in opioid management by prescribing status.
Key Issue 3
The vast majority of respondents either agree or strongly agree that knowledge and competence should be required before prescribing opioids (Table 2). On a scale of 1 to 4 with 4 being “strongly agree,” responses averaged a 2.85 regarding the effectiveness of testing and 2.73 regarding voluntary participation. If there were a mandated requirement for opioid education, 73% would favor a CME-accredited, test-based learning tool of 30 (29%) or 60 (39%) minutes in length.
Discussion
Our survey respondents included a greater percentage of clinicians licensed (84%) and having prescribed an ER/LA opioid in the past year (42%) compared with cumulative CO*RE activity participation data (59% and 33%, respectively). This translates to a greater percentage of our survey respondents (42%) meeting the participant criteria to count toward the FDA's training goal compared with actual participants in CO*RE's activities (33%) who meet the criteria.
Results indicate little misinterpretation or hesitation over license and prescribing status questions, but open-ended comments reveal modest confusion. Since answers to these questions determine whether one is “counted,” we suggest including a description of Schedule 2 and 3 drugs with the participant criteria questions. Although there is no apparent reluctance to answer questions, it is important to note that our survey was anonymous, whereas the participants in the REMS course are asked to provide their name and e-mail address when answering the criteria questions.
Once an opioid analgesic prescription is written, other nonprescribing health care professionals are involved in the safe and effective management of that patient. Professional associations and health care systems increasingly recognize the value of interprofessional education and team-based care to improve outcomes and manage costs. 11 As highlighted in the National Pain Strategy, the most effective pain care requires a multimodal, interdisciplinary approach, and the involvement of the entire care team is essential to optimal outcomes. 12 Our findings confirm that many respondents who have not recently prescribed ER/LA opioids themselves play critical roles in the initiation, management, and monitoring of opioids. They typically take the lead in counseling, discussing, and consulting about these drugs with patients. Indeed, one quarter of these nonprescribing clinicians are recommending whether or not opioids should be initiated in the first place. Thus, these “uncounted” clinicians do, in fact, contribute to the ultimate REMS goal of reducing serious adverse outcomes.
The high frequency of IR opioid prescribing among our survey audience aligns with feedback from CO*RE faculty and advisors: IR opioids are as much a part of the problem as ER/LA opioids. These findings support the FDA advisory committees’ early recommendations that a universal approach was warranted for both ER and IR opioid preparations. 8 , 13 Although further investigation into IR opioid prescribing patterns was beyond our survey scope, we conclude that IR opioids are commonly used in health care practice and recommend factoring them into education plans and outcomes metrics.
The lengthy content requirements for this REMS education, coupled with no option to demonstrate prior knowledge or competency, are incompatible with effective adult education principles. 14 Our survey respondents favor a 30- to 60-minute, accredited, test-based learning tool option if circumstances lead to mandated education. CO*RE supports offering such an option, which would certify competence for those with content mastery and serve as a diagnostic for those who may require additional support. The tool could be sent to past participants who did not meet the FDA participant criteria (and therefore were not counted) and to new learners to gauge their knowledge while preparing them for additional education. Data collected from such a tool could also guide the development of future opioid education materials.
There are limitations to our study. Our survey was anonymous, whereas participants in the ER/LA opioid REMS CME/CE are asked to provide name and e-mail address when submitting evaluation responses. By using a convenience sample, self-selection and nonresponse bias may limit generalizability of our results to larger populations of clinicians. Our dissemination method meant that we could only estimate the total number of survey recipients, and our overall response rate estimate of 11.4% is based on known subgroup response rates. By some statistical benchmarks, our response rate is considered low. However, because CO*RE Partners are similarly organized, with members who share common demographic variables within their profession, a low response rate may still be fairly generalizable. Had we applied different recruitment tactics and secured a more definitive—and higher—response rate, we could have higher confidence in our results.
Conclusion
With current ER/LA opioid REMS participant totals falling short of FDA goals, this study was launched to shed light on the large gap between total versus counted participants in RPC-funded CME/CE provided by the CO*RE educational collaboration. We surveyed learners to explore possible factors underlying the gap and conclude that (1) the likelihood of underreporting is small, but given some reported confusion, there is an opportunity to clarify license and prescribing questions; (2) opioid management responsibilities are distributed among nonprescribing team members who play roles in reducing adverse outcomes from both ER/LA and IR opioids, who would therefore benefit from REMS education; and (3) clinicians favor a test-based learning tool, should future circumstances warrant it. These findings could have implications for planning future ER/LA opioid REMS curriculum and for setting and interpreting training goals for the FDA's ER/LA opioid REMS program.
Footnotes
Acknowledgments
The CO*RE Publications Committee are Piyali Chatterjee, Robin Heyden, Cynthia Kear, Marie-Michele Leger, Michele McKay, Tom McKeithen, Anne Norman, Eric Peterson. The CO*RE Partners are American Academy of Hospice and Palliative Medicine (Julie Bruno), American Association of Nurse Practitioners (Anne Norman*, Michele McKay), American Academy of Physician Assistants (Marie-Michele Leger, Eric Peterson), American College of Emergency Physicians (Lori Vega), American Osteopathic Association (Stephanie Townsell, Sharon McGill), American Pain Society (Cathy Underwood*), American Society of Addiction Medicine (Penny Mills*, Arlene Deverman), California Academy of Family Physicians (Cynthia Kear*, Jerri Davis), Healthcare Performance Consulting (Tom McKeithen, Mary K. Van Kleunen, Chris Larrison), Interstate Postgraduate Medical Association (Mary Ales, Kate Nisbet), Medscape (Cyndi Grimes, Piyali Chatterjee), Nurse Practitioner Healthcare Foundation (Phyllis Zimmer, Pam Jenkins-Wallace), Physicians Institute for Excellence in Medicine (Adele Cohen, Sara Bennett). The CO*RE Operations and Project Management are Forefront Collaborative (Sheila Robertson, Katie Detzler) and Heyden Ty (Robin Heyden, Neil Heyden). The CO*RE Faculty Advisory Panel are David Bazzo, MD, Ron Crossno, MD, Katherine Galluzzi, DO, Carol Havens, MD, Randall Steven Hudspeth, PhD, MBA, MS, APRN-CNP/CNS, FRE, FAANP, Catherine R. Judd, MS, MPA-C, DFAAPA, Barbara St. Marie, PhD, ANP, GNP, Edwin A. Salsitz, MD, DFASAM, Seddon R. Savage, MD.
*Executive Team.
Funding
The Collaborative for REMS Education (CO*RE) is supported by independent educational grants from the ER/LA Opioid Analgesic REMS Program Companies (Grants EG-000146, EG-000259, EG-000319). See 
for a listing of the member companies. The educational activities produced by CO*RE are intended to be fully compliant with the ER/LA Opioid Analgesic REMS education requirements issued by the US Food and Drug Administration. The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Author contributions
Cynthia Kear is a member of CO*RE's Executive and Operations teams and is lead project manager. She assisted with the survey design, analyzed the resulting data, and helped to write and revise the article. Tom McKeithen and colleagues at Healthcare Performance Consulting, Inc., were responsible for study design, data collection, analysis, and reporting on this project. He helped with editing and data presentation for the article. Sheila Robertson works with CO*RE's Operations and Project Management teams. She was the lead writer on the article.
References
Supplementary Material
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