Approximately 40% of all newly approved drugs are subject to safety restrictions inclusive of Risk Evaluation and Mitigation Strategies (REMS), which were created with the US Food and Drug Administration Amendments Act of 2007. This law expanded Food and Drug Administration (FDA) authority to require REMS of manufacturers but left implementation to the FDA. As a result, the potential access to medications that are effective but not without safety concerns has improved, yet the converse is also true because access may be restricted due to REMS requirements (eg, physician or patient registration). With the July 2012 reauthorization of the Prescription Drug User Fee Act, the FDA was given additional authorities and mandates for enhancing and modernizing the drug safety system-specifically, measuring the effectiveness of REMS as well as standardizing and better integrating REMS into the overall health care system. So, are REMS, which were conceived as a tool to improve medication safety, working? Specifically, are REMS achieving their intended outcomes (mitigating safety risks of effective drugs) without causing unintended consequences (creating a burden to the health care system and physicians and/or diminishing patient access to drugs)? Sitting squarely in the crosshairs, the approved shared REMS for extended-release/long-acting opioid analgesics provide a lens through which this question can be examined. This article discusses the current status, stakeholders, and key policy issues for clinicians with a focus on the shared REMS for opioids, as well as the anticipated role of clinicians in optimizing patient care in the new world of REMS.

Purpose: The purpose of this initiative was to develop and implement an interprofessional panel aimed to expose a university audience to the magnitude of opioid misuse and abuse, as well as demonstrate each health professional’s role in curbing the epidemic. Further, this experience was to provide a platform for interprofessional discussion and to share with attendees tangible action items to begin combatting the opioid epidemic. Methods: An interdisciplinary committee of healthcare professionals collaborated to initiate a dialogue around opioid misuse and abuse to highlight the power of interprofessional (IP) collaboration in addressing the opioid epidemic. Each panel member shared a personal vignette about his or her professional experience with the epidemic, then the audience members were asked to participate in a question and answer session. Primary outcomes from this IP experience were derived from an eight-item satisfaction survey. The event was held in April 2016. The interdisciplinary committee marketed this event to all students, faculty, and staff in the Rueckert-Hartman College of Health Care Professionals one month before the event through electronic emails and posters. Results: Forty-four (63%) of participants completed the satisfaction survey of which 88.6% were students of healthcare professions. The satisfaction survey evaluative results were positive and referenced the panel as being an excellent IP event that was helpful, informative, and enjoyable. The results support that the initiative successfully increased understanding of the magnitude of the opioid epidemic for the attendees of this pilot event. The target audience of students expressed a greater awareness of the magnitude of the problem (43.2%) and an increased appreciation of the IP aspects of opioid management strategies (36.4%). Attendees also identified the need for ownership of their role as existing and future health care professionals and the need to work as an IP team to address the problem. Conclusion: An interprofessional panel format as an optional extracurricular event is an effective way to communicate key educational messages about opioid misuse and abuse to a target audience of graduate students at a mid-sized college of health professions.

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Objective: A well-functioning healthcare team is important to optimizing the health outcomes of patients. As such, the use of Team Based Learning (TBL) in the education of health professionals has emerged as one of the more common active learning strategies. In various anecdotes with preceptors, it had been observed that student pharmacists educated in a TBL classroom exhibited increased skills in the affective domain. This qualitative pilot study begins to examine affective domain skills that are important to pharmacy practice and which of those skills may be developed uniquely through TBL. Methods: Random samples of preceptors and students (first through fourth-year cohorts), were engaged using a predesigned interview protocol to guide the discussion. Ad hoc questions resulting from the interview were also captured. A grounded theory approach was utilized to develop an a priori theme codebook that was utilized to analyze the interviews with preceptors and focus groups with students. Results: Nine preceptors were interviewed, and 23 student pharmacists participated in focus groups. Preceptors identified 1) communication, 2) emotional intelligence, 3) education, 4) time management, and 5) advocacy as the top themes important to being a leader. While students identified 1) communicate with or listen to others, 2) accountability/responsibility, 3) patience, 4) self-reflection / feedback as skills developed by TBL. Participants indicated that they believed that TBL was a contributor to the development of affective domain skills among student pharmacists. Conclusion: Among preceptors and student pharmacists, this initial study found both alignment and divergence with identified skills in the affective domain related to the development of leadership skills.  Additional research is needed to further explore and develop an instrument to measure the role of TBL in affective skill development, in the context of being a leader in the pharmacy profession.

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