Optimization of REMS Program Compliance in a Large Academic Health System.

Ensuring compliance with all applicable Risk Evaluation and Mitigation Strategies (REMS) programs within a health system is challenging. These FDA-mandated programs are numerous, unique, and ever-changing. Actions require several stakeholders and moving parts. In addition, the effectiveness and impact of these programs has been challenged and is not always clear, which hampers buy-in and therefore compliance. F&MCW is a health network in southeastern Wisconsin that includes five hospitals and almost 40 clinics. Since 2014, several system-wide approaches to medication use, including formulary alignment and REMS program optimization, have taken place with an over-arching goal of providing efficient, safe, and consistent care for the patients and populations served. This manuscript describes the steps that took place over the past six years or so related to REMS program optimization. It also offers practical tips for other health systems based on lessons learned through this one institution's experiences.

Implementation and Evaluation of Near-Peer Facilitated Journal Club Activities in a Required MLE Course Series.

Objective. To describe and evaluate the implementation of multiple, content-integrated journal club activities into a large, required medical literature evaluation (MLE) two-semester course series using near-peer student facilitators. Methods. Using near-peer, third-year (P3) students as a significant source of instructional personnel, 10 journal club activities were incorporated annually into the second-year (P2) MLE series. Activities included preparation, quiz, journal club, and debriefing. Each activity divided the P2s into groups of 8-12 students. In the fall semester, journal clubs were facilitated by faculty members and near-peers as P2s participated. In spring, P2s also facilitated, while faculty members' and near-peers' roles shifted to providing rubric-facilitated feedback and mentoring. Near-peers and P2s provided feedback on the experiences. Results. Over four years, two course faculty members and 62 near-peers facilitated (fall) or provided feedback/mentoring (spring) for 346 P2 MLE I/II students in 419 individual journal clubs. Course faculty members covered 80 journal clubs, while near-peers covered 339. Faculty and near-peer ratings of P2 facilitators demonstrated good P2 preparation. P2 facilitators were best at facilitating discussion of implications and results, while being most challenged by introduction and methods. P2 survey responses highly favored the addition of journal club activities and the use of P3 near-peer facilitators. Conclusion. The use of near-peers in the implementation of integrated journal club activities in a large, required MLE course series was successful. Future study will include refining formative feedback processes, exploring benefit to near-peers, and exploring near-peer use in other didactic settings.