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2021-05-11
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Section
Pharmacy Practice & Practice-Based Research
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Copyright (c) 2021 Audrey B Kostrzewa
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright of content published in INNOVATIONS in pharmacy belongs to the author(s).
Optimization of REMS Program Compliance in a Large Academic Health System
Audrey B Kostrzewa
Froedtert & the Medical College of Wisconsin (F&MCW) & Concordia University Wisconsin (CUW)
DOI: https://doi.org/10.24926/iip.v12i2.3853
Keywords: Risk Evaluation and Mitigation Strategies, REMS, Medication Safety, Health System, FDA
Abstract
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.
