The Future of REMS Technology at the REMS Industry Consortium
Friday, March 31, 2023
The inaugural REMS Industry Consortium (RIC) Annual Meeting began on March 22, overlooking the cherry blossoms in Washington, D.C. The RIC board of directors opened with a panel titled, ‘Why RIC, Why NOW?’ and this topic set the tone for the two-day event – a coming together of drug manufacturers, the U.S. Food and Drug Administration (FDA), and industry vendor partners to drive improvements, efficiencies, standardization, and, ultimately, better ways to keep patients safe while on therapy requiring a REMS and reducing the burden on healthcare professionals taking care of those patients.
A particularly exciting topic woven throughout the event was how to leverage technology and stakeholder feedback to create better programs and better experiences for all REMS stakeholders. Participants must use different systems and follow unique rules for each REMS, which can create confusion and frustration in the marketplace. The FDA and manufacturers alike will look to vendor partners to bring efficient technology solutions to alleviate these burdens. As we determine solutions as part of this ask for innovation, manufacturers want to hear the business case as to why investments should be made: what are the benefits as they relate to safety, risk, compliance, and finance?
The FDA is particularly enthusiastic about the CodeX REMS Integration use case, which uses HL7 FHIR APIs to integrate REMS requirements into prescriber workflows within their EHR and into patient workflows within patient portals. This solution will allow for REMS verifications and electronic communication between prescriber offices, patient portals, and REMS administrator systems, ensuring that by the time the patient gets to the dispensing location they can obtain their therapy without additional complications. The appeal of the CodeX solution is that it allows prescribers and patients to work in their current systems and workflows to complete tasks that are performed outside of their workflow today, either by navigating to the REMS website or contacting the coordinating center. There is an active call from the FDA to manufacturers to participate in piloting this solution and a call to REMS vendor partners to build and integrate the solution.
As the leader in REMS administration, it is our responsibility to act in response to the industry’s call for standardization, innovation, and efficiency. We should all consider our own way of doing things and challenge the status quo. How can we standardize and scale so that the process of selling, defining, building, launching, and maintaining REMS can be more efficient, faster, and achieved with higher quality? There are opportunities along every step of the way to reduce burdens and delight REMS customers, both internally and externally. UBC is proud to be a member of this important group within the REMS space and to have participated in this inaugural meeting.
About the Author
Michelle Rice is the Director of REMS Technology & Support at UBC. She brings over 16 years in health care technology, including 5 years in Risk Evaluation and Mitigation Strategy, to her role at UBC. In this role, she is focused on the REMS technology service offering, specializing in application development, product development, technology support, and client relationships. This includes overseeing new REMS implementations, enhancements, modifications, maintenance, incident and problem management, and product development.