T-04: Incorporating HIT Within REMS Programs to Address REMS Stakeholder Burden
Director REMS Technology
Celgene Corporation United States
To evaluate the current regulatory and HIT environments to determine how REMS programs can be incorporated within established REMS Stakeholder HIT workflows, treatment plans, and clinical administrative and decision-making processes.
A REMS HIT interoperable strategy was developed by identifying data exchange points between REMS Stakeholders and REMS Administrators, and evaluating publically available regulatory and HIT landscapes, in order to better incorporate REMS programs within prescriber and pharmacy electronic workflows.
Due to the safety risks of embryo-fetal toxicity associated with thalidomide, lenalidomide, and pomalidomide, each product is available in the U.S. only through a Risk Evaluation and Mitigation Strategy (REMS) program. The Celgene REMS programs require prescribers, patients, and pharmacists to complete mandatory REMS tasks beyond typical prescription/dispense interactions before those products can be taken by patients. REMS Stakeholders may use a variety of channels to participate in the REMS program, but an ability to perform those tasks within the stakeholder’s systems (e.g. EHR, PBM, etc.) is needed to reduce the rate of REMS administrative burden.
Our evaluation of the HIT environment yielded many findings. Multiple established electronic information exchange standards (e.g. NCPDP REMS telecommunication standards, HL7 FHIR®, etc.) exist, while regulatory/governmental initiatives (ONC Shared Nationwide Interoperability Roadmap, FDA REMS initiatives [REMS Standardization SPL Pilot and Common REMS Platform]) are currently ongoing. They either support the concept of REMS HIT integration or are specifically applicable to REMS. Tangible solutions (e.g. EHR, ePrescribing, pharmacy systems, and Switch technology) and alternative data channel/technical prospects (text messaging, mobile apps, biometric trackers, bots, etc.) are available for exploration and consideration.
Using our findings, we determined a viable and comprehensive roadmap of REMS HIT integration opportunities to enhance and support our REMS stakeholders’ participation in our REMS programs. This concept, REMS 2020 Vision, has been internally embraced and is currently being piloted and implemented via supporting projects and initiatives. It is not a static approach as it is continuously refined and improved due to a dynamic HIT environment.
REMS programs exist in various forms. While some programs consist of a Medication Guide and Communication Plan, others involve complex restricted distribution systems that may entail mandatory REMS tasks such as program enrollment, knowledge assessments, laboratory tests, and real-time safe-use verifications. Recent efforts by FDA (e.g. the REMS Integration Initiative, REMS Common Platform, etc.) to reduce REMS administrative burden for REMS Stakeholders (Prescribers, Pharmacists, and Patients) have been heavily discussed and debated. Through this investigation and analysis, we determined that the regulatory, technical solutions-based, and stakeholder environments are particularly primed to support and advance REMS programs by 1.) enabling Health IT systems to electronically obtain REMS definitions, 2.) interpreting REMS requirements, and 3.) exchanging REMS transactional messages with a REMS Administrator via open interoperable standards. Through a goal of implementing REMS technology solutions that support REMS interoperability, we aim to reduce REMS administrative burden for our stakeholders as well as increase program compliance to ensure that our REMS programs continue to meet their goals.