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Appl Clin Inform 2023; 14(02): 354-355
DOI: 10.1055/s-0043-1767683
Response to the Letter to the Editor

Implementation and Integration of Risk Evaluation and Mitigation Strategies into the Health Care System

George A. Neyarapally
1   Regulatory Science and Applied Research Team, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States
,
Edward D. Millikan
2   Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland, United States
,
Claudia Manzo
2   Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland, United States
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Tajchman et al highlight important Risk Evaluation and Mitigation Strategies (REMS) implementation research gaps and the need to automate REMS programs.[1] The authors point out that a collaboration approach that involves all stakeholders is needed for the adoption of data standards–based approaches to REMS automation.

In 2021, the U.S. Food and Drug Administration (FDA) funded the MITRE Corporation to develop an open-source prototype that demonstrates how data standards, including the increasingly utilized Fast Healthcare Interoperability Resources (FHIR) standard, can be used to integrate REMS into prescriber and pharmacist workflow, and to automate data flows across the REMS ecosystem, including patients, prescribers, pharmacists, and REMS administrators. FDA is also championing a use case under the HL7 FHIR Accelerator Common Oncology Data Elements eXtensions (CodeX), which is building on and iterating this prototype, based on collaborative feedback from an open community of stakeholders.[2] Solutions from the related HL7 FHIR Accelerator Da Vinci, focused on prior authorization, are leveraged and incorporated into the prototype, advancing the value proposition and economies of scale. The initial prototype uses synthetic data to demonstrate the art of the possible in the use of FHIR to exchange REMS data across mock prescribers, REMS administrators, and pharmacy systems. The prototype also delineates the automation potential, showing, for example, how data can be automatically pulled from the EHR for submission to a REMS Administrator, such as required demographic and lab information.[3]

In October 2022, FDA and Duke-Margolis[4] (an independent Center for Health Policy) held a public workshop on REMS integration and innovation during which panelists and stakeholders generally expressed broad support for this standards-based approach.[5] The CodeX REMS Integration Use Case is open to the public, and there are regular public calls as well as leadership calls for those interested in contributing. The use case is currently in the planning stage with plans to pilot the updated REMS integration prototype in 2023 with select REMS drug(s), and drug sponsors who are interested in participating, in real health and pharmacy systems, using synthetic data first. Learnings will inform further iteration of the prototype with input from the community of stakeholders, the development of an FHIR implementation guide, and the next stage, a real-world study. The public and stakeholders are invited to contribute to this standards-based solution, and the software code is made freely available on GitHub.[6] Based on the need to leverage medical (e.g., lab test results), e-prescribing, and pharmacy data, the CodeX REMS integration team and stakeholders are working with HL7 and National Council for Prescription Drug Programs (NCPDP) to leverage both FHIR and NCPDP SCRIPT standards in future iterations of the prototype and in the pilot. Connecting both HL7 and NCPDP standards development organizations under these auspices can also foster future collaborations across several other use cases in which both medical and pharmacy data and related standards are needed, e.g., specialty pharmacy management, value-based arrangements, and prior authorization.

In summary, the CodeX REMS Integration Use Case is an open, collaborative, stakeholder-driven approach to developing a scalable, standards-based solution for REMS integration and implementation. This solution can reduce REMS implementation burden, generate higher quality, standards-based data for timely REMS program feedback and evaluation and REMS program optimization, and ultimately improve patient safety and health outcomes.

Protection of Human and Animal Subjects

The described initiative did not involve human subjects research and thus such approval is not applicable.




Publication History

Received: 11 January 2023

Accepted: 21 February 2023

Article published online:
10 May 2023

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