Standardization and the Evolving REMS Landscape

This October, Jim Shamp, UBC Vice President of Data Intelligence and Program Analytics, participated in a panel at the World Drug Safety Congress Americas 2024 that discussed the evolving risk evaluation and mitigation strategy (REMS) landscape due to regulatory updates and compliance challenges. One key element of this landscape is the standardization of REMS implementation.

According to the FDA, the purpose of a REMS is to mitigate a serious, drug-specific risk listed in labeling, such as a severe adverse event. While REMS have been in place for nearly 20 years, little has been done to standardize REMS implementation. This is primarily because while the FDA may require a REMS for a drug, they do not have the authority to require standardized implementation. Additionally, healthcare delivery systems have changed drastically with the adoption of electronic health records (EHRs). In general, REMS have not kept pace with advances in EHRs.

In May 2024, the FDA released a draft guidance titled REMS Logic Model: A Framework to Link Program Design with Assessment Guidance for Industry. The guidance focuses on the design, implementation, and evaluation of a REMS and is intended as a recommendation to industry for a structured approach for REMS implementation.

The framework provided by the guidance provides strategies and substrategies for implementing a REMS, including substrategies to affect knowledge, such as a communication plan, and strategies to affect safe-use behavior. It is important to understand that knowledge is not an indicator nor a measure of behavior - so a knowledge-based strategy simply provides information that may reduce risk from a drug, and cannot guarantee it will be implemented. This is further complicated by the fact that current communication methods for REMS information are often not effective. For example, most REMS communication plans include emailing healthcare providers that are likely to prescribe or dispense the REMS-related drug, a large majority of which are never opened.

While the framework is a step towards standardizing REMS implementation, more industry effort and resources need to be focused on the use of standardized application programming interfaces (APIs). This can be achieved by using the open source HL7® FHIR® APIs, which are intended to promote healthcare system interoperability, to integrate REMS into prescriber and pharmacy workflows. The CodeX Use Cases provide an excellent framework to utilize for implementing these standards. The FDA has been a champion in furthering the use of these standards, and UBC has been an early adopter and industry partner with the FDA in demonstrating proof of concept prototyping of these standards in REMS implementation.

About UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.

About the Author
Jim Shamp, Vice President of Data Intelligence and Program Analytics at UBC, has over 20 years of REMS and Risk Management experience. He provides senior leadership for UBC's REMS Stakeholder Audit services and several complex REMS. Mr. Shamp plays a critical role in ensuring safe and effective access to important pharmaceutical products.

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