P315: Investigating REMS Burden: What Are the Opportunities for Standardization?
Poster Presenter
Sarah Tanios
Pharmacovigilance and Medication Safety Fellow
Purdue University United States
Objectives
The objective of this study is to further characterize the definition and types of burden that Risk Evaluation and Mitigation Strategies (REMS) may impose on REMS participants and identify potential metrics and approaches for evaluating REMS burden.
Method
A literature review on REMS burden was performed. In addition to FDA guidance documents, public information was also reviewed: docket comments, public meetings, patient advocacy group & professional association statements, and assessment plans in REMS approval letters. Data and trends were analyzed.
Results
Our research revealed that REMS participants (e.g., patients, health care providers, and applicants) may experience the different types of REMS burden depending on their role in the REMS process. Examples of REMS burden can be organized into three types: REMS Program Enrollment, Required Administrative Tasks to Document and Verify Safe Use Conditions, and REMS Program Operations and Changes. In addition, our review suggests that REMS burden may generate unintended or undesired direct and indirect impacts. Examples we found of direct impacts include: additional time, increased costs, lost revenue, and inability to obtain or delay in treatment. Additional time can involve extra visits or communication among patients, pharmacies, prescribing offices, or clinics. Increased costs and lost revenue can result from hiring more team members to complete REMS activities and implementing new technology systems to enable participation in REMS. Examples we found of indirect impacts include: intentional avoidance of prescribing a product due to REMS requirements, fewer number of readily certified prescribers and dispensers, REMS participant noncompliance, and potential patient safety issues.
In general, 1) there is a lack of standardized terms and approaches to identify and measure REMS burden for approved REMS with elements to assure safe use (ETASU), 2) while we found examples of REMS burden, the categorizations of ‘burden type’ and associated activities are not specifically defined, and 3) a limited amount of studies and scientific articles examining REMS burden and its potential outcomes are published. Preliminary findings also suggest that direct and indirect impacts of REMS burden are not well established. Additional scientific literature search and public domain analytics to further contextualize these findings are forthcoming.
Conclusion
Although REMS programs have existed for over 15 years, REMS burden remains understudied. Our research identified multiple factors that contribute to REMS burden. Therefore, our findings highlighted the need for a comprehensive definition and the categorization of REMS burden types that represent multiple perspectives and outcomes applicable to REMS participants. Once REMS burden types and categories are established, more standardized strategies to identify and then measure REMS burden can be developed. As REMS burden becomes more understood, means of proactive assessment and subsequent program improvement to alleviate REMS burden may become more evident and feasible.
Disclaimer: This abstract reflects the views of the authors and should not be construed to represent FDA’s views or policies.
