P110: Risk Evaluation and Mitigation Strategy (REMS) Standardization of Assessment Plan Metrics
Poster Presenter
Zarnab Jillani
Medication Error Pharmacovigilance and Risk Management Fellow
FDA United States
Objectives
Identify metrics that can be standardized for REMS Assessment Plans
Method
We retrieved REMS Assessment Plans and reviewed the metrics for two assessment categories (Program Outreach and Communication and Program Implementation and Operations) to identify opportunities to standardize metrics by reorganizing, refining, and prioritizing.
Results
We reviewed 11 REMS Assessment Plans approved during the last two years, with a focus on metrics in two categories (Program Outreach and Communication and Program Implementation and Operations) described in FDA’s REMS Assessment: Planning and Reporting Draft Guidance for Industry.
Our preliminary review identified multiple inconsistencies that can lead to uninformative data for assessing the REMS. These inconsistencies include the selection of different wording for similar metrics, redundant metrics, and products with similar REMS requirements having different metrics to report and assess similar data. Many of the metrics only requested numbers or findings without an analysis (e.g., trends, implications or evaluation of the data). We also identified that some REMS Assessment Plans further organized the metrics into subcategories (e.g., Certification and Enrollment, Utilization, Compliance). Our review found that these subcategories were helpful in organizing the metrics within the assessment categories.
After initial analysis, standardized metrics for each category were developed and organized by subcategories.
Continued review and analysis is in progress.
Conclusion
Our review of the metrics from recently approved REMS Assessment Plans identified multiple opportunities to standardize metrics.
Standardized metrics will provide a framework for establishing criteria and standards to better inform REMS assessments. The standardization of metrics will also allow for more efficient review and development of REMS Assessment Plan metrics to yield high quality REMS Assessment Reports. The data generated from standardized metrics will be more readily comparable across products with similar REMS requirements. Additional data analysis and metric refinement is ongoing, with a goal to continue revising the metrics for the Program Outreach and Communication and Program Implementation and Operations categories. Future efforts will be expanded to review and standardize metrics in additional assessment categories.
The views expressed in the abstract do not necessarily represent the views of the U.S. Food and Drug Administration.
1 Medication Error Pharmacovigilance and Risk Management Fellowship
2 U.S. Food and Drug Administration, Silver Spring, MD, USA
