Back to: Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
🔔 Note: Stop playback at 57:05 to complete this lesson.
Presenters
Victoria Sammarco, PharmD, MBA, BCPS, BCPPS
Risk Management Analyst
Division of Risk Management (DRM)
Office of Surveillance and Epidemiology (OSE)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Suzanne Robottom, PharmD
Associate Director
Division of Risk Management (DRM)
Office of Surveillance and Epidemiology (OSE)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Abstract
This presentation introduces the REMS Logic Model, a systematic framework designed to enhance the design, implementation, and evaluation of Risk Evaluation and Mitigation Strategies (REMS). A REMS is a drug safety program mandated by the FDA to ensure a drug’s benefits outweigh its risks, aiming to mitigate serious risks associated with drug use. The REMS Logic Model, which is a Program Logic model influenced by the Theory of Change, functions as a roadmap, making explicit the scientific evidence, assumptions, and underlying logic behind a REMS. It clarifies the relationship between objectives, strategies, and assessment results, helping to identify what is important to measure. The model consists of interconnected phases: a design phase (involving risk assessment and care gap assessment to define REMS goals and objectives), an implementation phase (detailing inputs like strategies and resources, activities, and their direct outputs), and an evaluation phase (focused on short-term outcomes, long-term outcomes, and the ultimate impact of mitigating the adverse event). The process is iterative, allowing for continuous refinement and adaptation based on new information and the definition of key performance indicators to measure success.