Communicating Drug Safety and Safe Use Conditions in Risk Evaluation and Mitigation Strategy Materials.

INTRODUCTION

The FDA requires Risk Evaluation and Mitigation Strategy (REMS) programs for certain drugs with serious safety risks.

OBJECTIVE

The aim of this study was to analyze the structure, readability, and informational content of educational materials used in REMS programs to assess their potential to communicate drug-related risks and support safe use for 13 drugs with active REMS programs as of 2021.

METHODS

Materials were collected from manufacturers' REMS websites between July 2021 and February 2022. From patient-, prescriber-, and pharmacist-facing documents-including fact sheets, guides, training materials, enrollment forms, and knowledge assessments-we extracted audience targeting; Flesch-Kincaid readability scores; estimated reading time; inclusion of REMS goals, drug indications, risks, and benefits; presence of comprehension assessments and reporting mechanisms. Results REMS packages contained a median of 14 documents (range 4-23) and 69 pages (range 8-414). All programs targeted prescribers and pharmacists, while 12 targeted patients. The median Flesch-Kincaid reading level was 10.5 for patient materials, 12.7 for prescriber materials, and 12.5 for pharmacist materials. Reading time varied, with patient-directed materials requiring a median of 18:08 min per drug. REMS-specific risks were discussed in a median 80% of documents, while drug indications were noted in a median of 33%, and efficacy or other safety concerns were often not included. Ten (77%) programs included comprehension assessments, and 10 (77%) provided patient enrollment forms. Adverse event reporting instructions were inconsistent. Conclusions REMS educational materials varied in length, complexity, and content, often exceeding recommended readability levels for patient-directed materials. Streamlining content and enhancing clarity and completeness may improve comprehension and support safe use of REMS-covered drugs.