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

Educational materials for 13 drugs with Risk Evaluation and Mitigation Strategy (REMS) programs contained a median of 14 documents and 69 pages per program. Patient-directed materials had a median tenth-grade reading level, above the sixth-grade level recommended by the AMA, and took a median of 18 minutes per drug to read. REMS-specific risks appeared in a median of 80% of documents and drug indications in 33%, while drug benefits went unmentioned in 8 of 13 packages. Streamlining REMS materials for all audiences may improve comprehension and support safe use.