Drug safety · 2026
Communicating Drug Safety and Safe Use Conditions in Risk Evaluation and Mitigation Strategy Materials.
СтатьяНазвание и аннотация: Перевод в очереди
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Sarpatwari Ameet, Tessema Frazer A, Mitra-Majumdar Mayookha, Lee Su Been, Zakoul Heidi, Brown Beatrice L, Toyserkani Gita A, Oswell Kate Heinrich, LaCivita Cynthia, Dal Pan Gerald J, Woloshin Steven, Avorn Jerry, Kesselheim Aaron S
Аннотация
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.
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.