BACKGROUND: Draft FDA guidance requires Risk Evaluation and Mitigation Strategies (REMS) that include a medication guide (MG) to be assessed through a survey of patients’ understanding of the serious risks of the drug. With more REMS comes significant diversity in the products, disease areas, and patient populations represented. Experience suggests that many factors can influence REMS survey results, including patient characteristics, type of treatment (e.g., chronic vs. acute), severity of the disease and potential risks, and REMS program elements (MG only vs. programs with other elements).
OBJECTIVE: To compare results across multiple REMS surveys to explore how patient knowledge of the key risk messages varies by certain factors.
METHODS: Anonymized pooled data were examined from six REMS assessment surveys ranging in size from 200 to 9,000 respondents. Awareness of primary risk was stratified by MG receipt and review, type of REMS, disease type, and other patient characteristics, and compared across surveys to identify patterns.
RESULTS: The six patient surveys covered drugs in five disease areas: two for acute conditions, one for an intermittent condition, and three for chronic conditions. Awareness of the primary risk associated with each product ranged from 24% to 98% and was lowest for acute conditions. In all studies, awareness was higher in patients reporting having received and read the MG. For each survey, over half of participants reported receiving the MG (range, 64% to 99%), and 47% to 97% of respondents indicated they had read the MG. Awareness was higher for the drug that included elements to assure safe use. Awareness also was higher in patients who were new users, reported being counseled by a health care provider, and were in subgroups specifically identified as being at higher risk.
CONCLUSIONS: Results from REMS assessment surveys vary significantly across programs and can be influenced by many factors. Reviewing results across surveys provides an opportunity to evaluate the potential factors associated with knowledge of information communicated in the MG, as well as provides critical information that can help to improve design for future REMS programs.
