Assistant Professor of Medicine Brigham & Womens Hospital/Harvard Medical School Boston, United States
Background: Before 2007, some manufacturers agreed to enact safety programs for prescription drugs with serious risks. In 2007, Congress gave FDA the authority to require such programs, relabeled Risk Evaluation and Mitigation Strategies (REMS). A core component of REMS is written materials informing patients, prescribers, and pharmacists of drug risks and safe use requirements, but their presentation and content are not well-studied.
Objectives: To evaluate the presentation and content of REMS materials for 13 drugs (alemtuzumab, alvimopan, ambrisentan*, bosentan*, clozapine*, isotretinoin*, lenalidomide*, lomitapide, pegvaliase, pomalidomide, sodium oxybate*, thalidomide*, vandetanib) – 7 of which (*) had pre-existing safety programs – focusing on their potential to engage, inform, and influence readers.
Methods: From August 2021 to February 2022, we downloaded patient-, prescriber-, and pharmacist-facing materials on manufacturers’ REMS websites. We developed an instrument to capture data on content, reporting, knowledge assessments, and readability from the materials. Two scorers independently coded the materials using the instrument, with discrepancies resolved by discussion. We analyzed variations in the number and reading time of documents across all REMS and between REMS with and without precursor safety programs. Additionally, we identified REMS that included knowledge assessments, safe use conditions, compliance attestations, drug benefits, and non-REMS-related risks.
Results: Eleven of 13 REMS included materials for patients, prescribers, and pharmacists; 1 REMS did not have patient materials, and 1 REMS did not have pharmacist materials. Across REMS, there were a median of 4 materials for patients, 6 for prescribers, and 3 for pharmacists, which took a median of 18, 42, and 20 minutes to read, respectively. The median number of materials and reading time were greater for REMS with pre-existing safety programs (patients: 5 vs. 1 documents, 49 vs. 22 minutes; prescribers: 8 vs. 5 documents, 46 vs. 22 minutes; pharmacists: 4 vs. 3 documents, 33 vs. 8 minutes). Enrollment forms for 10 REMS explained safe use conditions and required a compliance attestation. Eight REMS did not describe the drug’s benefits and 6 did not describe non-REMS-related risks. Six REMS included a prescriber knowledge assessment and 4 a pharmacist knowledge assessment.
Conclusions: Overall, materials of newer REMS are less burdensome for readers, which may increase engagement and, thus, safe and effective use of REMS-covered drugs. Streamlining literature for older REMS, adding drug benefits and non-REMS-related risks, and incorporating prescriber and pharmacist knowledge assessments may help further these goals.
