Physician Understanding and Perceptions of Risk Communication Related to Drugs Covered by Risk Evaluation and Mitigation Strategy Programs.

Abstract

To help ensure that a drug's benefits outweigh its risks, the US Food and Drug Administration may require a Risk Evaluation and Mitigation Strategy (REMS) program with requirements such as laboratory tests or special education. Since physicians are often responsible for REMS testing or education, it is critical to understand how they view the implementation of REMS programs. This study aimed to assess physicians' understanding of REMS programs, perception of the programs' value, and preferences for risk communication. Between April 2022 and June 2023, we conducted approximately 1 h semi-structured interviews with 50 physicians-6 to 9 per drug-experienced with REMS programs covering the following drugs: alemtuzumab, ambrisentan, clozapine, isotretinoin, lenalidomide/pomalidomide/thalidomide, pegvaliase, and sodium oxybate. We used qualitative content analysis to code the transcript interviews. Most physicians were knowledgeable about REMS-related risks but expressed concern about side effects of the drugs not covered by the REMS programs. In the REMS certification process, physicians valued learning information about the clinical use of the drugs and monitoring algorithms intended to keep patients safe. Some physicians reported informational gaps in REMS enrollment forms, and several desired integration of REMS programs with electronic medical records (EMRs). Physicians preferred to learn about REMS programs via electronic communications that include a summary of the drug's benefit-risk profile and REMS obligations, as well as accessible links to clinical trial results and scientific articles. Physicians also recommended that REMS materials be updated in a timely fashion as new safety data emerge. While physicians largely expressed awareness of REMS testing requirements and found REMS programs to be valuable sources of risk communication, they would like more information on managing side effects, more accessible information on REMS requirements, integration of REMS programs with EMRs, and timely updates to REMS materials as new safety information emerges. When a drug carries a serious safety risk, the US Food and Drug Administration can require a special safety program, called a risk evaluation and mitigation strategy (REMS), which requires the completion of such steps as extra training, patient education, and laboratory testing. We interviewed 50 doctors who prescribed one of seven different drugs with REMS programs, asking what they had learned, how useful they found the materials associated with the REMS program, and how they preferred to receive safety information. Most doctors understood the risks the REMS programs were designed to address, but many were also concerned about other side effects the program did not cover. Doctors who prescribed REMS‐covered drugs less often found training to be particularly helpful. Nearly all doctors preferred short, electronic materials, like emails and brief videos, over paper mailings. Many also wanted these programs integrated with their electronic medical records to reduce paperwork. Our findings suggest the safety programs could be improved by covering more side effects, staying current as new information emerges, and making requirements easier to access and understand.