Assistant Professor of Medicine Brigham & Womens Hospital/Harvard Medical School Boston, United States
Background: The FDA can mandate manufacturers of approved drugs with serious safety risks to implement Risk Evaluation and Mitigation Strategies (REMS), which can include prescriber certification and patient monitoring (with or without lab tests), among other safe use conditions.
Objectives: To understand physicians' perceptions of and experiences with REMS safe use conditions for ambrisentan (pregnancy tests, contraception use); bosentan (liver and pregnancy tests, contraception use); clozapine (neutrophil tests); isotretinoin (pregnancy tests, contraception use); lenalidomide, pomalidomide, and thalidomide (“multiple myeloma drugs”) (pregnancy tests, contraception use), and sodium oxybate (concomitant drug use monitoring).
Methods: We created and tested a 63-question closed-field instrument covering physicians’ perceptions of and experiences with REMS prescriber certification and patient monitoring requirements, focused on their utility and burden. From IQVIA, we obtained the names and contact information of physicians who had prescribed the drugs in 2021 and invited them to participate, seeking 200 respondents per drug. Survey administration included postal and email contacts and ran from May 2022 to January 2023.
Results: We received 1124 (21%) responses from 176 ambrisentan, 150 bosentan, 194 clozapine, 203 isotretinoin, 211 multiple myeloma drug, and 198 sodium oxybate physicians. A large majority supported the safe use conditions: ambrisentan (85%), bosentan (86%), clozapine (77%), isotretinoin (74%), multiple myeloma drugs (70%), and sodium oxybate (77%). Many ambrisentan (73%), bosentan (76%), clozapine (74%), and sodium oxybate (79%) physician prescribers and fewer isotretinoin (53%) and multiple myeloma drug (57%) physician prescribers believed REMS certification provided useful information. Respondents also varied widely in whether they believed REMS facilitated patient-physician discussion (from 52% of clozapine prescribers to 74% of ambrisentan prescribers). Most ambrisentan (58%), bosentan (69%), clozapine (69%); isotretinoin (73%); and multiple myeloma drug (62%) physician prescribers agreed the safe use conditions were burdensome to patients, and over half of bosentan (58%), clozapine (60%), isotretinoin (85%), and multiple myeloma drug (54%) physician prescribers agreed the safe use requirements had delayed receipt of prescriptions.
Conclusions: Most physicians believed that the safe use conditions of the REMS-covered drugs were necessary and found that the certification process provided useful information. However, physicians also reported REMS-related patient burdens, including delays in receiving medication.
