A qualitative study involving 63 participants examined their experiences with REMS (Risk Evaluation and Mitigation Strategies) programs associated with four specific drugs: Natalizumab, Riociguat, Sodium Pxybate, and Vigabatrin. While many participants found these programs reassuring, some experienced confusion due to unclear program materials, difficulties accessing medications, and concerns about data-sharing. These findings suggest a need for changes to better ensure Elements to Assure Safe Use (ETASU).
The importance of REMS stems from the FDA Amendments Act of 2007, which empowered the FDA to impose safety requirements on drugs with elevated risks. These requirements can include prescriber certification and routine lab testing. The most complex REMS involve ETASU systems, which may require patient enrollment in a registry and impose restrictions on the person, place, and volume of medication. However, simpler REMS programs like EasyREMS provide medication guides and communication guides to promote appropriate use.
Despite the significance of REMS, little was known about patient or caregiver opinions on these programs until a qualitative study conducted by the NIH from 2016 to 2017. Results indicated that while most participants were aware of REMS programs, they lacked insight into the FDA-mandated safety aspect. Many found it difficult to understand program education, experienced burdens in accessing medication, and faced challenges related to traveling to certified prescribers. Concerns were also raised about manufacturer access to patient information and data.
Altogether, REMS requirements are found helpful by both patients and caregivers but can most definitely improve in within the aspects of communication, simplicity and data-sharing concerns.