Evaluating REMS Burden: A Comparative Time Analysis of 3 Channels for REMS Stakeholders to Perform Mandatory REMS...

To determine the time taken to perform 5 Risk Evaluation and Mitigation Strategy (REMS) tasks across 3 channels for the Celgene REMS programs, with an aim to better understand which channels may minimize REMS administrative burden.

Five mandatory REMS tasks (new prescriber and patient enrollments, prescriber and patient surveys, and pharmacy dispenses) were performed across applicable REMS channels (online portals, telephone interactions with customer care representatives [CCRs], or an interactive voice response [IVR] system). Five REMS representatives, who had ≥1 year of experience as a CCR, simulated the completion of the same set of testing activities across REMS channels. The execution time for each task by channel was measured and averaged across the participating CCRs.

Using the online portal, less time was taken to enroll a new prescriber (1.3 minutes) and adult male (6.7 minutes), compared to when the CCR channel was used (21.9 and 25.9 minutes, respectively). Similarly, completion of 3 AFRP prescriber surveys, the adult male patient survey, and 5 pharmacy dispenses was faster using the online portals (3.1, 1.3, and 1.7 minutes, respectively) compared to when the CCR (4.9, 1.8, and 3.4 minutes, respectively) and IVR (10.7, 4.0, and 11.3 minutes, respectively) channels were used.

The use of online channels may alleviate some of the REMS burden by reducing the administrative time it takes for prescribers, patients, and pharmacy stakeholders to complete mandatory REMS tasks. More education and awareness of the available efficient channels should be provided to REMS stakeholders.