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W 14: Evaluating REMS Burden: A Comparative Time Analysis of Three Options for REMS Stakeholders to Perform Mandatory REMS Tasks
Associate Director, REMS Training and Technology
Celgene Corporation United States
Describe time differences among 3 available options/channels (online, telephone w/CCR, or IVR) for REMS stakeholders to perform mandatory REMS tasks (enrollment, survey participation, pharmacy dispense confirmation) for the Celgene REMS programs for thalidomide, lenalidomide, and pomalidomide.
ORAL PRESENTATION SCHEDULED: Session 2A at 10:00 - 10:10 AM
We performed a simulated comparative time analysis of REMS stakeholders completing mandatory REMS tasks across 3 different options/channels (online, telephone interactions with Celgene Customer Care Representatives (CCR), or Interactive Voice Recordings Systems (IVR)).
Due to the safety risks of embryo-fetal toxicity associated with thalidomide, lenalidomide, and pomalidomide, each product is available in the U.S. only through a Risk Evaluation and Mitigation Strategy (REMS) program. The Celgene REMS programs require prescribers, patients, and pharmacists to complete mandatory REMS tasks beyond typical prescription/dispense interactions before those products can be taken by patients.
The objective was to analyze the time it takes for a REMS stakeholder to perform the same REMS task across the available options/channels. Five Celgene representatives executed a total of 110 tests representing 5 different REMS tasks (prescriber enrollment, patient enrollment, prescriber survey participation, patient survey participation, and pharmacy dispense confirmation) across multiple channels. Associated execution times were recorded. It was assumed that the times were representative of the REMS stakeholder population. The execution times for the same REMS task across channels varied substantially. For a new Adult Male patient enrollment task, the average execution time using the prescriber/patient online portal (www.CelgeneRiskManagement.com) was 6.7 minutes (285% faster) compared to 25.9 minutes with a CCR (p<2.2 x 10-16). To enroll a new prescriber using the online system, the average time was 1.3 minutes, while with a CCR averaged 21.9 minutes (p<2.2 x 10-16). To complete the prescriber survey task, the average time to complete 3 prescriber surveys using the online system was 3.1 minutes, 4.9 minutes with a CCR, and 10.7 minutes using the IVR. The average time to complete a patient survey online was 1.3 minutes, 1.8 minutes with a CCR, and 4 minutes using the IVR. For a pharmacy dispense task, the average of 5 dispenses using the online Pharmacy Portal (www.CelgeneREMSPharmacyPortal.com) was 95% faster than CCR (p= 5.05 x 10-7). The averages for Pharmacy Portal, CCR and IVR were 1.7 minutes, 3.4 minutes, and 11.3 minutes respectively.
In this comparative analysis, the performance of REMS tasks using available online systems was significantly faster than other available options/channels to perform the same REMS tasks, while the IVR required the most amount of time. The perception of REMS burden may be driven by the experience stakeholders have when interacting with REMS programs, their understanding of REMS program rationale to mitigate serious safety risks, and treatment outcomes. We acknowledge that stakeholder preference will determine how they perform REMS tasks and how they interact with REMS programs. Ultimately, REMS burden on stakeholders is determined by multiple factors in addition to time spent on mandatory REMS tasks. We propose, however, that more education and awareness of available efficient options to complete REMS tasks be provided to REMS stakeholders to facilitate the decrease of REMS burden. Finally, we recommend that prescribers, patients, and pharmacy stakeholders of the Celgene REMS programs consider, if and when possible, utilizing online systems to complete their Celgene REMS transactions to potentially lessen some of the REMS burden by reducing the time it takes to complete these mandatory REMS tasks.