Implementation of a safety program initiative for monitoring infusion disease modifying therapies for multiple sclerosis.

Abstract

Objective: To determine the efficacy of a safety program designed for monitoring infusion disease-modifying therapies (DMTs) prescribed for multiple sclerosis (MS).

Background: Infusion-based high-efficacy DMTs represent a major advance in the treatment of MS. However, safe administration requires close monitoring. Non-adherence to safety monitoring can lead to DMT-related complications.

Methods: A safety nurse navigator reviewed charts for infusion DMT patients from November 2020 to December 2022, and contacted them to address incomplete safety monitoring. Patients were screened for the primary outcome of incomplete safe infusion, including outdated safety labs, imaging, and/or recent follow-up with their neurologist. Logistic regression was performed for predictors of incomplete safety monitoring and of successful safety intervention.

Results: Three hundred and forty-three patients were on infusible DMTs over the study time period: 75 natalizumab, 31 rituximab, and 237 ocrelizumab. Two hundred and eighty-six (83%) patients did not meet the criteria for safe infusion; 64% lacked safety labs, 47% prescriber follow-up, and 26% an MRI. The nurse succeeded in 82% of interactions. B-cell depletion was linked to outdated lab monitoring, whereas natalizumab use was associated with outdated appointments and imaging.

Conclusions: This safety initiative identified gaps for managing infusion-based MS DMTs. Our safety nurse navigator successfully identified incomplete safety monitoring and intervened to avoid drug-related complications.