Distribution and administration of SPRAVATO®
SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy). A REMS program is in place to ensure the safety of all patients treated with SPRAVATO®. The Rochester Center for Behavioral Medicine’s SPRAVATO® Program operates underneath the REMS program for service implementation at our office.
The goals of the REMS are to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO® administration and abuse and misuse of SPRAVATO® by ensuring SPRAVATO® is only dispensed and administered to patients in medically supervised healthcare settings that monitor these patients, ensuring pharmacies and healthcare settings that dispense SPRAVATO® are REMS certified, ensuring patients are informed about serious adverse outcomes from dissociation and sedation and the need for monitoring, and enrolling all patients who receive treatment in an outpatient healthcare setting in a REMS registry to characterize the risks further and support safe use.
