Outpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to prescribe product.
SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, due to risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO. SPRAVATO® is intended for use only in a certified Healthcare Setting.
Outpatient Healthcare Settings are required to enroll patients prior to patient treatment and submit Patient Monitoring Forms after each patient treatment to the SPRAVATO® REMS.
Outpatient Healthcare Setting Enrollment is intended only for outpatient medical offices and clinics.
Emergency departments within hospitals are certified through the Inpatient Healthcare Setting enrollment.