Healthcare Settings Type*
All REMS-certified Inpatient and Outpatient Healthcare Settings must have a healthcare provider counsel patients on the safety risk of SPRAVATO® and monitor patients post-dose.
Inpatient Healthcare Settings
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Covers inpatient units, inpatient pharmacy, and emergency departments
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Before prescribing SPRAVATO® treatment, complete and submit the Inpatient Healthcare Setting Enrollment Form
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Before starting SPRAVATO® treatment, inpatient settings are not required to enroll the patient in the SPRAVATO® REMS
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During SPRAVATO® treatment, inpatient settings do not require the Patient Monitoring Form. Report all suspected adverse events to the SPRAVATO® REMS
Outpatient Healthcare Settings
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Covers outpatient medical offices and clinics
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Before prescribing SPRAVATO® treatment, complete and submit the Outpatient Healthcare Setting Enrollment Form
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Before starting SPRAVATO® treatment, enroll the patient by completing and submitting the Patient Enrollment Form to the SPRAVATO® REMS
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During SPRAVATO® treatment, submit the Patient Monitoring Form and report all suspected adverse events to the SPRAVATO® REMS
*To get started, find more information on how to certify as a healthcare setting and/or pharmacy, and to view all REMS requirements and attestations by type of REMS stakeholder, visit www.SPRAVATOrems.com or call 1-855-382-6022 (Monday – Friday, 8 AM to 8 PM ET).
Reference:
1.SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.