Spravato REMS: First-Time Patient Enrollment Guide

Last updated: April 13, 2026

What is REMS?

The Spravato (esketamine) Risk Evaluation and Mitigation Strategy (REMS) is an FDA-required safety program. Every patient must be enrolled before their first treatment — and every treatment must occur at a REMS-certified healthcare setting.

Prerequisites (Before You Start)

Make sure these are already in place:

  • Practice is REMS-certified (Healthcare Setting enrollment complete)

  • Prescribing provider is REMS-certified (Healthcare Provider enrollment complete)

  • The patient has a valid Spravato prescription

Step-by-Step: Enrolling a New Patient

Step 1 — Access the REMS Portal Go to www.SpravatoREMS.com and log in with your certified provider credentials.

Step 2 — Navigate to Patient Enrollment Select "Enroll a Patient" from the dashboard.

Step 3 — Enter Patient Demographics You'll need:

  • Full legal name

  • Date of birth

  • Gender

  • Address and phone number

Step 4 — Verify Patient Eligibility Criteria The system will prompt you to confirm the patient:

  • Has been assessed for suicidal ideation/behavior

  • Does not have active psychosis, unstable cardiovascular disease, or other contraindications

  • Has a support person available post-treatment (for transportation home)

Step 5 — Patient Attestation / Informed Consent

  • Patient reviews and signs the Patient Enrollment Form (paper or e-signature depending on your workflow)

  • The form covers: risks of dissociation, sedation, abuse potential, and the observation requirement

  • Keep a copy in the patient's chart

Step 6 — Submit Enrollment Submit through the portal. You'll receive a Patient Enrollment ID — document this in the patient's chart and in your EHR (O360).

Step 7 — Link the Treatment Session Each treatment administration must also be logged in REMS. After enrollment, you'll log every session confirming:

  • Date and time of administration

  • Patient remained on-site for the required 2-hour monitoring period

  • Patient was not allowed to drive themselves home

Observation & Monitoring Requirements (Every Visit)

Requirement

Detail

Minimum monitoring window

2 hours post-administration

Who monitors

Clinical staff must be present throughout

Driving restriction

Patient cannot drive on treatment day

Where treatment occurs

Must be in the REMS-certified setting only

Common First-Time Pitfalls

  • Enrolling too late — enrollment must happen before the first dose, not same-day without planning

  • Missing the support person — patient needs a confirmed ride home before treatment begins

  • Forgetting to log the session — enrollment ≠ session logging; both are required

  • Prescriber not yet certified — double-check provider certification status before scheduling

Quick Reference Contacts

  • Spravato REMS Support Line: 1-855-382-6220

  • Portal: SpravatoPREMS.com

  • Janssen CarePath (patient assistance): 1-844-4JNSPRV