Spravato (esketamine) is only available through a federal safety program, the SPRAVATO REMS (Risk Evaluation and Mitigation Strategy). Every dose is given in a certified healthcare setting, under supervision, followed by monitoring.1 If you’re a psychiatrist, nurse practitioner or practice leader thinking about offering it, this is what certification involves and what running the program day to day takes.
The official forms, training and login are all on the SPRAVATO REMS website. Requirements change from time to time, so treat that site as the final word on the current versions.
The certification steps
- Choose an authorized representative. Each healthcare setting designates one person who is accountable for the setting’s compliance with the program.2
- Enroll the setting in the SPRAVATO REMS. Outpatient and inpatient settings enroll separately, through the REMS website.
- Train the relevant staff, and keep the records. Training covers the risks the program exists to manage: sedation, dissociation, respiratory depression, and abuse and misuse. Training records are checked in audits.2
- Equip the monitoring space. Patients are monitored for at least two hours after every dose, with blood pressure checks, and the setting must have a pulse oximeter to monitor patients onsite.13
- Set up supply. Spravato reaches certified settings only through certified pharmacies or contracted distributors, and the setting keeps records of every shipment received and every dose given. It is never sent home with a patient.2
- Enroll each patient, and document each session. Outpatients are enrolled in the program, and a Patient Monitoring Form is completed for treatment sessions and submitted to the REMS.2
Certified settings are audited, and a setting that doesn’t follow the requirements can be suspended or de-certified.2
What running a program actually takes
Getting certified is the easy part. What decides whether a Spravato program helps patients, and stays viable, is operations:
- Chair time. Every session takes a little over two hours, and new patients come twice a week for the first month.1 That’s a lot of room and staff time per patient.
- Clinical coverage. Someone qualified watches every patient for the full monitoring period, and responds to blood pressure rises, sedation or distress.
- Insurance. Prior authorizations, renewals and appeals are constant. A program that can’t get approvals quickly loses patients before their first dose.
- Transport. Patients can’t drive until the next day, so every visit needs a ride home. Some patients drop out over this alone.
