SPRAVATO (esketamine) is not a medication you simply add to your formulary. It is administered only within the SPRAVATO REMS — a Risk Evaluation and Mitigation Strategy program — and only in healthcare settings certified in that program.
When I established SPRAVATO services in my own practice, the clinical learning curve was the easy part. The work was operational: building a setting, a schedule, and a documentation flow that could satisfy the program every single session. The practices that launch smoothly are the ones that get ready before they apply.
What the REMS requires of your setting
- Your healthcare setting must be certified in the REMS; SPRAVATO is never dispensed for patients to take home.
- Patients self-administer the nasal spray in your office, under the direct observation of a healthcare provider.
- Every patient is monitored for at least two hours after administration, with blood pressure assessed before dosing and during the observation period.
- Patients must be enrolled in the REMS registry, and every administration is documented.
- Product is sourced through REMS-certified pharmacy channels — not ordinary wholesale ordering.
Program details can change, so verify the current requirements at spravatorems.com before you build around them.
The readiness checklist most practices skip
Space. A dedicated, calm monitoring room — patients stay with you for two hours or more, often in recliners, and the room has to work for observation.
Staffing. Coverage for the entire monitoring window, every session, with a prescriber available for assessment. Two-hour observation blocks are where thin staffing plans break.
Scheduling. Session blocks built around the treatment cadence — twice weekly in the early phase, then weekly to every two weeks in maintenance.
Documentation. EHR flowsheets for vitals, observation checks, and registry reporting, built before the first patient — not after.
Policies. Written criteria for patient selection, post-treatment driving restrictions (patients cannot drive until the following day), and escalation procedures.
Where launches stall
Three places, in my experience: certifying the setting before the room and schedule actually exist; assuming existing staff can absorb two-hour monitoring on top of their current work; and treating documentation as paperwork to catch up on later. Every one of those is a sequencing error, and sequencing is fixable.
SPRAVATO can be an important option for adults with treatment-resistant depression. Getting it running is a build — setting certification, space, staffing, sourcing, and documentation in the right order. That build is exactly what I now help other practice owners plan and execute.
Planning a SPRAVATO program? See how our TMS & SPRAVATO Startup & Implementation Consulting works or book a TMS & SPRAVATO Strategy Call.
Educational business information only—not medical, legal or financial advice. Review clinical, privacy, communications and financial decisions with appropriately qualified professionals.