Spravato® compliance,
in plain terms.
Guides to the REMS program and the treatment day, written for the people who run the floor. There's a clear note wherever something is a judgment call for your prescriber or counsel.
Looking for the software rather than the background? See what Lucido does for a Spravato® clinic day.
Certification, enrollment, the monitored session, and the Patient Monitoring Form — the four obligations the program puts on a clinic.
When the clock starts (anchor it to the first device), the blood-pressure re-check at the 40-minute peak, and what must be true before the patient leaves.
Seven calendar days, holidays included, and the duty sits with the clinic, not the clinician who ran the room. Where the week goes, and how clinics keep the deadline.
The four things a review asks for, the five places clinics come up short, and a ten-session drill you can run this week to find out where you actually stand.
Carton-level records from delivery to waste, lot numbers that match the monitoring form, controlled-substance recordkeeping, and reconciliation against the doses actually given — and why the spreadsheet stops being enough.
What a month-end reconciliation covers, who should sign it, the device a 56 mg dose leaves behind, and the two DEA forms around it: Form 41 for destructions and Form 106 for a theft or loss.
From certification to first session: enrollment, the monitoring space, staffing the day, and deciding early how session records are captured, which sets how hard your Patient Monitoring Forms will be to produce.
These guides are general operational information, not legal, clinical, or regulatory advice — always defer to the current official SPRAVATO® REMS program materials and your own counsel. Lucido is an independent product and is not affiliated with, sponsored by, or endorsed by Janssen Pharmaceuticals.
Try it at your own clinic.
Sign up and set your clinic up yourself, no sales call needed, or request demo access and a 20-minute live walkthrough with the founder.