Certified-Setting Enrollment
Placeholder: site and patient must be REMS-verified first.
- Required: REMS program (placeholder note)
- Pharmacy+clinic: Certified sites (placeholder note)
- Mandatory: Patient enrollment (placeholder note)
- Not permitted: Self-use (placeholder note)
Enrollment verification
Placeholder: prescriber, pharmacy, and patient checked against REMS registry.
Self-Administered Nasal Spray
Placeholder: patient self-doses while staff directly observes.
- Intranasal: Route (placeholder note)
- Self, observed: Administration (placeholder note)
- 1–2: Devices per session (placeholder note)
- Prohibited: Take-home (placeholder note)
Observed dosing procedure
Placeholder: device technique confirmed and dose time logged.
2-Hour On-Site Observation
Placeholder: patient stays under observation for two hours.
- 120 min: Monitoring length (placeholder note)
- ~30 min: Check interval (placeholder note)
- 20–40 min: Peak effect window (placeholder note)
- Not allowed: Early exit (placeholder note)
Observation timeline
Placeholder: clock tracks elapsed minutes against required window.
Blood Pressure and Dissociation Checks
Placeholder: vitals and dissociation symptoms scored at intervals.
- Multiple: BP check points (placeholder note)
- >15 mmHg: Elevated BP flag (placeholder note)
- >30 mmHg: Hold threshold (placeholder note)
- CADSS-based: Dissociation scale (placeholder note)
Vital sign safety gating
Placeholder: elevated BP or dissociation delays progression.
Placeholder: sustained BP elevation triggers clinical hold.
Discharge Criteria Confirmation
Placeholder: clinician confirms readiness before discharge.
- Full checklist: Discharge gate (placeholder note)
- Near baseline: BP requirement (placeholder note)
- Resolved: Dissociation requirement (placeholder note)
- Required: Escort home (placeholder note)
Final safety sign-off
Placeholder: all checklist items must clear before release.