💉 Esketamine Nasal Spray (Spravato) REMS Simulator

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.