Spravato Policies and Procedures

Indication

Spravato has a dual indication for Treatment Resistant Depression (TRD), and Depressive Symptoms in Adults with Major Depressive Disorder with Suicidal (MDSI) Thoughts or Actions.

Updated (2025):

As of January 2025, SPRAVATO® (esketamine) is FDA-approved for the treatment of treatment-resistant depression (TRD) in adults either as monotherapy or in conjunction with an oral antidepressant.

SPRAVATO® is still indicated in combination with an oral antidepressant for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Monotherapy is not approved for this indication at this time.

In plain terms this means that a patient is no longer required to be on an oral anti-depressant while being treated with Spravato for TRD. They must still meet all other criteria.

References

• FDA Label (2025)
• FDA Approval Letter (sNDA)
• J&J Press Release

---

Qualification and Contraindications to Spravato treatment

---

Treatment Phases

• Induction (4 weeks)
  The induction phase of treatment lasts 4 weeks during which time patients receive twice weekly Spravato treatment and observation in our Tulsa Spravato REMS certified treatment center.
• Maintenance phase (weeks 5-9)
  Patients are treated once weekly
• Maintenance phase (Beyond week 9)
  Patients will decide with their treating provider what frequency will work best for them.

  The dosing interval may be extended to the longest duration at which the patient maintains symptom relief.

The Spravato Treatment Guide is sent to patients via Charm prior to their first treatment. The guide covers what to expect during their first month of treatment.

Spravato Treatment Guide

---

Spravato Patients

The vast majority of Spravato patients will be via internal referral by their primary Tulsa Family Psychiatry & Wellness provider. We also receive external referrals to manage Spravato treatment for patients.

External referrals, TFAM is responsible only for Spravato, unless psychiatric care is formally transferred.

---

Pre-treatment

Counseling

Prior to a patient beginning Spravato treatment, their primary TFAM provider will counsel the patient on the need for enrollment, monitoring, risks of sedation and dissociation, and changes in vital signs.

Spravato REMS Enrollment

Each patient must be enrolled in the Spravato REMS program prior to receiving treatment with Spravato. https://spravatoremsenroll.com/

After submission of the enrollment, the REMS ID will be placed in the “Red Sticky” in the chart. If a patient does NOT have a REMS ID, treatment can not take place.

Verification of REMS Enrollment

Patient enrollment must be verified by logging into https://spravatoremsenroll.com/
You will be able to verify enrollment by referencing the “REMS Status” column. A status of “Enrolled” verifies the patient has completed enrollment.

If a patient’s REMS Status does not say “Enrolled”, treatment can not take place.

Personal Device Usage During Treatment

Advise patients to use caution when selecting auditory-visual input via smart phone or other personal electronic device during the treatment period due to an altered state of mind.

Transportation

Patients can not drive themselves after Spravato and will need to have a ride.
This is covered more comprehensively in the Treatment Procedures section below.

---

Medication Preparation & Handling

This section outlines the standardized process for preparing Spravato treatments and materials based on appointment timing. Proper handling and organization are essential for safety, compliance, and patient experience.

Normal Business Hours (8:00 AM – 4:30 PM)

• Spravato medication will be pulled per patient at the start of the day.

• Individual patient charts will be prepared and organized for the day’s scheduled treatments.

• Medication will be placed on the silver tray inside the medication closet and will only be removed once the specific patient has arrived.

  After-Hours Treatment Appointments (5:30 PM – 7:30 PM)

  • Patient charts will be fully prepared during normal business hours in advance.

  • Medication and patient clipboard will be stored in the medication closet and placed on the silver tray for easy retrieval at time of treatment.

  • Blanket preparation:

    • Patients with assigned blankets will have theirs placed inside the bench labeled with their initials.

    • Patients who are new, seen PRN, or do not have an assigned blanket will be provided with a clean blanket.

  • Following treatment, each patient will have their own labeled blanket and storage bag for future sessions—regardless of whether they are seen during normal or after-hours appointments.

---

Treatment Procedures

Check-in

1. Patients will enter the lobby and a medical assistant or other staff member will greet them and show them to their office.
2. If this is the first treatment, a valid photo ID must be presented to verify identity. This should match the photo ID in the EMR.
3. Patient will be presented with a PHQ-9 or QIDS-SR to complete
4. APRN/PA-C/MA/ or Nurse will ask how the patient is doing over all and document this briefly
5. Verify Spravato REMS enrollment – DO NOT proceed with treatment if patient is not enrolled.
6. Vital signs will be checked at this time

• If BP exceeds 140/90, treatment cannot proceed
  • If clinically indicated, patient can be given 0.1 mg of Clonidine – this decision must be made by a licensed clinical staff member.
  • If baseline blood pressure is > 160/100, give Clonidine 0.1 mg PO and recheck in 30 mins
• If blood pressure is < or = 140/90, treatment can be initiated

Spravato Self-administration

1. A tissue will be provided to the patient to blow their nose before self-administration.
2. The patient will be seated at this time for the administration. The patients head must be at a 45-degree angle for administration.
3. The MA/nurse will remove the device from the packaging ensuring that both indicator lights are green.
4. The device is given to the patient. The index and middle finger are placed on the finger supports, while the thumb is supporting the plunger.
5. The patient will insert the tip into the first nostril. The nose rest should touch the skin in between nostrils at this time.
6. The patient will close the opposite nostril and breathe in through the nose while pushing the plunger all the way up until it stops. The patient will continue to sniff gently after spraying to keep medications inside the nose.
7. The start time needs to be documented to ensure proper timing in between devices.
8. Patient will rest in a comfortable position (Preferably semi-reclined) for 5 minutes after each device.54mg dose- 1^st  device administered WAIT 5 MINUTES 2^nd device administered.84mg dose 1^st device administered WAIT 5 MINUTES 2^nd device administered WAIT 5 MINUTES, 3^rd device administered start timer for 40 min vitals check
9. Check that the indicator light shows no green dots. If you see a green dot, have the patient spray again into the second nostril.
10. If liquid drips out, dab with tissue, instruct patient to pinch nose closed and lean forward, or instruct patient to recline slightly to help keep the medication from dripping. Instruct patient not to blow their nose after Spravato has been administered.

---

Encounter Documentation

Spravato encounter template

Use the EMR template titled “(TF) Spravato Tx_Practice” for each treatment session.

Depression Screening and Running Record

PHQ-9
QIDS-SR

Flow Sheets

Each depression screening score will be recorded via the appropriate flow sheet (PHQ-9, or QIDS-SR).

---

Observation and Discharge

• The patient will need to be monitored by a healthcare professional throughout their treatment. The patient must have their BP taken at 40 minutes post the start time and prior to the end of the observation period (approx. 10 mins before end time). If the BP increases beyond the acceptable range inform the DO/MD/APRN/PA-C immediately.
• The patient will remain under the supervision of a health care professional for at least two hours from the start time after the administration of Spravato.
• If the patient experience nausea or vomiting they may be treated with 8mg Zofran ODT. Emesis bags will be provided in the treatment room if a patient may need. Alternately, each treatment station has a lined trashcan that can be utilized.
• Sedation has been reported with the administration of If the patient displays a decreased level of consciousness, or low respiratory rate notify the physician or mid-level provider on site immediately.
• Dissociation is common with the administration of Spravato. If a patient is experiencing a hallucination or dissociation the healthcare provider will ensure that patient remains seated and reassured that they are in a safe
• The patient is eligible to leave the office after being monitored for 2  hours. The patient vitals and mental status must be back to baseline before discharge. The patient will be provided with additional time if needed.
• The patient must have a driver for them to be discharged. (see Post-Treatment Transportation below for more details)
• The patient monitoring form must be completed and submitted online through Spravato REMS at the end of each day.

Post-Treatment Transportation

Patients are not able to drive after Spravato treatment. They are informed of this prior to their first treatment. They will also need to have signed the “(TF) – Spravato Initial Treatment” questionnaire in Charm which covers this information as well as “(TF) – Spravato Post Treatment Transport.”

_TF__-_Spravato_Initial_Treatment_Questionnaire

_Spravato_Post_Treatment_Transport_Questionnaire

• • Ride share (Uber/Lyft, etc.) may be used.
  • If using ride share → please show the receptionist, the confirmation before leaving.
  • If using a family member or friend → they must come inside the clinic to verify they are your ride.

---

Follow up with primary provider

All patients receiving Spravato at TFAM—whether managed internally or referred by an external psychiatric provider—must maintain regular face-to-face follow-up visits with the provider overseeing their overall psychiatric care. These follow-ups are separate from Spravato administration visits and are essential for safe, coordinated care.

Follow up Summary Table

Time Point	Required Action	Provider Type
✅ 1 Month Post-Induction	Face-to-face visit with psychiatric provider	Internal (TFAM) or External Psychiatrist
✅ End of Month 2	Face-to-face visit with psychiatric provider	Internal or External
✅ End of Month 3	Face-to-face visit with psychiatric provider	Internal or External
🔄 Ongoing (Month 4 and beyond)	Continued follow-up at least once every 6 months Adjust frequency based on clinical status	At provider discretion, but never >6 months

Communication with External Providers

For patients receiving Spravato treatment at TFAM whose primary psychiatric care is managed externally, a treatment progress report must be sent to the referring provider at least once every 3 months.

Patient_Treatment_Progress

Scheduling Spravato Treatments

The recommendation is to keep Spravato appointments at least 10-15 mins apart if working as the sole MA/nurse. This allows time to get their PHQ-9 or QIDS screener completed, initial pre-treatment vitals, and dosing interval times.

Induction Phase Scheduling  – Covered in individual training sessions.

Maintenance Phase Scheduling – Covered in individual training sessions.

Patient Transfers

If a patient is transferring care to an alternate REMS-certified Treatment center,  we must notify REMS and the receiving facility. REMS can be reached at 855.382.6022.

Spravato Acquisition, Receiving, Storage, Logs

Spravato Acquisition

Pharmacy Stock

Buy and Bill Stock

Receiving & Storage

• Verification: Check medication packaging for integrity and confirm the expiration date upon receipt.
• Proper Storage: Store according to manufacturer guidelines: 2°C–8°C (36°F–46°F), protected from light.
• Inventory Control: Maintain a secure inventory log to track doses received, administered, and remaining stock.
• Access: Spravato will be stored in the medication closet. Only authorized personnel are allowed to retrieve and store the medication.

Logging Protocol

Change of Authorized Representative

In the event that the authorized representative changes, a new SPRAVATO_REMS_Outpatient_Healthcare_Setting_Enrollment_Form will be completed and submitted via fax to 877-778-0091.

Staff Training

Refer to “Spravato Training Log.pdf”