1. The Professional Director shall send a copy of the SPRAVATO REMS Outpatient Healthcare Setting Enrollment Form to the DMH Pharmacy Chief by emailing pharmacy@dmh.lacounty.gov
    

1. Authorized Personnel shall upload the completed form in the client's medical record under Pharmacy/TAR/Labs folder.
    

1. Authorized Personnel shall upload the completed form in the client's medical record under Pharmacy/TAR/Labs folder after each session.
    

1. Verify that client has made arrangements to safely get home by obtaining a verbal confirmation from the client that transportation arrangements have been made other than driving themselves home.
   1. Any client who is unable to make such arrangements shall have their appointment rescheduled. 
   2. The accompanying driver is not required to physically stay at the clinic during the entire treatment session as long as a reachable phone number is provided to Authorized Personnel for emergency and notification for pick-up purposes.
   3. Authorized Personnel shall escort the client out to an awaiting transportation vehicle unless the accompanying driver is present with the client at the end of the treatment session.
2. Verify that client is enrolled in the SPRAVATO REMS program.
3. Verify that client has not eaten food for at least 2 hours and has not consumed liquid for at least 30 minutes prior to administration.
4. Verify that no nasal corticosteroid or nasal decongestant is administered within 1 hour prior to taking SPRAVATO.
5. Provide counseling to the client on the following:
   1. Client is required to enroll in the SPRAVATO REMS program.
   2. The risk of sedation, dissociation, perception disturbances, dizziness, vertigo, and anxiety. Client will need to be monitored by Authorized Personnel until these effects resolve and remain at the clinic until Authorized Personnel decides it is safe for the client to leave but no less than 2 hours.
   3. SPRAVATO may cause side effect changes in vital signs, such as
      1.  Increased blood pressure
         •  Client should notify Authorized Personnel right away if experiencing chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO.
      2. Decrease in oxygen saturation (i.e. a sign of respiratory depression)
   4. Client should look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted.
   5. SPRAVATO is a controlled substance; there is a risk for abuse or physical and psychological dependence.
   6. Client should not drive or use heavy machinery until the next day after a restful sleep post SPRAVATO administration.
   7. Client should inform the physician of any side effects or reactions from SPRAVATO prior to the next visit.
   8. How to self-administer SPRAVATO.
6. SPRAVATO shall be administrated by the client under the direct observation of the Authorized Personnel, and clients are required to be monitored by the Authorized Personnel for at least 2 hours. Authorized Personnel shall complete the SPRAVATO REMS Patient Monitoring Form and submit it online at www.SPRAVATOREMS.com or by fax at 1-877-778-0091 on the same day of treatment following administration of every dose.
7. Authorized Personnel shall notify SPRAVATO REMS in advance if client treatment will be transferred from one REMS-certified Healthcare Setting to another.
8. Authorized Personnel shall document client self-administration in accordance with DMH Policy 352.10. In addition, Authorized Personnel shall follow the attached procedure to monitor and document blood pressure at baseline, 40 minutes after administration, and prior to treatment session completion in the DMH electronic health record system.
    

1. Obtain blood pressure prior to administration of SPRAVATO.
   1. If baseline blood pressure is elevated (e.g. SBP greater than 140 mmHg or DBP greater than 90 mmHg), notify the physician to assess risks versus benefits and consider delaying therapy.
2. .Obtain blood pressure at 40 minutes post-administration
   1. Additional monitoring at a frequency that is clinically warranted. 
3. Obtain blood pressure at the completion of the treatment session.
4. If blood pressure is decreasing and the client appears clinically stable for at least two (2) hours post-administration, the client may be discharged at the end of the post-dose monitoring period if the client is safe to leave; otherwise, continue to monitor.
5. If blood pressure remains high, notify physician.
6. Call 911 if the client is experiencing symptoms of a hypertensive crisis or hypertensive encephalopathy.
7. Document all blood pressure readings in client's medical record under Vitals Entry.
    

1. Obtain oxygen saturation using a continuous pulse oximetry monitor prior to administration of SPRAVATO. 
   1. If oxygen saturation is 92% or below, notify the physician to assess risks versus benefits and consider delaying therapy.
2. Monitor oxygen saturation using a continuous pulse oximetry monitor for a minimum of 2-hours after SPRAVATO administration and longer if clinically indicated. 
   1. If oxygen saturation decreases to 92% or lower, notify the physician to determine if further evaluation and emergency medical assistance is required.
3. Document all oxygen saturation readings in client's medical record under Vitals Entry.
    

1. Authorized Personnel Preparation:
   1. Check expiration date of device.
   2. Do not prime device before use.
   3. Before administering first device, instruct client to blow nose.
   4. Confirm dose and number of devices needed to deliver the prescribed dose. Each nasal spray device delivers a total of 28 mg of esketamine.
      1. Dose 28 mg = 1 device = 2 sprays
      2. Dose 56 mg = 2 devices = 4 sprays
      3. Dose 84 mg = 3 devices = 6 spraysCheck expiration date of device.
   5. Peel blister and remove device from blister package.
   6. Check that the indicator shows two green dots. If not, dispose of device and get a new one.
   7. Hand device to client.
       
2. Client Self-Administration
   1. Preparation and Positioning:
      1. Hold device with the thumb gently supporting the plunger.
      2. Do not press the plunger.
      3. Recline head at about 45 degrees during administration to keep medication inside the nose.
   2. Administration:
      1. Insert tip straight into the first nostril with nose rest touching the skin between the nostrils.
      2. Close opposite nostril.
      3. Breathe in through nose while pushing plunger all the way up until it stops.
      4. Sniff gently after spraying to keep medication inside nose.
      5. Switch hands to insert tip into the second nostril.
         • Repeat steps under administration to deliver second spray.
3. Authorized Personnel Confirmation
   1. Take device from client.
   2. Check indicator shows no green dots. If you see a green dot, have client spray again into the second nostril.
   3. Check indicator again to confirm device is empty.
   4. Instruct client to rest in a comfortable position (preferably semi-reclined) for five (5) minutes after each device. If liquid drips out, dab nose with a tissue. Do not blow nose.
       
4. Administer Next Device (if applicable):
   1. Repeat Steps 1-3 until the full prescribed dose is delivered.
   2. Ensure client waits five (5) minutes after each device to allow medication to absorb.

 Storage, Disposal, and Returns

1. Storage
   1. SPRAVATO device(s) shall be stored in accordance with DMH Medication Storage Policy 352.14. 
2. Disposal
   1. Used devices shall be disposed of as medical waste in a pharmaceutical waste container. 
3. Returns
   1. Partially used devices or unused devices shall be disposed of through the SPRAVATO Disposal Program:
      1. Reasons for Return include, but are not limited to
         • Unused devices stored at the clinic beyond 45 days of receipt from dispensing pharmacy,
         • ​​​​​​​Unused devices due to client discontinuation of treatment,
         • Unused devices due to prescriber discontinuation of treatment,
         • Client received one (1) spray and then it was decided not to continue with treatment by either the patient or healthcare provider, or
         • Incorrect dosage kit ordered  
      2. Refer to attachment "SPRAVATO (Esketamine) Returns Job Aid" for detailed instructions on processing Returns
   2. Expired devices shall be returned to the dispensing pharmacy. 
   3. Malfunctioning devices shall be reported to Janssen Medical by calling 1-800-726-5536 to report a product quality complaint. Arrange product replacement with the client’s insurer to ensure the client does not miss a scheduled dose, if possible.