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 pulse oximetry (i.e. respiratory depression)
         • Client will be monitored for respiratory depression using pulse oximetry for at least 2 hours after receiving SPRAVATO. 
   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.
    

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.

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. Returns and Disposal
   1. Used devices shall be disposed of as medical waste in a pharmaceutical waste container. 
   2. Partially used devices shall be disposed of through the SPRAVATO Disposal Program (see H3).
   3. Unused devices stored at the clinic beyond 14 days of receipt from dispensing pharmacy shall be disposed of through the SPRAVATO Disposal Program. 
   4. Unused devices due to discontinuation of treatment shall be disposed of through the SPRAVATO Disposal Program. 
   5. Expired devices shall be returned to the dispensing pharmacy. 
   6. 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. 
3. SPRAVATO Disposal Program
   1. Registration (if new user) 
      1. Go to the INMAR Healthcare Returns Management (HRM) Portal: https://hrm.reskureturns.com/landing  
      2. Click “Register”. 
      3. Complete all required fields in User Registration Form.  
         • Registration Type: “I plan to use the Manufacturing Return Authorization application for managing returns to an INMAR affiliated manufacturing client.” 
         • User Category: “Clinics or Physicians” 
   2. Complete the Unused SPRAVATO Return Form 
      1. Access the form at https://www.jnjmedicalconnect.com/media/attestation/documents/7/spravato-unused-spravato-returns-form.pdf 
      2. One form may be used for multiple devices if the Reason for Return is the same (e.g., exceeded 14 days since receipt, discontinued by patient, discontinued by prescriber). 
      3. If returning devices for different reasons, complete a separate form for each return type. 
      4. Assign a “Return Form Number” using the following format: request date (MMDDYY) + your initials + form sequence number (e.g., 010125AA1, 010125AA2). 
      5. Save the completed form as a PDF named: SPRAVATO Returns Form - Return Form Number (e.g., SPRAVATO Returns Form - 010125AA1) 
         • Upload the PDF to:
           • INMAR HRM Portal 
           • DMH Pharmacy SPRAVATO Returns Microsoft Form 
      6. Print one copy of the completed form to include inside the return package.  
   3. Create Return in INMAR HRM Portal 
      1. Go to the INMAR HRM Portal: https://hrm.reskureturns.com/landing 
      2. Click “Login” 
      3. Log in using your registered email address. Your name should appear in the upper-right corner of the homepage. 
      4. Click the “Returns Authorization” tab, then select “Create Manufacturer Return.” 
         • Create a separate Returns Authorization (RA) for each completed Unused SPRAVATO Return Form. 
         • Verify displayed information (e.g., Return Type, Address, DEA Number, Business Name), then click “Submit”.  
         • Enter the following details: 
           • Debit Memo Number: Use the “Return Form Number” on the completed Unused SPRAVATO Returns Form (e.g., 010125AA1). 
           • Debit Memo Date: Today’s date (MM/DD/YYYY). 
           • Quantity on Hand: Number of devices being returned. 
           • Claimed Amount: $0.00. 
           • Number of RA Labels Needed: Enter the number of labels required. If the devices listed on the same return form will be shipped in multiple boxes, enter one label per box.
           • RA contains controlled substances: “Yes” 
           • Return Reasons: Select appropriate return reason 
           • Special Returns Programs: “Non-Applicable” 
           • Label options 
             • Enter your DMH email 
             • “Include Shipping Label” 
               • Deselect to use FedEx courier service (prints only the RA label without the standard UPS shipping label, leaving a blank space for the FedEx shipping label). Note: DMH currently uses FedEx for all scheduled pick-ups. 
               • Select to use UPS courier service (prints the RA label with a pre-paid UPS shipping label). Only use if the package can be handed off during a routine UPS delivery or pick-up can be arranged with UPS. 
             • Select “Display Labels”  
         • Click “Next to Satisfy Additional Requirements.” 
         • Verify the displayed information is correct 
         • “Upload Debit Memo or Reference Document”: attach the saved Unused SPRAVATO Returns Form PDF. 
         • Click “Next”, then “Submit / Print Box Labels and Search for New Client”  
   4. Packaging and Shipping the Return 
      1. RA labels will appear in a new pop-up window. If no pop-up appears, check email entered under Label Options. 
         • In the upper right-hand corner of the RA label, you’ll find the INMAR warehouse code assigned to your clinic, followed by the Unused SPRAVATO Returns Form number linked to your RA.  
      2. Print RA Label   
         • DO NOT print multiple copies of this RA or make copies on a copier. Each RA is unique and has a # under the barcode/box code that must correspond to a single shipment box. 
         • If using FedEx courier service, the RA label will print without the standard UPS label (Figure 1)  
           
           Figure 1. 
            
         • If using UPS courier service, the RA label will print with the standard UPS label (Figure 2) 
           
           Figure 2. 
           
           

Remove all patient information before returning device(s) 

Package the product according to the following guidelines (Figure 3).  

• For unused devices, discard the outside carton and return only the blister-pack devices. 
  
  Figure 3.  

Enclose one printed copy of the Unused SPRAVATO Returns Form inside the return package. 

Package Labeling  

• Ensure the Unused SPRAVATO Returns Form number printed on the RA label matches the number on the return form enclosed in the package. 

• If using FedEx courier service 

  • Trim the blank white space underneath the AR Label to fit the packaging, ensuring all RA label information remains visible (Figure 4).
    
    Figure 4. 
    
    

  • Attach the RA Label to the outside of return package. 
  • Email pharmacy@dmh.lacounty.gov to become an authorized user on the DMH FedEx account (if new user). 
  • Create FedEx shipping label and arrange pick-up. Include the following details: 
    • Ship From Contact Details 
      1. Contact Name: [Your Name] 
      2. Company Name: LACDMH – [DMH Clinic Name] 
      3. Phone Number: [Your Phone Number] 
      4. Email: [Your email address] 
    • Ship From Address 
      1. Country/Territory: United States 
      2. Address: [DMH Clinic Address]
      3. Zip Code: [DMH Clinic Zip Code]
      4. State: CA
      5. City: [DMH Clinic City] 
    • Deliver to Contact Details  
      1. Contact Name: INMAR RX SLNS, INC 
      2. Company: INMAR RX SLNS, INC
      3. Phone Number: 1-800-967-5952 
    • Deliver to Address 
      1. Country/Territory: United States 
      2. Address: 3845 Grand Lakes Way, Suite125
      3. City: Grand Prairie
      4. State: Texas 
    • Package Details 
      1. Packaging: “Your Packaging” 
      2. Packages: [# of packages with same return type]
      3. Weight: [estimated total, including devices] 
      4. Dimensions: [LxWxH (inches)] 
    • Service 
      1. FedEx Ground 
    • Service Options 
      1. Signature options: Adult signature required 
    • Pick-up/drop-off 
      1. Pickup date 
      2. Earliest Possible Time (7:00AM – 2:00PM in 30-min intervals) 
      3. Latest Possible Time (1:00PM – 9:00PM in 30-min intervals) 
      4. Pick-up Instructions: Add specific on-site directions (e.g., who to ask for upon arrival) 
    • Notifications 
      1. Select Add Shipment Notifications 
      2. Shipper email address: add your email to receive updates 
      3. Select desired notification types 
  • Download and print FedEx shipping label. 
  • Attach FedEx shipping label to the return package, ensuring it does not cover the RA label (see example in Figure 5). 
    
    Figure 5. 
    
    
  • Hand off the package to the FedEx driver during scheduled pick-up.
     
• If using UPS courier service 
  • Attach the RA label and the UPS shipping label to the return package so that both remain visible (Figure 6). 
    
    Figure 6. 
    
    

  • Hand off the package to the UPS driver during routine delivery or scheduled pick-up.