The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO by:
Ensuring that SPRAVATO is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients
Ensuring pharmacies and healthcare settings that dispense SPRAVATO are certified
Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and need for monitoring
Enrolling all patients who receive treatment in an outpatient healthcare setting in a registry to further characterize the risks and support safe use
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
Healthcare settings that dispense Spravato for outpatient use must:
To become certified to dispense
Have a prescriber onsite during spravato administration and monitoring.
Have a healthcare provider(s) onsite to monitor patients.
Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the healthcare setting.
Have the authorized representative review the Spravato prescribing information and REMS Program Overview.
| REMS Program Overview |
Have the authorized respresentative enroll in the REMS Program by completing the Outpatient Healthcare Setting Enrollment Form and submitting it to the REMS Program.
| Outpatient Healthcare Setting Enrollment Form |
Establish processes and procedures to enroll the patient in the REMS Program.
Establish processes and procedures to counsel the patient on the need for enrollment, monitoring, and risks of sedation and dissociation, and changes in vital signs.
Establish processes and procedures to verify the patient is enrolled in the REMS Program before each administration and that Spravato is not dispensed for use outside the certified healthcare setting.
Establish processes and procedures to complete and submit the Patient Monitoring Form after each administration within 7 calendar days.
| Patient Monitoring Form |
Train all relevant staff involved in prescribing, dispensing, and administering Spravato on 1) Counseling the patient on the need for monitoring and risks of sedation and dissociation, and changes in vital signs; 2) Patient administration under the supervision of a healthcare provider; and 3) Monitoring for resolution of sedation and dissociation and changes in vital signs for a minimum of 2 hours.
Establish processes and procedures to identify all staff involved in prescribing, dispensing, and administering Spravato and ensure they are trained on 1) Counseling the patient on the need for monitoring and risks of sedation and dissociation, and changes in vital signs; 2) Patient administration under the supervision of a healthcare provider; 3) Monitoring for resolution of sedation and dissociation and changes in vital signs for a minimum of 2 hours.
Before treatment initiation (first dose)
Counsel the patient on the risks and need for monitoring for resolution of sedation and dissociation and changes in vital signs.
Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS Program.
| Pharmacy Enrollment Form |
Before administering
Counsel the patient on the need for monitoring for resolution of sedation and dissociation, and changes in vital signs.
Verify the patient is enrolled in the REMS Program through the processes and procedures establishes as a requirement of the REMS Program.
During and after administering, for at least 2 hours
Assess the patient for administration of Spravato and resolution of sedation and dissociation, and changes in vital signs.
After administering, within 7 calendar days
Document and submit to the REMS Program using the Patient Monitoring Form.
| Patient Monitoring Form |
To maintain certification to dispense
Have any new authorized representative enroll in the REMS Program by completing the Outpatient Healthcare Setting Enrollment Form.
| Outpatient Healthcare Setting Enrollment Form |
At all times
Not dispense Spravato for use outside the certified healthcare setting.
Not distribute, transfer, loan, or sell Spravato.
Maintain records documenting staff's completion of training.
Maintain records that all processes and procedures are in place and are being followed.
Maintain records of all shipments of Spravato received and dispensing information including patient name, dose, number of devices, and date administered.
Comply with audits carried out by Janssen Pharmaceuticals, Inc. or a third party acting on behalf of Janssen Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.
Healthcare settings that dispense Spravato for inpatient use (including emergency departments within certified healthcare settings) must:
To become certified to dispense
Have a prescriber onsite during Spravato administration and monitoring.
Have a healthcare provider(s) onsite to monitor patients.
Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the healthcare setting.
Have the authorized representative review the Spravato prescribing information and REMS Program Overview.
| REMS Program Overview |
Have the authorized representative enroll in the REMS Program by completing and submitting the Inpatient Healthcare Setting Enrollment Form.
| Inpatient Healthcare Setting Enrollment Form |
Establish processes and procedures to counsel the patient on the need for monitoring and risks of sedation and dissociation, and changes in vital signs.
Establish processes and procedures to verify Spravato is not dispensed for use outside the certified healthcare setting.
Train all relevant staff involved in prescribing, dispensing, and administering Spravato on 1) Counseling the patient on the need for monitoring, risks of sedation and dissociation, changes in vital signs, and the need to have arrangements to safely leave the healthcare setting and not engage in potentially hazardous activities; 2) Patient administration under the supervision of a healthcare provider; and 3) Monitoring for resolution of sedation and dissociation and changes in vital signs for a minimum of 2 hours.
Before administering
Counsel the patient on the need for monitoring for resolution of sedation and dissociation, and changes in vital signs and the need to have arrangements to safely leave the healthcare setting and not engage in potentially hazardous activities
During and after administering, for at least 2 hours
Assess the patient for administration of Spravato and resolution of sedation and dissociation, and changes in vital signs.
To maintain certification to dispense
Have any new authorized representative enroll in the REMS Program by completing the Inpatient Healthcare Setting Enrollment Form.
| Inpatient Healthcare Setting Enrollment Form |
At all times
Not dispense Spravato for use outside the certified healthcare setting.
Not distribute, transfer, loan, or sell Spravato.
Maintain records documenting staff's completion of training.
Maintain records that all processes and procedures are in place and are being followed.
Maintain records of all shipments of Spravato received and dispensing information including patient name, dose, number of devices, and date administered.
Comply with audits carried out by Janssen Pharmaceuticals, Inc. or a third party acting on behalf of Janssen Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.
Patients who are prescribed Spravato:
Before treatment initiation (first dose)
Receive counseling from a healthcare provider on risks and the need for monitoring for resolution of sedation and dissociation, and changes in vital signs.
For outpatients: Enroll in the REMS Program by completing the Patient Enrollment Form with a healthcare provider. Enrollment information will be provided to the REMS Program.
| Patient Enrollment Form |
During treatment, before each dose
Receive counseling from a healthcare provider on the need for monitoring for resolution of sedation and dissociation; and changes in vital signs.
During treatment, during and after administration for at least 2 hours
Be monitored for taking Spravato, resolution of sedation and dissociation, and changes in vital signs at the healthcare setting.
Pharmacies that dispense Spravato must:
To become certified to dispense
Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
| Pharmacy Enrollment Form |
Establish processes and procedures to verify that a healthcare setting is certified in the REMS Program before dispensing Spravato.
Train all relevant staff involved in dispensing that Spravato must only be dispensed to a certified healthcare setting.
Before dispensing
Verify that the healthcare setting is certified through the processes and procedures established as a requirement of the REMS Program.
At all times
Not distribute, transfer, loan, or sell Spravato except to certified dispensers.
Not dispense Spravato for use outside a certified healthcare setting.
Maintain records documenting staff's completion of training.
Maintain records that all processes and procedures are in place and are being followed.
Maintain records of all shipments of Spravato received and dispensing information including patient name, dose, number of devices, and date dispensed.
Comply with audits carried out by Janssen Pharmaceuticals, Inc. or third party acting on behalf of Janssen Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.
Wholesalers-distributors that distribute Spravato must:
To be able to distribute
Establish processes and procedures to ensure that Spravato is distributed only to certified healthcare settings and certified pharmacies.
Train all relevant staff involved in distributing on the REMS Program requirements.
At all times
Distribute only to certified healthcare settings and certified pharmacies.
Maintain and submit records of all shipments of Spravato.
Comply with audits carried out by Janssen Pharmaceuticals, Inc. or a third party acting on behalf of Janssen Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.
What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Spravato REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
01/03/2022
Modified to reflect changes to the Spravato REMS Patient Monitoring Form, including revisions to the format of some of the data-capturing fields and the addition of a field to capture the lot number field of Spravato.
07/31/2020
Modified to change the requirements for the certified healthcare setting based on inpatient or outpatient setting in the REMS document; aligning the patient enrollment form, REMS website, and REMS Program Overview with these requirements; and replacing the single healthcare setting enrollment form with setting specific enrollment forms.
06/25/2019
Modified to amend some of the data-capturing fields in the Healthcare Setting Enrollment Form, Pharmacy Enrollment Form, and Patient Monitoring Form.
03/05/2019
Approval of the REMS.
Disclaimer: This webpage provides general information about REMS programs
to various REMS participants (e.g., patients, pharmacies, and healthcare providers).
The summary information provided herein is not comprehensive and may not include
all of the information relevant to REMS participants. This webpage does not
constitute a replacement, modification, or revision of the approved REMS document,
including any appended REMS materials. Refer to the approved REMS document
for complete information on the REMS requirements for each approved application.
