SPRAVATO® REMS Patient Enrollment Form

Important Information:

Before submitting this form, please complete the New Patient Form so our office can properly evaluate your request. After completing the New Patient Form, return to this page to finish the final step.

Click HERE to open the New Patient Form in a new window.

 

Patient's Name
Patient's Birthdate
Patient's Address

Patient Agreement

 

By signing this form, I understand and acknowledge that:

•Before my treatment begins, I will:

• Receive counseling from a healthcare provider on:
• The risk of sedation, dissociation, and respiratory depression.
• The need for monitoring for resolution of sedation, dissociation, respiratory depression, and other changes in vital signs.
• The need to have arrangements to safely leave the healthcare setting and not engage in potentially hazardous activities.

• For outpatients: Enroll in the REMS by completing the Patient Enrollment Form with a healthcare provider. Enrollment information will be provided to the REMS.

During treatment, before each dose, I will:

• Receive counseling from a healthcare provider on the requirement for monitoring for resolution of sedation, dissociation, and respiratory depression, and other changes in vital signs, and the need to have arrangements to safely leave the healthcare setting and not engage in potentially hazardous activities.
During treatment, during and after administration for at least two hours, I will:
• Be monitored for taking SPRAVATO®, resolution of sedation, dissociation, respiratory depression, and other changes in vital signs at the
healthcare setting.

I understand:

• I understand that my protected health information will be stored in a secure and confidential database and shared for the management of the
REMS.
• I understand that Janssen Pharmaceuticals, Inc. and its agents may contact me or my prescriber via phone, mail, fax, or email to support
administration of the REMS.
• I give permission to Janssen Pharmaceuticals, Inc. and its agents to use and share my personal health information for the purposes of enrolling
me into the REMS and administering the REMS, coordinating the dispensing of SPRAVATO, and releasing my personal health information to the Food and Drug Administration (FDA) as necessary.

 

 

If the patient is under 18 years of age, a parent or legal guardian is required to agree and sign the electronic form
Patient or Parent/Guardian Date of Birth
Today's Date
AGREE
By selecting the “I AGREE” button, I am signing this document electronically. I agree that my electronic signature is the legal equivalent of my manual/handwritten signature on this document. By selecting “I agree” using any device, means, or action, I consent to the legally binding terms and conditions of this document. I further agree that my signature on this document is as valid as if I signed the document in writing. I am also confirming that I am authorized to enter into this Agreement. If I am signing this document on behalf of a minor, I represent and warrant that I am the minor’s parent or legal guardian. I may decline to electronically sign this document and withdraw my consent to sign this document electronically by contacting the signature requestor directly, which may delay transactions. I may contact the signature requestor separately to request to sign this document on paper or to receive a paper copy of the signed document. Any fees for such paper copy will be charged then by the signature requestor. When I sign the document, I will receive a copy of this document via email.