Spravato Patient Monitoring Form Instructions

: June 5, 2024
: Spravato

Table of Contents

Spravato Patient Monitoring Form
INSTRUCTIONS
Patient Monitoring Form Outpatient Use Only
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Spravato Patient Monitoring Form

Spravato Patient Monitoring Form PRODUCT

INSTRUCTIONS

This form is intended only for use by outpatient medical offices or clinics, excluding emergency departments.

Complete all required fields on this form after every treatment session for all outpatients enrolled in the SPRAVATO REMS.
Submit completed patient monitoring forms within 7 days, online at www.SPRAVATOrems.com or by fax (1-877-778-0091).

Patient Information (PRINT)

First Name:| MI:| Last Name:| Birthdate (MM/DD/YYYY):| Sex

Male Female

Other

Concomitant Medication|
Is the patient currently taking any of the following medication(s) that may cause sedation or blood pressure changes?

Benzodiazepines: Yes OR No

Non-benzodiazepine sedative hypnotics: Yes OR No

Psychostimulants: Yes OR No

Monoamine oxidase inhibitors (MAOIs) :Yes OR No

Healthcare Provider Conducting Patient Monitoring (PRINT)
First Name| Last Name
Telephone| Email
Healthcare Setting Information (PRINT)
Healthcare Setting Name
Healthcare Setting Address 1| Healthcare Setting Address 2:
City*:| State| ZIP
Patient Treatment Session Information (Administration and Monitoring)
Treatment Date| Date (MM/DD/YYYY):
Dose Administered| 56 mg 84 mg Other: | Lot Number: __
__

Treatment Duration

| Total time __minutes (from 1st device administration to completion of monitoring)

Patient must be monitored for at least 2 hours

__

REMS Evaluation Question

| If there was not a 2-hour minimum monitoring requirement, when would this patient have been ready to leave/no longer require monitoring? minutes from start of administration
** **

Monitoring of Vital Signs

| Vital signs were in acceptable range prior to:

administration? Yes OR No

treatment session completion? Yes OR No

__

Monitoring of Blood Pressure

| Prior to administration

__**/ __** mmHg

| 40 mins post-administration

__**/ __** mmHg

| Prior to treatment session completion

__**/ __** mmHg

Did the patient experience Sedation and/or Dissociation
Sedation : Yes No| Dissociation : Yes No
Onset of symptoms from start of administration

1-29 mins 30-59 mins 60-89 mins 90-120 mins >120 mins

| Onset of symptoms from start of administration*

1-29 mins 30-59 mins 60-89 mins 90-120 mins >120 mins

Resolution of symptoms within 2 hours?
- Yes
- N

Specify total time to resolution: __ minutes

| Resolution of symptoms within 2 hours?

Yes
No

Specify total time to resolution: __ minutes

Medications given for sedation?

Yes
No
If YES, name and dose of medications: __

| Medications given for dissociation?

Yes
No
If YES, name and dose of medication __

Patient Monitoring Form Outpatient Use Only

Patient Information (PRINT)

Hospitalization
Disability or permanent damage
Death
Life-threatening
Important medical event defined as any event that may jeopardize the patient or may require intervention to prevent one of the above outcomes

All non-serious adverse events or product quality complaints that are should be reported toJanssen at 1-800-JANSSEN 1-800-526-7736 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Did the patient experience a serious adverse event?| Yes| __| No If YES, describe below| | |
Event resulted in the following

check all that apply

| Event Timing| Event Description

Please list one event per row

| Event Resolution
__

Hospitalization

Disability or permanent damage Death

Life-threatening Important Medical Event

| __

During treatment sessions

Between treatment sessions

| __

__