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Patient Monitoring

Spravato Patient Monitoring Operating instructions

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www.SPRAVATOrems.com Fax: 1-877-778-0091
Phone: 1-855-382-6022
© Janssen Pharmaceuticals, Inc. 11/2021
For Healthcare Setting Use Place
Patient Label or Barcode Here
SPRAVATO® REMS
Patient Monitoring Form - Outpatient Use Only
INSTRUCTIONS:
This form is intended only for use by outpatient medical oces or clinics, excluding emergency departments.
1. Completeallrequiredeldsonthisformaftereverytreatmentsessionforall outpatientsenrolledintheSPRAVATO®REMS.
2. 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*:
Concomitant Medication
Isthepatientcurrentlytakinganyofthefollowingmedication(s)thatmaycausesedationorbloodpressurechanges?
•Benzodiazepines* Yes No
•Non-benzodiazepinesedativehypnotics* Yes No
•Psychostimulants* Yes No
•Monoamineoxidaseinhibitors(MAOIs)* Yes 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 No
• treatmentsessioncompletion? Yes No
Monitoring of Blood Pressure* Prior to administration
/ mmHg
40 mins post-administration
/ mmHg
Prior to treatment session completion
/ mmHg
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Male Female
Other
* Indicates Required Field
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 No
Specifytotaltimetoresolution*:____________minutes
Resolution of symptomswithin2hours?* Yes No
Specifytotaltimetoresolution*:____________minutes
Medication(s) given for sedation?* Yes No
•IfYES,nameanddoseofmedication(s):
Medication(s) given for dissociation?* Yes No
•IfYES,nameanddoseofmedication(s):
www.SPRAVATOrems.com Fax: 1-877-778-0091
Phone: 1-855-382-6022
© Janssen Pharmaceuticals, Inc. 11/2021
For Healthcare Setting Use Place
Patient Label or Barcode Here
Patient Information (PRINT)
FirstName*:
MI:
LastName*: Birthdate*(MM/DD/YYYY): Sex*:
Healthcare Provider Conducting Patient Monitoring (PRINT)
FirstName*: LastName*:
Phone*: Email:
TreatmentDate(MM/DD/YYYY):
Serious Adverse Events (PRINT)
A serious adverse event (SAE) for this SPRAVATO® REMS is dened as any event that results in/is:
• Hospitalization
• Disability or permanent damage
• Death
• Life-threatening
• Important medical event
– dened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 not dened above, should be reported to:
Janssen 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 Yes
No
Unknown
DateofEvent
(MM/DD/YYYY)
Hospitalization
Disabilityorpermanentdamage
Death
Life-threatening
ImportantMedicalEvent
Duringtreatmentsessions
Betweentreatment
sessions
Yes
No
Unknown
DateofEvent
(MM/DD/YYYY)
Hospitalization
Disabilityorpermanentdamage
Death
Life-threatening
ImportantMedicalEvent
Duringtreatmentsessions
Betweentreatment
sessions Yes
No
Unknown
DateofEvent
(MM/DD/YYYY)
JanssenPharmaceuticals,Inc.,SafetyDepartmentmayfollowuptoobtainmoreinformationabouttheseevents.
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SPRAVATO® REMS
Patient Monitoring Form - Outpatient Use Only
* Indicates Required Field
Male Female
Other
/