Spravato Patient Monitoring Operating instructions

Brand: Spravato

Model: Patient Monitoring

Type: Operating instructions

Spravato Patient Monitoring provides comprehensive monitoring of vital signs, sedation, and dissociation during and after SPRAVATO® treatments. It enables healthcare professionals to make informed decisions about patient readiness for discharge, contributing to enhanced patient safety and adherence to REMS program requirements.

www.SPRAVATOrems.com Fax: 1-877-778-0091

Phone: 1-855-382-6022

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

Page1of2

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

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

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

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

Unknown

DateofEvent

(MM/DD/YYYY)

JanssenPharmaceuticals,Inc.,SafetyDepartmentmayfollowuptoobtainmoreinformationabouttheseevents.

Page2of2

SPRAVATO® REMS

Patient Monitoring Form - Outpatient Use Only

* Indicates Required Field

Male Female

Other

Spravato Patient Monitoring Operating instructions

Spravato Patient Monitoring Operating instructions

Spravato Patient Monitoring Operating instructions

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