CLINICAL CERTIFICATION EXAMINATION:
ESKETAMINE (SPRAVATO) THERAPY & REMS PROTOCOLS
200 Comprehensive Board-Style Questions with Detailed Clinical
Rationales for Treatment-Resistant Depression
Target Patient Case Context: A 34-year-old patient with treatment-
resistant major depressive disorder (TRD) being evaluated for
esketamine (Spravato) nasal spray therapy.
Domain 1: REMS Program Requirements, Certified Settings, and
Monitoring Protocols
Question 1: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
, symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
Question 2: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
Question 3: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
, C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
Question 4: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
, Question 5: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
Question 6: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
ESKETAMINE (SPRAVATO) THERAPY & REMS PROTOCOLS
200 Comprehensive Board-Style Questions with Detailed Clinical
Rationales for Treatment-Resistant Depression
Target Patient Case Context: A 34-year-old patient with treatment-
resistant major depressive disorder (TRD) being evaluated for
esketamine (Spravato) nasal spray therapy.
Domain 1: REMS Program Requirements, Certified Settings, and
Monitoring Protocols
Question 1: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
, symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
Question 2: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
Question 3: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
, C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
Question 4: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
, Question 5: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
D) Continuous electrocardiographic (ECG) telemetry is mandatory
for all patients during the post-dose period.
Correct Answer: A
Rationale: Under the FDA-mandated Spravato REMS program,
patients must be monitored by a healthcare provider in a certified
clinical setting for a minimum of 2 hours following each
administration, assessing blood pressure, sedation, and dissociative
symptoms until the patient is deemed clinically stable by the provider
prior to discharge.
Question 6: Which of the following is a mandatory regulatory
requirement under the Spravato Risk Evaluation and Mitigation
Strategy (REMS) program regarding patient monitoring
immediately following administration?
A) Patients must be monitored by a healthcare provider for at least 2
hours until clinical stability is confirmed.
B) Patients may self-monitor in the waiting room for 30 minutes
before immediate discharge.
C) Blood pressure must be checked every 60 minutes throughout an
8-hour observation window.
