Free Practice Quiz Question List

7 REMS and Restricted Drug Programs Online Quiz Questions

Use this free practice quiz with 20 questions to review 7 REMS and Restricted Drug Programs, test your knowledge, and prepare for your next test or exam.

20 questions

True or false

1 point

True or false: Every REMS restricts who may receive or be dispensed a drug.

A
True
B
False

Choose one

1 point

Which statement best distinguishes a REMS from a drug’s DEA controlled-substance schedule?

A
A REMS is the DEA schedule assigned to a controlled substance.
B
A REMS is an FDA-required safety program that is distinct from a drug’s DEA schedule.
C
A REMS applies to every prescription drug, while DEA schedules apply only to pharmacies.
D
A REMS and a DEA schedule are two names for the same safety requirement.

Fill in the blank

1 point

REMS requirements are to a medication’s safety risks.

Choose all

1 point

Which of the following may be Elements to Assure Safe Use (ETASU) in a REMS? Select all that apply.

A
Certification of prescribers or pharmacies
B
Assignment of a DEA controlled-substance schedule
C
Dispensing only in specified settings
D
Required testing, monitoring, or patient enrollment

Choose one

1 point

During a REMS check, staff cannot verify a condition the program requires before dispensing. What should the pharmacy do?

A
Dispense if the prescription appears otherwise valid.
B
Use a prior authorization as a substitute for checking the condition.
C
Pause dispensing and resolve the issue through the REMS program and prescriber.
D
Ask the patient to confirm the condition instead of checking program requirements.

Written response

1 point

In the example, what test requirement must the pharmacy confirm before dispensing?

True or false

1 point

True or false: Once a pharmacy is certified for a REMS, individual staff training or enrollment can never be required.

A
True
B
False

Choose one

1 point

A pharmacy receives a prescription for a medication it has dispensed before. What is the safest first step for determining whether REMS requirements apply?

A
Assume no REMS applies because the medication is familiar.
B
Identify the applicable REMS and check its current drug-specific requirements.
C
Use the process from the most recently dispensed REMS medication.
D
Check only the drug’s DEA schedule before proceeding.

Choose all

1 point

Which tasks may be assigned to a patient under a restricted REMS? Select all that apply.

A
Enroll or acknowledge program materials if required.
B
Follow treatment and monitoring instructions.
C
Operate the program’s enrollment system or authorization service.
D
Complete required tests or follow-up.

Written response

1 point

Which participant may operate a REMS enrollment system or authorization service?

Fill in the blank

1 point

If information is missing or inconsistent, contact the prescriber’s office and, when needed, the .

Open ended

1 point

A pharmacy has received a REMS dispensing authorization, but staff discover that information about another required safe-use condition is missing or inconsistent. Explain what the pharmacy should verify and do before dispensing.

Written response

1 point

A REMS requires measures such as prescriber certification, patient enrollment, and required testing. What acronym names this category of measures?

Choose one

1 point

A pharmacy knows a medication’s DEA controlled-substance schedule but has not checked its REMS status. Which conclusion is justified?

A
The medication’s schedule determines whether it has a REMS.
B
Controlled-substance scheduling and REMS are distinct; one does not establish whether the other applies.
C
Every medication with a REMS is also a controlled substance.
D
A medication cannot be subject to both a REMS and controlled-substance scheduling.

Choose one

1 point

A REMS administrator runs an enrollment system and communicates program requirements. Which participant responsibility does this illustrate?

A
Assess the patient and order required tests.
B
Verify the prescription and provide required counseling.
C
Operate program tools such as enrollment systems or authorization services.
D
Follow treatment and monitoring instructions.

Choose one

1 point

A pharmacy is certified for a drug’s REMS, but staff training status is unclear. What should the pharmacy do before dispensing?

A
The pharmacy’s certification automatically satisfies every staff requirement.
B
Individual staff must be enrolled for every REMS, whether or not the program requires it.
C
Prior experience dispensing the drug replaces any required training.
D
Check the specific program to determine whether the setting and individual staff have required certifications, training, or enrollment.

Choose one

1 point

A familiar medication has been dispensed at the pharmacy before. A new prescription arrives, but staff have not confirmed the current REMS requirements. What is the best first step?

A
Use the process followed for the last prescription.
B
Identify the drug and formulation, then consult the current REMS requirements.
C
Dispense first and check the REMS only if a problem arises.
D
Assume the drug has no REMS requirements because it is familiar.

True or false

1 point

Once a pharmacy has obtained a REMS authorization, that authorization proves every later requirement for the prescription has been met.

A
True
B
False

Written response

1 point

During a required REMS check, the pharmacy cannot verify a condition that must be met before dispensing. What should staff do with dispensing?

Choose one

1 point

A pharmacy is deciding how to document its checks for a specific REMS. Which approach best supports compliance?

A
Follow the REMS recordkeeping instructions and applicable requirements; do not substitute an informal note for a required form or system entry.
B
Keep only a general note that the prescription was reviewed.
C
Record authorization results but omit other checks because they are not part of the REMS.
D
Use whichever record format is easiest, even if the REMS specifies a different one.