CSP REMS Programs and Risk Mitigation Strategies 1

Question 1

What does REMS stand for in the context of the FDA?

Accepted Answer

Risk Evaluation and Mitigation Strategy

Answer

REMS stands for Risk Evaluation and Mitigation Strategy, which are FDA-required programs to ensure certain drugs with serious safety risks are used appropriately.

Question 2

Under which federal law did the FDA gain formal authority to require REMS programs?

Accepted Answer

Food and Drug Administration Amendments Act (FDAAA) of 2007

Answer

The FDAAA of 2007 granted the FDA explicit statutory authority to require REMS when necessary to ensure benefits of a drug outweigh its risks.

Question 3

Which of the following is a required component of ALL REMS programs?

Accepted Answer

Timetable for submission of REMS assessments

Answer

A timetable for submission of REMS assessments to the FDA is required in every REMS program; all other elements are optional and included only when needed.

Question 4

What are ETASU in the context of REMS programs?

Accepted Answer

Elements to Assure Safe Use

Answer

ETASU (Elements to Assure Safe Use) are the most restrictive REMS components that can include requirements such as prescriber certification, pharmacy certification, and patient monitoring.

Question 5

Which specialty pharmacy action is required when a REMS program with ETASU mandates pharmacist certification?

Accepted Answer

The pharmacy must enroll in the REMS program before dispensing the medication

Answer

When ETASU require pharmacy certification, the specialty pharmacy must formally enroll in the specific REMS program before it is authorized to dispense that medication.

CSP - Certified Specialty Pharmacist Practice Test

CSP - Certified Specialty Pharmacist Practice Test

CSP REMS Programs and Risk Mitigation Strategies 1