Which statement about ETASU is correct?

• A. REMS is a drug safety program that can be required by the FDA for medications with serious safety concerns.
• B. ETASU is optional and rarely used.
• C. ETASU is a separate program from REMS.
• D. An Element to Assure Safe Use (ETASU) is the most extensive component of a REMS program and involves specific actions that healthcare professionals must execute prior to prescribing, dispensing, or continuing the drug.

Answer: (D)

ETASU, or Element to Assure Safe Use, refers to the part of a REMS that enforces the most stringent safeguards for a drug with serious safety concerns. The FDA can require REMS for such medications, and ETASU are not optional or separate from REMS. They represent the extensive set of requirements that healthcare professionals must carry out before and during prescribing, dispensing, or continuing therapy. These actions can include prescriber training or certification, patient enrollment in the program, restricted dispensing through certain pharmacies, verification of specific lab tests or eligibility criteria, and providing or confirming use of a medication guide. Because ETASU are designed to ensure safe use, they tend to be the most comprehensive and burdensome components of a REMS.