As of July 2016, how many REMS incorporate ETASU?

• A. About 10
• B. About 60
• C. About 43
• D. About 80

Answer: (C)

REMS are FDA-required programs designed to manage known or potential serious safety risks of certain medicines after they reach the market. ETASU, or Elements to Assure Safe Use, are the specific requirements that go beyond standard labeling to ensure a drug is used safely. These can include restricted distribution to certified entities, mandatory prescriber or patient enrollment in a registry, required education for prescribers or patients, and monitored or restricted dispensing settings.

Not every REMS includes ETASU; some REMS use only risk communication or other non-ETASU components. As of July 2016, roughly forty-three REMS incorporated ETASU.