Elements to assure safe use (ETASU) in a REMS

Question

Which requirements can FDA impose as elements to assure safe use in a REMS? Select all that apply.

1. APharmacies must be specially certified before they can dispense the drug✓ Correct

   Correct. Requiring pharmacies to be certified is one ETASU option.

2. BThe drug may be dispensed only in specific settings, such as hospitals or infusion centers✓ Correct

   Correct. Restricting the settings where a drug is dispensed is an ETASU option.

3. CThe drug is dispensed only with documented safe-use conditions, such as a required lab result✓ Correct

   Correct. Dispensing can be tied to evidence of safe-use conditions like lab tests.

4. DEach patient who receives the drug is enrolled in a registry✓ Correct

   Correct. Patient registry enrollment is an ETASU option.

5. EThe drug must be ordered from the wholesaler on a DEA Form 222✗ Incorrect

   Incorrect. Form 222 is a DEA ordering rule for schedule I and II drugs, not a REMS element.

6. FThe buyer's name and address must be written in a logbook at the time of sale✗ Incorrect

   Incorrect. Purchase logbooks belong to the federal pseudoephedrine sales rules, not to REMS.

Answer

A. Pharmacies must be specially certified before they can dispense the drug · B. The drug may be dispensed only in specific settings, such as hospitals or infusion centers · C. The drug is dispensed only with documented safe-use conditions, such as a required lab result · D. Each patient who receives the drug is enrolled in a registry

Rationale

A REMS may include one or more elements to assure safe use. These can include certification of prescribers or pharmacies, limits on dispensing settings, evidence of safe-use conditions, patient monitoring or registries. DEA Form 222 and pseudoephedrine sales logbooks are addressed under separate federal requirements.