REMS safe-use requirements

Question

Which requirements might a pharmacy technician encounter in a medication-specific REMS? Select all that apply.

1. ACertification of a dispenser✓ Correct

   Some programs require dispenser certification.

2. BDocumentation of a safe-use condition before dispensing✓ Correct

   Some programs require documentation before the drug is dispensed.

3. CIdentical requirements for every medication✗ Incorrect

   Each program is tailored to its medication and risks.

4. DAutomatic removal of the medication from the market✗ Incorrect

   REMS activities address a medication’s safety concerns; a recall is a different process.

5. EElimination of all program activities before dispensing✗ Incorrect

   Some activities must occur before dispensing.

Answer

A. Certification of a dispenser · B. Documentation of a safe-use condition before dispensing

Rationale

A REMS can require certification or documentation of a safe-use condition. Requirements vary with the medication, so the technician should use the applicable program instructions.