What a REMS is

Question

A pharmacy technician sees that a newly stocked medication is listed as 'subject to a REMS.' Which description of a REMS is accurate?

1. AA safety program FDA can require for some drugs that carry serious risks, adding safe-use steps beyond the labeling✓ Correct

   Correct. A REMS is an FDA-required drug safety program for a small number of drugs whose serious risks need more than labeling.

2. BA DEA process for placing a drug into a controlled substance schedule✗ Incorrect

   Incorrect. Scheduling under the Controlled Substances Act is separate from FDA REMS programs.

3. CA voluntary action by a manufacturer to remove a defective lot from the market✗ Incorrect

   Incorrect. That describes a recall.

4. DA state database that collects information on dispensed controlled substance prescriptions✗ Incorrect

   Incorrect. That describes a state prescription monitoring program.

Answer

A. A safety program FDA can require for some drugs that carry serious risks, adding safe-use steps beyond the labeling

Rationale

A REMS is an FDA safety program, required for certain drugs when labeling alone is not enough to make sure a drug’s benefits outweigh a specific serious risk. A REMS can include a Medication Guide, a communication plan for prescribers, and elements to assure safe use such as certified pharmacies or required lab results. Only a few drugs need one, and it targets a particular serious risk, not every side effect.