REMS requires that a drug must be dispensed with one of the following. Which is a valid REMS dispensing requirement?

• A. Medication Guide or Package Insert
• B. Communication Plan to Healthcare Providers
• C. Elements to Assure Safe Use
• D. Each Patient Enrolled in Registry

Answer: (A)

REMS dispensing requirements are about what must accompany the drug at the point of sale to help ensure safe use. The patient-focused document that is routinely provided with the drug is the Medication Guide, which explains risks, warnings, and how to use the medication safely. In some cases, the package labeling (the Package Insert) can also serve as the required document to accompany the drug. Because the question asks for what must be dispensed with the drug, Medication Guide or Package Insert is the appropriate choice.

The other items are REMS components that relate to education for providers, program safeguards, or monitoring (such as a plan to communicate with clinicians, the specific safety-use elements, or enrolling patients in a registry), but they are not the documents typically handed to patients with the drug at dispensing.