Table 1.

Elements to Ensure Safe Use

A REMS program to ensure safe use incorporates one or more of the following elements:

Health care providers who prescribe the drug have specialized training or experience or are certified in a specific field. Pharmacies, practitioners, or health care settings that dispense the drug are certified in a specific field. The drug is dispensed to patients only in certain health care settings (e.g., hospitals). The drug is dispensed to patients with evidence or other documentation of safe-use conditions (e.g., laboratory results). Patients are subjected to certain monitoring requirements. Patients are enrolled in a registry.

Data from FDA Amendments Act of 2007.²