Establish Processes and Procedures to Notify

**Semantic type:** Activity

**Definition:** In the context of REMS, the healthcare provider or setting must establish a system to notify a REMS participant about safe use concerns or safe use conditions required by the REMS. For purposes of this definition, "safe use condition" refers to any activity that must be completed before the drug is dispensed (e.g., communicate information about the patient's disposition, adverse events, reminders about safe use conditions).