REMS Counsel Patient

**Semantic type:** Activity

**Definition:** In the context of REMS, the healthcare provider or setting must counsel the patient. The REMS may require that the counseling cover a specific topic, that the counseling use a specific REMS material (such as a Patient-Prescriber Agreement Form or Medication Guide), or both.

**Synonyms:** - Counsel Patient - Risk Evaluation and Mitigation Strategies Counsel Patient