What does REMS stand for and in what context is it used?

REMS stands for Risk Evaluation and Mitigation Strategies. This term is used in the context of drugs that carry significant risks of serious adverse events. The Food and Drug Administration (FDA) requires that certain medications have a REMS program in place to help ensure the benefits of the medication outweigh its risks. This program is designed to inform and manage the risks associated with specific medications while promoting their proper usage.

For drugs that fall under a REMS program, healthcare providers, patients, and pharmacies may need to fulfill specific requirements such as safety monitoring, patient education, and reporting adverse events to ensure safe use. REMS is an important part of the regulatory framework aimed at protecting public health by mitigating risks associated with powerful medications or therapies.

The other options do not accurately reflect the definition or purpose of REMS; hence they do not convey the critical role that REMS plays in managing the safety of certain high-risk medications.