What is the purpose of REMS in medication management?

The primary purpose of Risk Evaluation and Mitigation Strategies (REMS) in medication management is to ensure both the safety and efficacy of certain medications that have been identified as presenting specific risks. REMS is a formal program required by the FDA to manage the potential risks associated with a drug while maintaining its therapeutic benefits.

By implementing REMS, healthcare providers and patients receive the necessary information to make informed decisions about the use of high-risk medications. This may involve requirements such as specific patient monitoring, restrictions on who can prescribe the medication, and guidelines for patient education. These strategies aim to mitigate risks such as severe side effects, while still allowing patients access to important therapies.

In contrast, enhancing drug marketing is not a function of REMS; it focuses instead on safety. Simplifying packaging does not address the complexities involved with high-risk medications, and while improving access to medications is a goal in healthcare, REMS is more concerned with careful management and risk communication regarding specific drugs rather than access.