What is the main purpose of Risk Evaluation and Mitigation Strategies (REMS)?

The primary purpose of Risk Evaluation and Mitigation Strategies (REMS) is to ensure that the benefits of a medication outweigh its risks. REMS is a safety program mandated by the FDA for certain medications that have significant risks associated with their use. These strategies are designed to manage and mitigate these risks to ensure patients can receive the drugs safely while also confirming that the potential therapeutic benefits of the medication justify those risks.

REMS can include requirements such as medication guides, communication plans, and restricted distribution methods. By implementing these strategies, healthcare providers are better equipped to inform patients about the risks involved, monitor their use more effectively, and ultimately support safer prescribing and dispensing practices.

The other options, while related to medication management, do not encapsulate the core purpose of REMS. For instance, while improving access to medications and setting standards for packaging can be noteworthy goals, they do not directly address the critical balance of risk and benefit that REMS aims to maintain in drug therapies. Monitoring prescription medication sales is also not a function of REMS; rather, it focuses on managing risks to ensure patient safety.