What is the main purpose of a REMS program?

The main purpose of a Risk Evaluation and Mitigation Strategy (REMS) program is to assure the safe use of specific drugs that have significant risks associated with their use. REMS programs are mandated by the FDA and are designed to manage the risks of certain medications to ensure that their benefits outweigh their risks. This often involves implementing specific requirements such as patient monitoring, restricted distribution, healthcare provider training, and providing patient education.

By having a REMS in place, healthcare professionals can better identify and mitigate potential risks, ensuring that patients are using these high-risk medications safely and effectively. This targeted approach to risk management plays a crucial role in protecting patient safety while allowing access to necessary therapies that might otherwise be deemed too risky without stringent controls.