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

The primary purpose of the Risk Evaluation and Mitigation Strategies (REMS) program is to ensure the safe use of medications. REMS is a regulatory initiative created by the FDA to address specific safety concerns associated with certain medications. By implementing risk management strategies, REMS aims to provide necessary information about the risks and benefits of a drug, thus promoting informed prescribing and safe medication use among patients.

REMS may include requirements such as communication plans, elements to assure safe use (ETASU), and patient monitoring to mitigate risks while still allowing patients to access these essential medications. By focusing on the safe use of potentially dangerous drugs, REMS plays a crucial role in preventing adverse effects and ensuring that healthcare providers and patients understand how to use them safely.

While reducing medication errors and enhancing patient compliance are important aspects of medication management, they are not the primary focuses of the REMS program. The intent is more specifically centered around managing risks associated with certain high-risk medications to protect patients and ensure they are used appropriately.