Which medication classification requires risk evaluation and mitigation strategies (REMS)?

The classification that requires risk evaluation and mitigation strategies (REMS) primarily includes certain high-risk medications, often Schedule II substances. REMS programs are specifically designed for medications that have serious safety concerns in order to help ensure that the benefits of the medication outweigh the risks. These medications can pose significant risks if not used properly, which is why regulatory authorities, such as the FDA, mandate these strategies.

REMS may involve medication guides, communication plans for healthcare providers, and monitoring requirements, among other measures designed to enhance patient safety. High-risk medications may include potent opioids, certain antipsychotics, and medications that can cause severe adverse reactions. In contrast, over-the-counter medications typically do not require such stringent safety measures, as they are generally considered safe for use without a prescription. Additionally, while all prescription medications have specific safety considerations, only those with a higher potential for serious risks necessitate REMS. Non-steroidal anti-inflammatory drugs (NSAIDs), while they can have safety concerns, do not generally require REMS unless associated with specific scenarios or adverse effects. Thus, the focus on high-risk medications aligns with the need for careful management and monitoring to ensure patient safety.