What is a primary characteristic of medications included in REMS programs?

Medications included in Risk Evaluation and Mitigation Strategies (REMS) programs are primarily characterized by their high risk compared to their benefits. REMS is a safety strategy mandated by the FDA to manage known or potential serious risks associated with a medication. It aims to ensure that the benefits of the drug outweigh its risks, which is critical for protecting patients and ensuring safe use.

The high-risk nature of these medications often stems from their potential side effects or the specific populations in which they can be used. For instance, certain medications may pose a risk of severe adverse effects, leading to the need for additional monitoring or special requirements to be fulfilled before a patient can receive the drug. This is contrasted with typical medications, where the benefits significantly outweigh the risks without additional safeguards.

In contrast, the other options do not accurately capture the primary characteristic of REMS medications. While limited distribution can be a requirement for some REMS drugs, it is not universal to all medications within these programs. Similarly, cost is not a defining factor of REMS drugs, nor is the requirement of physician approval for all patients typically mandated. Instead, the focus remains on the balance of risk and benefit, which is the essence of the REMS framework.