What is a primary purpose of the REMS program?

The primary purpose of the Risk Evaluation and Mitigation Strategy (REMS) program is to ensure the safe use of medications that come with significant risks. The REMS is a federally mandated strategy that drug manufacturers must develop and implement for certain high-risk medications to mitigate the risks associated with their use. This program may involve special requirements such as patient registration, healthcare provider education, or limited distribution to ensure that medications are prescribed and used appropriately, ultimately protecting patients from potential adverse effects.

Medications that fall under the REMS program typically have risks that require additional safety measures beyond standard prescribing information. This includes drugs with a high potential for serious side effects or those associated with severe health risks, making the REMS program critical in promoting safety in medication use. The goal is not only to facilitate the availability of these medications but to do so in a manner that safeguards patients' health, addressing the dangers they may pose if not monitored or managed properly.