What does the iPLEDGE program specifically relate to?

The iPLEDGE program is a mandated risk management program specifically related to isotretinoin, a medication used for the treatment of severe acne. Isotretinoin has a high risk of causing severe birth defects if taken during pregnancy, which is why the program was established. It requires healthcare providers, pharmacies, and patients to follow strict protocols to ensure that women of childbearing age do not get pregnant while on the medication.

Under iPLEDGE, patients must be enrolled and meet specific criteria, including using effective contraception and undergoing regular pregnancy testing before and during treatment. This helps to minimize the risks associated with the drug and ensures that all parties involved understand their responsibilities in preventing potential harmful outcomes.

Thus, the focus on stringent controls makes this program crucial for ensuring patient safety with isotretinoin use. Other options, like those pertaining to generic drug approval, mental health support, or opioid prescription tracking, do not accurately reflect the purpose or scope of the iPLEDGE program.