A prescription for isotretinoin must be filled at a pharmacy that uses which program?

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The correct answer is C, iPLEDGE. iPLEDGE is a risk management program mandated by the FDA specifically for isotretinoin, which is a powerful medication used to treat severe acne. This program is designed to prevent fetal exposure to the drug due to its high teratogenic potential.

Pharmacies must be registered with the iPLEDGE program to dispense isotretinoin, and they must ensure that patients meet certain eligibility criteria, including participation in the program to receive necessary counseling on the risks and prevention of pregnancy. It enforces strict controls, such as requiring patients to use two forms of contraception and to undergo pregnancy testing during their treatment.

Other programs mentioned, such as Step therapy, are typically used to try lower-cost treatments before moving on to more expensive medications but are not specifically related to isotretinoin. The FDA Adverse Event Reporting System (FAERS) and MedWatch are both surveillance systems for reporting adverse drug events but do not govern the dispensing of isotretinoin. Therefore, the unique requirements and risk management associated with isotretinoin are entirely encapsulated in the iPLEDGE program, making it the correct choice for this question.

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