Pharmacy Technician Certification Board Practice Exam

Isotretinoin, often recognized by its brand name Accutane, is a medication that must participate in a Risk Evaluation and Mitigation Strategy (REMS) program primarily due to its significant teratogenic effects, which can harm a developing fetus if taken during pregnancy. The risks associated with isotretinoin include severe birth defects, especially when used in the first trimester, making it critical for healthcare providers to monitor and manage its use closely.

The REMS program for isotretinoin aims to ensure that patients, particularly women of childbearing age, understand the potential risks and adhere to specific requirements such as pregnancy testing before, during, and after treatment. This ensures that strict protocols are followed to minimize the risk of pregnancy while using the drug.

Other medications listed do not have the same level of risk associated with pregnancy that necessitates a REMS program. For instance, while digoxin and lithium have their own risks, they do not specifically pose the same direct risks to fetal development as isotretinoin does. Gabapentin, while it has its own set of precautions, is not categorized similarly regarding pregnancy risks. Thus, isotretinoin stands out as the medication that requires participation in a REMS program due to its serious