Question

___________________________ (Absorica, Amnesteem, Clarvis, Myorisan, Zenatone) has a required REMS program called iPLEDGE. The REM program dictates that pharmacies can only purchase isotretinoin products from iPLEDGE-registered wholesalers. This means that a pharmacy cannot sell or lend isotretinoin to another pharmacy.

Answer 1

Isotretinoin is a medication used for severe acne treatment, associated with a high risk of birth defects, which leads to the strict iPLEDGE REMS program dictating its distribution.

Step-by-step explanation:

The medication commonly known as isotretinoin, which includes brand names such as Absorica, Amnesteem, Claravis, Myorisan, and Zenatone, is used to treat severe forms of acne.

It is a potent teratogen, which means it can cause birth defects, such as cardiac, oral, otological, thymic, and central nervous system abnormalities. Consequently, the U.S. Food and Drug Administration (FDA) mandates a strict Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE for all isotretinoin products to prevent fetal exposure due to the high risk of severe birth defects associated with its use.

Under the iPLEDGE program, isotretinoin can only be dispensed by pharmacies that are registered and meet all the conditions of the iPLEDGE program, which also prevents the lending or selling of the medication between pharmacies.