Question

question 12

a pharmacy technician should recognize that the risk evaluation and mitigation strategy (rems) program for isotretinoin (ipledge) was established primarily to address which of the following concerns?

• the risk of bone marrow suppression
• the risk of severe birth defects if taken during pregnancy
• the risk of antibiotic resistance
• the risk of drug diversion and abuse

Explanation:

Identify the core drug and program

Using the Isotretinoin Regulations and iPLEDGE Program knowledge points
The question asks about the primary concern addressed by the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin.

Analyze the clinical risks of isotretinoin

Using the REMS Programs knowledge point
Isotretinoin is a highly effective medication for severe acne, but it is a powerful teratogen. Exposure during pregnancy carries an extremely high risk of severe birth defects, miscarriage, or infant death.

Evaluate the given options

Using the iPLEDGE Program knowledge point

• Bone marrow suppression is not the primary risk managed by iPLEDGE (clozapine REMS manages neutropenia).
• Severe birth defects during pregnancy is the primary teratogenic risk targeted by iPLEDGE.
• Antibiotic resistance is unrelated to isotretinoin, which is a retinoid.
• Drug diversion and abuse is managed for controlled substances, not isotretinoin.

Answer:

• The risk of bone marrow suppression
• The risk of severe birth defects if taken during pregnancy (Correct answer)
• The risk of antibiotic resistance
• The risk of drug diversion and abuse