Question 83

The iPLEDGE program is a set of steps that all patients, prescribers, and pharmacists must follow prior to dispensing isotretinoin.

Isotretinoin is the medication that requires adherence to the iPLEDGE program, which is designed to prevent fetal exposure due to the drug's teratogenic effects.

A) dofetilide

Dofetilide is an antiarrhythmic medication used for the treatment of certain types of irregular heartbeats. It does not require the iPLEDGE program, as it is not associated with the same teratogenic risks that necessitate such precautions.

B) clozapine

Clozapine is an antipsychotic medication used primarily for treatment-resistant schizophrenia. While it has a risk of agranulocytosis and requires monitoring, it does not involve the iPLEDGE program, which specifically addresses the risks associated with isotretinoin.

C) thalidomide

Thalidomide is known for its serious teratogenic effects and is managed under the STEPS program rather than iPLEDGE. Although both drugs have similar concerns regarding fetal exposure, thalidomide's monitoring system is separate, making this option incorrect in the context of the iPLEDGE program.

D) isotretinoin

Isotretinoin is an oral retinoid used to treat severe acne and is well-known for its potential to cause severe birth defects if taken during pregnancy. The iPLEDGE program requires patients, prescribers, and pharmacists to follow strict guidelines to prevent fetal exposure, making this option correct.

Conclusion

The correct answer is isotretinoin, as it is the only medication in the provided options that mandates adherence to the iPLEDGE program to mitigate the risks of teratogenic effects. All other options either do not involve the same level of risk or are governed by different safety programs, thus confirming that isotretinoin is the sole choice requiring the iPLEDGE protocol.