Question

question 112

a pharmacy technician should recognize that a prescription for isotretinoin (accutane) must be filled at a pharmacy that uses which of the following?

• ipledge
• medwatch
• step therapy
• fda adverse event reporting system (faers)

Explanation:

Identify the drug and its associated risks

Isotretinoin (commonly known by the brand name Accutane) is a highly effective medication used to treat severe recalcitrant nodular acne. However, it is a powerful teratogen, meaning it carries an extremely high risk of causing severe birth defects if a fetus is exposed during pregnancy.

Evaluate safety monitoring programs

To mitigate the risk of fetal exposure, the Food and Drug Administration (FDA) mandates a strict Risk Evaluation and Mitigation Strategy (REMS) program specifically designed for isotretinoin. This computer-based risk management program is called iPLEDGE.

Analyze the role of the pharmacy

Under the iPLEDGE program, wholesalers, prescribers, patients, and pharmacies must all be registered and active in the system. A pharmacy technician cannot dispense isotretinoin unless the pharmacy is registered with iPLEDGE and obtains an authorization to dispense for each prescription.

Differentiate from other options

• MedWatch: The FDA's safety information and adverse event reporting program, used for voluntary reporting of serious adverse events.
• Step therapy: A prior authorization process used by health insurance plans requiring patients to try less expensive drugs before "stepping up" to more expensive ones.
• FDA Adverse Event Reporting System (FAERS): A database that contains information on adverse event and medication error reports submitted to the FDA.

Answer:

• iPLEDGE (Correct answer)
• MedWatch
• Step therapy
• FDA Adverse Event Reporting System (FAERS)