FDA Issues Updates to iPLEDGE® REMS Program

Isotretinoin capsules are FDA approved for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Due to the risk of severe life-threatening birth defects and risk of embryo-fetal toxicity, isotretinoin is only available under the iPLEDGE® Risk Evaluation and Mitigation Strategy (REMS) program.

On November 30, 2023, the FDA posted an update to the iPLEDGE® program“…to minimize burden on patients, pharmacies, and prescribers while maintaining the safe use of isotretinoin”. Several changes include:

  • Pregnancy test is no longer required to be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab
  • Home pregnancy tests can be utilized during and after isotretinoin treatment
    • The burden is on the prescriber to ensure strategies are in place to decrease the likelihood of patients falsifying results
    • Pre-treatment pregnancy tests must still be performed in a medical setting such as an office or lab

Patients who cannot become pregnant and pharmacies dispensing isotretinoin products will see no changes to the iPLEDGE® program requirements. Pharmacies will still need to:

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  1. Assign a responsible site pharmacist
  2. Enroll online in the iPLEDGE® REMS program by completing the pharmacy activation and annual reactivation
  3. Have the dispensing pharmacist obtain a Risk Management Authorization (RMA) before filling and dispensing the prescription
  4. Obtain and document the “Do Not Dispense To Patient After” date
  5. Follow all other applicable program requirements

PAAS Tips:

  • For the full list of modifications to the iPLEDGE® REMS program, visit ipledgeprogram.com
  • Pharmacies dispensing isotretinoin products can refamiliarize themselves with the iPLEDGE® program requirements for pharmacies by reading the iPLEDGE® Pharmacist Guide
  • Consider promoting over-the-counter (OTC) pregnancy tests to a person who can become pregnant at the time of dispensing an isotretinoin prescription to facilitate patient adherence to the iPLEDGE® guidelines

Sara Hathaway, PharmD