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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- Assign a responsible site pharmacist
- Enroll online in the iPLEDGE® REMS program by completing the pharmacy activation and annual reactivation
- Have the dispensing pharmacist obtain a Risk Management Authorization (RMA) before filling and dispensing the prescription
- Obtain and document the “Do Not Dispense To Patient After” date
- 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
I enjoy assisting pharmacy staff both pre- and post-audit and enjoy providing them with knowledge and tools to decrease audit risk going forward. I write articles for Third-Party Newsline each month and answer member questions daily. I look forward to building professional relationships with each of our members and assisting you with your next audit.
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