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Breaking Down the FDA-Mandated Changes to the iPLEDGE Program for Isotretinoin

Featuring John Barbieri, MD, MBA, FAAD |

Director of the Advanced Acne Therapeutics Clinic  
Brigham and Women's Hospital  
Chestnut Hill, MA

| Published January 02, 2024

The FDA has recently mandated significant modifications to the iPLEDGE program, which is designed to manage the risks associated with isotretinoin use. In this video, Dr John Barbieri of Brigham and Women’s Hospital and Harvard Medical School breaks down the details of the key updates. 

Streamlined Counseling for Individuals not of Childbearing Potential 

One of the most noteworthy changes is the elimination of monthly counseling documentation for individuals not of childbearing potential. Previously, this requirement added an unnecessary burden for both patients and clinicians. Under the new guidelines, counseling documentation will only be required at enrollment, potentially providing a substantial reduction in the frequency of patient visits. Dr Barbieri underscores how this change can enhance flexibility for clinicians, making it easier to prescribe isotretinoin and subsequently improve access to this crucial acne treatment. 

Removal of the 19-Day Lockout Period 

A second pivotal change involves the removal of the 19-day lockout period. Currently, patients face a stringent 7-day window to pick up their prescription; if missed, patients are required to wait 19 days before taking another pregnancy test. This measure, sometimes considered overly punitive to patients, is now being eliminated, aligning the iPLEDGE program with other similar programs. Under the new requirements, patients who miss the initial 7-day window can repeat a pregnancy test, granting them eligibility to receive the drug. This modification addresses issues related to pharmacy stock and prior authorization hurdles, ensuring patients can access the medication without unnecessary delays. 

Shift Towards Home Pregnancy Testing 

Another substantial update involves a shift from requiring CLIA-certified pregnancy tests to allowing home pregnancy testing for patients of childbearing potential. While the first 2 tests, to enroll the patient and after the 30-day waiting period, still need to occur in an office-based setting, subsequent tests after the initiation of isotretinoin can be conducted either in a medical setting or using a home pregnancy test. Dr Barbieri suggests steps to minimize falsification, such as having patients write their names and dates on the test, ensuring accuracy and convenience for patients. 

Anticipated Implementation 

These transformative changes are eagerly anticipated, and isotretinoin manufacturers have been given a 6-month window to respond to the FDA's recommendations. Dr Barbieri expresses hope that collaboration with stakeholders, including dermatologists, patients, and pharmacists, will be key to implementing changes that prioritize patient safety while ensuring continued and accessible isotretinoin treatment.


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