The Food and Drug Administration has approved modifications to the iPLEDGE REMS for isotretinoin intended to reduce administrative burden while maintaining pregnancy prevention safeguards. Under the changes, prescribers may allow patients to complete pregnancy testing at home during and after treatment, although pre-treatment testing must still occur in a medical setting. Patients who miss the seven-day prescription pickup window may now complete a repeat pregnancy test immediately without an additional waiting period.
The updates also remove monthly REMS counseling documentation requirements and the 30-day prescription window for patients who cannot become pregnant. In addition, clarifying language reinforces that pharmacies must complete annual staff training and maintain records of that training. The modifications take effect 180 days after the Feb. 9 approval, on Aug. 8.
You can read the FDA bulletin on the approval here.
