The FDA has approved modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, a powerful medication used to treat severe acne. These changes, announced on , aim to reduce the burden on patients, prescribers, and pharmacies while maintaining the drug’s safe use. The modifications will take effect , 180 days after the approval date. Until then, the FDA will continue to exercise enforcement discretion regarding existing pregnancy testing requirements.
What is Isotretinoin and Why the iPLEDGE Program?
Isotretinoin, formerly known as Accutane (though that brand is no longer available in the US), is a prescription retinoid used for the treatment of severe, recalcitrant nodular acne. It’s typically reserved for cases that haven’t responded to other treatments, as it can have significant side effects. Treatment duration varies, but generally lasts around six months, though this can be adjusted based on individual patient response.
Isotretinoin carries a serious risk of causing severe birth defects if taken during pregnancy. Because of this, the iPLEDGE program was established in 2005, and formalized as the iPLEDGE REMS in 2010. This program is a “shared system” REMS, meaning it applies to all FDA-approved isotretinoin products. It’s designed to prevent fetal exposure to the drug by requiring strict adherence to pregnancy prevention measures.
Common side effects of isotretinoin include dryness of the skin, lips, and eyes, nosebleeds, and increased sensitivity to the sun. More serious, though less common, side effects can include mood changes like depression and anxiety. Careful monitoring and open communication between patients and their healthcare providers are crucial during treatment.
Key Changes to the iPLEDGE REMS
The recent modifications to the iPLEDGE REMS introduce greater flexibility in how pregnancy tests are conducted. Previously, all pregnancy tests – including the initial pre-treatment test – had to be performed in a medical setting. Now, with a prescriber’s approval, patients can complete pregnancy tests outside of a medical setting, such as at home, during and after treatment. However, the pre-treatment pregnancy test will still need to be completed in a medical setting.
Another change addresses the timeframe for repeat pregnancy testing. If a patient doesn’t pick up their isotretinoin prescription within a 7-day window, a repeat pregnancy test can now be performed immediately, without requiring an additional waiting period. This streamlines the process and reduces delays in treatment for patients who may have experienced a temporary logistical issue.
For patients who are unable to become pregnant, the new guidance removes the requirement for prescribers to document counseling sessions. While counseling remains an important part of the iPLEDGE program, the administrative burden of documentation has been lifted.
What This Means for Pharmacists
Pharmacists play a critical role in the iPLEDGE REMS, and these changes will require some adjustments to workflow. The removal of the 30-day prescription window for patients who cannot get pregnant means pharmacies will need to ensure that authorizations are reversed promptly in the REMS if a prescription isn’t picked up, and the medication is returned to stock.
The FDA also emphasizes the importance of annual training for pharmacy staff involved in dispensing isotretinoin. Pharmacies must maintain records of training completion for their authorized representatives. This ensures that staff are up-to-date on the latest REMS requirements and can accurately process prescriptions.
Pharmacists should anticipate an increase in patient questions regarding the new testing guidelines. Clear communication about which tests can be performed at home and which still require a medical setting will be essential. It’s also important for pharmacies to review and update their internal processes to align with the revised REMS requirements, particularly regarding documentation, timing, and staff training.
The FDA’s modifications to the iPLEDGE REMS represent a step towards balancing the need for safe medication use with the goal of reducing administrative burdens for patients and healthcare providers. By allowing for greater flexibility in pregnancy testing and streamlining certain procedures, the FDA hopes to improve access to this important medication while continuing to protect against the risk of fetal harm.
