12/13/2021
Ipledge Changes 12/13/2021
Dear patients on isotretinoin,
Isotretinoin is in many ways a life changing medication we have used in dermatology for acne for decades. There have been massive changes to the Ipledge system, a government controlled system designed to prevent pregnancies while taking isotretinoin. Ipledge has always been a huge administrative burden and studies have shown that it does nothing to prevent pregnancies (see below references). Unfortunately, we have no way around using this system to continue to prescribe isotretinoin. Even males and females with a hysterectomy, who cannot become pregnant, are subject to the stringent rules and administrative burdens Ipledge imposes.
For the time being, the changes that occurred 12/13/2021 have frozen our ability to write any prescriptions or register any new patients. The Ipledge administrators are not even answering the phone anymore where previously there were 3-4 hour long waits to get a human. This is a national problem affecting dermatology offices all over the country. Isotretinoin is such a vital part of our approach to severe acne that we will continue to fight for the ability to prescribe it. Unfortunately, you will likely experience severe delays until it can be sorted out.
We apologize for any inconvenience this may cause. Rest assured that while your treatment may be interrupted temporarily, the effect of Isotretinoin is not diminished by an interruption. Day to day dosing is less important to your improvement than the overall cumulative affect you will get from treatment over many months. We appreciate your patience.
If you wish to voice your displeasure with Ipledge, please consider calling 1-866-495-0654 (if you can get a human). Our staff have absolutely zero control over the problem.
Miranda Smith, MD
Tracy Beswick, MD, PhD
1) JAMA Dermatol. 2019;155(10):1175-1179. doi:10.1001/jamadermatol.2019.1388
“US Food and Drug Administration Reports of Pregnancy and Pregnancy-Related Adverse Events Associated With Isotretinoin”
2) International Journal of Dermatology. “Stringent Risk Management Programs May Not Decrease Isotretinoin-Exposed Pregnancies”. April 9, 2018
