pairing which can result in pregnancy would be categorized as a patient of child-bearing potential.This patient would continue to follow iPLEDGE’s requirements and recommendations of pregnancy testing and contraceptive counseling. Conversely, a transgender male with intact pelvic organs who is exclusively sexually active with a partner pairing that cannot lead to pregnancy would be categorized as a patient of non-childbearing potential. Although we focus on transgender patients in this article, similar guidelines may need to be considered for cisgender female patients who are exclusively engaging in intercourse with cisgender females, and thus not at risk of pregnancy. This highlights the importance of taking patient’s sexual orientation and sexual practices into account during iPLEDGE registration as part of a patient-centered approach to care.
CONCLUSION
None of the current 3 patient categories in iPLEDGE seemed appropriate for our patient, who was a transgender male of childbearing potential. After an open and very frank discussion with the patient, he was required to comply with iPLEDGE’s contraceptive counseling. The patient requested to be registered as “male,†however doing so would result in provider noncompliance and subsequent deactivation from the iPLEDGE system.
We urge the FDA to consider implementing the AAD and AMA’s proposed gender-neutral model of registration for iPLEDGE along with our proposed questionnaire which will allow providers to assess patient’s childbearing potential by elucidating whether a pre-menopausal patient has a uterus and ovaries, and whether the patient is engaging in sexual practices that can lead to pregnancy. This will accurately stratify patients’ risk when taking isotretinoin across all gender identities and types of sexual behaviors. It is important for the field of dermatology to remain on the leading edge of patient safety and advocacy issues and to remain compassionate and adaptable when facing new patient care issues.
We urge the FDA to consider implementing the AAD and AMA’s proposed gender-neutral model of registration for iPLEDGE along with our proposed questionnaire which will allow providers to assess patient’s childbearing potential by elucidating whether a pre-menopausal patient has a uterus and ovaries, and whether the patient is engaging in sexual practices that can lead to pregnancy. This will accurately stratify patients’ risk when taking isotretinoin across all gender identities and types of sexual behaviors. It is important for the field of dermatology to remain on the leading edge of patient safety and advocacy issues and to remain compassionate and adaptable when facing new patient care issues.
DISCLOSURES
The authors have no conflict of interest to declare.
ACKNOWLEDGMENT
The authors thank Ken Katz MD, Stanley Vance MD, and Wilson Liao MD for contributing to critical revision of the manuscript.
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AUTHOR CORRESPONDENCE
Tina Bhutani MD Tina.Bhutani@ucsf.edu
