for testosterone-induced recalcitrant acne. Isotretinoin is highly teratogenic; as a result, the US Food and Drug Administration (FDA) implemented a risk evaluation and mitigation strategy (REMS) program (iPLEDGE) in 2006 in order to prevent fetal exposure to isotretinoin and to inform providers as well as patients about the drug’s risks.9 Importantly, pre-menopausal transgender men who have a uterus and ovaries may still become pregnant while undergoing masculinizing hormonal therapy if engaging in vaginal intercourse.10 Registering patients into iPLEDGE mandates that prescribers classify patients into 1 of 3 mutually exclusive categories: male, female of non-childbearing potential, or female of childbearing potential. Females of childbearing potential are required to comply with contraception requirements.
Currently, iPLEDGE does not provide written guidance to providers on how to register transgender individuals. iPLEDGE requires patients to be registered according to sex assigned at birth, which means transgender men must be classified as females.7 This categorization scheme is incongruent with transgender men’s gender identity. Misgendering transgender patients in this manner is a powerful contributor to underlying gender dysphoria, which may contribute to uncomfortable, culturally incompetent clinical encounters, and ultimately lead patients to reject starting treatment with isotretinoin.7
These issues have been raised in the past, with several articles from 2016 to 2019 urging for gender-neutral registration.10-13 A gender neutral patient categorization model of iPLEDGE is also supported by both the American Medical Association (AMA) and American Academy of Dermatology (AAD).14,15 However, despite the pleas from clinicians and patients, no change has yet been made to iPLEDGE.
We add our voices to the echo of frustrated providers who find themselves forced to choose between prioritizing their patients’ gender identity and FDA regulations. We agree with gender neutral registration as proposed by the AAD and AMA, and additionally propose assessing for childbearing potential at the time of registration to yield a total of two possible patient registration categories in iPLEDGE: patient of child-bearing potential and patient of non-childbearing potential. We propose the following questions as a guide for providers to follow as part of history taking during the iPLEDGE registration process in order to assess the reproductive potential of their patients in a culturally sensitive manner:
We suggest asking these questions during monthly iPLEDGE visits as the answers to some of these questions may change over time, as patients may change sexual partners and/or may have surgeries later in the course of treatment. Following these proposed parameters, a pre-menopausal transgender male with intact uterus and ovaries who is sexually active with a partner
Currently, iPLEDGE does not provide written guidance to providers on how to register transgender individuals. iPLEDGE requires patients to be registered according to sex assigned at birth, which means transgender men must be classified as females.7 This categorization scheme is incongruent with transgender men’s gender identity. Misgendering transgender patients in this manner is a powerful contributor to underlying gender dysphoria, which may contribute to uncomfortable, culturally incompetent clinical encounters, and ultimately lead patients to reject starting treatment with isotretinoin.7
These issues have been raised in the past, with several articles from 2016 to 2019 urging for gender-neutral registration.10-13 A gender neutral patient categorization model of iPLEDGE is also supported by both the American Medical Association (AMA) and American Academy of Dermatology (AAD).14,15 However, despite the pleas from clinicians and patients, no change has yet been made to iPLEDGE.
We add our voices to the echo of frustrated providers who find themselves forced to choose between prioritizing their patients’ gender identity and FDA regulations. We agree with gender neutral registration as proposed by the AAD and AMA, and additionally propose assessing for childbearing potential at the time of registration to yield a total of two possible patient registration categories in iPLEDGE: patient of child-bearing potential and patient of non-childbearing potential. We propose the following questions as a guide for providers to follow as part of history taking during the iPLEDGE registration process in order to assess the reproductive potential of their patients in a culturally sensitive manner:
- What is your current gender identity?
- What are your chosen pronouns?
- What is the sex listed on your original birth certificate? Male/female (for purposes of identifying childbearing potential)
- Have you ever had any of the surgeries listed below? If so, please specify which procedures
- Hysterectomy (surgery to remove the uterus); bilateral oophorectomy or salpingo-oophorectomy (surgery to remove the ovaries or surgery to remove the ovaries and fallopian tubes); tubal ligation (“tying†of the fallopian tubes); orchiectomy (surgery to remove testicles); vaginoplasty (surgery to remove the penis, scrotum, and testes, and creates a vulva and vagina)
- What is the sex assigned at birth of your sexual partner(s)?
We suggest asking these questions during monthly iPLEDGE visits as the answers to some of these questions may change over time, as patients may change sexual partners and/or may have surgeries later in the course of treatment. Following these proposed parameters, a pre-menopausal transgender male with intact uterus and ovaries who is sexually active with a partner
