Advances in trans and gender diverse pharmacology: A step forward in challenging times

Published: 27 Jun 2024
By Alice Tseng, PharmD, Kimberly K. Scarsi, PharmD, MS, Mona Loutfy, MD, MPH

Author’s note: The term 2SLGBTQI+, which is used throughout this blog, stands for Two-Spirit, Lesbian, Gay, Bisexual, Transgender, Queer/ Questioning, Intersex and “+” which signifies inclusion of people who may use additional terminologies. 2S appears at the front of the acronym in recognition of Two-Spirit people as the first 2SLGBTQI+ communities in North America. Terminology is continually growing and changing, representing increasing inclusivity of the variance in gender, sexuality and identity within the community.
In much of the world, June marks Pride Month, and is an opportunity to celebrate the contributions and achievements of 2SLGBTQI+ communities and allies. In the Society’s Pride 2023 blog, Chloe Gynne highlighted important pharmacology-related milestones and initiatives to improve healthcare access for LGBTQI+ people in the United Kingdom , but an urgent need for continued progress remains. Trans and gender diverse people are an underserved and underrepresented population, despite facing complex medical, pharmacological, psychosocial and societal challenges. 
The UK has a mixed track record on supporting the rights of trans and gender diverse people to self-determination and access to care. While the Gender Recognition Act (GRA) was enacted in 2004, many now consider the Act outdated and draconian. In July 2018, the government commissioned a consultation on reforming the GRA, but ultimately no changes were made. The Scottish government attempted to modernize legal gender recognition by passing the Gender Recognition Reform (Scotland) Bill in December 2022, but the bill was blocked by the UK government in 2023.
This was followed by another blow in March 2024, when England’s National Health Service released a policy update prohibiting use of puberty suppressing hormones as a routine treatment option for children and young people with gender incongruence/gender dysphoria.This action mirrors those taken in many parts of the European Union, Canada and the United States. These policies are harmful and potentially life-threatening, and contradict guidance of major medical associations including the Canadian Paediatric Society, American Academy of Medicine, the American Academy of Child and Adolescent Psychiatry, and the World Professional Organization For Transgender Health.
Trans and gender diverse individuals are often excluded from clinical trials, resulting in knowledge gaps on beneficial interventions. How many times has the phrase, “cannot be recommended due to lack of data….” made clinicians hesitate to prescribe a needed therapy?   Research databases and/or medical healthcare record systems may only offer binary gender options or record only the individual’s legal name and sex assigned at birth. This practice further enhances misrepresentation and causes significant emotional harm. Concerns about negative drug-interactions between antiretrovirals and hormones may lead to under-prescribing of one or both life-saving therapies. Hormone therapy may alter physiologic parameters and it is often appropriate to use biological reference ranges aligning with identified gender; continuing to use sex at birth in clinical calculators may lead to inappropriate management or unnecessary exclusion of individuals from needed therapies.

Amid this complex and often discouraging backdrop, we are proud to announce the release of a special themed issue in the British Journal of Clinical Pharmacology on Trans and Gender Diverse Populations to celebrate Pride Month 2024. This themed issue includes contributions that highlight important insights on conducting inclusive research and improving clinical care for trans and gender diverse people. We encourage further research in this area, and welcome ongoing submissions to this themed issue.
The BPS is committed to demonstrating sustained support and allyship with trans and gender diverse communities and their providers. With the anniversary of the Stonewall Inn Riot on 28 June, we urge members to contemplate what initiatives are necessary in their region to optimise clinical care, uphold social justice, and advance legal rights of trans and gender diverse people.   


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About the author

Alice Tseng

Alice Tseng, BScPhm, PharmD, FCSHP, AAHIVP is a Pharmacotherapy Specialist, Immunodeficiency Clinic, Toronto General Hospital and Associate Professor, Faculty of Pharmacy, University of Toronto. Her research interests include antiretroviral interactions, pharmacokinetics and polypharmacy.  She serves as an Executive Editor, British Journal of Clinical Pharmacology and is Chief Editor of a website/mobile app on HIV/hepatitis C drug interactions. Dr. Tseng is a Fellow of the Canadian Society of Hospital Pharmacists and is the 2024 recipient of the CAHR-CANFAR Excellence in Research Award, Clinical Sciences.

Kimberly K. Scarsi

Dr. Kim Scarsi is a Professor at the University of Nebraska Medical Center (UNMC), with appointments in both the College of Pharmacy and College of Medicine. Her clinical pharmacology research program focuses on optimizing therapies for persons living with HIV, with an emphasis on sex/gender related issues. Dr. Scarsi is an active investigator in the ACTG clinical trial network, where she is a scientific member of the Women’s Health Collaborative Science Group. Locally, Dr. Scarsi is a clinical consultant in the UNMC HIV clinic. Nationally, she has served terms on the U.S. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, the Board of Directors for the HIV Medical Association, and the NIH Office of AIDS Research Advisory Council.

Mona Loutfy, MD, MPH

Dr. Mona Loutfy is an Infectious Diseases Specialist, Clinician Scientist and Professor at Women’s College Hospital and the University of Toronto in Toronto, Canada. Her main clinical  and research areas specialize in care of cis and trans women, youth and couples with HIV and reproductive health and HIV. She proudly uses community-based research approaches deemed important to cis and trans women and gender-diverse people living with HIV.

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