Case Scenario

Miley (she/her), a 21-year-old assigned male at birth, visits your pharmacy to fill a prescription for estradiol 2 mg tablets. She has transitioned socially and is starting to transition medically. She is happy that hormonal treatment has finally begun but feels very anxious about the effects of the new medicine.

Learning Objectives

After reading this article, pharmacists should be able to:

  • Describe the ways transgender and gender diverse people might affirm their gender
  • Discuss medicines commonly used for medical gender affirmation, including usual doses, adverse effects and monitoring requirements
  • Describe how to provide transgender and gender diverse friendly healthcare in the pharmacy.

Competency standards addressed (2016): 1.1, 1.4, 1.5, 2.1, 2.2, 2.3, 2.4, 3.1, 3.5

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Introduction

Advances in the psychological sciences have led to a global challenge of the assumption that humans are either men or women, and that use of the gender binary may not be the most scientific assumption. Terms such as genderqueer, non-binary, assigned female at birth (AFAB) and assigned male at birth (AMAB) have joined our vernacular, particularly in younger and LGBTQIA+ circles.1 Gender identity is an internal sense and can be described using a variety of terms such as man, woman, transgender, non-binary, agender and genderqueer.1,2

Community pharmacists can support people who are transgender and gender diverse (TGD) by providing gender-affirming medicines and preventive care in an inclusive environment.5,6

Many people who are TGD report that pharmacists’ lack of transgender healthcare knowledge and limited cultural awareness are barriers to accessing healthcare in the pharmacy.7

Both the Pharmaceutical Society of Australia’s Professional Practice Standards and its Code of Ethics require pharmacists to display non-judgemental attitudes and provide culturally appropriate, respectful patient-centred care.8,9 All people who are TGD should be treated without discrimination.10 Federal and state anti-discrimination laws protect TGD people from being discriminated against at work, in public and in any organisation setting, including healthcare.10,11 For example, in New South Wales, any refusal of care, discrimination or negative treatment while accessing care from a treating practitioner, including a pharmacist, may result in a complaint to the Health Care Complaints Commission.10

People who are TGD have diverse healthcare needs.6,12 Gender dysphoria is intense distress experienced by people who are transgender due to the feeling that their gender identity is incongruent with their assigned sex at birth.13 It may start in early childhood, but some people may not experience it until adolescence or adulthood.13 Gender affirmation therapy may reduce gender dysphoria and improve quality of life.14 Some people who are TGD seek hormonal treatments for gender affirmation, but it is important to note that many do not and are content with a social and/or legal transition only.6

Community pharmacies provide easy access not only for hormonal treatments but also preventive services such as cardiovascular health screening and smoking cessation.5,6

Box 1 – Definitions

Transgender and gender diverse (TGD) persons refers to persons whose gender identity differs from their sex presumed at birth.3
Sex referring to the biological attributes of an individual based on chromosomes, gene expressions, hormone levels and reproductive organs is categorised as male, female, or intersex.4
Gender refers to the combination of the socially constructed characteristics, roles, behaviours, expressions and identities of girls, women, boys, men, and gender diverse people.4

Box 2 – Abbreviations

  • TGD: Transgender and gender diverse
  • AFAB: Assigned female at birth
  • AMAB: Assigned male at birth
  • LGBTQIA+: Lesbian, gay, bisexual, transgender, queer, intersex and asexual

Providing TGD-friendly care in the pharmacy

Gender-affirming care and services should be delivered in a TGD-friendly environment.15 An inclusive pharmacy environment and LGBTQIA+ culture competent staff are essential for adequate healthcare delivery to people who areTGD.16 Avoid asking unnecessary questions relating to gender identity or gender affirmation if that information is not relevant to the patient’s clinical need.16 Also, it is important not to assume a patient’s gender identity because of their appearance or dressing style.16 Using inclusive language, avoiding gendered terms like ‘sir’ or ‘madam’, and calling patients by their last name in the waiting area may avoid misgendering and outing patients in public.16 Patients should be provided with the opportunity to update their information about preferred name, title and pronouns in the dispensing record.16 Mirroring patient language used for describing themselves and their body parts forms a positive interaction.16 Being respectful in all patient interactions establishes trust and provides a safe environment for TGD people.16

Pharmacists should provide a welcoming and inclusive pharmacy environment for people who are TGD by:

  • Being familiar with gender identity terminology.5,6,17
  • Using inclusive language. Asking for patient’s preferred names and pronouns and using those in patient interactions.If you make a mistake, apologise, and move on.16,17
  • Displaying TGD-friendly materials or flags to indicate that the pharmacy is a safe space for TGD patients.12
  • Training staff to provide culturally respectful patient-centred care.6
  • Being aware of local TGD-friendly healthcare practitioners, support groups and services to refer to when appropriate.12

Some useful TGD healthcare education resources for pharmacists and patients:

  • World Professional Association for Transgender Health Standards of Care Guidelines18
  • Position Statement on the Hormonal Management of Adult Transgender and Gender Diverse Individuals17
  • TransHub provides gender-affirmation resources for TGD patients, allies and health professionals (www.transhub.org.au)
  • Many Genders, One Voice (MGOV) is a social/support group for people who are TGD (www.manygendersonevoice.org).

The gender-affirmation process

People who are TGD may choose to affirm their gender through a social, legal, medical or surgical transition. It is a unique journey for each patient.16,18

Gender-affirming treatment for adults

Access to gender-affirming hormonal treatment improves mental health outcomes and is lifesaving.12 Pharmacists can educate people who are TGD about their medicines, including expected timelines for desired effects, adverse effects and their management, and possible drug–drug interactions.5,6 Most gender-affirming hormonal treatments are prescribed off-label, so product information, consumer medicines information and other commonly used pharmacy resources may not be appropriate sources of information.

Medical affirmation with hormones

Hormonal treatment is commenced considering the patient’s goals of aligning the secondary sexual characteristics to their affirmed gender (Table 1).18,20 Although clinical effects may be visible in the first year of hormonal therapy, the maximum effect is observed in 2–3 years.17,18 Desired effects may not be apparent in a short period, and increased dosing would not change this timeline, but only increase the risk of adverse effects.15 Considering the patient’s comorbidities and concurrent medicines, including complementary medicines, is essential to exclude contraindications, avoid exacerbation of existing conditions, and identify possible drug–drug interactions.21 Contraindications for hormonal therapy include cerebrovascular and coronary artery disease, liver disease, gall bladder disease and hormone-sensitive cancers.18,20 Regular monitoring of laboratory values, clinical effects and adverse effects is necessary every 3 months for the first 6 months of the therapy, then every 6–12 months.17,18

People who are TGD need to be made aware of the possibility of permanent infertility with hormonal therapy.15,17 Although ovulation usually returns after testosterone is stopped, transmen and non-binary AFAB patients can opt to freeze their eggs.17,19 Testosterone use can be temporarily ceased for patients who may wish to become pregnant.17 Testosterone is a teratogen and does not always suppress ovulation.17 Therefore, it is essential to discuss suitable contraceptive options such as condoms or progesterone-based depot, pills or intra-uterine devices with these patients.17 Transwomen and non-binary AMAB patients using feminising hormones may choose to freeze their sperm, as estradiol reduces spermatogenesis.17,18

Masculinising hormonal treatment for transmen and non-binary AFAB patients

Testosterone

Testosterone, often referred to as ‘T’ by people in the TGD community, is a cornerstone of masculinising therapy.15,17 While injectable and topical forms are widely used, testosterone patches are rarely used.22 Doses are adjusted according to the clinical response.15,17-19 The target serum level for total testosterone is maintained at 10–15 nmol/L, which is at the lower end of the male reference range.17,22 Low-dose testosterone may be preferred by some non-binary AFAB patients who may not want full masculinisation effects.15 Hormonal levels of non-binary patients may lie between male and female hormonal ranges.15 Appropriate counselling is required for use of each dosage form.21

Concurrent administration of testosterone and some hypoglycaemic agents may cause hypoglycaemia.23,24 The doses of hypoglycaemic agents may need to be lowered.24 Co-administration of warfarin and testosterone may increase the anticoagulant effect and bleeding risk.25 This combination should be used with caution with frequent INR monitoring.25 Testosterone may reduce the metabolism of cyclosporin and increase its toxicity; therefore, if used concurrently, cyclosporin levels should be monitored.24,25 Dose adjustment is necessary when testosterone is used with protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs).26 PIs may reduce testosterone concentration, while NNRTIs may increase its concentration.26 Some complementary medicines such as Angelica dahurica, chaparral, comfrey, eucalyptus, germander tea, jin bu huan, kava, pennyroyal oil, skullcap and valerian may affect liver function.24 Avoid concurrent administration of testosterone and complementary medicines that may affect liver function.24

Progestins

If testosterone is unable to suppress menstruation, and menses causes significant distress in the patient, oral or injectable progestin or a progestin-containing intrauterine device (IUD) may be considered as suitable options.17,18

Feminising hormonal treatment for transwomen and non-binary AMAB patients

Estrogen and androgen blockers are mostly used in combination as a first-line feminisation treatment.15,18 The goals of treatment are adjusted according to the patient’s goals.17 Some non-binary AMAB patients may not want full feminisation effects.17 This may be achieved by using an androgen blocker with or without low-dose estrogen, or by using feminisation treatment for a short period.15,27

Phosphodiesterase-5 inhibitors such as sildenafil may be prescribed to maintain erectile function.15

Estrogens

Estradiol, oral and transdermal, is commonly used for gender affirmation.17 It is recommended to start at low doses and up-titrate gradually every 3–4 months, adjusting the dose according to clinical response.17,18 Serum levels of estradiol and testosterone are targeted in the premenopausal female reference ranges of 250–600 pmol/L and <2 nmol/L, respectively.17 Oral estradiol is inexpensive and easy to administer; however, it is not a suitable option for patients with thromboembolic risk.17 The venous thromboembolism (VTE) risk may be lowered by using the lowest effective dose.17 Smoking increases VTE risk.15,17 Therefore, smoking cessation should be encouraged.15,17 Transdermal estradiol or a subdermal estradiol implant is preferred for patients over 40 years of age or with thromboembolic risk factors.15,28

Ethinyl estradiol (a common ingredient in contraceptive pills) and conjugated equine estrogens (Premarin or compounded products) are not indicated for gender affirmation due to inaccuracy of measurement of their blood levels and increased risk of thromboembolic and cardiovascular disease.15,17

Estradiol levels may be reduced by CYP3A4 enzyme inducers such as carbamazepine, glucocorticoids, phenytoin, phenobarbital, topiramate, griseofulvin, rifampicin, rifabutin and St John’s wort.29 Estradiol levels may be increased by CYP3A4 enzyme inhibitors such as azole antifungals (fluconazole, ketoconazole, itraconazole, voriconazole), macrolides (erythromycin, clarithromycin), diltiazem, verapamil and grapefruit juice.29 Concurrent administration of HIV or HCVPIs and NNRTIs may increase or decrease estradiol levels.26,30 Fosamprenavir, a prodrug of amprenavir, should not be co-administered with estradiol.15 Estradiol may reduce amprenavir serum levels leading to virologic failure.15 There is limited evidence that suggests estradiol lowers the serum levels of tenofovir/emtricitabine – a commonly prescribed pre-exposure prophylaxis (PrEP) medication.31-33 People can commence or continue PrEP at the usual dose when estradiol is commenced.

Anti-androgens

Anti-androgens lower endogenous testosterone levels and suppress its masculinising effects.17,18 When used concurrently with estradiol, anti-androgens allow the use of a low dose of estradiol to attain the required estrogen levels.17 Cyproterone acetate and spironolactone are the most commonly used anti-androgens.15,17 Cyproterone exhibits both progestogenic and anti-androgenic effects.15 The lowest effective dose should be used to avoid the risk of hepatotoxicity, meningioma and prolactinoma that have been reported with high doses.15,17 Cyproterone acetate is metabolised by CYP3A4.34,35 Therefore, its metabolism may be inhibited by CYP3A4 inhibitors and increased by CYP3A4 inducers.34,35 Dose adjustment may be necessary with concurrent use.35 The risk of rhabdomyolysis may increase with co-administration of atorvastatin and simvastatin, which are also metabolised by CYP3A4.34,35

Spironolactone, when used at higher doses, exhibits anti-androgen effects, and suppresses testosterone production.15,22 It may cause hypotension and hyperkalaemia.15,22 Concurrent use with medications such as non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists may increase the risk of hyperkalaemia.22,29 The combination should be used with extreme caution.29

Bicalutamide 25–50 mg daily can be used for androgen blockade, but it is a non-PBS item, and hepatotoxicity monitoring is required.15,27 Bicalutamide is a CYP3A4 inhibitor and should be cautiously used with the medications metabolised by CYP3A4.36 Bicalutamide can increase the effect of warfarin.36 Therefore, when used concurrently, INR should be closely monitored, and warfarin dose adjusted accordingly.36

Progestins

Although they may be prescribed for some patients, there is no evidence that progestins increase breast growth.17,18 Micro-pulverised progesterone (Prometrium or compounded) 100 mg orally once daily at bedtime may be used.28 Current guidelines do not recommend using progestins for feminisation, due to increased risk of thrombosis, nausea, weight gain and depression.17,18

Gonadotrophin-releasing hormone(GnRH) agonists

GnRH agonists such as goserelin may be added to hormone therapy to reduce testosterone levels.17,19 They are not available on the PBS for gender-affirmation and are expensive, which may restrict use.17

Table 1 – Hormonal treatment options for gender-affirmation

Medicine Dose PBS/Non-PBS Monitoring

Masculinising treatment options
Testosterone – Injectable Monitor sex hormone levels, liver and renal function, blood pressure, cardiovascular risk, lipids, acne, red blood cell count (polycythaemia risk), weight gain, pelvicpain, vaginal atrophy, obstructive sleep apnoea, mood changes, BMD*

Cancer screening as required – mammogram, Pap smear
Testosterone undecanoate (Reandron) 1000 mg IM with first two doses 6 weeks apart, then 1000 mg IM 12-weekly PBS, Authority required
Testosterone enantate (Primoteston Depot) 125 mg IM every 2 weeks, then 250 mg IM 2-weekly Non-PBS
Testosterone esters (Sustanon 250) 125 mg IM every 2 weeks, then 250 mg IM 2-weekly Non-PBS
Testosterone – Transdermal
Testosterone 1% gel sachets (Testogel) 1 sachet daily PBS, Authority required
Testosterone 1% gel pump (Testogel) 4 pumps daily PBS, Authority required
Testosterone 5% cream (AndroForte 5) 2 mL daily PBS, Authority required

Feminising treatment options
Estrogen – Oral Monitor sex hormone levels, liver and renal function, blood pressure, cardiovascular disease risk, triglycerides, serumprolactin (macroprolactinoma risk), weight gain, mood changes, VTE, BMD*

Cancer screening as required – mammogram, prostate screening
Estradiol valerate (Progynova) or estradiol hemihydrate (Zumenon) 2–8 mg daily PBS
Estrogen – Transdermal
Estradiol patches (Climara, Estradot, Estraderm) 100–150 mcg/24 hr every 3–4 days PBS
Estradiol gel (0.1%) (Sandrena) 2 sachets daily PBS
Anti-androgens
Cyproterone acetate 12.5–25 mg daily PBS Liver function, mood changes
Spironolactone 100–200 mg daily PBS Electrolytes levels, blood pressure

References: Deutsch15, Cheung17, Coleman18, Hembree19

*BMD= Bone mass density, test at baseline and as required depending on risk factors

Surgical affirmation

Some people who are TGD may desire to affirm their gender through surgery.15,17 Surgical options are expensive, and Medicare may not cover some gender-affirming surgery.17 Options for feminisation include breast augmentation, facial feminisation surgery, orchidectomy, vaginoplasty, chondrolaryngoplasty for reducing thyroid cartilage, laryngoplasty and vocal cord surgery for voice feminisation.15,17 Patients desiring breast augmentation surgery are usually recommended to wait for at least 2 years after they start taking estradiol, as breast tissue may grow for up to 3 years after starting estradiol.17,19 For all feminisation surgery, estradiol may need to be stopped some time before surgery to reduce the risk of thromboembolism.17,19 Masculinising surgical procedures include mastectomy, hysterectomy, oophorectomy, metoidioplasty and phalloplasty.15,17

Vocal training

The voice is vital to gender expression.17 Inability to communicate in a voice that matches the gender expression may lead to gender dysphoria in people who are transgender.17,37 Sometimes, they may experience misgendering due to their voice.17 Voice training has been found effective in reducing gender dysphoria, leading to significant improvement in mental health and quality of life.15

Transmen who are using testosterone therapy may experience changes in their voice. However, they are less likely to seek professional vocal training.38 Pharmacists are in a unique position to emphasise the importance of visiting a qualified speech language pathologist (SLP) to transmen collecting their testosterone prescription for adapting their new voice without causing harm. Oestrogen therapy has an insignificant effect on voice, and changing the voice is often a large step towards affirming a patient’s gender.17 Transwomen often seek an SLP to assist with this change, but if they have not, the provision of estrogen therapy by a community pharmacist is a great opportunity to encourage them to seek professional help.

Other interventions such as facial hair removal through laser or electrolysis, chest binding, and genital tucking and packing may assist in gender affirmation.15,17

Conclusion

People who are TGD may choose to affirm their gender through the social, medical, surgical or legal transition. Providing TGD-friendly care in an optimised, inclusive environment is critical to enhance a sense of belonging and foster better interactions with people who are TGD. Pharmacists have a role in medicine dispensing, counselling and engaging patients in preventive healthcare services, thus improving the health outcomes of this patient group.

Case Scenario Continued

You dispense her medicine, introduce yourself to Miley with your pronouns and ask for Miley’s preferred name and pronouns. You counsel her on the medication’s dose and adverse effects, such as headaches, nausea, weight gain and infertility. You emphasise that although she might notice desired physiological changes occurring in a few months, the time required for the full effect of hormones is 2–5 years. You provide a timeline for the desired physiological effects, advising that while taking estradiol, regular monitoring of hormone levels, liver function, lipid levels and blood pressure is necessary for early detection and management of serious adverse effects such as VTE, macroprolactinoma, mood changes and hepatic dysfunction. You encourage a balanced diet and regular exercise for maintaining a healthy weight, and provide VTE-prevention advice, including smoking cessation. You provide Miley with details of local TGD support groups and services. She feels less anxious and excited to connect to the local support group to hear about the experiences of others and share her transition journey.

Key Points

  • Pharmacists have an important role in providing medicines and preventive healthcare services to TGD patients in a TGD-friendly pharmacy environment.
  • People who are TGD may affirm their gender through social, legal, medical and surgical transition.
  • Testosterone is a mainstay hormonal treatment for masculinisation in transmen and non-binary AFAB patients.
  • Estradiol is used with or without androgen blockers for feminisation in transwomen and non-binary AMAB patients.

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SWAPNA CHAUDHARY BPharm (Hons), GradCertAppPharmPrac is a PhD candidate and lecturer at the College of Medicine and Dentistry, James Cook University, Townsville.

ASSOCIATE PROFESSOR ROBIN RAY RN, BEd, MHlthSc, PhD is an Adjunct Associate Professor at the College of Medicine and Dentistry, James Cook University, Townsville.

PROFESSOR BEVERLEY GLASS BPharm, BSc (Hons), PhD, NHD (Marketing), ARPharmS, FPS is Professor of Pharmacy at the College of Medicine and Dentistry, James Cook University, Townsville.

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