Hormone replacement therapy (HRT) via injections is the preferred method for certain patients. However, the availability of hormone replacement therapy for transgender men and women, both in the U.S. and internationally, is being disrupted due to supply chain issues.
Torrin Williams, a 26-year-old warehouse worker from Savannah, Georgia, was overjoyed to begin testosterone injections in December 2020. He had been on a waiting list for five months to see the only provider of gender-affirming hormone therapy within a five-hour drive, and finally received his prescription. However, his excitement turned to frustration when he encountered difficulties for his prescription.
In August 2021, Williams’s pharmacy was unable to provide him with his three-month supply of weekly 0.4 milligram (mg) shots. The pharmacist suggested alternative brands, but they were more expensive, so he decided to go for a cheaper generic version. Unfortunately, this choice led to a severe allergic reaction, forcing him to switch to a more costly brand. However, even that was not consistently available.
The shortages were so prolonged that Williams experienced a three-month period without his weekly shots. “Luckily, I have a big trans community where I live and I’m really good friends with a lot of them. So if they have extra [topical testosterone] cream they would just be like, ‘Here, just use this,’ and it would get me by for a minute. I would just rub it on me to make it last because I didn’t know when I was going to get [shots] again,” Williams said.
Once, a friend outside Savannah was lucky enough to get an injectable testosterone drove to meet him at a halfway point and gave him a shot before going home.
“That’s dangerous, [when] I don’t even know what I’m using,” Williams added. “But I feel like I have to use it or else all these things are gonna start happening again.” Without access to testosterone, the things he feared took place: return of his menstrual cycle, redistribution of body fat to his hips once more, and the loss of his deep voice.
According to his account, the impact was severe on his mental wellbeing, and he experienced a constant sense of physical vulnerability whenever he ventured outside due to the heightened risk of violence associated with his more noticeable transgender identity.
Injectable Hormone Shortages Affecting Trans and Cisgender Individuals
Williams is among many individuals in the US who are currently facing persistent supply challenges when it comes to obtaining injectable testosterone and estrogen.
While hormone replacement therapy is commonly used by transgender individuals for gender-affirming care, these medications are also utilized by cisgender individuals. Cisgender women may rely on hormone therapy to alleviate menopause symptoms, while cisgender men may utilize it to address symptoms of hypogonadism.
The shortage of injectable hormone therapy has been an intermittent issue in the country since 2016, but the current shortages appear to have intensified and continue to persist today. Monthly updates from the American Society of Health-System Pharmacists (ASHP), a national trade association, indicate that the shortages are projected to persist for at least one more month. These supply challenges are not confined to the US alone, as shortages of at least one of these hormones have been reported in Canada, the UK, and Mexico since December 2022.
In the case of synthetic estrogen (estradiol valerate) injections, there is currently only one option available from a single supplier in the United States: Depo-Estradiol, manufactured by Pfizer. The company has reported ongoing shortages caused by manufacturing delays since early 2022.
Regarding synthetic testosterone (testosterone cypionate), suppliers Cipla, Hikma, and Sun Pharma have not provided reasons for their shortages, according to ASHP. On the other hand, Pfizer attributes their supply challenges to increased demand and manufacturing delays. However, a fifth supplier named Padagis does have testosterone cypionate available.
Desperation Makes Them Resort to Nonprescription Use of Hormone Therapy
In a study published in the Annals of Family Medicine, data collected revealed that 9.2 percent of transgender adults in the country who were undergoing gender-affirming hormone therapy obtained their hormones without a prescription. Given the ongoing shortages, this percentage could potentially increase.
Besides injections, there are alternative options available for hormone therapy. Pills, gels, patches, a topical spray for estrogen, and a subdermal pellet for testosterone are all viable choices. According to UCSF Transgender Care, each option carries its own set of side effects, time-release mechanisms, emotional impacts, potential for allergic reactions, and others. It is important to consider these factors to determine the most suitable method and brand. Transitioning from injections to another delivery method is not straightforward.
Kaydee, a 24-year-old EMT residing in the Minneapolis–St. Paul metro area, made the decision to switch from estrogen pills to Depo-Estradiol 20 mg injections for her transition. The pills required her to take them twice daily and dissolve them sublingually for 20 minutes, which was less convenient. On the other hand, injections only needed to be administered once a week. Kaydee also noted that the injections provided her with greater emotional stability.
However, Kaydee encountered difficulties filling her prescription for injectable estrogen in March 2022, prompting her to change pharmacies multiple times in search of the medication in stock. During the periods when she couldn’t find injections, she resorted to using pills for weeks. Currently, she has accumulated a reserve supply of injectable estrogen to prepare for potential future supply issues.
“Having the stockpile is reassuring. Not only because if there is a shortage I’ve got that backup, but also with the current state of the country, if all of a sudden I had to leave and go somewhere else, it’s nice that I can have that extra,” she explained. “I also keep a stockpile of the pills from way long ago as well, just in case.”
Supply Problems Caused Partially Growing Demand Worldwide
Supply chain issues are the root cause of the shortage, as with many other drugs right now.
“One manufacturer has indicated delays with manufacturing, but the cause of those delays is unknown,” Michael Ganio, PharmD, said. He’s the senior director of pharmacy practice and quality at ASHP. “Other manufacturers have not disclosed a reason for the shortages. A release of more estradiol injection is expected this month, but manufacturers of the testosterone injection have not provided an estimated time for resupply of those products.”
Since the issuance of guidance by the National Institute for Health and Care Excellence, the United Kingdom has experienced a significant increase in prescriptions for estrogen hormone replacement therapy for cisgender women experiencing menopausal symptoms. This surge in demand led to shortages of estrogen pills and patches starting in 2018, prompting prescribers to turn to injections. However, even injections could not keep up with the growing demand, resulting in ongoing estrogen shortages in the UK. Currently, the National Health Service has issued four “serious shortage protocols” for estrogen products, accounting for a quarter of all current protocols.
Australia also faced estrogen shortages, with the government issuing “serious shortage substitution notices” in 2020 and 2021. The final notice expired in May 2022. These global supply chain disruptions have not spared the United States either. In August 2016, the U.S. Food and Drug Administration (FDA) declared a shortage of injectable estrogen, which was later resolved in June 2017.
However, since then, estrogen has experienced chronic shortages in the United States as well. In December 2016, over 500 healthcare professionals specializing in LGBTQ+ health signed a letter to the FDA, highlighting the unequal treatment between estrogen therapy for cisgender women and transgender women and urging action to address what they deemed a public health crisis.
Joel Itzkowitz, a pharmacist at Fenway Health in Boston, has witnessed intermittent shortages of injectable and topical testosterone during his nearly five years of work at the LGBTQ+ community health clinic. While the 100 mg dose of injectable testosterone is currently unavailable through Fenway Pharmacy’s drug wholesaler, Itzkowitz has the option to order the 200 mg dose.
“So the 10 mg would go unavailable, but you can get the 20. Or the 40 would go unavailable and you get the 20 and 10,” Itzkowitz explains. “So there’s always some form that’s available. So for us, we would just work with the doctor to switch the prescription to whatever the current formulation that’s available and adjust dosing based on whatever is currently available. So the patients aren’t going without.”
According to Itzkowitz, the constant presence of news stories, pandemic surges, and panic buying of medications that are running out of stock has a continuous impact on the supply of numerous drugs. Currently, the FDA has identified over 130 drugs that are experiencing shortages.
To ensure that patients never go without their hormone therapy, Itzkowitz suggests several options, such as:
– Opting for mail-order prescriptions.
– Exploring different pharmacies that work with wholesalers.
– Seeking telehealth care in a different geographical area.
– Requesting doctors to rewrite prescriptions for different doses that can be divided.
– Contacting a health center that specializes in transgender healthcare.
Struggling to Gain Access to Transgender Healthcare
Access to gender-affirming healthcare for transgender individuals in the United States is hindered by various obstacles, including health insurance limitations and legal complexities. According to a 2015 survey conducted by the National Center for Transgender Equality, while 78 percent of transgender adults have expressed a desire for hormone therapy at some point in their lives, only 49 percent have actually received it.
Obtaining a doctor’s prescription for hormone therapy is merely the initial step towards receiving the necessary treatment. Additional challenges include the cost of medication and locating a pharmacy that is willing and able to fulfill the prescription.
Williams and Kaydee, for instance, encountered pharmacies that stocked their required hormones but were unwelcoming towards transgender patients, prompting them to switch to different pharmacies. In one instance, Williams was denied his prescription because his appearance did not match the “F(emale)” designation on his identification.
In September 2022, Williams began visiting a compounding pharmacy that formulates its own testosterone, thus avoiding supply chain issues. Since then, he has not encountered any problems obtaining his prescriptions. However, he is required to pay $75 for each visit, submit paperwork to his insurance for reimbursement, and endure up to an hour-long drive each way to reach the pharmacy.
He’ll do everything because these changed his life. He talked about how he felt when he started his testosterone in 2020: “For the first time in my entire existence, I had felt good, I felt happy, I was confident in a way that I never really thought I would be,” Williams said. “When it’s taken away from you, you go back into a place that you never wanted to see again.”
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