How to Navigate the Shortage of Hormone Replacement Therapy Medications

The number of women using hormone replacement therapy to ease the symptoms of perimenopause and menopause has nearly doubled in the past decade, according to a study released by Epic Research in July. The rising demand has made it difficult for drug manufacturers to keep pace with demand, leading to shortages of some medications, particularly transdermal patches.

Shalini Gupta, an assistant professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at Rutgers Robert Wood Johnson School of Medicine, discusses how the medications are used – and what patients can do if they have difficulty getting their prescriptions filled.

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What are the symptoms that might make someone consider hormone replacement therapy, or HRT? The clearest indication for HRT is bothersome vasomotor symptoms, including hot flashes and night sweats.

I also recommend it when menopause-related symptoms are meaningfully affecting quality of life, including sleep disruption, particularly when night sweats are driving the problem, vaginal dryness, painful intercourse, burning or irritation and urinary symptoms related to menopause, such as urgency and recurrent urinary tract infections.

Mood symptoms, weight gain, loss of libido, brain fog and joint pain may improve indirectly, but they are not, by themselves, the strongest evidence-based indications for systemic HRT.

What forms of medication are available?

There are many options, which is helpful because treatment can be tailored to individual patients.

Systemic estrogen can be given as an oral tablet, transdermal patch, topical gel or spray. These medications raise estrogen levels in the bloodstream and can treat hot flashes, night sweats and other systemic symptoms, as well as vaginal symptoms.

Local vaginal estrogen is available as creams, vaginal tablets or inserts, and vaginal rings. Most of these products deliver very small amounts directly to vaginal and vulvar issues, helping relieve dryness, burning, painful intercourse, urinary discomfort and recurrent urinary tract infections. Very little estrogen reaches the bloodstream.

Progesterone can be taken orally, as part of combination estrogen-progesterone tablets or patches, and in some situations through a progesterone-containing intrauterine device, or IUD. I tell patients estrogen grows the lining of the uterus and progesterone protects the lining. Progesterone is prescribed along with systemic estrogen therapy for patients who have a uterus to reduce the risk of excessive growth of the uterine lining and endometrial cancer.

What do you tell patients who are unable to obtain their medication?

I generally do not recommend stopping treatment without first speaking with a physician.

My approach would be to ask a pharmacist to check other pharmacy locations and wholesalers or allow substitution among equivalent Food and Drug Administration–approved manufacturers when appropriate, rather than insisting on one generic manufacturer or brand.

If one strength is unavailable, see whether the dose can reasonably be supplied using a different available formulation. If patches remain unavailable, consider an equivalent estradiol gel or spray. Oral estradiol may also be reasonable for some patients, although it is not automatically interchangeable from a risk standpoint.

Ask about mail-order or online pharmacies, which sometimes use a different supply chain.

Most importantly, patients should contact their pharmacy or physician before they run out of medication so there is time to find an interim solution.

Is there anything patients or doctors can do to speed up the process to get more estrogen into the marketplace?

The FDA is already working directly with all six manufacturers to increase production. However, where clinicians can help is by reporting persistent shortages and access problems and writing prescriptions that allow clinically appropriate manufacturer substitutions.

On a broader level, professional societies and patients can advocate for more manufacturers, expanded production capacity, reliable supply chains and insurance and formulary policies that do not make it unnecessarily difficult to substitute one Food and Drug Administration–approved estradiol formulation for another during a shortage.

One positive aspect of the increased demand is that more people are seeking treatment for symptoms that can significantly affect quality of life.