How to Deal With a Shortage of Hormone Replacement Therapy Drugs

BYLINE: Claire Mulhern

Newswise — Use of hormone replacement therapy to relieve symptoms of perimenopause and menopause has nearly doubled over the past decade, according to an Epic Research study released in July. That growing demand has made it harder for manufacturers to keep up, creating shortages of some medicines, especially transdermal patches.

Shalini Gupta, an assistant professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at Rutgers Robert Wood Johnson School of Medicine, explains how these medications work and what patients can do if they cannot get their prescriptions filled.

What symptoms might lead someone to consider hormone replacement therapy, or HRT? The strongest reason to use HRT is bothersome vasomotor symptoms, such as hot flashes and night sweats.

I also recommend it when menopause-related symptoms are affecting quality of life, including disrupted sleep, especially when night sweats are the cause, as well as vaginal dryness, painful intercourse, burning or irritation, and urinary symptoms tied to menopause, such as urgency and recurring urinary tract infections.

Mood changes, weight gain, reduced libido, brain fog and joint pain may improve indirectly, but on their own they are not the most evidence-based reasons to use systemic HRT.

What forms of medication are available?

There are many options, which allows treatment to be tailored to each patient.

Systemic estrogen can come as an oral tablet, transdermal patch, topical gel or spray. These medicines raise estrogen levels in the bloodstream and can treat hot flashes, night sweats and other systemic symptoms, along with 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 concerns, helping ease dryness, burning, painful intercourse, urinary discomfort and recurring 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 cases through a progesterone-containing intrauterine device, or IUD. I tell patients that estrogen grows the lining of the uterus and progesterone protects it. Progesterone is prescribed with systemic estrogen therapy for patients who have a uterus to reduce the risk of excessive uterine lining growth and endometrial cancer.

What do you tell patients who cannot get their medication?

I usually do not advise stopping treatment before speaking with a physician.

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

If one strength is unavailable, see whether the dose can be supplied through a different available formulation. If patches are still 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.

Patients can also ask about mail-order or online pharmacies, which sometimes rely on 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 a temporary solution.

Can patients or doctors do anything to speed up the process of getting more estrogen on the market?

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

More broadly, professional societies and patients can advocate for more manufacturers, greater production capacity, dependable 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 encouraging effect of the higher demand is that more people are seeking treatment for symptoms that can significantly affect quality of life.