Experts say there is a lack of menopausal care, leading to delays in care.
Dr. Stéphanie Fabion, president of the Menopause Society, said medical schools need more training on menopause to prevent misdiagnosis and improve patient care.
Physicians have been working for years to improve the care of menopausal and perimenopausal women, from training to setting standards for hormone replacement therapy.
Now they fear the effort will be undermined by the lack of access to the most commonly prescribed drugs for menopause. And they’re asking the Food and Drug Administration to do more.
A women’s group led by the founders of Midi Health, the largest provider of menopause care in the United States, is meeting with FDA officials on Wednesday, May 6, to discuss solutions to the estrogen patch shortage.
Estrogen patches have been in short supply since the beginning of the year.
The FDA told USA TODAY in April that it was in talks with the five largest patch manufacturers to ensure all companies were up to speed. Officials said they have not yet classified the difficulty in finding patches as a shortage, but some health care providers and patients disagree.
USA TODAY has reached out to the FDA for updated information.
How did we get here?
According to a recent Midi survey, nearly half of women on hormone replacement therapy say they have trouble filling prescriptions for estrogen patches. More than 8,000 women from 49 states responded to the survey.
One in 10 women surveyed said they had stopped treatment due to shortages. Additionally, 9 out of 10 women said they were unsure whether they would be able to fill their next prescription.
“Women are no longer confused about menopause. They’re informed patients. They’ve found a provider, they’ve had a conversation, and now they have a prescription,” says Tamsen Fadal, Midi’s chief women’s health ambassador and author of How to Menopause. “We bring them here and say, ‘Congratulations for being here, but right now we don’t have what you need.'” Women are rationing patches and stopping treatment. ”
One-third of women surveyed said lack of estrogen patches was affecting their health.
According to the Menopause Society, hormone replacement therapy (often a combination of estrogen and progestin) is the preferred treatment for menopause.
“The shortage is only going to get worse,” says Kathleen Jordan, Midi co-founder and chief medical officer. “We need the FDA to recognize this shortage and that manufacturing is not keeping up with demand.”
Patches do more than just relieve symptoms like night sweats and irritability. Estrogen helps protect against osteoporosis and can also help improve blood pressure, mood, memory, and sex drive. Recent studies have also shown that this patch is an effective part of treatment for some men with prostate cancer.
Some women are forced to use different brands of estrogen every month, resulting in inconsistent care. Other transdermal methods that avoid blood flow, such as gels and creams, are often not covered by insurance and cost three times as much as patches.
Some drug companies blame the shortage on increased use of patches since the FDA removed black box warning labels last fall.
This warning has kept many women away from hormone replacement therapy for more than two decades, ever since a 2002 Women’s Health Initiative study linked it to an increased risk of breast cancer, heart attack, and stroke in postmenopausal women. This later-recognized risk was primarily seen in women who were older when they started hormone therapy.
The impact of this study has affected millions of women, and over the past two decades, the use of hormone replacement therapy has fallen from 40% to 5%, as many doctors stopped prescribing it, and even if they did, women were reluctant to take it.
Solution for estrogen patch deficiency
Still, use of hormone replacement therapy has remained stable over the past six years, with about 5% of menopausal or perimenopausal women using hormone replacement therapy, Jordan said. So while the label change has increased patch usage since November, it hasn’t been large enough to cause a shortage.
“The problem isn’t the increased demand for patches; it’s the manufacturers,” Jordan said. “As access to care improves, demand will only increase.”
Some companies, including Bayer, have stopped producing patches in 2023. Sandoz, one of the leading manufacturers of estrogen patches, is working to expand its global production capacity.
A company spokesperson told USA TODAY that the patch is more complicated and time-consuming to manufacture than other medicines. In the meantime, the company is allocating additional quantities to patients in the U.S. to meet demand.
Many women still struggle to find menopausal care, but things are improving. In recent years, more health care providers have become certified in menopause care. The nonprofit Menopause Association’s membership has quadrupled to 4,000 in the past decade. And telemedicine companies are growing, with some taking insurance, like Midi, and others offering their own medicines and supplements.
Women are also receiving hormone replacement therapy for longer periods of time. Jordan says women begin the treatment several years before perimenopause, the last menstrual period when women may experience fluctuations in estrogen. Nowadays, women often continue taking medication as long as they have symptoms, and in some cases continue to take medication until they are in their 80s.
Jennifer Weiswolf, an attorney who has advocated for improved health care for women, said insurance companies still dominate the drug access market.
“Rather, this story is an indictment of a broken insurance industry, the result of market concentration, perverse incentives, and the admission that insurance companies own the pharmacy benefit managers who effectively control drug access for the vast majority of users,” she wrote in a recent editorial in the Los Angeles Times.
Weiswolf, executive director of the Birnbaum Center for Women’s Leadership at New York University School of Law, will publish a book in October called “Menopause: A User’s Manual and Citizen’s Guide.”
She’s hopeful about the growing demand for better menopause coverage, with more than 60 bills introduced in state legislatures last year aimed at menopause education and workplace protections.
“The FDA is part of this wave of movement,” she told USA TODAY. “They can make a huge difference in ensuring all women have access to the medicines they need.”
Laura Trujillo is a national columnist focused on health and wellness. She is the author of “Stepping Back from the Ledge: A Daughter’s Search for Truth and Renewal” and can be reached at ltrujillo@usatoday.com.
