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Menopause awareness and support
Bay Area biotech giant Genentech is offering a comprehensive program to help women employees going through menopause. On the Nine, Gasia Mikaelian speaks with Cori Davis, Genentech's Chief People Officer, and Lisa Raja, a certified menopause coach, on the topic that has historically been a "taboo" topic of discussion in many spaces.
SAN FRANCISCO - An increasing number of women who use estrogen patches to help deal with perimenopause and menopause symptoms have been scrambling to access their transdermal drug amid a nationwide shortage of the increasingly popular hormone replacement therapy.
In recent years, demand for the patches has grown as updated health guidelines for hormone therapy and increased awareness surrounding menopause have emerged.
"There has been a very significant awareness brought to menopause and menopausal management, and many people now are getting the message that they should be on estrogen therapy, regardless of whether or not they have symptoms or even before they have symptoms," UCSF obstetrician and gynecologist Dr. Tami Rowen shared with KTVU.
Pharmacy chains are pointing to manufacturer supply interruptions, which have largely affected the twice-weekly estradiol patches.
"Manufacturers have been unable to provide sufficient supply of hormone replacement therapies (HRT) over the last several weeks," CVS Health spokesperson Roslyn Guarino confirmed to KTVU in an email.
Amazon Pharmacy is notifying many customers that it's been unable to fill prescriptions for the popular estradiol twice-weekly patches.
"This medication may be periodically unavailable until this shortage is resolved. We apologize that your order is impacted by this industry-wide shortage. Unfortunately, we are unable to provide a date when this shortage may be resolved," Amazon Pharmacy sent out to customers who use the patches. "You can speak to your prescriber's office about alternatives to prevent a lapse in your therapy," the online drug provider advised.
Benefits of estrogen patches
The patches are touted as an effective and convenient remedy for many women struggling with the effects of perimenopause and menopause.
"It can relieve symptoms like hot flashes, trouble sleeping, anxiety, depression, skin and hair changes, ‘brain fog’ challenges to memory and focus as well as addressing the many other symptoms of menopause that occur," according to Chief Medical Officer Dr. Kathleen Jordan with Midi Health, a Silicon Valley-based virtual clinic designed for women experiencing midlife hormonal changes.
"By addressing these symptoms, these therapies can overall improve a woman’s quality of life while also supporting long term bone, metabolic and heart health, and overall health outcomes," Jordan explained.
The doctor said her practice has seen shortages intermittently over the past several years.
"But the last few months it’s been more widespread with more patients affected than ever before," Jordan explained.
Black box warning removed
Dig deeper:
Experts noted that supply disruptions ramped up around November, when the Food and Drug Administration announced it was removing the black box warnings from estrogen patches and many other menopausal hormone therapy (MHT) products.
The FDA’s move led to increased demand for the patches as women have felt more comfortable using the hormone replacement therapy as a safe option.
Rowen said the removal of the black box warning may have also spurred more doctors to recommend HRT for women.
"I never practiced according to the black box warning, because anyone that does menopausal medicine, was very aware of the limitations, and we always were all very good at having risk-benefit alternative conversations with our patients," the doctor shared, adding, "But I imagine many other providers were and patients also were more reticent to use these products when there was a black box warning and now that it's been removed and publicized that it was removed, I can see why there would be a significant increase in demand."
What they're saying:
Estrogen patch manufacturer, Viatris, said it is meeting its supply demands but acknowledged the industry-wide issue. "We know demand for this product has increased," a company spokesperson said, "and we are currently taking steps to optimize current capacity and further expand production long-term."
Companies like Bayer, which manufactures the drug under the brand Climara, offer a once-weekly transdermal patch.
In an email correspondence, the company told KTVU that its patch "remains an active product on the market in the United States."
Communications Director Nicole Hayes added, "As with many prescription products, availability can vary by distributor and pharmacy."
Twice-weekly vs. once-weekly
Dr. Rowen said the twice-weekly patches tend to be the more favored method over the once-weekly estradiol patches.
"We usually prefer the twice-weekly because they're smaller, and when you change it once a week, sometimes by the last day or two, it starts to peel off a little bit. It can cause more irritation. So I've been trying to do an alternative of giving people Climera, which is the weekly, but even that is now running low."
Big picture view:
Rowen said the supply issue is demonstrative of a bigger problem when it comes to women’s health.
And she expressed disappointment that the industry was not more prepared. More than one million U.S. women enter menopause each year.
"I think this is low-hanging fruit for the pharmaceutical companies. I'm surprised and disappointed that they hadn't been upping their manufacturing because this was such a huge market in general," the UCSF expert said. "I keep saying, you know, this is one of the issues with menopausal medicine is that, this is over half the population. Every single person with ovaries is going to go through menopause."
The doctor also noted that the percentage of women on menopausal hormone therapy is currently low, in the single digits. It plummeted after the 2002 Women’s Health Initiative report, which led to the FDA’s boxed warnings. But with the agency's latest move related to MHT, the numbers are expected to see a resurgence.
SEE ALSO: This Bay Area company is leading the way in menopause care for workers
"I'm just very surprised that the manufacturers weren't reading the tea leaves on this," Rowen said.
Alternative therapy options
Despite the shortage of patches, the doctor said, the positive news is that there are a number of hormone therapy options out there.
"A lot of times in the menopause space, we talk about how transdermal is preferred, and that may be the case," Rowen said, adding, "The patches are oftentimes just the easiest to talk about, but a lot of people aren't familiar with the alternatives."
They range from oral therapy, to other transdermal options that come in the form of a gel or a spray, to Femring, a prescription vaginal ring that contains estradiol.
Rowen said manufacturers need to be prepared for the increased demand across the board.
"Those alternatives, especially the transdermal formulations, they need to start upping their production as well," the expert stressed.
There can be side effects or drawbacks with each therapy, so the bottom line is patients should discuss with their health care provider what the best option would be for them.
Doctors also recommended patients might first try and get their prescription filled at other pharmacies, though it may be months before the supply issue is resolved.
"Their first response is often to check if other pharmacies might have what they need but as the shortage impacts more pharmacies this is becoming increasingly difficult," Dr. Jordan said.
Women can also check with the American Society of Health-System Pharmacists' website to see what brands are affected by the shortage.