A worldwide shortage of hormone replacement therapy medication is affecting women around the globe, leaving them unable to find relief from menopausal symptoms that range from inconvenient to debilitating, reports CBC.
Drug Shortages Canada, an online database of drug shortages and discontinuations in the country, shows that since 2017, there have been 92 shortages and four discontinuations of products containing oestradiol, a form of oestrogen commonly used in HRT drugs. The products include transdermal patches, pills, vaginal rings, topical gels and creams.
“If a woman can’t get her medication, she’s not going to be functioning as well. She’s not going to be sleeping. Her mood may drop significantly,” Dr Alison Shea, an obstetrician-gynaecologist and assistant professor at McMaster University, told CBC, adding that HRT shortages also put a burden on doctors and pharmacists, who then have to spend extra time finding alternatives for their patients.
Health Canada said while HRT drugs were mostly generally available in the country, the exception was oestrogen/progestin patches.
Complex supply chain
Mina Tadrous, a pharmacist and associate professor in the facility of pharmacy at the University of Toronto, said it can be complicated to pinpoint the exact source of a shortage.
Drugs often pass through multiple countries and several different facilities before reaching Canadian pharmacies, he said.
“If anything along that supply chain breaks, it becomes like a slow-moving train because it takes a few weeks or months for it to hit,” Tadrous said.
Also, manufacturing hormones is particularly specialised, involving specific chemical reactions and careful handling of sensitive molecules.
“You have a product that’s a little harder to make, and then all of a sudden, you also have very few companies that are active in the marketplace,” he added.
Producing a drug can take anywhere from 18 to 24 months, from sourcing raw materials to production to quality control to distribution, said Christian Ouellet, vice-president of corporate affairs at Sandoz Canada, which produces a range of HRT products.
Though there have been shortages of HRT drugs from Sandoz Canada over the past few years, Ouellet said the company was meeting demand.
With HRT drugs specifically, shortages are driven primarily by a recent surge in demand, which Ouellet said was “several times more than what it was five years ago”.
Expanding HRT use
Several experts point to social media and greater advocacy among women for their own health as factors driving demand.
A 2002 study linking HRT drugs to increased instances of breast cancer and heart disease has also been debunked in the past decade, resulting in more doctors prescribing them.
Tadrous was sceptical about seeing an end of HRT shortages without major action, like bolstering production or giving pharmacists the authority to replace a therapy that’s not available with another equivalent drug or combination of drugs.
Despite the fact that demand for HRT has grown, it’s still a relatively small market compared with other drugs, Tadrous said, noting that increasing the market size for HRT drugs – in other words, prescribing it to more women – might actually incentivise manufacturers to ramp up production overall.
“If we actually used it more often, then the pharmaceutical companies would want to make more,” he said.
A number of menopause specialists want to see access to HRT drugs expanded.
Dr Michelle Jacobson, a gynaecologist who sits on the board of the Canadian Menopause Society, thinks every woman who is of average age for menopause, doesn’t have other major health issues, and is experiencing symptoms like hot flushes and night sweats, should be offered hormone therapy.
“That is agreed upon by every guideline and every organisation out there who have opinions on menopause,” she said. But she adds that some physicians are still hesitant to prescribe hormone therapy – sometimes just from a lack of knowledge.
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