Explained: What's behind the shortage of HRT products?

A number of Hormone Replacement Therapy products are in short supply due to a surge in demand, according to manufacturers
Explained: What's behind the shortage of HRT products?

Muireann Duffy

Shortages of Hormone Replacement Therapy (HRT) products have become an increasing worry for women across the country who use the treatments to relieve severe symptoms of the menopause.

Earlier this week, of the seven oestrogen-only medicinal products currently authorised for HRT use in Ireland, two were contained on the Health Products Regulatory Authority's (HPRA) Medicinal Product Shortages list.

With warnings from doctors that continuity of treatment is important with HRT, health authorities both in Ireland and internationally have been pushing manufacturers to speed up production in order to ensure patients' needs are met.

Here's everything you need to know about HRT and the recent supply issues...

What is HRT?

According to the HSE, Hormone Replacement Therapy (HRT) is a treatment used to alleviate symptoms of the menopause, including hot flushes, night sweats and mood swings.

HRT products can come as tablets, gels and vaginal creams, as well as skin patches, pessaries or rings.

These therapies work by providing hormones that fall approaching the menopause, with oestrogen-only, progestogen-only and combined options available in various strengths, which a doctor can prescribe based on factors such as the severity of the symptoms and whether the uterus is intact.

HRT is usually avoided for patients who have a history of some cancers (breast, ovarian or womb), blood clots, liver disease or those with untreated high blood pressure, in addition to those who are pregnant.

What is causing the supply issues?

Manufacturers have said the supply issues impacting HRT drugs is down to a spike in demand.

In Ireland, figures from the Department of Health show the supply of the three most-used strengths of one range of HRT patches has increased by between 77-117 per cent compared to 2020.

Despite this increase in supply, the shortages are indicative of the uptick in demand, with the department adding the company "expects a similar increase in the demand for all strengths during 2022".

"This would mean that the usage of this patch in Ireland would be approximately 4.5-7.5 times higher in 2022 (depending on the strength) compared to 2019."

Similarly in England, data from the NHS shows prescriptions for HRT have more than doubled over the past five years.

The recent surge in demand has in-part been attributed to public health campaigns which have raised awareness of the various options available to those suffering from symptoms of the menopause.

What products are currently affected?

A number of the more commonly prescribed treatments in Ireland have faced delays so far this year, including oestrogen-only options Evorel, Estradot and Oestrogel.

The manufacturers of the Evorel patch said the shortages have since been addressed, while Oestrogel was removed from the HPRA's Medicinal Product Shortages list on Friday as it was due to return to shelves earlier this week.

Estradot, a patch available in multiple strengths, remains on the HPRA list. The four strengths included on the list were added at various points in mid-to-late February and the products are not expected to return until July.

How are the shortages impacting people on HRT?

The Irish College of General Practitioners' (ICGP) lead on women's health, Dr Ciara McCarthy said HRT "has a hugely positive impact on symptom control and quality of life for many women", so the lack of availability is causing anxiety for those who rely on the treatment to manage their symptoms.

The shortage has led some pharmacies to ration stocks, meaning longer-term prescriptions are not being filled in order to give short-term prescriptions to a larger number of people in the hope that supplies will level out in the meantime.

What is being done to address the shortages?

The Department of Health said the HPRA coordinates a multi-stakeholder medicines shortages framework "to prevent, where possible, and manage medicine shortage when they occur", adding that the authority is in "regular and ongoing engagement with suppliers" about the HRT shortages.

"Regarding the HRT patches, the suppliers have confirmed that they have increased the planned supply of HRT patches to Ireland during 2022 in response to this increased demand. In the interim, the company is working to find solutions to the immediate supply issues," a statement from the department said.

"The current supply situation has arisen due to significant increases in demand for HRT medicines and is not linked to regulatory matters. However, the HPRA continues to review available options within its regulatory remit to facilitate increased supply where at all possible.

"In particular, the HPRA has advised the companies that they are open to providing accelerated regulatory approval to supply a product originally intended for other markets if available. The HPRA is awaiting further information from the companies in this regard," the statement added.

What should people on HRT do?

Anyone having difficulty filing their HRT prescription is advised to contact their GP or pharmacist to discuss their options.

Dr McCarthy said GPs have received guidance from the HSE Medicines Management Programme regarding alternative and equivalent HRT products, which "may involve a change in the route of administration from the initial prescription, such as a change from an oestrogen patch to a gel, spray or tablet".

However, Dr McCarthy warned that treatment continuity is vital as "suddenly stopping HRT may result in a decline in symptom control".

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