Making menopause more inclusive : HRT and the prescription system

The prescription and availability of HRT is affected by several issues. Funding is one of them. Donna Ferguson explains why the system needs to change and how it can be done.

This series of articles has been commissioned by Eleanor Mills, Editor in Chief at Noon about the inequalities facing Queenagers in health care. This series of articles has been edited by her and reflect her editorial judgement. The articles have been paid for by Theramex.

It was just over a year ago that 49-year-old pilates instructor Molly Cooper started tasting metal in her mouth continuously. “It was this really awful taste. And I couldn’t taste anything else,” the north Londoner says. She consulted her local GP and a nutritionist. “Nobody could diagnose it.”

Six months later, after trying alternative treatments, going on a special diet, scouring the internet for answers and chatting with other women, she began to suspect she had a menopausal symptom called ‘burning mouth syndrome’. “In the end, I worked out that this problem must be to do with menopause, myself.”

She went back to her GP and “insisted” he prescribe her Hormone Replacement Therapy (HRT). “I started on HRT and the problem went away within ten days.”

But her GP only prescribed her enough oestrogel to last her a month. When that ran out, her local pharmacy couldn’t get her anymore. “I had to go back to the GP and get a different prescription.” But this new prescription was, again, impossible to fill at several local pharmacies. “They kept saying: no chance, no chance.”

As the weeks went on without any HRT, her symptoms came back, and she grew increasingly desperate. “I was on the phone endlessly. There was one day where I phoned in excess of 30 pharmacists.”

Eventually, in July, after wasting nearly 30 hours of her life trying to get hold of the HRT she needed, she managed to find a single pharmacy which could fulfil her prescription. “It turned out they work with 17 stockists. It was like finding gold dust.”

Sadly, Molly’s experience is not unusual. Across the UK, major shortages of some body-identical HRT products were reported earlier this year. The government then imposed a three-month limit on prescriptions for some HRT products, to ease nationwide supply issues. But even now, in different parts of the country, menopausal women are struggling to get hold of the different medications they need, says Kate Muir, author of Everything You Need to Know About the Menopause (but were too afraid to ask) and producer of the Davina McCall documentary about menopause on channel 4 “I put a call out on my instagram a few weeks ago asking what the situation is like around the UK. And hundreds and hundreds of women all over the country replied and said: I can’t get Estradot patches, I can’t get Oestrogel, I can’t get Lenzetto spray. There are different shortages all over the country for different products.”

Over the past five years, prescriptions for HRT have more than doubled in England, according to data collected from the NHS. One reason, experts suggest, is increased demand from patients. More and more women have realised that newer forms of HRT – body-identical HRT gels, patches and sprays, which provide menopausal women with precise duplicates of the hormones they lack – are safer and better-tolerated than the old combined pills, says Muir. “Women want body-identical HRT, they deserve it and they are taking less days off work because of it. It’s a no brainer,” she says.

But this rise in demand does not explain why there are shortages of different HRT products in different parts of the country. According to Tina Backhouse, who is the general manager of HRT manufacturer Theramex, NHS bureaucracy is the main reason why so many women face this postcode lottery.

The problem, she says, is that every local NHS Clinical Commissioning Group (CCG) and hospital trust in the country has its own process of approval for introducing new healthcare treatments locally. This is the case even for very well-regarded new medicines, like the body -identical HRT treatments which have already been approved at a national level by the Medicines and Healthcare products Regulatory Agency (MHRA).

“It’s this really antiquated system, and the approval process is full of red tape,” Backhouse says. “It relies on a doctor filling in copious amounts of forms, which is repeated in different ways in every single locality.”

At least one doctor in each different local area must “redo the same work over and over again,” she says, asking that prescriptions for a drug or treatment be approved for funding locally and put on a list of medicines known as the ‘local formulary’.

Then, the matter needs to be discussed by the area’s local formulary committee, which is made up of local medical professionals. Backhouse says: “Some of those committees have a two-year backlog, because of Covid.”

The committee may not be inclined to prioritise discussions about HRT over, for example, new, life-saving oncology drugs. “So the doctor might have to wait a while for a meeting to come up. The doctor then needs to go to the meeting, and defend why they want to prescribe the treatment. And then, the formulary committee will decide whether or not to add the drug to their list,” says Backhouse.

Only products that have been licensed by the MHRA can be added to these local formularies. Backhouse says: “The MHRA has done the work on the licence and they say it’s safe to be used, so I’m not sure what it is, at a local level, these formularies think they are doing.”

The doctors who participate are not paid anything extra for their time filling in forms or attending formulary meetings. “It takes up their time when they could be seeing patients. It just doesn’t make sense,” says Backhouse.

A system that relies on time-poor local doctors advocating for new, effective modern medicines creates a postcode lottery for treatments: “What you find is that some local formularies are very quick to take on new products, but some are not,” she says.

Carolyn Harris, the Labour MP for Swansea East and menopause champion in the UK parliament, thinks there is an easy solution to this problem: “What we need is a national formulary, a list of nationally approved HRT products,” she recently told Eleanor Mills, Founder of for this series of articles about Queenager Health Inequalities. Click to read Carolyn Harris’ interview article. The current process is stupid, she says, and needs to be fixed: “The boards aren’t meeting regularly enough. It’s just a mess.”

Although GPs across the country are allowed to prescribe any drug licensed for use in the NHS by the MHRA and the Department for Health, Backhouse says most GPs have been “conditioned” by their local CCGs to only prescribe treatments that have been approved for funding through the CCG’s local approval process – and are listed in their local formulary.

This leads to local black spots where HRT isn’t available – often not because there isn’t any, but because that local formulary hasn’t approved many different varieties and the ones that have been authorised have run out.

It also means HRT manufacturers like Theramex are stockpiling their newly licensed body-identical HRT drugs, because only a few local formularies have so far approved their products, and so only a few GPs are prescribing these new drugs: “There is a HRT shortage and I’ve got £1m-worth of HRT products in a warehouse that I will have to destroy in a year, because they will go past their expiry date,” says Backhouse.  “It’s really frustrating.”

She estimates that there are around 120 formularies across Britain, but so far only 13 have put Theramex’s latest new MHRA-approved product, Bijuve, on their list. It is the first – and only – body-identical hormone therapy treatment for estrogen deficiency symptoms in post-menopausal women, and yet few women around the country can access it. Even though it has the official greenlight.

Like Harris, Backhouse thinks the obvious solution is to set up a brand new, national formulary, which “takes recommendations from experts, stops wasting NHS time and creates equal access to HRT for all women, wherever they happen to live.”

Dr Nighat Arif, a GP with a specialist interest in women’s health, has been through the process of trying to get new HRT treatments approved by her own local formulary. “It’s a long process,” she says. Yet,  at the moment, there is “very much a postcode lottery of whether the pharmacist might have the HRT my patient needs.”

She says a national formulary has been top of her wishlist for the last five years. “I want to know that what I’m prescribing is available, and not postcode dependent.”

Muir agrees: “We need a national formulary so that every doctor in Britain looks at the same list of possible prescriptions and deals with that.” Until that happens, she fears that the current postcode lottery for HRT treatment will continue to exist and the HRT shortage will persist, even though there are “massive stocks” of Bijuve, for example, piling up in warehouses in Britain. “It’s absolutely bonkers – and yet the answer is quite simple. It would take one day to set a national formulary. One day.”

She hopes that Liz Truss’ government will see the economic case for supplying more women with HRT, which she estimates would save the NHS billions, as well as making the economy more productive. “One in ten women leave work because of menopause symptoms,” she says, citing a recent Fawcett Society poll of over 4,000 people. “

“We need Thérèse Coffey, the new secretary of state for health and social care, to listen to what we’re saying. Because if the government at the very top understands that these quick changes can be made, which would make a huge difference to women, that that will trickle down.”

At the moment, she says, “NHS bureaucracy is holding everything up.”

By Donna Ferguson

Donna Ferguson is an award-winning freelance journalist for The Guardian, The Observer, the Mail on Sunday and Good Housekeeping magazine. She is a committee member of Women in Journalism UK.

If you are fired up by watching this and would like to sign the Noon petition, backed by everyone on the panel, to make menopause a QOF then click here

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