Why the HRT crisis could put women’s lives at risk: As NHS stocks run critically low, more and more women are trying alternatives – with worrying consequences
- Tens of thousands of women have been unable to get usual HRT prescriptions
- Experts now raised concerns that patients may be tempted to try other therapies
- Alternative therapies offered by private clinics, but medics say they are less safe
Women are calling it the ‘great hormone shortage of 2019’. Internet forums and Facebook groups are ablaze as women swap stories of traipsing from pharmacy to pharmacy, only to go home empty-handed, unable to fill their HRT prescriptions.
There have been reports of women bulk-buying hormone patches while on holiday in Spain, while pharmacists closer to home have said those worried about running out are asking for a six-month supply, rather than their usual three months.
Medical leaders — from the Royal College of Obstetricians and Gynaecologists, the Faculty of Sexual and Reproductive Healthcare and the British Menopause Society — have called on the Government to act, and there’s a petition, which is gaining momentum, to get the matter discussed in Parliament.
As first reported in the Mail earlier this month, tens of thousands of women up and down the country have been unable to get their usual prescription for HRT (hormone replacement therapy), while many more are left wondering if they will be able to renew theirs.
Known as the ‘great hormone shortage of 2019’, tens of thousands of women in Britain have been unable to get their usual prescription for HRT (stock image)
Paula Briggs, a consultant in sexual and reproductive health for Southport and Ormskirk Hospitals NHS Trust, says: ‘There is understandably a lot of anxiety if patients think they’re not going to be able to access something that makes a big difference to them.Patients are asking if what they’re on is going to be in short supply.’
And now experts have raised serious concerns that, faced with not being able to get their usual medication, women may be increasingly tempted to try aggressively marketed alternative hormone therapies offered by private clinics, but which medics say are less safe.
HRT is given to relieve symptoms of the menopause, including hot flushes, low mood and libido, vaginal dryness and memory problems, which can be debilitating. It works by replacing the hormones that diminish as women stop having periods.
Unless a woman has had a hysterectomy, HRT typically involves taking a combination of both oestrogen and progesterone, and sometimes testosterone. Medication can be given as a tablet, a pessary, a patch or gel applied to the skin — or a Mirena coil, which releases progesterone, can be fitted in the womb.
More than 2.5 million prescriptions are issued for HRT every year.
But slowly but surely, stocks of certain products have dwindled. Six products normally available on the NHS — including FemSeven Sequi and Conti patches and combined pills such as Clinorette and Cyclo-progynova — are out of stock, according to the latest information released by the Department of Health.
Half of all options for oral oestrogen tablets are currently unavailable. While stocks of three strengths of commonly prescribed oestrogen patches — Evorel, which has 40 per cent of the market share — are due to run out in October. Supplies of Evorel’s lowest strength patches (25mcg) are also predicted to run out by February 2020.
Now, experts have raised serious concerns that women may be increasingly tempted to try aggressively marketed alternative hormone therapies offered by private clinics (stock image)
For information about which products are in stock or not and when out of stock products are likely to be back, the British Menopause Society has recently published an update on its website (thebms.org.uk) as has the Pharmaceutical Services Negotiating Committee (psnc.org.uk).
How, then, has this been allowed to happen? Although matters seem to have reached a crisis point this month — with doctors reporting it has become increasingly difficult to prescribe oestrogen patches in particular, problems in the supply chain for some HRT medications were first reported to the Department of Health back in December 2018.
This is something that manufacturers are required to do if there is likely to be a serious interruption to stocks. However, those on the ground say the problem dates back even further.
‘We’ve had shortages of different products on and off over the past year or two,’ says Michael Savvas, a consultant gynaecologist at King’s College Hospital London and member of the British Menopause Society’s medical advisory board. The production of several strengths of Elleste tablets was ‘interrupted’ according to its manufacturer Mylan, which said this was due to an issue with its ‘manufacturing partner’.
Then, in an unrelated incident, the firm behind a number of patches had issues relating to the quality of the glue that sticks them to the skin.
The shortage of these products — which have been unavailable since the end of last year — appears to have had knock-on effects. When patients couldn’t get hold of their usual drug, they were prescribed another, and suddenly a disproportionately high number of people were after the same drug, resulting in pressure on supplies.
WHAT’S OUT OF STOCK?
- FemSeven Conti combined skin patches. Contain oestrogen (estradiol hemihydrate, 1.5mg) and progesterone (levonorgestrel, 0.525mg). DUE BACK IN STOCK: Feb 2020
- FemSeven Sequi skin patches. Contain oestrogen (estradiol hemihydrate, 1.5mg) and progesterone (norehisterone acetate, 1.5mg) DUE BACK: Feb 2020
- Zumenon oral tablet. Contains oestrogen only (estradiol hemihydrate). DUE BACK: Mid-September
- Bedol oral tablets, 2mg. Contain oestrogen only (estradiol) DUE BACK: Not known
- Clinorette combined HRT tablets. Contain oestrogen (estradiol, 2mg) and progesterone (norehisterone acetate, 1mg) DUE BACK: Not known
- Climanor oral tablets. Contain progesterone (medroxyprogesterone, 5mg). DUE BACK: Not known
SOURCE: Department of Health Pharmaceutical Services Negotiating Committee
That’s certainly the case with the widely prescribed Evorel patches. According to the manufacturer, Janssen, the current shortage is down to ‘an unusual increase in demand’.
Many people posting online have wondered if the threat of a No Deal Brexit is a factor. But according to the Pharmaceutical Services Negotiating Committee (which acts as a go-between for pharmacies and the NHS) this is not thought to be the case.
Although the PNCS has previously highlighted that the prospect of a No Deal Brexit was affecting supplies of other drugs, such as the painkiller naproxen, HRT is ‘not one that’s been picked up as a particular concern’ according to a spokesman.
It’s also possible, some experts have suggested, that shortages have been triggered at least in part by more women asking for HRT, as confidence grows that it is safe. This comes in the wake of high-profile support from celebrities such as Mariella Frostrup and books such as Oestrogen Matters, published last year by two doctors, which made the case for HRT.
This is contrary to previous reports and outdated evidence — that has since been debunked —suggesting it can significantly raise the risk of breast cancer. The NICE guidelines were changed in 2015 to encourage the prescribing of HRT, urging that twice as many women could benefit than do so currently.
‘Some of the current shortage is due to manufacturing problems, but some of it is due to increased demand,’ confirms Louise Newson, a GP specialising in menopause and author of the Haynes Menopause Manual. ‘I think as messages have filtered through about the benefits and safety there is more confidence around HRT and women do feel more empowered to ask for it.’
‘There’s definitely been an increase in interest lately,’ adds Dr Briggs.
‘In our area, we recently ran an informal drop-in session for women considering HRT and 350 turned up!’
So what can you do if you are affected by the great hormone shortage?
While acknowledging the severity of the current supply problems, all of the experts Femail spoke to for this piece were keen to reassure women that there are still effective HRT alternatives to their usual brand available — although GPs rather than menopause specialists may not have been updated about which products are and aren’t in stock.
‘Women who find they can’t get their usual products should go back to their prescribing doctor, who should be able to find a good equivalent,’ says Dr Savvas.
Haitham Hamoda, a consultant gynaecologist at King’s College Hospital, London, and chair of the British Menopause Society, advised that doctors should ‘find equivalent types by looking at the oestrogen and progestogen component and matching it as closely as possible to another brand’.
Experts say the alternative therapies offered by private clinics are less safe (stock image)
Meanwhile, Dr Newson suggests that women who find they are unable to get their oral oestrogen tablet — such as Mylan’s Zumenon, which is in short supply — should consider asking their doctor about alternative forms of oestrogen, such as a gel or patch, as evidence suggests these may be safer.
‘I tend not to prescribe oestrogen as a tablet any more,’ she says. ‘When oestrogen goes through the skin as a patch or gel there’s no risk of blood clots. This is because it doesn’t have to be processed by the liver, which produces clotting factors.’
Tania Adib, a consultant gynaecologist at Queen’s Hospital in Romford, who also sees patients privately (adib.org.uk), adds that if you are switched to a different brand of patch and find it doesn’t work as well, it may be that the dose needs adjusting.
‘Different products absorb slightly differently as the ‘carrier’ products they use alongside the active hormone will vary – and it will depend on your skin type, too,’ she explains. ‘The same dose of gel will be absorbed differently by different women. So you may find you need a higher dose of a new product.’
SAFETY FEARS
In 2000, six million HRT prescriptions were issued.
But this has fallen by two-thirds, due to studies — since branded overblown — linking it to cancer.
Saska Graville, who runs Mpowered Women, a website which aims to break taboos around menopause and provide women with reliable information (mpoweredwomen.net), understands why women might feel they have nowhere else to turn.
She says: The NHS, wonderful as it is, is not good enough at supporting women through the menopause. With GPs, it’s a lottery whether you’ll get one who is really helpful — because many aren’t.’
For Deborah Tydings, 55, an IT director from Kingston, South-West London, this was certainly the appeal of going to a private clinic where she was prescribed a customised mix of hormones, known as compounded bio-identical hormones.
This is where the exact dose of hormones varies from one woman to the next and some swear by this — including celebrities such as Patsy Kensit, Kelly Hoppen and Jeanette Winterson.
‘I can talk to my consultant without the pressure you feel you’re under with your GP,’ says Deborah. ‘They are welcoming and understanding and, at times, the same can’t be said for women looking for help on the NHS.
‘I pay approximately £200 every four months for the medication and on top of that there are fees for consultations, blood tests and pelvic scans.’
Dr Newson says it is not unusual for women to spend as much as £500 a month on HRT at private clinics.
Quite apart from the financial burden, this week the British Menopause Society and the Royal College of Obstetricians and Gynaecologists issued a joint statement expressing serious concerns about the safety of these compounded forms of HRT, which are not as well regulated and researched as the products used by the NHS and many other private doctors.
‘Every expert in the field shares the concerns about compounded hormones: it’s unsafe, untested and unnecessary,’ said Haitham Hamoda in a statement at the time.
‘I am worried women will turn to these alternative forms if they can’t get their usual products on the NHS,’ says Dr Newson.
‘Women are paying a lot for something that there’s no evidence is any better than what you can already get on the NHS.
In particular, there are serious concerns these compounded HRT could increase the risk of cancer of the womb lining.
‘It’s very important if you’re taking oestrogen that you also get enough progesterone to prevent cancer of the endometrium (womb lining),’ says Dr Savvas.
‘Oestrogen causes the lining of the womb to thicken — this happens naturally in younger women every month — and then progesterone causes the lining to be thin and shed again.
‘If women on HRT don’t get enough progesterone as well as oestrogen, they can develop endometrial hyperplasia — or a thickened endometrium — which is pre-cancerous.’
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