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Vaginal estrogen to be made available without a prescription in the UK, says MHRA

Vaginal estrogen to be made available without a prescription in the UK, says MHRA

Postmenopausal women will be able to access Gina vaginal estrogen over the counter for the first time from September 2022.

Postmenopausal women will be able to access vaginal estrogen over the counter for the first time in the UK after the Medicines and Healthcare products Regulatory Agency (MHRA) gave the green light.

Gina 10 microgram vaginal tablets (containing estradiol) will be available without a prescription from September 2022.

A vaginal hormone replacement therapy (HRT), Gina is used to treat vaginal atrophy caused by estrogen deficiency in postmenopausal women aged 50 years and over who have not had a period for at least one year.

Decision made following safety review and consultation

The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public consultation which sought views from patients, pharmacists, prescribers and stakeholders.

The consultation received 1,229 responses, with over 88% being in favour of the reclassification.

Increased access to treatment

MHRA chief healthcare quality and access officer Dr Laura Squire said: ‘This is a landmark reclassification for the millions of women in the UK who are going through the menopause and experience severe symptoms that negatively impact their everyday life.

‘Women will be able to safely obtain a local vaginal HRT product without a prescription, which increases women’s access to treatment and gives them greater control over their choices while relieving pressure on frontline GP services.’

Well-established safety profile

Low-dose vaginal estradiol has been widely used for the treatment of postmenopausal vaginal symptoms as a prescription medicine since 1991 and has a well-established safety profile.

Pharmacists will have access to training materials and a checklist to advise women on whether the treatment is appropriate and safe for them to use and to give information they need to make informed choices.

Other vaginal tablets containing estradiol, including Vagifem 10 microgram vaginal tablets, will remain available on prescription.

Step in right direction – but with exclusions

Newson Health Menopause Society chair Dr Louise Newson said: ‘This is a certainly a step in the right direction that women will be able to buy this treatment to improve their localised symptoms.

‘It is known that the majority of menopausal women experience symptoms related to vaginal dryness and urinary symptoms yet only the minority receive treatment.

‘However, it is going to cost around £30 for one packet which will last around three months which clearly is expensive.

‘Also there are many exclusions – for example women who have had cancer in the past, women who are under the age of 50 and women who have a risk of clot will not be able to buy Gina – despite this treatment being very safe and not systemically absorbed. This clearly will mean that many women suffering with these symptoms will still not be able to buy this product.’

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