LTB 362/22 – Postmenopausal HRT medication now available for over-the-counter purchase at high street Pharmacies from this month following Landmark MHRA Reclassification

No. 362/2022

9 September 2022

Our Ref:  P4/22 

To:  All Branches

Dear Colleagues,

Postmenopausal HRT Medication Now Available For Over The Counter Purchase At High Street Pharmacies From This Month Following Landmark MHRA Reclassification:

For the first time ever, from this month, September 2022, postmenopausal women in the UK will now be able to access a low dose Hormone Replacement Therapy (HRT) product from their local pharmacies via straight forward over the counter purchase without prescription. This follows an announcement by the Medicines and Healthcare Products Regulatory Agency (MHRA) in July.

The decision to reclassify the medication ‘Gina 10 microgram tablets’ follows a safety review by the MHRA, independent advice from the Commission on Human Rights (CHM) and a public consultation. The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists, the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.

This Low-dose HRT medication treatment of postmenopausal symptoms has been a prescription medicine since 1991 and has a well-established safety profile. The product will be supplied from a pharmacy when it is considered safe and suitable to do so, following consultation with a pharmacist.

Pharmacists are trained healthcare professionals. They will have access to training materials and a checklist that will enable them to advise women on whether these low dose vaginal tablets are appropriate and safe for them to use and to give the information they need, so they can make informed choices. Other vaginal tablets that also contain Estradiol, will still be available on prescription.

The MHRA stated; “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. In reaching this decision, MHRA have seen positive support from a wide range of people, including many women aged 50 years and above who could benefit from this decision. MHRA will continue to improve women’s access to medicines for menopausal care when it is safe to do so, and to place their views at the centre of MHRA regulatory decisions.”

Boots pharmacies are selling the HRT therapy drug ‘Gina’ over the counter from this week and it is due to be rolled out to pharmacies nationwide in the coming months.

A lack of oestrogen causes symptoms that affect an estimated six million women in Britain. At least half of post-menopausal women are affected but many suffer in silence, reluctant to discuss taboo symptoms. The condition can even affect patients’ mental health.

Gina is now available in Boots stores and online at £2.50 for a week’s dose. People who were only able to get treatment from their GP now have Gina as an easily available option.

‘Systemic HRT medicines’ circulate in the blood and are used to treat hot flushes and other menopausal symptoms. They include oral tablets and patches (transdermal patches) and gels which are put on the skin. ‘Local HRT medicines’ such as ‘Gina’ are applied directly to the vagina and gradually releases into the vaginal tissue with very little absorption into the bloodstream.

Yours sincerely

Dave Joyce
National Health, Safety & Environment Officer

22LTB362 Postmenopausal HRT Medication Now Available For Over The Counter Purchase At High Street Pharmacies From This Month

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