Postmenopausal women will be soon able to access a low dose Hormone Replacement Therapy (HRT) product from their local chemist without prescription, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period for at least 1 year. This product is locally-applied, meaning it is inserted into the vagina and not taken orally.
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. 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.
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. 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, including Vagifem 10 microgram vaginal tablets, will still be available on prescription.
We’re putting women’s health to the top of the agenda – our Women’s Health Strategy published today is testament to that. More widely we’re continuing to work with suppliers and manufacturers to secure sustainable short-term and long-term access to HRT and our UK-wide menopause taskforce will tackle taboos and issues surrounding menopause.
Minister for Health, Maria Caulfield
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