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The UK Medicines and Healthcare products Regulatory Agency (MHRA) have launched a public consultation on whether to make Gina 10 microgram vaginal tablets (Estradiol) available without prescription.
Prof Maralyn Druce, Professor of Endocrine Medicine, Queen Mary, University of London; and member of the Society for Endocrinology, said:
Is this about all HRT or about one specific drug?
“This is about one specific preparation. Although it falls under the ‘HRT’ remit it is a local oestradiol product. Minimal oestrogen is absorbed into the bloodstream; it is administered into the vagina for local effects and mainly to deal with the symptoms of vaginal dryness and discomfort that menopausal women experience due to the drop in their oestrogen levels. The treatment is likely to be aimed at improving quality of life and the drug is not absorbed sufficiently to provide the other impacts of HRT (such as impact on bone mineralisation).
Is this product actually HRT or is it something different?
“It is a local oestrogen product but does not provide systemic replacement or a progesterone component.
What do we know from evidence about what could be the pros and cons of making this drug available without prescription?
“There is pretty good evidence for the safety of this drug. There is likely to be a small amount of local absorption so if someone had or has a hormone-dependent pelvic cancer this would still be a potential consideration and should be discussed with their medical practitioner. An advantage is that patients can access it promptly and without consultation, a potential disadvantage is that they may miss out on the opportunity for a detailed consultation about other aspects of systemic HRT options and to take the time with a professional to consider what might be available for them and what the pros and cons might be of all the choices that are available.”
Dr Asha Kasliwal, President of the Faculty of Sexual and Reproductive Healthcare (FSRH), said:
“We strongly support improved access to menopause care, including to treatment such as HRT.
“The Faculty of Sexual and Reproductive Healthcare (FSRH) is aware of proposals to make one method of HRT, a vaginal estrogen tablet (Gina 10 microgram vaginal tablets), available without prescription in pharmacies. This method is indicated for the treatment of vaginal atrophy in postmenopausal women aged 50 years and above, who have not had a period for at least one year.
“We will respond to the public consultation and work with the Medicines and Healthcare Products Regulatory Agency (MHRA), who is consulting on the proposals, to ensure that all women have access to safe and timely menopause treatment. It is equally important that women can access all the help and information they need, to make the best decision about their own treatment.”
Declared interests
None received.