MHRA Looking into Making Menopause HRT Drugs Available Over-the-Counter

Pavankumar Kamat

February 03, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a public consultation on making Gina (estradiol hemihydrate) 10-µg vaginal tablets available to menopausal women in the UK over the counter through pharmacies.

A set of new proposals aims to reclassify the local hormone replacement therapy (HRT) product for the first time, which would enable women to purchase it at a pharmacy, without the need for a prescription.

The consultation seeks opinion from GPs, pharmacists, and members of the public on expanding the accessibility of the product for women aged 50 years and older, who have had the menopause for at least a year.

Minister for Women’s Health, Maria Caulfield, said: "This consultation is another step forward to ensure women’s voices are being heard loud and clear on how they want to access HRT to reduce the impact of the menopause on their lives."

Safety Concerns

Scores of women in the UK go through menopause each year, with many experiencing unpleasant symptoms such as vaginal dryness. HRT products, such as the drug Gina, are used to treat vaginal dryness have a direct action at the application site, with minimal systemic absorption.

"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," said Prof Maralyn Druce from Queen Mary, University of London.

The Commission on Human Medicines has deemed the product safe to be dispensed as a Pharmacy medicine.

Highlighting the pros and cons of the making the product available over-the-counter, Prof Druce added: "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.”

Support from the FSRH

The Faculty of Sexual and Reproductive Healthcare (FSRH) has expressed strong support for the public consultation. Dr Asha Kasliwal, President of FSRH, commented: "We strongly support improved access to menopause care, including to treatment such as HRT. We will respond to the public consultation and work with the 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, she added."


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