The MHRA has launched a public consultation on whether hormone replacement therapy (HRT) should be available from pharmacies.
Hormone replacement therapy is a treatment to relieve symptoms of menopause. It replaces hormones that are at a lower level as you approach menopause. It can help relieve most menopausal symptoms such as hot flushes, vaginal dryness, and night sweats. Some types of hormone replacement therapy can increase the risk of breast cancer, but it is generally believed that the benefits outweigh the risks.
Menopause occurs when women stop having periods and are no longer able to get pregnant naturally. It is a natural part of ageing that usually occurs between 45 and 55 years old, as a woman’s oestrogen levels decline.
Reclassifying hormone replacement therapy
Medicines and Healthcare products Regulatory Agency (MHRA) have proposed the reclassification of the first hormone replacement therapy product named Gina 10, formally known as Vagifem; microgram vaginal tablets would mean women in the UK could access a menopausal treatment over the counter at a pharmacy for the first time. This is the MHRA’s first reclassification consultation for a hormone replacement therapy product locally applied in the vagina. This product is inserted into the vagina and not taken orally.
Gina 10, a form of vaginal hormone replacement therapy, treats vaginal dryness, caused by estrogen deficiency in postmenopausal women.
Should this product be reclassified, topical hormone replacement therapy products containing estradiol will continue to be available on prescription from GPs. The Commission on Human Medicines has advised that it is safe for this product to be made available as a Pharmacy (P) medicine.
Consulting the public
The MRHA is consulting GPs, pharmacists, and members of the public for their views on whether this hormone replacement therapy product should become a pharmacy medicine and be available over the counter, without a prescription. This product would be available to women over 50 years and above who have not had a period for at least one year.
This is the first time such a change has been considered and the MHRA stress the importance that women’s and the public’s views are heard.
Pharmacists are trained healthcare professionals. If the product is reclassified, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied with this medicine safely.
Dr Laura Squire, Chief Healthcare Quality and Access Officer at the MHRA, said: “Every response we receive will be vital in helping us gain a better picture of whether people think this form of vaginal HRT should be available over the counter.
“The menopause can cause unpleasant symptoms and HRT-based medications form an important part of alleviating them. This is why it’s so important for us to hear what women think about this possible reclassification.
“We want to hear from as many people, health care professionals and women’s groups as possible.”
Minister for Women’s Health, Maria Caulfield, said: “As a woman and a nurse, I know how challenging the symptoms of menopause can be. In the Women’s Health Strategy call for evidence, women across the country were clear – menopause support is a key issue which we need to do more to address.
“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 menopause on their lives.
“More widely, we’ve set up a UK-wide Menopause Taskforce and we’ll continue to address menopause as part of the Women’s Health Strategy, as well as working with campaigners and stakeholders, to make sure we’re supporting women as best we can.”