UK Watchdogs considering over-the-counter vaginal estrogen for the first time
At present in the UK, all types of HRT and all local vaginal hormone treatments need a prescription from a doctor or a nurse after consultation with the patient. Reports this week confirm that the regulatory body for medicines (the MHRA) has begun a consultation process to allow a 10 microgram estradiol vaginal tablet to be given over-the-counter in pharmacies without the need for a prescription.
Also known as Vagifem, Gina is a vaginal pessary (or tablet) containing 10 micrograms of estradiol and it is prescribed for those experiencing genitourinary syndrome of menopause (GSM) which includes symptoms of dryness, soreness, irritation, frequency and urgency of urination, and incontinence, as well as an increase in infections like cystitis.
The estradiol tablet is inserted into the vagina, usually at night time so it can stay in place for several hours, and it is effective at relieving symptoms, improving urinary function, reducing episodes of UTIs and minimising pain and discomfort for women.
Symptoms relating to GSM affect around 80% of women, but currently in the UK only around 8% of those suffering receive treatment for these often embarrassing symptoms despite the severe impact it can have on many women’s quality of life.
This is the first consultation of its kind relating to re-classifying hormone treatments for the perimenopause and menopause and the consultation is open to healthcare professionals and members of the public to give their views and can be done via this link before the 23rd February 2022.
The consultation only relates to women over 50 years receiving the Gina product specifically, and if they have not had a period for at least 12 months. If the product is reclassified, pharmacists will have the appropriate training to identify which women can be given this product. The Commission on Human Medicines has agreed that it is safe for this product to be made available as an over-the-counter treatment.
Vaginal estrogen products are not the same as systemic HRT as very little estrogen is absorbed into the bloodstream, and they are widely considered a very safe and effective treatment that can be used on its own or alongside systemic HRT, and can be taken long term with no associated risks.
For clinical guidelines on the management of GSM, including details of the various types of vaginal estrogen products click the button below.