OTC HRT gets green light
Soon, for the first time ever in the UK, postmenopausal women aged 50 and over will be able to buy HRT over the counter from pharmacies.
MHRA, the medicines regulator, has approved the POM to P switch of Gina 10mcg tablets, following a consultation that saw 88 per cent of respondents – including pharmacists, prescribers and members of the public – voiced their support.
Gina tablets contain estradiol and are indicated for 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 one year. They are designed to be inserted into the vagina and gradually release into the vaginal tissue, with very little absorption into the bloodstream, says the MHRA. Low-dose vaginal estradiol has been widely used for the treatment of postmenopausal vaginal symptoms since 1991 and has a well-established safety profile.
From September, pharmacies will be able to supply Gina when it is considered safe and suitable to do so, following consultation with a pharmacist.
MHRA chief healthcare quality and access officer Dr Laura Squire called the switch “a landmark reclassification” for millions of women. Health minister Maria Caulfield added: “We’re putting women’s health to the top of the agenda – our Women’s Health Strategy [see story below] is testament to that.”