The MHRA (Medicines and Healthcare products Regulatory Agency) has launched a public consultation on removing prescription-only status for a locally-applied hormone replacement therapy (HRT) product to treat the cause and relieve the symptoms of vaginal atrophy.
If approved, the application by Novo Nordisk would allow over-the-counter sale of its product Gina, a vaginal tablet containing the hormone oestradiol, under the supervision of a pharmacist.Vaginal atrophy can cause vaginal dryness, soreness, itching, burning and painful intercourse. It affects around half of post-menopausal women but many do not discuss the problem with their doctor.Michelle Riddalls, CEO of PAGB, the consumer healthcare association, said: “We fully support the application to reclassify this vaginal oestrogen therapy from a prescription-only medicine (POM) to one which is available over the counter under a pharmacist’s supervision (P).
“The effects of vaginal atrophy – dryness, soreness, itching, burning, and painful intercourse caused by post-menopausal oestrogen depletion – can be hugely debilitating, affecting women’s emotional well-being and self-esteem.“Thanks partly to a growing menopause-awareness movement supported by women in the public eye, the impact of menopause and the challenge of dealing with symptoms such as vaginal atrophy is being recognised as never before.“Allowing over-the-counter sale of Gina would improve women’s access to vaginal oestrogen therapy, where appropriate, by removing the need for a GP appointment and a prescription.“Switching products from prescription-only to make them available over the counter, once their safety and efficacy has been rigorously assessed and established, is a positive step.“It enables people to self care where appropriate, minimising inconvenience for individuals and protecting NHS resources such as GP appointments for those who need them most.“The MHRA consultation is another key moment for women’s health following the reclassification earlier this year of two types of contraceptive pill from a prescription-only medicine to one which can be sold under supervision of a pharmacist.“As expert healthcare professionals, pharmacists are fully equipped to offer advice to anyone seeking information about over-the-counter medicines.“They will be given specific training to enable them to identify whether Gina is suitable for a particular individual and pinpoint any issues that might warrant further consultation with a GP or specialist.”
