HRT SSP

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on plans to reclassify a locally-applied hormone replacement therapy product to treat the cause and relieve the symptoms of vaginal atrophy.

The MHRA is proposing that Gina 10 microgram vaginal tablets, containing oestradiol, be made available over the counter as a “self care” product, under the supervision of a pharmacist.

The Commission on Human Medicines too has advised that the application by Novo Nordisk, which is used to treat vaginal dryness, caused by oestrogen deficiency in postmenopausal women, can be made available as a pharmacy (P) medicine.

The MHRA has been asking GPs, pharmacists and members of the public for their opinions on whether the tablets can be made available to women aged 50 and over who have not had a period for at least a year.

If the reclassification goes ahead, pharmacists will be given training materials and a checklist to help them supply the medicine safely.

Dr Laura Squire, from the MHRA, said: “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.”

Minister for Women’s Health Maria Caulfield said: “As a woman and a nurse, I know how challenging the symptoms of the menopause can be.

“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.”

Michelle Riddalls, CEO of PAGB, the consumer healthcare association, said: “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.

“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.”

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