Hormone replacement therapy could be made available over the counter in the UK for the first time under proposals to reclassify one form of the treatment, vaginal oestrogen tablets, which are used to offset symptoms of the menopause. The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on plans to make Gina 10 vaginal tablets available from pharmacies. The regulator denied reports that suggested all forms of HRT could become available without a prescription. This product is only inserted into the vagina and not taken orally. The consultation follows a series of recent moves by the government to improve accessibility of HRT. The Guardian reported last year how ministers were planning to “reset the dial” on women’s health to tackle decades of gender inequality in England, with plans to appoint a women’s health tsar, eradicate medical taboos, ban harmful “virginity repair” operations and increase menopause support. It has already been announced that the cost of repeat prescriptions for HRT is to be significantly reduced in England. Millions of women in the UK go through the menopause every year, with the majority experiencing some symptoms that can be severe and have a negative impact on everyday life. The particular type of vaginal tablets – called Gina 10 or estradiol – that could be reclassified, are a form of HRT that treat vaginal dryness, caused by oestrogen deficiency in postmenopausal women. GPs, pharmacists and the public are being asked for their views on whether this product should become available over the counter, without a prescription. If reclassified, it would only be made available over the counter to women aged 50 and above who have not had a period for at least a year. Pharmacists would have access to training materials and a checklist enabling them to identify women who can be supplied with this medicine safely. Dr Laura Squire, the 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.” The minister for women’s health, Maria Caulfield, said menopause support was a key issue the government needed 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 the menopause on their lives,” she said. The Proprietary Association of Great Britain (PAGB), which represents the makers of branded over-the-counter medicines, welcomed the move as a “positive step”. Michelle Riddalls, its chief executive, said: “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 wellbeing 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.” But Fiona McKay, a businesswoman whose own experience prompted her to launch Menopause Maze, a programme to help women going through the menopause while in the workplace, expressed concerns about the move. “This is great as a short-term access point for women who perhaps can’t get their repeat prescription and need it urgently,” she said. “However, HRT isn’t one size fits all, it’s a very individual medication and can take a real ‘trial and error’ process to get the balance of hormones right. “I worry that, by allowing increased access via over-the-counter HRT, it’s an abdication of care for women – putting the onus back on them to totally ‘self-solve’ one of the biggest life transitions that they will face.” Dr Edward Morris, the president of the Royal College of Obstetricians and Gynaecologists, said: “While we support increased access to products like Gina 10, every woman will experience the menopause differently and there is no one size fits all. It is vital that treatment is tailored to her needs and symptoms. “It is important that women feel that they can speak to a doctor about their symptoms, and discuss all the different treatments available for the menopause, including the different types of treatment which may include HRT. We will be responding to the consultation.”
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