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The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently conducted a public consultation on the proposal to reclassify Gina vaginal tablets, which contain 10 mcg of estradiol, from a prescription only medicine (POM) to a pharmacy (P) medicine.1 The proposed indication for the P product is ‘treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year’.2 This is the first hormonal product aimed at relief of local symptoms resulting from the menopause to be considered for this reclassification and is a welcome step forward in self-care.
Vulvovaginal atrophy is associated with reduced oestrogen levels in vaginal tissue and is often accompanied by symptoms that include dryness, irritation of the vulva, burning sensation, dysuria, dyspareunia and vaginal discharge.3 Such symptoms can have a significant impact on a woman’s quality of life. It is estimated that symptoms of vulvovaginal atrophy affect around 4% of early premenopausal women and almost 50% of those in the late postmenopause.3 First-line treatments include non-hormonal vaginal moisturisers and lubricants. Evidence suggests that local administration of estradiol 10mcg produces a modest reduction in the ‘most bothersome symptoms’ (painful sexual intercourse, vaginal dryness and itching) with one study reporting a placebo-adjusted improvement in symptom score of 0.4 points on a 4 point scale.2 4 The proposed summary of product characteristics states that there is very low systemic absorption of estradiol and that the risks associated with systemic hormone replacement therapy (HRT) apply to a lesser extent to oestrogen products for vaginal application.2
We await the results of the MHRA’s consultation, which we hope will reflect the views of a wide range of patients and healthcare professionals. We broadly support this reclassification, as a positive opportunity to make more widely available a product that empowers women to manage vulval and vaginal symptoms attributable to the menopause. Nevertheless, there may be some challenges ahead to clarify the wording of promotional, educational and training materials so that prospective users are aware that the product addresses local rather than systemic symptoms. There is also a need to counteract misleading headlines implying that all HRT will be available without prescription.5 In addition, pharmacists will need to be able to discuss evidence of the product’s efficacy, the clinical significance of its effects and potential harms as part of a shared-decision making discussion with prospective purchasers.
Reclassification of Gina vaginal tablets and the proposal to introduce a single annual NHS prescription charge for HRT in England are small steps forward in addressing the impact that the menopause has on many women’s well-being. Despite increased recognition of widespread gender-based health inequality in the UK for a broad range of conditions, there has been little public discussion until recently about the impact of the menopause on women’s quality of life, relationships with family and friends or performance in the workplace. The average age for the menopause is 51 years, at which point over 80% of women are classified as participating in the labour market,6 and many sectors such as health and social care and hospitality have a dominantly female workforce. It has been encouraging to see greater understanding of the workplace challenges facing women during the menopause and greater recognition that more needs to be done for women during the menopause transition and to provide support in the workplace.7 8
We hope this opportunity to reclassify a topical treatment for postmenopausal vaginal atrophy is part of a move to a progressive and positive culture in which women are able to openly discuss their experiences of the menopause and are more easily able to access help and support.
Competing interests None declared. Refer to the online supplementary files to view the ICMJE form(s).
Provenance and peer review Commissioned; externally peer reviewed.
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