Exploring Views Regarding 'Over the Counter' Vaginal Oestrogen and Expansion of HRT

Champion K, Cotzias E, Bruce E, Guys and St Thomas’ Hospital Trust, London, UK.

Background;

Symptoms of menopause affect many women, compounded by a lack of knowledge regarding, and access to, treatment options including hormone replacement therapy (HRT). Post-hoc analysis from the REVIVE EU Study, reported that only 27% of woman with symptoms of vaginal atrophy were receiving treatment (1) despite the fact none of the risks associated with systemic HRT have been demonstrated with local vaginal oestrogen therapy (2).

July 2022 Gina 10 microgram Estradiol vaginal tablets was reclassified from a ‘prescription only medication’ to a ‘pharmacy medication meaning it can be bought over the counter (OTC) for £29.99 for 24 vaginal oestrogen tablets (compared to £9.65 UK prescription price) by women in the UK over 50, who have been amenorrhoeic for at least 1 year.

We aimed to explore British Menopause Society (BMS) member’s views regarding;

Concerns, benefits, and impact of vaginal oestrogen being available to purchase OTC? 

Whether other forms of HRT should be available OTC? 

Whether a broader range of women should be able to access OTC vaginal oestrogen?

Results:

94% Saw benefits of vaginal oestrogen being available to purchase OTC.

68% Noted improvement in ease of access to vaginal oestrogens, allowing the bypassing of GPs.

24% Emphasised empowerment and autonomy the change provided women (see figure 1). 

52% Had no concerns regarding the change.

25% Voiced concerns that patients would not receive a full diagnostic review.

13% Voiced concerns regarding cost- RRP is 3x a standard NHS prescription cost.

12% Cited lack of sufficient counselling when purchasing as a major issue.

70% Supported widening eligibility criteria to perimenopausal, amenorrhoeic for >1y, age <50.

79% Did not believe other forms of HRT should be available OTC.

Discussion:

The majority supported reclassification of vaginal oestrogens due to the ease it presented women in accessing menopause treatment and their reassuring safety profile.

Concerns were raised regarding safety, particularly in those with a history of breast cancer, and misdiagnosis by women of vulval cancer/lichen sclerosis as vaginal atrophy. Concerns were also raised regarding the price potentially limiting access for women from lower socio-economic backgrounds.

 Many felt women might miss out on the systemic benefits of HRT or experience under treatment of their vaginal symptoms if not reviewed by a doctor. It was felt these issues could be minimized by affective counselling at time of purchase, but it was felt further pharmacist training beyond the existing protocol and safety list would be required, alongside educating the wider population.

Conclusions:

Vaginal oestrogens being available OTC is supported by the majority of BMS members.

Further education/publicity  amongst both medical professionals and the general population is required to expand knowledge on use/availability of OTC vaginal oestrogen as well as optimise management of both systemic and local menopausal symptoms.

Although reclassifying of other forms of HRT to OTC was unsupported, expansion to allow other women (perimenopause etc.) to access vaginal oestrogen OTC was popular due to the low risk profile.