Postmenopausal women will now have access to a low dose Hormone Replacement Therapy (HRT) product from their neighbourhood pharmacies without a prescription for the first time ever in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) stated today.
For the treatment of vaginal symptoms like dryness, discomfort, itching, burning, and painful sex brought on by oestrogen insufficiency in postmenopausal women aged 50 and over who have not had a period for at least a year, use Gina 10 microgram vaginal tablets (containing estradiol).
This medication is locally applied, which means it is put into the vagina rather than being ingested.
The MHRA safety study, independent counsel from the Commission on Human Medicines (CHM), and a public consultation all played a role in the decision to reclassify these vaginal pills. Patients, pharmacists, prescribers, and a variety of stakeholders, including the Royal College of Obstetricians & Gynecologists, the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission, and the British Menopause Society, were asked for their opinions by the UK regulator.
Since 1991, low-dose vaginal estradiol has been frequently used to treat postmenopausal vaginal symptoms, and its safety profile is well known.
When it is deemed appropriate and safe to do so, following consultation with a pharmacist, the product will be given by a pharmacy.
Healthcare practitioners with training in pharmacy work.
They will have access to training materials and a checklist that will enable them to counsel women about whether these low dose vaginal pills are suitable and safe for them to take and to provide the information they require so they can make educated decisions.
There will still be other vaginal tablets that also contain estradiol, such as Vagifem 10 microgram vaginal tablets, that can only be obtained with a prescription.
For the many millions of women in the UK who are going through the menopause and endure severe symptoms that have a detrimental impact on their daily lives, this is a historic reclassification, according to Dr. Laura Squire, Chief Healthcare Quality and Access Officer at the MHRA.
Without a prescription, women will be able to safely purchase a local vaginal HRT medication, increasing their access to care and giving them more say in their treatment decisions while reducing the burden on front-line GP services.
We have received enthusiastic support for this choice from a wide spectrum of people, including many women in their 50s and older who stand to gain from it. We would like to express our gratitude to everyone who participated in our public consultation.
When it is safe to do so, we will continue to increase women’s access to menopausal medications and prioritise their needs when making regulatory decisions.
Every year, menopause affects hundreds of millions of women, but for some, its symptoms can be crippling, and for many others, they can be misunderstood or disregarded.
Making Gina available over the counter is a significant step in ensuring that women may access HRT as conveniently as possible and maintain their quality of life while navigating the menopause.
Our Women’s Health Strategy, which was just released, demonstrates that we are giving women’s health top priority.
In addition, our UK-wide menopause taskforce will address taboos and challenges surrounding menopause.
More generally, we are continuing to work with suppliers and manufacturers to secure sustainable short-term and long-term access to HRT.
Hot flushes and other menopausal symptoms are managed using systemic HRT medications, which circulate in the blood.
They consist of oral tablets, skin-applied gels and patches (transdermal patches).
Gina is an example of a local HRT that is given directly to the vagina and released gradually into the vaginal tissue with very minimal absorption into the bloodstream.