The MHRA will be asking for views from pharmacists, GPs and the public on whether Gina 10 microgram vaginal tablets “should become a pharmacy (P) medicine and available over the counter”, it announced today (February 2).
License holder Novo Nordisk has applied to the MHRA for its Gina 10mcg tablets to be switched from prescription-only medicine to P medicine, the MHRA wrote in its consultation document.
If the reclassification is approved, Gina 10mcg will become available over the counter to those aged 50 and above “who have not had a period for at least one year”, the MHRA added.
This is the MHRA’s first reclassification consultation for a hormone replacement therapy (HRT) product, it wrote.
If the product is reclassified, “pharmacists will have access to training materials” as well as a checklist to help them identify people who are suitable for the tablets.
Improving access to HRT
MHRA chief healthcare quality and access officer Laura Squire said the watchdog is hoping “to hear from as many people, healthcare professionals and women’s groups as possible”.
“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,” Dr Squire added.
Meanwhile, pharmacy and women’s health minister Maria Caulfield said that the 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”.
The consultation will run until February 23.
Ms Caulfield said a “UK-wide Menopause Taskforce” has been set up and that the DH will “continue to address the menopause as part of the Women’s Health Strategy”.
In October 2021, the DH moved to cut the cost of repeatable HRT prescriptions and implement longer prescription cycles for the treatment as a way to reduce prescription charges, C+D reported last year.
Pharmacies have been dealing with significant HRT medicine shortages for a number of years. C+D reported in 2019 that HRT is the category of medicines that is most often in shortage in pharmacies after conducting a survey in September of that year showing that 84% of pharmacy teams had struggled to source them over a six month-period.
