Gina (estradiol) 10 microgram vaginal tablets will be reclassified from a prescription-only medicine (POM) to a pharmacy medicine (P), making them the first HRT product to be available over the counter from a pharmacist. The low-dose vaginal tablets are indicated for the 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.
The MHRA says pharmacists will have access to training materials and a checklist that will enable them to advise women whether the product is appropriate and safe for them to use, and to give the information they need to make an informed choice.
The decision to reclassify Gina follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public consultation. The UK regulator sought views from patients, pharmacists, prescribers and a 'wide range of stakeholders' including the Royal College of Obstetricians & Gynaecologists, the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.
The public consultation, which ran from February 2 to February 23 this year, received 1229 responses, of which 88% were in favour of reclassification of Gina.
Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: 'This is a landmark reclassification for the millions of women in the UK who are going through the menopause and experience severe symptoms that negatively impact their everyday life. Women will be able to safely obtain a local vaginal HRT product without a prescription, which increases women’s access to treatment and gives them greater control over their choices while relieving pressure on frontline GP services.
'In reaching this decision, we have seen positive support from a wide range of people, including many women aged 50 years and above who could benefit from this decision. We would like to thank everyone who submitted their view in our public consultation.'
Other vaginal tablets containing estradiol, including Vagifem 10 microgram vaginal tablets, will continue to be available on prescription.
The reclassification was announced on the same day as the government published its first Women's Health Strategy for England, as part of which it says it has taken 'decisive' action to increase access to HRT in response to fluctuating stock levels, including issuing serious shortage protocols to even out distribution and allow community pharmacists to supply specified alternatives where appropriate.