The Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light for certain vaginal HRT tablets to be available over the counter without a GP prescription.
The regulator launched a public consultation in February on whether to reclassify HRT medication Gina 10 microgram (estradiol) vaginal tablets to allow women to access it in a pharmacy without a prescription from their GP.
This was the first time an application has been made for an HRT product in the UK to be available as a pharmacy (P) medicine – meaning that it can be purchased over the counter from pharmacists.
The MHRA today announced that ‘from September, women in the UK will be able to access Gina 10 microgram vaginal tablets [from local pharmacies] without requiring a prescription’.
It said: ‘The decision to reclassify these vaginal tablets 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 and Gynaecologists, the Faculty of Sexual and Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.’
More than 88% of the 1,229 responses to the public consultation were in favour of the reclassification, it added.
The locally-applied and low-dose HRT tablets are used to treat postmenopausal vaginal symptoms of vaginal atrophy such as dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in women aged 50 years and over who have not had a period for at least a year.
Other vaginal tablets that also contain active ingredient estradiol, including Vagifem 10 microgram vaginal tablets, will still be available on prescription, it added.
The MHRA said that the Gina tablets will only be supplied by pharmacies without a prescription ‘when it is considered safe and suitable to do so’ and ‘following consultation with a pharmacist’.
It added that ‘low-dose vaginal estradiol has been widely used for the treatment of postmenopausal vaginal symptoms as a prescription medicine since 1991 and has a well-established safety profile’.
Pharmacists will have access to ‘training materials and a checklist’ so they can ‘advise women on whether these low dose vaginal tablets are appropriate and safe for them to use and to give the information they need, so they can make informed choices’, it said.
MHRA chief healthcare quality and access officer Dr Laura Squire said the move should relieve pressure on GP practices.
She 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.’
Health minister Maria Caulfield added: ‘Making Gina available over the counter is a huge step forward in enabling women to access HRT as easily as possible, ensuring they can continue living their life as they navigate the menopause.
‘We’re putting women’s health to the top of the agenda – our Women’s Health Strategy published today is testament to that. More widely we’re continuing to work with suppliers and manufacturers to secure sustainable short-term and long-term access to HRT and our UK-wide menopause taskforce will tackle taboos and issues surrounding menopause.’
Prescription-only medicine status is required if any of the following apply:
- A direct or indirect danger exists to human health, even when used correctly, if used without medical supervision
- There is frequently incorrect use which could lead to direct or indirect danger to human health
- Further investigation of activity and/or side effects is required
- The product is normally prescribed for parenteral administration (by injection)
However, the MHRA concluded that ‘none of the criteria apply to Gina as all risks can be managed’ through the product information and pharmacist training.
The consultation document previously set out that the pharmacy training materials include symptoms that ‘would prompt the pharmacist to refer a woman to a doctor rather than supply Gina’, as well as instances where pharmacists should supply the tablets ‘only after a woman has sought advice from a prescriber’.
‘Symptoms, conditions and concurrent medications which require a GP to confirm suitability for treatment before Gina can be supplied are also listed in the guide’, it said.
It added: ‘To ensure continuity of care, women are encouraged to inform their doctor and other healthcare professionals that they have obtained Gina from their pharmacy.’
It comes amid shortages of HRT medicines that have seen measures introduced to allow pharmacists to substitute (HRT) products for alternatives if the original prescription is out of stock without needing to seek authorisation from the patient’s GP.
This was in addition to new rules introduced in April meaning three HRT drugs would be limited to be supplied for three months to mitigate shortages.