Six health bodies, including the RCGP, have joined forces to issue a safety alert over prescribing of high-dose hormone replacement therapy (HRT).
They are raising concerns about increasing numbers of menopausal women being started on high doses of oestrogen which exceed the product licenses and is not in line with any clinical guidelines.
And it warns in the ‘exceptional circumstances’ where a higher than licensed dose is necessary the dose of progestogen should also be increased proportionately.
The alert issued as a joint statement from the RCGP, British Menopause Society, Faculty of Sexual and Reproductive Medicine, Royal College of Obstetricians and Gynaecologists, Society for Endocrinology and the Royal College of Nursing Women’s Health Forum comes after reports that some patients are being started on high doses by private clinics with GPs then asked to continue prescribing.
‘Oestrogen should not be regularly prescribed in doses higher than the upper limit listed in the individual Summary of Product Characteristics (SmPC) as these limits are informed by the results of clinical trials, to ensure patient safety,’ the safety alert said.
‘If in exceptional circumstances a higher than licensed dose is deemed necessary for symptom control, informed consent should be obtained according to good medical practice guidance and patients must be made aware that treatment falls outside of reassuring safety evidence.’
Established guidelines on HRT set out by the National Institute for Health and Care Excellence (NICE), MHRA and internationally is to aim for the lowest effective dose to control symptoms, the alert said.
Dose-finding studies have been done to ensure symptom control is achieved within robust safety parameters and following best practice guidelines, the bodies added.
‘This is to ensure that patient safety remains paramount, and this ethical consideration must continue to influence prescribing of products, including oestrogen, once they are licensed.’
In addition, there is good clinical evidence on the dose of progestogen required, alongside licensed doses of oestrogen, to adequately protect the endometrium against hyperplasia with atypia, a risk factor for endometrial cancer, the statement continued.
‘Endometrial cancer is becoming more common in association with rising obesity and effective endometrial protection is more important now than ever.
‘Routine use of minimal/insufficient doses of progestogen should therefore be avoided.
‘Progestogen intolerant patients receiving lower doses of progestogen (with informed consent) require regular endometrial surveillance in specialist centres with direct access to ultrasound, endometrial biopsy, and hysteroscopy if required.’
The latest figures from the NHS Business Services Authority show a 35% increase in HRT prescriptions last year.
The data was compiled to support work being done by the Department of Health and Social Care, NHS England and HRT suppliers to address supply chain issues and taboos around the topic.
The roll out of the new HRT prepayment certificate (PPC) started on April 1 and will reduce prescription costs to £19.30 per year, against a list of eligible HRT items including patches, tablets and topical preparations.
In summer the House of Commons Women and Equalities Committee recommended that GPs need mandatory menopause training and targeted communications around the HRT scheme.
But in January the government said this was ‘not necessary’ with the RCGP stating this was already part of the curriculum for GP training.
The Davina effect
Davina McCall
However it will not be Davina who gets sued, reported to the GMC etc etc when it all goes wrong “I would never have taken it if I had been told . . . ” .