Patient Safety Spotlight: Menopause Awareness Month special - the risks of prescribing and supplying hormone replacement therapy (HRT)
While the rise in prescribing of hormone replacement therapy (HRT) in recent years has had a positive impact, the risks of inappropriate provision of treatment need to be minimised to ensure everyone who needs it receives safe and effective treatment
As part of our work, we have identified examples where women may have received inappropriate combinations of HRT. To coincide with Menopause Awareness Month this October, in this article co-produced by, Dr Liz Horrocks, Menopause Specialist, Senior Clinical Pharmacy Advisor, Neha Ramaiya and Chief Pharmaceutical Officer’s Clinical Fellow, Amira Chaudry, we explore these concerns and highlight best practice to help pharmacy professionals provide menopause management safely and effectively.
According to the World Health Organisation, menopause marks the end of the monthly menstrual cycle for most women resulting in a decrease in the hormone, oestrogen. This increases the chance of a women experiencing menopause type symptoms, which can include hot flushes, joint pains, vaginal dryness, impact on mental health and sleep disturbances among many others. The symptoms can have a significant impact on women’s lives. HRT has a role to play in this group by reducing symptoms.
HRT given systemically typically consists of two hormones, oestrogen and progestogen (synthetic progesterone). Examples of systemic formulations include tablets, patches and gels as opposed to vaginal pessaries and creams which provide localised treatment only.
Oestrogen in HRT helps relieve menopause symptoms. However, systemic oestrogen will also thicken the lining of the womb, which could lead to endometrial cancer. Progestogen plays a vital role in protecting the womb against this thickening. Women who have not had a hysterectomy should receive both oestrogen and progestogen as part of their HRT treatment. Women who have had a hysterectomy for severe endometriosis may also still require progesterone as well.
Traditional HRT comprised both hormones in a combined product where the two hormones were both contained within the same patch or tablet.
HRT patterns have recently changed to include a greater proportion of single hormone constituents where these hormones are increasingly prescribed separately, which allows for greater flexibility of strength and tailored treatment.
See the British Menopause society’s information on HRT preparations and equivalent alternatives.
Treatment with separate hormones may increase the risk of women obtaining HRT treatment without the appropriate progestogen constituent. This may occur through inappropriate prescribing, supplying or due to unintended misuse which has the potential to compromise patient safety.
Prescribing and supplying HRT treatment
Confusion between combination preparations and single constituent preparations for HRT can easily occur. For example, Evorel which is an oestrogen-based preparation can be confused with combination patches such as Evorel Conti or Sequi, which mean that the patient does not receive the protection from the progesterone hormone as a result.
Mirena intrauterine devices (IUD), are a type of progesterone hormonal coil, which can protect the uterus by releasing the hormone into the womb. New guidance from the Faculty of Sexual and Reproductive Healthcare (FSRH) recommends that any IUD containing 52mg of levonorgestrel can be used for 5 years as part of HRT for endometrial protection. Examples of these include off-label Levosert and Benilexa. Confusion may arise as IUDs can also be used as a contraceptive and the expiry date of the IUD may differ based on the indication of use. Women fitted with IUDs may be unaware of the expiry date of their device.
In line with our guidance for pharmacist prescribers, [PDF 897 KB] prescribing pharmacists should ensure that they have reliable and accurate information about the person’s health and medicines prior to prescribing to ensure person centred care. This may be through ensuring appropriate access to medical records or discussing with the person’s regular practitioner if they have one.
It is vital that pharmacy professionals prescribing HRT treatments have sound knowledge of the condition they are prescribing for. And that they maintain the competencies specific to their scope of practice.
See the British Menopause Society’s HRT practical prescribing guide for more information.
A serious shortage protocol for Utrogestan 100mg Capsules, a form of progesterone was issued across the UK on 19 May 2023. This may mean that pharmacy teams may not be able to fulfil the progestogen constituent of the HRT prescription.
Pharmacy teams should not supply oestrogen therapy on its own to women who have not had a hysterectomy without the assurance that they will be able to obtain the progesterone part of their treatment
Pharmacy teams may be required to contact the person’s regular practitioner to ensure that clinically appropriate alternative treatment is prescribed.
See the British Menopause Society’s response to the ongoing HRT shortages, which provides information for clinical practitioners about alternative treatments.
Pharmacy teams should seek opportunities to appropriately counsel patients on their HRT treatment
Dosing instructions can often be complicated due to terminology, particularly when women are prescribed Sequential HRT and are experiencing symptoms of menopause before their menstrual cycle has stopped. This may result in unintentional underuse of the medication.
A reported side effect of progesterone in the British National Formulary (BNF) is drowsiness. This means many women may often choose to take the medication at night, which may be a different time from when they take their oestrogen.
As the oestrogen provides the symptomatic relief of menopause, there is a risk that the progesterone may be forgotten. It is crucial that pharmacy professionals explain the importance of remembering to take progesterone to ensure that women understand the protective role of this medication.
“I share this term with allied healthcare professionals and patients to reinforce the message that progesterone helps to thin womb lining and protect against endometrial cancer,” says Dr Liz Horrocks.
Educating and training the pharmacy team
Pharmacy professionals should ensure adequate training for themselves and their teams to be able to manage HRT requests and prescriptions.
This includes effective counselling and signposting patients to other healthcare professionals to receive appropriate treatment and advice.
When working from a registered pharmacy, our standards require that there are ‘enough staff, suitably qualified and skilled, for the safe and effective provision of the pharmacy services provided’ and that they have ‘the appropriate skills, qualifications and competence for their role and the tasks they carry out, or are working under the supervision of another person while they are in training’.
Equality, diversity and inclusion
Trans men and non-binary people may experience symptoms of menopause. However, if they are not represented in the language around healthcare, this can raise issues of inequality and impact on access to care. The impact of the menopause on different groups and the use of inclusive language is recognised in many national publications such as the Women and Equalities Committee (House of Commons) report on Menopause and the Workplace.
Find out more
GPhC standards and guidance
- The standards for pharmacy professionals highlight that pharmacy professionals must provide person centred care, work in partnership with others, communicate effectively, maintain, develop and use their professional knowledge and skills, and use their professional judgement.
- The standards for registered pharmacies set out the requirements to deliver safe and effective services for patients and the public.
- Our guidance for pharmacist prescribers [PDF 897 KB] shares key areas which pharmacist prescribers should consider in order to prescribe safely and effectively. This includes HRT.
- Our guidance for registered pharmacies providing pharmacy services at a distance, including on the internet, [PDF 581 KB] explains what pharmacy owners should consider before deciding whether any parts of their pharmacy service can be provided safely and effectively at a distance (including on the internet)
Other sources of information
- The British Menopause Society have produced a range of documents and tools for clinicians in relation to menopause and HRT, including:
- The British Menopause Society have released a response in relation to the Utrogestan shortage
- Dr Liz Horrocks has produced a short animation video for patients to improve awareness about menopause and HRT