Shaping the new frontiers of women’s health

pharmafile | March 16, 2022 | Feature | |   

March 8 was International Women’s Day and provided a perfect opportunity for Pharmafocus to dive deep into women’s health. Lina Adams and Ana Ovey explore the barriers that are being broken down, the obstacles still in the way, and what ideas are in the pipeline to support women.

Women’s health has always faced issues with visibility, empathy, and investment. From endometriosis and its numerous misdiagnoses, to societal pressures upon women, pharma and the reform of healthcare services have a huge role to play in the improvement of women’s health. 

The last two years amid a global pandemic via numerous lockdowns have cemented the importance of community and solidarity in bringing about meaningful improvements in women’s health, as companies recognise that recovery requires a collaborative effort. However, this has not been without its issues. At the peak of lockdown, young mothers struggled to maintain a healthy balance between family responsibilities and their professional careers, receiving little support from their workplace. The prioritisation of urgent care over the past few years has compounded the neglect of chronic illnesses, such as rheumatic and musculoskeletal (RMDs) diseases, which women are statistically more likely to suffer.1

In 2020, a study from Manual, a wellbeing platform for men, analysed health data for 156 countries worldwide across ten categories to find out which country has the largest gender health gaps.2 These categories included life expectancy, rates of diseases such as diabetes, cancer, obesity, mental health disorders, and daily alcohol intake. The study found that the UK had the largest female health gap among G20 countries, and the 12th largest female health gap globally.

Furthermore, a study revealed the difference in waiting time between men and women who went to A&E with abdominal pain: women waited an average of 65 minutes to be seen by a doctor, while men waited only 49. The women in this study were additionally less likely to be given painkillers.3

According to research, women have been disproportionately affected by the pandemic, which has only exacerbated challenges already being faced. According to a survey, 79% of women delay taking care of their own health, in order to prioritise looking after their loved ones. Compounded with problems accessing treatments, and areas of little or no research, women’s health is an area filled with unmet need.

Research in 2016 by University College London revealed that women with dementia received worse medical treatment than men with the condition, and were more likely to be given potentially harmful medication.3 More research, published by Oxford University in 2019, showed that women were 13% less likely than men to receive life-saving drugs, like statins, following a heart attack.4 “Women, older people, and deprived populations are particularly prone to receiving suboptimal care,” the study shared. “All were more likely to be first diagnosed during a hospital admission. This may suggest that, in these patients, early signs and symptoms have not been appropriately recognised in non-acute healthcare settings.”

In 2021, the UK Government announced its development of the first Women’s Health Strategy, which is currently still in its early stages. The first major step of this process has included a call for evidence to ask women about their needs and experiences, as well as companies working closely with women’s health, to inform the priorities, content and actions of the strategy. In her Ministerial Foreword to the strategy’s Call for Evidence, Nadine Dorries, at the time serving as Minister of State in the Department of Health and Social Care, commented: “77% of the NHS workforce and 82% of the social care workforce are women, and throughout the pandemic women have been on the frontline ensuring that people receive the health and care they need. Investing in all aspects of women’s health, including within the workplace, is essential to women’s ability to reach their full potential and contribute to the communities in which they live.”

The Women’s Health Strategy Call for Evidence also highlighted the need for a further focus and investment on women’s health: “Women in the UK spend a greater proportion of their lives in ill health and disability. Women spend around over a quarter of their lives in ill health or disability, compared with around one fifth for men. Moreover, in recent years, healthy life expectancy has fallen for women but has remained stable for men.”

At the margins: Menopause, mental and physical health

The problems are broad, with vital areas of women’s health being underserved. The menopause, for example, is a period which will affect around half of the population over the age of 45, and its impacts are broad and far-reaching. 

Pharmafocus spoke to Tina Backhouse, UK General Manager of Theramex, who gave us an insight into the prevalent health problems that arise when women fail to put their own health first: “Lack of access to treatments for symptoms of the menopause can have negative impacts on the individual’s mental and physical health as well as broader impacts on society. A 2019 survey conducted by BUPA and the Chartered Institute for Personnel and Development (CIPD) found that three in five menopausal women, between the ages of 45 and 55, were negatively affected at work. Furthermore, 30% of the women surveyed had taken sick leave because of their symptoms.5 This all adds up to a picture that it is not necessarily women that are failing to prioritise their own wellbeing but that we are living in a society that has not prioritised women’s health.”

We also spoke to Rizvan Faruk Batha, Superintendent Pharmacist of Specialist Pharmacy, who shared insights into the impact of the menopause: “The transition into menopause is gradual, with the ovaries producing less oestrogen, causing changes in duration and flow of periods, and symptoms such as hot flushes, vaginal dryness, loss of libido, insomnia, brain fog, and mood swings. Progesterone levels also decline, as with no ovulation taking place, the corpus luteum can no longer produce progesterone and the body has no other stores, unlike oestrogen, which is stored in fat and the adrenals. This can result in symptoms such as anxiety, bone loss, insomnia, and low mood.”

The menopause and perimenopause are clearly significant junctures, with far-reaching side-effects. Dr Batha elaborates: “A drop in hormones can negatively impact upon the cardiovascular system, brain function, and bone density, leading to all sorts of health risks. Oestrogen falls from pre-menopausal levels of 30-400pg to below 30pg during menopause. This dramatic drop can cause rapid ageing of the skin due to a lack of collagen and dryness and the hair can become dry and brittle, further damaging a woman’s self-esteem.

“Many women are choosing to have children later in life, so may find themselves facing menopause at the same time as having to deal with difficult teenagers, causing a feeling of being overwhelmed and an inability to cope. Women are also very often having to continue their high-pressured jobs throughout this transitional phase, with employers who don’t have any specific menopause workplace policies, meaning it can be a difficult and isolating time, both emotionally and physically. Overall, menopause can impact on mood, energy, cognitive function, confidence, sleep, and pain, amongst others, all of which can be improved when hormones are reintroduced and balanced.”

In spite of this significant medical need, with the menopause impacting both physical and mental health, much of it is left unaddressed. Hormone replacement therapy (HRT) is used to relieve symptoms of the menopauses, replacing hormones that are at a lower level as the menopause is approached, and diminishing symptoms such as hot flushes, mood swings, and night sweats. Dr Batha continued: “With approximately 11 million women over the age of 45 in the UK (according to the 2011 consensus), there is a sizeable number of women who would benefit from HRT. In the future, this number will only increase due to an ageing and increasing population. If not addressed, it will further negatively impact upon the health system. Unfortunately, menopause is highly under-recognised and undertreated in this country. One of the first symptoms many women notice is a low mood and when consulting with their GPs, they are often diagnosed with depression and prescribed antidepressants. 

“Menopause training for GPs is also something which has been lacking (mainly due to the negative connotations with HRT following the results of the Women’s Health Initiative study back in 2002), making it difficult for them to piece the symptoms together. Women with no uterus are automatically prescribed oestrogen-alone therapy, as progesterone is only considered necessary to control the growth of the endometrium, completely ignoring the other benefits it provides, such as improving sleep, reducing anxiety and acting as a natural antidepressant. 

“Women are therefore being given unopposed oestrogen, rather than aiming for a hormone balance, resulting in all sorts of undesirable side effects and causing many women to cease their treatment. The media has been raising a lot more awareness surrounding menopause, which is a positive thing, as it encourages women to seek help. However, there are many women out there who suffer from menopause in silence due to these previous negative connotations, and are not seeking help from healthcare professionals to help them.”

Scheming is believing – what does the new women’s health strategy entail, and what does it aim to achieve?

As mentioned, for the first time ever, the UK is developing a Women’s Health Strategy, which aims to put women’s voices at the forefront of their care. With HRT therapy potentially becoming an OTC medicine in England depending on the outcome of a consultation, it appears that significant growth is being made in improving treatment options for notorious conditions affecting women, such as menopause and endometriosis. 

The Women’s Health Strategy aims to improve women’s health outcomes, identifying the stages, transitions, and settings where there are opportunities to promote good health in the lives of women and girls. The strategy pledges to place women’s voices at the centre of their health and care, through expanding services that meet their reproductive health needs, and ensuring that national healthcare policy and services consider women’s needs specifically. Most importantly, all women, including those with additional risk factors or who face additional barriers in accessing services, should have equal access to these services. Whilst these measures are a quantum leap for women’s health, it is evident that there is far more work to be done. All areas of women’s health need new, innovative products to transform patient outcomes, such as endometriosis, UTIs, and osteoporosis. 

Tina Backhouse told Pharmafocus: “Firstly, it is important to be correct in our reporting of this. It is not being currently proposed that all HRT is OTC – rather just a vaginal HRT product. This is important to get right because of the great work that many women have done, including Diane Danzebrink from Make Menopause Matter and Carolyn Harris MP, in successfully lobbying the Government to reduce the cost of HRT to one prescription charge per year. This is incredibly important in making sure that women who cannot afford it, still benefit from it.

In the UK, access to new medicines to support women with the menopause is not equitable to all. Research from the University of Warwick found that the HRT prescription rate was 29% lower in GP practices from the most deprived quintile compared with the most affluent. In addition, it was found that there was a significantly higher tendency to prescribe oral HRT (administered by mouth) than transdermal preparations (administered through the skin) in more deprived practices.”6

In addition, most women are unable to access new menopause treatments without paying privately for them. In the call for evidence that informed the Vision for the Women’s Health Strategy for England, some respondents reported that they had experienced difficulties in accessing HRT.7 This is leading to a postcode lottery of women’s access to care for symptoms of the menopause.

“Currently, hospital formularies are able to add new products but, due to delays caused by the pandemic, primary care formularies are experiencing a backlog of approvals. This – coupled with a lack of education on innovative menopause treatments amongst the HCP community – means that many individuals cannot access newer medicines from their primary care professional.”

Building bridges: How can collaboration accelerate treatment improvements for women? 

Of the many lessons that the pandemic has taught us, it has highlighted the importance of collaboration between pharma companies and public healthcare systems to ensure the best possible outcomes for patients. Backhouse told Pharmafocus about how collaboration can be done to improve treatments for conditions such as endometriosis, as well as other prominent female health issues: “The DHSC should ensure equity in patient access to NICE approved medicines for HRT, particularly if they are licensed and endorsed by bodies such as the British Menopause Society. Work should also be done to educate GPs in the full range of available treatments to ensure all women are given a choice in their care, including these newer HRTs.”

“Aligned with this, Theramex would welcome a focus on formulary realignment in relation to access to HRT, in conjunction with the formalisation of integrated care systems early this year. These challenges in market access and reimbursement cause a lack of predictability in the UK market, making it difficult for companies to invest and bring new products into the UK. The presence of these conflicts with the Government’s vision for the UK, as set out in the Life Sciences Vision, which states that the desire to ensure the ‘right business environment in the UK’ in which companies can “commercialise their products”.8

“We are conducting analysis this year to further understand the regional disparities. However, addressing the issue with GP formularies will help to address some of the immediate challenges with patient access and ensure that women have choice in their healthcare and are able to live their best lives.”

Free for all: How can market access to women’s health treatments be advanced?

The market for women’s health medicines has been steadily growing over the last decade, due in no small part to the increased proliferation of chronic health concerns and conditions such as hormonal infertility and endometriosis. There is a growing demand for medications to help manage symptoms of menopause, such as hot flushes and vaginal dryness, as well as the chronic pains associated with endometriosis, to name a few. There is an increasing need for treatments that have few side effects and are easy to administer to address these needs. 

One solution Dr Batha puts forward is a more personalised healthcare system, with compounded medicine available. Speaking on the benefits of compounded medicine for the management of the menopause, Rizvan shares: “Compounding of hormones follows a prescription that is based on an individual patient (taking into account their diagnosis, symptoms and blood hormone levels) resulting in a tailored dose. The premise of BHRT is to balance and replace what is low or suboptimal, rather than flooding the body with higher doses of hormones than physiologically necessary. When clinicians are treating women with BHRT, they are offering a holistic approach as they often look into the different pillars that can affect women’s health including; gut health, diet and lifestyle, genomics and supplements etc., Compounding Pharmacies can play a role in supporting clinicians by helping to formulate medications based on an individual patients’ needs including looking at their allergies, intolerances and sensitivities.”

Strides have been made for women’s healthcare in the past few decades, but more are needed, and one innovation which has the potential to bring around significant change is the personalised structure offered by compounded medicines. Rizvan comments: “Menopause symptoms are unique to every woman in terms of their frequency, intensity and duration, so it makes sense that their treatment should also be unique to them. By tailoring the prescribing of hormones, doses and strengths a woman needs, we can try to reduce the severity of any adverse effects, improve patient satisfaction and compliance, and produce better outcomes for patients.

“Compounded hormones can be combined into a variety of formulations to fit into a patient’s individual need. For example, rather than using, say, three different products (as may be the case with standard HRT), the three hormones could be combined into one cream, providing a convenient treatment, which could improve tolerability and compliance to therapy.”

This differs to current standard management in the UK: “Standard menopause care within the NHS provides women with restricted options for HRT treatment and after a short consultation, medication is prescribed based on the severity of the symptoms, often with a combination of hormones when potentially the patient only needs a ratio of hormones that is less than what is found in licensed treatments.

“In contrast, seeing a BHRT practitioner, an in-depth consultation discussing her past medical history and current symptoms will take place, along with blood tests measuring her current hormone levels. These results, along with symptoms, will provide the practitioner with a clear picture as to which hormones need balancing/replenishing and a personalised prescription can be written accordingly. This can offer better symptom management and the ability to personalise the dose means women who previously couldn’t tolerate or were unsuitable for HRT therapy, now have the opportunity to have treatment that can help them.

Not having HRT options available can have serious impacts: “there is only one form of bioidentical progesterone available as a licensed treatment (Utrogestan), which is available in one fixed strength in capsule form only and is too strong for many women to tolerate,” Rizvan shared with us. “The high dose can cause undesirable side effects such as drowsiness and nausea, and is unsuitable for those who have difficulty swallowing. Its use is therefore limited to a select group of women.” A solution is “compounding that very same bioidentical progesterone into cream/lozenge/sublingual drop form in any strength the prescriber deems appropriate”. In doing so, the medication is “suitable for those individuals who were not suitable or may have not tolerated the licensed form.”

Back to the future

Decades of gender health inequality are hard to unravel. By statistics alone, efforts to amend disparities in healthcare systems across the globe, and focused in the UK, are clearly uphill battles. Undoubtedly, certain areas of women’s health, including treatment for endometriosis, were acutely hit by the pandemic. When considering the impact of the last two years, it is clear that the Women’s Health Strategy has great potential – with plans to expand services in areas such as gynaecological conditions, postnatal support, and the menopause. However, whilst measures such as over-the-counter HRT make for a promising start, it is evident that deeper change is needed to ensure that the needs of women everywhere are consistently being met. As Dr Edward Morris, president of the Royal College of Obstetricians and Gynaecologists, articulates: “This isn’t about getting it right for those who know where it is, it’s about getting it right for everybody.”9

The Figures

29%

Lower prescription rates for HRT in GP practices with the most deprived patients

11 million

Approximate number of women over the age of 45 in the UK who would benefit from HRT

Three out of five 

Of menopausal women, between the ages of 45 and 55, are negatively affected at work

30%

Of people surveyed took sick leave off work because of their symptoms

77%

Of NHS staff are women

82%

Of social care staff are women

13% 

Women are 13% less likely than men to receive life-saving drugs

12th 

UK has the 12th largest female health gap

Terms Defined

Endometriosis is an often-painful condition in which tissue similar to the lining of the uterus grows elsewhere, most commonly in the ovaries, fallopian tubes, and tissue lining the pelvis.

Urinary tract infections, or UTIs, are infections of any part of the urinary system, including the kidneys, bladder, ureters, and urethra.

Osteoporosis is a health condition that weakens bones, causing them to be so brittle that even mild stresses such as coughing can cause a fracture.

Menopause describes the point in time when a person stops having periods, and is no longer able to get pregnant naturally. The years leading up to that point, during which monthly cycles may be changed or interrupted, and other symptoms such as hot flushes are also experienced, are known as the perimenopause.

References

1. Visit: https://www.frontiersin.org/articles/10.3389/fgwh.2021.670310/full

2. Visit: https://www.manual.co/mens-health-gap/

3. Visit: https://www.ucl.ac.uk/news/2016/dec/women-dementia-receive-less-medical-attention

4. Visit: https://pubmed.ncbi.nlm.nih.gov/18439195/

5. Visit: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002805

6. Visit: http://www.gov.uk/government/publications/our-vision-for-the-womens-health-strategy-for-england/our-vision-for-the-womens-health-strategy-for-england 

7. Visit: www.cipd.co.uk/about/media/press/menopause-at-work#gref 

8. Visit: bjgp.org/content/70/700/e772

9. Visit: assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042631/dhsc-our-vision-for-the-women_s-health-strategy-for-england.pdf

10. Visit: assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1013597/life-sciences-vision-2021.pdf