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Interest in GLP-1 receptor agonists has grown significantly over the past 12-18 months, with frequent mentions in news and online discussions. These medications are a major advance in helping people lose weight, proving effective across different patient groups.

The key points from this interview are summarised below:

1. Mechanism of action

GLP-1 receptor agonists (e.g. semaglutide) work in several ways:

• Slowing gastric emptying so that people feel full longer
• Boosting satiety so that smaller meals are satisfying
• Reducing appetite by directly influencing brain areas that control appetite.
• Balancing blood sugar – GLP-1 analogues prevent the release of glucagon, leading to more stable blood sugar levels and fewer glucose spikes after meals.

In addition, tirzepatide (Mounjaro) a dual agonist (with combined GLP-1 and GIP effects), enhances insulin secretion, especially during meals, and improves insulin sensitivity, working together with the GLP-1 effects

Clinical trials have indicated that tirzepatide results in a greater average weight loss – around 21-22%, compared to about 15% with semaglutide. Tirzepatide may be particularly suitable for obese individuals with pre-diabetes.

2. Common side effects

The most common side effects are related to delayed gastric emptying, including reflux, nausea, vomiting and constipation. Patients should be counselled about what to expect and how to manage side effects.

Long-term side effects can include muscle loss (sarcopaenia) and osteoporosis.

3. Obtaining a supply of GLP-1 RAs

An in-person, face-to-face consultation is the safest way to obtain a supply – so that BMI can be verified and the risks and benefits of GLP-1 treatment can be assessed.

These medicines are approved for adults with a BMI of 30 or a BMI of 27 with a comorbidity such as a hypertension or pre-diabetes. NHS thresholds can be higher. While the NHS route is an option, it may involve challenges, such as long waiting times and limited medication choices.

Patients should be wary of obtaining supplies of GLP-1 RAs from unregistered online providers because of the risks of counterfeit medicines and inappropriate prescribing. Patients should check that the online pharmacy is registered with the General Pharmaceutical Council (GPhC) and has a visible GPhC number on its website.

The General Pharmaceutical Council has issued Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet to strengthen safeguards for people obtaining supplies online.

4. Ongoing management

Prescribers should schedule regular follow-up appointments to evaluate treatment efficacy, monitor side effects, and adjust dosages as necessary. The following points should be covered:

Understanding the science: Discuss the importance of understanding the science behind weight loss to help patients psychologically adapt to weight loss, overcome body dysmorphia, and address fears of eating properly.

Lifestyle changes: Emphasize the importance of lifestyle modifications, including diet and exercise, for achieving sustainable weight management

Strength training: Throughout the use of these drugs, strength and muscle mass training are crucial for preventing sarcopenia.

Protein intake: Advise patients to consume protein-rich foods to help maintain muscle mass.

Referrals: If patients do not respond to maximum doses of either medication, consider referral to an endocrinologist.

Long-term strategies: Discuss strategies for maintaining weight loss after stopping medication, focusing on gradual dose reduction and continued lifestyle modifications.

5. Dosing considerations

Doses are individual and not everyone needs the maximum dose. Some people respond to one drug but not the other and switching is possible

6. Stopping treatment with GLP-1 RAs

There is very little data to help prescribers decide how to take people off the medication. The body is biologically designed to regain the weight that has been lost. Stopping treatment abruptly often leads to regain of weight. One strategy is “to come down the doses just as you went up them” to mitigate this effect.

7. Communication with GPs

Private providers of GLP-1 RAs should inform the patient’s GP (with the patient’s consent) that they are taking these medications.  There may be interactions with other medicines and it could be important if the patient becomes pregnant or is planning elective surgery.  Patients taking GLP-1 or GIP/GLP1 RAs may be at risk of aspiration under general anaesthesia (see MHRA guidance).

Conclusion

GLP-1 and GIP/GLP-1 receptor agonists represent a significant advance in the treatment obesity and related metabolic disorders. Effective use of these agents will lead to better patient outcomes and transform the way in which weight management is approached.

About Deborah Evans

Deborah Evans, a pharmacist with 40 years of experience, who specialises in women’s hormonal health and weight management. She is the superintendent pharmacist and clinical director at Remedi Health. About 80% of her time is spent in the clinic facing clients.

How menopause affects women and why we should offer treatment

There is a considerable unmet need for menopause services. “I think at the moment the data suggests only about 15% of women are prescribed hormone replacement – that’s 85% of women who are not, she says.

Menopause symptoms can be many and varied as all body systems adjust to declining hormone levels. They can include physical effects such as hot flushes, joint pains and genitourinary syndrome of menopause, cognitive effects such as brain fog and memory loss and mental effects such as anxiety and depression.

Long-term hormone deficiency itself carries risks including increased risks of cardiovascular disease (e.g. heart attacks and strokes), type 2 diabetes,  osteoporosis (where oestrogen replacement is a first-line therapy) and some cancers (e.g. bowel and bladder). In addition, there’s emerging evidence to suggest that Alzheimer’s disease increases as well.

“I think it’s really important to understand the role that HRT plays in addressing the symptoms that I’ve described …… Fundamentally unless we’re addressing the decline in hormones then we can’t fully address the symptoms”, says Mrs Evans.

How the benefits of hormone replacement therapy outweigh the risks

Despite fears raised by older studies there is no increased risk of blood clots or breast cancer when HRT is delivered using transdermal, body-identical oestrogen. In fact, HRT has a number of important beneficial effects.

Current data show that HRT

• reduces the risk of osteoporosis by between 26 and 37%
• reduces the risk of diabetes by 30%
• reduces the risk of coronary heart disease by 50%
• reduces risk of dementia by between 22 and 32%
• reduces the risk of age-related macular degeneration by a third
• reduces the risk of depression by 50%
• reduces the risk of all-cause mortality by 30%

“Women should be offered HRT unless there’s a good reason not to go on it, just based on the longevity and the health benefits long-term”, Mrs Evans says.  The long-term health benefits are best achieved by starting HRT as soon as possible, but there is no limit on the length of time for which it can be taken and age per se is not a contra-indication.

The menopause clinic at Remedi Health offers detailed evaluation and follow up. HRT can be prescribed and supplied

Why you could add testosterone to menopause treatment

Testosterone is an important hormone for women and may need replacement alongside oestrogen and progesterone, says Mrs Evans. Replacing testosterone in menopausal women helps with brain fog, cognitive function, motivation, sharpness, confidence and memory, amongst other things.

At present there is no licensed testosterone product for use in women in the UK, although this could change in the future, says Mrs Evans.  In the meantime, the options are either to use (off-label) the UK product that is licensed for use in men or to use a product that is licensed for women in Australia. She favours the use of the Australian product that has been designed for women, noting that there are practical difficulties in using the UK-licensed male product.

Choosing a transdermal oestrogen and tackling genitourinary syndrome of menopause

Transdermal oestrogen products and the management of genitourinary syndrome of menopause are two important topics in menopause management. Selecting the most appropriate treatments should take into account individual needs and preferences.

There are three different formulations of transdermal oestrogen – patches, gels and spray.  Women need to be aware of the pros and cons of each of these so that they can decide which will be best for them.

Genitourinary syndrome of menopause’ (GSM) describes the vulvovaginal and urinary tract symptoms caused by thinning and shrinking of the tissues of the vulva, vagina, urethra, and bladder as a consequence of oestrogen deficiency.  Appropriate care for GSM is part of keeping a woman in good health. The topical transdermal oestrogens – will help but many women find that they need local oestrogen therapy delivered as a cream, pessaries or a slow-release device. “We’ve seen a lot of women who’ve had significant, life-changing [effects]” as a result of local oestrogen therapy, Mrs Evans explains.

Tips for building a successful pharmacy menopause service

Working in the menopause clinic is professionally rewarding and there is a wealth of resources available for keeping up-to-date. Awareness of  the latest evidence and the ability to provide good quality, sound information is key to a successful service says Mrs Evans. She recommends that colleagues should be menopause-aware whatever their area of interest or specialty practice. She advocates the use of a menopause tracker app for patients such as the Balance tracker from Newson Health.

Deborah Evans’ closing message to everyone is: “I think there are many myths out there about menopause and HRT – so make sure that you’re well-informed. That’s not just from the social media …..,  it’s actually looking at making sure that the evidence that you’re looking at is good quality, sound evidence with the appropriate data behind it”.

About Deborah Evans

Deborah Evans is a pharmacist independent prescriber who specialises in women’s reproductive and sexual health, including the menopause. She owns and runs Remedi Health, a clinic in Winchester, Hampshire. She combines the roles of Clinic Director, Superintendent Pharmacist and hands-on practitioner.

Read and watch the full series on our website or on YouTube.

“I have never worked in a more rewarding area  – it gives me immense pleasure to support women during this difficult time”, says Deborah Evans.  She recalls that her own experiences of menopause and perimenopause were difficult – “ironically, I didn’t really know what was happening to me”, she says. Now she sees HRT as an important part of her care for her own personal health – probably for the rest of her life. Building on this experience she has established the menopause clinic at Remedi Health. The clinic deals with a wide range of women from diverse backgrounds. “What they have in common is the impact that this period of change and transition in their life is having on them – and that could be relationships with their children, with their family, with their spouses, their partners [or] it could be that they’ve lost their confidence at work”, she says.  One case she remembers clearly was a barrister who had to give up her work because she could no longer perform satisfactorily in court – she kept losing the thread of what she was trying to say. She had to give up a previously thriving career as a result. “What we can do by listening to someone and helping her come to an informed choice about where she wants to go with her treatment is [to] support her in a way that means that she’s ….. empowered [and] she understands what she’s doing with her hormones. ……   The changes two to three months on are phenomenal – and women are of course extremely grateful. ….. What I can see is the significant change in their overall health and well-being”, she says.  “So,  absolutely –  the most enjoyable consultations to have – they just warm your heart – to help people in that way”, she adds.

If the patient’s problems are more complex or beyond Mrs Evans’ scope of practice then suitable avenues for referral exist. “At Remedi Health we pride ourselves on having a big network of tertiary care consultants that we can refer to if we need to.  So, we’ll do our best to support a woman but if we feel that her problems are more complex, then we will of course refer on and this could be to an endocrinologist, [or] it could be to a gynaecologist ……  ”, she explains.

Resources and training

For those who want to learn more about menopause management one source that Mrs Evans recommends is the health care professional resources from Newson Health, led by Dr Louise Newson. These provide up-to-date, evidence-based information.  The British Menopause Society also has useful resources. Mrs Evans also suggests careful study of the NICE guidance – although the guidelines are currently being reviewed.  The Primary Care Women’s Forum has good resources on the menopause and also the Faculty of Sexual and Reproductive Health. “We shouldn’t forget that many women in their perimenopause are still fertile and still can get pregnant ……so making sure that contraception is also a part of this picture is a really important part of the jigsaw”, she emphasises.

Tips for success

Mrs Evans recommends that colleagues should be menopause-aware whatever their area of interest or specialty practice. “If you’re seeing a woman in your consultation room and she’s suffering with mental health issues or a range of symptoms which are difficult to put in a normal [diagnostic] box”, she may be experiencing menopause symptoms.  “From a healthcare professional point of view, I would say remember to look at women through that [menopause] lens”, she says.

For patients, Mrs Evans offers two tips – first, use a tracker app and second, do not forget that premature menopause also occurs.

Newson Health produces a Balance tracker app that can held on a mobile phone and is useful to monitor symptoms and follow progress over time.

If a young person is experiencing menopause symptoms she says “Don’t be put off by someone who might say to you,  ‘you’re too young’ –  because we’ve known people go through the menopause at 18 and younger. So, you wouldn’t say to somebody ‘you’re too young to get heart disease or type 2 diabetes’ – we just wouldn’t say that to somebody  – we would look at the person in front of us and do our evaluation”.

Deborah Evans’ closing message to everyone is: “I think there are many myths out there about menopause and HRT – so make sure that you’re well-informed. That’s not just from the social media …..,  it’s actually looking at making sure that the evidence that you’re looking at is good quality, sound evidence with the appropriate data behind it”.

About Deborah Evans

Deborah Evans is a pharmacist independent prescriber who specialises in women’s reproductive and sexual health, including the menopause. She owns and runs Remedi Health, a clinic in Winchester, Hampshire. She combines the roles of Clinic Director, Superintendent Pharmacist and hands-on practitioner.

Read and watch the full series on our website or on YouTube.

There are three different formulations of transdermal oestrogen – patches, gels and spray.  Women need to be aware of the pros and cons of each of these so that they can decide which will be best for them. “Patches can be very convenient; you stick them on, you leave them on for three to four days and you change [them]. So, you don’t have to think about your oestrogen replacement in between those times”, explains Mrs Evans.  They are designed to provide a constant level of oestrogen throughout a 24-hour period. “They can be very useful for women who have been suffering an increase in migraines or headaches during their perimenopause because it smooths out the peaks and troughs of their hormone [profile]. The downside is that once we’ve prescribed a particular strength of oestrogen patch then there’s little flexibility to go up and down around that”, she adds. However, once a woman is stabilised on a dose, then the patches can work very well.  “Another downside of the patch is that for women with a very active lifestyle who might be swimming a lot or taking long baths or sweating a lot in the gym, then they can fall off. [Also], some women get irritation from the adhesive”, she says.

“There is also a patch that contains a progestogen which can be helpful for women who might have some compliance issues about taking the sort of micronised progesterone that is part of an HRT regime”, says Mrs Evans.

The gel is very flexible for dosing and it comes in either a sachet or in a pump dispenser. “You apply the gel daily so what you would do is get into a routine that works well for you. Maybe, [take] a shower in the morning, dry your skin very well and then [apply] a couple of pumps of the gel, one on the inside of each thigh; spread over a large surface area, let it dry and get dressed”, explains Mrs Evans. The main downside for gels is the time required for the gel to dry before dressing.

The other formulation is a metered-dose spray which also offers very flexible dosing and dries more quickly than the gel. Women who need more than three-four actuations of the spray can run out quite quickly which may be an important consideration for women who have to pay for private prescriptions.

Genitourinary syndrome of menopause

About 70% of women post-menopause will experience genitourinary problems. These can include weaker bladder, leakage of urine, incontinence and weaker pelvic floor muscles.  Also, women are at risk of urinary tract infections because the microbial flora in that area changes. In addition, there is what used to be called vulvo-vaginal atrophy.  The vulvovaginal and urinary tract symptoms caused by thinning and shrinking of the tissues of the vulva, vagina, urethra, and bladder as a consequence of oestrogen deficiency are now known as ‘genitourinary syndrome of menopause’ (GSM).

Mrs Evans explains: “In the same way that we lose collagen and flexibility in our skin, …..  the skin in our vulva and vagina also declines, becomes thinner. In fact, it can become so thin that women can be prone to bleeding and can get very, very sore. Sexual intercourse becomes incredibly painful if not impossible and they can be prone to vaginal infections, such as thrush. Of course, it’s an area that that women either accept …… or they’re not really thinking about because maybe they’re not as sexually active as they were or they’re just putting it down to old age”.  She also notes that many women in residential care homes suffer from recurrent urinary tract infections which put them at risk of acute kidney injury – partly as a result of lack of appropriate care for GSM. “So, it isn’t just sorting out your dry fanny, this is about making sure that you keep yourself as healthy as you possibly can. It’s super-easy to fix  – systemic HRT … – the topical transdermal oestrogens – will help enormously. But actually, what many women find is that they need local oestrogen so that would be either a cream application or a pessary that they can use and leave in for three months or vaginal pessaries that you insert and that will release oestrogen into the [surrounding tissue]”, she explains.

The amount of oestrogen delivered by these vaginal formulations is very small indeed but it is very effective. “It can change again the cells of the vagina and vulva. It has a local effect on the urethra and the area around the bladder; it can tone up the pelvic floor – although we still need to do our pelvic floor exercises of course. …..  We’ve seen a lot of women who’ve had significant, life-changing [effects] – you know, women that have been nervous to go out because they’ll pee themselves or they have to know exactly where the loo is. Just simply replacing their oestrogen has been enough to address the symptoms”.

“Women with a history of breast cancer can also use these [oestrogen] pessaries because the level is so low that sometimes a woman with a history of breast cancer who can’t use systemic HRT can at least have her GSM sorted out”, she adds.

About Deborah Evans

Deborah Evans is a pharmacist independent prescriber who specialises in women’s reproductive and sexual health, including the menopause. She owns and runs Remedi Health, a clinic in Winchester, Hampshire. She combines the roles of Clinic Director, Superintendent Pharmacist and hands-on practitioner.

Read and watch the full series on our website or on YouTube.

Once replacement of oestrogen and progesterone deficiencies has been optimised the next thing to consider if whether testosterone replacement is also required, Deborah Evans explains. “We would do that once [oestrogen and progesterone] levels have been optimized and we’re comfortable that she’s got the most out of her symptom control from that replacement”, she says.  “We check in with women two weeks after initiation; we check in with women if we’re concerned at all and they know that they can walk in, phone up or email us for any advice during that process”, she adds.

The rationale for testosterone replacement in menopausal women is that testosterone levels fall in menopausal women alongside oestrogen and progesterone. Mrs Evans says: “Testosterone is also in decline so by the time we hit our mid-40s it’s probably half the level we had in our mid-20s – and, as I mentioned earlier, testosterone is a really important neurological hormone. So, we find that the benefits of replacing testosterone really help with brain fog, cognitive function, motivation, sharpness, confidence and memory. It can also help with aches and pains, sleep and, of course, libido which is the only indication really within the NICE guidelines”.   Although the NICE guideline stipulates that testosterone may be offered for sexual dysfunction, Mrs Evans says that for many women this is not the top symptom. “For a lot of women coming into the clinic what is worrying them more than anything is their memory loss, the fact that they’re not sharp, that they’ve lost their Mojo, their motivation. They really can’t be bothered; they’ve just lost their ‘get up and go’ and that’s where we see testosterone having its bigger benefit. Now, of course, when they feel more like themselves and …… just more like they were, then, of course, their libido becomes more important to them”, she explains.

One not inconsiderable hurdle is the lack of availability of a licensed testosterone product for use in women in the UK, although this could change in the future says Mrs Evans.  In the meantime, the options are either to use the UK product that is licensed for use in men (off-label) or to use a product that is licensed for women in Australia.  The UK-licensed male product has to be used in about one tenth of the male dose. In practice, this means getting  eight or 10 doses out of a 2.5ml sachet of gel, with all the associated accuracy and product stability problems that this entails.  The Australian-licensed product has been developed for use in women and this represents a safer and more effective testosterone replacement treatment for menopausal women, she says.

About Deborah Evans

Deborah Evans is a pharmacist independent prescriber who specialises in women’s reproductive and sexual health, including the menopause. She owns and runs Remedi Health, a clinic in Winchester, Hampshire. She combines the roles of Clinic Director, Superintendent Pharmacist and hands-on practitioner.

Read and watch the full series on our website or on YouTube.

In the past the benefits of HRT were underplayed. Moreover, studies published in the early 2000s caused scares about possible breast cancer and this was reinforced  by irresponsible reporting in the media, says Mrs Evans.  Unfortunately, the story has stuck and many women (and some doctors) continue to worry about breast cancer with HRT. “You’re much more likely to be at risk of breast cancer if you’re overweight, obese, [or] drink more than two or three units [of alcohol] a day on a regular basis”, she says. She also emphasises the importance of referring to the latest evidence and relevant products.

“The body-identical oestrogen that we replace through the skin in the licensed transdermal preparations that we use ….. [has been] shown to not increase risk of breast cancer. There’s no increased risk of blood clotting – beyond the woman’s natural risk of blood clots – if she’s using transdermal oestrogen; there is an increased risk from taking oral oestrogens and in modern practice, unless there is a particular reason why we need to use an oral HRT product, we don’t start there – we start with the transdermal, neutral-risk-for-blood-clots oestrogen replacement – and that works very well for the majority of women”, explains Mrs Evans

“In fact, there’s evidence to show that women that get breast cancer when they’re on HRT …… have a lower death rate from their breast cancer than women who don’t. We also know that ….. women who take oestrogen only [HRT] have an equal or better breast cancer rate than women who are not on HRT at all”, she adds.

HRT replaces the hormones that women no longer make. The aim of HRT is to restore the hormone levels to where they would have been throughout their natural reproductive life. Modern HRT does this using body-identical hormones “with the same molecular structure as the molecules that they made themselves and so it makes it makes sense, actually, for there to be very little increased risk associated with HRT”, she explains.

Benefits of HRT

Current data show that HRT

• reduces the risk of osteoporosis by between 26 and 37%
• reduces the risk of diabetes by 30%
• reduces the risk of coronary heart disease by 50%
• reduces risk of dementia by between 22 and 32%
• reduces the risk of age-related macular degeneration by a third
• reduces the risk of depression by 50%
• reduces the risk of all-cause mortality by 30%

“Women should be offered HRT unless there’s a good reason not to go on it, just based on the longevity and the health benefits long-term”, Mrs Evans says.

How old is too old?

Another thing that women have been told is that they are too old for HRT and various age limits have been quoted.

Mrs Evans says: “We know from the data that the long-term health benefits can be best achieved if you start HRT earlier and, actually, the sooner the better. So, any myth … that you can only have it for five years we’re going to dispel right here, right now. It’s really important to recognise that if you need hormone replacement then the earlier you start the better for your long-term health. However, there are [older] women who can benefit from being on HRT and again it’s about that individual in front of you, personalising her care, evaluating the risks versus the benefits. …But I’ve started women in their 70s on HRT and they haven’t looked back”.

She describes one case of a woman who had experienced drenching night sweats for more than 20 years and was having to change the sheets every morning. No-one had suggested HRT until she consulted Remedi Health. Now, “she says she’s never going to come off it! But she said it’s absolutely been the best decision for her health that she could have made and she’s living a normal life – not to mention the other symptoms that have gone. So, as long as we look at that individual in the same way that we would for anybody at any age, then certainly age is not a contraindication”.

Menopause clinic at Remedi Health

A cornerstone of the service at Remedi Health is to start by carefully listening to women who consult for menopause symptoms.

Mrs Evans describes a recent case of a woman in her early 60s who initially consulted for worsening irritable bowel syndrome (IBS). On further questioning she described troublesome night sweats of recent onset coupled with extreme joint pain.

“It’s not unusual for someone to experience symptoms after their menopause. …. Some women go through perimenopause without too many problems but then it’s when their hormones are really low that they suffer”, says Mrs Evans.

“Looking at a woman’s health through the lens of her hormones makes us perhaps make some connections that she hasn’t done already. The key aspect of our service is listening and so our initial menopause consultations will last up to an hour and during that time we go through a questionnaire process so that she has the opportunity to reflect on a wide range of symptoms”, she explains. The questionnaire is used again at each follow up consultation to check on progress. The interview involves a full gynaecological and obstetric history as well as previous medical history, including prescribed medicines and supplements.  Remedi Health can also offer blood tests for hormones, if required.

The initial consultation usually results in prescribing and supply of HRT,  in line with the guidelines. A review is offered at two to three months to check progress and adjust treatment if necessary. This is important because there is considerable inter-individual variation in oestrogen absorption and handling, explains Mrs Evans.  Thereafter, “Depending on how she’s getting on we could potentially leave her until her annual review, repeating her medicines every quarter”, she says.

About Deborah Evans

Deborah Evans is a pharmacist independent prescriber who specialises in women’s reproductive and sexual health, including the menopause. She owns and runs Remedi Health, a clinic in Winchester, Hampshire. She combines the roles of Clinic Director, Superintendent Pharmacist and hands-on practitioner.

Read and watch the full series on our website or on YouTube.

There is a considerable unmet need for menopause services. “I think at the moment the data suggests only about 15% of women are prescribed hormone replacement – that’s 85% of women who are not. ……  In the main I would say there are many, many, many women from [their] 40s, if not before, and upwards through to end of life who are suffering needlessly as a result of not being listened to and treated”, says Mrs Evans.  Some women will experience a natural menopause that can take several years and others will experience an abrupt menopause as a result of surgery or chemotherapy. There is a belief that “we get through the menopause” but “in my experience, both personally and professionally, I think many problems only just begin once periods have stopped and the menopause has been met”, she says.

Menopause symptoms are many and various. While hot flushes and brain fog are often mentioned, declining levels of oestrogen and other hormones have wider effects. Also, these come at a time of life when women can be managing teenage children, ageing parents and busy careers – and so problems are often put down to stress. Oestrogen, progesterone and testosterone are not just our sexual and reproductive hormones – “they are all powerful neurological hormones which means they have a big impact on the brain so when they’re either out of balance, fluctuating or in decline or all three – then we can really feel it mentally”, says Mrs Evans. Some women experience anxiety and depression for the first time with the menopause and those who’ve had it in the past can feel significantly worse. Cognitive function can decline and women describe brain fog and memory loss. Other troublesome symptoms include loss of libido, sleep difficulties, joint pains, pins and needles, tinnitus, dry eyes, dry skin, sore mouth, bleeding gums, flare-ups of irritable bowel syndrome (IBS). About 30% of women do not experience hot flushes, she notes. There is also genitourinary syndrome of the menopause (GSM)  characterised by combined vulvovaginal and urinary tract symptoms as a result of thinning of the tissues of the vulva, vagina, urethra, and bladder caused by oestrogen deficiency. “It’s a peak time for women to seek referrals to specialists when, in actual fact, addressing their hormone decline would make all the difference to how they feel and their symptoms”, she says.

In the past the risks of hormone replacement therapy (HRT) were very heavily emphasised and much of this type information is still around – and it frightens women off HRT.  Whilst a healthy lifestyle can help, “I think it’s really important to understand the role that HRT plays in addressing the symptoms that I’ve described …… Fundamentally unless we’re addressing the decline in hormones then we can’t fully address the symptoms”, says Mrs Evans. The benefits of HRT also need to understood – “What we now know from the evidence is that women as a population who take HRT live longer from all-cause mortality than women that don’t take HRT and this is because living with long-term hormone deficiency, particularly oestrogen, carries risks”, she explains. These are increased risks of cardiovascular disease (e.g. heart attacks and strokes), type 2 diabetes,  osteoporosis (where oestrogen replacement is a first-line therapy) and some cancers (e.g. bowel and bladder). In addition, there’s emerging evidence to suggest that Alzheimer’s disease increases as well. “So, by taking HRT women are not just addressing their immediate symptoms, which can go long beyond the menopause itself, but also looking at protecting their long-term health and we know from the evidence ……. that those benefits for health protection are particularly relevant if you start HRT within 10 years of completing the menopause – so one year post-[last]-period – and/or under the age of 60 [years]. ….. I hear a lot of women say to me, “Oh well,  I’ve got through the menopause;  my mother got through it – I’m going to get through it”, as if we’re going to get some sort of badge of honour! …..  The reality is that before the health protection elements that we now have we weren’t living much beyond our reproductive years. So, I don’t believe it’s natural to live in this [state of oestrogen-deprivation] and, in fact, if it was any other hormone, such as thyroid, we would replace it without [further] thought”.

About Deborah Evans

Deborah Evans is a pharmacist independent prescriber who specialises in women’s reproductive and sexual health, including the menopause. She owns and runs Remedi Health, a clinic in Winchester, Hampshire. She combines the roles of Clinic Director, Superintendent Pharmacist and hands-on practitioner.

Read and watch the full series on our website or on YouTube.

Semaglutide and how it makes you want to eat less

Ms Evans explains that semaglutide mimics the action of glucagon-like peptide-1 (GLP-1) – a hormone produced in the intestines in response to the presence of food. It helps to regulate appetite by promoting feelings of fullness and reducing the urge to eat more. “One of the side effects of this medicine …… is that we can end up feeling really quite full to the point of nausea”, she comments.

She emphasises that getting the best out of semaglutide involves some lifestyle changes. “It’s important to make sure people understand how these medicines work, listen and tune in to their body, adopt a healthy eating plan and exercise – and then they will lose weight”, she says.

Wegovy or Ozempic – does it matter?

Both Wegovy and Ozempic are brand names for semaglutide – the difference is that Ozempic is licensed for treatment of type 2 diabetes whereas Wegovy is licensed for weight management. Some problems have arisen as widespread publicity has driven demand for semaglutide and at present (June 2023) Wegovy is not yet available in the UK. For this reason, off-label Ozempic has been prescribed for obesity treatment and shortages in the supply of Ozempic have occurred.

The two drugs are presented in slightly different concentrations and dose schedules. In the landmark STEP1 trial semaglutide was given at a dose of 2.4 mg but Ozempic is not available in this dose. “If I go to the dosing of Wegovy,  you start at 0.25 then you go up to 0.5 then you do one milligram then you do 1.7 milligram and then you do 2.4 milligram and  you only reach 2.4 milligram by month five where whereas with Ozempic we do 0.25 for a month, 0.5 for a month then you probably stick around that for months three and four but you could go up to one milligram in the third month and then it stops”, says Ms Evans. Higher doses can then be prescribed if required.

Semaglutide: what you need to know about online supply and effective use

Online supply of semaglutide has the advantage of making the medicine more accessible but may not provide adequate support to enable people to get the best out of the treatment, says Ms Evans.

“For us the engagement with the individual face-to-face is incredibly important. It’s important for a number of reasons – we can properly understand some of the struggles that an individual has had with their weight …. [and] what their goals of treatment are. We can talk to them honestly and openly about the benefits of treatment but also the risks”, she says.

Another important aspect of treatment with GLP-1 analogues is dose titration.  “If we were to go in with the therapeutic dose straight away most people would have a significant amount of side effects – this feeling of fullness, delayed gastric emptying. They probably would be sick or feel sick and may have headaches”, she explains.

How to provide semaglutide in an ethical weight-loss clinic

Taking time to understand a patient’s weight loss goals and checking their medical history to ensure there are no underlying problems that may need onward referral are both key elements of an ethical weight-management service.

Once again, Ms Evans emphasises that weight loss with semaglutide is not a quick fix and should be the result of an informed decision by the patient. “We use behavioural techniques to support them in whatever change they want to [make] and make sure that this is part of a broader health and well-being approach. ….  It’s not cheap – it’s an expensive treatment – and it could make them feel really quite unwell to start off with. People describe feeling nauseous [and] having headaches as they titrate up their medicine”, she says.

Another important aspect of the service in clinical governance – especially important when the medicine has not been available for long and long-term safety data are lacking. “We need to make sure that we’re safeguarding our patients and making sure that everything that we do is appropriately documented and supported with evidence”, says Ms Evans.

Offering the best weight-loss service for the patient

People seeking semaglutide for weight management from a pharmacy-led service need to feel assured that the service is ethical and legal and has their best interests at heart.

Ms Evans suggests that there are a number of questions that people should ask and points that they should check to satisfy themselves that a potential supplier is offering a high-quality service. These include checking that online services are registered with the General Pharmaceutical Council (GPhC) (or General Medical COucnil (GMC) and checking that the information provided covers benefits, risk and side effects and what to do if something goes wrong.

Putting it all into perspective Ms Evans says:

“It is incredibly important to address the issue of being overweight and obesity. ……  For me, it’s about helping those individuals who have for years struggled with being overweight or obese and are now heading to perhaps a shortened lifespan”.

About Remedi Health

Ms Evans has a hands-on clinic role and regularly has 30–60-minute consultations with clients. Remedi Health offers a wide range of services including a menopause service, phlebotomy, diagnostics, vaccinations, ear health, allergy testing, DNA testing and pharmacogenomics. It also draws on the services of specialists including  dermatology specialist, an endocrinologist and a nutritional therapist.

Read and watch the full series on our website or on YouTube.

“When we’re prescribing, we may need to make sure that self-interest is taken off the table. If we’re prescribing with our own commercial gain in mind then we’re not following the ethical and legal practice associated with the responsibility of prescribing”, says Ms Evans. “If you’re prescribing privately, are you making the right decision for the patient or are you making a decision that makes you more money? ….. You need to make sure that all your practice is evidence-based, that you engage the patient in the decision that you make and that you’re documenting that and you can honestly justify your decision for prescribing is in the best interests of that patient”, she continues.

Questions to ask and things to look for

Ms Evans suggests that there are a number of questions that people should ask and points that they should check to satisfy themselves that a potential supplier is offering a high-quality service.

“Do your research to make sure that you are engaging with a bona fide service”, she says. The following points should be considered:

• If using an online service, check that it is registered with the General Pharmaceutical Council (GPhC). If the GPhC logo is displayed with the registration number she advises checking the number on the GPhC register. “[Being registered] doesn’t mean that that practice is going to be bad or good but it’s the first step to make sure that they are at least being overseen by a regulator”, she says.
• Look at the service that’s being offered: Is the prescriber and the organisation competent to prescribe in this area? Do they have the appropriate licenses to prescribe and supply?
• Are you receiving good information about benefits, risks and side effects of treatment? If you’re only being told of the benefits then that should raise some concerns. “Also, you should be being told – and it may be in the small print – that this is an off-label use of semaglutide, if it’s Ozempic”, she says.
• How will you be supported in your weight loss journey? “This is not a small undertaking financially or physically – it is going to affect how you feel – ….. so how are you going to be supported? How can you contact the prescriber and the supplier if something doesn’t go as expected?
• Are you being informed about some of the more serious side effects – such as acute pancreatitis – and what to do?
• When using a face-to-face service – is this somewhere that feels professional? Does it feel like a clinical environment where people are well-trained and know what they’re doing? In terms of the interaction they have with you, the information they take from you – are they asking about previous medical history, family history, any drugs that you’re taking at the moment?

The answers to these questions should give a good indication about the level of service that is provided “but if your gut is telling you this doesn’t feel right then it probably is not”, says Ms Evans.

 GLP-1 analogues in perspective

“It is incredibly important to address the issue of being overweight and obesity. ……  For me, it’s about helping those individuals who have for years struggled with being overweight or obese and are now heading to perhaps a shortened lifespan”, says Ms Evans. GLP-1 analogues have been hailed as ‘game-changers’ in obesity management and if used safely and responsibly with the right supporting frameworks, the results could be excellent. “We’re already seeing people that are having great effects. However, as a pharmacist, I feel incredibly responsible and accountable to make sure that this is done in a way where people are kept safe and that we use the medicines as they’re intended and that people do get the benefits that they need. What we don’t know is …… how they’re going to affect people longer term. So, [as with] any new medicine we need to bear that in mind and continue in our safe and responsible practice to help patients”, she concludes.

Read and watch the full series on our website or on YouTube.

“At Remedi Health we take a full clinical history and we take time to question and listen to an individual’s weight issues – what they’ve tried before, what’s worked – and their understanding of how this particular medication might work for them. We check that there are no contraindications and that they are not on any medicines that might be an issue. We may also undertake further diagnostic testing to see whether there are any other underlying reasons for gaining or not being able to lose weight, for example, hormonal issues such as low thyroid [function] or if they’re going through the menopause”, explains Ms Evans. Checks for high blood pressure and pre-diabetes/diabetes are also made, in case an onward referral is required.

Once again Ms Evans emphasises that weight loss with semaglutide is not a quick fix and should be the result of an informed decision by the patient. “We use behavioural techniques to support them in whatever change they want to [make] and make sure that this is part of a broader health and well-being approach so that they can adopt these practices in the long term.  We will always explain the benefits, risks and side effects. At the end of the day this is a joint decision. It’s very person-centred and they need to decide that this is something that they want to embark on. It’s not cheap – it’s an expensive treatment – and it could make them feel really quite unwell to start off with. People describe feeling nauseous [and] having headaches as they titrate up their medicine. One of my clients [has] experienced quite a significant amount of reflux and discomfort which means she can’t eat after four o”clock in the afternoon – so it is important to recognize that it can take a while to get to a therapeutic dose and that you have to potentially go through some side effects before you get to somewhere that your body’s comfortable with”, she says.

In addition, practical details are important, such as training people in the administration technique and agreeing a regular follow-up schedule.  “We’ll also check with them about how frequently they want to come in and be weighed and to talk about progress – how they overcome some of the barriers. A lot of clients will talk about how this makes them more accountable to their program and supports weight loss going forward”, says Ms Evans.

The NICE technology appraisal for semaglutide recommends that the drug should be used (at NHS expense) within a specialist weight management service providing multidisciplinary management of overweight. Remedi Health is able to offer a range of support services to “support an individual across the board”.  “What’s important, I think, is to understand where my competence ends and somebody else needs to begin. So, we can make referrals to their GP or to other private practitioners including an endocrinologist who works with us”, she adds.

Clinical governance

When a community pharmacy offers a weight management service, including the supply of semaglutide, it is important to ensure that appropriate safeguards are in place. This is especially important when the medicine has not been available for long and long-term safety data are lacking. “We need to make sure that we’re safeguarding our patients and making sure that everything that we do is appropriately documented and supported with evidence.”, says Ms Evans. For prescribing pharmacists this means that they must be working within their field of competence and are able to provide evidence of the training undertaken, she explains. “We also need to engage our patient in the decision regarding prescribing so that they’re fully informed of risks and benefits and that’s particularly important …… because if it’s Ozempic that we’re providing, it is off-label”, she adds. In addition, detailed records of batch numbers and expiry dates need to be kept.

Read and watch the full series on our website or on YouTube.

The availability of semaglutide via online suppliers has the merit of giving “wide access to an important medicine for many people who are struggling with being overweight, …. many of whom have …… comorbidities and are at risk of developing ….. cardiovascular disease”, says Ms Evans. However, it is not the model that is followed at Remedi Health. “For us the engagement with the individual face-to-face is incredibly important. It’s important for a number of reasons – we can properly understand some of the struggles that an individual has had with their weight over the years, what’s worked for them, what hasn’t worked for them [and] what their goals of treatment are. We can talk to them honestly and openly about the benefits of treatment but also the risks”, she continues.  It is also important to demonstrate how to use (inject) the medicine and to ensure that clients “understand what to do if things don’t go according to plan”.  In addition, “we can engage them in behavioural change and [use] motivational interviewing techniques to make sure that any supply of medicine for weight loss is combined with a broader weight management program”., explains Ms Evans. “The vast majority of people will go on to gain weight once they stop the program that they’re on, so you end up with this ‘yo-yoing’ which is not good for your health but it also is incredibly demoralising”, she adds. Helping people to establish healthier habits and to understand that it’s a long-term programme rather than a quick fix is important.

Ms Evans also notes that Ozempic has been widely advertised (by online suppliers) and she points out that in the UK it is illegal to promote prescription-only medicines to the public.

Titration of dose

Another important aspect of treatment with GLP-1 analogues is dose titration – carefully increasing the dose as higher doses are tolerated. “If we were to go in with the therapeutic dose straight away most people would have a significant amount of side effects – this feeling of fullness, delayed gastric emptying. They probably would be sick or feel sick and may have headaches so what we do is we titrate people up nice and slowly. So, we’ll stick on a starting dose – usually of 0.25 milligrams, if we’re prescribing Ozempic – for a month. So that’s four weekly doses of 0.25 milligrams then we’ll go up to 0.5 milligrams for the second month then we go up to one milligram for the third month and we titrate to [response] – to when people feel comfortable”, explains Ms Evans. Responses to the drug vary. Some people do not need the full therapeutic dose while others can be impatient to increase the dose as quickly as possible to get the weight loss that they desire.  This is where the counselling is helpful “because people need to be encouraged that sticking with this, particularly when you don’t feel great, is important because you will reach a therapeutic dose when it starts to have a big impact on weight loss, but it may not be immediately”, says Ms Evans.

Read and watch the full series on our website or on YouTube.

Both Wegovy and Ozempic are brand names for semaglutide – the difference is that Ozempic is licensed for treatment of type 2 diabetes whereas Wegovy is licensed for weight management. “They’re presented at slightly different concentrations and dose schedules, so there is a difference there, but for many people the question will be, ‘so what?’ and actually in clinical practice if a prescriber is prepared to prescribe Ozempic instead of Wegovy …… they will be prescribing off-label, so in other words outwith the license.”, explains Ms Evans.  This situation can arise because at present (June 2023) Wegovy is not yet available in the UK.

There is a considerable demand for semaglutide for weight loss and this has led to shortages in the supply of Ozempic. “It is a real problem. We’re finding now that you can’t get the lower entry doses of Ozempic and in fact I tried today and I couldn’t get the high dose either. So, it is in short supply and the company have informed us that it’s likely to be in short supply throughout the whole of this year. What that means is that for people that have been prescribed it for type 2 diabetes they’re not going to be able to get their medicine and potentially an alternative is going to have to be found”, says Ms Evans.  In these circumstances it is important for prescribers and pharmacists to make patients aware that the drug is being used off-label (for weight loss) and that they themselves are have adequate professional indemnity cover in place in case anything goes wrong.

Dosing differences

In the landmark STEP1 trial semaglutide was given at a dose of 2.4 mg but Ozempic is not available in this dose. “If I go to the dosing of Wegovy,  you start at 0.25 then you go up to 0.5 then you do one milligram then you do 1.7 milligram and then you do 2.4 milligram and  you only reach 2.4 milligram by month five where whereas with Ozempic we do 0.25 for a month, 0.5 for a month then you probably stick around that for months three and four but you could go up to one milligram in the third month and then it stops”, says Ms Evans. Higher doses can then be prescribed if required.

Prescription or PGD?

Semaglutide products are prescription only medicines (POMs) so they should be prescribed by a licensed prescriber who has enough expertise to be competent to prescribe in this area.  POMs can sometimes be supplied under an alternative mechanism – under a patient group direction (PGD). Currently, Saxenda (liraglutide), which was the first of the GLP-1s to be available, can be supplied under a PGD and there are a number of community pharmacies that have this type of protocol in place.  “Essentially, a patient group direction is what it says – it’s a protocol that, provided the individual in front of you ….. meets the requirements, and there are no reasons why they can’t have the medicine, then they can be supplied it. …..In that instance the supplying pharmacist does not have to be a prescribing pharmacist”, Ms Evans explains. However, there are no PGDs at present for semaglutide because the only available product is Ozempic and it would be inappropriate to have a PGD for off-label Ozempic. “We’ll have to wait to see if anyone develops a commercial Patient Group Direction for Wegovy but for the moment it needs to be prescribed by an appropriately qualified and licensed prescriber who’s prescribing within their scope of practice”, she adds.

Read and watch the full series on our website or on YouTube.