Have we forgotten the importance of emollient therapy, the 'unsung heroes' of dermatological treatments? - a Dermatology Nurse consultant's perspective - Paula Oliver RGN BSc(Hons)MSc INP

Emollients have been part of human life for centuries; records suggest that the ancient Greeks used wool fat to moisturise their skin as early as 700BC¹. However, today emollients are much more user-friendly and cosmetically acceptable to wear on the skin. Whilst they do have cosmetic purposes, they act, first and foremost, as the mainstay of treatment for patients with dry skin conditions to aid maintenance of healthy skin barrier function.

The skin is a complex organ, acting as a barrier to the external environment and as a protector. It is our ‘cutaneous envelope’ and, when healthy and intact, it prevents penetration of pathogens and allergens, while also helping to ensure water is held in the skin.

More recently, filaggrins have been identified as critical proteins in the skin; they bind to keratin fibres in cells, giving skin the structure that is essential to maintaining a healthy barrier. Loss of filaggrin leads to increased skin permeability (due to the loss of barrier function), reduction in natural moisturising factors and increased pH of the skin, which leads to inflammation. Emollients are vital for minimising these effects².

So, what are emollients?

The terms emollient and moisturiser are often used interchangeably in everyday practice. The word emollient is a Latin derivative and implies a product that softens and smoothes the skin. Emollients should reduce the clinical signs of dryness such as scaling and lichenified skin and reduce sensations such as tightness and itch.

It’s important and well documented that patients should find an emollient product that they find cosmetically acceptable enough to maintain their usual lifestyle. In dermatology, we know that if a patient doesn’t like the emollient product they have been prescribed, they simply won’t use it, which can lead to wastage at a time when optimisation of budgets is so important in the NHS.

The ingredients of emollients vary but most contain lipids (fats, waxes and oils), which influence how occlusive they are, with greasy (high lipid content) emollients on one end of a continuum and more water-based (low lipid content) emollients on the other. There are many different types and formulations so it’s important to consider what is best for each individual on a case by case basis.

Types of emollients available

• Lotions have a cooling effect and may be preferred to ointments or creams for application over a hairy area. Lotions in an alcoholic base can sting if used on broken skin.
• Creams are emulsions of oil and water and are generally well absorbed into the skin. They tend to be more cosmetically acceptable than ointments because they are less greasy and easier to apply.
• Gels consist of active ingredients in suitable hydrophilic or hydrophobic bases and generally have a high-water content. Gels are particularly suitable for application to the face and scalp.
• Ointments are greasy preparations which are normally anhydrous, insoluble in water and are more occlusive than creams, making them particularly suitable for chronic, dry lesions. The most commonly used ointment bases consist of soft, liquid and hard paraffin.

Ref: BNF 71 2016 [3]

The current problem

Since 2018 many patients have contacted the National Eczema Society stating that there are emerging problems with obtaining their emollients on prescription via their General Practitioner (GP). According to the National Eczema society (NES), recent NHS guidance recommended GPs stop prescribing emollient for mild dry skin and mild irritant dermatitis. However, this guidance was misinterpreted by some commissioners, who believed emollient prescriptions should be stopped altogether.
The NES recommend that an adult with widespread skin disease should use approximately 500g per week (250g for children) to manage their skin condition effectively. Despite this, prescribing of lower volumes is often considered a way to save costs and patients are often asked to reduce their usage and make their emollient last longer^4,5.

Emollients form part of all care plans for eczema patients and can be as, if not more, important in their treatment than medicated treatments such as topical steroids. We find that increased use of emollients results in better eczema control, leading to reduced flare ups, fewer hospital admissions and less need for topical steroids.

Despite their importance in optimising treatment outcomes, recent NHS UK guidance suggests patients buy emollients direct from pharmacy, reserving prescriptions and GP-involvement only for more severe cases of eczema, psoriasis and ichthyosis⁶. This encouragement for patients to self-fund their emollient therapy may further reduce the chance of adequate volumes being used and this, combined with the necessity to reduce prescribing costs, has the potential to undermine the importance of emollient therapy in the eyes of patients.

The BATHE study in 2018 found that pouring emollient additives into the bath does not add any clinical benefit over standard management. Standard management of childhood eczema includes soap avoidance, leave-on emollients and corticosteroid ointments⁷. NHS England now recommend that bath emollients should not be prescribed for any new patient, and “deprescribing” should be encouraged for existing patients. However, some dermatology patients do like to immerse themselves in a warm bath with an added oil so an alterative to a bath oil is to dissolve an ointment-based emollient in hot water and then to vigorously incorporate it into the bath water to disperse the lipid.

CCG Formulary

Clinical Commission Group (CCG) formularies are important to consider and prescribing decisions made by practitioners should be rational, evidence-based and cost effective. In terms of emollient prescribing, the practitioner needs to consider the most appropriate emollient formulation(s) for the patient’s skin condition and, most importantly, involve the patient in the prescribing decision. It’s also key to follow guidance and, where possible, prescribe the emollient with the ‘lowest acquisition cost’ from the range of emollients on the formulary. If a patient’s emollient products are changed to a cheaper alternative, it’s also important to ensure that it is comparable with, or better than the original one.

Take home messages

• Emollients are used to help manage dry skin conditions such as eczema, psoriasis and ichthyosis and can help to reduce inflammation and flare ups of these common dermatological conditions
• Patients with skin conditions should have access to prescribed emollient therapy to manage their diagnosed skin condition
• Consider the appropriate emollient formulation for each individual and ensure sufficient quantities are prescribed
• Consider prescribing low cost products that are comparable with, or better than, higher costed products

Declaration of competing interests

The author has been reimbursed by Aspire Pharma, distributor of the Dermatological emollient range.

References

1. Marks R. 2001 Sophisticated emollients. Thieme Publishing Group, Stuggart
2. British Dermatology Nursing Group. Best Practice in emollient Therapy December 2012
3. British National Formulary 71 March- September 2012 British Medical Association - Royal Pharmaceutical Society
4. National Eczema Society (NES) November 2012 [accessed online 27/05/19] www.eczema.org/emollients-on-prescription
5. National Eczema Society Emollient PILS [accessed 28/05/19] file:///C:/Users/paula/AppData/Local/Packages/Microsoft.MicrosoftEdge_8wekyb3d8bbwe/TempState/Downloads/Emollients%20091018%20(1).pdf
6. NHS England Emollients [accessed online 27.05/19] https://www.nhs.uk/conditions/Emollients/
7. Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness by Miriam Santer, Matthew J Ridd, Nick A Francis, Beth Stuart, Kate Rumsby, Maria Chorozoglou, Taeko Becque, Amanda Roberts, Lyn Liddiard, Claire Nollett, Julie Hooper, Martina Prude, Wendy Wood, Kim S Thomas, Emma Thomas-Jones, Hywel C Williams, Paul Little. BMJ. May 2018

Contenr provided by Paula Oliver RGN BSc(Hons)MSc INP

GAG layer therapy clinic - a urology nurse consultant's perspective - Carol Edmunds

Interstitial cystitis or bladder pain syndrome (IC/BPS) is a chronic condition characterised by chronic pelvic pain in the absence of a proven urinary tract infection. The symptoms vary on a patient to patient basis but may include pain related to bladder filling, frequency and urgency. IC/BPS may be considered a functional chronic pain disorder affecting the pelvis, rather than a condition specific to the bladder. IC/BPS is a poorly understood bladder condition that is more common in females [1] and probably has a multifactorial cause; it can have a significant impact on lifestyle, work, emotional wellbeing and relationships. As IC/BPS is a diagnosis of exclusion with allodynic symptoms and non-specific diagnostic features without any pathognomonic findings, it is consequently a very difficult condition to diagnose which can take on average up to seven years to diagnose and start treatment; this significantly adds to the condition’s impact on a person.

GAG layer therapy

It has been hypothesised that a defect of the glycosaminoglycan (GAG) layer of the bladder results in IC/BPS. The GAG layer comprises hyaluronic acid, heparin sulphate, chondroitin 4-sulphate, dermatan sulphate and keratin sulphate, and it is thought that this functions as a barrier for the bladder surface. GAG therapy has been used since the 1990s and is widely accepted as a successful treatment option for patients diagnosed with IC/BPS who have had a poor response to other treatment methods.

GAG therapies are also recommended to treat recurrent urinary tract infections, chemical induced cystitis including BCG therapy and radiation induced cystitis [2,3,4] but I am focusing only on patients with IC/BPS in this article.

The treatment pathway

Prior to being referred to the clinic the patient should have been asked to complete a bladder / food diary and, if indicated, eliminate triggering food and drink – these can sometimes be re-introduced once the patient's symptoms are controlled.

The patient will have been assessed on an individual basis and options discussed regarding trigger points, if identified these may include advice on smoking cessation (as smoking and the chemicals in tobacco are known bladder irritants), pelvic floor exercises, and relaxation therapy to assist in lowering stress levels which in some cases can act as a trigger point of a flare in IC/BPS symptoms.

It is important to remember when meeting the patient for the first time that it may have taken a long time for that individual to get to this point and often patients feel that nothing will ever help control their symptoms and give them back quality of life. Consequently extra time may be needed with these patients and I feel this is a vital part of the patient's journey in accepting that bladder instillation therapy can work.

Intravesical hyaluronic acid (HA) is still not available in every hospital to treat IC/BPS which may be as a result of variable response rates. In 2007 Lavazzo et al. concluded that the efficacy of HA remained unproven in controlled and blinded trials [5], although response rates range from 30% to as high as 71% in different studies [6,7].

GAG layer therapy is widely available commercially in different formats (Table 1) but due to lack of awareness or funding is still not widely used in all hospitals. When I first started my instillation clinic back in 2011 there were even fewer hospitals undertaking this service and no widely available recommendations for its schedule of use so I decided to trial a few regimes and see which one seemed to work best for patients. I still use this regime with most of my patients now.

Treatment regime

The regime I use is Cystistat^® 50ml administered once weekly for six weeks then monthly for six months if symptoms have improved. If there is no improvement I will introduce iAluril® (hyaluronic acid with chondroitin sulphate in a pre-filled syringe) as my second-line treatment using the same regime. iAluril^® contains 20 times the concentration of HA compared with Cystistat^®. This format also has the added benefit of the patient being able to self-administer if appropriate and being available on FP10. Hyacyst^® (Sodium Hyaluronate) is also available in a pre-filled syringe format and is available on FP10. If a patient is able to self-administer it means fewer hospital visits which, from a patient perspective, reduces the impact of the treatment on their life [10].

Why do I use the above regime? The answer is simple: it is mostly due to consultant choice with evidence of its efficacy and from a hospital / Clinical Commissioning Group perspective cost-efficiency, especially when compared with long-term oral medication some of which can often be stopped once the treatment has started. The current European Association of Urology (EAU) guidelines, which serve as an ongoing review of current evidence highlights the fact that most studies are uncontrolled and involving small patient numbers in spite of intravesical therapy being in use for around 20 years [11]. Several commercial formulations are available, as summarised in Table 1.

Patients are fully assessed before each instillation to ensure the correct drug is being administered based on symptomatic response, and referred back to the referring consultant if there is no improvement or worsening of symptoms for consideration of other treatment options. Ideally we should see an improvement in the patient’s symptoms before the end of the weekly regime.

With my regime, at the end of the six months the patients are discharged on a SOS basis which gives them the chance to request re-assessment if they feel more treatment is required. I will fully assess these patients prior to any treatment being restarted to ensure this is the correct pathway for the patient and review by the consultant is not indicated.

Intravesical GAG instillation is well tolerated with most side-effects being as a result of the need for urethral catheterisation to administer the drug which may cause urethral or bladder discomfort and a low risk of infection.

Early in 2018, I was able to trial a new way of administering iAluRil^® without the need for catheterisation. Instead of a catheter being inserted to administer iAluRil^®, an adapter, called the iAluadapter^® was fitted to the syringe (Figure 1), which is used to reduce the risk of catheter side-effects. This is only licensed for use with iAluRil^® and is now included as standard in all iAluRil^® packs.Early in 2018, I was able to trial a new way of administering iAluRil^® without the need for catheterisation. Instead of a catheter being inserted to administer iAluRil^®, an adapter, called the iAluadapter^® was fitted to the syringe (Figure 1), which is used to reduce the risk of catheter side-effects. This is only licensed for use with iAluRil^® and is now included as standard in all iAluRil^® packs.

From a personal perspective, I have found the iAluadapter^® easy to use and well tolerated by patients although the patients need to be able to void prior to administration of iAluRil^® using this method as they are required to keep it within their bladder for 30 minutes for maximum effect. Patients sometimes find their pain is worse when the bladder is full and I have found if the patient has not been able to completely empty their bladder prior to the instillation this increases the risk of leakage of the instilled solution. If I do find there is leakage on instillation and I am unable to administer iAluRil^® by using the iAluadapter^® I revert to inserting a catheter to empty the bladder and then administer iAluRil^®, which is not a common occurrence. The use of the iAluadapter^® removed the fear of catheterisation in some patients and, as with other GAG-layer therapies, can allow for some self-administration regimes, but we need further studies to identify better patient selection and use of such therapies earlier in the treatment pathway.

Take home message

• Bladder pain syndrome / interstitial cystitis is a difficult condition to treat.
• Intravesical GAG replacement therapies may be used as an alternative to long-term drug therapy.
• Intravesical GAG layer therapy is easy to administer and is well-tolerated.
• There is a wealth of clinical experience available but a lack of high quality research evidence to support its use; more clinical trials are required to enable standardisation of treatment regimes.

References

1. Clemens JQ , Link CL, Eggers PW, et al. Prevalence of painful bladder symptoms and effect on quality of life in black, Hispanic and white men and women J Urol 2007;177(13):90-4.
2. Damiano R, Quarto G, Bava I, et al. Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol 2011;59(4):645-51.
3. Imperatore V, Creta M, et al. Intravesical instillation of sodium hyaluronate–chondroitin sulfate in patients with Bacillus Calmette-Guérin-induced chemical cystitis unresponsive to conventional therapies: Preliminary experience with 1 year follow-up. Eur Urol Suppl 2014;13:e466.
4. Gacci M, et al. Bladder instillation therapy with hyaluronic acid and chondroitin sulfate improves symptoms of post radiation cystitis: prospective pilot study. Clin Genitourinary Cancer 2016;14(5):444-9.
5. Lavazzo C, Athanasiou S, Pitsouni E, Falagas ME. Hyaluronic acid: an effective alternative treatment of interstitial cystitis, recurrent urinary tract infections, and hemorrhagic cystitis? Eur Urol 2007;51(6):1534-40.
6. Morales A, Emerson L, Nickel JC, et al. Intravesical hyaluronic acid in the treatment of refractory interstitial cystitis. J Urol 1996;156:45-8.
7. Cervigni M, Natale F, Nasta L, et al. A combined intravesical therapy with Hyaluronic acid and Chondroitin for refractory painful bladder syndrome/interstitial cystitis. Int Urogynecol J Pelvic Floor Dysfunct 2008;19(7):943-7.
8. Kallestrup EB, Jorgensen SS, Nording J, et al. Treatment of interstitial cystitis with cystistat an hyaluronic acid product. Scand J Urol Nephrol 2005;39:143-7.
9. Nickel JC, Egerdie B, Downey J, et al. A real life multicenter clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis. BJU Int 2009;103:56-60.
10. Willard K. Poster 27: A patient centred approach in the management of painful bladder syndrome. 24th UKCS Annual Scientific Meeting 2017.
11. Engeler D, Baranowski AP, Borovicka J, et al. EAU Guidelines on Chronic Pelvic Pain. 2018.

Carol Edmunds,
Nurse Consultant Urology, North West Anglia NHS Foundation Trust.
E: This email address is being protected from spambots. You need JavaScript enabled to view it.

Declaration of competing interests:

The author has been reimbursed by Aspire Pharma, the manufacturer of iAluRil® to attend a conference to discuss GAG layer therapy and her hospital was a trial centre for the new iAluadapter^®.

Figure 1: iAluril^® with iAluadapter^®.

Hot quote: "With my regime, at the end of the six months the patients are discharged on a SOS basis which gives them the chance to request re-assessment if they feel more treatment is required"

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