The journal of the British Dermatological Nursing Group
Dermatological Nursing September 2021 Vol 20 Issue 3
Editorial Tackling the COVID backlog Recovery and restoration
Clinical Review Basal cell carcinoma: A review and summary of the
British Association of Dermatologists guidelines for its management in adults (2021) The cost effectiveness of emollients for atopic dermatitis
Research Skills How to critically appraise a clinical trial Professional Setting up remote consultations for people with skin Development conditions: ensuring patients are seen in the right place,
at the right time Reflections on revalidation Survey of dermatology nurses’ experience of redeployment
Research Study Atopic dermatitis, dupilumab, and ocular effects: An interesting patient
Ask The Pharmacist Is tranexamic acid effective for melasma? Patient Voice Life after the 467, a tale of bullous pemphigoid BDNG News • UK Dermatology Clinical Trials Network (UK DCTN) update • Making guidelines approachable • Preparing for the conference
THE BDNG WOULD LIKE TO THANK
FOR SPONSORING OUR MEMBERS JOURNAL
The sponsorship covers the cost of production and distribution of this journal. The sponsorship includes advertising space in the journal. AbbVie has no involvement in the journal’s editorial content.
Established by the BDNG in 1997 www.bdng.org.uk
SKYRIZI
®
(risankizumab)
now only
ONE
INJECTION PER DOSE
INTRODUCING
THE SKYRIZI 150 MG PEN1 SKYRIZI 150 MG PEN Loud clicks at start and stop of injection Comfortable hand grips
PATIENT SATISFACTION 2 * †
EASE OF USE 2 * †
CONVENIENCE 2 * †
97.6%
97.6%
97.6%
Satisfied or highly satisfied with the SKYRIZI PEN
Rated the SKYRIZI PEN as extremely/ very easy to use
Rated the SKYRIZI PEN as convenient/ very convenient
(n=81/83)
Hidden needle with automatic needle guard Window allows patients to see the medication followed by a yellow indicator when the injection is complete
(n=81/83)
(n=81/83)
Same efficacy and safety profile, now even simpler with SKYRIZI 150 mg PEN and PFS compared to 2 x 75 mg PFS1,2
SKYRIZI® (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1 Currently, supply of SKYRIZI 150 mg (PEN & PFS) to Northern Ireland is only available through homecare. *Patient satisfaction with self-injection was measured at Week 28 (4 injections total) in patients using the SKYRIZI Pen by the Self-Injection Assessment Questionnaire (SIAQ), a validated instrument for measuring patient feelings and experiences with self-injection. Score measures proportion of subjects achieving the best two categories in post-dose SIAQ by visit (observed cases; intention-to-treat population). Subjects achieving the best two categories in postdose SIAQ by visit (observed cases; intention-to-treat population).3 †Patient satisfaction was also assessed for (n=83, observed cases): satisfied with frequency of injection (97.6%), satisfied with duration of injection (96.4%), continue self-injecting your medication (100.0%), and continue self-injecting at home (97.6%). PFS, Pre-filled syringe. PRESCRIBING INFORMATION (PI) SKYRIZI® (risankizumab) 75 mg solution for injection in pre-filled syringe (PFS); 150 mg solution for injection in pre-filled pen (PEN) and PFS. Refer to Summary of Product Characteristics (SmPC) for full information before prescribing. PRESENTATION: Each PFS contains 75 mg risankizumab in 0.83 ml solution or 150 mg risankizumab in 1 ml solution. Each PEN contains 150 mg risankizumab in 1 ml solution. INDICATION: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis. Dosage: Skyrizi 150 mg solution for injection in PEN and PFS: the recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4 and every 12 weeks thereafter. Skyrizi 75 mg solution for injection in PFS: the recommended dose of Skyrizi is 150 mg (two 75 mg injections) by subcutaneous injection at weeks 0, 4, and every 12 weeks thereafter. Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. Renal or hepatic impairment: No dose adjustment
required. Paediatric Population: No data available. CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections. SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be evaluated for tuberculosis infection prior to initiating treatment. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Completion of all appropriate immunisations should be considered prior to initiating therapy. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. Skyrizi 75 mg solution for injection contains 68.0 mg sorbitol and less than 1 mmol sodium (23 mg) per 150 mg dose. Skyrizi 150 mg solution for injection contains less than 1 mmol sodium (23 mg) per PEN or PFS. INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated.
PREGNANCY AND LACTATION: Women of Childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure. Lactation: It is not known whether Skyrizi is excreted in breast milk. Skyrizi may be used during breast-feeding if clinically needed. Fertility: The effect of Skyrizi on human fertility has not been evaluated. ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions. LEGAL CLASSIFICATION: POM MARKETING AUTHORISATION NUMBERS/PRESENTATIONS/ NHS LIST PRICE: Great Britain (GB) PLGB 41042/0033, Northern Ireland (NI) EU/1/19/1361/001, Skyrizi 75 mg solution for injection in PFS (Pack of 2 pre-filled syringes); GB PLGB 41042/0045, NI EU/1/19/1361/002, Skyrizi 150 mg solution for injection in PEN; GB PLGB 41042/0046, NI EU/1/19/1361/003, Skyrizi 150 mg solution for injection in PFS: £3326.09 FURTHER INFORMATION: available from AbbVie Ltd, Maidenhead, SL6 4UB DATE OF REVISION: May 2021 PI-Skyrizi-002
Adverse events should be reported. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk. Adverse events should also be reported to AbbVie on GBPV@abbvie.com
References: 1. SKYRIZI Summary of Product Characteristics. 2. Data on File, AbbVie Inc. ABVRRTI71818 150 mg data package [M15-999 and M16-005]. 3. Keininger D, Coteur G. Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ). Health Qual Life Outcomes. 2011;9:2. doi:10.1186/1477-7525-9-2. UK-SKZD-210059 Date of preparation: April 2021
Dermatological Nursing Note to members: The sponsorship funding goes directly towards the print, post and distribution costs associated with providing your journal and has no involvement in deciding or influencing any editorial content. The sponsorship includes advertising space within the journal. The BDNG would like to thank for their sponsorship and support in helping bring our members this vital membership benefit
Editorial
6
Tackling the COVID backlog Rebecca Penzer-Hick
8
Recovery and restoration Polly Buchanan
Clinical Review
Basal cell carcinoma: A review and summary of the British Association of Dermatologists guidelines for its management in adults (2021)
10
Ibrahim Nasr
Research Skills
26
How to critically appraise a clinical trial Hywel C. Williams, Alison J.G. Lowe
Professional Development
Setting up remote consultations for people with skin conditions: ensuring patients are seen in the right place, at the right time
31
Emma Le Roux, Julia K. Schofield
Clinical Review
37
The cost effectiveness of emollients for atopic dermatitis Julie Van Onselen
Case History
43
Atopic dermatitis, dupilumab, and ocular effects: An interesting patient Elaine Brown
Professional Development
47
Reflections on revalidation Debra Brown
50
Survey of dermatology nurses’ experience of redeployment Julia Wheeler, Holly Nagle, Hannah Lakin
Ask The Pharmacist
Is tranexamic acid effective for melasma?
Sponsored by
|
55
Sponsored by
|
55
Rod Tucker
Patient Voice
Life after the 467, a tale of bullous pemphigoid Ingrid Thompson
Podcast
Making guidelines approachable
Bdng News
UK DCTN update Preparing for the conference
| Sponsored by | Sponsored by
62 65 66
New product: Doublebase Once Dermal, specialists in innovative topical formulations, have launched Doublebase Once, a new once daily, highly moisturising and protective emollient gel for the management of dry skin conditions such as eczema, psoriasis and ichthyosis. Doublebase Once is an advanced emollient, specially formulated to provide 24 hours’ skin hydration from 1 application. Doublebase Once is very effective, easy to apply, absorbs quickly and cosmetically acceptable. All age groups can use Doublebase Once. Doublebase Once 100g is available on the Drug Tariff for NHS prescription from 1st September 2021 at NHS price of £2.69. PIP code: 418-7886.
www.bdng.org.uk
References • Comparison of the skin hydration of HAPA Gel (Doublebase Once) emollient with Epaderm Ointment in a 24‑hour, single application study, in subjects with dry skin. Data on file. Dermal Laboratories Ltd, Hitchin, UK. • Evaluation of performance and acceptability of a novel, long acting (24h) emollient gel. Data on file. Dermal Laboratories Ltd, Hitchin, UK.
Dermatological Nursing, 2021, Vol 20, No 3
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The journal of the British Dermatological Nursing Group
Dermatological Nursing Editorial staff
Editorial board
Kathy Radley
Mandy Aldwin/Sarah Griffiths-Little
Michelle Ogundibo
Chair of the Editorial Board Senior Lecturer, School of Life and Medical Sciences, University of Hertfordshire, and Dermatology Nurse Specialist, East & North Hertfordshire NHS Trust
Ichthyosis Support Group
Paediatric Dermatology Nurse Specialist, Chapel Allerton Hospital (Leeds Teaching Hospitals Trust)
Polly Buchanan
Podiatrist and Associate Professor, Southampton
Clinical Editor Community Dermatology Nurse Specialist,, NHS Fife dneditor@bdng.org.uk pbuchanan1@nhs.net
Rob Mair
Fiona Cowdell
Jean Robinson
Professor of Nursing and Health Research, Faculty of Health, Education and Life Sciences, Birmingham City University
Clinical Nurse Specialist Paediatric Dermatology, Royal London Hospital, Barts Health NHS Trust, London
Karen Stephen
Steven Ersser
Lead Dermatology Nurse, NHS Tayside
Managing Editor Rob.Mair@pavpub.com
Tony Pitt Art Director Tony.Pitt@pavpub.com
Advertising Mark Freeman Advertising & sponsorship dnadvertising@bdng.org.uk 07957 404 831
Julie Brackenbury Aesthetic Nurse Specialist, JB Cosmetic, Bath
Rebecca Penzer-Hick
Ivan Bristow Sara Burr
Senior Lecturer, Postgraduate Medicine, University of Hertfordshire & Dermatology Specialist Nurse, Dermatology Clinic Community Services, Cambridgeshire
Community Dermatology Specialist Nurse/Clinical Lead Community Skin Integrity Team, Norfolk Community Health and Care NHS Trust
Nurse Consultant Skin Cancer & Dermatology, Kingston Hospital NHS Foundation Trust
Professor of Nursing & Dermatology Care & Head of Department of Nursing Science, Bournemouth University
Saskia Reeken
Jackie Tomlinson
Tanya Flavell
Dermatology Clinical Nurse Specialist, Addenbrooke’s Hospital, Cambridge University Hospitals Foundation Trust
Advanced Nurse Practitioner in Dermatology, Withington Community Hospital, Manchester University Hospitals NHS Trust
Rod Tucker Community Pharmacist/Researcher with a Special Interest in Dermatology, East Yorkshire
Mark Goodfield
Andrew Thompson
Consultant Dermatologist, Leeds Teaching Hospitals NHS Trust
Clinical Health Psychologist & Reader in Clinical Psychology, University of Sheffield
Karina Jackson
Julia Wheeler
Nurse Consultant, St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust, London
Dermatology Outreach Nurse, Buckinghamshire NHS Trust, Education Development Nurse, BDNG
Ibrahim Nasr
Carrie Wingfield
Retired Consultant Dermatologist, Gloucester
Dermatology Nurse Consultant, Norfolk and Norwich University Hospital
bdng Dermatological Nursing is the official journal of the BDNG. To contact the BDNG, email: admin@bdng.org.uk or tel: 028 905 11402 Printed in Great Britain by Gemini Print, Dolphin Way, Shoreham-by-Sea, West Sussex BN43 6NZ The BDNG logo and name are Registered Trademarks. All registered rights apply.
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Dermatological Nursing (ISSN 1477-3368) is published by the BDNG, Forsyth House, Cromac Square, Belfast, BT2 8LA. Tel: 028 905 11402, www.bdng.org.uk All rights reserved. No part of this publication may be reproduced, stored or transmitted in any form or by any means without the prior written permission of the BDNG. Opinions expressed in articles are those of the authors and do not necessarily reflect those of the BDNG or the editorial/advisory board. Advertisements have no influence on editorial content or presentation.
Dermatological Nursing, 2021, Vol 20, No 3
www.bdng.org.uk
Offers an effective, simple and different approach
Why is Adex Gel Different? Highly moisturising and protective emollient gel which also contains an added ancillary anti-inflammatory medicinal substance to help reduce inflammation and redness Offers an effective, simple and different approach to the treatment and management of mild to moderate eczema, contact dermatitis and psoriasis
Benefits of Adex Gel
Evidence for Adex Gel When used for patients with eczema and psoriasis, study data showed that: patients’ feedback after using Adex Gel was very positive1 nearly 95% of patients found their skin benefited from using Adex Gel1 approximately half of the patients reported that they needed to use less of their other anti-inflammatory treatments when using Adex Gel. The remainder used about the same amount and none used more of their anti-inflammatory treatments1
✓ Developed for dry skin conditions prone to inflammation, such as mild to moderate eczema and psoriasis ✓ An easily absorbed, highly moisturising gel ✓ Specially formulated emollient with added nicotinamide to help reduce inflammation and redness ✓ Recommended for use as long as necessary – either occasionally, such as during flares, or continuously ✓ Suitable for frequent and regular application ✓ Steroid free ✓ Can be used all over the body including on the face and on creases of the skin ✓ For use by adults, the elderly and children aged 1+
Simple to prescribe, simple to use
Visit AdexGel.com for further information
Reference: 1. Djokic-Gallagher J., Rosher P., Hart V. & Walker J. Steroid-sparing effects and acceptability of a new skin gel containing the anti-inflammatory medicinal substance-nicotinamide. Clinical, Cosmetic and Investigational Dermatology 2019;12:545-552.
Adex Gel ™
Presentation: White opaque gel. Uses: Highly moisturising and protective emollient with an ancillary anti-inflammatory medicinal substance for the treatment and routine management of dry and inflamed skin conditions such as mild to moderate atopic dermatitis, various forms of eczema, contact dermatitis and psoriasis. Directions: Adults, the elderly and children from 1 year of age. For generalised all-over application to the skin. Apply three times daily or as often as needed. Adex Gel can be used for as long as necessary either occasionally, such as during flares, or continuously. Seek medical advice if there is no improvement within 2-4 weeks. Contra-indications, warnings, side effects etc: Do not use if sensitive to any of the ingredients. Keep away from the eyes, inside the nostrils and mouth. Temporary tingling, itching or stinging may occur with emollients when applied to damaged skin. Such symptoms usually subside after a few
days of treatment, however, if they are troublesome or persist, stop using and seek medical advice. Rarely skin irritation (mild rashes) or allergic skin reactions can occur on extremely sensitive skin, these tend to occur during or soon after the first few uses and if this occurs stop treatment. Vitamin B derivative requirements are increased during pregnancy and infancy, however, with prolonged use over significant areas, it may be possible to exceed the minimum recommended levels of nicotinamide in pregnancy. Safety trials have not been conducted in pregnancy and breast feeding therefore, as with other treatments, caution should be exercised, particularly in the first three months of pregnancy. Instruct patients not to smoke or go near naked flames. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a potential fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Ingredients: Carbomer, glycerol, isopropyl myristate, liquid paraffin, nicotinamide, phenoxyethanol, sorbitan laurate, trolamine, purified water. Pack sizes and NHS prices: 100g tube £2.69, 500g pump pack £5.99.
Legal category: Class III medical device with an ancillary medicinal substance. Further information is available from the manufacturer: Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. Date of preparation: July 2020. ‘Adex’ is a trademark.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse 11mm events should also be reported to Dermal.
www.dermal.co.uk
ADXPR230/SEP20
Essential Information
GUEST EDITORIAL
Tackling the COVID backlog Rebecca Penzer-Hick Rebecca Penzer-Hick is Senior Lecturer, Postgraduate Medicine, University of Hertfordshire, Dermatology Specialist Nurse, Dermatology Clinic Community Services, Cambridgeshire, and President of the BDNG.
A
s the COVID-19 pandemic moves from an acute to a chronic phase, healthcare providers will be faced with different challenges. Dermatology services will need to manage significant backlogs of patients who have had to wait longer than usual to see a health care professional. As well as impacting on patients, this backlog will impact on dermatology nurses. Waiting list initiatives are one way that Trusts are attempting to reduce the everexpanding lists of patients needing dermatology care. Putting on additional clinics in evenings and at weekends have come with extra central government funding, but staffing these additional services has been difficult for Trust management. The BDNG has become aware of occasions where nursing staff have been asked to deliver these clinics, which have, on occasion, required our members to take on roles that they are not properly remunerated for. Our strong recommendation for all staff is that if you are being asked to undertake extra work you should ensure: 1. That you are competent and confident to undertake the roles you have been asked to do. Waiting list clinics may involve fewer colleagues being available to support you, and it is critical that you have the competence to work independently at the required level. 2. That you are properly paid for the level of work that you are 6
undertaking, especially if you are working at a senior level, and ensure support staff are also paid appropriately. BDNG role descriptors are a useful resource to help determine whether the roles you are being asked to undertake are appropriate for your skill level and the amount you are being paid. The more independent your work and the more complex the decisions you are making about patient care, the more you should be paid. Whilst having conversations about pay and levels of responsibility with managers can be difficult, it is critical in terms of patient safety and your own registration that you do so. If you feel your organisation is taking advantage of you in this way, we would be very interested to hear from you and would endeavour to put you in touch with other members who may be able to share their own experiences with you.
The annual conference Conference season is upon us and the BDNG executive committee are pleased that we moved our conference from June to September. This has meant that we could plan a face-to-face live conference! We cannot wait to see you there. We have made a few changes to the format this year, and, as always, are keen to get your feedback. 1. Our workshops, which bring some interactive learning to conference, will be spread across Wednesday and Thursday, rather than being delivered all together in a block. 2. The old scientific session has been renamed ‘Innovations in Dermatology Nursing’. This is to encourage those that are undertaking innovative practice and introducing change, but not necessarily doing this through a research project, to present their work to us.
Dermatological Nursing, 2021, Vol 20, No 3
3. So that more people can attend, we have moved the AGM to lunchtime on the Wednesday. We will be making announcements about new people to join the Executive Committee and updating you all on the work of the BDNG over the last two years. Please come along if you are at conference on Wednesday. 4. The pandemic has meant that we have learnt to be savvier with technology. We will be using the BDNG app to allow us to get feedback from you quickly, but also to allow for voting interaction in some of the lecture sessions. If you haven’t already downloaded the app, please do so. You will find it in your phone’s app store. Search for ‘Engagefully’ and then enter ‘BDNG’ and you will be able to download our app. We will also have self-registration points that will be efficient and COVID secure. To ensure the maximum safety of attendees, we will be asking for proof of double vaccination, and if this is not possible, a negative COVID test taken within 48 hours of arrival. Anyone without these will be asked to take a lateral flow test. We hope you will all feel able to support our efforts to remain COVID secure. 5. After 18 months of little social interaction, I have no doubt that you will all be looking forward to our annual dinner. This year’s dinner takes on a birthday party vibe as we celebrate our 30th annual conference. It will be a much less formal affair than previous years, with a shorter prize-giving section and a buffet rather than a silver service dinner. There will be various fun activities as well as a disco and plenty of dancing. We hope it will be an evening to remember! DN www.bdng.org.uk
Like Ella, Dermol can also do two things at once! Dermol knocks out Staph and soothes itchy eczema
mol
crobial emollients
SHO
N CREAM BATH
Dermol A family of antimicrobial emollients WASH SHOWER LOTION CREAM BATH • Specially formulated to be effective and acceptable on sensitive eczema skin The Dermol family of antimicrobial emollients – for patients of all ages • As Dermol antimicrobial emollients contain antiseptics, not antibiotics, the risk of developing antibiotic resistance is minimised who suffer from dry and itchy skin conditions suchchlorhexidine as atopic eczema/ benzalkonium chloride, hydrochloride, liquid paraffin, isopropyl myristate • Significant antimicrobial activity against MRSA and FRSA (fusidic acid-resistant Staphylococcus aureus) 1 dermatitis. A family of antimicrobial emollients • Helping eczema patients for more than 20 years www.dermal.co.uk SHOWER LOTION CREAM BATH
Dermol
Dermol® Wash Cutaneous Emulsion, Dermol® 200 Shower Emollient and ® Dermol 500 Dermol Lotion benzalkonium chloride, chlorhexidine hydrochloride,
Dermol Contra-indications, warnings, side effects etc: Please refer benzalkonium chloride, chlorhexidine dihydrochloride,
liquidchloride paraffin, isopropyl liquid paraffin, myristate SPC for isopropyl full details before prescribing. Do not use if Benzalkonium 0.1%myristate w/w, chlorhexidine to individual generalised emollients allergic reaction) to any of the dihydrochloride w/w, liquid paraffin 2.5% A family of0.1% antimicrobial emollients Asensitive family(especially of antimicrobial ingredients or, in the case of the wash, shower, lotion or cream, w/w, isopropyl myristate 2.5% w/w. SHOWER LOTION CREAM BATH WASH SHOWER LOTION CREAM BATH if there is a possible history of allergic reaction to a chlorhexidine
Dermol® Cream
Benzalkonium chloride 0.1% w/w, chlorhexidine dihydrochloride 0.1% w/w, liquid paraffin 10% w/w, isopropyl myristate 10% w/w.
Dermol
Uses: Antimicrobial emollients for the management of dry antimicrobial emollients
ER
Uses: Antimicrobial bath emollient for the management of dry, scaly and/or pruritic skin conditions, especially eczema and dermatitis Directions: Adults, children and the elderly: Add to a bath of warm water. Soak and pat dry.
and pruritic skin conditions, especially eczema and dermatitis, and for use as soap substitutes. Directions: Adults, children and LOTION CREAM BATH the elderly: Apply direct to the dry skin or use as soap substitutes.
Dermol® 600 Bath Emollient
Benzalkonium chloride 0.5% w/w, liquid paraffin 25% w/w, isopropyl myristate 25% w/w.
compound. In the unlikely event of a reaction stop treatment. Local skin reactions are very rare (<1/10,000 based on spontaneous reporting). Reactions have been observed occasionally when used excessively as a leave-on application in the anogenital area. Keep away from the eyes. Take care not to slip in the bath or shower. Instruct patients not to smoke or go near naked flames. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a potential fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Dermol 500 Lotion: 500ml pump dispenser £6.04, PL00173/0051. Dermol Cream: 100g tube £2.86, 500g pump dispenser £6.63, PL00173/0171. Dermol 600 Bath Emollient: 600ml bottle £7.55, PL00173/0155. Legal category: P . MA holder: Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. Date of preparation: May 2019. ‘Dermol’ is a registered trademark.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Dermal. Reference: 1. Gallagher J. et al. Poster presented at EADV Congress 2009.
10mm
Dermol
Package quantities, NHS prices and MA numbers: Dermol Wash: 200ml pump dispenser £3.55, PL00173/0407. Dermol 200 Shower Emollient: 200ml shower pack £3.55, PL00173/0156.
A family of antimicrobial emollients LOTION SHOWER WASH
DEMPR047/AUG19
Prescribing Information
EDITORIAL
Recovery and restoration Polly Buchanan Polly Buchanan is a Community Dermatology Nurse Specialist at NHS Fife, Queen’s Nurse, and Clinical Editor of Dermatological Nursing.
H
aving just read Ingrid Thompson’s contribution to our Patient’s Voice series in this issue of Dermatological Nursing, it really brought to mind how difficult it can be for people living with a chronic skin condition – and not just the varying severity of disease, but also the angst and worry experienced when in a healthcare system (or when not in an appropriate healthcare system). We often hear of patient pathways being effective and efficient, but are they at this time of a global viral pandemic? With key criteria being cited for specific referrals to dermatology, many patients can face unwarranted delays for many weeks and months before being seen, receiving a diagnosis or a management plan. At the height of the COVID-19 pandemic, many dermatology services were suspended and team members redeployed elsewhere. Many services are now playing catch-up following the temporary suspension of services during ‘lockdown’. All this change is causing stress for patients, families, and health professionals. How have we suffered over the last few months? Can we
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recover from this? Can we restore what has been lost? I am increasingly hearing of colleagues suffering from ‘compassion fatigue’ and ‘burnout’, as well as reports of nurses retiring early or leaving the profession due to the overwhelming negative experiences during the pandemic. Dermatology nurses have been disillusioned and stressed when redeployed to acute COVID settings, feeling unsupported, being placed at risk, and being asked to do tasks for which they do not feel confident or competent.
I am increasingly hearing of colleagues suffering from ‘compassion fatigue’ and ‘burnout’ I have heard of incidences whereby experienced dermatology nurses are being left in sole charge of an acute ward which is unfamiliar, or working 12-hour shifts, drug rounds, and being left with no supervision or senior experienced nurse on shift at the same time. Other members of our profession have made the redeployed dermatology nurses feel ‘inadequate and useless’. This is unacceptable in nursing today. We are regarded as ‘angels’ by the public, but when it comes to caring for our own, we can be the complete opposite. First and foremost, we must feel safe in our working environment, and we must not let anyone place us in a risky or unsafe position.
Dermatological Nursing, 2021, Vol 20, No 3
Care and compassion are fundamental to nursing, and we need to consider caring for ourselves and valuing who we are and what we do. There is no doubt in my mind that dermatology nurses have unique knowledge, skills and understanding of others, especially persons living with lifelong skin conditions. What we need to focus on now is our own individual recovery; recovery of the team spirit and recovery of our belief in what we do and what we can contribute. This is the time to pull together, bond, and restore the specialty of dermatology nursing. Currently, we hear the buzz words of ‘recovery and restoration’ all the time within the NHS. Yes, this is important, but please consider your own recovery and restoration in being the best nurse you can be. We have all suffered a great deal of loss in the last 18 months. The experiences of the pandemic will fade and we will hopefully recover to be able to demonstrate the care and compassion needed for our patients. However, we must focus on ourselves in the first instance, then our colleagues. The BDNG annual conference is in Harrogate on 21-23 September. This will be the ideal opportunity to network, support, recover and restore. Please take every opportunity, if you can, to value and reflect on what we have in dermatology nursing when at conference. If unable to attend this year, reflect and value the positives within your team and colleagues. Stay safe. DN
www.bdng.org.uk
TOPICAL IVERMECTIN IS RECOMMENDED BY NICE AND PCDS as a first-line treatment for mild to moderate papulopustular lesions of rosacea1-3 This convenient, once-daily treatment is more effective at reducing inflammatory lesions at 16 weeks4 and gives patients more time clear (IGA 0)5 vs topical metronidazole 0.75%.
IGA, Investigator global assessment. References: 1. NICE. Scenario: Rosacea. June 2020. Available at: https://cks.nice.org.uk/ topics/rosacea/management/ rosacea/. Accessed: Feb 2021. 2. Primary Care Dermatology Society Primary Care Treatment Pathway. October 2019. Available at: http://www.pcds.org.uk/ee/images/uploads/ general/Rosacea_Treatment_2019-web.pdf. Accessed: Feb 2021. 3. Primary Care Dermatology Society. Rosacea. 2019. Available at: http://www.pcds.org.uk/clinical-guidance/rosacea. Accessed: Feb 2021. 4. Taieb A, et al. Br J Dermatol 2015;172;1103–1110. 5. Taieb A, et al. J Eur Acad Dermatol Venereol 2015;829–836.
SOOLANTRA 10MG/G CREAM ABBREVIATED PRESCRIBING INFORMATION (UK & IRE) Presentation: 10mg/g ivermectin cream Indications: Topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients. Dosage and Administration: One application per day for up to 4 months. The treatment course may be repeated. It can be applied as monotherapy or as part of combination treatment. Treatment should be discontinued after 3 months if no improvement. Apply a pea sized amount to each of the 5 areas of the face: forehead, chin, nose, each cheek. Cutaneous use only. Apply only to the face; avoiding the eyes, lips and mucosa. Hands should be washed immediately after application. Contraindications: Hypersensitivity to the active substance or any excipients. Precautions and Warnings: Soolantra has not been studied in patients with renal or hepatic impairment. Caution should be exercised in patients with severe hepatic impairment. Contains cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis), methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed) and propylene glycol which may cause skin irritation. Interactions: No interaction studies have been performed. Caution is advised when ivermectin is administered concomitantly with potent CYP3A4 inhibitors as the plasma exposure may be significantly increased. Pregnancy and Lactation: Soolantra is not recommended during pregnancy. A risk to a suckling child cannot be excluded; a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Soolantra therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Undesirable Effects: In clinical trials the most common adverse reactions were typically mild to moderate in severity, and usually decreased when treatment was continued. Adverse reactions include: Common (≥1/100 to <1/10): Skin burning sensation; Uncommon (≥1/1,000 to <1/100): Skin irritation, pruritus, dry skin, rosacea aggravation; Unknown frequency: Erythema, dermatitis contact (allergic or irritant), swelling face, increased transaminases. Packaging Quantities and Cost: 30g UK £18.29 IE €23.50 MA Number: UK: PL 10590/0063, IE: PA 22743/015/001 Legal Category: POM Marketing Authorisation Holder: UK: Galderma (UK) Ltd, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, Telephone: +44 (0) 1923 208950 IE: Galderma International S.A.S.,Tour Europlaza, La Défense 4, 20 Avenue André Prothin, 92927, France Date of Revision: August 2020 Adverse events should be reported Adverse Event Reporting For the UK: Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for Yellow Card in the Google Play or Apple App Store. For Ireland: HPRA Pharmacovigilance Website: www.hpra.ie Adverse events should also be reported to Galderma (UK) Ltd, Email: Medinfo.uk@galderma.com Tel: +44 (0) 1923 208950
Job Code: UKI-SOC-2100034
DOP: Aug 2021
Clinical REVIEW
Basal cell carcinoma: A review and summary of the British Association of Dermatologists guidelines for its management in adults (2021) Ibrahim Nasr
Basal cell carcinoma (BCC) is the most common skin cancer worldwide. It can cause morbidity to the patient if left untreated, and can be costly to treat. In 2021, the British Association of Dermatologists published the updated management guidelines, which included an updated review of BCC in adults and recommendations for its treatment. This article is a review of the up-to-date knowledge about the aetiology, pathogenesis, and clinical types of this tumour, as well as an overview of the new updated guidelines. Nasr I. Basal cell carcinoma: A review and summary of the British Association of Dermatologists guidelines for its management in adults (2021). Dermatological Nursing 2021. (20)3:10-23
Introduction Basal cell carcinoma (BCC), also known as ‘rodent ulcer’, is a non-melanoma skin cancer (NMSC) of the keratinocyte cancers type (KC). Skin cancers are divided into malignant melanoma (MM) and NMSC. NMSC is a name for all other types of skin cancers that are not MM, which includes the KC (BCC and cutaneous squamous cell carcinoma [SCC]), Merkel cell carcinoma, dermatofibrosarcoma protuberans, cutaneous lymphoma, sebaceous carcinoma, angiosarcoma, malignant fibrous histiocytoma, various malignant appendage tumours, and any other rare skin cancers.1
Ibrahim Nasr is a retired Consultant Dermatologist and member of the Dermatological Nursing Editorial Board. He was also lead author of the BAD guidelines for the management of adults with basal cell carcinoma
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In a recent systematic review study looking into the risk of mortality after a diagnosis of a KC, it was found that patients with SCC are at increased risk of death from any cause compared to the general population, whereas patients with BCC did not have increased all-cause
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mortality;2 that is to say, BCC is not a cause of increased mortality compared to the general population. Although rarely metastatic, if not treated properly BCC can produce substantial local destruction along with disfigurement, and may involve extensive areas of soft tissue, cartilage, and bone.3 A recent study suggests that the rate of increase of BCC cases in the UK may be higher than in European counterparts,4 hence the BCC cost burden has also increased. 5 Therefore, it is essential to treat BCC appropriately, both in the NHS and private health care settings, and utilise Getting It Right First Time (GIRFT).6
Aetiology The three most important aetiological factors in developing BCC are exposure to ultraviolet radiation (UV), immunosuppression, and genetic predisposition. 5,7,8 Other independent aetiological factors include skin type (Fitzpatrick skin types I & II), www.bdng.org.uk
Clinical REVIEW
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} photosensitiser medicine (e.g., thiazide diuretics) intake, radiotherapy site, arsenic ingestion, and previous KC. 5,7,8 The major preventable risk factor for developing BCC is the intermittent exposure to UV, mainly UVB, in the form of sunbathing, recreational tanning, occupational exposure and childhood sunburns. 5,8 An observational study on 73,494 white female nurses in the USA for 20 years (1989-2009) showed a strong dose-response relationship between UVB and UVA tanning bed use and skin cancer risk, especially BCC; this association was stronger for patients of younger age at exposure.9 Although skin type is an independent risk factor, the combination of UV exposure and having fair skin, red or blond hair, light eye color, and inability to tan (Fitzpatrick skin type I) can www.bdng.org.uk
increase the risk of developing BCC by 19 times compared to African (Fitzpatrick skin types V & VI) and by 1.5-2.5 times compared to other skin types (Fitzpatrick skin types II-IV).10,11 Immunosuppression plays a considerable role in developing skin cancer including BCC, and carries a higher risk of BCC recurrence after treatment.7,12 Although there are many causes for immunosuppression, dedicated skin cancer surveillance clinics had been set for people who have had organ transplants (OT), haematologic malignancy such as chronic lymphocytic leukaemia (CLL), and HIV infection.3,8,12-14 In OT, 24% of the skin cancers were BCC; 13 in CLL the risk of developing skin cancer was found to be eight times more than in the people without CLL; 12 and people with HIV
infection are three times more likely to get KC skin cancers, especially if they are not taking antiretroviral therapy for it.14 Several genetic syndromes with increased BCC development and recurrence after treatment have been described, the most recognised are the Naevoid BCC syndrome, also known as Gorlin syndrome (GS), and xeroderma pigmentosum (XP). 5,8,10 GS is a rare (<0.00003%) autosomal dominant disorder that is characterised by aberrant upregulation of the sonic Hedgehog pathway (please see the pathogenesis section and Box 1. Types of BCC below) with resultant developmental defects and multiple neoplasms, including BCCs. GS patients can develop >1,000 BCC throughout their lives, although some may develop none. 5 XP is a
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Clinical REVIEW rare (<0.0004%) autosomal recessive syndrome characterised by impaired DNA repair and hypersensitivity to UVinduced mutagenesis. 5,7,10,15 XP have a 1000-fold increased risk of cutaneous malignancies, including BCC. 5,15
Pathogenesis and histopathology
Pathogenesis Sporadic BCCs arise from long-term resident keratinocyte progenitor cells
of the interfollicular epidermis and upper infundibulum that undergo mutagenesis. 5,7,8 Nearly all BCCs, sporadic or genetically-induced, show constitutive activation of Hedgehog signaling pathway (Hh), which has a significant role in human development and cutaneous carcinogenesis. 5,16 Development of BCC is associated in most of the cases with loss of inhibition of Hh signaling, exhibiting
aberrant Hh pathway activation. 5,16 The sonic Hedgehog signaling pathway has emerged as playing a pivotal role in the pathogenesis of BCC; and activating mutations in a number of molecules in this pathway have been implicated in its development.3,5,7,8 Inactivating mutations in the PTCH1 (patched 1) gene on chromosome 9q, which codes for the sonic Hedgehog
Figure 1a Nodular BCC histology low power Nodular BCC: there are large nodules of basaloid cells with focal attachment to the epidermis. Contributed by Antonina Kalmykova, M.D. and Phillip H. McKee, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www. pathologyoutlines.com/topic/skintumornonmelanocyticbcc.html )
Figure 1b Nodular BCC histology high power Nodular BCC: the tumor cells have uniform hyperchromatic nuclei and scant cytoplasm. There is conspicuous nuclear palisading at the tumor margin and cleft formation is evident. Contributed by Antonina Kalmykova, M.D. and Phillip H. McKee, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www. pathologyoutlines.com/topic/skintumornonmelanocyticbcc.html )
Figure 2 Nodular keratotic BCC histology Keratotic BCC: foci of keratinization are uncommon in BCC but are seen every now and then. In rare cases, it predominates such that the tumor can be confused with trichoepithelioma (a harmless skin growth arising from hair follicle). Immunohistochemistry may be necessary for their distinction. Contributed by Sate Hamza, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https:// www.pathologyoutlines.com/topic/skintumornonmelanocyticbcc.html )
Figure 3 Nodular adenoid BCC histology Adenoid BCC: marked mucin production gives rise to this pseudoglandular appearance. Contributed by Antonina Kalmykova, M.D. and Phillip H. McKee, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www.pathologyoutlines.com/ topic/skintumornonmelanocyticbcc.html)
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Clinical REVIEW receptor, are the underlying cause of nevoid BCC syndrome, and are present in approximately 30-90% of sporadic BCCs.3,5 Specific UV-induced mutations in the tumour suppressor gene p53 appear to be a common event in BCC development.3,5,7,8 Histopathology Although there are few distinct BCC clinical types, BCC is diagnosed
histologically if the specimen has tumour cells resembling basal cells of the epidermis with large, hyperchromatic, oval nuclei and little cytoplasm; 7,17 and the tumour cells are aggregated together in one large mass; and the tumour cells in the periphery of the tumour align in a palisading pattern.7,17,18 Histologically, BCC types are divided into two categories, namely
differentiated and undifferentiated.7 Differentiated BCC is a nodular BCC (Figures 1a and 1b) with a slight differentiation toward cutaneous appendages, e.g., hair (keratotic BCC; Figure 2), and tubular glands (adenoid BCC; Figure 3).17,18 Undifferentiated BCC includes pigmented BCC (Figure 4), superficial BCC (Figure 5), and infiltrative BCC (Figure 6).7,17,18
Figure 4 Nodular pigmented BCC histology Pigmented BCC: in this image, most of the melanin is present within macrophages. This variant can be clinically mistaken for melanoma. Contributed by Antonina Kalmykova, M.D. and Phillip H. McKee, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www.pathologyoutlines.com/topic/skintumornonmelanocyticbcc.html )
Figure 5 Superficial BCC histology Superficial BCC: small tumor aggregates are suspended from the epidermis. Palisading is conspicuous. Contributed by Antonina Kalmykova, M.D. and Phillip H. McKee, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www. pathologyoutlines.com/topic/skintumornonmelanocyticbcc.html )
Figure 6 Infiltrative BCC histology Infiltrative BCC: irregular strands and elongated cords of tumor cells with conspicuous loose stroma characterise this variant. Perineural infiltration should be sought. Contributed by Antonina Kalmykova, M.D. and Phillip H. McKee, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www.pathologyoutlines.com/ topic/skintumornonmelanocyticbcc.html )
Figure 7 Morphoeic/sclerosing BCC histology Morphoeic BCC: the tumor is compressed into thin strands by the dense collagenous stroma. There is abundant mucin. Perineural infiltration should be sought. Contributed by Antonina Kalmykova, M.D. and Phillip H. McKee, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www.pathologyoutlines.com/topic/ skintumornonmelanocyticbcc.html )
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Clinical REVIEW
Figure 8 Micronodular BCC histology Micronodular BCC: in this variant, the small tumor aggregates may be confused with trichoepithelioma. In cases where doubt exists, immunohistochemistry is sometimes essential. This example also shows a focal adenoid pattern. Contributed by Antonina Kalmykova, M.D. and Phillip H. McKee, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www.pathologyoutlines.com/topic/ skintumornonmelanocyticbcc.html )
Figure 9 Basosquamous carcinoma histology Basosquamous carcinoma: there is an admixture of basal and squamous cell carcinoma. This variant is often highly aggressive and may be difficult to treat. Contributed by Eduardo Calonje, M.D. (Copyright © 2021 Antonina Kalmykova and Phillip H. McKee: https://www.pathologyoutlines.com/topic/skintumornonmelanocyticbcc.html )
Biologically, BCC histological types are divided into low-risk (superficial and nodular BCC) and high-risk (infiltrative, morphoeic/sclerosing (Figure 7), micronodular (Figure 8), and basosquamous carcinoma (Figure 9)).7,17,18
were more commonly males, with a male:female ratio of 12:1.4 The median age at time of incident tumour was between 62-80 years old.4 The majority of BCCs are located in the head and neck region, especially on the face.4,5,7,8
Epidemiology
Clinical presentation
The estimated lifetime risk for BCC in the white population is 33-39% for men and 23-28% for women. 5,7,8,10 The highest rates of BCC occur in South Africa and Australia, i.e., areas that receive high amounts of UV, while Finland has a low reported incidence that is approximately one quarter of the southern states of the USA. 5,7 Data indicates that BCC incidence is far higher (more than 100-fold) in people aged 55-70 years than in those aged 20 years and younger. 5,7 A recent study in the UK reporting the incidence of BCC found that the absolute first BCC per patient per annum had increased from 145,817 in 2013 to 166,448 in 2015; and the European age-standardised incidence rates to be 352 per 100,000 person years in males and 219 per 100,000 person years in females.4 The same study found that more than 85% of BCCs in the UK occurred in England as compared with other UK nations.4 Patients with first all-time BCC 14
Symptoms and past medical history Patients often complain of a slowly enlarging nonhealing ulcerated lesion, hence the old name ‘rodent ulcer’, that may sometimes bleed. They may also complain of pruritus or report no symptoms at all. 5,7
History of any prior treatment, including radiotherapy to a previous or recurrent BCC, should be elicited, as well as a history of any other skin cancer Patients often have a history of chronic sun exposure, including recreational sun exposure (e.g., sunbathing, outdoor sports, fishing, boating) or occupational sun exposure (e.g., farming, construction).7 History of any prior treatment, including radiotherapy to a previous or recurrent BCC, should be elicited,
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as well as a history of any other skin cancer, especially NMSC.7 History of immunosuppression would be essential for clinical assessment and for prospective management planning. 5,7 Physical examination and clinical types of BCC Most BCC lesions are typical and are easily diagnosed clinically, under good lighting with or without magnifying lens, as being a shiny pearly patch, papule, or nodule with smooth surface and rolled borders. 5 A simple clinical test to confirm the diagnosis and to accurately delineate the borders of the BCC lesion is the stretch test. By stretching the skin, you empty the tumour microcirculation and expose the characteristic translucent pearly edge to the examining clinician.19 The clinical diagnostic accuracy of BCC is also enhanced by using dermoscopy, which is now considered to be an essential clinical examining tool in dermatologic practice.20 A typical BCC would be diagnosed if dermoscopy shows arborising telangiectasia and at least one of the following structures: blue-grey ovoid nests; maple leaf-like areas; a spokewheel pattern; and/or ulceration that is not associated with recent trauma.20 However, different BCC clinical types might have specific dermoscopic www.bdng.org.uk
Clinical REVIEW features depending on their specific histology (Figure 10).20
NMSC or MM that the patient might not be aware of.3,7,13,21
After examining the presenting lesion and diagnosing, or suspecting the diagnosis of BCC, a full skin examination is recommended to detect other BCCs,
The most common clinical type of BCC is the low-risk nodular type (Figures 11a, 11b, 11c) accounting for nearly 60% of cases. 5,7 The other low-risk BCC
type is the superficial type (Figure 12) accounting for further 10%-30% of cases. 5,7 The high-risk BCCs are usually uncommon (<10%) and include the infiltrative type (infiltrating, morphoeic, micronodular) and the rare (<2%) basosquamous carcinoma. 5,7 The
BOX 1 Types of BCC Nodular BCC is the typical BCC with a shiny, pearly papule or nodule with a smooth surface, rolled borders (Figures 11a, 11b, 11c), and arborising telangiectasias under dermoscopy (Figure 10 – B subset) with a predilection for sun-exposed areas of skin, especially the head and neck. 5,7 Figure 10 Dermoscopy of some types of BCC Dermoscopy of some types of basal cell carcinoma (BCC). (A) Superficial BCC: spoke-wheel areas (circle), fine telangiectasias (black arrow), and multiple erosions (white arrows); note the shiny white-red structureless areas and white structures. (B) Nodular BCC: arborizing telangiectasias and whitish structures. (C) Morphoeic BCC with scant branching (black arrow) located mainly at the edge of the tumor and associated with central ulceration (white asterisk). (D) Linear BCC with multiple erosions (black arrows) following a skin fold. (Copyright © 2020 M. Álvarez-Salafranca: https://ars.els-cdn.com/ content/image/1-s2.0-S0001731020305147-gr5_lrg.jpg )
Figure 11a Nodular BCC: typical nodular BCC on cheek. (Copyright © 2012 Klaus D. Peter: https://commons. wikimedia.org/w/index.php?title=File:Basalioma_02. jpg&oldid=460277773 )
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Figure 11b Nodular BCC: typical ulcerated nodular BCC on left nostril. (Copyright © 2010 Doc James: https://commons.wikimedia. org/wiki/File:Basal_cell_carcinoma3.JPG )
Figure 11c Nodular BCC: suspected pigmented nodular BCC on right nostril, diagnosis confirmed after excision. Copyright © 2009 Watplay: https://commons. wikimedia.org/w/index.php?title=File:BCC-mini. jpg&oldid=466980338 )
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Clinical REVIEW BOX 1 (Continued) Types of BCC Superficial BCC is a wellcircumscribed and erythematous thin plaque or patch with scale, central clearing, thin rolled borders (Figure 12), and under dermoscopy shows arborizing telangiectasias, ulcerations, spoke-wheel areas and sometimes other structures (Figure 10 – A subset); they appear most commonly on the trunk. 5,7 Infiltrative BCC (Figure 13) is an uncommon, poorly-defined, indurated, flat or depressed plaque with white,
yellow, or pale pink color that may have overlying crusts, erosions, ulcerations, or papules. 5,7 Dermoscopy could be challenging in such cases, but on careful examination short fine telangiectatic vessels, white structures, structureless hypo- and hyperpigmentation may be seen.23 Morphoeic BCC, also known as sclerosing BCC, (Figure 14) is another uncommon, infiltrated plaque with poorly defined borders and shiny surface that is commonly found on the
Figure 12 Superficial BCC (Copyright © 2012 Mikael Häggström: https://commons.wikimedia.org/wiki/ File:Superficial_basal_cell_carcinoma.jpg )
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Micronodular BCC is an uncommon aggressive BCC subtype that is not prone to ulceration, it may appear as an erythematous macule or thin
Figure 15 Locally advanced BCC (Copyright © 2008 Klaus D. Peter: https://commons.wikimedia.org/w/index. php?title=File:Basalioma.jpg&oldid=460277821 )
Figure 13 Infiltrative BCC dermoscopy Infiltrative basal cell carcinomas. (a) Flat clinical presentation with typical dermoscopic features in thin tumors (milky-red background, short fine telangiectatic vessels) in combination with white structures. (b) Nodular clinical presentation: Numerous pigmented features with structureless hypo/hyperpigmentation are identified. (Copyright © 2015 Mirjana Popadić: https://ijdvl.com/content/126/2015/81/6/Images/ijdvl_2015_81_6_608_168343_f3.jpg )
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head and neck. It appears as a white or yellow, waxy, sclerotic plaque that rarely ulcerates. 5,7 Dermoscopy could also be challenging in such cases, but in general a milky-red background, with arborising telangiectatic vessels, short fine telangiectatic vessels, white lines, structureless hypopigmentation and multiple small erosions may be seen.23
Figure 14 Morphoeic/sclerosing BCC dermoscopy On dermoscopy, a milky-red background, with arborizing telangiectatic vessels, short fine telangiectatic vessels, white lines, structureless hypopigmentation and multiple small erosions are seen. (Copyright © 2015 Mirjana Popadić: https://ijdvl.com/content/126/2015/81/6/Images/ ijdvl_2015_81_6_608_168343_f2.jpg www.bdng.org.uk
Clinical REVIEW BOX 1 (Continued) Types of BCC papule or plaque that turns to yellowwhite when stretched, it is firm to the touch, and it may have a seemingly well-defined border. 5,7 Dermoscopy is very challenging, but there have been reports of truncated vessels and multiple blue-grey globules.20,23 Basosquamous carcinoma is a rare well-defined nodular or superficial BCC that when diagnosed histologically, either by biopsy or after excision, shows features of both the BCC and the invasive SCC. It is mainly found on the head and neck. 5,24 Some basosquamous tumours are the result of a BCC colliding with an adjacent SCC. Others represent truly biphenotypic tumours, many of which may advanced BCC is a neglected, large and aggressive BCC that could be locally advanced (Figure 15) or rarely (0.003-0.55%)22 metastatic (see the exact definition of ‘advanced BCC’ in the BAD BCC guidelines summary below). 5,7,18 Other clinical types of BCC, such as cystic, fibroepithelial, follicular, metatypical, and pleomorphic types were described. 5,7,8
Diagnosis BCC is usually diagnosed clinically, without the need for biopsy. Recent skin imaging tools, such as reflectance confocal microscopy and optical coherence tomography, if available, may help the diagnosis of a suspected BCC especially in high-risk sites.25,26 A biopsy would be indicated if there is a doubt about the diagnosis, if the type of the BCC will influence the treatment choice, to confirm a suspected recurrence of a previously treated BCC, or if the decided treatment is radiotherapy. In most cases, shave or curette biopsy should be sufficient to make a positive diagnosis, but if the exact type of BCC is required, then a deep incisional or excisional biopsy is advised.3,7,8,21,27 www.bdng.org.uk
have started as BCC, but have subsequently undergone prominent partial squamous metaplasia.3,24 Dermoscopy shows the presence of both the BCC arborizing telangiectatic vessels, and the SCC keratin masses, together with white structureless areas.20,24 Naevoid BCC syndrome (GS). Ordinary common BCC lesions are a feature of GS. Other features associated include: Intellectual disability Palmar and plantar pits Absent or undescended testes Bony jaw cysts Mesenteric benign lymphatic cysts that can cause abdominal pain Medulloblastoma Computed tomography (CT) scanning or magnetic resonance imaging (MRI) should be considered if deeper involvement by the tumour is suspected clinically.3,7,8,21,27
Summary of the British Association of Dermatologists guidelines for the management of adults with basal cell carcinoma 2021 The published full British Association of Dermatologists (BAD) guidelines for the management of BCC 2021 is published in the British Journal of Dermatology in 22 pages. It can be found as a free access article at https:// onlinelibrary.wiley.com/doi/abs/10.1111/ bjd.20524.27 The BAD BCC guidelines were first produced in 1999. The current 2021 guidelines is an update to the previous edition of the guidelines published in 2008, but differs in three main points: methodology, definitions, and recommendations.
Methodology The BAD commissioned a guideline development group (GDG) composed of 10 consultant dermatologists, a consultant plastic surgeon, a consultant
Ocular and skeletal abnormalities, such as: Hypertelorism (wide distance between the eyes) Short 4th and 5th fingers secondary to short 4th and 5th metacarpals Bifid ribs and pectus excavatum (depressed sternum) Ectopic calcification of the falx cerebri. The BCCs in GS ranges from none to hundreds, and if they appear they could be single or multiple. They usually appear after puberty and can appear anywhere on the skin – even the areas never exposed to UV. Although the majority are low-risk BCC, some can be aggressive, especially around the eyes and nose. 5,7 oral and maxillofacial surgeon, a clinical oncologist, a pathologist, two primary care physicians, a clinical nurse specialist, two patient representatives and methodologists. It is based on a systematic review of literature found in PubMed, MEDLINE, EMBASE and Cochrane databases up to January 2020. The result was 4,072 abstracts screened and 978 full-text papers assessed for eligibility, from which 171 papers were used in the guidelines, including 77 comparative studies (random controlled trials or RCT) and 12 systematic reviews. In formulating the recommendations, the evidence for overall certainty of any recommendation was rated according to the GRADE system (high, moderate, low, or very low). The GDG made several clinical questions to guide the formulation of the recommendations, based on the importance of these recommendations to the treated patients. These questions covered the issues of referral to the next care level, the clinical effectiveness of the various treatments to low-risk and high-risk BCCs, the appropriate surgical margin to be used in surgery, and what is the appropriate follow-up period of the treated people with BCC.
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Clinical REVIEW Defintions In these guidelines, the GDG defined three important issues in order to specify the terms used in the recommendations. For the first two definitions, namely the low-risk/high-risk BCC definition and the advanced BCC definition, the GDG recognised the fact that the Union for International Cancer Control 8th edition (UICC8)28 version of TNM8 has been endorsed for use in the UK,29 instead of the American Joint Committee on Cancer 8th edition cancer staging manual (AJCC8),30 hence they used it in their guidelines. Regarding the third definition of the General Practitioner with Extended Role (GPwER), the GDG recognised the National Institute for Health and Care Excellence (NICE) guidance on the management of low-risk basal cell carcinomas in the community,31 and the RCGP framework 2018,32 in formulating that definition. Low-risk/high-risk BCC definition This definition was presented as a table associated with footnotes defining marked terms in the table, in addition to a figure defining areas M and H (Figure 16). In that table, the low-risk/high-risk BCC was defined based on clinical and pathological criteria as follows: Clinical criteria: Area L = trunk and extremities but excluding hands, nail units, genitals, pretibia, ankles and feet Area M (Figure 16) = cheeks, forehead, scalp, neck and pretibia. Area H (Figure 16) = “mask areas” of face (central face, eyebrows, periorbital, nose, lips (cutaneous and vermilion), chin, mandible, preauricular, postauricular, temple, ears); genital areas; hands, nail units, ankles, and feet, but excluding the eyelid Low-risk BCC is a welldefined primary BCC on area L ≤20mm, or area M ≤10mm, in a patient who is not immunosuppressed and on a site that was not treated before by radiotherapy 18
Figure 16 Areas M and H diagram Area M (light colour) = cheeks, forehead, scalp, neck and pretibia. Area H (dark colour) = “mask areas” of face (central face, eyebrows, periorbital, nose, lips (cutaneous and vermilion), chin, mandible, preauricular, postauricular, temple, ears); genital areas; hands, nail units, ankles and feet, but excluding the eyelid [This figure is adopted from the BAD guidelines for the management of adults with BCC 2021]
high-risk BCC is a poorly defined recurrent BCC on area L >20mm, or area M >10mm, or area H any size, in a patient who is immunosuppressed and on a site that was treated before by radiotherapy. N.B. Any one or more criteria equals high risk, unless stated differently in the summary of the recommendations, or in an explanatory note. Pathological criteria: Low-risk BCC is a nodular or superficial BCC with absent basosquamous differentiation, invading to dermis or subcutaneous fat to a depth ≤6mm, with no involved margins and no perineural invasion; in other words, it is a completely excised pT1 tumour high-risk BCC is an Infiltrative (infiltrating, morphoeic, micronodular) BCC, with basosquamous differentiation +/- lymphovascular invasion, invading beyond subcutaneous fat to a depth >6mm, with involved or histologically
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close (<1mm) margins, with perineural invasion in a named nerve or a nerve with diameter ≥0·1mm or a nerve beyond the dermis; in other words, it is a pT2, pT3, or pT4 tumour. N.B. Any one or more criteria equals high risk, unless stated differently in the summary of the recommendations, or in an explanatory note. Advanced BCC definition This was not defined before, except in one publication,33 so for the purpose of this guidelines, the GDG adopted and modified that definition to be: An advanced BCC is a BCC that is either (1) metastatic (mBCC) or (2) locally advanced (laBCC) with one or more high-risk factors, in which current treatment modalities are considered potentially contraindicated by tumour* or patient factors**. *Clinical tumour factors that may contribute individually or in combination to a BCC being regarded as locally advanced include: www.bdng.org.uk
Clinical REVIEW Tumour size, location, and cosmetic/ functional consequences of treatment Large numbers of co-existing tumours Tumour subtype (e.g., infiltrative tumours with poorly defined margins) Likelihood of successful treatment compromised by previous treatment. **Patient-driven factors that may contribute individually or in combination to a BCC being regarded as locally advanced include: Patient performance status Presence of patient comorbidities potentially interfering with surgery Presence of patient factors potentially interfering with radiotherapy Patient opinions and beliefs regarding treatment and/or their impact on quality of life. General Practitioner with Extended Role (GPwER) definition A GPwER is an accredited GP who has suitable training and has demonstrated competency in General Dermatology and/or skin lesion management. A GPwER, depending on their training level and availability of treatment, can diagnose and manage skin diseases and skin lesions, including skin cancers, using both surgical and non-surgical techniques, relevant to their clinical training. However, GPwER is expected to follow those aspects of the NICE recommendations relevant to their agreed scope of practice; in particular, they should NOT treat high-risk BCC, especially on areas M or H, recurrent BCC, BCC with high-risk pathological criteria, except after discussing it with the skin multidisciplinary team (MDT).
Key recommendations The guidelines presented 26 recommendations (15 strong positive recommendations, 5 strong negative recommendations, 3 weak recommendations, and 3 good practice points), and 3 ‘no’ recommendations. All the recommendations were specifically worded and important, and they should be read carefully from www.bdng.org.uk
the original guidelines, but the key recommendations were: Offer verbal and written information about BCC to all adults with BCC Refer to skin MDT member all adults with high-risk BCC, and all adults with low-risk BCC in the absence of an accredited GPwER or if the primary care facility is not suitable for surgery Offer surgery [standard surgical excision (SSE) or Mohs micrographic surgery (MMS)] as a first-line treatment option to adults with lowrisk or high-risk BCC as follows: SSE with immediate reconstruction as a first line treatment option to low-risk BCC, or high-risk primary BCC with well-defined margins SSE with delayed reconstruction and at least 5mm surgical margin as a first line treatment option to highrisk primary BCC with poorlydefined margins in a high-risk anatomical skin area SSE with delayed reconstruction and at least 5mm surgical margin as a treatment option to high-risk recurrent BCC with at least one other high-risk factor SSE requires 4mm surgical margin to excise low-risk BCC, and at least 5mm surgical margin to excise high-risk BCC; and in addition, SSE must ensure adequate excision at the deep margin to a clear plane, including a fat layer where present, and other deeper structures if needed MMS as a first line treatment option to high-risk primary BCC with poorly-defined margins in a high-risk anatomical skin area MMS as a first line treatment option to high-risk recurrent BCC with at least one other high-risk factor, especially if the tumour is at a high-risk site SSE, MMS, radiotherapy, and vismodegib (if available) are treatment options to advanced BCC after discussion in an MDT
Offer radiotherapy as a treatment option to adults (suggested age ≥60 years) with low-risk and high‑risk BCC who are unsuitable for or decline surgery, especially for nodular BCC, or infiltrative BCC with sufficient planning margin, or excised BCC with involved margins Do not offer radiotherapy as a treatment option to adults who are unsuitable for or decline surgery, if it is a recurrent BCC after previous radiotherapy, or a BCC in GS or XP syndromes; and also if it is in an area of poor circulation e.g., lower limbs, or the patient is young (suggested age <60 years), or if it is invading bone or cartilage Offer topical imiquimod, topical 5-fluorouracil, cryosurgery, or topical PDT as treatment options to adults with low-risk BCC who are unsuitable for or decline surgery Do not offer topical imiquimod, topical 5-fluorouracil, cryosurgery, or topical PDT as treatment options to adults with high-risk or advanced BCC who are unsuitable for or decline surgery, except for palliation and after discussion in an MDT Advise adults with BCC who decline all treatments that the risk of significant progression of the tumour is at least 25% over two-tofive years There is insufficient evidence to recommend ‘no treatment’ as an option for adults with: recurrent BCC with at least one other high-risk factor advanced BCC who are not suitable for or decline Mohs micrographic surgery or standard surgical excision Offer further standard surgical re-excision to adults with excised high-risk BCC with involved histological margin unless there is a contraindication Refer all adults with excised highrisk BCC with a close histological margin (<1mm) for MDT discussion of management options
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Clinical REVIEW Do not routinely offer follow-up to patients with adequately treated isolated BCC, unless for a postoperative review Offer, if possible, at least a yearly follow-up to adults with a history of multiple BCCs who are likely to develop further tumours or recurrence within 12 months.
Algorithm of BCC treatment pathway (Figures 17 and 18) Other important relevant issues discussed in the guidelines In addition to the above, the guidelines discussed other important relevant issues, namely: patient related factors to be considered when treatment selection is discussed, why eyelids were excluded from treatment recommendations, role of digital photography in managing BCC, BCC in children and young people, the prevention of developing a further BCC in the future, and the recommended auditing of treating surgical operators.
Figure 17 Treatment pathway algorithm of adults with BCC presenting to GP [This figure is adapted from the BAD guidelines for the management of adults with BCC 2021]
Patient related factors to be considered when treatment selection is discussed The patient, or the person with the power of attorney for health matters, should be counselled sufficiently on all aspects of the treatment approach being considered and post-treatment care, especially with respect to the possibility of developing a scar. In addition, the following issues should be considered before deciding which is the best treatment for the patient: Performance status of the patient Presence of comorbidities, including serious, life-limiting conditions Presence of genodermatoses Presence of immunosuppression Regular medications taken by patient Risk of morbidity or mortality associated with the chosen treatment of the BCC The likelihood of treatment success Whether the patient has an implanted cardiac device Patient preferences (see ‘Patients’ perspective’ section below).
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Figure 18 Treatment pathway algorithm of adults with BCC presenting to skin cancer MDT member [This figure is adapted from the BAD guidelines for the management of adults with BCC 2021] Why eyelids were excluded from treatment recommendations The eyelid has a pathological staging system for the primary BCC tumour and lymph nodes which is different to the rest of the skin sites. It is essential that this different system for the eyelid is better recognised and used by clinicians, pathologists, and skin cancer MDTs. However, with regards to its management, even a pT1 stage BCC
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on the eyelid still constitutes a high-risk BCC as it is situated within area H. This would require a treatment option similar to all high-risk BCCs in area H, i.e., with either Mohs micrographic surgery or standard surgical excision with delayed definitive reconstruction. Role of digital photography in managing BCC Digital photography, with or without digital dermoscopic photography, is relatively easy nowadays and is highly www.bdng.org.uk
Clinical REVIEW recommended for clear documentation, and to monitor treatment response. It is also useful in helping patients with regular self-examination of their skin, especially if the images are stored in the patient’s personal device. However, information governance and data protection rules apply to the use of medical digital photography. BCC in children and young people BCC is very rare (<1%) in children under 15 years of age, and when seen it is generally in the context of inherited conditions such as GS and XP. Nevertheless, the first‐line treatment option for childhood BCC is surgery, with either standard surgical excision or Mohs micrographic surgery. Other treatments are either contraindicated, have significant side effects, or have high recurrence rates especially in children. However, reducing the risk of future development of BCC should start in childhood with strict ultraviolet protection at school, at home, and during holidays. The prevention of developing a BCC The prevention of developing a BCC is highly recommended. The cornerstone advice in preventing further new BCC is avoidance of UV exposure, which should start from childhood. This would require following NICE guidance on avoiding the sun and other sources of UV rays,34 and taking vitamin D supplements.35 There are medications that were reported to prevent BCC, namely: oral non-steroidal anti-inflammatory drugs (NSAID) of the cyclooxygenase-2 (COX-2) inhibitors group; oral retinoids; oral nicotinamide; and topical retinoids; but they either cause severe side effects, or their benefit is very limited and requires a lifelong commitment to them. Hence, they should not be considered except for selected patients. The recommended audit for the treating surgical operators All clinicians treating skin cancer should audit their histological concordance and their ‘complete excision’ rates. Individual operators and units should regularly audit their outcomes, with a www.bdng.org.uk
target of ≥95% complete excision rate being defined as acceptable. There are currently existing national audit tools for dermatologists (the British Society for Dermatological Surgery (BSDS) audit tool) and for the primary care clinicians (the Community-Based Surgery Audit (CBSA) tool), but any alternative audit tool is acceptable so long that it shows the excision rate of the surgical operator.
Although BCC has an excellent survival prognosis, it can result in significant morbidity and cosmetic disfigurement if it is not treated properly the first time or if neglected Prognosis Although BCC has an excellent survival prognosis, it can result in significant morbidity and cosmetic disfigurement, especially if it is not treated properly the first time or if neglected. Metastasis is very rare to be accounted for in prognosis, and each BCC metastasis case must be evaluated individually. The morbid prognosis could be predicted36 if the BCC was: Histologically a high-risk BCC especially in a high-risk site Treated inappropriately and was left with involved margins Recurrent BCC after radiotherapy or after extensive surgery Locally advanced or metastatic BCC In such cases, a thorough discussion with the patient on various options of treatment and discussing the case within the MDT is very important. Equally important is to have in place a support team to inform the patient of methods to improve cosmetic outcome following primary treatment. If psychological need has been identified, a referral should be made to appropriate services and a key worker should be identified to support the patient during this process.
Patients’ perspective The GDG patient representatives raised the following concerns: In order to have good cosmetic results, a curative treatment might not be chosen or might not be performed adequately Many patients having surgery are unprepared about what will be the actual size of their scars Some patients might not have been given enough information to give informed consent Mohs surgery might not be offered if there is no local Mohs surgeon. To address these concerns, the GDG anonymously recommends the following: A curative treatment should always be offered and discussed with the patient and the best clinician with high good cosmetic results should be chosen Patients having surgery should be informed of how big the scar might be All relevant information should be given to all patients in order to get informed consent Mohs surgery should be offered and discussed even if there is no local Mohs surgeon. There was only one published qualitative study37 about patient preferences, where the patients expressed their wish: To receive relevant information tailored to their specific situation To be seen by the same clinician during treatment and follow-up To have a full-body skin examination during follow-up To participate in shared decisionmaking.
References 1. Karimkhani C, Boyers LN, Dellavalle RP, Weinstock MA. It’s time for “keratinocyte carcinoma” to replace the term “nonmelanoma skin cancer”. J Am Acad Dermatol 2015. 72(1):1867 2. Wehner MR, Cidre Serrano W, Nosrati A, et al. All-cause mortality in patients with basal and squamous cell carcinoma: A systematic review and meta-analysis. J Am Acad Dermatol 2018. 78(4):663-672.e3
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Clinical REVIEW Abbreviations BAD British Association of Dermatologists BCC Basal cell carcinoma BSDS British Society for Dermatological Surgery CBSA Community-Based Surgery Audit CLL Chronic lymphocytic leukaemia COX-2 Cyclooxygenase enzyme 2 CT Computed tomography scanning GDG Guideline development group 3. National Comprehensive Cancer network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer Version 1.2019. available at: https://www.nccn.org/professionals/ physician_gls/pdf/nmsc.pdf [Last accessed December 2020] (Membership required) 4. Venables ZC, Nijsten T, Wong KF, et al. Epidemiology of basal and cutaneous squamous cell carcinoma in the U.K. 2013-15: a cohort study. Br J Dermatol. 2019. 181(3):474-482 5. Cameron MC, Lee E, Hibler BP, et al. Basal cell carcinoma: Epidemiology; pathophysiology; clinical and histological subtypes; and disease associations. J Am Acad Dermatol 2019. 80(2):303317. 6. Timmins N (2017). Tackling variations in clinical care: Assessing the Getting It Right First Time (GIRFT) programme. Available at: https:// www.kingsfund.org.uk/publications/tacklingvariations-clinical-care [Last accessed August 2021] 7. Bader R. Basal cell carcinoma. Available at: https://emedicine.medscape.com/article/276624overview In, Vol. 2019: Medscape. 2019. [Last accessed August 2021] 8. Peris K, Fargnoli MC, Garbe C, et al. Diagnosis and treatment of basal cell carcinoma: European consensus-based interdisciplinary guidelines. Eur J Cancer 2019. 118:10-34 9. Zhang M, Qureshi AA, Geller AC, Frazier L, Hunter DJ, Han J. Use of tanning beds and incidence of skin cancer. J Clin Oncol 2012. 30(14):1588-1593 10. Roewert-Huber J, Lange-Asschenfeldt B, Stockfleth E, Kerl H. Epidemiology and aetiology of basal cell carcinoma. Br J Dermatol 2007. 157 Suppl 2:47-51 11. Khalesi M, Whiteman DC, Tran B, et al. A meta-analysis of pigmentary characteristics, sun sensitivity, freckling and melanocytic nevi and risk of basal cell carcinoma of the skin. Cancer Epidemiol 2013. 37(5):534-543 12. Onajin O, Brewer JD. Skin cancer in patients with chronic lymphocytic leukemia and non-
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GIRFT Getting It Right First Time GPwER General Practitioner with Extended Role GS Gorlin syndrome Hh Hedgehog signalling pathway KC Keratinocyte cancer MDT Multidisciplinary team MM Malignant melanoma MMS Mohs micrographic surgery MRI Magnetic resonance imaging NICE National Institute for Health and Care Excellence
NMSC Non-melanoma skin cancer NSAID Non-steroidal antiinflammatory drugs OT Organ transplant PTCH1 Patched gene number 1 PDT Photodynamic therapy SCC Squamous cell carcinoma SSE Standard surgical excision UV Ultraviolet rays XP Xeroderma pigmentosum
Hodgkin lymphoma. Clin Adv Hematol Oncol 2012. 10(9):571-6
causing death. Arch Dermatol 2003. 139(5):643648
13. Harwood CA, Mesher D, McGregor JM, et al. A surveillance model for skin cancer in organ transplant recipients: a 22-year prospective study in an ethnically diverse population. Am J Transplant 2013. 13(1):119-129
23. Popadić M. Dermoscopy of aggressive basal cell carcinomas. Indian J Dermatol Venereol Leprol 2015. 81(6):608-610
14. Zhao H, Shu G, Wang S. The risk of nonmelanoma skin cancer in HIV-infected patients: new data and meta-analysis. Int J STD AIDS 2016. 27(7):568-575 15. Fromm LJ. Xeroderma pigmentosum available at: https://emedicine.medscape.com/ article/1119902-overview In, Vol. 2019: Medscape. 2019. [Last accessed August 2021] 16. Sehgal VN, Chatterjee K, Pandhi D et al. Basal cell carcinoma: pathophysiology. Skinmed 2014. 12:176-81 17. Mackiewicz-Wysocka M, BowszycDmochowska M, Strzelecka-We˛klar D, et al. Basal cell carcinoma - diagnosis. Contemp Oncol (Pozn) 2013. 17(4):337-342 18. Kalmykova A, McKee PH. Basal cell carcinoma. PathologyOutlines.com website. Available at: https://www.pathologyoutlines.com/ topic/skintumornonmelanocyticbcc.html [Last accessed August 2021]
24. Gualdi G, Soglia S, Fusano M, et al. Characterization of Basosquamous Cell Carcinoma: A Distinct Type of Keratinizing Tumour. Acta Derm Venereol 2021. 101(1):adv00353 25. Kadouch DJ, Leeflang MM, Elshot YS et al. Diagnostic accuracy of confocal microscopy imaging versus punch biopsy for diagnosing and subtyping basal cell carcinoma. J Eur Acad Dermatol Venereol 2017. 31(10):1641-1648 26. Sahu A, Yélamos O, Iftimia N, et al. Evaluation of a Combined Reflectance Confocal Microscopy-Optical Coherence Tomography Device for Detection and Depth Assessment of Basal Cell Carcinoma. JAMA Dermatol 2018. 154(10):1175-1183 27. Nasr I, McGrath EJ, Harwood CA, et al. British Association of Dermatologists guidelines for the management of adults with basal cell carcinoma 2021. Br J Dermatol (Published online). 2021. Available at: https://onlinelibrary.wiley.com/ doi/abs/10.1111/bjd.20524 [Last accessed August 2021]
19. Mellor RH, Bulstrode N, Withey S, et al. The stretch test in basal cell carcinoma: a clinical indicator of tumour. Br J Plast Surg 2002. 55(7):594-595
28. Gospodarowicz MK, Brierley JD, Wittekind C. TNM classification of malignant tumours: John Wiley & Sons. 2017
20. Álvarez-Salafranca M, Ara M, Zaballos P. Dermoscopy in Basal Cell Carcinoma: An Updated Review. Dermatoscopia del carcinoma basocelular: revisión actualizada. Actas Dermosifiliogr (Engl Ed) 2021. 112(4):330-338
29. Keohane SG, Proby CM, Newlands C, et al. The new 8th edition of TNM staging and its implications for skin cancer: a review by the British Association of Dermatologists and the Royal College of Pathologists, U.K. Br J Dermatol 2018. 179(4):824-828
21. Cameron MC, Lee E, Hibler BP, et al. Basal cell carcinoma: Contemporary approaches to diagnosis, treatment, and prevention [published correction appears in J Am Acad Dermatol. 2019 Jul. 81(1):310]. J Am Acad Dermatol 2019. 80(2):321-339 22. Robinson JK, Dahiya M. Basal cell carcinoma with pulmonary and lymph node metastasis
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30. Califano JAL, William M, Nehal KS, et al. Cutaneous squamous cell carcinoma of the head and neck. In: AJCC Cancer Staging Manual: Springer 2017. 171-81 31. National Institute for Health and Clinical Excellence (NICE). Improving outcomes for people with skin tumours including melanoma www.bdng.org.uk
Clinical REVIEW Test your knowledge 1. Which is the correct statement? a. Only genetically induced BCCs, show constitutive activation of Hedgehog signaling pathway, which plays a significant role in developing the tumour. b. The three most important aetiological factors in developing BCC are exposure to UV, immunosuppression, and genetic predisposition. c. Data indicates that BCC incidence is the same in persons aged 55-70 years as in those aged 20 years and younger. d. All of the above. e. None of the above. 2. Which of the following statements is NOT true? a. The eyelid has a pathological staging system for the primary BCC tumour and lymph nodes different than the rest of the skin sites. Therefore, its treatment is different than treating BCC in areas M and H. b. The patient, or the person with the power of attorney for health matters, should be counselled sufficiently on all aspects of the treatment approach being considered and post-treatment care, especially with respect to the possibility of developing a scar. c. Digital photography, with or without digital dermoscopic photography, nowadays is relatively easy and is highly recommended for clear (update). In: The management of low-risk basal cell carcinomas in the community. London: National Institute for Health and Clinical Excellence (NICE) 2010 32. Cunliffe T, Schofield J. Guidance and competences to support the accreditation of GPs with Extended Roles (GPwERs): Dermatology and Skin Surgery. In. London 2018. 1-37 33. Lear JT, Corner C, Dziewulski P et al. Challenges and new horizons in the management of advanced basal cell carcinoma: a UK perspective. Br J Cancer 2014. 111(8):1476-81 34. National institute for Health and Care Excellence (NICE). Sunlight exposure: risks and benefits NICE guideline [NG34) https://www. nice.org.uk/guidance/ng34. In, Vol. [Last accessed www.bdng.org.uk
documentation, and to monitor treatment response. d. BCC is extremely rare (<1%) in children under 15 years of age, and when seen it is generally in the context of inherited conditions such as GS and XP. e. It is important to have in place a support team to inform the patient of methods to improve cosmetic outcome following primary treatment. 3. Which is the correct statement? a. Most BCCs can be easily diagnosed clinically without the need for biopsy. b. The clinical diagnostic accuracy of BCC is enhanced by using dermoscopy. c. In most cases, shave or curette biopsy should be sufficient to make a positive diagnosis, but if the exact type of BCC is required, then a deep incisional or excisional biopsy is advised. d. All of the above. e. None of the above. 4. Which BAD guidelines recommendation for management of BCC is NOT true? a. Offer verbal and written information about BCC to all adults with BCC. b. Offer surgery (standard surgical excision or Mohs micrographic surgery) as a first-line treatment option to adults with low-risk or high-risk BCC. August 2021]. London, United Kingdom: National institute for Health and Care Excellence. 2016 35. National institute for Health and Care Excellence (NICE). Vitamin D: supplement use in specific population groups [PH56] https://www. nice.org.uk/guidance/ph56. In, Vol. [Last accessed August 2021]. London, United Kingdom: National Institute for Health and Clinical Excellence. 2014 [Last update: August 2017]
c. Offer topical imiquimod, topical 5-fluorouracil, cryosurgery, or topical PDT as treatment options to all adults with BCC who are unsuitable for or decline surgery. d. Offer radiotherapy as a treatment option to adults with BCC who are unsuitable for or decline surgery, especially for nodular BCC, or infiltrative BCC with sufficient planning margin, or excised BCC with involved margins. e. Offer further standard surgical re-excision to adults with excised high-risk BCC with involved histological margin unless there is a contraindication. 5. Which of the following statements is true? a. After diagnosing and adequately treating a BCC, there is no need for a full-body skin examination or booking a further follow up. b. Because BCC is not a life-threatening condition, good cosmetic results should be the main aim when choosing the treatment option. c. There is no need nowadays to give full information on BCC as the patient can search for it online. d. The cornerstone advice in preventing new BCC is avoidance of UV exposure, which should start from childhood. e. Mohs surgery should not be offered or discussed if there is no local Mohs surgeon. 37. van Egmond S, Wakkee M, Droger M, et al. Needs and preferences of patients regarding basal cell carcinoma and cutaneous squamous cell carcinoma care: a qualitative focus group study. Br J Dermatol 2019. 180(1):122-129.
36. Kyrgidis A, Vahtsevanos K, Tzellos TG, et al. Clinical, histological and demographic predictors for recurrence and second primary tumours of head and neck basal cell carcinoma. A 1062 patient-cohort study from a tertiary cancer referral hospital. Eur J Dermatol 2010. 20(3):276-282
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The AbbVie Dermatology Medical Team of Nurse Consultants and Medical Science Liaisons in the UK runs a number of CPD-/RCNaccredited medical education programmes, which have been developed with leading Dermatologists and Dermatology Nurse Specialists. Contact your Abbvie Dermatology Medical Team at dermdialogue@abbvie.com for more information.
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A series of interactive modules with practical nurse guidance on the care of atopic dermatitis including disease assessment tools
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This medical education programme is developed and funded by AbbVie Ltd for UK healthcare professionals only. ABBV-UK-00212-FM | May 2021
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Dermatology Educational Sessions CPD & RCN accredited sessions. This large range of educational sessions are tailored for: • Nurses new to managing psoriasis and atopic dermatitis • Experienced Dermatology Nurses who require updates on latest management of psoriasis and atopic dermatitis Interactive and engaging sessions led by your local Medical Science Liaison and Nurse Consultant at dates and times to suit you and your team. Email dermdialogue@abbvie.com to arrange your educational sessions.
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Research SKILLS
How to critically appraise a clinical trial Hywel C Williams, Alison JG Lowe
This is the third article in a series relating to research and dermatology nursing, and describes why critical appraisal skills are necessary for dermatology nurses. It suggests a quick critical appraisal approach that can be used – ‘read, write and reflect’. The approach advises nurses to consider PICO, types of bias, and validity. The importance of utilising critical appraisal in practice is discussed, as well as the need for it to become a necessary skill for dermatology nurses. Williams H, Lowe A. How to critically appraise a clinical trial. Dermatological Nursing 2021 20(3):26-28
What has critical appraisal of a clinical trial got to do with me? Dermatology nurses are key professionals with increasing responsibility for initiating and discussing treatment options with patients within a multi-disciplinary team. We now live in an age of evidence-based practice (EBP) where all dermatology professionals are required to integrate the best external evidence with the care of individual patients. Clinical trials usually offer the most reliable form of evidence of the effectiveness of interventions to improve skin conditions (these could be medicines or psychological support or devices such as bandaging techniques), and therefore dermatology nurses are increasingly expected to read trials and to understand them in order to Hywel Williams is Professor of DermatoEpidemiology and Co-Director, Centre of Evidence-Based Dermatology, Nottingham University Hospitals NHS Trust. Alison Lowe is a Dermatology Clinical Nurse Specialist, University Hospitals Sussex NHS Foundation Trust.
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help their patients. The Nursing and Midwifery Council1 (NMC) Code requires nurses to “Always practice in line with the best available evidence”, whilst the British Dermatological Nursing Group (BDNG) nursing role descriptors2 list critical appraisal and the use of evidence to inform practice as a skill for all dermatology nurses. We argue that critical appraisal of a clinical trial is a key skill for all dermatology nurses and is not something that is best left for others to do. There is nothing quite like reading and understanding a clinical trial yourself, but just like any other skill, you might need some guidance on how go about the task simply and efficiently. Here, we provide a brief guide for dermatology nurses to get more confidence in how to tell a good clinical trial from a bad one, and how to apply that knowledge to your patient. But, I don’t know where to start? Many nurses and doctors may feel paralysed when trying to critically appraise a clinical trial. They may get a sense of what it is all about by reading the bottom line of the abstract and perhaps some of the discussion, but they lose confidence or just don’t understand the methods section or statistics – ironically the most important things to look at to ‘sort the sheep from the goats’. Try this approach: Read, write, then reflect.
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Give yourself 30 minutes with a clinical trial paper in front of you and try the following approach: Step 1 (5 mins). Read/speed read: Read the title and abstract to orientate yourself and to get an idea of ‘where they are coming from’, and to clarify what the aims and objectives are. In other words, what is it all about and why did the authors do this study? The end of the introduction/ background section is a good place to look as it should end with a clear statement of why the study was done given previous work. Then consider: Who was behind it? Were they independent investigators funded by government or charity funds, or was it an output from a pharmaceutical company? It is not always obvious, so look closely at the conflicts section at the end of the paper. The Consolidated Standards of Reporting Trials (CONSORT3) trial reporting guidelines are a minimum set of recommendations based on evidence for how clinical trials should be reported, and all good journals will adhere to this. Nurses can use the CONSORT reporting checklist to aid their critical appraisal by providing reminders of what the trial report should include, starting from the title of the paper. www.bdng.org.uk
Research SKILLS Step 2 (15 mins). Write/slower focus: Now go to the methods section to confirm that this was a clinical trial. Clinical trials involve people to answer (test) a specific clinical question about treatment(s). The question may be new, or may aim to provide more information where the evidence is unclear, or may be to confirm an unexpected or important previous result. Decide, when you read the paper, if it answers a clinical question. Next, orientate yourself with some structure and see if you can write down the PICO (i.e., who were the Patients, what was the Intervention being tested, what was it being Compared with and how were they going to measure whether it did any good or harm i.e. what was the primary Outcome?) After PICO, try and assess the internal validity of the study – put simply, whether you believe the results are true or ‘internally valid’. Another way to understand internal validity is to imagine it as the extent to which the observations in a trial can be attributed to the intervention and not to bias or statistical error. Here you could use the simpler version of the Cochrane risk of bias tool.4 For more on bias see Table 1. To start, search the methods section to see how the randomisation was done, i.e., are you convinced that the allocation of participants to two or more groups was done in a truly random way? For example, by a third party computer randomisation. Randomisation is absolutely key as we need the study groups to be as similar as possible apart from the intervention being tested. If you are satisfied that an effective method was used to generate the randomisation, it is now important to see how the authors have described how that randomisation code was hidden from the people entering patients into the study – also known as concealment of allocation. Hiding the code from those entering study participants is really important, as studies have shown how those with vested interests might end up putting people with more favourable outcomes into one group rather than the other. www.bdng.org.uk
Now that you have looked at how randomisation was done and the description of how it was concealed from investigators (you can answer these items as ‘yes’, ‘no’ or ‘unclear’), the next thing is to look for blinding. Phrases such as ‘double blind’ do not help much, as up to five different groups of people can be blinded in a clinical trial. Therefore, you need to see who was blinded to knowing who was given what study medications. Many drug trials are compared against a placebo (either a dummy tablet or saline infusion or just a plain or ‘vehicle’ cream/ointment). Single blinding means the patient is not informed if they are taking a placebo or ‘active’ treatment. Double blinding means that the researcher is also not informed if the patient is receiving active or placebo treatment. Patients who know they are on active treatment are more likely to report positive effects, and if researchers have preconceived ideas about this active treatment, this may prejudice their observations. Are you convinced from the description in the methods section that the control placebo/vehicle had the same look or smell or colour as the active treatment? Don’t take the authors’ word for it. For example, many studies of capsaicin cream are described as ‘double blind’ but patients quickly knew if they were on active treatment as capsaicin (made from chillies) burns the skin! Try and write down who you think was blinded (nowadays more correctly called ‘masked’) and whether you are convinced (yes/no/unclear). After blinding, look to see if all of those who were initially randomised were included in the main analysis for the primary outcome. The best place to look for this is in a trial flow diagram and see if the numbers randomised at the top of the chart correspond to the numbers analysed at the bottom. It does not matter if some patients drop out after randomisation, but it does matter if they mysteriously disappear and are not included in the analysis. Including all those randomised is usually referred to as ‘intention to treat analysis’. Again, decide if it is a yes/no/unclear for intention to treat analysis.
Finally, try and see if the outcomes reported and highlighted in the trial are the ones that the authors planned to report – rather than just the outcomes that ‘looked good’. Most good journals now insist that all clinical trial protocols have to be registered in a clinical trial register before recruitment starts. These registers are in the public domain, so you can check them. It only takes a moment, but you need to be in front of a computer. Look for the clinical trials registration number, for example, ISRCTN71423189. Copy this into your web browser and you should find yourself looking at a structured protocol. Scroll down and see what the primary and secondary outcomes were and compare them to those reported in the paper. If they are the same, all well and good. However, if they are different without good explanation, then you must conclude that some degree of selective reporting outcome bias might have occurred, i.e., not good. The above may sound like quite a lot, but with some practice, it should take only 15 minutes as you learn what to look for and where. Just make a note on a checklist of your yes/no/unclear responses. Don’t try and add them into a score, just think about them and decide if you still believe the results. Step 3 (10mins). Reflection: Reflect on the results in relation to your clinical world by deciding on the external validity of the trial. External validity is the extent to which the results from the trial can be generalised to a population, and especially the population identified in the trial, for example ‘children with atopic eczema’. Therefore, in step 3, you are asked to reflect on whether you think you can apply the results to your patients – if you were totally unconvinced by the internal validity check in step 2, then stop there – no point trying to apply poor evidence to your patient. But if you thought that the study was reasonably valid, then you now need to think about whether the results apply to your patients. See Box 1 for more information.
Utilising your critical appraisal Sharing your critical appraisal of a clinical trial is good practice. It could
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Research SKILLS be at a local meeting (such as a clinical governance or journal club) so that other professionals and patients can benefit from the shared knowledge. This can improve your confidence too. Other professionals and patients can also add to their knowledge and their insights too. You can include your activity in your clinical professional development (CPD) portfolio. However, the most important rule of all is to try and apply the results of the study to individual patients – good evidence-based practice (EBP) starts with patients and ends with patients.
Conclusion This article suggested that utilising evidence in practice is a professional standard, and this requires dermatology nurses to critically appraise the research they use. It also describes a quick way of appraising clinical trials by advising nurses to try the ‘read, write and reflect’ approach which includes the identification of PICO, bias, and validity by using some key questions. There appears to be a paucity of papers on dermatology nursing and critical appraisal. There is no dermatology nursing competency for critical appraisal, although this is a basic building block for EBP, and utilising evidence in practice is included in the BDNG core quality standards for dermatology nursing interventions and services.6 Dermatology nurses need to develop their confidence and skills in critical appraisal. Stevens, Ricketts and Bruneau7 capture this issue by describing how nurses are taught and supported in practising technical skills, and are encouraged to use EBP, but are not generally supported in practising critical appraisal. This is not a new issue, but one which needs to be addressed if nurses are to be confident in practicing EBP. DN Correspondence to: Prof. Hywel Williams, Centre of Evidence-Based Dermatology, Nottingham University Hospitals NHS Trust, Nottingham NG7 2UH, UK Hywel.williams@nottingham.ac.uk 28
Table 1. Main types of bias in clinical trials (from the Cochrane Handbook5) Selection bias
Systematic differences between the baseline characteristics of the groups compared
Performance bias Attrition bias
Systematic differences in the care provided or in the exposure to other factors (other than the intervention) between the groups Systematic differences between groups in withdrawals from a study
Detection bias
Systematic differences in groups in how outcomes are determined
Reporting bias
Systematic differences between reported and unexpected findings
BOX 1 External validity: Question prompts to help reflect on applicability How similar are the study participants to your patients? They don’t have to be identical, but just be aware that studies often exclude older people with multiple co-morbidities. If the trial was done on adults, are you happy extrapolating those results to children? – children are not small versions of adults after all. Are the benefits convincing? If the benefit was statistically significant, was it clinically important in your view? For example, a 10% reduction in inflammatory spots in a trial of a new treatment for acne compared to placebo may be statistically significant, but it is unlikely that a teenager sitting in front of you will be equally impressed with such a result. How does the treatment fit in with your patient’s beliefs? Did they come for treatment or just for information? Have they had the treatment before and had a bad experience and if so, why? What are the side effects of the treatment and would they be acceptable to your patient? Side effects (often reported at the end of the results section) are often not reported very well and are often glossed over in the discussion, so have a look for yourself and come to a judgement on whether they are likely to be an issue for your patient.
References 1. Nursing and midwifery Council, 2015 (updated 2018), The Code: professional standards of practice and behaviour for nurses, midwives and nursing associates. Available at: https://www.nmc.org.uk/ globalassets/sitedocuments/nmc-publications/nmccode.pdf [last accessed August 2021] 2. Griffiths T, Millington G, Penzer-Hick R, Jackson K, Lawton S, Wheeler J., Clinical dermatology role descriptors: guidance on scope of practice. British Dermatological Nursing Group 2019. Available at: https://bdng.org.uk/wp-content/ uploads/2020/08/BAD-BDNG-RCN-NURSINGWORKSTREAM-A4-LANDSCAPE-002.pdf [last accessed August 2021] 3. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010. 340;c332
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4. Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019. 366: l4898 5. Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Churchill R, Chandler J, Cumpston MS (editors), Cochrane Handbook for Systematic Reviews of Interventions version 5.2.0 (updated June 2017), Cochrane, 2017. Available at: www.training.cochrane.org/ handbook [ last accessed August 2021] 6. Buchanan P. Core quality standards for Dermatology nursing interventions and services. Dermatological Nursing 2014. 13(4):s1-s23 7. Stevens LK, Ricketts ED, Bruneau JEE. Critical appraisal through a new lens. Nursing Leadership 2014. 27(2):10-13. www.bdng.org.uk
Introducing the BDNG App We are delighted to introduce the BDNG App. This will give members year-round access to membership benefits conveniently on your phone or tablet. Step 1 Download the Engagefully App for the App Store or Play Store.
disable this at any time. You can change your preferences by clicking on your account and selecting the ‘Manage’ button in the organisational preferences section.
Step 5 Step 2 Enter BDNG into the search bar and tap on our name to select.
Step 3 Customise the App by switching it to the BDNG logo. This will change the icon on your phone/tablet.
Click on the menu button to get started.
Step 6 Setting up your account: 1. Click on the account icon and enter your emails address (that you can access from your phone/tablet). You will receive an email to activate your account. 2. BDNG website login. Login into you BDNG account in the normal way. Don’t worry there are links to reset your password or contact us directly if you have forgotten your details. That’s you all set up to access the member’s only content through the BDNG App as well as any events that you have registered for.
Step 4 Allow notifications. We promise that we won’t bombard you with endless notifications and you can
We hope you enjoy using the BDNG App. If you have any comments or questions about it or would like to suggest other content to add to it, please contact us at admin@bdng.org.uk. DN
Professional DEVELOPMENT
Setting up remote consultations for people with skin conditions: ensuring patients are seen in the right place, at the right time Emma Le Roux, Julia K Schofield
This article – the second in their series – looks at remote consultations, providing a summary of what they are in relation to patients with skin conditions and detailing the guidance that has been developed by the Dermatology National Outpatients Transformation Programme, which it is hoped will lead to more personalised care in the field. Le Roux E, Schofield JK. Setting up remote consultations for people with skin conditions: ensuring patients are seen in the right place, at the right time. Dermatological Nursing 2021. 20(3):31-34
Introduction
Dr Emma Le Roux is a GP and Specialty Doctor Dermatology, Cheltenham, Gloucestershire, Editor Primary Care Dermatology Society Bulletin and Joint Dermatology Clinical Lead, National Outpatient Transformation Programme. Dr Julia K Schofield MBE is Associate Professor in Learning and Teaching University of Hertfordshire, Consultant Dermatologist United Lincolnshire Hospitals NHS Trust and Joint Dermatology Clinical Lead, National Outpatient Transformation Programme www.bdng.org.uk
The ambition of the NHS Long Term Plan1 is to redesign services with high-quality, personalised, joined-up care, in the optimal care setting. The National Outpatients Transformation Programme (NOTP) was established by NHS England and NHS Improvement in 2019 to work on transforming services to deliver these changes. The Dermatology NOTP specialty programme started work in mid-2020 and includes several workstreams,2 one of which is about optimising the use of remote consultations for people with skin conditions. This article provides an overview of what remote consultations are and summarises the guidance that the NOTP dermatology team has developed and published, which we hope will ensure that remote consultations are used in a way that benefits patients and personalises care. Dermatology is a visual speciality and for many patients a face-to-face consultation will be necessary to make a diagnosis or to review response to treatment.
What are remote consultations and how can they be delivered? Remote consultations are appointments that take place between a patient and a clinician over video or telephone. Remote consultations have played an important role in the NHS response to the COVID-19 pandemic, helping hospitals and clinics to reduce the number of physical attendances at their sites. They offer patients further choice in how they access care where their clinical circumstances allow. Remote consultations should be personalised and inclusive and offered to all patients where clinically appropriate. Healthcare professionals should reiterate patient choice at every stage, and it should never be assumed a patient would prefer a remote consultation because they have had one previously. Patients should always be given the option to opt in or out without the need to justify their decision. Furthermore, if the appointment involves reviewing
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Professional DEVELOPMENT diagnostic results, it is recommended that the patient is asked ahead of time how they would prefer to receive their results regardless of the diagnostic outcome. The aim should be to provide a comparable level of care as with face-to-face assessment which requires clinicians to identify when they are clinically appropriate. Whilst any clinician who is trained in face-to-face consultations can undertake remote consultations, there is a requirement for additional training, as specific extra skills are required to optimise outcomes e.g., gaining confidence with using the required technology, managing issues such as patient consent, confidentiality, and addressing the inevitable reduced visual and non-verbal cues.
What might be the benefits for dermatology beyond the pandemic? Remote consultations can provide the opportunity to improve equity and speed of access for all patients with skin disease, reduce unnecessary hospital visits and relieve capacity for clinicians alongside increasing patient choice in how their care is delivered.
The pandemic has proved that remote consultations are a safe and effective way of delivering patient care A video or telephone consultation can take place in a place that is convenient to patients who will not need to go into the hospital or clinic for an appointment. That means no more wasted time, money and stress travelling to appointments. It also means less pollution which helps reduce carbon emissions, creating a healthier environment which benefits us all. Telephone and video consultations not only increase flexibility for patients, but they also increase options for flexible working for medical professionals and mean they can use their time more effectively, giving them more time to spend with their patients. The pandemic has proved that remote consultations are a safe and 32
effective way of delivering patient care. A national survey undertaken by the Psoriasis Association during the COVID-19 pandemic for patients suffering with psoriasis and psoriatic arthritis, showed that 78% were satisfied with their care delivered via either a telephone or video consultation with 79% expressing that they would be happy to participate in future remote consultations, although 57% preferred a combination of face-to-face and remote consultations for long-term follow-up.3
Guidance for setting up remote consultations for people with skin conditions The dermatology NOTP dermatology speciality programme has developed guidance for setting up remote consultation services for people with skin conditions4 and this section of the article describes the process used to develop the guidance and summarises some of the key messages in the document. We hope that this information will help you to ensure that remote consultations are used appropriately for the right patients in your organisation.
How was the guidance developed? The NOTP remote consultations team have a lot of generic resources which we were able to access. Our starting point was to ask stakeholders on our NOTP dermatology Advisory Group for their views about how remote consultations might work for people with skin conditions. Our patient representatives proved key to these discussions and provided us with invaluable information about which technology and when a remote consultation is most suitable, particularly for people with long-term skin conditions. Our specialist and primary care colleagues provided their views on how the remote consultations might work and the guidance has the support of all key stakeholders.
Who is likely to benefit and is everyone suitable for remote consultations? In identifying the opportunities for remote consultation, it is important to consider that dermatology is a largely visual specialty with high volumes of cancer activity which are
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not suitable for remote consultations. Patient choice is important, but the clinician view about whether a remote consultation is clinically appropriate is key to enable safe and appropriate appointment types. Specific groups of patients who could be considered for remote consultations include: Those with long-term stable conditions such as eczema and psoriasis requiring routine drug monitoring or follow-up progress, or where they have an acute flare of their condition and require a remote consultation as a ‘stop gap’ prior to a face-to-face consultation becoming available People with low-risk non-melanoma skin cancers being followed up for results or discharge Follow-up for patients with acne on isotretinoin medication (except female patients of childbearing age on the Pregnancy Prevention Plan). There are some specific issues for people with skin conditions where remote consultations are not suitable: Where an examination or test is required that cannot be facilitated adequately by a remote consultation e.g., skin cancer patients requiring lymph node examination and a full skin check New patient referrals particularly for patients with long-term inflammatory conditions where it is important to utilise a face-to-face consultation to establish a diagnosis and treatment regimen Skin conditions in sensitive body sites e.g., breasts/genitalia/buttocks or in a site that is difficult to assess by video e.g., scalp will require a face-to-face consultation Patients with skin lesions where a dermoscopic image is not available or of inadequate quality are not appropriate to be seen via remote consultations Patients suffering with complex clinical needs or significant social or psychological impact from their skin condition www.bdng.org.uk
Professional DEVELOPMENT Female patients of childbearing age on the pregnancy prevention programme are not suited to remote consultations at present because of current MHRA guidance. 5
Key considerations before offering a remote consultation Alongside patients’ preference and suitable clinical selection of patients, there are specific considerations before offering a remote consultation. For example, it is important to assess whether there is appropriate privacy for both patient and clinician and reliable access and confidence with the technology required. If there are uncertainties around mental capacity, safeguarding concerns or uncertainty whether a remote consultation is suitable for a child or young person then flexibility to convert to a face-to-face appointment is essential.
Choosing the right technology and optimising the remote consultation The mode of remote consultation will depend on the type of skin condition and symptom control e.g., telephone consultations may be more suitable for monitoring disease activity and medications in people with stable long-term disease, whereas video consultations may better suit when a person’s skin condition is flaring. Video consultations allow healthcare professionals to observe behaviours, spot social cues and physical characteristics which may not be possible over the telephone. As dermatology is a visual speciality, remote consultations can be optimised by the addition of: Pictures of the skin submitted via a secure platform Pre-assessment questionnaires sent via a secure platform such as quality of life assessment tools and disease severity monitoring tools e.g., the Patient Orientated Eczema Measure (POEM) App6 Post consultation personalised information about the patient’s skin condition to support the consultation. www.bdng.org.uk
What are the risks associated with remote consultations and how can these be mitigated? Some of the potential risks from undertaking remote consultations include missed skin cancers and missed diagnosis, particularly when poor quality images or video conferencing is used, or from not examining ‘hard to see’ body sites such as the back. The severity of the skin condition may be underestimated due to limited ability to examine all affected areas and unless clinicians are suitably trained, it may be harder to assess emotional and psychological wellbeing, particularly with a telephone consultation. Many of the long-term inflammatory conditions require practical training on the use of topical treatments, together with information and education for self-care and monitoring which is less available with remote consultations. Patients may lose confidence in the healthcare professional’s ability to assess their condition, which can result in poor seeking of future advice and worse clinical outcomes. There are additional risks relating to privacy, breach of confidentiality and informed consent with respect to confidential and secure capture, transfer and storage of clinical images used to support clinical decisionmaking in dermatology, particularly in the context of skin conditions in intimate areas. Many of the risks can be mitigated by specialist-led triage to ensure the correct patients are booked to remote consultations. Without this, there is the possibility of double activity, with patients having a remote consultation and also a face-to-face consultation. It is important to provide information e.g., technology requirements, to manage patient expectations and to support them with remote consultations together with a shared decision that this mode of consultation is suitable for them. Healthcare professionals need to be suitably trained and have adequate time in an appropriate environment with access to all relevant patient records and
supporting documentation as expected for a face-to-face consultation. There should not be an expectation that a remote consultation will take less time than a face-to-face consultation; the time requirements are similar. There needs to be flexibility to convert to a face-to-face consultation alongside provision of safety netting, contact information and escalation plans if they are experiencing more urgent symptoms.
The mode of remote consultation will depend on the type of skin condition and symptom control
Third parties should be identified and documented clearly in what capacity they are joining e.g., relative/ friend/carer or chaperone/interpreter/ trainee. Chaperones (appropriately trained healthcare professional) should be offered for any situation where they would also be offered in a face-to-face setting.
What issues need to be thought about when setting up remote consultation services for people with skin conditions? The following list summarises the key steps for you to think about when setting up your service: It is important to consider accessibility when planning remote consultations through undertaking an equality and health impact assessment. Factors such as hearing impairment, disability, age, and social deprivation may affect an individual’s access to remote consultations. We need to ask whether someone has a private space and can access the consultation, rather than assuming they can or cannot Develop written information for the patient about how a remote consultation works, together with information on the technology and information needed to access their appointment. It is recommended
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Professional DEVELOPMENT that test calls are offered to all patients in advance of their appointment to test equipment, to practice joining a video consultation and to ensure patients are comfortable proceeding with their scheduled appointment Use specialist-led triage to ensure that the correct patients are booked into remote consultation appointments, thereby avoiding duplication of activity Equip healthcare professionals with safeguarding and consent guidance to deliver remote consultations in a safe manner. Also consider providing training to healthcare professionals to better understand how to deliver care through remote consultations. Examples of topics include: video consultation platform training, understanding non-verbal cues, behavioural top tips for delivering care via video consultation to help patients feel more engaged, importance of patient choice, importance of combining video consultation with face-to-face appointments
The COVID-19 pandemic has necessitated and accelerated the rollout of telephone and video consultations to deliver high-quality care while also minimising face-to-face contact Think about developing designated remote consultation spaces, or suites, to optimise the use of clinical space so that remote consultations are separated out from face-to-face consultations. Using this approach will mitigate the risk of missing remote consultation appointment
34
times if running late in a face-toface clinic Agree arrangements for consent, receipt, and storage of images to support clinical decision making particularly if patients provide images of intimate areas (breasts, genitalia, perianal area) Think about and agree pathways for patients when blood tests or imaging are required before or following remote consultation, particularly patients on longterm immunosuppression where sometimes special tests (e.g., P3NP) or continuous monitoring are needed Make sure there are robust arrangements in place for the provision of information resources that should be provided to the patient after the consultation Agree arrangements for prescribing of medications following a remote consultation, including the supply of unlicensed or hospital only medications Make sure you are collecting information about the outcomes of remote consultations (e.g., number of patients who rejected a remote consultation and why; numbers needing further follow-up remotely; numbers discharged; new to follow up ratios; number of video or telephone consultations answered per month; appointment length; qualitative feedback of patient and clinician experience) and use the information to develop and evolve the service.
Summary The COVID-19 pandemic has necessitated and accelerated the rollout of telephone and video consultations to deliver high-quality care while also minimising faceto-face contact. Harnessing digital transformation through the adoption
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of remote consultations for people with skin conditions can support the transformation of outpatient services to deliver more personalised care for our patients. However, careful patient selection is essential if this approach is to work successfully, and we hope that the guidance will support the safe and effective use of remote consultations for people with skin conditions. DN Get in touch To find out more or get involved please contact us NHS England and NHS Improvement’s National Outpatient Transformation Programme at nhsi.outpatienttransformation@nhs.net.
References 1. NHS Long Term Plan. Available at: https://www. longtermplan.nhs.uk/ (last accessed April 2021) 2. Schofield JK, Le Roux E. The National Outpatient Transformation Programme. Dermatological Nursing 2021. 20(1):6 3. A survey on telephone and video consultations for psoriasis and psoriatic arthritis during the COVID-19 pandemic; Personal Communication from the Psoriasis Association. November 2020 4. Setting up remote consultation services for people with skin conditions. NHS Futures Available at: https://future.nhs.uk/system/logi n?nextURL=%2Fconnect%2Eti%2FOutpatient Transformation%2Fviewdocument%3Fdocid% 3D99385349 (account required) (last accessed August 2021) 5. Oral retinoid medicines: revised and simplified pregnancy prevention educational materials for healthcare professionals and women. MHRA 2019. Available at: https://www.gov.uk/drugsafety-update/oral-retinoid-medicines-revisedand-simplified-pregnancy-prevention-educationalmaterials-for-healthcare-professionals-and-women (last accessed August 2021) 6. POEM – Patient Oriented Eczema Measure. Centre of Evidence Based Dermatology. Available at: https://www.nottingham.ac.uk/ research/groups/cebd/resources/poem. aspx#:~:text=Overview,as%20experienced%20 by%20the%20patient (last accessed August 2021)
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Clinical REVIEW
The cost effectiveness of emollients for atopic dermatitis: Article review Julie Van Onselen
This article examines the recent ‘Cost effectiveness of emollients for AD’ study, including an analysis of methodology and findings, and considers what the implications are for dermatology nurses. Van Onselen J. The cost effectiveness of emollients for atopic dermatitis: Article review. Dermatological Nursing 20(3):37-40
Review ‘Cost effectiveness of emollients for atopic dermatitis (AD)’ was published in Clinical, Cosmetic and Investigational Dermatology and was presented as a symposium and poster at the British Association of Dermatologists (BAD) Annual Meeting 2021.1 This is a review of the article, including methodology and research findings, with comparisons made to other recent randomised controlled trial (RCT) studies on emollients and current National Institute for Health and Care Excellence (NICE) atopic eczema management in children under 12 years guidance.2 The study and findings are summarised in the poster presented at the BAD, which is reproduced within this article.
Julie Van Onselen is a Dermatology Lecturer Practitioner, Dermatology Education partnership Ltd, MySDSHealthcare, South Birmingham CCG, Skin Health UK, and The National Eczema Society www.bdng.org.uk
The review of this article has been carried out following the CONsolidated Standards of Reporting Trials (CONSORT) statement on transparent reporting of trials.3 The CONSORT statement is an evidence-based minimum set for recommendations for reporting on clinical trials.2 Title and abstract This is a comparative study rather than an RCT. The title describes the study objective and the abstract states the design is a cost-effectiveness study based on a three-state Markov stimulation model. The conclusions are clearly stated in the abstract. Introduction: Background and objectives The study introduction focuses on the incidence and remitting-relapsing symptoms of AD. The literature review is included in the analytical framework section and outlines evidence from studies and guidance. The literature reported in the study tells us that moisturising between flare-ups can prevent or increase time between relapses, but topical steroids do not prevent relapses. Relapses impact on patient Quality of Life (QoL), expenditures and societal costs.1 NICE guidance recommends moisturisers as first-line treatments in delaying flare-ups and corticosteroids for the acute phase.2 The background and literature review found that despite a large number of
emollients, efficacy is not well known, and few cost effectiveness studies have been published. The study objective is clearly defined: the aim of the study is to assess the cost effectiveness of four emollients on AD relapses. It considers the health results as well as the cost of intervention for the health system.1 Methods The trial design was an aggregated Markov stimulation model with 28 cycle days. Cost and efficacy data was extracted from RCTs4 and a literature review. A cost effectiveness study was designed and applied. Two dermocosmetic emollients (A and D) were compared to a mass market emollient (B), a medical device (C), and no emollient. The study population was 99 participants, with a mean age of 11.5-12.6 years; 26% were aged 16 years or older; 56.6% were female and 43.4% male, with a mean duration of AD for six years.1 Markov models have been used extensively in medical literature, and offer a framework for modelling medical decision making, with the potential for powerful applications in decision support systems and health economics analysis. 5 The assumption for the Markov model in this study was the equality of transition probabilities between maintenance and flare-up states (Mf)
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Clinical REVIEW Table 1. Study emolients
Figure 1 Markov model used to model cost efficiency of different emollients. and between the post-corticosteroid and flare-up state (Pf). The poster shows the Markov model with the three health states. The outcomes measured were time without flare-ups, with the quality adjusted life years (QALYs) assessed as a secondary outcome. A QALY is a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to one year of life in perfect health (score 1=perfect health to 0=dead).6 The study participants were pre-treated with corticoids to achieve SCORAD <20, to enter a maintenance state. The study included expenses associated with cost of: emollients; topical corticosteroids (TCS); consultations; hospitalisations; prescriptions; lost productivity; and outof-pocket expenses. The costs were worked out from previous research. Medical costs, such as hospitalisation and doctor’s visits during the flare-up states, were taken from the dupilumab technology appraisal.7 On average, a patient visits a GP 1.363 times, and a specialist in an outpatient 0.579 times a year. The incremental cost effectiveness ratio was used to calculate the cost involved for the addition of another QALY. This was used to compare the effectiveness versus cost between different emollients in the study. The statistical analysis was performed with Microsoft Excel and deterministic sensitivity (DSA) and probabilistic sensitivity analysis (PSA) applied.1 38
Emollient
Type
A
Lipikar Baume AP+
B
Dexeryl cream (UK comparator Doublebase and Cetraben) Atopiclair cream
Dermo-cosmetic Aqua posae + microresyl (for rebalancing the microbiome), thermal spring water from La RochePosay, niacinamide, 8% glycerin, and 20% shea butter Mass market Petroleum, mineral oil, and glycerin
C D
Eucerin AtopiControl body lotion body
No emollient
No emollient applied
Emollient device
Glycyrrhetinic acid, telmesteine, hyaluronic acid shea butter, vitamins C and E
Dermo-cosmetic Glycerin, vitis vinifera seed oil, oenothera biennis oil, caprylic/capric triglyceride, cyclomethicone, dimeticone No emollient
Results Based on the effectiveness model, Emollient A was proven to be the most effective therapy, as patients gained 4.58 years without flare-ups within the six years (equivalent to 0.097 years without flare-ups in comparison to Emollient B and 0.60 years without flare-up in comparison to no emollient). Based on the QALY: Emollient A offered 4.19 QALYs; Emollient B offered 4.18 and no emollient offered 4.12. While these differences might look small, when converted to days, Emollient A offered more than 35 days without flare-ups versus Emollient B and seven months without flare-ups compared to no emollient. Based on the cost model over the six years, Emollient B was the cheapest therapy, amounting to £1,802.75, followed by Emollient A at £1,844.23. No emollient was the most expensive therapy at £2,251.01, where the most expense comes from doctor’s visits. Based on calculating the incremental cost effectiveness ratio (ICER), Emollient A becomes the dominant therapy with willingness to pay £428.30 more per additional year without flare-ups versus Emollient B.
Dermatological Nursing, 2021, Vol 20, No 3
Active Ingredients
Adding the lost productivity expense, Emollient A becomes the cheapest and the most effective therapy. The results were well presented and showed the application cost of emollients plus TCS of a 28-day treatment cycle. This is illustrated graphically in Figure 1. The emollient costs were based on two applications per day and TCS costs, one application a day for two weeks, and then three applications for two weeks (giving a total of 20 applications).1 The cost per cycle for mean daily use was: Emollient A= £6.27 Emollient B= £3.81 Emollient C= £62.67 Emollient D= £10.63 The cost per cycle of corticosteroids = £12.74. No use of emollients was the most expensive option, Emollient B was the least expensive option, but there were 35 more flare-free days with Emollient A, and seven flare-free months with Emollient A compared to no moisturiser.1 Emollient C and D were both more expensive options; Emollient C was more expensive but most effective, and D was less expensive but the least effective.1 www.bdng.org.uk
Clinical REVIEW Atopiclair ® was cost effective against regular emollient in mild-to-moderate paediatric atopic dermatitis in the countries included in the study. This study examined only cost savings of emollient from a societal perspective, and did not include the range of associated costs and productivity loss, specific to AD.10
Figure 2 Cost effectiveness of emollients in the prevention of flare-up in atopic dermatitis Discussion The main discussion points of the study, which is thought to be the first cost effectiveness analysis of emollients, included:1 Emollient therapies are proven to be more effective than no emollient Emollient A is the most effective therapy in prevention of AD flareups with a possible remission period of seven months compared to no emollient Emollient A is still the dominant therapy versus Emollient B with willingness to pay £42.00 more and gain 35 remission days Adding estimated costs behind productivity loss, Emollient A was the cheapest emollient therapy versus Emollient B with a difference of £872 in cost in favour of emollient A over six years.
What does this study add to the current evidence-base? The importance of emollients as a firstline treatment in dry skin and AD is well documented in the literature. There are a small number of RCTs comparing different emollients in terms of AD prevention and effectiveness; as well as existing national NICE guidance, which will now be discussed in comparison to this study. www.bdng.org.uk
This study gives evidence that emollients can prevent flare-ups in patients with a history of AD.1 The Barrier Enhancement for Eczema Prevention (BEEP) study, published in 2020, recruited term infants (at least 37 weeks’ gestation) at high-risk of developing AD. In this RCT, the study group was 1,394 term new-borns with a family history of atopic disease who were randomly assigned (1:1) to application of emollient daily (either Diprobase® cream or DoubleBase® gel) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The study results concluded that there was no evidence that daily emollient use during the first year of life prevents AD in high-risk children, and there was some evidence to suggest increased risk of skin infections.9 The BEEP study looked at infants who had a risk of developing AD only, so a comparison cannot be drawn. The study provides evidence on cost effectiveness of emollients, by exploring costs associated with AD and flareups. A similar study in 2015, utilising a Markov decision model, was developed to evaluate the cost effectiveness of Atopiclair ® versus regular emollient in 12 Asia-Pacific countries, grouped by income categories based on gross domestic product (GDP) per capita.
The study provides evidence for emollient choice, based on time between flare-ups and relapses. The feasibility Choice of Moisturiser for Eczema treatment (COMET) tested a hypothesis to research the best emollient for children, which informed the current BEE (Best Emollients for Eczema) study,11 research that will improve the treatment of childhood AD by finding out which emollients are most acceptable and effective. The BEE study results are expected by the end of 2021.12 NICE guidance for children with atopic eczema under 12 years was updated in 2021.2 The emollient guidance states that healthcare practitioners (HCPs) should offer a choice of unperfumed emollients to use every day for moisturising, washing and bathing, the emollients should suit the child’s needs and preferences, and an alternative should be offered if an emollient cause irritation.2 HCPs should inform parents/carers to use emollients in larger amounts, more often than other treatments, and on the whole body, even when eczema is clear.2
Implication for dermatology nurses Patient preference is paramount when dermatology nurses are helping patients select emollients. Dermatology nurses can help patients to make an informed choice by helping them to consider the suitability and formulation of different emollients and assisting them in finding one which works with their lifestyle. An effective formulation will help treat dry skin, repair the skin barrier, and will be cosmetically acceptable to the patient. This study helps emphasise the importance of emollients and patient preference, as stated by NICE
Dermatological Nursing, 2021, Vol 20, No 3
39
Clinical REVIEW COST-EFFECTIVENESS OF EMOLLIENTS IN PATIENTS WITH ATOPIC DERMATITIS E CABOUT1, R LAUNOIS1, S SEITÉ2, C TAIEB3,4
(1) Network for Evaluation in Health Economics, REES France, Paris, France (2) La Roche-Posay Dermatological Laboratories, Levallois-Perret, France EMMA, Fontenay-sous-Bois, France - (4)Hôpital Necker Enfants-Malades, Santé Publique, France
(3)
INTRODUCTION
Atopic dermatitis (AD) is an inflammatory, relapsing skin disorder defined by inflammatory flares followed by periods of remission. The management of atopic dermatitis requires visits to the doctor, specific clothing, but also the need to apply local treatments to calm periods of crisis. All this care has a strong impact on the health and quality of life and social patients. The prevalence rate is estimated at 15%. The follow-up of AD and the prevention of relapses have a great impact on health care, society costs but also on patient’s expenditures.
OBJECTIVE The aim of the study is to demonstrate the medical value of emollient prescribing and explore the cost-effectiveness of different emollients prescribed to AD patients.
METHOD
STRUCTURING CHOICE
- 5-year period with cycle of 28 days - Two perspectives: 1°NHS/PSS, 2°societal which adds productivity losses and outof-pocket expenditures. - The target population is composed of patients with AD who have just been treated with corticoid to remove flare-ups. - Four different emollients were compared: A, B, C, D with a no emollient strategy. - Two outcomes: Time without flare-ups and QALY. - Costs: Consultations, hospitalizations, prescriptions, lost productivity and out-ofpocket.
MODELLING
Patients were treated with topical glucocorticosteroid during flare-ups periods. The post-corticoid state represents the phase following the one during which patients were treated with corticosteroid, and lasts 28 days, i.e. 1 cycle. Therefore, patients can’t stay in this state after a cycle, they either undergo new flare-ups or enter thee maintenance state.
pf
3.89
3.80
D
No Emollient
3.57
3.48
3.38
3.55
3.54
3.51
3.50
3.49
Emollient
434.87 €
258.32 €
4 345.93 €
720.97 €
0,00 ¤
Glucocosticosteroids
130.24 €
145.71 €
189.15 €
207.60 ¤
225.61 ¤
Hospitalization
124.28 €
128.32€
139.67 €
144.49 ¤
149.19 ¤
Consultations
Costs
909.08 €
1 017.13 €
1 320.33 ¤
1 449.12 ¤
1 574.83 ¤
Lost of productivity
0.00 €
0.00 €
0.00 €
0.00 ¤
0.00 €
OOP (excluding emollient)
0.00 €
0.00 €
0.00 €
0.00 €
0.00 €
Total
1 598.46€
1 549.48 €
A
1 598.46 €
No emollient D C
1 549.48 €
ΔC
Costs B
5 995.07 €
Benefit
2 522.17 ¤
The strategy with A is a little more expensive by £42 but also more effective by 0.082 year without flare-ups corresponding to a 30 days difference without flareups. All other treatments (no emollient, D and C) are more expensive and less effective than A. They are therefore dominated. The ICER is £513 by year without flare-ups. The ratio means that it would cost £513 with A for an additional year without flare-ups compared to B.
1 0.9
1 949.63 ¤
ΔB
ICER
A is the dominant strategy compared to no treatment: 184 more days without flareups and £302 cheaper. The efficiency frontier, composed of all the efficient treatments links Strategies A and B. They are the only two efficient treatments.
3.803 48.98 ¤
3.885
0.082
599.19
1 949.63 €
351.17 ¤
3.380
-0.505
Dominated
2 522.17 €
923.71 ¤
3.475
-0.410
Dominated
5 995.07 €
4 396.61 ¤
3.573
-0,312
Dominated
0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 £0
A
B
C
434.87 €
264.44 €
4 345.93 €
737.30 €
0,00 ¤
77.59 €
86.81€
112.69 €
123.68 ¤
D
No Emollient
134,41 ¤
124.28 €
128.32€
139.67 €
Consultations
909.08 €
1 017.13 €
1 320.33 ¤
1 449.12 ¤
1 574,83 ¤
641.83€
716.16 €
924.74 €
1 013.34 ¤
1 099.83€
OOP (excluding emollient) Total
£4 000
£6 000 Lipikar
Hospitalization Lost of productivity
£2 000
Emollient A
Costs Glucocosticosteroids
Deterministic and probabilistic sensitivity analyses were performed, as well as scenario analyses.
0.8
SOCIETAL PERSPECTIVE Emollient
SENSITIVITY ANALYSIS
POSTCORTICOID
Efficiency probability
Time without relapse (years)
100%
1-pf
SENSITIVITY ANALYSIS C
Effectiveness QALY
FLARE-UPS
MAINTENANCE
BASE CASE (NHS/PSS PERSPECTIVE) B
It is an evidence-based model constructed from the literature: randomized clinical trials and literature review for the efficacy of treatments, resource utilization and quality of life from real world data, unit prices from official prices lists.
mf
RESULTS A
DATA
1-mf
A Markov model with 3 health states: “Flare-up”, “Post-corticoid” and “Maintenance”
144.49 ¤
149,19 ¤
216.54€
224.53 €
246.97 €
256.50 €
265.80 €
2 404.18€
2 437.38 €
7 090.32 €
3 724.42 ¤
3 224.05 ¤
The societal perspective considers the out-of-pocket of the patients but also the productivity losses for society (absenteeism and presenteeism). With the support of productivity losses and the out-of-pocket costs, the strategy A becomes the cheapest strategy (£2,112.90). The strategy with B costs £2,141.57. The difference between these two strategies is now £28.67 in favor of A. In terms of efficacy, A is the only strategy on the efficiency frontier and dominates all other strategies because they are more expensive and less effective.
No moisturizer
£8 000 Threshold Dexeryl
£10 000 Atopiclair
Emollient B Emollient C
£12 000
£14 000
Eucerin Emollient D
With probabilistic analysis, A remains mostly more effective and a little more expensive than B. A is the most efficient strategy starting from a willingness to pay of £500. It maximizes the net monetary benefit. Itreaches an efficiency probability of 80% for a willingness to pay off £8000
DISCUSSION • Emollients are treatments with preventive effects on effective relapses compared to no emollient. • Emollient A makes it possible to improve as much as possible this period of remission by 0.6 years (about 183 days without flare-ups) compared to no emollient. • The different perspectives and in particular the societal perspective, which takes into account productivity losses and out-of-pocket expenditures, emollient A becomes the cheapest strategy.
REFERENCES 1. Seite S, Moyal D. Observational Study on Patients with Atopic Dermatitis. Skin J Cutan Med: 2017: 1(3.1):42. doi:10.25251/skin.1.supp.41 2. Tiplica GS, Boralevi F, Konno P, et al. The regular use of an emollient improves symptoms of atopic dermatitis in children: a randomized controlled study. J Eur Acad Dermatol Venereol JEADV: 2018; 32(7):1180-1187. doi:10.1111/jdv.14849 3. Van Zuuren EJ, Fedorowicz Z, Christensen R, Lavrijsen AP, Arents BW. Emollients and moisturisers for eczema. Cochrane Skin Group, ed. Cochrane Database Syst Rev. February 2017. doi:10.1002/14651858.CD012119.pub2 4. Launois R, Ezzedine K, Cabout E, et al. Importance of out-of-pocket costs for adult patients with atopic dermatitis in France. Journal of the European Academy of Dermatology and Venereology. 0(0). doi:10.1111/jdv.15581 5. Sanders GD, Neumann PJ, Basu A, et al. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016;316(10):1093. doi:10.1001/jama.2016.12195 6. Office for National Statistics. Inflation and price indices - Office for National Statistics. https://www.ons.gov.uk/economy/inflationandpriceindices. Published 2019. Accessed March 12, 2019. 7. Fenwick E. Economic Evaluation,. In: Encyclopedia of Health Economics. Elsevier; 2014:224-231. doi:10.1016/B978-0-12-375678-7.01419-X
guidance.2 Additionally, the study adds to knowledge by assessing cost effectiveness of emollients, which can help the nurse in a patient advocate role by helping the patient to identify the right emollient to suit their needs in the long-term management of atopic dermatitis. DN
4. Seite S, Zelenkova H, Martin R. Clinical efficacy of emollients in atopic dermatitis patients – relationship with the skin microbiota modification. Clinical, Cosmetic and Investigational Dermatology 2017. 10(4):25-33 5. Komorowski M, Raffa J. Markov Models and Cost Effectiveness Analysis: Applications in Medical Research. In: Secondary Analysis of Electronic Health Records 2016. Springer, Cham.
References
6. NICE. Glossary QALYS definition 2021. Available at: https://www.nice.org.uk/ glossary?letter=q [last accessed September 2021]
1. Cabout E, Eymere S, Launois R et al. Cost effectiveness of emollients in prevention of relapses in atopic eczema. Clinical, Cosmetic and Investigational Dermatology 2020. 13:987-996
7. NICE. Dupilumab for treating moderate to severe eczema 2018. Available at: https://www. nice.org.uk/guidance/ta534. [last accessed September 2021]
2. NICE. Atopic eczema in children under 12 years 2021. Available at: http://www.nice.org.uk/CG57 [last accessed September 2021]
8. Norrlid H, Hjalte F, Lundqvist A et al. Cost effectiveness of maintenance treatment with a barrier strength moisturising cream in patients with atopic dermatitis in Finland, Norway and Sweden. Acta Derm Venerol 2016. 96(2):173-176
3. Consort. The Consort Statement. 2020. Available at: http://www.consort-statement.org [last accessed September 2021]
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Dermatological Nursing, 2021, Vol 20, No 3
9. Chalmers J, Haines RH, Bradshaw LE et al, Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. 2020. Lancet 395(10228):962-972 10. Tang MB, Leong KF, Ou LS, et al. Costeffectiveness study of pediatric AD in Asia: atopiclair vs. regular emollient (AD-ATOP). Journal of Drugs in Dermatology: JDD 2015. 14(2):169-175 11. Ridd MJ, Garfield K, Gaunt DM et al. Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care. BMJ Open 2016. 6 e012021 12. University of Bristol. Best emoillients for Eczema (BEE) Available at: http://www.bristol. ac.uk/primaryhealthcare/researchthemes/beestudy/ [last accessed September 2021]
www.bdng.org.uk
APPLIED
SCIENCE
2
4
UR HO
TRIPLE
QV Cream contains three types of moisturisers to help soothe and replenish dry and sensitive skin providing 24-hour moisturisation. Suitable for use with eczema, psoriasis, dermatitis and a range of dry skin conditions. QV Cream - seals in natural moisture - free from fragrance, colour and other irritants - added benefit of glycerin for skin hydration
Recommend QV, and let your dry-skin patients enjoy a welcome demonstration of applied science. www.qvskincare.co.uk Further information and samples are available from QVSkincareUK @QVSkincare_UK @qvskincareuk qvskincare.uk@egopharm.com QVSkincareUK
@QVSkincare_UK
@qvskincareuk
PUTTING SCIENCE INTO SKINCARE
N
O
As a healthcare professional, every clinical decision you make has a
MOISTURISING FORMULA TI H Y DRA
LICENSED FOR PSORIATIC ARTHRITIS (PsA) AND PSORIASIS (PsO)1
LIFE IS
demonstrated sustained relief in psoriatic arthritis* out to 1 year and psoriasis† out to 5 years2-4
Tremfya® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.1
*Sustained improvements in psoriatic arthritis disease severity (as measured by ACR scores, HAQ-DI scores and resolution of enthesitis and dactylitis). †Sustained improvements in psoriasis disease severity (as measured by PASI 90 scores) Adverse events can be found in the prescribing information below. Please refer to the Tremfya® Summary of Product Characteristics for the full safety information before prescribing.1
Tremfya® is indicated in the treatment of active psoriatic arthritis in adult patients, alone or in combination with methotrexate, who have had an inadequate response or have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.1 ACR20 improvements in the DISCOVER clinical trials: DISCOVER-2: At Week 24: Full analysis set: 64% for Tremfya® q8w (n=248) vs 33% for placebo (n=246; p<0.0001). At Week 52: NRI population. 74.6% for Tremfya® q8w (n=248). DISCOVER-1: At Week 24: Full analysis set: 52% for Tremfya® q8w (n=127) vs 22% for placebo (n=126; p<0.0001). At Week 52: NRI population. 59.8% for Tremfya®q8w (n=127).3-6 PASI 90 response at Week 252 in the VOYAGE 1 clinical trial (NRI through Week 48, TFR beyond): 84.1% for Tremfya® SC q8w (n=391).2
References: 1. Janssen-Cilag Ltd. Tremfya® Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/search?q=guselkumab. Accessed July 2021. 2. Griffiths C, et al. Maintenance of Response Through 5 Years of Continuous Guselkumab Treatment: Results From the Phase 3 VOYAGE 1 Trial. Presented at the 16th Annual Coastal Dermatology Symposium. October 15-16, 2020 New Jersey, USA. 3. McInnes IB, et al. Arthritis Rheumatol 2021;73(4):604-616. 4. Ritchlin C, et al. Guselkumab, an IL-23 Inhibitor That Specifically Binds to the IL23p19-Subunit, for Active Psoriatic Arthritis: One Year Results of a Phase 3, Randomized, Double-blind, Placebo controlled Study of Patients who Were Biologic-Naïve or TNFa Inhibitor- Experienced. Presented at EULAR 2020. 5. Mease PJ, et al. Lancet 2020;395:1126-1136. 6. Deodhar A, et al. Lancet. 2020;395:1115-1125. DISCOVER-1 was a multicentre, double-blind, randomised, placebo-controlled, Phase 3 trial enrolling adults with active PsA. About 30% of study participants could have previously received one or two TNF inhibitors.5 DISCOVER-2 was a multicentre, double-blind, randomised, placebo-controlled, Phase 3 trial in bio-naïve patients with active PsA.6 VOYAGE 1 was a multicentre, double-blind, randomised, placebo- and active comparator-controlled study in patients with moderate-to-severe plaque psoriasis.2 PsO, psoriasis; PsA, psoriatic arthritis; HAQ-DI, Health Assessment Questionnaire Disability Index; TNF, tumour necrosis factor; TFR, treatment failure rules; PASI, Psoriasis Area Severity Index; NRI, non-responder imputation; SC, subcutaneous; ACR20, 20% improvement in the American College of Rheumatology Score.
Tremfya▼100 mg solution for injection in pre-filled pen PRESCRIBING INFORMATION ACTIVE INGREDIENT(S): Guselkumab Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Treatment of active psoriatic arthritis in adult patients, alone or in combination with methotrexate, who have had an inadequate response or have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. DOSAGE & ADMINISTRATION: For use under guidance/supervision of physician experienced in diagnosis and treatment of conditions for which Tremfya is indicated. Subcutaneous injection. Avoid areas showing psoriasis. Adults: For both indications,100 mg at weeks 0 and 4, followed by maintenance dose every 8 weeks. In the case of psoriatic arthritis, for patients at high risk for joint damage according to clinical judgement, consider a dose of 100 mg every 4 weeks. Consider discontinuation if no response after 16 weeks of treatment for plaque psoriasis and after 24 weeks for psoriatic arthritis. Children: No data available in children/adolescents <18 years. Elderly: No dose adjustment required, limited information in subjects aged ≥ 65 years, very limited information > 75 years. Renal & Hepatic impairment: Not studied. CONTRAINDICATIONS: Serious hypersensitivity to active substance or excipients; clinically important, active infection. Refer to SmPC for full list of excipients. SPECIAL WARNINGS & PRECAUTIONS: Infections: Potential to increase risk. If signs/symptoms of clinically important chronic/ acute infection occur, monitor closely and discontinue Tremfya until resolved. Tuberculosis: Evaluate patients for TB pre-treatment; monitor for signs/symptoms of active TB during and after treatment. Consider anti-TB
Job code: CP-247667
Date of preparation: July 2021
therapy prior to Tremfya if past history of latent/active TB and adequate treatment course not confirmed. Serious hypersensitivity reaction: Includes anaphylaxis. Some serious hypersensitivity reactions occurred several days after treatment and included urticaria and dyspnoea. If occurs, discontinue Tremfya immediately and initiate appropriate therapy. Hepatic Transaminase Elevations: An increased incidence of liver enzyme elevations has been observed in patients treated with Tremfya q4w compared to patients treated with Tremfya q8w or placebo. When prescribing Tremfya q4w in psoriatic arthritis, consider evaluating liver enzymes at baseline and thereafter according to routine patient management. If increases in ALT or AST are observed and drug-induced liver injury is suspected, Tremfya should be temporarily interrupted until this diagnosis is excluded. Immunisations: Consider completing all appropriate immunisations prior to Tremfya. Do not use live vaccines concurrently with Tremfya; no data available; before live vaccination, withhold Tremfya for at least 12 weeks and resume at least 2 weeks after vaccination. SIDE EFFECTS: Very common: Respiratory tract infection. Common: headache, diarrhoea, arthralgia, injection site reactions, transaminases increased. Other side effects: hypersensitivity, anaphylaxis, rash, gastroenteritis, herpes simplex infections, tinea infections, neutrophil count decreased, urticaria. Refer to SmPC for more detail on side effects. PREGNANCY: Avoid use of Tremfya; no data. Women of childbearing potential should use effective contraception during and for at least 12 weeks after treatment. LACTATION: It is unknown whether guselkumab is excreted in human milk. A decision should be made to discontinue, or abstain from initiating treatment with Tremfya taking into account the benefit of breast-feeding to the child and the benefit of Tremfya therapy to the woman. INTERACTIONS: No dose adjustment when
co-administering with CYP450 substrates. Concomitant immunosuppressive therapy or phototherapy not evaluated. Refer to SmPC for full details of interactions. LEGAL CATEGORY: Prescription Only Medicine (POM) PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS PRESENTATIONS
PACK SIZES
MARKETING AUTHORISATION NUMBER(S)
BASIC NHS COSTS
Pre-filled pen (100mg)
X1
NI: EU/1/17/1234/002 GB: PLGB 00242/0665
£2250
MARKETING AUTHORISATION HOLDER: Northern Ireland: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. Great Britain: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.Prescribing information last revised: June 2021 Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com. © Janssen-Cilag Limited 2021
Case HISTORY
Atopic dermatitis, dupilumab, and ocular effects: An interesting patient Elaine Brown
This short case study looks at the history of a young woman with eczema who had been referred to dermatology services via an ophthalmology acute referral clinic due to a history of epiphora and uncomfortable red eyes. Brown E. Atopic dermatitis, dupilumab, and ocular effects: An interesting patient. Dermatological Nursing 2021. 20(3):43-44
A young lady was seen recently in the ophthalmology acute referral clinic. She had been referred by her optometrist approximately six months previously with a history of epiphora (excessive watering) and uncomfortable red eyes and had been seen on several occasions over the previous five months at the nurse practitioner clinics. She had been treated symptomatically with ophthalmic lubricants and antibiotics, and while these treatments provided initial relief, her condition would generally relapse. At the most recent visit, she was very frustrated with the recurring ophthalmological symptoms and was upset and tearful. The optometrist referral and the nurse practitioner clinic notes focused on her ophthalmic history and symptoms; therefore, we went through her lifestyle and medical history to identify anything that could potentially be contributing to her eye condition. Elaine Brown is a Staff Nurse at Princess Alexandra Eye Pavilion, Edinburgh www.bdng.org.uk
I could see from the condition of her skin that she probably had eczema, which she confirmed and told me that she started treatment with dupilumab in early April 2020. The lady had been a contact lens wearer but had chosen to stop doing so around the time of commencing dupilumab (Dupixent®). I was unfamiliar with the drug but identified from the British National Formulary (BNF) that ophthalmic sideeffects are common or very common1 and we discussed this. The patient indicated that she had read the summary of product characteristics (SPC),2 had noted this herself, and was now considering stopping treatment with dupilumab. She was advised only to do so in discussion with her dermatology team.
Understanding dupilumab Dupilumab is a biologic medicine, administered subcutaneously, that modulates inflammation mediated by the cytokines interleukin-4 and interleukin-13.2,3 It is licensed for the treatment of moderate-to-severe eczema/atopic dermatitis (AD) in adults who have not improved with at least one other immunological medication, or when other medications are contraindicated,2 and is accepted for specialist use by both The National Institute for Health and Care Excellence (NICE)4 and the Scottish Medicines
Consortium (SMC). 5 Dupilumab is currently the only biologic medicine licensed to treat atopic eczema.3
Dupilumab is associated with several ophthalmic adverse effects Dupilumab is associated with several ophthalmic adverse effects including conjunctivitis; blepharitis (swollen, puffy eyelids); eye pruritus; and Herpes Simplex Virus (HSV) infection, which are common and reported to affect >10% of patients. Keratitis (inflammation of the cornea) and ulcerative keratitis have also been reported and may affect <1% of patients.2 Real-world experience suggests that these rates may be higher. A retrospective analysis of consecutive AD patients treated with dupilumab found that half (14/28) developed ocular adverse effects, with a mean onset of seven weeks after starting treatment. Nine patients developed conjunctivitis in whom there was cicatrisation in two and periorbital skin changes in four. Of the nine patients, four had a history of atopic keratoconjunctivitis. Six patients required ongoing maintenance therapy to manage their ocular symptoms and one patient discontinued dupilumab because of ocular side effects.3
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Case HISTORY Eczema and eyes However, it’s worth considering that atopic dermatitis/eczema are also associated with ophthalmic problems. For example, the eyelids can be affected and may appear red and inflamed and change in colour. Inflammation of the eyelids in some cases leads to the eyelid and its lining becoming inflamed, pruritic and with a warm burning sensation which results in epiphora and mucus-like discharge. The eyebrows and lashes can often become sparse due to continuous rubbing. In some cases, continuous rubbing of the itchy eye can eventually lead to changes in the cornea (keratitis and keratoconus),6-9 although the exact relationship between AD and the development of keratoconus is still unclear.6 A large Danish study involving more than 10,000 patients with AD found that 12% were prescribed antiinflammatory ophthalmic preparations.7
In some cases, continuous rubbing of the itchy eye can eventually lead to changes in the cornea They also reported increased risks for conjunctivitis, keratitis, and keratoconus, and that the magnitude of increased risk appeared to be associated with the severity of AD. The mechanism of dupilumabassociated conjunctivitis is not fully understood, but shares several features with atopic blepharoconjunctivitis and allergic eye disease with decreased goblet cells, eosinophilia, and increased Demodex infestation due to changes in the ocular surface environment.3,7-9 It may also be that AD patients considered for dupliumab treatment have a higher incidence of undiagnosed ocular surface inflammation, 5 and Maudinet et al found that 64% of patients had undiagnosed blepharoconjunctivitis on examination prior to starting dupilumab treatment.8 Such findings may help to explain why ocular side effects appear to be rare when dupilumab is used for asthma, its other licensed indication, with only 44
keratitis being listed in the SPC2 and said to affect <0.1% of patients. Ocular adverse effects are reported commonly with dupilumab when prescribed for persons with AD and these are generally reported within the first month or two of treatment. This lady presented to ophthalmology approximately six months after starting treatment, so while her symptoms were consistent with the adverse effects reported for dupliumab, they could also have been related to her AD, which can also cause similar ocular symptoms. She was prescribed ophthalmic lubricants and advised to continue these in the longer term. She was also advised on lid and lash hygiene. Ongoing care was transferred to a unit closer to her home and so it is not possible to report on the final outcome with regard to her eye health or ongoing treatment with dupilumab. As was the case with our patient, it is likely that ophthalmology advice and assessment are only sought after patients have been started on dupilumab and ocular symptoms become problematic.3 However, and particularly for those with a positive history or possible symptoms of blepharoconjunctivitis, it may be appropriate to seek ophthalmological advice prior to starting dupilumab therapy to ensure that ocular health is optimised.3,8
The effects experienced by this lady were consistent with the adverse effects reported for dupilumab when used for AD Summary The effects experienced by this lady were consistent with the adverse effects reported for dupilumab when used for AD, but the timing was delayed compared with other reports. AD can also cause similar symptoms, but it is not possible to say which was the main contributor in this case.
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Interestingly, ocular effects are much more limited when dupilumab is used in asthma, which in itself is not associated with ocular symptoms, and so it may be that dupilumab is potentiating or unmasking ocular involvement in AD. The epiphora was most likely a consequence of the irritation and inflammation caused by the blepharoconjunctivitis. The ocular side effects attributed to dupilumab are well recognised and, while distressing for the patient, were not clinically serious. A yellow card was therefore not submitted. DN
References 1. British National Formulary. Dupilumab [Monograph]. National Institute for Health Care Excellence. Available at: https://bnf.nice.org.uk/ drug/dupilumab.html [last accessed August 2021] 2. Dupixent® Summary of Product Characteristics. Electronic Medicines Compendium. 22 December 2020. Available at: https://www.medicines.org.uk/emc/product/10619/ smpc [last accessed August 2021] 3. Popiela MZ, Barbara R, Turnbull AMJ, et al. Dupilumab-associated ocular surface disease: presentation, management and long-term sequelae. Eye 2021. 4. Dupilumab for treating moderate to severe atopic dermatitis (TA534). National Institute for Health Care Excellence. 1 August 2018. Available at: https://www.nice.org.uk/guidance/TA534 [last accessed August 2021] 5. SMC2232 Dupilumab (Dupixent®) is accepted for restricted use in NHS Scotland. Glasgow, Scottish Medicines Consortium. 13 January 2020. Available at: https://www.scottishmedicines. org.uk/medicines-advice/dupilumab-dupixentabbreviated-smc2232/ [last accessed August 2021] 6. Leonardi A, Hall A. Mechanisms of corneal allergic reaction: new options for treatment, Expert Review of Ophthalmology 2010. 5:4 7. Thyssen JP, Toft PB, et al. Incidence, prevalence, and risk of selected ocular disease 8in adults with atopic dermatitis. J Am Acad D9ermatol 2017. 77:280-6 8. Maudinet A, Law-Koune S, Duretz C, Lasek A, Modiano P, Tran THC. Ocular surface diseases induced by dupilumab in severe atopic dermatitis. Ophthalmol Ther 2019. 8:485-90 9. Thyssen JP. Could conjunctivitis in patients with atopic dermatitis treated with dupilumab be caused by colonization with Demodex and increased interleukin‐17 levels? Br J Dermatol 2018. 178:1220. www.bdng.org.uk
A simple oral choice for your patients with less severe plaque psoriasis OTEZLA® (apremilast) 10mg, 20mg and 30mg film coated-tablets Prescribing Information Refer to the Summary of Product Characteristics (SPC) before prescribing Presentation: 10mg, 20mg and 30mg film coated-tablets. Indications: Psoriatic arthritis: Alone, or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to prior DMARD therapy. Psoriasis: Moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Dosage and administration: Treatment should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis. The recommended dose is 30mg twice daily taken orally in the AM and PM, approximately 12 hours apart, with no food restrictions. The tablets should be swallowed whole. An initial dose titration is required: Day 1: 10mg AM; Day 2: 10mg AM, 10 mg PM; Day 3: 10mg AM, 20mg PM; Day 4: 20mg AM, 20mg PM; Day 5: 20mg AM, 30mg PM; Day 6 and thereafter: 30mg twice daily AM and PM. No re-titration is required after initial titration. If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time. Patients with severe renal impairment: Reduce the dose to 30mg once daily in patients creatinine clearance of less than 30mL per minute. For initial dose titration in this group, titrate using only the AM doses. Paediatric population: Safety and efficacy in children up to 17 years have not been established. No data available. Contraindications: Hypersensitivity to the active substance(s) or to any of the excipients, pregnancy. Pregnancy should be excluded before treatment can be initiated. Special warnings and precautions: Diarrhoea, nausea and vomiting: Severe diarrhoea, nausea, and vomiting have been reported. Most events occurred within the first few weeks of treatment. Some patients were hospitalised. Patients 65 years of age or older may be at a higher risk of complications. Discontinuation of treatment may be necessary. Psychiatric disorders: Increased risk of psychiatric disorders such as insomnia and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed. Assess the risks and benefits of starting or continuing treatment if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Instruct patients and caregivers to notify the prescriber of changes in behaviour or mood and suicidal ideation. Discontinue treatment if patients have new or worsening psychiatric symptoms, suicidal ideation or suicidal attempt. Severe renal impairment: see dosage and administration. Underweight patients: May cause weight loss. Monitor body weight regularly in patients who are underweight at the start of treatment. Evaluate patients who have unexplained and clinically significant weight loss, and consider discontinuing treatment. Lactose content: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Interactions: Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of Otezla, which may result in a loss of efficacy. Concomitant use of strong CYP3A4 enzyme inducers e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, St. John’s Wort
is not recommended. In clinical studies, Otezla has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy. Can be co-administered with a potent CYP3A4 inhibitor such as ketoconazole, and methotrexate in psoriatic arthritis and with oral contraceptives. Pregnancy, lactation and fertility: Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment. Do not use during breast-feeding. No fertility data are available in humans. Undesirable effects: Psychiatric disorders: In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour were reported, while completed suicide was reported post-marketing. The most commonly reported adverse reactions are gastrointestinal (GI) disorders including diarrhoea (15.7%) and nausea (13.9%). GI adverse reactions generally occur within the first 2 weeks of treatment and usually resolve within 4 weeks. Adverse reactions reported in the psoriatic arthritis and/or psoriasis clinical trial programme and post marketing experience include: very common (≥ 1/10) diarrhoea*, nausea*; common (≥1/100 to <1/10) bronchitis, upper respiratory tract infection, nasopharyngitis*, decreased appetite*, insomnia, depression, migraine*, tension headache*, headache*, cough, vomiting*, dyspepsia, frequent bowel movements, upper abdominal pain*, gastroesophageal reflux disease, back pain*, fatigue; uncommon (≥1/1,000 to <1/100) hypersensitivity, suicidal ideation and behaviour, gastrointestinal haemorrhage, rash, urticaria, weight loss; not known (cannot be estimated from the available data) angioedema. *At least one was reported as serious. Please consult the SPC for a full description. Pharmaceutical Precautions: Do not store above 30°C. Legal category: POM. Basic Costs, Presentation and Marketing Authorisation Numbers Great Britain (GB): Initiation pack (4 x 10mg, 4 x 20mg, 19 x 30mg), 27= £265.18 – PLGB 13832/0047; 30mg tablet, 56= £550 PLGB 13832/0048. Marketing Authorisation Holder GB: Amgen Limited, 216 Cambridge Science Park, Milton Road, Cambridge, CB4 0WA, UK. Basic Costs, Presentation and Marketing Authorisation Numbers Northern Ireland (XI): Initiation pack (4 x 10mg, 4 x 20mg, 19 x 30mg), 27= £265.18 – EU/1/14/981/001; 30mg tablet, 56= £550 – EU/1/14/981/002. Marketing Authorisation Holder XI: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands. Further information is available from Amgen Limited, 216 Cambridge Science Park, Milton Road, Cambridge, CB4 0WA, UK. Otezla is a trademark owned or licensed by Amgen Inc., its subsidiaries, or affiliates. Date of preparation: May 2021 (Ref: GB-OTZ-0421-00016). Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse events should also be reported to Amgen Limited on +44 (0) 1223 436441 OTEZLA® is a trademark owned or licensed by Amgen Inc., its subsidiaries, or affiliates. Date of preparation: May 2021
GB-OTZ-0521-00006
This is a promotional advertisement from LEO Pharma for UK healthcare professionals.
NEW
For the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy1
TIME TO PRESS PLAY Introducing Adtralza®
Not an actual patient. For illustrative purposes only.
The first licensed biologic that inhibits IL-13 alone,1 a key driver of atopic dermatitis signs and symptoms.2
Learn more at www.adtralza.co.uk Prescribing Information for Adtralza® (tralokinumab) 150 mg solution for injection in pre-filled syringe Please refer to the full Summary of Product Characteristics (SmPC) (www.medicines.org.uk/emc) before prescribing. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Indications: Treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Active ingredients: Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution (150 mg/mL). Dosage and administration: Posology: The recommended dose of tralokinumab is an initial dose of 600 mg (four 150 mg injections) followed by 300 mg (two 150 mg injections) administered every other week as subcutaneous injection. Every fourth week dosing may be considered for patients who achieve clear or almost clear skin after 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve further with continued treatment every other week beyond 16 weeks. Tralokinumab can be used with or without topical corticosteroids. The use of topical corticosteroids, when appropriate, may provide an additional effect to the overall efficacy of tralokinumab. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. If a dose is missed, the dose should be administered as soon as possible and then dosing should be resumed at the regular scheduled time. No dose adjustment is recommended for elderly patients, patients with renal impairment or patients with hepatic impairment. For patients with high body weight (>100 kg), who achieve clear or almost clear skin after 16 weeks of treatment, reducing the dosage to every fourth week might not be appropriate. The safety and efficacy of tralokinumab in children below the age of 18 years have not yet been established. Method of administration: Subcutaneous use. The pre-filled syringe should be not shaken. After removing the pre-filled syringes from the refrigerator, they should be allowed to reach room temperature by waiting for 30 minutes before injecting. Tralokinumab is administered by subcutaneous injection into the thigh or abdomen, except the 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used. For the initial 600 mg dose, four 150 mg tralokinumab injections should be administered consecutively in different injection sites. It is recommended to rotate the injection site with each dose. Tralokinumab should not be injected
into skin that is tender, damaged or has bruises or scars. A patient may self inject tralokinumab or the patient’s caregiver may administer tralokinumab if their healthcare professional determines that this is appropriate. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions and warnings: If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of tralokinumab should be discontinued and appropriate therapy initiated. Patients treated with tralokinumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination. Patients with pre-existing helminth infections should be treated before initiating treatment with tralokinumab. If patients become infected while receiving tralokinumab and do not respond to antihelminth treatment, treatment with tralokinumab should be discontinued until infection resolves. Live and live attenuated vaccines should not be given concurrently with tralokinumab. Fertility, pregnancy and lactation: There is limited data from the use of tralokinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of tralokinumab during pregnancy. It is unknown whether tralokinumab is excreted in human milk or absorbed systemically after ingestion. Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology. Side effects: Very common (≥1/10): Upper respiratory tract infections. Common (≥1/100 to <1/10): conjunctivitis, conjunctivitis allergic, eosinophilia, injection site reaction. Uncommon (≥1/1,000 to <1/100): keratitis. Precautions for storage: Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light. Legal category: POM. Marketing authorisation number and holder: PLGB 05293/0182, EU/1/21/1554/002. LEO Pharma A/S, Ballerup, Denmark. Basic NHS price: 4 prefilled syringes: £1,070 (each syringe contains 150 mg/mL). Last revised: July 2021. Reference number: REF-19086(2) Reporting of Suspected Adverse Reactions Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Drug Safety at LEO Pharma by calling +44 (0)1844 347333 or e-mail: medical-info.uk@leo-pharma.com
IL, interleukin. References: 1. Adtralza® SPC. 2. Bieber T. Allergy 2020;75:54–62.
Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Horizon, Honey Lane, Hurley, Berkshire SL6 6RJ. E-mail: medical-info.uk@leo-pharma.com ® Registered trademark
Date of preparation: August 2021 UK/MAT-49295
Professional DEVELOPMENT
Reflections on revalidation Debra Brown In this short reflection, Debra Brown, a Clinical Nurse Specialist at Guys and St Thomas’ NHS Foundation Trust, looks back on her 46-year career in nursing and considers what has changed in that period and where the profession could go in the future. Brown D. Reflections on revalidation. Dermatological Nursing 2021. 20(3):47-48 The World Health Organization (WHO) designated 2020 as the International Year of the Nurse and Midwife.1 This will also be my 46th year as a Registered Nurse,2 and as such, an appropriate time for me to reflect on my career. I have chosen The Gibbs model of reflection3 because it would allow me to reflect in an organised and systematic way, something which might not have been possible – or at least somewhat shambolic – given that my career has lasted so long. I also agree with the Royal College of Nursing (RCN) that it is particularly suited to nursing reflection.4 Reflection has become embedded in the practice of nursing and is included in The Code5 that embodies the Nightingale Pledge,6 that I so remember reciting on graduation day on a warm afternoon in Bradenton, Florida, USA in 1974. Both the Pledge and The Code are also represented in all the values and behaviours of my Trust.7 I have been a Clinical Nurse Specialist in Medical Dermatology for the past 17 years and continue to work full-time. Prior to that, I was Sister and Practice Development Nurse in Post Anaesthesia Critical Care. Before coming to this country 33 years ago, I was a Critical Care Nurse in the United States, starting at staff nurse level and becoming the senior nurse in charge of the unit.
Debra Brown is a Clinical Nurse Specialist at Guy’s and St Thomas’ NHS Foundation Trust www.bdng.org.uk
I can remember, as a newly graduated nurse, that feeling of “I’m going to save all my patients and the world”. Still wet behind the ears but not knowing it, I had a rude awakening by the older and more experienced nurses, and to this day I don’t know how I survived. Looking back now it was considered a rite of passage for new nurses to walk barefoot over hot coals with little support or encouragement. Bullying new nurses was rife at that time (I can only speak of American nurses) and the dropout rate was high. This phenomenon has since come to be known as “nurses eating their young”, a phrase coined by Judith Meissner, a professor of nursing8 which described a Darwinian nursing version of survival of the fittest. It’s certainly not the best way to start a vocation that is based on care and compassion, but it did help to develop a resiliency in me that nurses must have to survive.
There is a dearth of initiatives aimed at retaining or improving the working situation of older nurses I was determined not to become one of those nurses and have based the rest of my career on those memories. The new nurse is idealistic and frightened, and needs support and mentorship to flourish without diminishing the ideals. I have discovered that in nursing,
knowledge is indeed power and as time has gone on, it has become obvious that one is never too old to learn. Confidence and competence is gained through experience and so is resilience. Benner goes on to eloquently describe the evolution of a nurse that can be related to experience9 and the title of her work, From Novice to Expert, so aptly describes the career stages I went through and what is so often the case – time usually equals experience. Time also allows for a certain maturity to develop, including a greater understanding of the human experience, a characteristic essential to nursing. I look back and see just how much nursing has changed over the years, mostly for the better. However, I still think that we haven’t got it quite right, although I’m not sure what is lacking. Maybe this feeling is just a symptom or indication of how this profession is continuously growing and evolving. My personal philosophy of learning to be a nurse, to paraphrase and juggle the words of Florence Nightingale, is that “nursing is impossible to solely learn from a book – it also has to be learned in the wards of a hospital”.10 Much has been written about the art and science of nursing as if one seems to exclude the other. The same used to be said for the educated nurse. Which brings me to the present days of my career. I still feel that nursing is a vocation. I strongly feel that Registered Nurses should be
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Professional DEVELOPMENT listened to and allowed to be nurses, and cannot understand why the nursing workforce as a whole should perpetually be redesigned without becoming innovative instead of going back to past structures.11 The main reason for this is long-term issues with the nursing workforce, including recruitment and retention.12 These issues have been around for years, highlighting the perpetual nursing shortage. The reasons for this are varied but mostly are due to economic, and thus, political policy. The Nursing and Midwifery Council (NMC) has calculated that 33% of nurses leaving the profession are aged 60 and above. This will result in a huge deficit of experienced nurses. As an “older” nurse, I have seen that not much, if anything, has been done to retain this group of nurses, with resources being directed towards newly qualified nurses and surprisingly, recruiting overseas nurses. Could this be a result of intentional or unintentional ageism? Many Trusts, including my own, have developed initiatives to enhance job satisfaction and wellbeing for staff, but many of these schemes seem to be aimed at specific groups such as LGBTQ, BME and even menopausal staff, but there is a dearth of initiatives aimed at retaining or improving the working situation of older nurses. Rota flexibility, respecting experience and involvement in contributing to service development should be examined as ways of enhancing the older nurse’s job satisfaction. Even pay structures seem to discriminate against experienced older nurses by penalising nurses who do not wish to become nursing managers and who are paid at a higher grade13 by finalising pay at the top level of each pay band. My opinion is that history indeed repeats itself and adding levels of job titles with the word ‘nursing’ in them does not enhance nursing care and will be no more successful in improving job satisfaction rates of registered nurses than previous restructuring efforts. To let nurses be nurses, the support should come from 48
outside the profession and truly assist nurses by providing real assistance in administrative tasks, technical support, and other non-clinical activities. Nurses have been saying these things throughout my entire career, both here and in the US.
I can remember, as a newly graduated nurse, that feeling of “I’m going to save all my patients and the world” I have welcomed this opportunity to reflect on my career as a nurse, and in particular my career as an older nurse – even though I’m not deserting the profession just yet! In doing so, I have recognised that while there has been an enormous culture shift, two major changes stand out. Firstly, there has been the recognition of nursing as a profession in and of itself, as opposed to being the doctor’s handmaiden. Secondly, nursing now requires a degree-level education, even at entry level. To date, these developments have happened hand-inhand, but I wonder if, in 15 years’ time, this might regress to something more akin to an apprenticeship-style training approach to to meet the demands of workforce requirements. I wonder if there will ever come a time when new nurses will be mentored and nurtured from the moment they set foot on a ward and the knowledge/ experience gap will be managed empathetically and professionally. It is also heartening to see that nursing remains a profession based on care and compassion, and nurses have found their voice in advocating for their patients and themselves, another testament to the profession. At the age of 71, I am aware that I may be closer to my sell-by date, but until I cannot function safely, I’m still in the game. I can honestly say that I couldn’t or wouldn’t have made this milestone in my career without the guidance, mentorship and educational opportunities afforded me by those ‘older’ nurses who came before me.
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References: 1. Year of the Nurse and Midwife. World Health Organization 2020. Available at: https://www.who. int/campaigns/annual-theme/year-of-the-nurse-andthe-midwife-2020 [last accessed May 2021] 2. Florida Nursing. Florida State Board of Nursing 1974. Available at [https://floridasnursing.gov/] 3. Gibbs G. Learning by Doing: A guide to teaching and learning methods. Oxford: Further Education Unit 1988 [last accessed May 2021] 4. Revalidation requirements: Reflection and reflective discussion. Royal College of Nursing 2013. Available at: https://www.rcn.org.uk/ professional-development/revalidation/reflectionand-reflective-discussion [last accessed May 2021] 5. The Code. Nursing and Midwifery Council. Available at: https://www.nmc.org.uk/standards/ code/ [last accessed May 2021] 6. Gretter L. Nightingale Pledge Ferrand Training School for Nurses. Detroit, Michigan. 1893 7. Values and Behaviours. Guy’s and St Thomas’ NHS Foundation Trust. Available at: https://www. guysandstthomas.nhs.uk/resources/careers/valuesand-behaviours-framework.pdf [last accessed May 2021] 8. Meissner JE. Nurses: are we eating our young? Nursing 1986. 16(3):51-3 9. Benner. P. From Novice to Expert. Addison-Wesley Publishing Company Inc.1984 10. Nightingale F. Notes on Nursing: what it is and what it is not. Dover Publications Inc. 1969. Originally published by D. Appleton and Company 1860 11. Standards of proficiency for nursing associates. Nursing and Midwifery Council. Available at: https://www.nmc.org.uk/standards/standards-fornursing-associates/standards-of-proficiency-fornursing-associates/ [last accessed May 2021]. 12. The Nursing Workforce. House of commons Health Committee 2018. Available at: https:// publications.parliament.uk/pa/cm201719/cmselect/ cmhealth/353/353.pdf [last accessed May 2021] 13. NHS Terms and Conditions (AfC) pay scales – Annual. NHS Employers 2020. Available at: https:// www.nhsemployers.org/pay-pensions-and-reward/ nhs-terms-and-conditions-of-service---agenda-forchange/pay-scales/annual [last accessed May 2021]
Test your knowledge answers The answers to the questions in the article A review and summary of the British Association of Dermatologists guidelines for its management in adults (2021) (page 23): 1. b 4. c 2. a 5. d 3. d www.bdng.org.uk
Kind to skin. Kind to budgets.
Introducing the newest addition to the EPIMAX® range EPIMAX® Moisturising Cream Similar formulation to E45 Cream1
Light relief for mild symptoms to soften, protect and moisturise dry skin. Everyday moisturisation Keeps dry skin at bay Skin feels soft
Recommend a range that gives your patients the choice they need:
✓ Save up to 61% vs. the best-known emollient brands1 ✓ Similar formulations to the best-known emollient brands ✓ Fully recyclable 500g tottles (top-down bottles)* ✓ Free from SLS, parabens and perfumes
® www.epimax.co.uk Economise without compromise Epimax Range Product Information Presentation: Creams and gels available in a 500g Flexi-dispenser or 100g tube, ointments available in a 500g or 125g tub (Epimax Ointment only). Main ingredients: White soft paraffin, light liquid paraffin, anhydrous lanolin, Avena sativa (oat) kernel flour; Isopropyl myristate , yellow soft paraffin, Polyoxyethylene, hydrogenated castor oil. Indications: All products: As an emollient for the relief of dry skin in eczema, psoriasis and other dry skin conditions. Creams: For use as a soap substitute Gels: For the relief of dry or chapped skin which may also be itchy or inflamed. Ointments: Bath additive or soap substitute. Method of use: Adults, Elderly and Children: apply to the skin areas as frequently as required. As a soap substitute: Use as required instead of soap. As a bath additive: melt 4g in hot water and add to the bath. Dosage: Use as required. Warnings: Do not smoke or go near naked flames
References:
– risk of severe burns. Fabric that has been in contact with these products burns more easily and is a serious fire hazard. Avoid contact with the eyes. Talk to your doctor or healthcare professional before use if the skin is broken, badly cracked, infected or bleeding. Contraindications: Patients with known hypersensitivity to any ingredient, including: Lanolin, Cetostearyl Alcohol, and Hydroxybenzoates, Phenoxyethanol, Isopropyl Palmitate and Benzyl Alcohol, Triethanolamine; Side effects: Rarely mild reactions such as skin rash can occur. Allergic reactions. Product classification: Class I Medical Devices. Cost: Epimax Moisturising Cream: £2.99 (500g), £1.99 (100g) [NHS Price List]; License holder: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Date reviewed: February 2021. Version number: 1010451581 v 6.0.
* Our 500g creams and gel formulations are packaged in tottles and our ointments in 500g tubs 1. https://www.mims.co.uk/ (accessed August 2021)
10104511264 v 1.0 August 2021
Professional DEVELOPMENT
Survey of dermatology nurses’ experience of redeployment Julia Wheeler, Holly Nagle, Hannah Lakin During the pandemic, many dermatology nurses have had to contend with redeployment. This article looks at the results of a BDNG survey sent out in March, as well as testimonials from two dermatology nurses who were redeployed. Wheeler J, Nagle H, Lakin H. Survey of dermatology nurses experience of redeployment. Dermatological Nursing 2021. 20(3):50-52
As the country continues its recovery, it may seem a bit dismal to be reflecting on our professional experiences over the past year. However, with the threat of new variants and the rise of infection in some areas of the UK, it is important that we recall these struggles to prepare our minds for future disruptions to dermatology services which may arise over the coming months.
Despite overwhelming emotions of fear and outrage, dermatology nurses have continued to provide patient care in challenging circumstances and unfamiliar clinical settings
Julia Wheeler is a Dermatology Outreach Nurse, Buckinghamshire NHS Trust, Educational Development Nurse for the BDNG, and a member of the BDNG Editorial Board. Holly Nagle, Healthcare Assistant. Hannah Lakin is a Skin Cancer Specialist Nurse.
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So, what have dermatology nurses been up to throughout the pandemic and how have they been impacted professionally? You may recall that in March we sent out a survey to our members to gather their insights on professional encounters over the last 12 months. Approximately 5% of members responded to the survey to share their experiences with us. Three-quarters of respondents reported that they had been redeployed at some point during the COVID-19 pandemic. The locations they were sent to were wide-ranging, from vaccination hubs to ITU. Of those nurses who were redeployed, the vast majority were sent to work for their total working hours. A small number were able to continue their support in dermatology services for part of their working week. The duration of redeployment ranged from a few weeks to six months, with many nurses reporting that it had been cut short due to ill-health caused by either psychological distress or COVID infection. Many nurses reported being redeployed in both the first and second waves of the pandemic and cited a feeling of injustice for being selected on both occasions. Threats of disciplinary action were made to some nurses who protested about the decision. Some nurses reported feelings of isolation in their new environment, receiving hostility and expressions of
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frustration from new colleagues who failed to acknowledge their background and usual scope of professional practice. Condescending remarks conveyed the perception that all nurses should be familiar with completing medicine rounds and have the confidence to handle technical equipment. Fear of being held to account for failures and omissions was reported. Understandably, some nurses felt unwelcome and disillusioned, so much so that they had considered leaving the nursing profession altogether. Although training was provided, it felt slow in coming and difficult to access under the pressure of the clinical load. It often involved teaching on ventilators and high flow oxygen therapy, when perhaps the completion of unfamiliar paperwork and blood glucose monitoring may have been a more relevant introduction. Maths tests and IV drug administration assessments were accessed by some with signoffs for competency hastily achieved in pressured and constrained clinical environments.
Observing the negative experiences of redeployed colleagues caused pain and feelings of guilt to some nurses who were left to manage dermatology patients www.bdng.org.uk
Professional DEVELOPMENT Holly’s story
Hannah’s story Hannah, aged 28, is a skin Cancer CNS with no previous ward experience. She felt terrified by the prospect of redeployment to ICU in a London hospital. She explains how she accepted the challenge.
Holly, a young healthcare assistant fresh into dermatology, gave us an insight into her personal experiences of redeployment. In January, I was told that of the 20 nurses in the department, I would be one of six members of staff to be redeployed. This scared me as I had no previous experience or training to care for in-patients. I was also frightened of the impact on my family, particularly my vulnerable grandparents who required care and support. After speaking to the senior nurse in charge of redeployment, I was sent to a neuro-rehabilitation ward caring for patients with brain injury. Thankfully, two of my colleagues accompanied me, and this increased my confidence and ability to adapt to the long 12-hour shifts. One of my concerns was around the use of PPE and the fear of not being able to use FFP3 face masks when caring directly for COVID positive patients. Although this was in line with infection control policy, I felt uneasy wearing only a surgical mask whilst providing close-up personal care.
One of my concerns was around the use of PPE and the fear of not being able to use FFP3 face masks when caring directly for COVID positive patients During my six-week placement, I endured many nights of disrupted sleep. Exhaustion took its toll on my resilience and I felt increasingly anxious. Physically, I suffered with constant headaches and I developed pruritus all over my body. I sought help from the wellbeing team, but eventually accessed further support from my GP. Despite feeling unwell, I was absent for only one day of work; I’ve always been terrible at taking sick days! I found that I relied quite heavily on the support of my colleagues back in dermatology, and I regularly caught up with them for a chat and advice. Hearing about the increased pressures they were facing made me feel desperate to get back to my normal role. I felt sad to be separated from the team and frustrated at not being able to support the increasingly urgent needs of patients; many of whom I had come to know. Despite my difficult experience of redeployment, I was able to learn a lot from it. It gave me an introduction into ward-based care and an insight into the complex communication needs of patients rehabilitating from stroke. I feel I have demonstrated an ability to adapt to service demands which has rounded me as a person. I am excited to start my nurse training but very much hope that the uncertainty of redeployment will not be repeated anytime soon. www.bdng.org.uk
I was not redeployed during the first wave. Our team of five was down to three before COVID was a household word, so we couldn’t spare nurses from our team. This left me with a lingering feeling of guilt, and even shame, that I hadn’t done “more”. As I now look back, having been on both sides of the coin – the redeployed and the left behind – I can say with certainty that neither option was an easy ride. I would like to preface my reflections by saying that I have the utmost respect and admiration for the nurses and healthcare staff who stayed behind and held the NHS together whilst it was on its knees. The day I was told I would be redeployed will stay with me forever. It was New Year’s Eve, and we were approached by our Matron to ask if there were any volunteers. I jumped at the opportunity, having wanted to rid myself of this aforementioned guilt for some time. This eagerness was naïve, as I had not prepared myself for the reality of my offer. “Excellent, you’re going on Monday”. I remember having to compose myself in the bathroom, sweating and shaking. What had I done? How on earth was I going to do this? Horror stories from the previously redeployed and scary media coverage of ICUs were spiralling on repeat in my head. I called my parents, trying to put on a brave face but they know me too well. I remember sombrely walking home that day and feeling what I can only describe as the closest feeling of being sent to war as I hope I will ever have to experience. Living alone during lockdown, with the New Year’s countdown on the TV, I put my head in my hands and cried.
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Professional DEVELOPMENT Hannah’s story - continued My first day on ICU was equally terrifying. I remember being bundled in the break room of ICU, many other terrified faces around me. A register was called, and that was it. PPE on, in you go. “Have you had your training?” said one of the senior ICU staff, trying to implement some level of organisation. A significant number of us – myself included – had not. “Oh…OK. You’ll have it soon. Here, you’ll be looking after bed 11 and 12 with Tim”. Tim (not his real name) was bank staff with ICU experience. I thank my lucky stars for Tim. He was patient, kind, good humoured, and didn’t shout at me when I couldn’t remember Living alone during lockdown, how to set up an NG feed. He did, however, warn me – “You need with the New Year’s to learn fast because people don’t countdown on the TV, I put my have the time to teach you”. That head in my hands and cried warning stuck with me, and I don’t think I have ever learned faster in my life. Had it not been for Tim giving me the time and space to build my confidence, I don’t think my time in ICU would have been as bearable as it was. There were two things that really surprised me during my time on ICU. Firstly, how quickly I managed to pick things up. After a week I was getting by OK, which was fortunate as most of the training was on the job. Secondly, the overwhelming kindness and compassion of the ICU staff – not only to the surge nurses, but to the patients and each other. So far out of my comfort zone, I have never felt more at home. From the daily deep chats in the break room, to the patience and support on the floor. I shudder to repeat the overused tagline, but we really were all in this together. The suffering and pain witnessed on ICU is not something a person can shake off easily. It is something I find myself thinking about all the time. With no visitors allowed, family and friends would communicate with their loved ones through an iPad, facilitated by us. I heard too many goodbyes. Too many lives breaking. People who will never be the same. Remembering it is difficult but feeling sad is guilt-inducing. It is not my pain to claim. My loved ones are well. You got to know these voices and faces so well, hearing them daily. You would only pray that you would never meet them face-to-face. Visitors were only allowed under one circumstance and meeting them meant only one thing; their loved one was dying. It was hard to stay sane in this limbo world we were living in. For days on end, I wouldn’t see daylight. Working endless night shifts on a background of dark mornings and dark evenings, the feeling of jetlag and nausea lingered for weeks on end. I will always carry with me my experience of redeployment as something enormously powerful and important. Although I hope we will never have to experience it again, I would sign up in a heartbeat.
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To add to these pressures, there was an expectation that some nurses would comply, resulting in both physical and mental exhaustion. Observing the negative experiences of redeployed colleagues caused pain and feelings of guilt to some nurses who were left to manage dermatology patients. Increased communication was supportive to both parties, and teams were strengthened despite the physical disconnection of staff. For some, however, the experience of redeployment was more positive. It was described by practitioners as a great opportunity to refresh clinical skills and temporarily return to ward-based practice. Others took the opportunity to share their dermatological expertise and support patients and colleagues with their skin concerns. New networks and friendships were established. Despite the fragmentation of teams, support networks increased, and remote group chats were identified to be beneficial.
Conclusion From the results of our survey and the perspectives of Holly and Hannah, we see that the last 18 months have brought both professional and personal challenges which have stretched us beyond our previous limits. Despite overwhelming emotions of fear and outrage, dermatology nurses have continued to provide patient care in challenging circumstances and unfamiliar clinical settings. Despite the fragmentation of teams, and the collective experience of stress, camaraderie and team spirit have sustained many of us. Small acts of kindness and words of support have held increased significance. We must continue to acknowledge the emotional burden faced by our colleagues and learn to prioritise our personal health and wellbeing. Let’s ensure these valuable experiences are used to overcome inevitable challenges in the future; the first of which is the reduction of unacceptable waiting lists and the limitation of the suffering endured by so many dermatology patients. DN www.bdng.org.uk
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*AEs of special interest also included malignancies, non-melanoma skin cancer, injection site reactions and drug-related hypersensitivity reactions.1 †When assessed at Week 28, compared with other targeted treatments that are usually assessed between 12 weeks and 16 weeks (such as brodalumab, guselkumab, ixekizumab, infliximab and secukinumab).4 References: 1. Thaçi D, et al. Br J Dermatol 2021. DOI: 10.1111/bjd.19866. 2. Reich K, et al. Lancet 2017;15:276–288. 3. ILUMETRI® Summary of Product Characteristics. Almirall. 4. NICE. Tildrakizumab for treating moderate to severe plaque psoriasis. Available at: https://www.nice.org.uk/guidance/ta575. 5. ILUMETRI® MIMS. Available at: https://www.mims. co.uk/drugs/skin/psoriasis-seborrhoea-ichthyosis/ilumetri.
Prescribing Information Please consult the Summary of Product Characteristics (SmPC) before prescribing. ILUMETRI® 100 mg solution for injection in pre-filled syringe. Active Ingredient: Each pre-filled syringe contains 100 mg of tildrakizumab in 1 ml. Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Indication: ILUMETRI is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Dosage and Administration: The recommended dose of ILUMETRI is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter. In patients with certain characteristics (e.g. high disease burden, body weight ≥ 90 kg) 200 mg may provide greater efficacy. Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks. Injection sites should be alternated. Elderly: No dose adjustment is required. Paediatric population: No data available. Renal or hepatic Impairment: No dosage recommendations can be made. Consult SmPC and package leaflet for full method of administration. Contraindications, Precautions and Warnings: Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1. Clinically important active infection, e.g. active tuberculosis. Precautions: In order to improve traceability always record the batch number of the administered product. ILUMETRI may have the potential to increase the risk of infections. If a patient develops a serious infection, the patient should be closely monitored and treatment with ILUMETRI should not be administered until the infection resolves. Exercise caution in patients with a chronic infection or a history of recurrent or recent serious infection. Instruct patients to seek medical advice if signs or symptoms of an infection occur. Patients should be evaluated for tuberculosis (TB) prior to initiation of treatment and monitored for signs and symptoms of active TB during and after treatment. In patients with a past history of latent or active TB, consideration for anti-TB therapy should be given. Discontinue use if a serious hypersensitivity occurs. All appropriate immunisations should be completed prior to start of treatment with ILUMETRI. Patients treated with ILUMETRI should not receive live vaccine during treatment and for at least 17 weeks after treatment. Consult SmPC and package leaflet for more information. Fertility, pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during treatment and for 17 weeks after treatment. As a precautionary measure, it
is preferable to avoid the use of ILUMETRI during pregnancy. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ILUMETRI therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. The effect of ILUMETRI on human fertility has not been evaluated. Consult SmPC and package leaflet for more information. Adverse Reactions: Very common (≥1/10):Upper respiratory tract infections, including nasopharyngitis. Common (≥1/100 to <1/10): Headache, gastroenteritis, nausea, diarrhoea, injection site pain, back pain. Consult SmPC and package leaflet for further information. Legal Category: Ireland: Subject to prescription which may not be renewed (A). United Kingdom: POM Price: United Kingdom: UK NHS Cost: (excluding VAT). 1 x 100 mg solution in a pre-filled syringe - £3,241 2 x 100 mg solution in a pre-filled syringe - £3,241 Marketing Authorisation Number(s): EU/1/18/1323/001 EU/1/18/1323/002 Further information available from: Almirall Limited, Harman House, 1 George Street, Uxbridge, Middlesex, UB8 1QQ, UK. Date of Revision: 05/2020. Item code: IE-ILU-2000011
UK-Adverse events should be reported. Reporting forms and information can be found at MHRA https://yellowcard.mhra.gov.uk Adverse events should be also reported to Almirall Ltd. Tel. 0800 0087 399 IE-Adverse events should be reported. Reporting forms and information can be found at HPRA Website: www.hpra.ie, email: medsafety@hpra.ie Adverse events should be also reported to Almirall Ltd. Tel. +353 (0) 1431 9836
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Is tranexamic acid effective for melasma? Melasma can be defined as an acquired pigmentary condition that occurs most commonly on the face and which affects around 1% of the general population,1 although it is more common in women and those with Fitzpatrick skin types III – V.2 However, estimates of the prevalence vary considerably, for example, in one US study of a private dermatology practice, 8.2% of Latino patients had melasma.3 In contrast, in a study of Arab Americans, melasma was present in 14.5% of women.4 The term melasma is derived from the Greek ‘melas’ meaning black, and clinically, the condition presents with hypermelanosis as brown-coloured, irregular macules, usually on sun-exposed areas. 5 The precise cause of melasma remains uncertain, though multiple factors have been implicated including genetics, solar radiation, hormonal effects and drugs.6 There appears to be a strong genetic influence for melasma as revealed in one survey of 324 women, where 48% reported a family history of the condition, with 97% stating that this was in a first-degree relative.7 The effect of solar radiation on melasma has been extensively studied, especially since UV radiation is the main stimulus for melanin production or melanogenesis, and patients often report a worsening of their condition during the warmer months. Nevertheless, there is still some uncertainty over precisely www.bdng.org.uk
how UV radiation interacts with melanocytes, keratinocytes and even fibroblasts, to cause melasma.8 The influence of female hormones is another important aetiologic factor with between 14.5-56% of pregnant women and 11.3-46% of women prescribed an oral contraceptive reporting the condition.9 Finally, there are several drugs known to induce hyperpigmentation including nonsteroidal anti-inflammatory agents, anti-hypertensives and anti-malarials.9
Treatment of melasma Although melasma is incurable and follows a relapsing, remitting pattern, a recent review concluded that triple topical treatment with hydroxyquinone, tretinoin and corticosteroids, such as fluocinolone 0.01%, remained the most effective option.10 In addition to topical therapy, avoidance of sun exposure and the application of sunscreens that offer protection against UV radiation and visible light appear to play an important, adjunctive therapeutic role in melasma.11 However, in recent years, another potential treatment option has emerged – the procoagulant, tranexamic acid.
Tranexamic acid for melasma Tranexamic acid is a synthetic antifibrinolytic agent that controls bleeding. Under normal physiological conditions, fibrin, formed in a clot, activates plasminogen, which is converted into plasmin and causes
breakdown of the clot. The conversion of plasminogen to plasmin occurs via plasminogen activator (PA) and tranexamic acid binds to five sites on PA, thus preventing it from converting plasminogen into plasmin and the subsequent breakdown of a blood clot.12 In other words, tranexamic acid promotes clot stability and reduces excessive bleeding. In relation to melasma, it is known that UV radiation induces the synthesis of PA in cultured keratinocytes13 and PA induces tyrosinase activity with a resultant increase in melanogenesis,14 and by inhibiting PA, tranexamic acid attenuates this UV-induced melanogenesis.
The precise cause of melasma remains uncertain though multiple factors have been implicated including genetics, solar radiation, hormonal effects and drugs The efficacy of tranexamic acid in melasma has been explored in several studies. In a 2017 review of 11 such studies with 667 participants, it was found that use of tranexamic acid produced a decrease in the melasma area and severity index (MASI) of 1.6 (95% CI 1.20 – 2.0, p < 0.001). Furthermore, when tranexamic acid
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ASK THE PHARMACIST was used as an adjunctive treatment, there was also a significant reduction in the mean MASI score of 0.94 (95% CI 0.10 – 1.79, p = 0.03) and these improvements became apparent after three months of treatment. While oral tranexamic acid is clearly effective, there is also evidence to support the use of a topical formulation. In a double-blind 12week, split-face study in 50 Iranian patients, topical application of a 3% tranexamic solution was found to be as effective as 3% hydroxyquinone and 0.01% dexamethasone solution.15 Furthermore, in a study of 84 female and 16 male patients with melasma, a 3% topical formulation of tranexamic acid was shown to have equal efficacy to 3% hydroquinone alone.16 There is even an intradermal formulation of tranexamic acid which has been used in the treatment of melasma. In a 2019 split-face study of 49 patients with melasma, Pazyar et al17 compared 4mg/ml and 10mg/ml intradermal tranexamic acid injections every two weeks for 12 weeks with topical 4% hydroquinone cream. The results showed that the MASI scores for both doses of tranexamic acid reduced to a similar extent, although the 4mg/ml intradermal tranexamic acid was less effective than 4% hydroquinone cream. In summary, studies suggest that tranexamic acid appears to be an effective treatment for melasma, and with oral, topical and intradermal formulations, clinicians have a wide choice of treatment modalities. The drug is not licensed for the treatment
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What remains uncertain is where tranexamic acid should sit within in the melasma treatment ladder of melasma, although the Primary Care Dermatology Society does suggest that an oral dose of 250mg twice daily for 12 weeks appears to be effective for some patients.18 Nevertheless, what remains uncertain is where tranexamic acid should sit within in the melasma treatment ladder and further studies should aim to more clearly define this position. DN
1. Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb) 2017. 7(3):305-18 2. Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol 2014. 89(5):771-82 3. Sanchez M. Cutaneous diseases in Latinos. Dermatol Clin 2003. 21(4):689-97 4. El-Essawi D, Musial JL, Hammad A, Lim HW. A survey of skin disease and skin-related issues in Arab Americans. J Am Acad Dermatol 2007. 56(6):933-8 5. Kwon SH, Na JI, Choi JY, Park KC. Melasma: Updates and perspectives. Exp Dermatol 2019. 28(6):704-8 6. Aishwarya K, Bhagwat PV, John N. Current concepts in melasma - A review article. Journal of Skin and Sexually Transmitted Diseases 2020. 2:13-7 7. Ortonne JP, Arellano I, Berneburg M, Cestari T, Chan H, Grimes P, et al. A global survey of the role of ultraviolet radiation and hormonal influences in
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8. Lee AY. Recent progress in melasma pathogenesis. Pigment Cell Melanoma Res 2015. 28(6):648-60 9. Filoni A, Mariano M, Cameli N. Melasma: How hormones can modulate skin pigmentation. J Cosmet Dermatol 2019. 18(2):458-63 10. Mckesey J T-gA, Pandya AG et al. Melasma treatment: an evidence-based review. Am J Clin Dermatol 2020. 21:173-225 11. Fatima S, Braunberger T, Mohammad TF, Kohli I, Hamzavi IH. The Role of Sunscreen in Melasma and Postinflammatory Hyperpigmentation. Indian J Dermatol 2020. 65(1):5-10 12. Reed MR, Woolley LT. Uses of tranexamic acid. Continuing Education in Anaesthesia Critical Care & Pain 2015. 15(1):32-7 13. Tse TW HE. Tranexamic acid; an important adjuvant in the treatment of melasma. J Cosmet Dermatol 2013. 12:57-66
References
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the development of melasma. J Eur Acad Dermatol Venereol 2009. 23(11):1254-62
14. SL S. Using Tranexamic Acid: What’s Known and What’s Next. Cutis 2018. 101:E7-E8 15. Ebrahimi B NF. Topical tranexamic acid as a promising treatment for melasma. J Res Med Sci 2014. 19(8):753-7 16. Janney MS, Subramaniyan R, Dabas R, Lal S, Das NM, Godara SK. A Randomized Controlled Study Comparing the Efficacy of Topical 5% Tranexamic Acid Solution versus 3% Hydroquinone Cream in Melasma. J Cutan Aesthet Surg 2019. 12(1):63-7 17. Pazyar N, Yaghoobi R, Zeynalie M, Vala S. Comparison of the efficacy of intradermal injected tranexamic acid vs hydroquinone cream in the treatment of melasma. Clin Cosmet Investig Dermatol 2019. 12:115-22 18. Primary Care Dermatology Society. Melasma 2021 [Available at: https://www. pcds.org.uk/clinical-guidance/melasma-synchloasma1#management [last accessed August 2021].
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At 5 years, 67% of 194 adult patients with moderate to severe plaque psoriasis maintained complete skin clearance (PASI 100) - As Observed, UNCOVER-3 long term extension1
Plaque Psoriasis: Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.2 In the UNCOVER-3 phase 3 trial, Taltz achieved superiority at the coprimary endpoints: PASI 75 and sPGA score of clear or minimal (0/1) with at least a two-point reduction from baseline at week 12 vs etanercept and placebo.3 Adverse reactions in clinical studies and post-marketing reports: The most frequently reported adverse drug reactions (ADRs) with Taltz are injection site reactions (15.5 %) and upper respiratory tract infections (16.4 %, most frequently nasopharyngitis). Common ADRs (≥1/100 to <1/10) are tinea infection, herpes simplex (mucocutneous), oropharyngeal pain and nausea.2 References: 1. Blauvelt A, et al. J Am Acad Dermatol. 2021;85:360-368. 2. Taltz® Summary of Product Characteristics 3. Griffiths CEM et al. Lancet. 2015;386:541–51 TALTZ® (ixekizumab) PRESCRIBING INFORMATION Presentation Ixekizumab solution for injection in a pre-filled syringe or pre-filled pen. Each single use pre-filled syringe and pre-filled pen contains 80 mg of ixekizumab in 1 mL solution. The solution is clear and colourless to slightly yellow. Uses Treatment of moderate to severe plaque psoriasis in • adults who are candidates for systemic therapy. • in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy. Treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (alone or in combination with methotrexate). Treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Dosage and Administration Posology Plaque psoriasis in adults Recommended dose: 160 mg by subcutaneous injection (two 80 mg injections) at week 0, followed by 80 mg (one injection) at weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg (one injection) every 4 weeks. Paediatric plaque psoriasis (age 6 years and above) The recommended dose given by subcutaneous injection in children is based on the following weight categories: Greater than 50 kg: 160 mg (two 80 mg injections) at week 0, followed by 80 mg every 4 weeks thereafter. 25-50 kg: 80 mg at week 0, followed by 40 mg every 4 weeks thereafter. Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional using the commercial Taltz 80 mg/1 ml prefilled syringe. For instructions on preparation of Taltz 40 mg, see SmPC. Doses less than 80 mg must be prepared by a healthcare professional. For children prescribed 80 mg, Taltz can be used directly from the prefilled syringe. Use the Taltz 80 mg pre-filled pen only in those children that require a dose of 80 mg and do not require dose preparation. Taltz is not recommended for use in children with a body weight below 25 kg. Paediatric body weights must be recorded and regularly re-checked prior to dosing. Psoriatic arthritis Recommended dose: 160 mg by subcutaneous injection (two 80 mg injections) at week 0, followed by 80 mg (one injection) every 4 weeks thereafter. For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis. Axial spondyloarthritis (radiographic and non-radiographic) Recommended dose: 160 mg (two 80 mg injections) by subcutaneous injection at week 0, followed by 80 mg every 4 weeks (see SmPC for further information). For all indications consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment. Some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks. Special populations Elderly: No dose adjustment required. Renal or hepatic impairment: Taltz has not been studied in these patient populations. No dose recommendations can be made. Paediatric plaque psoriasis (below a body weight of 25 kg and below the age of 6 years) There is no relevant use of Taltz in children below a body weight of 25 kg and below the age of 6 years in the treatment of moderate to severe plaque psoriasis. Paediatric population Paediatric psoriatic arthritis The safety and efficacy of Taltz in children and adolescents aged 2 to less than 18 years in the treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been
established. No data are available. There is no relevant use of Taltz in children below 2 years for the indication of psoriatic arthritis Method of administration For subcutaneous injection. Injection sites may be alternated. If possible, areas of skin that show psoriasis should be avoided as injection sites. Must not be shaken. For instructions on preparation of the medicinal product before administration, refer to the SmPC. Pre-filled syringe Doses less than 80 mg which require dose preparation should only be administered by a healthcare professional. Contra-indications Serious hypersensitivity to the active substance or excipients. Clinically important active infections (e.g. active tuberculosis). Warnings and Special Precautions Infections: Treatment associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections. Should be used with caution in patients with clinically important chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If an infection develops, patients should be carefully monitored and discontinued if the patient is not responding to standard therapy or if the infection becomes serious. Taltz should not be resumed until the infection resolves. Must not be given to patients with active tuberculosis (TB). Anti-TB therapy prior to initiation of Taltz in patients with latent TB should be considered. Hypersensitivity: Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported. If a serious hypersensitivity reaction occurs, administration should be discontinued immediately and appropriate therapy initiated. Inflammatory bowel disease (including Crohn’s disease and ulcerative colitis): Cases of new or exacerbations of inflammatory bowel disease have been reported (see SmPC). Ixekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, ixekizumab should be discontinued and appropriate medical management should be initiated. Immunisations: Should not be used with live vaccines. No data are available on the response to live vaccines: there are insufficient data on response to inactive vaccines. Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say essentially “sodium-free”. (See SmPC for full information on excipients). Interactions Safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated. In population pharmacokinetic analyses, clearance of ixekizumab was not affected by concomitant administration of oral corticosteroids, NSAIDs, sulfasalazine, or methotrexate. When Taltz was co-prescribed with substances metabolised by CYP3A4, CYP2C9, CYP2C19, CYP1A2 or CYP2D6 in patients with moderate to severe psoriasis no clinically significant impact on the pharmacokinetics of these substances was found. Fertility, Pregnancy, and Lactation Women of childbearing potential: Should use an effective method of contraception during treatment and for at least 10 weeks after treatment. Pregnancy: Recommended to avoid the use of Taltz during pregnancy. Breast-feeding: A decision should be made whether to discontinue breast-feeding or to discontinue Taltz. Fertility: The effect of ixekizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility. Effects on ability to drive and use machines Taltz has no or negligible influence on the ability to drive
This content has been developed and funded by Eli Lilly and company and is intended for UK/ IE Healthcare professionals. PP-IX-GB-1506 August 2021 ©2021 Eli Lilly and Company, All Rights Reserved Taltz® and Lilly are registered trademarks of Eli Lilly and Company
and use machines. Undesirable Effects Summary of the safety profile: The most frequently reported adverse reactions were injection site reactions (15.5 %) and upper respiratory tract infections (16.4 %) (most frequently nasopharyngitis). Injection site reactions: The most frequent injection site reactions observed were erythema and pain. These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of Taltz. Infections: In the placebocontrolled period of the phase III clinical studies in plaque psoriasis in adults, infections were reported in 27.2 % of patients treated with Taltz for up to 12 weeks compared with 22.9 % of patients treated with placebo. The majority of infections were non-serious and mild to moderate in severity, most of which did not necessitate treatment discontinuation. Serious infections occurred in 13 (0.6 %) of patients treated with Taltz and in 3 (0.4 %) of patients treated with placebo. Infection rates observed in psoriatic arthritis and axial spondyloarthritis clinical studies were similar to those observed in the plaque psoriasis studies with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis. Paediatric population: The safety profile observed in children with plaque psoriasis is consistent with the safety profile in adult patients with plaque psoriasis with the exception of the frequencies of conjunctivitis, influenza, and urticaria which were common. Inflammatory bowel disease was also more frequent in paediatric patients, although it was still uncommon. Very common (≥ 1/10): Upper respiratory tract infection, injection site reactions. Common (≥ 1/100 to < 1/10): Tinea infection, herpes simplex (mucocutaneous), oropharyngeal pain,nausea. For full details of these and other side-effects, please see the Summary of Product Characteristics, which is available at United Kingdom: http:// www.medicines.org.uk/emc/, or Ireland: http://www.medicines.ie/. Legal Category POM Marketing Authorisation Numbers and Holder EU/1/15/1085/001, EU/1/15/1085/004. Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. Cost (UK only) £1,125 per pack of 1 pre-filled pen, £1,125 per pack of 1 pre-filled syringe, An Irish price is available on request; please see section below for contact information. Date of Preparation or Last Review December 2020 Further Information is Available From Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL. Telephone: UK: + 44-(0) 1256 315 000, Ireland: + 353-(0) 1 661 4377 E-mail: ukmedinfo@lilly. com Website: www.lilly.co.uk; www.lilly.ie.
Adverse events and product complaints should be reported. Reporting forms and information can be found at UK: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store, or Ireland: www.hpra.ie. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000, or Lilly Ireland on 01 664 0446.
PATIENT VOICE
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Life after the 467, a tale of Bullous Pemphigoid Ingrid Thompson
M
y name is Ingrid and in April of 2015 I was diagnosed with a rare autoimmune blistering skin disease called bullous pemphigoid (BP). Why 467 you may ask? That is the number of blisters on my body when I was hospitalised on 8 April, 2015. Pemphigus and pemphigoid (as well as some related diseases) are groups of auto-immune diseases that affect the skin and/or mucous membranes. They are also grouped under the title auto-immune bullous diseases (AIBD). Like other auto-immune diseases, they occur when your immune system starts to attack parts of the body that it shouldn’t. Nobody knows what causes bullous pemphigoid, though there is suspicion it could sometimes be caused by certain medications. There is new research being conducted into this which I am involved with. Bullous pemphigoid is the most common of the various autoimmune blistering diseases, and in the over 70s it is now considered uncommon rather than rare. However, I was 55 when diagnosed, and this is still in the rare category. In my case, most of these ‘bullae’ appeared whilst I was on holiday in Madeira, leading to one of the worst weeks of my life. I had no idea such a disease could exist.
The beginning To understand the background to my story I need to rewind to the previous year – 2014 was my (to quote the Queen) “Annus Horribilis”. It was an extremely stressful year and, although there is no proof, my friends, family and myself believe that stress played a big part in me developing 58
BP. One of my best friends died in June, my work was increasingly stressful, with a very nasty incident involving threats to me and my staff, and then the next day my mum had a heart attack. Towards the end of 2014, I developed an itchy, red and patchy rash. It started to spread so I went to my GP. Many GPs know little or nothing about the disease, let alone seen someone with it. I was given a relatively low dose of prednisolone (a steroid) which had no effect, as well as some gentle steroid cream. The rash spread and various diagnoses were suggested, like eczema, contact dermatitis and scabies (a common a suggestion with BP). It was starting to affect my life and I was covering up because I was so uncomfortable most of the time. I had a week off work, Christmas came and went, but it wasn’t getting better. In fact, it was getting worse.
old daughter, who was really looking forward to it. She had GCSEs coming up so it was a last break. I’d looked bullous pemphigoid up but thought “That can’t be me as I’m only 55. It’s for the over 70s. It’ll wait until I get home.” Oh how wrong I was.
The emergence On Saturday 28 March, we flew out. I still had the rash and one little blister had appeared on my thumb, but I thought the steroids would keep everything at bay. Overnight, my skin flared and the next day I already had several large blisters on my arms, and the rash was starting to cover them and became sore and itchy.
Luckily for me, one doctor at my practice tentatively suggested that I may have BP, but it came too late for me to get a dermatology appointment before Easter and hence the week of hell in Madeira. We had booked the week’s holiday to Madeira just before Easter and I really wanted to go, especially considering the horrible time I’d been having. Just before we flew, I was given a week’s worth of steroids (about 15mg a day). The GP, with my backing, suggested that would help. We arranged for a follow-up a fortnight after the holiday. Hindsight is a wonderful thing and if I had known what was going to happen, I wouldn’t have gone on holiday. But the blisters emerged so rapidly and I didn’t want to disappoint my 16-year-
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By the 30 March I could see things were getting out of hand and the blisters were exploding and bursting leaving raw skin in need of dressings. www.bdng.org.uk
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wait three days to see a doctor as it was Easter Saturday when we flew back.
I was getting very scared and thought nobody else has this. The itch was unbearable and I couldn’t sleep. I found an Amazon audible title called ‘Psoriasis Relief’ which had subliminal hypnosis. It did help and I use it still today, but it only gave me a few hours’ sleep. Random internet searching led me to a lady called Isobel, who guided me to the Facebook group Pemfriends, which offered me a lifeline, and I will talk about in more detail later. By 1 April my blisters were so severe I was worried about infection and my husband was aspirating them with a needle which he sterilised with a flame. I was using sanitary towels on the open wounds as trying to get dressings in Madeira was impossible. I didn’t really want to show anyone in a pharmacy the open sores. I was already fairly sure that it was some sort of PEM, but try explaining that in Portuguese; it’s hard enough to explain in English! The other difficult thing to get across in any language is that you’re not infectious. In fact, being seen by people who think you are infectious can become quite stressful. The flight home was horrendous with people staring at me, and I had to
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PATIENT VOICE
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On Tuesday 7 April, I got an appointment with my GP. He took one look at my skin and realised I needed help quickly. He got me an emergency walk-in appointment for dressings to be applied. I still remember the look of shock on the face of the clinician who came into the room to dress my blisters. My GP also arranged for a next day appointment at the hospital’s Dermatology department. The next day, my husband drove me to the Leicester Royal Infirmary for an emergency dermatology appointment. I hadn’t slept as my skin was so sore and itchy. The clinician who saw me was nice and asked the poor student who was with her to count my blisters. The legendary 467 was then established. I didn’t realise it at the time but I was very lucky in some ways, as the clinician is one of the top blister experts in the country. Her name is Karen Harman and she still looks after me today. She told me I needed to be admitted and I wanted to cry, but I wasn’t sure if it was relief or upset. I know my husband was very relieved as he had been really worried about me. He was exhausted and needed a break from looking after me. In the end we were both relieved by the admission as we had found out that bullous pemphigoid can be fatal.
As mentioned previously, it tends to be a disease for the over 70s, so at 55, I was young to be diagnosed with it. My husband went home to get me some nightwear and they found me a space on the ward. A well-meaning healthcare assistant took me to the showers and offered to help me wash. I politely declined the offer and then pretended to shower. Those of you with blisters know how uncomfortable showering can be and even after six years it still is, as my skin is now very sensitive. I was immediately put on a wheelbarrow full of drugs, including steroids which helped the blisters to disappear quickly, but have side effects. My diagnosis was bullous pemphigoid with gingival inflammation.
Learning to live After a few days I still had sleepless nights, but there was always something to photograph in the early hours. I was a bit of a star (sort of), as the dermatology consultants wanted to bring students so they could see me. It’s a teaching hospital so I consented, as people need to learn about this awful disease. From their faces you could tell they hadn’t really heard about bullous pemphigoid. They had trouble taking my blood pressure as I had so many blisters everywhere, so for a while they used my ankle.
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PATIENT VOICE In the end, I spent nearly three weeks in hospital in 2015, and my whole life had changed. Medications, side effects, constant tiredness, retirement. The list is endless. Thank you steroids. I know they are little round, white double-edged swords, but despite the weight gain, moonface, aching joints, mood swings and tiredness (especially when tapering), I firmly believe they saved my life. On the plus side, my face is as smooth as a baby’s proverbial and I got my sense of smell back, (I’d had anosmia for several years). I know I may need to go back on steroids occasionally, but I hope a short, sharp shock will do the trick, so I don’t have to taper again. You really must taper very slowly if you have been on them for a length of time. I don’t want to sound pessimistic, but from various conversations I have had, I do not think PEM ‘goes away’. It goes into remission but bubbles under. Having said that, it can be controlled and you learn to live with it, like you learn to live with other problems.
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The present It’s been a bit of a roller-coaster ride since I developed bullous pemphigoid. Six years on and I still live with the consequences of this condition. The disease has had a significant impact on my lifestyle, including early retirement. It’s very hard to explain to some people (especially when you don’t have blisters) that it’s a bit more than ‘just’ a skin complaint. As I have mentioned, I believe I am living with the consequences of starting treatment late. I don’t blame anyone, but I do believe that a rare disease will remain rare because of a vicious circle: it’s rare, nobody talks about it, so it remains rare. I’m not blaming my GP, but my mission is to get AIBDs out there so that earlier diagnosis will mean less severe treatment, in particular steroids. Whilst I still feel there are some cases where steroids are needed (my blisters needed treating quickly), doctors prescribe them fairly easily. Patients going on them may not realise the consequences and BP patients are often elderly so do not have the resources to check, or the confidence to ask the
doctor about other treatments. I cannot emphasise too much how hard it is coming off steroids and how slowly it should be done. For the last year, I have been pretty stable, but tiredness is still a constant reminder that I’m living with an autoimmune disease. During the COVID-19 pandemic I have been shielding due to immunosuppressant drugs and the side effects of my medication have led to high blood pressure and diabetes. Although BP can go into remission, the current pandemic stress seems to have caused a lot of people to flare. Despite all the challenges I have discussed, I found that connecting with others who have one of the PEM conditions has helped me a great deal. Just knowing that you’re not alone out there can be a great comfort. This is why we (myself and some others with PEM conditions) have recently launched a new website: www.pemfriendsuk. co.uk to support and inform patients and carers of people with autoimmune blistering skin diseases. We produce a magazine, have badges and t-shirts and banners, all to help spread awareness about PEM. There are a few of us out there who know what you are going through, and we can help. DN
For more information visit https://www.pemfriendsuk.co.uk/. Skin after one month
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MEN/135/0520 Date of Preparation: May 2020
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THE WATERPROOF STEROID TAPE PATIENT VOICE
Effectively treats inflammatory dermatoses, including hand eczema and finger tip fissures1. Good news for patients especially with increased handwashing situations.
Previously called Haelan tape
Easy to use on joints and awkward areas to allow patient mobility without disturbing the dressing.
Fludroxycortide Tape S T E R O I D I M P R E G N AT E D TA P E
For both children and adults
UNIFORM METERED DOSE AVAILABLE IN 2 PACK SIZES
Scan the QR code to view the application video. Alternatively visit typharm.com or call 01603 722480 for more information Typharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk, NR13 6LH. UK
1/FT/12/2104/506 Date of preparation: May 2021
1. Layton A. Reviewing the use of Fludroxycortide tape (Haelan Tape) in Dermatology Practice. Typharm Dermatology.
Abridged Prescribing Information Fludroxycortide 4 micrograms per square centimetre Tape See Fludroxycortide Tape Summary of Product Characteristics (SmPC) prior to prescribing. Presentation: Transparent, plastic surgical tape impregnated with 4 µg/cm2 fludroxycortide. Indications: Adjunctive therapy for chronic, localised, recalcitrant dermatoses that may respond to topical corticosteroids and particularly dry, scaling lesions. Posology and Method of Administration: Adults and the Elderly: For application to the skin, which should be clean, dry and shorn of hair. In most instances the tape need only remain in place for 12 out of 24 hours. The tape is cut so as to cover the lesion and a quarter inch margin of normal skin. Corners should be rounded off. After removing the lining paper, the tape is applied to the centre of the lesion with gentle pressure and worked to the edges, avoiding excessive tension of the skin. If longer strips of tape are to be applied, the lining paper should be removed progressively. Children: Courses should be limited to five days and tight coverings should not be used. If irritation or infection develops, remove tape and consult a physician. Contra-indications: Chicken pox; vaccinia; tuberculosis of the skin; hypersensitivity to any of the components; facial rosacea; acne vulgaris; perioral dermatitis; perianal and genital pruritus; dermatoses in infancy including eczema, dermatitic napkin eruption, bacterial (impetigo), viral (herpes simplex) and fungal (candida or dermatophyte) infections. Special Warnings and Precautions for use: Not advocated for acute and weeping dermatoses. Local and systemic toxicity of medium and high potency topical corticosteroids is common, especially following long-term continuous use, continued use on large areas of damaged skin, flexures and with polythene occlusion. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (HPA) axis suppression. Long-term continuous therapy should be avoided in all patients irrespective of age. Application under occlusion should be restricted to dermatoses in very limited areas. If used on www.bdng.org.uk the face, courses should be limited to five days and occlusion should not be used. In the presence of skin
infections, the use of an appropriate antifungal or antibacterial agent should be instituted. For children, administration of topical corticosteroids should be limited to the least amount compatible with an effective therapeutic regimen. Children may absorb proportionally larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. Pregnancy and Lactation: Use in pregnancy only when there is no safer alternative and when the disease itself carriers risks for mother and child. Caution should be exercised when topical corticosteroids are administered to nursing mothers. Undesirable Effects: The following local adverse reactions may occur with the use of occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acne form eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria, striae and thinning and dilatations of superficial blood vessels producing telangiectasia. Transient HPA axis suppression. Cushing’s syndrome. Hyperglycaemia. Glycosuria. Adrenal suppression in children may occur. Local hypersensitivity reactions. Stop treatment immediately if hypersensitivity occurs. Precautions for Storage: Store in a dry place, below 25°C. Pack size and price: Polypropylene dispenser and silica gel desiccant sachet in a polypropylene container, with a polyethylene lid, packed in a cardboard box, containing 20cm or 50cm of translucent, polythene adhesive film, 7.5cm wide, protected by a removable paper liner. 7.5cm x 20cm £12.49. 7.5cm x 50cm £18.75. Legal Category: POM Marketing Authorisation Number: PL 00551/0014 Marketing Authorisation Holder: Typharm Ltd. 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH. Tel: 01603 722480, Fax: 01603 263804. Date of Revision of Text: February 2021.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Dermatological Nursing, 2021, Vol 20, No 3 Adverse events should also be reported to Typharm Limited on 02037 694160.
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PODCAST
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Making guidelines approachable Emmanuel Toni, Aisling Clery
H
osting five episodes of the BDNG podcast has been an incredible experience so far. We have been fortunate enough to talk with some of the top experts in the field of dermatology about upcoming NHS projects, reflecting on the dermatology nurse role, and the future of dermatology nursing. It has been inspiring to hear about the National Outpatient Transformation and the Getting It Right First Time programmes, and how dermatology nurses will be at the forefront of these transformations and key to their successful implementation in practice. Being full-time NHS employees has meant recording these podcasts has come with plenty of logistical challenges – time, scheduling and travel being the big ones. Additionally, managing the episode content was at first difficult, as it can appear too overloaded with heavy information and guidance discussion. However, each guest was so passionate about the projects they have been working on that it was truly a joy to discuss and easy to follow. The excitement from the guests was palpable and we hope this translates into each episode. We discussed so many issues that have a genuine impact on our day-to-day work that it was impossible to not engage.
We hope that by listening to these episodes you will also be inspired and equipped with the knowledge to improve your dermatology service The project has also given us the opportunity to research and read into upcoming and current guidance, as well as reflect on the implications on our daily practice. This will hopefully allow us to go back to our clinical areas and help lead and implement such strategies where needed. We hope that by listening to these episodes you will also be inspired and equipped with the knowledge to improve your dermatology service and implement fresh new guidance. Currently there are two podcasts uploaded on the BDNG app accessible to all members.
and Lynne Skrine discuss how they adapted their services during and following the COVID-19 pandemic. There are many upcoming episodes to look forward to which include: An overview of the collaborative BAD and BDNG education nursing work stream and the Clinical Dermatology Nursing Role Descriptors Project- with Karina Jackson (Consultant Nurse) Getting It Right First Time, and the the proposed recommendations for dermatology, with Professor Nick Levell Experience of redeployment during the COVID-19 pandemic, with Julia Wheeler and Holly Nagle National Outpatient Transformation Programme, with Dr Emma le Roux and Dr Julia Schofield. The response we have received from the dermatology community has been a huge drive for us. We have received a lot of positive comments, and we do always seek and welcome feedback (positive or negative) as it is fundamental to growth. We hope that the BDNG podcast continues to create up-to-date information on what is happening in the dermatology world.
DermaExchange
1. In conversation with Rebecca PenzerHick: In this episode Julia Wheeler, BDNG Educational Development Nurse, hosts the podcast and speaks with BDNG President, Rebecca Penzer-Hick about her role within the organisation and some of the highlights of her term of office. 2. Adapting dermatology services: In this episode, Lucy Moorhead
DermaExchange
DermaExchange
Happy listening!
DN
The space for new ideas in dermatology DermaExchange
At DermaExchange, you can discover high-quality educational content from leading dermatologists and enjoy open discussions with fellow professionals. Register for the latest webinars and catch up with recorded events from our archive. Start exploring today at dermatology.almirallmed.co.uk/dermaexchange feel the science
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Website contains promotional material
Dermatological Nursing, 2021, Vol 20, No 3
IE-NOP-2100049 June 2021
www.bdng.org.uk
A Bigger
splash A hydrating solution for dry irritated skin CREAM • • • •
Pleasant, non clinical scent SLS and Paraben Free Has a non-greasy feel 500ml Airless pump dispenser for better patient experience, waste reduction and cost savings For more details contact us:
E: info@dermauk.co.uk W: dermauk.co.uk T: 0191 375 9020 ULTRABASE® Cream - Abbreviated Prescribing Information Presentation: Ultrabase® Cream is a white cream containing soft white paraffin 10% w/w. Uses: Ultrabase® Cream is a moisturising cream that can be used in the relief of the symptoms of dry skin conditions associated with eczema, psoriasis and other commonly occurring skin conditions where dry skin is a component. Dosage: The cream should be smoothed onto the skin as often as required. Contraindications: Do not use if you know you are hypersensitive (allergic) to any of the ingredients. Precautions: Contains stearyl alcohol which may cause local skin reactions. Benzoic acid may cause an allergic skin reaction (possibly delayed). Warning: Do not smoke or go near naked flames while applying this product as there is a risk it might ignite and cause severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Side Effects: Hypersensitivity skin reactions including redness and itching have been reported. Package Quantities: 500ml
pump dispensers. Basic NHS Price: £7.01 Ultrabase® Cream is a Class 1 Medical Device. It is produced by Derma UK Ltd, Toffee Factory, Ouseburn, Newcastle upon Tyne NE1 2DF, UK. “Ultrabase” and “Derma UK” are registered Trade Marks. Date of Revision of Text: June 2021. Adverse events should be reported. Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Derma UK Ltd, UK on 0191 375 9020.
Date of Preparation: June 2021.
ULTMD/17/0621
BDNG NEWS
UK DCTN update Carron Layfield (UK DCTN Network Manager) All studies listed below are funded by National Institute for Health Research funding streams.
Newly funded studies BEACON We are delighted to announce that funding is confirmed for the BEACON (Best Systemic Treatments for Adults with Atopic Eczema over the Long Term) trial; a randomised, assessorblind study comparing ciclosporin, methotrexate, dupilumab and a Janus kinase inhibitor. BEACON aims to establish the comparative effectiveness, tolerability, and cost-effectiveness of these four key treatments used to treat moderate-tosevere eczema in adults. This trial will, for the first time, enable doctors and patients to benefit from knowing how systemic treatments for atopic eczema compare directly to each other on a level playing field in a way that reflects NHS practice. BEACON will be set up as a multi-arm, multi-stage platform trial capable of adding new arms as novel treatments emerge and will be, to our knowledge, the first of its kind globally in dermatology. If you feel that your site could take part in and contribute to what we feel is a very important and exciting study, then please get in touch with the trial team by contacting Tess Cheetham on Tess.Cheetham@gstt.nhs.uk.
Update on recruiting trials SAFA The SAFA (Spironolactone for Adult Female Acne) randomised controlled trial (RCT) has now recruited 369 patients, and due to the success of using social media to identify potential participants is well on track www.bdng.org.uk
to recruit to the planned target of 398 by the recruitment end date of 31 August 2021. The study protocol was recently accepted for publication in BMJ Open and a full update can be found at https:// www.southampton.ac.uk/safa/index.page.
The closing date for this UK DCTN Award is fast approaching so if you are thinking of applying, please do start preparing soon. We have opened the award out to a wider range of dermatology nurses, and you no longer need to be actively involved in research to be eligible to apply.
THESEUS THESEUS – a prospective cohort study aiming to identify the best treatment options for hidradenitis suppurativa (HS) when first line treatment fails – has now recruited to target, with 150 participants now recruited. Patient follow-ups will continue for the next 12 months and a huge thank you to the 10 sites involved (Stoke Mandeville, Oxford, Forth Valley, Chelmsford, Newcastle, Cardiff, Barnsley, Guy’s & St Thomas, Salford, and Brighton).
The two-year educational award has £1,750 allocated to cover expenses for several activities including: the BEES (Better Evaluation of Evidence and Statistics) course, spending time at the UK DCTN Co-ordinating Centre in Nottingham, and joining the Steering Committee for the duration of the award. For more information, including details of the application form, please contact Network Manager Carron Layfield carron.layfield@nottingham.ac.uk
For further information, please see the new study website at https://www. nottingham.ac.uk/research/groups/cebd/ projects/5rareandother/theseus.aspx .
Exploring training and development needs in clinical research
ALPHA ALPHA, an RCT comparing the effectiveness of alitretinoin and PUVA for the treatment of severe hand eczema, closed for recruitment at the end of June. In total, 441 participants were recruited (against a target of 455) making it the largest hand eczema study of its kind ever conducted worldwide. This is testament to the determination of the Chief Investigator (Dr Miriam Wittmann, Leeds), the study team, and all the sites involved across the UK. Please see https://ctru.leeds.ac.uk/ alpha for full details.
Training and development opportunities
Our next informal online session will be exploring the article on critical appraisal of dermatology clinical trials which appears in this journal issue.
UK DCTN Steering Committee vacancy We currently have a vacancy for a dermatology-nursing representative on the UK DCTN Steering Committee, which meets three times a year (travel expenses are paid). It is crucial we maintain nursing representation to ensure that we have input from the nursing community at the very early stages of trial development when study ideas are first presented. Tenure is for three years and interested candidates should contact the network manager at carron.layfield@nottingham.ac.uk. DN
UK DCTN Nurse or Pharmacist Fellowship Award – closing date Monday 25 October Dermatological Nursing, 2021, Vol 20, No 3
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BDNG NEWS
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Preparing for the conference Julia Wheeler
O
ver the summer I have been focused on conference planning with much of my time being spent on preparing teaching for Derm School: Core Skills in Dermatology, which is specifically for the podiatrist, novice nurse and aesthetics delegate. This is scheduled to take place on the opening day of the conference and will be supported by a wide range of speakers with relevant clinical experience. Breakout sessions have been planned to accommodate the specific learning needs of delegates from each stream. These will include teaching on the cutaneous manifestations of the lower limb for podiatrists with practical training on compression bandaging. Aesthetics is a relatively new topic within our conference programme this year. It is becoming increasingly relevant to many of our members working in private practice. I am particularly grateful to the support of colleagues working in this specialist field who have offered guidance with the content and support with teaching. For nurses attending the novice stream, the programme aims to provide a solid foundation in the fundamental skills for dermatology nursing. We have the support of an expert patient to offer insights into living with chronic
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skin disease. This will be followed by practical advice on the management of pruritus. Advice with career planning aims to inspire delegates to consider their potential scope of practice and professional progression throughout their future career. We hope that the opportunity for smaller, focused group work within the programme will enable a practical approach to learning with increased opportunity for interaction and support. Following the introduction of our new BDNG App, we hope to increase access to additional complementary teaching resources specifically for conference delegates. In particular, we have been assisted with the production of some fabulous short videos on the pathophysiology of chronic skin diseases and we hope these will serve to consolidate teaching focused on anatomy and physiology of the skin. For members wanting to attend the main conference, the full programme has now been confirmed and can be reviewed on the website. We have received huge support from our pharmaceutical sponsors and feel confident that this year’s event will not disappoint. As well as offering insights into the latest evidence, innovations, and therapies, we also hope to provide an important opportunity to engage and network with wider colleagues. This support is all the more important
Dermatological Nursing, 2021, Vol 20, No 3
as we face continuing struggles to meet patients’ needs throughout the ongoing pandemic. For those of you who have not yet noticed, we have recently released a new series of podcasts. We really hope that you will find this light approach to education both informative and challenging. We have started with some recordings with the executive committee, which will inform you more about their background in dermatology and their role within the BDNG. We hope this will inspire new leaders and increase future engagement which serves to promote care for patients with skin disease. For those attending the virtual European Academy of Dermatology and Venereology (EADV) nurses’ conference, I look forward to seeing you on the day. Since the EADV has opened membership to nurses, I believe this event will become increasingly important to dermatology nurses throughout Europe. This year’s event focuses on vulval disease, genital dermatoses, mental health, and the burden of skin disease. In the meantime, I very much look forward to welcoming you to the conference to mark our belated 30th birthday celebrations. Please look out for me and say hello, particularly if you are attending the conference alone this year. DN
www.bdng.org.uk
SKYRIZI
®
(risankizumab)
Durability 85% of patients achieved PASI 90 through to 3.3 years*1
now only
ONE
Simplicity Now only
4 injections per year after 2 initiation injections**2 Available in a SKYRIZI PEN and PFS
INJECTION PER DOSE
Safety profile Consistent safety profile through to 4 years†1
Same efficacy and safety profile, now even simpler with SKYRIZI 150 mg PEN and PFS compared to 2 x 75 mg PFS2,3
SKYRIZI® (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.2 Currently, supply of SKYRIZI 150 mg (PEN & PFS) to Northern Ireland is only available through homecare. *Data from LIMMitless; an ongoing phase 3, single-arm, multicentre, international, open-label extension in which all patients receive SKYRIZI (150 mg) every 12 weeks. The 172 week analysis included patients who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base phase II/III studies. Results from 172 week interim analysis including integrated data from five phase 2/3 studies (UltIMMa-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study. Efficacy was assessed every 12 weeks by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed every 24 weeks by DLQI 0/1. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 90 = 90% improvement in Psoriasis Area and Severity Index. **Maintenance dosing (1 injection/dose) every 12 weeks following a starter dose at Week 0 and Week 4. If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time. †Long term safety included patients in LIMMitless who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base Phase II/III studies (patients with continuous SKYRIZI use). The 208 week interim analysis includes integrated data from the five Phase 2/3 studies (UltIMMa-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study.
PRESCRIBING INFORMATION (PI) SKYRIZI® (risankizumab) 75 mg solution for injection in prefilled syringe (PFS); 150 mg solution for injection in pre-filled pen (PEN) and PFS. Refer to Summary of Product Characteristics (SmPC) for full information before prescribing. PRESENTATION: Each PFS contains 75 mg risankizumab in 0.83 ml solution or 150 mg risankizumab in 1 ml solution. Each PEN contains 150 mg risankizumab in 1 ml solution. INDICATION: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis. Dosage: Skyrizi 150 mg solution for injection in PEN and PFS: the recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4 and every 12 weeks thereafter. Skyrizi 75 mg solution for injection in PFS: the recommended dose of Skyrizi is 150 mg (two 75 mg injections) by subcutaneous injection at weeks 0, 4, and every 12 weeks thereafter. Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. Renal or hepatic impairment: No dose adjustment
required. Paediatric Population: No data available. CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections. SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be evaluated for tuberculosis infection prior to initiating treatment. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Completion of all appropriate immunisations should be considered prior to initiating therapy. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. Skyrizi 75 mg solution for injection contains 68.0 mg sorbitol and less than 1 mmol sodium (23 mg) per 150 mg dose. Skyrizi 150 mg solution for injection contains less than 1 mmol sodium (23 mg) per PEN or PFS. INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated.
PREGNANCY AND LACTATION: Women of Childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure. Lactation: It is not known whether Skyrizi is excreted in breast milk. Skyrizi may be used during breast-feeding if clinically needed. Fertility: The effect of Skyrizi on human fertility has not been evaluated. ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions. LEGAL CLASSIFICATION: POM MARKETING AUTHORISATION NUMBERS/PRESENTATIONS/ NHS LIST PRICE: Great Britain (GB) PLGB 41042/0033, Northern Ireland (NI) EU/1/19/1361/001, Skyrizi 75 mg solution for injection in PFS (Pack of 2 pre-filled syringes); GB PLGB 41042/0045, NI EU/1/19/1361/002, Skyrizi 150 mg solution for injection in PEN; GB PLGB 41042/0046, NI EU/1/19/1361/003, Skyrizi 150 mg solution for injection in PFS: £3326.09 FURTHER INFORMATION: available from AbbVie Ltd, Maidenhead, SL6 4UB DATE OF REVISION: May 2021 PI-Skyrizi-002
Adverse events should be reported. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk. Adverse events should also be reported to AbbVie on GBPV@abbvie.com
References: 1. Papp K, et al. Poster 1366, presented at European Academy of Dermatology and Venereology (EADV) Congress, October 2020. 2. SKYRIZI Summary of Product Characteristics. 3. Data on File, AbbVie Inc. ABVRRTI71818 150 mg data package [M15-999 and M16-005]. UK-SKZD-210060 Date of preparation: April 2021
The British Dermatological Nursing Group Corporate Sponsors
The BDNG would like to thank all our corporate sponsors for their support and continued investment with the BDNG