Nursing in General Practice Mar/Apr '23 by GreenX Publishing

BONE HEALTH

Practical advice from the Irish Osteoporosis Society

SCOLIOSIS: An overview

RESPIRATORY MEDICINE

GINA and GOLD guidelines

IMMUNOLOGY

Living with vasculitis

PRACTICE DEVELOPMENT

A message from your Professional Development Coordinators

ISSUE 2 VOLUME 16 MARCH-APRIL 2023 IRELAND’S INDEPENDENT JOURNAL FOR GENERAL PRACTICE NURSES

“ Cow’s milk allergy is associated with dysbiosis and increased susceptibility for infections, and it has been suggested that it can be managed (in part) by pro-, pre-, and synbiotics ””

Clinically proven to restore the gut microbiome in infants with cow’s milk allergy,2-6 supporting immune development and long-term health7-10

Visit our sampling service at www.nutricia.ie or scan the QR code

DRACMA: Diagnosis and Rationale for Action against Cow’s Milk Allergy; GOS: Galacto-Oligosaccharides; FOS: Fructo-Oligosaccharides

1. DRACMA Jensen SA et al. World Allergy Organization Journal. 2022;15:100668. 2. Burks AW et al. Pediatr Allergy Immunol. 2015;26(4):316–22. 3. Candy DCA et al. Pediatric Res. 2018;83(3):677–86. 4. Fox AT et al. Clin Transl Allergy. 2019;9(1):5. 5. Chatchatee P et al. JACI. 2021;0091-6749(21)01053-8 6. Van der Aa LB et al. Clin Exp Allergy. 2010;(40):795–804. 7. Mar tin R et al. Benef Microbes. 2010;1(4):367–82. 8. Wopereis H et al. Pediatr Allergy Immunol. 2014;25:428–38. 9. West CE et al. J Allergy Clin Immunol. 135(1):3–13. 10. Walker WA et al. Pediatr Res. 2015;77(1):220–228.

IMPORTANT NOTICE: Breastfeeding is best. Foods for special medical purposes should only be used under medical supervision. May be suitable for use as the sole source of nutrition for infants from different ages, and/or as part of a balanced diet from 6 months onwards. Refer to label for details.

Nutricia Ireland, Deansgrange Business Park, Deansgrange Co. Dublin. Date of publication: Jan 2023

THIS INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY GOS/FOS FOS/FOS SYN EOTM OURPATENTED COMBINATION

NEW DRACMA 20221

Only Nutricia’s SYNEO range contains prebiotics and probiotics (synbiotics):

Integrated care through integrated learning, information-sharing, and ongoing practice development

Hello and welcome to the March/April edition of Nursing in General Practice (NiGP) Spring has finally arrived after another long, challenging winter in healthcare, but despite the days getting longer and a little more bird-song in the mornings, healthcare beds, staff, and a huge array of services remain in short supply and at breaking point across Ireland. As always, we are bringing you the latest updates in healthcare news from around the country, but it isn’t all bad. In fact, the overwhelming evidence suggests that healthcare professionals in Ireland continue to provide a high standard of patient-centred, integrated care in spite of these massive deficits and shortfalls.

In reality, providing integrated care as part of a fragmented and heavily burdened system can be challenging, particularly for general practice nurses (GPNs) due to the unique nature of your role and the demands it brings. As your independent journal, we want to continue to help GPNs in Ireland overcome some of these challenges, which is why we are working with your Professional Development Coordinators (PDCs), and others, to help build an integrated service through integrated education, information sharing, networking, and practice development. This edition features an overview of the role of the PDC, how this service can enhance your development, and what resources your PDC can offer you. Despite there currently being only four-of-nine PDCs in post, they continue to offer support and guidance to the new GPN, as well as support in career development to

the GPN who is established in their role.

Also in this edition, we bring you the latest clinical evidence, recommendations, and guidance on an array of topics to meet the wide range of knowledge your role requires, as well as some insights into the lived experience of the patient. Julie Power, founder of Vasculitis Awareness Ireland, provides a personal insight into living with a rare autoimmune disorder and how important the nurse’s role is in managing the physical, mental, and emotional dimensions of vasculitis.

Following on from our feature in the last edition that outlined the recent changes to the GINA guidelines for asthma management, Dr Shane Brennan and Dr Dermot Nolan provide an in-depth CPD module exploring the evidenced-based diagnosis and management of asthma in adults and adolescents. Also featuring in our respiratory update, Ruth Morrow explains how the significant changes to the recent GOLD guidelines impact on the management of COPD. Both these articles will keep you up-to-date with the most recent changes in the management of two of the most common respiratory disorders seen in general practice.

In bone health, we examine scoliosis and osteoporosis. Theresa LowryLehnen provides a comprehensive overview of scoliosis, while Michele O'Brien, CEO of the Irish Osteoporosis Society, dispels many myths surrounding osteoporosis, provides an overview of its manifestations and management, and gives practical advice to help patients live as well as possible. Osteoporosis is a largely preventable condition that

continues to place significant burden on our health services and carries a range of negative outcomes for patients, particularly the older population. Moving from the older generations to the young, Dr Kevin Conlon provides a detailed account of managing diabetes in children, from ketoacidosis to insulin therapy, and outlines national guidelines. And finally, we bring you the highlights from the Primary Care Dermatology Society of Ireland’s recent annual conference to keep you up-to-date with the latest developments in skin care.

As always, we invite you our readers to keep getting in touch with your suggestions, feedback, and opinions, or if you would like to write an article or contribute to the journal in any way. We value your input hugely and want to keep bringing you the information you want to read. Therefore, we will continue to work with you our readers, healthcare experts, and other organisations to bring you the best available evidence, educational modules, and practical advice about career and practice development. Wishing you all a happy and safe St Patrick’s Day and Easter from the team at NiGP.

NiGP is now a fully independent publication and is no longer the official journal of the IGPNEA. If you are interested in writing an article for NiGP, please email denise@greenx.ie

A message from Ruth Morrow, Contributing Editor, and the team at NiGP

C ONT

EDITOR

Denise Doherty denise@greenx.ie

CONSULTING EDITOR

Ruth Morrow

SUB-EDITOR

Emer Keogh emer@greenx.ie

CREATIVE DIRECTOR

Laura Kenny laura@greenx.ie

NMBI seeks feedback on development of digital health competencies for nurses and midwives

The Nursing and Midwifery Board of Ireland (NMBI) has launched a public consultation on its draft Digital Health Competency Standards and Requirements for Undergraduate Nursing and Midwifery Education Programmes. NMBI has developed the draft following extensive consultation with nurses and midwives, and in collaboration with an expert working group to align with national and international evidence-based practice. The draft document aims to ensure that digital health is incorporated into education programmes that lead to registration, and to ensure nurses and midwives learn about digital tools as part of their education. They also aim to align with national and international evidence-based practice in a changing

digital health environment.

NMBI CEO Sheila McClelland highlighted the importance and challenges of educating future generations of nurses and midwives in a rapidly evolving healthcare system, and how the document “aims to ensure digital health skills and competencies are embedded within nursing and midwifery school curricula, training, and continuing professional development activities”. She also described how “the Report of the Expert Review Body on Nursing and Midwifery (2022) , Sláintecare Implementation Strategy and Action Plan 2021–2023 , Health Service Executive service plan and the Health Services People Strategy 2019–2024 all set digital health as a key enabler to support the significant redesign of

services required to implement the Sláintecare model of care.” NMBI’s Director of Education, Policy, and Standards Carolyn Donohoe called for feedback on the draft from nurses, midwives, and other professionals before the standards are finalised. She said: “We now want to hear feedback from registered nurses and midwives, recent graduates, those working in education bodies, people using services, and those with further expertise in the field of digital health. All feedback received will be analysed and used to inform the final standards and recommendations, which will be published following approval by NMBI’s Board.”

You can take part in the consultation by going to www.nmbi.ie before 5pm on Tuesday, 11 April 2023.

NMBI PUBLISHES NEW EDUCATION STANDARDS FOR DXA SCANNING

The Nursing and Midwifery Board of Ireland (NMBI) has published new educational standards and requirements to regulate the practice of dual energy x-ray absorptiometry (DXA) scanning

by nurses. DXA is a modern technology that combines x-rays, a computer, and software that provides quantitative and qualitative assessment of body tissues. Nurses in Ireland can undertake the practical aspects of DXA scanning if

they have completed the education programme, which will address safety standards for protection against the dangers arising from exposure to medical ionising radiation.

The programme marks the first DXA

nursing education standards published by a regulator in Ireland and will enhance public safety when nurses perform DXA procedures. The new requirements aim to ensure a standardised approach to DXA education programmes and that nurses are competent to administer a DXA scan to adult service users in a healthcare setting. The standards set out the key aims of ensuring nursing practice in this area is safe, compassionate, professional, and accountable. NMBI developed the standards with the support of a national interdisciplinary group, including representatives from the HSE and Irish DXA Society. NMBI also engaged with the regulators of ionising radiation, the Environmental Protection Agency, and the Health Information and Quality Authority (HIQA).

NMBI CEO Sheila McClelland welcomed the publication of the

programme and acknowledged that NMBI is the first regulator in Ireland to introduce standards in line with Irish and EU legislation. She said: “We hope [the standards] will contribute to public safety and provide nurses with the required training and competence in DXA scanning. I want to thank all the stakeholders who engaged with us in support of the development and implementation of these important new standards, and we look forward to working with education bodies as education programmes are developed and rolled out for the nursing profession.”

Carolyn Donohoe, Director of Education, Policy, and Standards at NMBI added: “The development and implementation of standards of practice and education is a key function of our role as a regulator. This document aims to support education

bodies and associated healthcare providers to develop high-quality training and education for nurses in this area of practice, which will ensure quality and safe services to all patients. The document also provides guidance for nurses on what to expect from the education programme. We look forward to working with our stakeholders to ensure these standards support the training and development of nurses to provide DXA scans within their scope of practice.”

The programme, Nurses undertaking the practical aspects of dual energy x-ray absorptiometry (DXA) scanning for adults (1st Edition), can be accessed at: www.nmbi.ie/NMBI/media/NMBI/ Nurses-Undertaking-the-PracticalAspects-of-Dual-Energy-X-RayAbsorptiometry-(DXA)-Scanning-forAdults.pdf.

NMBI ANNOUNCES NEW BOARD PRESIDENT

Dr Louise Kavanagh McBride has been elected as the new Board President of The Nursing and Midwifery Board of Ireland (NMBI). Dr Kavanagh McBride has served on the Board since 2015, when she was appointed by the Minister for Health as the Technological Higher Education Association (THEA) Institutes of Technology representative. She has been Vice-President of the Board since 2017. During her time on the Board, Dr Kavanagh McBride served as chair of the Education, Training and Standards Committee, and has also served as a member of the Business, Strategy and Finance Committee and the Fitness to Practise Committee.

Originally from Duleek, Co Meath and living in Co Donegal, Dr Kavanagh McBride is a registered general nurse and nurse tutor, specialising in orthopaedics and emergency nursing.

She is currently Head of the Department of Nursing and Healthcare at Atlantic Technological University, Donegal, providing undergraduate and post-

graduate nursing and healthcarerelated studies in the north-west. She is currently involved in funded research projects in the area of mental health and wellbeing of third level students in partnership with University of Ulster. In her new role, Dr Kavanagh McBride will oversee the implementation of NMBI’s new Statement of Strategy 2023-2025 .

Speaking on her appointment, Dr McBride said: “l am delighted to have been elected by my Board colleagues to take up the position of President. I want to thank my former colleague and outgoing President, Essene Cassidy, for her leadership over the past seven years. I look forward to using my knowledge of the Board and my professional, academic experience and practice to further NMBI’s mission to protect the public and uphold the highest standards of nursing and midwifery education and practice.”

Dr Louise Kavanagh McBride

The first and only treatment indicated to reduce: • all-cause mortality

• frequency of CV-related hospitalisations in patients with wild-type or hereditary ATTR-CM.

• all-cause mortality

• frequency of CV-related hospitalisations in patients with wild-type or hereditary ATTR-CM.1

61MG SOFT CAPSULES

ATTR-CM=transthyretin amyloid cardiomyopathy; CV=cardiovascular.

References:

ATTR-CM=transthyretin amyloid cardiomyopathy; CV=cardiovascular.

MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016. 2. VYNDAQEL Summary of Product Characteristics. Vyndaqelq 61 mg soft capsules (tafamidis) Prescribing Information: Before prescribing Vyndaqel please refer to the full Summary of Product Characteristics. Presentation: Vyndaqel 61 mg soft capsules. Each soft capsule contains 61 mg tafamidis.

Uses: Vyndaqel is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Dosage: Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. When there is a suspicion in patients presenting with specific medical history or signs of heart failure or cardiomyopathy, etiologic diagnosis must be done by a physician knowledgeable in the management of amyloidosis or cardiomyopathy to confirm ATTR-CM and exclude AL amyloidosis before starting Vyndaqel, using appropriate assessment tools such as: bone scintigraphy and blood/urine assessment, and/or histological assessment by biopsy, and transthyretin (TTR) genotyping to characterise as wild-type or hereditary. The recommended dose is one capsule of Vyndaqel 61 mg (tafamidis) orally once daily. Vyndaqel 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine, tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Vyndaqel should be started as early as possible in the disease course when the clinical benefit on disease progression could be more evident. Conversely, when amyoid-related cardiac damage is more advanced, such as in NYHA Class III, the decision to start or maintain treatment should be taken at the discretion of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. There are limited clinical data in patients with NYHA Class IV. If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible. If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual. There are no recommended dosage adjustments for elderly patients or patients with renal or mild and moderate hepatic impairment. Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min). Tafamidis has not been studied in patients with severe hepatic impairment and caution is recommended. There is no relevant use of tafamidis in the paediatric population. Method of Administration: The soft capsules should be swallowed whole and not crushed or cut. Vyndaqel may be taken with or without food.

Contra-indications: Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1 of SPC. Warnings and Precautions: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis and for one month after stopping treatment. Tafamidis should be added to the standard of care for the treatment of patients with transthyretin amyloidosis. Physicians should monitor patients and continue to assess the need for other therapy, including the need for organ transplantation, as part of this standard of care. As there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued in patients who undergo organ transplantation. Increase in liver function tests and decrease in thyroxine may occur. This medicinal product contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of

Based on in vitro data, the maximal predicted changes in AUC of OAT1 and OAT3 substrates were determined to be less than 1.25 for the tafamidis 61 mg dose, therefore, inhibition of OAT1 or OAT3 transporters by tafamidis is not expected to result in clinically significant interactions. No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis. Undesirable Effects: The following adverse events were reported more often in 176 ATTR-CM patients treated with tafamidis meglumine 80 mg compared to placebo: flatulence [8 patients (4.5%) versus 3 patients (1.7%)] and liver function test increased [6 patients (3.4%) versus 2 patients (1.1%)]. A causal relationship has not been established. Safety data for tafamidis 61 mg are not available as this formulation was not evaluated in the double-blind, placebo-controlled, randomised phase 3 study. Legal category: S1A. Marketing Authorisation Numbers: EU/1/11/717/003– 61mg (30 capsules).

Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at EUMEDINFO@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500. Last revised: 04/2021 q 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. See section 4.8 of the SmPC for how to report adverse reactions.

References: 1. Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016. 2. VYNDAQEL Summary of Product Characteristics. Vyndaqelq 61 mg soft capsules (tafamidis) Prescribing Information: Before prescribing Vyndaqel please refer to the full Summary of Product Characteristics. Presentation: Vyndaqel 61 mg soft capsules. Each soft capsule contains 61 mg tafamidis. Uses: Vyndaqel is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Dosage: Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. When there is a suspicion in patients presenting with specific medical history or signs of heart failure or cardiomyopathy, etiologic diagnosis must be done by a physician knowledgeable in the management of amyloidosis or cardiomyopathy to confirm ATTR-CM and exclude AL amyloidosis before starting Vyndaqel, using appropriate assessment tools such as: bone scintigraphy and blood/urine assessment, and/or histological assessment by biopsy, and transthyretin (TTR) genotyping to characterise as wild-type or hereditary. The recommended dose is one capsule of Vyndaqel 61 mg (tafamidis) orally once daily. Vyndaqel 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine, tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Vyndaqel should be started as early as possible in the disease course when the clinical benefit on disease progression could be more evident. Conversely, when amyoid-related cardiac damage is more advanced, such as in NYHA Class III, the decision to start or maintain treatment should be taken at the discretion of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. There are limited clinical data in patients with NYHA Class IV. If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible. If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual. There are no recommended dosage adjustments for elderly patients or patients with renal or mild and moderate hepatic impairment. Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min). Tafamidis has not been studied in patients with severe hepatic impairment and caution is recommended. There is no relevant use of tafamidis in the paediatric population. Method of Administration: The soft capsules should be swallowed whole and not crushed or cut. Vyndaqel may be taken with or without food.

sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Pregnancy and Lactation: Tafamidis is not recommended during pregnancy and in women of childbearing potential not using contraception.Available data in animals have shown excretion of tafamidis in milk.A risk to the newborns/infants cannot be excluded. Vyndaqel should not be used during breastfeeding. Interactions: In a clinical study in healthy volunteers, 20 mg tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4. In vitro tafamidis inhibits the efflux transporter BCRP (breast cancer resistant protein) at the 61 mg/day tafamidis dose with IC50=1.16 μM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib). In a clinical study in healthy participants, the exposure of the BCRP substrate rosuvastatin increased approximately 2-fold following multiple doses of Page 2 of 2 2020-0065522 61 mg tafamidis daily dosing. Likewise, tafamidis inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 μM and IC50=2.36 μM,respectively,and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine). Based on in vitro data, the maximal predicted changes in AUC of OAT1 and OAT3 substrates were determined to be less than 1.25 for the tafamidis 61 mg dose, therefore, inhibition of OAT1 or OAT3 transporters by tafamidis is not expected to result in clinically significant interactions. No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis. Undesirable Effects: The following adverse events were reported more often in 176 ATTR-CM patients treated with tafamidis meglumine 80 mg compared to placebo: flatulence [8 patients (4.5%) versus 3 patients (1.7%)] and liver function test increased [6 patients (3.4%) versus 2 patients (1.1%)]. A causal relationship has not been established. Safety data for tafamidis 61 mg are not available as this formulation was not evaluated in the double-blind, placebo-controlled, randomised phase 3 study. Legal category: S1A. Marketing Authorisation Numbers: EU/1/11/717/003– 61mg (30 capsules).

Ref: VY 61MG 2_0

ATTR-CMIS LIFE-THREATENING1

there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued

Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at EUMEDINFO@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500. Last revised: 04/2021 q This medicinal product is subject to additional monitoring. This will allow quick identification of new safety

for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). ORAL VYNDAQEL

Indicated

The first and only treatment indicated to reduce:

Further information available upon request.

Maurer

Indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

2 ORAL VYNDAQEL

FREE ONLINE COURSE ON MANAGEMENT OF MENOPAUSE BY THE ICGP

To mark International Women’s Day on March 8, the ICGP’s new online course in the management of menopause is going live and available free for all allied health professionals, including nurses, midwives, GPs, and pharmacists. The course comprises a range of modules on the diagnosis and management of the menopause, including menopause consultation in general practice, lifestyle advice, bone health, prescribing HRT, alternatives to HRT, genitourinary syndrome of the menopause, and testosterone replacement therapy.

Celebrating the launch of the course, the ICGP’s Director of Women’s Health Dr Nóirín O’Herlihy highlighted that over 90 per cent of menopause care is provided in general practice.

She added: “This course gives a solid grounding in learning about the menopause, from symptoms to lifestyle and prescribing HRT.” The ICGP/HSE Clinical Lead for

Women’s Health Dr Ciara McCarthy, also commented on the launch, saying:

“Menopause is a major life event affecting all women in a variety of ways, with up to 80 per cent of women experiencing physical and/or emotional symptoms during that time. With the growing awareness and discussion of this life event, we believe this course will be a valuable resource for a huge range of health professionals, from hospital-based doctors to community-based teams, pharmacists, and midwives, for example.”

You can access the course at: www.icgp.ie/go/courses/ women_s_health/menopause.

Renewed calls to address the ongoing GP workforce crisis

The Irish College of General Practitioners (ICGP) and Association of University Departments of General Practice in Ireland (AUDGPI) are calling for urgent action on the funding and development of undergraduate general practice placements to help address the ongoing GP workforce crisis. The joint call for action seeks a more formal and structured collaboration between the ICGP Specialist Training Programme and the Medical Schools Departments of General Practice. A new report, entitled Medical Student to General Practitioner –an Urgent Call to Action, was published on

March 4 at the 2023 AUDGPI ICGP Joint Annual Scientific Meeting in the University of Galway. Against the background of a growing GP workforce crisis, this report highlights the low visibility of general practice at undergraduate level in the country’s medical schools, makes recommendations to promote general practice as a positive career choice, and proposes a clinical academic training pathway in general practice.

CEO of the ICGP Mr Fintan Foy said: “The ICGP knows that not enough graduates of Irish medical schools select general practice as a career, which leaves our long-term workforce planning in

a highly vulnerable position. This joint report with the AUDGPI sets out 14 recommendations to change that.” Dr. Maureen Kelly, Lead Author and Associate Professor, School of Medicine, University of Galway, added: “We need to develop and implement a national funding model that supports the hosting and delivery of undergraduate general practice placements for medical students in all medical schools. The report is a forwardthinking and ambitious approach to GP education. It emphasises the importance of viewing GP education as a continuum.”

You can read the report at www.audgpi.ie/eventsnews/.

HSE launches new suite of clinical practice guidelines in obstetrics and gynaecology

The HSE has launched a new suite of clinical practice guidelines in obstetrics and gynaecology, offering up-to-date, evidence-based, clinical recommendations for care of women in maternity and gynaecology services, and to promote a standardised approach to care across the country. Led by Prof Keelin O’Donoghue and supported by Ms Nicolai Murphy as programme manager, the guidelines are a programme of work agreed between the HSE’s National Women and Infants Health Programme (NWIHP) and the Institute of Obstetricians and Gynaecologists of the Royal College of Physicians of Ireland. The following guidelines have been developed and launched:

1. Assessment and Management of Postmenopausal Bleeding.

2. Assessment and Management of Stress

Urinary Incontinence in Women.

3. Diagnosis and Management of Placenta Accreta Spectrum.

4. Diagnosis and Management of Mesh Complications.

5. Recurrent Miscarriage.

6. Investigation and Management of Complications of Early Termination of Pregnancy.

7. Prevention and Management of Primary

Postpartum Haemorrhage.

8. Diagnosis and Management of Pelvic Organ Prolapse.

9. Prevention of Early Onset Group B Streptococcal Disease in Term Infants.

10. Stillbirth - Prevention, Investigation, Management, and Care.

11. The Foetal Anatomy Ultrasound.

12. Vaginal Birth after Caesarean Section. This first suite of guidelines will be followed with over 30 updated clinical practice guidelines during 2023 and 2024. Each new guideline will be accompanied by a summary document, which will support healthcare professionals with an easy reference guide and a plain language summary, which explains the impact the new guideline will have on women’s care in a simple format. The Guideline Programme Team is also using a mobile app to facilitate easier access to the guidelines for working healthcare professionals around the country.

Commenting on the guidelines, Dr Cliona Murphy, Clinical Director at the National Women and Infants Health Programme, described them as “an important resource” and acknowledged that they will strengthen new initiatives in ambulatory gynaecology, endometriosis, and menopause, that were developed by The National Women and Infants Health

Programme with the support of the Women’s Health Taskforce. She also added that she was “particularly pleased to see plain language documents also produced, which are essential for shared decision making in our maternity and women’s health services”. Prof Keelin O’Donoghue, Clinical Lead for the National Clinical Practice Guidelines, added: “Clinical practice guidelines assist healthcare practitioners, service users, policymakers, and other stakeholders to make informed decisions about health practice, public health and health policy. Clinicians also need up-todate and reliable resources to keep up their knowledge, and guidelines are important to address this need. I would like to acknowledge the time and effort of the committed teams of healthcare professionals and other stakeholders who worked on these guidelines.”

The updated National Clinical Practice Guidelines can be found at: www.hse.ie/eng/about/who/acutehospitals-division/woman-infants/ clinical-guidelines/national-clinicalguidelines.html and https://www.rcpi. ie/Faculties-Institutes/Institute-ofObstetricians-and-Gynaecologists/ National-Clinical-Guidelines-inObstetrics-and-Gynaecology.

Cutting-edge fertility clinic opens in Limerick

Beacon CARE Fertility has announced the opening of its new satellite clinic on Barrington Street in Limerick. Patients attending the satellite Clinic will have direct access to Beacon CARE Fertility’s internationally respected, science-based fertility treatments and

technology, including embryo analysis and genetics, and recurrent miscarriage treatment. The Limerick Satellite marks Beacon CARE Fertility’s continued nationwide expansion following the launch of its first Satellite in Drogheda in October. Medical Director Dr Ahmed Omar commented on the significant

advancements in IVF treatment in recent years and how the clinic will deliver the latest international techniques here in Ireland. He said: “Our motivation from day one was to deliver the latest international techniques, science, and expertise to fertility patients in Ireland, without the need to travel abroad.”

Mental Health Ireland and Iarnród Éireann invite the nation to ask ‘how are you?’ on March 30

Hello, how are you? is a national campaign about connection and engaging in open conversations about mental health. On March 30, the campaign invites communities all over Ireland to say hello and ask the question ‘how are you?’ in a meaningful way. Now in its second year, the national campaign highlights the importance of staying connected, helps tackle loneliness, creates a sense of belonging, and builds relationships. It also encourages early help-seeking through reliable information on mental health support services and signposting.

Findings from a recent survey conducted by Behaviour and Attitudes on behalf of Mental Health Ireland showed that 92 per cent of people are comfortable having a conversation with friends about worries. However, 21 per cent of people

are not confident in knowing how to support friends with worries. The campaign speaks to this by offering support and resources to help with starting and having these more difficult conversations.

On Thursday, March 30, there will be volunteers hosting events all over the country, such as coffee mornings and fundraising challenges, and there are many ways for communities, healthcare professionals and organisations, schools, and workplaces to

get involved. Iarnród Éireann will be supporting the mental health campaign with Hello champions and volunteers at Heuston (Dublin), Cork (Kent), and Galway (Ceannt) stations on March 30. Iarnród Éireann Wellbeing Champions will also be leading Hello events across the country.

Jo Donohoe, Mental Health Promotion Manager, Mental Health Ireland, said “Last year, the first year of Hello campaign, we were blown away by the level of engagement

across the country. This year, partnering with Iarnród Éireann will help us elevate the campaign to bring it to every community in Ireland. Hello, how are you? is all about connecting, as is Iarnród Éireann, which is why this partnership is a great fit. On March 30, we are inviting organisations, schools, workplaces, and individuals to say hello and ask how are you? From coffee mornings to sharing information, getting out for a walk and chat, or even simply picking up the phone, there’s so many ways to connect and celebrate this campaign. We are a nation of great talkers and this campaign offers the tools to ask the question ‘how are you?’ with confidence and meaning and really listen to the answer.”

For free Hello resources, toolkits and all the information you need in different languages, go to www. hellohowareyou.info/resources.

INMO CALLS ON HSE TO COMMIT TO SAFETY AT NOWDOC SERVICE

Further to recent commentary delays in triage at NOWDOC, the INMO, on behalf of nurses working in Donegal/Leitrim, has called on the HSE to properly fund the service to ensure it is safe for patients and staff. INMO Industrial Relations Officer Neal Donoghue has stated that before and throughout the pandemic, nurses working in NOWDOC consistently

highlighted what he called a “serious lack of investment” in the out-of-hours GP service and criticised the HSE for its inadequate response.

He said: “Nurses in the service have a vast range of knowledge and expertise in telephone triage and endeavour to provide the highest standards of service to their communities. However, the HSE continues to employ nurses on temporary

contracts in insufficient numbers, which is simply unsustainable given the demand for their skills and expertise elsewhere and the service needs…. In the north-west, the HSE have fundamentally failed to put in place the necessary structures and supports required to manage NOWDOC. Nurses are reporting that this weakness is contributing to risks to the public in terms of delays in patients being seen by GPs.”

The Pharma Nord Education Series

Pharma Nord is one of Europe’s largest manufacturers of preventive dietary supplements and herbal remedies, aiming to compensate for the shortcomings of modern diet through supplements with high bio-availability and clinically documented effects.

· Learn how to support emotional stability by feeding the imbalanced brain what it craves.

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Integrative ways to control dysglycemia and address insulin deficiency

Friday the 5th of May 2023, 10am- 4pm Talbot Hotel Stillorgan, Stillorgan Rd, Dublin

Friday the 19th of May 2023, 10am- 4pm

The Connacht Hotel, Old Dublin Rd, Galway

Friday the 16th of June 2023, 10am- 4pm

Radisson Blu Hotel, Ditchley House, Little Island, Cork

Maria Plaias, MSc regNT

Advanced Functional Medicine Practitioner (the Kharrazian Institute)

How targeted nutrient therapy supports mental health

Saturday, 22nd April 2023, 10am- 4pm

The Connacht Hotel, Old Dublin Rd, Galway

Saturday, 20th May 2023, 10am- 4pm Radisson Blu Hotel & Spa, Ditchley House, Cork

Friday, 26th May 2023, 10am- 4pm Talbot Hotel Stillorgan, Dublin

Edelle O’Doherty-Nickels, BSc PGDip Reg NT

Functional Medicine Clinician

(Institute of Functional Medicine) Certified Ketogenic Nutrition Specialist (American Nutrition Association)

The events are free, with a registration fee of €10. Lunch, tea& coffee, and goody bag are included.

IE_Edu_Ad_Update_214x275_0323

ICGP WELCOMES THE PUBLICATION OF THE INTERIM REVIEW INTO CAMHS

The Irish College of General Practitioners (ICGP) has welcomed an interim report arising from an independent review of the provision of Child and Adolescent Mental Health Services (CAMHS) by the Inspector of Mental Health Services. The report found that children and young people accessing mental health services with open cases have been ‘lost’ to follow-up care and recommends immediate review and action. Major findings from the report include:

 In one Community Healthcare Organisation (CHO) alone, there were 140 cases within the CAMHS team that did not have an appointment;

 Some cases reached their 18th birthday with no planning, discharge or transition to adult services, or any advice about medication;

 Some CAMHS teams were not monitoring antipsychotic medication in accordance with international standards;

 Some children were taking medication without appropriate blood tests and physical monitoring;

 Many team members were working beyond their contracted hours, often without compensation, to continue to provide a service;

 Teams often lack key staff, especially consultant psychiatrists, are significantly below recommended staffing levels, often work in unsuitable buildings, and lack digital infrastructure;

 There was evidence of stress and burnout in a significant number of team members;

 CAMHS staff worked extremely hard within the often-limited resources to try to provide a good service to the public. The Inspector decided to produce an Interim Report due to "the serious concerns and consequent risks for some patients" that were found across the four

CHOs that had been examined so far, so that urgent and targeted action can be taken to address these risks.

Immediate recommendations made by the Inspector include:

 An immediate clinical review of all open cases in all CAMHS teams, with particular focus given to identifying and assessing open cases of children who have been lost to follow-up and physical health monitoring of those on medication.

 That the Minister for Mental Health ensures, as a priority, that there is immediate regulation of CAMHS, under the Mental Health Act 2001.

Responding to the publication of the interim review, Medical Director of the ICGP Dr Diarmuid Quinlan highlighted that many GPs have no alternative but to refer children and young people to already burdened emergency departments to access mental health services.

He also said: “GPs all over the country have experienced the deficiencies in CAMHS services highlighted by this review. GPs are the first port of call for families worried about children with mental health difficulties. GPs refer young people with moderateto-severe mental health illness to CAMHS for specialist care. However, the experience is that many CAMHS referrals are declined because of their narrow acceptance criteria. These criteria vary hugely from area to area.” The ICGP’s Assistant Medical Director Dr Brian Osborne also commented, highlighting that “GPs see children and adolescents with anxiety, ADHD, depression, emotional problems, selfharm, and eating disorders. There are huge numbers of children waiting for their first appointment with CAMHS. Care needs to be child-centred with an emphasis on working together for the benefit of the child and family.”

The Inspector's review is continuing and this will involve further meetings with young people, parents, and stakeholders in the remaining CHO CAMHS. The Inspector's final report is due for publication later this year.

Also commenting on the report, Damien McCallion, HSE Chief Operations Officer, said: “This Mental Health Commission report comes at a time when we have a major CAMHS improvement process underway, and we will be putting a senior clinical/operational team in place to drive and support that process. This interim report, as well as the current prescribing review and other ongoing HSE audits in CAMHS, combined with the service improvement work underway, will all contribute to this process.”

The Maskey Report – a result of the investigation into alleged overprescribing of medication to children in South Kerry CAMHS – was published in January 2022 and contains 35 recommendations covering a broad range of areas, such as re-establishing trust in CAMHS, governance of the service, delivery of clinical services, improved clinical practice, and the use of information and communication technology to support the delivery of services. In order to provide assurance to those who use CAMHS, the HSE’s National Oversight Group commissioned several national audits in relation to prescribing practice, compliance with the HSE CAMHS operational guidelines, and research on service user and key stakeholder experiences of CAMHS. Information from these national audits will guide continued efforts to bring youth mental health services in line with the National Mental Health Policy, Sharing the Vision . The HSE says it will continue to work in a targeted way to continue to improve mental health services throughout 2023.

A BLEAK PICTURE OF THE REALITIES OF UNSAFE NURSE STAFFING

Commenting on the publication of three HIQA inspection reports, the Irish Nurses and Midwives Organisation (INMO) has said the HSE and Department of Health must heed warnings on insufficient nurse and midwife staffing. HIQA’s reports into Cork University Maternity Hospital, University Hospital Kerry, and Tallaght University Hospital paint what INMO General Secretary Phil Ní Sheaghdha described as a “bleak picture of the realities of unsafe nurse staffing”. She said: “Of the 10 HIQA reports carried out in hospitals in the last 11 months, not one hospital has been found fully

compliant when it comes to staffing. This is totally unacceptable, but not a surprise to our union. The INMO has been long sounding the alarm on the very real human impact that unsafe staffing has on both nurses and the patients they are trying to provide care for.” She also stated that these reports should be a catalyst for change and should not “just sit on a shelf or in an inbox”.

Commenting about plans for industrial action, the General Secretary also said: “Ballots for industrial action have been sanctioned on a location-by-location basis, as it is clear that the staffing levels in certain locations are enduring

a huge shortfall. We know that many hospitals cannot keep up with the pace at which nurses are leaving to work in safer environments.” INMO President Karen McGowan also commented on the current state of staffing in Irish healthcare settings. She said: “Safe staffing should not be a pipe dream for nurses. Patients should be made aware of the severity of the staffing deficits our members are trying to work through. Hospital management in each location cannot keep trying to fill from an empty cup. The expectation that we can run our health service at a less-than-safe staffing capacity must be challenged.”

Minister for Health announces the development of a National Endometriosis Framework

The Minister for Health

Stephen Donnelly TD has announced the development of the National Endometriosis Framework, which sets out a defined clinical care pathway for women with endometriosis for the first time in Ireland. Developed by the HSE’s National Women and Infants Health Programme (NWIHP), the framework will be implemented on a phased basis, commencing this year. It is built around the principle of ‘right care, right place, right time’ and proposes that women with symptoms of endometriosis be treated on the basis of presumed diagnosis. Commenting on the framework, Minister Donnelly said: “Since 2019, the Women's Health Taskforce has heard testimony from women with endometriosis who have described their experiences

of the disease as 'painful, isolating, misdiagnosed, lonely, and dismissed’. This framework, along with investment in holistic treatment teams and in two supra-regional hubs for complex cases, are important steps towards improving their experiences and outcomes."

Endometriosis is one of the most common gynaecological conditions in Ireland and affects approximately onein-10 women. It is estimated that 47 per cent of women who experience fertility issues have the condition, and in many cases, endometriosis may only be suspected or diagnosed when a woman undergoes fertility investigations. Most cases can be managed successfully at primary care level in general practice, but some patients will require additional multi-disciplinary support at secondary care level. This is being facilitated with the setting up of five

interdisciplinary teams to support the holistic treatment of endometriosis in each of the maternity networks. A small number of women with more complex cases will require expert treatment in two supra-regional endometriosis specialist centres, which are currently in development.

Clinical Director for the National Women and Infants Health Programme Dr Cliona Murphy also welcomed the announcement, describing the framework as “a significant development in our efforts to improve endometriosis care”. She said: “Together with the establishment of other specialist women’s health services, such as ‘see and treat’ ambulatory gynaecology services, specialist menopause clinics, and regional fertility hubs, we are delivering tangible improvements in women’s healthcare."

‘Shape-shifting’ implanted medical device to provide clinically accepted continuous blood pressure monitoring outside of hospital

The European Union has awarded a European consortium €4.4million for the SMARTSHAPE project to focus on developing an implantable medical device for continuous blood pressure monitoring. The SMARTSHAPE consortium is led by Prof William Wijns, a Science Foundation Ireland (SFI) funded Research Professor in Interventional Cardiology at University of Galway’s College of Medicine, Nursing, and Health Sciences.

Hypertension is the leading global contributor to premature death, accounting for more than 9 million deaths each year. Many high-risk patients require long-term monitoring to tailor drug treatments and improve healthcare outcomes, but there is no clinically accepted method of continuous blood pressure monitoring that patients can use outside of the hospital setting. According to Prof Wijns, “the best innovations start with a clinical need.” Commenting on the project, he said: “Patients who require monitoring are better off in their own homes rather than in a hospital setting. There is a huge market opportunity for a medical-grade, user-friendly, and minimally invasive solution for continuous blood pressure monitoring.”

Also commenting, Dr Atif Shahzad, joint Director of the Smart Sensors Lab at the University of Galway and a research fellow at the Institute of Metabolism and Systems Research at the University of Birmingham described how the team will address current challenges by creating a novel temperature-dependent shape memory polymer (SMP). He explained: “SMPs will enable the development of a microsensor that can be curled up, introduced into

the body through a minimally invasive procedure, and ‘opened up’ when placed at body temperature to take a predefined shape,” before outlining current barriers like biocompatibility, longevity, and delivery to target tissue that must still be overcome before the technology is complete.

Kevin Michels-Kim, Chief Executive of Merakoi, which facilitates patient collaboration in research also commented. He said: “We are committed to putting the patient at the centre of SMARTSHAPE, allowing us to create novel solutions that truly meet the needs of patients. Merakoi will play a crucial role in the SMARTSHAPE consortium by integrating the patient voice across the product lifecycle. Our ability to harness deep patient understanding from the start enables

the consortium to develop patientbeneficial solutions that maximise the adoption and impact of innovative technologies and devices.”

Dr Sandra Ganly, Senior Research Fellow in Cardiovascular Risk Factor Research, College of Medicine, Nursing and Health Sciences, at the University of Galway, added: “Blood pressure monitoring will represent the first SMARTSHAPE application. However, the potential of this sensing solution goes significantly beyond BP monitoring. Continuous physiological pressure monitoring can provide key information for early diagnosis, patient-specific treatment, and preventive healthcare in a wide range of healthcare indications. This will significantly broaden the potential and open avenues for other products and research innovation.”

Dr Atif Shazid, University of Birmingham; Prof William Wijns, University of Galway; Profr Ciarán Ó hÓgartaigh, President of University of Galway; and Dr Sandra Ganly, Senior Research Fellow at University of Galway

NEW RESEARCH ILLUMINATES CHALLENGES FOR GENERAL NURSES WORKING IN ADDICTION TREATMENT SERVICES

Asystematic review of the challenges experienced by general nurses working in addiction treatment services has been carried out

research, Ms Makiwa made the following recommendations:

by Samantha Makiwa

RGN, MW, BSc, MSc, and Nurse Manager

at Dublin Simon

 Training institutions to develop a structured training programme covering all aspects of caring for patients experiencing substance use disorders;

Community’s

Blood Borne Virus and Respite Stabilisation Unit. The objective for carrying out the research was to determine the cause of the current exodus of nurses in addiction settings. There is a high turnover of general nurses in addiction treatment services as compared to nurses who work in other departments or sectors. The challenges identified in the research included challenging behaviour from patients, the legal implications surrounding patient care, difficulties with the work environment itself, the psychological effect of working in addiction treatment services, the stigma faced by nurses working in addiction treatment services, and organisational processes that are lacking and/or unclear.

When patients failed to complete their rehabilitation and returned for detoxification within a short space of time, this was found to be demotivating to staff. An increased risk of overdose and the use of new substances, such as Gamma Hydroxybutyrate, or GHB, also proved concerning. Nurses experienced

violent and aggressive behaviour from patients under the influence of illicit substances, and when illicit substances were discovered and discarded. They feared lawsuits if resuscitation couldn’t be carried out successfully, along with the prospect of losing their registration pin as a consequence.

It was found that addiction clinics tended to be situated in old, run-down buildings, with inadequate private spaces to attend to patients. So too, caring for patients in addiction was found to be emotionally draining. Nurses also felt that there was a stigma around working in addiction treatment services, and that they were looked down upon or deemed to be inferior by others working in the medical field.

A lack of effective clinical supervision, and access to a

supervisor with knowledge of illicit substances was also recognised as an issue, along with a lack of support around decision making. A lack of clarity around policies and procedures relating to drug-taking behaviour within addiction treatment services was also identified as problematic. In terms of nursing practice, it was found that rehabilitative care was limited to a few patients who showed readiness to transform, while patients with the greatest need could end up being left without treatment.

The findings reveal that these challenges are experienced internationally, but with proper training, accreditation, recognition, and support, morale could be improved, leading to better retention of general nurses working in addiction treatment services. In concluding the

 Comprehensive inductions for new nurses to settle well into the job;

 Policies, guidelines, and procedures to protect the patient, staff, and the organisation;

 Multidisciplinary collaboration, (for example, Garda liaison where illicit substances are found within the addiction treatment service);

 Consistent clinical supervision and support to allay anxiety;

 Peer group meetings for staff to share their concerns and experiences to help to identify problems and make early interventions where necessary. Commenting on her research, Ms Makiwa said: “Addiction nursing is an important speciality that should be embraced, recognised, and accredited in the same way that other specialities are. I believe that the findings from this study can be the starting point in the mitigation of the challenges experienced by nurses, thereby improving the retention of nurses and improving the quality of care at addiction treatment services.”

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AUTHOR: Marie Cantwell, Professional Development Coordinator for General Practice Nurses

HAVE YOU CONNECTED WITH YOUR PROFESSIONAL DEVELOPMENT COORDINATOR LATELY?

AS PDCS FOR GENERAL PRACTICE NURSING, WE ARE EMPLOYED BY THE HSE TO SUPPORT GPNS AT AN INDIVIDUAL AND COLLECTIVE LEVEL

We know that working in general practice presents a variety of challenges that are unique in comparison to any other kind of nursing. Unlike your colleagues in the public sector, as GPNs, you update your skills and knowledge in your own time and at your own expense. In addition, that knowledge must span across the entire life cycle and encompass the entire spectrum of public health issues, disease prevention, health promotion, chronic disease management, acute disorders, pregnancy and breastfeeding, child development, and myriad other areas general practice brings. We also recognise that working in general practice means you lack the diverse multidisciplinary team to collaborate with and management system to regulate and govern practice that exists within the public sector.

The reality is that some GPNs work in very small practices, in very rural areas, and with minimal support, professional networks, or opportunities for career development. Many also work in practices where demands and expectations can sometimes extend beyond your scope of practice. We know that the role can be demanding, challenging, and in some cases, lonely and isolated. The supportive role of the professional development coordinator

(PDC) is designed to bridge many of these gaps in current practice, as well as the one between the public and private settings. We will be updating you regularly as we work with Nursing in General Practice (NiGP) to meet your needs and build a stronger network of GPNs in Ireland.

As PDCs for general practice nursing, we are employed by the HSE to support GPNs at an individual and collective level. The team is available to provide support at all career stages, from induction as a new or transferring GPN, to all levels of enhanced practice, including RNP and ANPs. We provide practical advice and

guidance in continuing professional education, assist with development of practice policies, facilitate training, and offer career support and advice. We also develop and maintain training programmes in collaboration with national clinical offices in areas such as chronic disease management, cervical screening, and immunisation. Some of the direct support and resources available includes:

 New GPN induction;

 Service/policy development;

 Training needs analysis;

 Professional development planning;

 Signposting to training and

education and facilitation where available;

 RNP/ANP candidacy support;

 RNP/ANP audit support;

 Drugs and therapeutics committees/ prescribing site coordinators;

 Information circulation via GPN mailing lists;

 Educational meetings and webinars.

The purpose of the PDC role is to ensure that as non-HSE employees, GPNs are supported and represented, and that the service is strategically developed in line with national strategy and policy. We are currently working with all stakeholders at a national level towards the strategic development of general practice nursing, including working towards established career and academic pathways, and the recognition of general practice nursing as its own division of the NMBI speciality register. Online educational content developed in partnership with National Clinical Programme Offices, the Primary Care Strategy Office, Office of the Nursing and Midwifery Services Director (ONMSD), and others includes:

 Type 2 diabetes;

 Chronic disease management;

 Immunisation training;

 Make every contact count;

 Infection prevention and control;

 Cancer nursing in the community. We also represent general practice nursing on local and national working groups in a diverse range of areas, such as the National Cancer Screening Service, the Primary Palliative Care Steering Group, and Enhanced Community Care implementation committees. National and international groups on which the PDCs represent GPNs include:

 Primary care management teams;

 Slaintecare steering group;

 ECC integrated care implementation groups x CHO;

 National healthy childhood committees: Immunisation, healthy weight for children, active and healthy, breastfeeding;

 National cancer control programme, community nursing working group;

 Cervical check education standards working group;

 National clinical programmes in chronic disease management, diabetes, COPD, adult weight management, primary palliative care, immunisations;

 International Cervscreen project (WHO as a key stakeholder). Overall, we act as a conduit for information, news, and updates in health services, educational opportunities, and developments in primary care for the GPN population. We welcome the recent report from the Expert Review Body on Nursing

and Midwifery that was published in March. The report makes several recommendations pertaining to the role of GPNs and PDCs. We are actively working with the INMO and the HSE towards the early implementation of these recommendations and will be supporting them as and when they happen. The full report can be accessed at www. assets.gov.ie/219846/ea2cf1ee-ec4c-4a55aeb7-2e5504e62c5d.pdf.

Following retirements and relocations, there are currently only four out of the original nine PDC posts filled countrywide. Regardless, we are available to provide urgent advice and support throughout Ireland and encourage any GPN that would like more information or assistance to make connect with any of us. All PDCs have a background in general practice nursing, therefore, we are familiar with your unique status as being employed by a GP and the challenges this brings. Any data you share with us is maintained under GDPR legislation and is only used for training and development activity or workforce development purposes. We look forward to hearing from you and to building towards integrated education, integrated care, and an integrated discipline of nurses general practice. l

We are currently updating our website so keep an eye on www.hse.ie/eng/services/list/2/primarycare/practicenursing/

CHO 4. Cork, Kerry Marie Courtney marie.courtney@hse.ie 086 787 2408 CHO 9. Dublin, North City and County Marie Cantwell marie.cantwell@hse.ie 087 607 8925 CHO 1. Sligo, Leitrim, Cavan, Monaghan, Donegal Kathy Taaffe kathy.taaffe@hse.ie 087 132 1424 CHO 2. Galway, Roscommon, Mayo Mairead Murphy mairead.murphy11@hse.ie 087 120 6184

ALL PDCS HAVE A BACKGROUND IN GENERAL PRACTICE NURSING, ... BEING EMPLOYED BY A GP AND THE CHALLENGES THIS BRINGS

DIAGNOSIS AND MANAGEMENT OF ASTHMA IN ADULTS AND ADOLESCENTS: A REVIEW

THE FOLLOWING EXPLORES THE DIAGNOSIS AND MANAGEMENT OF ASTHMA IN ADOLESCENTS AND ADULTS

nurse CPD

To complete this module and earn free CPD points, go to www.nurseCPD.ie and answer the 10 true or false questions and complete the five MCQs based on this article.

Asthma is a major long-term, non-communicable disease affecting both adults and children. It is the most common chronic disease found in children. In 2019, asthma affected an estimated 262 million people worldwide and was responsible for 455,000 deaths. In Ireland, one-in-13 people have asthma, costing €472 million per annum.

Asthma is included in the World Health Organisation (WHO) Global Action Plan for the Prevention and Control of NonCommunicable Diseases and the United Nations 2030 Agenda for Sustainable Development. Asthma cannot be cured, but it can be managed with appropriate use of medication, allowing patients to enjoy a normal and active life.

Definition

The Global Initiative for Asthma (GINA) defines asthma as a heterogenous

disease, usually characterised by chronic airway inflammation. It is defined by a history of respiratory symptoms, such as wheeze, shortness of breath, chest tightness and cough, that vary over time and intensity, together with variable expiratory airflow limitation. Variations in airflow are typically triggered by factors such as exercise, allergen, or irritant exposure, change in weather or viral respiratory infections. Symptoms may resolve spontaneously or in response to medications and be absent for months at a time.

Asthma is a heterogenous disease, however, recognisable clusters do emerge based on demographic, clinical and pathophysiological characteristics, and are referred to as asthma phenotypes. Some of the most common phenotypes are:

 Allergic asthma: Often commences in childhood and is associated with past and/ or family history of allergic disease such as eczema, allergic rhinitis, or food or drug allergy. Patients usually respond well to inhaled corticosteroid (ICS) treatment.

 Non-allergic asthma: Asthma that is not associated with allergy. Patients often display less short-term response to ICS.

 Adult-onset asthma: Asthma which presents for the first time in adult life. Patients tend to be non-allergic and often require higher doses of ICS or are relatively refractory to corticosteroid treatment. Occupational asthma should

be ruled out in patients presenting with adult-onset asthma

More recently, there is growing academic endorsement for the classification of asthma into type 2 and non-type 2 asthma. Type 2 inflammation is cell mediated with T-helper type 2 cells playing a key role. In response to allergens there is a release of cytokines leading to a cascade of immune responses resulting in inflammation. Typically, type 2 inflammation is linked to eosinophilia and increased IgE. Various conditions including asthma, atopic dermatitis, and rhinitis are linked to type 2 inflammation. Usually, type 2 asthma has a good response to ICS. Severe asthma with type 2 inflammation is associated with a higher risk of exacerbation, hospitalisation, and death than if type 2 inflammation is not present. It is this group that is being targeted for new biological therapies for asthma. Dupilumab, for example, was endorsed in the UK by the National Institute for Health and Care Excellent (NICE) in December 2021 and is licensed for treating severe asthma with type 2 inflammation.

Diagnosis

Making a diagnosis of asthma in a patient not on controller treatment is based on recognising both a characteristic pattern of respiratory symptoms and demonstrating variable expiratory airflow limitation. Typical respiratory symptoms

AUTHORS: Dr Shane Brennan, GP registrar, South East Training Scheme; and Dr Dermot Nolan, former ICGP/HSE National Clinical Lead for Asthma

include cough, wheeze, dyspnoea, and/or chest tightness. Symptoms are often worse at night or early morning. Symptoms vary over time and in intensity. Symptoms are precipitated by viral infections, exercise, allergen exposure, changes in weather, or irritants such as cigarette smoke or exhaust fumes.

Once a classical pattern of respiratory symptoms has been recognised it is important to confirm the diagnosis of asthma with documentation of variable

expiratory airflow limitation. This is to avoid unnecessary treatment or over treatment, and to avoid missing alternative diagnoses. A recent study of patients aged 18 years and over with a diagnosis of asthma in the previous five years found that when subjected to spirometry, 33 per cent had asthma excluded. Similarly, approximately 50 per cent of children diagnosed with asthma have been found to have been incorrectly diagnosed.

Confirmation of variable expiratory

airflow limitation is a two-step process. First, expiratory airflow limitation should be documented. At a time when FEV1 is reduced, confirm that FEV1/FVC is reduced compared to the lower limit of normal, ie, >0.75-0.80 in adults and >0.90 in children. Second, excessive variability in lung function should be documented, ideally via a bronchodilator (BD) responsiveness test. This is deemed to be positive when there is an increase in FEV1 of ≥12 per cent and ≥200ml measured 10-to-15 minutes post 200400mcg salbutamol, compared with prebronchodilator readings.

If spirometry is not available, excessive variability can be demonstrated by diurnal peak expiratory flow (PEF) measurement over two weeks. This is positive if the average daily diurnal PEF is >10 per cent

FIGURE 1: Medication management of asthma in adults and adolescents >12 years. GINA 2022

MORE RECENTLY, THERE IS GROWING ACADEMIC ENDORSEMENT FOR THE CLASSIFICATION OF ASTHMA INTO TYPE 2 AND NON-TYPE 2 ASTHMA

in adults and >13 per cent in children. Diurnal PEF variability is calculated from twice-daily readings as the daily amplitude percent mean, ie, ([day’s highest – day’s lowest]/mean of day’s highest and lowest) x 100.

If possible, variable expiratory airflow limitation should be documented before treatment is initiated because variability typically decreases with ICS treatment as lung function improves.

Management of asthma

Medications for the management of asthma can be divided into two broad categories: Controller medications and reliever medications.

Controller medications contain ICS. They reduce airway inflammation, control symptoms, and reduce future risks of exacerbations and decline in lung function.

Reliever medications are used for as-needed relief of breakthrough symptoms, including during worsening asthma or exacerbations.

In 2019 GINA endorsed a fundamental change in asthma management when it made a recommendation against the treatment of asthma in adults and adolescents with a short-acting beta agonist (SABA) alone. Low-dose ICSformoterol as a reliever is now the preferred approach recommended by GINA. When a patient at any step along the treatment ladder has asthma symptoms they should use ICS-formoterol as-needed for symptomatic relief. In addition, patients on steps 3-to-5 of the GINA treatment ladder should take ICS-formoterol as regular daily treatment. This is known as low-dose ICS-formoterol as maintenance and reliever therapy (MART).

Where ICS-formoterol as reliever is not possible, GINA recommends that for those patients with mild asthma on a SABA asneeded therapy alone, they should have a low-dose ICS added to their therapy, to be taken in combination with, or right after, the SABA for symptomatic relief.

The recommendation by GINA for extending the recommendation for asneeded ICS-formoterol stemmed from

several considerations. Patients with mild asthma and infrequent symptoms can still have severe or fatal exacerbations. A single day with increased as-needed ICS-formoterol reduces the short-term risk of severe exacerbation compared with SABA use alone. GINA points out that recommending that patients should be provided with a controller medication from the outset of management allows for consistent messaging. It avoids the scenario previously, where a patient starts out on a SABA alone and then is asked to add a daily controller despite treatment being adequate from the patient’s perspective, thus avoiding over-reliance on SABA as the main asthma treatment.

recommends as-needed ICS-formoterol for steps 1-to-2.

Step 3 refers to patients who experience daily symptoms or wake from sleep due to asthma once a week or more. These patients should be commenced on regular low-dose ICS-formoterol as maintenance in addition to reliever therapy, ie, MART.

Step 4 refers to those patients who experience daily symptoms or wake from sleep once a week or more and exhibit low lung function. GINA recommends in such patients increasing to medium-dose ICS-formoterol.

Step 5 refers to those with severe, uncontrolled asthma. These patients will require referral to specialist clinics with access to biologic therapies including antiIgE (omalizumab), anti-IL5 (mepolizumab), anti-IL5R (benralizumab), anti-IL4 (dupilumab), and oral corticosteroids.

The usual dose of as-needed budesonide-formoterol in mild asthma is a single inhalation of 200/6mcg. The maximum recommended dose of asneeded budesonide-formoterol in a single day corresponds to a total of 72mcg formoterol (12 inhalations of budesonideformoterol 200/6mcg). ICS-formoterol formulations other than budesonideformoterol have not been studied for as-needed only use, but beclomethasoneformoterol may also be suitable. Rinsing the mouth is generally not needed after as-needed use of low-dose ICS-formoterol.

Figure 1 sets of the step-wise approach to the management of asthma. Steps 1-to-2 refers to patients who experience symptoms less than four-to-five days a week. As discussed above, GINA

Note that for all treatment steps, GINA highlights that leukotriene receptor antagonists (LTRA) and sublingual immunotherapy (SLIT) are potential alternative controller options. Immunotherapy involves desensitisation to specific allergens and works by reducing the inflammatory response to the sensitised antigen. SLIT involves delivering desensitising doses of an antigen under the tongue. Currently in Ireland, SLIT is limited to grass pollen allergy, however, house dust mite and tree pollen therapies are in development.

Once asthma treatment has been commenced, controller treatment should be adjusted up or down in a step-wise approach to achieve good symptom control and minimise risk of exacerbations. Once good control has been achieved for two-to-three months, treatment may be stepped down to find the patient’s minimum effective treatment.

If a patient has ongoing poor symptom control despite two-tothree months of controller treatment, assess for any modifiable factors before stepping up treatment. Common causes for poor symptom control include poor inhaler technique, poor adherence to treatment, persistent exposure to

THE RECOMMENDATION BY GINA FOR EXTENDING THE RECOMMENDATION FOR AS-NEEDED ICSFORMOTEROL STEMMED FROM SEVERAL CONSIDERATIONS

allergens such as cigarette smoke and air pollution, or to medications such as beta-blockers and non-steroidal antiinflammatory drugs (NSAIDs).

Asthma and Covid-19

People with asthma do not appear to be at increased risk of contracting Covid-19 and studies do not indicate that people with well-controlled asthma are at increased risk of Covid-19-related death. However, the risk of Covid-19related death was increased in those who recently required oral corticosteroids for their asthma. Therefore, it is essential to continue good asthma management through the maintenance of good symptom control and the minimisation of oral corticosteroid use. It is essential that patients continue to take asthma medications as prescribed, including ICS. Stopping ICS can lead to potentially

dangerous worsening of asthma.

Written asthma actions have added importance in the context of Covid-19. These enable the patient to recognise the symptoms of worsening asthma, how to increase medications, and when to seek medical help.

Nebulisers can transmit respiratory viral particles up to one metre. Use of nebulisers should be restricted to the management of life-threatening asthma exacerbations in acute care settings. In all other instances, SABA for acute asthma should be delivered via a pressurised metered-dose inhaler and spacer with a mouthpiece and tightly-fitting face mask.

Conclusion

Asthma is one of the most common chronic respiratory conditions, with burdensome implications in terms of morbidity for the patient and cost to the State. The

TRUE/FALSE QUESTIONS

first step in reducing this burden is for clinicians to be able to recognise the classical respiratory symptom patterns of asthma, allied to objective documentation of variable expiratory airflow limitation to confirm the diagnosis.

Treatment of asthma has evolved over the last number of years. Chief among this being GINA’s recommendation that ICS-formoterol form the cornerstone of asthma management. New biological and immunological therapies are now entering the management protocol across all severities of asthma, which will further reduce the symptom burden on patients. Clinicians should strive to implement and encourage adherence to personalised asthma management plans, particularly in the context of the ongoing Covid-19 pandemic. l

References on request

Q1 Asthma is the most common chronic disease found in children.

True or false?

Q2 Adult-onset asthma typically responds well to inhaled corticosteroids.

True or false?

Q3 Type 2 inflammation is associated with increased IgE.

True or false?

Q4 Spirometry is the only means of confirming variable expiratory outflow limitation.

True or false?

Q5 GINA recommends that adults with mild asthma (ie, symptoms less than twice a month) can be treated with SABA alone.

True or false?

Q6 All combinations of ICS/ LABA inhalers can be used for maintenance and reliever therapy.

True or false?

Q7 The maximum recommended dose of as-needed budesonideformoterol 200/6mcg in a day is 12 inhalations.

True or false?

Q8 Sublingual immunotherapy involves desensitisation to

specific allergens and works by reducing the inflammatory response to sensitised antigen.

True or false?

Q9 Patients with asthma are at increased risk of contracting Covid-19.

True or false?

Q10 Nebulisers should be restricted to the management of asthma in acute care settings.

True or false?

To see the answers to these questions and to earn free CPD points, complete this module on www.nurse.ie

GOLD 2023: IMPLICATIONS FOR PRACTICE

THE GLOBAL INITIATIVE FOR CHRONIC LUNG DISEASE HAVE RELEASED THEIR UPDATED GUIDELINES WITH SOME SIGNIFICANT CHANGES AND HOW THEY IMPACT ON THE MANAGEMENT OF COPD

In November 2022, the Global Initiative for Chronic Lung disease (GOLD) released their updated guidelines with some significant changes. This article reviews these changes and how they impact on the initial and ongoing pharmacological management of chronic obstructive pulmonary disease (COPD).

The definition of COPD has been revised – “COPD is a heterogenous lung condition characterised by respiratory symptoms (dyspnoea, cough, sputum production) due to abnormalities of the airways (bronchitis, bronchiolitis) and alveoli (emphysema) that cause persistent and often progressive airflow obstruction.”

In 2016, Ireland was noted as having the highest hospitalisation rates per 100,000 head of population in the OECD in relation to COPD. It is estimated that 380,000 people are living with COPD in Ireland and yet only 110,000 are diagnosed. It is more prevalent in the more vulnerable in society, including people from areas with high social deprivation.

The GOLD Refined Assessment Tool, first introduced in 2017, included spirometric assessment of airflow obstruction and grouping of patients based on symptoms (primarily breathlessness) and recent history of exacerbations (as an indicator of future exacerbation risk). The original model stratified patients into four groups (A, B, C, and D) based on high or low exacerbation risk and high or low symptoms using the COPD Assessment

Test (CAT score) and/or Medical Research Council Score (MRC) (Figure 1). Initial pharmacological treatment was based on these groupings. The recommendation for patients with a low exacerbation risk and a low symptom burden (CAT <10) (Group A) was a short-acting bronchodilator. For those with a high symptom burden (CAT >10) and a low exacerbation risk (Group B) was a long-acting bronchodilator (LABA) or long-acting muscarinic agent (LAMA). For patients with a high exacerbation risk and a low symptom burden (Group C), a LAMA was recommended. For those with a high symptom burden and a high risk of exacerbation (Group D), combination therapy (LAMA + LABA or LABA + inhaled corticosteroid [ICS]) was recommended. While the assessment of severity based on spirometric evaluation remains, the grouping of patients by symptom burden and future exacerbation risk has changed in the 2023 update (Figure 2), along with the recommended initial pharmacotherapy for each group (Figure 3).

Management of patients with a low risk of future exacerbations

The treatment for patients with a low risk of exacerbation and low symptom burden (Group A) remains the same (Figure 3). The 2023 report is very clear that there is no longer a role for the LABA + ICS combination for the initial treatment of patients with COPD at low risk for exacerbations.

Management of patients with a high risk of future exacerbations

Perhaps the most significant change is that patients at high risk for exacerbations are no longer stratified by symptom burden. Instead, these patients are grouped together as Group E, with initial treatment being a LABA + LAMA combination ( Figure 3). For these patients, a more rational approach to ICS use is recommended, guided by clinical factors and blood eosinophil levels. Patients that are unlikely to benefit from an ICS are those with a blood eosinophil count of 300 cells/µL, a history of hospitalisation for COPD exacerbations with ≥2 moderate exacerbations a year or with a history of, or concomitant asthma. When considering starting an ICS, blood eosinophils are not the only useful factor. There are known harms of ICS use, including an increased risk of pneumonia and of mycobacterial infection. Patients with a history of recurrent pneumonia and those with a previous mycobacterial infection should not routinely be started on ICS as the harms may well outweigh the benefits. These fundamental changes to the classification and initial treatment of patients with a high risk of future exacerbations reflect the findings of the ECLIPSE study. This study demonstrated that an eosinophil count, an indicator of underlying inflammation, was a better predictor of response to ICS therapy

AUTHOR: Ruth Morrow, Registered Advanced Nurse Practitioner (Primary Care), Respiratory Nurse Specialist (WhatsApp Messaging Service Asthma Society of Ireland), and Nurse Educator and Consultant

FIGURE 1: The original refined GOLD ABCD Assessment Tool (2017) FIGURE 2: The updated GOLD ABE Assessment Tool

For patients not adequately controlled on dual therapy with moderate to severe COPD

UNLEASH THE PROTECTION

OF TRIXEO1,2 Significant protection against exacerbations*

TRIXEO Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.1

*Significant reductions in the rate of moderate or severe exacerbations vs LAMA/LABA (24%, n=2137 vs n=2120, annual rates 1.08 vs 1.42, 95% CI 0.69–0.83; p<0.001) and ICS/LABA (13%, n=2137 vs n=2131, annual rates 1.08 vs 1.24, 95% CI 0.79–0.95; p=0.003).1,2 COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist. In the clinical trial programme for TRIXEO, LAMA/LABA refers to glycopyrronium/formoterol fumarate and ICS/LABA refers to budesonide/formoterol fumarate. ©AstraZeneca 2022. All rights reserved.

ABRIDGED PRESCRIBING INFORMATION

TRIXEO AEROSPHERE® 5 micrograms/7.2 micrograms/160 micrograms

pressurised inhalation, suspension (formoterol fumarate dihydrate/ glycopyrronium/ budesonide)

Consult Summary of Product Characteristics (SmPC) before prescribing. Indication: Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Presentation: Pressurised inhalation, suspension. Each single actuation (delivered dose, ex-actuator) contains 5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2 micrograms of glycopyrronium and budesonide 160 micrograms.

Dosage and Administration: The recommended and maximum dose is two inhalations twice daily (two inhalations morning and evening). If a dose is missed, take as soon as possible and take the next dose at the usual time. A double dose should not be taken to make up for a forgotten dose. Special populations: Elderly: No dose adjustments required in elderly patients. Renal impairment and Hepatic Impairment: Use at recommended dose in patients with mild to moderate renal impairment, and patients with mild to moderate hepatic impairment. Can also be used at the recommended dose in patients with severe hepatic impairment, severe renal impairment or end-stage renal disease requiring dialysis, only if expected benefit outweighs the potential risk. Patients with severe hepatic impairment should be monitored for potential adverse reactions. Paediatric Population: No relevant use in children and adolescents (<18 years of age). Method of administration: For inhalation use. Patient’s inhaler technique should be regularly reviewed by physician or other healthcare professional. Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer.

Contraindications: Hypersensitivity to the active substances or to any of the excipients.

Warnings and Precautions: Not for acute use: Not indicated for treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. Paradoxical bronchospasm: Administration of formoterol/glycopyrronium/budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life threatening. Treatment should be discontinued immediately. Assess patient and institute alternative therapy if necessary. Deterioration of disease: Recommended that treatment should not be stopped abruptly. If patients find the treatment ineffective, continue treatment but seek medical attention. Increasing use of reliever bronchodilators indicates worsening of the underlying condition and warrants reassessment of the therapy. Sudden and progressive deterioration in the symptoms of COPD is potentially life threatening, patient should undergo urgent medical assessment. Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol. Use with caution in patients with clinically significant uncontrolled and severe cardiovascular disease. Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval. Systemic corticosteroid effects: May occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Potential effects on bone density should be considered particularly in patients

on high doses for prolonged periods that have co existing risk factors for osteoporosis. Visual disturbances: May be reported with systemic and topical corticosteroid use. If patient presents symptoms such as blurred vision or other visual disturbances, consider ophthalmologist referral for evaluation of possible causes. Transfer from oral therapy: Care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Clinical features of such infections can overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia: Potentially serious hypokalaemia may result from ß2-agonist therapy. This has potential to produce adverse cardiovascular effects. Caution is advised in severe COPD as this effect may be potentiated by hypoxia. Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics. Hyperglycaemia: Inhalation of high doses of ß2-adrenergic agonists may produce increases in plasma glucose. Blood glucose should be monitored during treatment following established guidelines in patients with diabetes. Co-existing conditions: Use with caution in patients with thyrotoxicosis. Anticholinergic activity: Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrowangle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop. Co-administration with other anticholinergic containing medicinal products is not recommended.

Drug Interactions: Co-treatment with strong CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products, are expected to increase the risk of systemic side effects and should be avoided unless the benefit outweighs the increased risk, in which case patients should be monitored for systemic corticosteroid adverse reactions. This is of limited clinical importance for short-term (1-2 weeks) treatment. Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms. Other antimuscarinics and sympathomimetics: Co-administration with other anticholinergic and/or long-acting ß2-adrenergic agonist containing medicinal products is not recommended as it may potentiate known inhaled muscarinic antagonist or ß2-adrenergic agonist adverse reactions. Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects, therefore caution is required when prescribed concomitantly with formoterol.

Medicinal product-induced hypokalaemia: Possible initial hypokalaemia may be potentiated by xanthine derivatives, steroids and non potassium sparing diuretics. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. ß-adrenergic blockers: ß-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concurrent use should be avoided unless the expected benefit outweighs the potential risk. If required, cardio-selective ß-adrenergic blockers are preferred. Other pharmacodynamic interactions: Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines

can prolong QT interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics. Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. Elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.

Pregnancy and Lactation: Administration to pregnant women/women who are breast-feeding should only be considered if the expected benefit to the mother justifies the potential risk to the foetus/child.

Ability to Drive and Use Machines: Dizziness is an uncommon side effect which should be taken into account.

Undesirable Events: Consult SmPC for a full list of side effects. Common (≥ 1/100 to < 1/10): Oral candidiasis, pneumonia, hyperglycaemia, anxiety, insomnia, headache, palpitations, dysphonia, cough, nausea, muscle spasms, urinary tract infection. Uncommon (≥ 1/1,000 to < 1/100): Hypersensitivity, depression, agitation, restlessness, nervousness, dizziness, tremor, angina pectoris, tachycardia, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles), throat irritation, bronchospasm, dry mouth, bruising, urinary retention, chest pain. Very Rare (< 1/10,000): Signs or symptoms of systemic glucocorticosteroid effects, e.g. hypofunction of the adrenal gland, abnormal behaviour. Not known: Angioedema, vision blurred, cataract, glaucoma.

Legal Category: Product subject to prescription which may be renewed (B)

Marketing Authorisation Number: EU/1/20/1498/002 120 actuations

Marketing Authorisation Holder: AstraZeneca AB, SE-151 85, Södertälje, Sweden.

Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, College Business and Technology Park, Blanchardstown Road North, Dublin 15 Tel: +353 1 609 7100.

TRIXEO and AEROSPHERE are trademarks of the AstraZeneca group of companies.

Date of API preparation: 05/2022

Veeva ID: IE-3823

Adverse events should be reported directly to; HPRA Pharmacovigilance, Website: www.hpra.ie Adverse events should also be reported to AstraZeneca Patient Safety on Freephone 1800 800 899

1. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. Summary of Product Characteristics. Available at www.medicines.ie

2. Rabe KF et al. Triple inhaled therapy at two glucocorticoid doses in modeate-tovery-severe COPD. N Engl J Med. 2020;383:35–48. doi: 10.1056/NEJMoa1916046 COPD. N Engl J Med. 2020;383:35–48. doi: 10.1056/NEJMoa1916046

Veeva ID: IE-4248 Date of Preparation: September 2022

than was a high symptom burden.

Management of patients with ongoing symptoms or exacerbations

The rational approach to the use of ICS therapy based on evidence of an underlying inflammatory process greatly simplifies both the approach to initial treatment and the follow-up treatment decisions (Figure 3). The first step for any patient with ongoing symptoms or repeated exacerbations is to review and optimise their current treatment regimen – check inhaler technique, check adherence to treatment, and consider whether any comorbid conditions are present or require review. Next steps depend on whether the patient has ongoing breathlessness or repeated exacerbations (treatable traits), regardless of their initial grouping (Figure 4). Patients with ongoing breathlessness who were receiving bronchodilator monotherapy can be escalated to combination LABA + LAMA therapy. For those already on combination therapy, switching to an alternative device or molecule can be considered alongside a focus on treatment optimisation, ie, adherence and inhaler technique. Non-pharmacological management such as pulmonary rehabilitation, and investigation of alternative causes of breathlessness should also be explored. Patients with ongoing exacerbations can

be escalated to triple therapy including an ICS if eosinophils are elevated >300 cells/ µL if not contraindicated. Triple therapy with the addition of ICS can subsequently be offered for patients who experience a severe exacerbation (requiring hospitalisation) or who experience two moderate exacerbations within a year. If it is not clear which treatable trait (dyspnoea or exacerbations), is most predominate, it is recommended to follow the pathway for exacerbations.

Management of patients without features of asthma

Patients with breathlessness as their major clinical feature and who do not have features of asthma will not benefit from ICS therapy and their treatment should focus on bronchodilation, SABA, LABA or LABA + LAMA depending on the impact of their breathlessness on their daily activities. Patients who are exacerbating can start on a SABA in addition to single agent bronchodilation with a LAMA or LABA. If breathlessness is still impacting on their activities of daily living, then dual long-acting bronchodilator therapy (LABA + LAMA) can be commenced. ICS (triple therapy) can be used in addition to dual bronchodilation if they continue to experience exacerbations. At each stage, medication optimisation should be undertaken, including checking the

patient's inhaler technique and their adherence to therapy. In addition, ongoing monitoring of patients should include reviewing for comorbidities (especially alternative causes of breathlessness) and whether pulmonary rehabilitation has been offered and attended, as well as treating tobacco dependency and offering appropriate vaccinations.

As we have seen from the ECLIPSE study, ongoing breathlessness is not a good indicator for response to ICS therapy and it was for this reason that the 2023 GOLD update elected to require elevated eosinophils as a marker of underlying inflammation as a pre-requisite for initiation of ICS therapy. Using triple therapy as an option for patients with ongoing breathlessness is concerning as it is unlikely to prove much benefit in relieving their breathlessness and may cause a delay in seeking alternative causes for their chronic breathlessness. This approach will mean that a proportion of patients will be escalated to triple therapy and receive an ICS which they will gain no clinical benefit from, and which may place them at increased risk for pneumonia.

Patients with an asthma component are likely to benefit from ICS and this should form a part of their initial treatment regimen.

Vaccinations

In addition to influenza, pneumococcal and Covid-19 vaccines, the US CDC recommends the Tdap vaccine (pertussis, tetanus, and diphtheria) for COPD patients who were not vaccinated in adolescence, as well as routine use of shingles vaccine in all COPD patients over 50 years.

COPD exacerbations

The definition of COPD exacerbations has been revised to: “An exacerbation of COPD is defined as an event characterised by dyspnoea and/or cough and sputum that worsen over <14 days. Exacerbations of COPD are often associated with increased local and systemic inflammation caused by airway infection, pollution, or other insults to the lungs.”

FIGURE 3: Initial pharmacological treatment (GOLD 2023)

Currently, exacerbations are classified after the event has occurred as:

 Mild (treated with short-acting bronchodilators only, SABDs);

 Moderate (treated with SABDs and oral corticosteroids ± antibiotics); or

 Severe (patient requires hospitalisation or visits the emergency room). Severe exacerbations may also be associated with acute respiratory failure.

GOLD 2023 proposes the following changes based on a clinical approach based on the current best available evidence:

1. Complete a thorough clinical assessment for evidence of COPD and potential respiratory and nonrespiratory concomitant diseases, including consideration of alternative causes for the patient's symptoms and

signs: Primarily pneumonia, heart failure, and pulmonary embolism.

2. Assess:

Symptoms, severity of dyspnoea that can be determined by using a VAS, and documentation of the presence of cough.

Signs (tachypnoea, tachycardia), sputum volume and colour, and respiratory distress (accessory muscle use).

3. Evaluate severity by using appropriate additional investigation, such as pulse oximetry, laboratory assessment, CRP, arterial blood gases.

4. Establish the cause of the event (viral, bacterial, environment, etc).

Conclusions

Steroid stewardship, both OCS and ICS, remains relevant to avoid exposing patients to treatments that they will not

benefit from, and which may in fact place them at risk for side-effects. Managing patients according to their treatable traits is one of the most significant changes to the GOLD 2023 guidelines. This allows healthcare professionals to provide a more holistic approach to COPD management as it recognises the trait which is most problematic for the patient and allows treatment to be individualised and more targeted. While a cure for COPD remains elusive and treatment is largely reactive to clinical presentation, there is much we can do to ensure patients receive treatments that relieve their most impactful daily symptoms, optimise their lung function, and reduce their risk for life-threatening exacerbations. l

References available on request

FIGURE 4: Follow-up pharmacological treatment (GOLD 2023)

Sondelbay® Awarded as a Best Value Medicine (BVM) Teriparatide

The Medicines Management Programme recommends Sondelbay® as a BVM for teriparatide.

Prescribing Sondelbay® to your patients will lead to signiﬁcant savings for the health service.1 strength for independence

SONDELBAY® is indicated in adults for treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.2

Abbreviated Prescribing Information

Please refer to the Summary of Product Characteristics (SmPC) before prescribing Sondelbay ▼ (teriparatide) 20 micrograms/80 microlitres solution for injection in pre- lled pen. Presentation: One pre- lled pen of 2.4 ml contains 600 μg of teriparatide. Each dose contains 20 μg of teriparatide in 80 μL. Indications: Indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a signi cant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated; Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Dosage and Administration: Recommended dose of Sondelbay is 20 μg administered once daily. Maximum total duration of treatment should be 24 months. The course should not be repeated over a patient’s lifetime. Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate. Following cessation of Sondelbay therapy, patients may be continued on other osteoporosis therapies. Elderly: Dosage adjustment is not required. Renal impairment: Must not be used in patients with severe renal impairment but should be used with caution in patients with moderate renal impairment. No special caution is required for patients with mild renal impairment. Hepatic impairment: Should be used with caution as no data are available. Paediatric population and young adults with open epiphyses: Should not be used in paediatric patients (<18 years), or young adults (>18 to 29 years) with open epiphyses due to lack of safety and e cacy data. Method of administration: Sondelbay should be administered once daily by subcutaneous injection in the thigh or abdomen. Patients must be trained to use the proper injection techniques. Contraindications: Hypersensitivity to the active substance or to any of the excipients; Pregnancy and breast-feeding; Pre-existing hypercalcaemia; Severe renal impairment; Metabolic bone diseases other than primary osteoporosis or glucorticoid-induced osteoporosis; Unexplained elevations of alkaline phosphatase; Prior external beam or implant radiation therapy to the skeleton; Patients with skeletal malignancies or bone metastases. Warnings and Precautions: Traceability: The name and batch number of the administered product should be clearly recorded. Serum and urine calcium: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent teriparatide injection. Routine calcium monitoring during therapy is not required. Urolithiasis: Sondelbay should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. Orthostatic hypotension: In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension

were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. Renal impairment: Caution should be exercised in patients with moderate renal impairment. Younger adult population (>18 to 29 years): Experience is limited (including premenopausal women). Treatment should only be initiated if the bene t clearly outweighs risks in this population. Excipient: Contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”. E ects on ability to drive and use machines: No or negligible in uence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided. Fertility, Pregnancy & Lactation: Women of childbearing potential: E ective methods of contraception should be used during use of teriparatide. If pregnancy occurs, Sondelbay should be discontinued. Pregnancy and breast-feeding: Contraindicated for use. It is not known whether teriparatide is excreted in human milk. Fertility: The e ect on human foetal development has not been studied. The potential risk for humans is unknown. Adverse Events include: Adverse events which could be considered serious: Common: Syncope, dyspnoea, hiatus hernia. Uncommon: tachycardia, nephrolithiasis. Rare: anaphylaxis, renal failure/impairment. Other Very Common adverse events: Pain in limb. Other Common adverse events: Anaemia, hypercholesterolaemia, depression, dizziness, headache, sciatica, vertigo, palpitations, hypotension, nausea, vomiting, gastro-oesophageal re ux disease, sweating increased, muscle cramps, fatigue, chest pain, asthenia, mild and transient injection site events. See SmPC for details of other adverse events. Shelf Life: Unopened vial – 2 years. Pack size: available in pack sizes of 1 pre- lled pen or 3 pre- lled pens. Each pre- lled pen contains 28 doses of 20 micrograms (per 80 microliters). Marketing Authorisation Numbers: EU/1/22/1628/001-002. Marketing Authorisation Holder: Accord Healthcare S.L.U. World Trade Centre, Moll de Barcelona s/n, Edi ci Est, 6ª Planta, 08039, Barcelona, Spain. Legal Category: POM. Full prescribing information including the SmPC is available on request from Accord Healthcare Ireland Ltd, Euro House, Little Island, Co. Cork, Tel: 0214619040 or www.accord-healthcare.ie/products. Adverse reactions can be reported to Medical Information at Accord Healthcare Ltd. via email: medinfo@accord-healthcare.com or Tel: +44(0)1271385257.

Date of Generation of API: February 2023. IE-02019

February 2023 | IE-01873

References 1. Best Value Medicines https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-value-medicines/ Accessed February 2023 2. SONDELBAY® Summary of Product Characteristics Prescribe SONDELBAY® by Brand Name

AUTHOR: Michele O'Brien, CEO of The Irish Osteoporosis Society

OSTEOPOROSIS ‘THE SILENT KILLER’

AND PROVIDES PRACTICAL LIFESTYLE ADVICE TO OPTIMISE MANAGEMENT OF THE DISEASE

Osteoporosis is a silent disease with no signs or symptoms to suggest a person is experiencing bone loss. This is why osteoporosis is known worldwide as ‘the silent killer.’ No one feels bone loss, which is why patients must be screened for risk factors to prevent disease progression. 25 per cent of men and 50 per cent of women over 50 will sustain a fracture due to osteoporosis. Many of these fractures will be preventable with the correct interventions.

Overview of osteoporosis

Most people have heard of the condition, but many are not aware of the horrific consequences undiagnosed and untreated osteoporosis can bring, such as hip and other major fractures. These major fractures, in turn, present a further risk of an array of additional complications. 20 per cent of people over 60 who fracture a hip will die within six-to-12 months due to complications like blood clots, pneumonia, and infection. A further 50 per cent will lose the ability to wash themselves, dress themselves, and walk across a room unaided. 84 per cent of those who fractured in 2021 were admitted from home.

90 per cent of total hip fractures are due to osteoporosis. The fact that only 19 per cent of patients are diagnosed with the condition is unacceptable, which is why every healthcare professional needs to know the basics of the disease,

and that it is preventable and treatable for most people. There is a significant amount of misinformation regarding osteoporosis in the public domain. Common myths include:

 A person cannot improve his/her bone health;

 Osteoporosis only effects older women;

 A calcium and vitamin D supplement is an osteoporosis treatment;

Dear Michele, I wanted to thank your organisation for the help and guidance I received from you regarding my mum’s osteoporosis. The improvement has been substantial and together with the practical steps we took to adapt her house, her quality-oflife has improved substantially, to the point that she is mobile and active again. We recently took her to Bath, UK, to celebrate her 90th birthday and she will go on a Mediterranean cruise with my sister next month! My Mum and I are extremely grateful for your guidance that has truly given her a new lease of life. Well done and keep up the great work.

 A DXA scan contains high doses of radiation;

 People over 80 cannot be helped.

The Irish Osteoporosis Society (IOS), who are the national experts in bone health in Ireland, supports and guides sufferers towards an improved quality-of-life, and have even helped 88-year-olds in wheelchairs to regain their independence. A letter outlining the outcomes of one such example is outlined in Figure 1 . The woman described had become wheelchair-bound due to multiple vertebral fractures when her son contacted the IOS. He had been told by three different healthcare professionals that nothing could be done to help his mother.

Causes of osteoporosis

Best

Regards, Vincent C

There is a massive array of factors that contribute to osteoporosis development. Some of the 200 causes of bone loss includes family history (especially a fractured hip), steroids, eating disorders, low vitamin D levels, smoking, excess alcohol, over exercising, chemotherapy, radiation, drugs (including Arimidex, aromatase inhibitors for prostate cancer, warfarin, heparin, some diuretics, some anti-depressants, proton pump inhibitors, some medications for epilepsy, stroke, and paraplegia), high levels of stress, diabetes, being bed or wheel chair bound, Coeliac disease, gluten and wheat sensitivity, lactose intolerance, cystic fibrosis, Crohn’s disease, irritable bowel syndrome,

MICHELLE O'BRIEN DISPELS THE MYRIAD MYTHS SURROUNDING OSTEOPOROSIS FIGURE 1: Letter from IOS service user

ulcerative colitis, and hemochromatosis. A massive range of factors contribute to the loss of bone density.

Skeletal changes

Many believe that as we age, it is normal to lose height and for posture to change as part of the ‘normal’ aging process. People can indeed lose height due to wear and tear in the vertebrae and discs in their spine. However, it is very important that loss of height is investigated to ensure it is not due to undiagnosed osteoporotic fractures. The common types of vertebral fractures are outlined in Figure 2. It is also important to note that 75 per cent of people with vertebral fractures do not have constant pain. Many do experience initial back pain, but it generally progresses to become more intermittent in nature.

Signs and symptoms

The consequences of undiagnosed osteoporosis are also the only signs and symptoms of the disease. The most common presentations include:

 Upper, middle, or lower back pain that is intermittent or constant;

 Decreasing height;

 Head beginning to protrude forward from the body;

 Shoulders have become rounded;

 A hump has started to develop on the back;

 Development of a pot belly (not from excess food intake);

 Body shape has changed. The secondary effects on the vertebrae

are not reversible. Figure 3 shows how vertebral wedge fractures can cause a Dowager’s hump to develop. This can happen at any age. The person’s head protrudes forward from the body, which causes the centre of gravity to shift. This places the patient at high risk of falling, and falls usually result in further fractures. The ribs drop down as there is not enough bone in the spine to keep the person upright. The abdomen is pushed out and the rib cage ends up resting on the hip area. All these changes affect the person’s overall body shape, which can have a detrimental effect on self-image, mental health, quality-of-life, and independence.

Diagnosis

A dual energy x-ray absorptiometry (DXA) scan is similar to an x-ray, is completely painless, and only takes 15 minutes. It contains only 10 per cent of the radiation of a regular chest x-ray. In fact, a flight from Dublin to New York results in more radiation exposure than a DXA. Repeat DXA scans should be done every two years at a minimum if bone loss has been diagnosed. It is an essential part of an overall treatment plan, for monitoring

the person’s response to osteoporosis treatment, and to ensure they have not continued to lose bone, as bone loss is silent. Research shows that most fractures occur between a DXA scan T-score of -1.5 and -2.49, which indicates moderate-tomarked osteopenia.

Management

How much a person can improve their bone health usually depends on the following:

 How early the disease is diagnosed and treated;

 The causes of bone loss;

 If the causes of bone loss have been investigated and addressed;

 If the person has taken the medication/ treatment prescribed;

 If the person has/has not followed IOS recommendations, such as: “It is not safe for most senior citizens to lift children (especially those with bone loss). Have your grandchild placed on your lap.”

 If the person has continued or started an exercise programme that is not appropriate for those with bone loss, such as touching the toes. This can cause vertebral fractures for those with bone loss.

FIGURE 2: Types of vertebral fractures FIGURE 3: Skeletal progression in osteoporosis

Exercise

When it comes to an exercise programme, everyone with bone loss should be progressed slowly to reduce the risk of fracture. The IOS does not recommend the following activities for those with bone loss, especially those who have vertebral fractures:

 High impact exercise;

 Heavy weights;

 Trampolines;

 Vibration machines;

 Regular sit ups;

 Touching the toes (forward flexion);

 Twisting of the back with the feet planted on the ground;

 Yoga;

 Riding a bike bent forward at the waist.

Calcium

Nutrition has a very important part to play in keeping bones healthy. Calcium, vitamin D, first class proteins, and adequate calories are essential for bone and overall health. Older people need three servings of calcium per day, and if getting it from milk or yogurts, they should try to ensure that products are fortified with vitamin D. One serving of calcium is equal to:

 A glass of milk;

 An ounce (matchbox size) of cheese;

 A carton of yogurt. Tips to boost calcium intake include:

 A bowl of breakfast cereal with milk;

 Cheese on crackers or toasted cheese sandwich;

 Fruit salad with yogurt;

 Lasagne;

 A fruit smoothie or milkshake;

 Mug of hot chocolate;

 Baked potato with grated cheese;

 Pancakes;

 Skimmed milk powder added to soups/smoothies/sauces;

 Porridge made with milk.

Vitamin D

Low levels of vitamin D reduces calcium absorption from the gut, triggering the secretion of parathyroid hormone (PTH) from the parathyroid glands. PTH

stimulates the release of calcium from bones to maintain normal levels in the blood. Vitamin D and calcium levels should both be checked at least annually. The causes of bone loss also need to be investigated, and osteoporosis should not be assumed. Absorption of vitamin D should also be assessed. It is important to be aware of malabsorption issues and gut disorders.

Anyone who cannot obtain their daily amount of vitamin D through food, or who is not in the sunshine regularly, should consider a vitamin D supplement. Not only is vitamin D essential for the absorption of calcium, but it is also crucial for healthy bones, and it is vital for a healthy immune system. Low levels of vitamin D can also cause aches and pains all over, which can mimic the symptoms of fibromyalgia and can place a person at risk of multiple other diseases.

Facts about osteoporosis

There are many myths about osteoporosis, and the following information is to dispel some of these myths and arm you with additional information:

 Patients will not feel their bones getting weaker or stronger;

 Those who eat healthily and exercise regularly can still develop osteoporosis;

 Osteoporosis effects men and women of all age groups;

 More men die from untreated osteoporosis than are diagnosed with prostate cancer;

 More women die from complications of osteoporosis, such as fractures, than from cancers of the ovary, uterus, and cervix combined;

 The most common bones to break first are the forearm, hip, and bones in the back, however, any bone can be affected;

 Having an unhealthy skeleton puts patients at risk of losing their independence;

 Prevention should start in utero;

 There are 200 causes of bone loss, not just the menopause;

 The causes of a person’s bone loss

should never be assumed, and should always be investigated and addressed;

 The biggest indicator of undiagnosed osteoporosis is breaking a bone from a trip and fall, even if it happened on cement, ice, or another harsh surface;

 From age 75, a person is 25 times more likely to fracture a hip;

 Currently, over €500 million is being spent on treating broken bones;

 Premature menopause (before 45 years), either natural or surgical, regular menopause, Depo-Provera contraceptive, irregular periods, loss of periods not due to pregnancy, and endometriosis are all high-risk factors for bone loss;

 The risk of further broken bones is much higher in postmenopausal women who have already fractured;

 The commonest cause of osteoporosis in males is hypogonadism, which may be the result of a variety of conditions, including abnormal chromosomes, infection of testes, mumps after puberty, and excessive physical or psychological stress;

 Osteopenia is the early stages of bone loss and should be investigated to prevent further bone loss;

 50 per cent of women with vertebral fractures are undiagnosed;

 It is very rare that exercise and nutrition alone can treat osteoporosis;

 If physical education was made mandatory in schools, (part of the Junior and Leaving cert curriculum), it would reduce the number of children at risk of osteoporosis, as well as many other chronic conditions, like obesity, diabetes, and mental health imbalances.

For further information about osteoporosis and the supports, resources, and services we provide, please contact the IOS, who are the National experts on osteoporosis at 01 637 5050 or email: info@irishosteoporosis.ie

If you would like to be added to the notification list for our annual medical conference for health professionals on Saturday 21 October 2023, please email: events@irishosteoporosis.ie l

References on request

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References

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AUTHOR:

Theresa Lowry-Lehnen,

SCOLIOSIS

THERESA LOWRY-LEHNEN PROVIDES A COMPREHENSIVE OVERVIEW OF THE PRESENTATION, DIAGNOSIS, AND MANAGEMENT OF SCOLIOSIS, AS WELL AS UPDATES ON CURRENT ADVANCES IN TREATMENTS AND WAITING-TIMES

Scoliosis is a spinal deformity characterised by lateral curvature and rotation of the vertebrae. The curve can veer to the left or the right, and can be situated in the lumbar, thoracic or thoracolumbar regions. In some cases, there can be an S-shaped double curve. The condition is most often diagnosed in childhood or early adolescence, and affects approximately one per cent of children and adolescents in Ireland. Scoliosis can be classified as congenital, neuromuscular, adult degenerative, syndromic, or idiopathic, depending on the aetiology. 1,5,9

Congenital scoliosis results from embryological malformation of one or more vertebrae and may occur in any location of the spine. Vertebral abnormalities cause curvature and other deformities of the spine because one area of the spinal column lengthens at a slower rate than the rest. The location and geometry of the abnormalities will determine the rate at which the scoliosis progresses as the child grows. As these abnormalities are present at birth, congenital scoliosis is usually detected at a younger age than idiopathic scoliosis. 1

Neuromuscular scoliosis is secondary to neurological or muscular diseases and includes scoliosis associated with

www.rnoh.nhs.uk/services/scoliosis

cerebral palsy, spina bifida, muscular dystrophy, spinal muscular atrophy, and spinal cord trauma. This type of scoliosis generally progresses more rapidly than idiopathic scoliosis and often requires surgical treatment. 1

Adult degenerative scoliosis occurs most frequently in the lumbar spine and usually affects people age 65 and older. It is often accompanied by spinal stenosis, or narrowing of the spinal canal, which makes it difficult for spinal

nerves to function normally. Back pain associated with degenerative scoliosis usually begins gradually and is linked with activity. The curvature of the spine in degenerative scoliosis is often relatively minor and surgery may only be advised if conservative methods fail to alleviate pain associated with the condition. 1

Syndromic scoliosis:

Some syndromes in which scoliosis is

RGN, PG Dip Coronary Care, RNP, BSc, MSc, PG Dip Ed (QTS), M Ed, PhD Clinical Nurse Practitioner, and Associate Lecturer South East Technological University

www.rnoh.nhs.uk/services/scoliosis

likely to occur are connective tissue disorders (Marfan’s and Ehlers-Danlos syndrome), trisomy 21, Prada-Willi, Rett’s syndrome and Beale’s syndrome. 11

Idiopathic scoliosis is a diagnosis provided when all other causes are excluded. It comprises approximately 80 per cent of all scoliosis cases. 1 There is no identifiable cause for idiopathic scoliosis. Theories include hormonal causes, asymmetric growth, muscle imbalance, and genetic factors. Almost 30 per cent of patients with adolescent idiopathic scoliosis (AIS) have a family member with scoliosis. 2 AIS occurs in around two-to-three per cent of the general population. 9

Scoliosis in children is classified by age:

 Infantile: From birth to three years;

 Juvenile: From three-to-10 years;

 Adolescent: From age 11 and older, or from onset of puberty until skeletal maturity.

Infantile scoliosis occurs before age three and is seen more frequently in boys. Although neurological involvement

is possible, many cases resolve spontaneously, however, some may progress to severe deformity. Juvenile scoliosis is found more frequently in girls between the ages of three and 10. These curves are at a higher risk for progression and often require surgical intervention. Adolescent scoliosis occurs between age 10 and maturity, and may start at the onset of puberty or become apparent during an adolescent growth spurt. Females are at higher risk, often requiring surgical treatment, if non-operative treatment fails to halt the curvature. 9

Idiopathic scoliosis comprises most cases that present during adolescence. AIS is the most common form of paediatric scoliosis occurring in individuals between the ages of 10-to-18. Depending on its severity and the age of the child, scoliosis is managed by close observation, bracing, and/or surgery. In children with congenital scoliosis, there is a known increased incidence of

other congenital abnormalities, most commonly associated with the spinal cord, genitourinary system, and the heart. It is important that evaluation of the neurological, genitourinary, and cardiovascular systems is undertaken when congenital scoliosis is diagnosed. 1,2

Scoliosis in adulthood is distinctive from childhood scoliosis, as underlying causes and goals of treatment differ in patients who have reached skeletal maturity. Most adults diagnosed with scoliosis are patients who did not receive treatment when they were younger; who were surgically treated as adolescents; or adults with degenerative scoliosis. 1

Complications of scoliosis

Idiopathic scoliosis can cause weakness of respiratory muscles and reduced exercise capacity. Distortion of the spinal column may cause restriction of the chest with impairment of lung

function, and compression of abdominal contents can also occur. Severe deformity may impinge on the spinal cord and cause paraplegia. Treatment of scoliosis without recognition of ArnoldChiari malformations or syringomyelia may result in paraplegia. Scoliosis can be associated with psychological problems, especially in adolescents. 9

Presentation and diagnosis

Presentation: Usually, patients present with spinal deformity or chest wall and back asymmetry. Posterior chest wall prominence is the most outward manifestation of spinal curvature. Symptoms of scoliosis may include uneven shoulders, with one shoulder more prominent than the other; an uneven waist; one hip higher than the other; one side of the rib cage jutting forward; and a prominence on one side of the back when bending forward. In some cases, changes in the body may include height loss and an uneven alignment of the hips and pelvis. While not typically a presenting symptom, back pain is not unusual. 3

Diagnosis: Scoliosis is confirmed through a thorough history, physical examination, and spinal radiograph (posteroanterior and lateral x-rays of the spine). CT and MRI scanning may be used to assess the spinal canal, the structure of the vertebral column, and threat to the spinal cord. The curve is measured by the Cobb Method and is diagnosed in terms of severity by the number of degrees. A positive diagnosis of scoliosis is made based on a coronal curvature measured on a posterior-anterior radiograph of greater than 10 degrees. A curve is considered significant if it is greater than 25-to-30 degrees. Spinal curves exceeding 45-to-50 degrees are considered severe and often require more aggressive treatment.1,3,9

A simple initial screening test called the Adam's Forward Bend Test can help

detect potential problems, but cannot determine accurately the exact type or severity of the deformity. During this test, the patient leans forward with their feet together and bends 90 degrees at the waist. Any asymmetry of the trunk or any abnormal spinal curvatures can be detected by the examiner from this angle. Radiographic tests are required however, for an accurate and positive diagnosis.1,3 Attention should be paid to the patient’s developmental history to rule out any other aetiologies of scoliosis. The physical exam must include a neurologic assessment as well as evaluation of the curve’s shape, form,

Treatment and management

The management of scoliosis is complex and treatment options depend on a variety of individual factors, including skeletal maturity; the degree and extent of curvature of the spine and how it affects the patient's life; location of the curve and possibility of curve progression. After these variables are assessed, different treatment options may be recommended and include observation, bracing, and surgery.1,5

Observation: In many children with scoliosis, the spinal curve is mild enough to require no treatment. However, if there is concern that the curve may be increasing, the child should be monitored and examined every fourto-six months throughout adolescence. In adults with scoliosis, x-rays are usually recommended once every five years, unless symptoms are getting progressively worse.1

and flexibility. Differential diagnosis is important to rule out scoliosis from other causes, such as neurologic (including Arnold-Chiara malformation or syringomyelia), neuromuscular, congenital, and syndromic issues. 2,9 Depending upon the age of the patient and other findings, more investigations may be indicated. In some patients a dual energy x-ray absorptiometry (DEXA) scan may be necessary to assess bone density. Oxygen saturation, lung function tests, and forced vital capacity may be necessary for those with more severe deformity. 9,10

Bracing: Brace treatments are only effective in patients who have not reached skeletal maturity. If the child is still growing and the curve is between 25-to-40 degrees, a brace may be recommended to prevent the curve from progressing. There are many different types of braces available and brace designs have improved over the years. For optimal effectiveness, the brace should be checked regularly to ensure a proper fit and may need to be worn 16-to-23 hours daily until growth stops. Patients and families must be informed of the risk that bracing may not be successful, but that the chances of success are improved with adherence to wearing the brace for the recommended time.1,9

Surgery: Two primary goals of surgery in children are to stop the curve from progressing during adulthood and to diminish spinal deformity. Surgery is usually only recommended when the spinal curve is greater than 40 degrees

IT IS IMPORTANT THAT EVALUATION OF THE NEUROLOGICAL, GENITOURINARY, AND CARDIOVASCULAR SYSTEMS IS UNDERTAKEN WHEN CONGENITAL SCOLIOSIS IS DIAGNOSED

and there are signs of progression. Surgery can be carried out using an anterior or a posterior approach, depending on the individual case.1 Some adults who were treated as children may need revision surgery, particularly if they were treated many years ago, before major advances in spinal surgery procedures were implemented. Surgery in adults may be recommended when the spinal curve is greater than 50 degrees and the patient has nerve damage to their legs, and/or is experiencing bowel or bladder symptoms. Adults with degenerative scoliosis and spinal stenosis may require decompression surgery with spinal fusion and a surgical approach from both the front and back.1

Several factors can lead to increased surgical-related risks in older adults with degenerative scoliosis. These factors include advanced age, being a smoker, being overweight, and the presence of other health/medical problems. Both surgery and recovery time are expected to be longer in older adults with scoliosis.1 Although a large percentage of scoliosis patients benefit from surgery, there is no guarantee that surgery will stop curve progression and symptoms in every individual.

The posterior approach is the most commonly performed surgery for AIS and involves posterior spinal fusion with instrumentation and bone grafting. This is performed through the back while the patient lies on their stomach and the spine is straightened with rigid rods, followed by spinal fusion. Spinal fusion involves adding a bone graft to the curved area of the spine, which creates a solid union between two or more vertebrae. Metal rods attached to the spine ensure that the backbone remains straight while spinal fusion takes effect. The procedure takes several hours in children, but will generally take longer in older adults. With recent advances in technology, most people with idiopathic scoliosis are released from hospital within a week of surgery, and usually do

not require post-surgical bracing. Most patients can return to school or work in two-to-four weeks post-surgery and can resume pre-surgical activities within four-to-six months.1,2

The anterior approach. The patient lies on their side during the surgery. The surgeon makes incisions in the patient's side, deflates the lung and removes a rib to reach the spine. Video-assisted thoracoscopic (VAT) surgery offers increased visualisation of the spine and is a less invasive surgery than an open procedure. The anterior spinal approach has many potential advantages, including better deformity correction, quicker patient rehabilitation, improved spine mobilisation, and fusion of fewer segments. The disadvantage is that many patients require bracing for several months post-surgery. This approach has a higher risk of morbidity, although VAT surgery has helped to reduce this.1,2

During decompressive laminectomy the laminae of the vertebrae are removed to create more space for the nerves. A spinal fusion with or without spinal instrumentation is often recommended when scoliosis

and spinal stenosis are present. Devices, including screws or rods, may be used to enhance fusion and support unstable areas of the spine.1

Minimally invasive surgery (MIS) is sometimes performed via smaller incisions to achieve fusion. Use of advanced fluoroscopy and endoscopy has improved the accuracy of incisions and hardware placement, minimising tissue trauma, while enabling the MIS approach. Not all cases can be treated in this manner and several factors contribute to the surgical method used.1

Kyphosis

While scoliosis and kyphosis share some similarities, they are separate conditions. Scoliosis refers to an S-shaped or C-shaped spinal deformity in the coronal plane, while kyphosis is a condition of increased forward spinal angulation (rounded upper back) in the sagittal plane. Kyphosis can be divided into five main types:

 Postural kyphosis;

 Congenital kyphosis;

 Developmental kyphosis;

 Scheuermann’s kyphosis, a spinal condition where the vertebrae of the spine form in a wedge shape, causing the spinal curve to be deformed;

| SCOLIOSIS | NURSING IN GENERAL PRACTICE | MARCH-APRIL 2023 | 37

 Injury-induced kyphosis. Most cases of kyphosis can be treated effectively with specific postural correction exercises and stretches, postural traction, and kypho-bracing when necessary. Advanced manual approaches, such as chiropractic biophysics, can be highly effective in resolving kyphosis cases. Only in very severe cases is surgery required, and this is usually due to the risk of progression and further complications. Many cases of postural kyphosis can be improved or resolved.

Scheuermann’s disease is far less common and results in an increased kyphosis throughout teenage years whilst growth is occurring. It is a growth plate disorder in the vertebrae themselves, which causes them to become more wedged and compressed at the front, resulting in structural deformity as the bone formation is altered. Scheuermann’s cannot be cured or reversed, however, the right treatment at the right time can help to significantly reduce the progression of the deformity. Bracing in certain cases has been shown to be a very effective treatment when combined with specific posture exercises. 12

Scoliosis: Progress in Ireland since 2017

In May 2017 in Ireland, the Children's Hospital Group established a Paediatric Scoliosis Services Co-Design Group and engaged with three scoliosis advocacy groups: The Scoliosis Advocacy Network Group, Scoliosis Ireland, and Scoliosis Awareness and Support Ireland; to design the scoliosis services needed to meet the needs of children, young people, their families, and healthcare professionals. The work of the co-design group was completed in February 2018 and formed the basis for developing scoliosis services. The developments were prioritised in a 10-Point Scoliosis Action Plan in 2018. In February 2018, the Orthopaedic

Surgery Implementation Group was established to implement the orthopaedic elements contained within the HSE Service Plan 2018, and to implement the prioritised actions agreed by the Scoliosis Co-Design Group in the action plan. 6

While progress was being made in 2019 on reducing waiting lists for paediatric orthopaedic surgeries, the Covid-19 pandemic and the HSE cyberattack greatly impacted all hospital systems, capacity, and procedures, leading to further delays in scoliosis treatment and management in Ireland. In February 2022, the Minister for Health, Stephen Donnelly, approved

children with conditions such as scoliosis and spina bifida have a positive outcome from their surgeries.” 7

The plans set out the following targets:

 Reduce the number of scoliosis patients waiting over four months, from 94 at the end of January 2022 to none by the end of 2022;

 Increase scoliosis spinal surgeries by 92 in 2022;

 Reduce the total scoliosis waiting list, from 224 at the end of January 2022 to 128 by end of 2022;

 Treat an additional 107 spina bifida cases.

Number of targeted actions to be implemented:

 An increase in in-patient/day case capacity through increased access to the theatres at Crumlin, Temple Street, and Cappagh, as well as additional theatre space, beds, and MRI capacity;

 Expansion/reconfiguration of outpatient cases and additional active clinical triage;

 Ringfenced and protected orthopaedic theatre time and beds;

 Increased activity in Cappagh;

ambitious plans from Children’s Health Ireland and Cappagh Orthopaedic Hospital to reduce waiting times for children and adolescents awaiting paediatric orthopaedic surgery for conditions such as spina bifida and scoliosis. Minister Donnelly said: "I held a number of meetings with the clinical teams from Crumlin, Temple Street, and Cappagh Orthopaedic Hospital, along with senior management from these hospitals and the HSE, to discuss the development of an orthopaedic waiting list plan for children in Ireland. I have approved the plan and welcome the target to ensure that no scoliosis patient is waiting over four months for a procedure by the end of this year. Time is a critical factor in ensuring

 Enhanced use of private sector facilities. The Waiting List Scoliosis/Spina Bifida Action Plan and funding was formally agreed with the HSE and Department of Health in April 2022. Funding approved in February/March 2022 totalled €19.23 million. This plan covered paediatric orthopaedic services in Crumlin, Temple Street, Cappagh, and Blackrock Clinic. At the end of August 2022, across these hospitals, 342 spinal procedures had been undertaken, 100 more surgeries compared with 242 cases undertaken in the same period in 2021. The following progress has also been made in reducing the longest waiting times for scoliosis treatment: 8

 Reduction in the number of patients waiting over four months from 99-to-72 (27 per cent reduction since January 2022);

BRACING IN CERTAIN CASES HAS BEEN SHOWN TO BE A VERY EFFECTIVE TREATMENT WHEN COMBINED WITH SPECIFIC POSTURE EXERCISES

 Reduction in patients waiting over 12 months for surgery from 34-to-21 (38 per cent reduction since January 2022);

 The total spinal waiting list reduced from 224 to 212 in the same period.

A post Covid-19 surge in referrals to hospitals was expected, but numbers could not be predicted. In Crumlin and Temple Street, there was a 33 per cent increase in referral numbers for spinal fusions from 2019 to 2022 (164-to-218). Despite this increase in referrals and resulting increase in the numbers on the waiting list, more children are being treated and waiting times are coming down. Dr Ike Okafor, Clinical Director, Children’s Health Ireland, and Clinical Director for the Orthopaedic Service said: “Despite challenges, our staff and clinical teams have made significant progress with

plans to improve the orthopaedic service and continue to do so. Some 24 additional beds have been added to Crumlin and Temple Street, all of which will be in use by the end of this year. The addition of a fifth theatre, when operational in Temple Street, will make a significant difference to our theatre activity…. We are acutely aware of how delays impact our patients and families and are extremely grateful for the investment and support from Department of Health and the HSE. This investment is making a difference by improving access to care and reducing waiting times, and we will continue to update on this progress.” 8

Outlook

The global scoliosis treatment market has significantly grown over recent

years and is expected to register significant growth in the next decade.

The pharmaceutical and healthcare sectors are rapidly evolving, with innovations in technology, increasing healthcare spending, and improving healthcare facilities and systems. Many hospitals, ambulatory surgical care centres, and clinics across the globe are adopting advanced devices and equipment.

Technology currently exists to identify children who are genetically at-risk for developing idiopathic scoliosis, as well as opportunities for early-stage intervention, however, this will require continued and expanded research, adoption of the technology by mainstream medical communities, and acceptance by patients and the public. 13,14 l

REFERENCES

1. American Association of Neurological Surgeons (2022). Scoliosis. Available at: www. aans.org/Patients/NeurosurgicalConditions-and-Treatments/ Scoliosis.

2. Menger P. (2022). Adolescent and idiopathic scoliosis. In StatPearls Publishing. Available at: www.statpearls.com/ArticleLibrary/ viewarticle/686.

3. Janicki JA, Alman B. Scoliosis: Review of diagnosis and treatment. Paediatric Child Health. 2007 Nov; 12(9):771-6. doi: 10.1093/ pch/12.9.771.

4. Mayo Clinic (2022). Scoliosis. Available at: www.mayoclinic.org/ diseases-conditions/scoliosis/ symptoms-causes/syc-20350716.

5. Health Service Executive (2017). Overview of the HSE Scoliosis Waiting List Action Plan. Available at: www.hse.ie/eng/about/who/ acute-hospitals-division/waitinglist-action-plans/overview-of-thescoliosis-action-plan-2017.pdf.

6. Children Hospital Group (2018). Scoliosis co-design 10-point action plan. Ireland. Available at: www. hse.ie/eng/services/publications/ hospitals/scoliosis-design-plan.pdf.

7. Department of Health (2022). Minister Donnelly approves ambitious proposals to alleviate paediatric orthopaedic waiting times. February; 2022. Available at: www.gov.ie/en/press-release/ c4e26-minister-donnellyapproves-ambitious-proposalsto-alleviate-paediatricorthopaedic-waiting-times.

8. CHI Temple Street (September 2022). Update on progression of wait lists and access to orthopaedic services. Dublin, September 2022. Available at: www.cuh.ie/2022/09/update-onprogression-of-wait-lists-andaccess-to-orthopaedic-service/.

9. Tidy C. (2021). Scoliosis. Patient. UK. Available at: https://patient. info/doctor/scoliosis-and-kyphosis.

10. National Health Service (2022). Scoliosis surgery in adults.

Cambridge University Hospital, UK. Available at: www.cuh.nhs. uk/patient-information/scoliosissurgery-in-adults/.

11. Scoliosis Association UK (2022). Syndromic Scoliosis. Available at: https://sauk.org.uk/types-ofscoliosis/syndromic-scoliosis/.

12. UK Scoliosis Clinic (2022). Scoliosis and Kyphosis. What’s the difference? Available at: https:// scoliosisclinic.co.uk/blog/scoliosisand-kyphosis-whats-the-difference/.

13. Stitzel C. (2022). Scoliosis treatment timeline: Past, present, and future. Scoli Smart. Available at: www.treatingscoliosis.com/ blog/scoliosis-treatment-history/.

14. Biospace (2022). Scoliosis treatment market research report on future trends, growth opportunities, and industry statistics till 2030. Available at: www.biospace.com/article/ scoliosis-treatment-marketresearch-report-on-future-trendsgrowth-opportunities-andindustry-statistics-till-2030/.

DIABETES IN THE PAEDIATRIC POPULATION

Diabetes is one of the most common chronic diseases in the world, with an estimated one-in-11/12 people worldwide affected by it (more in some countries).1 The vast majority of cases are found in adults, but it remains a significant health burden for children worldwide, behind only asthma in prevalence among chronic diseases of childhood. It is important, therefore, that any medical professional working with children is comfortable with the diagnosis of diabetes, its day-to-day management, and the recognition and treatment of diabetic emergencies.

Traditionally diabetes was defined as either insulin-dependent or non-insulindependent, but the current approach sees diabetes defined by its mechanism of action. 2

Type 1 diabetes mellitus (T1DM) is an autoimmune condition characterised by destruction of beta cells of the pancreas, leading to an absolute insulin deficiency.3 It occurs in individuals with a genetic susceptibility, typically following a trigger by an environmental agent, such as a virus, and as the initial progression of beta cell destruction takes place, the patient initially remains asymptomatic. T1DM currently accounts for greater than 95 per cent of cases of diabetes mellitus in paediatric populations in the UK and Ireland. Type 2

diabetes mellitus (T2DM) is most typically seen as a disorder of insulin resistance associated with a relative insulin deficiency.4 While more common in adult populations, T2DM was traditionally uncommon in paediatric populations. However, with the growing problem of childhood obesity (particularly in the Western world), T2DM is becoming a more common paediatric diagnosis in late adolescence.

Secondary forms of diabetes mellitus also exist; cystic fibrosis-related diabetes (CFRD) is a complication of CF associated

with a relative rather than absolute insulin deficiency following beta cell destruction, but with some elements of insulin resistance also noted.5 It has been associated with increased morbidity and mortality in this patient cohort. Mature onset diabetes of the young (MODY) is an autosomal-dominant condition associated with ineffective insulin production or secretion and is caused by a single gene defect in one of a number of recognised genes.6 For this reason, it is also known as monogenic diabetes. There are other, rarer

TYPE 1 DIABETES IS THE MOST COMMON TYPE IN CHILDREN, ACCOUNTING FOR TWO-THIRDS OF NEW CASES IN CHILDREN. IT IS ONE OF THE MOST COMMON CHRONIC CHILDHOOD DISEASES AUTHOR: Dr Kevin Conlon, Paediatric Endocrinology SpR, Children’s Health Ireland (CHI) at Crumlin. Reviewed by Prof Declan Cody, Consultant in Paediatric Endocrinology and Diabetes, CHI Crumlin, and Clinical Professor, University College Dublin

causes of diabetes mellitus in the paediatric population, including gestational diabetes in the case of pregnancy.

Presentation

The typical presentation of diabetes mellitus is with a classic triad of symptoms (polydipsia, polyuria, and weight loss) and a raised blood glucose of >11.1mmol/L. Other symptoms that can also be features of presentation include nocturnal enuresis, lethargy, blurred vision, increased appetite, recurrent infections, slow-healing injuries, and constipation.7 Patients should have their blood glucose, blood ketones, and blood gases assessed at time of first presentation, and it is recommended to have blood tests sent to look for the presence of autoantibodies associated with T1DM (antiGAD, anti-IA2 and anti-ZnT8 antibodies).

Diabetic ketoacidosis

It is also possible for patients to present in diabetic ketoacidosis (DKA) as a first presentation of diabetes mellitus; a recent study of an Irish paediatric population shows that 25 per cent of presentations with T1DM were in DKA, with a higher level in children aged under two years.7

DKA is a medical emergency and is the leading cause of morbidity and mortality among the paediatric T1DM population,8 with the rare case of mortality occurring as a result of cerebral oedema.9 In DKA, high levels of glucose unchecked by insulin cause osmotic diuresis in the kidneys, leading to polyuria and dehydration; as well as causing beta oxidation of free fatty acids into ketones, which cause metabolic acidosis.10

The aims of managing DKA are to correct acidosis, reverse ketosis, correct dehydration, restore blood glucose to nearnormal, monitor for complications of DKA, and treat any underlying cause for DKA.9 Initial management is with assessment and resuscitation as required, including the use of boluses of 0.9 per cent NaCl to restore circulating volume. Following this initial stage, fluid requirements should be calculated to account for both maintenance requirements and the fluid deficit present in the patient, and this should be administered

over 48 hours. DKA is a naturally hypokalaemic state, with depletion of total body potassium through osmotic diuresis; however, initial serum potassium levels can appear normal. KCI should be added to IV fluids once urine output is confirmed or blood tests confirm the patient is not hyperkalaemic.

Insulin administration should be delayed until at least one hour after maintenance fluids have begun; this is associated with a lower risk of cerebral oedema.9 Despite being associated with acidosis, there is no role for bicarbonate in the management of DKA, and evidence suggests it being associated with a greater risk of worsening tissue hypoxia and cerebral acidosis.

Management

The long-term treatment and management of each variant of diabetes mellitus should be appropriate for the underlying pathophysiology behind each individual subtype. As T1DM is fundamentally caused by a lack of insulin, the treatment required for patients with T1DM is insulin.11 The decision regarding what particular insulin regime to commence in a well patient should be made following consultation with a consultant paediatric endocrinologist, but in general, starting doses vary between 0.75-1.0 units/kg/day.

This total daily dose of insulin can then be divided between long-acting basal insulin (eg, Levemir, Lantus, Tresiba) and short-acting bolus insulin (eg, NovoRapid, Fiasp).

A typical starting ratio is to divide the total daily insulin dose into 50 per cent basal and 50 per cent bolus insulin;12 basal insulin is designed to replace background endogenous insulin and is given once or twice a day, while bolus insulin is given prior to eating and is typically divided in three doses (prebreakfast, pre-lunch, and pre-dinner). These initial set doses for bolus insulin will ideally give way in time to more precise doses calculated, based on the amount of carbohydrate in the meal about to be eaten, following education.

Initial management for a new diagnosis of T1DM should focus on commencing insulin as outlined above, as well as education for the family around the essential skills required for living with diabetes.13 This includes information about what diabetes is, a basic management routine, developing the skills of blood glucose testing and insulin administration, and management of hypoglycaemia, hyperglycaemia, and intercurrent illness. Future education sessions should focus on strategies for optimising good glycaemic control.

Outpatient appointments should be offered every three months for clinical examination and assessment of glycaemic control through review of blood glucose diaries/blood glucose sensor data and monitoring of HbA1c.14 Annual review appointments should include screening for common autoimmune conditions (thyroid disease, Coeliac disease), screening for microalbuminuria, and a lipid profile. After the age of 12, referral should be made to the Diabetic Retinopathy Screening Programme (www. diabeticretinascreen.ie).

For both T1DM and T2DM, the role of the multidisciplinary team (MDT) is a central feature of patient management. Patients should have access to endocrinologists, diabetes clinical nurse specialists, dieticians, and psychologists. The most important initial function of the MDT is structured education for both dayto-day management and management of diabetes-related emergencies.11

T1DM CURRENTLY ACCOUNTS FOR GREATER THAN 95 PER CENT OF CASES OF DIABETES MELLITUS IN PAEDIATRIC POPULATIONS IN THE UK AND IRELAND

Insulin pumps and CGM

Continuous subcutaneous insulin infusion (CSII) therapy, also known as ‘insulin pumps’, is rapidly becoming the standard of care for paediatric patients in health systems in the developed world.15 They work by continuously delivering a basal rate of rapid-acting insulin via a subcutaneous giving set, replacing the need for long-acting insulin – this delivery of insulin more closely resembles the physiological action of insulin in the body of a person without diabetes.

This move towards CSII therapy is

occurring alongside developments in blood glucose monitoring.

Continuous glucose monitoring (CGM) uses a subcutaneous sensor to measure interstitial glucose levels and offer realtime feedback on blood glucose levels; it is considered to be the preferred option of blood glucose monitoring in the paediatric setting.16 CGM also offers a new therapeutic goal by providing information on how long a patient spends within a normal range for blood glucose; this ‘time in range’ value is considered more accurate than HbA1c as it is not confounded by

episodes of hypoglycaemia.17

There is a new generation of CSII pumps, which have the ability to communicate with CGM sensors to offer a number of functions, including suspending insulin delivery if blood glucose falls below a certain value, or real-time alteration of insulin delivery in response to blood glucose levels (the hybrid closed-loop system). As CSII and CGM technology improves, it continues to offer patients with T1DM more opportunities to maintain good glycaemic control, reduce the risk of adverse effects, and improve quality-of-life.

NATIONAL CLINICAL GUIDELINES ON DIABETES IN CHILDREN

A Model of Care for all children and young people with type 1 diabetes was published in 2015. The primary aim of this model of care is to define excellent diabetes care, and improve access, quality, and value for all children with T1DM in Ireland. That document is available at: www.hse.ie/eng/about/Who/ clinical/natclinprog/paediatricsand neonatology/paedsmoc.pdf.

A Model of Care was developed in 2012 for the provision of continuous subcutaneous insulin infusion (CSII) therapy in children aged under five years of age and was updated in March 2015. That document is available at: www.lenus.ie/hse/bitstream/10147/275652/1/ProvisionContinSubcutaInsuInfusiontreat Type1DiabetesUnderFives.pdf.

In March 2019 the HSE published a series of national clinical guidelines on diabetes care in children, with a number of updates and additions since then: Care of the child newly diagnosed with type 1 diabetes without DKA (updated April 2021); Identification and management of hypoglycaemia in children with type 1 diabetes (updated April 2021); Annual Review and co-morbidity screening in type 1 paediatric diabetes (Version 1, November 2020); Management of

continuous glucose monitoring for children type 1 diabetes (Version 1, October 2020); Management of paediatric type 1 diabetes patient with a HbA1c >9 per cent (75mmol/ mol) (Version 3, March 2019); General principles in the management of children with diabetes requiring surgery (updated April 2021); Management of paediatric diabetic ketoacidosis (updated April 2021); Management of paediatric type 1 diabetes patient with an intercurrent illness (hospital) (updated April 2021); and Management of paediatric type 1 diabetes patient who did not attend (DNA), were not brought or repeatedly cancels their appointments (March 2019). All these clinical guidelines can be accessed at: www.hse.ie/eng/about/ who/cspd/ncps/paediatrics-neonatology/resources/.

For parents and caregivers, there is also a Paediatric Type 1 Diabetes Resource Pack , which was developed jointly by paediatric clinical nurse specialists and dietitians working in Irish specialist services on behalf of the National Clinical Programme for Paediatric Diabetes. The aim is to give a clear, concise advice on common scenarios as the parent/child begins learning about diabetes. It is available at: www.hse.ie/eng/about/who/cspd/

ncps/paediatrics-neonatology/resources/paediatric-type-1-diabetesresource-pack.pdf.

The latest HSE document is the Meeting the care needs of primary school children with type 1 diabetes during school hours guideline, which is a useful resource for parents, carers, teachers, and school staff and was published in the summer of 2022. The document sets out clear guidelines that will help structure the conversation and preparations between the family, diabetes team, and school staff. It explains diabetes and diabetes management to teachers and school staff and sets out clear lines of responsibility for all partners. The document also includes a Personal Pupil Plan to agree on current diabetes management and the needs of a child, which includes information, such as personal hypoglycaemia symptoms, what to eat during hypoglycaemia, and when to check glucose levels and deliver insulin. The school can have a personalised ‘information pack’ for all their pupils with T1DM. This document can be accessed at: www. hse.ie/eng/about/who/cspd/ncps/ paediatrics-neonatology/resources/ meeting-care-needs-primary-schoolchildren-with-diabetes1.pdf.

FOR THE TREATMENT OF DIABETES MELLITUS IN ADULTS, ADOLESCENTS AND CHILDREN FROM THE AGE OF 6 YEARS1

patients on their basal insulin journey1

insulin glargine

• Help your find balance

HbA1c hypoglycaemic •Off ers (+/- 3 hours) dosing

can administer patients with T2DM.1 and dose adjustment insufficient glucose adherence to the prescribed relevant factors must be exercised, and hypoglycaemic episodes required. Warning signs groups, potentially include patients in gradually, an autonomic subcutaneous insulin glargine intensified metabolic administration may have been reported with risk factors for should be observed for should be discontinued labels must always be insulins. Patients must DoubleStar prefilled must not be re-used. controlled clinical trials. in pregnant women malformative nor feto/neonatal clinically needed.

† Toujeo® is available Toujeo® up to 3 hours

hen needed, patients can administer tudies, in patients with T2DM.1

Prescribing Information: of Product Characteristics DoubleStar pre-filled pens.

Careful excreted in breast adjustment of insulin severe hypoglycaemia including redness, pain, in relation to other SoloStar 5 pen pack:

Authorisation

Prescribing Information: Toujeo (insulin glargine 300 units/ml) Please refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Toujeo SoloStar and DoubleStar pre-filled pens. Each ml contains 300 units of insulin glargine. SoloStar pen contains 1.5ml (450 units) of solution for injection. DoubleStar pen contains 3ml (900 units) of solution for injection. Indication: Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years. Dosage and Administration: Toujeo is administered subcutaneously, by injection into the abdominal wall, the deltoid or the thigh, once daily, at any time of the day, preferably at the same time every day. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis. The dose regimen (dose and timing) should be adjusted according to individual response. Do not administer intravenously. In type 1 diabetes mellitus, Toujeo must be combined with short-/rapidacting insulin to cover mealtime insulin requirements. In patients with type 2 diabetes mellitus, recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments. Toujeo can also be given together with other anti-hyperglycaemic medicinal products. Switch between insulin glargine 100 units/ml and Toujeo: Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable. When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit-to-unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels. When switching from Toujeo to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%). Switching from other basal insulins to Toujeo: A change of dose and/or timing of the basal insulin and concomitant anti-hyperglycaemic treatment may be required. Dose adjustments may also be required if the patient’s weight or lifestyle changes, the timing of insulin dose is changed, or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia. Toujeo must not be mixed or diluted with any other insulin or other medicinal products. Close metabolic monitoring is recommended during a switch and in the initial weeks thereafter. SoloStar 1-80 units per single injection in steps of 1 unit and DoubleStar 2-160 units in steps of 2 units. When changing from Toujeo SoloStar to Toujeo DoubleStar, if the patient’s previous dose was an odd number, then the dose must be increased or decreased by 1 unit. Toujeo DoubleStar prefilled pen is recommended for patients requiring at least 20 units per day. Special Populations: Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. Paediatric: When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimise the risk of hypoglycaemia. The safety and efficacy of Toujeo in children and adolescents below 6 years of age have not been established. Contraindications: Hypersensitivity to insulin glargine or any excipients. Precautions and Warnings: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Toujeo is not the insulin of choice for treatment of diabetic ketoacidosis. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood

1.5ml (450 units) of solution injection. Indication: Treatment age of 6 years. Dosage into the abdominal wall, same time every day. Injection to the next in order to regimen (dose and timing) intravenously. In type 1 to cover mealtime insulin daily starting dose is 0.2 together with other anti-hyperglycaemic units/ml and Toujeo: Insulin directly interchangeable. done on a unit-to-unit achieve target ranges for units/ml, the dose should to Toujeo: A change of treatment may be required. lifestyle changes, the timing susceptibility to hypoor other medicinal products. the initial weeks thereafter.

Holder: Further information is Campus, Dublin 24 or MAT-IE-2200355 (V1.0)

glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered. Hypoglycaemia: In case of insufficient glucose control or a tendency to hyper/hypoglycaemic episodes, the patient’s adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Particular caution should be exercised, and intensified blood glucose monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or who are elderly. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. Intercurrent illness: Requires intensified metabolic monitoring and often it is necessary to adjust the insulin dose. Insulin antibodies: administration may cause insulin antibodies to form. Use with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Medication errors: Insulin labels must always be checked before each injection to avoid errors between Toujeo and other insulins. Patients must be instructed to never use a syringe to remove Toujeo from the SoloStar or DoubleStar prefilled pen, A new sterile needle must be attached before each injection. Needles must not be re-used. Pregnancy and lactation: There are no data from exposed pregnancies in controlled clinical trials. However, there is a large amount of data on use of insulin glargine 100 units/ml in pregnant women indicating no specific adverse effects on pregnancy and no specific malformative nor feto/neonatal toxicity. The use of Toujeo may be considered during pregnancy, if clinically needed. Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk. Interactions: Substances that affect glucose metabolism may require adjustment of insulin glargine. Adverse Reactions: Very common: Hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening. Common: Lipohypertrophy, injection site reactions, including redness, pain, itching, hives, swelling, or inflammation. Prescribers should consult the SmPC in relation to other adverse reactions. Legal Category: POM. Marketing Authorisation Number: SoloStar 5 pen pack: EU/1/00/133/035; DoubleStar 5 pen pack: EU/1/00/133/038. Marketing Authorisation Holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. Further information is available from: Medical Information, Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of preparation: July 2022. MAT-IE-2200355 (V1.0)

be found at reported to Sanofi Ireland IEPharmacovigilance@sanofi.com

2-160 units in steps of patient’s previous dose unit. Toujeo DoubleStar day. Special Populations: renal or hepatic impairment. basal and bolus insulin hypoglycaemia. The safety have not been established. Precautions and Warnings: products, the name and Toujeo is not the insulin to perform continuous and cutaneous amyloidosis. glycaemic control following in the injection site to

Intended for Healthcare Professionals in the Republic of Ireland only.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie; email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com

Intended for Healthcare

Abbreviations: HbA1c, Hemoglobin A1c; PD, Pharmacodynamics; PK, Pharmacokinetics; T1DM, Type 1 Diabetes Mellitus; T2DM, Type 2 Diabetes Mellitus.

Abbreviations: HbA1c,

References: 1 Toujeo® Summary of Product Characteristics July 2020. 2. Home PD, et al. Diabetes Care 2015;38(12):2217-2225. 3. Matsuhisa M, et al Diabetes Obes Metab 2016;18(4):375-383. 4. Danne T, et al. Diabetes Care 2020; 43(7):1512–1519. 5. Riddle MC, et al. Diabetes Care 2014;37:2755-2762. 6 Yki-Jarvinen H, et al Diabetes Care 2014;37:3235-3243. 7. Bolli GB, et al Diabetes Obes Metab 2015;17:386-394. 8 Singh R, et al Eur Endocrinol 2018;14:47-51. 9 Pohlmeier H, et al. J Diabetes Sci Technol 2017;11;263-269.

MAT-IE-2200486 (v1.0) | December 2022

sanofi

H, et 2018;14:47-51. 9 Pohlmeier

References: 1 Toujeo® Diabetes Obes Metab 6 Yki-Jarvinen

MAT-IE-2200486 (v1.0)

FOR ADOLESCENTS

YEARS1 your journey1 om

sanofi

≥6 years

T2DM management

The management of T1DM contrasts with T2DM, which rather than being a failure of insulin production is instead caused by a problem with the action of insulin in the body. As such, the mainstay of treatment is not insulin therapy, with first-line advice being management of diet and exercise to counter the risk of insulin resistance.14 Aside from these non-pharmacological interventions, there are several medications, which have a role in T2DM management; metformin decreases glucose production in the liver and increases sensitivity

REFERENCES

to insulin in the body tissues;14 GLP1 agonists (eg, liraglutide, semaglutide) enhance glucose-mediated insulin secretion and reduce postprandial glucagon secretion;18 and insulin may be required by a small proportion of T2DM patients, but is recommended for any T2DM patient with evidence of ketosis or who have a significant raised blood glucose level (HbA1c >69mmol/mol).19

Future

The future of T1DM management is moving away from novel therapies and focusing on screening and

ketoacidosis1.pdf.

immunotherapies for prevention. Recent studies taking place around the world are investigating the role of autoantibodies as predictors of T1DM, both in families with a history of T1DM and in general populations. 20,21 Although at the early stages of development, the possibility of someday being able to prevent T1DM is an exciting one, and mirrors the innovation which has already transformed the management of diabetes since Banting and Best first isolated insulin just over 101 years ago. For patients and staff alike, the next century looks to be just as exciting as the last. l

1. International Diabetes Federation. IDF Diabetes Atlas (2021). Available at: https:// diabetesatlas.org/.

2. World Health Organisation. Diabetes factsheet (2022). Available at: www.who. int/news-room/fact-sheets/detail/diabetes.

3. Atkinson MA, Maclaren NK. The pathogenesis of insulin-dependent diabetes mellitus. N Engl J Med. 1994 Nov 24;331(21):1428-36.

4. Temneanu OR, Trandafir LM, Purcarea MR. Type 2 diabetes mellitus in children and adolescents: A relatively new clinical problem within paediatric practice. J Med Life. 2016 Jul-Sept;9(3):235.

5. Moran A, Doherty L, Wang X, Thomas W. Abnormal glucose metabolism in cystic fibrosis. J Paediatr. 1998 Jul 1;133(1):10-7.

6. Sanyoura M, Philipson LH, Naylor R. Monogenic diabetes in children and adolescents: Recognition and treatment options. Curr Diab Rep. 2018 Aug;18(8):1-3.

7. Roche EF, Menon A, Gill D, Hoey H. Clinical presentation of type 1 diabetes. Paediatric Diabetes. 2005 Jun;6(2):75-8.

8. Edge JA, Ford-Adams ME, Dunger DB. Causes of death in children with insulin dependent diabetes 1990-96. Arch Dis Child. 1999 Oct 1;81(4):318-23.

9. HSE. Management of paediatric diabetic ketoacidosis (2021). Available at: www.hse.ie/eng/about/who/cspd/ ncps/paediatrics-neonatology/resources/ management-of-paediatric-diabetic-

10. Kitabchi AE, Umpierrez GE, Miles JM, Fisher JN. Hyperglycaemic crises in adult patients with diabetes. Diabetes Care 2009 Jul 1;32(7):1335-43.

11. HSE. Care of the child newly diagnosed with type 1 diabetes without DKA (2021). Available at: www.hse.ie/ eng/about/who/cspd/ncps/paediatricsneonatology/resources/care-of-the-childnewly-diagnosed-with-type-1-diabeteswithout-dka.pdf

12. Levitsky LL, Misra M. Insulin therapy for children and adolescents with type 1 diabetes mellitus (2022). Available at: www.uptodate.com/contents/insulintherapy-for-children-and-adolescents-withtype-1-diabetes-mellitus.

13. Haller MJ, Atkinson MA, Schatz D. Type 1 diabetes mellitus: Etiology, presentation, and management. Paediatric Clinics. 2005 Dec 1;52(6):1553-78.

14. American Diabetes Association. Children and adolescents: Standards of medical care in diabetes – 2021. Diabetes Care. 2021 Jan 1;44 (Supplement_1):S180-99.

15. Phillip M, Battelino T, Rodriguez H, Danne T, Kaufman F. Consensus Forum Participants. Use of insulin pump therapy in the paediatric age-group: Consensus statement from the European Society for Paediatric Endocrinology, the Lawson Wilkins Paediatric Endocrine Society, and the International Society for Paediatric and Adolescent Diabetes, endorsed by

the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2007 Jun 1;30(6):1653-62.

16. Chiang JL, Kirkman MS, Laffel LM, Peters AL. Type 1 Diabetes Sourcebook Authors. Type 1 diabetes through the life span: A position statement of the American Diabetes Association. Diabetes Care. 2014 Jul 1;37(7):2034-54.

17. American Diabetes Association. Diabetes technology: Standards of medical care in diabetes – 2020. Diabetes Care 2020 Jan 1;43(Supplement 1):S77-88.

18. Lee YS, Jun HS. Anti-diabetic actions of glucagon-like peptide-1 on pancreatic beta-cells. Metabolism. 2014 Jan;63(1): 9-19.

19. Copeland KC, Silverstein J, Moore KR, Prazar GE, Raymer T, Shiffman RN, et al. Management of newly diagnosed type 2 diabetes mellitus (T2DM) in children and adolescents. Paediatrics. 2013 Feb;131(2):364-82.

20. Mahon JL, Sosenko JM, RafkinMervis L, Krause-Steinrauf H, Lachin JM, Thompson C, et al. The TrialNet Natural History Study of the development of type 1 diabetes: Objectives, design, and initial results. Paediatric diabetes. 2009 Mar;10(2):97-104.

21. McCulloch DK, Palmer JP. The appropriate use of B-cell function testing in the preclinical period of type 1 diabetes. Diabetic Medicine. 1991 Nov;8(9):800-4.

AUTHOR: Julie Power, Chairperson and founder of Vasculitis Ireland Awareness

A window into living with vasculitis

Iwas relieved when I got my diagnosis of Wegener’s granulomatosis, at least then I knew I did not have Crohn’s disease, that all these strange symptoms were related, and that there was a valid reason why I had been feeling so rotten for the past year or so. Vasculitis is a group of rare, systemic, auto immune conditions, where the immune system attacks the blood vessels. Delays in diagnosis and treatment lead to irreversible organ damage. There are 18 known conditions. Some call them diseases, but this sounds like they are contagious, which they are not. Because Wegener was involved in the Nazi concentration camps, the name of my condition changed to granulomatosis with polyangiitis vasculitis (GPA). This new name also describes some of the symptoms of my condition.

We are told we are rare. I was told six-in-a-million, but since I have been diagnosed, and through our support group, I have met so many people with the same condition. I suspect, therefore, that this number is much higher and that the lower estimates are due to either delayed diagnosis or misdiagnosis. My life and that of my family changed very dramatically. I was a young mother who had a job I loved, and we looked forward to lots of adventures in life. Suddenly, I was not as independent anymore and was unable to return to work. Our future changed overnight, physically, socially, and financially.

There is no cure for vasculitis. We manage it with harsh medications and often have ongoing issues with drug side-effects and unmanaged symptoms. These are not life-threatening, but do impact our quality of life. For example, I developed a saddle nose, whereby the cartilage in my nose was eaten away during active disease. I now have a huge cavity into my sinus area. This

was not life-threatening and my disease was under control, but I had frequent sinus infections, lots of sinus pain, and a deformed nose that drew lots of unwanted attention. I did not recognise myself in the mirror between this flattened nose and the usual steroid side-effects. I found it hard to not let this interfere with my life or that of my family, so it was a blessing when I met Prof Malata in Cambridge Hospital, who agreed to fix my nose with a piece of my rib. This changed my life. I still have lots of sinus issues, but now I look reasonably normal. Who knew I was a little vain?

I think for people living with a chronic condition, a lot goes on beneath the surface. We get up and get out, we attend to things like other people, turn up for our appointments, and life seems good. But behind closed doors, there is usually a lot of effort going into being independent. We usually plan everything in advance, we prioritise what is important to achieve that day, we manage pain levels, fatigue levels, and our psychological wellbeing. I enjoy a reasonable quality-of-life, but I am sure you would not think I practically roll out of bed every day, just to get up on my feet.

Even though I worked in the health profession for nearly 20 years, I had never heard of vasculitis, and if I had, it did not register. I now see a different side to treating people. I see the importance of listening and not claiming to know everything. I despair if someone comes to me and says they are an expert, as I fear they will not seek alternative opinions if they do not understand what is going on with me. I know my own body and how this illness affects me. If I suspect something is not right or recognise a familiar symptom, my first port-of-call is the specialist nurse at our clinic. Sometimes all it takes is to talk it through and we can

solve it quickly, which is good all round. I do not want to exacerbate my condition with anxiety and worry. Awareness within the healthcare team allows members to move quickly and avoid a crisis developing. We, the patients, and the clinical teams rely so much on our valued nursing staff and are very grateful to them for their role in managing the disorder.

I found having a rare condition very lonely. It was hard to explain what was wrong with me, never mind telling people the name of it. I can see their eyes glaze over before I finish the first words. That is why I started looking for a support group. I finally met another person with GPA who lived fairly near me and the relief in being able to talk without explaining everything was so good. That was the start of Vasculitis Ireland Awareness (VIA). It is a safe place to meet and chat, share information, and learn more about how we can live better with these conditions. We welcome all who are living with any of the vasculitis conditions, their families, carers, and all interested healthcare professionals. We can all learn so much from each other and save valuable time and resources.

We have meetings online on the first Monday evening of the month and are planning our annual conference later in the year, when we meet up with healthcare professionals and service providers to share details of the latest research projects we are involved in, best practice guidance, and available services to help us manage our conditions better. If you are interested in learning more about us and our work, or would like to know more about how vasculitis might affect the quality-of-life of your patients, please do not hesitate to get in touch. You can join our mailing list or come along to any of our meetings. l

THE REALITY OF LIVING WITH VASCULITIS AND THE ROLE OF THE NURSE IN THE MANAGEMENT OF THE CONDITION

PCDSI ANNUAL CONFERENCE 2023 ROUND-UP

Dr Caroline Burke relays some pearls from the experts Dr Chin Whybrew, Mrs Julie Van Onsolen, and Dr Julian Pearce who delivered the Basic Dermoscopy day at the PCDSI 2023 Annual Conference in Kilkenny, which took place from 3-4 March:

D“ermoscopy helps” particularly in keeping the basic and benign lesions out of secondary care, ie, reducing referral rates and to reassure yourself that if you think something looks like, for example, a simple warty lesion or, eg, a seborrheic keratosis that that is in fact what it is. Naevi should not grow beyond midlife so any concerning moles, particularly in this age and beyond, should be referred.

“Dermoscopy is fun” and there were lots of food analogies used to aid the pattern recognition which is built up over time when viewing lesions dermoscopically. Seborrheic keratosis can resemble chocolate muffins, sebaceous hyperplasia can have a resemblance to marshmallows, and actinic keratosis on the ear can show a ‘cornflake sign’! The advice was to always send any lesion resected away for histology.

Tips were given in terms of types of

dermatoscopes – ideally one with options for polarised light and without. Lots of different types are on the market and information on brands is available on the www.pcds.org.uk/ website.

For contact fluids, alcohol gel is advised and simple lubricant for broken skin or around the eye. Clingfilm can be applied on the dermatoscope for broken or bleeding skin for infection control reasons. Simple tape can be used to strip off dead skin/scale from a pigmented lesion. Remember to optimise image quality by wiping excess fluid to remove air bubbles. Alcohol wipes are handy if reviewing numerous lesions over a large area, eg, the back. Some lesions will not require contact with the dermatoscope and it will not be possible with convex surfaces eg, nose. Too much pressure with the dermatoscope can cause issues in viewing the blood vessels, eg, in looking at a basal cell carcinoma (BCC).

Some other handy tips included using (with consent) the patient’s phone for taking the dermoscopic picture and they can then email it through to the practice via Healthmail in order to file on their chart. This helps with data management and security. A handy app is the ‘Snipping tool’ app to reduce the size of the photo file for saving. It is important to take a localising photo (can show surrounding sun damage), a close-up clinical photo, and a dermoscopy photo. This builds up your knowledge when you get a response from dermatology naming the lesion and can be used for educational purposes.

The speakers were full of energy and

enthusiasm telling the audience that Ireland has the highest level of fake tan users per capita, and showing an interesting way of applying basic table salt to pyogenic granuloma in order to reduce their vascularity and bleeding risk.

Suggested books included Diagnostic Dermatology: The Illustrated Guide by Johnathon Bowling, and Dermoscopy: The Essentials

It is important to expose as much of the skin as possible and ensure all make-up is removed, and examine with the naked eye first before using the dermatoscope as not everything needs one.

History from the patient is essential in terms of general history (age/ skin type/previous skin concern/ immunosuppression/family history/sun exposure) and history in relation to the lesion (duration/solitary or multiple/any change and timescale of same/crusting, bleeding, itch, pain, inflammation?).

It is important when referring to describe the lesion properly (site/ size/single or multiple/shape/colour/ surface/papule, nodule, plaque or cyst/tender or not/inflamed or not). Also describe the site and www. anatomymapper.com is a useful site for the exact terminology. Beware always of the ‘ugly duckling’ lesion and always consider when viewing a lesion – could this be a melanoma?

The six common keratinising tumours were covered in detail in terms of their dermoscopic features – actinic keratoses, Bowen’s, squamous cell carcinoma (SCC), keratoacanthoma, seborrheic keratosis

AUTHORS: Dr Caroline Burke, GP Registrar with Cork GP Training Scheme, and PCDSI Committee member; and Dr Lorna Wilson, GP, Shankill, Co Dublin, and PCDSI Committee member

and viral warts. Colours and patterns, and defining and worrying features were discussed over the course of the afternoon. For example, haemangiomas are raised from the surface and are benign overgrowths of blood vessels and are often soft and show a ‘grapefruit segmentation’ type pattern under dermoscopy. There will be red/purple lacunae and a pinkish colour with a sharply-demarcated edge and fibrous white stroma. They routinely never have vessels that cross the middle/go over the top and should not have brown or grey colours. If they are thrombosed, they can look terrifying as they may have black present, which is blood.

Dermatofibromas, which are always palpable from the outset, retain their original morphology and have a dimple sign when you squeeze either side where there is subcutaneous fat as they will shrink inwards, and on dermoscopy classically have a central white structureless area, which is paler than surrounding skin and have peripheral pigment clods.

SCC show the triad of white circles, irregular vessels around the periphery, and a central keratin mass/erosion

Dr Lorna Wilson shares her highlights from the Advanced Dermoscopy Course and day two of the 2023 PCDSI Annual Conference:

After a brief introduction by the chair Dr Kashif Ahmed, we welcomed Dr Jonathan Bowling up to discuss acral melanomas. This was a very comprehensive talk on the importance of distinguishing between benign and malignant nail pigmentation through our dermatoscopes. We were reminded that

present. These are often tender and have a high risk of metastases.

One should have a high index of suspicion for BCC if there is a linear lesion on the head or neck which has not healed within four weeks. The patient may say “I think I scratched it” and BCCs may occur in skin creases. Infiltrative BCCs on the face may look like a scar and a good tip is to stretch it and you can see it projecting out in different directions. BCCs under dermoscopy often show arborising vessels on a translucent pink background and can have ulcerations and micro-erosions and white strands and blotches. If there is pigmentation on the BCC always refer for urgent review.

With regard to melanocytic lesions, the worrying features include chaos under dermoscopy and a lack of symmetry, eg, of colour, border, pattern, and more than two colours. Normal benign naevi under dermoscopy should fade out towards the periphery and have a regular pattern/network and they generally do not contain streaks, polymorphous vessels, white lines or blue/white structures. In deciding re asymmetry, one might use the tip: “If

this lesion was a pizza – would everyone get the same toppings?” – if not this may be suggestive of chaos in the lesion.

Lots of melanomas are picked up incidentally and are not always the lesion the patient comes in expressing concern about. One should be wary of nail melanomas which contain a pigment band that is widest at the proximal end and has irregular pigmentation, sometimes destroying the nail plate. Ask regarding a history of trauma if there is curved edges, jagged lines, and a purple colour. Drug-induced pigmentation is caused by medications, such as amiodarone and fungal nails start distally.

Other uses of dermoscopy were described, including looking at head lice, patterns on the skin in scabies, seeing if alopecia areata is scarring or non-scarring, and in looking at lichen planus, and of course in assessing diamonds for clarity, etc.

Overall, this was an informative and enjoyable session which the audience enjoyed. It was peppered with sociable coffee and lunch breaks, and lots of quizzes and interaction from the audience.

variable bands of parallel pigmentation and nail dystrophy in the solitary nail, without a history of trauma, was suspicious for melanoma. Hutchinson sign was also discussed, whereby the nailfold is involved and this is indicative of melanoma. This talk was followed by a remote presentation from Prof Aimilios Lallas on ‘White lesions and white structures’. Here, Prof Lallas differentiated between real white and pseudo white structures; the former being caused as a result of fibrosis, epidermal hyperplasia, and keratin deposits in the skin. The take-home message was that white scar-like fibrosis in a pigmented lesion is always suspicious for melanoma and these are seen much more

clearly under polarised light. Keratin plugs are common in seborrheic keratosis and can also be seen in SCC. Finally, epidermal hyperplasia is commonly seen in conditions such as psoriasis and lichen planus.

Prof Giuseppe Argenziano gave a very interesting talk on lesions from head to toe. He discussed benign lesions of the face, including actinic keratosis and solar lentigos, and he had a number of beautiful slides explaining their features. He went through some dermascopic images of melanoma and lentigo maligna and explained their features in detail. He also discussed genital lesions and differentiated between melanosis, which is a benign entity, and melanoma in this region.

After a coffee break, Prof Andreas Blum discussed collision lesions in detail with the aid of a number of slides to illustrate his points. He discussed how these lesions are more common in males than in females, 50 per cent of cases are found on the trunk, and the mean age for developing these lesions is between 53-to-60 years of age. In the head and neck region we are more likely to see a BCC collision lesion, and in the trunk we are more likely to see a melanocytic collision lesion. These lesions are linked to a history of higher UV exposure in the past, especially in the head and neck area.

Prof Lallas followed this talk up again remotely on lesions in the mucus

membranes. Here he described pigmented lesions of the genital area which complimented Prof Argenziano’s talk from earlier. He also described non-pigmented lesions in the genital area, such as psoriasis, lichen sclerosis, Zoon balanitis, fungal infections, and Erythroplasia of Queyrat, which is SCC in situ of the penis.

Dr Jonathan Bowling gave a talk on ‘difficult seborrheic keratosis’, which included inflamed, traumatised, hypopigmented, hyperpigmented and clonal seborrheic keratosis. He also explained the immune interaction in seborrheic keratosis and how this changes the colour of seborrheic keratosis to a grey granular pigment.

After lunch, Prof Argenziano discussed his top tips for the more experienced dermoscopist, and this was followed up with Prof Blum showing us an array of dermascopic images in his talk on chameleon melanoma, which in essence described the variability of melanomas through pictures.

The evening presentations included excellent talks by Prof Mark Davis on lupus and the skin, and oral problems. Dr Eoin Storan also gave very interesting presentations on connective tissue diseases and the skin, as well as systematic diseases and the skin. These were very relevant and well received by all in the audience.

Basic general dermatology for everyday practice

Dr Chris Bower started the morning session off with an overview of nails where he discussed onycholysis, onychomycosis, and pterygium in detail. This was followed up by Prof Anthony Bewley with his interesting talk on psychodermatology. This presentation described delusional infestation and how to manage this very tricky complaint in general practice.

Dr Colin Long gave us the ‘Ten commandments in dermatology’, which described how to avoid common pitfalls in our day-to-day practice, including not describing all rashes as macular-papular!

Dr Brian Malcolm then joined Dr Bower in a very engaging talk on ‘Interesting cases from Devon’, where they went through a number of slides on different unusual presentations to their practice.

After coffee, Prof Fergal Moloney gave an excellent talk on how to prevent our patients getting skin cancer. He described the predisposing factors for the development of melanoma and

the correlation between deprivation and melanoma. He also explained how Nicotinamide twice-daily reduced the risk of developing BCC by 23 per cent.

Dr David Buckley gave a very comprehensive talk on the management of psoriasis in primary care and held an interactive quiz, the winner of which won a copy of his new textbook.

Ms Sheila Ryan gave a very practical talk on wound care where she described the most appropriate dressings for wounds in all their varying stages.

After lunch in the advanced dermatology section, Dr Síona Ní Raghallaigh gave an excellent talk on managing the four different subtypes of rosacea from topical to systemic treatment. She also discussed the options for treating complications of severe rosacea such as disfiguring rhinophyma.

Dr Jerry Tan gave a very detailed and comprehensive presentation on dealing with acne scars. Dr Tan described the different types of acne scars, from ice pick and boxcar to rolling and saucer

scars. He went through chemical peels, micro-needling, laser therapy, and dermal fillers and their role in reducing the appearance of disfiguring acne scars. He also brought into his talk the use of topical retinoids and oral isotretinoin in aiding in this process.

Prof Anthony Bewley was welcomed back to stage again for a very interesting talk on the effects of acne and rosacea on the psyche, and gave very useful pointers on how to deal with patients in these categories.

Finally, Dr Ní Raghallaigh concluded the evening with a very useful talk on the red spotty face not caused by rosacea or acne. Dr Ní Raghallaigh described the management of seborrheic dermatitis, peri-orofacial dermatitis, steroid rosacea, and pityriasis folliculorum.

This was a wonderful, informative, and sociable meeting. We are all very much looking forward to the next PCDSI Conference being held in Galway on 11–13 April 2024. For more information keep an eye on www.pcdsi.com.

Accord’s Sondelbay awarded best value biologic medicine in Ireland

In February of this year, Accord received confirmation from the HSE Medicines Management Programme that Sondelbay has been awarded best value biologic (BVB) medicine status for teriparatide. Sondelbay is a biosimilar, subcutaneous injection pen that is self-administered once daily to optimise bone health. It is indicated for the treatment of osteoporosis in postmenopausal women and for men at an increased risk of fracture.

This is the company’s fourth biosimilar and joins Accord’s established and growing portfolio. The active substance, teriparatide as a solution for injection has shown to have an anabolic effect on osteoporotic

bone via the receptor for parathyroid hormone. In postmenopausal women, the product has displayed a notable reduction in the incidence of vertebral and non-vertebral fractures. It is also recommended in the treatment of osteoporosis

associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Commenting on the achievement, Tracy Kivlehan, Accord Healthcare Ireland’s Head of Hospitals and Specialty Brands, said: “We are delighted to have been awarded the BVB status for Sondelbay in Ireland. It is an addition to our emerging bone health franchise and our hightech range. Osteoporosis takes a huge toll, not only clinically on the patient, but also on overstretched health systems. This launch reinforces our commitment to continue to improve access to essential medicines for the patients that need them most.”

Upadacitinib available for the treatment for moderate-to-severe ulcerative colitis in Ireland

AbbVie has announced the availability of Upadacitinib for the treatment of adult patients with moderately-to-severely active ulcerative colitis. On 1 December 2022, the HSE PCRS reimbursed Upadacitinib following the approval by the European Commission (EC) in July 2022 of Upadacitinib for the treatment of adult patients with moderately to

severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. The recommended dose of Upadacitinib in ulcerative colitis is 45mg as an induction dose, and 15mg or 30mg maintenance doses.

Discovered and developed by AbbVie scientists, Upadacitinib

is a selective and reversible JAK inhibitor. The EC approval is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance.

During the U-ACHIEVE and U-ACCOMPLISH induction trials, 26 per cent and 33 per cent of patients treated with Upadacitinib

45mg achieved clinical remission at week eight, the primary endpoint, compared to 5 per cent and 4 per cent of patients who received placebo. During the U-ACHIEVE maintenance trial, 42 per cent and 52 per cent of patients treated with Upadacitinib 15mg or 30mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 per cent of patients who received placebo. Upadacitinib is also licensed in the following therapeutic indications in the EU:

 Rheumatoid arthritis: Upadacitinib is indicated for the treatment of moderate-to-severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more diseasemodifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

 Psoriatic arthritis: Upadacitinib is indicated for the treatment of

active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Upadacitinib may be used as monotherapy or in combination with methotrexate.

 Axial spondyloarthritis (Non-radiographic axial spondyloarthritis): Upadacitinib is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicataed by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal antiinflammatory drugs (NSAIDs).

 Ankylosing spondylitis (AS, radiographic axial spondyloarthritis): Upadacitinib is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

 Atopic dermatitis: Upadacitinib is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Commenting on the new treatment, Consultant Gastroenterologist and Honorary Personal Professor at University Hospital Galway Eoin Slattery said: "I’m very excited by the recent HSE approval for the reimbursement for RINVOQ/ Upadacitinib for ulcerative colitis. It adds another important tool to the gastroenterologists’ armamentarium in the management of this extremely debilitating and often silent disease that affects between 20-to-30,000 people in Ireland. RINVOQ’s potential to bring rapid and sustained relief via an oral formulation is the reason I look forward to introducing it in my daily clinical practice.”

Clonmel Healthcare launch Paralief soft capsules

Clonmel Healthcare is delighted to announce the launch of Paralief 500mg soft capsules (each capsule contains 500mg of paracetamol). Paralief 500mg soft capsules are indicated for the short-term treatment of headache, toothache, muscle ache, lumbago, fever, and pain with flu and colds. Paralief 500mg soft capsules are available in a pack size of 20. You can contact Clonmel Healthcare on 01 620 4000 if you require any additional information on Paralief 500mg. A copy of the summary of product characteristics is available on request or at: www.clonmelhealthcare.ie

ACROSS

Across

1 - Reference point; norm (8)

DOWN

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5 - Char (4)

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5 Char (4)

8 Public meeting for open discussion (5)

2 Take into custody (6)

8 - Public meeting for open discussion (5)

3 Eg, width or length (9)

4 Actually (6)

SCRIBBLE BOX

2 - Take into custody (6)

3 - Eg width or length (9)

9 Incredible (7)

9 - Incredible (7)

10 Civil action brought to court (7)

12 Fulfil a desire (7)

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11 Storage building (9)

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14 Juicy citrus fruit (6)

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17 Solely (4)

18 - Support or strengthen (7)

19 - Labour organisation (5)

20 - Repudiate (4)

4 - Actually (6)

6 - One of a kind (6)

7 - Opposite of positive (8)

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14 - Juicy citrus fruit (6)

15 - Rigid; stern (6)

17 - Solely (4)

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21 - Not long ago (8)

Diagnosis and management of asthma in adults and adolescents - a review

This module explores the latest diagnosis and management approaches for asthma in adolescents and adults, including the most recent international guidelines

Authors: Dr Shane Brennan, GP registrar, South East Training Scheme; Dr Dermot Nolan, ICGP/HSE National Clinical Lead for Asthma

Successful completion of this module will earn you

2 CPD credits

Free independent CPD for Irish nurses A B C Free, independent CPD for Irish nurses by Irish nurses

www.medilearning.ie/nursecpd

nurse CPD