ISSUE 6 VOLUME 14 | NOVEMBER-DECEMBER 2021 O LANRUOJLAICIFF • LANRUOJLAICIFFO • O FFICIALJOURNAL • OFFICIALJOURNAL • RESPIRATORY Irish Osteoporosis Society meeting report COPD ● SPIROMETRY ● RSV ● FLU VACCINES CPD MODULE DIABETIC FOOT DISEASE IGPNEA AGM New NEC and photo competition winners
One dose* One less thing
to worry about *One
Con dence, Convenience, Compliance
Please refer to the Summary of Product Characteristics (SmPC) before prescribing Pelgraz▼(peg lgrastim) 6 mg solution for injection in pre- lled injector.
Presentation: Each pre- lled injector contains 6 mg of peg lgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**. *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
** The concentration is 20 mg/mL if the PEG moiety is included. Indications: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Dosage and Administration: Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Posology:
One 6 mg dose (a single pre- lled injector) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. Safety and e cacy of Pelgraz in children and adolescents has not yet been established and no recommendation on a posology can be made. No dose change is recommended in patients with renal impairment, including those with end-stage renal disease. Method of administration: Pelgraz is for subcutaneous use. The injections should be given subcutaneously into the thigh, abdomen or upper arm. See SmPC for instructions on handling of the medicinal product before administration.
Contraindications: Hypersensitivity to peg lgrastim or any of the excipients in Pelgraz. Warnings and precautions: To improve the traceability of biological medicinal products, the trade name of the administered product should be clearly recorded. The long-term e ects of peg lgrastim have not been established in acute myeloid leukaemia (AML); therefore, it should be used with caution in this patient population. Granulocyte-colony stimulating factor (G-CSF) can promote growth of myeloid cells in vitro and similar e ects may be seen on some nonmyeloid cells in vitro. The safety and e cacy of peg lgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML. The safety and e cacy of peg lgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established. The safety and e cacy of peg lgrastim have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens. Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary in ltrates or pneumonia may be at higher risk. The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary in ltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS). In such circumstances peg lgrastim should be discontinued at the discretion of the physician and the appropriate treatment given.
Oncology & Haematology www.accord-healthcare.ie
Glomerulonephritis has been reported in patients receiving lgrastim and peg lgrastim. Generally, glomerulonephritis resolved after dose reduction or withdrawal of lgrastim and peg lgrastim. Urinalysis monitoring is recommended. Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of peg lgrastim. Spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. Treatment with peg lgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia.
Sickle cell crises have been associated with the use of peg lgrastim in patients with sickle cell trait or sickle cell disease. Therefore, use caution when prescribing peg lgrastim in patients with sickle cell trait or sickle cell disease, monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vasoocclusive crisis. White blood cell (WBC) counts of 100 x 109 /L or greater have been observed in less than 1% of patients receiving peg lgrastim. No adverse reactions directly attributable to this degree of leukocytosis have been reported. Such elevation in WBCs is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic e ects of this medicinal product. Consistent with the clinical e ects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 x 109 /L after the expected nadir, this medicinal product should be discontinued immediately. Hypersensitivity, including anaphylactic reactions, have been reported with peg lgrastim. Permanently discontinue peg lgrastim in patients with clinically signi cant hypersensitivity. Do not administer peg lgrastim to patients with a history of hypersensitivity to peg lgrastim or lgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. StevensJohnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with peg lgrastim treatment. If the patient has developed SJS with the use of peg lgrastim, treatment must not be restarted at any time. As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against peg lgrastim is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present. Aortitis has been reported after lgrastim or peg lgrastim administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased
in ammatory markers (e.g. C-reactive protein and WBC count). In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of lgrastim or peg lgrastim. The safety and e cacy of Pelgraz for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive boneimaging ndings. This should be considered when interpreting bone- imaging results. This medicinal product contains 50 mg sorbitol in each unit volume, which is equivalent to 30 mg per 6 mg dose. Pelgraz contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free’. The needle cover contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Pregnancy and Lactation: Peg lgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception. A decision must be made whether to discontinue breastfeeding or to discontinue/ abstain from peg lgrastim therapy taking into account the bene t of breastfeeding for the child and the bene t of therapy for the woman. Adverse Events include: Adverse events which could be considered serious include: Common: Thrombocytopenia. Uncommon: Sickle cell crisis, capillary leak syndrome, glomerulonephritis, hypersensitivity reactions (including angioedema, dyspnoea, anaphylaxis), splenic rupture (including some fatal cases), Sweet’s syndrome (acute febrile dermatosis), pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema and pulmonary brosis have been reported. Uncommonly cases have resulted in respiratory failure or ARDS which may be fatal. Rare: Aortitis, pulmonary haemorrhage, Stevens-Johnson syndrome. Other Very Common adverse events: Headache, nausea, bone pain. Other Common adverse events: Leukocytosis, musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain), injection site pain, non-cardiac chest pain. See SmPC for details of other adverse events. Shelf Life: 3 years. Store in a refrigerator (2°C – 8°C). Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded. Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely a ect the stability of Pelgraz. Keep the container in the outer carton in order to protect from light. Pack
Size: One pre lled injector with one alcohol swab, in a blistered packaging. Marketing Authorisation Number: EU/1/18/1313/002. Marketing Authorisation Holder (MAH): Accord Healthcare S.L.U, World Trade Center, Moll de Barcelona, s/n, Edi ci Est, 6a planta, Barcelona, 08039 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: 021-4619040 or www.accord-healthcare.ie/products. Adverse reactions can be reported to Medical Information at Accord-UK Ltd. via E-mail: firstname.lastname@example.org or Tel: +44(0)1271385257.
Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie), or by e-mailing email@example.com. Adverse events should also be reported to Medical Information via email; firstname.lastname@example.org or tel:0044 (0) 1271 385257
May 2020. IE-01429
out how the Pelgraz® Patient App
The Pelgraz® Patient App Find
can help your patients to confidently self inject from home
One Dose for ANC Recovery NEW Pelgraz® Device & PatientApp
per chemo cycle
Abbreviated Prescribing Information
Date of Generation of API December 2019. IE-01454
MEDICAL 'SPEAK' IS AN ISSUE WITH PATIENTS
I recently attended the ANAIL (Respiratory Nurses Association of Ireland) annual virtual conference at which the subject of health literacy was addressed. I was startled at the low levels of health and numeracy literacy in Ireland.
The EU Health Literacy Survey in 2012 showed that four-in-10 Irish adults had limited health literacy. How many of us have found ourselves in a position where we have to ask for something to be explained in plain English so that we can understand it – a situation that comes to mind is when talking to a bank manager or financial consultant and they are using ‘financial speak or jargon’ and it is all double Dutch. This is what it must feel like for patients and many don’t have the courage or feel empowered enough to ask for the message to be explained in plain English without the risk of being portrayed as being inadequate.
The implications are huge in terms of people’s health and their ability to be active participants in managing their health. Having limited health literacy can potentially mean people do not fully understand their condition
or treatment which may result in errors with taking medication. Further implications include presenting at the later stages of disease, increased risk in attending the emergency department, increases in not attending for screening appointments, admission to hospital is more likely, and increased risk of premature death and patients reporting poorer overall health.
Why is health literacy important?
One-in-five Irish people are not fully confident that they understand the information they receive from their healthcare professional, while 17 per cent of people have taken the wrong dose of medication. Furthermore, 43 per cent of people would only sometimes ask their healthcare professional to clarify the information if they did not understand something they had been told; while 66 per cent of people have difficulty understanding the signs and directions in Irish hospitals.
So, what can we do?
The National Adult Literacy Agency (NALA) recommend:
Communicating in plain English – NALA describes plain English as “a way of
writing and presenting information that helps someone understand it the first time they read or hear it. It involves short clear sentences and using everyday words. It does not involve small print or unnecessary jargon”.
Check that people understand what has been said by asking them to repeat back to you what is their main problem, what they need to do, and why it is important that they need to do this.
Give clear, easy to follow verbal information explaining any medical terminology.
Ensure that all practice staff are aware of literacy and numeracy and to respond in an appropriate and sensitive manner, eg, have an alert in the patient’s notes to inform staff that the patient has difficulty.
Ensure signage and layout is clear and easy to follow.
GPNs are ideally placed to address patients’ concerns and provide explanations in a manner that patients can understand in an environment that is non-judgemental, open and honest, so patients feel comfortable and will ultimately become a more empowered and active participant in managing their health.
Wishing you all a peaceful and restful Christmas and a happy and healthy New Year.
Welcome NOVEMBER-DECEMBER 2021 1
A message from Ruth Morrow, Consulting Editor
Emer Keogh email@example.com
Laura Kenny firstname.lastname@example.org
Graham Cooke email@example.com
Daiva Maciunaite firstname.lastname@example.org
NEC and Irish healthcare news
A meeting report on the 2021 Irish Osteoporosis Society Annual Medical Conference
Dermatology Advanced Nurse Practitioner Gillian
O’Brien gives an overview of the current guidelines on the assessment and management of lower limb wound presentations in general practice
Please email editorial enquiries to Priscilla Lynch email@example.com
Nursing in General Practice is produced by GreenCross Publishing Ltd (est. 2007).
© Copyright GreenCross Publishing Ltd. 2021
18 FROM BRITTLE BONES TO FULL BONE HEALTH
Sarah Buckley details her remarkable journey from being diagnosed with severe osteoporosis in her early 40s to full recovery
Please email publishing enquiries to Publisher and Director, Graham Cooke firstname.lastname@example.org
The contents of Nursing in General Practice are protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means – electronic, mechanical or photocopy recording or otherwise –whole or in part, in any form whatsoever for advertising or promotional purposes without the prior written permission of the editor or publishers.
The views expressed in Nursing in General Practice are not necessarily those of the publishers, editor or editorial advisory board. While the publishers, editor and editorial advisory board have taken every care with regard to accuracy of editorial and advertisement contributions, they cannot be held responsible for any errors or omissions contained.
AN UPDATE ON COPD Respiratory Nurse Specialist
Ruth Morrow gives an update on the latest GOLD guidelines, and diagnosis and treatment approaches to COPD
PRACTICE NURSE OF THE YEAR
Advanced Nurse Practitioner
Orla Loftus Moran discusses her win of the ‘Practice Nurse of the Year 2021’ award at the Irish Healthcare Awards
DIABETIC FOOT DISEASE
This CPD module by Theresa Lowry-Lehnen provides a detailed overview of the prevention, diagnosis, and management of diabetic foot disease
37 CHRONIC PAIN
Chronic Pain Ireland has launched a new patient support leaflet on chronic pain
44 FLU VACCINATION
Dr Tom Barrett , National Immunisation Office, details the 2021/22 flu vaccination programme, with a focus on the children’s LAIV
49 RESPIRATORY SYNCYTIAL VIRUS INFECTION
Theresa Lowry-Lehnen gives a detailed overview on the presentation and treatment of this common and contagious viral pathogen
Respiratory Nurse Specialist
Ruth Morrow outlines the importance of spirometry and how to safely re-introduce it into primary care during the pandemic
54 BOOK REVIEW
George Winter reviews Prof Brendan Kelly’s latest book, The Science of Happiness
55 PRODUCT NEWS
A round-up of the latest pharmaceutical-related news
Test your word knowledge
Contents 2 NOVEMBER-DECEMBER 2021
Elevated cholesterol can affect patients of all backgrounds and is a risk factor for coronary heart disease.
Daily use of Benecol products containing plant stanols equals reduced cholesterol for your patients.
The plant stanols in Benecol reduce cholesterol IN ADDITION to cholesterol lowering medication and dietary modification
The plant stanols in Benecol are clinically proven to lower cholesterol.
Simply put, Benecol adds up to lower cholesterol for patients.
PER DAY ONE =
7-10% REDUCTION IN CHOLESTEROL*
* Plant stanol ester has been shown to lower cholesterol. High cholesterol is a risk factor in the development of coronary heart disease. A daily intake of 1.5-2.4g plant stanols, has been shown to lower cholesterol by 7-10% in 2-3 weeks.
Sophie, 25 Familial Hypercholesterolemia (FH) Tom, 37 Overweight / Obese Emma, 41 Diabetes Sarah, 59 Familial Hypercholesterolemia (FH) Harry, 69 Statin
Hannah, 63 Statin intolerant
STUDY SHOWS INCREASES IN SMOKING AND VAPING IN IRISH TEENS
For the first time in 25 years, rates of smoking among teenage boys in Ireland are increasing, according to a new study published in ERJ Open Research.
The study also shows that rates of vaping among teenagers have risen in the last four years and that teenagers who use e-cigarettes are more likely to smoke.
The researchers say their findings indicate that Ireland will not meet its targets to reduce smoking rates and adds to evidence that vaping could be promoting a new generation of young people addicted to nicotine.
In this study, researchers examined data on Irish teenagers from the European School Survey Project on Alcohol and Other Drugs (ESPAD), a cross-sectional survey of around 100,000 15-to-16 year-olds, conducted every four years in 35 European countries. There were 1,493 Irish teenagers involved in the 2015 survey and 1,949 teenagers in the 2019 survey.
Results from the 2019 survey showed that 16.2 per cent of boys were smokers, compared to 13.1 per cent in 2015, while in 2019 12.8 per cent of girls were smokers compared to 12.8 per cent in 2015.
The increase in current smoking in 15-to-16 year-olds in Ireland between 2015 and 2019 was associated with e-cigarette use, truancy, household composition, familial regulation, and peer smoking.
Ireland was the only country to include questions about e-cigarettes in the 2015 ESPAD survey, offering a unique opportunity to
monitor the trend in e-cigarette use and the effect on smoking rates in teenagers.
In 2015, 23 per cent of teenagers said they had used e-cigarettes at some point and this increased to 37 per cent in 2019. In 2015, 10.1 per cent said they were currently using e-cigarettes, and this increased to 18.1 per cent in 2019.
The data also showed that teenagers who said they had used e-cigarettes at some point or were currently using them were also 50 per cent more likely to smoke.
Teenagers who had ever-used e-cigarettes were significantly more likely to be current smokers and this risk was more pronounced for boys [IRR 1.33, 95% CI 1.17-1.51] than for girls [IRR 1.27, 95% CI 1.11-1.45].
Similarly, current-use of e-cigarettes was significantly associated with increased risk of current smoking for both girls and boys and the risk was much higher for girls [IRR 1.49, 95% CI 1.26-1.75] than for boys [IRR 1.39, 95% CI 1.21-1.60].
The study was led by Prof Luke Clancy, Director General of the Tobacco Free Research Institute Ireland, based in Dublin. He said: “Smoking rates among teenagers have been falling in Ireland, as with many other countries in Europe and in the US. On the other hand, use of e-cigarettes is increasing around the world.
“The dangers of smoking are well-known. We are still learning about the effects of e-cigarettes, but we know that the nicotine they contain can cause brain damage in teenagers. There’s also a concern that they could lead to an increase in smoking.”
Prof Clancy pointed out that the Government
has commited to make the country ‘tobacco-free’ by 2025, meaning the rates of smoking should be below 5 per cent. “Our previous research suggested this goal may not be met for the whole population, but until now, we thought it could be achieved in teenagers. That now looks very unlikely, meaning that smoking and all the death and disability that is associated with it will continue.”
Prof Jonathan Grigg, who was not involved in the research, is Chair of the European Respiratory Society Tobacco Control Committee and Professor of Paediatric Respiratory and Environmental Medicine at Queen Mary University of London, UK. He said: “Any increase in teenage smoking rates is extremely worrying because we know that cigarettes cause harm to children and young people. The rise in use of e-cigarettes is also worrying. Teenagers need to know that e-cigarettes are not harmless in themselves, and this study indicates that using e-cigarettes is also linked to smoking.
“Governments around the world need to take notice of the increase in the use of e-cigarettes and how they are promoted so they can protect teenagers from nicotine addiction.”
Prof Clancy and his colleagues will continue with their research on smoking and vaping among Irish teenagers. He adds: “We hope to bring attention to the policy needs to protect young people from the continued use of tobacco and the role e-cigarettes may play. We plan to do more research on the links between smoking and vaping, in particular to examine the role of social media and how companies are using these platforms to promote nicotine products.”
NMBI INVITES APPLICATIONS FOR BOARD VACANCY
The Nursing and Midwifery Board of Ireland (NMBI) would like to invite applications from suitably qualified individuals to fill a casual vacancy on the Board in accordance with paragraph 7(2) of the Nurses and Midwives Act 2011.
This vacancy arises under section 22(1)(c)(iv) of the Nurses and Midwives Act 2011:
A registered nurse or a registered midwife
employed in the public health sector and engaged in the education of nurses or midwives. Interested parties must ensure that they fulfil the criteria set out in section 22(1)(c)(iv) and hold current registration as a nurse or as a midwife with NMBI. The term of the casual vacancy will be to 14 January 2025.
If you are interested forward a CV and cover letter by email to Orla Coady at email@example.com.
The closing date for receipt of applications is Friday, 3 December 2021 at 3pm.
Shortlisted candidates will be selected for interview. Shortlisting will be on the basis of the written application received. Interviews will take place in the week beginning 6 December 2021.
Further information is available in the Being a Board Member booklet available on the NMBI website, www.nmbi.ie/.
News 4 NOVEMBER-DECEMBER 2021 NEWS
NEW NATIONAL CLINICAL EFFECTIVENESS GUIDELINE ON CHRONIC OBSTRUCTIVE PULMONARY DISEASE
The National Clinical Effectiveness Committee has published a new National Clinical Guideline on the Management of Chronic Obstructive Pulmonary Disease (COPD).
This new guideline was developed by a multidisciplinary guideline development group supported by the HSE National Clinical Programme for Respiratory Medicine, and chaired since 2020 by Dr Desmond Murphy, and previously by Prof Tim McDonnell.
This guideline outlines the best practice care and services for people with COPD or at risk of developing COPD. This guideline will help healthcare workers provide care based on the best available evidence. NCEC National Clinical Guideline No 27 was quality assured by the Department of Health’s National Clinical Effectiveness Committee (NCEC).
COPD is the most prevalent respiratory disease in adults and is a major cause of morbidity and mortality for patients in Ireland. At least 1,500 patients die each year of this disease and over 15,000 patients are admitted to hospital with COPD in Ireland.
COPD has considerable impact on the quality-of-life of the patient, families, and carers, involving ongoing medical care, frequent hospital admissions for treatment of exacerbations, and often resulting in premature death.
The development of this national clinical guideline for COPD is a major step forward in that it will ensure that COPD patients across the country receive consistent and standardised care, based on the best available evidence, according to the Department of Health.
This document has been written with the intention of providing assistance to healthcare professionals in all healthcare settings when assessing and managing COPD, by outlining evidence-based treatment protocols. In doing so, it also
aims to assist policy makers and those planning services for COPD patients. It covers the full spectrum of care provided in hospitals and in the community.
The Model of Care for COPD outlined in this document details how physicians, nurses, physiotherapists, and other healthcare professionals will work with patients to make the clinical decisions most appropriate to a patient’s circumstances. It is envisaged that this will facilitate self-management by patients at home through their empowerment and by promoting collaboration with and between specialist healthcare professionals in providing optimal care.
Specifically, the key aims are to:
Prevent or delay the onset of COPD;
Improve the delivery of care to people with COPD across all levels of care; and
Save the lives of people with COPD. Through the implementation of the end-to end COPD Model of Care, the Irish health service will be ensuring that the right care is delivered to people with COPD at the right time and in the right place.
Dr Desmond Murphy, Chair of the Guideline Development Group and Clinical Lead, HSE National Clinical Programme, Respiratory, commented that: “The NCEC document for COPD represents the culmination of a lot of work, by a lot of people to develop a framework to support the provision of optimal care for COPD patients in Ireland. The document has been reviewed by multiple different elements within the Irish healthcare provider system and also by patient advocacy groups, with feedback incorporated. Furthermore, it has been reviewed by recognised international experts in COPD. It is a pleasure to see the document launched. I believe this represents significant progress for patients with COPD in Ireland.”
The guideline notes that Ireland has the highest rate of hospitalisation for COPD of all OECD countries. In 2015 (the latest year for which OECD data are currently available), the age-standardised hospitalisation rate in Ireland based on OECD age-standardisation equated to 367 per 100,000 population. The national age-sex standardised hospitalisation rate for COPD increased between 2009 and 2018, with 354 hospitalisations per 100,000 population in 2018 compared with 303 hospitalisations per 100,000 population in 2009. Most countries in the OECD have reported a reduction in hospitalisation rates for COPD over recent years, perhaps as a result of improvements in access to, and the quality of, primary care. As in previous years, the OECD reported that Ireland had the highest age-sex standardised hospitalisation rate for COPD in 2015. While Ireland’s average rate has decreased from 379 hospitalisations per 100,000 population in 2005, to 367 in 2016, the OECD average also declined (214 to 187).
In Ireland during the three-year period from 2016-2018, the age-sex standardised hospitalisation rate by county of residence ranged from 242 hospitalisations per 100,000 population in Kerry to 552 hospitalisations per 100,000 population in Offaly. Episodes of care with a primary or secondary diagnosis of COPD accounted for almost 12 per cent of inpatient bed days in adult acute hospitals in Ireland in 2016, among adults aged 35 years and older, so the burden of COPD on our hospital system is significant and needs to be further addressed.
The full guideline is available at: www.gov.ie/en/publication/5df41national-clinical-guideline-no27management-of-chronic-obstructivepulmonary-disease-copd/.
News NOVEMBER-DECEMBER 2021 5
NEW OUTPATIENT AND EMERGENCY CARE UNIT AT CHILDREN’S HEALTH IRELAND AT TALLAGHT OPENS
The new 4,600m² Paediatric Outpatient and Emergency Care Unit (ECU) at Children’s Health Ireland (CHI) at Tallaght has opened.
The new three-storey CHI centre, located adjacent to the main entrance to the Tallaght University Hospital (TUH) includes:
A new emergency care unit with two triage rooms, a modern well equipped resuscitation room, a designated area for minor injuries and procedures ,and 16 single examination and treatment rooms. The unit will provide 24-hour emergency care;
A new paediatric outpatient department with 13 consultation rooms for Monday to Friday appointments in general and specialist paediatrics including neurodisability, and orthopaedics;
A new radiology unit for x-rays and ultrasound examination;
A new Medical Forensic Examination suite and clinic for the CHI Child Sexual Assault Counselling and Therapy services;
Within the Emergency Care Unit there is capacity to deliver short-stay care so that children can have full consultant assessments and treatment and be discharged home without needing a 24-hour admission. This model currently exists in CHI at Tallaght and has worked very well;
Specially commissioned artwork throughout the unit that makes CHI at Tallaght a warm and welcoming place for children, young people and their families which will assist with their wellbeing;
The facilities are designed and built for children, young people and their families - it is bright and spacious with plenty of changing facilities, areas designated for breast feeding and specialist sensory areas within the ECU and Outpatient Department. These expanded services are in addition to the current inpatient, day case, theatre and outpatient services in CHI at Tallaght which will remain there until the new children’s hospital opens.
CHI at Tallaght provides secondary and tertiary care to children and young people from Dublin South West, South City and the surrounding areas of Kildare and Wicklow. When fully operational it is expected that this new facility in CHI at Tallaght
will provide up to 17,000 additional outpatient opportunities and will provide care to more than 30,000 emergency care presentations annually.
The opening of this new facility in CHI at Tallaght marks a significant milestone in the children’s hospital project and the opportunity to expand services being delivered to children, young people and their families. It follows the successful opening of a similar facility in CHI at Connolly in Blanchardstown in July 2019. Since services in CHI at Connolly opened, it has contributed to a 65 per cent reduction in waiting lists for general paediatric services. To-date, 18,078 outpatient appointments have taken place there and more than 16,807 children and young people have been treated in the five-day Urgent Care Centre.
Work on expanding children’s services in CHI at Tallaght has also included a significant investment in TUH, including the delivery of a new changing and administration block, a new crèche, and the upgrade of roads and pavements, car park and electrical infrastructure. In addition, TUH will have the benefit of additional clinical space in the radiology and emergency departments when the children’s service moves in November 2021.
In the past few weeks, CHI rolled out a public information campaign targeted at families and key stakeholders including GPs and healthcare professionals, to raise awareness about the relocation of the existing ECU and the new services CHI will provide.
News 6 NOVEMBER-DECEMBER 2021
Respimat®: for your COPD patients, for your planet
Respimat® is a soft-mist inhaler - not a DPI or a pMDI.1,2
Respimat®: for your COPD patients, for your planet
Respimat® is a soft-mist inhaler - not a DPI or a pMDI.1,2 Respimat® is also reusable - using one Respimat® inhaler with six cartridges can reduce its carbon footprint by 71% vs using the inhaler with one cartridge every month for six months.3
Respimat® is also reusable - using one Respimat® inhaler with six cartridges can reduce its carbon footprint by 71% vs using the inhaler with one cartridge every month for six months.3
Respimat® is a soft-mist inhaler - not a DPI or a pMDI.1,2 Respimat® (tiotropium) achieved greater lung deposition compared with tested DPIs.3* Respimat®
Respimat® is a soft-mist inhaler - not a DPI or a pMDI.1,2 Respimat® (tiotropium) achieved greater lung deposition compared with tested DPIs.3* Respimat®
NEW WEBSITE TO HELP PARENTS OF INTENSIVE CARE BABIES IS LAUNCHED BY THE NATIONAL MATERNITY HOSPITAL
The National Maternity Hospital (NMH) has launched a comprehensive, educational site www.nmhnicu.ie, which is dedicated to supporting parents with babies in the neonatal intensive care unit (NICU) and their families. The site was funded by Rethink Ireland through the NMH Foundation.
The NMH Neonatal unit is recognised as a centre of excellence for the care of premature babies and is one of four tertiary level NICUs in Ireland. The NMH NICU and its specialist neonatal multidisciplinary team care for nearly 1,500 premature babies from all over Ireland each year.
The website was developed specifically for parents of babies who are or who may be admitted to a neonatal unit, to help them to understand the challenges their babies face while in a NICU and to give them the skills and confidence they need to be an integral part of their baby’s care from day one.
The website is divided into three key sections
In the NICU, Care and Support, and Going Home and takes parents along the journey that their baby experiences in each area, while being mindful of the complex emotions and stress
that parents often feel at this time. Information is subdivided into key sections, each providing comprehensive but easy to understand explanations of often complex terminology and procedures. A beautiful inspirational gallery 'From NICU Graduate to Preschool Graduate' offers hope and reassurance to parents, while the website also provides links to key professional external resources and a glossary of commonly used terms.
The website replaces a 120-page booklet previously handed to parents when their new-borns were admitted to the hospital’s NICU. The information that had been in the original booklet has been extensively updated and meticulously transformed into this state-of-the-art online resource. The website is a collaboration between NICU clinicians and its multidisciplinary team who updated and expanded previous paper-based resources for parents to provide an optimal online resource to guide parents through their precious baby’s journey through the neonatal unit. The information contained within the site represents the knowledge, expertise, and experience of a highly committed group of
neonatal healthcare staff including doctors, nurses, midwives, dieticians, physiotherapists, pharmacists, psychologists, clinical engineers, and social workers. The team focused on ensuring that the resource communicates clearly and in an easy-to-understand manner.
The NICU team in the NMH is deeply grateful to those parents who have participated in the development of this resource for use by other parents whose babies in the future may need to be admitted to a NICU. They have contributed enormously to the understanding and continuous improvement of patient experience and neonatal outcomes at the NMH.
The Master of the Hospital, Prof Shane Higgins, said: “I would like to pay tribute to all the staff at the NMH who collaborated to produce this remarkable website for parents and their families. Funding received from Rethink Ireland through the NMH Foundation facilitated the development of this site and I would like to take this opportunity to thank both organisations most sincerely. We hope that it will be of huge benefit to families nationwide and indeed globally, who have babies in neonatal care.”
RESEARCH REVEALS WHAT FACTORS IMPACT IRISH WOMEN'S EXPERIENCE OF MENOPAUSE
Research undertaken by Boots Ireland has revealed that almost two-thirds of women (64 per cent) say that menopause caused them to experience physical or psychological symptoms that have significantly affected their day-to-day life.
The research undertaken by Empathy on behalf of Boots Ireland showed that amongst women who have experience of menopause, half (50 per cent) said that they have experienced a lack of confidence caused by the menopause, with almost four in 10 (39 per cent) agreeing that women become less visible as they experience menopause.
Almost two-thirds of women say that
menopause causes them to experience physical or psychological symptoms that have significantly affected their day-today life. In addition, hormonal changes during menopause typically bring unpleasant symptoms and indignities. Amongst those who have experienced menopausal symptoms which have significantly impacted their day-to-day life, the most common symptoms experienced are hot flushes, sleep problems, or weight gain.
Almost a third, 30 per cent, of those who took part in the research don't know what perimenopause is. Furthermore, even though all women will experience menopause, four
in 10 (41 per cent) women reported feeling like the subject of perimenopause and menopause is not treated seriously, despite it touching on many important issues, such as gender equality and ageism, and most critically, the health and wellbeing of women.
In addition, half of those surveyed say there is not enough information available generally, with a similar proportion (40 per cent) claiming that there is not enough information available on the options available to treat symptoms.
Founder of the Menopause Health Clinic and menopause specialist and GP, Dr Caoimhe Hartley, said: "By 2025, it's estimated that there
News 8 NOVEMBER-DECEMBER 2021
will be over one billion women experiencing menopause in the world, equal to 12 per cent of the entire world population. As such, it is likely that everybody knows someone currently experiencing menopause. It's disappointing to learn that despite this fact, four in 10 (41 per cent) women feel like the subject of perimenopause and menopause
is not treated seriously, with a similar percentage believing that there is not enough information available on the options available to treat symptoms.”
Lorraine Keane, broadcaster and businesswoman, praised the research by saying: "As someone who has spoken openly about my own journey through
perimenopause and now menopause, the results of this research resonated with me. It's comforting to know that I'm not alone in the physical and psychological symptoms I've experienced, which at times have had a significant impact on my life. The good news is that support and advice is becoming more readily available."
MAJORITY OF IRISH ASTHMA PATIENTS ARE PLANNING TO GET THE FLU VACCINE THIS WINTER
Results of a recently conducted Asthma Society of Ireland survey revealed that 77 per cent of respondents availed of the flu vaccine in 2020 with 12 per cent of those receiving the vaccine for the first time. The high uptake of the flu vaccine seen in 2020 due to the threat of Covid-19 looks likely to be replicated this year with 83 per cent of respondents saying that they intend to get the flu vaccine this winter.
The survey was conducted in recent weeks among 1,602 people with asthma and their carers by the Asthma Society of Ireland. The HSE advises that all people with moderate to severe asthma should ensure that they get their flu vaccine, which is available free of charge to them as part of the at-risk group. People with moderate to severe asthma are at a higher risk of flu-related complications, while flu is known to exacerbate asthma symptoms. The HSE is keen to ensure as big an uptake of flu vaccination this winter as possible and has procured a record 2.2 million doses of flu vaccine for the 2021/22 flu season. This season there is 20 per cent more influenza vaccines available for at-risk groups compared to last season. Typically GPs administer 70 per cent, pharmacies administer 20 per cent, and HSE locations administer 10 per cent of flu vaccines annually.
Of those with asthma surveyed by the Society, 9 per cent have been diagnosed with severe asthma with 29 per cent and 28 per cent with moderate and mild asthma, respectively. A large majority said they would get a flu vaccine as they are very concerned about protecting themselves (74 per cent) and family members (35 per cent) against contracting flu this winter,
and 40 per cent of respondents said they would vaccinate to avoid prompting an asthma attack.
Sarah O’Connor, CEO of the Asthma Society said: “It’s great to see such a positive response to vaccine uptake. It is so important to take extra precautions this time of year, and we know that colds and flu, along with respiratory infections, can be triggers for many people with asthma.”
She added: “It is heartening that 50 per cent of those surveyed intend to speak with their GP or respiratory specialist this year. We would encourage all asthma patients to speak to your doctor or asthma nurse specialist about getting the flu vaccine.”
Dr Dermot Nolan, GP, former ICGP National Clinical Lead on Asthma and member of the Asthma Society Medical Advisory Group, noted that the same precautions to prevent the spread of Covid-19 can be applied with flu. “Cover your nose and mouth with a tissue when you cough or sneeze, throw away the tissue and thoroughly wash your hands afterwards. Try to avoid touching your mouth, eyes and nose, especially after coming into contact with an ill person. Washing your hands regularly with soap and water or using hand sanitiser can also minimise the spread as well as regularly cleaning hard surfaces such as your phone, keyboard and door handles.”
For a detailed list of the groups at-risk and more information on the flu vaccine, visit www.immunisation.ie.
For more information on the Asthma Society and the patient support services available, visit www.asthma.ie.
The Asthma Adviceline is available on 1800 44 54 64.
The Adviceline is proven to have a positive impact on the health of people with asthma, with appointments tailored to the needs of each caller. The Adviceline respiratory specialist nurses work through every aspect of life with asthma: what to do in the event of an asthma attack, answering questions after a GP or consultant appointment, dealing with triggers that may be bringing on asthma symptoms, and helping users put together an Asthma Action Plan to self-manage their condition. After speaking to one of the Adviceline nurses, users will be fully equipped with the information and skills they need to improve their health and stay as well as possible.
Callers can book a free call back appointment by calling the freephone number between 09:00 and 17:00 Monday to Friday. The Asthma Society then arranges a nurse appointment at a time that suits the patient.
In 2019, the Asthma Adviceline was awarded an independent quality mark by the Helplines Partnership, one of only three helplines in Ireland to have achieved this standard.
About the Asthma WhatsApp Messaging Service
The Society also offer a Sláintecare-funded Asthma WhatsApp text service, which allows patients with asthma, and their family and carers, to text 086 059 0132 for real-time one to one communications with an asthma nurse about all aspects of their disease management.
News NOVEMBER-DECEMBER 2021 9 NEWS
NMBI ISSUES NURSING REGISTRATION REMINDER
The Nursing and Midwifery Board of Ireland (NMBI) annual registration process is now well underway.
By mid November, more than 8,000 (10 per cent) of nurses and midwives had completed their annual registration.
Registrants can renew through the online portal, MyNMBI, up to 31 January 2022, but are encouraged to do so as soon as possible to avoid peak times.
Notices containing details on how to renew
were issued by email to registrants. If you have not received your notice, please check your spam or junk email folders. If your email is not in these folders, you can contact the NMBI customer care centre at 0818 200 116 or email firstname.lastname@example.org.
The NMBI have developed a number of guidance documents which can be accessed through the Annual Renewal section of its website www.nmbi.ie.
“We would like to remind registrants that payments must be made online through MyNMBI and we are no longer accepting renewal
PRACTICE NURSE REQUIRED
Practice nurse sought for Bayview Medical, Killiney Shopping Centre, Killiney, Co Dublin as soon as possible (bayviewmedical.ie).
Experience in practice nurse duties such as phlebotomy, childhood vaccinations, smear-taking ideal but not essential. Pleasant workplace, good location, parking. Generous remuneration.
Interested applicants please contact email@example.com with your CV
PRACTICE NURSE REQUIRED
Practice nurse required for a full-time, part-time or job sharing position with Johnstown Medical Centre, Dun Laoghaire, Co Dublin. Vocational training an advantage. CV and inquiries to firstname.lastname@example.org
PRACTICE NURSE REQUIRED
Nurse required for practice nurse position in our North Dublin GP surgery. Flexible hours to include mornings, experience preferable in childhood immunisations, phlebotomy, and cervical smear services.
Role supported by healthcare assistants and our GP team. Surgery located on Navan Road, Dublin in a modern purpose-built GP practice. Competitive permanent package available along with training opportunities supported.
Enquiries should be sent to email@example.com or call 087 1251 815
payments by phone.
“You can pay online using your own debit/ credit card or if you are using a card issued to another person, please ensure that you have authorisation to do so. Under new EU requirements, the card provider/bank will request authentication to complete the payment.
"We encourage registrants to login to MyNMBI and renew as soon as possible. Peak dates for renewals are 29-31 December and processing during this time may take longer."
PRACTICE NURSE REQUIRED
Practice nurse required for a busy GP surgery in Skerries, North Co Dublin. Ideal candidate either has recent practice nursing experience or seeking nurses with acute care, phlebotomy or ED experience, seeking to branch into the general practice field. Good communication skills and the ability to work well within a team is essential.
Requirement to carry out all aspects of practice nursing including: Phlebotomy, all Immunisations, chronic disease management, smear taking, diabetic screening, 24-hour BP monitoring, etc.
Please apply with your CV for further details in relation to this practice nurse job to firstname.lastname@example.org
PRACTICE NURSE REQUIRED
Practice nurse required for GP surgery in Dublin 5 - Tonlegee Medical Practice. Flexible hours. Two doctor practice. Helix Practice manager software. Candidate would ideally be confident in adult and childhood immunisations, phlebotomy and the taking of cervical smears would be an advantage.
Previous experience in a GP clinic an advantage. Active NMBI registration (RGN) required. Friendly colleagues and pleasant working environment. Applicants to kindly forward CV and
details with a cover letter telling us about you and your nursing experience.
Job types: Full-time, part-time, permanent
Salary: €38,000.00-€45,000.00 per year
Monday to Friday
Please email CV to email@example.com
If you would like to place a recruitment advert in the next edition, please contact Louis@mindo.ie.
News 10 NOVEMBER-DECEMBER 2021
A successful AGM took place virtually on 16 October.
A new NEC was elected during the AGM and is as follows:
Chair - Mary Jordan , Waterford branch
Vice-Chair - Siobhan Leacy, Kildare branch
Hon Treasurer - Sarah O'Donnell, Waterford branch
Joint PRO - Sonja Corrigan, Dublin, and Rachel Dyer, Dublin branch
The AGM speakers, hosted via medcafe.ie, included Dr Brendan O’Shea who spoke about ‘Improving end of life care’ and how talking better about dying, death and bereavement benefits our patients, and Dr Tom Barrett, Senior Medical Officer, HSE National Immunisation Office, who gave a talk on the Primary Immunisation Schedule with particular emphasis on catch-up vaccinations.
Both talks are available through our website, irishpracticenurses.ie, for those that missed them.
The AGM was well attended, being the second time that it was held virtually and the first time under our new name of IGPNEA. One of the positives to come out of the Covid-19 pandemic is how competent we have all become in the use of virtual learning and meeting platforms.
The next NEC meeting will be held virtually via zoom on Wednesday, 2 February, 2022 at 8pm.
Our monthly webinars via Medcafe.ie continue, with a presentation on 9 November on the ‘Management of obesity in general practice’, given by Dr Michael Crotty. The next
Medcafe webinar is on Tuesday, 30 November and the topic is 'GPN career developmentopportunities and obstacles’.
The AGM ended with the announcement of the winners of the photo competition, which was judged, anonymously, by Kildare GP and Specialist in Occupational Medicine at The Bridge Medical Centre, Dr Brendan O’Shea, who is a keen photographer himself. Congratulations to the winners.
Branch Locale winner
Taken by Ruth Morrow, Cavan/Monaghan branch
Title 'Lovely Leitrim'
Commenting on the photo, Dr O’Shea said: “Beautiful and striking image of what can only be found in Ireland! Great composition and contrast, with interest in the overall landscape and in beautiful detail of fields, hedgerows, the brooding sky, and darkling water...."
Taken by Aisling Walls, Waterford branch
Title: 'Any excuse to get out of the vaccine clinics' #lockdownbaby
Commenting on the photo, Dr O’Shea said: “Striking black and white image and
very classic subject. Mother and sleeping baby, caught in a wonderful moment of tranquility, intimacy, and with a radiant beauty and vitality, full of promise, hope, and tenderness – a great image.”
Humour winner Image: 9
Taken by Norma Sheehan, Waterford branch
Title: ‘Pandemic Shamdemic!!’
Commenting on the photo, Dr O’Shea said: “Truly an image for these last years, cocking a snook at the awfulness of the pandemic. Possibly art, definitely fun!!”
News NOVEMBER-DECEMBER 2021 11
Siobhan Leacy Sonja Corrigan
Dr Brendan O'Shea
Dr Tom Barrett
News 12 NOVEMBER-DECEMBER 2021
Humour winner, taken by Norma Sheehan. Pictured L-R: Norma Sheehan, Toni Finnegan, and Catherine Maher from the Keogh practice
Wellbeing winner, taken by Aisling Walls Branch Locale winner, taken by Ruth Morrow
NEW FLAVOUR Contact your Nutricia representative or call 1800 923 404 to request recipe cards for your patients This information is intended for healthcare professionals only. Fortini Compact Multi Fibre is a food for Special Medical Purposes for the dietary management of disease related malnutrition and growth failure in children from one year onwards, and must be used under medical supervision. * Various 1.5kcal/ml, 200ml paediatric ONS with fibre available on the market. Product can be provided to patients upon the request of a healthcare professional. They are intended for the purposes of professional evaluation only. Nutricia Ireland, Block 1, Deansgrange Business Park, Deansgrange, Co. Dublin. Date of publication: 10/2021 Use your phone to scan the QR code or visit Nutricia.ie Request Products for professional evaluation^ ^ Enjoy chilled or warm SM A L L O N S I Z E 7.2 Big on Nutrition Fortini Compact Multi Fibre packs the nutrition of a standard paediatric oral nutritional supplement* in 38% less volume
Author: Priscilla Lynch
IRISH OSTEOPOROSIS SOCIETY, ANNUAL MEDICAL CONFERENCE FOR HEALTH PROFESSIONALS
The 25th Irish Osteoporosis Society Annual Medical Conference for health professionals was held virtually on Saturday 23 October 2021
DENOSUMAB COMPLIANCE IS SUBOPTIMAL
Osteoporosis patients on denosumab, the twice-yearly injectable monoclonal antibody, must be adequately educated on the risks of treatment non-compliance, such as rapid rebound bone loss and increased fracture risk, the Irish Osteoporosis Society (IOS) 2021 Annual Medical Conference heard.
Dr Kevin McCarroll, Consultant Physician and Geriatrician specialising in bone health and osteoporosis at St James’s Hospital, Dublin, strongly advised against ‘drug holidays’ of denosumab, which had been a particular issue during Covid-19 despite guidelines being in place to continue and facilitate scheduled denosumab injections as a priority.
Research has shown that followon denosumab administered after nine-to-12 months versus the advised six months results in a 50 per cent decrease in bone mineral density (BMD) gains, with rapid BMD loss even after one month, and early risk of vertebral fracture (x five) and, later, other fractures, Dr McCarroll told the conference.
“The single biggest predictor [for a fracture after denosumab delay/ stoppage] is probably previous vertebral fracture, the next biggest being duration of therapy….”
Giving an overview of the benefits of denosumab in eligible osteoporosis patients, Dr McCarroll said that it is the most powerful antiresorptive bone mass agent currently available, and has better persistence than oral bisphosphonates, with its use continuing to rise in Ireland.
Patient studies have shown more satisfaction and preference for denosumab than weekly or monthly bisphosphonates. In addition, it has been proven to be cost-effective, with a potential cost saving in over75s, those with previous fracture, and higher-risk patients, he said.
Patients at high risk of fracture should probably continue denosumab therapy indefinitely, Dr McCarroll stated, emphasising the need to replace denosumab with a bisphosphonate “to close it off” and to continue checking bone markers if it is stopped. However, BMD loss can continue despite taking
zoledronic acid after denosumab; and the risk of vertebral fracture may still be 5-to-10 per cent (in high-risk patients) after stopping despite bisphosphonate use.
“So it won’t eliminate fracture risk,” Dr McCarroll stated.
Quoting the results of a newly published Irish study on denosumab compliance, which looked at older patients newly prescribed oral bisphosphonates or denosumab during 2012–2017 from 44 general practices in Ireland, Dr McCarroll noted that denosumab continuation (persistence) at two years was 53.8 per cent in the 1,615 reviewed patients. Only 5.7 per cent switched to alternative therapy (83 per cent of them transitioned to an oral bisphosphonate). Predictors of lower discontinuation of denosumab included having an osteoporosis diagnosis and being a medical card holder.
Dr McCarroll said patients and clinicians need to be made aware of the risks of denosumab treatment stoppage, to help improve compliance.
Strategies to improve compliance
Conference Osteoporosis 14 NOVEMBER-DECEMBER 2021
include multi-component education, pharmacist support, and shared decisionmaking, and he noted that treatment satisfaction is important for persistence. Dr McCarroll also suggested that recall
systems to remind GPs and patients of when the next dose of denosumab is due are useful, as has been shown by research in Australia and other countries.
“So, in conclusion, denosumab
persistence is suboptimal, 70 per cent at two years. Doses should not be missed by more than one month. What is key and crucial is education of patients and doctors about not stopping the injection....”
VITAMIN D DEFICIENCY PREVALENCE IS HIGH IN IRELAND
Vitamin D deficiency in the Irish population is high, and there should be a national strategy to address the issue, including consideration of mandatory food fortification, according to Prof Bernard Walsh, Clinical Professor, Trinity College Dublin (TCD) and Mercer’s Institute St James's Hospital (SJH), Dublin.
SJH recently completed a vitamin D geomapping study of Ireland, which investigated vitamin D status in a population of GP-requested samples within the SJH catchment area between 2014-2018. The study aimed to explore the effects of gender, age, geolocation, and season on vitamin D status over a five-year period, Prof Walsh told the IOS 2021 Annual Medical Conference
The findings reveal that nearly 40 per cent of the geo-mapping study population were either vitamin D deficient (<30nmol/L) or insufficient (31-50nmol/L) - (25 per cent in summer and 50 per cent in winter <50nmol/l), and levels remained stable over the five years.
Interestingly, more detailed research into children under 17 years (1,269 in study) show they had the same level of deficiency and insufficiency as adults, during a crucial time for bone development.
According to the results, those at greatest risk of low vitamin D are young males in lower socioeconomic areas in winter.
Only 16.7 per cent of the study’s SouthAsian group had a 25(OH)D status greater than
50nmol/L, and 66 per cent of this Asian group were deficient <30mol/l. Those exceeding 125nmol/L were rare (3 per cent) of the total number in the SJH geo-mapping study of 36,466.
The study, as well as other similar research, highlights the need for a national public health strategy to mandate for fortification to address this widespread deficiency, Prof Walsh maintained.
He noted that all children require an oral intake of vitamin D 400 units (10mcg) a day and adults need 800 (20mcg) units a day to ensure a vitamin D >50nmol/l.
Low vitamin D levels are also strongly associated with severe disease in patients with Covid-19, as well as COPD incidence, Prof Walsh added.
THE LATEST APPROACHES TO MALE INCONTINENCE
Male incontinence affects one-ineight men, significantly affecting quality-of-life, the IOS 2021
Annual Medical Conference heard. However, there are effective treatment strategies and a more proactive approach and increased awareness could help relieve the impact of this condition,
Ni Eochaidh, Chartered
Physiotherapist, Women’s and Men’s Health and Continence, Bon Secours Consultants Clinic, Galway, gave a comprehensive presentation on the risk factors and latest treatment approaches to male incontinence. Her clinic’s main patient cohort in this area are men who have had a radical or robotic prostatectomy, men with benign prostate enlargement, and men with a history of prostatitis.
“Pelvic floor muscle dysfunction and
osteoporosis are linked, which you might be surprised to hear, and we have good evidence to support this in women, (I know we are talking about men today). But as osteoporosis unfortunately progresses with spine flexure, the tummy protrudes, the ribs can end up resting on the pelvis, and that pressurises the pelvic floor muscles and the woman or man can have incontinence. Urge incontinence is of course a falls risk, so just keep that in mind,” she commented.
Bladder retraining is the recommended treatment and will cure urinary incontinence in 75 per cent of cases: “You could have the best pelvic muscle floor function, but if you have poor bladder habits the man is still going to have issues.”
“Pelvic floor muscle training from the pelvic physio side of things is the gold standard for treatment,” Ms Ni Eochaidh reported, while
other male incontinence treatments include electrical stimulation, bulking agents, male slings, artificial sphincters, and other devices.
She stressed the importance of early intervention and “pre-rehab for men undergoing prostate cancer surgery”, praising her urology colleagues in Galway for referring such cases to her before surgery to begin bladder training.
Ms Ni Eochaidh also discussed an online pelvic floor muscle training solution her clinic developed during Covid-19, which facilitated the continuation of services, and continues to be particularly useful given that clients are referred from all areas of the country and there is a national shortage of pelvic physiotherapists.
In relation to digital rectal examination (DRE), she said it gives GPs a great opportunity to assess pelvic floor muscle function when they are carrying out a prostate check or assessing piles, etc.
Conference Osteoporosis NOVEMBER-DECEMBER 2021 15
EXERCISE ADVICE FOR OSTEOPOROSIS PATIENTS
Exercise is very beneficial for bone health, and people should be encouraged to do more rather than less, though exercises that involve spinal flexion are associated with vertebral fracture, the 2021 IOS Annual Medical Conference was told.
Ciara Shields, Chartered Physiotherapist and a Clinical Specialist in Musculoskeletal Physiotherapy, and owner of IONA Physiotherapy, Drumcondra, gave a presentation entitled ‘Stay Strong – Exercise for Bone Health’. She recently assisted the IOS in making exercise videos for their new website; with a focus on individuals with bone loss and who have a very low current level of activity.
She stressed the importance of using positive language (avoiding the “f word”, ie, falls), focusing on what people can do to maintain independence and continue to enjoy participating in social activities and prevent fractures.
In terms of promoting bone mineral
density, the combination of both weightbearing exercise with impact and progressive resistance exercises is found in research to have the most positive impact, whereas exercise programmes that include both resistance exercises and balance exercises are effective against falls prevention, an important goal for those with osteoporosis, Ms Shields said.
Exercise programmes that focused on strengthening alone or balance exercises alone were not found to be effective in terms of falls prevention. Therefore, to optimise bone health for those with osteoporosis, an exercise programme should include all three of the following: weight-bearing exercise with impact, progressive resistance exercises, and balance exercises. The dosage and frequency of the exercises will depend on whether the patient has a history of vertebral fractures, low trauma fractures, falls and their current level of activity. Assessment and advice from
a chartered physiotherapist, at least at the beginning of the programme, is recommended, she stated.
While walking is commonly advised for those with osteoporosis, Ms Shields highlighted research which reported that walking alone does not reduce falls, and brisk walking for those with a falls history may increase their risk of falls – strength and balance exercises may be required first before increasing physical activity. The research supports a more comprehensive assessment and exercise prescription, than solely advising people with osteoporosis to walk.
Exercises that involve spinal flexion are associated with vertebral fracture, whereas exercises that activate the spinal extensors appear to have a long-term protective effect against vertebral fracture. "Exercise should form part of a broad approach that includes other positive lifestyle changes, combined with pharmacological treatment where appropriate,” she concluded.
VIRTUAL 2021 IOS CONFERENCE A GREAT SUCCESS
The 2021 IOS Annual Medical Conference for Health Professionals took place online on 23 October and featured a stellar line up of expert speakers discussing the latest prevention, diagnosis and treatment strategies for this common disease. There was also a very uplifting presentation from Prof Jim Lucey, Clinical Professor of Psychiatry at Trinity College, Dublin, and Consultant Psychiatrist at St Patrick's University Hospital, based on his new book, A whole new plan for living: Achieving balance and wellness in a challenging world. Prof Lucey discussed strategies for improving wellbeing, self-care, and stress management, with an emphasis on
being mindful – to stay focussed, and flexible – to deal with change.
Speaking to Update, President of the IOS Prof Moira O’Brien said: “We were delighted with the turnout, especially for a Saturday. The highlights were the take-home messages of the importance of screening people for risk factors for bone loss as only 19 per cent are diagnosed, and monitoring patients is essential. A DXA scan result is only part of the clinical evaluation to determine the most effective treatment for an individual and in an ideal world vitamin D levels would be taken annually, especially in senior citizens.”
See www.irishosteoporosis.ie for more information.
Young Investigators Award
'Secondary hyperparathyroidism and its relationship to bone mineral density and bone markers'
Dr Finlay Brennan, St James’s Hospital, Dublin
Best Overall Scientific Abstract
'High prevalence of hypercalciuria in patients attending a bone health clinic–implications for treatment'
Dr Finlay Brennan, St James’s Hospital
'Proton pump inhibitors associated with hyperparathyroidism and higher bone turnover'
Dr Kevin Moloney, St James’s Hospital
Clinical Case x 1
'Indolent systemic mastocytosis- a rare cause of osteoporosis'
Dr Jonathan O'Toole, St James’s Hospital
Conference Osteoporosis 16 NOVEMBER-DECEMBER 2021
Author: Priscilla Lynch
‘FROM BRITTLE BONES TO FULL BONE HEALTH’
Sarah Buckley's remarkable journey from being diagnosed with severe osteoporosis in her early 40s to full recovery
Amoving and uplifting presentation by a patient detailing her remarkable journey from being diagnosed with severe osteoporosis in her early 40s to full recovery was one of the highlights of this year’s Irish Osteoporosis Society (IOS) Annual Medical Conference for Health Professionals, which took place virtually on 23 October.
Ms Sarah Buckley, 48, from Dublin, shared her story about how she recovered from severe osteoporosis in her spine to achieve full bone health over a period of six years with a combination of medication, exercise, diet and lifestyle changes, and a full commitment to following professional healthcare advice.
She was initially diagnosed with osteoporosis in her lumbar spine at the age of 41, following a DXA scan and blood tests as part of an investigation for suspected early menopause.
“My GP described it as mild and not requiring specialist care and prescribed a bisphosphonate (alendronic acid) and calcium and vitamin D supplements. The diagnosis was a shock as I’d believed that I was fit and healthy – I was very active, sporty, had a balanced diet, and was health conscious. I thought that osteoporosis was something that affected only old women and not something to be worried about at my age. This really highlights that just because a person eats healthy and exercises, everyone needs to remember that it's a silent condition that can affect all ages,
including fit and healthy people.”
Though her GP advised that he would treat her, Ms Buckley was concerned about her spinal health because she has scoliosis and had had 12 vertebrae fused as part of corrective surgery when she was a teenager. She was thus referred to a rheumatologist, who she said took her off her alendronic acid, advising it was not necessary due to her age, low risk of fracture, and the fact she was not on a contraceptive pill.
Despite continuing to maintain a healthy diet and lifestyle, with good calcium and vitamin D intake, over the next two years her yearly DXA scans showed the osteoporosis continued to deteriorate until it became severe with a T-score of -3.6 in the lumbar spine, which was an average of the four vertebrae. The rheumatologist prescribed a bisphosphonate (risedronate) and advised Ms Buckley to start taking a contraceptive pill, and reduce her exercise regime, which
was difficult as she was very active with cycling. Dissatisfied at being told she could at best expect her bones to remain stable, and being advised against using injections to treat her condition, Ms Buckley decided to seek further intervention.
A new direction
“A work colleague recommended that I go and see Prof Moira O’Brien for a second opinion and this was when things really started to change for the better in my journey back to bone health. Before the first consultation, I had a DXA scan, full bloods, and completed a very comprehensive questionnaire to identify risk factors, covering medical history, diet, exercise etc.
"At the consultation, the Professor went through all my results in detail with me, including explaining DXA scan scores in my spine and hip, something that my GP and previous consultant hadn’t done. She confirmed that I had severe osteoporosis in my lumbar spine with two stress fractures and osteoarthritic changes, often seen in cyclists, as well as moderate osteopenia in my hips.”
Ms Buckley was taken off risedronate and moved onto teriparatide, a daily injectable form of parathyroid hormone which improves bone density, to be taken for two years, along with continuing the calcium and vitamin D supplements. She also saw a dietician to make sure her diet was supporting bone health.
Feature Osteoporosis 18 NOVEMBER-DECEMBER 2021
Ms Sarah Buckley
The plan after the first consultation was to have repeat blood tests every six months and a repeat DXA every year. She was also given very clear advice on her exercise regime.
“I was to stop the long-distance cycling completely while recovering; focus on weightbearing exercise; and avoid over-exercising, doing a maximum of one hour per day. She [Prof O’Brien] recommended that I see a chartered physiotherapist with an osteoporosis specialism to get a programme of strength and conditioning exercises tailored for bone health.
“Though it was very upsetting to be told to give up the cycling – something that I loved – and I worried about my mental health as a result, the Professor warned that if I didn’t do it, things could really deteriorate and I could be in serious trouble later in life mobilitywise. When I heard that, I knew that I had to follow the advice and do exactly what I was told, whether I liked it or not, and my motivation to get better long-term outweighed the short-term sacrifices.”
Another issue that needed to be addressed was her high cortisol levels, which were
She started denosumab six months after starting teriparatide, so took the two drugs together for a period of 18 months until the teriparatide course was complete.
“My DXA scan after year one of treatment under the care of the Professor showed a strong improvement. In my spine, I had improved from severe osteoporosis to marked osteopenia, with no additional fractures, and my hips improved from moderate to mild osteopenia. I was absolutely delighted with such a marked improvement and felt that all the sacrifices and hard work had really been worth it.
“For the next three years my DXA results remained stable, with no change, which was very positive. I was happy that I was on an even keel and that things were under control. I am currently still on Prolia, taking this every six months, as well as the calcium and vitamin D supplements, as I had improved on the DXA scan, but my bone markers showed I was still losing bone. I maintained the lifestyle changes and increased exercise to about an
“I was looking at a life in fear of breaking bones, pain, losing mobility and a loss of my active life that was so important to me. With the right consultant, treatment and lifestyle changes – which were hard and took a lot of motivation and dedication – I got a result much better than I could ever have hoped for. I’m very positive about the future and intend to maintain the lifestyle changes to which I’ve now become accustomed. I look forward to a long and active life with continued bone health. Thank you to Prof O’Brien and the Irish Osteoporosis Society for your support with my journey.”
Speaking to NiGP, Ms Buckley noted that osteoporosis is a complex condition and identifying the causes is key to putting the right treatment plan in place and reversing it, where possible.
“In my case, a risk factor assessment indicated that the causes included overexercising and doing non-weight bearing exercise only (cycling), an eating disorder in my teens, genetics (my Mum and sister also have it) and high cortisol, caused by being on the COCP, which increases cortisol-binding globulin.”
affecting her bone health, and lifestyle changes she could make to reduce stress. High cortisol continued to be an issue picked up in blood tests, in spite of lifestyle changes, so Ms Buckley was referred to an endocrinologist. No clinical features of cortisol excess were found and the high levels were attributed to being on one of the combined oral contraceptive pills (COCP), which increases cortisol-binding globulin. She was changed onto a different oral contraceptive pill and her cortisol levels slowly came down to normal levels.
The next stage in treatment was starting on a second osteoporosis drug, denosumab, taken as a six-monthly injection, as Ms Buckley's bone markers showed she needed it in order to get the maximum benefit from the teriparatide.
hour and a half per day, following the same programme and taking care not to overexercise. I started back cycling again last year, covering shorter distances and not pushing as hard. The only additional change was starting to take a vitamin K2 supplement last year.”
Her latest DXA results in January 2021 were quite remarkable.
“I am now completely osteopenia- and osteoporosis-free in my spine and hips and have recovered to normal bone density. I never would have believed that this was possible at the start of my journey, having been told that the best I could hope for was that my bone density could be held where it was, in osteoporosis, and that the risk of fracture would increase as I got older.
She believes that the key to her recovery was the combination of interventions: Medication; changing her exercise routine to focus on weight-bearing and strength exercises under physio care; changing the contraceptive pill she was on; and full commitment to following the treatment plan.
“It's really important to find the right consultant and get the right treatment, even if it means getting second opinions and not settling for one medical point of view.”
Ms Buckley stressed that clinicians need to be aware that younger women can also be affected by osteoporosis and that prevention of fractures is less painful and more cost-effective than treating multiple fractures. “The key message I would give is that young and healthy people can get osteoporosis; it is preventable and curable with the right treatment; and early treatment is definitely a better option than a life with multiple fractures, pain, and mobility issues in later life.”
NOVEMBER-DECEMBER 2021 19
It's really important to find the right consultant and get the right treatment, even if it means getting second opinions and not settling for one medical point of view
Author: Ruth Morrow, Registered Advanced Nurse Practitioner (Primary Care), and Respiratory Nurse Specialist (WhatsApp Messaging Service, Asthma Society of Ireland)
AN UPDATE ON COPD
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease that is characterised by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. The chronic airflow limitation that is characteristic of COPD is caused by a mixture of small airways disease (eg obstructive bronchiolitis) and parenchymal destruction (emphysema), the relative contributions of which vary from person to person (Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2021). The risk of developing COPD is related to tobacco use, indoor air pollution, occupational exposures, outdoor air pollution, genetic factors, age and gender, lung growth and development, socioeconomic status, asthma and airway hyper-reactivity, chronic bronchitis, and infections.
A shift in the COPD paradigm
The paradigm of COPD as a predominantly male disease is changing as smoking rates in both males and females are now similar and the number of deaths due to COPD among women has surpassed that of men. Women appear more susceptible to the effects of cigarette smoke, developing COPD earlier and with lower cigarette exposure than men. Women also commonly exhibit a COPD phenotype with airway dominant disease in comparison with emphysema and they also vary in response to treatment.
The diagnosis of COPD involves a detailed history, spirometry,
investigations, and assessment of symptoms.
The history should include:
Medical and surgical history,
Smoking history, including pack year history,
Post-bronchodilator ratio of FEV1/ FVC <70 per cent or 0.7 indicates COPD. Table 1 illustrates the severity of obstruction using FEV1.
Blood screen to include FBC and TFTs
Assessment of symptoms
The characteristic symptoms of COPD are chronic and progressive dyspnoea, cough, and sputum production that can be variable from day-to-day. Dyspnoea is usually progressive, persistent and characteristically worse with exercise. Patients may have an intermittent cough which may be unproductive but many patients will commonly cough up white/ clear non-purulent sputum. Symptoms can be assessed using the COPD Assessment Tool (CAT test) and the Medical Research Council Dyspnoea (MRC) scale. The CAT test is an eight-item measure of health status impairment in COPD (http://catestonline.org). The MRC scale is illustrated in Table 2.
Feature Respiratory 20 NOVEMBER-DECEMBER 2021
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterised by airflow limitation that is not fully reversible
GOLD 1 Mild FEV1 >80% predicted GOLD 2 Moderate 50% <FEV1 <80% predicted GOLD 3 Severe 30% <FEV1 <50% predicted GOLD 4 Very severe FEV1 <30% predicted In patients with FEV1/FVC <70% Table 1: GOLD
(2021) classification based on FEV1
The paradigm of COPD as a predominantly male disease is changing as smoking rates in both males and females are now similar and the number of deaths due to COPD among women has surpassed that of men
ABCD assessment tool
The ABCD assessment tool (Figure 1) is a useful tool for assessing severity of COPD. The assessment of COPD has been refined to include assessment of symptoms and risk of future exacerbations.
Bronchodilator therapy remains the mainstay of the management of stable COPD. Pharmacological therapies are used to reduce symptoms, reduce the severity and frequency of exacerbations, improve exercise tolerance and health status.
The main groups of medications include:
Beta-agonists – these relax smooth muscle by stimulating the beta2 adrenergic receptors. Beta-agonists can be classified into short-acting (SABA) and long-acting (LABA). Eg, salbutamol (SABA), salmeterol (LABA), indacaterol (LABA), vilanterol (LABA), formoterol (LABA), olodaterol (LABA).
Antimuscarinic drugs block the bronchoconstrictor effects of acetylcholine on M3 muscarinic receptors. These can also be classified into short-acting (SAMA) and long-acting (LAMA). Eg, ipratropium (SAMA), tiotropium (LAMA), umeclidinium (LAMA), aclidinium bromide (LAMA), glycopyrronium (LAMA).
Combining bronchodilators may increase the degree of bronchodilation whilst lowering the risk of side-effects compared to increasing the dose of a single bronchodilator agent.
Methylxanthines – this group of drugs remain controversial as to their mechanism of action. There is evidence of bronchodilation in stable COPD. Theophylline is the most commonly used. However, there are significant drug interactions with its use and clearance of the drug declines with age.
Inhaled corticosteroids (ICS) should not be used as a single agent in the management of COPD. In patients with moderate to severe COPD, the use of ICS combined with a LABA is more effective than using either agent alone in improving lung function, health status, and reducing exacerbations (GOLD, 2021).
To-date, there is no conclusive clinical trial evidence that any existing medications for COPD modify the long-term decline in lung function (GOLD, 2021).
Pharmacological algorithms are given for
PLEASE TICK IN THE BOX THAT APPLIES TO YOU (ONE BOX ONLY)
mMRC Grade 0. I only get breathless with strenuous exercise
mMRC Grade 1. I get short of breath when hurrying on the level or walking up a slight hill
mMRC Grade 2. I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level
mMRC Grade 3. I stop for breath after walking about 100 meters or after a few minutes on the level
mMRC Grade 4. I am too breathless to leave the house or I am breathless when dressing or undressing
C D A B
the initiation, escalation or de-escalation of treatment according to the individual assessment of symptoms and exacerbation risk. In previous publications of GOLD reports, recommendations were only given for treatment initiation. Table 3 illustrates the pharmacological treatment options according to the patient’s COPD classification.
Poor inhaler technique can result in the use of multiple devices, due to lack of education on technique and older age. To improve technique, it is recommended that patients are educated and trained with the appropriate devices. The choice of device should be tailored to the individual
depending on the patient’s ability to use it and taking their preference into account. Inspiratory effort can be assessed using the In-Check Dial meter to ensure the patient has sufficient inspiratory effort to inhale the appropriate device.
Ongoing monitoring and follow-up
GOLD (2021) recommends that regular review should focus on dyspnoea and exacerbations. Whichever is the most problematic for the patient should be the focus of the review. For
NOVEMBER-DECEMBER 2021 21
EXACERBATION HISTORY ≥2 or ≥1 leading to hospital admission 0 or 1 leading to hospital admission mMRC 0-1 CAT <10 mMRC ≥2 CAT ≥10 SYMPTOMS
Table 2: Medical Research Council Scale
Figure 1: The revised ABCD assessment tool
COPD CLASSIFICATION TREATMENT OPTIONS AS RECOMMENDED BY GOLD (2016)
A SABA OR SAMA SABA: Salbutamol, terbutaline
SAMA: Ipratropium bromide
B LABA OR LAMA LABA: Salmeterol, formoterol, indacaterol, olodaterol
LAMA: Tiotropium, umeclidinium, aclidinium, glycopyrronium
INHALER DEVICE OPTIONS
MDI with spacer, Easi-breathe, Diskus, Turbohaler
MDI with spacer, Turbohaler, Breezhaler, Respimat
Respimat, Handihaler, Genuair, Elipta, Breezhaler
C ICS AND LABA OR LAMA
ICS/LABA: Budesonide/formoterol, vilanterol/ fluticasone
LAMA: Tiotropium, umeclidinium, aclidinium, glycopyrronium,
Turbohaler, Spiromax, Easyhaler, Elipta
Respimat, Handihaler, Genuair, Elipta, Breezhale
D LABA WITH ICS AND LAMA
ICS/LABA: Budesonide/formoterol, vilanterol/ fluticasone
LAMA: T iotropium, umeclidinium, aclidinium, glycopyrronium,
Turbohaler, Spiromax, Easyhaler, Elipta
Respimat, Handihaler, Genuair, Elipta, Breezhaler
Feature Respiratory 22 NOVEMBER-DECEMBER 2021
Figure 2: Pharmacological treatment with the ABCD assessment tool (GOLD, 2021)
Table 3: Pharmacological treatment options based on COPD classification (GOLD, 2021)
Fictional patient, for illustrative purposes only
For COPD patients on treatment with ICS/LABA and at risk of exacerbation* 1
*A worsening of symptoms or a history of exacerbation treated with antibiotics or oral corticosteroids in the past 12 months
It’s the things you do today that
make a big difference to their
TRELEGY Ellipta provides your patients with statistically superior improvements in lung function and health-related quality of life, and reduction in annualised rate of moderate/ severe exacerbations** vs. budesonide/formoterol***1–3
Moderate exacerbation is a worsening of symptoms or a history of exacerbation treated with antibiotics or oral corticosteroids. A severe exacerbation is a worsening in symptoms that required hospitalisation.
TRELEGY Ellipta (FF/UMEC/VI) 92/55/22 mcg OD is indicated for maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of a LAMA and a LABA1
▼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.
***Co-primary endpoints were change from baseline in trough FEV1 and SGRQ at week 24 (n=1810). A subset of patients (n=430) remained on blinded study treatment for 52 weeks. Trelegy showed an improvement in trough FEV1 of 171mL versus budesonide/formoterol (p < 0.001, 95% CI 148,194) at week 24. Trelegy showed an improvement in health-related quality of life (SGRQ) of 2.2 units (p <0.001, 95% CI 3.5, 1.0) at week 24. At week 52 in a subset of patients Trelegy showed a 44% reduction in annualised rate of moderate/severe exacerbations versus budesonide/formoterol (95% CI 15,63, p=0.006, Absolute difference 0.16).
TRELEGY Ellipta is generally well tolerated. Common adverse reactions include: pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain1 FF, fluticasone furoate; ICS, inhaled corticosteroid; LABA, long-acting ß2-agonist; LAMA, long-acting muscarinic antagonist; OD, once-daily; UMEC, umeclidinium, VI, vilanterol
References: 1. TRELEGY Ellipta SmPC 2019. 2. Lipson DA et al. Am J Respir Crit Care Med 2017; 196:438–446. 3. Lipson DA et al.N Engl J Med 2018; 378:1671–1680.
Trelegy▼ Ellipta (fluticasone furoate/umeclidinium/vilanterol [as trifenatate]) Prescribing information.
Please consult the full Summary of Product Characteristics (SmPC) before prescribing Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of fluticasone furoate (FF) 100 micrograms (mcg), umeclidinium bromide (UMEC) 62.5 micrograms and vilanterol as trifenatate (VI) 25 mcg provides a delivered dose of 92 mcg FF, 55 mcg UMEC and 22 mcg VI. Indications: Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting ß2-agonist (LABA) or a combination of a LABA and a long acting muscarinic antagonist. Dosage and administration: One inhalation once daily at the same time each day. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate). Precautions: Paradoxical bronchospasm, unstable or life-threatening cardiovascular disease or heart rhythm abnormalities, convulsive disorders or thyrotoxicosis, pulmonary tuberculosis or patients with chronic or untreated infections, narrow-angle glaucoma, urinary retention, hypokalaemia, patients predisposed to low levels of serum potassium, diabetes mellitus. In patients with moderate to severe hepatic impairment patients should be monitored for systemic corticosteroid-related adverse reactions. Eye symptoms such as blurred vision may be due to underlying serious conditions such as cataract, glaucoma or central serous chorioretinopathy (CSCR); consider referral to ophthalmologist. Increased incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroids. Risk factors for pneumonia include: current smokers, old age, patients with a history of prior pneumonia, patients with a low body mass index and severe COPD. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Trelegy. Acute symptoms: Not for acute symptoms, use short-acting inhaled bronchodilator. Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases. Therapy should not be abruptly stopped without physician supervision due to risk of symptom recurrence. Systemic effects: Systemic effects of ICSs may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Interactions with other medicinal products: Caution should be exercised with concurrent use of ß-blockers. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products), hypokalaemic treatments or non-potassium-sparing diuretics. Co-administration with other long-acting muscarinic antagonists or long acting ß2-adrenergic agonists is not
Start your patients on TRELEGY Ellipta today, expect more from tomorrow 1,2
recommended. Pregnancy and breast-feeding: Experience limited. Balance risks against benefits. Side effects: Common (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, arthralgia, back pain. Uncommon (≥1/1,000 to <1/100): viral respiratory tract infection, supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, dysphonia, dry mouth, fractures. Rare (≥1/10,000 to <1/1,000): Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, and rash. Not known (cannot be estimated from the available data): vision blurred. Marketing Authorisation (MA) Holder: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA No. [EU/1/17/1236/002]. Legal category: POM B. Last date of revision: September 2020. Code: PI-6725. Further information available on request from GlaxoSmithKline, 12 Riverwalk, Citywest Business Campus, Dublin 24. Tel: 01-4955000.
Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
TRELEGY Ellipta was developed in collaboration with
Today. Tomorrow. TRELEGY. 2-3
out more here: www.trelegy.ie
request a visit from a GSK representative ©2020 GSK Group of Companies or its licensor Trademarks are owned by or licensed to the GSK Group of Companies
PM-IE-FVU-ADVT-200014 | October 2020
patients with persistent breathlessness or exercise limitation on LABA/ICS treatment, LAMA can be added to escalate to triple therapy. Alternatively, switching from LABA/ICS to LABA/LAMA should be considered if the original indication for ICS was inappropriate (eg, an ICS was used to treat symptoms in the absence of a history of exacerbations), or there has been a lack of response to ICS treatment, or if ICS side-effects warrant discontinuation (GOLD, 2021). At all stages, dyspnoea due to other causes (not COPD) should be investigated and treated appropriately. Inhaler technique and adherence should be considered as causes of inadequate treatment response.
Where exacerbations are the predominant trait, prophylactic macrolide antibiotics should be considered following cardiovascular assessment. Assessment of eosinophils can be useful when the patient is experiencing exacerbations. If the eosinophils are above 0.1 and the patient has experienced two or more exacerbations with one hospitalisation or are above 0.3, initiating or escalating ICS can be beneficial (GOLD, 2021). Roflumilast, a treatment option, is a selective inhibitor of phosphodiesterase-4 (PDE-4) that has unique anti-inflammatory activity and is used to treat and prevent exacerbations.
1. Smoking cessation
Smoking cessation is of paramount importance in the management of COPD regardless of disease severity. Support given by health professionals significantly increases quit rates over self-initiated strategies. Even a brief (three-minute) period of counselling to urge a smoker to quit results in smoking quit rates of 5-to-10 per cent. Smoking cessation should be encouraged at all severities of the condition. Nicotine replacement therapy (nicotine gum, nasal spray, transdermal patch, sublingual tablet, or lozenge) as well as treatment with varenicline reliably increases long-term smoking abstinence rates and are significantly more effective than placebo (GOLD, 2021).
2. Pulmonary rehabilitation
Pulmonary rehabilitation has been proven to have significant benefits in reducing dyspnoea, fatigue, and exacerbations, and improving quality-of-life in people with COPD. Although an effective pulmonary rehabilitation programme is
six weeks, the longer the programme continues, the more effective the results. If exercise training is maintained at home, the patient’s health status remains above pre-rehabilitation levels (McCarthy et al, 2015).
Patients should be encouraged to carry out breathing exercises on a daily basis. These will assist in the expectoration of sputum. Exercises such as chest and shoulder exercises, shoulder raises, step ups and sit to stand exercises should be encouraged as this will assist in maintain upper body strength with the ultimate aim of prevention of muscle wasting. Patients can be directed to www.copd.ie for videos on pursed lip breathing and the active cycle of breathing.
Patients require ongoing education and support to assist them to live and maintain optimal lifestyles. Education about the disease process, inhaler technique, adherence to medication, immunisations, pulmonary rehabilitation, smoking cessation and long-term oxygen therapy are required. All patients should have a COPD communication card (Figure 3), which outlines their treatment including oxygen therapy.
Long-term oxygen therapy is indicated for stable patients who have:
PaO2 at or below 7.3 kPa (55mmHg) or SaO2 at or below 88 per cent, with or without hypercapnia confirmed twice over a threeweek period; or
PaO2 between 7.3 kPa (55mmHg) and 8.0kPa (60mmHg), or SaO2 of 88 per cent, if there is evidence of pulmonary hypertension, peripheral oedema suggesting congestive cardiac failure, or polycythaemia (haematocrit >55 per cent).
Once placed on long-term oxygen therapy (LTOT) the patient should be re-evaluated after 60-to-90 days with repeat arterial blood gas (ABG) or oxygen saturation while inspiring the same level of oxygen or room air to determine if oxygen is therapeutic and still indicated, respectively (GOLD, 2021).
Management of comorbidities
Many patients with COPD have co-existing illness such as diabetes, cardiovascular
disease, osteoporosis and depression to mention but a few. In general, the presence of comorbidities should not affect COPD treatment and co-morbidities should be treated according to standards and guidelines. Lung cancer is common in patients with COPD. Gastroesophageal reflux is common and is associated with an increased risk of exacerbations and therefore should be managed optimally. Osteoporosis is also common due to recurrent use of oral steroids, lack of weight-bearing exercise and being over- or underweight. GOLD recommends that treatments for comorbidities should kept as simple as possible to avoid polypharmacy (GOLD, 2021).
This article has focused on the diagnosis, management and prevention of COPD. The definition, classification, pharmacological, non-pharmacological, the importance of inhaler technique and co-morbidities have been addressed. There have been significant changes to the assessment tool which has simplified the classification of COPD, which will enable practitioners to individualise the patient’s management and treatment and ultimately improve patient outcomes and quality-of-life.
GOLD (2022) - The CDC recommends that adults with COPD who have not been vaccinated in adolescence have DTaP to protect against whooping cough. It is also recommended that adults aged >50 years have zoster vaccine to protect against shingles. Lung cancer - annual low dose CT scan is recommended for patients with COPD due to smoking.
1. Global Strategy for the Diagnosis, Management and Prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021. Available from: www.goldcopd.org/
2. McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. (2015) Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews
Feature Respiratory 24 NOVEMBER-DECEMBER 2021
of infants experience symptoms of regurgitation1
For bottle-fed frequent regurgitation
Clinically proven to reduce infant regurgitation episodes by 78%2
Aptamil Anti-Reflux is a thickened formula for the dietary management of reflux and regurgitation in bottlefed infants
the feed volumes more frequent an appropriate TRIAL a thickened
reduce infant regurgitation episodes by 78%2
AVAILABLE IN RETAIL AND PHARMACY OUTLETS
30 30% Pediatrics 2003;111:e355-9.
Aptamil Anti-Reflux formula for the reflux and regurgitation
* European Society for Pediatric Gastroenterology, Hepatology, and Nutrition
References: 1. Vandenplas Y et al., J Pediatr Gastroenterol Nutr 2015; 61(5): 531–537. 2. Wenzl TG et al. Pediatrics 2003;111:e355-9.
* European Society for Pediatric Gastroenterology, References: 1. Vandenplas Y et al.,
management of frequent reflux and regurgitation. available including breastfeeding. This product infants. Suitable for use as the sole source of
IMPORTANT NOTICE: Aptamil Anti Reflux is a food for special medical purposes for the dietary management of frequent reflux and regurgitation. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. This product should not be used in combination with antacids or other thickeners and is not suitable for premature infants. Suitable for use as the sole source of nutrition for infants from birth and as part of a balanced diet from 6 months.
IMPORTANT NOTICE: Aptamil Anti It should only be used under medical should not be used in combination nutrition for infants from birth and
Northern Ireland: www.eln.nutricia.co.uk
of Ireland: www.aptamilhcp.ie
FOR HEALTHCARE PROFESSIONAL
ORLA LOFTUS MORAN –PRACTICE NURSE OF THE YEAR 2021
Orla Loftus Moran, Advanced Nurse Practitioner at Knock Medical Centre, Mayo, won the ‘Practice Nurse of the Year 2021’ award at the Irish Healthcare Awards, which took place on 15 November. The awards are now in their 20th year and recognise innovation and excellence across the Irish healthcare sector
It is a great honour to have been awarded the Irish Practice Nurse of the year award at the 2021 Irish Healthcare Awards (IHCA). I wish to thank all those who contributed to my nomination, Dr Diarmuid C Murray, Knock Medical Centre; Associate Professor Mary Casey, UCD; Jane Campion and Gillian Redmond former National Chairpersons, IGPNEA and the 2020/2021 Executive Committee; Kathy McSharry, Professional Development Coordinator; Caroline Daughton, GPN, former IGPNEA Administrator; and Theresa Lowry-Lehnen, the 2020 IHCA ‘Practice Nurse of the Year' recipient. I also would like to pay tribute to my wonderful family Donal, Kevin, Claire, and Katie, my parents Mikey and Edie and brothers Mike, Patrick, and Joseph for putting up with me over the years. Sincere thanks also to my encouraging and supportive colleagues and patients in Knock Medical Centre, with special mentions to my friend and mentor Dr Diarmuid Murray Senior and CNS Maura Gannon who has shared this role with me for 22 years.
My adventure in general practice nursing (so far) has been a steep learning curve, often challenging and at times exhausting, but always rewarding and fulfilling. I have been privileged over the past 24 years to care for patients in Crossmolina, Knock, and Ballyhaunis, and in that time there has been laughter, tears, and everything in between. We work hard in general practice to build trusting therapeutic relationships with patients and I enjoy this unique aspect of continuity in our work. I grew up in general practice and learned the importance of its place in the community from my inspiring dad. When I first started working as a general practice nurse (GPN) I was so nervous and out of my comfort zone
that I could never have imagined achieving an award such as this. As my role developed, I was inspired by many fantastic GPNs, who provided leadership and guidance primarily through the IGPNEA (formerly IPNA). Their vision has been the foundation which we are all building on today.
As a workforce, GPNs remain central to improvements and expansion of services delivered in general practice, providing direct patient care during 7,749,615 consultations annually (Collins, 2021). GPNs are the largest professional body of sample takers for the national cervical screening programme CervicalCheck. The Irish College of General Practitioners (ICGP) in their 2021 pre-budget submission specifically emphasise the vital role of the GPN in enabling the roll-out of the community-based chronic disease programme, a central Sláintecare objective (ICGP, 2021). The
innovative and flexible response to the Covid-19 pandemic by GPs and GPNs in general practice ensured services remained fully operational, as Covid-19 assessments and referrals were absorbed into a difficult and already busy workload. The Covid-19 vaccination programme in general practice has been primarily nurseled. I believe mobilisation of the GPN workforce and advanced GPN roles can strengthen general practice, whilst providing benefits and safe care for patients - research demonstrates this and furthermore suggests that Irish GPN roles may be underutilised (Norful et al, 2017; Laurant et al, 2018; Halcomb and Ashley, 2019; Poghosyan et al, 2018). Therefore, with deference to our GP colleagues and other GP team members, whom I hope will understand, I dedicate this award to all GPNs who are often the unsung heroes of general practice, particularly acknowledging their role in the organisation and timely roll-out of the Covid-19 vaccination programme in general practice. It also must also be acknowledged that GPNs are so much more than expert vaccinators and contribute significantly to all aspects of general practice. I believe that general practice nursing is a unique nursing speciality which has not yet been optimised in Ireland. We have many barriers to role development; most notably access to education. I would encourage GPNs to value what you do, use every opportunity to promote your role and make your valuable voice heard: Ní neart go cur le chéile. I have often heard it said that GPs are the beating heart of general practice/primary care if this is so then without question GPNs are the atrioventricular (AV) node! GPNs make me so proud.
Thank you, Orla
Feature Practice Nurse of the Year 26 NOVEMBER-DECEMBER 2021
Orla Loftus Moran
Author: Theresa Lowry-Lehnen, GPN, RNP, PhD, Clinical Nurse Specialist and Associate Lecturer at IT Carlow
DIABETIC FOOT DISEASE IN FOCUS
This clinical module provides a detailed overview of the prevention, diagnosis, and management of diabetic foot disease
Diabetic foot ulceration (DFU) is a vascular complication of diabetes mellitus and associated with extensive periods of hospitalisation and a high degree of morbidity and mortality. The pathogenicity of diabetic foot ulcers are multifactorial. Diabetic foot syndrome (DFS) is associated with neurologic abnormalities and peripheral arterial disease (PAD) of the lower limbs of varied severity. DFS involves infection, ulceration, or destruction of deep tissues of the foot (including bones) in a patient with diabetes mellitus and is defined by the World Health Organisation (WHO) as an “ulceration of the foot (distally from the ankle and including the ankle) associated with neuropathy and different grades of ischaemia and infection".1,3
Diabetes mellitus is a disorder of glucose haemostasis, which causes hyperglycaemia. When high blood glucose levels persist, complications occur causing damage in the wall of blood vessels throughout the body systems. A combination of damage in both small and large blood vessels leads to the presence of DFS manifesting in DFU. Neuropathy and vascular abnormalities are involved in the development of DFS. The underlying cause of DFS is the complex interaction between large vessel disease causing PAD and small vessel disease leading to peripheral diabetic sensory neuropathy.2
Motor neuropathy results in atrophy of foot muscles, disturbing the flexor-extensor balance and
leading to contractures. Sensory neuropathy including abnormal sensation of pain, temperature, and touch exposes the patient to repeated uncontrolled injuries, increasing the risk of ulcerations. Autonomic neuropathy results in the formation of arteriovenous fistulae and trophic changes and atherosclerosis of the lower extremities results in foot ischaemia. All these changes are associated with the development of local osteoporosis and may also lead to osteomyelitis, avascular necrosis, fractures, dislocations, and Charcot foot arthropathy.3
DFS affects nearly 6 per cent of individuals with diabetes, and around 0.5-to-1.5 per cent of patients with DFS require amputation. Most amputations start with ulcerations and can be prevented with good foot care and screening to assess the risk of foot complications. DFS is associated with neurologic abnormalities and PAD of the lower limbs of varied severity.3
All patients with diabetes should have an annual screen to identify their foot ulcer risk status. Those with any risk factors require specific foot care education as well as regular contact with a healthcare professional, usually a podiatrist. Most important in the identification of the high-risk neuropathic foot is good clinical observation and removal of the shoes and socks, with careful inspection of the feet as part of the routine follow-up of all patients with diabetes.6
Risk factors for developing diabetic foot ulcers
All people with diabetes are at risk of developing foot ulcers. The trilogy of peripheral neuropathy, PAD and susceptibility to infection are the main predisposing factors for lesions on the foot. Other factors that increase the risk include poorly fitting or poor quality shoes, not washing regularly or thoroughly or not drying the feet well after washing, improper trimming of toenails, plantar calluses, elevated foot pressures, foot deformity, visual disturbance as a consequence of retinopathy, cardiac disease, renal disease, oedema, obesity, alcohol and tobacco use, ethnic and poor social backgrounds. DFU is most common in older men. It is the interaction and combination of risk factors working together that leads to skin breakdown.4,6 Of all the risk factors for DFU the most important is a past history of ulceration and/or amputation.
It is estimated that 19-to-34 per cent of patients with diabetes are likely to be affected by DFU in their lifetime, and the International Diabetes Federation reports that 9.1-to-26.1 million people will develop DFU annually. A UK population-based cohort study demonstrated that the development of DFU is associated with 5 per cent mortality in the first 12 months and 42 per cent mortality within five years. Patients with DFU were also found to have a 2.5-fold
CPD Diabetes NOVEMBER-DECEMBER 2021 27
increased risk of death compared with their diabetic counterparts without foot wounds.5
Effective glycaemic control reduces the incidence of DFU and decreases the risk of amputation. In assessing glycaemic control the HbA1c test should be performed routinely in all patients with diabetes. HbA1c is an indirect measure of average glycaemia and has a strong predictive value for diabetes complications. A target of 53mmol/l (7 per cent) or below is recommended as the optimal target for diabetes patients.8 Selfmonitoring of blood glucose (SMBG) allows real time measurement of blood glucose levels for individuals. It is important for patients who are self-monitoring to have a good understanding of glucose levels, what their targets are, how well they are achieving this, and to play an active role in managing and tailoring their levels and preventing complications.2
Routine diabetes foot screening should ensure that all patients with diabetes are offered annual screening and regular foot examinations from early diagnosis. Foot review and screening is carried out by appropriately trained staff and foot care education is provided to individuals according to their clinical and personal needs. Patients are regularly assessed for their risk of DFU and classified as low, at risk (moderate- or high-risk), or with active foot disease.7
Foot care management in diabetes is based on three categories of risk
1. Patients at low-risk of diabetic foot disease are managed preventatively through annual screening and regular foot examinations by primary care nurses. A low-risk patient has normal foot pulses, normal vibration and sensation to 10g monofilament, no history of foot ulceration, no significant foot deformity, or no visual impairment.7
2. Patients at risk of diabetic foot disease may be classed as either moderate- or highrisk. All patients will be under regular surveillance by primary care nurses/GPs. Moderate-risk patients will be referred to the podiatrist, either in the community or in the hospital, for an annual review and these patients will remain under the clinical
governance of the GP and podiatrist. The moderate-risk patient has either impaired peripheral sensation or impaired circulation or significant visual impairment or a structural foot deformity. High-risk patients will be reviewed at least annually by the diabetes foot protection team in one of the 16 designated centres and will be under the governance of the foot protection team for their foot care. The high-risk patient has an abnormality that predisposes them to foot ulceration. This can be impaired sensation and impaired circulation, or a previous foot ulcer, previous lower limb amputation or previous Charcot foot.7
radiology consultants, ward nurses, and emergency department (ED) staff.7
Screening and assessment
Patients previously classified as low-risk or patients newly diagnosed with diabetes mellitus should receive annual foot screening as part of their general diabetes care and have the following foot examination:7
Inspection of skin, nails and for structural foot deformity.
Vibration perception testing (128Hz tuning fork) and cutaneous pressure perception testing using the 10g monofilament.
Palpation of foot pulses.
Examination of footwear.
Foot care education involves:7
Daily self-examination of the feet.
Not walking in bare feet.
Checking footwear and hosiery before putting them on.
Breaking shoes in should never be attempted.
3. Patients with active diabetic foot disease have an active foot ulcer (full thickness skin break) or a Charcot foot and will be actively managed by a multidisciplinary specialist foot care service, in conjunction with vascular surgery, orthopaedics, and orthotics input as required. This is available in the eight Model 4 indicative hospitals.7 The HSE National Model of Care states that patients with active DFU should be referred to the multidisciplinary diabetic foot team (MDFT) in the Model 4 hospital within one working day.
Diabetic foot care involves a multidisciplinary team approach including a wide range of professionals as well as patients and their carers. Central to diabetes foot care are patients, carers, podiatrists, general practice nurses (GPNs) and other primary care nurses, GPs, diabetes specialist nurses, diabetes consultants, orthoptists, vascular surgeons, and orthopaedic surgeons. Other groups with an important input into diabetes foot care are tissue viability nurses, physiotherapists, infectious disease service,
No hot water bottles.
Checking bath and shower temperature.
Avoidance of home remedies, eg, corn plasters.
What to do and the appropriate person to contact if foot problems develop.
A low-risk foot information sheet should be provided.
A patient with low-risk of diabetic foot disease does not routinely need to see a podiatrist for diabetes-related purposes.
A patient at moderate-risk of foot complications has either a reduction in vibration or 10g monofilament sensation or has absent foot pulses in either or both feet. There must be no history of ulceration and no significant foot deformity.7 Foot examination frequency requires ongoing review by GP/ GPN or primary care nurse or hospital diabetes clinic as part of routine follow-up.
CPD Diabetes 28 NOVEMBER-DECEMBER 2021
Diabetic foot care involves a multidisciplinary team approach including a wide range of professionals as well as patients and their carers
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patients deserve a meter that’s more than just good enough. Upgrade your patients to the OneTouch Verio Reﬂect® meter today The only meter that gives them guidance with Blood Sugar Mentor™ messages to help them know what those numbers mean, and what they can do about them. Always use the current numerical result for immediate treatment decisions and consult a healthcare professional before making changes to a diabetes care plan. Always read and follow the label. © 2020 LifeScan IP Holdings, LLC. Trademarks are used under license by LifeScan IP Holdings, LLC. All rights reserved. CA-VRF-2000076 (20-013) Upgrade Now! Help them get more guidance. 8.9 Scan to download OneTouch Reveal for Free! www.myonetouch.ie For FOC OneTouch Verio Reflect meters email OneTouchSolutionsIreland@lifescan.com IR2021_23 PHY Poster A4_v1.2.indd 1 05.10.2021 17:11:25 Your patients deserve a meter that’s more than just good enough. Upgrade your patients to the OneTouch Verio Reﬂect® meter today The only meter that gives them guidance with Blood Sugar Mentor™ messages to help them know what those numbers mean, and what they can do about them. Always use the current numerical result for immediate treatment Upgrade Now! Help them get more guidance. 8.9 Scan to download OneTouch Reveal for Free! www.myonetouch.ie For FOC OneTouch Verio Reflect meters email OneTouchSolutionsIreland@lifescan.com
ON DIAGNOSIS OF DIABETES AND AT ANNUAL REVIEW THEREAFTER:
Trained practice nurse will examine patient’s feet and lower limbs for risk factors, this should include:
Testing vibration and 10g monofilament sensation
Palpation of dorsalis pedis and posterior tibial pulses in both feet
Inspection of any foot deformity
Inspection of footwear
ACTIVE FOOT DISEASE
Intact pressure and vibration sensation
No peripheral arterial disease (PAD)
All pedal pulses present
No signs or symptoms of PAD, ie, claudication pallor, dependent rubor, poor tissue vitality
No previous ulcer or lower limb amputation
No foot deformity
Any one of the following:
Loss of sensation/peripheral neuropathy
Signs or symptoms of PAD
Previous vascular surgery
Structural foot deformity
Significant visual impairment
Physical disability (eg, stroke or gross obesity)
PAD and sensory loss and/ or previous diabetes-related foot ulcer or lower limb amputation and/or previous Charcot neuroarthropathy
Active foot ulceration and/or active Charcot neuroarthropathy
Referral with rapid access (within 24 hours/next working day) to multidisciplinary foot care service in tertiary centre
Access to vascular, orthopaedics, orthotics
Annual foot screening in primary care
Practice nurse/primary care nurse to screen
Clinical nurse specialist and/or podiatrist to provide education to practice nurse/ public health nurse to provide screening
Patient education/ smoking cessation
Annual foot examination by foot protection team and ongoing review by podiatrist member of the foot protection team based in either the hospital or the community
Education in foot protection
Vascular assessment, biomechanical, orthopaedic assessment and orthotics if indicated
Referral to community podiatry for non-diabetic foot pathology
Called for formal review by foot protection team and routine ongoing review by GP/ practice nurse/hospital diabetes clinic
Examination for deformity, neurological and vascular status, and footwear and orthotics as indicated
Education in foot protection
If ulceration present then refer within 24 hours to multidisciplinary foot care service
(Model 4 hospital)
Access to vascular laboratory, radiology, microbiology, infectious disease
Once ulcer healed refer patient back to the foot care team in the referral Model 3 hospital
If the healed ulcer belongs to a patient who originated from Model 4 hospital, they remain under the care of the specialist diabetes foot service in the Model 4 hospital
CPD Diabetes 30 NOVEMBER-DECEMBER 2021
Figure 1: Foot assessment and classification protocol. (Source: HSE Model of Care for the Diabetic Foot)
Annual podiatry review by the specialist podiatrist is based either in the community or in the hospital.7
Patients previously classified as moderate risk should have the following foot examination:
Inspection for structural foot deformity.
Skin and nail examination.
Vibration perception testing (128Hz tuning fork) and cutaneous pressure perception testing using the 10g monofilament.
Palpation of foot pulses.
A comprehensive vascular assessment where indicated, including Doppler waveform analysis, ankle brachial index, and toe brachial pressure index calculation.
Examination of footwear.
If there is loss of vibration and 10g monofilament sensation the patient should be educated on how to protect their feet. If there is intact sensation and absence of foot pulses in either or both feet, the patient may require further vascular assessment, particularly if there are symptoms of vascular insufficiency. Foot deformity may not need any action, but if it is severe the patient should be referred for specialist assessment. Podiatry advice, biomechanical assessment and discussion of all treatment options including accommodative footwear and orthoses should be provided where required. In some cases orthopaedic surgery may be required. If there is other foot pathology such as nail conditions, corns, callus or verrucae, these can be dealt with during the examination by the podiatrist and a referral to a community podiatrist should be made.7 Foot care education as previously described should be provided for the patient.7
A patient with high risk of foot complications has both a reduction in vibration and monofilament sensation and PAD – absence of foot pulses. If there is a previous history of ulceration, lower limb amputation or Charcot neuro-arthropathy then the foot is classified as high risk automatically and remains in the high risk category. Foot examination frequency requires ongoing review by GP/ primary care nurse/hospital diabetes team. Patients will be called for formal annual
review or more frequently as required by the members of the foot protection team or service where appropriate.7
Patients classified as high-risk should have the following foot examination:7
Inspection for structural foot deformity.
A comprehensive neurological assessment.
A comprehensive vascular assessment where indicated, including Doppler waveform analysis, ankle brachial, and toe brachial pressure index calculation.
Examination of footwear.
The diabetes foot protection clinic should take place on a monthly basis at minimum, within the Model 3 or Model 4 hospital and should have input from a diabetes specialist, podiatrist, and diabetes nurse with input where necessary from vascular, orthopaedics, and orthotics.
Podiatrists within the foot protection team or foot care service should review the highrisk foot at least once every 12 months.
If ulceration is present the patient should be referred within 24 hours or the next working day to the multidisciplinary foot care service (Model 4 hospital).
The educational needs of the patient should be reviewed.
If there is a problem with footwear, the patient should be referred to a podiatrist/ orthotist for footwear assessment and orthoses provision.
The patient should be referred to vascular services.
If there is other foot pathology such as nail conditions, corns, callus or verrucae, referral to a community podiatrist should be made.
The hospital podiatrist will work closely with the community podiatrist in the joint care of high-risk foot patients.
Foot care education as previously described should be provided for the patient.
Active foot disease
All diabetes patients with an active foot ulcer or active Charcot foot should be referred to the diabetes foot clinic urgently and patients should be seen within 24 hours or on the next working day by the diabetes multidisciplinary foot care service, and
involve the appropriate specialties. Patients will be seen weekly by a member of the multidisciplinary foot care service until healing of the ulcer occurs and will be seen regularly in the specialist multidisciplinary foot care clinic until ulcer healing or the Charcot foot becomes stable and inactive.
Patients with active foot disease should have the following foot examination:
Inspection for structural foot deformity.
A comprehensive neurological assessment.
A comprehensive vascular assessment where indicated, including Doppler waveform analysis, ankle brachial, toe brachial pressure index calculation, and/or radiological imaging of the lower limb vasculature.
Radiology investigations where indicated including foot x-ray or MRI of the foot. Isotope bone scan may also be used in certain circumstances.
Examination of footwear.
The diabetes foot care clinic should take place on a monthly basis at minimum within the Model 4 hospital and should have input from a diabetes consultant, senior podiatrist and diabetes nurse, with input where necessary from vascular, orthopaedics, orthotics, tissue viability, physiotherapy, plastic surgery, and infectious disease.
Podiatrist within the foot care service should review the active foot disease patient at least weekly until healing occurs.
Review the educational needs of the patient.
Referral to a podiatrist/orthotist for footwear assessment and orthoses provision if required.
Refer to vascular and/or orthopaedics where necessary.
If there is other foot pathology such as nail conditions, corns, callus or verrucae, referral to a community podiatrist should be made.
If there are clinical signs of infection, antibiotics should be commenced immediately.
If there are clinical signs of severe/limbthreatening infection then the patient should be admitted urgently for intravenous antibiotic therapy.
If there is evidence or suspicion of
CPD Diabetes NOVEMBER-DECEMBER 2021 31
osteomyelitis the patient should be referred for radiological and orthopaedic review.
Control vascular risk factors.
Once the foot ulcer has healed and appropriate footwear organised for the patient, they can be moved back to the ‘high-risk group’ in the ‘at-risk’ category. However, if there is the likelihood of re-ulceration the patient should continue to attend the multidisciplinary foot care service in a Model 4 hospital.
The high-risk foot information sheet should be given to the patient.
A comprehensive assessment of the patient’s general health, glycaemic control, extent of peripheral neuropathy and detailed dermatologic and musculoskeletal examination are included in the evaluation. Clinical evaluation of the foot wound should include a detailed description of the site, size, and depth of wound. Neuropathic ulcers typically occur in the warm, but insensate foot, often under pressure-bearing areas, and are surrounded by callus. Ischaemic wounds tend to occur in the cool, poorly perfused foot and are often at lateral fifth metatarsal head regions or the medial first metatarsal head regions. Correct identification of the degree of ischaemia is of great importance when evaluating a wound.6
Ulcers are graded using the University of Texas Classification System (Figure 2), which is a validated tool specifically for diabetic foot ulcers. The Meggitt-Wagner grading system was regarded as the gold standard for many years. One problem with the Meggitt-Wagner
grading system is that the ischaemic status of the wound is not included and therefore a number of new classification systems for diabetic foot wounds have been proposed and validated over the last 20 years. The University of Texas Classification System incorporates the Meggitt-Wagner grades, but also enables the practitioner to stage the wound with respect to the presence or absence of infection and/or ischaemia.6,9
patient should be treated simultaneously with the foot lesion. Debridement is important as it reduces devitalised tissue, promotes proliferation, granulation, and epithelialisation, eliminates potential pathogens, allows exudate drainage, reveals the true extent of ulceration and reduces pressure on subcutaneous tissue.9
DFU should heal if there is an adequate arterial inflow, infection is aggressively managed, and pressure is removed from the wound and its margins. Pressure reduction is essential for a patient who has just been treated for a diabetic foot and off-loading or reducing the pressure plays a significant role in managing the healing process. There are various off-loading modalities, such as the total-contact casts (TCC), removable cast walkers (RCW) and half shoes, and studies have been conducted to compare their effectiveness to heal neuropathic foot ulcerations in diabetic individuals. Although less commonly used, results reveal that TCC is better and heals a comparatively higher number of wounds in a shorter duration of time. In the management of plantar neuropathic ulcers, offloading is critical and all efforts must be made to enhance patient understanding of the need for offloading.6,9
Treatment and management
Depending on the primary underlying cause of ulceration, the wound will be assessed and a management plan will be developed. The management of DFU is multifaceted and combines revascularisation, infection management, debridement of dead tissue and offloading of pressure in addition to hyperglycaemic treatment and wound care.2 Treatment of hyperglycaemia, ketoacidosis, renal insufficiency, and other comorbidities that may coincide in the ulcerated
Identification of infection in wounds can be challenging and particularly so in DFU. In the presence of neuropathy and ischaemia, signs of infection can be diminished as the normal inflammatory response is impaired. The correct diagnosis of infection in the diabetic foot wound is critical as it is often the combination of untreated infection and PAD that lead to amputation in the diabetic foot. If osteomyelitis is suspected plain x-rays can assist diagnosis, however, initially reports may prove normal and evidence of osteomyelitis may not be apparent for 14 days. Antibiotic usage should be guided by clinical signs of infection and microbiologic analysis of deep tissue specimens.6,9
Most adjunctive therapies have little evidence to support their use, although recent trials suggest efficacy for a number of topical therapies including LeucoPatch and sucrose octasulfate. Negative pressure wound therapy
CPD Diabetes 32 NOVEMBER-DECEMBER 2021
0 1 2 3 A Pre-ulcerative lesions No skin break Superficial wound No penetration Wound penetration tendon or capsule Wound penetration bone or joint B With infection With infection With infection With infection C With ischaemia With ischaemia With ischaemia With ischaemia D With infection and ischaemia With infection and ischaemia With infection and ischaemia With infection and ischaemia STAGE GRADE
Figure 2: The University of Texas Wound Classification System
Antibiotic usage should be guided by clinical signs of infection and microbiologic analysis of deep tissue specimens
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Neocate LCP From Birth Pepti 1 From Birth Pepti 2 From 6 mths References
1. O’Carroll E et al. (Abstract) Presented at The Nutrition Society Advancing Nutritional Science Spring Conference, Glasgow. 2018. 2. Nutricia Data on File, 2020
has also been shown to be helpful in certain cases. There is currently no indication for hyperbaric oxygen usage, whereas recent studies suggest that topical oxygen therapies may help wound healing.6,10
Wound dressings are important to keep the ulcer clean, but the placement of a large dressing on a wound may mislead the patient into believing that the dressing of an ulcer is curative. Although there has been much progress in the understanding and management of diabetic foot disorders over the last three decades, much of what we use in clinical practice today still lacks an evidencebase. This is particularly true for dressings and there is little evidence from randomised controlled trials (RCTs) that any dressing is superior to another.6
Prevention and recurrence
Prevention of diabetic foot disease can only be successful with the early identification of patients who have risk factors for foot ulceration. All patients with diabetes should, at whatever stage, be screened for evidence of complications at least annually. The principle aim of the annual review is to identify those with early signs of complications and provide appropriate management to prevent progression. The most important aspect of the annual foot review is the removal of shoes and socks with very careful inspection of both feet including between toes. Many neuropathic feet can be identified by this simple clinical observation, looking for features such as small muscle wasting, clawing of the toes, prominence of the metatarsal heads, distended dorsal foot pains, dry skin, and callus formation. For evidence of neuropathy, the perception of pressure using the 10g monofilament should be used at four sites in each foot. An additional test, which might include a vibrating 128Hz tuning fork, should also be used to confirm any abnormality. For the vascular assessment, foot pulse palpation is most important. The ankle brachial index may be falsely elevated in many patients with diabetic neuropathy and therefore listening to the Doppler signal may be more helpful.
Other simple devices developed for clinical screening that have been validated in clinical studies include the ‘Ipswich
Touch Test’, which assesses the ability of the patient to perceive the touch of a finger on the toes and the ‘Vibratip’, a battery-operated disposable vibrating stylus used to assess vibration sensation. A number of studies are currently looking at ‘smart technology’ in the prevention of recurrent DFU. These include the use of sensors in socks or shoes to detect pressure change and also various devices to measure differentials in skin temperature. These technologies aim to alert patients in the pre-ulcerative phase with the hope of preventing the actual ulcer from developing.6 Recurrence is common after the healing of neuropathic or neuro-ischaemic foot ulcers, and the patient is termed in remission rather than healed following an episode of DFU. While the symptoms may have resolved the underlying disease process remains and the symptoms of the disease will likely re-occur.
1. Tuttolomondo A, Maida C, Pinto A. (2015). Diabetic foot syndrome: Immune-inflammatory features as possible cardiovascular markers in diabetes. World J Orthop. 2015 Jan 18; 6(1): 62–76.doi: 10.5312/wjo.v6.i1.62
2. Wilson P, Fu W, Doyle J. (2021). Joining the dots… Diabetes mellitus and foot disease. Irish Pharmacy News, Volume 13, Issue 7, pp 68-69. Available at: www.pharmacynewsireland.com/ digital-magazines/
3. Rodríguez-Gutiérrez R, Quintanilla-Flores DL, Soto-Garcia AJ, Gonzalez-Gonzalez JG, Sieradzki J, Płaczkiewicz-Jankowska E. Diabetic foot syndrome. McMaster Textbook of Internal Medicine. Kraków: Medycyna Praktyczna. https://empendium.com/ mcmtextbook/chapter/B31.II.13.4.4
4. Healthline (2021). Diabetic ulcers: Causes and treatment. Available at: www. healthline.com/health/type-2-diabetes/ hyperglycemic-hyperosmolar-syndrome
5. Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan; 1411(1): 153–165. doi: 10.1111/nyas.13569
Rates of DFU recurrence are up to 40 per cent one year following DFU. It is important that patients and their families are educated about the persistence of DFS even in the absence of DFU.2
All individuals with diabetes should receive regular screening and structured education to empower them to maintain their own foot health. Early identification of problems and rapid referral to the specialist multidisciplinary team can reduce the risk of DFU and unnecessary amputations.9 Foot care programmes accentuating preventive management can reduce the incidence of foot ulceration through modification of self-care practices, appropriate evaluation of risk factors and formulation of treatment protocols directed at patient education/ re-education, early intervention, limb preservation, and prevention of new lesions.
6. Boulton A, Whitehouse W. (2020). The diabetic foot. NCBI. Available at: www.ncbi.nlm. nih.gov/books/NBK409609/
7. HSE (2011). Model of care for the diabetic foot. HSE. Available at: www.hse.ie/eng/ services/list/2/primarycare/east-coast-diabetesservice/management-of-type-2-diabetes/footcare/model-of-care-diabetic-foot.pdf
8. Diabetes Ireland (2021). Know your numbers and targets. Diabetes Ireland. Available at: www.diabetes.ie/are-you-at-riskfree-diabetes-test/a-numbers-game/
9. NUI Galway (nd). Foot screening and education of the patient with diabetes. Discipline of Podiatry School of Health Sciences NUI Galway. Available at: www.hse.ie/eng/services/ publications/clinical-strategy-and-programmes/ foot-screening-and-education-of-the-patientwith-diabetes.pdf
10. Niederauer M, Michalek J, Liu Q, et al. (2018). Continuous diffusion of oxygen improves diabetic foot ulcer healing when compared with a placebo control: A randomised, double-blind, multicenter study.
J Wound Care. 2018; 27 suppl 9:S30–S45
CPD Diabetes 34 NOVEMBER-DECEMBER 2021
Free independent CPD for Irish nurses
Q1. Diabetic foot ulceration is a non-vascular complication of diabetes mellitus and associated with a moderate degree of morbidity and mortality.
True or false?
Q2. Diabetic foot syndrome involves infection, ulceration, or destruction of deep tissues of the foot, including bones in a patient with diabetes mellitus.
True or false?
Q3: Diabetes mellitus (DM) is a disorder of glucose haemostasis, which causes hypoglycaemia. When hypoglycaemia persists, complications of DM occur causing damage in the wall of blood vessels throughout the body systems.
True or false?
Q4. The underlying cause of diabetic foot syndrome are the complex interaction between large vessel disease causing peripheral arterial disease
and small vessel disease leading to peripheral diabetic sensory neuropathy.
True or false?
Q5. All patients with diabetes should be screened every two years to identify their foot ulcer risk status.
True or false?
Q6. Only some people with diabetes are at risk of developing foot ulcers. Patients at low risk of diabetic foot disease can usually self-care, but are required to attend for screening and foot examination in primary care every two years.
True or false?
Q7. The trilogy of peripheral arterial disease, peripheral vision, and susceptibility to infection are the main predisposing factors for lesions on the foot.
True or false?
Q8. A low-risk patient has abnormal foot pulses, abnormal vibration, and sensation to 10g monofilament, no history of foot ulceration, no significant foot deformity, or no visual impairment.
True or false?
Q9. Patients with active diabetic foot disease have an active foot ulcer/full thickness skin break or a Charcot foot and will be managed by a multidisciplinary specialist foot care service, in conjunction with vascular surgery, orthopaedics, and orthotics input as required.
True or false?
Q10. Recurrence is uncommon after the healing of neuropathic or neuroischaemic foot ulcers. Once the underlying disease process has been treated, the symptoms of the disease are unlikely to re-occur.
True or false?
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.
CPD Diabetes NOVEMBER-DECEMBER 2021 35
A B C
PALEXIA® SR was associated with significant improvements in quality of life and function as measured by the Short Form-12 (SF-12) health survey and the EuroQol-5 Dimension (EQ-5D) health status questionnaire in patients with severe chronic low back pain with a neuropathic component2
PALEXIA SR® Prolonged Release Tablets Prescribing Information. Refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: 50 mg (white), 100 mg (pale yellow), 150 mg (pale pink), 200 mg (pale orange) and 250 mg (brownish red) prolonged-release tablets contain 50 mg, 100 mg, 150 mg, 200 mg and 250 mg of tapentadol (as hydrochloride) respectively. Indication: Palexia SR is indicated for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. Dosage and method of administration: Individualise according to severity of pain, the previous treatment experience and the ability to monitor the patient. Swallowed whole with sufficient liquid, not divided or chewed, with or without food. The tablet shell may not be completely digested and eliminated / seen in the patient’s stool which has no clinical significance as the active substance will have already been absorbed. Initial dose 50 mg twice a day. Switching from other opioids may require higher initial doses. Titrate in increments of 50 mg twice a day every 3 days for adequate pain control. Total daily doses greater than 500 mg not recommended. Discontinuation of treatment: Taper dose gradually to prevent withdrawal symptoms. Renal/hepatic impairment: Not recommended in patients with severe cases. Caution and dose adjustments with moderate hepatic impairment. Elderly: May need dose adjustments. Children below 18 years: Not recommended. Contraindications: Hypersensitivity to ingredients, suspected or having paralytic ileus, acute intoxication with alcohol, hypnotics, centrally acting analgesics or psychotropics. Not for use when mu-opioid receptor agonists are contraindicated (e.g. significant respiratory depression, acute or severe bronchial asthma or hypercapnia). Special warnings and precautions: Abuse and addiction potential of Palexia should be considered where there is increased risk of misuse, abuse, addiction or diversion. All patients should be carefully monitored for signs of abuse and addiction. Concomitant use with sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible. If used concomitantly, reduction of dose of one or both agents should be considered and the duration of the concomitant treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation. It is strongly recommended to inform patients and caregivers to be aware of these symptoms. At high doses or in mu-opioid receptor agonist sensitive patients, dose-related respiratory depression may occur. Caution and monitoring required with impaired respiratory function. Should not use in patients susceptible to intracranial effects of carbon dioxide retention (e.g. increased intracranial pressure, impaired consciousness or coma). Use with caution with head injury, brain tumors, moderate hepatic impairment, biliary tract disease including acute pancreatitis. Not recommended if history of or at risk of seizures. May increase the seizure risk in patients taking medicinal products that lower the seizure threshold. Not recommended in severe renal or hepatic impairment. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Care should be taken when combining with mixed mu-opioid agonists/antagonists (e.g. pentazocine, nalbuphine) or partial mu-opioid agonists (e.g. buprenorphine). Should not use with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Interactions: The concomitant use with sedating medicinal products such as benzodiazepines or other respiratory or CNS depressants (other opioids, antitussives or substitution treatments, barbiturates, antipsychotics, H1-antihistamines, alcohol) increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. When combined therapy with a respiratory or CNS depressant is contemplated, the reduction of dose of one or both agents should be considered and the duration of the concomitant use should be limited. Can induce convulsions and increase the potential for selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other medicinal products that lower the seizure threshold to cause convulsions. There have been reports of serotonin syndrome in a temporal connection with the therapeutic use of tapentadol in combination with serotoninergic medicinal products (e.g. SSIRs, SNRIs and tricyclic antidepressants). Use with strong inhibitors of uridine diphosphate transferase isoenzymes (involved in glucuronidation) may increase systemic exposure of Palexia SR. Caution if concomitant administration of strong enzyme inducing drugs (e.g. rifampicin, phenobarbital, St John’s Wort) starts or stops as this may lead to decreased efficacy or risk for adverse events, respectively. Avoid use in patients who have taken monoamine oxidase inhibitors (MAOIs) within the last 14 days, due to cardiovascular events. Pregnancy and lactation: Use in pregnancy only if the potential benefit justifies the potential risk to the foetus. Not recommended during and immediately before labour and delivery. Do not use during breast feeding. Driving and using machines: May have major effect on ability to drive and use machines, especially at the beginning or change in dosage, in connection with alcohol or tranquilisers. Undesirable effects: Very common (≥1/10): dizziness, somnolence, headache, nausea, constipation. Common (≥1/100, <1/10): decreased appetite, anxiety, depressed mood, sleep disorder, nervousness, restlessness, disturbance in attention, tremor, involuntary muscle contractions, flushing, dyspnoea, vomiting, diarrhoea, dyspepsia, pruritus, hyperhidrosis, rash, asthenia, fatigue, feeling of body temperature change, mucosal dryness, oedema. Other important undesirable effects observed in clinical trials and/or postmarketing: drug hypersensitivity, depressed level of consciousness, mental impairment, syncope (uncommon ≥1/1000, <1/100), impaired gastric emptying, respiratory depression, convulsion, angioedema, anaphylaxis and anaphylactic shock, drug dependence (rare ≥1/10,000, <1/1000), delirium (unknown). No evidence of increased risk of suicidal ideation or suicide with Palexia SR. Additional information is available on request. Overdose: Seek specialist treatment (see SmPC). Legal
classification: POM, CD (Schedule II). Marketing Authorisation numbers and pack sizes: 50 mg: PA 2242/12/4, 28 and 56 packs; 100 mg: PA 2242/12/5, 56 pack; 150 mg: PA 2242/12/6, 56 pack; 200 mg: PA 2242/12/7, 56 pack and 250 mg: PA 2242/12/8, 56 pack. Marketing Authorisation Holder: Grünenthal Pharma Ltd, 4045 Kingswood
Ireland. M-PLX-IE-03-20-0004. Date of Preparation: March 2020. References: 1. Palexia SR Summary of Product Characteristics. 2. Baron R, et al. Tolerability, Safety, and Quality of Life with Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR in Patients with Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-label, Phase 3b/4 Trial. Pain Practice. 2016;16(5):600-619. M-PLX-IE-11-20-0013 – November 2020
Author: Priscilla Lynch
CHRONIC PAIN IRELAND LAUNCHES NEW INFORMATION LEAFLET
Chronic Pain Ireland (CPI) has launched a new information leaflet, which will provide valuable information for patients with chronic pain attending healthcare services including general practice.
CPI was founded in 1992, and provides information and support to those living with chronic pain, their families and the general public. In addition CPI campaigns for greater education and awareness of chronic pain among healthcare professionals and the general public.
During the pandemic calls to CPI’s support line grew by 300 per cent. This was largely attributed to the Covid-19 pandemic lockdowns, impacting on patients as procedures and treatments fell to 26 per cent of pre-Covid levels, meaning many people suffering from chronic pain did not have access to the services they required. Many found it increasingly difficult to manage and cope with their pain.
Chronic pain, unlike acute pain, is pain which persists beyond the normal time of healing and this is generally accepted as pain that lasts longer than three months. Over a third, 35.5 per cent, of adults in Ireland suffer with chronic pain, according to a study conducted by researchers from the School of Psychology and Centre of Pain Research, NUIG Galway. This equates to two-in-five people suffering from chronic pain across the country.
The critical need for support and information for patients is evident with many remaining unaware of the support services provided by CPI. The distribution of leaflets into GP
surgeries, clinics and elsewhere will help raise awareness of the supports and services of CPI.
This new information leaflet was produced with the financial support from Accord Healthcare Ireland. Speaking on the partnership Martina Phelan, Chairperson of CPI said: “CPI are delighted with the support from Accord Healthcare Ireland.
CPI notes that it is important that the patient is prepared and able to give their healthcare professional as much information as possible during their visit. If they are anxious that they might forget something, they should write it down and bring it with them and they can also bring someone in with them if needed. It will be helpful if they can inform their GP/GPN of the following:
When pain began;
Was the onset of pain gradual, sudden, result of event/trauma, accident;
Description of their pain;
Region(s) of their body where they are experiencing pain;
Does it radiate (eg, starts and spreads to another location in their body);
Describe how severe the pain can be on a daily, weekly basis, does it vary;
When they are most affected (is it worse in the morning/night);
How often the pain occurs, is it constant, frequent, does it come and go;
This support enables us to fulfil our mission of creating greater awareness of chronic pain and to provide relevant information and support for those living with the condition, for their families and friends."
If you would like to avail of leaflets for display in surgery/clinic contact firstname.lastname@example.org.
Referral to healthcare services with pain
If people think that they may have chronic pain, it is important that they seek the appropriate help and the first step is speaking to their GP/GPN.
How intense is their pain (how would they rate it one-to-10 with 10 being worst);
If pain is affecting their ability to work, socialise or is it affecting their private/family life;
If pain is causing sleeplessness, poor concentration or low mood. The GP/GPN may also ask the patient to use a pain diary which involves recording their level of pain (on a pain scale) several times a day over the period of a week. A useful online tool can be found at www.changepain.com/en/pain-toolkit.
Feature Chronic Pain NOVEMBER-DECEMBER 2021 37
Over a third, 35.5 per cent of adults in Ireland suffer with chronic pain, according to a study conducted by researchers from the School of Psychology and Centre of Pain Research
The patient will be asked to note activities or other things that seem to increase pain, and note when taking any medication the effect it has on their pain. This can be very helpful in establishing whether there is any particular pattern to the pain, or any triggers that could be avoided.
The GP/GPN may also conduct a physical examination (which will vary depending on site and type of pain) to look for possible causes of pain and to rule out certain conditions. Once the patient’s pain has been assessed further tests may be conducted to try and determine the underlying cause of pain.
By the patient describing symptoms clearly and fully and the impact these have on their life, the GP/GPN will be better positioned to
make the correct diagnosis, begin treatment and/or refer to specialist services.
CPI has for many years been running workshops on self-management techniques. “The workshops are undoubtedly the most important aspect of our work. They afford people the opportunity to learn how to regain control over their lives thereby improving their health and wellbeing.”
The workshops have a maximum of 15 participants in an informal setting. Selfmanagement techniques are key in assisting people to cope more effectively with their condition. Details of pain self-management workshops can be found on CPI’s website, www.chronicpain.ie.
SUPPORT AND SERVICES
PROVIDED BY CHRONIC PAIN IRELAND
Support phone line
Public awareness meetings
Network of peer support groups
Partnerships with universities on research and studies
For more information go to www.chronicpain.ie
38 NOVEMBER-DECEMBER 2021
PALEXIA® SR was associated with significant improvements in quality of life and function as measured by the Short Form-12 (SF-12) health survey and the EuroQol-5 Dimension (EQ-5D) health status questionnaire in patients with severe chronic low back pain with a neuropathic component2
PALEXIA SR® Prolonged Release Tablets Prescribing Information. Refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: 50 mg (white), 100 mg (pale yellow), 150 mg (pale pink), 200 mg (pale orange) and 250 mg (brownish red) prolonged-release tablets contain 50 mg, 100 mg, 150 mg, 200 mg and 250 mg of tapentadol (as hydrochloride) respectively. Indication: Palexia SR is indicated for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. Dosage and method of administration: Individualise according to severity of pain, the previous treatment experience and the ability to monitor the patient. Swallowed whole with sufficient liquid, not divided or chewed, with or without food. The tablet shell may not be completely digested and eliminated / seen in the patient’s stool which has no clinical significance as the active substance will have already been absorbed. Initial dose 50 mg twice a day. Switching from other opioids may require higher initial doses. Titrate in increments of 50 mg twice a day every 3 days for adequate pain control. Total daily doses greater than 500 mg not recommended. Discontinuation of treatment: Taper dose gradually to prevent withdrawal symptoms. Renal/hepatic impairment: Not recommended in patients with severe cases. Caution and dose adjustments with moderate hepatic impairment. Elderly: May need dose adjustments. Children below 18 years: Not recommended. Contraindications: Hypersensitivity to ingredients, suspected or having paralytic ileus, acute intoxication with alcohol, hypnotics, centrally acting analgesics or psychotropics. Not for use when mu-opioid receptor agonists are contraindicated (e.g. significant respiratory depression, acute or severe bronchial asthma or hypercapnia).
Special warnings and precautions: Abuse and addiction potential of Palexia should be considered where there is increased risk of misuse, abuse, addiction or diversion. All patients should be carefully monitored for signs of abuse and addiction. Concomitant use with sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible. If used concomitantly, reduction of dose of one or both agents should be considered and the duration of the concomitant treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation. It is strongly recommended to inform patients and caregivers to be aware of these symptoms. At high doses or in mu-opioid receptor agonist sensitive patients, dose-related respiratory depression may occur. Caution and monitoring required with impaired respiratory function. Should not use in patients susceptible to intracranial effects of carbon dioxide retention (e.g. increased intracranial pressure, impaired consciousness or coma). Use with caution with head injury, brain tumors, moderate hepatic impairment, biliary tract disease including acute pancreatitis. Not recommended if history of or at risk of seizures. May increase the seizure risk in patients taking medicinal products that lower the seizure threshold. Not recommended in severe renal or hepatic impairment. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Care should be taken when combining with mixed mu-opioid agonists/antagonists (e.g. pentazocine, nalbuphine) or partial mu-opioid agonists (e.g. buprenorphine). Should not use with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Interactions: The concomitant use with sedating medicinal products such as benzodiazepines or other respiratory or CNS depressants (other opioids, antitussives or substitution treatments, barbiturates, antipsychotics, H1-antihistamines, alcohol) increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. When combined therapy with a respiratory or CNS depressant is contemplated, the reduction of dose of one or both agents should be considered and the duration of the concomitant use should be limited. Can induce convulsions and increase the potential for selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other medicinal products that lower the seizure threshold to cause convulsions. There have been reports of serotonin syndrome in a temporal connection with the therapeutic use of tapentadol in combination with serotoninergic medicinal products (e.g. SSIRs, SNRIs and tricyclic antidepressants). Use with strong inhibitors of uridine diphosphate transferase isoenzymes (involved in glucuronidation) may increase systemic exposure of Palexia SR. Caution if concomitant administration of strong enzyme inducing drugs (e.g. rifampicin, phenobarbital, St John’s Wort) starts or stops as this may lead to decreased efficacy or risk for adverse events, respectively. Avoid use in patients who have taken monoamine oxidase inhibitors (MAOIs) within the last 14 days, due to cardiovascular events. Pregnancy and lactation: Use in pregnancy only if the potential benefit justifies the potential risk to the foetus. Not recommended during and immediately before labour and delivery. Do not use during breast feeding. Driving and using machines: May have major effect on ability to drive and use machines, especially at the beginning or change in dosage, in connection with alcohol or tranquilisers. Undesirable effects: Very common (≥1/10): dizziness, somnolence, headache, nausea, constipation. Common (≥1/100, <1/10): decreased appetite, anxiety, depressed mood, sleep disorder, nervousness, restlessness, disturbance in attention, tremor, involuntary muscle contractions, flushing, dyspnoea, vomiting, diarrhoea, dyspepsia, pruritus, hyperhidrosis, rash, asthenia, fatigue, feeling of body temperature change, mucosal dryness, oedema. Other important undesirable effects observed in clinical trials and/or postmarketing: drug hypersensitivity, depressed level of consciousness, mental impairment, syncope (uncommon ≥1/1000, <1/100), impaired gastric emptying, respiratory depression, convulsion, angioedema, anaphylaxis and anaphylactic shock, drug dependence (rare ≥1/10,000, <1/1000), delirium (unknown). No evidence of increased risk of suicidal ideation or suicide with Palexia SR. Additional information is available on request. Overdose: Seek specialist treatment (see SmPC). Legal
classification: POM, CD (Schedule II). Marketing Authorisation numbers and pack sizes: 50 mg: PA 2242/12/4, 28 and 56 packs; 100 mg: PA 2242/12/5, 56 pack; 150 mg: PA 2242/12/6, 56 pack; 200 mg: PA 2242/12/7, 56 pack and 250 mg: PA 2242/12/8, 56 pack. Marketing Authorisation Holder: Grünenthal Pharma Ltd, 4045 Kingswood Road, Citywest Business
Ireland. M-PLX-IE-03-20-0004. Date of Preparation: March 2020. References: 1. Palexia SR Summary of Product Characteristics. 2. Baron R, et al. Tolerability, Safety, and Quality of Life with Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR in Patients with Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-label, Phase 3b/4 Trial. Pain Practice. 2016;16(5):600-619. M-PLX-IE-11-20-0013 – November 2020
Author: Gillian O’Brien, Dermatology Advanced Nurse Practitioner
IMPROVING CARE OF LOWER LIMB WOUNDS IN GENERAL PRACTICE
Lower limb ulcers are a common presentation in general practice. They are defined as a defect in the dermis located on the lower limb (HSE National Wound Management Guidelines 2018). Many of these patients present with symptoms such as leaking legs, advanced oedema, ulceration pain and malodour. It is estimated that the population of over-65s in Ireland will triple over the next few decades, which will likely increase the prevalence and incidence of wounds and have a major impact on healthcare finances. The cost associated with management in Ireland is poorly appreciated; however Gillespie et al (2016) estimated costs of €788.5 million per annum were spent on wound care in the Irish healthcare service. Guest et al (2015) found that the management of wounds and associated co-morbidities costs the NHS in the UK £5.3 billion per annum and estimated that 1.5 per cent of the adult population in the UK is affected by active leg and foot ulceration. Within the study Guest et al (2015) reported significant variation in care provision and the author suggests that similar variations in care exist in the Irish healthcare service. The UK has implemented a national wound care strategy to address these anomalies with a specific strategy for the management of lower limb ulcers (2020).
Whilst we are uncertain of the true extent of lower limb ulcers in the Irish healthcare setting, the majority
of these wounds are caused by chronic venous insufficiency. Arterial disease is prevalent in 15-to-20 per cent of presentations and other diseases, such as dermatological, immunological, skin tumours, and trauma, account for the remainder (HSE 2018). Leg ulcers can be time consuming and difficult to manage in general practice. This is further compounded by varied or poor access to specialised services and the
patients who present with lower limb ulcerations. In general practice settings this can either be the GP or the general practice nurse (GPN). The HSE National Wound Management Guidelines (2018) recommends that a clinician should possess post basic education and training in the assessment and management of wounds in order to comprehensively assess and put in
advanced wound care products required to safely and effectively manage these wounds. The purpose of this article is to inform staff working in general practice in Ireland of the current guidelines on the assessment and management of lower limb wound presentations. The information provided is based on the HSE National Wound Management Guidelines (2018) and the clinical practice recommendations therein.
Basic assessment of lower limb wounds
One of the key questions in the guidelines asks who should assess
place an evidence-based treatment plan to manage these patients.
When undertaking a lower limb assessment the following factors should be assessed:
Medical and surgical history including assessment of comorbidities and medications.
Previous or current DVT.
History of phlebitis.
Surgery or trauma of the affected leg.
Prolonged standing or sitting.
Physical examination including detailed examination of both lower limbs, the wound itself, and
Feature Wound Care 40 NOVEMBER-DECEMBER 2021
An overview of the current guidelines on the assessment and management of lower limb wound presentations in general practice
Whilst we are uncertain of the true extent of lower limb ulcers in the Irish healthcare setting, the majority of these wounds are caused by chronic venous insufficiency
the surrounding skin.
Leg wound history to include – duration, size.
Previous wounds and treatments used.
Vascular assessment (see Table 1 for indicators of aetiology), ABPI, pulse palpation.
Previous venous disease, presence of varicose veins or chronic skin changes.
Mobility and functional status.
Biochemical investigations where appropriate.
Ankle brachial pressure index (ABPI) and its interpretation
The ABPI is an investigation that compares ankle systolic pressure to central systolic pressure and the calculated index or result signifies the absence or presence of arterial disease, which will directly impact how the wound is managed. It is important to note that most general practices do not undertake this assessment, however, many public health centres have trained nurses
who can provide this assessment. The ABPI result must be interpreted (See Table 2) in conjunction with pulse palpation and overall clinical assessment. If pulses are palpable and there is no history of diabetes or peripheral arterial disease, lower limb wounds should be placed in compression therapy (HSE National Wound Management Guidelines 2018). Application of compression therapy must be undertaken by a competent practitioner.
General lower limb wound care – back to basics
The importance of making a positive impact from the first consultation with a patient presenting with a wound cannot be underestimated. Engaging in a positive relationship is underpinned by providing the patient with the assurance that we as clinicians know what we are doing or can refer on to the appropriate specialist for further assessment. If a patient needs to
be referred on for specialist opinion it is important to do so at the first contact and a plan put in place that will address the main issue that the patient is presenting with in the interim; for example, malodour, exudate management, or pain. Once a treatment plan is adhered to, ongoing evaluation is required to determine whether this has made a positive impact on the wound and the patient.
Atrophie blanche Muscle
Altered shape of the lower limb
Evidence of healed ulcers
Much has been written pertaining to variation in wound assessment and treatment in clinical practice (Guest et al, 2015). An expert group was formed and the World Union of Wound Healing Societies (WUWHS) published a consensus document (Strategies to reduce practice variation in wound assessment and management: The TIME Clinical Decision Support Tool 2020). The tool is widely used in wound care assessment and management. It was first developed by Schultz et al (2003) and has been updated to address changes in wound care practice (Moore et al 2019). The premises of the tool are to provide a structured approach to wound assessment, including holistic assessment of the patient and their wound. The tool was updated to assist clinicians who do not have specialist training in wound care management to assess patients and their wounds in a manner that provides a structured approach with clear rationale for treatment decisions. The TIME Tool assists in aiding the clinician to assess the tissue type in the wound bed, presence of inflammation or infection, moisture balance and the status of the wound edge. It gives a pictorial guide to descriptors and dressing types suitable to each descriptor and provides a structured wound management approach that enables consistency, which then contributes to better patient outcomes.
Wound hygiene has become an important concept in wound care (International Consensus Document Wound Hygiene, 2020). The concept was devised to address the growing burden of hard-to-heal wounds,
Feature Wound Care NOVEMBER-DECEMBER 2021 41
deposit Pale or bluish skin discolouration
and torturous veins
Table 1: Lower limb wound assessment
The following should be considered by clinicians when assessing lower limb wounds to differentiate between venous and arterial aetiology
Ankle brachial pressure index
ABPI > 1.00-1.3
ABPI = 0.8-1.0 Mild peripheral disease
ABPI ≤ 0.8-0.6 Significant arterial disease
ABPI < 0.5
ABPI > 1.3 Refer to vascular/ diabetic specialist
particularly in relation to biofilm and wound infection identification and management. The consensus document promotes the application of a wound cleansing strategy to improve the management of hard-toheal wounds through disruption of biofilm present in the wound bed, and prevention of its reformation. It consists of two stages with overlapping strategies:
Cleansing the wound and peri-wound skin.
Debridement as necessary, which may be more aggressive initially but reverts to maintenance debridement when clinically indicated.
Refashioning the wound edge.
Dressing the wound.
The document proposes that all hard-toheal wounds contain biofilm (International Consensus Document Wound Hygiene, 2020) and in the absence of good wound hygiene, progression to failure to heal becomes a real threat despite the use of dressings. Whilst it may seem strange that a strategy needs to be employed to promote wound cleansing, let us as practitioners reflect back on our practice and last dressing change. When cleansing the wound did you simply gently swipe moistened gauze over the wound bed itself and proceed to dressing or did you cleanse the wound bed aggressively enough to remove devitalised tissue, debris, and biofilm? Moreover,
Apply compression with caution
Use modified compression with caution – refer to specialist
Do not compress –refer urgently to vascular specialist
did you cleanse the peri-wound tissue to remove skin scales or callus or built-up dressing debris? This is perhaps a major failing in wound care practice today and failure to do so encourages growth of biofilm and transitioning of a wound to the hard-to-heal stage.
Debridement is also a vital part of wound hygiene and whilst the term itself may lend one to think of a scalpel, there are many forms of wound debridement that result in removal of necrotic tissue, slough, debris and wound biofilm (HSE National Wound Management Guidelines, 2018).
Wound edges can provide a sanctuary for biofilm to form and refashioning the edges in the aforementioned strategy alludes to simply removing necrotic or crusty material from the overhanging wound edges. It is also important to ensure the skin edges are aligned to facilitate the advancement of epithelial cells and in turn promote wound contraction or closure (International Consensus Document Wound Hygiene, 2020).
Finally, in order to address the remaining biofilm or prevent overt formation or delay growth of biofilm it is important to use appropriate dressings (HSE National Wound Management Guidelines 2018). These dressings may contain antimicrobial or anti-biofilm properties (Schultz et al 2017). Further consideration must be given to patient choice and engagement and to
availability. Dressings available can be prescribed for patients and dispensed in their local pharmacy. The pharmacy will have a list of what products are available on the medical card scheme. Referral to the local primary care centre with access to a dressing clinic can also be arranged, particularly for patients with wounds that are likely to become hard to heal.
As previously stated, the number of people living with complex conditions is increasing, which directly impacts on the increasing number of hard-to-heal wounds with both financial and social implications in a health service that has finite resources. Tackling these wounds in the early stages of onset may circumvent later complications and promote better patient outcomes.
1. Gillespie P, Carter L, McIntosh C, and Gethin G, (2016). Estimating the healthcare costs of wound care in Ireland. Unpublished poster presentation at EWMA 2016, May 10-13 2016, Bremen, Germany
2. HSE National Wound Management Guidelines 2018. Available at: www.hse.ie/eng/ about/who/onmsd
3. Moore Z, Dowsett C, Smith G, et al (2019). TIME CDST: An updated tool to address the current challenges in wound care. Journal of Wound Care 28(3): 154-61
4. Murphy C, Atkin L, Swanson T, et al (2020). International consensus document. Defying hard to heal wounds with an early antibiofilm intervention strategy: Wound hygiene. Journal of Wound Care 29(Suppl 3b): S1-28
5. National Wound Care Strategy Programme (2020). Recommendations for lower limb ulcers
6. Schultz GS, Bjarnsholt T, James GA, et al (2017). Consensus guidelines for the identification and treatment of biofilms in chronic non-healing wounds. Wound Repair and Regeneration 25: 744-757
7. Schultz GS, Sibbald RG, Falanga V, et al (2003). Wound bed preparation: a systematic approach to wound management. Wound Repair and Regeneration 11:1-28
8. World Union of Wound Healing Societies (2020). Strategies to reduce practice variation in wound assessment and management: The TIME Clinical Decision Support Tool. London: Wounds International. Available at: www. woundsinternational.com
Feature Wound Care 42 NOVEMBER-DECEMBER 2021
Table 2 : ABPI interpretation (Adapted from Andriessen et al, 2017)
ECZEMA, DERMATITIS, SENSITIVE SKIN & BABY CARE.
DRY, VERY DRY, ROUGH AND CRACKED SKIN.*
OILY, BLEMISHED AND ACNE PRONE SKIN.
HYPERPIGMENTATION AND MELASMA.
Pigment Solution ProgramTM www.relife.ie
Distributed by: A.Menarini Pharmaceuticals Ireland Ltd, Castlecourt,Monkstown Farm, Monkstown, Glenageary, Co. Dublin.
MY SKIN SAYS HOW I FEEL. Date of item Sept 2021 IE21055 IR-REL-186-2021 Not to be used on broken skin @RELIFEIreland @relife_ireland @RELIFEIrl
Author: Dr Tom Barrett , MB Dch MRCOG, Senior Medical Officer, HSE National Immunisation Office
2021/22 FLU VACCINE SEASON IN IRELAND – CHILD AND ADULT VACCINES
This year the seasonal influenza vaccination programme includes all children aged two-to-17 years. The aim of the programme is to prevent influenza and its complications in children and to reduce the spread of influenza to others in the community. The influenza vaccine offered to children is live attenuated influenza vaccine (LAIV), which is given intranasally, and is available free of charge from GP practices and community pharmacists.
Influenza is a very common acute viral respiratory illness which affects all age groups. The virus is seen all year round, but peaks every winter. The degree of influenza infection is unpredictable; however, each year in Ireland influenza is responsible for between 200 and 500 deaths and as many as a 1,000 during a particularly severe season (2008/2009).1
Since the start of the Covid-19 pandemic, influenza activity has remained at low levels. Reporting worldwide has also been low with only 0.168-0.65 per cent tested specimens positive for influenza virus reported by the World Health Organisation (WHO) and CDC surveillance.3,4 However, WHO has recommended that this data be interpreted with caution. Globally influenza virus detections have increased in recent weeks, albeit at low levels.2 The very low levels of flu in the last flu season may mean decreased immunity and potentially increased susceptibility or at least unknown susceptibility for
at-risk groups. With the relaxation of Covid-19 measures a rebounding in flu and Covid-19 cases may occur, which may place significant strain on the health and care system. Therefore, it is vitally important this season more than ever that those recommended the flu vaccine get vaccinated early. The flu vaccine is the best protection we have against flu.
This season three types of flu vaccines are being supplied by the HSE. All are quadrivalent flu vaccines (QIV); two non-live and one live vaccine.
The 2021/22 HSE seasonal flu vaccination programme will offer the following three vaccines:
Fluad Tetra manufactured by Seqirus
This adjuvanted QIV is a non-live influenza vaccine.
This is given intramuscularly.
It is only licensed for use in people aged 65 years and over, and is the recommended vaccine for this age group.
QIV (split virion, inactivated) manufactured by Sanofi Pasteur
This is a non-live QIV.
This is given intramuscularly.
It is licensed for use in those aged six months and over.
It is the recommend vaccine for:
Children aged six-to-23 months who are medically at-risk.
Adults 18-to-64 years who are in at-risk groups, pregnant women, healthcare workers, household contacts/carers of people with an underlying chronic health condition or Down syndrome.
Fluenz Tetra, manufactured by AstraZeneca
This is a LAIV.
This is given intranasally.
It is only licensed for use in children aged two-to-17 years. It is the recommended vaccine for children aged two-to-17 y ears including those with long-term conditions.
The focus of this article is on the LAIV vaccine for children. A summary of all three vaccines is available at the end of this article.
For the 2021/22 influenza season, the Department of Health, on National Immunisation Advisory Committee (NIAC) advice, once again includes children and young persons in the influenza vaccination programme, providing funding to the HSE to offer LAIV free to all children aged two-to-17 years inclusive.6
The aim of the extension of the influenza programme to children is to reduce:
Morbidity and mortality from influenza in children.
The number of people with influenza.
The number of hospital admissions.
Transmission of influenza to the elderly and persons in at-risk groups.
Transmission to healthcare workers in families with children.
Absenteeism of children from school and their parents from work.
Children outside of the two-to-17 years
Feature Vaccines 44 NOVEMBER-DECEMBER 2021
Flu spreads easily and infects both children and adults, but children are more likely than adults to get severe complications of flu
age group (aged six months to <two years) who have an underlying chronic medical condition should receive the QIV as in previous years.
Influenza in children
Children are among the most susceptible to influenza infection. It is estimated that 20-30 per cent of children develop influenza during each influenza season compared to 5-to-10 per cent of adults.7 Children, because they have limited pre-existing immunity, are primary vectors of influenza transmission in the community and shed the virus at higher viral titres. Children transmit the influenza virus for a longer period than adults; they can transmit the influenza virus for 10 or more days, compared to six days in adults, therefore increasing spread of the disease.
Approximately 10 per cent of children under 15 years attend their GP with influenza in an average influenza season. Influenza is an important cause of pneumonia, bronchitis, otitis media, croup and bronchiolitis in children. Incidence rates are highest in the younger age groups leading to high rates of excess outpatient visits, hospital admissions and antibiotic prescriptions.
In Ireland during the 2018/2019 influenza season, 1,245 children were hospitalised with influenza. Children aged under five years had the second highest hospitalisation rates for influenza after those aged 65 years and older.8
Between the 2009/2010 and 2018/2019 influenza seasons:
4,750 children aged 0-14 have required hospitalisation as a result of influenza,
183 required critical care,
41 children died.1
Influenza vaccination for children in other countries
Nine European countries, the US, Canada and Australia recommend influenza vaccine
for children. The UK gives LAIV to children, while Finland, the US and Canada give LAIV or QIV to children.9,10,11
In the US, LAIV has been recommended since 2004. LAIV has been authorised for use in Canada since 2011.
In 2013, the UK introduced trivalent LAIV for two- and three-year-olds with pilot programmes for primary school children. Quadrivalent LAIV was introduced during the 2014/2015 influenza season. The programme has extended year on year to include all children from two up to 15 years this year.12
In Finland, annual inactivated influenza vaccine was recommended for children aged sixto-35 months in 2007, and LAIV was introduced in 2015 to enhance vaccine uptake. Since then, all two- and three-year old children have been eligible for vaccination with either LAIV or inactivated influenza vaccine. The programme has recently been extended to include all children up to six years of age.
In Ireland, for the 2021/22 influenza season, vaccination of children will help minimise the burden of influenza, by preventing influenza in children and the transmission of influenza from children to those in at-risk groups. This should reduce morbidity from influenza as well as influenza-related hospital admissions in all the at-risk groups.
This is especially important this influenza season, to minimise the impact on our health services from dual outbreaks of influenza and Covid-19.
LAIV for 2021/22 influenza season
This flu season in Ireland the LAIV Fluenz Tetra (manufactured by Astra Zeneca) is being offered to all children aged two-to-17 years. It is administered intranasally. The vaccine contains the following four vaccine virus strains as
recommended by WHO:
An A/Victoria/2570/2019 (H1N1)pdm09like virus;
An A/Cambodia/e0826360/2020 (H3N2)like virus;
A B/Washington/02/2019 (B/Victoria lineage)-like virus; and
A B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.
LAIV may contain residues of egg proteins (ovalbumin), maximum amount of less than 0.024 micrograms and gentamicin. LAIV does not contain thiomersal or latex.
Since LAIV contains live attenuated viruses, it mimics natural infection with wild-type viruses, with the development of both mucosal and systemic immunity. Local mucosal antibodies protect the upper respiratory tract and may be more important for protection than serum antibodies, inducing more durable immune memory and so providing better longterm protection to children than inactivated influenza vaccines such as QIV.
In some studies, LAIV has been shown to be more effective in children compared with inactivated influenza vaccines.
In addition, LAIV may offer some protection against strains not contained in the vaccine, as well as virus strains that have undergone antigenic drift.
A recent meta-analysis of LAIV suggested an efficacy against confirmed disease of 83 per cent (95 per cent CI 69-to-91 per cent).13
The UK pilot primary school programme introducing LAIV was evaluated in 2014/2015 and showed a:
94 per cent reduction in primary schoolage children GP influenza-like consultations;
74 per cent reduction in primary school-age emergency department attendances with respiratory complaints;
93 per cent reduction in primary school-age confirmed influenza hospitalisations; and
59 per cent reduction in adult GP influenzalike illness consultations.14
LAIV dose and administration
Each LAIV vaccine comes as a prefilled nasal
Feature Vaccines NOVEMBER-DECEMBER 2021 45
GROUP AGE PREVIOUS VACCINATION DOSE Medically at risk Two-to-eight years Have never had any influenza vaccine Two doses four weeks apart Have had any influenza vaccine before One dose Nine-to-17 years Not relevant One dose Healthy Not relevant One dose
Table 1: Doses of LAIV required for children aged two-to-17 years
NAME OF VACCINE FLUENZ TETRA LAIV
Type of vaccine Reassortant influenza virus (live attenuated)
Active immunisation against four influenza virus strains (two A subtypes and two B types)
Licenced for Aged two-to-17 years
Two-to-17 year olds
QUADRIVALENT INFLUENZA VACCINE VIRUS (SPLIT VIRON, INACTIVATED) QIV
Influenza vaccine – surface antigen inactivated
Active immunisation against four influenza virus strains (two A subtypes and two B types)
Aged six months and over
Those aged six-to-23 months medically at-risk Those aged 18-to-64 years who are in at-risk group, pregnant women, healthcare workers, household contacts/carers of people with underlying chronic health condition or Down syndrome
Also children aged two-to-17 years in risk groups ONLY if contraindicated to receive LAIV
Dose 0.2ml (administered as 0.1ml per nostril) 0.5mls intramuscularly
Number of doses required One Two for at-risk groups specific age groups**
Interval For those requiring two doses: Four week interval between doses
Supplied by National Cold Chain Services (NCCS)
Box of 10 nasal applicators
Store in a refrigerator (+2°C to + 8°C).
Do not freeze Discard if the vaccine has been frozen
Keep the nasal applicator in the outer carton in order to protect from light
Appearance Nasal spray, suspension
Colourless to pale yellow
Small white particles may be visible
Two for at-risk groups or specific age groups*
For those requiring two doses: Four week interval between doses
Box of 10 prefilled syringes with needles
Store in a refrigerator (+2°C to + 8°C)
Do not freeze Discard if the vaccine has been frozen Keep the pre-filled syringe in the outer carton in order to protect from light
Reach room temperature before use Gently shake before use
After shaking gently, is a colourless opalescent liquid
Visually inspect - should not be used if foreign particles in the suspension
FLUAD TETRA a QIV
Influenza vaccine – surface antigen inactivated and adjuvanted Adjuvant MF59C1
Active immunisation against four influenza virus strains (two A subtypes and two B types)
Aged from 65 years and over only
65 years and older
*QIV - Two doses four weeks apart for children aged six months and less than nine years receiving the flu vaccine for the first time.
Two doses four weeks apart if post haematopoietic stem cell transplant or post solid organ transplant and receiving the vaccine post-transplant. Cancer patients who receive the vaccine while on chemotherapy and who complete their chemotherapy in the same season require two doses with the second dose at least four weeks after the completion of chemotherapy and at
least four weeks after the first dose (regardless of influenza vaccine in the last season).
**LAIV - Two doses four weeks apart for children aged two-to-eight years who are clinically at-risk and first time receiving any influenza vaccine. See the following for more information:
Not applicable (one dose only per flu season)
Box of 10 prefilled syringes with needles
Store in a refrigerator (+2 °C to +8 °C). Do not freeze Discard if the vaccine has been frozen
Keep the pre-filled syringe in the outer carton in order to protect from light
Gently shake before use After shaking the normal appearance is a milky-white suspension
*** Those with confirmed egg anaphylaxis or egg allergy can be given all of the above influenza vaccines in a primary care or school setting with the exception of those who have required admission to ICU for a previous severe anaphylaxis to egg. Those requiring inactivated influenza vaccine who have had a previous ICU admission for a severe anaphylaxis to egg should be referred for specialist assessment with regard to vaccine administration in hospital.
Feature Vaccines 46 NOVEMBER-DECEMBER 2021
Shelf life Until expiry date Until expiry date Until expiry date Ovalbumin content ≤0.024 micrograms per dose** ≤0.06 micrograms per dose*** ≤1.0 micrograms per dose***
applicator and each applicator contains 0.2ml nasal suspension. The vaccine is administered by the nasal route. One dose of LAIV is 0.2ml administered in divided doses into each nostril, ie, 0.1ml in each nostril.
If the child’s nose drips after vaccination, the vaccine dose does not need to be repeated. The vaccine is immediately absorbed after administration. Parents and guardians should be reassured the vaccine is still effective if this occurs. For the same reason the vaccine does not need to be repeated if the child sneezes or blows their nose after vaccination.
LAIV can be given together with or at any time before or after the administration of any other live attenuated (eg, MMR) or inactivated vaccines.
NIAC has recommended healthy children require one dose of LAIV. However, children in a medically at-risk group aged two-to-eight years inclusive are recommended two doses of LAIV if they have never had any influenza vaccine before (Table 1). The two doses should be given four weeks apart.
Contraindications to LAIV
Anaphylaxis following a previous dose of influenza vaccine or any of its constituents (other than ovalbumin – see precautions).
Acute exacerbation of symptoms increased wheezing and/or additional bronchodilator treatment in the last 72 hours.
Seek specialist advice if on regular oral steroids or previous ICU admission.
Significant immunosuppression due to disease or treatment.
Children who live with severely immunosuppressed persons (ie, post haematopoietic stem cell transplant).
Concomitant use of aspirin/salicylates.
Influenza antiviral medication within the previous 48 hours.
Those with severe neutropaenia (absolute neutrophil count <0.5 × 109/L) to avoid an acute vaccine related febrile episode. This does not apply to those with primary autoimmune neutropaenia who can receive influenza vaccine unless contraindicated.
Those on combination checkpoint inhibitors (eg, ipilimumab plus nivolumab) because of a potential association with
immune-related adverse reactions.
Those post cochlear implant until the risk of a cerebrospinal fluid (CSF) leak has resolved –consult with the relevant specialist.
Those with a cranial CSF leak. The following are NOT contraindications
Asymptomatic HIV infection.
● Topical or inhaled corticosteroids;
● Low dose systemic corticosteroids;
● Replacement therapy corticosteroids (eg, adrenal insufficiency).
Defer until recovered from an acute severe febrile illness.
As LAIV has an ovalbumin content ≤0.024mcg per dose, it can be given to children with confirmed egg anaphylaxis or egg allergy in a primary care setting except children who have required ICU admission to hospital for a previous severe anaphylaxis to egg who should be given LAIV in hospital.
Aspirin/salicylates should not be used for four weeks after vaccination unless medically indicated, as Reye’s syndrome has been reported following the use of salicylates during wild-type influenza infection.
Avoid influenza antiviral medication for two weeks post vaccination.
Children aged two-to-17 years for whom LAIV is contraindicated should be offered QIV (provided there are no contraindications to QIV).
Gelatin in LAIV
LAIV, like some other vaccines, contains gelatin derived from pork which is highly purified and hydrolysed and acts as a stabiliser. Gelatin in vaccines may cause concern to some members of the Muslim community. The National Immunisation Office has received a statement from the Chair of the Irish Council of Imams stating that vaccines containing gelatin are permitted. See www.immunisation.ie for further details.
Very common or common (more than one-in-10 to one-in-100)
Nasal congestion/rhinorrhoea, decreased
appetite, malaise, fever, headache, and myalgia. In post-marketing surveillance, overall rates of fever were similar to the rates following other childhood vaccines and were generally mild and of short duration.
Very rare (less than one-in-10,000)
Immediate allergic reactions - very rare cases of Guillain-Barré syndrome (GBS) have been observed in the post-marketing setting following influenza vaccination. The risk of GBS following influenza infection is significantly greater than that following influenza vaccination.
Can LAIV vaccine cause virus shedding?
The attenuated vaccine viruses in LAIV are cold adapted. They can replicate at the lower temperatures found in the nose, but cannot replicate efficiently at body temperature elsewhere in the body.
Vaccinated children can shed the attenuated virus for a few days after vaccination but the virus that is shed cannot cause infection. Peak incidence of shedding occurred two-to-three days post-vaccination in Fluenz clinical studies.10
Each chapter of NIAC immunisation guidelines advise that: “In some circumstances, advice in these guidelines may differ from that in the Summary of Product Characteristics (SmPC). When this occurs, the recommendations in these guidelines, which are based on current expert advice from NIAC, should be followed.”
NIAC advice, based on the current expert guidance, supersedes the advice in the licensed SmPC.
NIAC guidelines advise that: “Children who live with severely immunosuppressed persons requiring isolation (eg, post haematopoietic stem cell transplant) should not receive the LAIV nasal vaccine.” This is a precautionary measure.
Therefore NIAC advice is that LAIV vaccine can be given to any child, for whom the LAIV vaccine is not contraindicated, who is living with any other person unless the adult is in isolation, eg, following a HSCT.
Children who are vaccinated with LAIV can ‘shed’ very small amounts of the weakened virus that is in the vaccine for a
NOVEMBER-DECEMBER 2021 47
few days after vaccination. But the weakened viruses do not cause flu infection in others, or in the person vaccinated.
NIAC makes no recommendation that children avoid other vulnerable people, including a parent who is on chemotherapy or immunotherapy.
NIAC: “Millions of doses of LAIV have been administered in the US for over 10 years and serious illness amongst immunocompromised contacts inadvertently exposed to vaccine virus has never been observed.”
Increasing uptake of influenza vaccine
Research, both in Ireland and elsewhere, has consistently shown that doctors and other healthcare professionals are the most trusted sources of information on vaccination. A recommendation by a trusted healthcare professional has been shown to increase vaccine uptake.
Reminders to patients about vaccination have also been shown to increase vaccine uptake, be that by text, phone, email or letter.
1. Royal College of Physicians of Ireland. Immunisation Guidelines for Ireland, Influenza Chapter 11. www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter11.pdf
2. Health Protection Surveillance Centre. Influenza surveillance in Ireland – Weekly report influenza week 40 2021 (4th - 10th October 2021) www.hpsc. ie/az/respiratory/influenza/seasonalinfluenza/surveillance/influenzasurveillancereports/20212022seas on/Influenza_Surveillance_Report_Week%2040%20 2021_Finalv1.0_15102021.pdf
3. Adlhoch C, Mook P, Lamb F, Ferland L, Melidou A, Amato-Gauci AJ, Pebody R, the European Influenza Surveillance Network. Very little influenza in the WHO European Region during the 2020/21 season, weeks 40 2020 to 8 2021. Euro Surveill. 2021;26(11):pii=2100221. doi: 10.2807/1560-7917. ES.2021.26.11.2100221
4. Centers for Disease Control. US influenza Surveillance. www.cdc.gov/flu/weekly/index.htm
5. HSE. Seasonal Influenza Programme 2020/2021. www.hse.ie/eng/health/immunisation/hcpinfo/fluinfo/
6. HSE. Seasonal Influenza Vaccination Programme 2021/2022. www.hse.ie/eng/health/immunisation/ hcpinfo/fluinfo/
This influenza season, your recommendation to get the influenza vaccine to parents of children and other at-risk groups will be even more important, in order to maximise uptake.
The LAIV vaccine for children will help minimise the burden of influenza by protecting children from influenza and preventing transmission of influenza from children to those in at-risk groups.
This year there are three training modules available on flu vaccination for this year’s flu season; two on the LAIV and the other on QIV/ aQIV. These are available on www.hseland.ie.
The www.hse.ie/flu website has also been updated with materials and information on the current influenza season.
Influenza remains a major public health issue and never more so than during the Covid-19 pandemic. Influenza vaccination is the best intervention available. Continuing the influenza vaccination programme to children aged two-to-17 years aims to protect children and reduce transmission to others,
thereby reducing the burden on our health services at this crucial time. However, it is also important to continue vaccinating the other recommended groups for flu vaccine with the age-appropriate vaccine (as detailed in the reference guide at the end of the article).
The following resources on LAIV are available from the National Immunisation Office:
Frequently asked questions for healthcare professionals: www.hse.ie/eng/ health/immunisation/hcpinfo/fluinfo/flufaq/
Algorithms on flu vaccination for children for healthcare professionals: www.hse.ie/eng/health/immunisation/ pubinfo/flu-vaccination/laivalgorithm.pdf
Information materials for parents in different languages and posters: w ww.hse. ie/eng/health/immunisation/pubinfo/fluvaccination/information/
Commonly asked questions and answers on the safety of LAIV for parents: www. hse.ie/eng/health/immunisation/pubinfo/ flu-vaccination/flu-vaccine-for-children/ fluvaccineqas.html
7. Antonova EN, Rycroft CE, Ambrose CS, Heikkinen T, Principi N. Burden of paediatric influenza in Western Europe: a systematic review. BMC Public Health. 2012;12:968. 2012 Nov 12. doi:10.1186/1471-2458-12-968
8. The NHS national flu immunisation programme 2021/22. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/ file/1018779/Influenza_vaccination_information_document_for_healthcare_practitioners.pdf
9. Health Protection Surveillance Centre (HPSC). Annual epidemiological report, influenza and other seasonal respiratory viruses in Ireland, 2018/2019 (December 2019). www.hpsc.ie/a-z/respiratory/influenza/seasonalinfluenza/surveillance/influenzasurveillancereports/previousinfluenzaseasonssurveillancere ports/20182019season/Influenza%202018-2019%20 Season_Summary.pdf
10. The NHS national flu immunisation programme 2020/21. www.england.nhs.uk/wp-content/ uploads/2020/05/national-flu-immunisation-programme-2020-2021.pdf
11. Finnish Institute for health and welfare. Vaccination programme for children and adolescents [online]. Available from: https://thl.fi/en/web/vaccina-
12. Canadian immunisation guide chapter on influenza and statement on seasonal influenza vaccine for 2020–2021. www.canada.ca/en/publichealth/services/publications/vaccines-immunization/ canadian-immunization-guide-statement-seasonalinfluenza-vaccine-2020-2021.html#I1
13. Caspard H, Mallory RM, Yu J, Ambrose CS. Liveattenuated influenza vaccine effectiveness in children from 2009 to 2015-2016: A systematic review and meta-analysis. Open Forum Infect Dis. 2017 Jul 24;4(3):ofx111. doi: 10.1093/ofid/ofx111
14. Pebody RG, Green HK, Andrews N, Boddington NL, Zhao H, Yonova I, et al. Uptake and impact of vaccinating school age children against influenza during a season with circulation of drifted influenza A and B strains, England, 2014/15. Euro Surveill 2015;20(39):pii=30029. doi: 10.2807/1560-7917. ES.2015.20.39.30029
15. European Medicines Agency. Quadrivalent live attenuated influenza (LAIV), nasal, Fluenz Tetra (AstraZeneca Pharmaceuticals (Ireland) DAC) SmPC. www. ema.europa.eu/en/documents/product-information/ fluenz-tetra-epar-product-information_en.pdf
Feature Vaccines 48 NOVEMBER-DECEMBER 2021
Respiratory Syncytial Virus
Author: Theresa LowryLehnen, GPN, RNP, PhD, CNS, and Associate Lecturer at Institute of Technology Carlow
RESPIRATORY SYNCYTIAL VIRUS INFECTION: AN OVERVIEW
Respiratory syncytial virus (RSV), a member of the Paramyxoviridae family, is the leading cause of lower respiratory tract illness in infants
Respiratory syncytial virus (RSV) is a common, ubiquitous and contagious viral pathogen that infects the respiratory tract of most children by two years of age. RSV is an RNA pneumovirus of the Paramyxoviridae family, and humans are the only natural host.
RSV is primarily a childhood infection; however, it may occur at any age and can be most severe in infants under one year of age, the immunocompromised, and in people aged 65 years and older.3,7 It infects 90 per cent of children within the first two years of life and frequently reinfects older children and adults.10
RSV infection can present as a variety of clinical syndromes including upper respiratory tract infections, bronchiolitis, pneumonia, exacerbations of asthma and viral-induced wheeze.1
Worldwide, it is estimated that RSV is responsible for approximately 33 million lower respiratory tract illnesses, three million hospitalisations, and up to 199,000 childhood deaths annually. The majority of deaths are in resourcelimited countries.10 In medium- and high-resource countries, the RSV mortality rate in infants is almost nine times that of influenza.7
RSV has been shown to account for 22 per cent of all episodes of acute lower respiratory tract infection in children globally, with the greatest burden of severe disease requiring hospitalisation in infants under one year and particularly those under six months of age.2,5 For most babies and young children the infection is mild, presenting
with cold-like symptoms which usually last one-to-two weeks, but for a small percentage, RSV infection can lead to serious and sometimes life-threatening problems, such as pneumonia or bronchiolitis.4 The chance of developing severe infection is highest for premature babies, children less than 10 weeks old, children aged under two years with congenital heart or chronic lung disease, and infants and young children with a weak immune system or who are immunocompromised.3,4
Adults with weakened immune systems and those aged 65 years and older are also at increased risk of developing severe RSV disease. Approximately onein-20 older people develop RSV infection each year. Overcrowding, smoking, and passive smoking are recognised risk factors for infection.3
RSV infection has been a notifiable disease in Ireland since January 2012, and RSV activity in Ireland is monitored by the Health Protection Surveillance Centre (HPSC).3 According to the HPSC (2020), nearly all children have been infected with RSV at least once, by two years of age. Most cases are not specifically diagnosed as RSV; however, the infection causes 80 per cent of bronchiolitis and 20 per cent of pneumonia cases in young children and RSV is a significant cause of infection and outbreaks in hospitals, neonatal units, day units, and nursing homes.3 RSV infections occur in a seasonal pattern in temperate climates with epidemics from October to April.7
Outbreaks typically occur in the winter months with the highest numbers of infections usually reported in December
and January every year. The sharp winter peak varies little in timing or size from year to year, in contrast to influenza.3 In Ireland in recent weeks, there has been a significant surge in reported RSV cases and related presentations in general practice. There is only one serotype of RSV, but it is classified into two strains, A and B, with differences consisting of variation in the structure of several structural membrane proteins, most especially the attachment protein.10 One of the two major antigenic subgroups of RSV A or B, usually predominates each season.7 RSV typically spreads via hands, fomites and the airborne aerosol route. It spreads from person to person by aerosol droplets through coughing or sneezing, and is also spread through direct contact by touch. RSV can survive on surfaces and objects for 24 hours and spread can occur indirectly through contact with contaminated hands.1,4 Handwashing is the most effective infection control procedure.
Incubation period and symptoms
The incubation period for RSVinfected individuals ranges from three-to-eight days, but immunocompromised patients with severe infection may shed virus for up to four weeks. The frequent occurrence of mild or asymptomatic infection in otherwise healthy individuals makes infection control challenging.7
After inoculation into the nasopharyngeal or conjunctival
NOVEMBER-DECEMBER 2021 49
mucosa, the virus rapidly spreads into the respiratory tract, where it targets its preferred growth medium, apical ciliated epithelial cells. There it binds to cellular receptors using the RSV-G glycoprotein and uses the RSV-F fusion glycoprotein to fuse with host cell membranes and insert its nucleocapsid into the host cell to begin its intracellular replication.10
Symptoms include: Fever, rhinorrhoea, pharyngitis, nasal congestion, sneezing, and coughing, which can be croupy or barking in nature, tachypnoea, sore throat, wheeze, decreased appetite, and ear infections in children. In very young infants, irritability, decreased activity and breathing difficulties may be the only symptoms of infection.
Lower respiratory tract infections, such as pneumonia or pneumonitis, are most likely to occur during a child’s first infection with RSV and may develop in 30-to-70 per cent of those with a first infection. Typically, only between 1 and 3 per cent of infected infants require hospitalisation.7
The infectious period lasts from shortly before onset to one week post the onset of symptoms. Most children recover in eight-to-15 days. Even after recovery, however, very young infants and children with weakened immune systems can continue to spread the virus for one-to-three weeks. Immunity is incomplete and short-lived. Repeated RSV respiratory infections can occur, although these are usually mild and become less common with increasing age.3,7
Bronchiolitis is an inflammatory process in the small airways of the lungs and is the most common clinical syndrome associated with RSV infection. It typically presents in infants under one year of age, but may be diagnosed in children up to two years old, and is characterised by a short history of low-grade fever, cough, coryza, dyspnoea, and reduced feeding. The symptoms usually peak in clinical severity between day three and five of the illness. RSV bronchiolitis presents a significant clinical burden. In the UK, infection with RSV is responsible for up to 80 per cent of all cases of bronchiolitis, similar to that of 65-to-70 per cent in the US.3,8
In older children, RSV typically presents as an upper respiratory tract infection, viral pneumonia, episodic viral-induced wheeze, or an acute exacerbation of asthma. Viral pneumonia is a common illness with five million cases reported globally in children annually. A meta-analysis
of nine studies involving over 4,000 children investigating viruses identified by polymerase chain reaction (PCR), found that RSV was the causative organism in 11 per cent of communityacquired pneumonia cases.6
Diagnosis of RSV includes a thorough medical history and a physical exam. A chest x-ray may be requested and blood and urine tests may be carried out to rule out a bacterial infection or other conditions. Differential diagnosis can include asthma, bronchiolitis, influenza, croup, bronchitis and pneumonia.10 Respiratory viral testing may be used in a clinical setting to increase confidence in the diagnosis of a viral, rather than bacterial, cause for respiratory illness. RSV can be detected in nasopharyngeal aspirate, broncho-alveolar lavage, sputum, or swabs from the nose and throat by using real-time PCR, immunofluorescence, ELISA, and growth in cell culture. Reverse transcriptase-PCR (RT-PCR) assays are currently the gold standard in RSV testing and are available commercially. These are more sensitive than antigen detection and virus isolation methods. The sensitivity of antigen detection tests ranges from 80-to-90 per cent in children, but is less sensitive in adults. Serological tests are used less for routine diagnosis and more for seroprevalence and epidemiological studies.3,7
There is currently no vaccine available against RSV infection. Palivizumab, which is a humanised mouse monoclonal antibody specific for the F protein of RSV, provides passive immunity against RSV. Palivizumab inhibits RSV binding to host cells and prevents fusion of infected cells with adjacent cells. It is authorised in Ireland for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for RSV disease.7 Palivizumab prophylaxis reduces the absolute risk of RSV hospitalisation from about 10-to-5 per cent for premature babies, infants with chronic lung disease and haemodynamically significant congenital heart disease, particularly when complicated by large left-to-right shunts, and pulmonary hypertension. It does not reduce mortality or the need for mechanical ventilation.7,3
Palivizumab is given as an intramuscular
injection monthly (up to five doses) during the RSV season. As it is very expensive and has a half-life of 18-to-21 days, meaning monthly injections are required to maintain protective titres, cost-benefit analyses limit its use to only the most vulnerable infants, those born prematurely with moderate or severe BPD, haemodynamically significant, acyanotic congenital heart disease, severe combined immunodeficiency, or infants with other severe chronic lung conditions or requiring long-term ventilation.9 Differences in epidemiology, practice setting, healthcare systems, and drug cost have resulted in variability in palivizumab recommendations and use nationally and internationally.
Treatment and prevention
The mainstay of treatment for the vast majority of RSV infections is supportive including rest, fluids and paracetamol, but passive preventive immunisation is available for at-risk children, including premature infants and infants with a history of cardiac, pulmonary, or neuromuscular diseases. Those with severe respiratory illness require hospitalisation, oxygen therapy, IV fluids, and ventilatory support in the form of a highflow nasal cannula, CPAP, or intubation, and mechanical ventilation.7,10
Ribavirin is the only licensed antiviral medication for the specific treatment of RSV infection, but due to drug toxicity, including bone marrow suppression and potential carcinogenicity and teratogenicity and minimal clinical benefit, it has not been recommended for routine clinical use.9 Ribavirin may be considered for a small number of patients and treatment of RSV with ribavirin must be done under the supervision of an infection specialist, such as a consultant microbiologist or an infectious disease specialist.3
Other treatment modalities for bronchiolitis have been tried in the past and have failed to show broad, reproducible efficacy on clinically significant outcomes in RSV and bronchiolitis. These include albuterol, epinephrine, steroids, hypertonic saline, antibiotics, and chest physical therapy, and routine use of these interventions is not recommended.10 Antibiotics are not effective against RSV and it is important that unnecessary antibiotics are discontinued once a diagnosis is confirmed, to avoid adverse drug reactions and antibiotic resistance.3
Feature Respiratory Syncytial Virus 50 NOVEMBER-DECEMBER 2021
Respiratory Syncytial Virus
Although palivizumab may help prevent serious complications of RSV infection, it is not used to treat RSV infection.
Infants who are recovering from RSV bronchiolitis can continue to have respiratory symptoms including cough and post-bronchiolitis wheeze for several weeks/months. There is no evidence for the use of steroids, montelukast or other medications in preventing these symptoms, but the acute episodes often respond to antiasthma medication.9 High-risk infants with other co-morbidities may require longer admission and some may even require mechanical ventilation. However, the majority of children with RSV make a full recovery and have an excellent outcome. The majority of children who need hospital admission are usually discharged in several days. Some infants with RSV may develop wheezing, but recent studies do not show an increased risk of asthma.10
Prevention and patient education is key, and frequent, careful handwashing is the most important measure in preventing the spread of RSV. Respiratory etiquette should be properly maintained and people with cold/flu-like symptoms should cover their nose and mouth preferably with a tissue or cough and sneeze into their elbow and wash their hands afterwards for at least 20 seconds or use an alcohol-based rub/ gel. Used tissues should be properly disposed of. Sharing utensils with persons who have RSV illness should be avoided and cleaning contaminated surfaces such as door handles may help stop the spread of RSV.3 Parental smoking is a known risk factor for RSV infection in infancy, and parents or carers who smoke should be offered smoking cessation advice and encouraged to stop smoking. Breastfeeding also offers some protection against RSV infection.9 Persons with RSV should not attend crèches, school, work, and non-residential institutions until well. It is important to prevent young infants, frail older persons, and immunocompromised people coming into contact with individuals with respiratory infection.9
In the hospital setting, RSV transmission can be prevented by managing children with RSV together in the same ward, paying strict attention to handwashing guidelines, using barrier precautions and avoiding overcrowding through restriction of visitors.3 Several studies have shown that strict infection control practices
including hand hygiene, the use of personal protective equipment when necessary, timely detection and isolating or cohorting infants with RSV infection can reduce nosocomial RSV infection rates by 39-to-67 per cent.9
RSV research and outlook
The management of RSV disease in infants and children is primarily supportive with antiviral medications reserved for the most vulnerable.10 Palivizumab continues to be the only effective prophylactic medication licensed for use, however, its high cost prevents it from being used in all infants. The development of a well-tolerated, clinically-effective, and costeffective RSV vaccine and therapeutic agent remains a global health priority. It is likely that a licensed RSV vaccine is several years away, however, given the burden of RSV infection and the associated costs globally there is much ongoing research into the development of a welltolerated and effective vaccine. The main target populations for vaccination include infants, school-age children, pregnant women and older adults. Multiple different vaccine approaches are being considered including live-attenuated chimeric, whole-inactivated, particle-base,
1. Shi T, McAllister DA, O’Brien KL, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: A systematic review and modelling study. Lancet 2017; 390; 946–958
2. Barr R, Greene C, Sande CJ, Drysdale SB. Respiratory syncytial virus: diagnosis, prevention and management. Ther Adv Infect Dis. January 2019. doi:10.1177/2049936119865798
3. HPSC (2020). Respiratory syncytial virus (RSV). Health Protection Surveillance Centre. Ireland. Available at: www.hpsc.ie/az/respiratory/ respiratorysyncytialvirus/factsheet/
4. Dunkin M. (2021). Respiratory syncytial virus (RSV). WebMD Medical Reference. Available at: www.webmd.com/lung/rsv-in-babies
5. Bont L, Checchia PA, Fauroux B, et al. Defining the epidemiology and burden of severe respiratory syncytial virus infection among infants and children in western countries. Infect Dis Ther. 2016;5(3):271-298. doi:10.1007/
subunit, nucleic acid, and gene-based vectors. There are also ongoing efforts to develop longacting monoclonal antibodies for infants.2
Three agents; ribavirin, IVIG, and palivizumab, have been extensively used and investigated as antiviral treatments for RSV. To-date none have proven unequivocally beneficial, and effective treatments and research continues into future therapies. At least 14 anti-RSV treatment products are undergoing phase 1 and 2 clinical trials, of which five have included paediatric patients. Novel therapeutic molecules developed to date include fusion inhibitors, non-fusion inhibitors, polymerase inhibitors, antibodies, nucleoside analogues, small-interfacing RNAs, and a benzodiazepine. They have various targets on RSV, such as the F protein, RNA polymerase, nucleoprotein, and nucleocapsid mRNA. It is hoped that one of these products will become a licensed treatment for RSV infection in children and adults over the coming years.2 The development of a successful treatment or prophylactic agent has the potential to revolutionise the care and outcome for severe RSV infections in the world’s most vulnerable infant population.
6. Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet 2011; 377: 1264–1275. doi: 10.1016/S0140-6736(10)61459-6
7. HSE (2019). 18a Respiratory syncytial virus. Health Service Executive, Ireland. Available at: www.hse.ie/eng/health/immunisation/hcpinfo/ guidelines/rsvch18a.pdf
8. Taylor S, Taylor RJ, Lustig RL, et al. Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK. BMJ Open 2016;6:e009337. doi: 10.1136/ bmjopen-2015-009337
9. Drysdale S, Greene C, Sande C. Best practice in the prevention and management of paediatric respiratory syncytial virus infection. Ther Adv Infect Dis. 2016 Apr; 3(2): 63. doi: 10.1177/2049936116630243
10. Schweitzer JW, Justice NA. Respiratory syncytial virus infection. StatPearls Publishing. Available from: www.ncbi.nlm.nih.gov/books/ NBK459215/
NOVEMBER-DECEMBER 2021 51
Author: Ruth Morrow, Registered Advanced Nurse Practitioner (Primary Care), and Respiratory Nurse Specialist (WhatsApp Messaging Service, Asthma Society of Ireland)
RE-INTRODUCING SPIROMETRY IN GENERAL PRACTICE
Spirometry is an important tool used, in combination with the clinical picture, for diagnosing and assessing conditions such as asthma, COPD, pulmonary fibrosis, and cystic fibrosis
Spirometry can help to confirm the diagnosis of asthma or chronic obstructive pulmonary disease (COPD), ensuring patients receive appropriate treatment. The use of diagnostic spirometry in primary care was severely disrupted by the Covid-19 pandemic. Even prior to the pandemic, spirometry services were underutilised in primary care for a number of reasons, such as lack of equipment and trained healthcare professionals. Some GP practices and respiratory units have recommenced performing spirometry. However, at the time of going to print, the author is aware the ‘green light’ has not been given for recommencement. Spirometry is considered a non-aerosol generating procedure (AGP), but as most patients will cough during the spirometry, this is a risk. Sputum induction using nebulised hypertonic saline or inhaled mannitol is also considered an AGP as inhalation of these substances may potentiate sputum production and therefore should be considered as AGPs.
The most effective method to protect healthcare workers from the risk of Covid-19 infection is vaccination.
Patients likely to be infectious are those with clinical features suggestive of Covid-19 who require further evaluation, those with a diagnosis of Covid-19 who are still in the infectious period, and those who are
close contacts of confirmed cases of Covid-19 still in the period of selfisolation. These people can generally be identified by appropriate clinical assessment. Staff members who are likely to be infectious should not attend work. Even after full vaccination staff members who are symptomatic should not attend work themselves and should be assessed to determine if PCR testing is required. Pulmonary function tests can generally be deferred for patients until the infectious period has passed.1 It is important to differentiate as early as possible between those people likely to be infectious and those who are not, or in an exceptional circumstance where testing is deemed necessary.
Risk of infection associated with spirometry
Contact transmission: The surface of equipment used in performing spirometry may become contaminated with respiratory secretions that may contain infectious organisms such as SARS-CoV-2. The patient or the nurse may then touch the contaminated surfaces and transmit the infectious organisms to their eyes, nose or mouth.
Droplet transmission: The patient and the nurse may be in close proximity as it may not be possible to maintain physical distance for all steps of the process. Liquid respiratory particles of different sizes are generated when talking, sneezing or coughing or during expiration
for spirometry. There is therefore potential for transmission to the other person if either the patient or the nurse has an infectious respiratory disease transmitted through the air including Covid-19. Airborne transmission: As the patient and the nurse performing the procedure share the same air space for a period of time there is potential for airborne transmission if either the patient or the nurse has an infection transmitted by the airborne route. Although Covid-19 is predominantly transmitted over a short range (droplet), the potential for longer range (airborne) transmission has increased with the emergence of the alpha and delta variants. This risk is a particular concern in poorly ventilated areas.
Implement physical distancing pre-procedure
Consider to what extent adequate natural ventilation can be achieved in the clinical area.
Consider also how to implement social distancing in waiting areas, eg, the layout of the appointments should be carefully staggered to avoid multiple patients arriving at the same time. Patients should be encouraged to wait remotely (for example in their car/vehicle) to be admitted directly to the patient assessment area to minimise patient numbers in the designated waiting area. The
52 NOVEMBER-DECEMBER 2021
designated waiting area should be adapted (either by removing or marking seating) to ensure physical distancing is maintained. Develop contingencies in the event of unexpected congestion – identify sub-wait areas that can be used for overflow.
Patients identified as high-risk should be brought directly to the procedure room and avoid waiting in public areas.
Preparation for spirometry re-introduction
Ensure practice is in accordance with recommended local infection control procedures to ensure health and safety of patients and staff is consistently maintained.
Bacterial-viral filters should be used for all patients and thrown away by the patient at the end of testing.
During the procedure
As a general principle, ensuring natural ventilation and increasing the distance between the nurse and the patient during the examination reduces the exposure to liquid respiratory particles from either party. Unvaccinated people accompanying the patient should not enter the testing room unless they are essential for performing the test, such as an interpreter, parent, guardian or carer. If they are accompanying the person, they should be assessed for symptoms of Covid-19. They should wear a face covering or mask and maintain a safe distance from the procedure unless they need to be close to the person for a specific reason. If a pause is required between testing, eg, when assessing response to bronchodilator therapy, the patient should remain in the room until testing is complete.
direct contact with the patient should be performed using a cleaning product in line with local policy. Where coughing or throat clearing has been provoked with potential for droplet contamination of the environment, then the surfaces in the immediate space surrounding the patient should be wiped clean using detergent wipe/spray. Cleaning of the floor between patients is not required.
Disposable mouth pieces with antimicrobial filters and disposable spacers should be used. Cleaning, decontamination and maintenance of equipment used for spirometry should conform to the manufacturer’s specifications. Reusable equipment that has no contact with blood/ body fluids, mucus membranes or nonintact skin may be cleaned with a detergent and allowed to dry. Reusable equipment that is in direct contact with blood/body fluids, mucus membranes or non-intact skin of a patient must be de-contaminated; that is cleaned then disinfected using a one-step or two-step cleaning method.
Immunocompromised patients should be tested at the start of the day.
Infectious patients should be tested at the end of the day, and equipment should be stripped down and sterilised/parts replaced prior to reuse.
Ensure there is adequate natural ventilation in the location used for testing. A gentle circulation of air rather than strong air movement is the goal.
Consider use of a perspex screen where available – if not available, stand to the side of or behind the patient (not face-to-face).
As spirometry is considered a non-AGP, but cough is a risk,1 this should be managed as follows:
• Ask the patient to cough through a filter; or
• Have a mask or visor ready for the patient to cough into.
Use disposable spacers for bronchodilator reversibility testing.
All patients at standard risk and any accompanying persons are required to wear their own face covering in waiting areas or other areas where they are in contact with other members of the public unless their condition is such that they cannot tolerate a mask. The face covering should be worn at all times other than when removed to perform spirometry. The requirement of personal protective equipment (PPE) is based on an individual assessment of risk for the procedure. The exact level of PPE can be guided by the risk categorisation.1
Post procedure Cleaning
All staff should be aware of their role and responsibility in relation to cleaning. An adequate supply of suitable cleaning products in line with local policy should be available in the procedure room. After the procedure, cleaning of surfaces which have been in
1. Follow local infection control policy, ensuring health and safety of patients and staff is consistently maintained.
2. Prioritise spirometry for:
New presentations – those patients who require spirometry to confirm a diagnosis.
Backlog patients where it may impact their management.
3. Continue with the risk assessment and infection control measures already taken prior to the pandemic, in addition to new measures to protect both staff and patients.
4. Clearly document the patient history.
1. HSE. Guidance on the infection prevention and control measures required for pulmonary function tests (PFTs) in the context of the Covid-19 pandemic. V1.3 07.07.2021. Available at: https://rb.gy/exll2u
NOVEMBER-DECEMBER 2021 53
Although Covid-19 is predominantly transmitted over a short range (droplet), the potential for longer range (airborne) transmission has increased with the emergence of the alpha and delta variants
THE KEY LESSONS FOR A HAPPY LIFE
TITLE: The Science of Happiness
AUTHOR: Prof Brendan Kelly
PUBLISHER: Gill Books
REVIEWER: George Winter
Decades ago, during an idyllic camping trip to Finland and Norway, my wife and I lost a purse. At Tromsø Police Station a smiling officer transcribed our statement into Norwegian; I signed it… then he guffawed: “Hjör! Hjör! Hjör!” We stared at him. “You’ve just sold me your house!” he exclaimed. Our laughter erupted, mine tempered with relief that he was only joking. So, Prof Brendan Kelly’s citing of peer-reviewed studies showing that the Finns and Norwegians are among the five happiest nations in the world confirms my own experience.
But… the science of happiness? Conceding the subjective nature of happiness, Prof Kelly explains that his book “recruits the happiness science of the past few decades” to answer questions like “is there a single set of guidelines, core principles or essential strategies that I can recommend to people who come to see me and apply in my own life so as to increase happiness, wellbeing, and satisfaction”? The author’s interest was also sharpened when in 2020, with his 47th birthday approaching, Prof Kelly learned of multiple worldwide studies reporting that “47 is the age of minimum wellbeing and maximum unhappiness on planet earth”. At least one reader, well past 47, is always reassured to hear Otis Clay’s, The Only Way is Up (1980).
Written in two parts, the first – ‘The Science of Happiness’ – considers ‘Who we are’, ‘What we do’, and the ‘Six principles of a happy life’; and the second – ‘Strategies for Happiness’ – offers reflections on sleep, dreaming, diet, movement, doing, social connections, and losing oneself.
Thus far, I have had a life blessed with good health and good luck. But an unsettling thought arose as I began to read: Might this book prompt uneasy comparisons of my own life with Prof
Kelly’s happiness-related principles and strategies, raising uncomfortable questions?
The answer, I am pleased to say, was yes. This well-written, thought-provoking, and entertaining exploration of happiness-related research, afforded opportunities to examine my flaws, provided insights into their nature, and suggested possible means of amelioration. To take two (of many) examples; first, the role and relevance of dreams had passed me by (no; I had ignored them), and I shall follow up interesting evidence supporting Prof Kelly’s comment that “we do not dream enough and we do not sufficiently value our dreams”. Second, the merit of social connections outlined by the author chimes with my wife’s view that I could benefit from relationships not only with books, but with other people. Both he and she are right. Further, the ‘Connecting in the time of Covid-19’ section offers a timely perspective on human bonding.
I heartily agree with Kelly’s highlighting of the value of sleep (our bedtime is typically around 21.30), cats, gratitude, and other contributory factors to happiness. So too, losing oneself; but whereas the author got enjoyably lost in nighttime St Petersburg, I achieved it in broad daylight in what was then Leningrad, intrigued at the diverse ways in which tins of Soviet provender could be stacked in the windows of department stores. I largely share Prof Kelly’s views on
exercise, and I guess he too would endorse Rebecca Solnit’s view in Wanderlust: A History of Walking (2000) that walking is a state in which mind, body, and the world “are aligned, as though they were three characters finally in conversation together, three notes suddenly making a chord”. But even writing this while nursing an inflamed Achilles tendon, I maintain that my decades-long love of long-distance cross-country running has brought me much happiness, though admitting that immoderate bouts of strenuous activity don’t necessarily confer favours on one’s physiology. And even as I mounted my dietary high horse to demur at some of the author’s views, I was pleased with his welcome assertion that “[o]ther neglected nutrients that can help boost mental wellbeing include iodine, magnesium, and – of all things – cholesterol”, adding that dietary cholesterol “is necessary for brain health”.
In presenting a science of happiness, Prof Kelly’s thoughts on meditation, mindfulness, and belief necessarily approach a boundary with philosophy, a discipline that he is clearly comfortable with. So, is happiness necessary for a well-lived life? For example, we have this Shavian assertion in Man and Superman (1903): “A lifetime of happiness! No man alive could bear it: It would be hell on earth.” And might happiness, if uninterrupted, confer an immunity to failure, denying opportunities to learn from our mistakes? In her Ideals and Illusions (1941), philosopher Susan Stebbing contemplates “the pursuit of happiness” as voiced in the American Declaration of Independence (1776). She suggests that although the ideal was fine as a principle, it had not been translated into practice, citing Clive Bell’s view that all civilisations have stood on inequality. As a result, Stebbing considers that “it was unquestioningly taken for granted that the sort of happiness appropriate to the one must forever remain out of the reach of the other”.
My understanding of what it means to be alive is enriched by The Science of Happiness, and Prof Kelly must now order a supply of his favoured chocolate brownies and begin work on The Philosophy of Happiness.
54 NOVEMBER-DECEMBER 2021 Life Book Review
Prof Brendan Kelly
SAFETY RESULTS FROM LARGE REAL-WORLD SAFETY STUDY IN ZOELY PUBLISHED
Theramex, a global women’s health company, together with Consilient Health Ireland, have announced that the safety results from the PRO-E2 realworld safety study for Zoely (NOMAC-E2) have been published in The European Journal of Contraception and Reproductive Health Care (EJCRH).
The post-authorisation safety study (PASS), known as PRO-E2, was a large, prospective, non-interventional controlled cohort study of over 101,000 women. PRO-E2 compared the risks of using NOMAC-E2 versus combined oral contraceptives (COCs) containing levonorgestrel (COC-LNG), a commonly prescribed contraceptive.
The primary objective of the real-world study was to assess and compare the risk of cardiovascular events in NOMAC-E2 users with COC-LNG users. For the main clinical outcome, the risk of VTE was as least as low with NOMAC-E2 as with COC-LNG, consistent with findings of previous studies (0.59 Hazard Ratio [HR] 95% CI, 0.25-1.35).
PRO-E2 also demonstrated that contraceptive failure (the risk of unintended pregnancy), a key secondary outcome, was statistically significantly
lower with NOMAC-E2 compared with COC-LNG (0.45 HR, 95% CI, 0.34-0.60, [p<0.0001]). Further analyses showed that the lower rate of unintended pregnancy with NOMAC-E2 was even more pronounced in women under 35 years of age. The shorter hormone-free interval with NOMAC-E2, its longer half-life, and monophasic regimen may all contribute to fewer unintended pregnancies.
All 14 secondary outcomes of the study were met, with the risk of severe adverse events and depressive disorders or changes
BAYER NOTICE: SUPPLY OF QLAIRA
Bayer Limited regrets to advise that there will be a temporary supply interruption in the supply of Qlaira, the combined contraceptive pill.
The anticipated stock out date is currently mid-November 2021 but this may change if demand decreases or increases. Stock is expected to return to the market in Ireland
in early Q2 2022. The return to supply will be notified through the HPRA and the IPU medicines shortages list. We suggest that patients and users affected by the temporary shortage consult their treating physician. Bayer apologises for any inconvenience caused by this supply shortage.
in weight or acne score with NOMAC-E2 comparable to COC-LNG.
Dr Deirdre Lundy, GP, Bray Women’s Health Centre, Bray, Co Wicklow said: “We as prescribers welcome any quality research that confirms pill safety. I use Zoely regularly – it is a favoured COCP for younger patients because it has the non EE oestrogen and the short pill free interval.”
Consilient Health Country Manager Deirdre Kelly said: “The PRO-E2 study results will build further confidence in what has already been shown to be a reliable and effective birth-control option. As a company dedicated to improving women’s health, we are delighted that the wealth of evidence from this safety study can help clinicians and women make informed decisions about contraception.”
The publication on safety results is available online: www.tandfonline.com/doi /10.1080/13625187.2021.1987410 The efficacy publication will be available online later this month. Both publications will be available in the printed journal in December.
Results have also been submitted to the European Medicines Agency (EMA) and will be presented at the European Society of Gynecology congress in November this year.
For queries regarding availability of stock please contact customer service at Tel: 01 206 1520 or email@example.com.
For other queries regarding these products please contact Bayer Ltd, The Atrium, Blackthorn Road, Dublin 18; Tel: 01 216 3300; Fax: 01 206 1456; Email: firstname.lastname@example.org.
NOVEMBER-DECEMBER 2021 55 Product News
HSE APPROVES REIMBURSEMENT OF AJOVY▼ (FREMANEZUMAB) IN MIGRAINE
Teva Pharmaceuticals Ireland is delighted to announce the approval of Ajovy (fremanezumab) 225mg prefilled syringe for prescription under the High Tech Drug Payments Scheme.
Ajovy is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. Since October 1 2021, Ajovy has been reimbursed, under High Tech arrangements, for the prophylaxis of chronic migraine in adults who have failed three or more migrainepreventive treatments.
Ajovy offers the flexibility of monthly dosing (225mg once monthly), or quarterly dosing (675mg every three months) and is the only anti-CGRP with the additional benefit of switching between the two.
Between 12-to-15 per cent of Irish people suffer from migraine – this means that roughly half a million people suffer from migraine in Ireland. Migraine has an impact on almost every aspect of a patient’s life – a survey carried out amongst 265 adult migraine sufferers in Ireland revealed:
53 per cent of migraine suffers said that their partner is impacted;
57 per cent said migraines impacted the ability to provide unconditional support to their children;
41 per cent of
people with migraine said it impacted on their career.
Dr Martin Ruttledge, Consultant Neurologist, Beaumont Hospital, Dublin, said: "There are approximately one million people in Ireland who experience some level of migraine, a sometimes underestimated and misunderstood complex neurological disorder. The financial and societal burden of migraine is significant. It is the third most common disease in the world and is ranked as the second most disabling non-fatal medical condition in women by the World Health Organisation (WHO). People living with more chronic forms of migraine may be very disabled and frequently struggle to maintain a reasonable quality-of-life. The approval of fremanezumab (Ajovy) by the HSE is very much welcomed by the many patients who suffer from migraine and is a significant addition to the treatment options available to neurologists and headache specialists who treat migraine."
More information on Ajovy (fremanezumab) can be found at www.ajovy.ie.
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that TREMFYA (guselkumab), a first-in-class treatment for adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy, has been granted reimbursement in Ireland.
Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor. It is already approved for the treatment of patients with moderate to severe plaque psoriasis. IL-23 is an important driver of the progression of inflammatory diseases including psoriasis and PsA, among others.
The approval for this new indication was based on results from the DISCOVER-1 and DISCOVER-2 phase 3 clinical studies, which assessed safety and efficacy of guselkumab 100mg q4w and q8w in adult patients with active PsA. DISCOVER-1 evaluated 381 participants with active PsA who had an inadequate response to standard therapies, including participants (~30 per cent) previously treated with antitumour necrosis factor (TNF) alpha biologics. DISCOVER-2 included 739 patients who
were biologic-naïve only and had an inadequate response to standard therapies.
Data from these studies was published earlier this year in The Lancet (24-weeks; DISCOVER-1, DISCOVER 2). The published results show that in both studies, at week 24, adult patients with active PsA achieved statistical significance in the primary endpoint of American College of Rheumatology (ACR) 20 per cent improvement (ACR20) response (DISCOVER-1: p<0.001; DISCOVER-2: p<0.001) in both q4w and q8w guselkumab groups (DISCOVER-1: n=255; DISCOVER-2: n=493) vs the placebo groups (DISCOVER-1: n=126; DISCOVER-2: n= 246). In both studies, guselkumab was well-tolerated, and observed adverse events (AEs) were generally consistent with previous studies of guselkumab and current prescribing information.
Prof Doug Veale, Consultant Rheumatologist at St Vincent’s University Hospital, Dublin, welcomed the news stating: “The approval of reimbursement for guselkumab in Ireland is a significant advance in precision medicine for patients who suffer from psoriatic arthritis and plaque psoriasis. Guselkumab targets a new pathway that is specific to these conditions.”
56 NOVEMBER-DECEMBER 2021 Product News
TREMFYA▼ (GUSELKUMAB), APPROVED FOR REIMBURSEMENT IN IRELAND, FOR THE TREATMENT OF ACTIVE PSORIATIC ARTHRITIS (PSA)
7 Making (13)
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8 Time by which a task must be completed (8)
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5 Structure spanning a river (6)
6 Example (8)
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17 Film that makes one laugh (6)
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21 Army vehicle (4)
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APTAMIL TODDLER MILK
New FSAI Dietary Guidelines for Toddlers 2020
• Fortified foods and drinks may contribute to the intakes of Vitamin D, Iron & Omega 3 in toddlers2
• Daily Vitamin D supplementation of 5μg is recommended from Halloween to St. Patrick’s Day*2
Just 2 beakers a day (300ml) of Aptamil Toddler milk provides toddlers with 100% of the RDA3 for Vitamin D and 53% of the RDA3 for Iron
*Along with fortified foods and drinks where possible. Available in 800g powder, 200ml & 1 litre liquid.
Scan for more information. Alternatively, call our dedicated freephone on 1800 22 12 34 or visit nutricia.ie
Aptamil Toddler Milk should be
of a varied and balanced diet from 1 year. Recommended serving per day is 300ml. 1. Irish Universities Alliance (IUNA), National Pre-school Nutritional Survey. Further analysis for Danone Nutricia (data available on request). Main survey available at: https://www.iuna.net/surveyreports 2. Food Safety Authority of Ireland (FSAI), Scientific Recommendations for Food-Based Dietary Guidelines for 1 to 5 Year-Olds in Ireland. Available at: https://www.fsai.ie/Dietary_Recommendations_1-5_Year_Olds/ 3. Food Safety Authority of Ireland (FSAI), Recommended Dietary Allowances for Ireland 1999. Available at: https://www.lenus.ie/handle/10147/44808
THAN 90% OF 1-3 YEAR OLDS IN IRELAND DO NOT GET ENOUGH VITAMIN