Ukrainian doctors in Ireland
Catherine Reilly reports on the challenges faced by Ukrainian doctors who have arrived in Ireland since the outbreak of war
Building trust in cervical screening
Dr Aoife Doyle, Lead Pathologist of Cervical Cytology at the National Cervical Screening Laboratory, speaks to Niamh Quinlan about developing the service
Ongoing concern about paramedicine regulation
There is ongoing concern in the Pre-Hospital Emergency Care Council (PHECC) and the HSE about legislative “deficiencies” in the regulation of paramedicine. As previously reported by the Medical Independent , PHECC informed the Department of Health in 2019 that the situation placed the public “at risk”.
The Director of the HSE National Ambulance Service (NAS) Mr Robert Morton raised the matter during a presentation to the PHECC Council in December 2022.
Mr Morton said primary legislation was “urgently required” to address PHECC’s legislative “weaknesses”. His presentation also cited the development of specialist paramedicine as key to the NAS’s strategic plan, according to minutes.
In October 2022, PHECC Chairperson Dr Jacqueline Burke (PhD) informed the Council of an extended call with the Department regarding the legislative deficiencies and the “considerable time which had elapsed in addressing these”.
The following month, Dr Burke told the Council that the Department informed her “some work had commenced on the matter” and fundamental progress was envisaged by the end of 2023.
“However, the Chair pointed out that that this may not meet the expectations of Council members who are frustrated by the lack of progress to date. A meeting with the Minister for Health may be required…. The importance of legislative change in order to protect the public was reiterated.”
In July 2019, Dr Burke warned the then Minister Simon Harris that the failure to adequately regulate pre-hospital
emergency services put the public “at risk” and posed a “significant reputational risk” to the Minister and Department.
Dr Burke stated that “during this year, we (PHECC) have had to explain in public that while we can set and monitor standards, we have no medium to enforce their use”. PHECC did not have the ability to enforce registrants’ use of its clinical practice guidelines or enforce these standards generally, she added. These matters had been raised with the Department by the previous Council, the letter outlined.
The Future of Paramedicine, published by PHECC in 2016, stated that it had no enforcement powers to impose mandatory registration on people who wished to practise as emergency medical technicians, paramedics, or advanced paramedics.
In addition, PHECC did not have the power to restrict a practitioner’s registration through imposition of conditions or suspension or cancellation of registration.
PHECC had not commented by press time.
New consultant contract will be 'gradual change' – IHCA President
The new consultant contract will lead to a “gradual change, not a big bang”, the IHCA President Prof Robert Landers has told this newspaper.
The Department of Health confirmed to the Medical Independent (MI) that the new contract will be introduced “in the coming weeks”.
Prof Landers, speaking to MI at the National Health Summit in Croke Park on 8 February, said: “We are undertaking a consultation feedback process [with IHCA members] and then we are providing our feedback to the Department looking for minor modifications within that contract.”
“We’ll have that process finished, I hope, by the end of the month. Then we will be in a position to either endorse it or to give a neutral recommendation of the contract formally.”
Prof Landers added: “I think a lot of younger consultants will take it up and some older consultants who are perhaps a few years out from retirement might take it up.”
“But some existing consultants in the middle may look at it and say, 'there is no huge benefit to me in taking it up from a purely individual perspective.’ But in terms of takeup, it will progress over time as more new consultants come into the system.”
Speaking at the Summit earlier in the day, Prof Landers stated: “From our perspective it’s not a perfect contract, from the Department of Health’s perspective it’s not perfect; but it is a decent compromise.”
The IMO has also been in contact with the Department about a “range of clarifications” regarding the contract.
A melting pot of bad and good Moving to the US has made Dr Michael Conroy reflect on the negative and positive legacies of immigration
The Faculty of Pathology, RCPI, and Royal College of Pathologists, UK, recently signed a formal agreement to create additional exam centres to run FRCPath Part 2 in histopathology and haematology in Ireland.
Pictured L-to-R: Prof Michael Osborn, President, Royal College of Pathologists, presented with his certificate of Honorary Fellowship by Prof Mary Keogan, Dean, Faculty of Pathology, RCPI.
XELJANZ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
XELJANZ in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.
XELJANZ in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
XELJANZ is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.
OUR PAPER IS NOW COMPOSTABLE, AS WELL AS RECYCLABLE 21 FEBRUARY 2023 ● ISSUE 4 VOLUME 14 ● NEXT ISSUE 7 MARCH 2023 €5.95
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PP-XEL-IRL-0756 Date of preparation: June 2022 RA | UC | PsA | JIA | AS INDIC A T E D FOR
NEWS 1-14 ● OPINION 16-22 ● MCQ s 22 ● CLINICAL 23-28 ● CONFERENCE 10, 30-38 ● LIFE DIARY 40 ● QUIZZES 41 ● SPORT 42-43 ● GALLERY 44&45 ● PRODUCTS 46 PAGE 4-5
*Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1
Ryaltris™ 25 mcg/actuation + 600 mcg/actuation nasal spray, suspension.
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.
Presentation: One delivered dose contains mometasone furoate monohydrate equivalent to 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to 600 mcg olopatadine. White, homogeneous suspension.
Uses: In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.
Dosage: For nasal use only. Adults and adolescents (12 years of age and over) two actuations in each nostril twice daily (morning and evening). Elderly: no dose adjustment required. Children under 12 years: not recommended. Renal and hepatic impairment: no dose adjustment expected.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. Recent nasal surgery or trauma until wound healing has occurred.
Warnings and Precautions: Instances of nasal ulceration and nasal septal perforation have been reported. Not recommended in case of nasal septum perforation. Patients using Ryaltris™ over several months or longer should be examined periodically for possible changes in the nasal mucosa and for evidence of Candida infection. Instances of epistaxis have been reported. Visual disturbance may be reported with systemic and topical corticosteroid use. Consider referral to ophthalmologist with symptoms such as blurred vision or other visual disturbances as cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported after use of systemic and topical corticosteroids. Hypersensitivity reactions, including wheezing, may occur - discontinue.
Immunosuppression: use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex. Potential systemic effects of corticosteroids include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Hypercorticism and adrenal suppression may appear at higher than recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufﬁciency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris™ in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system (CNS) depressants. Increased risk of antihistamine adverse effects with concomitant use of olopatadine or other antihistaminic drugs administered via nasal, ocular or oral route. Paediatric population: It is recommended that the height of children receiving
prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
Interactions: No interaction studies have been performed with Ryaltris™. Any interactions from the combination of olopatadine and mometasone furoate are expected to reﬂect those of the components taken individually, no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination.
Olopatadine: No interactions with other drugs expected. Mometasone Furoate: Cotreatment with CYP3A inhibitors should be avoided unless the beneﬁt outweighs the increased risk of systemic corticosteroid side-effects and patients should be monitored.
Pregnancy and Lactation: Avoid use during pregnancy unless potential beneﬁt to mother justiﬁes potential risk to mother, foetus or infant. Assess before prescribing in lactating mothers.
Side Effects: Common: dysgeusia, epistaxis, nasal discomfort.
Uncommon: dizziness, headaches, somnolence, nasal dryness, dry mouth, abdominal pain, nausea, fatigue. Rare: bacterial vaginosis, anxiety, depression, insomnia, lethargy, migraine, blurred vision, dry eye, eye discomfort, ear pain, nasal inﬂammation, nasal mucosal disorder, oropharyngeal pain, sneezing, throat irritation, constipation, sore tongue, laceration. Frequency not known: pharyngitis, upper respiratory tract infection, hypersensitivity (including anaphylactic reactions, angioedema, bronchospasm, dyspnoea), cataracts, glaucoma, increased intraocular pressure and nasal septum perforation.
Pack Sizes: One bottle containing 30ml suspension (240 actuations).
Legal Category: POM.
Product Authorisation Numbers: PA 1543/002/001
Product Authorisation Holder: Glenmark Pharmaceuticals s.r.o., Hvezdova 1716/2b, 140 78 Prague 4, Czech Republic.
Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.
Date of Preparation: June 2022.
IR-RYL-04-2023 January 2023
1. Ryaltris™ Summary of Product Characteristics July 2021.
twice daily 1 1791_Ryaltris_A4_IR-RYL-04-2023_V2 FA.indd 1 30/01/2023 15:36
Council’s specialty recognition process paused again
The Medical Council’s specialty recognition process is “temporarily paused” for a second time since 2015.
The process was previously paused due to concerns there were “too many specialties recognised in Ireland, resulting in fragmentation of a very stretched health service”, heard a Council meeting in June 2022.
During this meeting, the Council decided to again suspend the process. A spokesperson informed the Medical Independent the process is “temporarily paused” while the Council consults with the Department of Health and the HSE on a national healthcare workforce strategy to inform the future needs of Irish healthcare services.
Currently, 57 specialties are recognised by the Council and there is one application being considered.
A commissioned review, completed in 2017, identified enhancements to the process and explored international
approaches to specialty recognition along with alternative options.
The report recommended exploring the possibility of credentialing, “but there was little appetite for this among the training bodies or the Medical Council at the time,” according to meeting minutes.
“The recommended enhancements… such as considering the potential impact on patient care, liaising with the Health Service Executive from the outset, and increasing patient and public involvement, were built into the revised application process, which was reo -
Mater Private Network
pened in March 2019.”
“The Council was informed that a position from the Department of Health and the Health Service Executive regarding healthcare needs and plans and where specialisation fits into the healthcare framework would provide guidance and focus for future aspirant specialties in their application; and to the Medical Council in assessing an application for recognition of a specialty.”
Special training certificates not requiring formal recognition by the Medical Council should also be explored as part of workforce planning, the meeting heard.
A ‘mean hourly’ gender pay gap of 6.75 per cent in the Department of Health is linked to overtime payments and management board representation, a report by the Department has found.
The Gender Pay Gap Information Act 2021 has introduced reporting requirements for organisations with over 250 employees.
Gender Pay Gap Report
The first set of results are based on a ‘snap-shot’ date in June 2022.
The gender pay gap is usually represented as the average difference in gross hourly earnings of men and women, expressed as a percentage of men's average gross hourly earnings.
The report noted the “gender pay profile is correlated to, and impacted by, the timing and impact of employee joiner, leaver, mobility, and promotion activities”.
“Overtime, when required, is offered to eligible grades equally. In the reporting period, overtime was availed of by more men, thereby increasing the male pay profile.”
The report, which was published in December, also noted representation on the management board “was 60/40 in favour of males for this reporting period, which also contributed to the pay gap and males were on higher points of their respective pay scales due to longer service at these grades”.
The report from the HSE found a mean hourly gender pay gap of 12 per cent, which it linked to the staff categories in which female employees principally work and the high number working part-time. The report noted that staff “choosing part-time work may be less likely to opt” for overtime.
The report highlighted the staff category of medical and dental as showing “strong growth” in the proportion of females, moving from 38 per cent reported in 2002 to 51 per cent in 2022.
Monday, 6th March | 7pm to 8.30pm
Online event only · CPD applied for Management
Ms. Liza McLornan,
Ms. Paula Manzi, Consultant Urologist
Dr. Mike Thompson, Imokilly Medical Centre, Midleton, Cork. Presentations will be followed by Panel Discussion / Q&A.
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Scan QR code or via www.MedCafe.ie
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 3 News
Overtime and management board representation causing gender pay gap – DoH
Consultant Urologist Small Renal Masses
Mr. Nicholas Hegarty, Consultant Urologist
Update on Management of Kidney Stones
Mr. Miguel Rodriguez, Consultant Urologist Urology
Update for Primary Care
1820 Urology Webinar_Medical Independent _240x165_FA.indd 1 15/02/2023 12:20
A winding road for Ukrainian doctors in Ireland
Hundreds of Ukrainian doctors have arrived in Ireland since the Russian invasion of their country in February 2022 and ensuing war. However, the road to medical registration is taking time to navigate.
Catherine Reilly reports
There is a desire among Ukrainian doctors in Ireland to enter the medical workforce. However, the first step many need to take is developing their English language skills.
Approximately 325 Ukrainian doctors, who have come to Ireland following the Russian invasion of their country and eruption of war, have provided details about their experience, English language training, and locations via a HSE survey.
Dr Kateryna Kachurets, a GP from Ukraine who has worked in Ireland for several years, told the Medical Independent (MI) that over 80 per cent of the doctors require some level of English language training as a starting point to their registration journey.
Dr Kachurets is pivotally involved in efforts to support Ukrainian doctors through the HSE and ICGP. She spoke to MI as a representative of the Association of Ukrainians in Ireland.
“Yes, they would love to practise medicine
in Ireland, but language is the main barrier for [many of] them right now,” she said.
“They have their qualifications, they want to put them to good use, they want to develop as medical professionals. So most of them do want to practise medicine in Ireland, but they do have to go through the whole process of getting registered first.”
Dr Kachurets said that, initially, some doctors may have felt their time in Ireland would be short-lived.
“But now it has been a year and becoming more and more apparent that we don’t know how long the war is going to take,” she noted. As such, some of the doctors are facing “a turning point… to make a decision about whether or not they want to go through the whole process of registration [with the Medical Council]. I mean, it is labour intensive, but it is worth it.”
According to a HSE spokesperson, the surveyed Ukrainian doctors were put in contact with the relevant postgraduate training bodies and provided with information about engage-
Dr Arina Biriukova speaks with clarity and enthusiasm about her chosen profession. She enjoys “solving complex clinical cases” and gains satisfaction from helping patients with challenging conditions.
During her two-year residency in internal medicine, she developed a particular interest in rheumatology and endocrinology. “I really like seeing the successful results like people entering remission, recovering from such conditions,” she tells the Medical Independent. “That is extremely rewarding. [These areas] can be very challenging at the same time.”
Dr Biriukova sounds like any doctor at an early stage of their career – hopeful about the opportunities ahead, but cognisant of the challenges.
The challenges she has faced over the past year, however, will surely surmount the travails of medicine. Dr Biriukova is one of over 60,000 Ukrainian people who have arrived in Ireland since Russia’s invasion of their country in 2022 and the ensuing war. It is an act of aggression that has terrorised the Ukrainian people, but has also spurred a defiant defence.
Working in her home city of Dnipro when the war erupted, Dr Biriukova continued with her hospital duties in addition to volunteering for her country’s defence.
“I provided medical supplies, [visual] equipment to search for the dead and wounded, and different ways of support to my colleagues who were on the frontline,” she recounted. She described this early period as “chaotic”. There were a limited number of doctors with experience in military medicine, for example.
“The help and involvement of everyone was extremely needed and vital, and we all dived into that,” explains Dr Biriukova, adding that the medical response has since become more structured.
Over time, the psychological burden of losing people mounted on Dr Biriukova.
ment with the Medical Council.
“They have also been provided with access to HSE library resources, and the HSE’s online national learning and development portal, to facilitate their further learning and maintenance of professional knowledge.”
Echoing Dr Kachurets’ comments, the spokesperson added: “For many doctors arriving from Ukraine the immediate challenge is to obtain the necessary English language proficiency. We know many are learning English.
“In this context, the Department of Health is funding clinical English language
“There were people, acquaintances, friends, who died and were severely injured, so the distress was very severe,” she says.
Meanwhile, many of the most vulnerable stratum of the population – pregnant women, people with children and older people – fled the war to foreign countries.
According to Dr Biriukova, these people were likely to need medical surveillance, which would mean the active involvement of foreign healthcare institutions. Therefore, to remain efficient and provide medical assistance to fellow citizens thus alleviating the potential strain on international colleagues, Dr Biriukova says she took a decision to follow Ukrainians who may need her help.
Since coming to Ireland in September 2022, Dr Biriukova has remained involved in assisting her people at home. She is keen to provide medical support to those who have arrived in Ireland, particularly where there are language barriers.
“I am still in touch with people [in Ukraine]; I am still doing my best to provide them with what they might need. But at the same time I needed to ensure I am productive. Because at that stage I realised I had no sleep, I was in severe emotional distress and I understood that the civilians who are in need for medical surveillance and assistance [in other European
training to support Ukrainian health professionals in achieving these English language requirements.”
A website has been established, www.regpath.ie, which provides information on the minimum English language proficiency levels required, the training available, and how to apply. This website is one of the outputs of a working group involving HSE National Doctors Training and Planning, HSE Human Resources, the Department of Health, the
countries] especially need the help of people who can speak their language and understand their pains; people who have sometimes shared the experience of what they have been through.”
Dr Biriukova speaks fluent English and also undertook a short medical elective in Ireland several years ago, so she had some familiarity. She is living in Co Cork and working in medical research while awaiting access to exams necessary for registration with the Medical Council.
Dr Biriukova expresses gratitude to the countries, such as Ireland, that have offered protection to Ukrainians.
“We are grateful for the support we have seen since the first days of war, when people who were forced to relocate were admitted to other countries, including Ireland, and we have seen the support, which is something we are immensely grateful for. But we don’t want to become a burden to the State that has admitted us. So I think it is fair for me as a doctor to come to Ireland… and do my bit to alleviate the medical part… to treat Ukrainians and integrate into the system and help treat the Irish people.”
Dr Biriukova is waiting to take the written pre-registration exam (PLAB 1). She says the earliest date she can access the exam is August 2023.
“I have successfully completed all the
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023
‘There were people, acquaintances, friends, who died and were severely injured’
Dr Arina Biriukova
Medical Council, the Forum of Irish Postgraduate Medical Training Bodies, the College of Anaesthesiologists of Ireland and the Dental Council.
The Executive’s spokesperson also advised that there was “ongoing” work to develop a new policy proposal to facilitate doctors awaiting registration to undertake ‘observerships’. This would constitute a “defined period of time” where doctors can attend a hospital or health service to observe the practice of medicine in that environment. The aim would be to become more familiar with the processes and procedures in Irish healthcare without being directly involved in patient care and in a strictly supervised fashion.
“A number of hospitals have already facilitated doctors in this way. These roles are not paid, are closely restricted, and those taking part are not working as doctors or providing patient care,” added the spokesperson.
“The HSE is not able to employ doctors to practise in Ireland without appropriate registration. The authority for registration and recognition of qualifications is the Medical Council of Ireland. We are engaging closely with the Medical Council to explore any and all options available in this regard.
“We are aware that some doctors have been employed as clerical staff, translators and other work within the health system, which does not require registration. The HSE is exploring the potential to expand and build on this. Developing opportunities to employ these doctors is part of an active programme of work within the HSE involving senior staff in clinical, operational, and human resources working in close collaboration.
“There is also close and active collaboration ongoing in respect of Ukrainian doctors
English language requirements, passed the IELTS test, I verified my documents through the systems that were listed, and now I am at the stage where I have to take the first medical exam…. The problem is there is a very long queue and very long list of people who are wishing to take the British exam….”
Being away from clinical practice is difficult from a professional and personal perspective. “I think this time lag is detrimental not only from the point of losing clinical practice. One’s occupation is a part of personal identity. In times of crisis, you tend to rely on this part, on something that is your strength, and that is just something that helps you and keeps you going. I think it is detrimental for medical professionals, for doctors, to be bereft of their occupation.”
She says it would be appreciated if any steps could be taken by authorities to improve access to the pre-registration exam.
“There are doctors who are still learning the language and there are people like me who have passed the language requirements and are ready to take medical exams and then start practising. So I think if something can be done to speed up this process that would be amazing, so we can start doing what we have always done, what we are here for, to start helping the people of Ireland and of Ukraine.”
More broadly, Dr Biriukova complimented the HSE for its efforts to assist doctors from Ukraine.
arriving into Ireland between the HSE, the Department of Health, the Medical Council, and the postgraduate training bodies for medical specialties, with meetings occurring on a weekly basis.
“The Department of Health has been working to provide a range of practical supports …. This is in addition to the other supports being put in place for those arriving from Ukraine generally such as language classes.
“…. The various postgraduate training bodies have individually provided a variety of supports to doctors from their area of specialties who have been identified to them.”
While language is a barrier for many of the Ukrainian doctors, some have very good English language skills (see panel). However, the waiting time to access the written pre-registration medical exam can be lengthy.
Doctors trained outside the EU/EEA, intending to pursue registration in the general or trainee specialist divisions, may be required to sit the pre-registration examination system (PRES), which is comprised of PRES 2 and PRES 3.
The Irish Medical Council does not operate its own written pre-registration exam (PRES 2), but recognises a number of exams run by other bodies internationally. The professional and linguistic assessment board (PLAB) 1 exam, operated by the UK’s General Medical Council (GMC), tends to be the popular option due to a variety of factors and is in high demand.
A GMC spokesperson told MI: “We have worked closely with the Medical Council of Ireland to make sure that candidates in Ireland seeking registration with the Medical Council have access to a suitable exam….
“I know they have started organising some English training courses for people who need support in language training and that is also amazing. I have seen some people have had observerships in the hospitals for several weeks…. I think this helps to integrate into the system, to see the system from the inside because there are those tiny, tiny practical differences.
“You know, starting with something very basic like where your instruments are when you are in your office, how you can access drugs, what scope of responsibilities your nurse has; all those tiny differences. Those differences have a huge impact when you start your work.”
Dr Biriukova said some orientation and forums to discuss ethics and legislation applicable to medical practice in Ireland would be important. In addition, knowledge of treating and communicating with a diverse patient population is vital for all doctors.
There are also many commonalities to medical practice in Ukraine and Ireland, according to Dr Biriukova. “People around the world operate by the same principles – like ‘do no harm’. We act out of the best patient interests. So that is similar. Theoretically, Ukraine has long operated European guidelines and we have been very much involved in the international scientific community, so Ukrainian doctors regularly took part in international congresses [etc].”
In the meantime, there continues to be
“This year the GMC will provide 22,000 PLAB 1 places for all those seeking registration in the UK. This is an increase from the 18,000 places offered in 2022, and includes offering exams in Belfast and from May, at a new centre in Dublin.”
According to a spokesperson for the Irish Medical Council: “The vast majority of doctors from Ukraine will need to sit the PRES before they can register with the Medical Council. All Ukrainian doctors who have applied to sit the PRES so far have been deemed eligible to sit the PRES 3 exam, though as yet, this is a small number of doctors. If these doctors are successful in the PRES 3 exam, this will entitle them to be registered in the general division. To date, one Ukrainian qualified doctor holds qualifications which has exempted them from the PRES, and they were made eligible for registration in the general division.”
In regard to the PRES 2 requirement: “Work is ongoing to put in place an exam which can be hosted in Ireland and further details of this will be made available in the very near future and the Medical Council continues to work with partners to deliver on this.”
The Council spokesperson added: “We are prioritising applications for registration as they come in. As some applicants may have difficulty providing all of the required documentation or providing verification of their medical credentials, the Medical Council is working with applicants to identify alternative ways of providing satisfactory evidence of holding requisite qualifications. A dedicated webpage with guidance on applying for registration as well as a dedicated email inbox have been set up to handle queries from this group.” See https://medicalcouncil. ie/ukraine/
alarming news bulletins from Dnipro and elsewhere in Ukraine, and there is a constant anxiety for family and friends.
“Several weeks ago there was this tragedy that you have probably heard of, where the Russian troops targeted a residential building [in Dnipro] and dozens of people died there…. That touched upon everyone and that is not a single case unfortunately, missiles are targeted at Dnipro every other day…. They are just preventing people from having normal lives….
“I find it difficult to talk about because on the one hand I know that Ukrainians are fighters, they do not moan, they do not complain, they adjust. For them, their freedom and their independence are the priority and people will not sacrifice that. People are adapting to the lack of mobile and internet connection, the lack of electricity. People are very creative; they find ways to keep functioning, to work, to provide for their families, to donate to humanitarian needs, to the army. People are doing everything they can to support their fellow citizens.
“But at the same time, that is all very difficult – objectively, it is very difficult. Not being able to reach your family when you see on the news there is a missile targeted at your city, and you see there was an explosion, and you are trying to reach out to your family and you cannot reach out to them as there is no electricity, but you never know what it is, whether it is electricity or… something else.”
13% reduction in overall mortality for women in Ireland from nine of the 10 most common cancers between 2011 and 2019, according to a country profile by the Organisation for Economic Co-operation and Development (OECD).
14% reduction in overall mortality for men in Ireland from nine of the 10 most common cancers between 2011 and 2019, reported the same OECD data.
487 admitted patients were waiting for beds on the morning of Monday 13 February, according to the Irish Nurses and Midwives Organisation’s Trolley Watch figures.
$55bn is yielded from commercial formula milk sales per annum, according to a series in The Lancet which has called for an end to the “exploitative marketing” used by the industry.
95% of internationally trained doctors surveyed in Ireland did not get intercultural training from their host hospital, new research from Trinity Business School has found.
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 5 Feature News
‘Build and test’ stage for IFMS project on target – HSE
The HSE has confirmed that the first part of the ‘build and test’ stage for its planned integrated financial management system (IFMS) was completed on schedule at the end of 2022.
As previously reported in the Medical Independent (MI), the project has been beset by numerous delays, such as the termination of contract with the former system integrator, DXC Technology, last year.
A public procurement process was conducted for a new system integrator to build, test and implement the approved IFMS design, and IBM was engaged in July 2022.
A HSE spokesperson told MI that following the on-schedule completion of the design validation and review stage in October 2022, the IFMS project progressed to the build and test stage which runs to May 2023.
“The first milestone for build and test stage (Sprint Group 1) was completed to plan in December 2022,” according to the spokesperson.
The build and test stage also includes: The development of detailed functional specifications; management of change
activities for implementation group 1 (IG1); IG1 ‘go-live’ preparation activities, including establishment in December 2022 of the IG1 steering group and local working groups; and IFMS data readiness for IG1 ‘go-live’.
Other elements of this stage are the development of a shared services operating model, including the establishment of the master data unit; the development of a procurement support model; playback demonstrations; system integration testing; and user acceptance testing.
“The project is due to progress to implementation and ‘hypercare’ stage in June 2023, with the first two of five implementation groups on track for go-live at half-year (July 2023) and at year-end (December 2023), respectively,” according to the spokesperson.
Hypercare is the period of time immediately following a system ‘go-live’ where an elevated level of support is available to ensure the adoption of a new system.
The spokesperson said the project is advancing on schedule to achieve the target of having 80 per cent of the expenditure of the health service transacted on the IFMS in 2025.
Pre-recorded clinical handovers ‘discontinued’
– St Luke’s Kilkenny
The practice of audio-taped and pre-recorded clinical handovers at St Luke’s General Hospital in Kilkenny “has been discontinued”, a spokesperson for Ireland East Hospital Group (IEHG) has informed the Medical Independent (MI).
“The process was phased out over the past number of years. The practice was never in place for medical handovers,” stated the spokesperson.
According to a HSE Internal Audit report, dated August 2022, the practice of audio-taped nursing handovers was taking place “in direct contravention” of a recommendation in national clinical guidance for the area. Recommendation 21 in the guideline states clinical handover should be conducted faceto-face where possible, be conducted verbally, supported by relevant documentation, and facilitate two-way communication processes. Pre-recorded clinical handover “must not” be used for shift or inter-departmental clinical handover “in any circumstances”, according to the recommendation.
The audit found that the hospital had developed a guideline for the practice of audiotape-recorded nursing handovers. “During staff interviews, it was stated that it was hoped that the Haddington Road agreement and recent reduction in working hours for nursing staff may allow for handover to be built into the roster, and therefore negate the need for the audio-taped nursing handovers.”
The audit report recommended that
St Luke’s management ensure this practice was discontinued. In an associated report, Internal Audit advised that the HSE National Director of Acute Operations should request Hospital Groups to review compliance with recommendation 21 in the guideline and request confirmation that the practice of audio-taped and pre-recorded clinical handover at acute hospitals, where the practice was occurring, is discontinued to comply with the guideline.
A HSE spokesperson told MI the National Director of Acute Operations “has received confirmation from the Hospital Groups that in line with recommendation 21… where the practice of audio-taped and pre-recorded clinical handover was occurring, it is being discontinued”.
“The HSE notes that, as per the national clinical guidelines, shift and inter-departmental clinical handover should promote a structure which allows for data verification, discussion, shared clinical decision-making, and identification of operational issues and other factors that may impact on clinical care.”
Employment of consultants not on specialist register raised at HSE meeting
on 14 October.
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Pictured L-to-R at South Infirmary Victoria University Hospital (SIVUH) in Cork are: Ms Lisa O’Riordan, Co-founder, HaPPE Earth; Mr Johnny Brackett, Healthcare Assistant; Ms Niamh Allen, Health Innovation Hub Ireland (HIHI) Clinical Liaison and HSE Clinical Nurse Manager; Dr Mary O’Riordan, Co-founder, HaPPE Earth; and Ms Lily Matthews, Clinical Nurse Manager 1. HIHI and the team at SIVUH have tested 7,000 environmentally friendly HaPPE aprons for wearability, acceptability, sustainability, and durability. The HaPPE apron reduces the carbon footprint of a standard low-density polyethylene apron by over 75 per cent, according to HaPPE Earth.
As of the end of January, there were 101 consultants employed by the HSE who were not on the Medical Council’s specialist register, according to figures provided to this newspaper.
A spokesperson told the Medical Independent that Saolta University Health Care Group was the group with the highest number of consultants not specialist-registered at 28. This was followed by South/South West Hospital Group, with 20, and Dublin Midlands Hospital Group with 13.
The continued employment of consultants not on the specialist register was raised at a meeting of the HSE people and culture committee
The HSE National Director of Human Resources (HR) Ms Anne Marie Hoey gave an update to the committee on the matter. She stated that the number had “reduced from 153 to 104”.
According to the minutes of the meeting: “It is HSE policy that when a consultant is being appointed all options to recruit a suitable candidate with specialist registration must be exhausted before appointing a candidate from the general register. The ND [National Director] HR provided the escalation process involved in appointing a consultant who is not on the specialist register.”
The committee requested follow-up information on the issue.
6 THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 News
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Patient impact of medical radioisotope supply disruption not as significant as feared
Disruption to the supply of medical radioisotopes, which occurred in November and early December 2022, impacted fewer patients than originally anticipated, a spokesperson for the National Cancer Control Programme (NCCP) has told the Medical Independent (MI)
A briefing note from NCCP National Director Prof Risteárd Ó Laoide to HSE Chief Clinical Officer Dr Colm Henry, dated 8 November 2022, stated the NCCP had been made aware of the “global situation regarding the production of Mo-99 [Molybdenum 99] targets for the production” of technetium-99m and iodine-131.
These radioisotopes are used routinely by hospitals in nuclear medicine procedures and certain cancer treatments.
The briefing note stated that due to a delay in the planned “restart” of the main European reactor as a result of a technical issue, and a number of worldwide reactors under routine maintenance, Mo-99 supply disruptions were anticipated for the month of November and possibly early December.
“These shortages and lack of supply will have a significant impact on service provision resulting in cancellations and deferrals of patient appointments,” according to the note released to MI through Freedom of Information law.
“The NCCP have engaged with nuclear medicine departments within hospitals nationally, both private and public. It is estimated that approximately 600700 patient appointments will be affected per week within public hospitals.”
The briefing note stated that while hospitals were notifying patients directly with regard to the postponement of their appointments, “it would be
Capacity issues highlighted at NCCP meeting
PAUL MULHOLLAND AND DAVID LYNCH
The National Cancer Control Programme executive management team (EMT) has discussed continuing capacity deficits in the delivery of systemic anti-cancer therapy in a number of hospitals.
The EMT meeting in November 2022 heard there were capacity issues in the following sites: St Vincent’s University Hospital (SVUH), Dublin; Cork University Hospital (CUH); South Infirmary Victoria University Hospital (SIVUH), Cork; University Hospital Waterford; and University Hospital Galway (UHG).
SVUH was awaiting approval from HSE Estates for funding to extend the day ward to increase the number of chairs, according to the meeting minutes.
sues for radiation oncology services generally continue to be staffing and capacity”. Work was ongoing to address these matters. It was noted that a national review of radiation therapists was due to commence in the coming weeks.
Meanwhile, concerns over the impact of “loss of experienced staff” in cancer care were raised at a HSE meeting in October.
The meeting of the HSE safety and quality committee heard about the recruitment difficulties within the area. In relation to cancer care, HSE Chief Clinical Officer Dr Colm Henry told members that “the loss of experienced staff and difficulties in recruiting new staff is impacting on services and may be adding to capacity challenges”.
helpful if the HSE was to issue a statement on this issue.”
An NCCP spokesperson told MI the reported number of patients impacted was lower than the original estimate.
“A number of hospitals mitigated patient impacts by bringing forward patient appointments, where possible and appropriate, to utilise the remainder of the radioisotope generator shipments before supply was interrupted,” according to the spokesperson.
On the week beginning 5 December, hospitals with nuclear medicine departments reported to the Programme that services were operating as normal.
“The radioisotope supplier to Ireland also reported that radioisotope shipments had resumed and were operating as normal,” added the spokesperson.
“Throughout the disruption the NCCP were in regular communication with the hospitals to understand patient impacts, while also in regular communication with the radioisotope supplier with regards to supply updates.”
There was also a fall in key performance indicator (KPI) metrics due to capacity issues in CUH. This was “the result of an ACU [aseptic compounding unit]/compounding issue in the unit”.
A “slight decrease” in KPIs in UGH was also due to capacity issues, the meeting heard. In addition, there were “data gaps” in relation to KPIs in St James’s Hospital, Dublin; Letterkenny University Hospital; and SIVUH.
During an earlier discussion on ‘cancer intelligence’ and the related KPI report, the meeting heard that the “situation remains challenging in UHG”.
“[The] recruitment and retention of radiographers was highlighted as a particular challenge,” stated the minutes.
In relation to CUH, the breast cancer KPI was “progressively improving”, while for prostate cancer, overall KPIs had returned to normal. However, the situation at CUH was “particularly challenging”.
“Issues of manpower and process are under review,” according to the minutes.
The meeting heard “the main is -
Our assessment found that repatriation of stem cell transplants to Ireland would reduce the financial, logistical, and emotional burden that these families face.
HIQA’s Director of Health Technology Assessment Dr Máirín Ryan (PhD) speaking on the publication of the Authority’s new health technology assessment of the repatriation of paediatric haematopoietic stem cell transplant services to Ireland.
Throughout her career Prof Hardiman has put her patients and their families first. This has been the main driver for her research and her contribution to advancing professional practice.
A HSE spokesperson told the Medical Independent that the referenced loss of staff and recruitment challenges were “not limited to consultants”.
“[It] is across the board in terms of doctors, nurses, radiation therapists, pharmacists, radiographers, medical laboratory scientists, and others,” according to the spokesperson. “This is not unique to cancer services or Ireland. Recruitment of skilled staff across these roles is a priority.”
Separately, the operation of the National Cervical Screening Laboratory (NCSL) was also discussed at the meeting.
The new NCSL at the Coombe Hospital in Dublin began processing CervicalCheck samples in December.
“The current staffing level at the NCSL is appropriate given the throughput of samples being processed,” said the HSE’s spokesperson. “The Coombe Hospital has recruited 11.9 additional whole-time equivalent (WTE) staff for the NCSL, including the role of Director, and Lead Pathologist for Cervical Cytology, with 5.3 WTE posts under recruitment.”
8 THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 News
While each winter record levels of overcrowding make headline news, our hospitals are operating beyond safe capacity limits all year round, leading to sustained and critical risks.
IMO President Dr Clive Kilgallen speaking on 8 February when representatives from the Organisation addressed the joint Oireachtas committee on health regarding the welfare and safety of workers and patients in the health service.
Dr Mairéad O’Driscoll (PhD), Chief Executive at the Health Research Board (HRB), on the decision to present the HRB Impact Award 2023 to Prof Orla Hardiman, HSE National Clinical Lead for Neurology.
Prof Risteárd Ó Laoide
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The 19th National Health Summit, Croke Park, Dublin, 8 February 2023
ALL REPORTS DAVID LYNCH
Regional health areas cannot be ‘mini HSEs’
The six new regional health areas (RHAs) should not be “six mini HSEs”, Ms Yvonne Goff, HSE National Director for Change and Innovation, told the 19th National Health Summit.
At the meeting, which was held in Croke Park on 8 February, Ms Goff said the implementation plan for the RHAs would be completed in “early 2023”.
“We are currently going through one of the biggest reform programmes in decades in the HSE,” she told attendees. “We are looking to devolve responsibility, authority, and decision-making. It is a very large reform programme.”
“What we don’t want to do, because we have very large entities here, we don’t want to create six mini HSEs. It’s very important that we focus on the ground up and make sure
that we are organising ourselves within an RHA that can deliver on integrated care.”
Kilkenny GP Dr Ronan Fawsitt, who is a member of the RHA advisory group, also spoke at the Summit. He told the Medical Independent (MI) that GPs have a crucial role to play in the new structures.
“At the moment [doctors] are not really aware of it; it’s not on their radar,” Dr Fawsitt said.
“We have had so many promises and false starts with primary care plans, different reports, Hospital Groups, CHOs and now we have RHAs. So they are thinking ‘are we moving the deckchairs on the Titanic?’. But we’re not. This is a fundamental reform and change and general practice needs to be at the heart of it.”
Concerns over rate of staff leaving the health service
The HSE needs to put greater focus on retaining healthcare staff than is currently the case, Mr Stephen Mulvany, acting HSE CEO, told the National Health Summit in Croke Park.
Speaking during an onstage interview, Mr Mulvany admitted the Executive must “work harder and better on retaining staff”.
He added that staff are not only concerned about pay and conditions, but want to be in the optimal position to provide care for patients.
“That to me is the secret to retention,” said Mr Mulvany. “We are losing more staff, there is no doubt about it. The level of turnover... is much higher than it was last year.”
Mr Mulvany referred to staff burnout after the Covid-19 pandemic as one of the reasons for the high level of turnover.
“Are some staff burned out? Yes, of course they are.”
He added that a number of staff delayed their retirement during Covid-19, “and some people delayed travel during Covid, so it is a complex [situation]. There is no one factor.”
On recruitment, Mr Mulvany said the HSE hired 17,800 additional staff between January 2020 and December 2022.
“So there has been more recruitment. But I think retention... that is the area we need to focus more on, because there are only so many staff that you are ever going to be able recruit.”
Earlier at the Summit, attendees heard warnings from the former Deputy Chief Medical Officer at the Department of Health that workforce retention difficulties will threaten policy goals.
Dr Ronan Glynn, who left his Department role last May and is now Health Sector Lead at EY Ireland, told the meeting the health service is facing numerous challenges. These include an ageing population, increased multi-morbidity, inequalities in access to health and “addressing the increasing cost in healthcare provision”.
Dr Glynn added that all these factors will lead to “additional requirements” in terms of the healthcare workforce.
“But it is coming at precisely the time that the WHO [World Health Organisation] is predicting an 18 million global shortfall in the health workforce by 2030,” he warned. “We know the pandemic has had an enormous impact on the healthcare workforce, who were working in extremely pressurised conditions and burnout and fatigue are very real issues.”
Dr Glynn said that retention and recruitment “are key challenges for health systems internationally and Ireland is no different”.
“We are seeing increasing rates of turnover; we are seeing many employees who were due to retire now retiring.”
He noted recent research from the Economic and Social Research Institute predicting the acute care sector will require “up to a 32 per cent increase in doctors, nurses, and allied health professionals by 2035”.
“Increasingly, the key question that is going to have to be asked for any new health initiatives proposed across the health system – where is the workforce going to come from to facilitate the implementation of that initiative?”
He told MI that GPs need to “develop a local voice at every acute hospital in Ireland”.
Dr Fawsitt cited GP engagement with St Luke’s General Hospital, Kilkenny, and Tallaght University Hospital, Dublin, as good examples to follow.
“GPs engage with consultants and can actually influence care pathways in and out of the hospital, front door and back door. I also think that general practice needs to be at the heart of the regional health areas, there needs to be representation on the RHAs in each of the six regions.
“I think there is no way you can move care out of the hospitals into general practice without involving GPs in its design and delivery. It will not happen. I think the earlier we are involved in that the better.”
Pace of Sláintecare implementation questioned
Concerns over the rate of progress with the Sláintecare reform agenda were raised at the National Health Summit in Dublin.
IHCA President Prof Robert Landers told attendees the health strategy “hasn’t yet delivered”.
He said the reform programme has not provided the promised increase in the number of hospital beds or consultant posts.
“We are all these years in the Sláintecare programme now and we are not really seeing it in the hospitals,” Prof Landers said.
He was asked during a questions and answers session whether the new consultant contract would deliver on a core aim of Sláintecare, which is removing private healthcare from public hospitals.
Prof Landers said: “It will play some role.”
“But when you look at the activity in our public hospitals at the moment, only about 4 per cent of the activity… is for private elective care,” he added.
“So, it’s going to take that out, but it is not going to deliver a huge increase in capacity that we need.”
Speaking during the same panel session, Dr Sara Burke (PhD), Director of the Centre for Health Policy and Management, Trinity College Dublin, said “the removal of private practice [from public hospitals] was never about increasing huge amounts of capacity in the system”.
“It was about providing equitable, universal access so everybody got care on the basis of need not the ability to pay. But it is just one cog in a very complicated machine and many more of those cogs need to move at the same time. So a big one that needs to move is this investment in the community... it is beginning to happen, but we need to do much more.”
Dr Burke said her overall assessment of Sláintecare was that implementation is occurring, albeit at a slow pace.
“I think if you look at all the policies and even the HSE service plans, Sláintecare is driving the policy intent. So it is there at a policy level. But I think at an implementation level, it has been slow.”
Dr Burke said that the Covid-19 pandemic contributed to implementation delays.
However, she added the pandemic also “accelerated aspects of Sláintecare”.
“We have seen a bigger investment in the health system, an investment at the level that was laid out in the original report. We have seen a significant increase in workforce despite the challenges.”
Dr Burke said that “clarity” was required on the governance of the Sláintecare programme. She said it was important to know “who is ultimately responsible for providing that reform”.
Mr Robert Watt, Secretary General at the Department of Health, was also part of the panel discussion. He said “as ever, in our system, the person who is ultimately responsible for delivering healthcare reform is Minister [for Health Stephen] Donnelly”.
According to Mr Watt, there had been some “fantastic change” taking place under Sláintecare.
“Most people in this room would also agree with that because that is their experience. But of course, we could do more and that is the challenge.... So the challenge for us is that we have this plan and we are committed to this plan.”
He also said change “can be difficult” for an organisation of the HSE’s size.
A SELECTION OF SOCIAL MEDIA REACTION TO THE NATIONAL HEALTH SUMMIT
“Inspiring start here at the #HealthSummit23 from Brian Dolan OBE. Changing the way we describe things in healthcare can help focus on what truly matters.”
Dr Rachel McNamara, @DrRachelMc
“If you ever get the chance to listen to @BrianwDolan you will be reminded how precious a patient’s time is, so it’s not
‘days in hospital’ it’s ‘days away from home’. We never know when will be our last 1,000 days, but we don’t want to spend them in hospital!
Lu Nugent, @lulunugent
“The HSE’s National Director of Change and Innovation, Yvonne Goff, spoke to the importance in innovating and redesigning regional health
areas to be leading change for service design in Ireland.” E-health Ireland, @eHealthIreland
“Super talk from @ronan_glynn @ey_ireland explaining how models of care are going to fundamentally change from what we have seen over the last 50 years #healthsummit23.”
Paul McCarthy, @PaulMcCarthy1
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 10 Conference Coverage
Building trust in cervical screening
Dr Aoife Doyle , Lead Pathologist of Cervical Cytology at the National Cervical Screening Laboratory, speaks to Niamh Quinlan about developing and growing the service
Dr Gabriel Scally’s final review of the implementation of the CervicalCheck scoping inquiry recommendations was published in November 2022.
During the same month, Dr Aoife Doyle took up the role of Lead Pathologist of Cervical Cytology in the new National Cervical Screening Laboratory (NCSL) at the Coombe Hospital in Dublin. Processing of CervicalCheck samples also resumed at the Coombe in December.
According to Dr Scally’s final review, activity at the Coombe was initially paused due to a cyberattack on the hospital in December 2021.
It had also been affected by the “critical loss” of cytopathologist staff due to retirement and long-term sickness absence. The hospital informed the review that the issues associated with sickness absence no longer applied and there had been engagement with and recruitment of cytopathologists.
In 2018 a strategic decision was made (arising from recommendations of Dr Scally’s first report) to develop a NCSL in conjunction with the Coombe. It is intended that the new NCSL will be a national centre of excellence for cervical screening.
The bespoke laboratory, which began processing samples in December 2022, incorporates accommodation over four floors providing cytology, HPV testing, training, audit, and research facilities. The laboratory is designed to become the principal provider of cervical screening laboratory services for the National Screening Service.
Dr Doyle is a Consultant Histopathologist with a specialist interest in cervical cytology. She was appointed as consultant to the Coombe and NCSL in January 2021.
At the time of Dr Scally’s review (the review team visited the Coombe in August 2022) the requirements of the role of lead pathologist were not met by any member of staff at the Coombe. The report described the role as “critically important to assuring the quality of the cytology element of the new pathway” (HPV primary screening with cytology triage).
Dr Doyle obtained her certificate of higher cervical cytology training from the Royal College of Pathologists, UK, in October 2021 while on maternity leave. Her appointment as Lead Pathologist was a significant step forward for the NCSL.
The new NCSL
Dr Doyle hopes that having a national laboratory will be a reassurance for women using CervicalCheck.
Cervical cytology is a “specialised skill and to be able to provide that on Irish soil… and as a woman who uses the service myself as well, I think that’s what people want”.
Currently, the Quest Diagnostics laboratory service in the US is still taking most of the national workload. Dr Doyle
hopes that the NCSL will become the primary provider of laboratory services for the national cervical screening programme within five years.
However, a key factor is workforce planning, recruitment to key roles and resilience.
She also noted that Dr Scally stated there will always be a need for a second laboratory for resilience in the service.
Dr Doyle said: “We need to ensure that the workloads that we take on can be managed…. We’d all love to see everything here,
The NCSL is currently in the process of “ramping up” its workforce to get the laboratory functioning at full capacity.
Dr Doyle told the Medical Independent: “This service can’t be reliant on any one person. I cannot be indispensable; there needs to be other people who are able to provide the service to ensure that women will always have the service that they require.”
In the cytology screening laboratory, there are currently 6.5 whole-time equiva-
cervical cytology has been reintroduced to the histopathology curriculum in the RCPI Faculty of Pathology.
Recently, Dr Doyle secured a second specialist registrar post in the NCSL, which she described as a “great step forward”.
“We’re going to have two trainees within the histopathology scheme that are rotating through the national cervical screening lab, meaning that we’re exposing doctors at an earlier stage to cervical cytology and hopefully piquing their interest to continue.”
Dr Doyle also acknowledged the possible reluctance by some to join the NCSL workforce for a “variety of reasons”.
She added: “I think probably one of the [reasons for] reluctance that maybe people have – given everything that has happened – is the scrutiny that will be on this lab. And absolutely, there will be scrutiny on this lab. But I welcome scrutiny…. Because it’s only through scrutiny that the public can have the trust that they need to have and the transparency that we should be providing to them in delivering our service.”
Quality assurance is an area of the “highest priority” in laboratory medicine, according to Dr Doyle.
Quality checks take place at each step of the screening process from specimen reception, where each specimen is ‘booked’ into the lab and then double-checked by a second secretary, to the final stage of examination.
Dr Doyle said: “One of my main goals is ensuring that at every step of the way, we are thinking about quality assurance for the patients under our care.”
She continued: “Quality assurance will always be at the forefront of the service that we provide…. With robust quality assurance processes, which are based on the… European guidance for quality assurance in cervical cytology and CervicalCheck quality assurance standards, we can reduce false negatives to the lowest acceptable level that’s comparable with our international peers.”
day one, but that can’t happen safely. This needs to be done correctly and not quickly.”
The NCSL is also working with international experts from cervical screening programmes in other countries. Dr Doyle said “strong links” have been established with programmes including the NHS cervical screening programme and training centres, such as the North of England Pathology and Screening Education Centre.
She added: “We always have learned from other countries and from our international colleagues, because we’re all a team in this, we’re all trying to do the best for the patients under our care. And there’s so much to learn from established systems.”
lent (WTE) screening scientists.
“In and around 16-to-18 [WTEs] ultimately would be the number that we would need to provide the majority of the service to the country,” according to Dr Doyle. Another consultant histopathologist has also been recruited to the lab.
As part of this workforce planning, the NCSL focuses on training within the laboratory to ensure “resilience longer term”.
Dr Doyle hopes the work done at the NCSL will “inspire trainees to at least consider entering into a role in this laboratory”. An in-person histopathology study day, held in January 2023, was a recent event to help generate such interest. Training in
The final Scally review stated there was now an excellent system of quality assurance for laboratory service provision in place, with a robust operating procedure developed by a quality assurance steering committee with international and national expertise.
However, at the time of the review, some quality assurance issues highlighted as “non-compliances” remained unresolved. These issues included access to IT and workforce recruitment, such as the recruitment of a second medically qualified consultant. According to Dr Doyle, these issues have been resolved since she took up her role.
She added: “My priority is to ensure that we meet the quality assurance standards to the best of our ability at every level so that people can have confidence in the service that we’re providing in the NCSL.”
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 12
Dr Aoife Doyle
It’s only through scrutiny that the public can have the trust that they need to have
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Resilience in the face of war: An update from an ED in Yemen
Eight years into the conflict, the war in Yemen is impacting every area of life for people in the district of Ad Dahi. Dr Matt Cloutier is part of the Médecins Sans Frontières team there and shares this update
It was my first week working as an emergency department (ED) doctor with Médecins Sans Frontières (MSF) in a rural hospital in the village of Ad Dahi in northwestern Yemen. Ad Dahi is small, but our hospital is the only one for miles which provides healthcare free of charge, so we are usually quite busy.
It was the end of a long day. In the ED, we typically see 70-to-100 patients every 24 hours and our 46 paediatric inpatient/intensive care beds are almost always fully occupied.
I was walking home with a nurse who is here to help with one issue in particular: Malnutrition.
About 50 per cent of our patients at the hospital are children and they come in with a wide variety of illnesses, including bacterial infections (lungs, meningitis, wounds, diarrhoea), convulsions, trauma, complications of sickle cell anaemia, dengue fever, and malaria.
However, one of the most difficult and complicated issues we see here is that of severe acute malnutrition.
The mothers we see in the ED are often gaunt and their babies look emaciated. Mothers often don’t have breastmilk to feed their babies because they themselves are malnourished, so they feed them sugar water or goat milk. These don’t have the right nutrients for infants to grow and can even be a source of illness – for example, if the water is contaminated.
Often, these babies will be eight-to-12 months old, but look like a premature neonate, weighing less than a few kilogrammes. Their skin is pulled taut over their tiny faces, and you can see every rib with every breath.
Dr Matt Cloutier
That day, I’d treated several of these babies in the ED. Their little distended bellies were covered with tiny scabs in patterns, and my Yemeni colleagues explained that when a child has a persistent health problem, traditional healers will make little burns on the skin. Here it is a sign that the problem is chronic – if they have gotten that far, it means that they have tried everything else.
The families are always trying everything within their power to help their children, but the sad truth is that if they could consistently afford adequate, nutritious food, it would fix nearly everything.
At the hospital, the families are keen to follow our recommendations, but we can
only do so much. We admit the babies to the ward, administer fluid, antibiotics, and specially formulated therapeutic milks. However, many of these babies are so sick that they need specialist care that our hospital is not equipped to provide and families cannot afford to access in a private hospital elsewhere.
For those who do survive their complications and start to regain weight from therapeutic foods, the families often need to take them home as soon as possible so they can care for the rest of their children. Once home, many cannot afford transport to the community feeding centres, so their children become progressively malnourished again, and the cycle continues.
Since I’ve been here, I’ve learned that almost all of the most common causes of
illness and death in children can be linked to the ongoing conflict.
The economy has been crippled by the conflict, which means not only that food and fuel are unaffordable to many, but also an increase in illnesses caused by poorly maintained infrastructure leading to contaminated water and food.
There are both public and private hospitals with well-trained staff here, but they are now overcrowded and largely defunded.
In our ED, we see diseases, which would normally be prevented through vaccination programmes, are returning. Women and babies are rushed in with childbirth complications, which could have been avoided through pre-natal checks or maternity care. Very often, patients die of illnesses that they otherwise would have survived had they been in a different context.
Locals tell me that before the conflict, roads were relatively well maintained and people followed traffic rules enforced by police. Now, the most common problem we see in adults at the ED is trauma by road traffic accident resulting in fractures, dislocations, haemorrhage, and brain injuries.
Kind and accepting
As my colleague and I walked the dirt road, that day in my first week, we were greeted by smiles, waves, and greetings of “salam!” and “hello!” from people of all ages. The people of Yemen I have come across have all been incredibly kind and accepting.
It made me think about the medical team (doctors, nurses, nurse aids). It is one of the most cohesive groups I have ever worked with, staying positive even under incredibly stressful situations, and always putting the patients first.
As we walked, a few donkey carts passed us carrying massive loads of fresh fruit. There were bananas, oranges, papayas, and apples. Many of these only cost about $1-2 (USD) for a kilogramme or more.
With so much food and it being so inexpensive, I asked my nurse colleague why we are seeing so much malnutrition. This is not like other contexts, where there is no food at all.
He answered in his usual way, short, quiet, with a shrug – “no money”.
That’s the reality here. The crisis here may not be a famine, but it is a humanitarian disaster unfolding in the shadow of this war.
The people here are generous, kind and hard-working. It is clear to me that with the constraints of this conflict removed, this place would flourish. The joy and positivity that I see on the street is put to the test by the difficulty we see in the hospital.
For more on MSF’s work in Yemen and around the world, see www.msf.ie
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 14
Since I’ve been here, I’ve learned that almost all of the most common causes of illness and death in children here can be linked to the ongoing conflict
The emergency department typically sees 70-100 patients every 24 hours
How the Medical University of Bialystok prioritises the integration and support of international students
As the globalisation of medicine expands, so does medical education. Many students now travel abroad to learn their clinical practice – either to bring home those skills or elsewhere.
It is important there are facilities and amenities for international students so they are able to fully integrate into student life and cultural life in a new country.
The Medical University of Bialystok (MUB) is located in Eastern Poland. It has a strong reputation for the recruitment, integration, and support of international students studying medicine within its English division. MUB has a wide range of extra-curricular activities and clubs for their students.
According to university: “The international community of English-speaking students is very active. They organise football tournaments, celebrate their national holidays, and integrate very well into the local community.”
The English division currently has students from over 30 countries, including Ireland, and offers a six-year MD programme with admission for 2023/2024 now open.
International students are also able to receive help on all aspects of life at MUB from the Welcome Centre.
According to MUB, the Centre’s staff are fluent English speakers, trained in assisting foreign students, and have attended international cooperation workshops, intercultural communication workshops, and specialised English language workshops. Issues that the Centre will assist with include opening a bank account, making a doctor’s appointment, organising a place to live in dormitories or off campus, and helping with Polish-English interpretation on other official matters.
The Welcome Centre is open Monday to Friday from 7.30am to 3.30pm and also has a suggestion box at the entrance to help drive continual improvement.
The Centre, alongside the Promotion and Recruitment Office in MUB, also organise integration events regularly. According to MUB, the university holds a range of social events for their academic community as a whole, “designed as an opportunity to bring us all together into a solid community.”
MUB also holds international activity days such as an international sports day and an international karaoke night, with prizes for participants and winners. Both events were funded by the Polish National Agency for Academic Exchange under the Welcome to Poland (2020) programme.
The university also organised another international integration event near the beginning of this semester: Welcome to Bialystok – [1st] International Sightseeing Day. The daylong event included a tour of the city of Bialystok and the nearby town of Tykocin, as well as providing food and snacks.
The university said: “It is an ideal opportunity to get to know the local culture, architecture, traditions, and regional cuisine.” The event was also funded by the Welcome to Poland programme.
The university also has a number of student organisations, similar to societies, including the University Choir, a student’s parliament, a Medical Association for Students of Spain in Bialystok, and an American Medical Student Association MUB Chapter.
The ‘CoNieCo’ student club organises events for entertainment, artistic meetings, and concerts. The club describes itself as “primarily a meeting place” and that it consists of “a group of friends and good acquaintances who, in addition to knowledge and skills, want to take unique memories from their studies”.
In September 2020, the International Cooperation Department launched the free app ‘myMUB’. It is “intended to make the everyday lives and experience easier and smoother for people who have come to our university from abroad”.
According to MUB: “The myMUB mobile application is a tool meant to facilitate the functioning of English-speaking students, PhD students, and scientists at the [university] as well as their integration with the entire MUB academic community.”
The university also said that, in its first two weeks of being live on the app store, the app was downloaded over 300 times.
Features on the app include an interactive campus map, with virtual walks and indicators of the nearest parking facilities. Information on currency exchanges from a range of foreign currencies are also available on the app. Information about Bialystok city can be accessed on the app, highlighting places to visit, public offices, and sports and cultural facilities.
The app also includes “essential” information on admission and tips for foreign students. It contains information on matters which the Welcome Centre can provide assistance, such as contact information of staff and emergency numbers.
The app also includes a module on International Cooperation.
This is “a module which describes, among others, MUB’s international cooperation with other centres from abroad, contact persons, [and] a procedure for applying for trips abroad”.
MUB’s International Cooperation Department is implementing the university’s Internationalisation Strategy 20212030. The strategy was published in May 2021 and aims to expand education offered in English, participate in international programmes such as ERASMUS+ and NAWA [the Polish National Agency for Academic Exchange], and obtain more international credits, among other planned actions.
So far, MUB has been included in 12 international university ranking lists, including on the Times Higher Education world university rankings where it is placed 1001-1020; US News Best Global University ranking where it is placed 742nd in the Clinical Medicine category; and the SCImago Institutions Rankings where it is placed 599th.
According to the university, inclusion in these rankings
will not only make MUB more attractive to incoming students, but will also positively impact graduate students in the labour market.
“The position in the international rankings is connected, not only with the scientific and teaching, [but also] infrastructure potential,” the university said. “Many times it also depends on the reputation of a university in the international research community.”
The university also currently has or is applying for three international accreditations, they allow international recognition of the universities achievements in education and other services. They include the Aspire to Excellence Certificate of Merit in Student Engagement from the Amee organisation of health professional education, the Agency for Public Health Education Accreditation (APHEA) certification of programme accreditation, and recognition from the Medical Board of California.
On campus, MUB offers several facilities in close proximity to each other, such as the Centre for Medical Simulation, the Experimental Medicine Centre, and the largest scientific medical library in the region. The university headquarters are also in the Branicki Palace, an 18th Century, Baroque-era, palace located in the city centre.
The city of Bialystok has been a multicultural hub since the 19th Century, with many different nationalities coming to the city to develop the economy and culture.
On its website, the university also recommends exploring the Podlaskie region, such as the nearby town of Tykocin. Appiah Sakyi Nana Adoma Nyamekye, a student attending MUB originally from the UK, said: “I think the city is very good, it is a very good student city. It is enough to keep you interested, but not too much to distract you.”
Two student accommodation dormitories are on campus, at a less than 10-minute walk to the clinical departments. The two dormitories are located near Branicki Park and the Philharmonic Hall, cinemas, sports facilities, shopping centres, restaurants, pubs, and clubs, all within walking distance.
Students who are part of the English Division stay at Dormitory 2, with a social area, laundry, and kitchen available on every floor. According to the university: “Residents can also use other amenities, such as a recreation room, photocopy centres, a convenience store, and a TV room.”
Monthly rent for 2022/2023 for one room in a unit with two single rooms and a shared bathroom range between 620 to 850 Polish Zloty – or €132 to €181 respectively. Highspeed internet is also available at an additional monthly fee.
If there are no vacancies available in the Dormitory, the Welcome Centre will provide contact details to a verified real estate office, which will help to arrange the formalities related to renting a flat or room off-campus.
More information about MUB and the facilities it offers is available on its website.
The article is financed by the Polish National Agency for Academic Exchange under the Welcome to Poland (2020) programme. Grant agreement no. PPI/WTP/2020/1/00017/U/00001
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 15 Feature Commercial
Medical simulation: Improving training and diagnostics to enhance patient care
Prof Dara Byrne and Dr Ann O’Shaughnessy provide an update on the RCPI’s simulation governance project
In recent years, simulation-based education has become a vital component of postgraduate medical education. This has been spurred on by improved understanding of how skills, knowledge, and behaviours are acquired, the prioritisation of patient safety and improved quality of care, and advances in the technology available to support the educational development of healthcare providers.
Simulation can be used to improve the individual, the team and the system. A translational simulation approach (irrespective of the location, modality, or content of the simulation) has been proven to support quality improvement efforts in hospitals. And what we are seeing now is increased support for simulation as a tool to address safety culture within organisations.
The RCPI has been incorporating simulation-based education into several of our programmes since 2014. We are now working to inform and implement a coordinated approach across all our training programmes through the simulation governance project.
Commencing in 2022, the project aims to develop and implement a College-wide strategy for managing the design, delivery, and evaluation of simulation-based education across all specialties. The project has gathered some momentum in consultation with stakeholders across the health service, and as we move towards implementation, we are entering into a second phase of consultation and evaluation.
When used correctly simulation has been shown to improve patient outcomes. In translational simulation, education and training is directed at a specific healthcare outcome target, not just an assumption of improved system performance as a result of improved individual knowledge or skills. Some examples include: Lowered infection rates as a result of targeted training for
General medicine registrars in the Saolta University Health Care Group attending an ultrasound basics course
central line insertion; reduction in perinatal asphyxia and neonatal hypoxic-ischaemic encephalopathy following team training for obstetric emergencies; and survival in cardiac arrest with a rapid cycle deliberate practice simulation approach. Improved outcomes for trauma patients, including decreased times from patient arrival to the CT scanner and to the operating room, have been reported following an in situ TeamSTEPPs educational intervention. There, targets involve individual and team knowledge and skills, but also complex, context-specific system issues.
Simulation provides opportunities for standardised clinical experiences and offers a safe environment to learn, rehearse, and practice safely. Simulation is useful for learning as an individual or within a team and can be used for mastering practical procedures as well as non-technical skills and supports a human factors approach to education and training. Interprofessional teams learning together improves psychological safety beyond
the simulation event. The knowledge, skills, and attitudes learned in simulation translate out into the working environment.
Using simulation as an educational intervention to directly improve patient outcomes and as a diagnostic tool to examine error or problems is a very powerful tool for modern healthcare organisations to improve the quality of patient care.
Introducing simulation into postgraduate training programmes requires careful planning to ensure effectiveness and sustainability. The RCPI has already incorporated
of the RCPI simulation governance project is to ensure that the RCPI’s simulation training is aligned with the priority areas identified in the National Strategic Guide to the Implementation of Simulation on Clinical Sites (March 2022). The guide outlines priority areas for the HSE and local sites to ensure that simulation activities meet an international standard, are accessible and resourced, and become embedded within healthcare education and provision organisations.
Within the College, the project informs –and is informed by – the outcome-based education review and the mandatory teaching review, with the combined aim of improving the quality of training and assessment for all RCPI trainees.
Long-term the project will manage the design, delivery, and evaluation of simulation-based education across the specialties.
To date, the project team has developed a project charter, met with key stakeholders, including those managing and working on simulation sites across the country, and established a steering committee consisting of the faculties, institutes, and other key groups to form a steering committee. We propose to identify several clinical sites and support them to develop their simulation capabilities. This will be done in line with the national strategic guide and the national simulation office, due to be established this year, and in collaboration with site staff and management to understand current and future capabilities. This is key to ensuring the success of the implementation plan.
Over the next six months the steering committee will meet monthly to oversee and implement a governance structure and strategy for the future development and delivery of all RCPI simulation programmes. Members of the committee will attend a workshop led by Prof Dara Byrne covering the key tenets of simulation training and the current situation nationally. A series of ‘Train the Trainer’ courses are also being developed for people intending to develop new simulation programmes in the future and will be rolled out as part of the implementation plan.
simulation-based education into several of its programmes. The next phase requires a coordinated approach across all our training programmes; the focus on the use of simulation needs to move from supporting the individual with procedural skill training to a team and interprofessional approach.
It is widely agreed that simulation is of significant value for hospitals and healthcare education. However, it must be better resourced. We need simulation facilities and expertise to be expanded and located on clinical sites across the country to see the system and our patients truly reap the benefits.
How will the simulation governance project help?
At the national level, one of the key objectives
Simulation-based education and the use of simulation as an educational intervention and diagnostic tool will continue to advance patient care. Ensuring that simulation activities are standardised, meet international standards and are sustainable requires considerable work in the form of strong expert leadership, faculty training, resource management, programme design and development, and quality assurances.
A coordinated approach to this across training bodies, higher education institutes, healthcare organisations, and healthcare professions is now required to ensure success.
The RCPI simulation governance project is led by Prof Dara Byrne and Dr Ann O’Shaughnessy.
References available on request
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 16
When used correctly simulation has been shown to improve patient outcomes
PROF DARA BYRNE, RCPI Clinical Lead for Simulation; and DR ANN O’SHAUGHNESSY, RCPI Head of Education
Dr Bernadette Lynch, Consultant Rheumatologist at University Hospital Galway, guides RCPI trainees through a simulated knee aspiration
Genuair®-has it ‘clicked’ yet?
The ONLY prefilled inhaler with visual and audible feedback for confirmed dose delivery1-4
Genuair - a simple to use inhaler for patients with COPD4
Abbreviated Prescribing Information
Eklira® Genuair® 322 micrograms inhalation powder. Please consult the Summary of Product Characteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a white inhaler with an integral dose indicator and a green dosage button. Each delivered dose contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium. Also, contains lactose. Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Dosage: For inhalation use. Recommended dose is one inhalation of 322 micrograms aclidinium twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to aclidinium bromide or to any of the excipients. Warnings and Precautions: Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Use with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma. Do not use in patients with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption. Interactions: Do not administer with other anticholinergic-containing medicinal products. No other interactions expected. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Risk to newborns/infants cannot be excluded. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Sinusitis, nasopharyngitis, headache, cough, diarrhoea, nausea. Uncommon (0.1-1%): Dizziness, blurred vision, tachycardia, palpitations, dysphonia, dry mouth, stomatitis, rash, pruritus, urinary retention. Rare (0.01-0.1%): hypersensitivity. Not known: angioedema, anaphylactic reaction. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing Authorisation Number: EU/1/12/778/002
Marketing Authorisation holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: February 2020
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 to: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@ hpra.ie. Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744.
Date of item: November 2020. IR-BRI-09-2020
Abbreviated Prescribing Information
Brimica® Genuair® 340 micrograms/12 micrograms inhalation powder. Please consult the Summary of Product Characteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a white inhaler with an integral dose indicator and an orange dosage button. Each delivered dose contains 396 µg aclidinium bromide (equivalent to 340 µg of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate. Also, contains lactose. Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage: For inhalation use. Recommended dose is one inhalation of 340 µg/12 µg twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Do not use in asthma. Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Discontinue if increases in pulse rate, blood pressure or changes in ECG occur. Use with caution in patients with a history of or known prolongation of the QTc interval or treated with products affecting the QTc interval. Use with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma. Hypokalaemia may occur, is usually transient and supplementation not needed. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment. Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Do not use in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Interactions: Do not administer with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products. Caution in use with methylxanthine derivatives, steroids, non-potassium-sparing diuretics, β-adrenergic blockers or medicinal products known to prolong the QTc interval. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Nasopharyngitis, urinary tract infection, sinusitis tooth abscess, insomnia, anxiety, headache, dizziness, tremor, cough, diarrhoea, nausea, dry mouth, myalgia, muscle spasms, peripheral oedema, increased blood creatine phosphokinase. Uncommon (0.1- 1%): Hypokalaemia, hyperglycaemia, agitation, dysgeusia, blurred vision, tachycardia, electrocardiogram QTc prolonged, palpitations, angina pectoris, dysphonia, throat irritation, stomatitis, rash, pruritus, urinary retention, increased blood pressure. Rare (0.01-0.1%): Hypersensitivity, bronchospasm, including paradoxical. Not known: anaphylactic reaction, angioedema. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing
Authorisation Number: EU/1/14/963/001 Marketing Authorisation holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: October 2019
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 via
Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@ hpra.ie. Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744. References: 1. MIMS Ireland November 2020 2. Eklira® Genuair® Summary of Product Characteristics, last updated November 2019 3. Brimica® Genuair® Summary of Product Characteristics, last updated August 2019 4 Magnussen, H et al. COPD. 2019 Apr;16(2):196-205
LAMA + LABA
Arecently published country profile by the Organisation for Economic Co-operation and Development (OECD) for the European Cancer Inequalities Registry provided further evidence of positive trends in Ireland with regard to cancer.
It highlighted the per capita mortality for nine of the 10 most common cancers between 2011 and 2019. Overall cancer mortality in this period reduced by 14 per cent for men and 13 per cent for women.
The OECD report said Ireland’s increased five-year cancer survival rates were indicative of “high-quality care”.
For the first time, the number of patients living after an invasive cancer diagnosis had exceeded 200,000. This was the equivalent to one-in-24 people in Ireland.
In a press release for World Cancer Day (4 February) following the publication of the report, the Department of Health highlighted the extra investment made in cancer services in recent years. The implementation of the National Cancer Strategy 2017-2026 was supported by an additional €20 million in funding in 2021 and again in 2022.
"Tackling cancer is a mammoth task, but we are seeing progress, and I’m very heartened that we are reporting increased survival rates and seeing more people live longer with, and beyond, cancer," according to Minister for Health Stephen Donnelly.
Positive developments are occurring, such as the CAR T-cell treatment programme, which recently opened in St James’s Hospital, Dublin. Also, in this issue of the Medical Independ-
ent (MI) we interview Dr Aoife Doyle about her welcome appointment as Lead Pathologist of Cervical Cytology at the National Cervical Screening Laboratory, which finally began operating in December 2022.
However, serious challenges remain. Another story in this edition of MI is about continuing capacity concerns within the area. The issue of capacity deficits has been raised repeatedly at executive management meetings of the National Cancer Control Programme. It was also raised at the HSE safety and quality committee meeting in October, with particular reference to recruitment.
HSE Chief Clinical Officer Dr Colm Henry told the meeting that “the loss of experienced staff and difficulties in recruiting new staff is impacting on services and may be adding to capacity challenges”.
Recruitment difficulties do not just apply to cancer care. It is a wider issue with which the health service has been struggling for some time, for a variety of reasons. At the recent National Health Summit in Croke Park, Mr Stephen Mulvany, acting HSE CEO, referred to staff burnout after the Covid-19 pandemic as one of the reasons for the high level of turnover across the HSE.
The delays to diagnoses and treatment caused by the pandemic have also put more pressure on already stretched services, including cancer care.
It is right to acknowledge the progress that has been achieved in cancer outcomes. But if this progress is to be maintained, there are many fundamental issues that still need to be tackled.
REACTION TO OUR NEWS FEATURE, '2023: A NEW START FOR GENETIC AND GENOMIC MEDICINE IN IRELAND', 7 FEBRUARY
“Nice piece from David Lynch on the potential of the new National Strategy for Accelerating Genetic and Genomic Medicine in Ireland." Systems Biology Ire, @sysbioire, 10 February
“I give my two (Euro) cents worth on how the strategy indeed ‘lays out a wider vision for Ireland’s future genetic and genomic service', but it ‘needs a stronger bioethical lens than currently the case.'" Oliver Feeney, @FeeneyOliver, 7 February
REACTION TO OUR EDITORIAL, 'HSE NEED MORE GOVERNMENT SUPPORT TO ROLL-OUT NATIONAL EHR', 7 FEBRUARY
“EHR requires significant ongoing investment. It appears @merrionstreet made the decision not to fund the IT required by @HSELive to implement the EHR. HSE getting blame! @slaintecare can’t be implemented without significant investment in IT. #CareCantWait @davidcullinane." Jackie O’Connell, @JackieMeath, 10 February
REACTION TO MEDICO-LEGAL ARTICLE BY DR MARY DAVIN-POWER (MEDISEC), 'DIAGNOSTIC UNCERTAINTY IN CLINICAL MEDICINE', 7 FEBRUARY
“Clinical risk advisor with Medisec, @MaryDavinPower hWas written this fascinating article in @med_indonews analysing the different factors that arise when doctors are considering diagnoses." MedisecIreland, @MedisecIreland, 7 February
REACTION TO OUR NEWS STORY, 'HSE CHANGES REPORTING LINE OF CONFIDENTIAL RECIPIENT DESPITE OPPOSITION', 7 FEBRUARY
“They do what they want despite advice. Ask about this please @HollyCairnsTD @TomClonan at Oireachtas disability forum. Who does it benefit most and who loses out etc?" Breeda Murphy, @breeda_murphy, 7 February
REACTION TO OUR NEWS STORY, 'DEFENCE FORCES SPENT OVER €5M ON AGENCY DOCTORS SINCE 2019', 7 FEBRUARY
“Not unlike the States #SAR service, better to spend our limited resources on private contractors than to pay our @DF_Medics a proper salary. Shameful waste. Defence Forces spent over €5 million on agency doctors since 2019." Senator G Craughwell, @GCraughwell, 7 February
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Progress in cancer to be welcomed, but many challenges remain
Calling the doctor-witness
As giving evidence at court can be a daunting prospect, Dr Ian Lavelle outlines a case scenario and provides advice
Dr V, a GP trainee, received a witness summons to provide evidence at family court. As part of her GP training scheme, Dr V had previously worked in paediatrics in the local public hospital. She had been involved in the care of a seven-yearold boy. During the patient’s admission, safeguarding concerns had been raised, as the patient had bruising consistent with non-accidental injury. After investigation by Tusla, the child had been placed in the temporary care of his maternal grandparents.
Dr V’s role at the family court was as a ‘witness to fact ’ , regarding her involvement in the patient’s care as an inpatient. The court asked Dr V to send in the statement she had already prepared, so that they could review this and discuss in more detail what to expect at the family court.
As a doctor, you may be asked to give evidence in many different types of hearings throughout your career. These may include the family, criminal, civil or coroner’s court, or an employment, mental health or fitness to practise tribunal.
What happens if you are called as a witness to court?
If you are called as a witness, it may be helpful to remember that your role is to provide impartial evidence to help the court reach its decision. You will either be required as a professional witness to supply factual information obtained in your capacity as the treating doctor in a particular case, or as an expert witness to provide an independent opinion on the facts of a case that you have not been personally involved in. In either scenario, it is important to stick to the facts, and not to stray into providing opinion beyond the scope of your expertise.
You will usually be put on notice that your attendance is required and asked beforehand for dates that are convenient to you. However, if you are served with a witness summons or subpoena, you must attend at the specified time and for the set duration. If you do not comply with a witness summons, you risk being found in contempt of court – this is a criminal offence and might, in addition, result in you being reported to the Medical Council. If you receive a witness summons but believe that you have a legitimate reason for being unable to attend, you should seek advice as soon as possible from
Medical Protection or your medical defence organisation.
It is worth mentioning that your duty of professional confidence is not automatically waived by being called to give evidence; therefore, you should not disclose or discuss confidential information without the patient’s express consent. If you are asked for this information, you should explain that you do not have the necessary consent to provide it and await the direction of the court. Furthermore, if you perceive any conflict of interest on your part you are obliged to make this known. However, you must disclose information when ordered by a judge in a court of law, or by a tribunal or body established by an Act of the Oireachtas.
Preparation for going to court
It is helpful to fully familiarise yourself with the case before attending court, as follows:
Read through your report and ensure you are fully familiar with it.
Review the medical records so that you are aware of the important facts of the case.
Be clear who has called you to attend.
Find out where the court is and how long it will take you to get there.
Find out how long you will be needed for.
Make sure the medical records and a copy of your report will be available at the court.
Make sure you have adequate cover arrangements in place for the duration of your anticipated attendance.
On the day, you should:
Dress professionally. In addition to being respectful, you are also likely to feel much more confident when giving your evidence.
Get to the court in good time – there is nothing worse than rushing or arriving late.
Take the medical records with you, if you have them, as well as a copy of your report.
Expect to be kept waiting.
The procedure is fairly similar for civil and criminal courts. The claimant in a civil action or the prosecution in a criminal trial will put their case first. Their witnesses will give evidence and be cross-examined; once this has happened, the other side will respond. After the evidence has been heard, both parties will make
closing speeches and the judge will sum up the evidence.
In a civil case, the judge will decide, on the basis of the law and the evidence presented, whether to find in favour of the claimant or the defendant. In most cases, the judge will also decide on the level of compensation that should be paid. In a criminal case, the judge will sum up the evidence and advise the jury on the law to be applied. The jury will then deliberate on the facts and give their verdict.
Whether you are giving evidence at a civil or criminal court case, the processes start off in a similar way. When it is your turn to give evidence, you will be shown to the witness box. A court officer will ask you to swear that the evidence you are about to give is the truth.
You will firstly undergo what is known as the examination-in-chief, the purpose of which is to make your evidence clear. The lawyer for the party that called you will take you through your evidence. The judge may wish to ask you questions to further clarify your evidence at this stage.
You are then likely to be cross-examined, during which the lawyer acting for the other party will question you about your evidence. Remember: Their role is to draw attention to any contentious issues of fact or opinion.
After the cross-examination has finished, the lawyer that called you may wish to re-question you to clarify any issues that may have been raised during the cross-examination. Once this has happened, the judge may wish to question you.
Tips on giving a successful performance in the witness box:
Remember that you are impartial – your duty is not to one side or the other. You are there to assist the court.
Speak clearly, using short sentences –try not to over-elaborate and explain any technical terms you may have to use.
You are giving evidence to the judge/coroner/chair, so ensure that you face them when answering a question.
Listen carefully to each question. Make every answer open, honest, and fair.
If you don’t know the answer or understand the question, say so.
Don’t lose your patience with the opposing counsel. Lawyers are working on behalf of their clients and disparaging comments can be a deliberate tactic – the best witnesses are those that remain neutral and focused.
You can appeal to the judge if you feel that a question is improper, or if you would like to expand on your answer.
Remember to take as much time as you need for each answer. A conscientious witness will pause for as long as necessary before speaking to ensure that they are giving evidence that really is “the truth, the whole truth, and nothing but the truth”.
For more tips visit medicalprotection.org/ ireland/resources/factsheets/factsheets/ roi-giving-evidence It is advisable to contact your medical defence organisation if you receive a request to attend a hearing.
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 19 Medico-Legal Opinion
DR IAN LAVELLE , Medico-Legal Consultant, Medical Protection
It is worth mentioning that your duty of professional confidence is not automatically waived by being called to give evidence; therefore, you should not disclose or discuss confidential information without the patient’s express consent
A melting pot of the bad and good
Coming to the US has made me reflect on the negative and positive legacies of immigration
DR MICHAEL CONROY
Read more by Dr Michael Conroy at www.mindo.ie
My neighbourhood in Baltimore, Canton, feels like a large brick village despite being on the edge of the city centre. It has a patchwork of townhouses, schools, some churches (including a Ukrainian one with golden spires) and a famous ice cream parlour, perversely still bustling in January. And it has a town square where society happens – O’Donnell Square. There are barbers, bars, and the kind of snooty coffee shop that sustains me. For years the square was overlooked by a statue of its namesake, John O’Donnell. A Limerick man who made a fortune trading in China (hence his estate was ‘Canton’), he was also a slaveowner. The statue was removed following the murder of George Floyd in 2020, although his name lingers on the square, streets, and housing developments.
For an Irish man immigrating to the US, it’s a pinching reminder of our mixed history as a people here. Our two-tone legacy is everywhere you look in the city. Its name came from the Anglo-Irish Baron Baltimore, one of the founders of a settlement that thrived while native people died from imported diseases. Its scattered Catholic schools educated generations of Irish Americans, but harboured abusers too. Its movers and shakers include former Mayor and Maryland Governor Martin O’Malley,
famous for progressive politics, but also anti-crime policies that left African American communities feeling more persecuted than ever. While the emblem image of Irish immigrants to America is victims fleeing famine, helpless, and almost hopeless, many before and after the famine were far from weak and far from angels.
Locals would be forgiven for treating this mixed history with a mixed response when they meet us. Instead, like virtually anywhere in the United States, introducing yourself as Irish elicits near-universal positivity. You are pre-ordained as a chancer and a charmer even if, like me, chancing and charming are not high on the CV. I’ve kept the façade up for now.
In fact, Americans take an uncommon delight in finding out who you are. This is not a strict question of where you were born. Anyone who has visited will be familiar with Americans whose ancestors left Moycullen two centuries ago still introducing themselves as Irish. When I first encountered this as a college student, we used to laugh at what seemed like an absurd clutching at Irish straw. Over the years, though, I’ve come around. I think we just have different ideas of what that tribal identity means.
So wildly diverse are the roots of American society that they have a very un-European approach to national identity. Half of the effort celebrates what they hope binds them – the beliefs in free speech and association, pursuit of happiness, and the other staples. They’re meaningful, but maybe a bit abstract. So for many in this nation of immigrants, their ancestry is the neatest way of defining their fit in the jigsaw puzzle. Sometimes it’s a nation, sometimes a religion, and sometimes a race. You may be Italian or Irish
A linguistic tour of Aussie slang
or Jewish, despite having never visited Italy, Ireland or a synagogue, but it is important that you are something. It’s a talisman that people bear with pride long after their living connections with that background have died.
In recent years, the prevailing winds of Irish media coverage about American society have been polar. This is fair sometimes. The killing of George Floyd and rise of militant nationalism were horrors and it is worrying when slow progress seems to become no progress at all. As I write, America’s cities are filled with protests over the death of Tyre Nichols after being beaten by Memphis police. You can see how people are cynical. I’m also mindful that this warmth of welcome for immigrants can be coloured by colour, and that too many immigrants suffer racist experiences.
But nor are things hopeless here, and this picture can ignore some extraordinary strengths. This city and my hospital are by far the most diverse places I have ever lived and worked. If America has historically been sceptical about first generation immigrants, it is also true that their following generation seem to weave into the fabric of the nation faster than anywhere else. My institution thrives by trying to draw on talent no matter where it comes from.
Like immigration anywhere in the world and like America itself, Baltimore’s immigrant experience is complex and messy and does not always have clear good guys and bad guys. But I like their celebration of many identities under an umbrella of some common values, and I think Ireland might do well to sometimes look with less jaded eyes towards our neighbours across the water. We have lived, and perpetuated, the best and worst of it.
Experiments by Australian linguists have confirmed the social effects of the country’s colourful colloquialisms
DR MUIRIS HOUSTON
Read more by Dr Muiris Houston at www.mindo.ie
Readers will be aware of my fascination with language and, in particular, its idiosyncrasies. A Christmas visit from my youngest (sadly, now one of our young medical diaspora) was an opportunity to catch up on the latest Australian English.
She tells me that converting as many words as possible into a diminutive ending in -o is de rigueur. Afternoons don’t exist Down Under, but ‘arvos’ do! The -ie diminutive isn’t far behind: The Australian ‘selfie’ was the Oxford English Dictionary’s “Word of the Year” for 2013 and is now happily ensconced in mainstream English.
But there are plenty of other notable -ie exports : ‘Budgie’, ‘greenie’, ‘pollie’, ‘surfie’, even ‘mozzie’ are now also making appearances in global English. In fact, such is the influence of ‘Strine’ (Aussie-English) that many of our regularly used phrases, such as ‘no worries’, ‘to put the boot in’, and ‘to rubbish (someone)’, came to us from Down Under.
Apparently, the Australian attachment to ‘slanguage’ (slang language) goes back to the earliest settlements of English speakers in Australia. As Edward Gibbon Wakefield noted in his 1829 Letter from Sydney : “The base language of English thieves is becoming the established language of the colony.… No doubt [terms of slang and flash]
will be reckoned quite parliamentary, as soon as we obtain a parliament.”
In those early days of exporting British criminals to the Antipodes, slang became an important way of fitting in and avoiding being labelled a stranger (or ‘new chum’).
Australians don’t agree with those who say they are lazy for clipping words. They are adamant that it’s just Aussies knocking words down to size – ‘Ta, we’ll have a glass of cab sav or savvy b instead of whatever that is in French.’
To add science to my research, I found a paper in The Conversation from some linguists at Monash University in Melbourne. They see the shortening of words as “endings that bond and bind us”. So pet names with endings in -ie and -o can show we have a warm or friendly attitude toward something or someone. Certainly, on names, -ie/y and -o are often affectionate (think ‘Susy’ and ‘Robbo’).
But, the academics note, the vast majority of Aussie diminutives are doing something different. For Australian National University linguist Anna Wierzbicka, these expressions are among the most culturally salient features of Australian English – expressions of informality and solidarity that are “uniquely suited to the Anglo-Australian ethos […] and style of interaction”.
Experiments by Australian linguists have confirmed the social effects of these embellished words. Colloquialisms, such as ‘barbie’ and ‘smoko’, are like accents – part of the glue that sticks Australian English speakers together.
Acknowledging that diminutives can die out when they take on the burden of new social meanings, the authors point out that “our (Australian) -ie/-y endings carry important, positive meanings, and there’s no sign yet that we’re giving up on them. Those ‘sunnies’, ‘scungies’, ‘boardies’, ‘cozzies’, ‘stubbies’, and ‘trackies’ are still the stuff of our sartorial
It seems that while slang might come and go, the process that transforms sunglasses into ‘sunnies’ and tracksuit pants into ‘trackies’ continues to thrive.
However, the Monash academics point out that while there is a steady refreshing of the stock of -ie/y words, the same can’t be said for those ending with -o.
“The earliest Australian examples (like ‘milko’, ‘rabbito’, ‘bottle-o’) date from the 19th Century and are abbreviated nouns referring to a person’s trade (“milkman”, “rabbit-seller”, “bottle-collector”). Sometimes they appear with -oh because of their association with street calls, and this use is old – think of those cockles and mussels of the18th Century, all very much ‘alive, alive-oh’.”
-O is also big in Australian place names like ‘Rotto’ (Rottnest Island), ‘Freo’ (Fremantle), ‘Paddo’ (Paddington), and in the diminutive of common nouns such as ‘compo’ (compensation), ‘preggo’ ( pregnant) and ‘ambo’ (ambulance).
But the authors are unable to explain why there are ‘wharfies’ and ‘truckies’, but not ‘wharfos’ and ‘truckos’; ‘garbos’ and ‘musos’, but not ‘garbies’ and ‘musies’. People who ride motorcycles are generally ‘bikers’; those who belong to motorcycle gangs tend to be ‘bikies’.
“So what’s wrong with ‘bikos’? And those who build houses are neither ‘buildos’ nor ‘buildies”, they say in a plaintive outpouring of ethnographic angst. What nuanced differences of meaning are involved between the ‘sicko’ (psychologically sick person) and the ‘sickie’ (leave you take when you’re sick)?
Are members of your family ‘rellos’ or ‘rellies’? I’d say definitely it’s ‘rellies’ chez Houston. However, Down Under, there are apparently a lot of lexicographers, linguists, and other word-nerds who have yet to figure this one out.
Opinion THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 20
Change the heart. Change heart failure
Reverse adverse cardiac remodelling, improve cardiac structure and pumping function, and target HF via a unique dual MOA that inhibits neprilysin and RAAS
In all stages of the HFrEF patient journey whether initiated in the hospital or outpatient setting
For patients living with heart failure, ENTRESTO® is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.
Abbreviated Prescribing Information
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
Entresto® (sacubitril valsartan) 24 mg/26 mg film-coated tablets, 49 mg/51mg film-coated tablets and 97mg/103mg film-coated tablets Presentation: Film-coated tablets of 24 mg/26 mg, 49 mg/51mg and 97 mg/103 mg of sacubitril and valsartan respectively (as sacubitril valsartan sodium salt complex). Indications: In adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction. Dosage and administration: The recommended starting dose of Entresto is one tablet of 49 mg/51 mg twice daily, doubled at 2-4 weeks to the target dose of one tablet of 97 mg/103 mg twice daily, as tolerated by the patient. In patients not currently taking an ACE inhibitor or an ARB, or taking low doses of these medicinal products, a starting dose of 24 mg/26 mg twice daily and slow dose titration (doubling every 3 - 4 weeks) are recommended. A starting dose of 24 mg/26 mg twice daily should be considered for patients with SBP ≥100 to 110 mmHg, moderate or severe renal impairment (use with caution in severe renal impairment) and moderate hepatic impairment. Do not co-administer with an ACE inhibitor or an ARB. Do not start treatment for at least 36 hours after discontinuing ACE inhibitor therapy. Entresto may be administered with or without food. The tablets must be swallowed with a glass of water. Splitting or crushing the tablets is not recommended. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Concomitant use with ACE inhibitors. Do not administer until 36 hours after discontinuing ACE inhibitor therapy. Known history of angioedema related to previous ACE inhibitor or ARB therapy. Hereditary or idiopathic angioedema. Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2). Severe hepatic impairment, biliary cirrhosis and cholestasis. Second and third trimesters of pregnancy.
Warnings/Precautions: Dual blockade of the renin angiotensin-aldosterone system (RAAS): Combination with an ACE inhibitor is contraindicated due to the increased risk of angioedema. Sacubitril/valsartan must not be initiated until 36 hours after taking the last dose of ACE inhibitor therapy. If treatment with sacubitril/valsartan is stopped, ACE inhibitor therapy must not be initiated until 36 hours after the last dose of sacubitril/valsartan. Combination of sacubitril/valsartan with direct renin inhibitors such as aliskiren is not recommended. Sacubitril/valsartan should not be co-administered with another ARB containing product. Hypotension: Treatment should not be initiated unless SBP is ≥100 mmHg. Patients with SBP <100 mmHg were not studied. Cases of symptomatic hypotension have been reported in patients treated with sacubitril/valsartan during clinical studies, especially in patients ≥65 years old, patients with renal disease and patients with low SBP (<112 mmHg). Blood pressure should be monitored routinely when initiating or during dose titration with sacubitril/valsartan. If hypotension occurs, temporary down-titration or discontinuation of sacubitril/valsartan is recommended. Impaired or worsening renal function: Limited clinical experience in patients with severe renal impairment (estimated GFR <30 ml/min/1.73m2). There is no experience in patients with end-stage renal disease and use of sacubitril/valsartan is not recommended. Use of sacubitril/valsartan may be associated with decreased renal function, and down-titration should be considered in these patients. Hyperkalaemia: Treatment should not be initiated if the serum potassium level is >5.4 mmol/l. Monitoring of serum potassium is recommended, especially in patients who have risk factors such as renal impairment, diabetes mellitus or hypoaldosteronism or who are on a high potassium diet or on mineralocorticoid antagonists. If clinically significant hyperkalaemia occurs, consider adjustment of concomitant medicinal products or temporary down-titration or discontinuation of sacubitril/valsartan. If serum potassium level is >5.4 mmol/l discontinuation should be considered. Angioedema: Angioedema has been reported with sacubitril/valsartan. If angioedema occurs, discontinue sacubitril/valsartan immediately and provide appropriate therapy and monitoring until complete and sustained resolution of signs and symptoms has occurred. Sacubitril/valsartan must not be re-administered. Patients with a prior history of angioedema were not studied. As they may be at higher risk for angioedema, caution is recommended if sacubitril/valsartan is used in these patients. Black patients have an increased susceptibility to develop angioedema. Patients with renal artery stenosis: Caution is required and monitoring of renal function is recommended. Patients with NYHA functional classification IV: Caution should be exercised due to limited clinical experience in this population. Patients with hepatic impairment: There is limited clinical
experience in patients with moderate hepatic impairment (Child Pugh B classification) or with AST/ALT values more than twice the upper limit of the normal range. Caution is therefore recommended in these patients. B-type natriuretic peptide (BNP): BNP is not a suitable biomarker of heart failure in patients treated with sacubitril/valsartan because it is a neprilysin substrate. Psychiatric disorders: hallucinations, paranoia and sleep disorders, in context of psychotic events, have been associated with sacubitril/valsartan use. Consider discontinuation if patient experiences such events. Interactions: Contraindicated with ACE inhibitors, 36 hours washout is required. Use with aliskiren contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2). Should not be co-administered with another ARB. Use with caution when co-administering sacubitril/ valsartan with statins or PDE5 inhibitors. No clinically relevant drug-drug interaction was observed when simvastatin and sacubitril/valsartan were coadministered. Monitoring serum potassium is recommended if sacubitril/valsartan is co-administered with potassium-sparing diuretics or substances containing potassium (such as heparin). Monitoring renal function is recommended when initiating or modifying treatment in patients on sacubitril/ valsartan who are taking NSAIDs concomitantly. The combination of sacubitril/valsartan and lithium is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended. Co-administration of sacubitril/valsartan and furosemide reduced Cmax and AUC of furosemide by 50% and 28%, respectively, with reduced urinary excretion of sodium. Co-administration of nitroglycerin and sacubitril/valsartan was associated with a treatment difference of 5 bpm in heart rate compared to the administration of nitroglycerine alone, no dose adjustment is required. Coadministration of sacubitril/valsartan with inhibitors of OATP1B1, OATP1B3, OAT3 (e.g. rifampicin, ciclosporin), OAT1 (e.g. tenofovir, cidofovir) or MRP2 (e.g. ritonavir) may increase the systemic exposure of sacubitril or valsartan. Appropriate care should be exercised. Co-administration of sacubitril/valsartan with metformin reduced both C max and AUC of metformin by 23%. When initiating therapy with sacubitril/valsartan in patients receiving metformin, the clinical status of the patient should be evaluated. Fertility, pregnancy and lactation: The use of sacubitril/valsartan is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy. It is not known whether sacubitril/valsartan is excreted in human milk, but components were excreted in the milk of rats. Sacubitril/valsartan is not recommended during breast-feeding. A decision should be made whether to abstain from breast-feeding or to discontinue sacubitril/valsartan while breast-feeding, taking into account the importance of sacubitril/ valsartan to the mother. No available data on the effect of sacubitril/valsartan on human fertility. Undesirable effects: Very common: Hyperkalaemia, hypotension, renal impairment. Common: Anaemia, hypokalaemia, hypoglycaemia, dizziness, headache, syncope, vertigo, orthostatic hypotension, cough, diarrhoea, nausea, gastritis, renal failure, acute renal failure, fatigue, asthenia. Uncommon:Hypersensitivity, postural dizziness, pruritus, rash, angioedema. Rare: Hallucinations, sleep disorders. Very rare: Paranoia. Please refer to SmPC for a full list of adverse events for Entresto. Pack sizes: Entresto 24 mg/ 26 mg - 28 tablet pack; Entresto 49 mg/51 mg - 28 and 56 tablet pack; Entresto 97 mg/103 - 56 tablet pack. Legal Category: POM. Marketing Authorisation Holder: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road Dublin 4, Ireland. Marketing Authorisation Numbers: Entresto 24 mg/26 mg film coated tablets EU/1/15/1058/001; Entresto 49 mg/51 mg film coated tablets EU/1/15/1058/002-003; Entresto 97 mg/103 mg film coated tablets EU/1/15/1058/006. Full prescribing information is available on request from Novartis Ireland Ltd, Vista Building, Elm Park Business Park, Merrion Road, Dublin 4. Tel: 01 2601255 or at www.medicines.ie. Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu. Prescribing Information last revised: May 2021
Reporting suspected adverse reactions of the medicinal product is important to Novartis and the HPRA. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported via HPRA Pharmacovigilance, website www.hpra.ie. Adverse events could also be reported to Novartis preferably via www.report.novartis.com or by email: email@example.com or by calling 01 2080 612.
REFERENCES: 1. Seferovic PM, Ponikowski P, Anker SD, et al. Clinical practice update on heart failure 2019: pharmacotherapy, procedures, devices and patient management. An expert consensus meeting report of The Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019;21(10):1169-1186. 2. Hollenberg SM, Stevenson LW, Ahmad T, et al. 2019 ACC expert consensus decision pathway on risk assessment, management, and clinical trajectory of patient hospitalized with heart failure: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2019;74(15):1966-2011. 3. Maddox TM, Januzzi JL, Allen, LA, et al; 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2021 Feb, 77 (6) 772–810. 4. CaReMe Heart Failure in Adults: Diagnosis & Management Algorithm. Available at: cardionewsuk.org. (Accessed: November 2021). 5. ENTRESTO Summary of product characteristics. Available at www.medicines.ie 6. Januzzi JL Jr, Prescott MF, Butler J, et al; for the PROVE-HF Investigators. Association of change in N-terminal pro–b-type natriuretic peptide following initiation of sacubitril-valsartan treatment with cardiac structure and function in patients with heart failure with reduced ejection fraction [published online ahead of print September 2, 2019]. JAMA. doi:10.1001/jama.2019.12821. 7. Desai AS, Solomon SD, Shah AM, et al; for the EVALUATE-HF Investigators. Effect of sacubitril-valsartan vs enalapril on aortic stiffness in patients with heart failure and reduced ejection fraction; a randomized clinical trial. JAMA. 2019;322(11):1077-1084. 8. Ramani GV, Uber PA, Mehra MR. Chronic heart failure: contemporary diagnosis and management. Mayo Clin Proc. 2010;85(2):180-195. 9. McDonagh T, Metra M et al ESC Scientific Document Group, 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the ESC With the special contribution of the HFA of the ESC, European Heart Journal, 2021;ehab368, https://doi.org/10.1093/eurheartj/ehab368 10. McMurray JJV, Packer M, Desai AS, et al; for the PARADIGM-HF Investigators and Committees; Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004. 11. Velazquez EJ, Morrow DA, DeVore AD, et al; for the PIONEER-HF Investigators. Angiotensin–neprilysin inhibition in acute decompensated heart failure. N Engl J Med. 2019;380(6):539-548. 12. Wachter R, Senni M, Belohlavek J, et al; on behalf of the TRANSITION Investigators. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in-hospital or early after discharge: primary results of the randomised TRANSITION per approved citation: study [published online ahead of print May 27, 2019]. Eur J Heart Fail. 2019. doi:10.1002/ehjf.1498. 13. Claggett B, Packer M, McMurray JJV, et al; for the PARADIGM-HF Investigators. Estimating the long-term treatment benefits of sacubitril–valsartan. N Engl J Med. 2015;373(23):22892290. 14. Lewis EF, Claggett BL, McMurray JJV, et al. Health-related quality of life outcomes in PARADIGM-HF. Circ Heart Fail. 2017;10(8):e003430.
15. Chandra A, Lewis EF, Claggett BL, et al. Effects of sacubitril/valsartan on physical and social activity limitations in patients with heart failure. A secondary analysis of the PARADIGM-HF trial. JAMA Cardiol. 2018;3(6):498-505. October 2021 | IE167236
Time is essential . So is starting with ENTRESTO®1-4 MOA=mechanism of action; RAAS=Renin-Angiotensin-Aldosterone System; HFrEF=heart failure with reduced ejection fraction. *In place of an ACEi or ARB. † For PCRS reimbursement of ENTRESTO ®, HF patients must meet the following criteria: HFrEF ≤ 35%, currently prescribed ACEi/ARB therapy, symptomatic (NYHA Class II-IV), Systolic Blood Pressure ≥ 100 mmHG, Potassium ≥ 5.4mmol/L.
Make a lasting difference patients can feel
Help your patients stay out of the hospital, live longer, and feel better, so they have more time for what matters most
Safety and tolerability profile similar to ACEi
12639_Entresto_PressAdvert_Resize_FEB23_01.indd 1 15/02/2023 12:40
ENTRESTO ® as early as possible in your HFrEF patients to help keep them at home and better protected†1-4
The heart-racing rush of fooling the fitness watch
The watch police haven’t yet learned a high heart rate doesn’t always mean exercise
therapist had told me I should use a heart rate monitor to gauge my exercise tolerance, which would help me to avoid an even earlier death by encouraging me to get off my arse and MOVE. She had told me this about a year ago; as usual, the pre-contemplation phase of my ‘cycle of change’ was particularly lengthy.
bizzy-buzz it jolts into my wrist when it notices that the aforementioned arse-sitting has gone on too long. It flashes little messages at me to ‘Get Up and Move’. Being a good little rule-abiding doctor, I am incapable of ignoring it. So, in the middle of an online meeting, I find myself suddenly leaping to my feet, and then realise my colleagues are looking strangely at me. I pretend I am reaching for a book on the shelf, or picking up a pen from the floor. Then I turn off the camera and frantically run on the spot for 20 second to satiate the beast on my wrist, before sitting demurely again in front of the camera and hope that no one can hear the unfit wheezes leaking out of my chest.
My children always write, “... and a surprise!”, at the end of their letter to Santa. They ask for a load of things that they really want and then they add that little bit of mystical hope at the end, imagining the endless possible wonders that Santa might choose to stuff into their stocking on a whim.
Adults don’t really receive surprise Christmas presents though, do we? We ask each other, “So, what do you want then?”, and we have to wrack our own brains to come up with something attainable, yet interesting, that we might like to see on our laps on Christmas Day. Many of us fall into the truly dismal habit of buying our own presents for ourselves, then handing them to our partner to wrap and put under the tree. (I won’t even begin to address the horror that is doing the wrapping yourself).
Anyway, in a new low, I decided that the present my family should give me in 2022 was a fitness watch. My physio-
MULTIPLE CHOICE QUESTIONS
So, I decided to join the hordes of #NewMe types soon after 25 December, armed with the second-cheapest branded “active wristwear” or whatever they call it, which sent me into sensory-overload orbit because it was so bulky and uncomfortable. I fiddled with the settings so that I could work out my SpO2 (useful for someone with a paranoia about pulmonary emboli) and checked for potentially fatal arrhythmias every time I drank a coffee. I discovered that this little device could tell me when my period is due (though I think I foiled it by having two Mirenas). It could analyse my sleep, but only if I wore it all night (interestingly, it seemed not to notice that I spent all night lying rigidly awake wondering if it was working). It asks me periodically, “How are you feeling?”, and I swear if it could patronisingly tilt its head at me, it would. It wanted me to tell it what I was eating, to the gram; the day I start weighing fig rolls is the day I know my life is devoid of all meaning.
The whole reason for getting it, though, was the little
What I have discovered, however, is that the wrist police equate high heart rate with vigorous exercise. How pleased was I when I discovered that when I spoke up at a meeting where I knew no one, my social anxiety led the watch to believe that I had been doing jumping jacks for 10 minutes (I can tell it is unfamiliar with my pelvic floor’s inadequacies). Also, my habit of listening to feminist podcasts while cleaning the bathroom means that my resting heart rate is around 120 while I’m scrubbing the toilet. Who knew that outrage and Domestos were the key to an effective workout? I listened to the audiobook of Everyday Sexism by Laura Bates, and this kept my weekly ‘activity’ well above the recommended 150 minutes.
I do realise that I may have missed the whole point of getting the bloody thing, but I am still delighted with myself when it pings at me that I have achieved my goals, and I giggle away about how clever I am to have duped it. And, of course, if I have actually managed to walk the sanctified 10,000 steps, I am so smug I can barely speak.
I think next time I might try asking for a surprise.
A. Symptoms normally start 20-to-30 minutes after exposure to the allergen.
B. By definition should involve one or both of two severe features: Respiratory difficulty and hypotension.
C. To drugs is as likely to occur when the drug is given orally as when given parenterally.
D. As soon as recognised, should be treated with intravenous injection of adrenaline.
E. TRUE. Or auditory ones
D. TRUE. Or under activity.
C. FALSE. With elevated mood, over exaggeration would suggest manic.
Rupture of the biceps tendon
A. Most often presents in 20-to-40-year-old men.
B. May cause a popping sound during some activity.
C. Shoulder aching may be worse at night.
D. May cause a visible mass between the shoulder and the elbow.
E. Treatment of choice is surgery.
In adults with hypothyroidism, the following statements are true of thyroxine treatment
A. The dosage may need to be increased if the patient gains weight.
B. Treatment should normally be started at double the expected replacement dose.
C. The starting dose should be 25 micrograms daily in those for whom cardiac disease is suspected.
D. Over-replacement would be indicated by a raised level of thyroxine-stimulating hormone (TSH).
E. The dosage should be adjusted if the symptoms suggest the need, even if the thyroid test levels are normal.
For patients with longstanding pruritus ani, helpful advice to minimise symptoms would include
A. Wash the anal area after defecation.
B. Use medicated soaps.
C. Wear cotton gloves at night.
D. Use moist tissues instead of lavatory paper.
E. Avoid highly seasoned and spiced foods.
Well recognised features of schizophrenia include
A. Thought insertion.
B. Poverty of speech and thought.
C. Sexual indiscretion.
E. Somatic hallucinations.
A. TRUE. Otherwise each patient’s dosage need remains very stable.
B. TRUE. Emotional emptiness, social withdrawal.
A. TRUE. Or other delusions.
E. TRUE. And avoid impervious underwear, which traps sweat.
D. TRUE. As normally used for babies’ bottoms.
C. TRUE. To reduce subconscious scratching.
B. FALSE. Avoid as may cause sensitisation.
A. TRUE. And dry by gentle dabbing not rigorous rubbing.
E. FALSE. If the thyroid levels are normal, you should look for other causes of the symptoms.
D. FALSE. This is indicated by a lowered TSH level.
C. TRUE. And increased by 25 micrograms every three-to-four weeks.
E. FALSE. Of debatable value, but may be helpful in young, athletic types.
D. TRUE. If not visible may well be palpable.
C. TRUE. Or painful during repetitive or overhead movements.
B. TRUE. Or sudden pain, snapping sensation.
A. FALSE. 40-to-60year-olds.
E. TRUE. In rare cases anaphylaxis may be caused by chilling.
D. FALSE. Intramuscular adrenaline repeated several times, at fiveminute intervals, if necessary.
C. FALSE. Far more likely if intravenous.
B. TRUE. First symptom often a perception by the patient that something is wrong.
A. FALSE. Within minutes and the quicker the reaction, the more severe symptoms tend to be.
B. FALSE. Can start at half the expected dose and increase over weeks.
E. May occur in patients who suffer cold-induced urticaria. ANSWER
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 22 Opinion
DR SARAH FITZGIBBON
Read more by Dr Sarah Fitzgibbon at www.mindo.ie
Dermatology: Common presentations in primary care
An overview of the most common dermatology presentations seen in general practice
Dermatological conditions affect between 30and-70 per cent of people worldwide and are the most frequent reason for consultation in general practice.2 An estimated 54 per cent of the Irish population is affected by skin problems annually, and up to 33 per cent could benefit from medical care at any one time. An estimated 15-to20 per cent of GP consultations relate specifically to dermatology. In Ireland this represents between 712,500-and-950,000 GP consultations for dermatological conditions each year.1
Many skin conditions can be managed in primary care and approximately 65,000 referrals occur annually to specialist dermatology departments for more complex forms of skin disease. Some of the most common skin diseases are increasing in frequency, with over 230 skin cancer-related deaths in Ireland annually. Approximately 50 per cent of referrals to dermatology are for skin cancer. The impact of skin diseases on quality-of-life can be profound, and many non-cancerous inflammatory skin diseases are chronic in nature.1
More than 2000 dermatological entities are listed in the International Classification of Disease (ICD 11), including rare or novel skin diseases, however, a small number account for most of the disease burden. These include inflammatory conditions such as eczema, psoriasis, acne, and rosacea; skin cancers; autoimmune conditions such as lupus and vitiligo; and hereditary diseases.2, 5, 6
No complete data on the prevalence of skin diseases across European countries is available. To estimate the prevalence of the most frequent skin conditions or diseases in 27 European countries (24 EU countries, plus Norway, Switzerland, and the UK (NEUKS)), a study using a population-based approach involving 44,689 participants (21,887 (48.97 per cent) men and 22,802 (51.03 per cent) women) was carried out and published in 2022.2 The aim of this study was to evaluate the prevalence of the most common dermatological diseases and conditions of adult patients across Europe. Results showed that 43.35 per cent of the NEUKS adult population reported having had at least one dermatological disease or condition.
The most frequent conditions are fungal skin infections (8.9 per cent), acne (5.4 per cent), and atopic dermatitis or eczema (5.5 per cent). Alopecia, acne, eczema, and rosacea are more common in women, and psoriasis in men. Acne affects mainly young adults, while psoriasis was more frequent in respondents older than 25 years.2
Timely and accurate diagnosis is key to determining the most effective management approaches for dermatological conditions. Depending on the severity of presentation and stage of disease, management ranges from prevention and self-management approaches to a variety of topical and oral medications, steroid injections, biologics, surgical interventions, and treatments such as phototherapy and chemotherapy. There is also a significant role for psychological and social supports to reduce the impact and burden of disease.1
Long waiting lists for dermatology services exist nationally. Historically, a significant part of dermatology outpatient department workload consisted of benign lesions, which require no treatment, or cosmetic problems. Examined by the National Clinical Programme for Dermatology (RCPI/HSE), exclusion criteria for GP referral to dermatology services unless there is diagnostic uncertainty now includes viral warts and verrucae; molluscum; seborrhoeic warts/keratoses; skin tags; dermatofibromas; spider naevi; epidermal cysts; sebaceous cysts; lipomas; tattoos; xanthelasma; physiological male balding; and melasma.1
Common dermatological presentations in primary care Rashes
Rashes and minor skin conditions are very common and can affect people of all ages. They can be troublesome
in adults and distressing when they occur in babies and young children. Referral to a dermatologist may be important for making difficult diagnoses and selecting certain treatments, however, many rashes are self-limiting, and most can be diagnosed and treated in primary care. Referral to dermatology should be used for the highest scope of practice because the workforce is limited, and specialty care is costly. 3,4
Fungal infection: Ringworm
Ringworm (Figure 1A/B) is a common contagious fungal infection caused by dermatophytes and is easily spread following contact with an infected person through skin-toskin contact, sharing towels, clothing and bed linen. Pets such as cats and dogs can also transmit the infection to humans. Classification is generally by the site of the body affected. The rash appears as a circular lesion with a raised outer rim and paler centre. The most common infections in pre-pubertal children are tinea corporis and tinea capitis, while tinea cruris, tinea pedis, and fungal nail infections such as onychomycosis are more frequently seen in adolescents and adults.4 Treatment varies with the site affected. For skin infections topical treatment is the first-line and some products can be purchased over the counter. Scalp ringworm (tinea capitis) is usually treated for a longer duration (two-to-four weeks) with terbinafine. Both the affected person and family members are advised to use an antifungal shampoo (Ketoconazole) twice-weekly for two weeks. Onychomycosis requires a longer course of oral medication before effect is achieved.4
Fungal infection: Athlete's foot
Athlete's foot, or tinea pedis, is an infection of the skin and feet that can be caused by a variety of different fungi (Figure 2). Although tinea pedis can affect any portion of the foot, the infection most often affects the space between the toes. If it is not treated, it can spread to the toenails and cause a fungal nail infection. Information on the treatment of dermatophyte and other fungal infections of the skin is available at:7 www. hse.ie/eng/services/list/2/gp/antibiotic-prescribing/conditions-and-treatments/skin-soft-tissue/dermatophyte-infection-of-the-skin/dermatophyte-skin.html
Eczema (frequently called dermatitis) is an inflammatory skin condition occurring in all age ranges, from babies through to older adults. There are different types of eczema, atopic being the most common (Figure 3), which follows a relapsing and recurring course. Diagnosis is made on examination and the patient typically presents with an acutely inflamed, red, sometimes blistered and weeping patches of skin. Although the rash can occur anywhere, common sites are the flexures of the elbows and backs of the knees.4
Eczema herpeticum is a dermatological emergency, warranting same day referral or contact with the local dermatology department. Treatment is with aciclovir.8
In infected eczema, swelling and a golden crust suggest probable staphylococcal infection. Swabs are not indicated unless treatment failure or atypical species is suspected. Restoring the barrier with appropriate topical steroids and emollients may reduce bacterial superinfection and lessen anti-microbial requirements.8 Topical antibiotics should be used for a limited period of under two weeks because of bacterial resistance. They should not be co-prescribed with oral antibiotics for the same reason. Using antibiotics, or adding them to steroids, in eczema encourages resistance and does not improve healing unless there are visible signs of infection.8 Bleach baths may reduce the bacterial load on the skin and contribute to reduced numbers of flares. It is recommended as a maintenance antimicrobial measure once or twice a week. During infective flares it may cause stinging.8 Information on the treatment of eczema is available at: www.hse.ie/eng/services/ list/2/gp/antibiotic-prescribing/conditions-and-treatments/ skin-soft-tissue/eczema/
Psoriasis causes patches of skin that are dry, red, and covered in silver scales.
Dermatology Clinical THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 23
Continued on p24 ▸
THERESA LOWRY-LEHNEN, RGN, PG Dip Coronary Care, RNP, BSc, MSc, PG Dip Ed (QTS), M Ed, PhD, Clinical Nurse Specialist and Associate Lecturer, South East Technological University
Figure 1A/B: Ringworm Source: www2.hse.ie/conditions/ringworm/
Figure 2: Athlete's foot Source: www2.hse.ie/conditions/athletes-foot/
Figure 3: Eczema Source: www.nhs.uk/conditions/atopic-eczema/symptoms/
Plaque psoriasis (psoriasis vulgaris) is the most common form, accounting for 80-to-90 per cent of cases (Figure 4). The scales appear on the elbows, knees, scalp and lower back, but they can appear anywhere on the body. The plaques can be itchy or sore, or both. In severe cases, the skin around the joints may crack and bleed.9
Scalp psoriasis occurs on parts of or the whole scalp. It causes red patches of skin covered in thick, silvery-white scales. Some people find scalp psoriasis itchy, while others have no discomfort. In extreme cases, it can cause hair loss, although this is usually only temporary.9
Nail psoriasis: In approximately half of all people with psoriasis the condition affects the nails, causing them to develop small dents or pits. The nails can become discoloured or grow abnormally, can become loose and separate from the nail bed, and in severe cases may crumble.9
Guttate psoriasis causes small drop-shaped sores on the chest, arms, legs, and scalp. The condition often disappears completely after a few weeks, but some people go on to develop plaque psoriasis. This type of psoriasis sometimes occurs after a streptococcal throat infection and is more common among children and teenagers.9
Less common types of psoriasis include: Pustular psoriasis, von Zumbusch psoriasis, palmoplantar pustulosis, acropustulosis, and erythrodermic psoriasis.9
Treatment depends on the type and severity of psoriasis and the area of skin affected. Treatment often starts with a topical cream applied to the skin, and then stronger treatments if required. Treatment falls into three main categories:9
Topical – creams and ointments applied to the skin.
Phototherapy – exposes the skin to certain types of ultraviolet light.
Systemic – oral and injected medications that work throughout the entire body.
Different types of treatment are often used in combination. Referral to a dermatologist may occur if the symptoms are severe.
Lichen planus is a less well-known rash than eczema or psoriasis, and is more common in adults than children (Figure 5). It is a non-infectious itchy rash, seen as small shiny, reddish raised papules most commonly on the wrist, ankles, elbows, and lower back although it can develop at any site. Lichen planus occasionally affects the oral cavity and may occur alone or in combination with symptoms at another site. It causes burning or stinging and discomfort in the mouth and on examination the mucosa is covered with painless white streaks. There is a more erosive form where painful ulcers occur, which are linked to an approximate 1 per cent risk of becoming cancerous (one-in-100 patients) over a period of 10 years. Resolution can occur spontaneously without treatment. When itching is severe a sedating antihistamine may be needed. A potent steroid cream, eg, Betnovate, can be used and the dose tailored to severity of symptoms, aiming to reduce once improvement is seen. In severe cases, systemic oral steroids can be prescribed (20mg daily for two-to-six weeks). Oral lichen planus can be treated with a topical steroid, but referral to
secondary care will be needed when symptoms are severe or response to treatment is inadequate.4
Chickenpox is a highly infectious condition caused by the varicella zoster virus (Figure 6). It is most prevalent in children under the age of 10 years, with over 90 per cent of cases occurring in this age group. Chickenpox is generally a mild illness, but can rarely be fatal in neonates and the immunocompromised, and can have more serious consequences in adults. Spread occurs by transmission from person-to-person by breathing in infected respiratory droplets via sneezing or coughing, or less commonly through contact with weeping spots. The rash develops 10-to-14 days after contracting the infection, but may take longer. The child is often unwell for a couple of days prior to developing the typically itchy rash, with additional symptoms of headaches, loss of appetite and fever. Adults generally have more serious symptoms, and 5-to-14 per cent of adults develop lung problems such as pneumonia, with smokers at greater risk.4
Treatment aims to ease symptoms and comprise of a sedating antihistamine and lotion to ease the itching. Paracetamol may be required if feverish, however, ibuprofen is not recommended as there is an increased risk of soft tissue infection. Adults may need antiviral treatment, ideally to commence within 72 hours of onset of the rash to reduce symptom severity. For adults’ acyclovir 800mg is taken five times daily at approximately four-hourly intervals, during waking hours. Treatment should continue for seven days.4,10
Full HSE treatment guidance is available at: www. hse.ie/eng/services/list/2/gp/antibiotic-prescribing/ conditions-and-treatments/skin-soft-tissue/chickenpox/
Herpes zoster, also known as shingles, is a secondary infection that occurs in some individuals as the result of reactivation of the latent varicella zoster virus, usually within a single ganglion (Figure 7). The individual lifetime risk of developing herpes zoster is between 24-and-30 per cent. Although herpes zoster can occur at any age, incidence increases with age. Two-thirds of cases occur in individuals aged 50 years and older and the risk of developing the disease in those aged 85 years and above is 50 per cent. Once the virus activates, it can lead to a painful, blistery rash. Early symptoms of herpes zoster including headache, fever, and malaise, are non-specific and may result in an incorrect diagnosis. These symptoms are commonly followed by sensations of burning pain, itching, hyperesthesia, or paraesthesia. Herpes zoster is di-
agnosed clinically, typically based on history and symptom presentation. The treatment of herpes zoster has three major objectives; treatment of the acute viral infection, treatment of the acute pain associated with herpes zoster and prevention of postherpetic neuralgia. Early identification and prompt treatment with antiviral drugs and analgesics frequently reduces acute rash and pain and may prevent some complications. Antiviral drugs have been shown to reduce acute pain and rash severity, accelerate rash resolution, and reduce duration of pain. Herpes zoster can be treated with antiviral medications acyclovir, valacyclovir, or famciclovir, most effective when started within 72 hours after the onset of the rash.13,14 Information on the treatment of shingles is available at: www.hse.ie/eng/services/list/2/gp/antibiotic-prescribing/ conditions-and-treatments/skin-soft-tissue/shingles/ 14
Human scabies is a parasitic infection and contagious skin condition caused by the Sarcoptes scabiei var Hominis mite, which burrows into the skin and causes severe pruritis, especially at night.11 Human scabies affects all age ranges and causes many infections worldwide each year. There are two types – classical scabies and crusted (Norwegian) scabies. Classical scabies is the more common type and occurs following contact with another infected person. It is commonly seen in overcrowded living conditions where spread readily occurs. Norwegian scabies is rarer, but more severe, and involves hundreds or thousands of mites infesting the host individual. The resulting infection is highly contagious, but differs
from classical scabies in that itching is absent or minimal.4 Treatment of scabies is recommended for all members of an infected household even if asymptomatic. All members must be treated simultaneously within 24 hours. Bedding and clothing should be washed at a high temperature to destroy the mites. Items that cannot be washed or dry cleaned should be sealed in a plastic bag for at least 72 hours or put in a freezer. Most people with scabies are cured after two applications of scabicide, but itching may continue for a few weeks after successful treatment. This may be relieved using an oral antihistamine and/or a topical steroid. If new burrows appear after a treatment course of two applications, a second treatment course should be considered.11,12 Treatment failure or recurrence is common, and isolat-
Clinical Dermatology THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 24
Figure 4: Plaque psoriasis
Continued on p26 ▸
Figure 5: Lichen planus
Figure 6: Chickenpox
▸ Continued from p23
Figure 7: Shingles Source: https://dermnetnz.org/
Figure 8: Scabies
ing the cause can help prevent further infection and limit outbreaks in communities. Reasons for treatment failure include not treating close contacts simultaneously, not decontaminating beddings and clothes at the time of treatment, and non-adherence to the treatment regimen. To prevent reinfection, it is important that all members of the household are treated, as well as any sexual partners over the last six weeks, in the case of genital scabies.11,12. Information on the treatment of scabies is available at: www.hse.ie/eng/services/list/2/gp/antibiotic-prescribing/ conditions-and-treatments/skin-soft-tissue/scabies/
Acne is a chronic inflammatory skin disease and is one of the most common dermatological problems seen in general practice (Figure 9 A/B). Acne usually occurs at puberty or in early adult life, when there is a surge of hormones, and it is more common in males than females. It can present with inflammatory and non-inflammatory lesions mainly on the face, but can also occur on the upper arms, trunk, and back. Hypersensitivity to fluctuations in hormones causes the pilosebaceous unit to over produce oil, leading to blocked pores called comedones.15
Grade 1: Comedones are of two types, open and closed. Open comedones are due to plugging of the pilosebaceous orifice by sebum on the skin surface. Closed comedones are due to keratin and sebum plugging the pilosebaceous orifice below the skin surface.
Grade 2: Inflammatory lesions present as a small papule with erythema.
Grade 3: Pustules.
Grade 4: Many pustules coalesce to form nodules and cysts.15
First-line treatment of acne is to tackle the excess oil and comedones. It is advisable not to scrub the skin or use astringents as these may rupture the comedones and promote inflammatory lesions. Acne washes containing salicylic acid 0.5-to-2 per cent may be helpful, however, most people will also need a topical retinoid, or retinoid agent or a combination of agents. Information on the treatment of acne is available at: www.hse.ie/eng/services/ list/2/gp/antibiotic-prescribing/conditions-and-treatments/ skin-soft-tissue/acne-vulgaris/ 16
Impetigo is a common infection of the superficial layers of the epidermis that is highly contagious and most commonly caused by gram-positive bacteria (Figure 10 A/B). It usually presents as erythematous plaques with a yellow crust
and may be itchy or painful. The lesions are highly contagious and spread easily. Diagnosis is typically based on the symptoms and clinical manifestations alone. Treatment involves topical and/or oral antibiotics and symptomatic care.17 Information on the treatment of impetigo is available at: www.hse.ie/eng/services/list/2/gp/antibiotic-prescribing/ conditions-and-treatments/skin-soft-tissue/impetigo/ 18
Urticaria, also known as hives, is a skin reaction that causes itchy welts, and is classified as acute or chronic (Figure 11). Acute urticaria is more common in children, while chronic urticaria is more common in adults. Acute urticaria presents as red raised areas of skin, often at several sites. This frequently resolves over a few hours, while chronic urticaria may persist for weeks. Acute urticaria is associated with possible triggers such as certain foods, medication, or contact with chemicals or latex products, however, up to 40 per cent of chronic urticaria cases are thought to be autoimmune related, eg, systemic lupus erythematosus (SLE), rheumatoid arthritis.4 For some patients no treatment is required, however, if itching is troublesome a non-sedating antihistamine such as cetirizine, or loratadine for adults and children, or fexofenadine may be needed. For severe symptoms, a course of oral corticosteroids (prednisolone 40mg daily for up to seven days) as well as an antihistamine may be needed if the rash is persistent and lesions are tender.4
Hidradenitis suppurativa (HS), also referred to as acne inversa, is a chronic, relapsing, inflammatory skin condition that typically occurs after puberty, with the average age of onset in the second or third decade of life (Figure 12). Patients with HS present with inflammation of hair follicles in the apo-
crine gland-bearing regions; armpits, genital area, groin, inframammary region, perianal region, and buttocks that initially manifests as painful nodules or boils and progresses to abscesses, sinus tracts, and scarring. The presentation of HS is distinct, although the condition is often not well-recognised in primary care. The most troublesome symptom of HS is chronic pain, which is reported by almost all patients. The pain associated with HS can be intense and is reported by patients as the most significant factor contributing to impaired quality-of-life. Early diagnosis is very important for patients with HS, to ensure the best possible course and prompt disease management. However, HS diagnosis generally occurs after an average seven-year delay, because the early stages are often mistaken for other conditions. Information on the treatment of HS is available at: www.hse.ie/eng/services/ list/2/gp/antibiotic-prescribing/conditions-and-treatments/ skin-soft-tissue/hidradenitis-suppurativa/ 20
Rosacea is a chronic inflammatory dermatosis mainly affecting the cheeks, nose, chin, and forehead (Figure 13). It is more common in women and people with lighter skin, but symptoms can be worse in men. It is not known what causes rosacea, but some triggers can make it worse, including alcohol, caffeine, spicy foods, exposure to sunlight, and aerobic exercise. There is currently no cure for rosacea, but treatment can help control the symptoms. 21,22 Symptoms often begin with episodes of flushing, where the skin turns red for a short period, but other symptoms can develop as the condition progresses, such as burning and stinging sensations; permanent redness; spots (papules and pustules); and small blood vessels in the skin becoming visible. Rosacea is a relapsing condition. Longterm treatment is usually necessary, although there may be periods when the symptoms improve and treatment can be stopped temporarily. For most people, treatment involves a combination of self-help measures and medication. 23 Topical medications are usually prescribed first. These include metronidazole cream or gel, azelaic acid cream or gel, and ivermectin cream. If symptoms are more severe, antibiotics may be required. Antibiotics often used to treat rosacea include tetracycline, oxytetracycline, doxycycline, and erythromycin. These medications
Clinical Dermatology THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 26
▸ Continued from p24
Continued on p28 ▸
Figure 9 A/B: Acne Source: www2.hse.ie/conditions/acne/
Figure 10 A/B: Impetigo
Figure 11: Urticaria
Figure 12: Hidradenitis suppurativa
Figure 13: Rosacea
Whether your patients’ moderate-to-severe AD is FIERCE or TAMER,
CIBINQO is a convenient once-daily oral JAK1 inhibitor for moderate-to-severe atopic dermatitis (AD) that o ers1-4
Signiﬁcant skin clearance at week 12, with sustained control at week 481,5
Rapid itch relief, superior to dupilumab + TCS at week 2 for CIBINQO 200 mg + TCS, with signiﬁcant results as early as day 41,6
A once-daily pill available in multiple doses that can be used with or without medicated topical therapies so you can tailor treatment to meet the individual needs of your patients1-3,7,8
CONSISTENT SAFETY PROFILE: Rigorously studied in >3100 patients across 7 clinical trials, including one ongoing LTE 9
PRESCRIBING INFORMATION CIBINQO® ▼ (ABROCITINIB)
Please refer to full Summary of Product Characteristics (SmPC) before prescribing Cibinqo®. Presentation: Film-coated tablets containing 50 mg, 100 mg, or 200 mg abrocitinib. Each tablet contains 1.37 mg, 2.73 mg, and 5.46 mg of lactose monohydrate, respectively. Indications: For the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. Dosage: Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. Posology: The recommended starting dose is 200 mg once daily. A starting dose of 100 mg once daily is recommended for patients ≥ 65 years of age. For other patients who may beneﬁt from a starting dose of 100 mg, see sections 4.4 and 4.8 of the SmPC. During treatment, the dose may be decreased or increased based on tolerability and e cacy. The lowest e ective dose for maintenance should be considered. The maximum daily dose is 200 mg. Can be used with or without medicated topical therapies for atopic dermatitis. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic beneﬁt after 24 weeks. Treatment initiation: Treatment should not be initiated in patients with a platelet count < 150 × 103/mm , an absolute lymphocyte count (ALC) < 0.5 × 103/mm3, an absolute neutrophil count (ANC) < 1.2 × 103/mm3 or who have a haemoglobin value < 10 g/dL. Dose interruption: If a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled. Interruption of dosing may be needed for management of laboratory abnormalities. Missed doses: If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, dosing should be resumed at the regular scheduled time. Interactions: In patients receiving dual strong inhibitors of cytochrome CYP2C19 and moderate inhibitors of CYP2C9, or strong inhibitors of CYP2C19 alone (e.g., ﬂuvoxamine, ﬂuconazole, ﬂuoxetine and ticlopidine), the recommended starting dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g., rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin). Renal impairment: No dose adjustment is required in patients with mild renal impairment, i.e., estimated glomerular ﬁltration rate (eGFR) of 60 to < 90 mL/min. In patients with moderate (eGFR 30 to < 60 mL/min) renal impairment, the recommended dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. In patients with severe (eGFR < 30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose. The maximum daily dose is 100 mg. Cibinqo has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy. Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Cibinqo must not be used in patients with severe (Child Pugh C) hepatic impairment. Elderly: The recommended starting dose for patients aged 65 years or more 100 mg once daily. Paediatric population: The safety and e cacy of Cibinqo in children under 12 years of age have not yet been established. No data are available. Cibinqo has been studied in adolescents 12 to < 18 years of age. However, because of bone ﬁndings in juvenile rats (comparable to a 3 month old human), additional long-term data in growing adolescents is needed to conclude that the beneﬁts outweigh the risks. Method of administration: This medicinal product is to be taken orally once daily with or without food at approximately the same time each day. In patients who experience nausea, taking Cibinqo with food may improve nausea. Tablets should be swallowed whole with water and should not be split, crushed, or chewed because these methods have not been studied in clinical trials. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Active serious systemic infections, including tuberculosis (TB), severe hepatic impairment, pregnancy, and breast-feeding. Warnings and Precautions: Serious infections: Serious infections have been reported in patients receiving Cibinqo. The most frequent serious infections in clinical studies were herpes simplex, herpes zoster and pneumonia. Treatment must not be initiated in patients with an active, serious systemic infection. Risks and beneﬁts of treatment prior to initiating Cibinqo should be considered. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated. The patient should be closely monitored, and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Tuberculosis: Patients should be screened for TB before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered. Abrocitinib must not be given to patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, preventive therapy for latent TB should be started prior to initiation of treatment. Viral reactivation: Viral reactivation, including herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical studies. The rate of herpes zoster infections was higher in patients 65 years of age and older and patients with severe atopic dermatitis at baseline. If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy. Patients with evidence of active hepatitis B or hepatitis C (positive hepatitis C PCR) infection were excluded from clinical studies. Patients who were hepatitis B surface antigen negative, hepatitis B core antibody positive, and hepatitis B surface antibody positive had testing for hepatitis B virus (HBV) DNA. Patients who had HBV DNA above the lower limit of quantiﬁcation (LLQ) were excluded. Patients who had HBV DNA negative or below LLQ could initiate treatment; such patients had HBV DNA monitored. If HBV DNA is detected, a liver specialist should be consulted. Vaccination: No data are available on the response to vaccination in patients receiving Cibinqo. Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating treatment with this medicinal product, it is recommended that patients be brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines. Thrombotic events including pulmonary embolism: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving abrocitinib. Cibinqo should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient’s risk for DVT/PE include older age, obesity, a medical history of DVT/PE, prothrombotic disorder, use of combined hormonal contraceptives or hormone replacement therapy, patients undergoing major surgery or prolonged immobilisation. If clinical features of DVT/PE occur, treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment. Malignancy (including non-melanoma skin cancers): Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical
1. Bieber T, Simpson EL, Silverberg JI, et al. N Engl J Med. 2021;384(12):1101-1112.
studies with abrocitinib. Clinical data are insu cient to assess the potential relationship of exposure to abrocitinib and the development of malignancies. Long-term safety evaluations are ongoing. The risks and beneﬁts of Cibinqo treatment should be considered prior to initiating in patients with a known malignancy other than a successfully treated NMSC or cervical cancer in situ or when considering continuing Cibinqo therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Haematologic abnormalities: Conﬁrmed ALC < 0.5 × 103/mm3 and platelet count < 50 × 103/mm3 were observed in less than 0.5% of patients in clinical studies. Treatment with abrocitinib should not be initiated in patients with a platelet count < 150 × 10 /mm3 an ALC < 0.5 × 103/mm3, an ANC < 1.2 × 103/mm3 or who have a haemoglobin value < 10 g/dL. Complete blood count should be monitored 4 weeks after initiation of therapy and thereafter according to routine patient management. Lipids: Dose dependent increases in blood lipid parameters were reported in patients treated with abrocitinib compared to placebo. Lipid parameters should be assessed approximately 4 weeks following initiation of therapy and thereafter according to the patient’s risk for cardiovascular disease. The e ect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Patients with abnormal lipid parameters should be further monitored and managed according to clinical guidelines, due to the known cardiovascular risks associated with hyperlipidaemia. In patients with a high burden of cardiovascular risk factors, the risks, and beneﬁts of abrocitinib compared to that of other available therapies for atopic dermatitis should be considered. If abrocitinib is chosen, interventions to manage lipid concentrations should be implemented according to clinical guidelines. Elderly: The safety proﬁle observed in elderly patients was similar to that of the adult population with the following exceptions: a higher proportion of patients 65 years of age and older discontinued from clinical studies and were more likely to have serious adverse reactions compared to younger patients; patients 65 years and older were more likely to develop low platelet and ALC values; the incidence rate of herpes zoster in patients 65 years of age and older was higher than that of younger patients. There are limited data in patients above 75 years of age. Immunosuppressive conditions or medicinal products: Patients with immunodeﬁciency disorders or a ﬁrst-degree relative with a hereditary immunodeﬁciency were excluded from clinical studies and no information on these patients is available. Combination with biologic immunomodulators, potent immunosuppressants such as ciclosporin or other Janus kinase (JAK) inhibitors has not been studied. Their concomitant use with abrocitinib is not recommended as a risk of additive immunosuppression cannot be excluded. Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deﬁciency or glucose-galactose malabsorption should not take this medicinal product. Drug Interactions: Potential for other medicines to a ect pharmacokinetics of abrocitinib: Abrocitinib is metabolised predominantly by CYP2C19 and CYP2C9 enzymes, and to a lesser extent by CYP3A4 and CYP2B6 enzymes, and its active metabolites are renally excreted and are substrates of the organic anion transporter 3 (OAT3). Therefore, exposures of abrocitinib and/or its active metabolites may be a ected by medicinal products that strongly inhibit or induce theses enzymes and transporter. Dose adjustments, as appropriate, may be required. Co-administration with products which increase gastric pH: The e ect of elevating gastric pH with antacids, H2-receptor antagonists (famotidine), or proton pump inhibitors (omeprazole) on the pharmacokinetics of abrocitinib has not been studied and may reduce the absorption of abrocitinib due to the low solubility of abrocitinib at pH above 4. Potential for Cibinqo to a ect pharmacokinetics of other medicinal products: No clinically signiﬁcant e ects of Cibinqo were observed in drug interaction studies with oral contraceptives. Caution should be exercised for concomitant use of abrocitinib with dabigatran. Caution should be exercised as the levels of P-gp substrates with a narrow therapeutic index, such as digoxin, may increase. The exposures of medicinal products metabolised by CYP2B6 (e.g., bupropion, efavirenz) and CYP1A2 (e.g., alosetron, duloxetine, ramelteon, tizanidine) may be decreased and of those metabolised by CYP2C19 (e.g., S mephenytoin) may be increased initially and then decreased, when used concomitantly with abrocitinib. Fertility, pregnancy, and lactation:
Women of childbearing potential: Women of reproductive potential should be advised to use e ective contraception during treatment and for 1 month following the ﬁnal dose of Cibinqo. Pregnancy planning and prevention for females of reproductive potential should be encouraged. Pregnancy: There are no or limited amount of data on the use of abrocitinib in pregnant women. Studies in animals have shown reproductive toxicity. Abrocitinib has been shown to cause embryo-foetal lethality in pregnant rats and rabbits, skeletal variations in the foetuses of pregnant rats and rabbits and to a ect parturition and peri/postnatal development in rats. Cibinqo is contraindicated during pregnancy. Breast-feeding: There are no data on the presence of abrocitinib in human milk, the e ects on the breast fed infant, or the e ects on milk production. Abrocitinib was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and Cibinqo is contraindicated during breast feeding. Fertility: Based on the ﬁndings in rats, oral administration of Cibinqo may result in temporary reduced fertility in females of reproductive potential. The e ects on female rat fertility were reversible 1 month after cessation of abrocitinib oral administration. Driving and operating machinery: Cibinqo has no e ect on the ability to drive or use machines. Side E ects: The most commonly reported adverse reactions are nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%) including herpes simplex, herpes zoster, and pneumonia. Refer to SmPC for further information on side e ects. Legal Category: S1A. Marketing Authorisation Numbers: EU/1/21/1593/002 - Cibinqo 50 mg (28 ﬁlm-coated tablets), EU/1/21/1593/007 - Cibinqo 100 mg (28 ﬁlm-coated tablets); EU/1/21/1593/012 - Cibinqo 200 mg (28 ﬁlm-coated tablets). Marketing Authorisation Holder: Pﬁzer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
For further information on this medicine please contact Pﬁzer Medical Information on 1800 633 363 or at medical.information@pﬁzer.com. For queries regarding product availability please contact: Pﬁzer Healthcare Ireland, Pﬁzer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 467 6500.
▼ This medicinal product is subject to additional monitoring. This will allow quick identiﬁcation of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
Last revised: December 2021.
Ref: CQ 1_0 IE.
2. Simpson EL, Sinclair R, Forman S, et al. Lancet. 2020;396(10246):255-266.
3. Silverberg JI, Simpson EL, Thyssen JP, et al. JAMA Dermatol 2020;156(8):863-873.
4. Boeri M, Sutphin J, Hauber B, et al. J Dermatolog Treat. 2020 Nov 2:1-10. doi:10.1080/09546634.1832185. 5. Reich K, Silverberg JI, Papp K, et al. Presented at the Revolutionizing Atopic Dermatitis Virtual Conference; 13 June 2021. 6. Ständer S, Yosipovitch G, Simpson EL, et al. Presented at the American Academy of Dermatology Virtual Meeting Experience 2021; 23-25 April 2021. 7. Cibinqo Summary of Product Characteristics. 8. Blauvelt A, Silverberg JI, Lynde CW, et al. J Am Acad Dermatol. Published online 17 August 2021. doi: 10.1016/j.jaad.2021.05.075. 9. Cork MJ, Deleuran MS, Geng B, et al. Presented at the European Academy of Dermatology and Venereology Virtual Congress 2021; 29 September-2 October 2021.
Although some clinical trials included adolescents, please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase 4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.1
AD=atopic dermatitis; JAK=Janus kinase; LTE=long-term extension.
© 2022 Pﬁzer Inc. All rights reserved. June 2022. PP-CIB-IRL-0020
▸ Continued from p26
are usually taken for four-to-six weeks, but longer courses may be necessary if the spots are persistent. Redness and telangiectasia can also sometimes be successfully improved with vascular laser or intense pulsed light (IPL) treatment. These treatments may also improve flushing. 22
Secondary and tertiary specialist dermatology care Lengthy waiting lists for dermatology services exist nationally, and many patients with debilitating skin con-
ditions are waiting for prolonged periods. Dermatology outpatient referral numbers have increased significantly over the past decade in Ireland. At the end of 2019 there were 44,147 people waiting for a HSE dermatology outpatient appointment. However, at the end of 2022 this figure had decreased to 39,979. 24
Approximately 50 per cent of referrals to dermatology are for skin cancer, rates of which are rising rapidly and expected to double between 2020-and-2040.1 There are 11 HSE Dermatology Departments (hub) and 16 Peripheral Clinics (spoke) operating a hub and spoke model (excluding CHI).
1. HSE. National Clinical Programme for Dermatology. A Model of Care for Ireland. 2019. Available at: www.hse.ie/ eng/about/who/cspd/ncps/dermatology/resources
2. Richard M, Paul C, Nijsten T, Gisondi P, Salavastru C, Taieb C, et al. Prevalence of most common skin diseases in Europe: A population-based study. J Eur Acad Dermatol Venereol 2022 Jul;36(7):1088-1096. doi: 10.1111/jdv.18050
3. Dusendang J, Marwaha S, Alexeeff S, Herrinton L. Presentation of rash in a community-based health system. Perm J. 2020 Nov;24:1-4. doi: 10.7812/TPP/20.035
4. Perry M. Rashes in adults and children: A guide for primary care nurses. Independent Nurse. 2020. Available at: www. independentnurse.co.uk/clinical-article/rashes-in-adultsand-children-a-guide-for-primary-care-nurses/216350/
5. White J, Lui H, Chute C, Jakob R, Chalmers RJG. The WHO ICD-
11 Classification of dermatological diseases: A new comprehensive online skin disease taxonomy designed by and for dermatologists. Br J Dermatol. 2022 Jan;186(1):178-179. doi: 10.1111/bjd.20656
6. World Health Organisation. ICD-11 (Dermatology specialty linearisation). Available at: https://icd.who.int/dev11/l-derma/en
7. HSE. Dermatophyte infection of the skin – Antibiotic prescribing. 2016. Available at: www.hse.ie/eng/services/list/2/gp/antibioticprescribing/conditions-and-treatments/skin-soft-tissue/ dermatophyte-infection-of-the-skin/dermatophyte-skin.html
8. HSE. Eczema – antibiotic prescribing. 2022. Available at: www.hse.ie/eng/services/list/2/gp/antibiotic-prescribing/ conditions-and-treatments/skin-soft-tissue/eczema/
9. HSE. Psoriasis. 2022. Available at: www2. hse.ie/conditions/psoriasis/
10. Health Products Regulatory Authority. Zovirax –summary of product characteristics. 2021. Available at: www.hpra.ie/img/uploaded/swedocuments/Licence_ PA1077-084-007_21052021090857.pdf
Diagnosis and management of asthma in adults and adolescents - a review
This module explores the latest diagnosis and management approaches for asthma in adolescents and adults, including the most recent international guidelines
Authors: Dr Shane Brennan, GP registrar, South East Training Scheme; Dr Dermot Nolan, ICGP/HSE National Clinical Lead for Asthma
11. HSE. Scabies. 2022. Available at: www.hse.ie/eng/ services/list/2/gp/antibiotic-prescribing/conditionsand-treatments/skin-soft-tissue/scabies/
12. NHS Inform. Scabies. 2022. Available at: www. nhsinform.scot/illnesses-and-conditions/skin-hairand-nails/scabies#diagnosing-scabies
13. HSE. Immunisation guidelines: Chapter 23 VaricellaZoster. 2020. Available at: www.hse.ie/eng/health/ immunisation/hcpinfo/guidelines/chapter23.pdf
14. HSE. Shingles (Herpes Zoster) antiviral prescribing. 2022. Available at: www.hse.ie/eng/services/list/2/gp/antibioticprescribing/conditions-and-treatments/skin-soft-tissue/shingles/
15. Sutaria A, Masood S, Schlessinger J. Acne vulgaris. In StatPearls 2022 Jan. Available at: www.ncbi.nlm.nih.gov/books/NBK459173/
16. HSE. Acne vulgaris – antibiotic prescribing. 2021. Available at: www.hse.ie/eng/services/list/2/gp/antibiotic-prescribing/ conditions-and-treatments/skin-soft-tissue/acne-vulgaris/
17. Nardi N, SchaeferT. Impetigo. In StatPearls Publishing. 2022 Jan. Available at: www.ncbi.nlm.nih.gov/books/NBK430974/
18. HSE. Impetigo – antibiotic prescribing. 2022. Available at: www.hse.ie/eng/services/list/2/gp/antibiotic-prescribing/ conditions-and-treatments/skin-soft-tissue/impetigo/
19. Irish Skin Foundation. What is hidradenitis suppurativa (HS)?. 2022. Available at: https://irishskin.ie/hidradenitis-suppurativa/
20. HSE. Hidradenitis suppurativa – antibiotic prescribing. 2022. Available at: www.hse.ie/eng/services/list/2/ gp/antibiotic-prescribing/conditions-and-treatments/ skin-soft-tissue/hidradenitis-suppurativa/
21. HSE, Rosacea. 2021. Available at: www2. hse.ie/conditions/rosacea/
22. NHS Inform. Rosacea. National Health Service, UK. 2023. Available at: www.nhsinform.scot/illnessesand-conditions/skin-hair-and-nails/rosacea
23. Irish Skin Foundation. A plan for waiting times? HSE Publishes Scheduled Care Access Plan 2019. Available at: https://irishskin.ie/2019/03/12/a-plan-for-waiting-timeshse-publishes-scheduled-care-access-plan-2019/
24. Irish Hospital Consultants Association. Press release: Almost 877,000 people now waiting to see a specialist or receive care, as hospital waiting lists continue to increase. 2021. Available at: www.ihca.ie/news-and-publications/ almost-877000-people-now-waiting-to-see-a-specialist-orreceive-care-as-hospital-waiting-lists-continue-to-increase
Clinical Dermatology THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 28 A B C
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Irish Society of Medical Oncology, Bursary Awards, the Mater Hospital, Dublin, 27 January 2023
ISMO Bursary Awards 2023
The annual ISMO meeting heard presentations on a wide range of high-quality cancer research taking place in Irish hospitals
The 2023 Irish Society of Medical Oncology (ISMO) Bursary Awards took place on Friday, 27 January. It was held in the Fintan Gunne Theatre, Catherine McAuley Centre, the Mater Misericordiae University Hospital, Dublin.
The Bursary candidate presentations, which were of a high quality, focused on a wide range of subjects. This article summarises the winning presentations.
The title of the presentation by Dr Aonghus Joyce, Cork University Hospital (CUH), was ‘Punch biopsy: A diagnostic keystone for metastatic pericardial angiosarcoma’. Angiosarcoma is a rare, aggressive malignancy originating from endothelial cells. Its diagnosis is histologically challenging. Dr Joyce’s presentation was based on a case involving multiple presentations and investigations, which were non-diagnostic until angiosarcoma was eventually diagnosed from a cutaneous lesion.
“Primary pericardial angiosarcomas are extremely rare and associated with high mortality,” according to Dr Joyce.
“Patients present with myriad symptoms depending on organ involvement. Histological diagnosis is challenging. This patient’s diagnosis was reached by punch biopsy of cutaneous lesions identified on full skin examination during his medical workup. This avoided more invasive procedures for tissue diagnosis, which had been planned.”
Dr Harriet Byrne, CUH, made a presentation titled ‘No MRONJ, no problem?’. Medication-related osteonecrosis of the jaw (MRONJ) is a clinical risk for patients on bisphosphonate therapy. The use of polypharmacy and variable regimes of antiresorptives, antiangiogenics, and immunotherapies for cancer implies an undisputable risk of MRONJ when prescribed as a targeted, or combination, therapy. The burden of dental disease, an initiating factor of MRONJ, has remained stagnant and increasingly relevant to the bone modifying agent prescriber. Reduced globalised awareness of dental disease and poor progress to combat dental disease was highlighted by the recent World Health Assembly Global Resolution 74.5 (May 2021). In this presentation, Dr Byrne illustrated a case of MRONJ, following administration of bisphosphonates for metastatic breast cancer.
“This case highlights the relevance of dental care in the setting of oncology patients on antiresorptive therapy,” according to Dr Byrne.
“The risk of MRONJ remains, even years after active bisphosphonate therapy. In the absence of proactive dental oncology protocols, we anticipate that in the coming decades, MRONJ will become increasingly relevant. The literature to date has reached no definitive consensus about the treatment and management of MRONJ, which heightens the importance of the role of preventative care for these patients. Antiresorptives have progressed from oncological regimes in the palliative setting to curative disease. This results in another cohort of patients exposed to bisphosphonates and at risk of MRONJ. For the practicing oncologist today, MRONJ risk is relevant.”
‘Primary STK11 adnexal tumour: A challenging diagnosis’ was the title of the presentation by Dr Róisín Rynne, CUH.
Primary STK11 adnexal tumours are a novel entity of rare malignancies harbouring a serine/threonine kinase 11 (STK11) gene mutation, which was first described in August 2021. STK11 encodes the protein liver kinase B1 (Lkb1). This protein plays key roles in cellular metabolism, cell polarity and DNA repair. Germline mutations in this gene leads to Peutz-Jeghers Syndrome (PJS), an autosomal dominant syndrome characterised by hamartomatous polyposis, mucocutaneous pigmentation, and a lifetime risk of cancer ranging from 37 to 93 per cent.
Dr Rynne discussed the experience with the challenges of diagnosis and management of this unique and newly defined tumour, with reference to a case study.
“There are currently 23 cases of primary STK11 adnexal tumours described in the literature, with 50 per cent of these cases being associated with PJS,” according to Dr Rynne.
“This histologically diverse tumour with a variable immunohistochemical profile is currently poorly understood and it is likely that it was previously mislabelled as female adnexal tumours of Wolffian origin and endometroid carcinomas. The comprehension of its features and natural history will become clearer as new cases are reported. It is anticipated to be an aggressive tumour with 50 per cent having metastases at diagnosis and an 80 per cent recurrence rate reported as part of the original case series published in 2021. However, further research is required to truly establish the prognostic signature of this tumour.”
“While this study does not reveal any differences in the outcomes and IrAEs comparing obese patients versus non-obese patients, this may be due to the small sample size,” according to Dr Clarke. “However, it does highlight the need for further research into the area as understanding this process may improve clinical outcomes for patients.”
The presentation by Dr Shane O’Sullivan, Mater Private Hospital, Dublin, concerned the use of ovarian function suppression (OFS) in combination with endocrine therapy in premenopausal women with breast cancer (BC).
Long-term follow-up of clinical trials studying the addition of OFS to adjuvant endocrine therapy have shown sustained improvements in disease free survival and recently for the first time an improvement in OS for premenopausal women with hormone receptor-positive BC.
There are no standard recommendations by professional societies regarding the optimal choice of gonadotropin releasing hormone (GnRH) analogue, or dose and frequency of administration. Practice guidelines also do not provide recommendations on how patients receiving OFS should be monitored.
A survey was designed to determine how medical oncologists manage and monitor OFS in premenopausal women. Most oncologists (70 per cent) reported using goserelin; 10 per cent triptorelin and 20 per cent leuprorelin. GnRH analogues were given monthly by 60 per cent; three-monthly by 14 per cent and others stated age, tolerance, and receipt of chemotherapy influenced their decision. There was significant variation in how GnRH analogues were initiated. One-third performed routine hormone profiles others reported sometimes (64 per cent) or never (five per cent). All testing was performed in local laboratories.
“OFS is considered standard of care for high-risk premenopausal women with ER-positive BC,” according to the study’s conclusion.
A study presented by Dr Rachel Clarke, University Hospital Waterford (UHW), examined the effect of excess weight on outcomes and immune-related adverse events following pembrolizumab treatment. A single-centre, retrospective audit of all patients who received pembrolizumab treatment between July 2019 to July 2022 was conducted. The primary aim was to assess the effect of obesity on clinical outcome and immune-related adverse events (IrAEs).
A total 70 patients who had received pembrolizumab in UHW were identified during the period studied. Of these, 31 patients did not have sufficient data to document BMI in outpatient records or in the pharmacy database and therefore were excluded. Out of the 39 patients analysed, 19 (47.5 per cent) were male and 11 patients (27.5 per cent) included were obese (BMI >30). The median age of patients included was 65 years [60-72] and median BMI was 28 [16-40.4]. Objective radiological response (ORR) was achieved in 11 patients (28 per cent), the median progression-free survival (PFS) was five months [one-45 months] and overall survival (OS) was 12 months [two-54 months].
The PFS was not significantly higher in patients with BMI >30 (five months vs four months, p=0.49), nor was OS (nine months vs 12 months, p=0.587). The objective response rate was not significantly higher in the obese group (63.6 per cent vs 75 per cent, p=0.47). The incidence of IrAEs was not significantly increased in patients with BMI >30 (33.3 per cent vs 22.2 per cent, p=0.46). The most common IrAEs in the study population were endocrinopathies, rash, and colitis.
“Our study shows how we administer and monitor it varies among specialists. We are expanding our survey internationally through ASCO [American Society of Clinical Oncology] and will open a study to understand the prevalence of ovarian function escape during OFS.”
The presentation by Ms Shivika Marwaha , CUH, was based on an assessment of real-world outcome of durvalumab in non-small cell lung cancer (NSCLC) post completion of concurrent chemoradiotherapy. Consolidative durvalumab is recommended as per PACIFIC clinical trial with significant benefit in median PFS of 16.8 months as compared to placebo.
A retrospective analysis of patients with NSCLC who received consolidative durvalumab from January 2021 to January 2023 was carried out. Clinicopathological data was collected. The duration of treatment and need for drug discontinuation, in addition to treatment related adverse events, recurrence free, and overall survival of patients was gathered.
“Our real-world analysis in our ongoing study with 14 patients to date has shown a median duration of treatment of seven months, high rate of treatment-related adverse events and median progression free survival of 10 months,” according to Ms Marwaha.
“Careful discussions of benefits of durvalumab and risks of toxicity are needed.”
Dr Catherine Weadick , CUH, spoke about risk stratification tools to help decide on adjuvant chemotherapy usage in resected soft tissue sarcomas (STS).
All new patients with resected soft tissues sarcoma discussed in the STS multi-disciplinary team's meeting in CUH between Jan 2017 – Dec 2021 were identified. The
Conference Coverage THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 30
Continued on p32 ▸
T he burden of dental disease, an initiating factor of MRONJ, has remained stagnant and increasingly relevant to the bone modifying agent prescriber
is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following platinum-based chemotherapy.1
Significant improvement in mOS by 8.8 months in the overall population with BAVENCIO +BSC vs BSC alone2
Bavencio (avelumab) + BSC (n=350) vs BSC alone (n=350) (23.8 vs 15.0 months HR: 0.76 [95% CI: 0.63 - 0.92]; p=0.0036)2
Data cut-off 4 June 2021. Median duration of treatment in the BAVENCIO® + BSC group was 25.3 weeks (range: 2.0–216.0);2
median duration of treatment in the BSC alone arm was 13.1 weeks (range: 0.1–231.7 weeks)3
Bavencio® (avelumab): Abbreviated Summary of Product Characteristics
▼ 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. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to theHPRA Pharmacovigilance via www.hpra.ie. Adverse events can also be reported to the HPRA by calling (01) 676 4971 or by emailing firstname.lastname@example.org
PRESCRIBING INFORMATION (MCC & UC) for Bavencio®▼(avelumab) concentrate for solution for infusion –Great Britain (GB), Northern Ireland (NI) & Ireland. Please refer to the full Summary of Product Characteristics before prescribing.
PRESENTATION: Pack of 1 vial. Each 10 mL vial contains 200 mg of avelumab.
INDICATIONS: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC) and first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.
DOSAGE AND ADMINISTRATION: Posology: The recommended dose is 800 mg administered intravenously over 60 minutes every 2 weeks. Method of administration: Intravenous infusion only with dilution with either sodium chloride 9 mg/mL or with sodium chloride 4.5 mg/mL solution for injection. Not to be administered as an intravenous push or bolus injection. See SPC for instructions on the preparation and administration of the product. Administration should continue according to the recommended schedule until disease progression or unacceptable toxicity. Pre-medication: Pre-medication with an anti-histamine and with paracetamol prior to the first four infusions and subsequently at the discretion of the treating physician. Treatment modifications: Dose escalation or reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. Special populations: Elderly (≥ 65 years old): No dose adjustment is needed. Paediatric population (< 18 years): Safety and efficacy has not been established in children and adolescents. Renal impairment: No dose adjustment is needed in patients with mild or moderate renal impairment. There are insufficient data in patients with severe renal impairment. Hepatic impairment: No dose adjustment is needed for patients with mild hepatic impairment. There are insufficient data in patients with moderate or severe hepatic impairment. Treatment-related skin reactions: For a Grade 3 rash, withhold treatment until recovery to Grade 0 to 1. Permanently discontinue therapy for any patients with Grade 4 rash, recurrent Grade 3 rash or confirmed Stevens–Johnson syndrome (SJS) or Toxic epidermal necrolysis (TEN).
CONTRAINDICATIONS: Hypersensitivity to avelumab or to the excipients.
PRECAUTIONS: Clearly record the batch number of avelumab administered to improve traceability as it is a biological medicine. Infusion related reactions: Monitor patients for signs and symptoms of infusion-related reactions including pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, back pain, abdominal pain, and urticaria. Reactions, which might be severe, have been reported. Stop and permanently discontinue therapy for Grade 3 or Grade 4 infusion related reactions. Reduce infusion rate by 50% for Grade 1 infusion related reactions. Temporarily discontinue therapy for patients with Grade 2 infusion related reactions, until Grade 1 or resolved, then restart with a 50% slower infusion rate. If recurrence of Grade 1 or Grade 2 infusion- related reaction, continue therapy under close monitoring, after appropriate infusion rate modification and pre-medication. Immune- related (IR) adverse reactions: Adequately evaluate suspected immune- related adverse reactions to confirm aetiology or exclude other causes. Based on the severity, withhold therapy and administer corticosteroids. If corticosteroids are used, initiate a taper of at least 1-month duration upon improvement. Consider administration of other systemic immunosuppressants if immune-related adverse reactions are not controlled with corticosteroid use. Monitor patients for signs and symptoms of: IR-pneumonitis, IR-hepatitis (including changes in liver function), IR-colitis, IR-pancreatitis, IR-myocarditis, IR-endocrinopathies [thyroid disorders (hypothyroidism/hyperthyroidism) (including changes in thyroid function), adrenal insufficiency, type 1 diabetes mellitus (including hyperglycaemia)], IR-nephritis and renal dysfunction (including elevated serum creatinine prior to and periodically during treatment) and other IR adverse reactions (myositis, hypopituitarism, uveitis, Guillain- Barré syndrome, myasthenia gravis, myasthenic syndrome and cystitis noninfective) reported in less than 1% of patients. Permanently discontinue therapy for any Grade 3 IR adverse reaction that recurs and for Grade 4 IR adverse reactions. Some of the IR adverse reactions should lead to permanent discontinuation regardless of grade. Sodium content: contains less than 1 mmol sodium (23 mg) per dose. Pregnancy/Breast- feeding/Fertility: Women of childbearing potential should be advised to avoid becoming pregnant while receiving avelumab and should use effective contraception during treatment with avelumab and for at least 1 month after the last dose of avelumab.
Breast-feeding women should be advised not to breast-feed during treatment and for at least 1 month after the last
dose due to the potential for serious adverse reactions in breast-fed infants. The effect of avelumab on male and female fertility is unknown.
ADVERSE REACTIONS: Very common (≥ 1/10): Anaemia, decreased appetite, cough, dyspnoea, nausea, diarrhoea, constipation, vomiting, abdominal pain, back pain, arthralgia, fatigue, pyrexia, oedema peripheral, weight decreased, infusion-related reaction.
Common (≥ 1/100 to < 1/10): Lymphopenia, thrombocytopenia, IR- hypothyroidism, IR-hyperthyroidism, hyponatraemia, headache, dizziness, neuropathy peripheral, hypertension, IR-pneumonitis, dry mouth, IR-rash, IRpruritus, IR-rash maculopapular, dry skin, myalgia, asthenia, chills, influenza-like illness, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, amylase increased, lipase increased, blood creatinine increased. Other serious adverse reactions: IR-pneumonitis, IR-hepatitis, IR-colitis, IR-endocrinopathies (thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus), IR-nephritis and renal dysfunction, hypersensitivity, anaphylactic reaction, IR-pancreatitis, IR-myocarditis, skin reactions including confirmed Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) and other IR reactions including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome, myasthenia gravis, myasthenic syndrome and cystitis noninfective. Prescribers should consult the Summary of Product Characteristics in relation to other adverse drug reactions.
LEGAL CATEGORY: POM.
MARKETING AUTHORISATION NUMBER AND PRICE ON APPLICATION: 1 vial (EU/1/17/1214/001, PLGB 11648/0262) £768. For price in Ireland, consult distributor Allphar Services Ltd.
MARKETING AUTHORISATION HOLDER: Bavencio (Great Britain): Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA; Bavencio (Ireland/Northern Ireland): Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands. For further information contact: UK: Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA. Tel: 020 8818 7373. Republic of Ireland: Merck Serono (Ireland) Limited, 4045 Kingswood Road, Citywest Business Campus, Dublin 24. Tel: 01 4687590.
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JOB NO: UI-AVEMCC-00036 & PP-BAV-GBR-1129
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1. Bavencio (avelumab) Summary of Product Characteristics. Date of access October 2022. Merck Ireland www. medicines.ie/medicines/bavencio-20-mg-ml-concentrate-for-solution-for-infusion-31395/spc
2. Powles T, et al.
ASCO Genitourinary Cancers Symposium, 17Ị 19 February 2022. 3. Pfizer data
Abstract No 487. Presented
Copyright © 2022 Merck KGaA, Darmstadt, Germany. All rights reserved. Legal Category S1A. IE-AVEBL-00014. PP-BAV-IRL-0056. Date of Prep November 2022.
histology and imaging of the identified patients were reviewed. Data regarding demographics, histology, treatment, and outcomes was collected. Risk assessment was done on all patients with an extremity or trunk sarcoma.
A total 93 patients were identified as having an STS resected – 61 of these were located on the trunk or extremities. This represented 24 different histological subtypes. Sarculator score was calculated for 41 of these patients (well differentiated liposarcomas and dermatofibrosarcoma protuberans were excluded). Two patients received adjuvant chemotherapy and one patient neoadjuvant chemotherapy.
“Our cohort is representative of the broad histological subtypes expected in sarcoma,” according to the conclusion.
“Sarculator score results correlate with international outcomes, with higher scores associated with increased mortality. In our cohort, sarculator score was more predictive of outcome than tumour grade/size.”
The title of the presentation by Dr Darragh O’Sullivan, UHW, was ‘The prevalence of statin use in geriatric oncology. Is there a role for cessation?’. Dr O’Sullivan said there is a need for clarity on the role of statins in geriatric oncology and when to de-prescribe. Data was retrospectively collected from a prospectively maintained database of patients attending the geriatric oncology assessment and liaision (GOAL) clinic in the South East Cancer Centre, UHW, since 2017.
“Overall survival of patients within this clinic is short of the 2.5 years required to provide benefit, based on meta-analysis results,” according to the conclusion.
“Therefore, there is evidence to stop this medication in the primary preventative group, once diagnosed with advanced cancer. The stage 4 disease group included patients undergoing secondary prevention, so treatment is, therefore, more efficacious. However, with an overall survival of 1.44 years, the window for benefit is small. A guideline would be helpful to guide clinical decision-making in this setting.”
The study presented by Dr Ronan McLaughlin, St Vincent’s University Hospital, Dublin, was on a real-world analysis of the clinical and economic impact of 21-gene recurrence score (RS) testing in early-stage node positive breast cancer in Ireland.
The study looked at clinical and economic impact of RS testing on treatment decisions in node positive patients.
From November 2011 to October 2022, a retrospective, cross-sectional observational study was performed of HR+, 1-3 node positive (N+) patients who had RS testing across two of Ireland’s largest oncology centres.
“Ireland was one of the first public healthcare systems to approve reimbursement for RS testing in N+ pts,” according to the conclusion.
“Over the period of this study a 55 per cent reduction in CT use was achieved with savings of over €1 million.”
Dr Aislinn Reilly, Beaumont Hospital, Dublin, presented on a study that examined biomarkers of response to immunotherapy in advanced NSCLC. Dynamic changes in cell-free DNA (cfDNA) or circulating tumour DNA (ctDNA) may represent a biomarker of response to immune checkpoint inhibitor-based therapy (ICI) in NSCLC. The study sought to explore the hypothesis that molecular response (MR) in cfDNA detected in exhaled breath condensate (EBC) and/or blood is associated with radiographic response to ICI+/-chemotherapy (RR).
A total of 10 patients were identified and provided preand on-treatment EBC and blood samples.
“In this descriptive analysis, we identify that dynamic changes occur in cfDNA in the EBC and blood in patients with NSCLC treated with ICI+/-chemotherapy,” according to the study’s conclusion.
“Specifically, we identify that a subset of patients with radiographic response to treatment have a MR in EBC+/-blood. Based on this, a prospective study is underway to evaluate MR in EBC+blood as a biomarker of response to ICI+/-chemotherapy in aNSCLC (n=108).”
Dr Karine Ronan, UHW, spoke about a multi-centre study, frequency of next-generation sequencing (NGS), prevalence of targetable mutations and response to targeted therapies among patients with metastatic urothelial cancer (mUC) in Ireland.
The study assessed the frequency of NGS, using either Oncomine or Foundation One panels in mUC patients at a number of cancer centres in Ireland, to ascertain the prevalence of genomic alterations in this population.
A total of 111 patients diagnosed with mUC between 2017 and 2022 were identified for inclusion.
“Our findings support the evidence that mUC is associated with a high prevalence of genetic alterations, which contributes to the therapeutic challenge of identifying actionable driver mutations amenable to targeted therapy,” according to the study.
“Observed responses to targeted therapies provide information to guide future investigation and clinical trial development.
“Although not all drugs with efficacy against targetable mutations are available in Ireland, identifying these mutations by carrying out NGS may define patient eligibility for clinical trials and is important.
“We observed a high prevalence of FGFR alterations, in line with published rates. The prevalence of ERBB2
alterations was lower in our study compared with published data. This may be related to the majority of NGS tests being carried out on initial tumour specimens, while a higher prevalence of ERBB2 mutations has been observed in metastatic lymph node biopsies.
“Response rates to trastuzumab combined with chemotherapy observed in this study were overall poor. Although the prevalence of ERBB2 mutations in mUC is higher than most other malignancies, further research is required to improve therapeutic responses to HER2-directed therapies.”
‘The genomic landscape of non-small cell lung cancer in the Republic of Ireland,’ was the title of the presentation by Dr Rachel Keogh, CUH.
The study aimed to identify the proportion of patients with advanced NSCLC in the Republic of Ireland whose tumours harbour actionable genomic alterations via broad NGS panel testing (eg, EGFR, ALK, KRAS, NRAS, BRAF, KIT, ROS1, RET, MET amplification, METexon14 skipping, PDGFRA, NTRK, HER2 , FGFR).
A total of 2,249 patients were included.
Actionable alterations were identified in 52.6 per cent of patients. KRAS was the most common oncogenic driver identified, of which KRAS G12C was most frequent. The study revealed a lower prevalence of patients with EGFR mutations and either ALK, ROS1, and RET fusions compared to similar datasets.
“These data have important implications for treatment prioritisation and clinical trial selection in the Republic of Ireland,” according to Dr Keogh.
Dr Mairi Lucas , St Vincent’s University Hospital, Dublin, presented on a study looking at tumour infiltrating lymphocytes (TILs) in hormone positive/HER 2 negative breast cancer. Archival tissue samples from patients in Ireland with early-stage ER+/HER2- breast cancer were used. A total of 409 samples were included in the analysis.
“The role of TILs in ER+/HER2 - breast cancer is still undefined,” according to the study.
“While the majority of ER+/HER2 - breast cancer samples had low numbers of TILs, there is clear heterogeneity within this subgroup. Further research is needed to assess how TILs may influence treatment response and prognosis.”
Phase III SUNLIGHT trial achieved ‘clinically meaningful improvement’ in overall survival
Data from SUNLIGHT, shared at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco last month, showed the phase III trial met its primary endpoint of overall survival (OS).
The SUNLIGHT trial investigated the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone in patients with refractory metastatic colorectal cancer (mCRC) following disease progression or intolerance on two prior chemotherapy regimens. Results from the main analysis demonstrated that the investigational combination provided a statistically significant and a clinically meaningful
improvement in OS of 3.3 months compared to trifluridine/tipiracil alone (10.8 months vs 7.5 months, hazard ratio [HR]: 0.61, 95 per cent confidence interval [CI]: 0.49-0.77, p<0.001). This improvement in OS represents a 39 per cent reduction in the risk of death in patients with refractory mCRC.
Regarding the key secondary endpoint, there was a statistically significant improvement for the trifluridine/tipiracil plus bevacizumab combination versus trifluridine/tipiracil alone in progression-free survival (5.6 months vs 2.4 months, HR: 0.44, 95 per cent CI: 0.36-0.54, p<0.001).
“The prognosis for metastatic colorectal cancer
patients who do not respond to chemotherapy remains poor, with median survival times typically ranging from four-to-eight months,” said Prof Josep Tabernero, Head of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, and Principal Investigator for the SUNLIGHT trial.
“Coupled with the fact that cases of colorectal cancer are increasing, there is an urgent need for new treatment options that can extend survival in patients with metastatic colorectal cancer in the later stages of disease. Findings from the SUNLIGHT trial represent an important development, which will be welcomed by the colorectal cancer community.”
Conference Coverage THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 32
▸ Continued from p30
Observed responses to targeted therapies provide information to guide future investigation and clinical trial development
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ALL REPORTS NIAMH QUINLAN
Irish Nephrology Society, Winter Meeting, RCSI, Dublin, 28 January 2023
Restructuring the INS for the future
In its 50th year of existence, the Irish Nephrology Society (INS) is examining how the Society can be restructured,
The INS Winter Meeting took place on Saturday, 28 January in the RCSI in Dublin.
Speaking to the Medical Independent (MI) at the meeting, INS President, and Consultant Renal Physician at Cork University Hospital, Prof Liam Plant, said that the number of nephrology practitioners has grown in recent years.
“The increase in [practitioners] and the increase in the opportunity to do all of these collaborations mean that we're reviewing the governance of our Society to try and focus on the different domains,” he said.
The INS currently has an executive – a President and two secretaries, with business meetings conducted with INS members.
As part of the restructuring proposals, there would be five committee officers appointed.
Another proposal is to appoint four 'domain leads' in research and innovation, clinical care and service development, training and education, and advocacy and external relationships.
A board would be formed, which would consist of these officers and leads, along with representatives from the National Renal Office, the Institute of Medicine, and at least two training representatives, amongst others.
Consultant Nephrologist at Beaumont Hospital, Prof Peter Conlon, who had early given a talk on the INS re -
search collective, said: “There [are] lots of people besides doctors and scientists that work in nephrology care, in particular nurses, some very senior nurses, [and] some technicians that keep the machines going. They should probably become a member of our society.”
“We need to refresh the membership,” Prof Plant also said.
He told MI the restructuring “really represents an ex-
pansion in the number of practitioners in Ireland, working in this domain, and the opportunities that this presents for us to participate in whatever it is we can do”.
Speaking about the state of the specialty in general, Prof Plant said: “There's a very big disease burden of kidney disease. So, we will probably be playing catch-up for a long period of time as to the number of practitioners we have. Nephrology… involves lifelong involvement in chronic disease management, but it's also involved in many exciting things like transplantation, intensive care, etc. And it always appears to have attracted doctors [and] nurses….
“I think it's an attractive and important specialty and that's why we're here.”
According to its mission statement, the INS aims to ensure high quality care for patients with kidney disease by promoting the highest standard of medical practice.
The Society also aims to be the primary vehicle underpinning collaborative research efforts into kidney disease across Ireland, North and South, and to ensure the education of nephrology trainees is to a high standard by provision of a comprehensive, structured training programme with a holistic approach to patient care.
The INS also seeks to assist in bridging the gap between innovation and implementation of novel research and, therefore, aims to establish strong links with industry innovators and to be the primary point of contact between industry and clinical nephrology researchers in Ireland.
INS hears about newest biomarker to be developed from the vasculitis registry and biobank
The RITA-Ireland Vasculitis RIV Registry and Biobank has helped to research a biomarker that has been shown to detect active renal vasculitis, the INS Winter Meeting heard.
Urinary soluble (us)CD163 was identified as a potential biomarker reflecting macrophage activation in inflammatory conditions.
Consultant Nephrologist at Cork University Hospital, Dr Sarah Moran, gave a presentation to the meeting about the registry and biobank, along with the development of this biomarker.
Referencing her 2021 study published in the Journal of the American Society of Nephrology, along with other research, Dr Moran showed that usCD163 is an effective biomarker that meets all necessary characteristics.
Currently, the biomarkers haematuria, proteinuria, and creatinine “are not sensitive or specific measures”, according to Dr Moran.
Turning to the registry, which has 45,000 samples
from over 900 patients, usCD163 was elevated at diagnosis of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV).
As a biomarker for AAV, usCD163 was shown to be biologically plausible and readily available, as it is collected through urine samples, Dr Moran said. Testing results are also highly sensitive and very specific.
The biomarker can be measured easily at low-cost.
Test results are fast and testing equipment “is avail-
able in any clinical laboratory in Ireland or throughout the world”, she added.
Levels of usCD163 vary rapidly with disease severity, with treatment response, and levels can aid in risk stratification of patients. It can also be used to accurately detect flare and flare mimics.
Addressing delegates, Dr Moran said: “usCD163 meets all of these biomarker characteristics and all of this was possible throughout the registry…. So it's really been a true collaborative effort to bring this test from the bench, now fortunately, to the bedside.”
Speaking to the Medical Independent (MI), Dr Moran said understanding the role of usCD163 in other kidney diseases may be a future development.
“Perhaps, could it be a marker of kidney inflammation beyond vasculitis, a prototypic rare disease, [and] much more common glomerular diseases? But I think that we could explore its role and maybe have it as a useful tool for those patients as well.”
Dr Moran also highlighted to MI that this work shows that “translational medicine is possible”.
She said: “We can develop biomarkers that can be used in clinical medicine, if we work as a community together and partner with our patients and use the available technologies to translate our clinical experience into actually useful tools.”
Dr Moran concluded her talk by speaking about the future of the biobank and registry, and future possible involvement with ERN-RITA (the European Reference Network for Rare Immunodeficiency, Autoinflammatory, and Autoimmune Disease).
This would centralise ethics applications, centralise the recruitment log, provide data management support, and also possibly provide additional support to managed access programmes.
Conference Coverage THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 34
Prof Liam Plant
We can develop biomarkers that can be used in clinical medicine, if we work as a community together and partner with our patients
Dr Sarah Moran
BRING PROTECTION TO LIFE
BY REDUCING THE RISK OF THE COMPOSITE OF DECLINING KIDNEY FUNCTION (BY ≥ 50%), ESKD, AND RENAL OR CV DEATH IN CONJUNCTION WITH OTHER CKD THERAPIES WHEN COMPARED TO PLACEBO*1
FORXIGA IS INDICATED IN ADULT PATIENTS FOR THE TREATMENT OF CKD.2
FORXIGA 10 mg
No titration required except in patients with severe hepatic impairment
*The DAPA-CKD study was an international, multicentre, randomised, double-blind, placebo-controlled study. In DAPA-CKD, the primary endpoint showed that FORXIGA in conjunction with other CKD therapies reduced the relative risk of the composite endpoint of ≥50% sustained decline in eGFR, reaching ESKD, and renal or CV death by 39% (5.3% ARR) vs placebo with other CKD therapies in 4304 adult patients with CKD with an eGFR of 75 to 25 mL/ min/1.73m2 and albuminuria (UACR ≥ 200 and ≤ 5000 mg/g) (median follow-up of 2.4 years; 9.2% vs 14.5%; HR 0.61; 95% CI (0.51 - 0.72; p<0.001).1 ESKD defined as sustained eGFR < 15 mL/min/1.73m2, chronic dialysis treatment or receiving a renal transplant. DAPA-CKD was stopped early due to efficacy benefit, because of the unplanned early stop, the secondary endpoints are considered nominally significant; Secondary endpoints showed that FORXIGA in conjunction with other CKD therapies reduced the relative risk of the composite of CV death or hHF by 29% (1.8% ARR: HR 0.71; 95% CI, 0.55 to 0.92; nominal p=0.009) and also reduced the relative risk of all-cause mortality by 31% (2.1% ARR; HR 0.69; 95% CI, 0.53 to 0.88; nominal p=0.004) vs placebo with other CKD therapies. There were comparable rates of the individual component of CV death, FORXIGA vs placebo (3.0% vs 3.7%; HR 0.81; 95% CI, 0.58, 1.12)1
The overall safety profile of dapagliflozin in patients with chronic kidney disease was consistent with the known safety profile of dapagliflozin.2 ©AstraZeneca 2022. All Rights Reserved.
ABRIDGED PRESCRIBING INFORMATION
FORXIGA® (dapagliflozin) 5MG & 10MG FILMCOATED TABLETS.
Consult Summary of Product Characteristics (SmPC) before prescribing.
Indications: Adults and children aged 10 years and above: Type 2 diabetes mellitus: For the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance, or in addition to other medicinal products for the treatment of type 2 diabetes.
Adults: Heart Failure: Indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease: Indicated in adults for the treatment of chronic kidney disease.
Presentation: Film-coated tablets. 5mg or 10mg of dapagliflozin (as propanediol monohydrate). Each 5mg tablet contains 25mg of lactose. Each 10mg tablet contains 50mg of lactose.
Dosage and Administration: Adults: Type 2 diabetes mellitus: The recommended dose is 10mg once daily. Consider a lower dose of insulin or insulin secretagogue such as a sulphonylurea when used in combination with dapagliflozin to reduce the risk of hypoglycaemia.
Children and adolescents: No dose adjustment in children aged 10 years and above. No safety and efficacy data available for children below 10 years of age. Heart Failure: The recommended dose is 10mg once daily. Chronic kidney disease: The recommended dose is 10 mg once daily. Children and adolescents: <18 years: Safety and efficacy not yet established. Elderly: ≥65 years: No dose adjustment is recommended based on age. Renal impairment: No dose adjustment is required based on renal function. Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. If GFR falls below 45 mL/min, additional glucose lowering treatment should be considered in patients with diabetes mellitus if further glycaemic control is needed. Mild or moderate hepatic impairment: No dose adjustment. Severe hepatic impairment: Starting dose of 5mg is recommended, if well tolerated, dose may be increased to 10mg.
Method of administration: Forxiga can be taken orally at any time of day with or without food. Tablets should be swallowed whole.
Contraindications: Hypersensitivity to dapagliflozin, or excipients.
Warnings and Precautions: Renal impairment: Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. The glucose lowering efficacy of dapagliflozin is dependent on renal function, and is reduced in patients with GFR < 45 mL/min and is likely absent in patients with severe renal impairment. Hepatic impairment: Exposure is increased in patients with severe hepatic impairment. Use in patients at risk of volume depletion and/or hypotension: Dapagliflozin increases diuresis which may lead to a modest decrease in blood pressure, it may be more pronounced in patients with very high blood glucose concentrations. Exercise caution in patients for whom a dapagliflozin induced drop in blood pressure could pose a risk, such as patients on anti hypertensive therapy with a history of hypotension or elderly patients. Careful monitoring of volume status and electrolytes is recommended in conditions leading to volume depletion, such as acute gastrointestinal illness. In volume depleted patients temporary interruption of dapagliflozin is recommended until volume depletion is corrected. Diabetic ketoacidosis (DKA): Rare cases of DKA, including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin. In a
number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14mmol/L (250mg/dL). The risk of DKA must be considered in the event of nonspecific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level. In patients where DKA is suspected or diagnosed, dapagliflozin treatment should be stopped immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised. Before initiating dapagliflozin, factors in patient history that may predispose to ketoacidosis should be considered. Patients who may be at higher risk of DKA include patients with a low beta cell function reserve (e.g. patients with low C peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse. SGLT2 inhibitors should be used with caution in these patients. Restarting SGLT2 inhibitor treatment in patients experiencing a DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved. Dapagliflozin should not be used for treatment of patients with type 1 diabetes. Necrotising fasciitis of the perineum (Fournier’s gangrene): Postmarketing cases have been reported in female and male patients taking SGLT2 inhibitors. Urgent surgical intervention and antibiotic treatment is required. Advise patients to seek medical attention if they experience a combination of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Either uro-genital infection or perineal abscess may precede necrotising fasciitis. If suspected, discontinue Forxiga and institute prompt treatment (including antibiotics and surgical debridement). Urinary tract infections: Temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis. Elderly (≥65 years): Elderly patients are more likely to have impaired renal function, be treated with medicines such as anti-hypertensives or diuretics, and be at a greater risk of volume depletion. Cardiac failure: Experience with dapagliflozin in NYHA class IV is limited. Chronic kidney disease: There is no experience with dapagliflozin for the treatment of chronic kidney disease in patients without diabetes who do not have albuminuria. Patients with albuminuria may benefit more from treatment with dapagliflozin. Lower limb amputations: Counsel patients with diabetes on routine preventative foot care as an increase in cases of lower limb amputation (primarily of the toe) has been observed in long term, clinical studies in type 2 diabetes mellitus with SGLT2 inhibitors. Urine laboratory assessments: Patients will test positive for glucose in the urine due to mechanism of action. Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Forxiga.
Drug Interactions: Diuretics: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues: Consider a lower dose of insulin or insulin secretagogue when used in combination with dapagliflozin to reduce the risk of hypoglycaemia. Interference with 1,5 AG assay: Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5 AG are
unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors. Alternative methods should be used. Interference with lithium: Dapagliflozin may increase renal lithium excretion and the blood lithium levels may be decreased. Serum concentration of lithium should be monitored more frequently after dapagliflozin initiation and dose changes. Please refer the patient to the lithium prescribing doctor in order to monitor serum concentration of lithium. Pregnancy and Lactation: Not recommended during the second and third trimesters of pregnancy. Treatment should be discontinued when pregnancy is detected. Do not use whilst breast-feeding.
Ability to Drive and Use Machines: Alert patients on the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea or insulin.
Undesirable Events: Consult SmPC for full list of side effects. Very common (≥1/10): Hypoglycaemia (when used with SU or insulin). Common (≥1/100 to <1/10): Vulvovaginitis, balanitis and related genital infections, urinary tract infection, dizziness, rash, back pain, dysuria, polyuria, haematocrit increased, creatinine renal clearance decreased during initial treatment, dyslipidaemia. Uncommon (≥1/1,000 to < 1/100): Fungal infection, volume depletion, thirst, constipation, dry mouth, nocturia, vulvovaginal pruritus, pruritus genital, blood creatinine increased during initial treatment, blood urea increased, weight decreased. Rare (≥ 1/10,000 to < 1/1,000): Diabetic ketoacidosis (when used in type 2 diabetes mellitus). Very Rare (< 1/10,000): Angioedema, necrotising fasciitis of the perineum (Fournier’s gangrene), Tubulointerstitial nephritis.
Legal Category: Product subject to prescription which may be renewed (B).
Marketing Authorisation Number: EU/1/12/795/002; EU/1/12/795/007.
Marketing Authorisation Holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden.
Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, College Business and Technology Park, Blanchardstown Road North, Dublin 15. Tel: +353 1 609 71 00.
FORXIGA is a trademark of the AstraZeneca group of companies.
Date of API preparation: 07/2022 Veeva ID: IE-4049
Adverse events should be reported directly to: HPRA Pharmacovigilance, Website: www.hpra.ie
Adverse events should also be reported to AstraZeneca Patient Safety on Freephone 1800 800 899
1. Heerspink HJL et al. N Engl J Med. 2020;383(15):1436–1446.
2. FORXIGA 10 mg film-coated tablets. Summary of product characteristics.
ARR = absolute risk reduction; CKD = chronic kidney disease; CV = cardiovascular; DAPA-CKD = Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease; eGFR = estimated glomerular filtration rate; ESKD = end-stage kidney disease; hHF = hospitalisation for heart failure; HR = hazard ratio. HFrEF = heart failure with reduced ejection fraction; T2D = type 2 diabetes
Veeva ID: IE-4598 Date of Prep: January 2023
J15135 AZ Forxiga Advert 250x346 IE-4598.indd 1 19/01/2023 12:04
Infectious disease in kidney transplant patients discussed at INS Winter Meeting
The INS Winter Meeting heard a presentation from Dr Eoghan de Barra, Consultant in Infectious Diseases at Beaumont Hospital, Dublin, concerning the infectious diseases that may affect transplant patients.
Speaking to the Medical Independent (MI), Dr de Barra said he hoped the nephrology specialists in attendance acknowledged the importance of “the screening, the prevention, and the changing epidemiology that I think is going to impact their specialty in the future”.
In his talk, Dr de Barra highlighted the diversification of the Irish population.
This meant there was also a diversification in the population of donors and recipients.
“I think that's going to change the spectrum of a lot of medicine, particularly transplant medicine, into the
future,” he said.
“Because that means different epidemiology [regarding infectious diseases].”
Dr de Barra said such diseases included tuberculosis, American trypanosomiasis, and HIV.
He also addressed the “post-transplant phase” and the “burden” of infectious diseases in the first year after transplantation.
“The thing that persists, really, are the urinary tract [infections],” he said. Due to antimicrobial resistance globally, “it means with [every] UTI that we experience, it's going to get harder and harder.”
According to a study from a 2020 Clinical Infectious Diseases article, other infectious diseases that persist during the first year post-transplant include herpes simplex virus, varicella zoster virus, and cytomegalovirus.
Dr de Barra also told delegates regarding the vaccina -
The road to halting chronic kidney disease
Halting the progression of chronic kidney disease (CKD) is within reach of the specialty of nephrology, according to Consultant Nephrologist, Dr David Lappin, University Hospital Galway.
Dr Lappin told the Medical Independent (MI): “We have to aim to halt [CKD]. At present, we're only slowing, but we have new tools now that allow us to improve the rate at which we're slowing patients down. And ultimately, I think we may well get to a point where we can halt the progression of chronic kidney disease.”
According to a 2012 study in the BMC Nephrology journal, 11.6 per cent of adults aged over 45 in the general population will develop CKD. Risk factors for developing CKD include cardiovascular disease, smoking, hypertension, and diabetes, Dr Lappin said.
“About half a billion people on the planet have diabetes. And they constitute about half the patients we see with chronic kidney disease,” he said. “Although only about 10 per cent of that group of patients end up with end-stage kidney disease, this still represents a huge number of patients presenting to our services.”
He added that “it is important to remember” early glycaemic control is most beneficial in preventing diabetic kidney disease progression, and optimising renin-angiotensin-aldosterone system (RAAS) blockade also “gives maximum benefit”.
“Remember, despite what we've been doing today, despite new checkpoint therapy… the residual risk of chronic kidney disease progression remains quite high,” he added.
Regarding this residual risk, Dr Lappin presented delegates with evidence from various studies and trials, such as CREDENCE and EMPA-Kidney, which showed the “foundational therapies, certainly for all patients, diabetic or not, [are] ACE inhibitors or SGLT2 inhibitors”.
Angiotensin-converting enzyme (ACE) inhibitors help to lower blood pressure and sodium-glucose Cotransporter-2 (SGLT2) inhibitors (also called flozins), also help to lower blood glucose in type2 diabetes and prevent kidney disease progression.
Dr Lappin highlighted research into finerenone, a non-steroidal MRA, and its possible benefits to the non-diabetic population of patients. As part of the KDIGO [Kidney Disease Improving Global Outcomes] guidelines, which focus on the management of those with kidney disease, finerenone has a “level 2 recommendation” for “all patients with diabetic kidney disease with residual cardiorenal risk”.
Dr Lappin added: “I wonder over time… whether there will be evidence that finerenone will be beneficial to the non-diabetic population.”
Dr Lappin also told MI: “Another important factor is that if we get in at a very early stage and recognise disease early and recognise the patients at higher risk. They're the patients, I think, that we can stop progressing.”
Dr Lappin told delegates that “profiling and looking for high-risk patients” and “getting them into specific clinics to manage them” will help prevent progressive kidney disease.
tion of people on transplant lists: “We need to be better.”
He spoke about the importance of influenza and Covid-19 vaccines among transplant patients.
Vaccinating this population can be difficult, as if they are living with chronic kidney disease they may “have a suboptimal response to vaccines”.
He said: “There are some studies enrolling at the moment to look at [live vaccines] in transplant recipients, because we need to try to protect them more and have more optimal vaccination strategies.”
Dr de Barra added when speaking to MI : “We all go to our own specialty conferences… and we feel in our comfort zone. But what's a lot harder, and you learn an awful lot more, is going to somebody else's specialty meeting in somebody else's world, because we all have a very different perspective on what's the priority. I think we need to learn from each other.”
Rare kidney stone disease ‘neglected'
The INS Winter Meeting heard a presentation on rare kidney stone disease identification, treatment, and prevalence from Consultant Nephrologist at the Royal Free Hospital, London, Dr Shabbir Moochhala.
Dr Moochhala said kidney stones are “neglected, I think, from a nephrology point of view”. He recommended a “quick screen of all patients” when they present with kidney stones.
Dr Moochhala also said it was important to determine the age of the patient when they got their first stone, the recurrence rate, and then a sample for testing to detect rare stones.
Genetic conditions can also cause stone formation; however, this only solves about 15 per cent of stones in monogenic conditions and 50 per cent of stones in polygenic conditions.
“It is not about just looking at genetics, it's not about looking at biochemistry, it's about looking at the patient,” said Dr Moochhala.
Paraphrasing one of his mentors, he added: “When you look back at the history of tubulopathies and a lot of other conditions, a lot of these were discovered by… just old-style clinical medicine, looking at patients and categorising them, [and] un-
derstanding what's going on.”
According to Dr Moochhala, “rare stones are really worth diagnosing” because they “are often treatable”.
“And even if you don't make a rare disease diagnosis, by controlling them more or reducing the risk, you're helping the patients, [and] you're also diagnosing cardiovascular disease.”
Knowing when to refer to a specialist is also important, Dr Moochhala added. He recommended referral in cases where stones develop under the age of 30, the stones are bilateral, it is a rare stone type, and there is unexplained chronic kidney disease.
Speaking to the Medical Independent, he said: “By giving patients a diagnosis [and] by enabling them to even self-manage sometimes, where appropriate, we can take the pressure off the health services by preventing them from having either episodes of acute kidney injury or stones,” he said.
“That's really what it's about in terms of trying to reduce the number of acute attendances at hospital; that will help the patients and the health service.”
Conference Coverage THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 36
The Irish Nephrology Society, Winter Meeting, RCSI, Dublin, 28 January 2023
Dr Shabbir Moochhala
It is not about just looking at genetics, it's not about looking at biochemistry, it's about looking at the patient
50mgs once daily
BETMIGA 25 mg prolonged-release tablets & BETMIGA 50 mg prolonged-release tablets.
Prescribing Information: BETMIGA™ (mirabegron)
For full prescribing information, refer to the Summary of Product Characteristics (SPC). Name: BETMIGA 25 mg prolonged-release tablets & BETMIGA 50 mg prolonged-release tablets. Presentation: Prolongedrelease tablets containing 25 mg or 50 mg mirabegron. Indication: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Posology and administration: The recommended dose is 50 mg orally once daily in adults (including elderly patients). Mirabegron should not be used in paediatrics for OAB. A reduced dose of 25 mg once daily is recommended for special populations (please see the full SPC for information on special populations). The tablet should be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed. The tablet may be taken with or without food. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC. Severe uncontrolled hypertension defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg. Warnings and Precautions: Renal impairment: BETMIGA has not been studied in patients with end stage renal disease (eGFR < 15 ml/min/1.73 m2 or patients requiring haemodialysis) and, therefore, it is not recommended for use in this patient population. Data are limited in patients with severe renal impairment (eGFR 15 to 29 ml/min/1.73 m2); based on a pharmacokinetic study (see section 5.2 of the SPC) a dose of 25 mg once daily is recommended in this population. This medicinal product is not recommended for use in patients with severe renal impairment (eGFR 15 to 29 ml/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors (see section 4.5 of the SPC).
Hepatic impairment: BETMIGA has not been studied in patients with severe hepatic impairment (ChildPugh Class C) and, therefore, it is not recommended for use in this patient population. This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving strong CYP3A inhibitors (see section 4.5 of the SPC). Hypertension: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients. Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg). Patients with congenital or acquired QT prolongation: BETMIGA, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies (see section 5.1 of the SPC). However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown. Caution should be exercised when administering mirabegron in these patients. Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB: Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medicinal products for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. A
controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with BETMIGA; however, BETMIGA should be administered with caution to patients with clinically significant BOO. BETMIGA should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB. Interactions: Caution is advised if mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised by CYP2D6. Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. In patients with mild to moderate renal impairment or mild hepatic impairment, concomitantly receiving strong CYP3A inhibitors, the recommended dose is 25 mg once daily. For patients who are initiating a combination of mirabegron and digoxin (P-gp substrate), the lowest dose for digoxin should be prescribed initially (see the SPC for full prescribing information). The potential for inhibition of P-gp by mirabegron should be considered when BETMIGA is combined with sensitive P-gp substrates. Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate. Pregnancy and lactation: BETMIGA is not recommended in women of childbearing potential not using contraception. This medicinal product is not recommended during pregnancy. BETMIGA should not be administered during breast-feeding. Undesirable effects: Summary of the safety profile: The safety of BETMIGA was evaluated in 8433 adult patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received BETMIGA for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for adult patients treated with BETMIGA 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections. The frequency of tachycardia was 1.2% in patients receiving BETMIGA 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving BETMIGA 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving BETMIGA 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving BETMIGA 50 mg. Serious adverse reactions included atrial fibrillation (0.2%). Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies. Adverse reactions: The following list reflects the adverse reactions observed with mirabegron in adults with OAB in the three 12-week phase 3 double blind, placebo controlled studies. The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be established from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse events are grouped by MedDRA system organ class. Infections and infestations:
Common: Urinary tract infection, Uncommon: Vaginal infection, Cystitis. Psychiatric disorders: Not known (cannot be estimated from the available data): Insomnia*, Confusional state*. Nervous system disorders:
Common: Headache*, Dizziness*. Eye disorders: Rare: Eyelid oedema. Cardiac disorders: Common: Tachycardia, Uncommon: Palpitation, Atrial fibrillation. Vascular disorders: Very rare: Hypertensive crisis*. Gastrointestinal disorders: Common: Nausea*, Constipation*, Diarrhoea*, Uncommon: Dyspepsia, Gastritis, Rare: Lip oedema. Skin and subcutaneous tissue disorders: Uncommon: Urticaria, Rash, Rash macular, Rash papular, Pruritus, Rare: Leukocytoclastic vasculitis, Purpura, Angioedema*. Musculoskeletal and connective tissue disorders: Uncommon: Joint swelling. Renal and urinary disorders: Rare: Urinary retention*. Reproductive system and breast disorders: Uncommon: Vulvovaginal pruritus. Investigations: Uncommon: Blood pressure increased, GGT increased, AST increased, ALT increased. * signifies adverse reactions observed during post-marketing experience. Prescribers should consult the SPC in relation to other adverse reactions. Overdose: Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended. Basic NHS Cost: Great Britain (GB)/Northern Ireland(NI): BETMIGA 50 mg x 30 = £29, BETMIGA 25 mg x 30 tablets = £29. Ireland (IE): POA. Legal classification: POM. Marketing Authorisation number(s): (GB): PLGB 00166/0415-0416. NI/IE: EU/1/12/809/001-006, EU/1/12/809/008-013, EU/1/12/809/015018. Marketing Authorisation Holder: GB: Astellas Pharma Ltd., 300 Dashwood Lang Road, Bourne Business Park, Addlestone, United Kingdom, KT15 2NX. NI/IE: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands. Date of Preparation of Prescribing information: January 2023. Job bag number: MAT-IE-BET-2023-00001. Further information available from: GB/NI: Astellas Pharma Ltd, Medical Information: 0800 783 5018. IE: Astellas Pharma Co. Ltd., Tel.: +353 1 467 1555. For full prescribing information, please see the Summary of Product Characteristics, which may be found at: GB: www.medicines.org.uk; NI: https://www.emcmedicines.com/en-GB/northernireland/; IE: www.medicines.ie.
United Kingdom (GB/NI)
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Astellas Pharma Ltd. on 0800 783 5018. Ireland
Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Website: www.hpra.ie or Astellas Pharma Co. Ltd. Tel: +353 1 467 1555, E-mail: firstname.lastname@example.org.
of preparation: January 2023 References: 1. Freeman R, et al. Current Medical Research and Opinion 2017. https://doi.org/10.1080/03007995.2017.1419170. MAT-IE-BET-2023-00003
His 14th walk in the park since the day he started BETMIGA1
12259_Betmiga_PARK_A4_JAN23_01.indd 1 16/01/2023 16:49
The Irish Nephrology Society, Winter Meeting, RCSI, Dublin, 28 January 2023
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 38
The winners of NCHD pathology team competition are (pictured L-to-R): Dr Paul O’Hara, Irish Nephrology Society (INS) Secretary; Dr Liam O’Neill, Beaumont Hospital, Dublin; Dr Eithne Nic an Riogh, Mater Misericordiae University Hospital (MMUH), Dublin; Prof Tony Dorman, Beaumont; Dr Dean Moore, MMUH; Dr Blathnaid O’Connell, Cork; and Prof Liam Plant, INS President
Prof Mark Griffin, Galway; Dr James Gleeson, Cork; and Prof Donal Reddan, Galway
Mr David Malone, AstraZeneca; and Mr Sean Lally, AstraZeneca
Prof Mark Little, Trinity College Dublin; and Dr Candice Roufosse, Imperial College London
Ms Julie Power, Vasculitis Ireland Awareness; Dr Safa Nowrooz, St Vincent’s University Hospital, Dublin; and Dr Eithne Nic an Riogh
Winner of the NCHD case competition: Dr Jennifer Scott, Tallaght University Hospital, Dublin; with Dr Paul O’Hara
Dr Sarah Moran, Cork; and Dr Claire Kennedy, St James’s Hospital, Dublin
Dr Suzanne D’Arcy, Galway; Dr David Gorey, Galway; Dr Cliona Cowhig, Cork; and Dr Tara O’Sullivan, Cork
Iron deficiency in cardiology 2022
An overview of the latest approaches and evidence in treating iron deficiency in patients with cardiovascular issues
Authors: Dr Robert M Evans, SpR in Cardiology, and Dr Patrick O’Callaghan, Consultant Cardiologist, University Hospital Waterford
A B C
Successful completion of this module will earn you 2 CPD credits Scan here or visit www.medilearning.ie/doctorcpd doctor CPD
WEDNESDAY 22 – THURSDAY 23
RCSI International Nursing and Midwifery Research and Education Conference, RCSI Dublin. The theme of the conference is ‘Nursing and midwifery – leading the world to better health’ and will feature insights from world-renowned nurse and midwife leaders. Speakers include: Prof Patricia M Davidson (FFNMRCSI Ad Eundem), Vice-Chancellor and President, University of Wollongong, Australia and former Dean, Johns Hopkins School of Nursing, Baltimore, US; Ms Margrieta Langins, Nursing and Midwifery Policy Adviser, Health Workforce and Service Delivery Unit, World Health Organisation; Dr Leslie Mancuso (FAAN), President and Chief Executive Officer, Jhpiego, Maryland, US; Dr Katie Huffling, Executive Director, Alliance of Nurses for Healthy Environments (ANHE), Mount Rainier, Maryland, US; Prof Laura Serrant OBE, Regional Lead Nurse, Health Education England (North East and Yorkshire) and Professor of Community and Public Health Nursing, Manchester Metropolitan University, UK. Visit www.rcsi.com/dublin.
WEDNESDAY 22 – FRIDAY 24
Irish Association for Cancer Research Annual Conference, Radisson Blu Hotel, Athlone. Visit www.iacr.ie
Cork University Hospital (CUH) Annual Nursing Conference. ‘A turning tide: Nurses influencing the future’ is the theme for the CUH Annual Nursing Conference 2023. The conference will provide a platform for consideration, information, and celebration of nurses and their work influencing the future.
FRIDAY 3 – SATURDAY 4
Primary Care Dermatology Society of Ireland (PCDSI) Annual Conference, Newpark Hotel, Kilkenny. The PCDSI annual meeting is focused principally on the management of dermatological conditions in general practice. The meeting, which will feature a number of world-renowned speakers, is open to PCDSI members and non-members and is principally targeted at GPs. There are reduced rates for PCDSI members and for those who register in advance online. Visit www.pcdsi.com
WEDNESDAY 22 – FRIDAY 24
30th International Meeting on Advanced Spine Techniques (IMAST) Convention Centre, Dublin. The IMAST, organised by the Scoliosis Research Society (SRS), will see leading spine surgeons and researchers come together to demonstrate and discuss recent advances in spine surgery. IMAST focuses on innovative and new methods/techniques for spinal pathology. Educational content includes instructional course lectures, four-minute paper presentations, case discussions, E-point presentations, and industry workshops, all led by a multidisciplinary and international faculty. Visit https://www.srs.org.
Blackrock Health Galway GP Study Day, Galway Bay Hotel, Galway. The event is organised by Investnet Healthcare Ltd.
Irish Nurses Cardiovascular Association 25th Jubilee event, Trinity College Dublin. The Association will hold its scientific meeting and cardiac excellence awards. The objective of the Association
is to keep members informed of new developments relating to cardiovascular disease, to promote ongoing research and education for nurses, and enhance the standards of nursing care and research. Visit www.incanursing.ie.
WEDNESDAY 29 – FRIDAY 31
Society of British Neurological Surgeons (SBNS) Spring Meeting, Clayton Hotel Silver Springs Conference Centre, Tivoli, Cork. The meeting will be hosted by SBNS colleagues at Cork University Hospital. Visit www.sbns.org.uk.
WEDNESDAY 29 – SATURDAY 1
14th World Congress on Brain Injury, Convention Centre, Dublin. Organised by the International Brain Injury Association (IBIA), the World Congress on Brain Injury is the largest gathering of international professionals working in the field. This year it is being held in partnership with Acquired Brain Injury Ireland. Visit https://braininjurycongress.org/.
THURSDAY 30 – FRIDAY 31
College of Psychiatrists of Ireland Spring Meeting. The College is the professional body for psychiatrists in the Republic of Ireland. Its mission is to promote excellence in the practice of psychiatry. Visit www.irishpsychiatry.ie.
THURSDAY 20 – SATURDAY 22
European Society of Gastrointestinal Endoscopy (ESGE) Days 2023, Convention Centre, Dublin. The ESGE Days meeting is organised by the ESGE and provides a platform where endoscopy professionals can meet and exchange education, innovation, and inspiration. Visit https://esgedays.org.
WEDNESDAY 26 – SATURDAY 29
56th Annual Meeting of the Association for European Paediatric and Congenital Cardiology (AEPC) 2023, Convention Centre, Dublin. The AEPC is hosted by the local organising committee from Children’s Health Ireland and the Royal Belfast Hospital for Sick Children. Visit www.aepc2023.org.
THURSDAY 4 – FRIDAY 5
Irish Society for Rheumatology (ISR) Spring Meeting, Hotel Kilkenny. The ISR is an organisation of doctors and scientific specialists working in the field for rheumatology. The Society organises and hosts regular platforms and conferences allowing members to present clinical and scientific material. Visit https://isr.ie.
FRIDAY 5 – SATURDAY 6
Irish Head and Neck Society Annual Conference, Lyrath Estate Hotel, Kilkenny. The Society is a multidisciplinary platform of professionals managing patients with head and neck cancer and promoting interdisciplinary collaboration in research and education to improve patient care. Speakers will include: Prof Ralph Gilbert (reconstructive surgery) University of Toronto, Canada; Dr Snehal Patel (surgery), Memorial Sloan-Kettering Cancer Center, New York, US; Dr Davide Lombardi (surgery), University of Brescia, Italy; Dr Justin Roe (speech and language therapy), Royal Marsden and Imperial College, London, UK; Dr Martin Forster (medical oncology), UCL Cancer Institute, London, UK; Prof Kevin Harrington (radiation oncology and cancer biology), Institute for Cancer Research/
Royal Marsden, London, UK; and Dr Hilda Stambuk (radiology), Memorial Sloan-Kettering Cancer Centre, New York, US.
TUESDAY 9 – FRIDAY 12
Joint Meeting of the Irish Institute of Clinical Neuroscience’s Irish Neurological Association and the Association of British Neurologists, International Convention Centre, Belfast. The meeting will see an exciting and wide programme of neurology education and presentations on new developments. Visit https://iicn.ie.
TUESDAY 9 – FRIDAY 12
World Association for Disaster and Emergency Medicine (WADEM) Congress on Disaster and Emergency Medicine, Killarney Convention Centre. The theme for the conference is ‘Complexity and continuity: Caring, coping, and overcoming in an increasingly challenging world’. The WADEM meeting brings together global experts to exchange knowledge and best practices on disaster medicine, prehospital care, and the health aspects of emergency management and complex humanitarian crises. Visit https://wadem.org.
WEDNESDAY 17 – SATURDAY 20
European and International Congress on Obesity, Convention Centre, Dublin. The ECO is the annual scientific congress of the European Association for the Study of Obesity. It brings together colleagues from every area of obesity research, prevention and management. Visit https://eco2023.org/.
MONDAY 22 – WEDNESDAY 24
Irish College of Ophthalmologists (ICO) Annual Conference, Great Southern, Killarney. The College is the recognised training and professional body for medical and surgical eye doctors in Ireland. The ICO’s goal is to provide and support education and learning for ophthalmologists and those who work alongside them delivering care to patients. Visit www.eyedoctors.ie.
MONDAY 12 – TUESDAY 13
22nd World Congress on Paediatric Neurology and Neuropathology, Convention Centre, Dublin. The theme for this conference is ‘A step forward in paediatric neuro and mental hygiene’. Visit https:// pediatric.neurologyconference.com/.
SATURDAY 9 – WEDNESDAY 13
European Congress of Pathology (ECP), Convention Centre, Dublin. The congress is being staged by the European Society of Pathology (ESP) and RCPI Faculty of Pathology. The theme for the ECP 2023, ‘Pathology – a bridge between science and medicine’, acknowledges the significant changes that practising pathologists have made and continue to make to their daily practice so as to ensure that new diagnostic and technological advancements are embraced and integrated into everyday practice. The meeting will reflect the dynamic developments in the field of pathology and update on these advancements through the programme prepared by the ESP working groups, ESP-affiliated societies, education and trainee subcommittees. Visit www.esp-congress.org/
THURSDAY 21 – FRIDAY 22
Irish Society for Rheumatology (ISR) Autumn Meeting, Fitzpatrick’s Castle Hotel, Killiney, Co Dublin. Visit https://isr.ie.
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 40 41 MINDO QUIZ Test your knowledge and win €50 42 SPORT Dublin Hospitals FC in Charity Cup game 44 GALLERY RCPI Fellowship Admission Ceremony 45 GALLERY RCPI Inaugural Trainers Conference
Post your answers to: Mindo Quizzes, The Medical Independent Greencross Publishing Ltd, 1st Floor Ebony House, Main St, Wicklow Town, A67R272. Closing date for entries is 7 March 2023
SPORTS QUIZ WIN €50 21 February 2023
Q1 Which golf course will host the Horizon Irish Open 2023?
Q2 Who was named Superbowl LVIII most valuable player?
Q3 Which team will Daniel Ricciardo work with in 2023 as reserve team driver?
Q4 Who is the new manager of Premier League strugglers Southampton Football Club?
Q5 Who will Katie Taylor defend her undisputed lightweight titles against on 20 May in Dublin?
Q6 How many host countries will there be in the 2026 World Cup and what are they?
21 February 2023
The winner of the 24 January 2023 Sporting Quiz Competition is Dr David Fitzsimons, Co Galway
The winner of the 24 January 2023 Crossword is Ms Fionnuala Cooney, Dublin 8
Q1 Ahead of the Six Nations opening weekend, who returns as Wales head coach? A: Warren Gatland
Q2 The first tennis Grand Slam of the year is ongoing in Melbourne. Who won the 2022 ladies singles title? A: Ashleigh Barty
Q3 Which two GAA clubs will face off next month in the AIB All-Ireland Club Championship final? A: Kilmacud Crokes of Dublin and Glen of Derry
Q4 Which Grand Prix was cancelled last month due to ongoing Covid-19 concerns? A: China
Q5 Which city will host the 2023 World Athletics Championships?
Q6 Which League of Ireland club play their home fixtures at Turners Cross? A: Cork City
Mindo Quizzes Life THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 41 Solution to Crossword Competition
Answers to Sports Quiz Competition Solution to Sudoku L A R N R C N A T U R E O P E N L Y W T A I V I I N T O D I S C O U N T M I E L I M I R A C L E P U N C H N T Y D T A S T R I P V I S I B L E E C D A O O R G A N I S M N O R M I L A O A O D O L L A R N A R R O W R Y Y D Y F 5 9 6 1 2 4 8 1 4 2 7 4 9 1 8 6 4 8 5 7 1 2 3 9 6 SUDOKU SCRIBBLE BOX 24 JANUARY 2023 ANSWERS, SOLUTIONS, AND WINNERS WIN €50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Across 1 - Relating to a city (5) 4 - Respire (7) 7 - Work of fiction (5) 8 - Composer or singer (8) 9 - Fluid made by bees (5) 11 - Hot and humid (8) 15 - Agreeable (8) 17 - Act of going in (5) 19 - Person not accepted by society (8) 20 - Concur (5) 21 - Extend an arm or leg (7) 22 - Military opponent (5) Down 1 - Small deliberative assembly (9) 2 - Variant of a thing (7) 3 - Lap of a track (7) 4 - Yellow fruit (6) 5 - Writer (6) 6 - Equine animal (5) 10 - 24 hours ago (9) 12 - Corridor (7) 13 - Official instruction (7) 14 - Turn to ice (6) 16 - Propel with force (6) 18 - ___ at the Museum: film (5)
ACROSS 1 Relating to a city (5) 4 Respire (7) 7 Work of fiction (5) 8 Composer or singer (8) 9 Fluid made by bees (5) 11 Hot and humid (8) 15 Agreeable (8) 17 Act of going in (5) 19 Person not accepted by society (8) 20 Concur (5) 21 Extend an arm or leg (7) 22 Military opponent (5) DOWN 1 Small deliberative assembly (9) 2 Variant of a thing (7) 3 Lap of a track (7) 4 Yellow fruit (6) 5 Writer (6) 6 Equine animal (5) 10 24 hours ago (9) 12 Corridor (7) 13 Official instruction (7) 14 Turn to ice (6) 16 Propel with force (6) 18 ___ at the Museum: Film (5) OUR NEW ADDRESS
5 8 6 4 9 1 2 3 7 3 7 2 8 5 6 9 4 1 4 1 9 2 7 3 5 6 8 2 6 4 7 3 5 8 1 9 1 5 3 9 8 4 6 7 2 7 9 8 1 6 2 3 5 4 9 2 5 6 1 7 4 8 3 8 3 7 5 4 9 1 2 6 6 4 1 3 2 8 7 9 5
DOWNPOUR IN DUBLIN DOESN’T DAMPEN DHFC SPIRITS IN CHARITY CUP GAME
Dublin Hospitals FC (Home) 2
Dublin Hospitals FC (Away) 2
Iveagh Grounds, Crumlin
Dublin Hospitals Charity Cup
For the Irish Wheelchair Association
Wednesday 11 January 2023
It was a wild Wednesday night in south Dublin as Dublin Hospitals FC (DHFC) hosted the first annual Charity Cup game to sponsor the Irish Wheelchair Association (IWA). The IWA provides vital nationwide assistance and support to people in Ireland with physical disabilities. IWA assisted-living services, community centres, and other support services help people in our country to live active, equal, and independent lives. The organisation relies on donations and public support in order to continue to provide these services and to develop further ways of supporting those in need.
DHFC players past and present came together for this one-off fixture to compete for the Charity Cup and show their support for the IWA. Torrential rain and howling winds promptly determined the type of game that was to be played. The grass surface at the Iveagh Grounds is one of the most pristine in the city. Previously the home of St James’s Gate and one of the first League of Ireland stadiums, the Trinity College grounds people keep an immaculate pitch here; however, it will take some time to recover from the mud-bath of that Wednesday night. The downpour did not deter the club photographer, Rodney Smythe, who was present as always to document the epic proceedings.
With no sign of the weather abating, the football got underway. The away side of John Cosgrove’s team kicked off in all navy and Rory Durand’s home team in traditional DHFC home green jerseys provided their opposition. Despite the challenging conditions, the men in navy started the game quite well. A midfield combination of Gareth Cosgrove, Emmet O’Brien, and Edward Wrynn combined experience with composure and speed to gain control of the early exchanges. Gareth Cosgrove is a St Vincent’s Hospital FC veteran, a midfield general with composure, his ability to remain calm under pressure and consistently make the correct decisions allows those around him to thrive. Wrynn, playing in an unfamiliar number 10 role, and the lively Conor Vaughan profited
most from the space created by the intelligent Cosgrove. It was Vaughan who caused early trouble down the rightwing with direct running at the midway point in the first-half, forcing a smart save from Mat Berkley in the home team’s goal. Vaughan was released by Cosgrove on numerous occasions in the first period and it seemed only a matter of time before the UCD medical student would find the back of the net. However, despite the direct running of Vaughan and the pace and trickery of the great Aidan McGrath, on the opposite wing, the away team were unable to break the deadlock. It is no mean task keeping McGrath quiet, so the home side’s back four and goalkeeper must be commended on their anticipation and resoluteness. McGrath is Dublin Hospitals all-time leading goalscorer, after all. It wasn’t all one-way traffic, and with four Brians in the home team’s squad there was nearly always one involved in any positive exchanges. Brian Conlon and Gaffney in particular displayed a telepathic relationship at times, perhaps this is unsurprising given the Galway natives have played together from a young age. Conlon, playing at right-
back, provided a number of crosses from overlapping runs, but the home front three of Gildea, Cheevers, and Trueick weren’t able to make any of them count in the first period.
With the scores tied at nil all, the halftime whistle was sounded.
A brief break saw three substitutions from each side, as reinforcements were enticed out of the comfort of the sheltered dugouts for the second-half. Off the bench came Ronan Murray, another Dublin Hospitals club legend. Murray’s goalscoring feats have only been bettered by McGrath; there are very
few players who have been as reliable and consistent as the prolific number nine over the years. It came as no surprise to spectators that through the combination of Murray, McGrath, and the incoming John Cosgrove that the away team gained further control in the second-half. Paul Schütze, having replaced Berkley in goal at half-time, pulled off two magical saves in the second-half, first from a pile-driver from Cilian Grant that seemed destined for the top corner and the second a reaction save from a John Cosgrove strike from 18 yards. At times it seemed an unfair advantage to have the German shotstopper on your side. No goalkeeper is
Life Sport THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 42
Aidan McGrath, all-time leading goalscorer for the club, capped a fine performance with an assist
After springing to life with four goals in the final 20 minutes, the referee blew the whistle for full-time
unbeatable, however. With 20 minutes remaining, it came as no surprise it was that man Ronan Murray who broke the deadlock. In typical fashion, Murray was too strong for his marker as a McGrath cross was cut back from the rightwing. Murray rolled the helpless centrehalf and neatly found the bottom corner from the penalty spot. It’s fair to say the two have a history. The combination of McGrath and Murray has been deadly for many years and one always seems to know where the other is without so much as a glance in their direction.
0-1 up and in control of the game, the away side made it two. This one was for the dubious goals committee. It was Gareth Cosgrove’s long-range pass that unleashed Vaughan down the right-wing for the umpteenth time. The attacker appeared to be offside; however, the referee didn’t see it that way. A cross-shot from the young winger took a deflection off a retreating defender and the ball slithered into the goal to put the away side two goals to the good. Vaughan’s name will go down on the scoresheet, but it was certainly one that would have benefitted from VAR technology at the Iveagh Grounds.
0-2 down, but not out, the home side made a few tactical changes, with Brian Gaffney taking position up front. All of a sudden it was all one-way traffic. Dominating possession and with the away team backs to the wall, a lobbed through ball from Conlon at right-back found the run of Gaffney, who unceremoniously smashed home on the volley from 12 yards out. A lifeline for the home team. Within five minutes, the men in green scored a second goal to level the scoreline at 2-2. Having received the ball in his own half, Durand had time to turn and play a forward pass into the path of Cheevers on the left-wing. Cheevers carried the ball with purpose towards the edge of the box. The surface at this stage was akin to quicksand and the away team full-back was helpless to prevent the cross. Again, it was Gaffney arriving in the nick of time to level the scores with a cleanly struck volley from point blank range that gave Barrett in the away team goal zero chance. After springing to life with four goals in the final 20 minutes, the referee blew the whistle for full-time. There was no time for a winner on this occasion and the first DHFC Charity Cup was shared between Cosgrove and Durand’s select teams.
The result was not the important factor this time.
Home team: P Schütze, B Conlon, B Waldron, R Winters, E Daly, R Durand, G Cheevers (capt), F Kerrigan, D Gildea, B Gaffney, R Trueick, M Berkley, B Moran.
Away team: R Barrett, L Sheerin-Purcell, E O’Connor, C Cosgrove, A Delany, G Cosgrove, E Wrynn, E O’Brien, C Grant, J Cosgrove (capt), C Vaughan (1), A McGrath, R Murray (1), B Neary.
PS: At the time of writing, the club has managed to raise €1,000 for IWA. The details for making an online donation are at the end of this article and the donation site will remain open until 3 March.
DHFC hopes to exceed the €2,000 target. Any additional donations are greatly appreciated and please follow the link below if you would like to support the Irish Wheelchair Association.
How to donate to the Irish Wheelchair Association
1. Type this url into your browser: www.idonate.ie/event/dublinhospitalsfcmatchforirishwheelchairassociation
2. Click donate.
3. Chose the amount you would like to donate and your payment method. All funds raised will be given directly to the Irish Wheelchair Association who will use them to continue their excellent work throughout the country.
To find out more about the Irish Wheelchair Association, go to www.iwa.ie Dublin Hospitals FC would like to thank our sponsors Medisec Ireland and medicalaccountant.ie for their continued support.
Sport Life THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 43
QR code: Scan the QR code to help DHFC raise essential funds for the Irish Wheelchair Association
Ray Winters in action for the home side
Colm Cosgrove representing the away team
RCPI Fellowship Admission Ceremony, No 6 Kildare Street, Dublin, 14 October 2022
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 44 Life Gallery
Photos: David Coleman - Bobby Studio
Pictured L-to-R: Prof Richard Costello, Citator; Prof Richard Reilly, Honorary Fellow; Prof Mary Higgins, Citator, Prof Geraldine McGinty, Honorary Fellow; Prof Mary Horgan, President, RCPI; Prof Des O’Neill, Citator; Prof Jane Macnaughton, Honorary Fellow; Prof Mary Daly, Honorary Fellow; and Prof Brendan Kelly, Citator
Prof Anthony Staines, Fellowship of the College; and Dr Una O’Shea
Prof Mary Horgan; Dr Solomon Asgedom, Fellowship of the College; and Ms Senait Goytom
Dr Sheelagh O’Brien, Fellowship of the College; Ms Grace Tiernan; Dr Terry McWade, CEO, RCPI; Ms Bridie McGinty; and Prof Geraldine McGinty
Dr Lucy Ann Behan; Ms Noeleen McLoughlin; Dr John Twomey, Fellowship of the College; and Dr Ann Treacy, Fellowship of the College
Prof Mary Higgins, Vice-President, RCPI; Dr Conor Harrity, Fellowship of the College; and Ms Fiona Harrity
RCPI Inaugural Trainers Conference, No 6 Kildare Street, Dublin, 9 December 2022
THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 45 Gallery Life
Photos: David Coleman - Bobby Studio
Pictured L-to-R: Prof Dara Byrne; Dr Maeve Doyle; Dr Aisling Smith; Prof Walter Eppich; and Prof Mary Horgan, President, RCPI Dr Tom Crotty; Dr Maeve Doyle; Prof Deirdre Bennett; and Ms Janet O’Farrell
Mr Ken Carmody and Dr Brenda Griffin
Dr Trevor Duffy; Dr Jim O’Neill; and Dr Mary Keoghan, Dean of the Faculty of Pathology, RCPI
Dr Claire Fallon and Dr Jim O’Neill
Dr Brenda Griffin; Dr Anna Rose Prior; Prof Breida Boyle; and Dr Aisling Martin
Dr Louise Kyne; Dr Alfonso Herrera; Dr Sinead Murphy; Dr Fionnuala O’Brien; and Dr Wasim Asif
ACCORD’S SONDELBAY▼ (TERIPARATIDE) AWARDED BEST VALUE BIOLOGIC (BVB) MEDICINE IN IRELAND
increased physical activity.
According to the World Health Organisation (WHO), rates of obesity have more than doubled globally since 1980. WHO defines obesity as having a BMI of ≥30kg/m² and it is classified as a disease by the American Medical Association. Ireland has the second highest rate of obesity in the European Union with more than a quarter (26 per cent) of adults having a BMI >30kg/m². While people living with obesity may have been advised to ‘eat less and move more’, clinical guidelines recommend going beyond this simplistic approach to address the root drivers of obesity. Instead, people living with obesity should have access to evidence-informed interventions, including medical nutrition therapy, physical activity, psychological interventions, pharmacotherapy and surgery.
Accord Healthcare’s Sondelbay is its fourth biosimilar. It joins the company’s established portfolio and marks its first branded product in a new bone health franchise representing another significant milestone in Accord Healthcare Ireland’s growing portfolio.
In February 2023, Accord Healthcare received confirmation from the HSE Medicines Management Programme that Sondelbay has been awarded best value biologic (BVB) medicine status for teriparatide.
In January 2022, Accord Healthcare received a positive opinion recommending the marketing authorisation for Sondelbay (teriparatide) as a biosimilar of the reference product Forsteo. Sondelbay is indicated for treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures, but not hip fractures, has been demonstrated. It is also indicated for treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk of fracture.
Please refer to the summary of product characteristics (SPC) for further information. The SPC is available from www.hpra.ie and www.accord-healthcare.ie
Osteoporosis is a condition where the bones lose their density and structural strength. This can lead to broken bones, pain and disability for the patient. The active substance teriparatide, as a solution for injection (20 micrograms of teriparatide per 80 microlitres of solution), has been shown to have an anabolic (building) effect on osteoporotic bone via the receptor for parathyroid hormone.
Osteoporosis is recognised as a hugely under-treated condition, with many patients not getting a diagnosis until they present with a fracture. According to a recent study, Ireland has one of the highest osteoporosis rates globally, with public hospital bed days increasing by almost 50 per cent in the past decade for osteoporotic fractures.
Ms Tracy Kivlehan, Accord Healthcare Ireland, Head of Hospitals and Specialty Brands, said: “We are delighted to have been awarded the BVB status for Sondelbay in Ireland. It is an addition to our emerging bone health franchise and our high-tech range. Osteoporosis takes a huge toll not only clinically on the patient, but also on overstretched health systems. This launch reinforces our commitment to continue to improve access to essential medicines for the patients that need them most.”
Accord, part of the Intas group, will manufacture the medicine in its own state-of-the-art facility, where they now have the second highest number of biosimilars in phase III to approval in the world.
SAXENDA (LIRAGLUTIDE 3MG) INJECTION APPROVED FOR REIMBURSEMENT IN IRELAND FOR ADULTS LIVING WITH OBESITY
Novo Nordisk recently announced that Saxenda (liraglutide 3mg) has been granted reimbursement in Ireland for the treatment of adults living with obesity. Liraglutide 3mg is the only obesity medicine reimbursed for people with an initial body mass index (BMI) of ≥35kg/ m², pre-diabetes and at least one cardiovascular risk factor, in combination with a reduced calorie diet and
Prof Donal O’Shea, HSE Clinical Lead for Obesity, said: “Today’s announcement of liraglutide 3mg reimbursement for obesity represents a landmark moment in Ireland’s changing response to how obesity is managed following the introduction of a new HSE Model of Care for the Management of Overweight and Obesity last year. Liraglutide 3mg has demonstrated, both in clinical studies and real-world use, clinically meaningful weight loss when combined with diet and exercise.”
Liraglutide 3mg was evaluated in the SCALE (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-Diabetic and Diabetic Adults) phase 3 clinical trial programme, which included more than 5,000 study participants who have obesity (BMI ≥30kg/m²) or who have overweight (BMI ≥27kg/m²) with weight-related comorbidities. Trial data showed that liraglutide 3mg, in combination with a reduced-calorie diet and increased physical activity, resulted in significantly greater weight loss than diet and physical activity alone.
Ms Susie Birney, Executive Director for the Irish Coalition for People living with Obesity, said: “We are delighted to have a treatment option reimbursed for people living with obesity in Ireland. For many people living with obesity, today’s announcement represents hope for the future in how obesity will be treated and recognised by society and treated by healthcare professionals as a complex disease with multiple causes, rather than just only a case of personal responsibility. We look forward to more improvements in access to obesity care in Ireland in the years to come.”
Mr Owen Treacy, General Manager and Vice President of Novo Nordisk Ireland, said: “We are very pleased to have gotten to the end of a long process of engagement with the authorities in Ireland to be able to provide the first pharmacotherapy for people living with obesity. We believe this is an important first step in changing how obesity is perceived and treated here and we are delighted to play our part in tackling this very significant health challenge.”
Liraglutide 3mg, a human glucagon-like peptide-1 (GLP-1) analogue, comes in pre-filled pens as a once-daily injection. Reimbursement is through a managed access protocol run by the HSE’s Medicines Management Programme. Those qualifying for reimbursement will need to satisfy the following eligibility criteria: BMI of ≥35kg/ m², pre-diabetes and at least one cardiovascular risk factor. For full details on reimbursement criteria: www.hse. ie/eng/about/who/cspd/ncps/medicines-management/ managed-access-protocols/liraglutide-saxenda-/
For people living with obesity who do not meet these criteria, the medicine can still be prescribed and purchased at the individual’s expense.
Treatment with Liraglutide 3mg should be discontinued after 12 weeks on the 3mg/day dose if people have not lost at least 5 per cent of their initial body weight. Further prescribing information can be found at: www.medicines.ie
NEW COUNTRY MANAGING DIRECTOR AND HEAD OF HUMAN PHARMA APPOINTED FOR BOEHRINGER INGELHEIM UK AND IRELAND
Boehringer Ingelheim UK and Ireland has announced the appointment of Ms Vani Manja as its new Country Managing Director and Head of Human Pharma.
Ms Manja has been with Boehringer Ingelheim for over 11 years in leadership roles in Germany, the United States and most recently as General Manager in India. Her career started as a commissioned officer in the Indian Army Ordnance Corps, which preceded leadership roles at Becton Dickinson and McKinsey. She brings extensive experience of strategy, marketing, sales, business development, people management, and cultural transformation, and is passionate about tackling healthcare inequalities, and advancing sustainable healthcare.
Commenting on her new role, Ms Manja said: “It is with great heart that I bring the spirit of conscious leadership to my new role. I look forward to being fully present and partnering with key stakeholders in the healthcare ecosystem in our collective quest to improve health for humans and animals in the UK and Ireland. Our customers, from healthcare professionals and patients, to veterinarians, farmers, pet, and horse owners, count on us for continued delivery of innovation and for reliable access to our products and services. Our people are what make our business special and my top priority is to ensure we maintain the values that Boehringer Ingelheim is known for throughout the world, including furthering conversations around equality, diversity, and inclusion.”
She continued: “My focus will also be to deliver on our purpose of transforming lives for generations. Like many health systems around the world, the UK and Ireland are experiencing challenging times. I believe we must continue to do all we can to drive innovation in a way that better supports patients and brings more value to healthcare systems locally and nationally.”
Ms Manja holds an MBA and MA in International Studies from the Wharton School at the University of Pennsylvania in Philadelphia, US, and a Bachelor’s degree with Honours in Chemistry from Delhi University, India.
SCREENING FOR MENTAL HEALTH PROBLEMS IN SCHOOL CAN PREVENT LATER PSYCHOTIC EXPERIENCES
In a first-of-its-kind study, researchers at RCSI University of Medicine and Health Sciences have found that a school-based screen for mental health problems, combined with a referral system, can be effective at improving and protecting the mental health of adolescents.
The research, published in BMC Public Health , is the first study to examine the impact of school-based interventions on preventing psychotic experiences, an early indicator of developing mental health disorders in children and adolescents.
Of the interventions tested, one consisting of a universal screener and selective intervention was found to both reduce the rates of, and prevent, psychotic experiences at 12-month follow up.
Prof Mary Cannon, Professor of Psychiatric Epidemiology and Youth Mental Health, Department of Psychiatry, RCSI, commented: “Prevention has two key objectives; to reduce the symptoms of mental health disorders, and prevent new incidence of symptoms. This study demonstrates that school-based interventions have the potential to be effective at both key aims of prevention and making a positive impact on public mental health.”
Lead author and RCSI PhD student, Ms Lorna Staines, outlined: “Psychotic experiences are particularly common in the adolescent population and are associated with a four-fold increased risk for psychotic disorder, and a three-fold increased risk for any mental disorder. This study has for the first time identified schoolbased programmes as an effective route to prevent psychotic experiences.”
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Classifieds & Recruitment THE MEDICAL INDEPENDENT | 21 FEBRUARY 2023 47
A round-up of news and oddities from left field by
Dr Doug Witherspoon
The máthair of all invention: How Irish innovations changed the world, from stethoscopes to spuds
As my grandmother used to say, "It'd be a grand little country if only you could put a roof on it." The Irish are well known internationally for the high quality of our medical graduates, as well as Guinness and music. It's worth pausing briefly to look at some of the other Irish innovations that can be traced to our home-grown inventors.
French physician René Laënnec is of course credited with
the invention of the stethoscope in 1816. This was in response to the discomfort of physician and patient alike at the doctor having to press his face against the chest of a patient, which was deemed to offend Victorian sensibilities.
Laënnec pioneered the device as a simple wooden tube, but less than 10 years later Dr William Stokes published the first treatise on the use of the stethoscope in English. Despite being treated initially with some ridicule and disdain, by the
Centre for Women’s Health
middle of the 19th Century, the value of the new device began to get some traction.
In 1851, Dr Arthur Leard presented his design for the binaural stethoscope at the Great Exhibition event. Sadly, Leard, a Wexford man, missed out on any commercial benefits from his work, leaving two US doctors to fight it out for the claim to be its originator.
On matters more topical – pardon the pun – parents with a newborn have pharmacist Thomas Smith to thank every time they pick up a tub of Sudocrem. A professor of pharmacy and retail pharmacist, he developed 'Smith's Soothing Cream' in the back of his humble premises in 1931, but soon had to rampup his production facilities to cope with demand. Today, more than 34 million pots of Sudocrem are sold worldwide each year in more than 50 countries.
The Irish were no slouches when it came to engineering innovations either. The induction coil, which is still used in car ignitions to this day, was the brainchild of Rev Nicholas Callan, a priest and Professor of Science in St Patrick's College in Maynooth. In 1836, Rev Callan was inspired to wind two long wires around the end of an electromagnet and connect the ends of one wire to a battery. When the current was interrupted, a spark was generated from the unconnected coil and the rest is history, as they say. Incidentally, during the initial testing stages of the coil, Rev Callan managed to knock a future Archbishop of Dublin unconscious with the shock. I will make no comment about whether he was charged with 'assault and battery'.
Gastronomy did not escape the attentions of Irish inventors. The humble cream cracker was invented by a Waterford family in the 1800s, namely the Jacobs, as you might expect. The initial production process was painstaking, with yeast dough left to ferment for 24 hours before the layers were carefully folded a number of times to create the famous layered cracker. Now, there are machines that can produce around one million crackers per hour to be sold in more than 35 countries worldwide.
We have Waterford butcher Henry Denny to thank for the bacon rasher, devised in 1820. He departed from the process of curing big chunks of meat in brine and instead he used long, flat slices of meat and substituted the brine for salt. This was a significant innovation for the time and was just one of the many bacon-curing processes patented by Denny.
Of course, the Irish are known for our love of crisps, or 'potato chips' for the trans-Atlantic among us. Here again we excelled, with innovation driven in part by Joseph 'Spud' Murphy's distaste for unflavoured crisps. This prompted Murphy, the founder of Tayto, to introduce the world's first ever potato crisps. In case you were wondering, yes, the cheese and onion crisp was the first out of the blocks, making 'Spud' a very wealthy man indeed.
An honourable mention must go to Dr Francis Rynd, another familiar name. He was the man who administered the first subcutaneous injection with a home-made hypodermic syringe in 1844.
For a little boost to your national pride, check out other Irish innovations, such as the guided torpedo, colour photography, the submarine, or the ejector seat, among others.
For a small country with no roof, we acquit ourselves well on the world stage in medicine and elsewhere.
If you have anything you would like to share, please email: email@example.com The Dorsal View THE MEDICAL INDEPENDENT |21 FEBRUARY 2023 48
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