The Medical Independent 6th October 2022

PAGE 10

‘Interim’ solution proposed on NCHD emergency tax

CATHERINE REILLY

The HSE is proposing an “interim” solution to NCHDs being put on emergency tax, which it intends to implement in January 2023.

The Executive’s proposal involves ‘automated advance payment’ to mitigate the impact of emergency tax where it arises, beyond an agreed threshold, for an individual NCHD during the annual rotation(s). This proposal would involve engagement with stakeholders including Revenue, the IMO, Department of Health, and voluntary agencies, according to correspondence from HSE CEO Mr Paul Reid to Minister for Health Stephen Donnelly on 26 August.

A version of this “emergency financial support arrangement” was offered recently to HSE South NCHD employees experiencing emergency tax issues, following discussions with the IMO.

The long-term strategy was the roll-out

of SAP HR and Payroll in the HSE and section 38 voluntary organisations. This would take place via the national integrated staff records and pay programme project.

However, Mr Reid indicated that as voluntary employers would remain as separate employers, the risk of emergency tax arising would still be a potential or likely problem, although better mitigated.

Mr Reid was responding to correspondence from Minister Donnelly on NCHD emergency tax. The Minister stated he had asked his officials to explore options to resolve this issue “once and for all”.

A HSE spokesperson said: “The HSE and IMO are currently in engagement regarding NCHD concerns surrounding emergency taxation and other issues affecting pay and conditions. The HSE will resolve these issues to a satisfactory level following this engagement, which is near conclusion. The IMO is to ballot their members on the outcome following conclusion of the talks.”

A tragic inferno

PAGE 20

HSE raises risk of climate action failure

LYNCH

DAVID

The risk that the HSE may not achieve a 51 per cent reduction in overall greenhouse emissions by 2030 has been included in its most recent corporate risk register, the Medical Independent (MI) has learned.

However, the HSE said that where “challenges have been identified in meeting these targets, appropriate mitigation and control measures are in place”.

In April, MI reported on the HSE's intention to include climate action “failure” as a risk on the register.

The HSE's risk register for the second quarter of this year was approved by the executive management team on 28 June.

“There is a risk of the HSE not achieving the 2021 Government commitment to a 51 per cent reduction in overall greenhouse gas emissions by 2030, and net 0 per cent by 2050 as a result of a

failure to invest in and implement appropriate carbon reduction and other sustainability activities,” according to the register, seen by this newspaper.

An Executive spokesperson said that “as one of the largest public sector energy users, the HSE must lead and act as an exemplar in emissions reduction, climate action, and the mitigation of adverse health effects of climate change”.

“Additional resources have been provided to the HSE Capital and Estates climate action and sustainability office to ensure the development and implementation of carbon reduction initiatives to meet Government targets. Where challenges have been identified in meeting these targets, appropriate mitigation and control measures are in place.”

Separately, the Department of Health told MI that its new climate change oversight group has met in plenary twice since September 2021.

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.

Trinity College Dublin has launched a new research network to enhance dementia care and outcomes and present opportunities for access to clinical trials. Dementia Trials Ireland, which is funded by the Health Research Board, launched on 27 September with the goal of offering every person in Ireland living with or at risk of dementia, the opportunity to access clinical trials. Pictured at the launch are the Forget Me Nots, a dementia-inclusive choir. Over 65,000 people in Ireland are living with the condition.

PAGE 4-5

Photo Credit: Mark Stedman

A new era for trauma Capacity issues may hamper implementation of the national trauma system. David Lynch reports

Future of CDM Niamh Quinlan speaks to GPs about possible expansion of the structured chronic disease management programme

Dr Lucia Gannon writes that some GP consultations are exercises in collusion and negotiation

Beaumont and Mater working on ‘clinical pathway' for head injuries

DAVID LYNCH

Clinical representatives from Beaumont Hospital and the Mater Misericordiae University Hospital in Dublin are currently “working in collaboration to develop a proposed clinical pathway for head-injured patients”, the HSE has informed this newspaper.

As reported in the Medical Independent (MI) in August 2021, the Government’s decision to designate the Mater as the major trauma centre (MTC) for the central trauma network led to criticism regarding neurosurgery provision. At the time, neurosurgeons at the national neurosurgical centre in Beaumont said they believed the centre needed to be co-located with the MTC.

Earlier this year, MI reported that a neuro-trauma clinical advisory group (CAG) had been established to work through detailed service considerations to enable an integrated model of care for neurotrauma/ neurocritical care services for the MTC in Dublin, as a

collaboration between both hospitals.

Regarding the CAG’s recent report to the HSE, an Executive spokesperson said clinical representatives from Beaumont and the Mater were working to develop a “proposed clinical pathway for head-injured patients” following a recent presentation to the HSE’s trauma programme steering group.

The MTCs in Cork University Hospital and the Mater are due to commence operation by the end of this year.

At the Mater, four consultant appointments have

been made with an additional six expected to commence shortly and a further three at an advanced stage of recruitment. Annual funding to appoint 17 consultants for the Mater MTC had been secured.

The HSE said it has provided annual funding to appoint 13 consultants for the MTC at Cork University Hospital for stage one of a three-stage implementation plan to deliver a fully functional MTC over the next seven years. Recruitment was “underway”. See news feature, p4-5.

CATHERINE REILLY

Senior HSE officials who had met with the Minister for Health were brought to an impromptu meeting with Fianna Fáil and Fine Gael Oireachtas members, where it seemed “highly personalised” remarks were directed to them, the HSE CEO complained to the Minister for Health.

On 29 June, Mr Paul Reid emailed Minister Stephen Donnelly about a meeting the previous day.

Mr Reid raised the short notice of the request to attend the Department to discuss emergency departments (EDs), the ED at University Hospital Limerick (UHL), and waiting lists. The HSE CEO, who was unable to attend, sent a senior delegation of national directors to address the agenda points.

“On arrival the HSE senior team met with yourself,” wrote Mr Reid. “It was stated that an update on waiting lists wasn’t planned but a brief update was given. After a brief discussion the HSE team were then asked to proceed to a meeting with ‘The Fine Gael parliamentary reps’. This caused quite a surprise to them, but they proceeded to the meeting room. When they got to the room, there were a total of nine both ‘Fianna Fáil and Fine Gael Oireachtas members from Limerick in attendance’.”

He continued: “The concerns raised to me was that there was strong and uninhibited language raised at the meeting addressed to the HSE team.”

Mr Reid indicated that the way the meeting had been arranged was not “good practice”.

He added: “Whilst the HSE team are strong individuals and well experienced in meeting with Oireachtas members, it does seem that some of the comments made in the meeting were inappropriate and highly personalised.”

A Department spokesperson said opposition Oireachtas members were not invited to the meeting due to an “inadvertent communications breakdown”.

“On September 13, the Minister invited all Oireachtas reps in the area to a meeting to discuss these matters. That meeting is due to be held in the next few weeks.”

The meeting between politicians and HSE officials followed a highly critical HIQA inspection report on capacity and staffing at the UHL ED, which was published on 17 June.

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The shadows looming over a new era for trauma

With two major trauma centres due to commence operation by the end of the year, it remains to be seen how recruitment and capacity issues may hamper implementation of the new national system. David Lynch reports

The coming months are set to mark the beginning of a new era for the Irish trauma system.

“It’s a long journey and it will take many steps,” Mr Keith Synnott, HSE National Clinical Lead for Trauma Services, said last month.

“We’ve got all the maps, we’ve got all the plans, but hopefully within the next month or two we’re going to take this first step on this long journey, which will take us towards full implementation of a trauma system for Ireland.”

The Consultant Orthopaedic and Spine Surgeon was speaking at the recent launch of the Major Trauma Audit National report 2019 and 2020 (see panel). Mr Synnott said that “we’re hoping to have major trauma services commence in each of the major trauma centres [Dublin and Cork] by the end of this year”.

It is now four years since the Trauma System for Ireland plan was published. It outlined a “whole-system approach addressing all elements of the trauma care pathway, including prevention, pre-hospital care, acute hospital care, rehabilitation, and supported discharge”. The report recommended the establishment of an “inclusive trauma system”, where a network of facilities and services co-ordinate in the care of injured patients along standardised pathways.

Implementation

Concerns have previously been raised over the pace of implementation of the plan. While the Irish Association for Emergency Medicine (IAEM) is supportive, last year its President Dr Fergal Hickey highlighted to the Medical Independent (MI) the amount of time it was taking to implement.

Speaking at the recent trauma audit launch, Mr Synnott said that much planning has been done, but that Covid-19 and the cyberattack had “interfered” with this work.

“But despite that, we have made some progress and I think we are about to get our foot on the ladder towards implementing a trauma system as was envisioned in the report [Trauma System for Ireland].”

According to Mr Synnott, a new trauma triage tool is to be rolled out in the system in the coming months. He added that there was a focus on “planned trauma care”.

“This is building on the idea that a lot of patients who sustain injury don’t need acute admission, don’t need to wait on a trolley... their treatment can be delivered on a planned, often as a day case basis... we have defined a model of care for delivering planned trauma care and we are in the process of trying

to identify how different units around the country can deliver this and network it to the general system itself.”

He said work was underway on how to better link rehabilitation services into the wider trauma system and on developing lists of trauma-related education and training opportunities in Ireland and abroad.

Governance

On the issue of governance, Mr Synnott said individual facilities will remain under the same governance structures that exist currently.

“The national office for trauma services won’t have a role in telling any hospital what it should or shouldn’t be doing,” he said.

However, the Clinical Lead added that the office would “try to provide some governance structure over the integrated piece, the networked elements of the trauma system”.

This would be to ensure that patients

are sent “to the places they need to be for treatment”.

He emphasised that the two major trauma centres (MTCs) are crucial to the plan.

In April 2021, the Government announced the designation of the Mater Misericordiae University Hospital, Dublin, as the MTC for the central trauma network. Cork University Hospital (CUH) had already been identified as the MTC for the south trauma network.

Mr Synnott described the MTCs as the “big change” in the new system. “If you have MTCs, you have a trauma system,” he said. “We are very much hopeful that there will be major trauma centres in Ireland by the end of the year, albeit with reduced capacity of what we will ultimately envisage.”

The Clinical Lead noted that “there’s lots of enabling pieces, there is lots of work to be done to enable the system to [be] what we want it to be, and we know it is going to take five-to-seven years”.

“We planned what we want to do and now it’s time to get going. It’s time to start doing things.”

Mater Hospital

Mr Synnott said that Mater Hospital had expected to be receiving major trauma patients from other hospitals in October. However, due to the need for extra beds, this will not be delivered “until towards the end of the year”.

However, in early 2023, the hospital will have the ability to accept patients bypassed from other areas in Dublin, “initially on the northside and hopefully then on the southside”.

“This will be the biggest change in the system and ultimately the Mater will see the biggest increase in the volume of patients and this change will necessarily be incremental. It won’t be all switched on at once.”

With the MTC in Cork, Mr Synnott said that “again we are hoping by the end of the year to commence major trauma services”.

He said CUH was different as it “has been delivering these services for patients in this area for quite a long time”.

“But to try and homogenise and standardise what is available, there is a lot of work being done to try and refine the process.” He said this will require both human and infrastructural resources to be put in place, noting that the “infrastructural challenges are not minor and need quite a bit of addressing”.

“Again, by the end of 2022 [and] ready for launch in 2023, there will be a major trauma centre [in Cork], albeit not to the full capacity that we would envisage ultimately.”

Mr Synnott said funding was secured for recruitment and this process was underway. He added that, later in the year, the HSE plans to organise a recruitment fair “that recognises the challenges across the system in recruiting people [and] to try to identify opportunities maybe for people to come to Ireland and work”.

“We do think the trauma system as we en-

Development of clinical pathway for head injuries

In Dublin, clinical representatives from Beaumont Hospital and the Mater Misericordiae University Hospital are currently working “in collaboration to develop a proposed clinical pathway” for patients with head injuries, the Medical Independent (MI) has been informed.

As reported in MI in August 2021, the decision to designate the Mater Hospital as the MTC for the central trauma network led to criticism regarding neurosurgery provision. At the time, neurosurgeons in Beaumont Hospital, where the national neurosurgical centre

is located, said they believed the national neurosurgical centre needed to be colocated with the MTC.

Earlier this year, MI reported that an advisory group on this issue had been established and it had recently reported to the Executive. This neurotrauma clinical advisory group (CAG) has been established to work through detailed service considerations to enable an integrated model of care for neurotrauma/neurocritical care services for the MTC in Dublin as a collaboration between the Mater

Hospital and Beaumont Hospital.

Regarding the CAG’s recent report to the HSE, an Executive spokesperson told this newspaper that “clinical representatives from Beaumont Hospital and the Mater Hospital are working in collaboration to develop a proposed clinical pathway for head-injured patients following the recent presentation on its work to the HSE’s trauma programme steering group”.

“These pathways will develop further as services commence at the major trauma centre.”

Mr Keith Synnott

visage it being [will be] an attractive place for people to work. So that will allow us to try and attract people back to fill some of the gaps that we have identified that are present.”

Recruitment

The hiring of consultants and other medical staff for the new trauma service takes place against an international recruitment situation, which the HSE officially describes as “challenging”. In August, MI reported that the Executive was developing a new recruitment strategic programme in response to “operating in a very competitive global recruitment market”.

Separately, the IMO and IHCA are currently in negotiations with the Department and the HSE in regards to a new consultant contract. A successful conclusion to these talks is regarded by many as key to tackling recruitment and retention issues in the health system.

In August, MI reported that two consultant appointments had been made for the new MTC at the Mater and annual funding to appoint 17 consultants for the MTC had been secured.

In updated recruitment figures supplied to this newspaper, the HSE said four consultant appointments have now been made, with an additional six expected to commence shortly. A further three are at an advanced stage of the recruitment process.

In Munster, the HSE said it had provided annual funding to appoint 13 consultants for the MTC at CUH for stage one of a three-stage implementation plan to deliver a fully functional MTC over the next seven years.

“Recruitment of consultant and other key clinical and support staff required to commence major trauma services at the MTC in Cork is underway,” the spokesperson added. While the two MTCs may be the most important hubs of the new national trauma service, further recruitment of consultants and other medical personnel will be required in other sites.

The national office for trauma services is currently working with hospitals in other geographical locations outside of the Mater and CUH to undertake a trauma unit accreditation process. The office “when planning the development of the trauma system, will consider additional consultant and other key clinical and support staff require-

ments for hospitals in other geographical locations”, said the spokesperson.

“A case will be made through the normal service planning mechanism in the coming years to support the additional resource requirements.”

Contract Difficulties in the recruitment of consultants, as well as beds capacity and equipment issues, are a barrier to the implementation of the trauma strategy, the IHCA told this newspaper.

“With over 900 permanent hospital consultant posts now vacant or not filled as needed, our ability to implement and deliver on health service plans will continue to be severely hampered,” IHCA Secretary General Mr Martin Varley told MI

“There are simply not the required number of consultants needed to provide timely, essential care – this includes specific services such as trauma care.”

Mr Varley said that the continuing negotiations between the Association and health service management on a new consultant contract was a “critical element”.

The new contract would need to ensure that “we address the current barriers to recruitment and retention, so that we can attract the number and calibre of consultants who are so urgently required”.

“In addition, Government needs to ensure funding for and delivery of the essential resources and capacity associated with the implementation of services like the major trauma service.

“Without the beds, staffing and equipment required, these services risk being seriously undermined to the detriment of our patients.”

IMO consultant committee Chair Prof Matthew Sadlier also believes that a new consultant contract that is attractive to doctors would have a positive impact on recruitment and retention.

“Certainly it can improve recruitment, and certainly if you reverse the 2012 pay cut that would improve recruitment to a certain extent,” Prof Sadlier, Consultant Psychiatrist and Clinical Director, North Dublin, told MI

However, he cautioned that even with a new contract, it would most likely take time before consultants were attracted in sufficient numbers to the Irish health service.

“Because are all the problems to do with pay? No. Are all problems to do with terms and conditions? No.”

Capacity

Prof Sadlier highlighted issues with bed capacity in hospitals and other infrastructural problems, such as surgeons not having sufficient theatre access.

He also referred to doctors “who can’t do elective surgery because there is a flu outbreak and all our [hospital] beds are gone”.

“Terms and conditions [of employment] is an issue, but the other is service provision. We are talking about the environment that people are working in and the service they can provide to their patients, that will take time to improve.”

Speaking on health policies in general, Prof Sadlier said that recruitment challenges were not always taken into account.

“There is not enough conversation [during the formation of health policy] with the main stakeholders, with staff, and I think there is a bit too much ‘blue sky thinking’ and engagement with theoretical ideas. There’s a bit too much theoretical health policy without enough talking to people who are working in the real world.”

Noting the Government’s recent announcement of plans to appoint almost 50 new emergency department consultants, Prof Sadlier said it was to be welcomed.

However, he said there needed to be planning around how to increase the number of doctors coming through the training system “and that takes years”.

Prof Sadlier said there needed to be discussion around possible fast-track training, “more engagement with the colleges” and other stakeholders, “rather than recruitment by press release.”

“In general, there is a huge problem with knee-jerk Government decision-making without joined-up thinking,” according to Prof Sadlier.

The Covid-19 pandemic and trauma

Falls in homes accounted for most major trauma injuries during the period 2019/20, according to the Major Trauma Audit Report 2019-2020, published last month.

The report looked at patients who had suffered a major trauma accident over the course of 2019 and 2020, with a focus on the early impact of the Covid-19 pandemic on trauma activity and care.

“The publication of this report presents the first picture of how trauma activity, care, and outcomes were affected during a very tumultuous time in the health service due to the pandemic,” said Prof Conor Deasy, Clinical Lead for the Major Trauma Audit (MTA). “The significance of this data

MINDO NUMBERS

€23.4

billion will be allocated to the public health service next year, as part of Budget 2023.

33 per cent of cervical cancer cases and a quarter of female breast cancer cases diagnosed during 2017-2019 were detected as a result of screening, according to a National Cancer Registry Ireland report.

2.8

– the percentage decrease per year since 2009 in the rates of cervical cancer following the introduction of screening.

2.5

– the percentage decrease per year in the rates of colorectal cancer in men following the introduction of screening in 2012, with a smaller, but still decreasing trend (0.3 per cent per year) in women since 1994.

3,869

can help to inform future public health strategies and the reconfiguration of the trauma system when such events like a pandemic or cyberattack occur.”

Ms Louise Brent, Audit Manager for the MTA, added: “The increase of falls in the home over the course of the first three waves of the pandemic shows us that there is a real opportunity for the public to use this information to ensure their homes are as safe as possible.”

“Using the data on falls in the home we have designed a very quick checklist that anyone can use to identify common causes and risks that may be present in the home, the majority of which are easily remedied. Ireland has achieved a lot

of improvement in the likes of road safety. We now must turn our attention to home safety as well.”

Some findings from the report include:

 The mean age of major trauma patients increased from 58 years in 2019 to 61 years in 2020.

 The percentage of falls of less than two metres increased from 58 per cent in 2019 to 62 per cent in 2020.

 The proportion of patients injured at home increased from 48 per cent in 2019 to 56 per cent in 2020.

 There was an approximately 10 per cent reduction in the number of major trauma admissions during 2020, compared with 2019.

was the average annual number of newly diagnosed cases of prostate cancer in Ireland between 2017 and 2019.

30

per cent of all invasive cancers in men (excluding non-melanoma skin cancer) were prostate cancers, making it the most commonly diagnosed invasive cancer in men in Ireland.

Mr Martin Varley

Prof Matthew Sadlier

HSE international doctors initiative continues to grow

The number of doctors participating in the HSE international medical graduate training initiative (IMGTI) has increased by 176 per cent since its introduction in 2014, according to statistics released to the Medical Independent The initiative began with 85 doctors in 2014 and increased to 235 in 2022. The period of clinical training provided under the IMGTI is ordinarily 24 months, after which the trainees are required to return to their country of origin. The programme is aimed primarily at doctors from countries with less developed health sectors.

At present, Pakistan and Sudan participate in the Scholarship IMGTI. In addition, some doctors are fully funded and salaried by their national government (these doctors comprised 56 of the total 171 participants in 2020).

“Specialties offered within the IMGTI have also grown from an initial three to nine specialties,” stated a HSE spokesperson. The IMGTI supports the HSE in fulfilling its responsibilities under the World Health Organisation global code of practice on recruitment of health personnel, added the spokesperson.

“Trainees enhance their own learning in the short-term, and in the medium- and long-term, improve global health services by transferring the skills and experience gained in Ireland.

“The IMGTI also increases the proportion of doctors in formal training programmes. Owing to the well-acknowledged positive impact of the IMGTI, all stakeholders continue to be committed to further expansion of the programme, with plans to increase the programme's intake annually.”

Radiologist loses WRC case for overtime payments

PAUL MULHOLLAND

The Workplace Relations Commission (WRC) has found against a consultant radiologist who claimed they were not paid overtime due to them.

The consultant, based in a hospital in the south-west, worked 80 additional hours during the weekend and at night in September 2019.

He claimed he was owed €6,717, which remained unpaid because of annual overtime limits.

The consultant also claimed for 240 extra hours during the nights and weekends in October, November, and December, which he said he would have to work for no pay due to exceeding the limit of hours worked.

At the hearing, the adjudication officer's attention was drawn to the fact that the consultant had, in April 2019, accepted and availed of the 2018 consultant contract High Court settlement agreement.

The HSE argued that in those circumstances, having availed of the agreement, the consultant was “essentially trying to litigate a matter in respect of which he has already entered into a binding agreement”, according to the case transcript.

The adjudication officer noted the first complaint related to the non-payment of overtime that had not happened at the time the complaint was submitted.

It was also noted the second complaint related to a non-payment in future months and pre-claimed an anticipated deduction.

“As no deduction relating to the specific compliant had been made by the respondent at the time the complaint was submitted, I find that I have no complaint relating to deductions before me,” according to the adjudication officer.

“However, I am aware from various past hearings of the long-running dispute between the parties over time on this issue and have decided that the above complaint can be covered by section 5.6 of the [Workplace Relations] Act.”

The adjudication officer stated “properly payable” was not defined in the Act, but the liability to make a payment to an employee must arise generally from either a written contract of employment, statute, a collective agreement, a verbal agreement, or an implied term of the contract of employment.

“The complainant, in his submissions or evidence, did not offer any supporting documentation to support any of these as grounds for the payment sought,” outlined the adjudication officer.

“The complainant is not an hourly paid employee and is paid an annual salary and additional payments for on-call and call-out. The maximum of these amounts are set out in a collective agreement, which he is bound by. The additional hours he worked are not, in any way, exceptional for a senior professional, especially one on an annual salary and additional payments such as the complainant earns. The complainant has failed to prove that the respondent is contractually bound to pay the additional hours he seeks payment for. The additional hours worked are also covered as a (reasonable) requirement by clause 7.e of the complainant’s contract.”

The final decision was that the consultant “failed to show that the income he claimed and has associated with the hours worked is properly payable and therefore he does not succeed in his complaint”.

The WRC hearing took place on 9 June 2022.

CATHERINE REILLY

*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.

Prescribing information

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-12-2022

Essential dentistry service for cancer patients yet to be put in place

PAUL MULHOLLAND

The HSE has yet to establish a permanent arrangement for patients with head and neck cancer who require dental work but cannot afford the relevant treatment.

Last year, the Medical Independent (MI) revealed that HSE National Director of Acute Operations Mr Liam Woods wrote to senior health officials in December 2020, stating he was aware of several cases where such patients who required attendance at the Dublin Dental Hospital (DDH) could not afford treatment.

Mr Woods stated that the services provided by the DDH were not free to people who did not have medical cards.

He recommended that the HSE should enable referring

cancer hospitals to pay for these patients, on an ex gratia basis, when the referral is cancer-related.

“This would address immediate patient issues and allows time for the NCCP [National Cancer Control Programme] and primary care to consider a better longterm solution,” Mr Woods wrote.

“Ultimately, this care may move to be provided in the cancer centres and not in DDH, depending upon NCCP views.”

In September 2021, this newspaper reported that the short-term solution had been implemented and any newly diagnosed head and neck cancer patients who required specialist dental treatment should be referred appropriately, with the cost paid by the cancer hospital.

However, a spokesperson for the HSE told MI that a

Over 6,000 ‘advanced clinical prioritisation’ consultations in 2021

CATHERINE REILLY

Approximately 6,300 advanced clinical prioritisation (ACP) consultations took place in 2021, according to a presentation to the HSE board on the scheduled care transformation programme.

ACP was among a number of “foundational steps” required to support longer-term reforms in scheduled care access and waiting times, which were outlined in the presentation

A HSE spokesperson told the Medical Independent that ACP is a process whereby a senior clinician contacts a patient on a waiting list and following assessment, expedites the patient to the most appropriate care pathway (eg, diagnostic, virtual consultation, face-to-face consultation, or management by GP). ACP has been implemented in various specialties across the country to date, including general medicine, orthopaedics, and ENT, the spokesperson added.

The presentation, which the HSE board discussed in June, also referred to further scheduled care reform initiatives in 2022. These included, among other measures, patient-centred

VOX BOX

Half a million additional people will be eligible to access free GP care. This is a gamechanger for our health service.

booking arrangements, patient-initiated reviews, and a strategy for managing ‘did not attends’ (DNAs).

A patient-initiated review would involve a review appointment not being scheduled automatically, but instead initiated by the patient/family/caregiver.

The HSE’s spokesperson outlined: “Both patient-centred booking and patient-initiated reviews are in the planning stages, including effective processes being put in place to manage clinical risk. While patient-centred booking aims to enable patient choice over the appointment time and date, it is not proposed that partial booking will be a requirement of the scheduling process. All processes are being designed in line with evidence-based practice.”

In relation to the DNA strategy, a draft is in development and a pilot is expected to commence by the end of 2022.

“The strategy seeks to ensure patients are provided with sufficient notice of the appointment time/ date and to implement appointment reminders.”

Minister for Health Stephen Donnelly following the Budget 2023 announcement that the eligibility of people for general practice access cards will be expanded. All children aged six and seven will be covered by the end of 2022 and, from 1 April 2023, eligibility will further be extended to people who earn the median household income of €46,000 or less.

permanent solution remains to be put in place, although work had commenced on the matter.

“The temporary solution is implemented, as well as the HSE allocation of two consultant clinicians (head and neck cancer dentistry specialists) to develop the public sector service,” according to the spokesperson.

“The job descriptions are currently being put together and the extra investment needed to support the clinicians should be considered for 2023.

“Once the two consultants are in place, further investment in the service will be needed to move to the permanent solution. Consideration will need to be given to services throughout the country, as well as defining the role of dentistry in prevention, early diagnosis, and rehabilitation of head and neck cancer patients.”

Danske Bank to be new HSE banking provider

DAVID LYNCH

Danske Bank will be the new banking provider to the HSE, this newspaper has been told.

The bank will be providing services to the Executive before next summer. As reported by the Medical Independent (MI) in March, the HSE had begun the process of selecting a new banking provider after Ulster Bank announced its intention to exit the Irish banking market.

Ulster Bank has provided banking services to the HSE since 2007.

“The HSE has received formal notification from its current banking service provider Ulster Bank that they intend to exit the Irish banking market,” a HSE spokesperson told MI

“Ulster Bank will stop providing banking services on 30 June 2023 and the transition to a new provider will happen in advance of 30 June 2023. Danske Bank currently provides banking services (under an existing Office of Government Procurement framework agreement) to a number of Government departments.”

The November 2021 meeting of the Executive’s audit and risk committee heard that the HSE Treasury had “engaged” with HSE Procurement and the Office of Gov-

The manner in which the Government has announced this measure is shocking in the context of the known facts about the current pressures facing general practice.

We have consistently warned that any expansion requires detailed planning and agreed implementation.

The IMO reacting to the announcement on the expansion of free GP care.

W]e cannot ignore the fact that

free GP care will inevitably mean longer waiting times for patients’ appointments with GPs, at a time of huge workforce and workload pressures.

Chair of the ICGP Dr John Farrell reacting to the free GP care provision in Budget 2023.

ernment Procurement regarding the HSE’s banking contract.

Danske Bank, formerly known as the National Irish Bank, is a bank operating in the Republic of Ireland and is a subsidiary of the Danske Bank Group.

The Group is a Danish multinational banking and financial services corporation based in Copenhagen.

expanding

the management of adult patients with type 2 diabetes 1 THE POWER TO ACCOMPLISH MORE

Multiple benefits 1,2

• Significant reduction in HbA1C vs placebo at 24 weeks

• Reduction in weight and blood pressure vs placebo 1*

Proven protection 3†

• Reduction in risk of CV death vs placebo in adult patients with T2D and CVD: 38% RRR, 2.2% ARR

JARDIANCE has a well established safety profile in T2D and consistent safety profile across the studied indications1

For adult patients with type 2 diabetes and CV disease

JARDIANCE

LICENSED

10mg

FOR

USE

down to an eGFR of mL/min/1.73m2 1 mL/min/1.73m

Type 2 diabetes mellitus JARDIANCE is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance - in addition to other medicinal products for the treatment of diabetes

Heart failure JARDIANCE is indicated in adults for the treatment of symptomatic chronic heart failure.

Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373:2117-2128 (& Supplementary Appendix).

Prescribing Information (Ireland) JARDIANCE® (empagliflozin)

Film-coated tablets containing 10 mg or 25 mg empagliflozin. Indication: Type 2 diabetes mellitus: Jardiance is indicated for the treatment of adults with insufficiently controlled Type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance; in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, refer to the Summary of Product Characteristics. Heart failure: Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Dose and Administration: Type 2 diabetes mellitus: The recommended starting dose is 10 mg once daily. In patients tolerating empagliflozin 10 mg once daily who have eGFR ≥60 ml/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg. Renal impairment: The glycaemic efficacy of empagliflozin is dependent on renal function; efficacy is reduced in patients with moderate renal impairment and likely absent in patients with severe renal impairment. If empagliflozin is used for cardiovascular risk reduction as add on to standard of care, a dose of 10 mg empagliflozin once daily should be used in patients with an eGFR between 30 and 60 ml/min/1.73 m2. If further glycaemic control is needed, the addition of other anti-hyperglycaemic agents should be considered. Dose adjustment recommendations according to eGFR or CrCL: In patients with type 2 diabetes mellitus and an eGFR 45 to <60 ml/min/1.73 m2 or CrCL 45 to <60 ml/min; do not initiate, but in patients already taking empagliflozin continue with 10 mg empagliflozin. In patients with type 2 diabetes mellitus with an eGFR below 45 ml/min/1.73 m2 or CrCL below 45 ml/min empagliflozin is not recommended. In patients with type 2 diabetes mellitus and established cardiovascular disease with an eGFR 30 to <60 ml/min/1.73 m2 or CrCL 30 to <60 ml/min; initiate or continue with 10 mg empagliflozin. Empagliflozin is not recommended in patients with an eGFR <30 ml/min/1.73 m2 or CrCL <30 ml/min. Heart failure: The recommended dose is 10 mg empagliflozin once daily. Renal impairment: For treatment of heart failure in patients with or without Type 2 diabetes mellitus, empagliflozin 10 mg may be initiated or continued down to an eGFR of 20 ml/min/1.73 m2 or CrCl of 20 ml/min. For patients with an eGFR <20 ml/min/1.73 m2 or CrCl <20 ml/min empagliflozin is not recommended. All indications: When used with sulphonylurea or insulin, a lower dose of these may be considered to reduce the risk of hypoglycaemia. If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day. Renal impairment:

Empagliflozin should not be used in patients with end stage renal disease (ESRD) or on dialysis. Monitoring of renal function: Assessment of renal function is recommended prior to initiation and at least annually; prior to initiation of any concomitant medicinal product that may have a negative impact on renal function. Hepatic impairment: No dose adjustment is required for patients with hepatic impairment. Not recommended in severe hepatic impairment. Elderly patients: No dose adjustment is recommended based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account.

Paediatric population: No data are available. Method of administration: The tablets can be taken with or without food, swallowed whole with water. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Ketoacidosis:

Rare cases of ketoacidosis, including life-threatening and fatal cases, have been reported in patients with diabetes mellitus treated with SGLT2 inhibitors, including empagliflozin. The risk of ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion,

unusual fatigue or sleepiness. Assess patients for ketoacidosis immediately, regardless of blood glucose level. In patients where ketoacidosis is suspected or diagnosed, treatment with empagliflozin should be discontinued 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 empagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised. Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered. Use with caution in patients who may be at higher risk of ketoacidosis. Restarting SGLT2 inhibitor treatment in patients with previous ketoacidosis while on SGLT-2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved. Jardiance should not be used in patients with Type 1 diabetes. Renal impairment: See under ‘renal impairment’ of Dose and administration section. Monitoring of renal function: See under ‘monitoring of renal function’ of Dose and administration section. Risk for volume depletion: Osmotic diuresis accompanying glucosuria may lead to a modest decrease in blood pressure. Therefore, caution should be exercised in patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75 years and older. In case of conditions that may lead to fluid loss (e.g. gastrointestinal illness), careful monitoring of volume status and electrolytes is recommended. Temporary interruption of treatment with empagliflozin should be considered until the fluid loss is corrected. Elderly: See under Dose and Administration; special attention should be given to volume intake of elderly patients in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE-inhibitors). Complicated urinary tract infections: Temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections. Necrotising fasciitis: Cases of necrotising fasciitis of the perineum (Fournier’s gangrene), have been reported in patients with diabetes mellitus taking SGLT2 inhibitors. This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment. Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis.

If Fournier’s gangrene is suspected, Jardiance should be discontinued and prompt treatment should be instituted. Lower limb amputation: An increase in cases of lower limb amputation (primarily of the toe) has been observed in long-term clinical studies with another SGLT2 inhibitor, counsel patients on routine preventative footcare. Hepatic injury: Cases of hepatic injury have been reported with empagliflozin in clinical trials. A causal relationship between empagliflozin and hepatic injury has not been established. Elevated haematocrit: Haematocrit increase was observed with empagliflozin treatment. Chronic kidney disease: There is experience with empagliflozin for the treatment of diabetes in patients with chronic kidney disease (eGFR ≥30 mL/min/1.73 m2) both with and without albuminuria. Patients with albuminuria may benefit more from treatment with empagliflozin. Infiltrative disease or Takotsubo cardiomyopathy: Patients with infiltrative disease or Takotsubo cardiomyopathy have not been specifically studied. Therefore, efficacy in these patients has not been established. Urine laboratory assessments: Due to its mechanism of action, patients taking Jardiance will test positive for glucose in their urine. Lactose: The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or

glucose-galactose malabsorption should not take this medicinal product. Sodium: Each tablet contains less than 1 mmol sodium (23 mg), essentially ‘sodium free’. Interactions: Use with diuretics may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues may increase the risk of hypoglycaemia therefore, a lower dose of insulin or an insulin secretagogue may be required. Empagliflozin may increase renal lithium excretion and the blood lithium levels may be decreased. Serum concentration of lithium should be monitored more frequently after empagliflozin initiation and dose changes. The effect of UGT induction (e.g. induction by rifampicin or phenytoin) on empagliflozin has not been studied. Co-treatment with known inducers of UGT enzymes is not recommended due to a potential risk of decreased efficacy. If an inducer of these UGT enzymes must be coadministered, monitoring of glycaemic control to assess response to Jardiance is appropriate. Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by coadministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide. Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives. Fertility, pregnancy and lactation: There are no data from the use of empagliflozin in pregnant women. As a precautionary measure, it is preferable to avoid the use of Jardiance during pregnancy. No data in humans are available on excretion of empagliflozin into milk. Jardiance should not be used during breast-feeding. No studies on the effect on human fertility have been conducted for Jardiance. Undesirable effects: Frequencies are defined as 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). Very common: hypoglycaemia (when used with sulphonylurea or insulin), volume depletion. Common: vaginal moniliasis, vulvovaginitis, balanitis and other genital infections, urinary tract infection (including pyelonephritis and urosepsis), thirst, constipation, pruritus (generalised), rash, increased urination, serum lipids increased. Uncommon: diabetic ketoacidosis, urticaria, angioedema, dysuria, blood creatinine increased/glomerular filtration rate decreased, haematocrit increased. Rare: necrotising fasciitis of the perineum (Fournier’s gangrene). Very rare: tubulointerstitial nephritis. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 10 mg; 28 tablets, 25 mg: 28 tablets. Legal category: POM.

EU/1/14/930/013; 25 mg/28 tablets EU/1/14/930/004.

MA numbers: 10 mg/28 tablets

Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, 55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Crescent Building, Northwood, Santry, Dublin 9. Prepared in June 2022.

Adverse events should be reported. Reporting forms and information can be found at https://www.hpra.ie/homepage/about-us/report-anissue. Adverse events should also be reported to Boehringer-Ingelheim Drug Safety on 01 2913960, Fax: +44 1344 742661, or by e-mail: PV_local_UK_Ireland@boehringer-ingelheim.com

NIAMH QUINLAN niamh.quinlan@mindo.ie

Future of the chronic disease management programme

The HSE structured chronic disease management (CDM) programme was a key development arising from the GP agreement between the IMO and health management in 2019. In addition to €120 million in FEMPI reversals (plus €10 million in pension contributions), €80 million was to be provided for the management of patients with chronic disease in the community as part of the agreement.

The programme commenced in 2020 and aims to reach full implementation in 2023. It was designed on an opt-in basis for GPs to treat eligible patients, with general medical scheme (GMS) or doctor visit cards.

The CDM programme allows GPs to provide a structured treatment programme for patients with one or more of four chronic diseases: Asthma; type-2 diabetes; chronic obstructive pulmonary disease; and cardiac diseases.

During the roll-out of the programme, various cohorts of patients, determined by age, qualify for different components.

It also now includes the opportunistic case finding (OCF) programme, which provides surgery-based assessments to identify patients with an undiagnosed chronic disease or at risk of development, and an annual CDM prevention programme for patients at high risk of cardiovascular disease or diabetes. Both of these elements were introduced this year.

In October 2021, the programme won an award from the United Nations Interagency Taskforce (UNIATF). The UNIATF awards recognise “outstanding contributions to multi-sectoral action in the prevention and control of non-communicable diseases” at local, national, regional or international level.

The award recognised the CDM programme’s work to develop the “GP chronic disease contract and rolling it out despite the Covid-19 pandemic”.

More recently, the First report of the Structured Chronic Disease Management Programme in General Practice, which was published on 5 August, showed positive results, feedback and uptake from GPs and patients alike.

Uptake

At the beginning of the Covid-19 pandemic, there were concerns the roll-out of the programme would be hindered by the virus and the restrictions in place.

However, HSE Clinical Lead for the Integrated Care Programme for the Prevention and Management of Chronic Disease, Dr Orlaith O’Reilly, told the Medical Independent (MI) that the pandemic actually aided the implementation of CDM within community care.

As a result of Covid-19, a modified CDM (MCDM) programme was introduced in June 2020, which facilitated early expan-

sion of the programme to eligible individuals over the age of 70 years. According to the recently published report, MCDM is in line with the 2019 GP agreement and “supports GPs in their delivery of chronic disease preventative and management activities through the use of telehealth”.

“We accelerated the implementation because we knew that… older people that had been cocooning with chronic disease were in need of care more than ever,” Dr O’Reilly said. “Back in 2020, in the first wave of Covid, the original plan had been [to introduce the programme] to the over-75-year-olds. But, in fact, we pulled it back to over-70s to include the full cohort of people who were cocooning.”

The first CDM report analysed two cohorts of patients who had consultations from 4 January 2020 to 11 September 2021: The initial cohort were seen during the first year; and the second cohort were from the next phase of the programme, which commenced in January 2021 to include individuals aged 65-to-69 years.

This amounted to total of 166,147 patients who were treated by 2,218 GPs across 1,080 practices.

The programme has a target uptake of 75 per cent among the eligible population. As of 11 September, the programme was open to those aged 65 and over, with an estimated uptake of 74.7 per cent among the group.

The report also stated 91 per cent of GPs are signed up with the CDM programme. Dr O’Reilly said she is “not sure we will ever get 100 per cent” uptake among GPs, as some smaller, single-handed practices may not have the IT infrastructure or nursing support necessary for the programme.

She told MI: “It is very difficult for doctors who aren’t computerised to participate in the programme.... But clearly, we would encourage everybody to get computerised and partake.”

In January 2022, the treatment programme opened to eligible patients over 18. In March, the OCF programme and prevention programme began for eligible patients over 65 years. According to Dr O’Reilly, these are “gaining momentum”, with the eligible age reducing further to 45 years and over next year.

Expansion

Dr O’Reilly also said: “We would like to in-

clude a few of the other smaller numbers of people with other cardiovascular conditions in the programme [as the] next step.”

For Budget 2023, the HSE’s integrated care programme for chronic disease management submitted a proposal to the Department of Health to expand the CDM programme to include conditions such as familial hypercholesterolemia, peripheral arterial disease, and all severities of hypertension.

Dr O’Reilly added: “I suppose the other big issue here is [that] it is only relevant for patients with medical cards or doctor visit cards. Whereas, of course, the other half of the population needs this too.

“We are giving a perverse incentive for people without medical cards to continue to show up in the hospital for this type of care…. It would be wonderful if this was made universally available. But that is a significant budgetary issue.”

Asked if expanding the programme beyond GMS patients was a higher priority than inclusion of more chronic diseases, Dr O’Reilly said: “It depends what sort of money is available. If a lot of money was available, I would love to see it universally available. If a smaller amount of money was available, I would like to expand it to the rest of the cardiovascular diseases that we didn’t manage to do the first time.”

Mental health

Drogheda GP Dr Amy Morgan said the CDM programme provides a “comprehensive template” that could be applied to other patients and support a more structured form of community care, “notably” for mental health.

Dr Morgan noted: “We would have patients who are on their psychiatric medications and would be at risk of developing metabolic syndrome, or complications of diabetes and weight-related changes.”

Patients on certain medications must already undergo monitoring tests twice a year, she added. “So there is already an agreed clinical care pathway for these people. But the problem is there is no actual dedicated resourcing [for it] in general practice.”

“This should be a priority to bring these people into the net… because as it stands, we would have a certain amount of patients who are on these medications and I feel their care is, for a variety of different reasons,

quite fragmented. And obviously this can lead to poor outcomes.”

In its pre-Budget submission for 2023, the IMO recommended “building on the success” of the CDM programme and investing in structured programmes within general practice for mental health, women’s health, and nursing home residents.

Chair of the IMO GP committee Dr Denis McCauley also told MI the CDM offers a “very useful template” in terms of how systems should be devised and rolled out in general practice.

He acknowledged that there have been discussions to add mental health to the programme.

“But really, it is inappropriate to talk about that because the access we have to mental health services in the primary care are so negligible that [new services] would be there in name only.”

He added: “Any talk of introduction of such measures would be totally premature because irrespective of our capacity issues, the ability for us to introduce services other than medication is absent.”

Capacity

Capacity within general practice is the biggest obstacle to expanding services within CDM, according to Dr McCauley.

He said: “It is a good template when capacity becomes available…. We [general practice] are having capacity issues with an increased workload for a whole lot of reasons, one of which is the chronic disease management and that has to be accepted.”

Dr McCauley said it was important that the OCF and prevention programmes, launched this year, become embedded “before we start getting overexcited and losing the run of ourselves [in terms of expansion], particularly because of the capacity issue”.

According to the ICGP data from March 2022, some 25 per cent of GPs are over the age of 60, many of whom will retire in the coming years. In its pre-Budget submission, the College stated it “may not be possible to train enough to meet projected demand”.

Speaking prior to the significant expansion of GP care announced in Budget 2023, Dr McCauley commented: “We are the vaccinators, we are the people who look after chronic disease management, we are the people that look after prevention. We can do all this when there are enough of us about and the resources follow the requests.”

Niamh Quinlan examines the ‘First report of the Structured Chronic Disease Management Programme in General Practice’ and speaks to doctors about future expansion

Dr Orlaith O’Reilly Dr Amy Morgan Dr Denis McCauley

First report of the Structured Chronic Disease Management Programme in General Practice

PRESCRIBING INFORMATION (PI)

RINVOQ® (upadacitinib) 15 mg and 30mg prolonged-release tablets. Refer to Summary of Product Characteristics (SmPC) for full prescribing information. PRESENTATION: Each 15 mg prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15mg of upadacitinib. Each 30mg prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 30 mg of upadacitinib. INDICATION: Treatment of moderate to severe active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate. Treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. Treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy. DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of conditions for which upadacitinib is indicated. Dosage: RA, PsA and AS: The recommended oral dose is 15mg once daily. Consideration should be given to discontinuing treatment in patients with AS who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. AD (adults): The recommended oral dose is 15 mg or 30 mg once daily based on individual patient presentation. 30 mg once daily dose may be appropriate for patients with high disease burden and for patients with an inadequate response to 15 mg once daily. The lowest effective dose for maintenance should be considered. For patients ≥ 65 years of age, the recommended dose is 15mg once daily. AD (adolescents from 12 to 17 years): The recommended oral dose is 15mg once daily for adolescents weighing at least 30 kg. Adults and adolescents 12 years and older: Upadacitinib can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used for sensitive areas such as the face, neck, and intertriginous and genital areas. Consideration should be given to discontinuing upadacitinib treatment in any patient who shows no evidence of therapeutic benefit after 12 weeks of treatment. Special Populations: Elderly: For AD, doses higher than 15mg once daily not recommended in patients aged 65 years and older. Limited data for patients aged 75 and older. Renal: No dose adjustment required in mild-moderate renal impairment. Upadacitinib 15mg once daily should be used with caution in patients with severe renal impairment. Upadacitinib 30 mg once daily is not recommended for patients with severe renal impairment. Upadacitinib has not been studied in subjects with end stage renal disease. Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Should not be used in patients with severe (Child Pugh C) hepatic impairment. Paediatric Population: No data available in the following paediatric patient populations: children with AD below the age of 12 years; children and adolescents with RA, PsA and AS aged 0 to less than 18 years. CONTRAINDICATIONS: Hypersensitivity to active substance or excipients. Active tuberculosis (TB) or active serious infections. Severe hepatic impairment. Pregnancy. SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. Immunosuppression: Combination use, with immunosuppressants e.g. azathioprine, ciclosporin, tacrolimus, and biologic DMARDs or other JAK inhibitors has not been evaluated in clinical studies and is not recommended as the risk of additive immunosuppression cannot be excluded. Serious infections: Serious and fatal infections have been reported. Caution when treating patients ≥65 years. Frequently reported – pneumonia and cellulitis. Bacterial meningitis has been reported. Opportunistic infections reported –TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis. Do not initiate treatment in patients with active, serious infection, including localised infections. Consider the risk/benefit of treatment in patients with: chronic or recurrent infection, history of serious or opportunistic infection, those exposed to TB, those who have resided or travelled in areas of endemic TB or endemic mycoses, those with underlying conditions that may pre-dispose patients to infection. Closely monitor patients and interrupt treatment if there are signs and symptoms of infection pre and post treatment. Tuberculosis: Pre-screen patients for active or latent TB. RINVOQ should not be given to patients with active TB. Consider anti-TB therapy in patients with previously untreated latent TB or in patients with risk factors for TB infection. Consult with a physician with experience in TB therapy to assess whether initiating anti-TB therapy is appropriate for an individual patient. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy. Viral reactivation: Cases of herpes virus reactivation have been reported e.g. herpes zoster. If herpes zoster is reactivated, consider interruption of upadacitinib therapy until the episode resolves. Screen for viral hepatitis and monitor regularly for reactivation before starting and during therapy with upadacitinib. Patients, positive for hepatitis C antibody/hepatitis C virus RNA and hepatitis B surface antigen/hepatitis B virus DNA were excluded from clinical studies. If hepatitis B virus DNA is detected while receiving RINVOQ, a liver specialist should be consulted. Vaccination: Use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunisations, including

HELP YOUR PATIENTS

THE ITCH & RASH OF MODERATE TO SEVERE ATOPIC DERMATITIS 1

RINVOQ demonstrated in an integrated analysis of the MEASURE UP 1 & 2 monotherapy studies at Week 16:

• EASI 75 skin clearance rates of 76% and 65% for patients treated with RINVOQ 30 mg QD and 15 mg QD, respectively, vs 15% with placebo (p<0.001 for both comparisons)2

• Itch reduction (mean percent change from baseline in Worst Pruritus NRS) of –70% and –58% for RINVOQ 30 mg QD and 15 mg QD, respectively, vs –24% with placebo (p<0.001 for both comparisons)2

prophylactic zoster vaccinations prior to starting therapy, in agreement with current immunisation guidelines. Malignancy: Immunomodulatory therapies may increase the risk of malignancies including lymphoma and nonmelanoma skin cancer in RA patients. Malignancies were observed in clinical studies. Periodic skin examination recommended for patients who are at increased risk for skin cancer. See SmPC for full details. Haematological abnormalities: Do not start therapy if Absolute Neutrophil Count <1 x 109 cells/L, Absolute Lymphocyte Count <0.5 x 109 cells/L and Hb <8 g/dL. Monitor patients and temporarily stop therapy if abnormal haematological parameters as specified are detected during routine patient management. Diverticulitis: Events of diverticulitis have been reported in clinical trials and post-marketing. Upadacitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis to prevent gastrointestinal perforation. Cardiovascular Risk: RA patients have an increased risk for cardiovascular disorders. Manage patient’s risk factors for e.g. hypertension, hyperlipidaemia as per usual standard of care. Lipids: Monitor total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) at 12 weeks and thereafter according to international guidelines. Elevated LDL in clinical trials decreased to pre-treatment levels in response to statin therapy, although evidence is limited. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Hepatic transaminase elevations: Monitor liver enzymes at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. In such cases therapy should be interrupted until this diagnosis is excluded. Venous thromboembolism: Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAKi, including upadacitinib. Use therapy with caution in patients at high risk for DVT/PE. Risk factors should be determined by patients age, obesity and medical history of DVT/PE, patients undergoing major surgery and prolonged immobilisation. If clinical features of DVT/PE occur discontinue therapy, evaluate and treat promptly. INTERACTIONS: Upadacitinib is metabolised mainly by CYP3A4 and plasma exposures may be affected by CYP3A4 inhibitors or inducers. Upadacitinib 15 mg once daily should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors. Upadacitinib 30 mg once daily dose is not recommended for patients receiving chronic treatment with strong CYP3A4 inhibitors. See SmPC for full details. FERTILITY, PREGNANCY AND LACTATION: Upadacitinib is contraindicated during pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of upadacitinib. Female paediatric patients and/or their parents/caregivers should be informed about the need to contact the treating physician once the patient experiences menarche while taking upadacitinib. Upadacitinib should not be used during breast-feeding. The effect of upadacitinib on human fertility has not been evaluated. ADVERSE REACTIONS: Refer to SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): upper respiratory tract infections, acne. Common adverse reactions (≥1/100 to <1/10): bronchitis, herpes zoster, herpes simplex, folliculitis, influenza, anaemia, neutropaenia, hypercholesterolaemia, cough, abdominal pain, nausea, urticaria, fatigue, pyrexia, increased blood CPK/ALT/AST, increased weight and headache. 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 HPRA Pharmacovigilance; website: www.hpra.ie.

LEGAL CLASSIFICATION: POM (S1A). MARKETING AUTHORISATION NUMBER/ PRESENTATION: EU/1/19/1404/001 and EU/1/19/1404/006 – Calendar blister packs containing 28 prolonged-release tablets. MARKETING

AUTHORISATION HOLDER: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany. Further information is available from AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

DATE OF REVISION: December 2021. PI-1404-005

Abbreviations: EASI – eczema activity and severity index; NRS – numerical rating scale; QD – once daily; EU – European Union.

* The recommended dose of RINVOQ is 15mg once daily for adolescents weighing at least 30kg. The safety and efficacy of RINVOQ in children with atopic dermatitis below the age of 12 years have not been established. No data are available. No clinical exposure data are available in adolescents <40kg. The posology in adolescent patients 30kg to <40kg was determined using population pharmacokinetic modelling and simulation.2

Reference: 1. Langan S. et al. Atopic dermatitis. The Lancet. 2020;396(10247):345-360. DOI: https://doi.org/10.1016/ S0140-6736(20)31286-1.

2. RINVOQ Summary of Product Characteristics, available on www.medicines.ie

3. Baricitinib Summary of Product Characteristics, available on www.medicines.ie

4. Abrocitinib Summary of Product Characteristics, available on www.medicines.ie

RINVOQ, the first and only oral JAK inhibitor indicated for the treatment of both adults and adolescents ≥12 years* with moderate to severe Atopic Dermatitis in the EU

Polio: A re-emerging global health threat

Bette Browne reports on the re-emergence of polio and the complexities of the struggle against the disease

The eradication of polio from Ireland and most other parts of the world was a triumph for medicine. However, there is growing concern about the disease re-emerging in New York, London, and Jerusalem, with some health officials warning this could be the “tip of the iceberg”.

The re-emergence of cases has been a wake-up call to the medical world. In 1988, health and aid organisations poured billions into the Global Polio Eradication Initiative (GPEI) and, since that time, cases of the disease have fallen dramatically from 350,000 to about 240 so far this year. In 2022, the cases have mainly arisen in Pakistan and Afghanistan, while there is still a risk of infection in parts of Africa and some Middle Eastern countries.

The countries that have had enduring cases of the disease have extremely low vaccination levels because of inadequate healthcare facilities, poverty or conflict. However, now cases are emerging in countries where it was believed the disease was eradicated.

Re-emergence

In March, Israel reported its first case since 1988. In June, British authorities discovered the virus in sewage, though no infections in people were identified. The UK government said all children in London aged one-to-nine would be offered a booster shot.

In July, US health officials detected the virus in an unvaccinated man in his 20s who was diagnosed with paralytic polio in Rockland County, New York.

The cases in Jerusalem, New York, and London are all derived from the oral polio vaccine and appear to be genetically linked, according to the World Health Organisation (WHO).

“The virus detected in environmental samples in New York is genetically linked to viruses detected in sewage samples from London and in sewage samples collected between January to June 2022 from Jerusalem,” the WHO stated on 14 September.

While all are derived from the oral polio vaccine, experts say the problem lies not with the vaccine itself, but with low vaccination coverage. Small groups of families in New York, for example, have not vaccinated their children against the virus and one such group is within the ultraorthodox Jewish community in Rockland County.

“Vaccine-derived polio virus is a well-documented type of polio virus that has mutated from the strain originally contained in the oral polio vaccine (OPV). The OPV contains a live, weakened form of polio virus,” the WHO said. “On rare occasions, when replicating in the gastrointestinal tract, OPV strains genetically change and may spread in communities that are not fully vaccinated against polio.” The

US Centres for Disease Control and Prevention (CDC) noted that “even a single case of paralytic polio represents a public health emergency in the United States”.

The level of concern increased further after a statement from a top health official in New York. “Based on earlier polio outbreaks, New Yorkers should know that for every one case of paralytic polio observed, there may be hundreds of other people infected,” New York State Health Commissioner Ms Mary Bassett said on 5 August.

“Coupled with the latest wastewater findings, the department is treating the single case of polio as just the tip of the iceberg of

much greater potential spread.”

On 13 August, a CDC official sounded a similar warning. The case first identified in New York in June was “just the tip of the iceberg” and an indication there “must be several hundred cases in the community circulating”, Dr José Romero, Director of the CDC’s national centre for immunisation and respiratory diseases, told CNN.

On 9 September, New York Governor Kathy Hochul declared a state disaster emergency to free-up more resources and expand the number of polio vaccine administrators after the virus was detected in wastewater from four other New York counties.

If a vaccine-derived polio virus strain is allowed to circulate among unvaccinated populations for long enough, the weakened virus can revert to a form that causes illness and, in some cases, paralysis, the CDC warned.

UK

The UK Health Security Agency (UKHSA) stressed that in the UK most people were protected by vaccination. “No cases of polio have been reported and for the majority of the population, who are fully vaccinated, the risk is low,” Dr Vanessa Saliba, Consultant Epidemiologist at the UKHSA, tweeted on 5 September.

Wild polio virus (WPV) is the best-known form of the disease and has been eradicated from most countries, with the exception of Pakistan and Afghanistan. However, vaccine-derived poliovirus (cVDPV) has been increasing in recent years, particularly in Africa and Asia, due to low immunisation rates and the impact of Covid-19.

The vaccines to combat the disease come in two types: The Jonas Salk injectable polio vaccine (IPV), made in 1954 with a ‘killed’ virus; and the Albert Sabin oral polio vaccine (OPV), made in 1960 with a live, but weakened virus, often called the ‘sugar lump vaccine’. This latter vaccine is the one at issue in the current resurgence. By the early 1970s most of the world was using this oral vaccine, but today many countries (including Ireland, the US and the UK) no longer do so. In 2001, the injectable IPV vaccine replaced the routine use of the OPV vaccine here.

Ireland

The first polio epidemic in Ireland occurred in 1942. The incidence of the disease fluctuated during the following years with epidemic waves in 1947, 1950, and 1953. The last major polio epidemic was in Cork in 1956.

Cases of polio in Ireland fell when the vaccine was introduced in 1957 and the last recorded case of polio was in 1984. “But the infection is still found in some parts of the world. Because of this, there is a very small risk that polio could be brought back to Ireland,” according to the HSE website.

In his 2006 memoir The Broken Boy, journalist Patrick Cockburn recounted his experience of contracting polio at the age of six, while living in Youghal, Co Cork. His brother Andrew, who was three years older, also contracted the disease.

Cockburn describes how frightening it was for young children to be taken away from their parents and siblings and placed in isolation. Treatment often meant being placed in a respirator known as an ‘iron lung’, which enclosed most of the body. “It was terrifying to be in the iron lung. One

Coupled with the latest wastewater findings, the department is treating the single case of polio as just the tip of the iceberg of much greater potential spread

Governor Kathy Hochul

Dr Vanessa Saliba

FOR ALL THAT MATTERS IN MEDICINE

girl in St Finbarr’s (Hospital) was put into an iron lung and she compared it to being buried in a coffin,” Cockburn recalled.

In Ireland today, memories have dimmed about the severity of the disease, which by the 1950s killed or paralysed over half a million people around the word every year. But the consequences of polio still blight the lives of thousands who suffer from the devastating effects of post-polio syndrome. In Ireland alone, as many as 7,000 polio survivors are living with disabilities from the late effects of the disease.

The charity Polio Survivors Ireland says about 40 per cent of polio survivors are experiencing a range of disabilities. Many have had years of rehabilitation to help regain independence, only to find their mobility affected in later life by post-polio syndrome. This is a neurological condition resulting in new symptoms in people who had polio, but whose condition has been stable for at least 15 years. It can occur from 20-to-40 years after the initial illness.

Post-polio syndrome may cause sleep impairment, fatigue, new muscle weakness, muscle and joint pain, wasting of muscle, a severe intolerance to cold, speech difficulties, difficulty swallowing, and respiratory problems. Many people end up needing mobility supports.

“Polio is gone,” Polio Survivors Ireland says, “but the legacy of polio is the ongoing support and help required by polio survivors.”

The campaigns to combat the re-emergence of the disease in London and New York will use the injectable vaccine. If further wastewater testing suggests that the polio virus has continued to spread, experts say it might be necessary to examine other options, one of which might be an emergency vaccine.

Vaccination

In 2020, the WHO listed a new polio vaccine for emergency use. This vaccine, which contains a live, but weakened virus that scientists believe is less likely to mutate into a dangerous form, performed well in clinical trials and was approved for emergency use by the WHO in April 2022. About 265 million doses are now being rolled out in 14 countries, primarily in Africa.

Infections from the OPV oral vaccine are appearing at a time when cases caused by the wild or naturally circulating virus continue to plummet. Since 2017, there have been 396 cases of polio caused by the wild virus, against more than 2,600 linked to the oral vaccine, according to the WHO. If a population is adequately immunised, however, it will be protected against both wild and vaccine-derived viruses.

The oral vaccine has been used because it is cheap, easy to administer and better at protecting entire populations where polio is spreading. But it can also cause polio in about two-to-four children per two million doses. In extremely rare cases, the weakened virus can also sometimes mutate into a more dangerous form and spark outbreaks, especially in places with poor sanitation and low

Mr Aidan O’Leary

vaccination levels.

These outbreaks typically begin when people who are vaccinated shed live virus from the vaccine in their faeces for many weeks afterwards. The virus can then spread within the community and, over time, turn into a form that can paralyse people and start new epidemics.

Many countries that eliminated polio switched to injectable vaccines containing a killed virus decades ago to avoid such risks. The Nordic countries and the Netherlands never used the oral vaccine. The goal is to move all countries to the injectable vaccine once wild polio is eradicated, but some scientists argue

that the switch should happen sooner.

Global Polio Eradiation Initiative

On 26 April 2022, the GPEI launched an ambitious strategy to eradicate all forms of polio in the world by 2026. However, to fully implement its aim of a polio-free world, it will need urgent additional funding of €4.8 billion. The GPEI’s goals include vaccinating 370 million children every year for the next five years and continuing global surveillance activities for polio and other diseases in 50 countries.

“Polio is a highly infectious disease, and if we did not know it before Covid-19, we certainly know now how quickly infectious diseases can spread globally. If we do not eradicate polio, this virus will resurge globally,” according to polio expert Mr Aidan O’Leary, originally from Ireland, who took over last year as WHO Director for Polio Eradication.

Mr O’Leary told the Gavi Vaccine Alliance’s Polio News : “My priority, and all of our priorities, must be simply this: Find and vaccinate every last child. If we do that, polio virus will have nowhere to hide. That means finding out where those last remaining unreached children are, and what obstacles stand in the way to vaccinating them. Is it because of lack of

infrastructure? Insecurity or inaccessibility? Lack of proper operational planning? Population movements? Resistance? Gender-related barriers? If we can identify the underlying reasons, we can adapt our operations and really zero-in on those last remaining virus strains.”

However, the battle against polio suffered a serious setback during Covid-19 when health workers and resources were focused primarily on the global struggle against that disease. According to WHO/ UNICEF data, 23 million children missed out on basic vaccines through routine immunisation services in 2020 because of the pandemic.

Polio immunisation activities were initially put on hold at the beginning of the pandemic in outbreak and endemic countries, although critical activities such as surveillance continued. The immunisation efforts resumed in those countries in July 2020. However, falling vaccination rates are also a major part of the problem in the US and other countries. During the pandemic, many children missed vaccinations when vaccine services were disrupted, noted the CDC in a report on the Rockland County polio case in New York.

The WHO also points out that “polio workers have been at the frontline of pandemic response and immunisation recovery efforts”.

“In many countries, particularly fragile and conflict-affected settings, the polio network provides critical support to the health system. Polio workers have decades of experience in identifying missed populations and using innovative strategies to reach them with healthcare.

“Maintaining these networks is important to strengthen public health (and) advance primary healthcare towards universal health coverage and to strengthen global health security.”

Polio workers killed for vaccinating children

A number of health workers fighting polio and other diseases in global conflict zones have paid the price for their courage with their lives.

Eight polio workers were killed in targeted attacks in Afghanistan on 24 February. Immunisation bans had been imposed by the ruling Taliban in parts of the country and the killings were the first such attacks since nationwide immunisation campaigns resumed last November.

Four of those killed were women.

Women tend to play a critical role in the vaccination programme, building community trust and reaching all children, often in house-to-house vaccination teams. One member of the vaccination transit team was killed in Taloqan district in Takhar province, while four members of house-to-house teams were murdered in two separate incidents in Kunduz city. Two vaccinators and a social worker were killed in the Imam Sahib district of Kunduz province, according to a UN statement.

The UN immediately suspended the national polio vaccination campaign in Kunduz and Takhar provinces.

On Twitter, Mr Ramiz Alakbarov, the UN Secretary-General’s Deputy Special

Representative for Afghanistan, said the assassinations were a violation of international humanitarian law.

The head of the World Health Organisation (WHO), Dr Tedros Adhanom Ghebreyeus, also expressed his shock. “We extend our deepest condolences to their families and colleagues,” he said on Twitter, adding that health workers should not be targeted.

This was not the first occasion that health workers have come under attack. In 2021, nine polio workers were killed during national polio vaccination campaigns in Afghanistan.

“These immunisation exercises are a vital and effective way to reach millions of children to protect them against polio and depriving them from an assurance of a healthy life is inhumane,” outlined the UN statement after the February attacks.

“This senseless violence must stop immediately and those responsible must be investigated and brought to justice. These attacks are a violation of international humanitarian law.”

The polio vaccination campaign in Afghanistan is supported by WHO, together with UNICEF and other partners.

Dr Ahmed Al-Mandhari, WHO Regional

Director for the Eastern Mediterranean, said the suspension of the programme in Kunduz and Takhar provinces left thousands of children unprotected. “These cowardly acts ultimately only harm innocent children who must be given every opportunity to live safe and healthy lives,” he said.

“WHO condemns all attacks on health workers in the strongest terms and appeal to the Taliban authorities to immediately identify and bring the perpetrators to justice.”

Local polio vaccination teams are often targeted by anti-vaccine militants, some of whom falsely claim vaccination is a Western plot to sterilise Muslims.

Such disinformation, spread by extremist clerics using mosque loudspeakers, radio stations, and by word of mouth, caused a sharp jump in polio cases in Pakistan and hit global efforts to eradicate the disease.

Polio workers continue to be targeted in Pakistan. In an incident in the north-west of the country in August two policemen guarding a polio vaccination team were shot dead by gunmen.

Pakistan and Afghanistan are the only countries where polio remains endemic.

Polio is a highly infectious disease, and if we did not know it before Covid-19, we certainly know now how quickly infectious diseases can spread globally

When a DPP-4 inhibitor is needed

Simplicity. Reinforced .

for a BROAD RANGE of adults with type 2 diabetes (T2D)

UNIQUE CONVENIENCE through always one dose, once daily 1 5mg once daily

Demonstrated

CV AND KIDNEY SAFETY PROFILE 2,3

PROVEN EFFICACY VS PLACEBO

for adults with T2D 1,4

References:

1. TRAJENTA® (linagliptin) Summary of Product Characteristics. SmPC available at: https://www.medicines.ie/

2. Rosenstock J, et al. JAMA. 2019;321:69–79

3. Rosenstock J, et al. Cardiovasc Diabetol. 2018;17:39

4. McGill JB, et al. Diabetes Care. 2013;36:237–44

Prescribing Information (Ireland) TRAJENTA® (Linagliptin)

Film-coated tablets containing 5 mg linagliptin. Indication: Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment; combination therapy in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control. Dose and Administration: 5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia. Renal impairment: no dose adjustment required. Hepatic impairment: pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.

Elderly: no dose adjustment is necessary based on age. Paediatric population: the safety and ef cacy of linagliptin in children and adolescents has not yet been established. No data are available. The tablets can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as possible but a double dose should not be taken on the same day. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Hypoglycaemia: Caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin; a dose reduction of the sulphonylurea or insulin may be considered. Acute pancreatitis: Acute pancreatitis has been observed in patients taking linagliptin. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Trajenta should be discontinued. If acute pancreatitis is con rmed, Trajenta should not be restarted. Caution

should be exercised in patients with a history of pancreatitis. Bullous pemphigoid: Bullous pemphigoid has been observed in patients taking Linagliptin. If bullous pemphigoid is suspected, Trajenta should be discontinued. Interactions: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. It is not an inducer of CYP isozymes. Linagliptin is a P-glycoprotein substrate and inhibits P-glycoprotein mediated transport of digoxin with low potency. Based on these results and in vivo interaction studies, linagliptin is considered unlikely to cause interactions with other P-glycoprotein substrates. Effects of other medicinal products on linagliptin: The risk for clinically meaningful interactions by other medicinal products on linagliptin is low. Rifampicin: Multiple co-administration of 5 mg linagliptin with rifampicin, a potent inductor of P-glycoprotein and CYP3A4, decreased linagliptin steady state AUC and Cmax. Thus, full ef cacy of linagliptin in combination with strong P-glycoprotein inducers might not be achieved, particularly if administered long term. Coadministration with other potent inducers of P-glycoprotein and CYP3A4, such as carbamazepine, phenobarbital and phenytoin has not been studied. Effects of linagliptin on other medicinal products: In clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, warfarin, digoxin or oral contraceptives (please refer to Summary of Product Characteristics for a full list of interactions and clinical data). Fertility, pregnancy and lactation: The use of linagliptin has not been studied in pregnant women. As a precautionary measure, avoid use during pregnancy. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin therapy taking into account the bene t of breastfeeding for the child and the bene t of therapy for the woman. No studies on the effect on human fertility have been conducted

for linagliptin. Undesirable effects: Adverse reactions reported in patients who received linagliptin 5 mg daily as monotherapy or as add-on therapies in clinical trials and from post-marketing experience. Frequencies are de ned as 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) or very rare (<1/10,000). Adverse reactions with linagliptin 5 mg daily as monotherapy: Common: lipase increased. Uncommon: nasopharyngitis; hypersensitivity; cough; rash; amylase increased. Rare: pancreatitis; angioedema; urticaria; bullous pemphigoid. Adverse reaction with linagliptin in combination with metformin plus sulphonylurea: Very common: hypoglycaemia. Adverse reaction with linagliptin in combination with insulin: Uncommon: constipation. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 28 tablets. Legal category: POM. MA number: EU/1/11/707/003. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Crescent Building, Northwood, Santry, Dublin 9. Prepared in September 2021.

Adverse events should be reported. Reporting forms and information can be found at https:// www.hpra.ie/homepage/about-us/report-an-issue. Adverse events should also be reported to Boehringer-Ingelheim Drug Safety on 01 2913960, Fax: +44 1344 742661, or by e-mail: PV_local_UK_Ireland@boehringer-ingelheim.com

RCPI’s annual conference to shine a light on patient care

The upcoming St Luke’s Symposium will focus on the topical issues of integrated and community-based healthcare

The RCPI is looking forward to the St Luke’s Symposium, its premier annual conference, that will take place from Tuesday 11 to Friday 14 October in No 6 Kildare Street and online. There are over 14 CPD credits available across the four-day conference, which is open for booking.

The theme for this year’s St Luke’s Symposium is integrated and community-based patient care, which is highly topical and a top priority for all in healthcare provision as we move towards our integrated model of care in line with Sláintecare.

After two years on the frontline of a global pandemic, this is a fantastic opportunity to reconnect with the College and colleagues to share learning, participate in discussions and meet colleagues and friends both in person and online. We have gathered a wide range of leading experts to share their insights on empowering patients to play an active role in managing their long-term health conditions; delve into current best practice in integrated care and community care; and to look forward to how this new model of care will expand and enhance medical practice and patient care in the years ahead. There will also be a focus on medical education and training and workforce planning, which are critical to the success of a new model of integrated healthcare delivery. We are confident that this year’s programme will be appealing and already are seeing strong bookings for all events.

Join us to hear from Dr Colm Henry, Chief Clinical Officer, HSE; Prof Breda Smyth, Interim Chief Medical Officer, Department of Health; Dr Niamh Lennox-Chhugani, Chief Executive, International Foundation for Integrated Care; Dr Oonagh O’Hagan, Community Pharmacist, Meagher’s Pharmacy Group; Prof Susan Smith, Professor of General Practice,Trinity College Dublin; Prof Áine O’Carroll, Professor of Healthcare Innovation and Improvement, University College Dublin (UCD); Dr Amir Niazi, National Clinical Advisor and Group Lead for Mental Health, HSE; Prof Andrew Green, Clinical Geneticist, Children’s Health Ireland at Crumlin; Prof Derek O’Keeffe, Consultant Physician, University Hospital Galway; Prof Jane McNaughton, Professor of Medical Humanities, Durham University; Dr Andrew Goddard, Immediate Past President, Royal College of Physicians (UK); and many more.

The conference begins with a special online event for NCHDs and consultant trainers interested in applying for entry to the Medical Council specialist division of the register. This is an online-only event. Alongside tips for applying, participants will hear first-hand accounts from consultants who have been through the process.

Public meeting

Putting the patient at the centre of their own care, the St Luke’s public meeting will explore how patients can, and are, making a difference in managing their own long-term health conditions. We are honoured to have a patient from the HSE’s Living Life Better Programme joining us to share how they have been able to enhance their quality-of-life.

The public meeting is one of the highlights of the St Luke’s Symposium. It gives the wider community access to leading experts and innovative care information in a truly accessible format. And, in particular, this session will be hugely valuable to those who have a long-term health condition and their families who wish to support them as best they can. Our experts will discuss how vaccines protect your health, the importance of diet and exercise in the management of chronic diseases, and how community pharmacists can offer support with your

self-care. Prof Sean Dinneen, HE National Lead for the Diabetes Clinical Programme, will chair a questions and answers session at the end of this meeting.

Integrated and community care

Integrated and community care are vital to the provision of an effective health service in Ireland. On Thursday 14 October, the St Luke’s Symposium will explore multiple themes within this context, kicking off with an analysis of the current state and exploring future directions for integrated and community care.

Throughout the day, we will delve into specific examples, such as community gynaecological services and Pathfinder – an alternative to the emergency department for older people who dial 999/112.

Consultant Clinical Geneticist Prof Andrew Green will examine the role of genetics and genomics in integrated care.

Continuing to look for opportunities to build on advancements in integrated and community care, our expert panellists will explore implementation, digital health technology, telehealth, and the future of medical training.

We know first-hand the commitment it takes for our trainees to advance their knowledge through continuous education and to provide world-leading care to their patients. It is crucial that the College facilitates robust conversation on the current and future state of training in Ireland, continually striving for better. Prof Anthony O’Regan, Dean of the RCPI Institute of Medicine,

was recently appointed to Chair the national taskforce on the NCHD workforce. Prof O’Regan will join a panel including Prof Brian Kinirons, Medical Director of the HSE National Doctors Training and Planning unit; Prof John Wilson, President of the Royal Australasian College of Physicians; and Dr Andrew Goddard, immediate past-President of the Royal College of Physicians (UK), to discuss trainee needs, medical training, and workforce planning, with a keen eye on the future.

RCPI will award the first Management Fellowships to doctors who completed a new collaborative programme between the College and PricewaterhouseCoopers. The programme will be expanded to other management consultancy firms to help to build the leadership and managerial capabilities of the next generation of clinical leaders.

Heritage Day

Celebrating the rich culture and heritage of medicine in Ireland and of our own College, St Luke’s would not be St Luke’s without Heritage Day. We are very excited to hear about the foundations and evolving role of medical humanities. Prof Jane McNaughton, Durham University, will present ‘Making breath visible: A medical humanities approach to breathlessness’, and Dr Elizabeth Barrett and Dr Clare Hayes-Brady (PhD), both from UCD, will discuss reflection, resilience, and recognition in healthcare.

Dr Brendan McDonnell will then chair a panel on medical history touching on accounts from the Dublin City coroner’s court in the late 1800s and the evolving role of doctors and family planning in Ireland.

While we have seen an impressive number of physicians admitted to the College with MRCPI or FRCPI over the past two years, due to restrictions it has not been possible to formally confer everyone who is eligible to become a member. We are thrilled to announce that we will host in-person conferring ceremonies at No 6 this year. Prof John Wilson and Prof Andrew Goddard will be awarded Honorary Fellowships of the RCPI.

Book your place at https://web-eur.cvent.com/event/ b5a14ab1-f337-42d2-934d-928735f74eb2/summary

Integrated and community care are vital to the provision of an effective health service in Ireland

DR SINÉAD MURPHY, Chair of the Academic Board and Director of Education and Academic Programmes, RCPI St Luke’s Symposium, RCPI, No 6 Kildare Street, 11-14 October 2022

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 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.

LAMA + LABA

LAMA

The reaction from doctors’ organisations to the extension of free GP care announced in Budget 2023 was not positive to say the least.

On Tuesday 27 September, Minister for Public Expenditure and Reform Michael McGrath stated that the provision of free GP care will be extended to more than 400,000 people. The extension to six- and seven-year-olds is due to take place before the end of 2022, while next year there will be an extension to those on or below the median income.

However, in a strongly worded statement following the announcement, the IMO described the initiative as “ill-conceived and poorly planned in the context of current capacity, workload, and workforce numbers”.

Given the current capacity issues within general practice, the Organisation warned that GPs will simply not be able to cope with the “consequences of this proposal”.

The IMO said: “While we support the objective of removing financial barriers to patients accessing care, such a significant expansion in patient numbers (over 25 per cent) requires long-term planning, not politically motivated Budget announcements.”

The IMO believes that this announcement, if implemented, will lead to a dramatic increase in pressures on GP practices and compromise current levels of care.

It said this will disproportionally affect those who are sickest and most vulnerable.

The IMO also pointed out that many GP practices are already closed to new patients.

“The manner in which the Government has announced this measure is shocking in the context of the known facts about the current pressures facing general practice,” according to the Organisation.

“We have consistently warned that any expansion requires detailed planning and agreed implementation.”

The ICGP made similar arguments in its reaction to the Budget announcement.

Chair of the ICGP, Dr John Farrell, acknowledged the proposals "in the context of preventative care and supporting families".

"However, we cannot ignore the fact that expanding free GP care will inevitably mean longer waiting times for patients’ appointments with GPs, at a time of huge workforce and workload pressures,” he said.

Dr Farrell added that, across the country, GP practices “have closed their doors to new patients, not because they want to, but because they have reached full capacity and can’t take on any more new patients”.

Universal healthcare is a goal worth aspiring to and is in line with the ultimate aims of Sláintecare.

However, the workforce crisis affecting general practice has not been sufficiently acknowledged by the Government.

The Medical Independent recently revealed the frustrations of new ICGP President Dr Paul Armstrong due to the lack of engagement from the Government and Minister for Health in response to calls from the College for a meeting on the issue.

It is hard to see how the roll-out of free GP care can proceed smoothly unless the lack of capacity within general practice is meaningfully addressed.

As part of Budget 2023, €23.4 billion will be allocated to the public health service, the highest annual allocation to date. But general practice is not the only area of healthcare suffering from staff shortages and resource deficits and, in the wake of the Covid-19 pandemic, it is more than likely services will continue to be stretched despite the increase in funding.

MINDO CARTOON

READER COMMENTS

REACTION TO OUR NEWS INTERVIEW, 'A NEW ERA FOR DEMENTIA TRIALS IN IRELAND', 26 SEPTEMBER

“Very honoured to be playing a very small part of @DementiaTrials and very much looking forward to the launch tomorrow!! Good luck team!" Anusha Mohanm, @AnushaMohan19, 26 September

“‘The vision of Dementia Trials Ireland (DTI) is to ensure that every person at risk of – or living with – dementia in Ireland has access to clinical research.'”

Hazelhill Family Practice, @BallyhaunisGP, 26 September

“It all begins tomorrow. Honoured to play a small role in this major new initiative in s earch of new ways to understand dementia and break the silence and stigma of a condition affecting so many of us. Congrats to all the hard-working people @DementiaTrials."

Mike Hanrahan, @mikehanrahan46, 26 September

“Further great coverage of our investment in @DementiaTrials and the importance of its work." Health Research Board, @hrbireland, 26 September

“Delighted to work with our @hrbireland funded colleagues @DementiaTrials to improve the quality of trials conducted for #Dementia patients in Ireland. #TrialsMethodology research leads to improved trial conduct, greater inclusion, and more meaningful trial results." HRB-TMRN, @hrbtmrn, 26 September

“Wonderful coverage for @DementiaTrials in @med_indonews today. Huge thanks to @CathyReilly for such a great piece!" Dementia Trials Ireland, @DementiaTrials, 23 September

“Looking forward to the launch of @DementiaTrials next week."

Laura O'Philbin PhD, @lauraoph, 23 September

REACTION TO OUR NEWS INTERVIEW, 'THE BENEFITS OF THE ICAT PROGRAMME', 26 SEPTEMBER

“A pleasure to interview old paediatric BST colleague @oconnorcathal1 and hear about his experience on his academic PhD journey #areyouthepaed."

Dr Jennifer Finnegan, @DrFino, 26 September

REACTION TO OUR NEWS FEATURE, 'INSIDE BRAY’S ENHANCED COMMUNITY CARE PROGRAMME', 5 SEPTEMBER

“We were delighted to be featured in this article by @niamhquinlan99 in @med_indonews. It gives a great overview of the wide breadth of healthcare services that are now available in the community under the #EnhancedCommunityCare programme."

HSE Community Healthcare East, @Ch6East, 22 September

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Roll-out of free GP care will be difficult if capacity crisis not addressed

A changing complaints landscape

Ms Sile O’Dowd , In-House Counsel of Medisec, reviews the guidance introduced by the Medical Council on the triage and investigation of complaints and looks at the changes to the regulatory process

The most recent annual report from the Medical Council shows that it received 279 new complaints in 2020. Complaints were made against 311 doctors, with some complaints relating to two or more practitioners. That equates to a decrease of approximately 35.3 per cent on the number of complaints received compared to 2019 when 431 new complaints were recorded; the highest number of complaints received in one calendar year. It is likely that the Covid-19 pandemic contributed to the reduction in complaints in 2020 and it remains to be seen if this trend will continue. Our own experience in Medisec suggests that a recent initiative to engage promptly and openly with patients at local/practice level has also been a contributing factor to the downward trend.

The 2020 report also confirmed that the preliminary proceedings committee (PPC) completed its investigations into 231 complaints during 2020. Interestingly, the PPC formed the opinion that there was no prima facie evidence to warrant further action in almost 90 per cent (205 out of 231) of the complaints investigated. These figures highlight that a large number of complaints are concluded at the initial investigation stages and begs the question as to whether some of these complaints warranted investigation by the PPC at all or whether they could have been more appropriately dealt with through alternative forums.

One of the key objectives of the Medical Council is to ensure that “medical regulation protects the public and supports registered medical practitioners”. However, when faced with a Medical Council complaint, practitioners unfortunately can often feel that the regulatory complaints process leans more in favour of the complainant. There is no doubt that the whole process can take its toll on a practitioner regardless of the merits or seriousness of the complaint. In this regard the Medical Council supported the recent introduction of the Regulated Professions (Health and Social Care) (Amendment) Act 2020, which is dealt with further below.

Triage guidance for preliminary proceedings committee (PPC)

The Medical Council has recently published what it describes as “guidance in relation to the initial assessment of complaints by the PPC, to ensure consistency, proportionality and transparency in the decision making process” (the ‘Guidance’).

The Guidance specifically acknowledges that: “Most doctors adhere to the standards expected. As with every job or profession, no matter how skilled, knowledgeable or careful, doctors can make mistakes at work. It is not the role of the Medical Council to punish them. A mistake does not necessarily mean that a doctor should be restricted from practising their profession.”

The Guidance is a welcome step in trying to assist the CEO of the Medical Council and the PPC in appropriately categorising complaints and filtering complaints at an earlier stage in the process. It should help to ensure effective use of Medical Council resources and it may also help address any perceived imbalance in the complaints process.

Role of PPC

The role of the PPC is to give initial consideration to complaints against registered medical practitioners and to identify those cases which raise serious concerns and where it is necessary to take further action, such as referral to the fitness to practise committee (FTPC).

Grounds of complaint

Before progressing a complaint, the PPC must consider whether the complaint falls within one of the following

grounds as prescribed by legislation (Section 57 (1) Medical Practitioners Act 2007):

▶ Professional misconduct;

▶ Poor professional performance;

▶ Relevant medical disability;

▶ Failure to comply with a relevant condition;

▶ Failure to comply with an undertaking or to take any action specified in a consent given to the FTPC;

▶ A contravention of a provision of the Medical Practitioners Act 2007 (‘the Act’) (including a provision of any regulations or rules made under the Act);

▶ A conviction in the State for an offence triable on indictment or a conviction outside the State for an offence consisting of acts or omissions that, if done or made in the State, would constitute an offence triable on indictment. Where a complaint does not come within one of the grounds of complaint listed above, it will not be progressed beyond the initial triage stage by the PPC.

Trivial or vexatious?

The PPC, at its first meeting to consider information supplied concerning a complaint, must first consider whether the complaint is:

▶ Trivial;

▶ Vexatious;

▶ Without substance; and/or

▶ Made in bad faith.

If the PPC is of the view that a complaint falls within the categories set out above, the PPC will form an opinion without delay that there is not sufficient cause to warrant further action being taken in relation to a complaint and inform the Medical Council, the complainant, and the practitioner of that opinion.

Other types of complaints

The Guidance has also helpfully provided some specific examples of other types of complaints which may not be progressed by the PPC beyond the initial triage stage, including complaints relating to:

▶ Fees;

▶ Waiting times in a doctor’s surgery and or appointment times or availability of appointments in non-urgent cases;

▶ The GMS (eg, costs/fees outside of the GMS scheme; notification of the change of GMS doctor and/or access to medical cards);

▶ An historic incident (ie, an incident that occurred in the past and where an investigation would not be practicable or possible due the passage of time);

▶ Matters that the complainant has no direct knowledge of;

▶ A misunderstanding or misinterpretation (i.e. a minor communication issue);

▶ A doctor’s role as an adviser to the Government and/or contributor to Government policy;

▶ The complainant taking issue with the doctor’s clinical opinion in respect of reports prepared for an employer, insurer, etc;

▶ Provision of medico-legal reports for civil proceedings. Anonymous complaints which are not serious and/or which cannot be investigated and repeated complaints about the same doctor, same practice, or the same issue(s) are also listed.

The above list is not definitive and each case will be assessed in respect of its own particular facts. The Guidance also reserves the right for the PPC to carry out an investigation in respect of one or more of the categories listed above if necessary.

It will be interesting to see how the list will be used by the PPC and whether it will be referenced by the PPC if forming an opinion that there is not sufficient cause to warrant further. Overall, the listing of specific examples which the PPC can refer to while triaging complaints can only be seen as a positive development and should help

the PPC filter out less serious complaints at an early stage.

The Regulated Professions (Health and Social Care) (Amendment) Act 2020

As mentioned above, the Regulated Professions (Health and Social Care) (Amendment) Act 2020 (“the 2020 Act”) has also introduced some welcome changes to the initial stages of the Medical Council’s complaints process and some of the key changes are summarised below:

1. Complaints to the CEO

The CEO of the Medical Council will take on a new role receiving complaints instead of the PPC. In future, following receipt of a complaint, the CEO with the assistance of an “authorised officer” will carry out investigations into complaints before sending it to the PPC for a decision. As part of this process, the CEO will also have the power to decide if a complaint is frivolous or vexatious.

2. PPC sub-committees

Under the 2020 Act, the PPC and FTPC can both establish sub-committees. These sub-committees will have the powers and authority to perform the same functions as the overall committee. This should expedite the complaints process considerably, because it provides scope for more frequent subcommittee meetings as opposed to the current arrangements where the PPC sit as one committee every four-to-six weeks.

3. Undertakings to the PPC

Perhaps one of the more fundamental and potentially impactful changes is that under the 2020 Act, the PPC will be able to request undertakings, for example an undertaking not to repeat the conduct complained of. This means that less serious cases, which are capable of being resolved by way of undertaking, may not need to proceed to FTPC inquiry stage. This could help reduce the significant stress on parties to complaints, as well as potentially reducing the legal costs incurred at inquiries.

4. Appeal of sanctions

Another key change under the 2020 Act is that it allows respondent doctors the right to appeal within 21 days against any sanction. Until now, the less serious sanctions (advice, admonishment or censure) could not be appealed to the High Court. It was only possible to appeal to the High Court against the imposition of conditions or suspension/cancellation of registration. The positive effect of this is that it extends the supervisory effect of the High Court to all sanctions as well as helping to reduce any perceived imbalance in the regulatory complaints process.

The future of complaints

The impact of the changes outlined above remains to be seen, but a likely consequence is that patients may be encouraged to try to use established local complaint procedures (such as a direct complaint to the hospital or GP practice) for matters which may fall within the less serious category at the PPC triage stage. With this in mind, it is more important than ever to have a complaints management policy in place. An effective complaints management policy clearly outlines in user-friendly language the practice’s approach to managing complaints. Any policy should be communicated to all staff members as well as to patients. There may be a reluctance to communicate a complaints policy to patients for fear of encouraging complaints, but having a clear complaints procedure allows doctors to take ownership of complaints and can make a patient feel that their complaint is being managed appropriately. This, in turn, could reduce the need for patients to go directly to the HSE or Medical Council.

If you require assistance in implementing or updating your complaints management policy, there are complaint management toolkits available from most indemnifiers/insurers.

MS SILE O’DOWD

A tragic inferno

Some GP consultations are exercises in collusion and negotiation

DR LUCIA GANNON

Read more by Dr Lucia Gannon at www.mindo.ie

The doctor stuck her head into the waiting room and called the last patient of the day. “Thank you for seeing me, doctor. I had an awful tragedy last night. I still can’t believe what happened.”

“Take a seat,” the doctor said, unperturbed, for despite her words, Margaret did not look the slightest bit injured or ill. The “awful tragedy”, the doctor figured must have happened to someone else. Margaret often visited the surgery suffering from other people’s misfortunes.

Margaret sat in the usual chair with a sigh and placed a large brown, apparently empty, shopping bag on the floor beside her. What was it with women and carrier bags? An unexplained medical symptom, the doctor wondered. ‘Excessive reliance on and attachment to shopping bags.’

“You’ll never believe it doctor,” Margaret was saying, leaning forward, her hands joined in front of her as if in prayer. “Last night, I was gathering up all my old empty medicine boxes to put them in the fire. I do that every so often. I keep them all until I have a big pile and then I burn them all together.”

Dr G shifted in her chair, but did not speak. The story would unfold in its own time. It would be counterproduc-

tive to try to rush it.

“Well, I gathered them all up and threw them in the fire and as soon as I did, I realised that I had thrown my D5s in along with them. I’m in an awful state over it, Dr G. I have none left. A tragic accident.”

The doctor sat forward, suddenly alert at the mention of D5s.

“Your Valium tablets,” she said. “What Valium tablets? Who on earth gave you Valium tablets?”

“Oh, it wasn’t anybody here,” Margaret said, barely suppressing a smirk. “It was my psychiatrist.” Margaret put added emphasis on the word psychiatrist, while at the same time raising her chin and holding the doctor’s gaze.

“Your psychiatrist! What psychiatrist? You don’t have a psychiatrist. You wouldn’t go to one when I wanted you to.”

“I know, but I didn’t like that woman you sent me to. Your nice new assistant sent me to a lovely young man last week. He’s lovely altogether. He really listened and when he heard my story, he said that a few Valiums every day would set me right.”

Dr G stared at Margaret.

“Did you tell him how much trouble you had coming off Valium, just a few years ago?” she asked in a calm, measured voice that came nowhere near masking her irritation. “Did you mention that you had addiction problems? Did he look at your file and read all the reasons why you should never be given anything addictive?”

Dr G’s voice was rising. Margaret reached into her shopping bag, withdrew a crumpled, stained brown envelope and pushed it along the desk to the doctor.

“It’s all in there,” she said. “Valium five milligrams

The ‘art’ of surgery

Ethical and other questions arise when performance art and cosmetic surgery collide

Read more by George Winter at www.mindo.ie

P‘encil on Head’ is my recent artwork. Comprising a blue pencil placed with geocentric defiance across my scalp, it reflects dominant ideological paradigms shaping current hegemonic narratives.

Forgive me, but I’ve been reading about Cyprus-born Aussie Stelios Arcadiou, who calls himself Stelarc and is a performance artist. According to his website, Stelarc was “intrigued about engineering a soft prosthesis using my own skin, as a permanent modification of the body architecture” and assumed that “if the body was altered it might mean adjusting its awareness”. This reasoning led to ‘Ear on Arm’ – undertaken in 2007 – and consisted of… well, you can guess.

Two points arise. First, does a stem cell-derived prosthetic ear surgically inserted into one’s inner forearm constitute art? Notwithstanding Stelarc’s assertion that he was “[e]ngineering an alternate anatomical architecture, one that also performs telematically”, I would say of Stelarc’s justification for his ‘Ear on Arm’ what my grandmother often advised me to do: “Away you, an’ catch yourself on.”

Second, is an ethical aspect. Confirming Stelarc’s spellbinding insight that “[t]he body is a living system which isn’t easy to surgically sculpt” is his admission of “several serious problems that occurred: A necrosis during the skin expansion process… [and after a microphone had been inserted into his ear – the ear on his arm, that is]… “it had to be removed. The infection caused by the implanted microphone

several weeks later proved to [be] serious.…”

Who, I wondered, would willingly place an ear in an arm, with or without a microphone? Having learned from the website of the Irish Association of Plastic Surgeons, that “[o] perations are being carried out in Ireland by doctors without proper surgical qualifications”, an immediate concern arose. Had a bunch of arty, non-qualified surgeons escaped the scrutiny of Irish regulators to undertake clandestine otic mischief? Thankfully, no. Stelarc’s surgical team, he reveals, comprised United States plastic surgeons Malcolm A Lesavoy, MD; Sean Bidic, MD; and J William Futrell, MD. According to the website of one of the team, his “education, awards and accomplishments speak for themselves”. Yet as far as I can tell one accomplishment apparently unable, or unwilling, to speak for itself is ‘Ear on Arm’. Why might this be? Is it, as Stelarc noted, that “several serious problems” occurred? Clearly, the principle of primum non nocere (first do no harm) was not upheld. But on the other hand (or foot?), if an individual wants a prosthetic ear inserted in their arm – or elsewhere, for that matter – is a plastic surgeon justified in refusing to undertake the procedure?

Not necessarily, according to bioethicist Dr Francesca Minerva, who reflects on ‘Cosmetic surgery and conscientious objection’ in the Journal of Medical Ethics (2017, 43: 230–233). Apart from citing Stelarc’s aural manoeuvres, Minerva notes that “French artist ORLAN underwent nine cosmetic surgeries over [five] years… [which]… included the implantation of two horns on her forehead… and… Mayra Hills is one of the women with the largest breast implants in the world…. They are so large that she cannot tie her own shoes”. Yet asserting the principle of respect for bodily autonomy, Minerva is adamant that “patients are entitled to decide if undergoing a certain treatment is in their best interest”.

It follows, therefore, that Minerva would have no objection

three times a day and he will see me again in one week. That’s the day after tomorrow. The only reason I am here is that after what happened last night, I need you to replace what I threw in the fire. The psychiatrist said I was to stay on them until he saw me again, so I better do as he says.”

Dr G sighed and turned to her computer.

“You know I don’t believe you,” she said, “about the fire. Don’t believe it for a second.”

Margaret did not reply. The doctor began typing. “How many tablets did you incinerate?” she asked.

Margaret hesitated, appearing to weigh up how many tablets she could wrangle out of the doctor. Dr G stopped typing and sat with her hands poised above her keyboard, looking at Margaret, her gaze steady, her face stern. She already knew how many tablets she would give her. Margaret sat back in her chair as if resigned to her fate.

“Three,” she replied at last. “Three will do until I see the psychiatrist. Don’t worry doctor. I know you don’t like giving them to me, but I really do need them and he seems to think that they will do me no harm.

“He doesn’t know you like I do, Margaret, and you really should have told him about your previous experiences with addictive drugs. If you did, I am sure he would not have given you Valium. In any case, that script is gone to the chemist now,” Dr G said rising from her seat and opening the door to the waiting room.

“Thank you, Doctor,” Margaret said with a smile. “You always look after me. I knew you wouldn’t see me stuck.” (Margaret is a composite character and not a real patient.)

to the website of the British Association of Aesthetic Plastic Surgeons (BAAP), whose members offer, in their phrase, “designer vaginas.” Perhaps it’s the case that females with ordinary, run-of-the-mill vaginas can acquire “designer” ones, thanks to those BAAP-accredited members whose vagina-shaping skills include the ability to undertake “…a number of surgical procedures to improve their appearance”. As an effective counterargument, however, Germaine Greer in her The Whole Woman (1999) rails against genital re-shaping, observing: “A surgeon is allowed to whittle away female genitalia if the operation is understood to be cosmetic.” Greer contrasts the apparent eagerness with which cosmetic genital surgery is undertaken in the developed world with the (rightful, in my view) condemnation that is heaped upon the practice of female genital mutilation in other parts of the globe.

And in Theoretical Medicine and Bioethics (2017, 38: 213–225) Dr Yves Saint James Aquino considers the ethics of medicalising Asian features, highlighting cosmetic surgery’s tendency “to conflate beauty and health as medical goals of surgery, overemphasising the value of appearance that can further displace women’s control over their own bodies”.

If cosmetic surgeons are to fly abroad to put ears into arms, and patients are to fly abroad for other possibly hazardous procedures, Massand et al, writing in Infectious Diseases in Clinical Practice (2022;30: e1142) warn that “[p] atients who undergo cosmetic surgery as medical tourists are placed at risk of infection by rapidly growing mycobacterial species. Management is highly morbid, and they are often left with extensive surgical scarring and unanticipated additional out-of-pocket expense.”

I know that some readers are sniggering behind me because I’ve eyes at the back of my head. Let me tell you how that came about.…

GEORGE WINTER

@LuciaGannon

MULTIPLE CHOICE QUESTIONS

Question 1

Hepatic metastases

A. Are the most common hepatic tumours.

B. Liver is almost always enlarged.

C. Characteristically cause moderate or severe biochemical disturbance (in LFTs).

D. Will develop in one-in-three of all carcinomas arising outside the portal venous area.

E. Should be treated in their own right.

Question 2

Chickenpox

A. Incubation period is six-to-10 days.

B. Lesions appear first on the limbs and face.

C. Whole illness seldom lasts more than a week.

D. May be complicated by acute cerebellar ataxia.

E. Patients should be advised not to bath.

Question 3

In the treatment of RA, methotrexate

A. Is 80-to-90 per cent excreted unchanged in the urine.

B. Patients should take folic acid supplements to prevent side-effects.

C. Prospective patients should be asked about their alcohol intake.

D. Recognised side-effects include stomatitis.

E. Initial dosage is by convention 2.5 micrograms daily.

Question 4

In pregnancy, pre-eclampsia

A. Is defined as hypertension that arises before 20 weeks’ gestation.

B. Predisposing factors include ‘new partner’ pregnancy.

C. Risks to the foetus arise from placental dysfunction.

D. Should be suspected if leg oedema develops.

E. Symptoms include acute abdominal pain.

Question 5

Ichthyosis vulgaris

A. Is an autosomal dominant condition.

B. Scales are small.

C. Skin is characteristically inflamed.

D. Scales are more obvious on the trunk than the limbs.

E. Patients also have keratosis pilaris.

E. TRUE. And headache, visual disturbances, epigastric pain, nausea.

D. FALSE. Common in most pregnancies. Developing facial and/or finger oedema can be more significant.

C. TRUE. So get premature delivery of a growth restricted infant.

B. TRUE. Or first pregnancy, multiple gestation, age extremes.

A. FALSE. Hypertension with proteinuria that arises after 20 weeks’ gestation and resolves by three months’ postpartum.

ANSWER 4

E. FALSE. 7.5 micrograms weekly.

D. TRUE. And GI upset, rash, headaches.

C. TRUE. As there is an association with abnormal LFTs if used in those who drink to excess.

B. TRUE. Patients on methotrexate should be co-prescribed a minimum dose of 5 milligrams folic acid once weekly, taken the day after the methotrexate dose.

A. TRUE. So any impairment of renal function may lead to bone marrow toxicity.

ANSWER 3

E. FALSE. Daily baths may help avert secondary infection.

D. TRUE. Occurs one-to-two weeks after the rash.

C. TRUE. As final crop appears, pyrexia settles.

B. FALSE. First on trunk or scalp.

A. FALSE. 11-to-20 (usually 14 or 15).

ANSWER 2

E. FALSE. Once present almost always indicates poor prognosis.

D. TRUE. And in at least 50 per cent of those arising in the splanchnic area.

C. FALSE. Produce little if any biochemical disturbance.

B. TRUE. And may be tender and nodular.

A. TRUE. Because of liver’s unique double blood supply

ANSWER 1

Melanin transfer and processing in focus

Attendees at UCD’s Charles Institute Seminar Series recently heard a presentation from Prof Duarte C Barral of the NOVA University of Lisbon on clinical research into melanin transfer and processing

The Charles Institute, Ireland’s national dermatology research and education centre, played host to a range of guest speakers who covered a variety of topics ranging from skin cancer to psoriasis, among others. The series, which is sponsored by RELIFE (part of the A.Menarini group), was designed to provide expert advice from a range of distinguished national and international experts in their respective fields and was chaired by Prof Desmond Tobin, Full Professor of Dermatological Science at UCD School of Medicine and Director of the Charles Institute of Dermatology. The seminars were broadcast to attendees with a special interest in dermatology in other locations, who accessed the talks remotely via an audio-visual link.

Attendees heard a presentation from Associate Prof Duarte C Barral (PhD) of the NOVA Medical School at the NOVA University of Lisbon, Portugal, who spoke on the topic ‘Molecular Mechanisms of Melanin Transfer and Processing’. Among other distinctions, Prof Barral has been a post-doctoral fellow at Brigham and Women’s Hospital Harvard Medical School, and is a tenured Associate Professor and Principal Investigator at the NOVA Medical School. He has experience spanning more than 20 years in the field of membrane traffic and its regulation by GTPases of the Rab and Arf families, and has helped to uncover the previously-unknown role of several of these proteins, namely Rab27a, Arl8b, Arl13b, and Rab35. Prof Barral explained how skin pigmentation relies on melanin, which is known to have a protective role against ultraviolet radiation-induced damage. He explained the basic pathway whereby melanin is produced by melanocytes and is subsequently transferred to keratinocytes, where it is then processed and forms supranuclear caps. However, despite the pivotal role of melanin secretion, as well as the transfer and processing by keratinocytes for skin pigmentation, the pathways involved are still controversial and remain poorly characterised.

“We have been studying these processes by characterising the pathways and regulators involved,” said Prof Barral. “We found that basal melanin secretion from melanocytes is regulated by Rab11b and the exocyst complex; that melanin uptake by keratinocytes occurs through PAR-2, Rac1- and Cdc42-dependent phagocytosis; and that melanin polarisation within

keratinocytes is dependent on Rab7-mediated transport along microtubules.”

Furthermore, he added, he and his team have uncovered a new melanin exocytosis pathway that is stimulated by keratinocyte-conditioned medium and regulated by Rab3a.

Transfer models

Prof Barral presented an overview of study data and melanin transfer models. He told the attendees that his team found that “melanin is surrounded by a single membrane in keratinocytes, but melanin in the extracellular space is not surrounded by a membrane”. He explained that the four basic melanin transfer models are via cytophagocytosis; exocytosis/phagocytosis; filopodia fusion – inoculation (as shown by the Tobin lab); and via vesicles/globules.

“The exocytosis/phagocytosis model predicts that the identity of the membrane will be different because in the melanocyte, the melanosomes are surrounded by a membrane that changes because it is derived from the plasma membrane of the keratinocyte in those cells,” said Prof Barral. “So, the markers will be different; there is a lot of tyrosinase-related protein 1 (TRP1) within melanocytes, surrounding melanosomes, and there is almost no TRP1 surrounding melanin when it is within keratinocytes. Therefore, the identity of the membrane changes, and this is only explained by this model. Thus, in human skin, this could be the predominant mode.” He also outlined research to show that different modes can be used to reflect different situations, depending on the stress exerted on the skin.

The work carried out by Prof Barral’s group has shown that Rab11b and the exocyst tethering complex regulate melanin exocytosis and transfer, supporting the exocytosis/phagocytosis model. In addition, depletion of Rab11b or exocyst subunits does not affect melanin synthesis. The in vitro model he and his team are currently using is a reconstructed human pigmented epidermis model to recapitulate melanin transfer mechanisms.

Melanocores

PAR-2 mediates the melanocore (a membrane-stripped melanosome) but not melanosome uptake, Prof Barral added. He briefly described how melanocores are surrounded by early and late endosomes/ lysosomes inside keratinocytes. He also told the seminar that melanocores localise to pre-loaded terminal lysosomes, and he told the attendees how melanocore uptake impairs autophagy in keratinocytes.

Touching briefly on melanin polarisation, he added: “We are still in the early stages of this research, because we have been focusing more on melanin clustering than the polarisation of supranuclear caps.” He also described wound-healing experiments where the researchers stimulated migration of keratinocytes in the would-healing process. “We saw a significant increase in melanin concentration at the leading edge area in migrating cells versus confluent cells, in which melanin is clustered all around the nucleus”.

Evolution

During an interactive clinical discussion and Q&A session, Prof Tobin commented on how in mammalian biology, pigmentation represents a unique example of how an organelle made by one histological cell type (melanocytes) is giving way to a different histological cell (keratinocyte). Geographic ancestry is also very important in this process, he added, but “the degree of variation in that system is phenomenal, and we wouldn’t be a successful species at all if we had not evolved under/with the sun”. If humans had not been able to transform melanin, then “we would not have progressed beyond the canopy of the jungle, where our closest relative, the chimpanzee, retains white skin underneath its black hair. So, this is a really important area in human evolution – selective pressure for gene traits, and so on. So, even for those of you who are not deep into cell biology of the skin, as a survivor of the species, you have depended enormously on this process working effectively.”

Prof Tobin posed the question: “You have suggested that there are two settings in keratinocytes, a basal setting and a stimulated setting. To what extent are those processes continuous in biological terms, or could they be uniquely different processes?” he asked. “Our research suggests that the skin, as the most exposed organ, needs to have several ‘languages’ to cope with the stresses it will experience. Do you consider that these [processes] reflect the same overarching model, or do you think that evolution has required a different machinery to facilitate rapid change – in tanning, for example – within hours?”

For its part, autophagic activity recognises melanocores within keratinocytes, and the extent of melanin processing determines skin colour. Prof Barral also synopsised the process of vesicle movement along cytoplasmic microtubules, which is required for melanin clustering in keratinocytes, and the observation that Rab7 and its effector RILP are required for this process, he added.

Prof Barral went into further detail on his research processes and results and told the attendees: “We found that autophagy can contribute to achieving the well-known differences between fair skin and darker skin,” said Prof Barral. “In darker skin, it has been described as the existence of more of the single, bigger granules than in white skin, which contains clusters of smaller melanin granules. This also contributes to establishing the colour of the skin under non-stimulated conditions… interestingly, autophagy levels are higher in lighter skin than they are in darker skin.”

Prof Barral replied: “It’s a very good point. Our view at the moment is that several modes coexist, and there was selective ‘multi-modal’ pressure in evolution,” he commented. “In terms of the machinery involved, I think it will differ. Regarding speed, the machinery will be different because there are fundamental differences that require different regulators, but we need to continue exploring this.

“I think the machinery has to be connected in order to switch from one mode to another, but there is the ability to be integrated… I think that when we have a clearer picture of the whole machinery in different modes of melanin transfer in human skin, then we can draw our conclusions. That’s why we focus on describing the regulators –we want to know the whole process, but we also want to know how it’s regulated.”

RELIFE has had no input into the content of this article or series of seminars

Prof Duarte C Barral

Interestingly, autophagy levels are higher in lighter skin than they are in darker skin

RELIFETM. MY SKIN SAYS HOW I FEEL.

ECZEMA, DERMATITIS, SENSITIVE SKIN & BABY CARE.

DRY, VERY DRY, ROUGH AND CRACKED SKIN.*

OILY, BLEMISHED AND ACNE PRONE SKIN.

HYPERPIGMENTATION AND MELASMA.

Distributed by: A.Menarini Pharmaceuticals Ireland Ltd, Castlecourt,Monkstown Farm, Monkstown, Glenageary, Co. Dublin.

PsO Let’s Talk Psoriasis

Managing paediatric psoriasis

Achronic, systemic, immune mediated skin disorder affecting at least 73,000 people in Ireland and approximately 125 million people worldwide, psoriasis does not discriminate and can occur at any age, affecting children as well as adults. Indeed, up to 1 per cent of children and adolescents may be living with this chronic and challenging skin condition, which can cause thick scaly skin plaques on visible areas of the body at a time of intense growth and development.

The good news is that the range of treatments for paediatric psoriasis has been growing, with many of the treatments effective in treating the adult form of the condition now licensed for children and adolescents. Yet understandably, for those children and their parents, the development of psoriasis can be a distressing and anxious time. And while a GP may initially diagnose the condition, some families only receive a diagnosis when they eventually see a specialist paediatric dermatologist, during which time concerns and worries can intensify.

Janssen Sciences Ireland UC this year launched the first series of its kind to offer access to guidance from leading healthcare professionals to help people manage their psoriasis while they wait to access specialist care. PsO Let’s Talk Psoriasis is a video and podcast series that has already been viewed and downloaded thousands of times since its launch in May this year.

Paediatric psoriasis is the focus of the third episode in the series, which sees experts address some of the biggest concerns of parents of children living with psoriasis, such as how to manage psoriasis in children and their treatment options, as well as practical issues, such as speaking about psoriasis to teachers and friends, and the transition from paediatric to adult care. The episode also sees the panel of experts answer some of the most common questions posed by parents.

Dr Maeve McAleer, who is a Consultant Dermatologist at St James’s Hospital and Children’s Health Ireland, notes that psoriasis is a relatively common inflammatory skin condition in children and it can present similarly to how it does in adults, albeit with some distinct differences.

Just like with adult psoriasis, “patients have very well demarcated plaques – you can almost draw a line between the affected skin and the unaffected skin,” Dr McAleer explains. “Psoriasis likes to pick out areas such as the elbows, the knees, the scalp, and the body folds. In some patients it can be small areas, whereas for others a large portion of their body can be affected.”

Psoriasis in children can sometimes spontaneously resolve after a few months, an outcome that is not typically seen with the adult form of the condition, Dr McAleer adds.

In terms of its appearance, it can be far more subtle. Children’s plaques can be thinner, with less of a scaly appearance –conversely, this can make the diagnosis

somewhat trickier in children. “Psoriasis in babies can even present as a troublesome nappy rash,” she says. Psoriasis can also sometimes be confused with atopic dermatitis, again delaying diagnosis.

“One Australian study found that a majority of children with psoriasis were initially diagnosed with atopic dermatitis,” Dr McAleer notes. With atopic dermatitis being 20 times more common than paediatric psoriasis, the likelihood of it being atopic dermatitis is greater “but a consultant paediatric dermatologist will be able to tell just by looking at the child”, she says. She also cautions that atopic dermatitis will have an “intense” itch associated with it, which affects sleep, whereas psoriasis patients tend not to be as itchy. “Children with psoriasis only have mild itch and it doesn’t typically affect their sleep.”

The first port of call for a concerned parent should be their GP, says Fiona Lawlor, Clinical Nurse Specialist in paediatric dermatology at Tallaght University Hospital. She says this should set the patient on the correct treatment pathway.

“Hopefully they will be able to give them a diagnosis, but psoriasis can be hard to differentiate so at that time if they don’t get a diagnosis, the GP will then send a referral to a dermatology department and they will get to see a specialist eventually.”

Ms Lawlor also highlights the crucial role played by the specialist nurse as part of the dermatology team looking after the psoriasis patient. “It is the dermatology nurse’s role to provide education and

advice to caregivers and patients when it comes to managing their psoriasis,” Ms Lawlor says. “We set them on the right track – knowledge is power for parents.” She adds that the parents and children and teenagers she sees are often stressed – by the time they reach the dermatology clinic, they may have been on a waiting list for quite some time.

“It’s heartbreaking for us, so we try to do everything we can to help them. It’s about giving them the tools to manage it and empower them through education.” This can range from determining which emollient would best suit their skin, to demonstrating exactly how to apply it.” Indeed, emollient therapy can be under-used, adds Ms Lawlor. “It’s really important to maximise the use of them because itch may not be the biggest issue, but it can still get itchy.”

Dr McAleer adds that many studies have shown that even emollients by themselves can improve psoriasis, but acknowledges they can be messy and time-consuming in their application. “The best emollient for you is the one you will use.”

“We need to carefully consider the impact of the disease on a child or young person,” Dr McAleer adds. “It can have a huge impact on kids and we have to carefully consider the impact on their education, their social interactions, their self-esteem, and even consider anxiety and depression in our young people. It is such a critical stage in their physical and emotional development. There are so many milestones that they have to hit in those years… we

need to be very aggressive with children and young people in treating it, because the impact on their development can be massive so I would be very aggressive in trying to control it.”

Dr McAleer is quick to highlight the positives – with numerous treatment options available, the odds that the psoriasis can be effectively cleared are higher than ever.

Treatment options for paediatric patients include topical therapies, phototherapy, and systemic therapies including methotrexate and many of the biologic therapies.

Dr McAleer says one of her first jobs is to reassure families that psoriasis is a treatable condition.

“We have a range of medications and we will work through them in a systematic way, depending on the extent of your disease, and we will be able to control your psoriasis so that there is minimal psoriasis.” Parents may be concerned about side-effects; to this, Dr McAleer says, “there are side-effects to doing nothing too.”

“We are very lucky in psoriasis – we are in an age now where we can treat successfully and manage the disease. There is no cure, but I think it’s very important that children and young people know that we can manage this.”

PsO Let’s Talk Psoriasis is available free of charge online at www.janssenwithme.ie/ pso/resources/pso-lets-talk-psoriasis. The podcast audio versions are also available wherever you access your podcasts.

References available upon request

Chris Mulligan, who lives with psoriasis; Fiona Lawlor, Clinical Nurse Specialist; Broadcaster Dr Ciara Kelly; and Dr Maeve McAleer, Consultant Dermatologist; pictured for the PsO Let’s Talk Psoriasis video and podcast series by Janssen Sciences Ireland UC

THERESA LOWRY-LEHNEN, RGN, GPN, RNP, BSc, MSc, M Ed, PhD, Clinical Nurse Specialist and Associate Lecturer, South East Technological University

Endometriosis: A review

While currently there is no cure for endometriosis, in most cases, symptoms improve with the use of medications, surgery, or both

Note: The author of this article recognises that there are individuals living with endometriosis who are transgender, who do not menstruate, who do not have a uterus or who do not identify with the terms used in literature. For the purposes of this article, the term “women with endometriosis” is used, however, it is not intended to, exclude, isolate or diminish any individual’s experience nor to discriminate against any group.

Endometriosis is a chronic, painful and debilitating gynaecological condition characterised by the presence of endometrial-like tissue in anatomical positions and organs outside of the uterine cavity.¹ Establishment and growth of such endometriotic tissue is oestrogen-dependent. The main clinical manifestations are chronic pelvic pain and impaired fertility. The exact prevalence of endometriosis is unknown, but estimates range from 2-to-10 per cent within the general female population and up to 50 per cent in infertile women. It is estimated that at least 190 million women and adolescent girls worldwide are currently affected by the disease during reproductive age, although some women are affected beyond menopause.2,5

The extent of disease varies considerably from isolated peritoneal lesions to widespread pelvic adhesions, infiltrating lesions, and ovarian cysts. Most endometriotic disease is located on the pelvic peritoneum including the ovaries, fallopian tubes, the bowel, and the areas in front, on the back, and to the sides of the uterus, while a smaller percentage involves the ureters, bladder, urethra, and the upper abdomen. The condition is not limited to the pelvis, and occasionally can cause damage to extra pelvic structures, such as the pleura and the pericardium, however, it rarely extends beyond the peritoneal cavity.1,2

Theories on the origin of endometriotic lesions in the peritoneal cavity exist, however, there is no coherent theory to explain all the different types of endometriosis, integrating the epigenetic, genetic, immunological, and environmental data. The most recognised pathogenic theory is Sampson’s theory, suggesting that with retrograde menstruation, viable cells and menstrual fragments can migrate through the fallopian tubes, infiltrate into the peritoneal cavity, then proliferate and cause chronic inflammation.2,3 However, the fact that retrograde menstruation is not enough to cause endometriosis in all affected women indicates that other factors also contribute to the development of the disease. Other theories, such as the coelomic metaplastic theory, the stem cell theory, the Müllerian remnant theory, and the vascular and lymphatic metastasis theory, are necessary to explain some forms of endometriosis.

The pathophysiology of endometriosis is strongly influenced by factors such as genetic predisposition, and hormonal factors such as resistance to progesterone, oestrogen dependence; inflammation, angiogenesis, and vascularisation processes. Oxidative stress, resistance to apoptosis, and immunological factors are also involved to various degrees in lesion development.3

Several predisposing factors have been linked with the risk of developing endometriosis. Early age at menarche (below 11 years old), shorter duration of menstrual cycles (of less than 27 days), menorrhagia, and nulliparity increase the risk for endometriosis, indicating that it is closely linked with the female hormonal system.

On the contrary, there are protective factors against endometriosis, mainly acting via lowering the inflammatory process, or by decreasing the levels of oestrogen in the body. Protracted breastfeeding, current oral contraceptive use, tubal ligation, and smoking are related to a decreased risk for endometriosis. Although the mechanism is still not clear, women who smoke have lower levels of oestrogen in the body.2

Presentation

The clinical presentation of endometrial disease differs not only in presentation, but also in duration. Symptoms of endometriosis can begin prior to the first menstrual period and for many it can persist into menopause and throughout their lives. Endometriosis triggers a chronic inflammatory reaction resulting in pain and adhesions, and can have a profound effect on an individual’s quality-of-life. Adhesions develop when scar tissue attaches separate structures or organs together. Pain and symptoms due to endometriosis may vary during the menstrual cycle as hormone levels fluctuate. Symptoms may be worse at certain times in the menstrual cycle, with ovulation, and prior to and during menstruation being the most severe for many. While some experience severe pelvic, bladder and/or bowel pain, others may have few or no symptoms or regard the symptoms as simply period pain or cramps.4 Typical symptomatology includes dyspareunia, dysmenorrhoea, dysuria, dyschezia, and/or infertility. The pain is usually characterised as chronic, cyclic, and progressive.2 Some women experience hyperalgesia, which indicates neuropathic pain.

Three subtypes of endometriosis often overlap; superficial peritoneal lesions, ovarian endometrioma, and deep infiltrating endometriosis. Patients with bowel endometriosis often present with a wide range of gastrointestinal symptoms, such as diarrhoea, constipation, abdominal pain or bloating, and mimic other clinical conditions like inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS). Rectovaginal endometriosis is a severe deep infiltrating form of the disease involving the vagina, rectum, and the rectovaginal septum. It can present with bowel irritation, dyspareunia, dysmenorrhoea, dyschezia, and rectal bleeding coinciding with menstrual bleeding.

Infertility is a main symptom that often leads clinicians to suspect endometriosis even in asymptomatic patients.2 Endometriosis is one of the leading causes of infertility, however, it is estimated that 60-to-70 per cent of women with endometriosis will conceive, and this may increase with the removal of endometriosis and the use of assisted reproductive techniques.4

Diagnosis and classification

Diagnosis of endometriosis is often delayed on average of four-to-11 years from the onset of symptoms. According to the Endometriosis Association of Ireland (EAI), the average delay in Ireland is nine years.2,4 This phenomenon is attributed to the non-existence of a pathognomonic test or biomarker to detect the disease, the diversity of symptoms being considered physiologic responses during menstruation, and to the wide range of reported symptoms that overlap with other gastrointestinal or gynaecological conditions.2

The diagnosis process commences by taking a detailed history and carrying out a gynaecological physical examination. Positive family history, pelvic pain, benign ovarian cysts, pelvic surgeries, and infertility issues can lead to a suspected diagnosis of endometriosis. Physical examination can reveal variable findings, depending on the location and size of the endometriotic lesion. Tenderness on vaginal examination, palpable nodules in the posterior fornix, adnexal masses, and immobility of the uterus are indications of endometriosis. The absence of physical findings cannot exclude the diagnosis of endometriosis.2

The European Society of Human Reproduction and Embryology (ESHRE) Guidelines on Endometriosis were updated in 2022, and offer best practice advice on the care of women with endometriosis, including recommendations on the diagnostic approach and treatments for endometriosis for both the relief of painful symptoms and infertility due to endometriosis. It provides more than 100 recommendations, is a full revision of, and replaces, the ESHRE Guideline on Endometriosis 2014, with major changes in recommendations regarding the relevance of diagnostic laparoscopy and

post-operative hormone therapy. In addition, a new section on endometriosis in adolescence provides information on diagnosis and appropriate treatments for symptom management in female adolescents and young adults. The topics of menopause, pregnancy, and fertility preservation in relation to endometriosis are addressed in more detail in the updated guidelines,5 which are available at: www.eshre.eu/Guidelines-and-Legal/Guidelines/Endometriosis-guideline.aspx

The ESHRE 2022 guidelines make the following recommendations: Laparoscopy is no longer the diagnostic gold standard, and is now only recommended in patients with negative imaging results and/or where empirical treatment was unsuccessful or inappropriate.

The ESHRE guideline development group (GDG) recommends that clinicians should consider the diagnosis of endometriosis in individuals presenting with cyclical and non-cyclical signs and symptoms; dysmenorrhoea, deep dyspareunia, dysuria, dyschezia, painful rectal bleeding or haematuria, shoulder tip pain, catamenial pneumothorax, cyclical cough/haemoptysis/chest pain, cyclical scar swelling and pain, fatigue, and infertility.5

The guidelines strongly recommend that clinicians should not use measurement of biomarkers in endometrial tissue, blood, menstrual, or uterine fluids to diagnose endometriosis.6 CA125 is elevated in patients with endometriosis, but should not stand alone as a diagnostic test. The reason is that CA125 can be increased in several pathological conditions, and is also not able to define the location of endometriotic lesions.2 The guidelines also strongly recommend that clinicians use imaging ultrasound (US) or MRI in the diagnostic work-up for endometriosis, but need to be aware that a negative finding does not exclude endometriosis, particularly superficial peritoneal disease.6

In patients with negative imaging results or where empirical treatment was unsuccessful or inappropriate, the GDG recommends that clinicians consider offering laparoscopy for the diagnosis and treatment of suspected endometriosis. They also recommend that laparoscopic identification of endometriotic lesions is confirmed by histology, although negative histology does not entirely rule out the disease.6

Classification: The American Society of Reproductive Medicine (ASRM) has developed a staging system to stage endometriosis and adhesions due to endometriosis.

 Stage 1 and 2 (minimal-to-mild disease): Superficial peritoneal endometriosis. Possible presence of small deep lesions. No endometrioma. Mild filmy adhesions, if present.4

 Stages 3 and 4 (moderate-to-severe disease): The presence of superficial peritoneal endometriosis, deeply invasive endometriosis with moderate to extensive adhesions between the uterus and bowels and/or endometrioma cysts with moderate to extensive adhesions involving the ovaries and tubes.4

The classification was originally developed to predict impairment to fertility, and is therefore focused on ovarian disease and adhesions. Patients with the same ‘stage’ of disease may have different disease presentations and types, and some forms of severe disease, such as invasive disease of the bowel, bladder, and diaphragm, are not included.4

Apart from the classification system, three subtypes of endometriosis can be distinguished according to localisation: Superficial peritoneal endometriosis, cystic ovarian endometriosis (endometrioma or ‘chocolate cysts’), and deep endometriosis, also referred to as deeply infiltrating endometriosis. The different types of disease may co-occur.4

 Superficial peritoneal endometriosis is the most common type. Lesions involve the peritoneum, are flat, shallow, and do not invade the space underlying the peritoneum.4

 Cystic ovarian endometriosis (ovarian endometrioma) occurs less commonly. The cyst is filled with old blood, and because of the colour are referred to as ‘chocolate cysts’. Most people with endometrioma cysts will also have superficial and/or deep disease present elsewhere in the pelvis.4

 Deep endometriosis is the least common subtype. An en-

dometriosis lesion is defined as deep if it has invaded at least 5mm beyond the surface of the peritoneum. Deep lesions involve tissue underlying the retroperitoneal space.4

Treatment

There is no cure for endometriosis, and treatment is broadly divided into two main categories; pharmacological and surgical. Currently, there is no specific drug that can inhibit disease progress, other than hormonal and non-hormonal agents used to alleviate symptoms and increase fertility rates.

Treatment of endometriosis depends on the severity of symptoms, reproductive plans, patient’s age, medical history and side-effects of both surgical and medical treatments. Regarding treatment of symptoms in post-menopausal women, the potential increased risk of underlying malignancy in this population should be keep in mind and the uncertainty of the diagnosis, as pain symptoms may present differently in this group compared to pre-menopausal women.6

NSAIDs or other analgesics, either alone or in combination with other treatments, can be used to reduce endometriosis-associated pain.8 ESHRE guidelines recommend offering women hormone treatment; combined hormonal contraceptives, progestogens, GnRH agonists or GnRH antagonists, as one of the options to reduce endometriosis-associated pain. The ESHRE GDG recommends that clinicians take a shared decision-making approach, and take individual preferences, side-effects, individual efficacy, costs, and availability into consideration when choosing hormone treatments for endometriosis-associated pain.5,6

Ovarian suppression can reduce disease activity and pain. Systematic reviews have confirmed the efficacy of combined hormonal contraceptives and continuous progestogens, including medroxyprogesterone acetate, norethisterone, cyproterone acetate, or dienogest, for pain associated with endometriosis. Second-line medical treatments include GnRH agonists and the levonorgestrel releasing intrauterine device (IUD). Danazol and the anti-progesterone gestrinone should not be used, as androgenic side-effects outweigh benefits.

Ovarian suppression with GnRH agonists improves symptoms but induces vasomotor symptoms in most women, and prolonged use of more than six months can lead to bone demineralisation. Prospective studies have shown that this bone loss is reversible and that concurrent treatment with a low-dose oestrogen and progestogen hormone replacement therapy (HRT) regimen or tibolone can extend use without reducing treatment efficacy. There is limited evidence from randomised trials to show superior efficacy of one ovulation suppression treatment for pain over another, and, in clinical practice, choice of treatment is commonly guided by the tolerability of available treatments. GnRH agonists are sometimes used to trial how a patient might respond to surgical menopause, but the predictive value of this approach is not known.7 In women with endometriosis-associated pain refractory to other medical or surgical treatment, it is recommended to prescribe aromatase inhibitors, as they reduce endometriosis-associated pain. Aromatase inhibitors may be prescribed in combination with oral contraceptives, progestogens, GnRH agonists or GnRH antagonists.6

Surgical treatment to eliminate endometriotic lesions and divide adhesions has long been an important part of the management of endometriosis. Historically, surgical approaches were achieved at open surgery, but in recent decades, laparoscopy has dominated. Elimination of endometriosis may be achieved by excision, diathermy, or ablation/vaporisation. Division of adhesions aims to restore pelvic anatomy. Some clinicians use interruption of pelvic nerve pathways with the intention of improving pain control.5

Surgery is recommended as one of the options to reduce endometriosis-associated pain. When surgery is performed, clinicians may consider excision instead of ablation to reduce endometriosis-associated pain. Clinicians can consider hysterectomy with or without removal of the ovaries, with removal of all visible endometriosis lesions, in women who no longer wish to conceive and who have failed to respond to more conservative treatments. The ESHRE GDG recommends that when hysterectomy is performed, a total hysterectomy is preferred.6 Women should be informed that hysterectomy will not necessarily cure the symptoms or the disease. When a decision is made to remove the ovaries, the long-term con-

EFI: Endometriosis

sequences of early menopause and possible need for HRT should be considered.5 Oestrogen as HRT is advised for those aged under 45 years and/or symptomatic women after oophorectomy for endometriosis, but HRT or tibolone can potentially lead to recurrence. There is, however, no indication to use combined HRT after hysterectomy for endometriosis.7,8

Infertility: An estimated 25-to-50 per cent of women with infertility have endometriosis, and around 30-to-50 per cent of women with endometriosis are infertile. The mechanisms linking endometriosis and infertility are poorly understood, and causation is not established. Even mild endometriosis can impair fertility, and severe disease can lead to tubal adhesions, reduced ovarian reserve and oocyte and embryo quality, and poor implantation. Endometriosis can further impair fertility by disturbing the function of the fallopian tube, embryo transport, and the eutopic endometrium.7

Treatment focuses on improving fertility by removing or reducing endometrial glands and stroma, and restoring normal pelvic anatomy. Treatment decisions for infertile women with endometriosis should consider pelvic anatomy, extent of disease, ovarian reserve and age, male factors, presence of endometriomas, and duration of infertility. Options can include expectant management, surgical removal of ectopic implants, ovulation induction, or IVF.7

For women with minimal or mild disease (stage I/II), expert consensus is that the decision to surgically resect endometriotic lesions before other treatments should consider the patient’s age and ovarian reserve. In women with endometriomas receiving surgery for infertility or pain, excision of endometrioma capsule increases the rate of spontaneous postoperative pregnancy compared with drainage and electrocoagulation of the endometrioma wall. Surgery for endometriomas, however, can also reduce ovarian reserve and fertility due to removal of normal ovarian tissue, and a Cochrane review concluded that surgical treatment of endometriomas before assisted reproduction treatment (ART) has no benefit over expectant management regarding clinical pregnancy rate. For advanced endometriosis, expert consensus recommends IVF to reduce time to pregnancy, reserving surgery for women who present with larger or symptomatic endometriomas. Controlled ovarian stimulation for IVF does not increase recurrence of endometriosis. If endometriomas are surgically removed, this should be by cystectomy rather than fenestration/coagulation or laser ablation as this reduces symptom recurrence and improves pregnancy rates.7

Complications

The main complications of endometriosis include infertility or sub-fertility, chronic pain, and debilitating persistent symptoms including dysmenorrhoea, dyspareunia, and dyschezia. Endometriosis can lead to complications of surgical procedures, anatomical abnormalities due to possible adhesions, bowel or/and bladder dysfunction, and in the case of ovarian endometriomas to the development of cancer. En-

dometriosis negatively affects patients’ health-related quality-of-life, and the social, emotional, sexual well-being, daily routines, family planning, and productivity of the individual in the working environment. Bowel dysfunction like constipation or other digestive problems can appear in those who have endometriosis because of the inflammatory process of irritation of the gastrointestinal system. Patients with endometriosis report higher stress levels, poor quality of sleep, and lower levels of physical activity.2 Patients with endometriosis have reduced chances of childbearing, and a higher risk for miscarriage and ectopic pregnancies compared to women free of the disease. Recurrence rates of endometriosis after surgery varies between 6-to-67 per cent. Medical treatment can be effective, but in 5-to-59 per cent of patients the pain continues to exist at the end of therapy, and pain recurrence has been reported at 17-to-34 per cent.2

Prognosis

While currently there is no cure for endometriosis, in most cases, symptoms improve with the use of medications, surgery, or both. Researchers continue to investigate and find new reasons why endometriosis occurs, and what influences its severity. Research is underway to find medications that are specifically designed to target endometriotic tissue, while leaving healthy tissue unharmed. These peptide medications work to fine-tune faulty molecular processes that lead to the growth of excess tissues. Scientists are also working to find medicines that may help treat endometriosis by altering or reducing levels of macrophages, and are also investigating if nano-medicine may be useful for treating and diagnosing endometriosis. Non-invasive therapies such as physical therapy are being tested to identify if they can reduce endometriosis symptoms. In a 2021 study, regular pelvic floor physiotherapy was found to reduce pain during intercourse, chronic pelvic pain, and improved pelvic relaxation in women with endometriosis.9

Researchers continue to look for ways to diagnose endometriosis earlier, improve treatment options, and ultimately reduce the risk of serious complications. Women’s health advocates also continue to call on the research community to fill serious knowledge gaps that make the diagnosis and treatment of endometriosis difficult. Patient education and raising awareness about the condition and its treatments can help support those experiencing the illness, and improve their quality-of-life. The EAI (www.endometriosis.ie) provides information and support for women with endometriosis in Ireland.

References

1. Hunt G, Allaire C, Yong P, Dunne C. (2021). Endometriosis: An update on diagnosis and medical management. BC Medical Journal. BCMJ, Vol 63, Issue 4, pp 158-163; May 2021

2. Tsamantioti E, Mahdy H. (2022). Endometriosis. Stat Pearls Publishing; 2022 Jan. Available at: www.ncbi.nlm.nih.gov/ books/NBK567777/

3. Malvezzi H, Marengo EB, Podgaec, S, et al. (2020). Endometriosis: Current challenges in modeling a multifactorial disease of unknown etiology. J Transl Med 18, 311. doi: 10.1186/s12967-020-02471-0

4. EAI (2022). Endometriosis. Endometriosis Association of Ireland. Available at: www.endometriosis.ie/about-endometriosis/

5. ESHRE (2022). ESHRE Guideline Endometriosis. The European Society of Human Reproduction and Embryology. Available at: www.eshre.eu/Guidelines-and-Legal/Guidelines/ Endometriosis-guideline.aspx

6. Becker C, Bokor A, Heikinheimo O, Horne A, Jansen F, et al. (2022). ESHRE Endometriosis Guideline Group, ESHRE Guideline: Endometriosis. Human Reproduction Open, Vol 2022, Issue 2, 2022, hoac009. doi: 10.1093/ hropen/hoac009

7. BMJ (2014). Endometriosis. doi: 10.1136/bmj.g1752

8. HSE (2021). Endometriosis. Available at: www2.hse.ie/ conditions/endometriosis/treatment/

9. Medical News Today. (2021). The latest in endometriosis research: Ways forward. Available at: www.medicalnewstoday.com/articles/ the-latest-in-endometriosis-research-ways-forward

Figure 1: ESHRE recommendations for treatment of endometriosisassociated infertility6 www.eshre.eu/Guidelines-and-Legal/ Guidelines/Endometriosis-guideline.aspx

Fertility Index. MAR: Medically-assisted reproduction

DR DEAN MOORE , SpR, Department

Renal Medicine, Mater Misericordiae University Hospital; and DR EOIN BRENNAN , Assistant Professor, Diabetes Complications Research Centre, School of Medicine, University College Dublin.

Managing diabetic kidney disease: What next?

ust over 101 years ago, in July 1921, Banting and Best first isolated insulin, revolutionising the treatment of diabetes, changing the natural history of the disease from a short, swift and brutal fatal illness to the chronic and manageable disease we have today. In the intervening century the strides in scientific discovery have been remarkable, with the development of continuous glucose monitoring, insulin pumps, and pancreatic transplants.

Concurrently, we have witnessed advances in understanding the aetiology of diabetes at the molecular level and we now see the promise of an artificial pancreas and targeted gene therapy on the horizon. As the medical world has reacclimatised to life in the post-pandemic world, renewed focus on novel treatments for the more ‘mundane’ diseases has resulted in new hope for clinicians and patients alike. Diabetes is a perfect exemplar in this regard.

More than half a billion people worldwide live with diabetes, with prevalent cases having tripled since 2000. The acceleration of incidence is not a phenomenon isolated to high-income countries; it is quickly becoming a disease of low- and middle-income countries. In resource-restricted settings the substantial attendant cardiovascular and microvascular morbidity is likely to exact a high price physically, financially, and psychosocially. While in Ireland no national diabetes registry exists, accepted estimates for prevalent cases in the Republic are more than 250,000, with close to 90 per cent of these cases being type 2 diabetes (T2DM). Interestingly, The Irish Longitudinal Study on Ageing (TILDA) 2015 showed that 10 per cent of adults aged 50 years and over in Ireland have T2DM, with one-in-10 people with diabetes being undiagnosed in this population. Given the magnitude of this visible and invisible disease burden both nationally and internationally, an understanding of recent developments in the treatment of diabetes and associated complications is relevant to most clinicians. The morbidity and mortality associated with T2DM is attributable to microvascular (nephropathy, retinopathy and neuropathy) and macrovascular disease (cardiovascular disease). The onset of T2DM is often surreptitious and therefore these complications are frequently present at time of diagnosis of diabetes. In many cases the onset of these complications can be delayed through risk factor modification; namely addressing dyslipidaemia, hypertension, and satisfactory glycaemic control. Once these complications have become established their progression can be delayed through similar means.

With regard the rates of microvascular complications in Ireland, the most

thorough estimate is from a systematic review and metanalysis in 2016, where prevalence of microvascular complications was varied, ranging from 6.5-to-25.2 per cent for retinopathy; 3.2-to-32.0 per cent for neuropathy; and 2.5-to-5.2 per cent for nephropathy. While these figures are similar to rates found internationally (apart from nephropathy, which is underrepresented), care must be exercised given the wide margin of variation, which is likely in part attributable to the varied study settings and heterogeneity in the diagnostic criteria for microvascular and macrovascular complications.

Current treatment options for DKD Diabetic nephropathy will complicate diabetes in 40 per cent of cases. Separately, diabetes is the most common cause of chronic kidney disease (CKD) and endstage kidney disease (ESKD), both worldwide and in Ireland. As already mentioned, prevention of diabetic complications can be achieved with good glycaemic control in both type 1 diabetes mellitus (T1DM) and T2DM. However, intensive glycaemic control in established microvascular disease has not been shown to improve cardiovascular outcomes or slow progression. When considering treatment options for established DKD, several agents are effective in slowing progression and reducing morbidity and mortality. In patients with albuminuria or proteinuria, the strong evidential basis for renin-angiotensin-aldosterone system (RAAS) inhibitor use has remained as a cornerstone in the treatment of DKD, regardless of the presence of hypertension. The dual use of both an angiotensin receptor blocker (ARB) and an angiotensin converting enzyme (ACE) inhibitor confer no clinical benefit across several trials, while increasing the risk of hyperkalaemia and acute kidney injury.

Since the initial trials of sodium-glucose cotransporter-2 (SGLT2) inhibitors reported improvements in declining renal function and proteinuria in 2016, there has been a large volume of randomised control trials and real-world data to support the use of SGLT2 inhibitors as an effective therapy in slowing DKD progression and reducing major adverse cardiac events. While the improvement with glycaemic control is modest, the improvement in renal and cardiac outcomes have demonstrated a strong class effect and have been incorporated as standard care in most proteinuric CKD and heart failure. Interestingly, recent data suggests that the effect of SGLT2 inhibitors seems to be more pronounced in patients with more advanced CKD. Safety data regarding initial greater rates of amputation in early trials have not been replicated since or in real world data, but the increase in UTIs

IMAGE 1: Diabetes and kidney disease

and fungal genital infections have been widely observed. While the incidence of euglycaemic diabetic ketoacidosis is increased with the use of SGLT2 inhibitors, the absolute risk remains relatively low.

Apart from SGLT2 inhibitors, the glucose-lowering agents with the greatest evidence of renal and cardiovascular protection are the glucagon-like peptide 1 (GLP1) receptor agonists. Great interest has arisen in the use of GLP1 mimetics due to the observation that significant weight loss has been associated with their use, particularly given the rapidly rising rates of obesity and its strong association with T2DM. With the emergence of more

long-term real-world data, the use of GLP1 agonists will likely increase.

Excessive activation of the renal endothelin system (particularly renal endothelin-1) has been shown to be an effective mediator of kidney injury in diabetes. The use of the endothelin receptor antagonist atrasentan had shown initial promise as a potential therapy in DKD. Pre-clinical studies demonstrated the efficacy of endothelin-A receptor antagonism in downregulating the inflammatory and fibrotic effect of endothelin-1. Phase 2 trials showed atrasentan decreased albuminuria in DKD already on maximum RAAS inhibition, however, a large phase 3 trial

of

When considering treatment options for established DKD, several agents are effective in slowing progression and reducing morbidity and mortality

Diabetes is the most common cause of chronic kidney disease (CKD), with a range of established and incoming treatment options to slow progression and reduce morbidity and mortality

showed that despite very selective inclusion criteria the adverse effect of oedema and worsening of heart failure was significant. While it may have a role in a highly selected patient population, its side-effect profile will preclude its adoption as a standard therapy.

With the role of RAAS inhibition in DKD being well elucidated, the downstream inhibition of aldosterone has been examined in the treatment of DKD in patients on a maximally tolerated ACE inhibitor or ARB. The mineralocorticoid receptor (MR), which binds aldosterone, has been studied in detail and its overactivation in both cardiac and renal disease is well established and implicated in inflammation, fibrosis, and cardiovascular disease.

The MR is a nuclear receptor expressed in a variety of tissues throughout the body, most pertinently in this case the kidney and heart. The MR is a promiscuous receptor and can be activated by other steroid hormones, namely cortisol and progesterone. The steroidal MR antagonists (MRAs) spironolactone and eplerenone have been shown to improve morbidity and mortality in heart failure with reduced ejection fraction (HFrEF), but not heart failure with preserved ejection fraction (HFpEF). The main limitation in the use of spironolactone is gynaecomastia and hyperkalaemia. Eplerenone was developed as a more selective MRA with trial data showing an incidence of gynaecomastia no different than placebo.

The novel agent finerenone has been developed as a non-steroidal MRA in an effort to mitigate the off-target effects of MR inhibition, with two large RCTs demonstrating its efficacy in DKD and cardiovascular disease (CVD) with no increase in sex hormone mediated side-effects. Higher rates of hyperkalaemia compared to placebo were again noted, particularly in patients with lower eGFRs, but perhaps lower when compared to spironolactone.

Targeting inflammation in DKD

While the established therapies discussed above focus primarily on neurohormonal modulation in an effort to slow and ameliorate end organ damage in diabetes, the role of inflammation in the pathogenesis of diabetes and DKD has become increasingly apparent. Inflammation is a vital element in the armamentarium of the host defence, with several highly conserved pathways conducting its initiation, progression, and resolution to ensure an effective and effectively controlled process to remove pathogens and enable tissue repair. This is a regulated and finite process in the healthy host under physiological conditions. A dysregulated inflammatory response is notable and notorious as the underlying mechanism for sepsis in an acute setting, but chronic and low-grade inflammation results in fibrosis, functional decline and ultimately can lead to organ failure.

With regard to T1DM, the role of inflammation and autoimmunity in its aetiology has been well established. Inflammation in pancreatic islet beta-cells results in cell depletion and loss of function. Findings from experimental models and observational studies in humans demonstrate a key role for macrophages in islet beta-cell inflammation in obesity and T2DM, driv-

en largely by responses to a family of cytokines including IFN-, TNF- and IL-1. Islet autoimmunity might also contribute to the functional decline of beta-cells during the course of T2DM.

The role of obesity as a driver of inflammation has been delineated and the mechanisms by which it contributes to insulin resistance has been identified in several studies. The metabolic function of adipose tissues is the storage of fat, with the expansion of adipose deposits, especially abdominal deposition, being associated with T2DM, CVD and insulin resistance. Adipose tissue is an active endocrine organ, which expresses a variety of cytokines and chemokines to regulate energy utilisation, with derangements in its function having demonstrable effects. In situations where the ability to store calories as white fat is exceeded, ectopic deposition in non-adipose tissues (skeletal muscle, liver, kidney, pancreas) occurs where it exerts what has been termed a lipotoxic effect on the non-adipose tissue in question, by invoking an inflammatory response, an example of sterile inflammation.

The role of inflammation in the development of microvascular and macrovascular damage in diabetes has led to the

and kidney disease, a randomised phase 2 trial demonstrated therapeutic potential of the anti-inflammatory CCR2 antagonist CCX140-B, with significant reductions in albuminuria when given in addition to standard care. While there is caution with respect to targeting DKD with anti-inflammatories, inflammation remains a plausible target to pursue, and it is worth noting that many of the established medicines currently used in practice, such as RAAS and SGLT2 inhibitors, have been demonstrated to exert anti-inflammatory effects.

Looking ahead: How can we improve the diagnosis and treatment of DKD?

The precision medicine era promises individual level healthcare decisions whereby your genetic, proteomic and metabolomic biomarker make-up will guide diagnosis and tailored pharmacotherapy. Central to this model of precision medicine is the need for accurate biomarkers, and for a long time this has been a challenge for DKD. However, technological advances in recent years are beginning to address this problem, now allowing for the simultaneous measurement of numerous proteins and metabolites in DKD patient blood and urine, offering hope for less invasive means of diagnosis and prognosis. As a result, bi-

9)? Given the complexity of DKD and the likely contribution of many DNA variants to disease risk, it is unlikely we will see the latter for some time, but this is no longer science fiction and such approaches could be closer than you might expect. This year, US-based Verve Therapeutics began a human trial using CRISPR DNA-editing technology to modify the PCSK9 gene in people with heterozygous familial hypercholesterolaemia, a condition that can lead to early-onset atherosclerosis and increased risk of CVD. PCSK9 is a protein involved in lowering LDL cholesterol, and several effective, but expensive PCSK9 inhibitors are now available for patients. In parallel with these drug development success stories, genetics studies discovered adults with naturally occurring mutations in their PCSK9 gene that seemed to switch off this gene, resulting in low cholesterol levels and overall excellent cardiovascular health. These lucky few had won the genetic lottery by coming up with the wining code. Taking advantage of this, Verve Therapeutics wants to introduce mutations into patient DNA and ultimately switch off the PCSK9 gene to lower LDL cholesterol levels. According to Verve Therapeutics, this would represent a ‘single-course, life-long treatment solution’. While we are not quite there yet with DKD, the scenario may arise in the not-too distant future where you can decide on conventional pharmacotherapy or one-shot gene therapy.

investigation of anti-inflammatory-based therapies. Such approaches are well known in the contemporary practice of medicine, from the use of NSAIDs in acute inflammatory pain, to the corticosteroid dexamethasone and the IL-6 receptor antibody tocolizumab in the cytokine storm of severe Covid-19. However, despite the use of anti-inflammatory strategies in certain circumstances, concerns exist regarding impairing the host response in other circumstances leading to inadequate response to exogenous pathogens.

Several examples of this are evident in the literature, for example, the TESTING trial, which examined the use of methylprednisolone in IgA nephropathy. A statistically-significant reduction in kidney function decline was noted with the use of the steroid, but excess infections and mortality in the treatment group mandated termination of the trial prematurely and redesign at a lower dose of steroid in an effort to reduce this adverse effect (which was ultimately unsuccessful).

Baricitinib, an inhibitor of the JAK-STAT inflammatory pathway, has been investigated in patients with DKD, with phase 2 trial data demonstrating a significant reduction in albuminuria, a key indicator of DKD progression. In patients with T2DM

omarker panels of proteins are being explored as a potential tool to better predict early kidney function decline as compared with or in tandem with more traditional markers – albuminuria and eGFR.

While studies of DNA in patients of many single-gene diseases have proven truly transformative, when searching for changes in the DNA code that might be associated with risk of a complex and multifactorial disease such as DKD, this has proven to be much more challenging. Nevertheless, several large-scale international studies have examined the DNA of patients with DKD, including Irish participants, pointing us to several regions of the human genome that if perturbed may alter one’s risk of developing DKD. One such study led by the GENIE consortium identified a protective DNA variant in the collagen 4-alpha 3 gene, and the presence of this variant was associated with a thinner glomerular basement membrane. Could carriers of this DNA variant be protected from developing advanced DKD? Armed with this type of genetic information, should we consider such disease-associated DNA variants as simple risk predictors for early diagnosis, or do we attempt to correct the DNA sequence using the latest genome-editing technologies (CRISPR/Cas-

Finally, stem cell therapy promises to revolutionise regenerative medicine for the treatment of many diseases, and diabetes management strategies will surely in time benefit from such developments. For T1DM, the holy grail centres on pancreatic beta cell replacement therapies, allowing for the implantation of insulin-producing beta cells. In this space, in June 2022 the US-based company Vertex Therapeutics announced exciting clinical trial data from the first T1DM patients receiving their beta cell therapy VX-880, demonstrating a remarkable lowering of blood glucose, without the need for regular insulin injections. While we eagerly await more data from this trial and consider the lingering concerns over the necessity for immunosuppressant medications in tandem with stem cell therapies, this has the potential to be a game-changer that could instantly improve the quality-of-life of so many patients with T1DM. This would inevitably have a positive impact on the global prevalence of vascular complications of diabetes, such as DKD.

Conclusion

DKD is a major global health challenge with high prevalence and an absence of predictive biomarkers that allow us to identify those in the population at greatest risk of developing this disease. Current therapies at best halt, but do not reverse kidney damage. Recent advancements in technologies may allow us to identify new diagnostic and prognostic biomarkers, as well as novel gene and cell-based next generation therapies. Such developments may be the only solution to this complex problem.

References on request

The role of inflammation in the development of microvascular and macrovascular damage in diabetes has led to the investigation of anti-inflammatory-based therapies

Centre for Colorectal Disease – Scientific Meeting

Irish and international experts gathered recently in Dublin to discuss the latest advances in technology for investigation and treatment of patients with intestinal and bowel disorders

The 29th Annual Scientific Meeting of the Centre for Colorectal Disease (CCD) at St Vincent’s University Hospital/UCD School of Medicine, Dublin, took place on 9 September in St Vincent’s Hospital for the first time in three years.

The meeting addressed the application of cutting-edge and emerging technology in the areas of colorectal can-

NCH D Role’s

cer, Crohn’s disease, and colitis, and featured talks from a number of high-profile speakers on how artificial intelligence (AI) is shaping changes in the fields of pathology, radiology, colonoscopy (use of camera technology), and colorectal cancer.

Speakers included Prof Joe Willis from Case Western University, Cleveland, US, and Dr Gerard Healy, a newly appointed radiologist at St Vincent’s/UCD, who

has worked on the role of AI in radiology in Toronto for the last few years.

Both speakers highlighted the potential for AI to assist the work of the pathologist examining biopsies down the microscope or the radiologist examining x-rays and scans to highlight potentially abnormal findings and ‘speed up’ their work flow. However, it is clear that at the moment AI cannot replace clinical judgement by a reporting radiologist or pathologist.

Both speakers also highlighted the importance of validation of AI tools in different populations of patients and in different healthcare settings to ensure they are robust for use in the real world of healthcare.

Dr Barry Hall, Gastroenterologist at Connolly Hospital Dublin/RCSI, spoke about recent developments in capsule endoscopy. This is a technology that is evolving rapidly, but at present it takes a gastroenterologist up to an hour to review the thousands of images captured in a single examination. Once AI becomes available to screen all the images the capsule generates and identify potentially abnormal findings, this has the potential to reduce the reading time from hours to minutes.

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These positions are particularly suited to those involved in, or interested in pursuing, higher studies.

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St. Vincent’s Private Hospital is the largest acute private hospital in Dublin. We offer the highest number of consultants and the widest range of specialist care in Ireland’s only integrated multi-hospital campus. We are the largest private provider of cancer care specialties (medical oncology, radiation oncology, surgery and brachytherapy) in the country.

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Prof Ronan Cahill, Professor of Surgery at UCD and a Colorectal Surgeon in the Mater Misericordiae Hospital, Dublin, spoke about the use of imaging technology and AI to guide decision-making by surgeons. “Most of the time an experienced surgeon will instinctively know where to make a cut in the bowel, but smart imaging and AI-based technology can assist in the minority of cases where the surgeon is uncertain,” said Prof Cahill.

Prof Louise McHugh, School of Psychology, UCD, introduced another novel application of technology currently being evaluated for the care of patients living with chronic conditions, such as Crohn’s and colitis. These people often suffer psychological distress arising from their illness and it can be difficult to get access to psychological supports. In work carried out in collaboration with Prof Hugh Mulcahy and colleagues at St Vincent’s, Prof McHugh discussed how using ‘chatbots’ to deliver automated psychological supports to patients at times of stress and distress is showing very promising initial results.

One particular highlight of the meeting was the live streaming of procedures from the endoscopy unit at St Vincent’s as part of the meeting.

Prof Glen Doherty, Consultant Gastroenterologist at St Vincent’s and full Clinical Professor in UCD School of Medicine and National Training

Prof Glen Doherty

Lead for GI Endoscopy, introduced a live demonstration of the use of AI during a colonoscopy procedure to assist in identifying polyps (which left untreated might progress over time to cancer). “This technology has great potential to assist those training to perform colonoscopy to find polyps and to know which to remove and which can be ignored,” he said.

The highlight of the meeting was when Prof Doherty introduced a state-of-the-art lecture by Dr Marietta Iacucci, a world expert in the use of endoscopy in patients with Crohn’s and colitis. She has been centrally involved in European and international studies to evaluate the latest technological advances. “We are extremely excited to welcome Marietta to Ireland, as she joins the community of gastroenterologists in Ireland at a time when we need such expertise,” commented Prof Doherty. Dr Iacucci takes up a position as Professor of Gastroenterology at University College Cork later this year.

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Extend overall survival for patients in 3rd line mCRC1

trifluridine/tipiracil

Lonsurf® (Trifluridine/ tipiracil): Abbreviated Prescribing Information: Please refer to the Summary of Product Characteristics before prescribing COMPOSITION*: Lonsurf 15 mg/6.14 mg: film-coated tablet containing 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride). Lonsurf 20 mg/8.19 mg: film-coated tablet containing 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride). INDICATION*: As monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. As monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease. DOSAGE AND ADMINISTRATION*: Recommended starting dose: 35 mg/m2/dose taken orally twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle, within 1 hour after completion of the morning and evening meals (20mg/m2/dose for patients with severe renal impairment). Dosage calculated according to body surface area, not exceeding 80 mg/ dose. Possible dosing adjustments based on individual safety and tolerability: permitted dose reductions to a minimum dose of 20 mg/m2 twice daily (15mg/m2/dose for patients with severe renal impairment), dose escalation not permitted after a dose reduction. CONTRAINDICATIONS*: Hypersensitivity to the active substances or to any of the excipients. WARNINGS *: Bone marrow suppression: Complete blood cell counts must be obtained prior to initiation of therapy, prior to each cycle and as needed. Treatment must not be started if absolute neutrophil count < 1.5 x 109/L, if platelet counts < 75 x 109/L, or if unresolved Grade 3 or 4 non-haematological clinically relevant toxicity. Patient should be monitored closely for infections, appropriate measures should be administered as clinically indicated. Gastrointestinal toxicity: anti-emetic, anti-diarrhoeal and other measures should be administered as clinically indicated, dose modifications should be applied as necessary. Renal impairment: not recommended if end-stage renal disease. Patients with renal impairment should be monitored closely; patients with moderate or severe renal impairment should be more frequently monitored for haematological toxicities. Hepatic impairment: not recommended if baseline moderate or severe hepatic impairment. Proteinuria: monitoring by dipstick urinalysis recommended prior to starting and during therapy. Excipients: contain lactose. INTERACTIONS*: Precautions: medicinal products that interact with nucleoside transporters CNT1, ENT1 and ENT2, inhibitors of OCT2 or MATE1, human thymidine kinase substrates (e.g. zidovudine), hormonal contraceptives. FERTILITY*. PREGNANCY AND BREASTFEEDING*: Not recommended. CONTRACEPTION*: For women and men, highly effective contraceptive measures must be used during treatment and for 6 months after stopping treatment. DRIVE & USE MACHINES*: Fatigue, dizziness or malaise may occur. UNDESIRABLE EFFECTS*: Very common: Neutropenia, leukopenia, anaemia, thrombocytopenia, decreased appetite, diarrhoea, nausea, vomiting, fatigue. Common: Lower respiratory tract infection, febrile neutropenia, lymphopenia, hypoalbuminaemia, dysgeusia, neuropathy peripheral, dyspnoea, abdominal pain, constipation, stomatitis, oral disorder, hyperbilirubinaemia, Palmar-plantarerythrodysaesthesia syndrome, rash, alopecia, pruritus, dry skin, proteinuria, pyrexia, oedema, mucosal inflammation, malaise, hepatic enzyme increased, blood alkaline phosphatase increased, weight decreased. Uncommon: Septic shock, enteritis infectious, lung infection, biliary tract infection, influenza, urinary tract infection, gingivitis, herpes zoster, tinea pedis, candida infection, bacterial infection, infection, neutropenic sepsis, upper respiratory tract infection, conjunctivitis, cancer pain, pancytopenia, granulocytopenia, monocytopenia, erythropenia, leukocytosis, monocytosis, dehydration, hyperglycaemia, hyperkalaemia, hypokalaemia, hypophosphataemia, hypernatraemia, hyponatraemia, hypocalcaemia, gout, anxiety, insomnia, neurotoxicity, dysaesthesia, hyperaesthesia, hypoaesthesia, syncope, paraesthesia, burning sensation, lethargy, dizziness, headache, visual acuity reduced, vision blurred, diplopia, cataract, dry eye, vertigo, ear discomfort, angina pectoris, arrhythmia, palpitations, embolism, hypertension, hypotension, flushing, pulmonary embolism, pleural effusion, rhinorrhoea, dysphonia, oropharyngeal pain, epistaxis, cough, enterocolitis haemorrhagic, gastrointestinal haemorrhage, pancreatitis acute, ascites, ileus, subileus, colitis, gastritis, reflux gastritis, oesophagitis, impaired gastric emptying, abdominal distension, anal inflammation, mouth ulceration, dyspepsia, gastrooesophageal reflux disease, proctalgia, buccal polyp, gingival bleeding, glossitis, periodontal disease, tooth disorder, retching, flatulence, breath odour, hepatotoxicity, biliary dilatation, skin exfoliation, urticaria, photosensitivity reaction, erythema, acne, hyperhidrosis, blister, nail disorder, joint swelling, arthralgia, bone pain, myalgia, musculoskeletal pain, muscular weakness, muscle spasms, pain in extremity, renal failure, cystitis noninfective, micturition disorder, haematuria, leukocyturia, menstrual disorder, general physical health deterioration, pain, feeling of body temperature change, xerosis, discomfort, blood creatinine increased, electrocardiogram QT prolonged, international normalised ratio increased, activated partial thromboplastin time prolonged, blood urea increased, blood lactate dehydrogenase increased, protein total decreased, C-reactive protein increased, haematocrit decreased. Post-marketing experience: interstitial lung disease. OVERDOSE* PROPERTIES*: Trifluridine is an antineoplastic thymidine-based nucleoside analogue and tipiracil hydrochloride is a thymidine phosphorylase (TPase) inhibitor. Following uptake into cancer cells, trifluridine, is phosphorylated by thymidine kinase, further metabolised in cells to a deoxyribonucleic acid DNA substrate, and incorporated directly into DNA, preventing cell proliferation. However, trifluridine is rapidly degraded by TPase and readily metabolised by a first-pass effect following oral administration, hence the inclusion of the TPase inhibitor, tipiracil hydrochloride.PRESENTATION* Pack of

or 60 film-coated tablets. Marketing

All the latest updates in neurology

The upcoming Annual Neurology Update Meeting in Dublin

The 21st Annual Neurology Update Meeting will take place on Friday, 7 October 2022 at the Hyatt Centric Hotel, Dublin, under the directorship of Dr Eavan McGovern.

Dr McGovern is a Consultant Neurologist at Beaumont Hospital, Dublin. Her special interest is in movement disorders.

This is a neurology education day, which will be of interest to neurologists, general physicians, and general practitioners.

The meeting will begin with Dr McGovern giving a short welcome and introduction. The first session is on epilepsy.

Prof Norman Delanty, Consultant Neurologist, Beaumont Hospital, will deliver the opening presentation. He is also Clinical Professor at the School of Pharmacy and Biomolecular Sciences, and a funded investigator at the FutureNeuro Research Centre at the RCSI.

Prof Delanty has been active in many translational research projects. He initiated the Irish epilepsy biobank, originally funded by the Higher Education Authority of Ireland, and collaborates nationally and inter-

has a packed

nationally with other investigators. He was the clinical instigator in the development of the now nationally used epilepsy electronic patient record. He is also the founder of the Irish Epilepsy and Pregnancy Register. The title of Prof Delanty’s talk is ‘Novel therapies in epilepsy’.

The next speaker is Dr Pat Moloney, Department of Genetics, Queen Square Institute of Neurology, London, UK. Dr Moloney is currently in the final year of his neurology higher specialist training.

Over the past two years, he completed a clinical research Fellowship as part of the RCSI StAR MD programme under the supervision of Prof Delanty and Prof Gianpiero Cavalleri.

Currently, he is undertaking a Richard Steevens Fellowship in Neurogenetics at Queen Square. He will speak about the genetics of focal epilepsy.

The next session is on peripheral nerve disease. ‘Disorders of the peripheral nerve’ is the title of the presentation by Dr Aisling Carr, Consultant Neurologist, MRC Centre for Neuromuscular Disease, Queen Square. Dr Carr was appointed to her position in 2016

and varied programme

after completing a clinical Fellowship in peripheral nerve disease. Her current clinical practice specialises in peripheral nerve and neuro-inflammatory disease.

Following Dr Carr’s talk, Prof Aisling Ryan, Consultant Neurologist, Cork University Hospital (CUH), will speak about neuromuscular disorders and channelopathies. Prof Ryan’s research interests include clinical and epidemiological aspects of neuromuscular disease and collaborative translational neuroscience projects.

At the next session, which is on neurotechnology, Ms Catherine Moran, Consultant Neurosurgeon Beaumont Hospital will deliver an update on deep brain stimulation in Ireland. This will be followed by a presentation on peripheral nerve ultrasound, which will be given by Dr Anna Whelehan, Consultant Clinical Neurophysiologist, Beaumont Hospital.

Prof Marie Vidailhet, Professor of Neurology, Salpêtrière Hospital, Sorbonne University, Paris, France, will deliver the sole lecture for the fourth session, which is on movement disorders. Prof Vidailhet has a long-standing interest in movement disorders, Parkinson’s

Irish Neurological Association, Annual Neurology Update Meeting, Hyatt Centric Hotel, Dublin, 7 October 2022 AGENDA

disease, and dystonia in clinical practice (through the National Reference Centre for Dystonia and the European Refence Network) and research – from pathophysiology to experimental therapeutics. Within her research group at the ICM Brain and Spine Institute, she has contributed to the understanding of the pathophysiology of dystonia and other, rare movement disorders and to the development of therapeutic approaches, such as deep brain stimulation in dystonia and non-invasive stimulation in tremor.

The final session of the meeting is on multiple sclerosis (MS). Dr Hugh Kearney, Consultant Neurologist, St James’s Hospital, Dublin, will give a talk entitled ‘Treatment of highly active multiple sclerosis’. Dr Kearney is part of the Academic Unit of Neurology in Trinity College Dublin and is developing a research group focused on translational research in MS, including the development of diagnostic biomarkers.

The other lecture during the session will be delivered by Dr Maria Gaughan, Consultant Neurologist, St Vincent’s University Hospital, Dublin. Dr Gaughan will speak about stem cell transplantation in MS.

12.20-12.45

Peripheral nerve ultrasound

Dr Anna Whelehan, Department of Neurophysiology, Beaumont Hospital, Dublin

12.45

13.00– 14.00

14.00– 14.45 SESSION IV – MOVEMENT

Movement disorders: Semiology tips and tricks from La Pitié Salpêtrière

Prof Marie Vidailhet , La Pitié-Salpêtrière, Paris, France

11.10

11.25– 11.55

11.55– 12.20

SESSION III – NEUROTECHNOLOGY

Deep brain stimulation in Ireland – an update

Ms Catherine Moran, Department of Neurosurgery, Beaumont Hospital, Dublin

14.45

15.15– 15.45

15.45–16.10 SESSION V – MULTIPLE SCLEROSIS

Treatment of highly active multiple sclerosis

Dr Hugh Kearney, Department of Neurology, St James's Hospital, Dublin

16.10– 16.35

Stem cell transplantation in multiple sclerosis

Dr Maria Gaughan, Department of Neurology, St Vincent's University Hospital, Dublin

16.35–

16.50

In

Because ON TIME is their time1

INFORMATION:

PRESCRIBING

Duodopa 20 mg/ml + 5 mg/ml intestinal gel (levodopa/carbidopa)

Refer to Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Intestinal gel containing 20mg/ml levodopa and 5mg/ml carbidopa monohydrate. Indication: Advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. Dosage and Administration: Adults/Elderly: Administration by portable pump directly into the duodenum or upper jejeunum via a percutaneous endoscopic gastrostomy (PEG) or radiological gastrojejunostomy tube. Initially a nasoduodenal/nasojejunal tube should be considered to determine patient’s response before a PEG-J tube is placed. Where the physician considers this assessment is not necessary, the nasojejunal test phase may be waived and treatment initiated directly with placement of PEG-J. Duodopa is given initially as monotherapy and dose adjusted to optimal response for the individual patient. Total dose/day is composed of three individually adjusted doses: morning bolus, continuous maintenance and extra bolus doses administered over approximately 16 hours. Total morning dose usually 5-10ml (100-200mg levodopa) but not exceeding 15ml (300mg levodopa). Continuous maintenance dose should be between 1-10ml/hr (20200mg levodopa/hr) but usually 2-6ml/hr (40-120mg levodopa/hr). Maximum recommended daily dose is 200ml. Extra bolus doses (if patient becomes hypokinetic during the day) are normally 0.5-2.0ml. Increase maintenance dose if more than 5 extra bolus doses/day are needed. Fine adjustments to the morning bolus, maintenance and extra bolus doses should be made over a few weeks after the initial dose setting. Sudden deterioration in response with recurring motor fluctuations indicates tube may have moved from duodenum/ jejunum into stomach and needs repositioning. Medicine cassettes are for single use only and should not be used for longer than 24 hours, even if some medicinal product remains. Treatment is usually administered during the patient’s awake period. If medically justified, Duodopa may be administered for up to 24 hours. Opened cassettes should not be reused. Children: No relevant use in the paediatric population. Renal/hepatic impairment: No studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic or renal impairment. Dose titration should be conducted with caution in patients with severe renal and hepatic impairment. Contraindications, Warnings, Precautions etc: Contraindications: Hypersensitivity to ingredients, narrow-angle glaucoma, severe heart failure or cardiac arrhythmia, acute stroke. Conditions where adrenergics are contraindicated (e.g. pheochromocytoma, hyperthyroidism, Cushing’s syndrome). Nonselective MAO-inhibitors and selective MAO type A inhibitors are contraindicated and should be withdrawn at least two weeks before starting Duodopa. Duodopa should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma. Warnings/Precautions: Not recommended for drug-induced extrapyramidal reactions. Caution in severe pulmonary or cardiovascular disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions, past or current psychosis, chronic wide-angle glaucoma, co-administration with antipsychotics with dopamine receptor blocking properties or with medicines which may cause orthostatic hypotension. In patients with a history of myocardial infarction who have residual nodal or ventricular arrhythmias, cardiac function should be monitored with care during initial dose adjustments. Monitor all patients for development of mental changes, depression with suicidal tendencies and other serious mental changes. Neuroleptic Malignant like Syndrome with secondary rhabdomyolysis has not been reported with Duodopa but may occur on abrupt dose reduction/withdrawal. Periodically evaluate hepatic, haematopoietic, cardiovascular and renal function during extended therapy. Increases in impulse control disorders have been reported and patients should be monitored and reviewed.

Patients and providers are advised to monitor for melanomas on a regular basis when using Duodopa. Ideally, periodic skin examinations should be performed by dermatologists. Dose may need to be adjusted downwards to avoid levodopa induced dyskinesia. Sudden or gradual worsening of bradykinesia may indicate an obstruction in the device and should be investigated. Duodopa contains hydrazine, a degradation product of carbidopa that can be genotoxic and possibly carcinogenic, clinical significance of exposure unknown. Reported complications in clinical studies include abscess, bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischaemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumonia (including aspiration pneumonia), pneumoperitoneum, post-operative wound infection and sepsis. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing Dopamine Dysregulation Syndrome (DDS). Polyneuropathy has been reported in patients treated with levodopa/carbidopa intestinal gel. Before starting therapy evaluate patients for history or signs of polyneuropathy and known risk factors, and periodically thereafter. Drug Interactions: Antihypertensives, tricyclic antidepressants, anticholinergics, dopamine receptor antagonists, benzodiazepines, isoniazide, phenytoin, papaverine, sympathicomimetics, iron, protein-rich diet, COMT inhibitors (e.g. tolcapone, entacapone) amantadine. Duodopa dose adjustment may be needed when used with these drugs. Duodopa can be taken with MAO type B inhibitors (e.g. selegiline) although serious orthostatic hypotension may occur and the dose of levodopa may need to be reduced. Fertility, Pregnancy and Lactation: Limited data relating to the use of levodopa/carbidopa in pregnant women. Duodopa is not recommended during pregnancy. Breast-feeding should be discontinued during treatment with Duodopa. No adverse reactions on fertility have been observed in preclinical studies with carbidopa or levodopa alone. Ability to Drive and Operate Machinery: Caution; Duodopa can have a major influence on the ability to drive and use machines. Refrain from driving/operating machinery if somnolence and/or sudden sleep episodes occur. Side Effects: Very common: Weight decreased, Anxiety, Depression, Insomnia, Dyskinesia, Parkinson’s disease, Orthostatic hypotension, Nausea, Constipation, Fall, Common: Anaemia, Increased weight, Amino acid level increased (Metylmalonic acid increased), Blood homocysteine increased, Decreased appetite, Vitamin B6 & B12 deficiency, Abnormal dreams, Agitation, Confusional state, Hallucination, Impulsive behaviour, Psychotic disorder, Sleep attacks, Sleep disorder, Dizziness, Dystonia, Headache, Hypoaesthesia, On and off phenomenon, Paraesthesia, Polyneuropathy, Somnolence, Syncope, Tremor, Heart rate irregular, Hypertension, Hypotension, Dyspnoea, Oropharyngeal pain, Abdominal distension, Diarrhoea, Dry mouth, Dysgeusia, Dyspepsia, Dysphagia, Flatulence, Vomiting, Dermatitis contact, Hyperhidrosis, Oedema peripheral, Pruritus, Rash, Muscle spasms, Neck pain, Urinary incontinence, Urinary retention, Fatigue, Pain, Asthenia. Device and Procedure Related Adverse Reactions: Very common: Postoperative wound infection, Abdominal pain, Excessive granulation tissue, Complications of device insertion, Incision site erythema, Post procedural discharge, Procedural pain, Procedural site reaction. Common: Incision site cellulitis, Post procedural infection, Abdominal discomfort, Abdominal pain upper, Peritonitis, Pneumoperitoneum, Pneumonia/Aspiration pneumonia, Device dislocation, Device occlusion, Gastrointestinal stoma complication, Incision site pain, Postoperative Ileus, Post procedural complication, Post procedural discomfort, Post procedural haemorrhage. Laboratory values: May change. Prescribers should consult the SmPC for the complete list of reported side effects. HCPs are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie. Marketing Authorisation

References: 1. Duodopa® Summary of Product Characteristics, available on www.medicines.ie 2. Nyholm D. The rationale for continuous dopaminergic stimulation in advanced Parkinson’s disease. Parkinsonism Relat Disord. 2007;13(suppl):S13-S17. doi:10.1016/j.parkreldis.2007.06.005.

IE-DUOD-210040. Date of Preparation: September 2021.

You can offer your patients continuous dopaminergic stimulation with Duodopa®1,2

the treatment of advanced Parkinson’s disease

Duodopa® is indicated for the treatment of advanced levodoparesponsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results1

People in this piece are models, not actual patients.

SPORTS QUIZ WIN €50 6 October 2022

Q1 Who has announced his departure from the Leinster coaching ticket to take up a new role with Racing 92 next season?

Q2 Which nation defeated Ireland in the under-21 European Football Championship play-off last month?

Q3 After missing out on a medal at the Olympics last year, name the Irish rower who partnered Zoe Hyde to take a bronze medal at the recent World Championships?

Q4 Who captained Team World to victory in the Laver Cup last month?

Q5 Which golf course hosted the recent Women’s Irish Open?

Q6 Who will Katie Taylor defend her undisputed lightweight titles against later this month?

CROSSWORD COMPETITION

6 October 2022

The winner of the 15 September 2022 Sporting Quiz Competition is Dr Fionnuala Toal, Co Cavan

The winner of the 15 September 2022 Crossword is Dr Patricia Daly, Dublin

Q1 Who is the new men’s singles US Open champion?

A: Carlos Alcaraz

Q2 Who became the first Premier League football manager to be sacked in the 2022/23 season? A: Scott Parker

Q3 Who stepped down as head coach of the Kilkenny hurling team after 24 years at the helm? A: Brian Cody

Q4 Ciara Mageean smashed the long-standing Irish 1500m record with a stunning run in the Diamond League in Brussels recently. Whose record did she break? A: Sonia O’Sullivan’s

Q5 Who will replace Daniel Ricciardo at McLaren Formula One next season? A: Oscar Piastri

Q6 Name the head coach of the Ireland ladies senior football team who has guided the country to the World Cup play-offs? A: Vera Pauw

11 Adversary (8)

15 Where one has a shower (8)

17 Furnish or supply (5)

19 The production and discharge of something (8)

20 From that time (5)

21 Eg, Usain Bolt (7)

22 Eg, taste or touch (5)

WHAT I HAVE LEARNED ABOUT FOOD AND DRINK

It has taken me an awfully long time to develop my rules of engagement with food and drink. If I’d had even a rough draft, say, 30 years ago, I would have saved myself a certain amount of angst and almost certainly money. I say 30 years ago because that was when I was on the nursery slopes of parenthood, had acquired a mortgage and – briefly –a proper job, so I still see it as the time when I put behind me childish things and became a grown-up.

Well, up to a point. I have no intention of ever going the whole hog on the growing up thing.

So, what have I learned? Well, over the past six or seven years I’ve been consuming vastly less sugar. I wish I had not swallowed the nonsensical reassurance that “sugar is just another food”. It’s not; it’s addictive and useless as anything other than an occasional treat. And the less you have, the less attractive it becomes. I used to love lemon curd roulade; it’s just too much for me now.

I’ve also discovered that strawberries and raspberries are deliciously sweet on their own; I used to think that they needed sugar to “draw out the flavour”, another nonsense peddled by sugar apologists.

Some 30 years ago, serious bread was a rarity, but these days I’ve learned to confine myself mostly to really good sourdough. Not only does it have terrific cohesion, it’s also easy to digest, and a little goes a long way. Toasted sourdough is an occasional treat, certainly not a daily thing. And I will confess that a toasted slice of Barron’s pan (from Cappoquin) beneath a layer of butter, supporting a softly poached egg, and some streaky bacon, makes a Sunday morning special – especially if there’s just enough left to accommodate a spoonful of homemade marmalade (sugar again!).

I’m surprised that it took me so long to realise that buying conventional pork is worse than a waste of time. Why eat meat with all the charm and flavour of compressed sawdust when you can have

the real thing in the form of free range meat from pigs bred for flavour and fat? My latest adventure with it was a chunk of free range belly (bones in) cooked on my Weber barbecue over indirect heat (ie, charcoal on the far side) with minimal air for two hours. Meltingly tender, with crisp, but not tooth-shattering, crackling on top, and that lovely touch of savoury smoke.

I wasted many years cooking with sunflower oil when I could have been using light olive oil or butter, straight from the fridge or clarified. Or other demonised, but delicious fats: Goose, duck, beef dripping, lard. In other words, the fats our great-grandmothers used, with the exception, in my case, of olive oil, as the people in question would have been from Monaghan and Offaly, where olive groves are thin on the ground.

It took me a long time to realise that the best part of a crab, by far, is what lies inside the main shell (excepting the mouth parts and the dead man’s fingers). I wasted decades when I ignored the joys of brown crab meat and failed to recognise all the good stuff that can be picked from the crab’s bony under-carriage if

you’re prepared to put in the time.

And then there are those foods that I tried to persuade myself to like: Liver (kidneys were never a runner), sardines, herring, kale, swede, foie gras.

There was even a time when I was so infected by wine snobbery that I refused to countenance even the idea of a cocktail and thus denied myself one of the greatest alcoholic pleasures that the world has to offer: The dry martini (ideally stirred, not shaken, being my preference). And, of course, the Manhattan, which I prefer to be made with an Irish pot still whiskey instead of those

over-assertive Bourbons.

At the same time, I tried to persuade myself that I like gin and tonic. I certainly did when I first encountered the combination at the age of 17, but over the years, I’ve come to find it too sweet. Instead, I enjoy gin with lots of ice, a good squeeze of fresh lime juice, topped up with chilled soda water.

On the other hand, when I first had a negroni, many years ago, I thought it was cloyingly sweet. These days, when I make it with gin, Campari and Punt e Mes with a very generous dollop of orange bitters, I cope very well with the sugar content. But, as always with sweet stuff, it’s an occasional treat.

What else have I learned over the years?

That the more expensive the kitchen, the less likely it is to see any serious cooking action. That I tend to freeze stuff knowing it will never be used. That guanciale really is better in a carbonara than pancetta. That pizza can be one of the world’s great dishes. That wild salmon is from a different solar system compared to the farmed stuff. That a slow-cooker is a brilliant investment….

And that classic wines are often overlooked in favour of newer, quirky ones. Which is a shame.

WINE OF THE MONTH

Acuro Rioja Reserva 2017 (€13.95, O’Brien’s) is possibly the best value red wine on the market at the moment, being reduced from over €20. It’s also made from organically grown fruit in the modern Rioja style with swathes of ripe fruit, but all nicely balanced and sensitively seasoned with new oak. It’s the kind of wine that cries out for a rare steak or some barbecued lamb that remains pink and moist, with a touch of smoke. I’ve certainly learned to stock up on such wines when I can.

Some 30 years ago, serious bread was a rarity, but these days I’ve learned to confine myself mostly to really good sourdough

RCPI Membership Conferring Ceremony, No 6 Kildare Street, Dublin, 26 August 2022

Pictured L-to-R: Prof Mary Horgan, President, RCPI; Dr Tim Geraghty; Dr Edward McKone; and Dr Lucy Geraghty, Chair, RCPI trainees' committee Dr Padraic Cooney; Mr Colman Rutherford; Ms Irene Murphy; and Dr Emily Rutherford

Dr Rana Jallad; Prof Colm O'Morain, Fellow, RCPI; and Dr Hafiz Muhammad Sohail

Dr Vicki Irwin, who received her Membership of the College, with her son Luca

Front: Prof Mary Horgan; and Dr Grace Madigan Back: Ms Katie Milligan; Ms Hilary Madigan; and Mr Denis Madigan

Dr Bill Boyd; Dr Sean Boyd, who received his Membership of the College; Prof Mary Horgan; and Dr Bridgette Byrne, Fellow of the College

Photos: David Coleman – Bobby Studio

Dr Ashley Lloyd; Dr Kishen Radhakrishna; and Dr Noman Naeem, who received their Membership of the College

Dr Rana Jallad; Dr Louise Kyne, Dean, Faculty of Paediatrics, RCPI; and Dr Fergal Dineen

Dr Afshan Zia Khan, who received her Membership of the College, pictured with her husband, Mr Zia Khan, FRCS

Dr Tim Geraghty, who received his Membership from the College; Prof Mary Horgan; Dr Brendan Geraghty, Dr Lucy Geraghty; and Dr Noreen Hanrahan

Dr Ambreen Nishat and Dr Shaima Khan, who received their Membership of the College

Prof Mary Higgins, Vice-President and Chair of Obstetrics and Gynaecology Exam Board, RCPI; Dr Tess Higgins, who received her Membership of the College; and Prof Shane Higgins, Fellow, Institute Obstetrics and Gynaecology, RCPI

GP REQUIRED

The Castlebar Family Practice in Co Mayo operates the following:

l Mix of GMS and private patients l 2 GPs, practice nurse, nurse practitioner, practice manager, phlebotomist l An excellent, fully supporting admin and reception team l Fully computerised – Socrates practice management system l No weekends or out-of-hours commitment l 15-minute appointments

Essential Requirements

l Must be registered with the Irish Medical Council (IMC) l Be fluent in the English language (both verbally and written) l Have a clear understanding of the IMC Standards and Regulations l Have recent relevant experience in family medicine l Flexible on sessions

Competitive rate offered. Enquiries and applications can be sent to our email

Starting date negotiable

Please contact us at deirdre@castlebarfamilypractice.com

GP REQUIRED

GP required for six-month contract for maternity cover (possible opportunity to extend)

Career opportunity for vocationally trained GP in Bettystown, Co Meath. 35 minutes from Dublin City centre. Group (4) practice. 7-8 sessions per week

Please apply to Jamie 086 126 8723 or forward your details to:  practicemanager@bettystownmedicalpractice.ie

2023 Medical Intern Training in Ireland

Online Application Process Opens 21st October 2022

The Internship Year is an essential step in your medical career in Ireland.

The number of intern places available has increased by 16% in recent years, in line with latest workforce planning requirements.

For information on eligibility and how to apply please visit: www.hse.ie/nchdinterns

Closing date for Stage 1 applications

4th November 2022

Don’t miss your opportunity to apply!

A round-up of news and oddities from left field by Dr Doug Witherspoon

A digital mystery: The finger of forensic curiosity points at King Charles and his ‘sausage fingers'

No sooner has Charles taken to the throne across the water, than speculation has arisen about his health. Eagle-eyed members of the public had already noticed Charles's swollen digits, but the increased focus on him since the recent death in the family that has moved him to the top of the pecking order and brought increased scrutiny.

For those who indulge in tabloid newspapers (no, neither do

I), the recent images of Charles at his coronation and his mother's funeral with swollen and reddened fingers has prompted widespread speculation about his health. A butcher's shop in New Zealand has even named a line of pork sausages after him. Naturally, a variety of doctors have since been quoted in mainstream media, speculating about the cause. Royal watchers have pointed out that the problem becomes particularly pronounced after he has been on a long flight or

For the treatment of active rheumatoid arthritis, severe recalcitrant disabling psoriasis & severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate

For the treatment of active rheumatoid arthritis, severe recalcitrant disabling psoriasis & severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate

when he is visiting hot countries.

British physician Dr Gareth Nye has speculated that oedema may be the culprit: "Oedema is a condition where the body starts to retain fluids in the limbs, normally the legs and ankles, but also in the fingers, which causes them to swell," he told British press. However, he also postulated the potential for "arthritis – another common condition in the over-60s. It often affects three main areas in the hand – the thumb joint or either joints in the fingers.

"Fingers usually become stiff, painful, and swollen and although medication can help with the pain, the swelling can remain." A high-salt diet or blood pressure medications have also been fingered – all apologies – as the potential cause.

In another publication, Dr Rinky Kapoor, Consultant Dermatologist, concurs: "The most common symptom of oedema is noticeable swelling in hands and legs and if you press the swollen area for about 15 seconds, a noticeable dimple is formed in the area. The second is a shiny and stretched look on the skin."

THE METHOTREXATE AUTO-INJECTOR WITH THE PATIENT IN MIND

Nordimet (methotrexate) Solution for injection in pre-filled pen

Please refer to the Summary of Product Characteristics (SmPC) for full prescribing information. Further information is available on request.

ml), 17.5 mg (in 0.7 ml), 20 mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in solution for injection. Indications: Active rheumatoid arthritis in adult patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.

Presentation: Pre-filled pen containing 7.5 mg (in 0.3 ml), 10 mg (in 0.4 ml), 12.5 mg (in 0.5 ml), 15 mg (in 0.6 ml), 17.5 mg (in 0.7 ml), 20 mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in solution for injection. Indications: Active rheumatoid arthritis in adult patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.

Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. Dosage and administration: Nordimet should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Nordimet should be performed under direct medical supervision. Nordimet is injected once weekly, administered subcutaneously. Rheumatoid arthritis:

Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. Dosage and administration: Nordimet should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Nordimet should be performed under direct medical supervision. Nordimet is injected once weekly, administered subcutaneously. Rheumatoid arthritis:

Recommended initial dose is 7.5 mg of methotrexate once weekly.

Recommended initial dose is 7.5 mg of methotrexate once weekly.

Depending on the individual activity of the disease & patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Polyarthritic forms of severe, active juvenile idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20mg/m² BSA per week. Use in children < 3 years of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to

Depending on the individual activity of the disease & patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Polyarthritic forms of severe, active juvenile idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20mg/m² BSA per week. Use in children < 3 years of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to

initiation of therapy is recommended. Recommended initial dose 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.

initiation of therapy is recommended. Recommended initial dose 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.

Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose.

Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose.

In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate. Crohn’s disease (adult patients): 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Maintenance treatment: 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission. Renal impairment, hepatic impairment or elderly patients: Please refer to SmPC. Note: When switching from oral to parenteral use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.

In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate. Crohn’s disease (adult patients): 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Maintenance treatment: 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission. Renal impairment, hepatic impairment or elderly patients: Please refer to SmPC. Note: When switching from oral to parenteral use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.

Contraindications: Hypersensitivity to methotrexate or to any of the excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency. Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis. Ulcers of the oral cavity and known active gastrointestinal ulcer disease. Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines. Special warnings and precautions: Patients must be clearly advised that the therapy is to be administered once a week, and not every day.

Contraindications: Hypersensitivity to methotrexate or to any of the excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency. Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis. Ulcers of the oral cavity and known active gastrointestinal ulcer disease. Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines. Special warnings and precautions: Patients must be clearly advised that the therapy is to be administered once a week, and not every day.

Patients receiving therapy should be appropriately monitored. Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. The possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with male and female patients of childbearing potential. Methotrexate contact with skin and mucosal membranes is to be avoided; in cases of contamination rinse the area with plenty of water. Interactions: Consult SmPC for detailed information on interactions. Undesirable

Patients receiving therapy should be appropriately monitored. Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. The possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with male and female patients of childbearing potential. Methotrexate contact with skin and mucosal membranes is to be avoided; in cases of contamination rinse the area with plenty of water. Interactions: Consult SmPC for detailed information on interactions. Undesirable

effects: See SmPCs for full list of undesirable effects. Very common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. Abnormal liver function tests (increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache. Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis. Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic events. Pulmonary fibrosis. Pneumocystis carinii pneumonia. Shortness of breath and bronchial asthma. Pleural effusion. Acute hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. Lymphoproliferative disorders. Severe courses of bone marrow depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative disorders). Legal classification: POM. MA numbers: EU/1/16/1124/001 – 008. Further information available from: Nordic Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin. Date of Prescribing Information: July 2021. Item code: IE/21/NOR/008-00.

effects: See SmPCs for full list of undesirable effects. Very common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. Abnormal liver function tests (increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache. Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis. Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic events. Pulmonary fibrosis. Pneumocystis carinii pneumonia. Shortness of breath and bronchial asthma. Pleural effusion. Acute hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. Lymphoproliferative disorders. Severe courses of bone marrow depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative disorders). Legal

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Nordic Pharma Ireland; info@ nordicpharma.ie or +353(0)1 4004141

Dr Nye added: "There aren’t any immediate health concerns to be concluded from swollen fingers and is most likely a sign of his age." Perhaps a reasonable assumption, considering the new monarch is 73 years old.

So is that the end of the matter? Perhaps, but the late Queen herself noted at Charles's birth that "the baby is very sweet and we are enormously proud of him. He has an interesting pair of hands for a baby". Back in 2012, Charles himself joked about his "sausage fingers" (his words) during a trip to Australia. So it appears to be a long-term issue.

But it would be hasty for any monarchists to panic over the prospect of Charles going for any length of time with an untreated condition. Being head of the British monarchy has certain advantages, including not having to wait two weeks for a GP appointment, or having to worry about access to a specialist. Indeed, following Charles's birth, the palace's Buhl Room was converted into a high-tech surgery with all the mod cons. As well as Charles, Andrew and Edward were also born in this room.

Aside from his digit problems, Charles also has some eccentricities that may interest our venerable psychiatrist readers. For example, the new king insists that his bath be filled to 18 centimetres and at 20 degrees, so a maid must be vigilant each morning and armed with a thermometer.

He also reportedly demands that the water in the shower be at a particular temperature, and the bath plug be positioned in a particular way. His towels must be stretched out on a chair to ensure the minimum drying effort.

In addition, Charles's butler is under instructions to leave the toothpaste ready on his toothbrush, with the paste to measure exactly 2.5cm. He never goes to bed without his pyjamas being ironed – with the windows wide open, even in freezing weather. He never ties his laces, which means that they have to be tied by his butler. But only after they have been ironed.

Must be good to be the king!

The late Queen herself noted at Charles's birth that 'the baby is very sweet and we are enormously proud of him. He has an interesting pair of hands for a baby'