The Medical Independent 19th December 2023

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A ‘silent epidemic’

Vhi’s changing model

War and peace

There is an urgent need for comprehensive action by policymakers to address the growing burden of kidney disease. Catherine Reilly reports

Priscilla Lynch speaks to the Managing Director of Vhi Health and Wellbeing, Ms Anne O’Connor, about the company’s move into primary care provision

Perhaps the most difficult thing we can do this Christmas is maintain peace in our hearts, writes Dr Lucia Gannon

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NEWS 1-13 ● OPINION 14-16 ● MCQS 17 ● CLINICAL 23-27 ● CONFERENCES 28-30, 32-38, & 40-41 ● LIFE DIARY 42 ● QUIZZES 43 ● BOOK REVIEW 44 ● GALLERY 45 ● PRODUCTS 46 ● CLASSIFIEDS 47

‘Paucity’ of transplant infrastructure leaves services ‘vulnerable to failure’ CATHERINE REILLY

A “demand capacity mismatch” has left transplant services “vulnerable to service provision failure” in surge periods, a HSE review found.

The internal review, finalised in December 2022, referenced a “paucity” of dedicated infrastructure and specialist staff for provision of complex care to these patients who have unique care requirements due to immunosuppression and multiple co-morbidities. It said the capacity issues were also causing staff recruitment and retention difficulties.

The review, obtained under Freedom of Information law, was commissioned after the cancellation of an organ transplant at the Mater Misericordiae University Hospital, Dublin, in late 2021. The transplant was cancelled due to lack of critical care capacity following a surge in Covid-19 cases. This matter was examined in a separate serious incident report.

According to the wider review, the requirements for transplant services and patients had not been formally mapped-

out, costed, or future-adjusted, and the governance for these services was “splintered”.

Executive powers rested entirely with Hospital Groups and transplantation had to compete with other service requirements. The clinical prioritisation of unscheduled care over all other services resulted in resources funded for transplantation being redirected.

There was also “limited information” available to manage the transplant process and drive performance improvement.

The review noted organ retrieval predominantly occurred out-of-hours because the donor hospital usually did not have emergency theatre space to accommodate retrieval during normal working hours.

“The restrictions of cold ischaemia time determines the timing of implantation, this all forces the whole process ‘out-of-hours’. When organs for donation are made available to the transplant centre the next day, [this impacts] elective surgery lists.”

Capacity shortfalls relating to protected beds, specialist Continued on p3 >>

€500k floated as possible ‘high earner’ threshold in HSE DAVID LYNCH

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Legal Category: S1A. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

PP-CIB-IRL-0014 Date of preparation: July 2022

The possibility of setting a threshold of €500,000 by which a HSE employee is defined as a ‘high earner’ was discussed at a recent Executive meeting.

As previously reported in the Medical Independent (MI), a proposal to increase the threshold is under “active consideration”.

The issue was raised at the September meeting of the HSE audit and risk committee during a discussion about an action plan regarding ‘high earners’. The committee welcomed the “significant work” done on the action plan.

According to minutes, there was “a reasonable case” for the high earner threshold to be increased from €300,000 to €500,000 “due to inflationary and other factors”.

The HSE previously told this newspaper the new consultant contract “may have an inflationary impact” on the level of earnings above €300,000.

A HSE spokesperson told MI that a “number of alternatives” for the high earner threshold were mentioned in discussions, including a figure of €500,000, “but no decision was taken in that regard.”

In October, the HSE CEO Mr Bernard Gloster told the Oireachtas public accounts committee the threshold was “likely to require adjustment”.

This was because “the new consultant contract will mean that a significant number of employees will be above that figure when all dimensions of the contract are factored in”.

University of Galway has conferred its highest award, an Honorary Doctorate Degree in Laws, to Croí CEO Mr Neil Johnson.

Mr Johnson (left), who is also founder and interim CEO of the National Institute for Prevention and Cardiovascular Health, is pictured with President of the University Prof Ciarán Ó hÓgartaigh.

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THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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News

Vhi moving into direct provision of GP care PRISCILLA LYNCH

Ireland’s largest healthcare insurer is in discussions with the ICGP about increasing the type of GP services for which it provides coverage, as well as launching direct primary care provision, the Medical Independent (MI) can reveal.

Ms Anne O’Connor, Managing Director at Vhi Health and Wellbeing, said it is in talks with the ICGP about developing a chronic disease management pathway in primary care. The pathway for its members would be like the HSE programmes in place for medical card/GP visit card patients.

She added that Vhi wanted to work with GPs and not “replace” them. “So we’re really trying to get into the nuts and bolts of primary care, but do it in a way that adds val-

>> Continued from p1 staff, theatre access, and critical care were raised in the review.

In regard to renal transplant at Beaumont Hospital, Dublin, for example, it was noted deceased donor transplantation (which usually involves two transplants per donor) competed for access to the emergency theatre.

As Beaumont was the site of the national neurosurgical centre and had an expanding catchment population, the demand for access to this theatre was “overwhelming”.

“To access the theatre with two transplants, which can occupy the theatre for between six to 10 hours at any given time, [would mean] other emergency cases are deferred.

Transplant surgeons have to frequently ‘negotiate’ with other colleagues as to which emergency is most pressing or can the transplant surgery be delayed to allow life or limb saving surgery to proceed instead. This has led to prolonged cold ischaemia times of over 20 hours in approximately 20 kidney transplants last year, which in turn, contributes to [the risk of] delayed graft function.”

At the Mater, general cardiac and thoracic cases competed for finite resources with the lung and heart transplant service as well as general emergency and acute cases. This meant that cardiac and thoracic, including cancer, cases were regularly cancelled when a transplant was being carried out, either due to lack of theatre provision or ward/ICU beds.

In common with the other programmes, the liver and pancreas transplant programmes at St Vincent’s University Hospital in Dublin competed for the same resources required for other emergency and urgent care cases.

Liver transplants took place in the same theatre as scheduled hepatopancreaticobiliary (HPB) cases so transplantation between Monday and Friday typically resulted in cancellation of two major HPB cases. Pancreas transplants usually occurred in one of the other gastrointestinal surgery theatres, again displacing scheduled (usually cancer) cases.

According to the review, increasing capacity so that patients with different urgent care needs are not competing for the same resources is fundamental to providing a consistent, quality-assured service.

“Transplantation is a highly effective therapy for complex patients with very acute healthcare needs. The relative scarcity of organs and the loss of individuals whilst on transplant waiting lists confers an urgency to this therapy that needs to be taken into consideration by the Government, the Department of Health, the HSE, and the hospital system when resourcing and implementing this service.”

Among the review recommendations was a formal strategy to quantify the requirements for transplantation services and an increase in critical care capacity to meet the requirements for all patients.

A HSE spokesperson said it is developing a strategy for organ donation and transplant services to deliver required outputs for the next 10 years.

The strategy is at final draft stage and will be presented to the HSE executive management team in early 2024.

ue, not actually strip anything away from anyone.”

The ICGP told MI it has had “some very early discussions on this matter” which will continue into 2024.

Vhi is also trialling provision of in-person GP services in addition to the online and phone GP and nurse services already provided.

This is initially being piloted on a small scale for some corporate members that have recruited short- and medium-term staff who are unable to access GP and primary care services locally. It will operate in the same manner as the existing reimbursement model.

“The feedback from some of our corporate members is

that their staff can’t get GPs and in particular we have a lot of tech companies bringing people in without access to a GP,” Ms O’Connor said.

After a trial period, the potential of introducing such services for the company’s wider membership will be assessed.

“We [also] have many people presenting to our urgent care clinics because they cannot access the GP. And we are now at a point where we are having to look at that,” Ms O’Connor commented.

She stressed that “we’re really not in the business of competing” with GPs. See news interview, p12-13.

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

THE METHOTREXATE AUTO-INJECTOR WITH THE PATIENT IN MIND 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 onlled request.

Nordimet (methotrexate) Solution for injection in pre-fi pen Presentation: Pre-fi lled pen of containing 7.5 mg (in 0.3 (SmPC) ml), 10 mg (in Please refer to the Summary Product Characteristics for full 0.4 ml), 12.5information. mg (in 0.5 ml), 15 mg (in 0.6 ml),is17.5 mg (inon 0.7request. ml), 20 prescribing Further information available mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in Presentation: Pre-filled pen containing 7.5 mg (in 0.3 ml), 10 mg (in solution for injection. Indications: Active rheumatoid arthritis in adult 0.4 ml), 12.5 mg (in 0.5 ml), 15 mg (in 0.6 ml), 17.5 mg (in 0.7 ml), 20 patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) solution for injection. Indications: Active rheumatoid arthritis in adult has been inadequate. Severe recalcitrant disabling psoriasis, which is not patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, adequately responsive to other forms of therapy such as phototherapy, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) PUVA, and retinoids, and severe psoriatic arthritis in adult patients. has been inadequate. Severe recalcitrant disabling psoriasis, which is not Induction of remission in moderate steroid-dependent Crohn’s disease adequately responsive to other forms of therapy such as phototherapy, in adult patients, in combination with corticosteroids and for maintenance PUVA, and retinoids, and severe psoriatic arthritis in adult patients. of remission, as monotherapy, in patients who have responded to Induction of remission in moderate steroid-dependent Crohn’s disease methotrexate. Dosage and administration: Nordimet should only in adult patients, in combination with corticosteroids and for maintenance be prescribed by physicians with expertise in the use of methotrexate of remission, as monotherapy, in patients who have responded to and a full understanding of the risks of methotrexate therapy. Patients methotrexate. Dosage and administration: Nordimet should only must be educated and trained in the proper injection technique when be prescribed by physicians with expertise in the use of methotrexate self-administering methotrexate. The first injection of Nordimet should and a full understanding of the risks of methotrexate therapy. Patients be performed under direct medical supervision. Nordimet is injected must be educated and trained in the proper injection technique when once weekly, administered subcutaneously. Rheumatoid arthritis: self-administering methotrexate. The first injection of Nordimet should Recommended initial dose is 7.5 mg of methotrexate once weekly. be performed under direct medical supervision. Nordimet is injected Depending on the individual activity of the disease & patient tolerability, once weekly, administered subcutaneously. Rheumatoid arthritis: the initial dose may be increased. A weekly dose of 25 mg should in Recommended initial dose is 7.5 mg of methotrexate once weekly. general not be exceeded. Once the desired therapeutic result has been Depending on the individual activity of the disease & patient tolerability, achieved, the dose should be reduced gradually to the lowest possible the initial dose may be increased. A weekly dose of 25 mg should in effective maintenance dose. Polyarthritic forms of severe, active juvenile general not be exceeded. Once the desired therapeutic result has been idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface achieved, the dose should be reduced gradually to the lowest possible area (BSA) per week. In therapy-refractory cases the weekly dose may effective maintenance dose. Polyarthritic forms of severe, active juvenile be increased up to 20mg/m² BSA per week. Use in children < 3 years idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A area (BSA) per week. In therapy-refractory cases the weekly dose may test dose of 5 - 10 mg subcutaneously administered one week prior to be increased up to 20mg/m² BSA per week. Use in children < 3 years ofDate age is recommended.

Psoriasis Ofnot Preparation: Aug 2021 vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to IE/21/NOR/011-00 Date Of Preparation: Aug 2021 IE/21/NOR/011-00

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 Once the desired therapeutic result has been achieved, dose should be methotrexate once weekly. The dose is to be increased gradually but reduced gradually to the lowest possible effective maintenance dose. should not, in general, exceed a weekly dose of 25 mg of methotrexate.

In a few exceptional cases a higher dose than 25 mg might be clinically Once the desired therapeutic result has been achieved, dose should be justified, but should not exceed a maximum weekly dose of 30 mg of reduced gradually to the lowest possible effective maintenance dose. methotrexate. Crohn’s disease (adult patients): 25 mg/week administered In a few exceptional cases a higher dose than 25 mg might be clinically subcutaneously. Once patients have adequately responded to justified, but should not exceed a maximum weekly dose of 30 mg of combination therapy, the corticosteroids should be tapered. Maintenance methotrexate. Crohn’s disease (adult patients): 25 mg/week administered treatment: 15 mg/week administered subcutaneously, as monotherapy, if subcutaneously. Once patients have adequately responded to the patient has entered remission. Renal impairment, hepatic impairment combination therapy, the corticosteroids should be tapered. Maintenance or elderly patients: Please refer to SmPC. Note: When switching from treatment: 15 mg/week administered subcutaneously, as monotherapy, if oral to parenteral use, a reduction in the dose may be required, due to the patient has entered remission. Renal impairment, hepatic impairment the variable bioavailability of methotrexate after oral administration. or elderly patients: Please refer to SmPC. Note: When switching from Contraindications: Hypersensitivity to methotrexate or to any of the oral to parenteral use, a reduction in the dose may be required, due to excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 the variable bioavailability of methotrexate after oral administration. µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < Contraindications: Hypersensitivity to methotrexate or to any of the 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency. µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis.

30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, Ulcers of the oral cavity and known active gastrointestinal ulcer disease. leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency.

Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines.

Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis.

Special warnings and precautions: Patients must be clearly advised Ulcers of the oral cavity and known active gastrointestinal ulcer disease. that the therapy is to be administered once a week, and not every day.

Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines.

Patients receiving therapy should be appropriately monitored. Doses Special warnings and precautions: Patients must be clearly advised exceeding 20 mg/week can be associated with significant increase in that the therapy is to be administered once a week, and not every day. toxicity, especially bone marrow suppression. The possible risks of effects Patients receiving therapy should be appropriately monitored. Doses on reproduction, pregnancy loss and congenital malformations should exceeding 20 mg/week can be associated with significant increase in be discussed with male and female patients of childbearing potential. toxicity, especially bone marrow suppression. The possible risks of effects Methotrexate contact with skin and mucosal membranes is to be avoided; on reproduction, pregnancy loss and congenital malformations should in cases of contamination rinse the area with plenty of water. Interactions: be discussed with male and female patients of childbearing potential.

Consult SmPC for detailed information on interactions. Undesirable 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 effects: See SmPCs for full list of undesirable effects. Very (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache.

Abnormal liver function tests (increased Alanine aminotransferase Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis.

(ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache.

Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression.

Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis.

Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. events. Pulmonary fibrosis. Pneumocystis carinii pneumonia.

Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances.

Shortness of breath and bronchial asthma. Pleural effusion. Acute Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. events. Pulmonary fibrosis. Pneumocystis carinii pneumonia.

Lymphoproliferative disorders. Severe courses of bone marrow Shortness of breath and bronchial asthma. Pleural effusion. Acute depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure.

Lymphoproliferative disorders. Severe courses of bone marrow Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: disorders). Legal classification: POM. MA numbers: EU/1/16/1124/001 Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar – 008. Further information available from: Nordic Pharma Ltd, haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative 4045 Kingswood Road, Citywest Business Park, Co Dublin. Date of disorders). Legal classification: POM. MA numbers: EU/1/16/1124/001 Prescribing Information: July 2021. Item code: IE/21/NOR/008-00.

– 008. Further information available from: Nordic Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin. Date of Adverse Information: events should be 2021. reported. forms and Prescribing July ItemReporting code: IE/21/NOR/008-00. information can be found at www.hpra.ie. Adverse events should also be reported to Nordic Pharma Ireland; info@ Adverse events should be reported. Reporting forms and nordicpharma.ie or +353(0)1 4004141 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

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

4

News Feature CATHERINE REILLY catherine@mindo.ie

Kidney disease: Confronting a ‘silent epidemic’ There is an urgent need for comprehensive action by policymakers to address the growing burden of kidney disease.

Catherine Reilly reports

I

reland has no national model of care for renal disease or HSE clinical programme comparable to those operational in many other disease areas.

Yet an estimated 500,000 people in Ireland are living with chronic kidney disease (CKD), which is rising in prevalence.

Ireland is not alone in this challenge. In June, a health economics analysis, commissioned by Kidney Research UK, described the situation as a pending “public health emergency”. Aging populations and risk factors, such as diabetes, hypertension, and cardiovascular disease, are contributing to increasing incidence.

Earlier intervention will deliver better health outcomes and reduce economic costs, heard Oireachtas members at a special briefing last month. The cost of dialysis alone is over €300 million annually.

The briefing session heard from professionals working in nephrology and audit, as well as patient representatives. It was led by the Irish Kidney Association (IKA) and hosted by Fine Gael spokesperson on health Deputy Colm Burke..

During the session, Prof George Mellotte, Clinical Lead of the HSE National Renal Office (NRO), emphasised the need to include CKD in the chronic disease management programme in general practice, where cases are being detected.

This issue was also covered in the five key actions that the IKA advocated to p ol ic y m a kers: Embed screening and treatment (i nc lud i ng c on s er v at i ve care) for CKD in all chronic Prof George Mellotte disease programmes; enhance a transitional service for teenagers moving to adult services; protect theatre and bed space for donation and transplant; provide for timely completion of required healthcare ahead of transplant and living donation; and implement an annual potential donor audit (see panel).

Overview CKD is often asymptomatic at earlier stages and is associated with an increased risk of cardiovascular disease and premature death.

Where CKD goes undetected and untreated, there is a greater risk of progression to end-stage kidney disease (ESKD).

Last year, there were around 2,500 people dialysing and 2,700 people living with a

kidney transplant.

An extra 134 people were treated by dialysis last year, which was equivalent to the demand for two additional satellite dialysis units, Prof Mellotte informed the Oireachtas session.

Currently, home dialysis therapies are accessed by only about 12 per cent of patients, he outlined. The barriers include financial costs (eg, additional electricity costs), absence of incentives and targets for hospitals, insufficient patient education and support, and the lack of an assisted home dialysis programme.

Kidney transplantation is the preferred treatment for ESKD, offering improved survival and quality-of-life for patients, and substantial cost savings for the State.

In 2022, there were 130 deceased donor kidney transplants and 33 living donor transplants (compared with 104 and 35 in the previous year).

Some 512 people were on the kidney transplant waiting list at the end of last year, according to the National Kidney Service Annual Report 2022. The shortage of organs relative to the number of patients waiting for a transplant had remained “an ongoing challenge”, stated the report.

In 2022, the median time on dialysis prior to first transplant was 35 months (21 months for those who received a living donor transplant; 39 months for those who received a deceased donor transplant).

The median time on the kidney transplant waiting list was 26 months (15 months for those who received a living donor transplant; 31 months for those who received a deceased donor transplant).

Early identification The structured chronic disease management programme in general practice has three elements: Opportunistic case finding (OCF) (aimed at identifying undiagnosed chronic diseases and people at high risk); an annual prevention review and a treatment programme for specified chronic dis-

eases. The programme is available to adults with medical/GP visit cards (the treatment programme has rolled out to adults over 18; the OCF and prevention programmes have rolled out to adults over 45).

A HSE spokesperson said 11.5 per cent of patients enrolled in the chronic disease management treatment programme also have CKD. “If unmanaged, CKD can lead to cardiovascular events, such as heart attacks, strokes, and kidney failure, with dialysis or kidney transplant implications. The HSE developed a business case for 2024 funding to include CKD and other less common, high-risk cardiovascular conditions (such as familial hypercholestrolaemia, peripheral vascular disease, and valvular disease) in the next phase of the CDM programme.

“Unfortunately, no further development funding was made available for 2024, but the HSE does intend to resubmit the bid for the 2025 National Service Plan. It was calculated that inclusion of these conditions in the CDM programme, in addition to improved health, could save 2,278 admissions, 9,278 bed days, 3,834 emergency department visits, and 26,047 outpatient department visits. This equates to a saving in monetary terms of over €17 million, compared to a cost of €7 million.”

Negotiation An IMO spokesperson said its understanding is that CKD is among the future programme enhancements being considered.

“Any such developments will be subject to negotiation and agreement with the IMO and we have not been approached in relation to discussions on further enhancements to date,” the spokesperson told the Medical Independent (MI).

The union stated it is focussed on the latest developments (ie, the recent inclusion of hypertension stage one, gestational diabetes, and pre-eclampsia, in the prevention programme.)

Pathways Currently, there is no structured care pathway for patients detected with less severe forms of CKD through the chronic disease programmes (they may be referred to nephrology waiting lists if deemed necessary). There are ICGP guidelines in place for diagnosis and management of CKD in primary care.

Prof Mellotte, a Consultant Nephrologist at St James’s Hospital and Tallaght University Hospital, Dublin, told MI that GPs must be empowered and supported to manage mild-to-moderate disease in the community.

Around 15 per cent of people aged over 50 have some degree of CKD, according to TILDA research. He said the epidemiological data indicates it will become “a major public health problem in the next 10-to-15 years”.

The development of a model of care is also important in the context of new drug indications. SGLT-2 inhibitors (initially developed for type 2 diabetes) have emerged as a treatment option in CKD and may stabilise or delay disease progression.

According to the European Medicines Agency, the following SGLT-2 medicines are approved for CKD in adults: Edistride and Forxiga, which both contain dapaglifozin, and Jardiance, which contains empagliflozin.

In July 2022, the National Centre for Pharmacoeconomics completed a rapid review assessment of Forxiga for treatment of CKD. It recommended that the HSE consider “not providing” this medicine unless it can agree a suitable price reduction with the pharmaceutical company.

The application for pricing and reimbursement of Forxiga for CKD remains under consideration within the HSE. The use of SGLT-2 inhibitors in CKD is a “very rapidly moving field”, according to Prof Mellotte.

He said it is likely a subgroup of people with CKD will benefit and that a management and treatment plan will need to be devised for prescribing and monitoring.

Clinicians will need to accrue knowledge on use of these medications in CKD, said Prof Mellotte, who added it was “an exciting period for nephrology”.

NRO At the Oireachtas briefing, IKA CEO Ms Carol Moore raised the under-resourcing for the NRO and the absence of an agreed model of care. She also outlined variations in the treatment and support of patients requiring dialysis.

She told MI it remains the prerogative of hospital management whether to support implementation of guidance.

“We would like to see a clear line of au-

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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Feature News

thority, that there would be very clear guidelines that all hospitals have to adhere to, because it does vary so sig n i f ic a nt ly between dialysis units and we also see resources that Ms Carol Moore were assigned to kidney disease being subsumed into hospitals’ other budgets,” she outlined.

The level of utilisation of arteriovenous (AV) fistula for patients undergoing haemodialysis is an example of variation across centres. Patients dialysing with a central venous catheter have a higher risk of infections, cardiovascular events, and mortality compared to those with an AV fistula.

“Fistula is not for everybody, but we think all [eligible] patients should be offered the choice… and we have talked to patients who have never heard of a fistula,” said Ms Moore.

She also underlined a lack of support for home dialysis and noted the high cost of living as being a major prohibitive factor.

“When you do it at home your electricity bill goes a lot higher. In other countries, they actually have fi nancial supports for patients, but here we don’t.”

While people on home dialysis can claim some of the costs back against tax paid, this is insufficient and many people do not benefit due to the terms of this scheme, according to the Association.

The IKA has also encountered instances “where people who can pay privately for tests and scans can get onto the transplant list quicker than people who can’t”, Ms Moore commented.

Review Prof Mellotte said renal medicine requires a distinct clinical programme similar to those that exist in other disease/specialty areas within the HSE. The NRO was established in 2009 before the initiation of the HSE clinical programmes. It has no Lead posts for primary care and nursing, which are part of many of the clinical programmes. MI understands the original remit of the NRO was ESKD and it requires more support for work in other areas, including preventative nephrology.

The consultancy fi rm EY has conducted a strategic review of the NRO and identified the need for additional supports, confi rmed Prof Mellotte. He told MI the “outcome and implementation” of the fi ndings are awaited.

Prof Mellotte also noted that the NRO’s role is advisory and strategic only. Decisions on funding and dispersal of allocations are ultimately the domain of other sections of the HSE. He acknowledged that significant funding was provided to renal services in 2022, which “has made a difference”.

According to the HSE, the EY review is “currently in draft as the recommendations are being considered in the context of the imminent changes in the HSE Centre and the Health Regions”.

Data In regard to AV fistula use, Prof Mellotte said there had been improvements after research led by Prof Austin Stack identified substantial variations across centres that were not explained by patient-related factors alone.

This research was “a call to arms” and the situation had improved significantly in the last two-to-three years. Prof Mellotte noted factors which may lower the use of AV fistula, such as late presentation/referral to

kidney services, cardiac fitness, access to vascular surgery, and patient preference.

However, he also acknowledged the need for better data and establishment of key performance indicators. In this respect, there is an ongoing project to extract data from the kidney disease clinical patient management system to enable its use for clinical audit and quality improvement projects.

Prof Mellotte has also been working to expand home dialysis, which he raised at the Oireachtas briefi ng. Home dialysis is associated with less infection risks and better quality-of-life for patients. It is also more cost-effective for the health system.

The NRO has recently achieved funding under the HSE’s modernised care pathway initiative for additional nurses and dieticians to support patient education.

If patients in the pre-dialysis clinic are educated at an early stage about home dialysis therapies, they are more likely to take up this option, explained Prof Mellotte.

The NRO has also submitted a proposal for an assisted home dialysis programme to ensure that patients with frailty can access treatment at home. Prof Mellotte is keen to develop new models for patients dialysing, including ‘self-care hubs’ in the community (a pilot is taking place in Tallaght).

In regard to in-centre dialysis, the NRO is seeking an increase in capacity to meet patient needs – including in the hinterland around Dublin. Prof Mellotte said conversations are ongoing with Hospital Groups in this respect.

Prof Mellotte noted that transplant activity is recovering after being adversely impacted by the Covid-19 pandemic.

Complimenting the efforts of staff, he added that more resources are required to facilitate timelier work-up of prospective living kidney donors.

Audit a vital component of improving access to transplant A potential donor audit (PDA) is key to improving access to transplant and must be implemented nationally, according to the CEO of the Irish Kidney Association (IKA) Ms Carol Moore.

In September, the National Office of Clinical Audit (NOCA) published its pilot PDA project report and recommended national roll-out in 2024.

According to the HSE: “The national potential donor audit will be rolled out on a phased basis nationally.”

Project Lead of the NOCA PDA, Dr Maria Kehoe (PhD), told the Oireachtas briefing session there is strong international evidence of improvement in organ donation rates following implementation of PDAs. Ireland’s organ donation rate is 16.78 per million population (PMP) compared to 46.3 PMP in Spain (International Registry on Organ Donation and Transplantation, 2022).

Ms Moore said a national audit must also examine the transplantation process. She said audit would identify gaps in the infrastructure and drive improvements in the process.

She also stated that investment in specialist organ donation personnel is a core element of the system in Spain, which is regarded as a world leader in this area.

Under the planned ‘soft opt-out system’, consent for organ donation will be ‘deemed’ unless the person has registered his/her wish not to become an organ donor after death.

Families will continue to be consulted, according to the Department.

Ms Moore emphasised the importance of a well-resourced and strategic public awareness campaign surrounding the opt-out register. She said there is some public confusion about the matter. She said if a person wishes to be an organ donor after

death, it will remain imperative that they communicate this to family members.

Ms Moore also expressed concern that the purpose of the register could be actively misrepresented by elements on social media, etc.

She said health authorities must be prepared to instigate a rapid communications response in this eventuality.

The HSE stated it has an ongoing public awareness campaign highlighting the importance of organ donation.

“Organ donation awareness will continue next year and will be planned in line with the progress of the Human Tissue Bill through the legislative process. Once the opt-out register goes live, there will be a specific campaign aiming to raise awareness on its introduction and what the new changes introduced mean for the public.”

MINDO NUMBERS

10,281

enquiries were received by the National Poisons Information Centre (NPIC) in 2022, with 46.4 per cent from healthcare professionals.

15,896+ agents were involved in cases of human poisoning in 2022.

Over half were drugs (including medications and drugs of abuse), 17 per cent were household products, and 13.8 per cent were chemicals, according to the NPIC annual report.

6,820

or 67.5 per cent of patients were asymptomatic when the NPIC was contacted.

300,000 people in Ireland are living with a rare disease, according to the Department of Health, which has announced the establishment of a national rare disease steering group to develop a revised national action plan.

463,921

people were waiting on lists beyond the 10- and 12-week Government targets at the end of the November, a 10 per cent reduction since February.

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

6

News

MedLIS project has entered ‘comprehensive testing phase’ CATHERINE REILLY

The initial build of the MedLIS laboratory information system has been completed and the project has entered a “detailed and comprehensive testing phase”, according to the HSE. Beaumont Hospital in Dublin has been identified as the first site for deployment, which is scheduled for May 2024.

“Further deployment and national roll-out will be based on risk and service need, but Our Lady of Lourdes Hospital, Drogheda, and Cavan General Hospital are most likely the next sites. Deployment

will also be aligned with roll-out of the national maternity newborn system,” the HSE spokesperson told the Medical Independent (MI).

The national MedLIS project aims to establish an integrated nationwide laboratory information system, which will ensure healthcare providers have rapid 24hour access to up-to-date laboratory data across all sites.

The initiative has been beset by delays.

HSE management first granted approval for the project in 2010. Cerner was identified as the preferred supplier in 2013 and a contract was signed in September 2015. When

the deployment component of the project commenced in late 2015, it was envisaged the last site would go live by June 2019.

A most recent setback was the cyberattack on the HSE in May 2021, which required the national MedLIS project team to be re-directed to support the acute and immediate response.

According to the website of HSE eHealth Ireland, the MedLIS “server environment and infrastructure” were also impacted by the cyberattack and a decision was made to “rebuild and host the application remotely in Sweden, in line with Cerner’s long-term strategy”.

International doctors’ scheme may facilitate extended leave CATHERINE REILLY

The duration of the HSE International Medical Graduate Training Initiative (IMGTI) for scholarship trainees from Pakistan and Sudan may be increased to 36 months, if extended leave is required.

The HSE stated that expanding the scholarship scheme from 24 to 36 months in these circumstances is being considered. The duration of training for trainees fully sponsored by their governments is now 36 months with the potential for a further 12-month extension to meet identified training needs.

“Under such circumstances, all arrangements put in place to facilitate this 12-month extension, including the necessary visa and Medical Council registration, are contingent on the doctors’ continued participation in the IMG programme and the continued requirement that the trainee will return home upon completion of the programme,” said the HSE spokesperson.

In September 2021, it was noted at a

meeting of the IMGTI joint committee that “if a trainee takes maternity leave on the programme they do not receive their full certificate of training”. The issue was raised during a section on the scholarship programme, according to minutes obtained under Freedom of Information law.

According to the HSE, the duration of training for the IMGTI scholarship programme is fixed at 24 months under partnership agreements with the College of Physicians and Surgeons Pakistan and Sudan Medical Specialisation Board.

“While on the scholarship programme, these trainees hold the NCHD contract and receive maternity leave and all other terms and conditions as per that contract.

If a trainee is required to take an extended period of leave during their 24 months, eg, maternity leave, the trainee will receive training credit only for the period of time in clinical training,” said the HSE’s spokesperson.

“If host countries are in support of an extension option in these circumstances the committee will progress discussions

with relevant Irish partners including the Medical Council, visa, and work permits.”

The Regulated Professions (Health and Social Care) (Amendment) Act 2020 provided that the period of clinical training in the supervised division of the medical register can be extended to 36 months.

Meanwhile, the HSE confirmed it does not employ doctors on the IMGTI sponsored programmes. The doctors “remain in the employ of their government sponsor for the duration of their training in Ireland”.

“They receive a salary and benefits package from their sponsor that is at least equivalent to that of an Irish doctor working at the same level in Ireland.

“Although not employed by the HSE, many of the terms of the NCHD contract apply to IMGTI trainees on the sponsored programme, for example: Registration status, reporting relationship, leave, and holidays, etc.”

In 2022 there were 238 IMGTI doctors (138 scholarship and 100 sponsored) working in the Irish healthcare system, an increase of 30 from the previous year.

Lack of facilities for patients with additional needs discussed by TUH board PAUL MULHOLLAND

A complaint was discussed at a meeting of Tallaght University Hospital’s (TUH) board about the lack of facilities for a patient with additional needs.

At the meeting in September, Ms Sandra McCarthy, interim Director of Nursing and Integrated Care, briefed the board about the negative experience of a patient who came through the hospital’s emergency department (ED).

According to minutes of the meeting, board member Dr Martin Lyes (PhD) outlined concerns regarding the presentation “in the context of the ED environment, communication, and lack of support for the patient during their experience in the department”.

Ms McCarthy said the ED Symphony system has been updated to identify the needs of patients with intellectual disabilities or sensory requirements.

The meeting heard that the introduction of a ‘health passport’ will assist in outlining the future requirements of patients to clinicians.

In recent years, the HSE has introduced health passports to support people with intellectual disabilities to express their needs in healthcare settings.

Ms McCarthy said TUH was also installing a sensory cubicle within the ED. TUH had an intellectual disability liaison clinical nurse manager who was “increasing staff awareness and providing education in this regard”.

In October 2022, a HIQA inspection re-

port noted that a number of person-centred initiatives were underway to improve the experience of patients attending the ED. However, it also outlined a lack of isolation rooms for infection control and concerns regarding the designated psychiatric assessment rooms in the ED. The report stated that staffing shortages meant the dementia-assessment rooms in the department were not always available.

A spokesperson for TUH told the Medical Independent the sensory cubicle referenced during the meeting is scheduled to open shortly.

Specialist lighting has been installed in the cubicle “to cater for those with sensory issues”, according to the spokesperson.

“This will facilitate a code upgrade to the latest supported version, alignment with a Cloud first policy and a robust disaster recovery environment. The rebuild in Sweden was completed in March 2023.”

The web post outlined that MedLIS had experienced “significant challenges and external shocks since the contract was signed with Cerner in 2015”. However, the vision remained the same in terms of paperless ordering and reporting, with a consolidated patient laboratory record, supported centrally by a dedicated national support team.

The cost associated with MedLIS since 2022 is €5 million, the HSE informed MI.

Transgender model of care due ‘within two years’ of clinical lead appointment DAVID LYNCH

A new integrated model of care and implementation plan for transgender services will be launched within two years of a new clinical lead being appointed, this newspaper has been told.

A HSE spokesperson told the Medical Independent (MI) it is currently recruiting a clinical lead for transgender services.

“The successful candidate will be responsible for developing and launching an integrated model of care and implementation plan for transgender services within two years of the start date of the clinical lead taking up this role,” said the spokesperson.

The spokesperson added that the model of care will be developed on a population health needs assessment basis.

“This is a systematic method for reviewing the health issues facing a population, leading to agreed priorities, appropriate resource allocation, and active management of the health and care provider landscape that will improve health outcomes and reduce inequalities.”

Meanwhile, in March, Minister for Children, Equality, Disability, Integration and Youth Roderic O’Gorman told the LGBTI+ national inclusion strategy committee he had contacted the CSO as part of the public consultation process on the next census.

“The Minister requested consideration be given to the inclusion of questions in the census on gender identity, sexual orientation, and variation of sex characteristics.”

A CSO spokesperson told MI that a census advisory group has convened and will make recommendations on the questions to be tested in a census pilot, which will be undertaken in 2024.

“It is expected that consideration will be given to the inclusion of questions on gender identity and sexual orientation. The purpose of the pilot is to test new questions, changes to existing questions, and new field methodology, in a selection of areas across the country. For the first time in 2024 an online response option to the census will be tested,” said the CSO spokesperson.

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THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

8

News Feature

2023: The healthcare year in review The Medical Independent presents a round-up of health news and views during the past 12 months JANUARY A total of 11,289 patients waited on trolleys in hospitals during the first month of the year, show figures compiled by the Irish Nurses and Midwives Organisation (INMO).

Minister for Health Stephen Donnelly receives Government approval to establish an interdepartmental working group to examine the rising cost of health-related claims and consider mechanisms to reduce costs. The group is expected to produce a report in early 2024.

The Medical Independent (MI) reports that the Medical Council will spend approximately €2.6 million on renovations at its rented headquarters, Kingram House, Dublin (the Council later issues a revised final cost of over €3.3 million).

FEBRUARY Speaking to MI at the National Health Summit in Croke Park, IHCA President Prof Robert Landers argues the new consultant contract will lead to a “gradual change, not a big bang” in the health service.

“We are undertaking a consultation feedback process [with IHCA members] and then we are providing our feedback to the Department looking for minor modifications within that contract,” Prof Landers says.

MI also reports that the board of Beaumont Hospital in Dublin had embarked on a significant governance compliance project amid concerns that appropriate board oversight of hospital activities was not in place.

MARCH The new public-only consultant contract 2023 (POCC23) becomes operational on 8 March.

The 2023 Waiting List Action Plan is published. The 30 ‘actions’ in the plan focus on delivering capacity, reforming scheduled care, and enabling scheduled care reform, according to the Department.

“While the Government recognises that acute hospital scheduled care waiting lists are far too long, and that many patients are waiting an unacceptably long time for care, we are beginning to see progress,” Minister Donnelly says upon the launch of the plan.

Mr Bernard Gloster takes up the position of HSE CEO. APRIL Dr John Cannon becomes the new IMO President at the Organisation’s AGM in Killarney, Co Kerry, which takes place on 13-16 of April.

The GP meeting hears continued concerns about the planned expansion of ‘free GP care’ to children aged six and seven and to all of people earning no more than the median income.

During his presentation to the meeting, new Chair of the IMO GP committee

a digital solution that aggregates patient healthcare records from various electronic data sources.

SEPTEMBER Spinal surgery in Children’s Health Ireland at Temple Street receives national attention following revelations about the use of unauthorised implantable devices, among other issues, for procedures at the hospital. Taoiseach Leo Varadkar “guarantees” the independence of the commissioned review and that the final report will be published.

Writing in MI to preview the IHCA AGM and Annual Meeting, the Association’s President Prof Landers states the take-up of the new consultant contract has been “far slower” than the previous contract. A total of 293 consultants had switched to POCC23 by the end of August.

Changes to the income threshold make an additional 215,000 people eligible for GP visit cards.

Dr Tadhg Crowley says GPs have questions over “the policy-making rationale” of the eligibility expansion and the “accuracy” of the Government’s projections.

“There is no clarity on the numbers and assumptions are being used. The number could be anywhere between the Government estimate of 430,000 (including those aged six and seven) and 800,000.”

MAY Minister Donnelly and Chief Medical Officer Prof Breda Smyth welcome the World Health Organisation’s declaration that Mpox no longer constitutes a global public health emergency.

The HSE launches a new model of care for dual diagnosis to set out “clear and integrated care pathways” for people with coexisting mental health and substance misuse conditions.

As reported in MI, RCPI President Prof Mary Horgan criticises the level of funding provided to the College for specialist medical training in the context of increasing trainee numbers. Prof Horgan makes her comments at a conference on the future of medical training organised by the Forum of Irish Postgraduate Medical Training Bodies on 31 May. JUNE Minister Donnelly confirms a significant increase in the number of GP training places, which will rise to 285 in July 2023 (up from 258 in 2022) and 350 in July 2024. ICGP CEO Mr Fintan Foy welcomes the announcement, adding: “The workforce and workload crisis in general practice is affecting patients who have to wait longer to see their GP, as well as thousands of patients who are unable to register with a GP practice. We need more GPs and this increase in training places is a significant measure to enable more doctors to become GPs here in Ireland.”

JULY The HSE publishes the outcome of two separate investigations undertaken following a serious sexual assault of a resident (pseudonym Emily) at a HSE community nursing unit in April 2020. A HSE staff member was convicted of the rape of Emily and sentenced in July 2020. An investigation by a safeguarding team finds reasonable grounds for concern in relation to physical or sexual abuse in relation to 21 past or current residents, among other findings. The HSE says the concerns have been managed in line with safeguarding policy and reported to the gardaí.

The final review of HSE child and adolescent mental health services (CAMHS) is published by the Mental Health Commission and confirms serious ongoing deficits.

Dr Patricia Byrne, Chair of the Faculty of Child and Adolescent Psychiatry at the College of Psychiatrists of Ireland, calls for “immediate investment and development” in CAMHS to support transformation in the area. Minister of State for Mental Health and Older People, Mary Butler, says she is assured that immediate concerns have been addressed by the HSE. “The Department of Health looks forward to working with the HSE in the implementation of the Child and Youth Mental Health Service Improvement Programme.”

The Government publishes an implementation plan for the transition to six new health regions.

AUGUST The extension of GP visit cards to children aged six and seven commences on 11 August.

A national shared care record (NSCR) will roll-out to “the first deployment area” in late 2025 under current HSE timelines, a spokesperson tells MI. The NSCR will be

OCTOBER On Friday 13 October, a memo from HSE CEO Mr Gloster states no new staff will be recruited next year except for approximately 2,000 posts where pre-existing commitments have been made. Plans to recruit an additional 7,000 staff will not proceed. The IMO states it is “appalled by the decision”. The embargo is imposed due to the financial difficulties faced by the Executive, which is expected to have a deficit of just over €1 billion at the end of 2023.

MI reveals the National Association of GP Co-ops has warned health management it can no longer provide out-ofhours services for patients who are not registered with a GP. NOVEMBER It is announced more than 1,000 consultants have signed the POCC23. The 1,056 total comprises 241 new-entrant consultants and 815 consultants who have switched from their previous contracts.

In the third expansion of the scheme this year, an additional 215,000 people are now eligible for GP visit cards.

A total of 11,493 patients, including 434 children, waited on trolleys in Irish hospitals in November, states the INMO. The INMO’s executive council holds an emergency meeting regarding potential industrial action in relation to the HSE recruitment embargo.

DECEMBER Latest figures reveal the total waiting list is approximately 7.1 per cent behind the 2023 Waiting List Action Plan target.

The provision of termination of pregnancy services in five additional maternity hospital sites is announced.

A national rare disease steering group is formed. The steering group is tasked with developing a new rare disease plan for Ireland.

For patients living with heart failure,

Time is essential.

So is starting with ENTRESTO®1-4 Change the heart. Change heart failure5-9 Reverse adverse cardiac remodelling, improve cardiac structure and pumping function, and target HF via a unique dual MOA that inhibits neprilysin and RAAS

Safety and tolerability profile similar to ACEi5,10-12 In all stages of the HFrEF patient journey whether initiated in the hospital or outpatient setting

Make a lasting difference patients can feel5,10,11,13-15 Help your patients stay out of the hospital, live longer, and feel better, so they have more time for what matters most

Start ENTRESTO® as early as possible in your HFrEF patients to help keep them at home and better protected†1-4 ENTRESTO® is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

MOA=mechanism of action; RAAS=Renin-Angiotensin-Aldosterone System; HFrEF=heart failure with reduced ejection fraction. *In place of an ACEi or ARB. †For PCRS reimbursement of ENTRESTO®, HF patients must meet the following criteria: HFrEF ≤ 35%, currently prescribed ACEi/ARB therapy, symptomatic (NYHA Class II-IV), Systolic Blood Pressure ≥ 100 mmHG, Potassium ≥ 5.4mmol/L. Abbreviated Prescribing Information Please refer to Summary of Product Characteristics (SmPC) before prescribing.

Entresto® (sacubitril valsartan) 24 mg/26 mg film-coated tablets, 49 mg/51mg film-coated tablets and 97mg/103mg film-coated tablets Presentation: Film-coated tablets of 24 mg/26 mg, 49 mg/51mg and 97 mg/103 mg of sacubitril and valsartan respectively (as sacubitril valsartan sodium salt complex). Indications: In adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction. In children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. Dosage and administration: Do not co-administer with an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB). Do not start treatment for at least 36 hours after discontinuing ACE-I therapy. The tablets must be swallowed with a glass of water. Splitting or crushing the tablets is not recommended.

Recommended starting dose is one tablet of 49 mg/51 mg twice daily, doubled at 2-4 weeks to the target dose of one tablet of 97 mg/103 mg twice daily, as tolerated by the patient. In patients not currently taking an ACE-I or an ARB, or taking low doses of these medicinal products, a starting dose of 24 mg/ 26 mg twice daily and slow dose titration (doubling every 3 - 4 weeks) are recommended. A starting dose of 24 mg/26 mg twice daily should be considered for patients with SBP ≥100 to 110 mmHg and moderate hepatic impairment. See SmPC for recommended dose and dose titration in paediatric patients.

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Concomitant use with ACE-I. Do not administer until 36 hours after discontinuing ACE-I therapy. Known history of angioedema related to previous ACE-I or ARB therapy. Hereditary or idiopathic angioedema. Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2). Severe hepatic impairment, biliary cirrhosis and cholestasis. Second and third trimesters of pregnancy. Warnings/Precautions: Dual blockade of the renin angiotensin-aldosterone system (RAAS): Combination with an ACE-I is contraindicated due to the increased risk of angioedema. Sacubitril/valsartan must not be initiated until 36 hours after taking the last dose of ACE-I. If treatment with sacubitril/valsartan is stopped, ACE-I therapy must not be initiated until 36 hours after the last dose of sacubitril/valsartan. Combination of sacubitril/valsartan with direct renin inhibitors such as aliskiren is not recommended.

Sacubitril/valsartan should not be co-administered with another ARB containing product. Hypotension: Treatment should not be initiated unless SBP is ≥100 mmHg for adults or ≥5th percentile SBP for the age of the paediatric patient. Patients with SBP below these values were not studied. Cases of symptomatic hypotension have been reported in adult patients treated with sacubitril/valsartan during clinical studies, especially in patients ≥65 years old, patients with renal disease and patients with low SBP (<112 mmHg). Blood pressure should be monitored routinely when initiating or during dose titration with sacubitril/valsartan. If hypotension occurs, temporary down-titration or discontinuation of sacubitril/valsartan is recommended. Impaired or worsening renal function: Patients with mild and moderate renal impairment are more at risk of developing hypertension. Very limited clinical experience in patients with severe renal impairment (estimated GFR <30 ml/min/1.73m2). There is no experience in patients with end-stage renal disease and use of sacubitril/ valsartan is not recommended. Down titration of Entresto should be considered in patients who develop a clinically significant decrease in renal function.

Hyperkalaemia: Treatment should not be initiated if serum potassium is >5.4 mmol/l in adults and >5.3 mmol/l in paediatric patients. Use of Entresto may be associated with increased risk hyperkalaemia although hypokalaemia may also occur. Monitoring of serum potassium is recommended, especially in patients who have risk factors such as renal impairment, diabetes mellitus or hypoaldosteronism or who are on a high potassium diet or on mineralocorticoid antagonists. If clinically significant hyperkalaemia occurs, consider adjustment of concomitant medicinal products or temporary down-titration or discontinuation of sacubitril/valsartan. If serum potassium level is >5.4 mmol/l discontinuation should be considered. Angioedema: Angioedema has been reported with sacubitril/valsartan. If angioedema occurs, discontinue sacubitril/valsartan immediately and provide appropriate therapy and monitoring until complete and sustained resolution of signs and symptoms has occurred. Sacubitril/valsartan must not be re-administered. Patients with a prior history of angioedema were not studied. As they may be at higher risk for angioedema, caution is recommended if sacubitril/valsartan is used in these patients. Black patients have an increased susceptibility to develop angioedema. Patients with renal artery stenosis: Caution is required and monitoring of renal function is

recommended. Patients with NYHA functional classification IV: Caution should be exercised due to limited clinical experience in this population. Patients with hepatic impairment: Limited clinical experience in patients with moderate hepatic impairment (Child Pugh B classification) or with AST/ALT values more than twice the upper limit of the normal range. Caution is therefore recommended in these patients. B-type natriuretic peptide (BNP): BNP is not a suitable biomarker of heart failure in patients treated with sacubitril/valsartan because it is a neprilysin substrate. Psychiatric disorders: hallucinations, paranoia and sleep disorders, in context of psychotic events, have been associated with sacubitril/valsartan use. Consider discontinuation if patient experiences such events. Sodium: Entresto contains less than 1 mmol sodium (23 mg) per 97 mg/103 mg dose i.e. is essentially ‘sodium free’. Interactions: Contraindicated with ACE-I, 36 hours washout is required. Use with aliskiren contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2). Should not be co-administered with another ARB. Use with caution when co-administering sacubitril/valsartan with statins or PDE5 inhibitors. No clinically relevant drug-drug interaction was observed when simvastatin and sacubitril/valsartan were co-administered. Monitoring serum potassium is recommended if sacubitril/valsartan is co-administered with potassium-sparing diuretics or substances containing potassium (such as heparin). Monitoring renal function is recommended when initiating or modifying treatment in patients on sacubitril/valsartan who are taking NSAIDs concomitantly. The combination of sacubitril/valsartan and lithium is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended. Co-administration of sacubitril/valsartan and furosemide reduced Cmax and AUC of furosemide by 50% and 28%, respectively, with reduced urinary excretion of sodium. Co-administration of nitroglycerin and sacubitril/valsartan was associated with a treatment difference of 5 bpm in heart rate compared to the administration of nitroglycerine alone, no dose adjustment is required. Co-administration of sacubitril/ valsartan with inhibitors of OATP1B1, OATP1B3, OAT3 (e.g. rifampicin, ciclosporin), OAT1 (e.g. tenofovir, cidofovir) or MRP2 (e.g. ritonavir) may increase the systemic exposure of sacubitril or valsartan. Appropriate care should be exercised. Co-administration of sacubitril/valsartan with metformin reduced both Cmax and AUC of metformin by 23%. When initiating therapy with sacubitril/valsartan in patients receiving metformin, the clinical status of the patient should be evaluated. Fertility, pregnancy and lactation: The use of sacubitril/valsartan is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy. It is not known whether sacubitril/valsartan is excreted in human milk, but components were excreted in the milk of rats. Sacubitril/valsartan is not recommended during breast-feeding. A decision should be made whether to abstain from breastfeeding or to discontinue sacubitril/valsartan while breast-feeding, taking into account the importance of sacubitril/valsartan to the mother. No available data on the effect of sacubitril/valsartan on human fertility. Undesirable effects: Very common: Hyperkalaemia, hypotension, renal impairment. Common: Anaemia, hypokalaemia, hypoglycaemia, dizziness, headache, syncope, vertigo, orthostatic hypotension, cough, diarrhoea, nausea, gastritis, renal failure, acute renal failure, fatigue, asthenia. Uncommon: Hypersensitivity, hyponatraemia, postural dizziness, pruritus, rash, angioedema. Rare: Hallucinations, sleep disorders. Very rare: Paranoia. Please refer to SmPC for a full list of adverse events for Entresto. Pack sizes: Entresto 24 mg/26 mg - 28 tablet pack; Entresto 49 mg/51 mg - 28 and 56 tablet pack; Entresto 97 mg/103 - 56 tablet pack. Legal Category: POM. Marketing Authorisation Numbers: Entresto 24 mg/26 mg film coated tablets EU/1/15/1058/001; Entresto 49 mg/51 mg film coated tablets EU/1/15/1058/002-003; Entresto 97 mg/103 mg film coated tablets EU/1/15/1058/006. Marketing Authorisation Holder: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland.

Full prescribing information is available on request from Novartis Ireland Ltd, Vista Building, Elm Park Business Park, Merrion Road, Dublin 4.

Tel: 01 2601255 or at www.medicines.ie. Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu. Prescribing Information last revised: May 2023 Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing drugsafety.dublin@novartis.com or by calling 01 2080 612.

REFERENCES: 1. Seferovic PM, Ponikowski P, Anker SD, et al. Clinical practice update on heart failure 2019: pharmacotherapy, procedures, devices and patient management. An expert consensus meeting report of The Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019;21(10):1169-1186. 2. Hollenberg SM, Stevenson LW, Ahmad T, et al. 2019 ACC expert consensus decision pathway on risk assessment, management, and clinical trajectory of patient hospitalized with heart failure: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2019;74(15):1966-2011. 3. Maddox TM, Januzzi JL, Allen, LA, et al; 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2021 Feb, 77 (6) 772–810. 4. CaReMe Heart Failure in Adults: Diagnosis & Management Algorithm. Available at: cardionewsuk.org. (Accessed: November 2021). 5. ENTRESTO Summary of product characteristics. Available at www.medicines.ie 6. Januzzi JL Jr, Prescott MF, Butler J, et al; for the PROVE-HF Investigators. Association of change in N-terminal pro–b-type natriuretic peptide following initiation of sacubitril-valsartan treatment with cardiac structure and function in patients with heart failure with reduced ejection fraction [published online ahead of print September 2, 2019].

JAMA. doi:10.1001/jama.2019.12821. 7. Desai AS, Solomon SD, Shah AM, et al; for the EVALUATE-HF Investigators. Effect of sacubitril-valsartan vs enalapril on aortic stiffness in patients with heart failure and reduced ejection fraction; a randomized clinical trial. JAMA. 2019;322(11):1077-1084.

8. Ramani GV, Uber PA, Mehra MR. Chronic heart failure: contemporary diagnosis and management. Mayo Clin Proc. 2010;85(2):180-195. 9. McDonagh T, Metra M et al ESC Scientific Document Group, 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the ESC With the special contribution of the HFA of the ESC, European Heart Journal, 2021;ehab368, https://doi.org/10.1093/eurheartj/ehab368 10. McMurray JJV, Packer M, Desai AS, et al; for the PARADIGM-HF Investigators and Committees; Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004. 11. Velazquez EJ, Morrow DA, DeVore AD, et al; for the PIONEER-HF Investigators. Angiotensin–neprilysin inhibition in acute decompensated heart failure. N Engl J Med. 2019;380(6):539-548. 12. Wachter R, Senni M, Belohlavek J, et al; on behalf of the TRANSITION Investigators. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in-hospital or early after discharge: primary results of the randomised TRANSITION per approved citation: study [published online ahead of print May 27, 2019]. Eur J Heart Fail. 2019. doi:10.1002/ehjf.1498. 13. Claggett B, Packer M, McMurray JJV, et al; for the PARADIGM-HF Investigators. Estimating the long-term treatment benefits of sacubitril–valsartan. N Engl J Med. 2015;373(23):2289-2290.

14. Lewis EF, Claggett BL, McMurray JJV, et al. Health-related quality of life outcomes in PARADIGM-HF. Circ Heart Fail. 2017;10(8):e003430. 15. Chandra A, Lewis EF, Claggett BL, et al. Effects of sacubitril/valsartan on physical and social activity limitations in patients with heart failure. A secondary analysis of the PARADIGM-HF trial. JAMA Cardiol. 2018;3(6):498-505.

August 2023 | IE167236-1

12835_Entresto_PressAdverts_MedIndo_AUG23_01.indd 1

15/08/2023 14:17

A407123 Pfizer Cibinqo (Itch Relief) Adverts-FA | 520x346 DPS Layout | 06/09/2023

PRESCRIBING INFORMATION CIBINQO® ▼ (ABROCITINIB)

Please refer to full Summary of Product Characteristics (SmPC) before prescribing Cibinqo®.

Presentation: Film-coated tablets containing 50 mg, 100 mg, or 200 mg abrocitinib. Each tablet contains 1.37 mg, 2.73 mg, and 5.46 mg of lactose monohydrate, respectively. Indications: For the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. Dosage: Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. Posology: The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics. A starting dose of 100 mg once daily is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy. If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily. A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered. The lowest effective dose for maintenance should be considered. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks. Cibinqo can be used with or without medicated topical therapies for atopic dermatitis. Treatment initiation: TTreatment should not be initiated in patients with a platelet count < 150 × 103/mm3, an absolute lymphocyte count (ALC) < 0.5 × 103/mm3, an absolute neutrophil count (ANC) < 1.2 × 103/mm3 or who have a haemoglobin value < 10 g/dL. Dose interruption: If a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled. Interruption of dosing may be needed for management of laboratory abnormalities. Missed doses: If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, dosing should be resumed at the regular scheduled time. Interactions: In patients receiving dual strong inhibitors of cytochrome CYP2C19 and moderate inhibitors of CYP2C9, or strong inhibitors of CYP2C19 alone (e.g., fluvoxamine, fluconazole, fluoxetine and ticlopidine), the recommended dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g., rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin). In patients receiving acid reducing agents (e.g. antacids, proton pump inhibitors and H2 receptor antagonists), 200 mg once daily dose of abrocitinib should be considered (see section 4.5). Renal impairment: No dose adjustment is required in patients with mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60 to < 90 mL/min. In patients with moderate (eGFR 30 to < 60 mL/min) renal impairment, the recommended dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. In patients with severe (eGFR < 30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose. The maximum daily dose is 100 mg. Cibinqo has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy. Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Cibinqo must not be used in patients with severe (Child Pugh C) hepatic impairment. Elderly: For patients 65 years of age and older, the recommended dose is 100 mg once daily. Paediatric population: The safety and efficacy of Cibinqo in children under 12 years of age have not yet been established.

No data are available. Cibinqo has been studied in adolescents 12 to < 18 years of age. However, because of bone findings in juvenile rats (comparable to a 3 month old human), additional long-term data in growing adolescents is needed to conclude that the benefits outweigh the risks. Method of administration: This medicinal product is to be taken orally once daily with or without food at approximately the same time each day. In patients who experience nausea, taking Cibinqo with food may improve nausea. Tablets should be swallowed whole with water and should not be split, crushed, or chewed because these methods have not been studied in clinical trials. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Active serious systemic infections, including tuberculosis (TB), severe hepatic impairment, pregnancy, and breast-feeding.

Warnings and Precautions: Abrocitinib should only be used if no suitable treatment alternatives are available in patients: • 65 years of age and older; • patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers); • patients with malignancy risk factors (e.g. current malignancy or history of malignancy) Infections/serious infections: Serious infections have been reported in patients receiving Cibinqo. The most frequent serious infections in clinical studies were herpes simplex, herpes zoster and pneumonia. As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients 65 years of age and older abrocitinib should only be used if no suitable treatment alternatives are available. Treatment must not be initiated in patients with an active, serious systemic infection. Risks and benefits of treatment prior to initiating Cibinqo should be considered. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated. The patient should be closely monitored, and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Tuberculosis: Tuberculosis was observed in clinical studies with abrocitinib. Patients should be screened for TB before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered. Abrocitinib must not be given to patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, preventive therapy for latent TB should be started prior to initiation of treatment. Viral reactivation: Viral reactivation, including herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical studies. The rate of herpes zoster infections was higher in patients who were treated with 200 mg, 65 years of age and older, with a medical history of herpes zoster, with a confirmed ALC < 1 × 103/mm3 prior to the event and patients with severe atopic dermatitis at baseline.

If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy. Patients with evidence of active hepatitis B or hepatitis C (positive hepatitis C PCR) infection were excluded from clinical studies. Patients who were hepatitis B surface antigen negative, hepatitis B core antibody positive, and

hepatitis B surface antibody positive had testing for hepatitis B virus (HBV) DNA. Patients who had HBV DNA above the lower limit of quantification (LLQ) were excluded. Patients who had HBV DNA negative or below LLQ could initiate treatment; such patients had HBV DNA monitored. If HBV DNA is detected, a liver specialist should be consulted. Vaccination: No data are available on the response to vaccination in patients receiving Cibinqo. Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating treatment with this medicinal product, it is recommended that patients be brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines. Venous thromboembolism (VTE): Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving abrocitinib. In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors. A higher rate of VTE was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. In patients with cardiovascular or malignancy risk factors abrocitinib should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, abrocitinib should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder. Patients should be re-evaluated periodically during abrocitinib treatment to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue abrocitinib in patients with suspected VTE, regardless of dose. Major adverse cardiovascular events (MACE): Events of MACE have been observed in patients taking abrocitinib.

In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients 65 years of age and older, patients who are current or past longtime smokers, and patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, abrocitinib should only be used if no suitable treatment alternatives are available. Malignancy (excluding non-melanoma skin cancer [NMSC]): Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including abrocitinib. In a large randomized active controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and non-melanoma skin cancer (NMSC) was observed with tofacitinib compared to TNF inhibitors. A higher rate of malignancies (excluding non-melanoma skin cancer, NMSC) was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. In patients 65 years of age and older, patients who are current or past long-time smokers, or with other malignancy risk factors (e.g. current malignancy or history of malignancy), abrocitinib should only be used if no suitable treatment alternatives are available. Nonmelanoma skin cancer: NMSCs have been reported in patients receiving abrocitinib. Periodic skin examination is recommended for all patients, particularly those who are at increased risk for skin cancer. Haematologic abnormalities: Confirmed ALC < 0.5 × 103/mm3 and platelet count < 50 × 103/mm3 were observed in less than 0.5% of patients in clinical studies. Treatment with abrocitinib should not be initiated in patients with a platelet count < 150 × 103/mm3, an ALC < 0.5 × 103/mm3, an ANC < 1.2 × 103/mm3 or who have a haemoglobin value < 10 g/dL. Complete blood count should be monitored 4 weeks after initiation of therapy and thereafter according to routine patient management. Lipids: Dose dependent increases in blood lipid parameters were reported in patients treated with abrocitinib compared to placebo. Lipid parameters should be assessed approximately 4 weeks following initiation of therapy and thereafter according to the patient’s risk for cardiovascular disease. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Patients with abnormal lipid parameters should be further monitored and managed according to clinical guidelines, due to the known cardiovascular risks associated with hyperlipidaemia.

Elderly: The safety profile observed in elderly patients was similar to that of the adult population with the following exceptions: a higher proportion of patients 65 years of age and older discontinued from clinical studies and were more likely to have serious adverse reactions compared to younger patients; patients 65 years and older were more likely to develop low platelet and ALC values; the incidence rate of herpes zoster in patients 65 years of age and older was higher than that of younger patients. There are limited data in patients above 75 years of age. Use in patients 65 years of age and older: Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of tofacitinib (another JAK inhibitor), abrocitinib should only be used in these patients if no suitable treatment alternatives are available. Immunosuppressive conditions or medicinal products: Patients with immunodeficiency disorders or a first-degree relative with a hereditary immunodeficiency were excluded from clinical studies and no information on these patients is available. Combination with biologic immunomodulators, potent immunosuppressants such as ciclosporin or other Janus kinase (JAK) inhibitors has not been studied. Their concomitant use with abrocitinib is not recommended as a risk of additive immunosuppression cannot be excluded. Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Drug Interactions: Potential for other medicines to affect pharmacokinetics of abrocitinib: Abrocitinib is metabolised predominantly by CYP2C19 and CYP2C9 enzymes, and to a lesser extent by CYP3A4 and CYP2B6 enzymes, and its active metabolites are renally excreted and are substrates of the organic anion transporter 3 (OAT3).

Therefore, exposures of abrocitinib and/or its active metabolites may be affected by medicinal products that strongly inhibit or induce theses enzymes and transporter. Dose adjustments, as appropriate, may be required. Co-administration with products which increase gastric pH: When abrocitinib 200 mg was administered concomitantly with famotidine 40 mg, an H2-receptor antagonist, abrocitinib active moiety exposures decreased by approximately 35%. The effect of elevating gastric pH with antacids, or proton pump inhibitors (omeprazole) on the pharmacokinetics of abrocitinib has not been studied and may be similar to that seen with famotidine. The higher 200 mg daily dose should be considered for patients treated concomitantly with products which increase gastric pH, as they may reduce the efficacy of abrocitinib. Potential for Cibinqo to affect pharmacokinetics of other medicinal products: No clinically significant effects of Cibinqo were observed in drug interaction studies with oral contraceptives. Caution should be exercised for concomitant use of abrocitinib with dabigatran. Caution should be exercised as the levels of P-gp substrates with a narrow therapeutic index, such as digoxin, may increase. Caution should be exercised when using abrocitinib concomitantly with narrow therapeutic index medicines that are primarily metabolised by CYP2C19 enzyme (e.g. S mephenytoin and clopidogrel). Dose adjustment may be required for other medicines primarily metabolised by CYP2C19 enzyme in accordance with their product information (e.g. citalopram, clobazam,

CIBINQO 200 mg offers

RAPID and SUPERIOR

RELIEF

vs dupilumab1

Results through week 2 in a head-to-head study of CIBINQO 200 mg vs dupilumab with background TCS.

Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy2 RAPID

H R E LI E

F

I

TC

With week 2 PP-NRS4 data: 48% of adults

taking CIBINQO 200 mg achieved PP-NRS4 at week 2 compared to

26% of adults

taking dupilumab (P<0.0001)

Additional information: PP-NRS4 response for CIBINQO vs dupilumab at week 2 was a primary endpoint controlled for multiplicity. The onset of pruritus relief was assessed through a step-down approach, day by day, from week 2 to earlier time points once statistical significance was demonstrated at week 2, at the 5% level of significance. P value at day 2 is controlled for multiplicity for the family of PP-NRS4 comparisons.

TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.

PP-NRS4 is a 4 point or more improvement in Peak Pruritus Numerical Rating Scale.

escitalopram and selumetinib). Fertility, pregnancy, and lactation: Women of childbearing potential: Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose of Cibinqo. Pregnancy planning and prevention for females of reproductive potential should be encouraged. Pregnancy: There are no or limited amount of data on the use of abrocitinib in pregnant women. Studies in animals have shown reproductive toxicity. Abrocitinib has been shown to cause embryo-foetal lethality in pregnant rats and rabbits, skeletal variations in the foetuses of pregnant rats and rabbits and to affect parturition and peri/postnatal development in rats. Cibinqo is contraindicated during pregnancy. Breast-feeding: There are no data on the presence of abrocitinib in human milk, the effects on the breast fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and Cibinqo is contraindicated during breast feeding. Fertility: Based on the findings in rats, oral administration of Cibinqo may result in temporary reduced fertility in females of reproductive potential. The effects on female rat fertility were reversible 1 month after cessation of abrocitinib oral administration. Driving and operating machinery: Cibinqo has no effect on the ability to drive or use machines. Side Effects: The most commonly reported adverse reactions are nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%) including herpes simplex, herpes zoster, and pneumonia. Refer to SmPC for further information on side effects. Legal Category: S1A. Marketing Authorisation Numbers: EU/1/21/1593/002 - Cibinqo 50 mg (28 film-coated tablets), EU/1/21/1593/007 - Cibinqo 100 mg (28 film-coated tablets); EU/1/21/1593/012 - Cibinqo 200 mg (28 film-coated tablets). Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 467 6500. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Last revised: 03/2023.

Ref: CQ 5_0 IE.

References: 1. Reich K, Thyssen JP, Blauvelt A, et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet.

2022;400(10348):273-282.

2. Cibinqo Summary of Product Characteristics.

© 2023 Pfizer Inc. All rights reserved. PP-CIB-IRL-0125 | August 2023.

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

12

News Interview

‘We are definitely changing our model’ Priscilla Lynch speaks to the Managing Director of Vhi Health and Wellbeing, Ms Anne O’Connor, about joining the insurer from the HSE and the company’s ongoing moves into direct healthcare provision

I

n her previous role as HSE Chief Operations Officer, Ms Anne O’Connor became a familiar face during the Covid-19 pandemic, when she gave regular media updates on ICU bed numbers, community services, and vaccination roll-out.

So having reached the top table of HSE management after a 27-year career in public health services, it was something of a surprise when Ms O’Connor announced in April 2022 she would be leaving to join the private health insurance sector (her departure was swiftly followed by the then HSE CEO Mr Paul Reid).

It was clearly a big decision to take over as Managing Director of Vhi Health and Wellbeing. What prompted the move?

“I think for me it was a personal decision to I guess learn something new, something different,” Ms O’Connor told the Medical Independent (MI). “I had been around [the HSE] for so long that I kind of knew most people, most people knew me. So on day one in Vhi I walked in the door of Abbey Street, I didn’t know anybody, I’d never set foot inside the building. It was August so it was very quiet, and I thought what have I done?

We are definitely getting into the space of early intervention, integrated care

“But very quickly I realised that it was the right thing,” she said. “I think for me it really gave me a kind of a kick again in terms of having to learn, having to think differently. Every day was a learning day.

It was exhausting because it was a whole language that I just didn’t speak in terms of… the insurance world. It’s a group with subsidiary companies. It’s commercial.

But underpinning that in terms of the health and wellbeing company, it’s about patients and developing services. So that bit of it was very familiar to me. And that’s what I’ve always loved.”

When people talk about the health service, they generally mean the HSE and public services, according to Ms O’Connor. However, she pointed out that in Ireland almost half the population have private health insurance.

“I’ve learned that there’s a whole world of healthcare that goes on outside the

Ms Anne O’Connor public service that I probably knew very little about in hindsight. I think when you’re in a public service role like that you’re often just so busy dealing with the stuff that comes at you that you don’t really look up and see all that’s going on, so it’s been fantastic for that really.”

The shift to care provision Traditionally, health insurers in Ireland reimbursed and provided cover for inpatient healthcare expenses and their plans were primarily hospital-based. In recent years, the model has changed significantly, as more insurers have come into the Irish

market and a wider range of healthcare expenses are reimbursed, particularly in community care and ‘wellbeing’.

Health insurance companies also started directly providing urgent care with minor injury clinics and online/phone GPs and nurses initially. Now Vhi has moved

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

13

Interview News

into providing a wider range of services in its larger ‘360 Health Centres’. These services include diagnostics (MRI, x-ray, and ultrasound), targeted screening, women’s health, paediatrics, orthopaedics, wound care, physiotherapy, psychology, and dermatology.

Heading up Vhi Health and Wellbeing, Ms O’Connor’s responsibilities include overseeing the 360 Health Centres, the clinical call centre, digital platforms, and the Hospital@Home service. Some 18 months into the role, these initiatives continue to expand under her leadership in terms of uptake and services provided.

By September of this year, Vhi’s Health and Wellbeing division recorded more than 420,000 interactions from its members for a wide variety of healthcare needs, an increase of 33 per cent from September 2022. This included 220,000 interactions with members across the company’s digital and phone-based services, an increase of 28 per cent on this time last year. It also recorded 120,000 healthcare interactions with members in its 360 Health Centres in Dublin (Carrickmines and Swords), Limerick, and Cork, an increase of 40 per cent.

“The reality is we are definitely changing our model. We are definitely getting into the space of early intervention, integrated care…. And I think what makes us [Vhi] different is the integrated service delivery piece,” said Ms O’Connor of the expanded 360 Health Centres.

“So it’s not just about going to see a doctor and that’s it – we actually have specialist multidisciplinary teams, specialist physios, we have a DEXA scanner… we have the whole package in terms of women’s health.

Equally, we have launched our dermatology service this summer [in Carrickmines] and Dr Rupert Barry is the Clinical Lead for that.

“And what that means is you can go into an AllView centre, have your scan done, and then you will be called in for a face-toface if you need to see a dermatologist… or if you need a procedure. That only launched in July and we’re up to nearly 1,300 consultations already since July.”

She said that for a condition such as acne, for example, there may be a significant psychological component of care and the Vhi has a psychology service available onsite.

“So the dermatologists are referring directly into the Positive Mind service for people. It is about developing that specialist pathway.”

The 360 Health Centre initiative will be expanded to Galway in 2024. Ms O’Connor said patients in the rest of the country will be able to access these services in a hub-and-spoke model through their local GP. Direct referral will also be available through the company’s online/phone healthcare team.

She also pointed to the significant number of patients being seen at the Vhi’s urgent care clinics who would otherwise be presenting to public emergency departments, minor injury clinics, or GPs. Chronic disease management A significant focus of Ms O’Connor’s division is, as the title says, health and wellbeing. This involves trying to prevent people from developing chronic diseases or needing acute care. The role echoes her previous work in the HSE where she worked on de-

veloping community pathways and services to try to prevent those with chronic conditions deteriorating or experiencing acute exacerbations.

Referencing her background as an occupational therapist, Ms O’Connor said she believes in the concept of helping people to look after their health in the first instance and “services stepping in as required at an appropriate level”.

“And in the public service it’s so complex and there’s so much demand, not enough supply. It is a constant challenge just to keep up. And the reality is the public service has to respond to the most vulnerable and the people with the highest levels of need, and people will and should be prioritised on that basis.

“And I think what is different for us is that… we are obviously in the PMI [private medical insurance] world. It’s a different demographic in some ways… we are ahead of the general population in terms of ageing, but [trying to keep people well and intervene early] is no different to what the State is trying to do.

“We are developing that integrated care pathway that supports people from wellness, staying well, through to health promotion, through to primary care, into specialist services, and then with access to acute services, and that’s our pathway.”

Increasing GP involvement Expanding Vhi’s provision and reimbursement of primary care services is also a key focus for Ms O’Connor, with work well underway in this area. She confirmed that the Vhi is currently in discussions with the ICGP on creating a chronic disease management pathway for its members. There are existing pathways for medical card/GP visit cardholders under the HSE’s chronic disease management programmes in primary care.

“If you look at the impact of these programmes, the evidence is coming through now from the studies with the ICGP after two or three years showing the very significant reduction in costs as people manage their health, and are supported to manage their health, and then receive early intervention.

“So that’s the journey we’re on…. We would know and be very aware that people with PMI actually do not fare as well now in the space of chronic disease as those potentially with a medical card. If you go into your GP and you have diabetes, for example, the GPs now have a very clear pathway…. It’s really good….

“If you go with PMI, you know, the GP will do a bit, you’ll pay for it, and potentially refer you to three different specialists, to external dietitians, podiatrists, whatever.

So there isn’t a clear pathway for people with chronic disease and we would know in terms of claims and our population that our members have the same challenges as anybody in terms of chronic disease.

“So we are looking at how we work with GPs – not replace them or take business or any of that stuff – but actually partner with GPs in respect of chronic disease management for members. We’re really trying to get into nuts and bolts of primary care, but do it in a way that adds value, not actually strip anything away from anyone.”

As well as expanded primary care service reimbursement, the next big pivot for

the company is into direct provision of primary care services, Ms O’Connor told MI. “The big gap for Vhi has been actual delivery of primary care…. It is something that we have to get in place and we are starting that this year. We are working with some corporates because we hear a lot from some of our corporate members where they have transient staff coming into the country for three, six, nine months… and have no hope of getting access to a GP. We are looking at going into corporates and providing primary care services… and in parallel we are working very closely with the ICGP.” The payment model for members attending a direct Vhi GP/primary care service will be the same as in the community in that they can claim back a percentage of the cost of attending the GP from the insurer.

in urgent care and injuries, but some people are presenting with a requirement for a different type of response, she noted.

“We are now looking at how we triage people differently in urgent care, so that we have a kind of a primary care path and an urgent care path. That’s happening by default, if you like, that wasn’t planned.”

Future plans Looking ahead at potential additional services, Ms O’Connor said Vhi’s target model is “completely aligned” with the public Sláintecare healthcare policy.

“It is that ‘shift left’. It is about supporting people where they need to be supported, when they need to be supported and for the things they need support with. And that is our focus for our members. So it’s no different [to the HSE/Sláintecare]. We are not

In the health sector in Ireland, if everybody did what they could do really well, then all boats could rise together

This new service is entering its trial stage and will be reviewed next year. If successful it could be expanded further, Ms O’Connor said. She added that she believes the model would be attractive for clinicians as well as patients.

“We [already] have a lot of multidisciplinary teams, very specialist staff, who have decided to come and work with Vhi for all sorts of reasons, but not least because they get to really hone-in on their clinical skills.

It’s an opportunity to work clinically without the… ‘noise’ of the public system. But it’s different, it’s very different here. You can focus on patient care.”

As with the public hospital system, many patients presenting at the Vhi’s 360 Health Centres for urgent care could ideally be seen in primary care, said Ms O’Connor.

She explained recent data, particularly over the last two years, has shown that cases presenting to Vhi’s urgent care clinics “are now probably half urgent care and half medical”.

“We have many people presenting to our urgent care clinics because they cannot access the GP. And we are now at a point where we are having to look at that.”

The staff in these clinics are highly skilled

in competition. In the health sector in Ireland, if everybody did what they could do really well, then all boats could rise together,” she maintained.

“We want to do the things that we can do well, doing it within correct scope, doing it with the right specialists, multidisciplinary teams, integrated care, etc, and growing from there.”

There will be services that Vhi will not provide. It has no plans, for example, to enter the social care space. “It wouldn’t be appropriate to do so, or severe injury and mental illness…. I can’t see us owning hospitals.

“We have to work in a more kind of strategic way, I think, and in partnership. And that’s certainly something that we’re very committed to,” Ms O’Connor said.

Like the public system, Vhi is also looking at how to change to a value-based model, incorporating outcomes-based performance as opposed to “just paying out money for services”.

Ms O’Connor said it is a “really exciting” period. “There’s a huge wind behind us. The pressure is on us now to deliver it… we are still early in our journey. But we have a plan and certainly it’s my intention that we will continue to deliver that.”

Biography Ms Anne O’Connor is responsible for the leadership of Vhi Health and Wellbeing, guiding the delivery of health and wellbeing services through Vhi’s network of healthcare facilities.

She joined the Vhi, which has over 1.1 million members, from the HSE in August 2022 where she held the position of Chief Operations Officer with national responsibility for the delivery of all community-based and acute hospital services. Ms O’Connor led the HSE’s operational response throughout the Covid-19 pandemic and the 2021 cyberattack.

During her 27 years in the HSE she also held a number of senior clinical and executive management roles, including National Director for Mental Health and National Director for Community Operations.

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

14

Editorial

Letters to: The Editor, The Medical Independent, Greencross Publishing Ltd, 3rd Floor, 45 Lower Baggot Street, Dublin 2, D02 RK53 or email paul@mindo.ie

PAUL MULHOLLAND

Resources should be in line with increased demand

T

he latest monthly update from the Department of Health on waiting lists follows what is becoming a familiar narrative. More patients are being seen. However, higher than expected demand is hampering progress in reducing waiting lists.

At the end of November, the total waiting list exceeding the 10/12-week Sláintecare targets was 463,921. This is a 10 per cent reduction compared to February 2023.

However, the total waiting list is approximately 7.1 per cent behind the 2023 Waiting List Action Plan target. The reason is additions to waiting lists were approximately 6.8 per cent higher than projected.

Does this call into question how the health service estimates demand? The IHCA thinks so.

“Despite treating significantly more patients than planned, waiting lists have remained at a virtual standstill, due to a higher-than-expected level of patient demand,” the Association said in a statement.

“The inability to accurately forecast this additional demand has contributed to the recently announced €1 billion supplementary budget for health in 2023.”

Consultants are calling on the Government to urgently implement plans promised by the Minister for Health to put in place 1,500 additional rapid build acute hospital beds and four elective hospitals to address lengthening waiting lists. The IHCA also says the intention to establish surgical hubs nationally should also be expediated.

“A significant €407 million has been allocated for next year’s Waiting List Action Plan, which is currently being finalised,” according to the

READER COMMENTS REACTION TO DR SARAH FITZGIBBON’S COLUMN, ‘THINKING AHEAD AND PLANNING FOR THE END’, 5 DECEMBER “‘I paused to reflect on how lucky I am to have been present for all these “extra” years’– @SarahFitzWiMIN. And I am overwhelmed with gratitude and awe at what you keep on achieving!! Great advice for Christmas!" Prof Nóirín Russell, @russellnoirin, 7 December “Loved the honesty of your article Sarah. Thanks so much for sharing your personal journey and taking some of the anxieties and stigma out of advance care planning. #thinkahead." Jennifer Allen, @jenniferc_allen, 6 December “Thank you for sharing, @SarahFitzWiMIN! We appreciate your support. Think Ahead Planning Packs are available to order here www.hospicefoundation.ie."

Irish Hospice Foundation, @IrishHospice, 6 December

REACTION DR NEASA CONNEALLY’S COLUMN, ‘THE FOLLY OF THE RECRUITMENT EMBARGO’, 5 DECEMBER “An excellent piece!" Dr Sarah Barry, @SarahBarry11, 6 December

Association’s President Prof Robert Landers.

“However, there is nothing to suggest we won’t be in the same position come December 2024, looking back at another year of wasted opportunities.”

In terms of emergency departments, progress is also difficult to see.

A total of 11,289 patients waited on trolleys in hospitals in January, according to figures compiled by the Irish Nurses and Midwives Organisation. Last month the figure was 11,493.

While the financial difficulties of the health service are well known and have led to the widely criticised recruitment embargo, without resources in line with the high demand, 2024 will not be any better for patients or healthcare workers. However, in the spirit of the season, we can hope the situation improves over the next 12 months.

And as this is the last issue of the Medical Independent for 2023, Merry Christmas and Happy New Year to all our readers.

MINDO CARTOON

REACTION TO DR EOIN KELLEHER’S LATEST CARTOON, 5 DECEMBER “A very true ref lection." Arlene J, @ArleneJCock, 5 December “Love this." Amanda Lynch, @Ontheboldstep, 5 December

REACTION TO OUR BREAKING NEWS STORY, ‘RCSI ENDORSES LANDMARK UK REPORT ON REDUCING CARBON FOOTPRINT IN SURGERY’, 4 DECEMBER “Very welcome news today! RCSI endorses landmark UK report on reducing carbon footprint in surgery – Medical Independent. Modern surgical practice comes at a high carbon cost. #SustainableHealthcare." Irish Doctors for the Environment, @IrishDocsEnv, 6 December

REACTION TO DR SARAH FITZGIBBON’S COLUMN, ‘THE CONTESTED NATURE OF “THE TRUTH”’, 7 NOVEMBER “We are deafened by shouts of ‘my truth is truer than yours’. I used to think that something was either true or not true. Then I grew up."

Dr Sarah Fitzgibbon, @SarahFitzWiMIN, 9 November

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Tel: 01 441 0024 Web: www. medicalindependent.ie. GreenCross Publishing (est. 2007) is owned by Graham Cooke (graham@greenx.ie). © Copyright GreenCross Publishing Ltd. 2023. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means – electronic, mechanical or photocopy recording or otherwise – whole or in part, in any form whatsoever for advertising or promotional purposes without prior written permission of the publishers.

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THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

15

Medico-Legal Opinion MS STEPHANIE O’CONNELL, Legal Counsel in Medisec

The role of the expert witness Ms Stephanie O’Connell outlines what to expect if you are called on to be an expert witness

D

octors are often asked to provide expert reports in legal cases and, if necessary, to give evidence in court, at inquests, or regulatory hearings in relation to those reports.

Th is article sets out the difference between an expert witness and a factual witness, explores the principal duties of an expert witness, and looks at some notable case law giving further guidance on the role.

What is an expert witness?

If a doctor is asked to prepare a report or give evidence in any proceedings, it is important to distinguish between giving evidence as a medical professional witness/factual witness and giving evidence as an expert witness.

A factual witness can give evidence concerning matters that they have personally witnessed, such as an examination of the patient in the course of treatment. They cannot give evidence of their opinion.

An expert witness, on the other hand, is an independent individual with no link to a case, who is retained to provide an expert opinion on matters outside the ordinary knowledge of the court. An expert witness can give evidence of what they know or believe to be true on the basis of their expertise.

The primary role of the expert witness is to provide the court with the necessary specialist knowledge to enable the court to apply that knowledge to the facts in issue and for the court to arrive at its own independent opinion on those facts.

Duties of an expert witness Order 39 Rule 57 of the Superior Court Rules states: “It is the duty of an expert to assist the court as to matters within his or her field of expertise. This duty overrides any obligation to any party paying the fee of the expert.”

It is crucial that any doctor acting as an expert witness does not to lose sight of the fact that their overriding duty is to the court, and not to the party instructing them. The Superior Court rules also require that experts acknowledge that duty by including a declaration to that effect in any report prepared by them. Expert witnesses are also obliged to disclose any fi nancial or economic interest in any business or economic activity of the party retaining them.

Experts must ensure that their reports and evidence are confi ned to their area of expertise and should not give opinions on matters falling outside of their expertise.

Experts should ensure that the evidence they provide in support of their opinion is accurate and not misleading.

Reasonable steps should be taken to ensure that all relevant and available information has been considered. An expert who clearly states that they cannot comment on a particular issue, or acknowledges that a particular point could be interpreted differently by others, will usually enhance their credibility by doing so.

The new ethical guide The Medical Council has provided guidance on the role and duties of an expert witness for the fi rst time in the ninth edition of the Guide to Professional Conduct and Ethics for Registered Medical Practitioners, (the ‘Guide’), which was recently published. It will become operational on 1 January 2024. The Guide makes it very clear that the fi rst duty of an expert witness acting in legal proceedings is to be of assistance to the relevant court or tribunal in providing an independent expert opinion.

The Guide sets out the following obligations when acting as an expert witness:  You must be honest and objective in all your spoken and written statements.

An expert witness… is an independent individual with no link to a case, who is retained to provide an expert opinion on matters outside the ordinary knowledge of the court

 You must make clear the limits of your knowledge and competence.  You must not act as an expert witness in areas outside your scope of practice, experience, and expertise.

The Guide confi rms that these obligations override any instructions from the person paying you a professional fee for your expert opinion.

The obligations set out in the Guide mirror the duties set out in the Superior Court Rules and case law. It is important for practitioners to bear in mind that any breach of the provisions of the Guide could result in allegations of poor professional performance or professional misconduct.

One important distinction between the approach to expert evidence in Ireland and the UK is that, in the UK, if an expert comments on a matter outside their expertise, their instructing solicitor can ask them to remove that comment from their report without impacting the expert’s duties to the court. There is no such equivalent provision in Ireland and any draft expert report provided by an expert to their instructing solicitor could be disclosed to the other side. For that reason, it is important that experts are clear on what their instructions are and are also able to resist any suggestion from instructing parties to amend their report, unless of course there are clear factual errors.

Case law The duties of an expert witness have been addressed in several cases in the Irish courts.

In Duff y v McGee T/A McGee Insulation and GMS Insulations Limited, a Court of Appeal judgment from November 2022, it was held that: “The overriding duty of the expert is owed to the court and includes the duty to provide an objective opinion. Objectivity by definition requires that one has regard to both sides of the case. An essential component of

the duty of the expert is to ascertain all relevant facts whether they support the client’s case or not.”

The expert in this case was a toxicologist, but had strayed far beyond his remit by commenting on other matters. The Court of Appeal held that: “Far too frequently, expert witnesses appear to fundamentally misunderstand their role and wrongly regard themselves as advocates for the cause of the party by whom they have been retained.”

The Court identified a number of ‘red flags’ in the expert’s evidence including:  Expressing views on legal doctrines when acting as a toxicologist.  Making categorical statements about disputed issues about which he had no independent knowledge.  Accusing the plaintiffs of misrepresentation.  Accusing the plaintiffs of not telling their treating doctors the full truth and criticising their doctor’s evidence as a result.  Expressing views on reports prepared by a psychiatrist.

Th is judgment serves as an important reminder to expert witnesses and legal practitioners alike of the strict parameters of the role and responsibilities of an expert witness when engaged in litigation.

In the 2015 High Court case of Waliszewski v McArthur, a medical expert failed to mention in his report that the plaintiff had been involved in a subsequent road traffic accident as he thought this might cause confusion.

The Court stated that “…his failure to do so is reprehensible and is to be deprecated” and rejected the expert’s explanation that the omission was with the intention of not causing confusion. It is noteworthy that the Court in that case directed that a copy of its decision be sent to the Medical Council.

Challenges Barriers to undertaking expert witness work, including time constraints and unfamiliarity with the legal system, mean that doctors who take on expert work are often those at the end of their careers, some of whom have been out of clinical practice for a considerable time.

Doctors might also be discouraged from acting as an expert witness in a case involving a colleague and this has traditionally been a difficulty in Ireland given the relatively small size of the medical community. Doctors should be reassured that knowledge of a party to litigation or inquiry does not necessarily disqualify them from acting, but they should be careful to disclose any connection that they might have with a case or party to it.

There is arguably a benefit to the profession, and indeed the administration of justice, if Irish experts can give evidence in Irish courts. A local expert, who is also a practising doctor, will have a keen understanding of the workings, and the nuances, of the Irish healthcare system.

Conclusion It is important that there are enough medical practitioners, across all disciplines of medicine, that are willing and able to act as expert witnesses. The new provisions in the Medical Council’s Guide provide very clear guidance to doctors considering taking on this important work. Doctors who act as expert witnesses should familiarise themselves with the obligations and duties associated with the role to ensure that they discharge their duty to the court appropriately and should bear in mind: “The acid test is whether the expert’s opinion would not change regardless of which party retained him or her.” (Supreme Court of Canada – White Burgess Langille Inman v Abbott and Haliburton).

References available on request

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

16

Opinion DR LUCIA GANNON

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

@LuciaGannon

A prayer for peace Perhaps the most difficult thing we can do this Christmas is maintain peace in our hearts

C

hristmas will be challenging this year as many people grapple with the horror of the escalation of the war in the Middle East. As we undertake our usual preparations, it is impossible not to feel the sadness that hovers within the collective consciousness or to grieve the loss of innocent lives of people just like us. Just 45 miles from Bethlehem, families and communities are being destroyed while those who survive are sentenced to lives of sorrow and pain.

These are the images that come to mind this year when I hear the strains of Little Town of Bethlehem or Oh, Holy Night. The melodies are punctuated by gunfire, rocket shells, and the sounds of people screaming.

It is impossible to comprehend that people like ourselves can inflict such suffering. It is even harder to understand that there is no way to stop the devastation, to know that even as I write, the numbers of dead and wounded are rising.

As a child, my parents insisted that we always consider the people less fortunate than ourselves: The sick, the homeless, the lonely. They reinforced this repeatedly at Christmas time, believing, I think, that this would make us more appreciative and grateful grown-ups. I never understood the rationale for thinking about other people’s suffering when I could not do anything to relieve it. To my child’s mind, it was the same flawed logic that led adults to insist that children eat everything on their plates because less

fortunate children were starving in Africa. These (un)wise pronunciations only made me feel powerless and guilty for being born into favourable circumstances and being able to enjoy the fruits of my parents’ labour.

Today, when I turn on the news or pick up a newspaper, I am struck by that same helpless feeling alongside low-level guilt that I can work and play and occupy myself with multiple trivial concerns while at the same time, others, no different from me, are cold, hungry, and frightened. While innocent people fear for their lives or wait impotently as multiple negotiating parties decide their fate. While remote powers decide who will be traded and who will remain in captivity.

I do not wish to write about the war as I am not qualified to do so. Neither do I think that a primer on the history of the Middle East would make me more capable. It is a war that, for me, defies opining or polarising. The scale and depth is too vast. No new information or insight could help me understand why people treat each other in such a manner. There is no justification for such horror. As Kurt Vonnegut said in support of his son’s conscientious objection to the war in Vietnam, “There is no hope in war.” War does not solve anything. It destroys everything in its path and leaves a legacy of fear, hatred, and revenge. Because of it, the world is a lesser place; we are all poorer in spirit while others suffer.

Of course, we are not the first to live through such atrocities. Families and generations still suffer the effects of World

War I and II. Unfortunately, humans do this to each other with regularity. Whether we like it or not, it is part of who and what we are. As Terence, a playwright in the Roman Republic, is purported to have said, “I am human and I think nothing human is alien to me.” So perhaps, under different circumstances, any one of us could commit atrocities.

In other circumstances, with our backs against the wall, to protect our birthright, our families or our future. Perhaps, unbelievable and all as it seems, any one of us could be driven to commit terrible deeds. I try to keep this in mind as I prepare to celebrate the holiday. How would I react to constant conflict, threat, and fear? I hope I never have to find out.

So, perhaps, the best that we can do while enjoying peace and freedom is to be respectful of and grateful for our good fortune. To light the dark evenings with Christmas lights, sing Christmas carols with our neighbours and friends, and send compassionate wishes to all people everywhere, victims and the perpetrators, rich and poor, sick and healthy.

Perhaps the most difficult thing we can do this Christmas is maintain peace in our hearts and in our corner of the world. Show tolerance for those who need refuge and respect the humanity in all.

So, as we come to the end of another year, thank you for your attention throughout the year and for all your kind comments. I wish you and yours a happy and peaceful Christmas, wherever you are, and whatever your circumstances. Nollaig faoi shéan agus faoi mhaise.

Opinion DR MUIRIS HOUSTON

Read more by Dr Muiris Houston at www.mindo.ie

@muirishouston

Why are festive songs such earworms?

Christmas music, whether we think it’s good or bad, is usually more popular than it might deserve to be

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or the first time ever, I experienced the run-up to Christmas in a warm climate.

The youngest H offspring has decamped to Melbourne for the foreseeable and so Mrs H and I decided we should go and visit her in November. Included in our festive experience was a brief en route sojourn in Singapore.

Seasoned travellers will not be surprised to hear that it is presently monsoon season in Singapore. So, although there’s not much in the way of sunshine, the city state was wet and warm, with temperatures in the high 30s.

Being a shopping Mecca, Christmas decorations were in full-on mode. I saw the most beautiful silver-coloured Christmas tree, with a Chanel logo on top stretching to five stories in height, in one vast mall.

Over in Melbs (it’s what the Aussies call the place), there were few enough fully decorated Christmas trees on the streets. Which seemed kind of appropriate given the long, light-filled summer evenings, and the pleasantly warm temperatures.

But there was no such restraint with the Christmas music. It was everywhere: Shops, restaurants, and on the streets. To this northern European, it seemed very odd indeed.

However, it seems that Christmas music has a self -soothing effect. So, whether you live in snow-capped northern mountains or in sun-filled equatorial Africa, Christmas music works its magic.

According to Daniel Levitin, a Professor Emeritus of Psychology and Neuroscience at McGill University in

Montreal in Canada, research has shown that most people in Western countries use music to self-soothe.

“They know that there are certain kinds of music that will put them in a good mood,” he said. “Christmas music is a reliable one for a lot of people.”

Levitin says that listening to a song that has not been heard in a long time can transport a person back in time.

And for those who find joy in Christmas music, the brain increases serotonin levels and may release the hormone prolactin.

Christmas music, like all forms of music, is powerful.

But this genre is perhaps more potent than other forms of music because the holiday season itself is emotionally charged. It represents the ideals that most humans strive for like equality, tolerance, love, and tranquility. “For some of us, that’s an inspiring message,” Levitin notes.

Apparently, Yuletide music was originally sung to celebrate the winter solstice. These songs were performed in communal, secular settings and as early as the 3rd Century Christianity adapted Yuletide festivals for celebrations of the birth of Jesus.

By the 20th Century, secular Christmas songs like I’ll Be Home for Christmas and White Christmas came into vogue, bringing solace, particularly to World War II soldiers who were posted far from families and loved ones.

These songs became popular during the war because people were seeking something traditional – some sense of family and peace – even as their whole world was being blown to smithereens.

Indeed, White Christmas by Irving Berlin is not only

consistently one of the most well-known Christmas songs, but is the best-selling song of all time.

Christmas tunes are more likely to become earworm music. And because of the dominance of Christmas music in public settings, such as shops and bars or on the radio, we all get a lot more exposure to the same songs than we do at other times of year. So you could argue that Christmas music helps bring us together.

The pattern of liking for an individual song over time is thought to fit an inverted U-shaped curve. According to this theory, when we first hear a new piece of music we tend to not like it very much. But repetition breeds liking – and repetition both within a song and through repeated listening over days and weeks will usually increase our liking in a fairly rapid linear way.

That means a lot of Christmas music, whether we think it’s good or bad, will be more popular than it might deserve to be as it usually only gets aired a few months of the year. And by the time the first week of January comes around, the curve falls away rapidly as we become thoroughly sick of Christmas tunes.

Whatever my perceptual difficulties with celebrating Christmas Down Under, it seems Christmas music transcends this. So, when my daughter and her friends descend onto the beaches of St Kilda on Christmas Day, they too can experience a true spirit of Christmas.

I would like to wish a Happy Christmas to all our readers, especially to the many doctors from abroad who keep our health service alive while they themselves are separated from family at home.

ANSWER 1 A. TRUE. Also endometriosis, chlamydia, intrauterine contraceptive device.

B. FALSE. Sudden abdominal pains followed by mild vaginal bleeding.

C. FALSE. Consider in any woman of reproductive age with unexplained abdominal pain whether has missed a period or not.

D. FALSE, May be mild, intermittent, or prolonged.

E. FALSE. May get cervical excitation tenderness, but a pelvic mass is not usually felt.

ANSWER 2 A. TRUE. Other risk factors include premature birth, neurological disorders, and Down syndrome. For many, no obvious cause.

B. TRUE. Easiest way to pick up the problem.

C. FALSE. Acquired convergent squint, which presents at two-to-three years, is frequently associated with hypermetropia.

D. FALSE. Constant squint is abnormal at any age and should be referred for treatment. An untreated childhood squint present after three months of age is unlikely to resolve without treatment.

E. FALSE. Has a good chance of establishing some basic form of binocular vision, but very rare for normal stereopsis to be attained.

ANSWER 3 A. TRUE. Sudden and may relieve the headache.

B. FALSE. Vice like or gripping pain that tends to occur early in the morning.

C. FALSE. Vomiting is not preceded by nausea.

D. TRUE. Usually with episodes of transient blindness.

E. TRUE. Any activity which increases intracranial pressure.

ANSWER 4 A. FALSE. Maximal at moment of onset with progressive resolution over minutes or hours.

B. FALSE. About one-in-six have a mild headache.

C. FALSE. Highly unusual.

D. FALSE. Many ‘negative’ symptoms.

E. TRUE. Symptoms attributable to focal areas of brain, eg, motor cortex or language areas.

ANSWER 5 A. TRUE. But use is limited by toxicity in higher doses.

B. FALSE. Unlike NSAIDs it does not cause fluid retention.

C. FALSE. There is no interaction.

D. TRUE. Maximum 6mg per course. Do not repeat course within three days.

E. TRUE. Nausea and vomiting are most common.

A. Is probably as effective as NSAIDs. B. Use is contraindicated in patients in heart failure.

C. Cannot be given to patients receiving anticoagulants.

D. Recommended dose is 0.5mg two-to-four times a day.

E. Side-effects include abdominal pain.

Question 5

IN THE TREATMENT OF ACUTE GOUT, COLCHICINE A. Deficit maximal three-to-four hours after onset of symptoms.

B. Severe headache.

C. Loss of consciousness.

D. ‘Positive’ features, eg, unwanted movement rather than loss of movement.

E. Limb symptoms clearly lateralised.

Question 4

CHARACTERISTIC FEATURES OF TRANSIENT ISCHAEMIC ATTACKS (TIAs) INCLUDE A. Projectile vomiting.

B. Headache worsening as the day goes on.

C. Continuous nausea.

D. Progressive loss of visual acuity.

E. Headache worsened by coughing.

Question 3

TYPICAL SYMPTOMS OF INCREASED INTRACRANIAL PRESSURE INCLUDE A. Common risk factors are if the child is nearsighted or farsighted.

B. Will make the corneal light reflexes asymmetrical.

C. In all cases require spectacle correction of hypermetropia.

D. If constant but small, should be observed for six-to-12 months to see if natural resolution occurs.

E. If convergent, will not benefit from surgery (other than cosmetically).

Question 2

IN CHILDREN, STRABISMUS A. Predisposing factors include assisted conception.

B. Abdominal pain follows vaginal bleeding.

C. Diagnosis should be considered only in women who have missed a period.

D. Pain is always severe and prolonged.

E. On physical examination, a pelvic mass is normally felt.

Question 1

IN ECTOPIC PREGNANCY

MULTIPLE CHOICE QUESTIONS MCQs 17

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

18

Clinical Dermatology

Article and series in association with

UCD CHARLES INSTITUTE SEMINAR SERIES

Targeting the integrin αvβ6 for imaging and therapy of carcinoma Attendees at UCD’s Charles Institute Seminar Series heard a presentation by Prof John Marshall on αvβ6 integrin expression and its role in modulating tumour growth

T

he Charles Institute, Ireland’s national dermatology research and education centre, hosted the fourth seminar of this series on 24 November 2023. The series is sponsored

by RELIFE (part of the A.Menarini group), and provides expert advice, research updates, and the best available evidence from a range of distinguished national and international experts in their respective fields.

It is 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 are held using a hybrid model, combining in-person attendance with interactive online access. Typical audiences include UCD researchers, dermatologists, and other clinicians with an interest in dermatology and cutaneous science.

The latest seminar was delivered by Prof John Marshall, Professor and Centre Lead for Tumour Biology, Bart’s Cancer Institute, London. Prof Marshall developed the widely used quantitative 3D organotypic invasion assays for the study of tumour-stroma interaction to help analyse integrin behaviour, and is co-recipient of the Pancreatic Cancer UK Grand Challenge Award. His insightful talk, entitled: ‘Targeting the integrin αvβ6 for imaging and therapy of carcinoma’, examined αvβ6 expression in several cancers, its correlation with poor survival and metastases, and how antibody blockade of the integrin can improve patient outcomes. Prof Marshall also described the discovery of the αvβ6-specific peptide A20FMDV2 and its role in radio-imaging αvβ6-expressing cancers.

Integrin αvβ6 and cancer Prof Marshall began by detailing the “very high” levels of αvβ6 expression seen in many cancer tissues and delivered a general overview of the epithelial-specific molecule. He said that αvβ6 is “weak or absent” in most resting tissues and is one of only two integrins that can activate latent TGFβ, “which is anchored into the extracellular matrix” and “drives a wound healing response”. Attendees also heard that excess αvβ6, and subsequent over-activation of TGFβ, is involved in fibrosis development in many idiopathic lung diseases and some kidney diseases.

Describing some of his work in cancer research, Prof Marshall presented the strong correlations between high expression of αvβ6 and poor prognosis and survival in various forms of carcinoma. Pancreatic ductal adenocarcinoma (PDAC), “the most common form of pancreatic cancer,” was the first focus of the talk. “We looked at hundreds of samples and found that 98 per cent of PDAC express αvβ6,” he said, and emphasised the

Prof John Marshall poor survival associated with the disease.

Prof Marshall also told attendees that in paired primary and metastases samples, all of the metastases were positive if αvβ6 was expressed by the primary. “If you had an αvβ6-targeted therapy that was effective, then you would be hitting the metastases as well,” he added. Prof Marshall then shared a range of research to identify an αvβ6-targeted therapy in PDAC, including the development of a human xenograft model, before examining the relationship between αvβ6 and breast cancer.

Attendees heard that 40 per cent of breast cancer samples expressed moderate-to-strong levels of αvβ6 in a cohort of 2,000 patients, and Prof Marshall again noted a strong link with poor overall survival.

He also discussed breast cancer subtypes, and described the “very strong relationship” between HER2-positive cancers and αvβ6.

“If you have high HER2 and high αvβ6, it is one of the worst diagnoses you can get in breast cancer,” he said.

Targeting αvβ6 Prof Marshall presented a range of research targeting various αvβ6 pathways throughout his talk, and placed particular focus on 264RAD – a human therapeutic antibody that binds to and inhibits αvβ6 integrin function. He explained that 264RAD can suppress, but not completely inhibit, the number of tumours; the rate of tumour growth; the number of metastases; and their rate of growth in various study models. Prof Marshall also gave some insight into ways he and his colleagues carried out “a slightly different analysis” during RNA sequencing to look for “a gene signature” – common gene changes that occurred when β6 was lost, or mice were treated with 264RAD. Prof Marshall described a positive gene signature as “a good matrix index”.

“A good matrix index can actually identify all the people with a better survival outcome in breast cancer,” Prof Marshall said, and

also demonstrated correlations between the matrix index and other forms of solid tumours, including ovarian, oesophageal, and lung. He then delivered an overview of findings from a study exploring sequential changes in gene expression profiles in breast cancer during treatment with the aromatase inhibitor, letrozole, that showed the matrix signature he and his team discovered was predictive of patient outcomes. “If you had a signature that could predict in two weeks if your drug was working, you would save any healthcare service millions,” Prof Marshall added. He then proceeded to describe various ways that αvβ6 drives a dynamic interaction with the microenvironment, before exploring imaging αvβ6 in cancer therapy.

Attendees were introduced to A20FMDV2, a peptide Prof Marshall and his colleagues discovered in foot and mouth disease while looking for proteins specific to αvβ6. They heard that A20FMDV2 permits radio-imaging of αvβ6-expressing cancers, and received an overview of the structure of A20FMDV2 while bound to αvβ6. Prof Marshall also explained that A20FMDV2 is particularly effective as it only binds to αvβ6-expressing cells and is rapidly internalised in cells by the αvβ6.

Prof Marshall then presented studies using αvβ6 inhibition as a means of differentially measuring idiopathic pulmonary fibrosis and more research to develop various peptide drug therapies for targeting αvβ6.

He showed that peptide drug therapy selectively kills αvβ6-positive PDAC spheroids, promotes DNA damage and cell apoptosis, and “surprisingly” causes no gross damage to normal β6-positive tissues in a variety of models.

“Targeting αvβ6-positive cancers with antibody blockade is likely to have a therapeutic effect. When combined with conventional treatment, I think it’s going to be an added benefit, particularly for targeting and suppressing metastases. Radio-imaging is a way of monitoring this progress and it will work in lots of different cancers. Because the αvβ6 is maintained in metastases, you may even be able to find those. Eliminating the αvβ6-positive cancers with drug therapy has been the most effective thing we’ve managed to do in the last 10 years, and it strikes me as probably the way forward when we think of delivering therapy. We can slow things down by blocking β6, but we can eliminate β6-positive cancers by sending in peptide therapy, or possibly antibody cytotoxic therapy.” αvβ6 and the skin Concluding from a dermatology perspective, Prof Marshall declared his interest in epidermolysis bullosa (EB). He noted that squamous cell carcinoma (SCC) “occurs at a 70-fold higher” rate in those with recessive

dystrophic EB (RDEB) than in non-RDEB patients, and that most have αvβ6, which is also present on EB blisters. “There’s masses of β6 on the keratinocytes,” Prof Marshall said. The area of EB and SCC was addressed again in a lively, post-talk questions and answers session.

Describing cancer as “a wound that never heals” and acknowledging the hugely increased risk of SCC in RDEB, Prof Tobin noted that the cancer these patients experience is generally “aggressive” and “different”. Prof Marshall agreed, and replied by describing RDEB as a “fascinating disease” for a tumour biologist. He said that in genetic analysis of SCC in RDEB and non-RDEB, “they are virtually identical”, and that the difference lies in the tumour microenvironment (TME).

“When you look into the TME, there are hundreds of different genes being switched on in the fibroblasts of non-RDEB patients versus a RDEB SCC. It’s a massive difference. This is the nearest you can get to proof that the TME is determining the outcome of the cancer.”

Prof Tobin was also keen for more information relating to the earlier data Prof Marshall had presented from mouse studies that targeted metastases, and asked if any unusual differences in αvβ6 expression had been recorded between the mice that were reduced to single metastases and those that persisted with multiple metastases. “In the metastases, the β6 expression is really patchy compared to the primary, and you can get metastases that are β6 null,” Prof Marshall replied. “I think the β6 is regulating that initial event at the primary tumour that is allowing the metastases to occur.”

Prof Tobin also asked about the “antibody effect”, clarifying that antibody therapy alone acts to slow growth, and that the cell tumour load is not changed. Prof Marshall replied by saying: “It does two things. It stops the growth and it stops the β6 effect on the TME via TGFβ. That’s why you’ve got that direct and indirect signalling going on.”

The interaction then evolved into whether the TGFβ pathway could be “another route to come in separately from” in cancer research. Prof Marshall explained that studies using antibodies and small molecule inhibitors have been ongoing within the TGFβ approach. “The problem is the way they gave them initially was too toxic,” he explained, and went on to describe the homeostatic mechanisms that are dependent on TGFβ processes and become affected by global TGF inhibition. He concluded by saying that brief, transient therapy may, however, provide palliative and tumour growth-slowing benefits in the future.

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THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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Commercial Meeting Report Irish Society for Rheumatology, Autumn Meeting, Fitzpatrick Castle Hotel, Killiney, Co Dublin, 21-22 September 2023

Optimising outcomes in RA During the Irish Society for Rheumatology Autumn Meeting, a dedicated symposium* took place, looking at improving patient outcomes in rheumatoid arthritis through increasing clinical remission rates

T

he AbbVie Symposium: The EVEREST Challenge: Peak Ambition in Advancing the Standards of Care in RA was chaired by Dr Carl Orr, St Vincent’s University Hospital, Dublin, and included presentations from Prof Grainne Murphy, Consultant Rheumatologist, Cork University Hospital; Dr Carmel Silke, Consultant Rheumatologist, Our Lady’s Hospital, Manorhamilton; and special guest speaker Associate Professor Andrew Östör, Consultant Rheumatologist, Malvern, Victoria, Australia.

Aims of EVEREST Dr Orr opened the session by giving a brief overview on the aims of EVEREST. “In short, EVEREST is an international network of opinion leaders who have come together to try to achieve better outcomes for our patients with rheumatoid arthritis (RA). What we mean by that is to get as many people into clinical remission as possible.”

He noted that there is “robust clinical data” showing that early intervention and working towards a specific defi ned target in RA, ie, remission, is associated with better longer-term outcomes across a range of disease and quality-of-life areas.

Dr Orr compared RA treatment today to 30 years ago – when management of RA was challenging, and a lack of effective treatments saw patients experience significant functional loss and irreversible joint damage.1 Advancements in the optimum use of methotrexate, new therapies such as the biologics, evidence-based treatment guidelines, and earlier diagnosis and treatment, coupled with treat-to-target approaches, mean that today, patients with RA experience more effective inflammation control, low disease activity is achievable, and remission is possible.2 However, despite these advances, remission rates remain suboptimal, Dr Orr acknowledged: “We now know that remission is a realistic target for most patients with RA, but we are not entirely sure how many patients actually experience that.”

Dr Orr said it is important to understand that there are multiple complex reasons as to why more RA patients aren’t experiencing disease remission, which the EVEREST initiative explicitly acknowledges and has designed tools and solutions to help address.

Unmet needs and barriers The next speaker, Prof Grainne Murphy, discussed the unmet needs and barriers rheumatologists and patients face in trying to achieve remission in RA. “In terms of our unmet needs in RA currently, in an ideal world we would like to see patients early, to treat-totarget with aggressive therapy… but we still face a scenario where we don’t diagnose patients in an early enough timeframe.”

She then outlined local and international data on remission rates in RA. Looking at a Swedish registry (SRQ), Prof Murphy noted that remission in RA patients (five years after symptom onset) increased from 16 per cent in 1999 to 45 per cent in 2009,3 with similar results in a Norwegian cohort (NOR-DMARD registry), where there was a two-fold increase in remission rates (at six months) observed between 2000–2010 in a large cohort of patients with RA.4 However, despite these improvements, many RA patients still do not achieve remission.5 A Danish cohort had even lower results – 75 per cent of patients were not in remission at six months (DANBIO registry), though she pointed out that the criteria used to defi ne remission can vary (DAS28, etc).6

Pictured L-to-R: Dr Carl Orr; Prof Grainne Murphy; Dr Carmel Silke; and Prof Andrew Östör, participating in a panel discussion

Irish research shows similar results: Prof Murphy reported data from the Irish CONTExT RA study, a multicentre cross-sectional observational study evaluating disease activity, quality-of-life and work productivity of 130 Irish patients with RA (mean age 60.1 years, mean duration of disease 11.6 years), where only 26.2 per cent of the cohort were classified as having achieved clinical remission and 32.3 per cent had low disease activity.7 “So why does remission matter?” she asked, pointing out that the study also showed a statistically-significant difference in quality-of-life, lower healthcare utilisation, and increased work productivity in the RA patients who were in clinical remission vs other disease activity states including low disease activity.6,7 The CONTExT RA study also found, however, that in only approximately one-third of RA patients with moderate/high disease activity (‘non-responders’), there was a plan in place to add or switch treatment, ie, try a different DMARD. Speaking again after Prof Murphy’s presentation, Dr Orr presented data from a survey of US patients with RA,8 which showed that despite high disease activity, many patients were not offered a treatment change or declined a treatment change, with UK research confi rming that remission as a concept is poorly understood by many patients, with over half never discussing it with their clinician.9 Remission The next speaker, Prof Andrew Östör, a member of the global EVEREST steering committee, discussed the need to improve knowledge and awareness of clinical remission in RA, and to engage patients in a shared care approach to optimise treatment and achieve better outcomes.

“Treat-to-target has been around for about 15 years, but how do we optimise it? We’ve come a long way; we’re about half-way up that mountain, but we want to achieve the peak. What do we need to achieve that? Th is is what EVEREST is trying to achieve.”

He explained that the EVEREST initiative was aware

that barriers varied from country to country so local solutions were needed to optimise the implementation of treat-to-target approaches, and that any tools the initiative created needed to be evidence-based, practical, and accessible.10 These tools have now been fi nalised into three key areas, including a telehealth toolkit, a shared decision-making toolkit, and a healthcare professional self-reflection learning tool, and will be disseminated next year.

There will then be an evaluation and assessment process, to determine if the tools make a difference and are useful, Prof Östör concluded.

Answering a question from Dr Orr about the tools being easy to use, Prof Östör stressed that they will not increase workload, rather “they will improve efficiency. Having somebody in remission is the easiest patient to deal with”.

Self-reflection The fi nal speaker Dr Carmel Silke, a member of the local EVEREST steering committee, gave more details on the EVEREST supports, explaining how they are a suite of tools that healthcare practitioners and patients can pick and choose from, depending on what is relevant for their practice/patients.

Dr Silke then focused on the self-reflection toolkit and explained how she had put it into practice with her own team.

“We know what treat-to-target is, we know we want to be doing it, but are we doing it, can we be doing it better, is it too difficult? And maybe self-reflection can help with that.”

Dr Silke spoke about the importance of self-reflection both on an individual and team level, and how it is about improving learning and outcomes. It can take the shape of looking at a difficult case or a case where something went well. “How did we do things? Could we have done things differently/better? What worked well? What can we learn?”

She commented that self-reflection is not complicated or about being critical/judgemental: “It has no hard or

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

21

Meeting Report Commercial Irish Society for Rheumatology, Autumn Meeting, Fitzpatrick Castle Hotel, Killiney, Co Dublin, 21-22 September 2023

set rules, keep it about what works for you,” and it can be incorporated into team meetings and individual review, “for 10 minutes at the end of a meeting, that is where I see it happening.”

In summary Pursuing a primary target of clinical remission is an established, evidence-based approach in RA and is integral to international treatment guidelines.1,2 Remission is associated with improved long-term outcomes including reduced disability, need for surgery, risks of serious infection, and associated complications, as well as increased work productivity and quality-of-life.2 Clinical remission criteria have evolved over time, reflecting different aspects of disease activity.

However, real-world attainment of remission in RA remains a challenge, with current rates suboptimal, the meeting heard. Barriers to achieving remission can include lack of awareness among patients, clinical inertia to try new/alternative treatments where the original strategy is not optimal, coupled with waiting list pressure and inadequate resources.

However, remission is achievable and doesn’t have to mean an increased workload – in fact, as Prof Östör noted, patients in remission are the easiest to treat. The EVEREST initiative has created a suite of resources to help support clinicians and patients in optimising clinical remission rates and gaining the best outcomes possible.

What is the EVEREST Initiative?

EVEREST is a quality improvement initiative using an innovative, sustainable, and implementation science-based approach to optimise treatment of RA patients.  For EVEREST, AbbVie have partnered with an international group of rheumatologists, chaired by Prof Maya Buch, UK. Th is group set about identifying small steps healthcare teams and patients could take to reach that optimal goal of clinical remission, using the analogy of climbing a mountain and reaching the summit.  It is not a ‘one-size-fits-all’ approach – local steering committees are inputting into what EVEREST looks like for each country, including Ireland.  The EVEREST initiative has created a suite of resources for healthcare teams intended to facilitate optimal management of the RA patient, and also some tools for patients to empower them in terms of their own treatment, eg, outcome measurement tools, disease activity calculators, links to published evidence, patient workbooks, checklists (pre/post visit), patient videos, etc.  Local dissemination of EVEREST toolkits will occur in 2024. These tools will be readily accessible to healthcare teams and, where relevant, patients.

References 1. Schett G, et al. Ann Rheum Dis. 2016;75:1428-1437 2. Smolen JS, et al. Nat Rev Dis Primers. 2018;4:18001 3. Einarsson M, et al. 2019, 10.1093/rheumatology/kez273

4. Aga, et al. 2013. Ann Rheum Dis. 74, pp.381-388;pubmed.ncbi. nlm.nih.gov/24285493/ 5. Olsen, et al. Rheumatology. 58, 3, 2019, 481-491, doi:org/10.1093/rheumatology/key338 6. Hetland ML, et al. 2010. Arthritis and Rheumatism. Vol 62, 1, 22-32 7. Murphy, et al. Abstract 22A156. ISR, Belfast 2022 8. Gavigan, et al. Data from a survey of US patients with RA (N=249) from the Arthritis Power Registry. Arthritis Research and Therapy.

2020, 22:4 9. NRAS. What does remission in RA mean? Infographic. 2014.

Available at: https://nras.org.uk/2014/10/09/nras-needs-you-jointhe-remission-mission-and-the-fight-against-rheumatoid-arthritis/ 10. Gossec L, et al. POS0607, EULAR 2022, Milan. Available at: https://ard.bmj.com/content/annrheumdis/81/Suppl_1/572.1.full. pdf

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie.

*AbbVie-organised medical education meeting ABBV-IE-00330-E

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1. WHAT GLUCOSAMINE PHARMA NORD IS AND WHAT IT IS USED FOR. Glucosamine Pharma Nord belongs to the group of medicines called non-steroid anti-inflammatory and anti rheumatic drugs. Glucosamine Pharma Nord capsules are used for the relief of symptoms in mild to moderate osteoarthritis of the knee. Your doctor may have given you Glucosamine Pharma Nord for other use. Always follow your doctor’s instructions. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLUCOSAMINE PHARMA NORD. Do not take Glucosamine Pharma Nord • if you are allergic (hypersensitive) to glucosamine or to any of the other ingredients. • if you are allergic (hypersensitive) to shellfish, as the active substance is extracted from shellfish. Take special care with Glucosamine Pharma Nord. Before you start treatment with Glucosamine Pharma Nord you should visit your doctor to exclude the presence of joint diseases which needs other treatment. Glucosamine Pharma Nord contains 2.2 mmol (87 mg) potassium per capsule.

To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Tell also your doctor: • if you have a known increased cholesterol level as increased cholesterol level in the blood has been observed in a few cases in patients treated with glucosamine. Control of cholesterol levels is advised before and during treatment: • if you suffer from asthma. When starting on glucosamine, you should be aware of potential worsening of symptoms. • if you suffer from diabetes mellitus. More frequent controls of your blood sugar levels may be necessary when starting treatment with glucosamine. Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to medicines obtained without a prescription, herbal medicines and strong vitamins and minerals. Caution should be exercised if Glucosamine Pharma Nord is taken concomitantly with other medicines, especially: • blood thinning medicines (warfarin). • tetracycline.

Taking Glucosamine Pharma Nord with food and drink: You can take the capsules with food and drink. Pregnancy and breast-feeding: Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy: Glucosamine Pharma Nord should not be used in pregnancy. Breast-feeding: Glucosamine Pharma Nord should not be used while breastfeeding. Driving and using machines: It is not known if Glucosamine Pharma Nord affects the ability to operate machinery or to drive. If you experience drowsiness, dizziness, nausea or vomiting after starting treatment with Glucosamine Pharma Nord, you should not be driving or operating machinery. 3. HOW TO TAKE GLUCOSAMINE PHARMA NORD. Adults and elderly. The usual dose is 1 capsule 3 times daily (corresponding to 1200 mg glucosamine). You can alternatively take all 3 capsules at the same time. The capsule(s) should be taken with a full glass of water. Glucosamine cannot be used for the treatment of acute pain. Relief of symptoms (especially pain relief ) may

www.pharmanord.ie not be experienced until after several weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be reevaluated. For oral use. Children: Do not use in children below the age of 18 without asking your doctor. Impaired kidney and liver function Follow your doctor’s advice. If you take more Glucosamine Pharma Nord than you should contact your doctor, emergency unit or pharmacist if you have taken more Glucosamine Pharma Nord than stated in this leaflet or more than your doctor has prescribed. If you forget to take Glucosamine Pharma Nord. Do not take a double dose to make up for a forgotten capsule. 4. POSSIBLE SIDE EFFECTS. Like all medicines, Glucosamine Pharma Nord can cause side effects, although not everybody gets them. The following side effects have been reported: Common side effects (occur in between 1 and 10 out of 100 treated): • Headache. • Tiredness. • Nausea. • Abdominal pain. • Indigestion. • Diarrhoea.

• Constipation. Uncommon side effects (occur in between 1 and 10 out of 1,000 treated): • Rash. • Itching. • Flushing of the skin. Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE GLUCOSAMINE PHARMA NORD. • Keep out of the reach and sight of children. • Do not store above 25°C. • Keep the bottle tightly closed. • Do not use Glucosamine Pharma Nord after the expiry (EXP) date which is stated on the label. The expiry date refers to the last date of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION. What Glucosamine Pharma Nord contains: • The active substance: glucosamine. Each capsule contains 676 mg of glucosamine hemisulphate potassium chloride complex (1:1) corresponding to 509 mg glucosamine hemisulphate corresponding to 400 mg glucosamine. • The other ingredients: magnesium stearate. • Capsule: gelatine. Colouring: titanium dioxide (E 171).

What Glucosamine Pharma Nord looks like and contents of the pack. Appearance: Glucosamine Pharma Nord is a white hard gelatine capsule containing a white crystallized powder. Pack sizes: 60, 90, 270 and 1000 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Pharma Nord ApS, Tinglykke 4-6, DK-6500 Vojens, Denmark. Tel: +45 75 85 74 00.

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

23

Pain Clinical PROF DOMINIC A HEGARTY, Consultant in Pain Management and Neuromodulation and Clinical Director, Mater Private Hospital, Cork; Associate Professor of Pain Medicine, University College Cork; President, World Institute of Pain (WIP); and Clinical Director of Pain Relief Ireland – www.painreliefireland.ie

Post-herpetic neuralgia: Diagnosis and management options

H

erpes zoster (HZ) is a relatively common disease; the estimated incidence of acute herpes infection in the European population varies from 1.2 to 5.2 per 1,000 people per year. There is a correlation between the incidence of the disease and age. People younger than 50 years have a low risk of developing HZ, which equals approximately 2 per cent. The incidence sharply rises in adults aged above 50 years; the risk makes up to at least 20 per cent and continues to increase further, reaching 35 per cent in people above 80 years.

The recent upswing in chickenpox infection and varicella-zoster virus (VZV) in the community has increased the risk of developing post-herpetic neuralgia (PHN). PHN is an extremely painful condition that can persist for many years, making life miserable for the unfortunate patient.

Early recognition is very important and can offset chronicity. For those who are not so lucky, there are advanced options to help manage the pain.

Epidemiology In the acute phase of inflammation, VZV reaches the sensory nervous system and remains latent in trigeminal or dorsal root ganglions (DRG) for a long period of time. Reactivation of VZV happens with advancing age, or immunosuppression can lead to the development of acute HZ. PHN occurs in a subset of the population suffering from an episode of acute HZ. Well-established risk factors for an acute HZ episode progressing to PHN include age, severe immunosuppression, the presence of a prodromal phase, severe pain during the zoster outbreak, allodynia, ophthalmic involvement, and diabetes mellitus.

A meta-analysis of the risk factors for the development of PHN, published in 2016, noted that approximately 13 per cent of patients ≥50 years of age with HZ would develop PHN. The association between increasing age and PHN is significant. According to some studies, at age 60, around 60 per cent of patients with HZ (shingles) develop PHN, and at age 70, this percentage rises to 75 per cent.

One month after the onset of HZ, 9-to-14.3 per cent of patients develop PHN, and at three months, this percentage becomes 5 per cent. At one year, 3 per cent of patients continue to have severe pain.

Family history has also been considered a risk factor for HZ. In a case-control study by Hicks et al, comprising 504 patients and 523 controls, it was observed that the blood relatives of patients were more likely to have HZ than the control group (39 per cent vs 11 per cent, p<.001). Moreover, this risk was more significant in patients with multiple blood relatives having HZ than those with a single blood relative having HZ. There is no sex predilection for PHN. Covid-19 and PHN In a retrospective cohort study of over two million people, it was highlighted that adults over 50 years of age who had mild Covid-19 were 15 per cent more likely to develop HZ within six months compared to those who had not been infected by coronavirus. The risk was 21 per cent greater in older people who were hospitalised with Covid-19 (Bhavsar et al. Open Forum Infectious Diseases).

Predictors The predictors of PHN development include advanced age, acute pain, severe rash, prodromal pain, presence of the virus in peripheral blood, and adverse psychosocial factors.

The associated pain with concomitant allodynia is traditionally attributed to the decrease in the activation threshold of pain-associated neuron clusters. Recently, some researchers have shown that TRVP1 receptor activation may also be implicated. This receptor may be a promising target for future analgesic drug development.

HZ can reactivate sub-clinically with no rash. This condition is called zoster sine herpete and is more complicated.

It affects the central nervous system at multiple levels and causes cranial neuropathies, myelitis, polyneuritis or aseptic meningitis.

Physical examination of a patient with PHN may reveal the following: f Evidence of cutaneous scarring on an area of previous HZ. f Altered sensation in the affected areas, either hypersensitivity or hypoesthesia. f Pain is produced by non-noxious stimuli, such as a light touch, known as allodynia. f Autonomic dysfunction, such as excessive sweating over the involved area.

Figure 1: Herpes zoster acute blister formation Antivirals

Simple analgesics

Neuropathic pain management

Topical

f Acyclovir (Sitavig, Zovirax) f Famciclovir (Famvir) f Valacyclovir (Valtrex) f Paracetamol f Ibuprofen f Naproxen f Pregabalin f Gabapentin f Amitriptyline f Lidocaine patches f Capsaicin cream f Ice packs

Table 1: Suggested agents to consider in the early management plan Pathophysiology The exact physiology that separates a self-limited HZ outbreak from PHN is not fully understood. Histological examinations of relevant peripheral and central nervous tissue from sufferers of PHN reveal myelin and axon deficiency and atrophy of the dorsal horn in certain instances.

One study compared the difference in epidermal axon densities between patients who suffered from PHN and those who had a self-limited occurrence of HZ. Those afflicted with PHN had, in most instances, far fewer axons in the relevant dermatomes than non-sufferers. Therefore, an anatomical derangement is likely at least partially responsible for the development of PHN. Some suggest that an unchecked inflammatory response at the neuronal level is the main culprit of the eventual development of PHN, specifically via the reduction of centrally-mediated inhibition of nociceptive input and the promotion of peripheral sensitisation via damaged nociceptors.

The DRG suffers the most damage during PHN. Firstly, the reactivated VZV in the DRG proliferates and destroys axons, causing demyelination and ion channel dysfunction. The damaged sensory nerves can generate abnormal electrical impulses that are transmitted to the spinal cord, transmitting pain and pain hypersensitivity. A significant number of inflammatory cells are shown to be invading into the DRG of patients with PHN. Then, the inflammatory mediators that follow promote increased pain pathway activity and cause central sensitisation.

Diagnosis The diagnosis of PHN is relatively straightforward and not one of exclusion. An episode of HZ is a prerequisite for PHN. Therefore, a history of rash with blisters in a dermatomal pattern would be expected. Rarely the characteristic rash will not be found. Persistent (more than or equal to three months) lancinating/burning pain, allodynia, paraesthesia, pruritus, dysesthesia, and/or hyperalgesia at or near the area of the rash is characteristic of PHN.

Investigations PHN is almost universally diagnosed based on the history and physical examination. However, laboratory tests and some targeted imaging may provide a degree of utility.

These are of greater value in atypical presentations of PHN, such as zoster sine herpete or HZ of the larynx. Serological testing for VZV IgG and IgM titres is possible, although the sensitivity and specificity are less than ideal. A four-fold rise has been used to diagnose subclinical HZ (zoster sine herpete). However, this rising titre may or may not be secondary to viral exposure or reactivation. Comparatively, immunofluorescence of vesicle scrapings detects VZV antigens in a highly specific and sensitive manner. Similarly, PCR is exquisitely sensitive for the detection of VZV DNA. Results of cerebrospinal fluid (CSF) analysis are abnormal in 61 per cent of patients. Pleocytosis, elevated protein, and VZV DNA are usually seen. Viral culture or immunofluorescent staining helps distinguish herpes simplex from HZ. Small-scale studies suggest that MRI may hold promise for diagnosing challenging PHN cases and differentiating between PHN and HZ. A study by Haanpaa et al reported that MRI revealed lesions attributable to HZ in the cervical cord and the brain stem in nine patients (56 per cent). At three months after the onset of HZ, PHN developed in five patients (56 per cent) who had an abnormal MRI. On MRI, seven patients with no HZ lesions did not develop residual pain.

Management options Three fundamental treatment approaches may be considered for post-herpetic neuralgia.

1) Prevention This focuses on identifying populations at risk for contracting HZ and administering a vaccine. At present, there are two licenced HZ vaccines in Ireland (MIMS May 2023) – Shingrix and Zostavax. Vaccination should be considered in those over 50 years and in those in the higher-risk groups. It is not necessary to determine whether patients have a history of varicella or zoster prior to vaccination because weaning antibodies in those previously exposed may lead to negative results despite past infection. A large (n =38,000) double-blind study published in the NEJM in 2005 showed that vaccination in the elderly reduced the incidence of HZ by 51 per cent and PHN by 66 per cent. Moreover, even among those who developed PHN, the burden of illness was reduced by approximately 61 per cent. It must be noted that the immune-boosting effect of the vaccination is not long-lasting, and interval re-vaccination is necessary to maintain its efficacy. Unfortunately, these vaccines are not part of the HSE’s national immunisation programme so patients need to discuss this option with their GP and self-fund the vaccine.

2) Early recognition Early recognition and treatment of an acute HZ infection may reduce the chance of developing PHN. The benefit of rapid treatment has been shown to be very useful. If a com-

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bination of agents can be commenced with 72 hours of first symptoms, this will lower the chance of compilations.

is required for 12 hours at a time and should be used over a prolonged period (four-to-eight weeks initially).

3) PHN management In the situation where PHN develops, the symptom management of PHN is best considered using multimodal medication regimens and interventional procedures. The evidence regarding the efficacy of these methods is mixed, but rapidly evolving and certain approaches appear to be more successful than others.

Complete resolution of the symptoms is rare. A 2014 study concluded that less than half of patients with PHN achieve significant symptom reduction. The age of the patient population increases the side-effect risk profiles of interventions. Relevant studies comparing treatments and their outcomes are often suboptimally designed.

There is no one superior treatment regimen; however, expert consensus suggests that multimodal therapy is likely the best approach.

Lastly, many of the advocated approaches treat chronic neuropathic pain in general and are not specific to PHN.

d) Capsaicin Capsaicin preparations in the patch and cream formulations are also available, but are not as well-studied as the lidocaine patch. The leading cause of discontinuing capsaicin treatment is pain and irritation at the application site, suffered by almost all users in proportion to the capsaicin concentration. The cream has a low concentration of capsaicin, requiring multiple applications to achieve a therapeutic effect throughout the day. Conversely, the capsaicin patch is available in an 8 per cent formulation, delivering a therapeutic dose in just one application. The higher concentration patch should only be provided by those trained in the application and monitoring of outcome. Nevertheless, encouraging case reports and other literature suggest the intervention warrants consideration and further study.

effective option is to use a peripheral nerve block or pulsed denervation of the DRG. Pulsed radiofrequency (PRF) is a minimally-invasive technique that applies pulsed current (300-500kHz) to the target nerve. The current is delivered in a pulse of 20ms (45V voltage) followed by a silent period of 480ms to avoid heat lesions. Recent studies have confirmed the beneficial effects of PRF against post-operative pain, peripheral neuropathic pain, and PHN. The thoracic nerves (T1-12) are the most commonly affected by PHN, with an incidence of up to 50 per cent of cases. Studies have shown that treating both the DRG and intercoastal nerve with PRF is effective in the management of thoracic PHN. Targeting the DRG has shown to have a better outcome in pain intensity and other quality-of-life domains (SF-36).

Other invasive therapies including botulinum toxin injections, sympathetic blockade with local anaesthetics, and epidural/intrathecal injections have a limited side-effect profile. However, more studies need to be conducted to evaluate their efficacy. The other invasive therapies mentioned carry the potential for significant peri-procedural risk and/or side-effects.

b) The use of opioids to combat PHN is controversial because of the changing landscape regarding what constitutes appropriate use, and also renewed governmental interest in their administration given the epidemic of abuse, addiction, and mortality. The above three medical societies recommend opioids as either first- or second-line treatments, which underscores the pain-reducing capability of this medication class.

e) Non-TCA antidepressants and NMDA antagonists There is limited evidence to support their usefulness. For example, larger studies involving serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) have not shown better outcomes than TCAs, and both classes possess a concerning side-effect profile, though typically less severe than TCAs. The use of ketamine infusions and related studies for treating a wide range of ailments, from neuropathic pain to depression, has also resulted in renewed interest in the role of NMDA antagonism in treating PHN. There are anecdotal reports that ketamine may prove beneficial, and a few small studies support this finding, but long-term data and largescale studies are non-existent.

Lidocaine infusions have also been considered. One double-blind study in 1999 showed that an intravenous lidocaine infusion provided clinically significant short-term pain reduction in patients with PHN. In general, small studies and case reports have established that novel therapies may be useful in certain PHN sufferers when combined with other adjuncts. The pathophysiology of PHN is complex, and sometimes an individualised non-traditional approach may prove beneficial for a particular patient.

c) Lidocaine patches Multiple studies have confirmed the short- and long-term efficacy of the lidocaine 5 per cent patch. This patch also has the additional benefit of a small side-effect profile that is mostly limited to application site reactions. Application

f) Invasive therapies Often when an individual presents to a chronic pain clinic they will have tried a number of agents, so interventional options need to be considered. If the pain persists in a specific dermatomal or nerve distribution, then a simple

Long-term enhancement of healthcare team outcomes Considering that PHN is difficult to treat and outcomes are variable, prevention is of paramount importance. Therefore, primary care physicians and geriatricians are tasked with administering vaccinations to at-risk populations. The ever-growing ageing population means that demands on this service will continue to increase. Inclusion of the shingles vaccines on the national immunisation programme by the Department of Health needs to be considered as a priority if we are to protect our venerable senior citizens. When preventative measures fail or are never instituted, experts in the field of pain management who have experience with the condition and multimodal treatment techniques should be consulted. Interventional pain management can offer solutions. An interprofessional approach to managing patients with PHN is the best way forward.

References

10. Helgason S, Petursson G, Gudmundsson S, Sigurdsson JA. Prevalence of postherpetic neuralgia after a first episode of herpes zoster: Prospective study with long-term follow-up. BMJ. 2000 Sep 30;321(7264):794-6 11. Chen F, Chen F, Shang Z, et al. White matter microstructure degenerates in patients with post-herpetic neuralgia. Neurosci Lett.

2017 Aug 24;656:152-157 12. Watson CPN, Deck JH, Morshead C, et al. Post-herpetic neuralgia: Further post-mortem studies of cases with and without pain. Pain.

1991 Feb;44(2):105-117 13. Werner RN, Nikkels AF, Marinović B, et al. European consensusbased (S2k) guideline on the management of herpes zoster – guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV), Part 1: Diagnosis. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):9-19 14. Koshy E, Mengting L, Kumar H, Jianbo W. Epidemiology, treatment and prevention of herpes zoster: A comprehensive review. Indian J Dermatol Venereol Leprol. 2018 May-Jun;84(3):251-262 15. Gilden D, Nagel MA, Mahalingam R, et al. Clinical and molecular aspects of varicella zoster virus infection. Future Neurol. 2009 Jan 01;4(1):103-117 16. Spiegel R, Miron D, Lumelsky D, Horovitz Y. Severe meningoencephalitis due to late reactivation of Varicella-Zoster virus in an immunocompetent child. J Child Neurol. 2010 Jan;25(1):87-90 17. Harbecke R, Oxman MN, Arnold BA, et al. Shingles prevention study group. A real-time PCR assay to identify and discriminate among wild-type and vaccine strains of varicella-zoster virus and herpes simplex virus in clinical specimens, and comparison with the clinical diagnoses. J Med Virol. 2009 Jul;81(7):1310-22 18. Haanpää M, Dastidar P, Weinberg A, et al. CSF and MRI findings in patients with acute herpes zoster. Neurology. 1998 Nov;51(5):1405-11 19. Lang PO, Ferahta N. Recommendations for treatment and

prevention of herpes zoster and associated pain in aged adults. Rev Med Interne. 2016 Jan;37(1):35-42 20. Kim SR, Khan F, Ramirez-Fort MK, et al. Varicella zoster: An update on current treatment options and future perspectives. Expert Opin Pharmacother. 2014 Jan;15(1):61-71 21. Argoff CE. Review of current guidelines on the care of postherpetic neuralgia. Postgrad Med. 2011 Sep;123(5):134-42 22. Raja SN, Haythornthwaite JA, Pappagallo M, et al. Opioids versus antidepressants in post-herpetic neuralgia: A randomised, placebocontrolled trial. Neurology. 2002 Oct 08;59(7):1015-21 23. Shrestha M, Chen A. Modalities in managing post-herpetic neuralgia. Korean J Pain. 2018 Oct;31(4):235-243 24. Baron R, Allegri M, Correa-Illanes G, et al. The 5 per cent lidocaine-medicated plaster: Its inclusion in international treatment guidelines for treating localised neuropathic pain, and clinical evidence supporting its use. Pain Ther. 2016 Dec;5(2):149-169 25. Derry S, Rice AS, Cole P, et al. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017 Jan 13;1(1):CD007393 26. Goncalves D, Rebelo V, Barbosa P, Gomes A. 8 per cent capsaicin patch in treatment of peripheral neuropathic pain. Pain Physician.

2020 Sep;23(5):E541-E548 27. Kim YH, Lee PB, Oh TK. Is magnesium sulfate effective for pain in chronic postherpetic neuralgia patients comparing with ketamine infusion therapy? J Clin Anesth. 2015 Jun;27(4):296-300 28. Baranowski AP, De Courcey J, Bonello E. A trial of intravenous lidocaine on the pain and allodynia of post-herpetic neuralgia. J Pain Symptom Manage. 1999 Jun;17(6):429-33 29. Apalla Z, Sotiriou E, Lallas A, et al. Botulinum toxin A in postherpetic neuralgia: A parallel, randomised, double-blind, single-dose, placebo-controlled trial. Clin J Pain. 2013 Oct;29(10):857-64 30. Johnson RW, Rice AS. Clinical practice. Post-herpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33

a) Traditional non-invasive treatments include oral and topical medications. The American Academy of Neurology (AAN), Special Interest Group on Neuropathic Pain (NeuPSIG), and European Federation of Neurological Societies (EFNS) all recommend an oral tricyclic antidepressant (TCA), pregabalin, and the lidocaine 5 per cent patch as first-line therapies. The anticholinergic, antihistaminergic, and alpha receptor-blocking side-effects of TCAs must be considered, as the elderly are more susceptible. As a result, it is commonplace to initially prescribe and titrate a gabapentinoid, keeping in mind that patients with reduced renal function should be started at a lower dose and up-titrated more slowly.

1. Isagulyan E, Tkachenko V, Asriyants S, et al. The effectiveness of various types of electrical stimulation of the spinal cord for chronic pain in patients with post-herpetic neuralgia: A literature review. Pain Res Manag. 2023 Mar 24;2023:6015680 2. Huang X, Ma Y, Wang W, et al. Efficacy and safety of pulsed radiofrequency modulation of thoracic dorsal root ganglion or intercostal nerve on post-herpetic neuralgia in aged patients: A retrospective study. BMC Neurol. 2021 Jun 24;21(1):233 3. Forstenpointner J, Rice ASC, Finnerup NB, Baron R. Up-date on clinical management of post-herpetic neuralgia and mechanismbased treatment: New options in therapy. J Infect Dis. 2018 Sep 22;218(suppl_2):S120-S126 4. Lu WH, Lin CW, Wang CY, et al. Epidemiology and long-term disease burden of herpes zoster and postherpetic neuralgia in Taiwan: A population-based, propensity score-matched cohort study. BMC Public Health. 2018 Mar 20;18(1):369 5. Gabutti G, Valente N, Kuhdari P, et al. Prevention of herpes zoster and its complications: From the clinic to the real-life experience with the vaccine. J Med Microbiol. 2016 Dec;65(12):1363-1369 6. Zorzoli E, Pica F, Masetti G, et al. Herpes zoster in frail elderly patients: Prevalence, impact, management, and preventive strategies.

Aging Clin Exp Res. 2018 Jul;30(7):693-702 7. Schutzer-Weissmann J, Farquhar-Smith P. Post-herpetic neuralgia – a review of current management and future directions. Expert Opin Pharmacother. 2017 Nov;18(16):1739-1750 8. Delaney A, Colvin LA, Fallon MT, et al. Postherpetic neuralgia: From preclinical models to the clinic. Neurotherapeutics. 2009 Oct;6(4):630-7 9. Hicks LD, Cook-Norris RH, Mendoza N, et al. Family history as a risk factor for herpes zoster: A case-control study. Arch Dermatol. 2008 May;144(5):603-8

g) Future therapy options Neuromodulation offers the possibility of long-term drugfree pain therapy in a wide range of neuropathic pain conditions. The development of the DRG stimulator to treat focal dermatomal neuropathic pain conditions is theoretically promising for PHN. Traditional spinal cord stimulation programming options can now target the painful area with greater accuracy. We need to extend studies to consider the role of technology to advance our options.

BRIDGING THE GAP IN PAIN RELIEF

DUAL ACTION PAIN RELIEF GETS TO

WORK

FAST

†

30%

MORE

PAIN RELIEF 1*

References: 1. Merry A, et al. AFT-MX-1, a prospective parallel group, double-blind comparison of the analgesic effect of a combination of paracetamol and ibuprofen, paracetamol alone, or ibuprofen alone in patients with post-operative pain. Department of Anaesthesiology, University of Auckland, New Zealand 2008. *compared with the same daily dose of standard paracetamol or ibuprofen alone. †Faster onset of action than standard Ibuprofen alone. Easolief DUO 500 mg/150 mg film-coated tablets Each tablet contains paracetamol 500 mg and ibuprofen 150 mg. Presentation: White, capsule shaped tablet with breakline on one side and plain on the other side. Indications:: Short-term symptomatic treatment of mild to moderate pain. Dosage: Adults/elderly: The usual dosage is one to two tablets taken every six hours up to a maximum of six tablets in 24 hours. Children:: Easolief DUO is contraindicated in children under 18 years. Contraindications Contraindications:: Severe heart failure, known hypersensitivity to paracetamol, ibuprofen, other NSAIDs or to any of the excipients, active alcoholism, asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs, history of gastrointestinal bleeding or perforation related to previous NSAID therapy, active or history of recurrent peptic ulceration/haemorrhage, severe hepatic failure or severe renal failure, cerebrovascular or other active bleeding, blood-formation disturbances, during the third trimester of pregnancy. Warnings and precautions: This medicine is for short term use and is not recommended for use beyond 3 days.

Clinical studies suggest that use of ibuprofen, particularly at a high dose may be associated with a small increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses should be avoided. Careful consideration should be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events. The use of paracetamol at higher than recommended doses can lead to hepatotoxicity, hepatic failure and death. Patients with impaired liver function or a history of liver disease or who are on long term ibuprofen or paracetamol therapy should have hepatic function monitored at regular intervals. Severe hepatic reactions, including jaundice and cases of fatal hepatitis, though rare, have been reported with ibuprofen. Paracetamol can be used in patients with chronic renal disease without dosage adjustment. There is minimal risk of paracetamol toxicity in patients with moderate to severe renal failure. Caution should be used when initiating treatment with ibuprofen in patients with dehydration.

The use of an ACE inhibiting drug, an anti-inflammatory drug and thiazide diuretic at the same time increases the risk of renal impairment. Blood dyscrasias have been rarely reported. Patients on long-term therapy with ibuprofen should have regular haematological monitoring. Like other NSAIDs, ibuprofen can inhibit platelet aggregation. GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. Use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension and patients taking antihypertensive medicines with NSAIDs may have an impaired anti-hypertensive response. Fluid retention and oedema have been observed in some patients taking NSAIDs. NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis and Stevens-Johnson syndrome. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Products containing ibuprofen should not be administered to patients with acetylsalicylic acid sensitive asthma and should be used with caution in patients with pre-existing asthma. Adverse ophthalmological effects have been observed with NSAIDs. For products containing ibuprofen aseptic meningitis has been reported only rarely. NSAIDs may mask symptoms of infection and fever. In order to avoid exacerbation of disease or adrenal insufficiency, patients who have been on prolonged corticosteroid therapy should have their therapy tapered slowly rather than discontinued abruptly when products containing ibuprofen are added to the treatment program. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA). Interactions: Warfarin, medicines to treat epilepsy, chloramphenicol, probenecid, zidovudine, medicines used to treat tuberculosis such as isoniazid, acetylsalicylic acid, other NSAIDs, medicines to treat high blood pressure or other heart conditions, diuretics, lithium, methotrexate, corticosteroids, flucloxacillin. Fertility, pregnancy and lactation: Easolief DUO is contraindicated during the third trimester of pregnancy. Driving and operation of machinery: Dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected patients should not drive or operate machinery.

Undesirable effects: Dizziness, headache, nervousness, tinnitus, oedema, fluid retention, abdominal pain, diarrhoea, dyspepsia, nausea, stomach discomfort, vomiting, flatulence, constipation, slight gastrointestinal blood loss, rash, pruritus, alanine aminotransferase increased, gamma-glutamyltransferase increased, abnormal liver function tests, blood creatinine increased and blood urea increased. Refer to Summary of Product Characteristics for other adverse effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 24 tablets. Marketing authorisation holder: Clonmel Healthcare Ltd. Waterford Road, Clonmel, Co.Tipperary.

Marketing authorisation number: PA0126/294/1. Supply through pharmacies only. Date last revised: October 2023. Date prepared: October 2023. 2023/ADV/EAS/179H

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

Fibromyalgia in focus Fibromyalgia is one of the most common chronic pain disorders, but remains poorly understood and under-treated

F

ibromyalgia is a chronic pain disorder, characterised by widespread musculoskeletal pain. It is a disorder of pain regulation and a neurosensory disorder where the individual is unable to process pain in the brain. People with fibromyalgia perceive pain from noxious stimuli at higher than normal levels of intensity compared to other individuals.1,2 The exact cause of fibromyalgia is unknown, but is believed to involve a combination of genetic, environmental, and psychological factors. The condition tends to run in families, so genetic factors are likely to contribute to the disorder, but no specific genes have been identified to date.2 Fibromyalgia is often associated with other comorbidities, such as depression, anxiety, irritable bowel syndrome (IBS), and chronic fatigue syndrome. It is thought to be triggered or aggravated by multiple physical and emotional stressors and is a heterogeneous condition that is often associated with specific diseases, such as infections, psychiatric or neurological disorders, diabetes, and rheumatic pathologies.3,6 Fibromyalgia is more common in women than men and the associated risk is higher for people with an existent rheumatic disease.2 It can affect people of any age, including children, but usually starts in middle age, and the risk of developing it increases with age.4 A major literature review (2017) on the prevalence of fibromyalgia shows that it ranges from 0.2-to-6.6 per cent in the general population, from 2.4-to-6.8 per cent in women, from 0.7-to-11.4 per cent in urban areas, from 0.1-to-5.2 per cent in rural areas, and from 0.6-to-15 per cent in special populations. This literature review update highlighted a significant increase in fibromyalgia prevalence globally in recent years.12 Pathophysiology The pathophysiology of fibromyalgia is not completely understood, but is thought to involve dysregulation of the central nervous system (CNS), including alterations in neurotransmitter levels and abnormal processing of pain signals. One proposed mechanism is the dysfunction of the hypothalamic-pituitary-adrenal axis (HPA), which plays a key role in the body’s response to stress and inflammation.

Studies have shown that people with fibromyalgia have lower levels of cortisol, which is involved in the regulation of the HPA axis. This can lead to a state of chronic inflammation and immune dysregulation, contributing to the symptoms of fibromyalgia. Another proposed mechanism is the alteration of neurotransmitters, such as serotonin and norepinephrine, which are involved in the regulation of pain, sleep, and mood. Other studies have shown that people with fibromyalgia have altered pain processing in the CNS, including abnormal responses to stimuli and increased sensitivity to pain, which may be due to changes in the function of the dorsal horn of the spinal cord and brainstem. Further research, however, is required to fully understand the underlying mechanism of fibromyalgia.11 Symptoms The main symptom of fibromyalgia is widespread musculoskeletal pain, bilateral in nature and involving both the upper and lower parts of the body. The pain may be localised initially, commonly in the neck and shoulders. Pain is often felt in the arms, legs, head, chest, abdomen, back, and buttocks, and often described as aching, burning, or throbbing.

The predominant symptom is muscle pain, but patients may also complain of joint pain.2 Fatigue, especially when waking from sleep, but also in the mid-afternoon, is a common complaint. Minor activities may aggravate the pain and fatigue, although inactivi-

turbances, and cognitive problems that many people with the disorder experience.4 Until recently, the diagnosis of fibromyalgia was based on the presence of specific tender points in certain areas of the body. However, healthcare professionals are now advised to consider the following when making a diagnosis of fibromyalgia – widespread pain lasting three months or more; fatigue and/or waking up feeling unrefreshed; cognitive symptoms and problems with thought processes like memory and understanding. Pain is considered widespread when it affects all four quadrants of the body, ie, pain on both the right and left sides, as well as above and below the waist.9

ty for prolonged periods can also increases the symptoms.

There is stiffness on waking in the morning and patients often complain of sleeping lightly with frequent wakenings and feeling unrefreshed in the morning even if they have eight-to-10 hours of sleep.2 Cognitive disturbances referred to as ‘fibro fog’ is a common symptom, whereby patients have difficulty with attention and doing tasks that require rapid changes in thought.2 Other symptoms include anxiety and/or depression, and headaches, which include migraines and tension types. Patients often complain of paraesthesia, particularly in both arms and legs, although detailed neurologic evaluations are often normal. IBS commonly correlates with fibromyalgia, and gastro-oesophangeal reflux disease (GORD) occurs more commonly in patients with fibromyalgia compared to the general population. Patients may also complain of dry eyes, dyspnoea, dysphagia, and palpitations.2 Diagnosis Fibromyalgia is a disorder that is often misunderstood and misdiagnosed due to its elusive and varied symptoms. Despite advances in the understanding of the pathologic process, fibromyalgia remains undiagnosed in up to 75 per cent of people with the condition.6 In 2019, an International Association for the Study of Pain (IASP) Working Group in cooperation with the World Health Organisation developed a classification system, included in the International Classification of Diseases (ICD-11), where fibromyalgia was classified as chronic primary pain, to distinguish it from pain which is secondary to an underlying disease.7 Diagnosis is based on clinical features and criteria that lack either a gold standard or supportive laboratory findings.7 There are no specific imaging studies or tests to confirm a diagnosis of fibromyalgia, and clinicians rely on the patient’s specific symptoms and a physical examination to help form their diagnosis. Blood and other tests may be ordered to rule out other conditions, but no specific blood test, x-ray or scan exists that can confirm a diagnosis, and typically, people with fibromyalgia will have normal results.

Laboratory findings along with the patient’s history and physical examination can help differentiate fibromyalgia from other differentials.9,10 Brain imaging studies and other research have uncovered evidence of altered signalling in neural pathways that transmit and receive pain in people with fibromyalgia.

These changes may also contribute to the fatigue, sleep dis-

Treatment Because of the subjective nature of fibromyalgia symptoms, absence of a diagnostic test and often modest response to treatments, fibromyalgia remains a challenge for treating healthcare professionals. However, there are a number of international treatment guidelines, including the 2017 EULAR revised recommendations for the management of fibromyalgia.1 Treatment for fibromyalgia focuses on relieving symptoms and improving quality-of-life. There is no cure for the condition, but a combination of medication, cognitive behavioural therapy, and lifestyle modifications can be effective in managing symptoms. The cornerstone of treatment is a combination of education, exercise, and pharmacological and psychological therapies. Medications, such as antidepressants, anticonvulsants, muscle relaxants, and analgesia, may be prescribed to reduce pain, improve sleep, and alleviate other symptoms. Antidepressants include tricyclic medications such as amitriptyline and other selective serotonin reuptake inhibitors (SSRIs) and norepinephrine reuptake inhibitors (SNRIs). Therapy most often initiates with tricyclic antidepressants. An SNRI or one of the anticonvulsants is an option in patients with inadequate response or intolerance to tricyclic antidepressants. Beneficial anticonvulsants include gabapentin and pregabalin.2,10 Living with fibromyalgia can be challenging, but there are steps that people can take to help manage their symptoms and improve their quality-of-life. Exercise, such as low-impact aerobics or swimming, can help to improve muscle strength and flexibility, reduce fatigue, and promote relaxation. Lifestyle modifications, such as stress reduction, adequate sleep, and a healthy diet may be helpful. Psychological therapies aim to change negative thoughts, introduce behaviour modification, and improve coping. Additionally, they can help relieve pain, improve health-related quality-of-life, and reduce negative mood and disability. Therapies such as acupuncture, massage, and chiropractic care may also be helpful for some people with fibromyalgia and help reduce pain, improve their range of motion, and promote relaxation. Joining a support group or seeking counselling may also be beneficial for some.

However, treatment is often challenging, and many people with fibromyalgia continue to experience chronic pain and other symptoms.4,5 As some patients with fibromyalgia turn to integrative, complementary, and alternative medicine, healthcare professionals should be knowledgeable about the safety and efficacy of such therapies and educate patients to prevent any potential harm.

The lack of visible signs of the condition can result in a lack of understanding by others of the pain and fatigue being experienced by the person living with fibromyalgia, which in turn can lead to increased feelings of frustration and depression. Patients with fibromyalgia must be educated about their condition and reassured that their illness is real. Education is well received when it is interactive, ongoing, goal-oriented, and anchored with shared deci-

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Pain Clinical

sion-making. Patients who are fully informed about their condition and the available treatment options can take charge and learn to live with fibromyalgia in the best way possible. It is important that patients are managed by an interprofessional team, dedicated to pain management, alleviating the symptoms, and improving quality-of-life. The key is to develop a trusting relationship with the patient so that compliance is maintained with treatments. Patients must be willing to engage with their treatment and play an active role in controlling their fibromyalgia, working closely with their healthcare professionals.2 Outlook Because of the litany of often severe symptoms, people affected with fibromyalgia are often referred to specialists and numerous medical providers over several years, before receiving an accurate diagnosis. Such a delay in diagnosis may occur because of complicated presentations and a lack of unified diagnostic guidelines for fibromyalgia.

Many demographic and psychosocial factors can significantly impact the prognosis and outcome of patients with fibromyalgia, including female gender, low socioeconomic status, unemployment, obesity, depression, and history of abuse. Factors associated with poor prognosis include a long duration of disease; high-stress levels; the presence of depression or anxiety that has not been adequately treated; long-standing avoidance of work; alcohol or drug dependence; and moderate-to-severe functional impairment.2 Recent advances in research and a growing understanding of the underlying mechanisms that contribute to the condition have led to improved approaches in treatment,

providing hope for people living with fibromyalgia. New medications are being developed that target specific neurotransmitters and immune cells involved in fibromyalgia, and may provide more targeted and effective treatments for fibromyalgia in the future. Research in to the use of biomarkers to identify people at risk of developing fibromyalgia may also be able to develop new diagnostic tools and personalised treatment plans.13,14 While there is still much to learn about the condition, new treatments and care approaches are emerging that offer the potential for improved outcomes and quality-of-life for people with fibromyalgia.

With continued research and advocacy, the outlook for the future of fibromyalgia is promising.

Support Living with a chronic condition like fibromyalgia can be challenging. For further information and supports on fibromyalgia, the Arthritis Ireland website, www.arthritisireland.ie, is a useful resource for both patients and healthcare workers.

FibroIreland is a patient-led initiative created by people in Ireland affected by fibromyalgia. It provides information on the latest research and where to get support in Ireland.

FibroIreland has supported several research projects and aims to see the development of a patient registry for the Republic of Ireland. See https://fibroireland.com for more information.

References 1. Macfarlane G, Kronisch C, Dean L, Atzeni F, Häuser W, Fluß E, et al. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 2. Bharjava J. Fibromyalgia. StatPearls [Internet]. 2023 [cited

2023]. Available at: www.statpearls.com/ArticleLibrary/ viewarticle/65391#ref_22094190 3. Hauser W, Fitzcharles M. Facts and myths pertaining to fibromyalgia. Dialogues Clin Neurosci. 2018;20(1):53-62 4. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Fibromyalgia. Updated July 2021. Available at: www. niams.nih.gov/health-topics/fibromyalgia 5. Busch A, Webber S, Brachaniec M, et al. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2021;15(5):358-367 6. Maffei M. Fibromyalgia: Recent advances in diagnosis, classification, pharmacotherapy, and alternative remedies. Int J Mol Sci. 2020 Oct 23;21(21):7877 7. Treede R, Rief W, Barke A, Aziz Q, Bennett M, Benoliel R, et al.

Chronic pain as a symptom or a disease: The IASP classification of chronic pain for the international classification of diseases (ICD11). Pain. 2019; 160:19-27 8. NHS. Fibromyalgia diagnosis. National Health Service, UK. 2022. Available at: www.nhs.uk/conditions/fibromyalgia/ diagnosis/ 9. Arthritis Ireland. Fibromyalgia. 2023. Available at: www. arthritisireland.ie/fibromyalgia#diagnosis 10. Centre for Disease Control and Prevention. Fibromyalgia.

Secondary fibromyalgia. 2021. Available at: www.cdc.gov/arthritis/ basics/fibromyalgia.htm 11. Littlejohn G, Guymer E. Neurogenic inflammation in fibromyalgia. Semin Immunopathol. 2018 Mar; 40(2): 291-300 12. Marques A, Santo A, Berssaneti A, Matsutani L, Yuan S. Prevalence of fibromyalgia: Literature review update. Rev Bras Reumatol Engl Ed. 2017 Jul-Aug;57(4):356-363 13. National Institute of Arthritis and Musculoskeletal and Skin Disease. Fibromyalgia. Available at: www.niams.nih.gov/healthtopics/fibromyalgia 14. Mayo Clinic. Fibromyalgia. Available at: www.mayoclinic. org/diseases-conditions/fibromyalgia/symptoms-causes/syc20354780

Oncology Clinical

Potential major changes in first-line NSCLC treatment with targetable tumour cell mutations

M

ore people with non-small cell lung cancer (NSCLC) are likely to benefit from new drugs that target molecular alterations in tumour cells, with less need for chemotherapy, following results of multiple landmark clinical trials reported for the first time in late-breaking presentations at the European Society for Medical Oncology (ESMO) Congress 2023. Better outcomes were achieved with combinations of experimental new drugs targeting common and rare tumour mutations than with standard treatments, with improvements seen in both early and late-stage NSCLC – the type of lung cancer responsible for approximately eight-out-of-10 cases of the disease.

“The results are very impressive and mean that we can expect major changes in first-line treatment for patients with NSCLC with these targetable tumour cell alterations and in the way we care for patients whose previous treatment has stopped working,” said Prof Alessandra Curioni-Fontecedro, University of Fribourg, Switzerland. “As a result, it will be more important than ever that lung cancer is diagnosed and treated by lung cancer specialists with access and understanding of molecular testing and findings,” she added.

Dr Elene Mariamidze, Todua Clinic, Tbilisi, Georgia, agreed: “We are entering an era of personalised medicine in NSCLC where we are using combinations of novel, targeted agents, and it will be essential to know the whole mutational burden of each patient at diagnosis so we can properly plan the most effective and least toxic approach. The future of lung cancer care lies in finding the right combination of targeted treatment, or chemotherapy with immunotherapy for each patient.”

Both Prof Curioni-Fontecedro and Dr Mariamidze

highlighted data from studies using a new combination of targeted drugs in patients with advanced or metastatic NSCLC who had an EGFR mutation – one of the most common tumour mutations. When people were given the combination as first-line treatment, progression-free survival (PFS) was significantly better than with the current most effective treatment for the mutation. In people who had already progressed on this current standard of care, the new targeted drugs, combined with chemotherapy, significantly improved PFS compared with chemotherapy alone.

“We still need to see that the new combination leads to improved overall survival compared with current treatment. We also need to understand more about the effects in patients with brain metastases as it appears that one of the newer EGFR-targeting agents used in these studies has good penetration of brain tissue,” commented Prof Curioni-Fontecedro.

“These studies show that patients now have a potentially new drug combination for their treatment that works partly by targeting EGFR mutations and partly by directing immune cells to destroy cancer cells. The fact that the combination worked better than the current standard of care, not just better than placebo, shows tangible benefits for this new approach,” added Dr Mariamidze.

Results of NSCLC studies presented at the ESMO Congress 2023 also suggest that using mutation-targeted treatment can reduce the need for chemotherapy in some patients, including those with some rarer tumour alterations for which targeted treatment options have previously been limited. These include patients with operable, early stage ALK-positive NSCLC, those with RET-mutated advanced NSCLC, and those with the less

common, more difficult to treat EGFR mutation, Exon 20 insertion, advanced NSCLC. In addition, study data reinforce the value of adding immunotherapy to chemotherapy in some types of NSCLC, including the use of this treatment before surgery for patients with operable cancers to shrink tumours and indicate likely response to further treatment after surgery.

“We know that patients have a better prognosis if pre-surgical treatment of lung cancer leads to tumour disappearance on pathology reports after surgery (pCR-pathologic complete response) than if there are still obvious cancer cells present in post-surgical material. The new results show that adding immunotherapy to chemotherapy before surgery, and then continuing with maintenance immunotherapy for a year after surgery, is more effective than just giving chemotherapy before surgery,” Dr Mariamidze pointed out.

Even for patients with advanced or metastatic NSCLC who have relapsed following previous treatments and can only be given chemotherapy, there is good news. Directing chemotherapy more precisely at tumours using antibody drug conjugates, namely antibodies that recognise specific proteins commonly found in lung cancers, significantly improved PFS compared to currently used chemotherapy.

“The approach using these antibody drug conjugates will make a big difference for the majority of patients with advanced or metastatic NSCLC who have stopped responding to first- and second-line treatments, irrespective of whether they have targetable mutations. We need to know more about the side-effects of this approach, but these findings are likely to change the standard of care for these patients,” predicted Prof Curioni-Fontecedro.

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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Conference Coverage ALL REPORTS PAUL MULHOLLAND

Irish Endocrine Society, Annual Meeting, Radisson Blu Hotel, Ballincar, Co Sligo, 24-25 November 2023

Evidence-base for management of CAH needs to improve – Prof Krone

T

he evidence-base for several aspects of care provision for congenital adrenal hyperplasia (CAH) remains weak, according to Prof Nils Krone, Professor of Paediatric Endocrinology, University of Sheffield,

UK. Prof Krone delivered the Paediatric Keynote Lecture at the Irish Endocrine Society Annual Meeting 2023 on the subject of CAH management.

The well-attended meeting took place in the Radisson Blu Hotel, Ballincar, Co Sligo, on 24-25 November.

CAH develops due to an inherited inability to synthesise the hormone cortisol. The classic form, occurring in one in 14,000 to 18,000 of the population based on newborn screening, is defined by severely reduced or absent enzyme activity with impaired cortisol production manifesting clinically in the neonatal period.

The aims of CAH treatment are the replacement of missing hormones through glucocorticoids and mineralocorticoids and the normalisation of androgens/sex hormones. Treatment also aims to prevent virilisation and optimise growth and development, while protecting against comorbidities.

Prof Krone referred to the United Kingdom Congenital Adrenal Hyperplasia Adult Study Executive (CaHASE),

which was established in 2003 to study the health status of CAH patients in adulthood.

According to the study, which had a cohort of 203 patients, only 10 per cent of adults with CAH appeared to be under the care of endocrine specialist centres in the UK. “Treatment was highly variable and overtreatment was common,” Prof Krone said, summarising the findings.

The study found that quality-of-life was compromised to levels comparable with congestive heart failure and chronic haemodialysis patients.

He referenced other research which demonstrated that poor outcomes were linked with suboptimal treatment.

‘Health status of children and young persons with congenital adrenal hyperplasia in the UK (CAH-UK): A cross-sectional multi-centre study’ was published in the European Journal of Endocrinology in 2022.

A third of the patients exceeded the recommended dose range of 10-to-15mg/m2/day hydrocortisone equivalent, according to the study.

The study, which had a cohort of 107 patients aged between eight and 18, showed an increased prevalence of problems with growth and weight gain in CAH children and a reduced quality-of-life. It also found 10-to-15 per cent of

patients required urgent psychological support.

Prof Krone told attendees there were currently no data indicating the superiority of specific monitoring strategies in relation to outcomes.

He said the approach to hormone replacement therapy should be individualised, “ideally based on the patient’s hormonal profile throughout the day in relation to medication.”

In conclusion, Prof Krone stressed the danger of overtreatment and the importance for patients to receive the correct dose at the correct time of the day.

“Treatment can be optimised by strategies replicating physiologic secretion patterns,” he said.

Prof Krone said more reliable biomarkers for monitoring and comparison of monitoring strategies were required.

Given the impact of CAH on mental health, dedicated psychology support should also be part of care packages.

Prof Krone is in the process of establishing CaHASE2 with colleagues.

It aims to answer several important questions in relation to corticosteroid replacement, metabolic co-morbidities, blood pressure, bone health, as well as psychological health for patients with CAH.

Poor outcomes for patients with adrenal insufficiency – Hadden Lecture

A

traditional highlight of the Irish Endocrine Society Annual Meeting is the Hadden Lecture. This year’s lecture was on the subject of adrenal insufficiency. It was delivered by Prof Gudmundur Johannsson, University of Gothenburg, Sweden.

The title of the lecture was ‘Disease burden and novel treatments in adrenal insufficiency’.

In the lecture, Prof Johannsson highlighted recent data showing relatively poor outcomes for patients with adrenal insufficiency.

The condition occurs when the adrenal glands do not produce sufficient quantities of cortisol.

Speaking to the Medical Independent (MI) prior to his lecture, Prof Johannsson pointed out how patients with type 1 diabetes (T1D) receive care “in a much more sophisticated and structured way” than patients with adrenal inefficiency.

Prof Johannsson said a reason why outcomes for patients are suboptimal is due to the challenges in administering

glucocorticoid replacement therapy.

The cornerstone of the therapy is oral hydrocortisone, taken in divided doses.

“The way we manage patients’ glucocorticoid replacement is not sufficient or adequate,” Prof Johannsson told MI. “And the reason is cortisol is one of the few hormones that has a very large diurnal variation – it is much higher during the morning and much lower during the night…. It is difficult to manage treatment in a way that mimics the normal physiology.”

He said attempts to improve the methods by which the treatment is administered have fallen significantly short of the progress achieved in how insulin is delivered for people with T1D. “There are ongoing attempts to do something similar for patients with adrenal insufficiency,” he said.

“Having pumps and other more sophisticated devices to deliver cortisol in a more physiological way. There are things happening, but we are approximately 20 or 30 years behind.”

While there are patients who benefit from current treatment options, “there is another group who do less well or quite bad on what we offer them.”

On the positive side, he stated some recent products have been developed “that could be of benefit to the patients”.

Also, there is currently no biomarker that can quantify the action of glucocorticoids.

Prof Johannsson and his research team have been attempting to identify biomarkers in relation to the condition.

He was involved in a 2021 study entitled ‘Identification of human glucocorticoid response markers using integrated multi-omic analysis from a randomised crossover trial’.

The study revealed networks of genes, metabolites, and microRNAs that are associated with glucocorticoid activity. One microRNA (miR-122-5p) stood out as a potential way to measure this activity.

Prof Johannsson said such research is “only the very tiny first step in identifying something that is clinically useful”.

Obesity crisis requires population-level and specialist individual approaches

A

‘two-pronged’ approach is necessary to address the obesity crisis, the Irish Endocrine Society (IES) Annual Meeting 2023 was told in this year’s McKenna Lecture.

The McKenna Lecture, which took place on the second day of the IES meeting, was delivered by Prof Francis Finucane, Consultant Endocrinologist at Saolta University Health Care Group, and Professor in Medicine at University of Galway.

At the beginning of the lecture, Prof Finucane spoke about his clinical research Fellowship at St James’s Hospital, Dublin.

This work investigated cardiovascular and metabolic perturbations in Irish children with obesity, as well as the response to exercise in young patients with type 2 diabetes (T2D).

He told attendees that it highlighted the much higher cardiovascular risk, and resistance to the benefits of exercise, in young people under 40 affected by T2D. Prof Finucane also completed a post-doctoral Fellowship at the MRC epidemiology unit at the University of Cambridge, UK.

It was during this Fellowship he was exposed to a 1985 paper, ‘Sick individuals and sick populations’ by the epidemiologist Prof Geoffrey Rose, which provided a framework to respond to public health crises.

The first part of the ‘two-pronged’ approach Prof Rose proposed was to address the “causes of incidence” in the population.

With obesity, Prof Finucane said this would involve removing the drivers of unhealthy diet, such as through sugar taxes and advertising bans.

The second part of the approach is the need for the provision of care to individuals as required, such as specialist clinical interventions for people with severe obesity.

Speaking to the Medical Independent (MI), Prof Finucane said his aim in the lecture was to describe the difference “between one type of intervention, which is the high-risk approach for individual patients, and the population-level approach for everybody”.

“We often mix those two up,” he said.

“And my fundamental objective was to make endocrinologists aware that there is a distinction between the types of interventions we can introduce.”

Prof Finucane told MI that neither population-level nor specialist individual approaches were currently being satisfactorily implemented in relation to addressing obesity in Ireland.

“I think if policymakers and medical experts truly understood obesity and how Geoffrey Rose’s ideas pertained to obesity, we’d be doing a lot better on both fronts.”

However, he also said that progress was being achieved in some areas.

Prof Finucane presented newly published research data about the benefits of purposeful weight loss in patients undergoing a commissioned structured lifestyle programme at Croí, the cardiac charity based in the west of Ireland.

Over 1,000 patients have enrolled on the programme since its inception in 2012.

In adults with severe obesity, the study found older age and good mental health were associated with programme completion and attaining ≥5 per cent weight loss.

Improvements in cardiovascular and metabolic outcomes were proportional to the amount of weight lost. “Our finding that improvements in mental health were also proportional to the amount of weight lost is particularly novel,” according to the study’s conclusion.

(pembrolizumab) Infusion 25mg/ml

KEYTRUDA: helping to redefine overall survival expectations for more patients with mNSCLC1-4

PD-L1 <1% or unknown

PD-L1 1-49%

PD-L1 >50%

NONSQUAMOUS

√

√

√

1st line Combination** Therapy3

SQUAMOUS

√

√

√

1st line*** Monotherapy4

NON-SQUAMOUS AND SQUAMOUS

X

X

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Line

Histology

1st line Combination* Therapy2

5113_Keytruda_Lung_250x346_Ad_Dec2023_v.indd 1

of pembrolizumab, administration of corticosteroids and/or supportive care. Immune mediated adverse reactions have also occurred after the last dose of pembrolizumab. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Immune-mediated adverse reactions are immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated nephritis, immune-mediated endocrinopathies (including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism), immune-mediated skin adverse reactions (also including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)). Refer to SmPC for more information and management of immune-mediated adverse reactions. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT): Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with classical Hodgkin lymphoma undergoing allogeneic HSCT after previous exposure to pembrolizumab. Infusion-related reactions: Grades 1, 2, 3 or 4 infusion reactions including hypersensitivity and anaphylaxis, could be seen with pembrolizumab treatment. Refer to SmPC for more information and management of infusion-related reactions. Overdose: There is no information on overdose with pembrolizumab. In case of overdose, monitor closely for signs or symptoms of adverse reactions and treat appropriately. INTERACTIONS No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. No metabolic drug drug interactions are expected. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. Corticosteroids can be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions. FERTILITY, PREGNANCY AND LACTATION Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Pregnancy No data on use in pregnant women. Do not use during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. Breast-feeding It is unknown whether pembrolizumab is secreted in human milk. A risk to newborns/ infants cannot be excluded. Fertility No clinical data available. SIDE EFFECTS Refer to SmPC for complete information on side effects.

Pembrolizumab is most commonly associated with immune-mediated adverse reactions. Most of these reactions resolved with appropriate medical treatment or withdrawal of pembrolizumab. The most serious adverse reactions were immune-mediated and infusion-related adverse reactions.

When pembrolizumab is administered in combination with axitinib or lenvatinib, refer to the SmPC for axitinib or lenvatinib prior to initiation of treatment. For additional lenvatinib safety information related to advanced RCC see the SmPC for Kisplyx and for advanced EC see the SmPC for Lenvima. Monotherapy: Very Common: anaemia, hypothyroidism, decreased appetite, headache, dyspnea, cough, abdominal pain, nausea, vomiting, constipation, musculoskeletal pain, arthralgia, asthenia, oedema, pyrexia, diarrhoea, pruritus, rash, fatigue. Common: pneumonia, thrombocytopenia, neutropenia, lymphopenia, hyponatraemia, hypokalaemia, hypocalcaemia, insomnia, neuropathy peripheral, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, hyperthyroidism, dizziness, dysgeusia, pneumonitis, colitis, dry mouth, hepatitis, severe skin reactions, vitiligo, dry skin, eczema, alopecia, dermatitis acneiform, erythema, dermatitis, myositis, pain in extremity, arthritis, influenza like illness, chills, AST and ALT increases, increase in blood alkaline phosphatase, hypercalcaemia, blood bilirubin increased, blood creatinine increased, infusion related reaction. In combination with chemotherapy: Very Common: neutropenia, anaemia, thrombocytopenia, leukopenia, hypothyroidism, hypokalaemia, decreased appetite, insomnia, neuropathy peripheral, headache, dizziness, dyspnoea, cough, diarrhoea, nausea, vomiting, abdominal pain, constipation, alopecia, rash, pruritus, arthralgia, musculoskeletal pain, myositis, pyrexia, fatigue, asthenia, ALT increase, AST increased.

Common: pneumonia, febrile neutropenia, lymphopenia, infusion related reaction, adrenal insufficiency, thyroiditis, hyperthyroidism, hyponatraemia, hypocalcaemia, lethargy, dysgeusia, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, pneumonitis, colitis, gastritis, dry mouth, hepatitis, severe skin reactions, erythema, dry skin, dermatitis acneiform, dermatitis, eczema, pain in extremity, arthritis, acute kidney injury, oedema, influenza-like illness, chills, blood creatinine increased, blood alkaline phosphatase increased, blood bilirubin increased, hypercalcaemia.

In combination with axitinib or lenvatinib: Very Common: urinary tract infection, anaemia, hypothyroidism, decreased appetite, headache, dysgeusia, hypertension, dyspnoea, cough, diarrhoea, abdominal pain, nausea, vomiting, constipation, rash, pruritus, arthralgia, musculoskeletal pain, myositis, pain in extremity, fatigue, asthenia, oedema, pyrexia, lipase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased. Common: pneumonia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, infusion-related reaction, adrenal insufficiency, hyperthyroidism, thyroiditis, hyponatraemia, hypokalaemia, hypocalcaemia, insomnia, dizziness, neuropathy peripheral, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), pneumonitis, colitis, pancreatitis, gastritis, dry mouth, hepatitis, severe skin reactions, dermatitis, dry skin, erythema, dermatitis acneiform, alopecia, arthritis, nephritis, influenza like illness, chills, amylase increased, blood bilirubin increased, blood alkaline phosphatase increased, hypercalcaemia. PACKAGE QUANTITIES KEYTRUDA 25 mg/mL: 4 mL of concentrate in a 10 mL Type I clear glass vial. Legal Category: POM. Marketing Authorisation numbers EU/1/15/1024/002 Marketing Authorisation holder Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. Date of revision: August 2023 © 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin, D18 X5K7 or from www.medicines.ie. II133 Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie.

Adverse events should also be reported to MSD (Tel: 01-2998700) References 1. Keytruda Summary of Product Characteristics, August 2023, available at www.medicines.ie.

2. Gandhi L, et al. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378:2078-2092.

3. Paz-Ares L, et al. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018;379:2040–2051.

4. Reck, M et al. Pembrolizumab versus chemotherapy for PDL1 positive-non-small cell lung cancer, N Eng J Med 2016, 375(19)1823-1833.

ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; mNSCLC=metastatic non–small cell lung carcinoma; PDL1=programmed death ligand 1.

Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7, Ireland.

IE-KEY-00792

KEYTRUDA® (pembrolizumab) ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. PRESENTATION KEYTRUDA 25 mg/mL: One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. INDICATIONS KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection. KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. KEYTRUDA as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1. KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy. KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. KEYTRUDA, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers Colorectal cancer (CRC) KEYTRUDA as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings: - first line treatment of metastatic colorectal cancer - treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy. Non-colorectal cancers KEYTRUDA as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with (a) advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation, (b) unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. KEYTRUDA, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 10. KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. DOSAGE AND ADMINISTRATION See SmPC for full details. Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. The recommended dose of KEYTRUDA as monotherapy in paediatric patients aged 3 years and older with cHL or patients aged 12 years and older with melanoma is 2 mg/kg bodyweight (up to a maximum of 200 mg), every 3 weeks administered as an intravenous infusion over 30 minutes. For use in combination, see the Summary of Product Characteristics (SmPC) for the concomitant therapies.

KEYTRUDA must not be administered as an intravenous push or bolus injection. When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first. Treat patients until disease progression or unacceptable toxicity (and up to maximum duration of therapy if specified for an indication). For the adjuvant treatment of melanoma or RCC, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year. Refer to the SmPC for dosing in neoadjuvant and adjuvant treatment of locally advanced, or early stage triple-negative breast cancer at high risk of recurrence. KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued (a) For Grade 4 toxicity except for: endocrinopathies that are controlled with replacement hormones; or haematological toxicity, only in patients with cHL in which KEYTRUDA should be withheld until adverse reactions recover to Grade 0-1; (b) If corticosteroid dosing cannot be reduced to ≤10 mg prednisone or equivalent per day within 12 weeks; (c) If a treatment-related toxicity does not resolve to Grade 0 1 within 12 weeks after last dose of KEYTRUDA; (d) If any event occurs a second time at Grade ≥ 3 severity. Patients must be given the Patient Card and be informed about the risks of KEYTRUDA. Special populations Elderly: No dose adjustment necessary. Renal impairment: No dose adjustment needed for mild or moderate renal impairment. No studies in severe renal impairment. Hepatic impairment: No dose adjustment needed for mild or moderate hepatic impairment. No studies in severe hepatic impairment. Paediatric population: Safety and efficacy in children below 18 years of age not established except in paediatric patients with melanoma or cHL. CONTRAINDICATIONS Hypersensitivity to the active substance or to any excipients. PRECAUTIONS AND WARNINGS Assessment of PD-L1 status When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations. Immune-mediated adverse reactions Immune-mediated adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab. Most immune mediated adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions

Date of Preparation: October 2023

* KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. ** KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults. *** KEYTRUDA, as monotherapy, is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.

30/11/2023 09:25

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

30

Conference Coverage Irish Endocrine Society, Annual Meeting, Radisson Blu Hotel, Ballincar, Co Sligo, 24-25 November 2023

Award winners show high standard of endocrinological research in Ireland

T

he winners of the awards at the Irish Endocrine Society (IES) Annual Meeting 2023 demonstrated the strength and variety of the research being undertaken in the specialty in Ireland. IES President Prof Fidelma Dunne told the Medical Independent the standard of this research has risen “significantly” over the past decade.

“You can see that in the presentations,” Prof Dunne, who is Consultant Endocrinologist in Saolta University Health Care Group, and Professor of Medicine at the University of Galway, said.

“They are all of a very high standard scientifically, and also in the way they are presented.”

The O’Donovan medal for the best oral presentation was awarded to Mr Reece Corbett, PhD researcher, Ulster University, Coleraine, Northern Ireland. The title of the study was ‘Once-daily oral administration of GPR120 agonist Compound A improves pancreatic islet and β-cell health through actions on the small intestine’. The long-chain FFA receptor, GPR120 (FFAR4) has received interest for the treatment of type 2 diabetes (T2D). “Further research is needed in identifying novel synthetic agonists with greater efficacy,” according to the research team.

One such agonist, Compound A, has shown potential due to its high selectivity (EC50=0.35µM). For the study, high-fat-fed (HFF) C57BL/6 mice were treated with a daily oral dose of Compound A (0.1μmol/kg) alone or in combination with sitagliptin (50mg/kg) for 21 days. After longterm treatment of obese-diabetic mice, metabolic effects, islet morphology, tissue gene (qPCR) and protein (immunohistochemistry) expression, insulin sensitivity, and glucose tolerance were assessed.

“Compound A is a viable treatment for T2D, as GPR120 agonism has beneficial effects on β-cells, mediated by GLP-1 from gastrointestinal L-cells, and in combination with sitagliptin reduces stress on L-cells through decreased demand for GCG gene expression,” according to the researchers.

PCOS The Montgomery medal for the best poster presentation was awarded to Dr Tara McDonnell, RCSI, and Beaumont Hospital, Dublin. The study conducted by Dr McDonnell and the research team was entitled ‘Clinical and metabolic phenotyping of a large prospective cohort of Irish women with polycystic ovary syndrome (PCOS): The relationship between insulin sensitivity and serum classic and 11-oxygenated androgens’.

Serum 11-oxygenated androgens constitute the bulk of circulating androgens in women with PCOS; however, their relationship with metabolic disease remains unclear.

The researchers aimed to delineate the relationship between circulating androgens and metabolic risk in a large prospective Irish cohort. They conducted standardised phenotyping, including anthropometric measurements, metabolic assessment and serum steroid profiling. Androgens were measured by immunoassay in all patients; serum multi-steroid profiling for classic and 11-oxygenated androgens by liquid chromatography tandem mass 67 spectrometry (LC-MS/MS) was performed in a subset of PCOS patients. The relationship between insulin sensitivity, body composition and androgens was assessed by Spearman correlation testing and linear regression analysis. A total of 118 participants with PCOS (median age 28.3 [IQR 26-33]; median BMI 32.6 [IQR 26.1-38.7]); and 40 control women were studied.

“This carefully phenotyped cohort highlights the complex relationship between androgens and insulin sensitivity in women with PCOS,” according to the research team.

“Future studies are required to dissect the mechanisms linking androgen excess with metabolic disease in this population.”

acceptably high rates of DKA at presentation in those under 15 years,” according to the study’s conclusion.

“These national register data provide important information to guide interventions to reduce the frequency of life-threatening DKA in our population.”

They are all of a very high standard scientifically, and also in the way they are presented

Diabetic ketoacidosis The Jennings medal for the best presentation in paediatrics was awarded for the study ‘A decade of diabetic ketoacidosis (DKA) at type 1 diabetes (T1D) diagnosis in children and young people nationally by Sláintecare region’. The study was led by Prof Edna Roche, Professor in Paediatrics at Trinity College Dublin, and Consultant Paediatrician and Paediatric Endocrinologist at Children’s Health Ireland at Tallaght University Hospital, Dublin.

DKA is a life-threatening complication of T1D. Increasingly DKA at diabetes onset is associated with adverse longterm metabolic outcomes. The objective of this study was to report the proportion, age, and severity of DKA at diabetes onset in children aged under 15 years of age (2011-2021) nationally by healthcare region. The Irish Childhood Diabetes National Register (ICDNR) is a prospective incidence register which monitors the frequency, clinical, laboratory and demographic characteristics of T1D in those under 15 years at diagnosis. Incident cases were categorised by year, age and severity using the International Society for Paediatric and Adolescent Diabetes definition of DKA. Participating centres were grouped into Sláintecare regions. Nationally in the period (2011-2021), there were 3,186 ICDNR registered incident cases of T1D. Biochemical data were available to define DKA status for 2,888 (90.6 per cent) of the cohort. Overall, 37.3 per cent of children presented in DKA of whom 16-to-27 per cent had moderate or severe DKA. The proportion presenting in DKA varied over time and by region. The proportion of children presenting in DKA within age groups was highest in the 10-to-14.99 year (41.2 per cent) and 0-to-4.99 year (39.3 per cent) ranges, and lowest in the five-to-9.99 (31.6 per cent) year group.

“Ireland has a high incidence of type 1 diabetes and un-

AR-NKGCD Dr Claire Reynolds, Children’s Health Ireland at Crumlin, Dublin, received the award for best case report. The title of the study was ‘MCM4 deficiency causing natural killer (NK) and glucocorticoid deficiency with DNA repair defect (AR-NKGCD): Experience from the Irish Traveller community’.

A new condition, autosomal recessive natural killer and glucocorticoid deficiency (AR-NKGCD) was first described in Irish Travellers in 2008. It was attributed to recessive mutations in MCM4/PRKDC gene in 2012. AR-NKGCD is characterised by short stature, glucocorticoid and NK cell deficiency, and is a disorder of DNA repair.

“Experience of the condition has expanded at our centres, as more cases have been confirmed,” according to the research team.

Data from available medical, laboratory, genetic and radiology records on patients over the past 10 years was compiled. Sequencing analysis of intron 1 of the MCM4/ PRKDC gene in all patients (n=19) revealed the presence of the c71-2A>G p.(Phe24Argfs) mutation in the homozygous state. In those for whom data was available, all were born small for gestational age, birth weight between 0.4th – 2nd centiles. In addition, all had delayed bone age, short stature, and low weight. Most children had mild dysmorphic features. Feeding difficulties, failure to thrive and recurrent infections were observed in infancy and young childhood. Fatigue, hyperpigmentation, and development delay were also observed. Over 60 per cent required corticosteroid replacement (hydrocortisone doses range 9-to-15mg/m2). In others only emergency treatment was recommended. Mineralocorticoid secretion was not impaired. Over 80 per cent had raised ACTH levels. A serious adrenal crisis following infection occurred in three patients.

“AR-NKGCD is a rare disorder with a variable phenotype,” according to the research team.

“There is an increased risk of primary adrenal insufficiency, adrenal crisis, infection, malignancies, and premature death. Input from endocrinology and immunology specialists is required.”

Quality measures in diabetes Finally, ‘Quality measures in the diabetes clinic’ was the title of research that won the award for the best audit or quality improvement project. It was conducted by researchers in University Hospital Limerick (UHL). The United States National Committee for Quality Assurance (NCQA) describes specific clinical process and outcome measures to promote the use of a performance measurement set for diabetes services. An audit of 106 consecutive adult attendances was conducted at UHL’s diabetes clinic using these measures against specified NCQA targets and a total weighted score.

Blood pressure control met the standard, while HbA1c control and lipid control did not. Neither nephropathy nor retinal assessment met targets, while foot assessment did.

“As measured against NCQA standards, our clinic did not reach desired targets,” according to the UHL researchers.

“Focused practical or educational solutions may improve measures on reaudit,” according to the researchers.

“Further evaluation is needed to determine if US-NCQA standards are applicable to an Irish tertiary care setting, particularly with most recent guidelines.”

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

insulin glargine

From the start,1 there to help your patients on their basal insulin journey1

• Help your patients find balance between HbA1c reduction and hypoglycaemic risk1-7

m

≥6 ye

ars

fro

• Offers flexibility† (+/- 3 hours) in dosing time1,8,9

Toujeo® DoubleStar™ prefilled pen is recommended for patients requiring at least 20 units per day.1 † Toujeo® is available in easy-to-use pens,1,8,9 to be administered once daily at any time of the day, preferably at the same time every day.1 When needed, patients can administer Toujeo® up to 3 hours before or after their usual time of administration. Flexible dosing time was evaluated in two randomised, open-label clinical studies, in patients with T2DM.1

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

Precautions and Warnings: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Toujeo is not the insulin of choice for treatment of diabetic ketoacidosis. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood

glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered. Hypoglycaemia: In case of insufficient glucose control or a tendency to hyper/hypoglycaemic episodes, the patient’s adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Particular caution should be exercised, and intensified blood glucose monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or who are elderly. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. Intercurrent illness: Requires intensified metabolic monitoring and often it is necessary to adjust the insulin dose. Insulin antibodies: administration may cause insulin antibodies to form. Use with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Medication errors: Insulin labels must always be checked before each injection to avoid errors between Toujeo and other insulins. Patients must be instructed to never use a syringe to remove Toujeo from the SoloStar or DoubleStar prefilled pen, A new sterile needle must be attached before each injection. Needles must not be re-used.

Pregnancy and lactation: There are no data from exposed pregnancies in controlled clinical trials.

However, there is a large amount of data on use of insulin glargine 100 units/ml in pregnant women indicating no specific adverse effects on pregnancy and no specific malformative nor feto/neonatal toxicity. The use of Toujeo may be considered during pregnancy, if clinically needed. Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk. Interactions: Substances that affect glucose metabolism may require adjustment of insulin glargine. Adverse Reactions: Very common: Hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening. Common: Lipohypertrophy, injection site reactions, including redness, pain, itching, hives, swelling, or inflammation. Prescribers should consult the SmPC in relation to other adverse reactions. Legal Category: POM. Marketing Authorisation Number: SoloStar 5 pen pack: EU/1/00/133/035; DoubleStar 5 pen pack: EU/1/00/133/038. Marketing Authorisation Holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. Further information is available from: Medical Information, Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of preparation: July 2022. MAT-IE-2200355 (V1.0) Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie; email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com

Intended for Healthcare Professionals in the Republic of Ireland only.

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

References: 1. Toujeo® Summary of Product Characteristics July 2020. 2. Home PD, et al. Diabetes Care 2015;38(12):2217-2225. 3. Matsuhisa M, et al.

Diabetes Obes Metab 2016;18(4):375-383. 4. Danne T, et al. Diabetes Care 2020; 43(7):1512–1519. 5. Riddle MC, et al. Diabetes Care 2014;37:2755-2762.

6. Yki-Jarvinen H, et al. Diabetes Care 2014;37:3235-3243. 7. Bolli GB, et al. Diabetes Obes Metab 2015;17:386-394. 8. Singh R, et al. Eur Endocrinol 2018;14:47-51. 9. Pohlmeier H, et al. J Diabetes Sci Technol 2017;11;263-269.

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

sanofi

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Conference Coverage ALL REPORTS PRISCILLA LYNCH

Irish Society of Gastroenterology, Winter Meeting, Killashee Hotel, Naas, Co Kildare, 7-8 December 2023

Intestinal ultrasound ‘a very accurate and useful modality’

I

ntestinal ultrasound (IUS) should be used more in the monitoring and assessment of inflammatory bowel disease (IBD) patients, as it is accurate, non-invasive and cost-effective, the Irish Society of Gastroenterology Winter Meeting 2023 heard.

Prof Kerri Novak, Consultant Gastroenterologist, Professor of Medicine, University of Calgary, Canada, an internationally renowned expert on the topic, said that despite the proven use of IUS in evaluation of the small and large bowel for inflammation, perforation, diverticulitis, and acute bow-

el obstruction, gastroenterology remains well behind other specialties in the adoption of this safe and effective diagnostic tool, which can be used at the bedside.

Prof Novak cited a number of IUS studies showing positive results in relation to high accuracy for detection of inflammation, fibrosis, and post-operative complications, as well as being preferred by patients over colonoscopy and being resource-saving.

This evidence included a multicentre, international, observational cohort study, which Prof Novak was involved in, assessing IBD patients for potential flares during the Covid-19 pandemic. Patients were evaluated with IUS alone or in combination with an in-clinic, unsedated sigmoidoscopy.

IUS identified active inflammation in two-thirds (n=102) of patients, and strictures in 14 per cent (n=22). Faecal calprotectin levels correlated with inflammation detected on IUS. In the majority of patients, clinical assessment with IUS led to an acute change in IBD-specific medications (57 per cent, n=90) and avoided or delayed the need for urgent endoscopy (85 per cent, n=134). “Those results are very reassuring; that it is a very safe and accurate modality.”

Prof Novak also implored delegates to “image ulcerative colitis patients more often”.

Speaking to the Medical Independent, Prof Novak said she had three key takeaway messages from her presentation.

“Number one, we have limited tools at the bedside and so this provides information that is indispensable, every day, at the bedside,” she said.

“Secondly, because we can see the bowel move and in cross section, it teaches us about the gut, similar to a cardiologist with an Echo… and thirdly, our guidelines currently do not include patient wishes into what tools we use… they have to have input, and if they did, they would pick ultrasound.”

IBD patients must be adequately screened

C

onsistent surveillance of IBD patients for the development of colorectal cancer is “crucial” given that they have a two-fold higher risk of developing the disease than the general population.

This is according to Prof Marietta Iacucci, Consultant Gastroenterologist and Professor in Gastroenterology, University College Cork, who gave a presentation titled ‘Changing concepts in managing dysplasia associated with IBD’ during the Irish Society of Gastroenterology Winter Meeting 2023.

Prof Iacucci noted that IBD-related colorectal cancer contributes to significant mortality in this cohort of patients.

Detection of flat lesions in IBD patients is challenging, however, and requires excellent bowel prep, she emphasised, as poor bowel prep is the most common reason for hindering chromoendoscopy.

She stressed the importance of key performance indicators, always striving to maintain and improve quality, and good communication.

Technology has improved in the last decade, and dye‐ based chromoendoscopy and virtual chromoendoscopy are now comparable as the latest data shows, and techniques for endoscopic removal of lesions continue to improve, Prof Iacucci reported, adding that skill and training are key.

Discussing the latest data on the use of biopsies, Prof Iacucci cited research showing that targeted and random biopsies detect similar proportions of neoplasia, but targeted biopsies appear to be more cost-effective so they are now the standard of care. “Though in high-risk patients still do random biopsies,” she added.

Prof Iacucci acknowledged the lack of standardised training in the detection of neoplasia in IBD – there is still no validated training course – but efforts are being made to improve the situation and she pointed to the latest European Society of Gastrointestinal Endoscopy guidelines in the area.

Briefly looking at the growing role of artificial intelligence in screening, Prof Iacucci said “there is a still a long road to go” in IBD, given the complexity of the disease and the organs involved.

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THE MEDICINES MANAGEMENT PROGRAMME RECOMMENDS HUKYNDRA AS A BEST VALUE BIOLOGICAL MEDICINE FOR ADALIMUMAB3 ABBREVIATED PRESCRIBING INFORMATION. Hukyndra 40 mg solution for injection in pre-filled syringe. One 0.4 ml single dose pre-filled syringe contains 40 mg adalimumab. Hukyndra 40 mg solution for injection in pre-filled pen. One 0.4 ml single dose pre-filled pen contains 40 mg adalimumab. Indications: 1) Rheumatoid arthritis 2) Juvenile idiopathic arthritis 3) Axial spondyloarthritis 4) Psoriatic arthritis 5) Psoriasis 6) Paediatric plaque psoriasis 7) Hidradenitis suppurativa (HS) 8) Crohn’s disease 9) Paediatric Crohn’s disease 10) Ulcerative colitis 11) Paediatric ulcerative colitis 12) Uveitis 13) Paediatric uveitis. Dosage: Refer to Summary of Product Characteristics. Method of administration: Hukyndra is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet. Hukyndra is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen. Thus, it is not possible to administer Hukyndra to patients that require less than a full 40 mg dose. If an alternate dose is required, other adalimumab products offering such an option should be used. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis or other severe infections such as sepsis, and opportunistic infections. Moderate to severe heart failure (NYHA class III/IV). Warnings and precautions: Infections (Serious infections, Tuberculosis, Other opportunistic infections), Hepatitis B reactivation, Neurological events, Allergic reactions, Immunosuppression, Malignancies and lymphoproliferative disorders, Haematologic reactions, Vaccinations, Congestive heart failure, Autoimmune processes, Concurrent administration of biologic DMARDS or TNF-antagonists, Surgery, Small bowel obstruction, Elderly and Paediatric population. Interactions: Refer to Summary of Product Characteristics. Fertility, pregnancy and lactation: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Hukyndra treatment. Hukyndra should only be used during pregnancy if clearly needed. Hukyndra can be used during breast-feeding. Driving and operation of machinery: Hukyndra may have a minor influence on the ability to drive and use machines. Vertigo and visual impairment may occur following administration of Hukyndra. Undesirable effects: Very common: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral), Leukopenia (including neutropenia and agranulocytosis), Anaemia, Lipids increased, Headache, Abdominal pain, Nausea and vomiting, Elevated liver enzymes, Rash (including exfoliative rash), Musculoskeletal pain, Injection site reaction (including injection site erythema). A copy of the SmPC is available upon request or go to www.clonmelhealthcare.ie . Pack size: Hukyndra 40 mg solution for injection in pre-filled syringe - 2 pre-filled syringes + 2 alcohol pads, Hukyndra 40 mg solution for injection in pre-filled pen - 2 pre-filled pens + 2 alcohol pads. Marketing authorisation holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. Marketing authorisation numbers: EU/1/21/1589/002, EU/1/21/1589/005. Distributed by Clonmel Healthcare Ltd. Medicinal product subject to medical prescription.

Date last revised: December 2021. 2023/ADV/HUK/130H. Date of Preparation: May 2023. *When compared with Humira®. For example, 0.4 mL instead of 0.8 mL for a Hukyndra® 40 mg dose. **STADA founded Bioceuticals Arzneimittel AG in 2000. 1. Hukyndra® SmPC (Jan. 2022).

2. Nash P et al. Rheumatol Ther 2016;3:257–270. 3. Best-value biological medicines https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-value-medicines/best-valuebiological-medicines/

http://biosimilars.stada

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Conference Coverage Irish Society of Gastroenterology, Winter Meeting, Killashee Hotel, Naas, Co Kildare, 7-8 December 2023

Evolving treatment and approaches to obesity

O

besity is a complex chronic disease which needs multiple treatments and a multidisciplinary approach, delegates attending the Irish Society of Gastroenterology Winter Meeting 2023 heard, during a dedicated symposium on the modern approach to obesity and bariatric surgery Noted obesity expert Prof Carel le Roux, Professor of Met-

abolic Medicine, University College Dublin, discussed the evolution of scientific evidence on obesity as a disease and the need to treat it like any other condition, such as cancer or diabetes. He described obesity as a neurological disease and a “fundamental biological dysregulation of where your [fat mass] thermostat is set”.

“The disease of obesity causes people to over-eat and if you

TWO WAYS ARE BETTER THAN ONE Mucosal healing is the ultimate treatment goal for Ulcerative Colitis (UC) patients.1 Show your mild to moderate patients the way to achieve this with PENTASA once-daily combination therapy.

ESG – a safe and effective procedure

1 g, 2 g & 4 g sachets

PENTASA combination therapy is proven to help more of your mild to moderate UC patients achieve mucosal healing and improve quality of life compared to oral therapy alone.2 The PENTASA range offers flexible and convenient treatment options for patients: · · · ·

The only time-dependent mesalazine that ensures delivery throughout the entire colon, due to its unique ethyl cellulose coating3-7 PENTASA once-daily vs. twice-daily dosing achieved comparable mucosal healing scores of 85% and 81%8 Always once-daily administration3-7,9,10 1g rectal suspension Range of formulations and dosages to aid patient compliance1,3–7,9,10

PENTASA ABBREVIATED PRESCRIBING INFORMATION. Please consult the Summary of Product Characteristics (SmPC) for full details before prescribing.

Name of product(s): Pentasa Sachet prolonged release granules 1g, 2g and 4g; Pentasa prolonged release Tablets 500mg and 1g; Pentasa Rectal Suspension 10mg/ml; Pentasa Suppository 1g. Indication: Sachets: The treatment of mild to moderate exacerbations of ulcerative colitis and for the maintenance of remission of ulcerative colitis. Tablets: The treatment of mild to moderate ulcerative colitis. Rectal Suspension: Management of active ulcerative colitis. Suppository: Treatment of ulcerative proctitis. Dosage and administration: Sachets: Active Disease (Adults): up to 4g once daily or in 2–4 divided doses. Maintenance Treatment (Adults): 2g once daily. Sachets and Tablets: Active Disease (Paediatric; 6 years≥): Determine individually, start with 30-50mg/ kg/day in divided doses. Maximum dose: 75mg/kg/day in divided doses. Total dose should not exceed 4g/day. Maintenance treatment (Paediatric; 6 years≥): Determine individually, start with 15-30mg/kg/day in divided doses. Total dose should not exceed 2g/day. Tablets: Active Disease (Adults): up to 4g once daily or in 2–3 divided doses.

Maintenance Treatment (Adults): 2g once daily. Rectal Suspension: (Adults): 1g/100ml rectal suspension at bedtime. Suppository: Active Disease (Adults): 1g twice daily for 2-4 weeks. Maintenance Treatment (Adults): 1-2g daily. The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately. Contraindications: Hypersensitivity to mesalazine, any of the excipients, or salicylates. Severe liver and/ or renal impairment. Warnings and Precautions: Caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). In case of acute symptoms of intolerance e.g. abdominal cramps, abdominal pain, fever, severe headache and rash, the treatment should be discontinued immediately. Caution is recommended in patients with impaired liver function. Liver function parameters like ALT or AST should be assessed prior to and during treatment, at the discretion of the treating physician. The drug is not recommended for use in patients with impaired renal function and in patients with haemorrhagic diathesis. The renal function should be regularly monitored (e.g. serum creatinine), especially during the initial phase of treatment. Mesalazine induced nephrotoxicity should be suspected in patients

developing renal dysfunction during treatment. The concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions. Caution is recommended in patients with active peptic ulcer. Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment; please refer to section 4.8. Mesalazine-induced cardiac hypersensitivity reactions (myo-and pericarditis) have been reported rarely. Serious blood dyscrasias have been reported very rarely with mesalazine (see section 4.5).

Blood tests for differential blood counts is recommended prior to and during treatment, at the discretion of the treating physician. Treatment should be discontinued on suspicion or evidence of these adverse reactions. Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content.

It is recommended to ensure adequate fluid intake during treatment. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of four weeks. If the findings are normal, followup tests should be carried out every three months. If additional symptoms occur, these tests should be performed immediately. Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported. Pentasa should be discontinued at the first appearance of signs and symptoms of severe skin reactions. Interactions: No interaction studies have been performed. Combination therapy with Pentasa and azathioprine or 6-mercaptopurine or thioguanine have shown a higher frequency of myelosuppressive effects, and an interaction cannot be ruled out, however, the mechanism behind the interaction is not established. Regular monitoring of white blood cells is recommended and the dosage regimen of thiopurine should be adjusted accordingly. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin. Driving and using machines: Pentasa has no or negligible influence on the ability to drive or use machines. Adverse reactions: Common side effects (≥ 1/100 to <1/10). All Formulations: Headache, diarrhoea, abdominal pain, vomiting, flatulence, nausea and rash (incl. urticaria, erythematous rash). Rectal Suspension 10mg/ml and Pentasa Suppository 1g: Anal discomfort/irritation at the application site, pruritus (anal), rectal tenesmus. Prescribers should consult the SmPC for further information and for a full list of all side effects. Presentation: Pentasa sachet 1g is presented in

T Top & T Tail 1g supposi suppository

packs of 50 aluminium foil sachets. Pentasa sachet 2g is presented in packs of 60 aluminium foil sachets. Pentasa sachet 4g is presented in packs of 30 aluminium foil sachets. Pentasa Tablet 500mg is presented in packs of 100 aluminium foil blisters.

Pentasa Tablet 1g is presented in packs of 60 aluminium foil blisters. Pentasa Rectal Suspension 10mg/ml is presented in cartons containing 7x100ml bottles. Pentasa Suppository 1g is presented in cartons of 28 suppositories. Legal category: Product subject to prescription which may be renewed (B). Marketing Authorisation Number: 1g sachet: PA1009/6/1, 2g sachet: PA1009/6/6, 4g sachet: PA1009/6/8, 500mg Tablet: PA1009/6/5, 1g Tablet: PA1009/6/7, 1g Suppository: PA1009/6/2, 10mg/ml Rectal Suspension: PA1009/6/3. Further information is available from the Marketing Authorisation Holder: Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24. Tel: (01) 4637355; Email: enquiries.ireland@ ferring.com UK-PA-2000061 Date of preparation: January 2021

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie.

References: 1. Lamb CA, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. June 2019. Available at: https://www.bsg.org.uk/wp-content/uploads/2019/12/BSG-IBD-Guidelines-2019. pdf. Last accessed July 2022. 2. Probert CSJ, et al. J Crohns Colitis. 2014;8(3):200–207.

3. Pentasa Sachet 1 g. SmPC. 4. Pentasa Sachet 2 g. SmPC. 5. Pentasa Sachet 4 g. SmPC. 6. Pentasa Slow Release Tablets 500 mg. SmPC. 7. Pentasa Slow Release Tablets 1 g. SmPC. 8.

Pentasa Rectal Suspension 1 g. SmPC. 9. Pentasa Suppositories 1 g. SmPC. 10. Bokemeyer B, et al. J Crohns Colitis. 2012;6:476–482.

Date of preparation: July 2022. IE-PA-2200011.

CORP-2022-076 IRELAND Pentasa Top + Tail (Lizzie) 240x165 - Medical Independent.indd 1

treat it, people will eat less.”

Prof le Roux pointed to the overall impact of obesity on the development/exacerbation of a number of health conditions, such as type 2 diabetes, cardiovascular disease, infertility, liver disease, sleep apnoea, gout and joint issues.

Treating the underlying condition, ie, obesity, can help dramatically improve/cure many of these associated conditions.

There are now a range of successful and evidence-based treatments for obesity, including bariatric surgery and medications, such as the GLP-1 inhibitors; however, treatment and access remain a challenge, Prof le Roux said. He added while diet and lifestyle offer benefits for some people, and should continue to be advised, they clearly do not work for the majority of those with obesity.

The data also show that the long-term benefit of anti-obesity medications, such as GLP-1 inhibitors, requires continued treatment, as once they are stopped most people regain the weight, Prof le Roux stated. He questioned reimbursement regimes that put a time cut-off on access to these medications.

Concluding, Prof le Roux said the future of obesity care will include chronic treatment “aimed at health gain not weight loss”, recognising the different subtypes of the disease, and the need for tailored treatments for each, and “not blaming our patients for their disease or if they don’t respond”.

08/08/2022 14:19

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ndoscopic sleeve gastroplasty (ESG) is no longer an experimental procedure and is a safe, effective minimally-invasive treatment option for obesity, the Irish Society of Gastroenterology Winter Meeting 2023 heard from an Irish pioneer in its usage.

Mr Jamie Kelly, Bariatric and Cancer Surgeon, Spire Southampton Hospital, UK, discussed the development of the procedure and the advancing evidence-base.

In ESG, the surgeon uses a suturing device attached to the endoscope to perform full-thickness stitching of the stomach to reduce gastric capacity and delay emptying. The folds of the stomach are pulled together, accordion-style, which creates a sleeve-like shape under a third of its original size. This leads to the patient losing a substantial amount of weight as they become fuller faster and for longer after eating.

“This is categorically not a physical barrier to someone overeating. I cannot stress that enough; this is turbocharging normal physiology so that they feel full quickly and can use that to portion control,” he explained.

A major benefit of ESG is that patients experience a faster recovery time and lower post-operative risks, both incidence rate and severity, compared to other weight-loss procedures and it is potentially reversible, if necessary, Mr Kelly explained.

“As the evidence has developed and the safety profile has been established, we can now use the procedure in a much bigger BMI range than we expected to… it is now a well-established procedure with over 15,000 cases recorded in the literature [>25,000 surgeries globally], and its safety profile is excellent,” he said, adding that it is a very good option for older patients.

Mr Kelly quoted from the recent MERIT trial, which concluded ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities, and recommended that it be considered as a synergistic weight loss intervention for patients with class 1 or 2 obesity.

ESG was also approved by the National Institute for Health and Care Excellence in the UK earlier this year as a weightloss option for obesity in the NHS, he noted.

Looking to the future, Mr Kelly predicted wider uptake of ESG and briefly discussed promising early data on the use of GLP-1 inhibitors in conjunction with ESG to treat obesity.

HIT BACK AGAINST CROHN’S DISEASE WITH RINVOQ®▼ (upadacitinib)

PRESCRIBING INFORMATION (PI). RINVOQ®▼ ▼ (upadacitinib) 15 mg prolonged release tablets; 30mg prolonged-release tablets; 45 mg prolonged-release tablets. Refer to Summary of Product Characteristics (SmPC) for full prescribing information. PRESENTATION: Each tablet contains upadacitinib hemihydrate, equivalent to 15mg of upadacitinib in the 15mg tablet, 30mg in the 30mg tablet and 45mg in the 45mg tablet.

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 diseasemodifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate. Treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). 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. Treatment of adult patients with moderately to severely active ulcerative colitis (UC) or moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 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, AS, and nr-axSpA: Recommended oral dose is 15mg once daily. Consideration should be given to discontinuing treatment in patients with AS and nr-axSpA 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: Recommended oral dose is 15 mg or 30 mg once daily based on individual patient presentation (see SmPC for details). A dose of 15 mg is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy. The lowest effective dose to maintain response should be used. For patients ≥ 65 years of age, the recommended dose is 15mg once daily. Adolescents from 12 to 17 years weighing at least 30 kg: Recommended oral dose is 15mg once daily. Consideration should be given to discontinuing upadacitinib treatment in any patient who shows no evidence of therapeutic benefit after 12 weeks of treatment. UC: Induction; Recommended oral dose is 45mg once daily for 8 weeks. For patients who do not achieve therapeutic benefit by week 8, 45mg once daily may be continued for an additional 8 weeks. Discontinue treatment in patients with no evidence of therapeutic benefit by week 16. Maintenance; Recommended oral dose is 15mg or 30mg once daily based on individual patient presentation (see SmPC for details). A dose of 15 mg is recommended for patients at higher risk of VTE, MACE and malignancy. The lowest effective dose to maintain response should be used. Patients ≥ 65 years of age: recommended dose is 15 mg once daily. In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care. For patients with UC receiving strong inhibitors of cytochrome P450 (CYP) 3A4 the recommended induction dose is 30 mg once daily and maintenance dose is 15 mg once daily. CD: Induction; Recommended oral dose is 45mg once daily for 12 weeks. For patients who have not achieved adequate therapeutic benefit after the initial 12-week induction, 30mg once daily may be considered. For these patients, upadacitinib should be discontinued if there is no evidence of therapeutic benefit after 24 weeks of treatment. Maintenance; Recommended oral dose is 15mg or 30mg once daily based on individual patient presentation (see SmPC for details). A dose of 15mg once daily is recommended for patients at higher risk of VTE, MACE and malignancy. The lowest effective dose to maintain response should be used. Patients ≥ 65 years of age: recommended dose is 15 mg once daily. In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care. For patients with CD receiving strong inhibitors of cytochrome P450 (CYP) 3A4 the recommended induction dose is 30 mg once daily and maintenance dose is 15 mg once daily. (see SmPC for more details). Special Populations: Elderly: Upadacitinib should only be used in patients ≥65 years if no suitable treatment alternatives are available. For AD patients ≥ 65 years of age, a dose higher than 15mg once daily is not recommended. For RA, PsA, AS and nraxSpA there are limited data for patients 75 years of age and older. For UC and CD maintenance therapy, a dose higher than 15 mg once daily is not recommended in patients ≥ 65 years of age. For UC and CD patients ≥ 75 years of age the safety and efficacy of upadacitinib has not been established. Renal: No dose adjustment required in mild-moderate renal impairment. Patients with severe renal impairment should use upadacitinib with caution (See SmPC for dose adjustments). Upadacitinib has not been studied in subjects with end stage renal disease and is therefore not recommended for use in these patients. 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: Safety and efficacy in RA, AS, PsA, nr-axSpA, UC and CD in children and adolescents aged 0 to 18 years and in AD in children under 12 years of age has not been established. No clinical exposure data are available in AD adolescents < 40 kg.

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. Upadacitinib should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older; with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers) or with malignancy risk factors (e.g. current malignancy or history of malignancy). Immunosuppression: Combination use, with immunosuppressants e.g. azathioprine, 6-mercaptopurine, 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 and sepsis have 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, those with

diabetes. Closely monitor patients for signs and symptoms of infection during and after treatment. Interrupt treatment if the patient develops a serious/opportunistic infection. If infection is controlled, resume treatment following risk/benefit consideration. A higher rate of serious infections was observed with upadacitinib 30mg compared to upadacitinib 15mg. 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 prophylactic zoster vaccinations prior to starting therapy, in agreement with current immunisation guidelines.

Malignancy: Lymphoma, NMSCs and other malignancies have been reported in patients receiving JAK inhibitors, including upadacitinib. There is a higher rate of malignancies and NMSCs with upadacitinib 30mg compared to 15mg. Periodic skin examination is recommended for all patients, particularly those with risk factors 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. Gastrointestinal perforations: Events of diverticulitis and gastrointestinal perforations have been reported. Use with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids). Patients with active Crohn’s disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation. Major adverse cardiovascular events: Events of MACE were observed in clinical studies of upadacitinib (See SmPC for full details). Lipids: Monitor total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) at 12 weeks and thereafter according to international guidelines for hyperlipidaemia. 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) were observed in clinical trials for upadacitinib. Use therapy with caution in patients with known VTE risk factors other than cardiovascular or malignancy risk factors. Risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder.

Patients should be re-evaluated periodically during upadacitinib treatment to assess for changes in VTE risk and treatment should be discontinued in patients with suspected VTE. Hypersensitivity: Anaphylaxis and angioedema have been reported in patients receiving upadacitinib. Discontinue treatment and institute appropriate therapy if significant hypersensitivity occurs. 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 with atopic dermatitis receiving chronic treatment with strong CYP3A4 inhibitors. For patients with ulcerative colitis or Crohn’s disease using strong CYP3A4 inhibitors, the recommended induction dose is 30 mg once daily and the recommended maintenance dose is 15 mg once daily (see Dosage and Administration). Avoid food and drink containing grapefruit during treatment with upadacitinib. 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, urinary tract infection, pneumonia, non-melanoma skin cancer, anaemia, neutropaenia, lymphopaenia, urticaria, hypercholesterolaemia, hyperlipidaemia, cough, abdominal pain, nausea, rash, 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: RINVOQ 15 mg prolonged-release tablets in cartons of 28 tablets; EU/1/19/1404/006: RINVOQ 30 mg prolonged-release tablets in cartons of 28 tablets; EU/1/19/1404/010: RINVOQ 45 mg prolonged-release tablets in cartons of 28 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: April 2023. PI-1404-010.

IE-RNQG-230025 | July 2023

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Conference Coverage Irish Society of Gastroenterology, Winter Meeting, Killashee Hotel, Naas, Co Kildare, 7-8 December 2023

De-escalation of treatment for IBD

D

e-escalation of treatment for inflammatory bowel disease (IBD) is possible and advisable in a number of scenarios, but patients need to be carefully assessed and monitored to deal with potential relapse swiftly, the Irish Society of Gastroenterology Winter Meeting 2023 heard.

Prof Peter Irving, Consultant Gastroenterologist, Guy’s and St Thomas Hospital, London, UK, discussed the latest data on de-escalation of treatment in IBD, biologics or immunosuppressants.

Pregnancy, tolerance, toxicity, lower risk of side-effects, cost, and achieved remission are among the key reasons to consider reducing treatment in patients, he explained.

Prof Irving outlined the latest data on such scenarios, both in monotherapy and combination therapy.

Careful patient assessment/risk stratification and discussion are crucial before considering de-escalation of

therapy, he stressed.

Regarding azathioprine, Prof Irving said he often withdraws it after six months in patients who have commenced the medication (where they take it in combination with infliximab).

In relation to pregnancy, while some medications are advised to be stopped due to teratogenicity, others are safe to continue. He advised careful discussion with patients on the risk of disease flare and the potential impact on pregnancy if they chose to discontinue treatment.

Looking at the data across a number of studies on stopping treatment in IBD patients, Prof Irving said those who relapse generally respond well to re-initiation of treatment. The landmark STORI trial found a remission rate of 88 per cent (38/43 patients) within 12 months of restarting infliximab in those who had taken a 'drug holiday' and reported no reactions. Other studies have also confirmed a high rate of clinical remission in response to restarting the same anti-TNF agent.

However, summarising the data on anti-TNF withdrawal, he said there is a 50 per cent relapse rate at two years, an increased risk of relapse over time, a risk of immunogenicity, and dose reduction “doesn’t appear worth it”.

In relation to predicting what patients are more likely to relapse, data (STORI) shows that risk factors include younger age at diagnosis, disease severity and surgery, haemoglobin ≤145g/L, faecal calprotectin ≥300μg/g, CRP ≥5.0mg/L, and leukocyte counts >6.0 × 10(9)/L. Prof Irving concluded by saying that consideration for de-escalation of therapy in IBD must be tailored, taking into account the risks and consequences of a flare, and patients’ preferences.

Early identification of relapse is key, so careful monitoring is needed.

Prof Irving also gave a separate presentation at the meeting on the use of janus kinase inhibitors in ulcerative colitis.

Good ergonomics ‘vital for endoscopists’

T

he consequences of poor ergonomics in endoscopy include acute or persistent musculoskeletal problems for the endoscopist, impacting ability to work or train, gastroenterologists attending the Irish Society of Gastroenterology Winter Meeting 2023 were warned.

Dr Keith Siau, Consultant Gastroenterologist, Royal Cornwall Hospitals NHS Trust, UK, who developed a framework on ergonomics in endoscopy, gave a practical presentation on ‘ergonomics for the endoscopist’.

He noted the topic was lacking in traditional endoscopy training and education.

“Often we don’t teach ergonomics when we have a trainee, but perhaps we should, as they copy what we do. And if we start bending and contorting, they will copy these bad habits.”

Endoscopy can involve long periods on the feet, working certain muscles quite hard and repetitively.

Posture can be impacted by bending down and looking up at monitors, which may not be in the ideal position, causing pain, neck, shoulder, and thumb issues for practitioners. Dr Siau said that, unsurprisingly, endoscopy-related injury is common.

He quoted US data showing women are more affected by upper body issues, while men tend to have more lower body issues.

This year saw the publication of an American Society for Gastrointestinal Endoscopy guideline on the role of ergonomics for prevention of endoscopy-related injury. Dr Siau discussed the five key points outlined in the guideline.

He outlined a pre-endoscopy ergonomic checklist with guidance on optimum equipment positioning; bed and monitor heights/elevations; correct posture; and using a cushioned floor mat, chair where possible, wheel extender, and comfortable footwear, as well as stretching and taking

regular 'micro' breaks.

Dr Siau also advised simplifying endoscopy procedures where possible to reduce rotation: “We are big fans in Cornwall of water-assisted colonoscopy, as it actually reduces the amount of torque you have to do… and you don’t need to turn the patient during the procedure and it is quicker and increases your adenoma detection rate….”

Newer technology, including the latest generation scopes, which are lighter and smaller, suiting female hands better, can also help reduce the physical burden on endoscopists, he commented.

Concluding, Dr Siau maintained that ergonomic considerations need to be proactively incorporated into endoscopy provision and training, and that practitioners should consider having their practice assessed (observed or videoed) to determine what changes they may need to protect themselves from injury.

The importance of exercise in disease prevention and treatment

T

he benefits of exercise and physical activity in a number of healthcare conditions was a key theme at this year’s Irish Society of Gastroenterology (ISG) Winter Meeting.

Prof Karen Boland, Consultant Gastroenterologist, Beaumont Hospital, Dublin, has studied the impact of diet and exercise programmes on outcomes in moderate-to-severe inflammatory bowel disease (IBD) and cirrhosis.

In her presentation to the meeting, Prof Boland highlighted the growing issue of healthcare issues being caused by poor lifestyle and obesity, including early-onset colorectal cancer.

She pointed out that 15-to-40 per cent of IBD patients are obese, with accumulating evidence connecting mesenteric fat and IBD/Crohn’s disease. Obesity also negatively impacts the response of various drug therapies in IBD, while these patients have lower muscle mass and function, she reported.

Exercise programmes, meanwhile, in IBD and liver cirrhosis have generated successful disease improvements, as confirmed in a number of studies.

Highlighting her key points to the Medical Independent

(MI), Prof Boland said healthcare professionals need to inform themselves on the official recommended activity levels and educate their patents. “The big challenge facing us is the ageing, frailer population. The one thing that all of the data points to is that resistance training and exercise will support your health and disease control along with standard therapies. So, my take home message is that we should be having that conversation with patients, as to what resistance exercise is; that they should be trying to do moderate intensity exercise for 150 minutes a week; and try to embed that habit into their lifestyle; and that the benefits that they will get from that are astronomical in terms of their longevity, their health and quality-of-life,” she told MI. Also speaking during this session, Prof Mike Trenell, Professor of Metabolism and Lifestyle Medicine, Newcastle University, UK, outlined the significant positive impact lifestyle interventions can have on liver disease, quoting from a number of studies. He acknowledged that behaviour change in relation to diet and lifestyle can be very difficult.

However, Prof Trenell maintained that it is possible with the right support and resources, and digital technologies

have a role to play. “Encouraging people to move more, and eat less is not enough… every patient should have access to structured education, best practice guidance, and that is not hard and we should be doing that,” he told MI. The meeting also featured a special ‘activity hour’, which ISG President Prof Orla Crosbie said gave everyone a chance to take a deep breath and get active before the meeting’s social activities and gala dinner. Prof Crosbie said the role of diet and activity in chronic diseases was an area she is particularly passionate about, “so it was good to hear the experts confirm that and also give us ideas for our practices.”

She described the meeting as a great success, and thanked all the speakers and the organising team. “We had a great variety of speakers on a broad range of topics in a lovely setting, here in the Killashee, which worked out very well. The standard of abstracts for the meeting – we had 59 – was outstanding and we had a very difficult time picking the winners.

Congratulations to our trainees, I have no concerns about the future of the profession.”

The next ISG meeting will be held in Cork next May. For full details see www.isge.ie.

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Legal Category: S1A. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com 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.

PP-XEL-IRL-0822 | Date of preparation: October 2022

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Conference Gallery Irish Society of Gastroenterology, Winter Meeting, Killashee Hotel, Naas, Co Kildare, 7-8 December 2023

Pictured L-to-R: Dr Garret Cullen and Prof Suzanne Norris

Prof Aiden McCormick and Prof Garry Courtney

Prof John Hegarty and Prof John Ryan

Prof Martin Buckley accepting the second poster prize for Dr Lucy Quinlivan from Prof Orla Crosbie, President, Irish Society of Gastroenterology

Dr Lisa McNeill; Dr Johnny Cash; Dr William Dickey; and Dr Seamus Murphy

Dr Geraldine McCormack and Ms Maureen Kennelly

Dr Fionn Nally and Dr Frank Keating

Medical independent ISG.pdf 1 13/12/2023 13:46:10

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Fewer Injections* ▼ Yuflyma® (Adalimumab) Abbreviated prescribing information

* with Yuflyma 80mg in IBD induction

Yuflyma 40 mg solution for injection in pre-filled pen. Each 0.4 ml single dose pre-filled pen contains 40 mg of adalimumab. Yuflyma 80 mg solution for injection in pre-filled pen. Each 0.8 ml single dose pre-filled pen contains 80 mg of adalimumab. Pharmaceutical Form: Solution for injection. Clear to slightly opalescent, colourless to pale brown solution. Indications: Please refer to SmPC for full information. 1) Rheumatoid arthritis 2) Juvenile idiopathic arthritis 3) Axial spondyloarthritis 4) Psoriatic arthritis 5) Psoriasis 6) Paediatric plaque psoriasis 7) Hidradenitis suppurativa 8) Crohn’s disease 9) Paediatric Crohn's disease (from 6 years of age) 10) Ulcerative colitis 11) Paediatric ulcerative colitis (from 6 years of age) 12) Uveitis 13) Paediatric uveitis Dosage: Please refer to SmPC for full information. Method of administration: Yuflyma is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet.

Adalimumab is available in other strengths and presentations. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis or other severe infections such as sepsis, and opportunistic infections. Moderate to severe heart failure (NYHA class III/IV) Warnings and precautions: Infections: (Serious infections, Tuberculosis, Other opportunistic infections) Hepatitis B reactivation, Neurological events, Allergic reactions, Immunosuppression, Malignancies and lymphoproliferative disorders, Haematologic reactions, Vaccinations, Congestive heart failure, Autoimmune processes, Concurrent administration of biologic DMARDs or TNF-antagonists, Surgery, Small bowel obstruction, Elderly, Paediatric population, Sodium contents Interactions: Please refer to SmPC. Fertility, pregnancy and lactation: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Yuflyma treatment. Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother’s last adalimumab injection during pregnancy. Yuflyma can be used during breastfeeding. Undesirable effects: Very common: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral) Common: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections. Please refer to SmPC.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Ireland HPRA Pharmacovigilance Website: www.hpra.ie Marketing Authorisation Holder: Celltrion Healthcare Hungary Kft.1062 Budapest Vaci ut 1-3. WestEnd Office Building B torony Hungary. Legal Category: POM. Marketing authorisation numbers: EU/1/20/1513/001-012, EU/1/20/1513/013-016. Further information available on request.

Marketed by: Celltrion Healthcare Ireland Ltd, 26, Arrow Building, Old Belgard Road, Tallaght, Dublin D24 ND70, Ireland. © Celltrion Healthcare Ireland Ltd. 2023 HCYUF-AD-1123/23IRE-03 Date of item: November 2023

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Conference Coverage ALL REPORTS JULINDA SCHROEDER

College of Psychiatrists of Ireland, Winter Conference, Sheraton Hotel, Athlone, 16-17 November 2023

Challenges of burnout and training raised by President

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sychiatry in Ireland continues to face the challenges of limited resources, and legislation and regulation which are not fitfor-purpose. This was the message from Dr Lorcan Martin, President of the College of Psychiatrists of Ireland, in his opening address at the College’s Winter Conference 2023 held on 16 and 17 November at the Sheraton Hotel in Athlone. The theme of the conference was ‘Global perspectives on psychiatry: Bridging borders for better mental healthcare’.

“Like our colleagues in other medical specialties, we are happy to offer our expert advice for development of policy and strategy, even if we have to bang loudly on the doors of power to get that opportunity,” he said.

Speaking to the Medical Independent, Dr Martin said the main challenges facing the profession tied in with some of the key messages from the conference.

“Obviously, the most important thing is that our patients have to come first, and in order to provide a gold standard service in a timely fashion, you need resourcing.”

He explained that one of the key difficulties faced by psychiatry was that many of the mental health teams in Ireland were under-resourced. “There aren’t enough of them to begin with, and the ones that are there don’t have the full complement of team members.” When it came to resourcing, one of the major problems was the proportion of the health budget allocated to mental health in Ireland, which was only 6 per cent. “In other comparable developed countries, it will be 12-to-13 per cent. This is something we have been saying for a very long time.”

He stressed that it was not about changing the system, as the system that was in place worked well when it was supported.

Another priority for the College was training specialists for the future, he said. Dr Martin pointed out the

College of Psychiatrists of Ireland has a comprehensive and established training scheme. Although the College was keen to take on more NCHDs who wanted to qualify in psychiatry, it again came down to resources: “You cannot train somebody on goodwill and aspirations.”

He stressed that training a doctor to become a specialist took significant effort, resources, and personnel.

The other key challenge highlighted by Dr Martin was that many doctors – as well as other team members – suffer from burnout and work-overload due to a lack of resourcing. “People are trying to do more and more with less and less.” It was not only a problem for those in the profession, he said, but “getting people to take up jobs”. This resulted in psychiatrists and other medical specialists moving abroad or retiring earlier than they might otherwise do “simply because the job is becoming too onerous”.

He referred to the new consultant contract which, he said, provided a much better salary for psychiatrists.

However, he stressed that there were issues beyond salary that needed to be addressed. These included long waiting lists, insufficient capacity, and out-ofdate technology. “These are the kinds of things people need to do their jobs properly and make sure that patients get what they need in a timely fashion. No one wants to hear about getting a wonderful service if you have to wait two years to get it.”

Dr Martin added that “psychiatry is fundamentally about people”.

“First and foremost, obviously, it is about the patients… and beyond that you are talking about the families and carers; they often need a lot of education and support. Looking after somebody with a serious mental illness can be extremely stressful for someone in their immediate vicinity.” He said psychiatrists and their teams also needed support. “It’s in a different way, a professional way, but has its own stresses.” And,

Dr Lorcan Martin

finally, Dr Martin said, it is important for doctors to be aware of their own health status. “If we do not look after ourselves, we cannot give our best to those we are supposed to be helping.”

Globalisation and the future of psychiatry

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rof Norman Sartorius presented a virtual address at the College of Psychiatrists of Ireland Winter Conference 2023 entitled, ‘The future of psychiatry in a globalised world’.

He is a former Director of Mental Health at the World Health Organisation, and former President of the World Psychiatric Association and European Psychiatric Association.

In his presentation, Prof Sartorius outlined the major socio-economic trends influencing the future of mental healthcare globally, one of which was urbanisation. “[Urbanisation] has a variety of consequences – most of the people going into towns are unlikely to [form] a community. So, the notion that the community will be the carrier of most of the care for peoProf Norman Sartorius ple with mental illnesses is gradually disappearing with urbanisation. [The people in these] communities rarely work together and help each other.”

The second trend he highlighted is commodification.

Health services, including mental healthcare, become commodities when “you have to pay for them… [or] make

money with them”.

The third trend is the change in the world’s demographic structure, with an increasingly aging population.

The fourth trend is ‘horizontalisation’. This is where members of society communicate in horizontal layers with people in the same age group as themselves. Because vertical communication was being reduced, wisdom that older people can pass to younger people was not being transmitted, he argued.

The fifth aspect was the fragmentation within professions, including psychiatry.

“Even in psychiatry there are a whole range of sub-dis-

The notion that the community will be the carrier of most of the care for people with mental illnesses is gradually disappearing with urbanisation

ciplines, which do not talk to each other.” Another trend was de-civilisation. He said one measure of civilisation was the level of care and attention society provides to vulnerable groups. Such care was being eroded at individual and local level and the State was often unwilling to bridge the gap, according to his presentation.

One major consequence of these trends was loneliness.

“Gradually, as communities vanish or fall apart, there is an incredible increase on the burden of care. Carers are suffering, with many reports of carers [experiencing] burnout and an increase in physical morbidity.”

He added: “Staff burnout is at much higher levels than ever before, and a number of people are now employed to do jobs for which they are not very well qualified. Equally, medicine has changed in many ways. Previously, being a doctor was a very special thing, now it is becoming a profession with all the professional advantages and disadvantages. Previously healthcare was an ethical imperative, now it has become an economic opportunity.”

In conclusion, Prof Sartorius said the capacity for empathy should be assessed when selecting candidates for entry into medical schools. Prof Sartorius further stressed the need for a review and revision of health legislation, while a greater emphasis on the primary prevention of mental disorders was also required. “At least one-third or half of all mental and neurological disorders are amenable to primary prevention. [Therefore] society must be made aware of the many opportunities for primary intervention.”

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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Coverage Conference College of Psychiatrists of Ireland, Winter Conference, Sheraton Hotel, Athlone, 16-17 November 2023

Disease-modifying treatments for Alzheimer’s disease

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t is unprecedented times for people working in neurodegeneration and Alzheimer’s disease (AD) with the advent of disease-modifying therapies, according to Prof Iracema Leroi, Professor of Geriatric Psychiatry at Trinity College Dublin, and the Global Brain Health Institute. She is also Consultant Geriatric Psychiatrist at St James’s Hospital, Dublin.

Prof Leroi delivered a presentation on the new class of treatments for AD at the College of Psychiatrists of Ireland Winter Conference 2023. She also discussed the outcomes of a working group which was convened to consider the implications of, and health system readiness for, disease-modifying treatments (DMTs) for the disease in the Irish context.

Speaking to the Medical Independent (MI), Prof Leroi said that there were significant challenges in Ireland to ensure these treatments were accessible and appropriate people received them.

“There is a lot of public education that has to occur to ensure that these things are happening, and that people’s expectations are managed, and they get the opportunity to receive treatment. But we are still a long way away, and a lot of work has to be done. I think Ireland has a tremendous potential to do this in the best possible way because we are a small community, we know each other, and we can work together.”

Prof Leroi told MI: “The support we have from the HRB [Health Research Board] in moving the research agenda forward for this population is absolutely critical.”

In her presentation, she told delegates that there was no licensed treatment to delay or slow the progression of the neurodegeneration that characterised AD until recently. “However, over the past decade, evidence sup-

Prof Iracema Leroi

porting the potential for dementia prevention through risk reduction has increased, alongside a growing pipeline of medications with the potential for disease modification, targeting the very earliest stages of AD, mild

cognitive impairment, and the mild stages of dementia.”

She explained that of the current ongoing trials of nearly 130 agents for AD worldwide, about 80 per cent were classified as DMT, as opposed to symptomatic therapies for cognitive enhancement or management of neuropsychiatric symptoms. “The current potential DMTs for AD include human monoclonal antibody-based agents targeting beta amyloid, two of which have recently received regulatory approval from the FDA in the US. While promising for the treatment of AD in Ireland, the complexity of drug eligibility, administration, cost, and safety of the DMTs necessitate adopting new models of treatment and care pathways to AD.” Prof Leroi is Co-Lead of Dementia Trials Ireland (DTI), which has recently been established. DTI is a research network, funded by the HRB, to increase the capability and capacity for conducting trials in dementia and people at risk of dementia in Ireland. It is an interdisciplinary group, formed to increase the involvement of people living with dementia in clinical trials.

“It is very important that people with dementia are counted and get the opportunity to become involved in research.”

Prof Leroi also highlighted that access to treatment was essential. “It’s all very well coming up with cutting-edge DMTs, but if you cannot implement these because you do not have the right ecosystem or environment, you’re essentially wasting your time.” In addition, improvements in the diagnostic landscape were also required.

“If you wait for clinical symptoms to appear, the horse has bolted. So, you need to start early in the pre-clinical stage. That is the holy grail in all neurodegenerative diseases. Because you have to be able catch it. But if you cannot detect the disease, you cannot treat it.”

Responding to the critics of psychiatry

“W

e are in the service industry and our purpose is to serve the population, but sometimes we forget this,” according to Prof Sir Robin Murray, Professor of Psychiatric Research at the Institute of Psychiatry in London, UK. At the College of Psychiatrists of Ireland Winter Conference 2023, Prof Murray delivered a talk entitled, ‘How should psychiatry respond to its critics – with vehemence or conciliation?’.

“Psychiatry sets out to provide care for those with mental health problems, ie, to provide a service to them,” he said.

“Service industries generally survey their consumers to assess their satisfaction or otherwise. However, the orthodox psychiatric response to criticisms of care has often been to discount sceptics as ill-informed, paranoid, or simply misled.

Some psychiatrists have attempted to have dialogue with the critics, not always Prof Sir Robin Murray successfully.”

Prof Murray said that, in the UK context, there was a spectrum of critics.

He told delegates that psychiatry was often criticised for the continued use of electro-convulsive therapy, preoccupa-

tion with the minutiae of DSM/ICD diagnoses, excessive use of medications, or compulsory treatment. The critics included pseudo-religious groups, such as the Scientologists, “with whom dialogue was impossible.”

They also includes “radical psychologists” who believed that members of their profession should be chiefly charged with the care of mentally ill populations. However, significant criticism also came from service user groups, and even fellow psychiatrists, among others.

According to Prof Murray, in the UK, service user and representative bodies were less antagonistic than their US equivalents. He also said criticism in the UK has reduced over the last two decades. He suggested this was perhaps due to the passing of legislation, which stipulates that service users must be involved in care models for all disorders, not only psychiatry.

He explained that priority was increasingly being given

Some psychiatrists have attempted to have dialogue with the critics, not always successfully

to the ‘voice of the patient’ when it came to rethinking psychiatry. For example, looking at alternatives to compulsory treatment was important. “There has been an astonishing rise in [compulsory admissions] under the Mental Health Act in the UK.” Prof Murray explained that compulsory admissions had risen from 22,000 in 1982 to 51,000 in 2020. This was the result of an emphasis on risk rather than care. “There is a lot of pressure, and many psychiatrists err on the side of safety," he argued.

Also, Prof Murray highlighted how cuts to mental healthcare budgets have resulted in a lack of capacity.

Looking at the conclusions to be drawn from these criticisms, Prof Murray said: “There are too few of us interested in the care of the mentally ill to spend time fighting each other.” Some of the questions he said the members of the profession should ask each other were: “Can we win arguments without being offensive or dismissive, and are critics more or less likely to be sympathetic to psychiatry after an encounter with us?”. He stressed, however, that a lot of criticism focused on the ‘brain disease model’ and there was a relative neglect of social factors. Prof Murray also asked whether psychiatry should be campaigning to improve the social conditions in which many patients lived. Another query was whether psychiatrists should play more of a role in talk therapy. He also questioned the widespread prescription of antidepressants, often in primary care.

In conclusion, he said psychiatry should be paying more attention to the views of service users.

Prof Murray pointed out that most service industries spent time assessing what their customers think of their product.

“Service industries that fail to provide what their customers want tend to go bankrupt, or be replaced by other providers,” he said.

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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Life Diary

2024 JANUARY

MI

FRIDAY 19 National Perinatal Epidemiology Centre (NPEC) Annual Study Day, Midlands Park Hotel, Portlaoise, Co Laois. The title of this hybrid meeting is ‘From pre-pregnancy to postpartum: Understanding maternal adverse outcomes’. Speakers include Prof Krish Nirantharakumar, Joint-Director for the Centre for Health Data Science and Deputy Director for the Institute of Applied Health Research at University of Birmingham, who will talk on multiple long-term conditions before and during pregnancy. Prof Deirdre Daly, Associate Professor, School of Nursing and Midwifery, Trinity College Dublin, will speak on the MAMMI Research Project. Other speakers include Dr Mas Mahady Mohamad, Consultant Psychiatrist; and Ms Edel Manning, Maternal Death Enquiry Ireland Co-ordinator. The day will also feature other topics from the NPEC and case studies from maternity units to support learning on morbidities in pregnancy and improve maternal outcomes. The call for abstracts is now open for poster and oral presentations and this year the organisers will be inviting authors to submit a five-minute recorded presentation of their e-Poster. This presentation will be displayed on the NPEC Study Day conference webpage. Visit https://www.ucc.ie/en/npec/.

MARCH TUESDAY 5 – THURSDAY 7 Trinity Health and Education International Research Conference 2024 (THEconf2024), Trinity College, Dublin 2. Organised by Trinity’s School of Nursing and Midwifery, THEconf2024 is designed

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TUESDAY 19 – WEDNESDAY 20 2nd All Ireland Paediatric Emergency Medicine Conference, Dublin (further information to be released). This conference will bring together professionals working in the field of paediatric emergency medicine. The theme for the event is ‘Without borders’. Visit https://www.ipem.ie.

APRIL THURSDAY 25 – FRIDAY 26 30th Health Services Research and Pharmacy Practice (HSRPP) Conference, University College Cork. The HSRPP conference has a long legacy of disseminating novel research pertaining to medication use and pharmaceutical care that guides practice and policy change in health services, ultimately making a difference to the care of patients and delivery of services. The conference places particular emphasis on sharing the work of early career researchers and in creating an encouraging environment to support delegates of all career stages. The theme of the 2024 conference is ‘Sustainable development in healthcare’. The conference will feature a range of keynote speakers, workshops, and presentations in both oral and

poster formats. Visit https://www.ucc.ie.

JUNE SATURDAY 1 – TUESDAY 4 16th European Glaucoma Society (EGS) Congress, Convention Centre, Dublin 1. The EGS is a not-forprofit charitable organisation advocating for the highest standards of glaucoma care across Europe.

The programme for this event has been designed to provide an update on all aspects of glaucoma management, from epidemiology and basic science to diagnosis and medical and surgical treatment.

It will feature a panel of internationally renowned speakers who are recognised experts in the field.

Visit https://egs2024.org.

SATURDAY 15 – WEDNESDAY 19 7th Congress of European Otorhinolaryngology and Head and Neck Surgery (ORL-HNS), Convention Centre, Dublin 1. This conference is organised by the Confederation of European Otorhinolaryngology – Head and Neck Surgery (CEORL-HNS). The Confederation aims to facilitate continuing medical education and professional development as well as maintaining and improving the welfare of ORL-HNS specialists in Europe. It also endeavours to advance science and research in ORL-HNS and allied disciplines, and to unify the advancement of ORL-HNS in Europe. Visit https:// ceorlhns2024.org.

JULY MONDAY 15 – FRIDAY 19 Society for the Study of Reproduction (SSR), 57th Annual Meeting, Convention Centre, Dublin 1. This meeting is organised by the SSR, which was founded in 1967 to promote the study of reproduction by fostering interdisciplinary communication among scientists, holding conferences, and publishing meritorious studies. The 2024 annual conference has the theme of ‘Evolution of reproductive sciences - where should we go’. Visit https://ssr.org.

SEPTEMBER WEDNESDAY 25 – SATURDAY 28 29th WONCA Europe Conference, Convention Centre, Dublin 1. WONCA (World Organisation of Family Doctors) was established by 18 members in 1972. It currently consists of 122 member organisations in 102 countries, with a total of 500,000 family doctors. The European regional branch, WONCA Europe, is the academic and scientific society for general practice/family medicine in Europe. It represents 47 member organisations and more than 90,000 family doctors in Europe. WONCA Europe’s Annual Conference in 2024 will take place in Dublin and be hosted by the ICGP. The theme of the conference is ‘The changing nature of family medicine – cultivating the future’. Visit https://www.woncaeurope2024.org/.

MINDO QUIZ

Test your knowledge and win €50

BOOK REVIEW Asylum – Inside Grangegorman by Prof Brendan Kelly

OCTOBER

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THURSDAY 3 – FRIDAY 4 Irish Association of Directors of Nursing and Midwifery (IADNAM), Annual Conference, Hodson Bay Hotel, Athlone, Co Westmeath. The IADNAM is a network of midwifery and nursing leaders from all disciplines, established to develop, promote and support excellence in healthcare.

IADNAM is a vibrant and dynamic association that provides expert advice to senior health officials in areas of clinical, operational and policy development. Visit https://iadnam.ie.

GALLERY

HSE National Doctors Training and Planning, National Medical Workforce Conference Blackrock Health Cardiac Arrhythmia Symposium

to stimulate discussions that address contemporary issues in health and healthcare education. The theme for the 2024 event is ‘New horizons in healthcare: Global impact, local relevance’. The event provides a forum for academics, clinicians, researchers, policy-makers, and service-users to present and discuss their research with the common aim of exploring innovation in practice to improve healthcare and health and wellbeing (including through education) across the lifespan.

Pre-conference workshops will be offered on 5 March, with the conference sessions being presented on 6-7 March. THEconf2024 is an inperson event. Visit https://nursing-midwifery.tcd.ie.

Convention Centre, Dublin

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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Mindo Quizzes Life

OUR NEW ADDRESS

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SPORTS QUIZ – THE SPORTING YEAR 19 December 2023 Q1

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Q2

Who captained Team Europe to success at this year’s Ryder Cup?

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Who managed Manchester City to the Premier League, Champions League, and FA Cup earlier this year?

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Name the Belgian who became only the fourth man from outside the United Kingdom to win the World Snooker Championship this year?

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Who won the 2023 Tour de France?

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CROSSWORD COMPETITION

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Who are the newly crowned ladies Football League of Ireland champions for 2023? A: Peamount United Who was named as World Rugby Player of the Year for 2023?

A: Ardie Savea As the qualifiers come to the conclusion for Euro 2024, which country will host the event next summer? A: Germany The first of snooker’s triple crown of tournaments, the UK Championship, begins next Sunday. Who is the defending champion from Northern Ireland? A: Mark Allen Which horse won the 2023 Melbourne Cup? A: Without a Fight Which football team won the promotion/relegation play-off match earlier this month and will play in the Premier Division of the League of Ireland next season? A: Waterford United

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The winner of the 21 November 2023 Crossword is Ms Susannah Kingston, Co Dublin The winner of the 21 November 2023 Sports Quiz Competition is Dr Albin Thomas, Dublin 15

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THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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Life Book Review

AN ILLUMINATING LOOK INSIDE THE WALLS OF GRANGEGORMAN TITLE: Asylum – Inside Grangegorman AUTHOR: Prof Brendan Kelly PUBLISHER: Royal Irish Academy REVIEWER: Dr Muiris Houston

W

hen I was growing up in Dublin, references to Grangegorman were rarely to the area. The more usual verbal reference was either slightly threatening, condescending, or somewhat fearful. It was often described in what we now would correctly regard as offensive language.

Despite my subsequent medical training and better understanding of psychiatry, it surprises me how clear those 40 odd year-old memories are. Prof Brendan Kelly’s latest book, Asylum – Inside Grangegorman, is a chance to see behind the walled-off institution and to get a better understanding of Dublin’s district asylum.

Recently published by the Royal Irish Academy, the book includes some anonymised patient case histories as well as quotations from resident medical superintendents (RMSs), all of which help to bring it to life.

“Mental asylums are Ireland’s awkward institutions,” Kelly writes. They assumed a life of their own, well beyond the treatment of mental illness. Meeting the complex needs of troubled families (often unrelated to mental illness) and alleviating social problems became the raison d’etre of mental institutions.

Kelly uses the case of Máire A, who was 23 when she was admitted to Grangegorman with ‘melancholia – cause unknown’, as the spine of his book. Subsequent medical notes refer to her as having “mild chronic melancholia” and being “an industrious working patient”. Despite the mildness of her diagnosis, she remained incarcerated for another 45 years, before dying in the asylum aged 68.

“This book tries to make sense of the story of Máire A and the many others like her who found themselves caught up in Ireland’s extraordinary and sometimes shameful system. These are the stories of people who were, for various reasons, consigned to institutions, often for several decades if not for life – with doctors unable to discharge them home and families either unable or unwilling to take them back,” the Trinity College Dublin Professor in Psychiatry writes.

One of the more enlightened RMSs was Dr Connolly Norman, who was in post from 1886 to 1908. The leading psy-

Prof Brendan Kelly Photo: Ruth Medjber

Kelly sounds a warning about the need for continued access to asylum archives

chiatrist of his generation, Connolly features heavily in the book. He was deeply opposed to prolonged asylum admission.

However, his efforts to change the system were rejected by a society and govern-

ment committed to institutionalisation.

One of his successors, Prof John Dunne (1937-1965), introduced better living conditions for patients in Grangegorman. He had singular success in finally reducing

inpatient numbers, from over 2,000 in 1937 to some 700 when he retired in 1965.

The extremely broad social reasons for admission to Grangegorman in the early 1800s included domestic disagreements, jealousy, pride, and “change of life consequent on marriage”. Most are well removed from mental illness. One poor man was committed for “excessive fondness of music”. It seems to this reviewer that being socially outmanoeuvred by a family member was a principal reason for admission.

The decanting of patients from what was now known as St Brendan’s continued under Prof Ivor Browne and Dr Dermot Walsh. The institution finally closed its door in 2013, leaving the modern Phoenix Care Centre in its wake.

Kelly sounds a warning about the need for continued access to asylum archives: “Despite their complexities – or more likely because of them – the buried stories of the Irish asylum patients need to be unearthed and told.”

He is right. Ireland managed to incarcerate many more people in asylums than other jurisdictions and was much slower to implement reform to a community-based model of psychiatry. This story represents a systematic disempowerment of the mentally unwell and a grossly disproportionate deprivation of liberty, despite the best efforts of asylum staff.

Ideally, future consideration of Irelands asylums would include communication from the patients. I realise this is going to be difficult to locate. Would it be possible to put together a collection of letters from patients to their relatives?

Not being a trained archivist, I’m not sure how realistic a proposal this is. But it would surely enrich the efforts of Kelly and others who seek to get behind the forbidding walls of asylums, such as Grangegorman .

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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Gallery Life HSE National Doctors Training and Planning, National Medical Workforce Conference, Clayton Hotel, Cardiff Lane, Dublin, 9 November 2023

Minister for Health Stephen Donnelly

Pictured at a panel session are Prof Mary Day, National Director, Acute Operations, HSE; Mr Liam Woods, National Director, HSE; Dr Colm Henry, Chief Clinical Officer, HSE; Dr Siobhán Ní Bhriain, National Clinical Director, Integrated Care, HSE; Prof John Higgins, CEO, South/South West Hospital Group; and Dr David Hanlon, National Clinical Advisor and Group Lead, Primary Care, HSE

Blackrock Health Cardiac Arrhythmia Symposium, Blackrock Clinic, 18 November 2023

Prof Brian Kinirons, Medical Director, National Doctors Training and Planning, HSE Photos: Conor Healy – Picture It Photography

Pictured L-to-R: Dr Peter Murray; Dr Steven Williams, Honorary Consultant Cardiologist, University of Edinburgh/ NHS Lothian, UK; Dr Noel Fitzpatrick, Consultant Cardiologist and Electrophysiologist, Mater Private Network; Dr Jonathan Lyne, Consultant Cardiologist and Electrophysiologist, Blackrock Health; Dr Louisa O’Neill, Consultant Cardiologist, Blackrock Health; Dr Matt Wright, Consultant Cardiologist and Electrophysiologist, Guy’s and St Thomas’ Hospital, London, UK; Prof Mattias Duytschaever, Professor in Electrophysiology, University of Ghent and Sint-Jan’s Hospital, Bruges, Belgium; Dr John Keaney, Consultant Cardiologist, Blackrock Health; Prof Mark O’Neill, Consultant Cardiologist and Professor of Cardiac Electrophysiology, Guy’s and St Thomas’ Hospital, London, UK; and Dr Daniel O’Hare, Consultant Cardiologist and Electrophysiologist, Blackrock Health

Prof David Keane, Consultant Cardiologist

Attendees at Blackrock Health’s Cardiac Arrhythmia Symposium

Dr Steven Williams; Dr Matt Wright; Prof Mark O’Neill; Prof Mattias Duytschaever; and Mr James O’Donoghue, CEO, Blackrock Clinic

Prof Mark O’Neill

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

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RXDX Product Focus

ABBVIE NAMED ON LIST OF BEST WORKPLACES IN PHARMA AND HEALTHCARE IN 2023

Pictured are AbbVie Citywest employees (L-to-R): Mr Pablo Lopez; Ms Rachel Edwards; Ms Blanaid O’Connell; and Ms Karen Vickers Great Place To Work, the global authority on workplace culture, has named biopharmaceutical company AbbVie on its 2023 Best Workplaces in Pharma and Healthcare in Ireland list. This is the second consecutive year that AbbVie has appeared on the list and it is one of only 20 companies and organisations recognised.

Ireland’s Best Workplaces in Pharma and Healthcare 2023 is an industry recognition compiled by Great Place to Work Ireland that recognises organisations building great cultures in the pharma and healthcare industries.

The recognition highlights listed companies as employers of choice in an increasingly competitive talent market. To be considered for Ireland’s Best Workplaces in Pharma and Healthcare in 2023, participating organisations were required to be certified as a Great Place to Work.

AbbVie, which employs more than 2,600 people across six Irish locations from Sligo to Cork and Mayo to Dublin, was named as one of the Best Large Workplaces in Ireland at the Great Place to Work 2023 Awards earlier this year – the 10th consecutive year that the company has featured on the list. The company was also acknowledged as one of the Best Workplaces for Women in Ireland for the fifth year in a row and was ranked number four on the World’s Best Workplaces list in November.

Speaking about this most recent accolade, Mr Gary O’Mahoney, HR Director for Ireland, said: “Being named as one of Ireland’s Best Workplaces in Pharma and Healthcare again this year is an incredible accomplishment for the company. It is a validation of our efforts to create an inclusive workplace that supports employee development and also empowers them to make a broader impact in the communities where they live and work.”

“I would like to thank colleagues across our six locations in Ireland for their commitment to our company culture and ongoing dedication to patients around the world.”

The Best Workplaces in Pharma and Healthcare list is published here: www.greatplacetowork.ie/great-workplaces/best-workplaces-in-pharma-healthcare/bestworkplaces-in-pharma-and-healthcare/

GLUCOSAMINE SHOWED DECREASE IN GLOBAL PAIN BASED ON VAS SCORES IN KNEE OSTEOARTHRITIS PATIENTS Glucosamine showed a decrease in global pain based on visual analog scale (VAS) scores in knee osteoarthritis (OA) patients, and is safe, according to a recent systematic review published in the journal Pharmacy.

“However, further studies of glucosamine are needed in patients who are taking warfarin or diabetic medicines. At the same time, doctors should also inform patients about possible interactions when using these drugs together,” stated the authors at the Faculty of Pharmacy, Ton Duc Thang University, Vietnam.

A total of 15 randomised placebo-controlled trials were

collected and the majority were limited to six months of treatment and conducted in 2015 or earlier.

In the review, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and VAS were considered the main outcome measures. The primary outcomes were the degree of pain (based on WOMAC/ VAS or other tools), the improvement in function, and the stiffness score from baseline to the end of treatment.

Safety was considered a secondary outcome.

The authors noted that measuring pain intensity is a commonality between WOMAC and VAS. Nevertheless, based on the research, the results showed a sizable gap.

“At the end of the follow-up, the VAS score had significantly improved, but the positive change in WOMAC pain was too slight to be influential,” they outlined.

“Additionally, neither the overall WOMAC score nor any of its subscales established a discernible clinical improvement. It is important to remember that the VAS global pain subscale was thought to have better assay sensitivity than the WOMAC pain subscale, which exhibited valuable authenticity as a primary result measure.”

Even though glucosamine has been found to mitigate discomfort, the scores in the placebo group also improved.

This improvement could be the result of the arthritis’ normal progression or the effects of a placebo. Other musculoskeletal structures have been affected by this issue.

Most of the articles collected utilised glucosamine sulfate rather than glucosamine hydrochloride. Despite inconsistent findings across studies, there was a tendency that glucosamine sulfate portrayed a noticeable and clinically meaningful impact on OA at high doses.

According to the authors, the most recent findings from clinical research still demonstrated the controversial debate about glucosamine’s therapeutic effects.

They concluded that the effects of glucosamine use have been shown to be effective in the short-term. However, since osteoarthritis is a chronic disease, patients will take medication for most of their lives if no alternative therapy is available. Therefore, future research should focus on performing long-term studies on the effects, effectiveness, and safety of glucosamine to assess the effectiveness of this use more accurately.

ASTELLAS’ VEOZA (FEZOLINETANT) APPROVED BY EUROPEAN COMMISSION FOR TREATMENT OF VASOMOTOR SYMPTOMS (VMS) ASSOCIATED WITH MENOPAUSE Astellas Pharma Co Ltd Ireland has announced the European Commission has approved fezolinetant 45mg for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause.

The approval is based on the results from the BRIGHT SKY programme, which included three phase 3 clinical trials that collectively enrolled over 3,000 individuals across Europe, the US, and Canada.

VMS, also known as hot flushes and/or night sweats, is a common symptom of menopause. Before menopause, there is a balance between oestrogens and neurokinin B (NKB), a brain chemical. This balance regulates the body’s temperature control centre located in a specific area of the brain. As the body goes through menopause, oestrogens decline and this balance is disrupted. This imbalance can lead to VMS. Prof Rossella Nappi, Full Professor of Obstetrics and Gynaecology, Chief of the Research Centre for Reproductive Medicine and Director of the Gynaecological Endocrinology and Menopause Unit, IRCCS San Matteo Foundation, University of Pavia, Italy, commented: “I’ve been awaiting the marketing authorisation of fezolinetant.

I’m happy to see this advancement in women’s health and that my patients will soon have this new nonhormonal treatment option available to control their moderate-to-severe VMS.” Ms Marci English, Vice President, Head of BioPharma Development, Astellas, said: “Fezolinetant’s novel mechanism of action targets the root cause of moderate-to-severe VMS associated with menopause. We are proud to

have developed a treatment option for a condition that has lacked scientific advancement for too long.”

Astellas has already reflected the impact from this result in its financial forecast of the current fiscal year ending 31 March 2024. Fezolinetant was first approved by the US Food and Drug Administration in May 2023 for the treatment of moderate-to-severe VMS associated with menopause.

MEAGHER’S PHARMACY GROUP ANNOUNCES ACQUISITION OF BHAGWAN’S PHARMACY IN BALLINTEER Meagher’s Pharmacy Group has announced the acquisition of Bhagwan’s Pharmacy in Ballinteer, Dublin. The acquisition means that Meagher’s now has 10 pharmacies across Dublin, as well as its online store Meagherspharmacy.ie.

Meagher’s took over running of the community pharmacy in Ballinteer, which was established in 1978, from Mr Lalloo Bhagwan.

Ms Oonagh O’Hagan, owner and Managing Director of Meagher’s Pharmacy Group, purchased the original Meagher’s store on Dublin’s Baggot Street from the Meagher family in 2001. Since then, Meagher’s has won multiple awards including being named as a Deloitte Best Managed company every year since 2015 and as one of Ireland’s Best Workplaces every year since 2020.

Ms O’Hagan commented: “We are delighted to have taken over the reins of Bhagwan’s Pharmacy today and are deeply committed to continuing the incredible work that Mr Bhagwan, his family, and exceptional team have been doing in the Ballinteer community for 45 years.

“Bhagwan’s is a pharmacy embedded in the local community that we have admired for many years for the exceptional service they provide to their customers, the expertise of the staff and the incredible work that they do, going above and beyond within the local community. It is a long-established family business with very similar values to us at Meagher’s, and therefore we feel we are perfectly aligned, with a very customer-centric patient care approach.

“Myself and my team at Meagher’s are honoured that Mr Bhagwan has chosen Meagher’s to continue the incredible legacy he has built in Ballinteer and we are looking forward to getting to know the customers and working with the team, welcoming them all into the Meagher’s family. We are excited to bring the renowned Meagher’s product offering and customer service to our new customers in the Ballinteer community.”

Mr Bhagwan commented: “Nóra and I first purchased the pharmacy in 1978. At this time, it was operated by Mrs Cranwell and was the first pharmacy in the Ballinteer area. Her wishes on selling were that it continues as a pharmacy. We have fulfilled that promise over the last 45 years, servicing Ballinteer and wider communities.”

Mr Lalloo Bhagwan and Ms Oonagh O’Hagan

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

47

Classifieds & Recruitment

EVENT

GP AVAILABLE Highly experienced GP seeks sessional work in south-east Dublin.

Available immediately.

ANNUAL GP STUDY MORNING Beacon Hospital’s Annual GP Study Morning will be taking place on Saturday 20th January 2024 in O’Reilly Hall, University College Dublin.

This will be a hybrid event with both in-person and online attendance offered. The theme of the morning is ‘Cancer MDT between consultant and GP’ and will feature a number of top cancer specialists from Beacon Hospital.

CME Accreditation has been applied for.

For further information or to register to attend, please visit the GP information section of beaconhospital.ie

HOLIDAY HOMES TO LET Holiday homes available for short-term holiday lets in the heart of Wicklow town.

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TO LET Exceptional leasing opportunity (Primary care centre) in west Galway City.

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There are exceptional leasing terms and conditions available to the right person willing to re-establish a primary care service on this site that already has a purpose-built premises and a local practice population-base.

For more information please contact: Mobile: 086 080 7744 Email: andrew@lydonhouse.com

To advertise, email Daiva at daiva@greenx.ie or Gemma at gemma@greenx.ie

AVAILABLE IN PRINT AND DIGITAL

THE MEDICAL INDEPENDENT | 19 DECEMBER 2023

48

The Dorsal View

If you have anything you would like to share, please email: info@mindo.ie

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

The substance behind the glitter: Why Christmas is good for us

N

o more needs be said about the benefits to mind and body of a break. The literature on the topic is extensive, but Christmas has particularly beneficial properties for the average person.

The whole season kindles memories of Christmas past, of loved ones both here and passed

on, and we get to re-experience the joy of the holiday vicariously through the innocence of children. The benefits are deeper than simply ‘time off work’. There is research into this particular field, but as the saying goes, you don’t need a study to know that you have a better chance of survival if you jump out of a plane with a parachute, rather than without one.

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Many’s the psychologist will tout the benefits of simple rituals, such as exchanging gifts, carving the bird, or whatever other traditions we might hold to. They help to ‘ground’ us and help us reconnect with ourselves and each other, providing a sense of belonging.

Odours are also powerful memory stimulants, and the smell of that turkey and ham while we pull a cracker with loved ones can instantly transport us back decades in time. Of course, Christmas can be a sad and painful time for some people and can put a strain on their mental health. Special appreciation should go to those who support these people in their seasonal anguish, whether they are healthcare professionals or not.

There are anecdotal studies and surveys to suggest putting up Christmas decorations early can provide a psychological boost and improve mood and energy levels. For this tidbit of information, I’m unapologetically using data from the American Christmas Tree Association. I’m sure they have branches everywhere.

Better to give than receive Everybody likes to get a gift, but there is also research out there to suggest that it really is better to give than to receive. According to the American Psychological Association, giving a gift or donating money to charity creates more interaction between the areas of the brain that are associated with processing social information and feeling pleasure. fMRI showed that study participants who spent money on others (they had the choice to spend it on themselves) had more generous and fair interactions with other people, and also reported higher levels of happiness after the experiment was finished.

Compared to winning or receiving rewards or money, giving gifts activates pathways in the brain that release the neuropeptide oxytocin and engender feelings of trust, safety, and connection.

If you were thinking of a gift for the medically-minded in your life, you could do worse than give them a copy of the book Twas the Nightshift Before Christmas, by doctor-t u r ned-comed ia n Adam Kay. It chronicles his travails as a young doctor and is broken into 25 anecdotes from his time in an obstetrics and gynaecology ward during a succession of Christmas shifts.