The Medical Independent 19th May 2022

Page 26

Health inequalities facing Travellers

There is still no plan to address Traveller health inequalities, which have worsened during the pandemic.

IMO AGM Preview

We preview the IMO AGM on 28 May and the key issues affecting doctors, with articles from all the union’s craft groups

PAGE 14-18

Rising HSE expenditure on medical agency staffing

CATHERINE REILLY

HSE expenditure on medical/ dental agency staff in statutory acute and community settings was €95.1 million in 2021, up from €93.8 million in 2020, according to figures obtained by the Medical Independent (MI) under Freedom of Information (FoI) law.

Last year, the spend mainly comprised of €61.5 million by HSE statutory acute hospitals (compared to €61.3 million in 2020) and €33.6 million by the nine Community Healthcare Organisations (CHOs) (compared to €32.5 million in 2020).

During the first two months of 2022, total HSE spend in statutory services was €17 million compared with €14.6 million for the same period of 2021.

In 2021 Midlands Regional Hospital, Portlaoise, expended the highest amount of all HSE statutory acute hospitals (€6.4 million), followed by University Hospital Limerick (€5.065 million), Letterkenny University Hospital (€5.025 million), and Cavan and Monaghan Hospital (€3.7 million).

Last year, the Hospital Group with the largest expenditure was Saolta University Health Care Group (€14.5 million), followed by Dublin Midlands Hospital Group (€11.7 million), Ireland East Hospital Group (€11.2 million), South/South West Hospital Group (€8.4 million), RCSI Hospitals (€8.2 million), and University of Limerick Hospitals (€7.5 million). These figures do not include voluntary hospitals.

In the CHOs, the highest expenditure was in CHO 8 (€7.3 million) and CHO 5 (€7.2 million). The lowest was in CHO 4 (€1.083 million) and CHO 6 (€1.442 million).

According to the FoI response, the figures for 2021 and 2022 were “draft, unaudited, and subject to change”.

The response also stated: “Agency costs for consultants and NCHDs are included in the medical/dental staff category, but are not separately identifiable....”

“The shortcomings in the HSE legacy financial systems are well acknowledged and their replacement by a single standard financial system for the health sector is at the core of the finance reform programme initiated by the Department of Health.”

‘Disappointment’ over stalled contract talks

Over eight months since the start of talks on a new consultant contract, doctors’ representative organisations have reiterated their concerns over the lack of progress.

Writing in the Medical Independent (MI) on the eve of the IMO AGM, Chair of the union’s consultant committee and incoming President Dr Clive Kilgallen said it was “very disappointing” that the talks remained stalled.

“As always, the IMO is willing to engage with the Department of Health and the HSE on developing a contract that is capable of delivering a solution to recruitment issues, capable of enabling consultants to do their job and develop skills and capable of being implemented in a fair and equitable manner,” writes Dr Kilgallen in our current edition.

“While those negotiations were suspended due to the departure of the independent Chair, it is very disappointing that the process has not restarted to date.”

The talks began in September 2021 and Minister for Health Stephen Donnelly said in October he hoped the process would be concluded “within weeks”. Senior Counsel Ms Marguerite Bolger was appointed Chair of negotiations last year, but has since been made a High Court judge. There has been no appointment of a new Chair and the talks have been halted since December.

The IHCA also expressed frustration to MI that the process has not progressed this year. The Department of Health told this newspaper that “it remains the Government’s intention that engagement will resume shortly and arrangements are being made to facilitate this, including consideration of a replacement for the previous Chair”.

The ‘Irish Mammy’ of healthcare

General practice carries much of the load of the health service without enough of the credit –just like an Irish Mammy, writes Dr Sarah Fitzgibbon

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Pictured at the recent RCPI masterclass on unconscious bias are (L-R): Prof Mary Horgan, President, RCPI; Ms Kathleen Halligan, guest speaker; Dr Sinead Murphy; and Dr Terry McWade, CEO, RCPI. Photo: David Coleman/Bobby Studio Niamh Quinlan reports
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No date set for National Traveller Health Action Plan

NIAMH QUINLAN

The HSE is still unable to confirm a date for the publication of the long-delayed National Traveller Health Action Plan (NTHAP).

In 2017, the National Traveller and Roma Inclusion Strategy 2017-2021 (NTRIS) recommended that a “detailed action plan” be implemented to address Traveller-specific health needs.

“The finalisation and publication of the National Traveller Health Action Plan is a priority area for action in the HSE service plan for 2022,” a HSE spokesperson told the Medical Independent. The Programme for Government – Our Shared Future (2020) also recommended that the NTHAP be implemented.

A Department of Health spokesperson said: “The Department has engaged with the HSE in the drafting of

the Traveller health action plan to ensure that the plan is aligned with the Department’s policy priorities, as set out in the Sláintecare Implementation Strategy and Action Plan 2021-2023, the Healthy Ireland Strategic Action Plan 2021-2025 and the Statement of Strategy 2021-2023.”

A draft of the plan from the HSE National Social Inclusion Office was circulated in March 2019. However, a report in November 2019 from the joint Oireachtas committee on key issues affecting the Traveller community said the draft “did not include dedicated resources, performance indica-

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tors, verification measures and an institutional mechanism to drive implementation”. A redraft was subsequently commissioned. The plan will take account of recommendations from the Oireachtas committee report.

An NTHAP “has the potential to make a significant impact on Traveller health in Ireland”, according to the HSE website. “This ambition should not gloss over the very significant challenges of developing and implementing such a plan that is evident from the All-Ireland Traveller Health Study (2010).” See news feature, p4-5.

The HSE has not sought funding from the Department of Health to meet the community service and support needs of families affected by foetal valproate syndrome (FVS), a Department spokesperson has told the Medical Independent

In 2019, a HSE group recommended a “package of community care and support” for people diagnosed with FVS and their families. It advised that a national co-ordinator be appointed to oversee the diagnostic, assessment and care planning system, but this post was not created.

Children exposed to sodium valproate (Epilim) in utero are at a high-risk of serious developmental disorders and congenital malformations.

Epilim was licensed in Ireland for treatment of epilepsy in 1975, when there was already evidence of its teratogenicity.

It was not until 2014 that the European Medicines Agency and national regulators took action to strengthen warnings and restrictions on use in women and girls, but these were later determined as insufficient.

A Freedom of Information request to the HSE did not identify any business cases for supports and services, although it is understood a small number have been developed.

In April, Minister for Health Stephen Donnelly stated there was “no specific package of supports available” for those affected.

According to the HSE, a “community pathway” has been introduced. The HSE and the Department had “ongoing engagement about funding requirements for this group of people, including components of the community pathway which are outside the scope of the HSE…”.

According to Organisation for Anti-Convulsant Syndrome (OACS) Ireland: “Families have found that there remains much to be done within the provision of healthcare services; in fact many have found the system chaotic. Although some liaison officers are quite good, they are finding it difficult to access services for families impacted.”

It called for the promised support package to be implemented immediately and warned that the HSE’s programme to prevent future FVS cases was not fully operational.

In November 2020, Minister Donnelly announced an inquiry into historical licensing and prescription of sodium valproate. A commencement date is awaited.

Thirty-five people have been diagnosed with FVS under a diagnostic pathway introduced in 2019. Over 1,000 children and adults have been affected, according to a HSE estimate. See news feature, p10.

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CATHERINE REILLY

Widening health inequalities facing Travellers

Health inequalities in Traveller communities have worsened during the Covid-19 pandemic, yet there is still no plan to address these disparities. Niamh Quinlan reports

In 2010, the All Ireland Traveller Health Study (AITHS) revealed the serious health inequalities faced by the Traveller community. Since then, the development and implementation of a plan to tackle these inequalities has been promised.

In each HSE national service plan since 2019, one of the Executive’s priorities and actions has been to “finalise” a plan in line with the National Traveller and Roma Inclusion Strategy 2017-2021 (NTRIS). The strategy is a cross-departmental initiative tasked with improving the lives of Traveller and Roma communities in Ireland.

In the foreword to the NTRIS, the then Minister of State with special responsibility for Equality, Immigration, and Integration, David Stanton, said the strategy was intended to reinvigorate “efforts by the State to ensure that Travellers and Roma interact fully with the public health sector in order to address some of the underlying health-related challenges facing those communities”.

A key recommendation in the NTRIS was for the HSE to develop and implement “a detailed action plan” based on the findings of the AITHS, “to continue to address the specific health needs of Travellers, using a social determinants approach”. However, the HSE and Department of Health have not confirmed a date for the publication of a National Traveller Health Action Plan (NTHAP).

‘Frustration’

The uncertainty surrounding the NTHAP has left many within the Traveller community and those working with Traveller communities frustrated.

A HSE spokesperson told the Medical Independent (MI) the finalisation and publication of the plan remained a priority.

A draft plan, which was circulated by the HSE in March 2019, was found by stakeholders to be inadequate in its provisions. As a result, the Executive committed to redrafting the plan.

“We’ve been 12 years, basically, waiting for it [NTHAP],” Policy Analyst and Traveller Health Researcher at Pavee Point, Ms Lynsey Kavanagh, told MI.

Ms Kavanagh said Pavee Point was urging the Department of Health and the HSE to give an indicative date for the publication, including a clear implementation plan and associated ringfenced budget for Traveller health. “It doesn’t have to be tomorrow. It doesn’t have to be next week. But we want an indicative date for the publication.”

“And Traveller organisations and Travellers on the ground are rightfully frustrated… [they] really bought into the process that this could potentially have a significant impact on Traveller health and yet we’re sitting in 2022 being told there’s no date,” said Ms Kavanagh. “And from our perspective, it’s this political football that’s being kicked around.”

A spokesperson for the Department told this newspaper: “The Department acknowledges the frustration of Travel-

ler organisations arising from the delay in publishing the plan. The publication and implementation of the plan is a priority for the Department and the HSE in 2022.”

Regarding the implementation of the NTHAP, Ms Kavanagh said Pavee Point was “on public record saying that without indicators, without resources, without budgets and also not reflecting the consultation report, we can’t endorse it and we can’t support it”.

The Department of Health and the HSE are in discussions to identify the resources required to implement the NTHAP, according to the Department spokesperson.

“The Department of Health is fully committed to providing the leadership and resources to ensure the implementation of the plan by the HSE, once agreed,” the spokesperson said.

A spokesperson for the HSE told MI: “Once published, actions within the NTHAP will be prioritised and submitted to the Department of Health for funding in line with the 2023 estimates process.” A budget “to strengthen health supports for Travellers and initiate implementation of the NTHAP” has been ringfenced.

In 2021, the Department also provided

€274,449 to expand Traveller health units (THU). A response to a parliamentary question in October 2021 stated that the Department had set aside €548,898 in 2022 for THU expansion.

The Department added that, upon implementation, “the plan will reflect the lessons from the public health response to Covid-19.”

Covid collaborations

The collaborations between Traveller rights organisations and public health during the Covid-19 pandemic must continue, according to Public Health Lead for Social Inclusion and Vulnerable Groups Dr Margaret Fitzgerald.

“Let’s not break that link now,” Dr Fitzgerald told MI. “Let’s keep going with the Traveller health…. Because it’s not just Covid. Now we’re looking at all the other health challenges Travellers have, with cancer, chronic diseases, early mortality… mental health, addiction.”

Dr Fitzgerald added that she also hopes collaborations during the pandemic helped Traveller communities to trust public health. “I think that wider trust in the health system is definitely going to help the [other] health issues for Travellers.”

‘A perfect storm’ – Traveller health inequalities aggravated by Covid

Covid-19 and its accompanying restrictions, combined with poor facilities and difficulties in carrying out isolation and social distancing on Traveller halting sites, meant health defences in the community against the virus were poor.

Policy Analyst and Traveller Health Researcher at Pavee Point, Ms Lynsey Kavanagh, described the pandemic as “a perfect storm, in terms of exacerbating those health inequalities”.

“What you had was Travellers who were living in really severely over cramped, overcrowded accommodation, without really the capacity to self-isolate, to be able to follow the basic hygiene that everybody was supposed to be able to do,” said Ms Kavanagh. “We were extremely concerned.”

While handwashing was a primary defence against the virus, many Travellers were without taps and running water. Traveller Primary Health Care Project (TPHCP) Assistant Coordinator, Ms Mary Brigid Collins, told the Medical Independent: “If you’ve only one tap between two trailers… that was quite difficult for them.”

The move to online interactions, including virtual health consultations, was also a challenge faced by Travellers. “If you have no internet connection, if you don’t have literacy, it was very difficult to go online,” according to Ms Collins. “And I think, with the huge health inequalities that we’re actually facing at the minute, that’s going to be difficult if [virtual healthcare is further embedded] in the future.”

According to the 2016 Census, 59.9 per cent of Travellers did not have access to the internet, compared to 18.3 per cent of the non-Traveller population. An estimated half of Travellers also struggled with literacy, according to The All Ireland Traveller Health Survey (AITHS) published in 2010. This has implications in terms reading medication and prescription information.

The AITHS revealed huge inequalities faced by the community compared to the general population: Traveller women and men had a life expectancy of 11.5 years and 15.1 years less than the general population, respectively; 12 per cent of Travellers had bronchitis compared to 3 per cent of the non-Traveller population; and 12.5 per cent had asthma compared to 6

per cent of the non-Traveller population.

Mental health was already a huge issue within the Traveller community before the pandemic. According to the AITHS, the rate of suicide among Traveller men was nearly seven times higher than the average population, with Pavee Point estimating 11 per cent of Traveller deaths were caused by suicide.

Addiction issues, already prevalent in the community were also exacerbated by lockdown conditions. Over 66.3 per cent of Travellers in the Republic said drugs were a problem within their own community, according to the AITHS. “That was in 2010,” said Ms Collins. “We know from the work that we do on the ground, and during the pandemic, that it has actually got much worse.”

THE MEDICAL INDEPENDENT | 19 MAY 2022 4
News Feature
Ms Missie Collins, Traveller Primary Healthcare Worker, holding a copy of the All Ireland Traveller Health Study in 2010

Cancer support for the Traveller community

The Marie Keating Foundation (MKF) has worked with the Pavee Point Traveller and Roma Centre to inform Travellers about cancer issues.

Together with Pavee Point, the MKF provided “accessible, timely, culturally appropriate cancer awareness, and prevention information sessions” on some of the most common cancers which affect the Traveller community in Ireland.

Director of Nursing Services at the Marie Keating Foundation, Ms Helen Forristal, said the MKF had continued to communicate with the Traveller primary healthcare project team at Pavee Point, despite the change of priorities due to the pandemic. The two organisations worked together over the last year to develop an educational ‘social inclusion hub’ on the MKF website. “Within that, we started conversations around targeting cancer awareness,” Ms Forristal told the Medical Independent

The Foundation also deployed bespoke cancer information resources to promote early detection and further awareness.

“We didn’t leave them alone, and I think that was very important,” she said. “We tried to make sure our Travellers felt that we would not walk away from them, that we would listen to them, that if we heard there was a major outbreak or there was a major upset, we would take it on board and do something.”

Since the beginning of the pandemic, the HSE National Social Inclusion Office (NSIO) understood that vulnerable groups “could be greatly affected” by the virus, according to Dr Fitzgerald.

“I focused on bridging the gap between our national and our local social inclusion teams, and between national and regional public health departments,” Dr Fitzgerald said. This included engagement and coordination with the HSE, other Governmental departments, and NGOs, such as Pavee Point.

A Covid-19 Traveller outbreak control team was established in September 2020, and continued until May 2021 to monitor and control breakouts in the Traveller community. Safetynet, a medical charity which provides health services to vulnerable groups, developed a Covid cluster rapid response team, mainly for the greater Dublin area, which was partly funded by the HSE. In association with local authorities, the NSIO carried out risk assessments on Traveller halting sites. “I think the Traveller community found that very, very useful,” said Dr Fitzgerald. “Because some practical improvements did take place [with regard to] hot running water, electricity, washing machines, these sorts of practical things.” Cleaning and disinfecting sites, waste removal, and additional mobile homes and demountable accommodation to facilitate isolation and alleviate overcrowding were also provided.

The effectiveness of risk assessments was referenced in the Report on the National Traveller Covid-19 Accommodation Preparedness Checklist, published in July 2021. This report said: “This collaboration between

One MKF workshop informed Traveller primary healthcare workers about the process of cervical screening and detection of ovarian cancer.

“I feel that we empowered the Traveller women to take some positive actions,” said Ms Forristal, “for the benefit of their own health and for their own wellbeing.”

She said the Foundation also spoke to a group of men about prostate cancer: “With prostate cancer, particularly, there may be no signs or symptoms and there may be no reason, even preCovid, to consider going to the doctor to talk about it.” Men were encouraged to look for a history of prostate cancer and speak to doctors or their primary healthcare worker about prostate specific antigen blood tests.

According to the AITHS, Traveller women attended breast and cervical cancer screens at almost twice the rate of non-Traveller women.

The activity of screening services was severely curtailed during the pandemic. “We now have to work on that again and get it up and running,” said Ms Collins.

[Department of Housing, Local Government and Heritage, local authorities, Traveller Health Units, HSE Social Inclusion, HSE Public Health, and primary healthcare for Traveller projects] has had a positive effect on the health outcomes of Travellers. This relationship should be encouraged and maintained beyond Covid-19.”

Travellers were also identified as a priority group for vaccinations.

“When vaccinations came in, we moved away from putting a huge emphasis on outbreak detection and control,” said Dr Fitzgerald. “And we put more emphasis into getting the vaccine out to the Travellers, improving the access and also… delivering the information to them in a way that they could engage with, because there was a lot of hesitancy.”

According to Dr Fitzgerald, much of the information about Government messages and measures was adapted “into a format that Traveller groups could relate to and understand and use their own WhatsApp and Facebook and their own ways of communication”. These also included resource pages on the HSE website and pop-up clinics around the country.

In terms of managing and responding to outbreaks of Covid-19 in Traveller communities, the HSE prioritised “working with THUs and non-Government organisation partners to enhance information and awareness about hygiene, Government measures on social distancing, restricted movements etc”.

According to the National Covid-19 Traveller Service User Experience Survey, published by the NSIO in October 2020, a combined 85.6 per cent of Travellers accessed information on Covid-19 through local Traveller projects and Traveller health units.

Pavee Point’s long-running Traveller primary healthcare project (TPHCP) also aided Safetynet and the HSE in providing help to the Traveller community, according to TPHCP Assistant Coordinator Ms Mary Brigid Collins. “I don’t think that the HSE would be able to do what they actually did out the ground without the sup -

port of the primary healthcare project,” Ms Collins told MI

“Because the primary healthcare projects have been going on since 1994 and we have the trust and relationship built out there with lots of Travellers.”

The TPHCP comprises Travellers who identify the health needs of the community. It aims to develop the skills of Travellers in providing community-based health services; liaising and assisting in dialogue between Travellers and health service providers; and highlighting gaps in health service delivery while working towards reducing inequalities that exist in established services.

Lack of data

There is concern, however, that the lack of accurate, disaggregated data based on ethnicity will continue to hinder progress in addressing Traveller health inequalities.

The HSE collected ethnic data on those who tested positive for Covid-19 from the second wave of the virus in August 2020 onward.

“At local level, also, some public health medical specialists were able to verify those as Travellers through their direct links and with Traveller health unit primary care workers,” a HSE spokesperson said. “Capturing ethnicity was not always done during Covid peaks especially if there were high caseloads of positive Traveller patients.”

Within the Covid case ethnic identification, “we also noted that there was a massive undercount,” Ms Kavanagh of Pavee Point told MI

“We would say that Travellers and Roma were disproportionately impacted by Covid-19 alongside other marginalised groups,” she said. “And that those particular consequences aren’t captured in official datasets, because we don’t have disaggregated data on the basis of ethnicity or ethnic equality monitoring.”

HIQA reported in March 2021 that Travellers were more at risk of contracting the virus than the general population. However, HIQA also said “limitations in the data relating to these hard-to-reach groups means that the estimates presented are considered to underestimate the true prevalence”.

Ethnic identifiers were also not embedded into the vaccination information system.

The concern around data extends beyond the pandemic.

“What we do need is an ethnic equality monitoring right across the health services and other Government and statutory agencies,” Ms Kavanagh added. “So that we’re able to join up the dots and then we’re not sitting another 15-20 years from now saying, ‘Look, do we need another piece of research?’”

The most robust data collection regarding Traveller health was in 2010 in the AITHS.

Dr Fitzgerald told MI: “The findings in the AITHS are still valid and any further research in recent years has confirmed that the findings are valid and the gap is widening in terms of the health status and life expectancy of Travellers.”

The November 2021 joint Oireachtas committee on key issues affecting the Traveller community reported: “The vast majority of the witnesses who appeared before the joint committee and those who made submissions called for the adoption of an ethnic identifier to allow for accurate information, better social policy and service planning.”

Implementing ethnic identifiers was also recommended in the NTRIS and the AITHS.

MINDO NUMBERS

7

in every 100 patients in acute hospitals in high-income countries will acquire at least one healthcareassociated infection, compared with 15 in low- and middle-income countries, according to the World Health Organisation (WHO).

1 in every 10 affected patients, on average, will die from their healthcareassociated infection, the WHO has highlighted.

10

-to-15 out of every 100 pregnant women are affected by depression and anxiety, with varying severity, Dr Margo Wrigley, HSE National Clinical Lead of Perinatal Mental Health, stated on World Maternal Mental Health Day (4 May).

60 – the percentage increase in patients experiencing perinatal mental health issues during the pandemic, according to Dr Wrigley.

260,000 cases of tuberculosis (TB) were recorded in the WHO European region in 2019, according to joint WHO and European Centre for Disease Prevention and Control data on TB prevalence in Europe.

THE MEDICAL INDEPENDENT | 19 MAY 2022 5 Feature News

Work on expanding bloodspot screening programme

The national screening advisory committee (NSAC) is progressing “the development of a methodology for prioritisation of conditions” for inclusion in the national newborn bloodspot screening programme.

However, a Department of Health spokesperson described the work as “lengthy and complex”.

Minutes of a NSAC meeting last October noted that “a significant amount of work would be required to research and produce a comprehensive prioritised list of conditions that may be included” on the screening programme.

The Department’s spokesperson told the Medical Independent (MI) that consideration of an expansion to the programme was a “priority” for the committee and the

Business practicalities of general practice covered at ICGP NEGs meeting

New GPs should be prepared for the practicalities and business aspects of running a practice, according to the ICGP Director of the Network of Establishing GPs (NEGs) Programme, Dr Knut Moe.

Speaking to Medical Independent (MI) about the ICGP’s NEGs spring meeting, held online on 7 May, Dr Moe said general practice differed from other specialties as “you have to learn how to run a business”. During training and in their early career, many GPs found the management aspect of general practice “quite daunting”.

There was a “good opportunity” for the College to further consider the general management skills needed in general practice, alongside the academic and clinical requirements of GP training, he suggested.

Some GPs can be “put off” by the prospect of becoming employers and managing the “nuts and bolts” of a small business, in addition to the clinical responsibilities of general practice, according to Dr Moe.

However, “having the autonomy, self-determination, and to really be able to set yourself up to be the sort of

VOX BOX

Minister for Health.

“The committee and the Department of Health are progressing the development of a methodology for prioritisation of conditions for consideration by the committee for evidence assessment and evaluation by HIQA,” the spokesperson told MI

“The committee’s procedures require that decisions and recommendations are based on validated evidence from national and international scientific sources, which includes consideration of submissions received in response to its first annual call for new programmes or changes to existing programmes.”

Asked which conditions were being considered, the spokesperson replied that during the deliberative process “it would not be appropriate for the committee to comment

on ongoing work”.

The spokesperson noted that HIQA was conducting a health technology assessment on the potential addition of severe combined immunodeficiency to the programme. They added that the NSAC was working on the development of a new ethics framework that “will be an important tool to help facilitate the deliberations of NSAC”.

“Work is now progressing through the next phase with the committee working with the Department of Health on the development of a high-level project plan.

“A reference group, comprising a number of experts in this area, is being convened to support and feed into the process. Once a draft framework has been developed with the NSAC and reference group, it will undergo wider stakeholder consultation before finalisation and publication.”

Sizable increase in new post approval applications to CAAC

There was almost a three-fold increase in the number of new post applications made to the consultant applications advisory committee (CAAC) last year. Some 414 new post applications were made in 2021, compared with 155 in 2020.

GP you want to be, is quite fulfilling as a career option,” he told this newspaper.

The speakers at the NEGs meeting aimed to “demystify the practice management elements” of general practice, Dr Moe added.

These elements included understanding the different capitation rates and subsidies within the GMS scheme, claiming reimbursements, buying and selling practices, and practice succession.

A greater understanding about the practical management side of general practice will lead to a more informed decision about career paths, Dr Moe told MI

The meeting also covered general practice career portfolios and self-care.

Speakers included President of the ICGP Prof Tom O’Dowd; GP and former President of the Medical Council Dr Rita Doyle; Louth GP Dr Amy Morgan; and Waterford GP Dr Austin Doyle.

According to CAAC’s annual report for 2021, there was also “a noticeable increase in the number of posts recommended for approval at CAAC, with an overall increase of 269 consultant posts recommended for approval (547 in 2021, 278 in 2020) approximately a 90 per cent increase”.

The largest number of posts approved was in general medicine, at 223 posts. This number included 189 new posts, with the remainder a combination of replacement and restructured posts. The next highest specialties were surgery, anaesthesiology, and pathology, with just over 50 posts each.

An IHCA spokesperson told Medical Independent that “simply approving additional consultant posts will not address the staffing crisis that continues to impact the delivery of specialist medical and surgical services and the quality of patient care provided – unless these posts can be filled”.

The CAAC annual report also included requests for changes to titles and qualifications received by the committee in 2021.

These included ‘Consultant Trauma Orthopaedic Surgeon with a special interest in lower limb arthroplasty’, ‘Consultant Respiratory Physician with a special interest in cystic fibrosis’, and ‘Consultant Breast Pathologist’. No changes to qualifications were required following feedback from the relevant postgraduate bodies. Consultation was ongoing regarding ‘Consultant Physician with a special interest in stroke medicine’.

THE MEDICAL INDEPENDENT | 19 MAY 2022 6 News
Ronan’s calm demeanour and knowledge of public health played a significant role in our national effort throughout the pandemic.”
NIAMH QUINLAN Taoiseach Micheál Martin commenting on the contribution of Deputy Chief Medical Officer Dr Ronan Glynn, who is shortly stepping down from his role to take up employment in the private sector.
Audit allows us to see what we are doing well and what we need to improve and we are outliers in international terms, as we do not currently have a national paediatric diabetes audit.”
Prof Nuala Murphy, Chair of the national paediatric diabetes audit feasibility steering committee at the National Office of Clinical Audit (NOCA). A NOCA feasibility study has recommended implementation of a national audit of type 1 diabetes on a phased basis, beginning in paediatric settings.
Virtual fracture assessment clinics were adopted early during the pandemic and are now part of clinical practice delivering safe, effective, and efficient care to patients presenting with stable fractures.”
CONSULTANT APPLICATIONS ADVISORY COMMITTEE CAAC Annual Report 2021
Mr Paddy Kenny, Joint National Clinical Lead at the National Clinical Programme for Trauma and Orthopaedic Surgery, commenting on the
impact of a consultant-led virtual process that is "improving outcomes and providing a cost saving of over €22 million to the health service”.

‘Transitions of care’ coming under HIQA spotlight

CATHERINE REILLY

HIQA will be examining ‘transitions of care’ as part of its revised methodology for monitoring and inspection of hospitals, Director of Healthcare Regulation Mr Sean Egan has told the Medical Independent

While the matter has arisen in previous inspections, the Authority will take a more “overt” approach to examining this area, with the aim of driving improvement.

There are known risks to patients when information about their care is transferred, noted Mr Egan. In addition, there are “challenges” regarding the health service’s ICT infrastructure.

“In the absence of the necessary investment that is required to progress those systems, that are badly needed, we need to make sure the systems we currently have in place, which are often very manual, are as effective and efficient as they can be….”

“What we are aiming to try and do is be proactive and try and drive an agenda in this area from an improvement perspective, as we look to try and also advocate for advancements in the health information and ICT infrastructure in the health service.”

This work may include examining the quality of discharge letters, as well as transitions of care within the hospital setting.

“We know from our experience, and sentinel patient safety incidents, that [issues around transfer of patient information] can be a key factor in harm for people who rely on services. It is only going to become a bigger issue as healthcare becomes more complex and as we look to try and redivert services into community settings.”

In April, HIQA announced it was commencing a new inspection and monitoring programme of public acute hospitals and rehabilitation and community inpatient healthcare services, which number 83 in total. All servic-

es will receive a minimum of two inspections in each three-year cycle, with risk-based inspections conducted as required. The frequency of inspections will not be greatly dissimilar to previous cycles, but inspections may be longer.

The Authority is aiming to take a “broader approach” to inspections.

It has published an assessment and judgement framework against all 45 standards in the National Standards for Safer Better Healthcare It will use the framework to conduct bespoke risk-based inspections as required.

Notably, the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 will legally require that HIQA is notified of serious patient safety incidents.

Mr Egan said the purpose of the assessment and judgement framework was to “future-proof our approach to monitoring so we can adapt to those changes that are coming”.

As part of the new inspection methodology, HIQA has developed a core framework of 11 standards, which will be examined in all announced and unannounced inspections. The 11 standards fall under five themes – leadership, governance and management; safe care (protecting patients from harm); effective care (evidence-based and monitored); workforce (support of staff); and the patient experience of person-centred care.

During all its monitoring inspections, HIQA intends to examine four principal risks: Medication safety; infection prevention and control; transitions of care; and the deteriorating patient. It will review the conditions in which

care is provided in emergency departments, as well as in other key clinical areas.

Mr Egan said the programme was “ambitious”, but that the Authority had enough resources to fulfil its commitment. HIQA is in discussions with the Department of Health about additional resources to carry out further responsibilities under forthcoming legislation.

On how it will determine the need and timing of riskbased inspections, on receipt of notifiable patient safety incidents, Mr Egan commented that the Authority already received information about services “all the time”. He said all information was reviewed and risk-rated before HIQA decided upon its response. The Authority does not have a remit for the investigation of individual clinical incidents (it can undertake statutory investigations of hospital services at the behest of the Minister for Health and the HIQA board).

In regard to criticisms of the repetitive nature of some HIQA findings, and the ultimate impact of inspections, Mr Egan said many of its reports had been “quite narrative”, but it has moved towards “a definitive calling of compliance or otherwise against standards”.

Currently, HIQA does not have enforcement powers in regard to findings and recommendations for hospitals. “I do have enforcement powers, for example, in the area of radiation protection and it is something that can be quite helpful in terms of focusing minds on the ground.”

HIQA will also regulate pathology services, with enforcement powers, under the Human Tissue Bill.

“It is an ongoing limitation of HIQA’s remit in the healthcare setting that we don’t have those enforcement powers in our more general approach to monitoring and we won’t have them through this new approach.”

Enforcement powers will be implemented under licensing legislation, “which is being worked on in the background but is a period of time away.”

TUH rolls out new electronic patient record on foot of national delays

Tallaght University Hospital (TUH) has deployed a new electronic patient record (EPR) as part of its Hospital Strategy Plan 2019-2024 to improve access to services, replace legacy systems and implement “digital-enabled care”.

The EPR is distinct from the national electronic healthcare record (EHR) being developed by the HSE as part of Sláintecare, which has experienced several delays in implementation.

“An electronic patient record is a longitudinal record of periodic care provided mainly by one institution,” a spokesperson for TUH told the Medical Independent (MI). “Typically, this relates to the healthcare provided by an acute hospital.”

TUH’s EPR is set to integrate with the national EHR when the roll-out of the latter commences, according to the hospital.

“We have built in that capability within our EPR to be able to share information with the national EHR, if and when it comes along,” TUH Chief Information Officer Mr David Wall told MI

The HSE worked closely with the hospital and was “very supportive” of the roll-out of the EPR in November 2021, according to Mr Wall.

“They invested in the underlying infrastructure and they replaced some of the underlying systems as well,” he said.

“If the national EHR had been there at the time, that’s something we would have availed of. Unfortunately, it wasn’t, so we had to proceed.”

TUH has also allocated patients a unique medical record number (MRN) identifier. “That unique number stays with you for the duration of your care in Tallaght Hospital over the years; it never changes,” said Mr Wall. “National-

ly, there is work going on regarding an individual health identifier that’s being rolled out. And when our time comes to join that programme, we will make sure that our MRN links with the individual health identifier.”

A HSE spokesperson told MI it supports the implementation of the EPR in TUH. “All digital initiatives, which benefit patient safety or improved efficiency, are [of] benefit to the overall digital fabric,” they said.

However, “the integration to a national EHR has not been considered at this time.”

Project Synergy

The TUH EPR, also named ‘Project Synergy’, was implemented because a number of legacy systems had reached end-of-life, according to Mr Wall.

“We wanted to make sure that no matter where the patient was, whether they were on the campus or off the campus in one of the off-campus facilities, that the information flows seamlessly with the patient,” he said.

“We also had an ever-increasing paper record within the hospital and a growing patient population.”

A number of existing IT systems were preserved, while others were upgraded or replaced. “We found ‘synergy’ was a good representation of bringing all that information together,” said Mr Wall.

Hospital departments use specialty-specific clinical information systems, which are interfaced into the EPR through an ‘Evolve platform’. This shows clinical staff all relevant information regarding a single patient. The platform works off of the wi-fi in the hospital and is cloud-hosted through a “fully secure” Amazon Web Services data centre.

There is also an extra functionality within the system that allows for further digitisation, which will be part of phase two and three of TUH’s digital care plan.

The records can be accessed in the 150-200 workstations on wheels that have been deployed throughout the hospital.

“The implementation of the workstations on wheels means these can be brought to the patient’s bedside for immediate access to information including patient history, laboratory results and care notes, as well as offering a localised entry point for data including reporting during ward rounds and updating patient vitals,” according to a press statement on Project Synergy.

Currently, the EPR is only available for use by healthcare professionals. However, TUH is looking to expand a patient portal where patients will be able to book and view appointments, according to Mr Wall.

THE MEDICAL INDEPENDENT |19 MAY 2022 7 News
Mr Sean Egan A member of the TUH team assesses a patient using one of its new workstations on wheels

In ORAL Solo, XELJANZ delivered rapid reduction in the signs and symptoms of RA as early as week 2, with significant reductions at month 3 vs placebo (P<0.001).1

XELJANZ® (tofacitinib) Prescribing Information:

Please refer to the Summary of Product Characteristics (SmPC) before prescribing XELJANZ 5 mg or 10 mg film-coated tablets, XELJANZ 11 mg prolonged release tablets or XELJANZ 1 mg/mL oral solution. Presentation: Film-coated tablet containing tofacitinib citrate, equivalent to 5 mg or 10 mg tofacitinib. Prolonged-release tablets containing tofacitinib citrate, equivalent to 11 mg tofacitinib. Oral solution containing tofacitinib citrate, equivalent to 1 mg/mL tofacitinib. Indications: Please note not all presentations are licensed for all indications, please see dosage section for details: In combination with methotrexate (MTX) 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. Can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. In combination with MTX 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. For the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. 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. For the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis, and extended oligoarthritis), and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Can be given in combination with MTX or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Dosage: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of the condition for which tofacitinib is indicated. Tofacitinib is given orally, with or without food. RA and PsA: The recommended dose is 5 mg twice daily or 11 mg once daily which should not be exceeded. Treatment with tofacitinib 5 mg film coated tablets twice daily and tofacitinib 11 mg prolonged release tablet once daily may be switched between each other on the day following the last dose of either tablet. AS:

The recommended dose is 5 mg twice daily. Available data suggest that clinical improvement in AS is observed within 16 weeks of initiation of treatment. Continued therapy should be carefully reconsidered in AS patients exhibiting no clinical improvement within this timeframe. UC: The recommended dose is 10 mg twice daily for induction for 8 weeks. For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance. Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16. The recommended dose for maintenance treatment is tofacitinib 5 mg twice daily.

Tofacitinib 10 mg twice daily for maintenance treatment is not recommended in patients with UC who have known venous thromboembolism (VTE) risk factors, unless there is no suitable alternative treatment available. For patients with UC who are not at increased risk for VTE, tofacitinib 10 mg twice daily may be considered if the patient experiences a decrease in response on tofacitinib 5 mg twice daily and failed to respond to alternative treatment options for UC such as tumour necrosis factor inhibitor treatment. Tofacitinib 10 mg twice daily for maintenance treatment should be used for the shortest duration possible. The lowest effective dose needed to maintain response should be used. Polyarticular JIA and juvenile PsA: The recommended dose in patients 2 years of age and older: 10 kg - < 20 kg: 3.2 mg (3.2 mL oral solution) twice daily, 20 kg - < 40 kg: 4 mg (4 mL oral solution) twice daily, and ≥ 40 kg 5 mg (5 mL oral solution or 5 mg tablet) twice daily. Patients ≥ 40 kg treated with tofacitinib 5 mL oral solution twice daily may be switched to tofacitinib 5 mg tablets twice daily. Available data suggest that clinical improvement is observed in paediatric patients within 18 weeks of initiation. Continued therapy should be carefully reconsidered in a paediatric patient exhibiting no clinical improvement within this timeframe. Dose interruption and adjustment:

Tofacitinib treatment should be interrupted if a patient develops a serious infection until the infection is controlled. Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia. It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 0.75 x 10 9/L, an absolute neutrophil count (ANC) less than 1x10 /L or with haemoglobin less than 9 g/dL. It is recommended not to initiate dosing in paediatric patients with an absolute neutrophil count (ANC) less than 1.2 x 10 9/L or with haemoglobin less than 10 g/dL. Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. Patients with severe renal impairment the dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal renal function is 5 mg twice daily or 11 mg prolonged-release tablet once daily. Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal renal function is 10 mg twice daily. Patients with severe renal impairment should remain on a reduced dose even after haemodialysis. Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment. Patients with moderate hepatic impairment dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal hepatic function is 5 mg twice daily or 11 mg prolonged-release tablet once daily. Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal hepatic function is 10 mg twice daily. Tofacitinib should not be used in patients with severe hepatic impairment. Elderly: No dose adjustment is required in patients aged 65 years and older. Use with caution as increased risk and severity of adverse events. See also Warnings & Precautions for use in patients over 65 years of age. Paediatric population: The safety and efficacy of tofacitinib in children less than 2 years of age with polyarticular JIA and juvenile PsA has not been established. The safety and efficacy of tofacitinib in children less than 18 years of age with other indications (e.g. ulcerative colitis) has not been established. The safety and efficacy of tofacitinib prolonged-release formulation in children aged less than 18 years have not been established. Interactions: TTofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g. ketoconazole) and in patients receiving 1 or more products that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g. fluconazole). Coadministration with potent CYP inducers (e.g. rifampicin) may result in a loss of or reduced clinical response. Coadministration with potent inducers of CYP3A4 is not recommended. Contraindications: Hypersensitivity to any of the ingredients, active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections, severe hepatic impairment, pregnancy and lactation. Warnings and Precautions: Patients treated with tofacitinib should be given a patient alert card. Use in patients over 65 years of age: Considering the increased risk of serious infections, myocardial infarction, and malignancies with tofacitinib in patients over 65 years of age, tofacitinib should only be used in patients over 65 years of age if no suitable treatment alternatives are available. Combination with other therapies: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies. Tofacitinib should be avoided in combination with biologics and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporin and tacrolimus. Venous thromboembolism (VTE): Serious VTE events including pulmonary embolism (PE), some of which were fatal, and deep vein thrombosis (DVT), have been observed in patients taking tofacitinib. In a randomised post authorisation safety

From the start of treatment with XELJANZ in patients with moderate to severe RA who responded inadequately to, or who are intolerant to one or more DMARDs.4
Published as of October 2020. Clinical trial program includes patients with RA who received ≥1 XELJANZ dose across the completed 2 phase 1, 10 phase 2, 6 phase 3, 1 phase 3b/4 index studies, and 2 open-label LTE studies. 2 RA=rheumatoid arthritis; JAKi=Janus kinase inhibitor; DMARDs=disease-modifying antirheumatic drugs; IR=inadequate responder; ACR=American College of Rheumatology; MTX=methotrexate. Xeljanz in combination with MTX is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Xeljanz given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. In patients over 65 years of age, patients who are current or past smokers, patients with other cardiovascular risk factors, and patients with other malignancy risk factors, XELJANZ should only be used if no suitable treatment alternatives are available.
RAPID RESPONSE
LARGEST SEE THE DIFFERENCE XELJANZ® PP-XEL-IRL-0722 © 2022 Pfizer Inc. All rights
a
b
WITH
AND THE
reserved. April 2022

1-3,a,b

LARGEST DATASET OF ANY JAKi IN RA, CAN MAKE FROM THE START

Starting as early as 2 weeks, DMARD-IR patients with RA who received XELJANZ monotherapy demonstrated a greater ACR20 response (secondary endpoint) vs placebo (30% vs 12%; P<0.001) in a phase 3, randomised, double-blind, placebo-controlled study (N=610)1,3

At month 3, significantly more DMARD-IR patients with RA who received XELJANZ monotherapy achieved ACR20 response (primary endpoint) vs placebo (59.8% vs 26.7%; P<0.001) in a phase 3, randomised, double-blind, placebo-controlled study (N=610)1

Proven in

to twice the upper limit of normal (2× ULN) versus those with D-dimer level <2×ULN. For patients with RA with known risk factors for VTE, consider testing D-dimer levels after approximately 12 months of treatment. If D-dimer test result is ≥ 2× ULN, confirm that clinical benefits outweigh risks prior to a decision on treatment continuation with tofacitinib. Tofacitinib should be used with caution in patients with known risk factors for VTE, regardless of indication and dose. Tofacitinib 10 mg twice daily for maintenance treatment is not recommended in patients with UC who have known VTE risk factors, unless there is no suitable alternative treatment available. Promptly evaluate patients with signs and symptoms of VTE and discontinue tofacitinib in patients with suspected VTE, regardless of dose or indication. Infections: Serious and sometimes fatal infections have been reported in patients administered tofacitinib. Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection. Patients should be closely monitored for infections, with prompt diagnosis and treatment. Treatment should be interrupted if a serious infection develops. 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. Tuberculosis: Patients should be evaluated for both active and latent TB prior to being treated with tofacitinib. Patients who test positive for latent TB should be treated with standard antimycobacterial therapy before administering tofacitinib. Viral Reactivation: In clinical studies viral reactivation and cases of herpes zoster have been observed. Screening for viral hepatitis should be performed in accordance with clinical guidelines prior to starting therapy with tofacitinib. The impact on chronic viral hepatitis is not known. Major adverse cardiovascular events (MACE): MACE have been observed in patients taking tofacitinib. In a randomised post authorisation safety study in patients with RA who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of myocardial infarctions was observed with tofacitinib compared to TNF inhibitors. In patients over 65 years of age, patients who are current or past smokers, and patients with other cardiovascular risk factors, tofacitinib should only be used if no suitable treatment alternatives are available. Vaccinations: Prior to initiating tofacitinib, it is recommended that all patients, particularly pJIA and jPsA patients, be brought up to date with all immunisations in agreement with current immunisation guidelines. Live vaccines should not be given concurrently with tofacitinib. Malignancy and lymphoproliferative disorder: Tofacitinib may affect host defences against malignancies. In a randomised post authorisation safety study in patients with RA who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of malignancies excluding non-melanoma skin cancer (NMSC), particularly lung cancer and lymphoma, was observed with tofacitinib compared to TNF inhibitors. Lung cancers and lymphoma in patients treated with tofacitinib have also been observed in other clinical studies and in the post marketing setting. Other malignancies in patients treated with tofacitinib were observed in clinical studies and the post marketing setting, including, but not limited to, breast cancer, melanoma, prostate cancer, and pancreatic cancer. In patients over 65 years of

the clinical trial program2,b

age, patients who are current or past smokers, and patients with other malignancy risk factors tofacitinib should only be used if no suitable treatment alternatives are available. NMSCs have been reported in patients treated with tofacitinib; the risk of NMSC may be higher in patients treated with tofacitinib 10 mg twice daily than in patients treated with 5 mg twice daily. Periodic skin examination is recommended in patients at increased risk for skin cancer. Interstitial lung disease: Caution is recommended in patients with a history of chronic lung disease as they may be more prone to infection. Asian patients are known to be at higher risk of ILD, caution should be exercised with these patients. Gastrointestinal perforations: Tofacitinib should be used with caution in patients who may be at increased risk, e.g. history of diverticulitis or concomitant use of corticosteroids or NSAIDs. Hypersensitivity: Cases of hypersensitivity associated with tofacitinib administration have been reported. Allergic reactions included angioedema and urticaria; serious reactions have occurred. If any serious allergic or anaphylactic reaction occurs, tofacitinib should be discontinued immediately. Laboratory Parameters: : Increased incidence of lymphopenia and neutropenia have been reported, and decreases in haemoglobin, which should be monitored in accordance with the SmPC. Monitor ANC and haemoglobin at baseline, 4-8 weeks and 3 monthly, ALC at baseline and 3 monthly. Tofacitinib has been associated with increases in lipid parameters, maximal effects were observed within 6 weeks. Monitoring should be performed 8 weeks after initiation and managed according to hyperlipidaemia guidelines. Increases in liver enzymes greater than 3x ULN were uncommonly reported; use caution when initiating with potential hepatotoxic medicinal products. Gastrointestinal obstruction with a non-deformable prolonged-release formulation: Caution should be used when administering tofacitinib 11 mg prolonged release tablets to patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic). Pregnancy & Lactation: Use of tofacitinib during pregnancy and breast-feeding is contraindicated. Side Effects: RA: The most common serious adverse reactions were serious infections; pneumonia, cellulitis, herpes zoster, UTIs, diverticulitis, appendicitis and opportunistic infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical studies were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension. UC: The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily were headache, nasopharyngitis, nausea, and arthralgia. Commonly reported adverse reactions (>1/100 to <1/10) across all indications were pneumonia, influenza, herpes zoster, urinary tract infection, sinusitis, bronchitis, viral upper respiratory tract infection, pharyngitis, anaemia, headache, hypertension, cough, abdominal pain, vomiting, diarrhoea, nausea, gastritis, dyspepsia, rash, arthralgia, pyrexia, peripheral oedema, fatigue, increased creatine phosphokinase. Refer to section 4.8 of the SmPC for further information on side effects, including description of selected adverse reactions. Legal Category: S1A. Marketing Authorisation Number: EU/1/17/1178/003 – 5 mg (56 film-coated tablets); EU/1/17/1178/007 – 10 mg (56 film-coated tablets); EU/1/17/1178/012 – 11 mg (28 prolonged-release tablets); EU/1/17/1178/015 1mg/mL oral solution. 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, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, + 353 1 467 6500.

Last revised: 03/2022.

Ref: XJ 15_0.

References: 1. Fleischmann R, Kremer J, Cush J, et al; for the ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med.2012;367(6):495-507. 2. Cohen SB, Tanaka Y, Mariette X, et al. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020;6(3):1-15. 3. Pfizer data on file. 4. XELJANZ Summary of Product Characteristics.
6
3
study in patients with rheumatoid arthritis who were 50 years of age or older with at least one additional cardiovascular risk factor, a dose dependent increased risk for VTE was observed with tofacitinib compared to TNF inhibitors. In a post hoc exploratory analysis within this study, in patients with known VTE risk factors, occurrences of subsequent VTEs were observed more frequently in tofacitinib-treated patients that, at 12 months treatment, had D-dimer level greater than or equal
phase
trials, with >7000 patients evaluated across treatment arms in

Valproate and the missing supports

Deirdre* has two sons in their 20s diagnosed with foetal valproate syndrome (FVS), following exposure to sodium valproate in utero.

She was prescribed Epilim (sodium valproate) for treatment of epilepsy, but was never warned about the nature of its risks in pregnancy.

“I hadn’t drank; I hadn’t smoked, I followed all the appropriate behaviours while you are pregnant…. I wouldn’t have even considered taking those tablets if I knew they were going to do that to them,” Deirdre told the Medical Independent (MI)

While sodium valproate is generally safe and effective for seizure control, children exposed in utero are at high risk of serious developmental disorders (in approximately 30-40 per cent of cases) and congenital malformations (in approximately 10 per cent of cases). Patients should not discontinue valproate medicines without consulting their doctor.

When Epilim was licensed in Ireland in 1975, there was already evidence of its teratogenicity. Internationally, patient organisations have argued failures by governments, medicines regulators, manufacturers, and prescribers to ensure patients were made aware of the risks in line with accumulating evidence.

A visual warning about risks in pregnancy on the outer packaging of valproate medicines was only mandated under stipulations announced by the European Medicines Agency (EMA) in 2018. The Agency’s first meaningful risk reduction measures were not instigated until 2014, but it later conceded that even these were inadequate.

Sanofi, the manufacturer of Epilim, has continued to deny liability in the face of legal action in France, where the government has opened a compensation scheme for families.

In Deirdre’s case, due to concerns about seizures, medical specialists increased her dosage of Epilim during her pregnancies. She noticed that her oldest child, now aged 26, appeared to have developmental issues by age three. He has since progressed well in his education, but his social skills are “quite poor”. She is unsure if he will ever be able to enter full-time employment. Her second oldest child, aged 23, has much higher support needs and will “need full-time care when my day comes”. Her sons only received the diagnosis of FVS in late 2021.

Deirdre, who is a lone parent, has one other child who does not have any disability. She had decided to discontinue her Epilim prescription prior to becoming pregnant 14 years ago, despite a specialist advising her that the risks from the drug were ‘low’.

Inquiry

In November 2020, Minister for Health Stephen Donnelly announced an inquiry into historical licensing and prescribing of the drug, but no timeline has yet been released. The announcement followed years of campaigning by Organisation for Anti-Convulsant Syndrome (OACS) Ireland, led by Chairperson Ms Karen Keely who has three adult sons with FVS, the oldest of whom – Harry – turned 35 on 11 May.

According to HSE estimates, up to 341 children experienced a major congenital malformation and up to 1,250 children experienced some form of neurodevelopmental delay following exposure to valproate in utero, between 1975 and 2015.

A HSE valproate response project was established in 2018, on foot of the EMA’s new safety measures. As part of the project, the HSE formed a subgroup to examine the community service and support requirements of people with FVS and their families. Its final draft report, dated July 2019, recommended medical cards for all individuals with FVS and “an agreed package of community care and supports” for each individual and their families. It said Community Healthcare Organisations (CHOs) should submit business cases to HSE National Community Operations for any additional support requirements.

At a conference in March 2019, attended by families and other stakeholders, subgroup Chair Mr Des O’Flynn, then a senior HSE primary care manager, discussed a potential ‘valproate passport’, indicating a streamlined mechanism for access to supports. This term was not included in the report, however.

As well as the appointment of local FVS liaison officers, the subgroup report recommended appointment of a national FVS co-ordinator officer to manage the programme incorporating diagnostics, assessment, and care planning processes. The national FVS co-ordination officer would be responsible for co-ordination of the assessment/approval process for business cases submitted to National Community Operations.

A Freedom of Information request to the HSE did not identify any business cases held by National Community Operations for additional supports for families (it is understood a very small number have been developed). No national FVS co-ordinator officer has been appointed.

To-date, only 35 people have been diagnosed with FVS under the diagnostic pathway introduced in 2019 – a fraction of the HSE’s estimation of the number of people affected.

MI understands that, in some cases, the HSE sent nurses to families to establish a comprehensive list of their needs, but no supports were provided. OACS Ireland has been in discussion with the HSE Office of the Chief Clinical Officer Dr Colm Henry for over four years on the support package and other matters related to valproate.

In April, in a parliamentary response to Sinn Féin Deputy David Cullinane, Minister Donnelly stated that there was “no specific package of supports available”.

A HSE spokesperson told MI a business case would have been needed or suggested if the CHO did not have the required budget to provide the relevant healthcare support or equipment. Their absence “means that CHOs have been able to allocate supports within their budgets”.

The HSE said some elements of the “proposed supports”, such as a change in the medical card regulations, would require a policy decision.

According to the Department of Health: “The HSE has not sought funding from the Department to specifically meet the needs of families affected by FVS. The HSE has not advocated for individuals with a diagnosis of FVS to have access to

a medical card, as eligibility for medical cards is essentially a policy matter for the Department of Health.” The Department “can consider providing medical cards to individuals affected by FVS; the Department is currently awaiting an update from the HSE regarding the total number of diagnoses from the most recent round of patient testing”.

Informed of the Department’s comments and asked why it did not seek funding, the HSE later added that it “fully acknowledges the challenges faced by families affected by FVS and that despite a lot of development within the health system, some of their needs can’t be met within the current arrangements”. There was “ongoing engagement” with the Department about funding requirements, “including components of the community pathway which are outside the scope of the HSE”.

OACS Ireland has expressed deep disappointment at the lack of HSE advocacy on the matter and is calling for it to implement the promised support package immediately. OACS and Epilepsy Ireland are also in ongoing discussions with the Department on the inquiry’s terms of reference. Ms Keely said she hopes to see the process proceed swiftly.

Traumatic

The promise of a support package offered hope to families. Deirdre has met with a local liaison officer who is making ongoing efforts to secure access to services and supports. However, to-date, “we have received one service.”

“I have been advised by the geneticist [who provided FVS diagnoses] to have my children’s hearts checked every year, ophthalmology was to be checked, physiotherapy, occupational therapy, some psychology….” It is understood the needs of each family would vary.

Deirdre, who has advocated through OACS Ireland, is aware that other families are also not receiving services and some liaison officers “haven’t even been in touch”. She said the promise of a support package seemed to be a “ploy on the HSE’s behalf so people don’t make legal claims against them”.

“Mentally, it is very traumatic on people. Any of the parents I have spoken to, and I have met quite a few of them, they are very up and down.” Many are “quite poverty stricken” as the care and support needs of their family member/s means they cannot enter employment. Deirdre also referenced the well-publicised inadequacy of disability services and noted that parents are increasingly anxious for progress as they “are not getting any younger”.

“I would like to know that some sort of provision would be made for the boys long-term,” she said.

Deirdre said Minister Donnelly needs to urgently proceed with the inquiry so issues of liability and redress can be established.

Green Party Deputy Patrick Costello, who has raised these issues in the Dáil, told MI: “We need a bespoke service for these very vulnerable, very complex needs families.” He also underlined the requirement for a stakeholder group to minimise the risk of future FVS cases, as advocated by OACS Ireland and Epilepsy Ireland (the Department said it is establishing this group).

“The families have been promised so much and I think we should be delivering on our promises,” he added.

Sinn Féin Deputy Pauline Tully, another advocate, said she has received phone calls from women prescribed the drug in pregnancy, who have children diagnosed with autism or developmental delay and are querying if they have FVS. She said the HSE must initiate an information campaign and provide the required supports.

Deputy Tully added: “There needs to be an inquiry team put together with a terms of reference and they need to be reaching out to the families affected and also looking into where fault lies; does it come down to drug manufacturers? Who is at fault?”

*Deirdre is not her real name. She preferred anonymity for her sons’ confidentiality.

THE MEDICAL INDEPENDENT | 19 MAY 2022
Promised HSE supports for people affected by teratogenic drug sodium valproate have failed to materialise, according to families. Catherine Reilly reports
News Feature CATHERINE REILLY catherine@mindo.ie
OACS Ireland Chair Ms Karen Keely and her son Harry

Think Once-Weekly Ozempic for People with Type 2 Diabetes who have Atherosclerotic Cardiovascular Disease1-3

Ozempic® provided a significant 26% risk reduction of MACE# in people with type 2 diabetes* and cardiovascular disease.1,2,§

This includes a 39% relative risk reduction in non-fatal stroke.1,2,‡

Ozempic® also has superior blood glucose and weight-loss efficacy across all head-to-head clinical trials in the SUSTAIN program.1-9,†,‡

* 26% CV risk reduction in patients with type 2 diabetes and high CV risk, compared to placebo, in addition to standard treatment.

# Major Adverse Cardiovascular Events

† Results apply to Ozempic® across SUSTAIN trials, which included placebo, sitagliptin, dulaglutide, canagliflozin, exenatide PR and glargine U100.1-9

§ p=0.02 for superiority

‡ p<0.05

Ozempic® is recommended by the ADA/EASD Consensus Report for people with type 2 diabetes who have established atherosclerotic cardiovascular disease10

PR = Prolonged Release; ADA = American Diabetes Association; EASD = European Association for the Study of Diabetes.

SUSTAIN = Semaglutide Unabated Sustainability in treatment of Type 2 Diabetes.

*SUSTAIN was the phase 3 clinical trial programme investigating the effects of once weekly semaglutide versus other anti-diabetic agents.

ABBREVIATED PRESCRIBING INFORMATION

Ozempic®t semaglutide

Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Ozempic® 0.25 mg solution for injection in pre-filled pen. Ozempic® 0.5 mg solution for injection in pre-filled pen. Ozempic® 1 mg solution for injection in pre-filled pen. One ml of solution contains 1.34 mg of semaglutide (human glucagon-like peptide-1 (GLP-1) analogue). Indication: Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 of the Ozempic® SmPC. Posology and administration: Administered once weekly at any time of the day, with or without meals. Injected subcutaneously in the abdomen, thigh or upper arm. Starting dose: 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control. When Ozempic® is added to existing metformin and/ or thiazolidinedione therapy or to an SGLT2 inhibitor, the current dose of metformin and/ or thiazolidinedione or SGLT2 inhibitor can be continued unchanged. When Ozempic® is added to a sulfonylurea or insulin, a reduction in dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Ozempic® is started and insulin is reduced. A stepwise approach to insulin reduction is recommended. Children: No data available. Elderly: No dose adjustment required, therapeutic experience in patients age ≥75 is limited. Renal impairment: No dose adjustment is required for patients with mild, moderate

or severe renal impairment. Experience in patients with severe renal impairment is limited. Not recommended for use in patients with end-stage renal disease. Hepatic impairment: No dose adjustment is required for patients with hepatic impairment. Experience with severe hepatic impairment is limited. Caution should be exercised when treating these patients with semaglutide. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Not a substitute for insulin. Diabetic ketoacidosis has been reported in insulin-dependent patients whom had rapid discontinuation or dose reduction of insulin. There is no experience in patients with congestive heart failure NYHA class IV and is therefore not recommended in these patients. Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function as nausea, vomiting, and diarrhoea may cause dehydration which could cause a deterioration of renal function. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, semaglutide should be discontinued; if confirmed, semaglutide should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Use of semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia, therefore consider reducing the dose of sulfonylurea or insulin when initiating treatment with Ozempic®. In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Caution should be exercised when using semaglutide in patients with diabetic retinopathy treated with insulin. These patients should be monitored closely and treated according to clinical guidelines. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded. When semaglutide is used

in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines. Fertility, pregnancy and lactation: Women of childbearing potential are recommended to use contraception when treated with semaglutide. Should not be used during pregnancy or breast-feeding. Discontinue at least 2 months before a planned pregnancy. Effect on fertility unknown. Undesirable effects: Very common (≥1/10): Hypoglycaemia when used with insulin or sulfonylurea, nausea, diarrhoea. Common (≥1/100 to <1/10): Hypoglycaemia when used with other oral antidiabetic medications, decreased appetite, dizziness, diabetic retinopathy complications, vomiting, abdominal pain, abdominal distension, constipation, dyspepsia, gastritis, gastrooesophageal reflux disease, eructation, flatulence, cholelithiasis, fatigue, increased lipase, increased amylase, weight decreased. Uncommon (≥1/1,000 to <1/100): Hypersensitivity, dysgeusia, increased heart rate, acute pancreatitis, injection site reactions. Rare (≥1/10,000 to <1/1,000): Anaphylactic reaction. Not known (cannot be estimated from available data): Angioedema. The SmPC should be consulted for a full list of side effects. MA numbers: Ozempic® 0.25 mg pre-filled pen EU/1/17/1251/002. Ozempic® 0.5 mg pre-filled pen EU/1/17/1251/003. Ozempic® 1 mg pre-filled pen EU/1/17/1251/005. Each pre-filled pen delivers 4 doses and includes 4 disposable NovoFine® Plus needles. Legal Category: POM. For complete prescribing information, please refer to the SmPC which is available on www. medicines.ie or by email from infoireland@novonordisk.com or from the Clinical, Medical and Regulatory Department, Novo Nordisk Limited, 1st Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9. Date last revised: March 2021.

tAdverse events should be reported to the Health Products Regulatory Authority. Information about adverse event reporting is available at www.hpra.ie. Adverse events should also be reported to Novo Nordisk on Tel: 1850 665 665 or complaintireland@novonordisk.com

versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulinnaive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol 2017;5: 355–66. 7. Sorli C et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol 2017; 5: 251–60. 8. Ahrén B et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol 2017; 5: 341–54. 9. Pratley RE et al. Semaglutide versus dulaglutide once-weekly in patients with type 2 diabetes (SUSTAIN

a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6275-286. 10.Buse JB et al. 2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2020 Feb; 43(2):487-493.

Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the SmPC.1 tThis medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Novo Nordisk Limited, First Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9, D09 X8W3, Ireland. Tel: 01 8629 700, Fax: 01 8629 725, Lo call: 1 850 665665. infoireland@novonordisk.com www.novonordisk.ie

Ozempic® and the Apis bull logo are registered trademarks owned by Novo Nordisk A/S.

Date of preparation: October 2021. IE21OZM00098

References: 1. Ozempic® Summary of Product Characteristics www.medicines.ie 2. Marso SP, et al; Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. (SUSTAIN 6) N Engl J Med. 2 2016;375:1834-1844. 3. Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(suppl1):S1-S108. 4. Lingvay et al, Once weekly Semaglutide vs Canagliflozin in type 2 diabetes (SUSTAIN 8) : a double blind phase 3 randomised control trial: Lancet Diabetes Endocrinol 2019; 7: 834–44. 5. Ahmann AJ et al. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care 2018;41:258-266. 6. Aroda VR et al. Efficacy and safety of once-weekly semaglutide
7):

Cystic Fibrosis Ireland, Annual Conference, virtual, 29-30 March 2022

Progress in CF care in Ireland

Ms Sarah Tecklenborg , Senior Research and Policy Coordinator, Cystic Fibrosis Ireland (CFI), reports on CFI's Annual Conference, which was held at the end of March

The impact of new modulator therapies on the lives of people with cystic fibrosis (CF) and advances in care for people who are not eligible for modulator therapies were among the key issues addressed at Cystic Fibrosis Ireland’s (CFI) 2022 Annual Conference, which took place virtually in March.

There have been dramatic improvements in CF treatment in recent years, including the development of CF transmembrane conductance regulator (CFTR) modulator therapies and standardised multidisciplinary patient care. Roll-out of the new triple combination CFTR modulator compound, Kaftrio (Vertex pharmaceuticals), started in Ireland in September 2020.

RECOVER study

Prof Paul McNally, Consultant in Paediatric Respiratory Medicine and Director of Research and Innovation at Children’s Health Ireland at Crumlin, shared research into the impact of ground-breaking new therapies for people with CF.

Prof McNally leads the RECOVER study, an ongoing multicentre real-world study in eight centres in Ireland and the UK. Funded by CFI, the CF Foundation (US), and the CF Trust (UK), the study is examining in detail the impact of Kaftrio on the lives and health of people with CF. RECOVER is looking at the impact of Kaftrio as it is prescribed clinically. The project will gather both routine health data and less commonly used clinical endpoints such as the lung clearance index (LCI), chest CT, gastrointestinal symptoms, inflammation, and medication adherence, providing unique insights into the effects of the triple combination drug.

In the first 12 months of RECOVER, 116 adults and adolescents have been recruited across UK and Irish sites. In line with what was seen in clinical trials, the team have seen significant improvements in sweat chloride, lung function, and nutrition in people with CF taking Kaftrio.

In people with CF there is a problem in moving chloride across cell membranes, which lead to higher concentrations of salt in sweat. The study has shown that, for participants with two copies of the F508del mutation, more than 40 per cent had a sweat chloride level well within the ‘normal’ range while on Kaftrio. The significance of this genotype advantage for those with two copies of the F508del mutation remains unclear and ongoing work is needed to ascertain whether this leads to long-term improved outcomes for this subgroup.

The team have also identified significant improvements in outcomes not used in the original clinical trials, including the LCI (a sensitive lung function test) and exhaled nitric oxide (a marker for airway inflammation).

Three new sub-studies have been established as part of RECOVER: A psychology sub-study, in collaboration with Trinity College Dublin, examining experiences of young people (12-to-17 years) who have started tak-

ing Kaftrio; a study examining the impact of Kaftrio on nasal and sinus disease in children with CF aged six-to-11 years in collaboration with the RCSI and St James’s Hospital, Dublin; and, finally, a study with the University of Amsterdam using breath analysis to detect changes in airway metabolism and inflammation with Kaftrio treatment.

Prof McNally and his team hope to further their work to investigate the duration of beneficial effect from modulator therapies and whether disease can be prevented in children if they begin modulator therapy early enough.

Experiences of people living with CF

The voice of people living with CF was central to the conference. Not all people with CF have access to an effective therapy and among those who do, the experience can vary. For some, however, Kaftrio has been life-changing.

bright future, knowing that my body will not let me down. Kaftrio has completely changed my life and I will never take that for granted."

person living with CF

CF treatment in the modulator era

As modulator therapies bring improvements in the health, symptom burden and experiences of people living with CF, questions are being asked by clinicians about what CF care now looks like in the era of modulator therapy. Prof Barry Plant, Consultant Respiratory Physician and Director of the Adult CF Centre in Cork University Hospital, discussed inhaled antibiotic therapies and how they may be best used to protect lung health in the era of precision medicine.

CF is characterised by inflammation of the airway, chronic infections and progressive decline in lung function. Studies have shown that up to 25 per cent of CF exacer-

a more individualised approach to their inhaled antibiotics may help to optimise their adherence.

How to reduce the treatment burden associated with CF has been identified as a top research question for the CF community. Daily nebulised treatments, often taking up to two hours a day, are considered burdensome. There are ground-breaking trials underway to find out if people taking Kaftrio can safely start to reduce the number of treatments they have to manage as part of their daily healthcare routine. Two randomised studies, CF STORM (UK) and SIMPLIFY (US), aim to assess if stopping certain daily muco-active nebulisers is safe for people taking Kaftrio. The studies will have patients actively disengage from their daily nebulised muco-active therapies (inhaled hypertonic saline and/or dornase alfa) and assess lung function over time. If people with CF choose to give up their nebulised therapies without trials like STORM and SIMPLIFY, there would be no quantified evidence for clinicians to refer to and confidently advise their patients. In the short-term, Prof Plant recommends encouraging patients to continue to use inhaled antibiotics, using personalised approaches to improve adherence where appropriate: “Modulator therapy works, but it probably works even better when used as an add-on to traditional CF therapies.”

Towards personalised medicine

"The last year of my life has been nothing short of a miracle and this is all down to the drug Kaftrio. Prior to December 2020, my life was getting more and more difficult to bear. I had constant chest infections, I couldn’t speak without violently clearing my throat, I had very low energy and regular hospital admissions. It really was becoming increasingly difficult for me to see myself living the life I wanted.

“In December 2020, with nervous excitement based on stories I had heard from the US, I started Kaftrio. Within a couple of hours it felt like a weight had been lifted off my chest. A week with little to no coughing turned into a month. Fourteen months later I can share with you that not only have I not needed one antibiotic for my chest or my sinuses, I have hardly coughed. I no longer have to plan my life around suspected hospital admissions. I no longer feel I need to sleep several times throughout the day and I no longer have to haggle with my medical team to prescribe me just one more oral antibiotic in a desperate attempt to avoid being locked in the CF isolation room in Christopher’s Ward. Thanks to Kaftrio, these are all things I no longer have to do. But let me tell you what I now can do.

“I can feel the air enter and exit my entire chest. I can laugh until my sides hurt without ending up in a coughing fit. I have healthier hair and brighter skin. I get up early to meditate and read instead of (doing) my rigorous CF treatments, and most of all I can plan for a

bations fail to recover to baseline pulmonary function levels after the exacerbation. Daily treatment regimens for CF include the use of inhaled antibiotics and mucolytics, which have led to significant improvements in respiratory disease and improved patient outcomes. Aerosolised antibiotics offer advantages over systemic therapy, as relatively high levels of the drug are delivered directly to the airways through a variety of delivery systems, including standard nebulisers or dry powder eFlow.

Patients on the new modulator therapies feel better, produce less sputum, and have fewer exacerbations. Prof Plant discussed his patients’ experiences on Kaftrio, noting that at three months post-initiation of therapy only approximately 10 per cent of patients could provide a sputum sample. This poses problems with monitoring the microbiological status of patients as they cannot provide a sample to confirm whether they do, or do not, have an infection.

As patients experience fewer exacerbations and produce less sputum, some have been discontinuing their other time-consuming burdensome therapies. A retrospective analysis of patient adherence to inhaled therapies before and after CFTR modulation with ivacaftor in the Cork CF clinic found there was a reduction in the frequency of use of inhaled therapies after starting the modulator.

In keeping with the increased liberation that Kaftrio has offered to people with CF,

Not everyone with CF is eligible for a modulator therapy like Kaftrio. Over 2,000 mutations in the CFTR protein, which causes CF, have been described. Many new drugs are mutation class-specific and are currently only being clinically tested in patients with specific mutations. These are often very common and well-described mutations. As a result, market authorisation and financial reimbursement of these drugs has been limited to specific subsets of people with CF. People with fewer common mutations, however, might also benefit from them.

Prof Kors van der Ent, Professor in Paediatric Pulmonology and co-ordinator of the European HIT-CF project, provided the meeting with an overview of the HIT-CF study, which aims to develop a path for access to therapies for individual patients who show response to therapy in a lab-based test. The HIT-CF project uses organoids, a tissue model derived from a person’s own cells obtained during a rectal biopsy. These organoids are used to test the efficacy of available therapeutics in a lab setting. Only patients with rare genotypes could participate in the study. Organoids from consenting participants will be stored in a biobank to use in future research and to test the efficacy of any future therapies, including genetic therapies. A follow-up clinical trial, CHOICES, is planned for later this year, which will assess the clinical impact of the therapy in people whose organoids responded highly. The trial aims to validate the organoid model of predicting clinical response to a therapy and this could pave the way for organoid-based personalised medicine in the future.

Conference Coverage THE MEDICAL INDEPENDENT | 19 MAY 2022 12
Daily treatment regimens for CF include the use of inhaled antibiotics and mucolytics, which have led to significant improvements in respiratory disease

Prescribing Information: Please read the Summary of Product Characteristics (SPC) before prescribing. Presentation: Prolonged-release tablet, containing mirabegron 25mg/50mg. Indication: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Posology and method of administration: The recommended dose is 50 mg once daily. A lower dose of 25mg is recommended for specific patient populations (renal and hepatic impairment) as well as in specific patient populations in combination with strong CYP3A inhibitors such as itraconazole, ketoconazole, ritonavir and clarithromycin.

Renal impairment: End stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis): Not recommended. Severe renal impairment (GFR 15 to 29 mL/min/1.73 m2): Reduce dose to 25 mg. Severe renal impairment and concomitant strong CYP3A inhibitors: Not recommended. Moderate renal impairment (GFR 30 to 59 mL/min/1.73 m2): 50 mg. Moderate renal impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. Mild renal impairment (GFR 60 to 89 mL/min/1.73 m2): 50 mg. Mild renal impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. Hepatic impairment: Severe hepatic impairment (Child-Pugh Class C): Not recommended. Moderate hepatic impairment (Child-Pugh B): Reduce dose to 25 mg. Moderate hepatic impairment and concomitant strong CYP3A inhibitors: Not recommended. Mild hepatic impairment (Child-Pugh A): 50 mg. Mild hepatic impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed. It may be taken with or without food Contraindications: Hypersensitivity to the active substance or to any of the excipients (see the SPC for a list of excipients). Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg. Special warnings and precautions for use: Renal impairment: Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) and, therefore, it is not recommended for use in this patient population. Data are limited in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2); based on a pharmacokinetic study a dose reduction to 25 mg is recommended in this population. This medicinal product is not recommended for use in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors. Hepatic impairment: Betmiga has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in this patient population. This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving

strong CYP3A inhibitors. Hypertension: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients. Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg). Patients with congenital or acquired QT prolongation: Betmiga, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies. However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown. Caution should be exercised when administering mirabegron in these patients. Patients with bladder outlet obstruction and patients taking antimuscarinic medicinal products for OAB: Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medicinal products for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with Betmiga; however, Betmiga should be administered with caution to patients with clinically significant BOO. Betmiga should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB. Interactions: Pharmacokinetic interactions: Mirabegron is a substrate for CYP3A4, CYP2D6, butyrylcholinesterase, uridine diphosphoglucuronosyltransferases (UGT), the efflux transporter P-glycoprotein (P-gp) and the influx organic cation transporters (OCT) OCT1, OCT2, and OCT3. Pharmacokinetic interactions involving the potential for other medicinal products to affect mirabegron exposures: Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate. Strong CYP3A inhibitors See Posology and administration above for dose adjustments recommended during concomitant use of strong CYP3A inhibitors in patients with renal or hepatic impairment. Mirabegron exposure (AUC) was increased 1.8-fold in the presence of the strong inhibitor of CYP3A/P-gp ketoconazole. CYP2D6 inhibitors: No dose adjustment is needed for mirabegron when administered with CYP2D6 inhibitors (or in patients who are CYP2D6 poor metabolisers). Inducers: Inducers of CYP3A (such as rifampicin) or P-gp may decrease the plasma concentrations of mirabegron. No dose adjustment of mirabegron is required as this effect is not expected to be clinically relevant. Pharmacokinetic interactions involving the potential for mirabegron to affect exposures to other medicinal products: Inhibition of CYP2D6: Moderate and time dependent inhibition of CYP2D6 by mirabegron may result in clinically relevant drug interactions. CYP2D6 activity recovers within 15 days after discontinuation of mirabegron. Caution is advised if mirabegron is co-administered with medicinal

50mgs

once daily

products metabolized by CYP2D6 with a narrow therapeutic index such as thioridazine, Type 1C antiarrhythmics (e.g.flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. Inhibition of P-gp: Mirabegron is a weak inhibitor of P-gp. For patients who are initiating a combination of Betmiga and digoxin, the lowest dose for digoxin should be prescribed initially. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect. The potential for inhibition of P-gp by mirabegron should be considered when Betmiga is combined with sensitive P-gp substrates e.g. dabigatran. Fertility, pregnancy and lactation: The effect of mirabegron on human fertility has not been established. Betmiga is not recommended during pregnancy and in women of child-bearing potential not using contraception. Mirabegron should not be administered during breast feeding. Refer to SPC for full guidance. Driving and use of machines: Betmiga has no or negligible influence on the ability to drive and use machines. Undesirable effects: Summary of the Safety Profile: the safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.

The frequency of tachycardia was 1.2% in patients receiving Betmiga 50 mg.

Tachycardia led to discontinuation in 0.1% patients receiving Betmiga 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving Betmiga 50 mg.

Urinary tract infections led to discontinuation in none of the patients receiving Betmiga 50 mg. Serious adverse reactions included atrial fibrillation (0.2%). Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies. The following adverse reactions were observed with mirabegron in the three 12-week phase 3 double blind, placebo controlled studies. The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be established from the available data) Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse events

are grouped by MedDRA system organ class. Infections and infestations: Common: urinary tract infection Uncommon: vaginal infection, cystitis Psychiatric disorders: Not known: Insomnia*, confusional state* Nervous system disorders: Common: headache* dizziness* Eye disorders: Rare: eyelid oedema Cardiac disorders:

Common: tachycardia Uncommon: palpitation, atrial fibrillation Vascular disorders:

Very rare: Hypertensive crisis* Gastrointestinal disorders: Common: nausea*, constipation*, diarrhoea* Uncommon: dyspepsia, gastritis Rare: lip oedema Skin and subcutaneous tissue disorders: Uncommon: urticaria, rash, rash macular, rash papular, pruritus Rare: leukocytoclastic vasculitis, purpura, angioedema* Musculoskeletal and connective tissue disorders: Uncommon: joint swelling Renal and urinary disorders: Rare: urinary retention* Reproductive system and breast disorders: Uncommon: vulvovaginal pruritus Investigations Uncommon: blood pressure increased, GGT increased, AST increased, ALT increased (*observed during post-marketing experience) Reporting of suspected adverse reactions: see below. Legal category: POM (S1B) Marketing Authorisation number: EU/1/12/809/003 25mg EU/1/12/809/010 50mg. Marketing

Authorisation holder: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands. Further information is available from: Astellas Pharma Co., Ltd, 5 Waterside, Citywest Business Campus, Dublin 24. Phone: +3531 467 1555. Summary of Product Characteristics with full prescribing information available upon request. Job number: BET_2019_0002_IE Date of preparation of API: 27 May 2019.

Reporting of 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:

HPRA Pharmacovigilance Astellas Pharma Co. Ltd

Earlsfort Terrace, IRL - Dublin 2 Tel: + 353 1 467 1555

Tel: +353 1 6764971 E-mail: Irishdrugsafety@astellas.com

Fax: +353 1 6762517

Date of preparation: June 2019 References: 1. Freeman R, et al. Current Medical Research and Opinion 2017. https://doi.org/10.1080/03007995.2017.1419170. Approval code: BET_2019_0005_IE
His 14th walk in the park since the day he started BETMIGA1
50mgs
Website: www.hpra.ie E-mail: medsafety@hpra.ie. 10988_Betmiga_PARK_A4_MAY19_01.indd 1 10/07/2019 16:40
once daily

Irish Medical Organisation, Annual General Meeting, Aviva Stadium, 28 May 2022

‘Wound inflicted on NCHDs requires more than a band-aid'

In advance of the IMO AGM on 28 May, Chair of its NCHD committee Dr John Cannon articulates why the group are balloting for industrial action

Almost a decade after NCHDs were forced to take strike action over dangerous and illegal working hours, they once again find themselves on the verge of major industrial action. The fruits of that strike was an agreement on a European Working Time Directive (EWTD) 'verification process', which has subsequently proven to be worth less than the paper it was printed on. The system of fines that was to be based on that process to verify NCHD working hours has also proven to be a toothless tiger, with little or no consequences for non-compliances. HR departments around the country are thus permitted –and some might even say, financially incentivised – to roster NCHDs for dangerous and career jeopardising rosters, with seeming impunity from the legal repercussions that protect all other workers from abuse in the State.

Evidently, something is not working with the verification process. The HSE report EWTD compliance with a 48-hour work week at or above 80 per cent, while the IMO’s recent survey on contract breaches reports that only 4 per cent of NCHDs are compliant with this fundamental – and I might add “lifesaving” – directive. If nothing else, this gaping disparity demonstrates the shambolic nature of the current system, which is clearly failing to protect doctors and patients from the inherent risks that come from physician fatigue and burnout.

By the way – calling the EWTD a “lifesaving” directive is not a ‘hot take’, as they might say in the media. Tired doctors make mistakes. Those mistakes can (sometimes) cause harm and even the loss of life in some cases. The stakes couldn’t be higher. We would never allow a bus driver, a pilot, or a train driver to operate for 36 hours in a row, or for 90 hours in a week. So, why do we ask our doctors to do it?

It seems common sense isn’t all that common after all. I have yet to meet a single person that thinks it is safe to ask a doctor to work between 80 and 100 hours a week. For NCHDs, what once seemed like a promising and auspicious career choice, now feels more and more like a medieval gauntlet. Our vocational calling to become doctors – our need to help people, to cure disease, and to ease suffering – feels more like a set of career manacles that perpetually shackle us to an employer who has little or no regard for our physical and mental health.

NCHDs have voiced their continuous incredulity every time EWTD compliance numbers are published by the HSE and even our politicians have acknowledged that they have heard first-hand of doctors claiming that working hours and timesheets are being falsified. Yet nothing is done about it and the train rolls on.

All the while NCHDs find themselves thinking: ‘Can I really work like this for the next 30 years?’; ‘Should I bite the bullet and move to Australia now?’; ‘How long will my family, my partner, my friends put up with my absenteeism?’; ‘Maybe medicine isn’t for me after all?’.

Eroded trust

Trust has been irrevocably eroded between NCHDs and their employer. NCHDs feel like an afterthought whose humanity and dignity are yet another resource to be sacrificed in an attempt to meet the infinite service needs of a health service in perpetual meltdown. Described as the ‘backbone’ of the acute medical workforce, NCHDs feel less like the linchpin that they are, and more like a hastily scribbled side note on their employer's ledger. I have no doubt, had NCHDs not chosen this moment to say “enough is enough” and stand up for themselves, the powers that be would have been perfectly content to allow the current

working conditions to continue ad infinitum

To their credit, at the onset of the pandemic, NCHDs shelved their discontent and put their shoulder to the wheel. Many of us were mortally afraid. We’d sit in our cars and cry. We still do. But now it’s from sheer exhaustion. From the fear we may not be able to make it through the next week, the next day, the next shift. In 2022, some 96.8 per cent of NCHDS reported having some form of depression, anxiety, exhaustion, stress, emotional stress, or other mental health condition related to, or made worse, by our jobs. These are the consultants and GPs of the future and many of them are thinking about quitting. Not just emigrating, but quitting medicine outright, such are the working conditions forced upon them.

I remember as a medical student I met a senior anaesthesiology trainee in Cork. He had one year left in his training. When I asked him what he planned to do when he qualified as a consultant, he said “quit”. He wanted a desk job, anything non-medical. Here was a man who had climbed the proverbial mountain, but he was so burnt out, so fed up, all he wanted to do was change profession. This country didn’t train that doctor, it harvested him.

What hope have we of solving the consultant workforce crisis when we treat our doctors like this? Take a cursory glance at social media and witness the outpouring of per-

sonal stories from NCHDs since the launch of the #StandingUp4NCHDs campaign. Multiple serious fatigue-related car crashes. Doctors with serious (life-changing) injuries as a result. Doctors being asked to work days after receiving life-saving surgery. Doctors falling asleep cycling to work. Doctors pleading with HR for time to see their loved ones, only to be told “They married a doctor, what did they expect?”. Seriously, what crime did NCHDs commit, besides wanting to care for their fellow man and woman?

NCHDs have grown tired of the perpetual equivocation by the HSE and lip service from our elected officials. While employers in many other sectors are engaging with their staff to see how a better work/life balance can be achieved in the post-pandemic world, NCHDs are battling to simply work safe and legal hours, and to get paid for those hours.

That’s to say nothing of the legion of international doctors who are promised the world to come here and are then used remorselessly to prop up our faltering health system only to find themselves in career purgatory. These doctors invest in Ireland. They uproot their families and commit themselves to a service that does not value or respect them. They arrive in Ireland and put down roots, marry, have children, and buy homes. They’re qualified, they’re talented, they’re committed. They want to stay in Ireland, but we give them next to zero opportunities. So, they’re forced to move on, and another western country – usually the UK – reaps the investment Ireland has made in onboarding them and integrating them into western healthcare. Shame on us for treating these professionals so poorly.

It is obvious to this cohort of doctors that the whole structure of NCHD training needs to be seriously rethought. The horrible truth – for anyone thinking about becoming a doctor – is that the model of training in Ireland is an anachronism from a bygone era, where a nomadic male doctor in his early 20s traipses around the country, and if he has any dependents (wife and kids), they traipse around after him. Despite the changing demographic of medical students and the introduction of the graduate-entry medicine pathway, it appears that no planning around this diversification took place and we are thus left with a system that utterly fails to meet the most basic of needs of the workforce. These demographic changes are completely incompatible with the current NCHD contract, which evidentially no longer reflects the employees it is intended for.

The Government stands at the precipice of alienating yet another generation of NCHDs. Unless there is a colossal paradigm shift, here and now, the majority of this generation will be lost for good. We will emigrate, change careers, or go into the private sector.

Ballot

NCHDs are balloting for industrial action. This is a clear message to Government and the HSE that we are no longer prepared to maintain the status quo or accept a few token changes. We want to engage in meaningful negotiations around contract breaches, contract reform and new structures that value NCHDs, and emphasise a healthy work/life balance. The Government and the HSE should be in no doubt as to the level of anger, frustration and indeed despair amongst NCHDs, and we are calling on them to use this opportunity to make a difference and to ensure we have even a chance of keeping Irish trainees in the system.

A band-aid is not capable of closing the wound inflicted on this current generation of doctors. The proposed changes must be substantial and sweeping if there is any hope of regaining the trust that has been eroded by years of neglect and empty promises.

Conference Preview THE MEDICAL INDEPENDENT | 19 MAY 2022 14
Dr John Cannon
NCHDs feel like an afterthought whose humanity and dignity are yet another resource to be sacrificed in an attempt to meet the infinite service needs of a health service in perpetual meltdown

‘We must ensure the specialty never gets left behind again’ S

Chair of the IMO public health committee Dr Anne Dee writes that while the 2021 public health agreement was a landmark achievement, it should only be seen as the starting point

o, 2021 has been a landmark year for public health as a specialty in Ireland. Finally, after many years of campaigning, advocating, and negotiating, the grade of consultant in public health medicine has been recognised and introduced in Ireland. This is as a result of the public health agreement negotiated by the IMO with the Department of Health and the HSE.

The agreement allows for the introduction of 84 consultant in public health medicine posts over a two-and-a-half-year period. The first 34 of these posts have now been brought on stream. It is expected that by the end of June 2022, in line with the agreement, that these first posts will have been filled. A further 30 posts are to be filled by June 2023 and the final 20 posts by December 2023.

This is the culmination of over 20 years of campaigning and the work of successive IMO public health committees in firstly fighting to get this on the agenda, then to get into negotiations, and finally to be in a position to conclude such negotiations.

For too long public health medicine has been a ‘Cinderella’ specialty in Ireland.

Under resourced, often ignored and poorly misunderstood. If the pandemic has had one positive it is that it has brought to the fore the importance of having a properly resourced, well-structured public health medicine service.

The initial 34 posts have largely (understandably) focused on health protection. Future tranches of posts will see other domains and pillars being filled with consultants now working in specific areas, and leading multi-disciplinary teams, allowing for a much greater range of specialisation and depth of work.

The agreement has shown the benefit of having a strong union with democratically elected committees to fight for its members. Even as we re-entered negotiations in March of 2021, the initial proposals were looking at 11 consultant posts to cover the whole of Ireland with the remainder of specialists staying at specialist in public health medicine (SPHM) grade. This was not and could not have been acceptable to the IMO and, thankfully, further funding was found to cover the total 84 posts. It is important to note that we must not see this as the end point for the specialty in Ireland, rather it is a starting point. Once the

agreement is implemented in full, and the IMO is working closely with the HSE and Department of Health to ensure that this is the case, it will be up to the service to advocate for additional resources, staff and consultant posts, as they become necessary.

While this is an exciting time for public health medicine, we must ensure now that we are treated in the same manner as all other consultants. Thankfully, the agreement sets out that we are on an equal contractual underpinning as all other consultants. But we must ensure that the specialty never gets left behind again and that it will become a sought-after specialty for our NCHDs, who will be the future of our public health service. We must also advocate and campaign now for doctors working at the senior medical officer grade and support them as they have supported SPHMs and directors of public health in the campaign for consultant status. It is only by working together through the IMO that we can achieve our shared objectives and common goals. I look forward to finally catching up with members in person at this year’s AGM and I hope that those in a position to attend will do so.

Community medicine: The battle for greater recognition

Chair of community health with the IMO Dr Ann Hogan reflects on what the last year has meant for community medicine and expresses disappointment about the continued inequitable treatment of area medical officers

As we prepare for the IMO AGM there is a lot to reflect on for community health and its role in 2021.

We have always argued for a greater recognition for the role of our community medicine doctors and we hope that the work during the Covid-19 pandemic will lead to this recognition.

The country entered 2021 in a very difficult position, with a further wave of Covid-19 and increasing levels of illness and hospitalisation. The roll-out of the Covid vaccine was a very welcome ray of light. Community medicine doctors were delighted to be part of the vaccination teams, which delivered the vaccine to patients and staff in nursing homes. Our experience from our role in the school immunisation programmes was useful.

During the pandemic we were also able to continue to deliver the school immunisation programmes, including the human papillomavirus (HPV) vaccine, to primary and secondary school students in large central clinics when the schools were

closed. Prior to the pandemic, significant work had been done to fight back against vaccine misinformation, leading to increased uptake of HPV vaccine among secondary school students. The extension of the HPV vaccination programme to boys had started well in September 2019. Our school immunisation programmes were severely disrupted during the pandemic. However, our teams stepped up in 2020 and 2021 to deliver the programmes, despite challenges such as school closures; lack of space in schools, which had to use halls as classrooms; staff shortages due to redeployment and due to Covid 19 illness; and different ways of working due to Covid 19 control measures, including social distancing.

Our senior medical officers and area medical officers continue to deliver child health clinics and the other key duties of the role.

Despite this commitment, we still need to see action by the HSE to address a number of the key challenges faced by our specialty.

I am very disappointed to again have to write about the continued unfair treat-

ment of our area medical officers. Since 2004, the IMO has been pursuing the rectification of this long-running unfairness. In 2021, we had been engaging with the HSE through a Workplace Relations Commission conciliation. The HSE had firmly committed to dealing with this through a separate process provided for under Building Momentum, the current public services pay agreement.

This process (the bargaining unit process) provided specific funding to address long running claims and disputes. The IMO had a number of engagements in late 2021 around this process. Unfortunately, despite the agreement providing for an implementation date of 1 February 2022, we have had no meeting in a number of months and indeed no specific feedback on our proposal on this issue.

We can see no reason for a delay with this, and it adds insult to injury that the HSE, Department of Health, and Department of Public Expenditure, far from acting promptly to resolve this issue, are in fact not even abiding by the timelines or keeping to the terms of the wider national agreement.

We note that, if this process does not address this issue appropriately, the IMO reserves the right to go the Labour Court on the matter.

In addition to the AMO issue, recruitment continues to be a challenge for the community medical service. We had engaged with the HSE on this prior to the pandemic and we are looking to resume this engagement in the coming months. There is a need for action to ensure adequate staffing levels in the community medical service as the workload is increasing in quantity and complexity. It is imperative that jobs can attract young doctors to replace those who will shortly retire.

So, we hope that the employer-side will show the same commitment and effort as our community medicine doctors have consistently shown. This commitment and effort has been taken for granted for too many years now and if urgent action is not taken, there will not be a service there able to provide the vital work in vaccinations and child health or to respond to new challenges, as we did during Covid-19.

Conference Preview THE MEDICAL INDEPENDENT | 19 MAY 2022 16
Irish Medical Organisation, Annual General Meeting, Aviva Stadium, 28 May 2022
While this is an exciting time for public health medicine, we must ensure now that we are treated in the same manner as all other consultants

The need to value and respect our consultant workforce

Chair of the IMO consultant committee and incoming

Covid-19 brought into sharp focus all the issues which, for over a decade, we in the IMO have been advocating for: The urgent need for significantly improved bed capacity and infrastructure; the crisis in medical workforce recruitment and retention; and the inherent dangers of longer and longer waiting lists. Throughout this time, our proposals have been falling on deaf ears and we now are living with the consequences of misguided cuts to health budgets, the implementation of inequitably and inherently unfair pay policy for consultants and no serious sustainable effort to tackle the effects of a decade of underfunding.

Political decisions have left our health service in a perilous state with a demoralised, overworked, and burnt-out workforce. Covid-19 and the HSE cyberattack have been devastating, presenting many challenges, which have taken their toll on the professional and personal lives of our members. However, Covid did not make the political decisions that have brought us to this point. We can and must do better. This requires political will to even make a start on addressing the problems. No single contract can resolve the problems that beset our service, but a contract can, at least, be designed to retain and attract much needed consultants into our public health services. Other jurisdictions are spectacularly successful at recruiting Irish consultants – why? Because they value, respect, support and enable them to have fulfilling careers. Successive Governments here, on the other

President Dr

Clive Kilgallen outlines how the medical profession have

been let down by successive Governments

hand, seem to adopt a position that consultants are the enemy and an obstacle. Nothing could be further from the truth. Consultants have for many, many years advocated strongly for a first-class health service that delivers timely care to patients, for a service that actively enables consultants to be leaders in delivering care. Yet any solutions we propose are, at best, met with lip service.

We now have more than 850 vacant posts. As the HSE recruitment struggles continue, what hope do we have of delivering upon the additional 2,000 consultants that will be required over the next five years. This crisis in our consultant workforce is a direct result of the unilateral 30 per cent pay cut imposed on our colleagues in 2012. The inevitable consequences, which were entirely predictable, are dangerously high waiting lists, which now sit above 1.3 million; a service that is incapable of delivering timely care; and a workforce that has no trust in Government or confidence that anything will change for the better.

It is, therefore, all the more unbelievable that the Government would produce a draft consultant contract that further exacerbated the problems and has been

met with an overwhelmingly negative response from both consultants and trainees. Not only are those consultants and trainees who are currently working in Ireland opposed to so many aspects of the proposals, but those working abroad have clearly indicated that they would not return on the basis of this draft contract.

As always, the IMO is willing to engage with the Department of Health and the HSE on developing a contract that is capable of delivering a solution to recruitment issues, capable of enabling consultants to do their job and develop skills and capable of being implemented in a fair and equitable manner. On behalf of consultants, we proactively engaged and proposed workable solutions to address the crisis and right the wrong that was imposed on our colleagues who took up consultant posts after October 2012. While those negotiations were suspended due to the departure of the independent Chair, it is very disappointing that the process has not restarted to date.

However, in the meantime, the Government decided to further disrespect and potentially breach current agree -

Reaching agreements and breaking those agreements

response by Government and the HSE

ments. The restoration of hours imposed during austerity is a key feature of the current public service agreement Building Momentum and we are appalled that any move would be made to exclude consultants from this process. Consultants are already working significantly over and above their contracted hours and this is simply not acceptable. Similarly recent indications from Government that consultants may not be paid their contractual and legitimate final FEMPI restoration payment in July 2022 is yet another example of not honouring agreements already reached. We must be able to trust that agreements reached will be honoured.

Reaching agreements and breaking those agreements have become an all too familiar response by Government and the HSE. We see the same happening to our NCHD colleagues, the very doctors we are depending on to keep the service going now and to be the consultants and medical leaders of the future. As consultants we are fully behind their campaign #StandingUp4NCHDs.

Let there be no doubt that we are with them in this fight. Many of the current cohort of consultants engaged in industrial action as NCHDs; we know their struggles and it is more than disappointing to see it all happening again. Our NCHDs look at our own working conditions and our own contract issues. Is it any wonder they choose to leave rather than pursue a consultant career here in Ireland? Will the Government never learn?

You have to treat your employees with dignity and respect, honour agreements, allow them to do their jobs, and listen to them.

Chair of the IMO GP committee Dr Denis McCauley describes the essential work GPs have undertaken during the pandemic and the progress achieved over the last year

Covid-19 remains very much a part of the GP working environment and we will be continually adapting as the disease evolves. The past two years have seen GPs and their teams stand up to the challenges that the pandemic has brought as we dealt with Covid assessments and test refer-

rals, the vaccination programme and maintaining normal GP services at the same time.

I am proud to say we have faced each and every challenge head on and proven the value of general practice. This is a tribute to every member of the GP team and testament to the ability of general practice to adapt to rapidly changing circumstances, while all the

time continuing to provide the continuity of care, which is a cornerstone of the specialty.

The incredibly successful Covid-19 vaccination programme was spearheaded by general practice, with over 3.5 million vaccinations being provided in general practice across primary doses and booster doses. This was not without its challenges and logistical difficulties Continued on p18

and the IMO worked closely with the HSE to address these issues and support our members. This support included a range of updates and webinars on the ongoing issues as well as providing support to members with regard to vaccine delivery and other issues.

Preview Conference THE MEDICAL INDEPENDENT | 19 MAY 2022 17
Irish
Medical Organisation, Annual General Meeting, Aviva Stadium, 28 May 2022
have become an all too familiar
‘We have faced each challenge and proven the value of general practice’

Covid-19 supports for assessment and referral for testing, as well as in-surgery respiratory assessments, agreed by the IMO with the State, continued and these were a vital support in helping deal with Covid in the community.

In addition to this, the chronic disease management programme, agreed as part of the 2019 GP agreement, continued to be rolled out. The main programme is now open to all GMS/DVC [doctor visit card] patients aged 18 and over and the prevention programme and the opportunistic case finding programme have now also been introduced for those GMS/DVC patients aged 65 and over.

This programme is now established as an essential component of general

practice, providing a real difference to patients. The integrated nature of the software solution also points to the future of general practice and helps make the recording of data and claiming from the Primary Care Reimbursement Service a seamless process.

From an IMO perspective, much has been achieved in the last year. The penultimate payment of the FEMPI reversal under the 2019 GP agreement was

paid in January of 2021 with the final increase being made in January 2022.

Due to Covid-19, some of the initiatives under that agreement in terms of community health networks, e-health and negotiations on under-12s were delayed, but will come on stream over the coming year.

All this being said, we must also be cognisant of the fact that there are many challenges facing general prac -

tice, not least in terms of GP capacity, locum availability and out-of-hours. We must look at creative capacity solutions, which could widen the general practice team as well as provide incentives for more GPs to work in clinical practice and indeed to take on GMS lists and partnerships. We have demonstrated time and time again that when supported and appropriately resourced, general practice can and will deliver – but equally Government must recognise the issues and be prepared to invest in the solutions.

So with the AGM fast approaching, I look forward to this one-day event in the Aviva in Dublin on 28 May and to meeting colleagues and members in person again. I hope that all those in a position to attend will do so and we can have the opportunity to meet and discuss the challenges ahead.

AGM PROGRAMME

9.00am–10.30am

GP national meeting NCHD national meeting Consultant national meeting

Public health and community health national meeting

Official Business Minutes, Treasurer’s Report, specialty committees for 2022/23 and deceased members

10.30am

Official handing over of Chain of Office from Dr Ina Kelly to incoming President

The medical response to armed conflict and displaced persons

Our guest speakers will discuss their experiences, on the ground and at home, and best practice approaches to providing medical care and assistance during armed conflict

11.00am–12.30pm

Confirmed speakers

• Dr Srihari Cattamanchi, International Committee of the Red Cross (ICRC)

• Prof Gregory Ciottone, President, World Association for Disaster and Emergency Medicine (WADEM), and Associate Professor, Harvard Medical School

12.30pm–1.30pm

Working lunch with financial seminar by IMOFS and Zurich

1.45pm–2.15pm

Address by Minister for Health

Beyond the pandemic –Key issues for the health service

Our guest speakers will discuss the priorities for the health service post-Covid 19, in terms of health system capacity, medical workforce planning and recruitment and the challenges of moving care from the hospital into the community

Confirmed speakers

• Dr Brian Turner, Economist and Senior Lecturer, UCC

• Dr Niamh Humphries, Senior Lecturer, RCSI Graduate School of Healthcare Management

• Prof Matthew Sadlier, Consultant Psychiatrist and Clinical Director, Dublin North 3.15pm–4.30pm

4.30pm

Gender equality in medicine –Time for a sledgehammer

Reflecting on the results of the IMO Gender Equality Survey, our expert panel will discuss progress made in addressing gender disparities in medicine and the persistent challenges that remain

Moderator: Dr Ina Kelly, IMO President and Chair IMO women in medicine working group

Confirmed speakers

• Dr Fiona Kiernan, Consultant in Anaesthesiology and Intensive Care Medicine and Founder of Zeumed

• Dr Gozie Offiah, Senior lecturer RCSI and National Clinical Lead for Intern Training, HSE

• Dr Rachel McNamara, Chairperson of the IMO NCHD women in medicine working group

• Dr Madeleine Ni Dhalaigh, GP, Castlerea, Co Roscommon

Meetings of specialty committees and IMO Council

Conference Preview THE MEDICAL INDEPENDENT | 19 MAY 2022 18
2.15pm–3.15pm
The incredibly successful Covid-19 vaccination programme was spearheaded by general practice
Continued from p17 ▸
Irish Medical Organisation, Annual General Meeting, Aviva Stadium, 28 May 2022

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Much to discuss at IMO AGM as frustration mounts

In this issue of the Medical Independent , we preview the IMO AGM. The meeting will be held in the Aviva Stadium on 28 May. It marks the first time since 2019 the AGM will be a fully face-to-face event since 2019 (the 2020 and 2021 events took place virtually as a result of the Covid-19 pandemic).

Covid-19 has taken an enormous toll on the medical profession. But many of the issues that doctors have written about in our preview coverage pre-date the pandemic. For instance, the failure of hospitals to comply with the European Working Time Directive (EWTD) had already been of concern to the IMO well before Covid.

In his article, Chair of the Organisation’s NCHD committee Dr John Cannon writes that the decision for NCHDs to ballot is a message to the Government and the HSE that the group will not accept the current status quo.

“We want to engage in meaningful negotiations around contract breaches, contract reform and new structures that value NCHDs, and emphasise a healthy work/life balance,” according to Dr Cannon.

“The Government and the HSE should be in no doubt as to the level of anger, frustration and indeed despair amongst NCHDs, and we are calling on them to use this opportunity to make a difference and to ensure we have even a chance of keeping Irish trainees in the system.”

Chair of the IMO consultant committee and incoming President Dr Clive Kilgallen argues that the medical profession have been let down by successive Governments and highlights the “overwhelmingly negative response” to the draft consultant contract.

The fact that negotiations have stalled due to the lack of an independ-

ent Chair does not auger well for those who hope such concerns can be addressed in a timely fashion.

A new contract has relevance for public health doctors, who last year were finally granted consultant status. The specialty fought hard for this designation for years. While the agreement is a landmark achievement, Chair of the IMO public health committee Dr Anne Dee writes that it should not be seen as an end point.

She says even when the agreement is implemented, public health doctors will still have to advocate for additional resources.

“We must ensure that the specialty never gets left behind again and that it will become a sought-after specialty for our NCHDs, who will be the future of our public health service,” according to Dr Dee.

Community medicine has also been seeking greater recognition. Chair of community health with the IMO Dr Ann Hogan writes that she hopes essential work undertaken by the group during Covid-19 will help this effort. However, Dr Hogan expresses her disappointment about the continued inequitable treatment of area medical officers, which may ultimately have to be resolved at the Labour Court.

In his article, Chair of the IMO GP committee Dr Denis McCauley outlines the progress made in general practice over the past two years, despite the pandemic, such as the final FEMPI reversals. However, Dr McCauley also points out how GPs face numerous challenges, in terms of capacity, locum cover, and out-of-hours.

So, all in all, there will be a lot for doctors to discuss at the AGM. And they will hope that solutions to these problems will be addressed sooner rather than later.

MINDO CARTOON

READER COMMENTS

REACTION TO OUR NEWS FEATURE, 'UNCERTAIN FUTURE FOR FINANCING OF GRADUATE ENTRY MEDICINE', 9 MAY

“Thank you @med_indonews for asking me to contribute to this article on behalf of current, future, and past graduate entry medicine students highlighting the discontinuation of @bankofireland GEM loan. Over €16,000 per year in fees without any financial support is not sustainable and will limit an already restricted access course to those who have the financing readily available. GEM was designed to encourage diversity in the career. Discontinuing the only loan available to us makes GEM utterly inaccessible and unfeasible for the very students the course was 'designed' for. Nobody is looking for a handout, simply financial support. We are pleading for @SimonHarrisTD to engage with us on this. At a time when retention of doctors in the HSE is a major challenge, it is important to also look at medical education access too." Laura Dowling, @lauradowling__, 10 May

“This is a massive problem. @bankofireland no longer providing finance for graduate entry medical students, thereby limiting access to medical education even more. 'Over 36 per cent of enrolments in medicine education came from affluent backgrounds.' This is not going to help." WiMIN, @WomenMedIreland, 9 May

REACTION TO OUR NEWS STORY, '"URGENT" MEASURES

REQUIRED FOR STAFF'S MENTAL HEALTH – SAOLTA', 9 MAY

“Get ready gang. Time for some more hot yoga and brain gym. Appropriate staffing numbers and reasonable working hours? Don't be silly." IrishHealthInsider, @health_irish, 6 May

REACTION TO OUR NEWS STORY, 'REJECTED GP CLAIMS UNDER MATERNITY SCHEME SKYROCKETED', 28 APRIL

“This is simply outrageous!!! Needs to be addressed by @IMO_IRL on behalf of its members. Otherwise patients will have to be charged for additional visits that they actually have an entitlement to once they fit certain criteria."

Asumpta Gallagher, @BestPracticeGP, 30 April

“Would be interesting to see whether upcoming FF women's health conference will cover this? Further underscores how GPs are not adequately resourced to see women in pregnancy."

Dr Amy Morgan, @amymorgangp, 29 April

REACTION TO OUR NEWS STORY, 'FAILURE TO APPOINT NATIONAL GENETICS LEAD', 28 APRIL

“Maddening! 37 per cent of people with rare conditions waiting more than five years for diagnosis. Genetics provides answers! Extraordinary waste of time, energy, and resources... @DonnellyStephen – what action are you taking to deliver programme for government? #RobertWatt – where are the financial resources to deliver this programme for government promise? Early accurate diagnosis transforms lives."

Rare Diseases IE, @RareDiseasesIE, 5 May

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Letters to: The Editor, The Medical Independent, Greencross Publishing Ltd, Top Floor, 111 Rathmines Road Lr, Dublin 6 or email paul@mindo.ie THE MEDICAL INDEPENDENT | 19 MAY 2022 20 Editorial

Giving evidence in court

Mr Liam Heffernan, Legal Counsel in Medisec, outlines what medical practitioners should know when called to be a witness in court

Receiving a solicitor’s letter asking you to confirm your availability to attend court as a witness concerning one of your patients can often be an unsettling request. It is understandable that doctors may have many queries about what such a request will mean for them and what to expect if they do have to appear in court to provide evidence.

Doctors may be requested to prepare medico-legal reports in various circumstances, including personal injuries cases, such as road traffic accidents or accidents at work. Doctors might also provide reports in family law proceedings on behalf of one of their patients.

This article will deal with issues arising for doctors who are requested to appear in court and provide evidence as a medical factual witness (ie, concerning treatment they provided to a patient), as opposed to where doctors are asked to provide an expert opinion on issues, such as liability/breach of duty and causation.

It is worth noting that most personal injury cases resolve between parties without the case proceeding to a full trial, and as a result, doctors are not called to give evidence in respect of the majority of reports they provide. The Courts Service has indicated that approximately 97 per cent of all personal injury cases resolve without the need to proceed to a court hearing.

However, when preparing a medico-legal report at the request of a patient’s solicitor, doctors should bear in mind that they may be called to give evidence, on oath, as to the contents of their report. It can understandably be a daunting prospect, particularly if a doctor has not previously attended court.

Request to attend court

You may be requested to attend to give evidence in court about the matters referred to in a medical report you prepared and submitted. Typically the patient’s solicitor will canvass your availability in advance to attend court on a particular date or dates. Unfortunately, we are aware of instances where very little notice is provided, which can result in significant difficulties for doctors with patient commitments and issues with finding cover at short notice. If a party other than the patient’s solicitor seeks your attendance at court to provide evidence, you should insist upon service of a subpoena or summons to witness (detailed below).

On receipt of a request to attend as a witness, we recommend liaising with the solicitor to try and narrow down a specific day/ time when you will be required (as some cases can run for days or weeks). You can also request to be immediately informed if a case settles or if your attendance is no longer required. You should also liaise with the solicitor in advance about fees and seek written confirmation that fees/expenses will be discharged.

However, ultimately if a witness (in this case a doctor) refuses to attend, they may be served with a subpoena to attend court. A witness must then comply with the direction

of the court to attend. There are two forms of subpoena, which you may receive:

 Subpoena ad testificandum: This requires you to attend court in order to give evidence.

 Subpoena duces tecum: This requires you to attend court in order to give evidence and to bring certain documents as well (for example specific patient medical records). Prior to attending court, you should fully review the patient’s medical records and any medical reports, which you have prepared on behalf of the patient.

You may be asked to give evidence in the context of family law proceedings. If you have treated both partners, it is preferable to insist upon receipt of a subpoena or summons to witness.

Attending court

You should clarify with the party requesting your attendance details, such as the location of the specific courtroom, the time of the hearing, the full name of the case and record number. You should bring any documents that were specified in the subpoena if you received one. It would also be helpful to bring a copy of any correspondence/reports that you may have prepared relating to the matter, or to have familiarised yourself with such documentation in advance of the court date.

It is important to dress professionally when attending court and to conduct yourself appropriately, including switching off your mobile phone or any other device before entering the courtroom and standing when the judge enters the court.

Typically, there will be other parties present, such as solicitors, barristers, the court registrar, a stenographer, and possibly some members of the public or court reporters. However, family law proceedings are held “in camera”, which means the case is held behind closed doors and members of the public and journalists are not permitted to attend.

Video link

Since the pandemic, in certain cases it has been possible for hearings to be held re-

motely and witnesses have been able to give evidence by video link. The Courts Service has provided useful guidance on remote hearings, titled Virtual Courtrooms, Guidance for Practitioners and Lay Litigants, which can be found on its website.

The guidance advises that you should treat the virtual courtroom as you would a physical courtroom. You should make sure that you are joining the virtual courtroom from a quiet, private location with appropriate lighting so your face can be clearly seen. Ensure that you have entered your full name on entering the courtroom as this may be the name displayed with your video and check that your background is appropriate for a formal scenario.

For connection details you should seek clarity in advance from the solicitor who has requested that you provide evidence. You should give yourself sufficient time in advance to access the virtual court and your sound should be muted unless you are providing evidence.

Giving evidence

A doctor’s role is to provide impartial evidence to assist the court. You should not act as an advocate for either party.

Before giving evidence in court, you must take an oath or affirmation (a verbal declara-

tion) that your evidence will be truthful. You will do this in the witness stand, typically located at the top of a courtroom, near the judge. For remote hearings, the Courts Service advises that if a witness wishes to take an oath on a Bible or other sacred text, you must have this text with you during the virtual hearing. You will be asked to hold this text up to ensure it can be seen by the court. In most cases, you will be asked to provide your name and role to the court. You will provide your evidence from the witness stand.

When giving evidence in court you should answer the direct questions raised by the barrister or solicitor representing the patient. They will ask you a number of questions based on your evidence/report (“examination-in-chief”). You should address your answers to the judge, who should be addressed as “Judge”.

You may be subsequently asked questions by the barrister or solicitor representing the other party to the case (“cross-examination”). This could include being asked about any inconsistencies or any possible alternative explanations in respect of the evidence you provided. The purpose of cross-examination is generally to test/challenge the evidence that you have provided.

Following this, the barrister or solicitor representing the patient/party who called you to give evidence may ask further questions to clarify the evidence provided by you on cross-examination. This is known as “re-examination”.

If the judge or barrister asks a question to which you do not know the answer, it is perfectly reasonable for you to simply state that you do not know or do not recall. It would be inadvisable for a doctor to attempt to answer a question that may be outside his or her clinical area of expertise or knowledge. Do not be afraid to keep your answers short and to the point.

With the permission of the court, you may refer to contemporaneous notes from the time of the patient’s attendance or your medico-legal reports.

When your evidence is complete, you will be asked to leave the witness stand in the courtroom. Most people conventionally bow towards a judge when they are leaving the door of the courtroom.

Lastly, although most court cases are open to the public and some personal injury cases are mentioned in the media, it is unusual for individual witnesses to be approached by the media and asked to comment. If this occurs, try to avoid responding immediately to a media query as you may be caught off guard without the time to consider an appropriate response, if any. You are not obliged to speak with the media and you should always bear issues of patient confidentiality in mind.

Appearing in court can be a stressful and challenging experience, so being as prepared as possible is crucial. If you need any advice regarding giving evidence in court or dealing with the media, please do seek assistance from your indemnifier.

THE MEDICAL INDEPENDENT | 19 MAY 2022
Medico-Legal Opinion MR LIAM HEFFERNAN
It would be inadvisable for a doctor to attempt to answer a question that may be outside his or her clinical area of expertise or knowledge

The ‘Irish Mammy’ of healthcare

General practice continues to carry much of the load of the health service, without getting enough of the credit

Read more by Dr Sarah Fitzgibbon at www.mindo.ie

The lunches are made, the uniforms are washed and nearly dry, the bags have been emptied of last week’s “art” and the fiver for the cake sale is zipped into the front pocket. Everyone is delivered to where they need to be. Washing machine on, dishwasher emptied, NCT booked, Granny’s present ordered, payback playdate sorted... and then to work.

Sound familiar? Any parent will have had a similar morning, but it is statistically more likely that the person involved here is a mother or, more specifically, an ‘Irish Mammy’.

We all know the stereotype: Multitasking like a Fossett’s juggler, rushing around picking up stray socks, wiping jammy faces, and feeding the dog, while also cooking a roast dinner with one hand and changing a nappy with the other. No one ever appreciates the work that is done by this woman, as she manages to do it all with no more than a passive-aggressive grunt and an occasional “Would you bloody clean up after yourselves?!!”

outburst that is usually easily mollified with a glass of Baileys and a box of Milk Tray. We all know that the place would collapse without her, but she’s just so good at it, and besides, she never lets us help anyway, because we

would only do it wrong (the football-boots-in-the-dishwasher saga will never be forgotten). So we glide along in her pre-prepared batch-cooked Tupperware-filled wake, knowing that the towels will be clean, the water will be hot and the tea will be ready for us when we come in out of the rain (yes, she did tell us to wear a jacket).

As I sat in yet another meeting with multiple healthcare professionals, department officials, and other HSE bigwigs and realised, once again, that I was the only representative from primary care in the room, it dawned on me that general practice is the Irish Mammy of the healthcare service. We are used to hearing various specialities describe themselves as ‘Cinderellas’ – mental health, women’s health, and other non-glamorous areas, such as medicine for the elderly and palliative care. The phrase is rarely used for general practice where, interestingly, most mental health, women’s health, elderly medicine, and end-of-life care actually takes place. In fact, ‘Cinderella’ has a wistful, romantic ring to it and, of course, the obligatory fairy-tale happy ending. Primary care, though, will be sweeping the ashes and cleaning the grate for ever and always, because we do it quietly, dutifully, and well. We mutter under our breath, and share our woes with our fellow drudges, and very occasionally reach a fit of pique where we suggest that everyone will have to make their own dinner because “we have had enough!”. And yet, the next morning, there we are again slicing the crusts off the bread and making sure that we have given the right child the right flavour of Petit Filous. No one ever really asks us how we do it all. They reckon

Breaking the job addiction

it all looks pretty easy, and the majority of people have witnessed Mammy-work first hand and figure if it was complicated, someone would surely have said. So when plans are being made around the health and wellbeing of our population, everyone always agrees that the best place to start is in “The Community”, without anyone present ever having actually worked in this mythical place that contains real people and real problems. They propose solutions that would work marvellously in a tertiary care centre with 50 nurses, four physios and a pleasant, but strict ward clerk. They are stunned to learn that most of the time Ms Test Patient has no requirement for the highly-skilled, carefully manicured care of a hospital-based doctor and their permanently pensionable allies, but in fact could really do with a chat with Tammy their local link worker, who can tell her where to find the nearest subsidised creche or help her to fill in the form for the clothing grant.

As GPs we need to avoid becoming the ultimate Irish Mammy, the martyred underdog who carries all of the load and gets none of the credit, building up a steam of resentment that will eventually erupt into a Shirley-Valentine-esque march into the sunset, leaving a trail of unfed and unwashed citizens behind us. It seems counterintuitive to give up some of our precious time to sit with nine-to-five-ing civil servants discussing policies, protocol, procedures, and anything else than begins with a ‘P’. But if we don’t take the opportunity to tell our side of the story and to embed primary care into every decision that is made about healthcare in Ireland, then all we can expect in thanks is a lousy box of Milk Tray.

Just what is the difference between doctors who are workaholics and those who are simply hard workers?

@muirishouston

Workaholic doctors tend to build their lives around their work. They may be perfectionists by nature and often deny any health problems. When they do fall ill, they tend to return to work before a full recovery. They often have an excessive workload, which contributes to their compulsion to work more.

Workaholism, which is essentially work addiction, has become more well-defined as its prevalence increases. In a 2014 study published in Occupational Medicine , physicians practising at a French university hospital took a survey based on their work addiction risk and psychosocial factors. Of 445 respondents, 13 per cent were highly work addicted and 35 per cent were mildly work addicted.

According to the Harvard Business Review, workaholics report more health complaints, more sleep problems, more emotional exhaustion, more cynicism, and more depression than those who merely work long hours – and they may struggle to psychologically detach from work.

Is it different for doctors who simply work long hours? Research suggests they are not mentally preoccupied with work, report fewer health complaints, fall asleep easily, and don’t feel restless when not working.

Let’s be honest, medicine has an implicit bias toward

overworking. “When we’re in training we hear a lot about this archetype of the self-sacrificing physician and this is what patients talk about admiringly,” Dr Elisabeth Netherton, a Consultant Psychiatrist and Regional Medical Director at Mindpath Health in Houston, Texas, told Medscape. “‘Dr Smith took such good care of me, and he was always there, and he always answered my phone calls.’”

She says that work/life balance can be tricky for physicians because, within medicine, there is the idea of the ideal doctor who doesn’t take full holidays, doesn’t go home for dinner, and stays at work for the requisite amount of hours necessary for everything to be completed.

We don’t claim to be superhuman but, on the other hand, the subculture is that doctors don’t need to sleep or eat; they are there to serve, help people and do everything right. It’s like a badge of honour.

Is physician workaholism ego-driven? Netherton says while she sees that less commonly, it doesn’t mean it’s not there, but she says there is a lot of reward in medicine. It feels good to put in additional work and effort and have a patient say thank you for making a difference. And if that comes with a rush of adrenaline or a hit of dopamine, well what’s not to like?

Busyness is a way we can hide and mask ourselves to shield pain from the uncontrollable things, like when a patient dies. And if you have just given someone a cancer diagnosis, the next patient is waiting for your undivided attention. Workaholism can be the key to keep moving professionally.

There are also other factors like the corporatisation of medicine, the endless documentation that doctors are responsible for, as well as physician shortages. They all contribute to doctors working later and later to catch up.

If you want to overcome work addiction, here are some

steps that might help. The first thing to do is pause. That doesn’t mean going on holidays, but rather assessing how you’re spending your time, and asking yourself if you enjoy what you’re doing. Do you schedule leisure activities as well as work time?

Are you getting breaks during the day? Try to take a decent lunch break, but at least take five minutes to sit by a window and take a mental space several times a day before running to the next task. The workaholic culture takes away our sense of control, so creating an atmosphere of better work/life balance can help us feel empowered and back in control.

As a profession we have to take steps to start cracking the façade of the ideal physician that never goes home, never sleeps, and never takes time off. “We have to recognise that’s a recipe for an unwell physician who might develop substance problems and struggle with burnout,” Netherton says.

And please do seek assistance. If you’re having trouble with work/life wellness, talking to a cognitive behavioural therapist and learning mindfulness-based techniques have been shown to help. A systematic review, published in the International Journal of Environmental Research and Public Health, on workaholism in occupational medicine found that cognitive behavioural therapy and mindfulness-based interventions show promising results for addictions, such as workaholism.

A valuable resource for doctors, dentists, and pharmacists who need help with workaholism is the Practitioner Health Matters Programme. Run capably and confidentially by Medical Director Dr Íde Delargy, the free service can be contacted at confidential@practitionerhealth.ie or by phoning 085 760 1274.

Opinion THE MEDICAL INDEPENDENT | 19 MAY 2022 22
@SarahFitzWiMIN
DR MUIRIS HOUSTON Read more by Dr Muiris Houston at www.mindo.ie

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The stigma of personality disorders

Naming a disorder should have the effect of increasing effective communication and facilitating research

oe was a big man with a loud voice. He had addiction problems, had been in prison a couple of times, was often depressed, and frequently required sutures for self-inflicted wounds. He was a demanding frequent attender, who liked to get his own way. As a recently qualified general practitioner, the sight of his name on my appointment list evoked a fight or flight response – rapid respiratory and heart rate, sweaty palms, and tremor – that intensified until I had completed the consultation and he had left the premises. One day, not long before I finished in that practice, Joe stormed out of my consulting room saying he was going to find someone who knew what they were talking about. I do not know if he ever returned.

Joe had a diagnosis of personality disorder (PD). The World Health Organisation (WHO) (1992) describes PD as comprising “deeply engrained and enduring behaviour patterns, manifesting themselves as inflexible responses to a broad range of personal and social situations”.

The WHO description does not capture the suffering and distress of people with personality disorder. Like Joe, many people diagnosed with PD have a low tolerance for frustration. They live their lives in a constant state of fight or flight, sensing danger and threat everywhere. PD is associated with a completed suicide rate of 10 per cent (almost 50 times that of the general population) and their life expectancy is decreased by 20 years. They do not have the advantage of stable, loving relationships; are frequently in

MULTIPLE CHOICE QUESTIONS

Question 1

Question 2

Question 3

Question 4

trouble with the law, due to difficulty with emotion regulation, and a strong propensity to impulsivity. PD is also associated with other mental health disorders, such as depression and eating disorders, but is not to be confused with such conditions. While there is lack of available data on the prevalence of PD in Ireland, internationally it is thought that PD has a prevalence of approximately 12 per cent in the general population, 25 per cent of presentations to primary care, and 50 per cent of attendances at psychiatric outpatient departments. The incidence of PD is higher in those who have survived institutional abuse and the children of mothers diagnosed with PD. People with PD often find themselves caught in a downward spiral of poor mental and physical health, poverty, isolation from family and friends, and marginalisation.

In January 2022, Dr Austin O’Carroll, a GP who has extensive experience of working with the marginalised, published an opinion article on PD in BJGP Life. He wrote that “the diagnosis of PD is harmful to the health of those so labelled”.

“A diagnosis of PD results in dehumanisation in that patients become abnormal and non-deserving of the respect afforded to other humans.”

His rationale is that as PD is based solely on symptoms, and not pathological findings, that we should not make this diagnosis because it simply attracts negative bias and stigma and excludes sufferers from appropriate services.

This may be so, but does the fault lie with the label “personality disorder”, or with the attitude of society and

medical professionals? It is true that the diagnosis of PD is based on clusters of symptoms, but this is true for many psychiatric disorders. Dr Brendan Kelly addresses this in his new book, In Search of Madness, explaining that despite years of research, science has repeatedly failed to find biological or pathological markers for most major mental health disorders. Despite this, we do have treatments that work even if we do not know why.

Naming a disorder should have the effect of decreasing stigma, increasing effective communication, and facilitating research. PD has been classified in both the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) and the International Classification of Diseases, 11th Revision (ICD-11). The strategy, A Vision for Change, launched in 2006, has been the main driver of mental health policy for almost two decades. This document contained recommendations about the need for evidence-based interventions for the treatment of PD. It was surprising to find that the most recent mental health policy, Sharing the Vision, A Mental Health Policy for Everyone, launched in 2020, makes no mention of services for people with PD. A recent position paper on PD by a dedicated group of psychiatrists from the College of Psychiatrist of Ireland has highlighted the level of unmet need for patients with this disorder and recommended improvements and expansion of future services.

People like Joe are challenging for all health professionals, but they deserve respect, compassion, and access to evidence-based treatments and supports.

Question 5

Oral candidiasis in young children

A. Is most likely in the under one-year-olds.

B. Produces lesions that are very hard to wipe off.

C. Is most likely to have come from the genital tract of the mother.

D. May be associated with candidiasis of the napkin area.

E. Should be treated with the anti-fungal agent amphotericin.

The following are characteristic features of anterior cruciate knee ligament injuries

A. Delayed post-injury swelling.

B. Inability to complete the match or game.

C. Caused by a sudden blow to the knee.

D. Once the acute pain has resolved, main complaint is of knee locking.

E. Once the acute episode has resolved, ongoing pain is not severe.

In patients with community-acquired pneumonia, adverse prognostic features include

A. Respiratory rate >30 per minute.

B. Confusion.

C. Bilateral involvement on the chest x-ray.

D. Aged over 40 years.

E. Oxygen saturation <92 per cent.

Patients with diverticular disease

A. If European, are affected throughout the colon.

B. In 80 per cent of cases are asymptomatic.

C. Can be reassured there is no causative association with cancer of the bowel.

D. Are best not treated with antispasmodic medicines.

E. Of the constipation-predominant variety, will be helped by stimulant laxatives, such as Senokot.

In acute ischaemia of the lower limb

A. Most patients are in atrial fibrillation or flutter.

B. Pain is not a prominent feature.

C. Mottled, purple-coloured skin is a good prognostic sign.

D. The limb is cold.

E. The patient should be admitted to hospital as soon as the diagnosis is suspected.

E. TRUE. Muscle necrosis may occur within two hours of the initial block, so the condition should be treated as an emergency.

D. TRUE. And pale with loss of pulses.

C. FALSE. This means the limb is no longer viable and amputation is inevitable.

B. FALSE. Normally there is sudden onset of severe pain.

A. TRUE. With thrombus in the left atrium, which embolises.

ANSWER 5

E. FALSE. Use high-fibre diet with bulking agents or osmotic laxatives.

D. FALSE. Is ‘irritable colon’, so can be helped by simple low-dose hyoscine or peppermint oil.

C. TRUE. Also no evidence that AUDD group benefit from a high fibre diet.

B. TRUE. Classified as asymptomatic uncomplicated diverticular disease (AUDD).

A. FALSE. Left side. In Africa tends to affect whole colon.

ANSWER 4

E. TRUE. Regardless of oxygen supplementation.

C. TRUE. Or multi-lobe involvement.

B. TRUE. Likely to be hypoxaemic.

A. TRUE. Or urea >7mmol/l.

ANSWER 3

E. TRUE. If present, suspect fracture or meniscal tear.

D. FALSE. Of instability.

C. FALSE. Primarily from sudden twisting or hyperextension of the knee.

B. TRUE. As is very painful.

A. FALSE. ACL has a small artery, so the swelling that occurs after it is ruptured is immediate.

ANSWER 2

E. FALSE. Agent of choice in children is nystatin suspension.

D. TRUE. The organism is swallowed and excreted allowing colonisation of the napkin area.

C. TRUE. If recurrent in baby, the mother should be asked about her symptoms.

B. FALSE. Lesions are easily wiped off, but may leave a bleeding surface.

A. TRUE. As their immune system is not fully developed.

ANSWER 1

D. FALSE . Over 65 years on British Thoracic Society’s pneumonia severity index.

Read more by Dr Lucia Gannon at www.mindo.ie @LuciaGannon THE MEDICAL INDEPENDENT | 19 MAY 2022
Opinion

The pharmacological treatment of HIV – from 1987 to present

CASE REPORT

Paul is a 35-year-old man living with HIV and his elderly parents are unaware of his diagnosis. He was diagnosed five years ago at routine STI screening. He was HIV negative one year before. Baseline viral resistance testing was negative: There were many therapeutic options available to him.

At presentation, his CD4 count was low normal and his vial load high. As per protocol he was immediately started on an antiretroviral therapy (ART). Six months later, his viral load was <50 copies per ml of blood. He was virally suppressed and his CD4 count had risen to a healthy range. Paul requested a single tablet regime (STR) to facilitate his adherence to this ART. He was started on Triumeq (dolutegravir/abacavir/lamivudine).

To further facilitate his care and to avoid his parents accidentally discovering his stash of tablets, he requested depot injection of his ART. This will be given in the clinic every two months. He is currently awaiting this therapy, which will be available to him shortly.

Iam guessing that I am not the only one who turned to television during our Covid-19 lockdowns. As a complete bookworm, I am not usually a TV watcher, except the news and Dr Pimple Popper. I need to gather CPD points wherever possible! I had many recommendations for possible viewing and one such recommendation was It’s a Sin, a miniseries on Channel 4, written by Russell T Davies. The series is set in London from 1981-1991 and charts the lives of three young gay men and their friends who move to London as news of a new disease was making its way from the US. This disease was caused by the human immunodeficiency virus (HIV) and the acquired immunodeficiency syndrome (AIDS), which for the majority was a consequence of untreated HIV. Some of our characters opted for denial and others set about informing themselves about this so-called ‘gay plague’. Of course, we the viewers knew what was to come: Decades of isolation, stigma, morbidity and, for many, death.

This series reminded me of the '80s when my relationship with HIV began. In another incarnation, I was a post-doctoral research fellow in the Nutrition Department in the University College California, at Berkeley. At this time, the gay community was being decimated by this gay plague. In 1981 the Centres for Disease Control and Prevention (CDC) in the US published in their Morbidity and Mortality Weekly Report a report of two very unusual diseases in the population; Kaposi's sarcoma and Pneumocystis pneumonia among homosexual men in New York City and California. In 1984 Dr Robert Gallo and his team identified a retrovirus they called HTLV-III, a name he initially chose because he considered it to be a relative of the leukaemia viruses his lab was studying. HTLV-III became known later as HIV-I and was subsequently identified as the cause of AIDS. In the papers a year earlier, however, on May 20, 1983, the French virologist Luc Montagnier and his team at the Pasteur Institute in Paris had published a paper in Science identifying a retrovirus they called lymphadenopathy associated virus (LAV), which they isolated from a patient with AIDS. Both Gallo and Montagnier later agreed to share the title of co-discoverers of the virus and they wrote several papers together describing their work.

Pathophysiology

HIV is a retrovirus, which is a virus that uses ribonucleic acid (RNA) as its genetic material. When a retrovirus infects a cell, it makes a DNA copy of its genome that is inserted into the DNA of the host cell. There are a variety of different retrovi-

ruses that cause human diseases, such as some forms of cancer and AIDS. HIV destroys CD4 T-lymphocytes, which are crucial for the immune system.

Opportunistic infections (OIs) are illnesses that occur more frequently and are more severe in people with HIV; which is because of the damaged immune system. Kaposi’s sarcoma and Pneumocystis jirovecii are examples of OIs. Other OIs include cytomegalovirus retinitis and cerebral toxoplasmosis to name but a few.

HIV-1 is the most common type of HIV and occurs all over the world. Approximately 95 per cent of people living with HIV have HIV-1. HIV-2 is mainly found in west Africa, but it is slowly starting to appear in other regions, including the US, Europe, and India. Though HIV-1 and HIV-2 are both retroviruses that can have similar effects on the human body, they are genetically distinct and not all tests and treatments work for both HIV-1 and HIV-2.

Treatment evolution

The medical and pharmaceutical care of those living with HIV/AIDS has changed hugely in the last three decades. We now have a large drug armamentarium to fight the HIV virus, depot injections may soon be generally available, and the search for an effective vaccine to prevent HIV is looking ever promising. This search has in no small part been facilitated by the technology garnered from the genesis of the mRNA Covid-19 vaccine. But for now, Biochemistry 101.

Zidovudine (ZDV) was the first anti-retroviral therapy

CYP3A4 is essential, and they were not suitable for all. Used with NRTIs it was expected that the replication of HIV would be compromised. It was.

The availability of PIs coincided with the routine measurement of HIV viral load. Initial sensitivities of this viral load assay were poor, with a cut-off of 1,000+ copies per ml, but this has improved hugely in recent years. Viral suppression means no onward transmission. This knowledge is hugely important for both physician and patient alike. It allays the fear of infecting a sexual or drug-using partner.

The non-nucleoside reverse transcriptase inhibitors (NNRTIs) directly inhibit the HIV-1 reverse transcriptase (RT) by binding in a reversible and non-competitive manner to the enzyme. They were the next class of drug to arrive on the market. Unlike NRTIs, NNRTIs are not structural analogs of nucleosides or nucleotides. The main difference between them is that the NRTIs need to undergo three-step phosphorylation to activate antiviral activity, while the NNRTIs do not need to undergo initial phosphorylation. NNRTIs bind directly to HIV RT at a hydrophobic site remote from the enzyme's active site to produce a conformational change that prevents substrate binding.

The next class of drugs used to treat HIV infection targeted the integration of viral DNA (made through reverse transcription of HIV RNA) into the host genome. This mechanism is facilitated by the enzyme integrase. Integrase inhibitors, or integrase strand transfer inhibitors (INSTIs) as they are termed, prevent the formation of covalent bonds with host DNA. This prevents incorporation of HIV into the host genome.

Two NRTIs form the backbone of many ART triple therapy regimens, and the third drug is usually from another class such as NNRTIs, PIs or INSTIs.

Co-formulated drug regimens (STRs) became popular to facilitate drug adherence in HIV treatment. Examples include Triumeq (abacavir and lamivudine, two NRTIs and dolutegravir, an INSTI), Biktarvy (emtricitabine and tenofovir alafenamide, two NRTIs and bictegravir and INSTI) and Eviplera (tenofovir disoproxil fumarate and emtricitabine, two NTRIs and rilpivirine, an NNRTI). Taking just one daily combination pill instead of two, three, or four pills simplifies treatment for people with HIV. It also improves the effectiveness of the drugs.

What now?

(ART) drug licensed to treat HIV infection, having been approved by the US Food and Drug Administration (FDA) in 1987 and it soon became available for use in Ireland. ZDV belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). In isolation, it halted HIV replication, but for a brief period. ZDV was also toxic, causing bone marrow suppression and severe myositis. We now know that used in isolation, the virus outsmarted the drug and became resistant to ZDV, thereby shortening its lifespan of efficacy.

Following the DELTA trial; a randomised double-blind controlled trial comparing combinations of ZDV plus didanosine or zalcitabine (two new NRTIs) with ZDV alone, dual therapy was consequently licensed in 1996.

This year was very important in HIV care. It heralded a further key class of anti-HIV drugs, termed protease inhibitors (PIs). These drugs were not without their problems, however. The pill burden was large with early PIs and they had many inherent toxicities. More importantly perhaps, all the PIs are metabolised by the cytochrome CYP3A4, so a thorough review of other prescribed medications also metabolised by

The pharmacological treatment of HIV has come a long way since monotherapy with ZDV in 1987, to STRs today. For some though, even talking one pill a day can seem daunting, they forget to take it, or, more commonly, they feel that it is a daily reminder of their HIV status. Many patients may opt for the newly-licensed injectable HIV treatments. The first such injectable is a two-drug regimen containing the INSTI cabotegravir, which has a long half-life, and rilpivirine, an NNRTI developed to lessen the chance of drug resistance. The two drugs are given separately into each buttock every one or two months. Early trial data on the injectables showed non-inferiority with oral ART. Some complain of soreness or bruising at the injection site, which is short-lived. Some physicians worry that if a patient is non-adherent with oral medications, missing a day or two now and again, it is not the end of the world. However, if they miss their injection at the appointed clinic time, every one or two months, that may prove problematic. There is a grace period of seven days, after which time drug levels decline; thereby risking viral resistance to the medications. Is it a sin to be HIV positive? Absolutely not. Is it a miracle that we have come so far in the treatment of this disease? Probably.

References on request

Virology Clinical THE MEDICAL INDEPENDENT | 19 MAY 2022 25
DR KEATING , Specialist in Sexual Health and HIV, Harold’s Cross Surgery, 254 Harold’s Cross Road, Dublin
The medical and pharmaceutical care of those living with HIV/AIDS has changed hugely in the last three decades
We now have a large drug armamentarium to fight the HIV virus, depot injections may soon be generally available, and the search for an effective vaccine to prevent HIV is looking ever promising

STIs and STI screening

A comprehensive overview of the most prevalent STIs in Ireland, and current screening, diagnosis and treatment approaches

Sexually transmitted infections (STIs) are a major public health concern and an increasing cause of ill-health globally. STIs are spread through intimate sexual contact, including unprotected vaginal, anal, and oral sex with an infected partner. Even protected sex can be a risk for contracting some sexually transmitted infections. STIs usually affect the genitals, anus, or mouth, but can also affect other areas of the body. Many STIs have no signs and symptoms and if left untreated have the potential to cause significant morbidity in women and men, including infertility, ectopic pregnancy, and other medical conditions, which is why STI screening is so important.

Some sexual activities pose higher risks than others, including unprotected sex with casual partners, multiple partners, or a partner who has taken risks – had unprotected sex with casual partners or with a partner who has injected drugs. Men who have unprotected anal sex with other men (MSM) are also at higher risk.

HSE public STI screening services are free in Ireland and are usually based in hospitals and special community clinic settings. Some GP practices and family planning services provide STI testing services for a fee. GPs and general practice nurses have an important role to play in both preventative and treatment services. Student health centres in third-level institutions provide an ideal opportunity to target at-risk populations for the promotion of safe sexual practices and STI screening and consultations in colleges are often free or subsidised. Well Woman Clinics and the Irish Family Planning Association (IFPA), both provide STI screening for men and women. Gay Men’s Health Service (GMHS) promotes sexual health among gay,

bisexual and MSM, through counselling and STI clinical services. A community-based multidisciplinary project team of medical and support staff provide free STI clinical services to MSM and trans people.

The HSE’s Sexual Health and Crisis Pregnancy Programme (SHCPP) currently provides a free home STI testing service in partnership with online STI testing provider SH:24 to people over the age of 17 years, in 22 counties. Instructions are provided on how to complete the test kit, with support available from SH:24’s clinical team by phone or text message. Results are communicated through the SH:24 clinical team by text or phone and if follow-up testing or treatment is required this is provided for free by HSE public STI clinics. This home STI testing service is for individuals who do not have symptoms of an STI.

STI screening at a clinic takes approximately 30 minutes and involves a consultation, physical examination, urine and blood samples, and swabs. Full STI screening includes tests for chlamydia, gonorrhoea, syphilis, genital herpes, HIV, hepatitis B, and hepatitis C, and may include testing for trichomonas. Other non-sexually transmitted infections, such as candidiasis and bacterial vaginosis, are sometimes detected and can be easily treated.

Chlamydia trachomatis (CT, chlamydia) is the most commonly diagnosed bacterial STI in Ireland and most cases occur in young people under the age of 25. Often asymptomatic in both males and females, symptoms in males can include dysuria and a urethral discharge; and in women, vaginal discharge, intermenstrual bleeding, and post coital bleeding. Infection can lead to epididymitis in males and pelvic inflammatory disease (PID) in females. PID is associated with an

increased risk of tubal factor infertility, ectopic pregnancy and chronic pelvic pain. Diagnosis can be made on first-void urine in males and vulvovaginal or endocervical swab (less sensitive) in females. Vulvovaginal swabs can be provider- or self-taken. In MSM, as well as first-void urine, pharyngeal and rectal sites should also be tested. Chlamydia is a notifiable disease.

Gonorrhoea (Neisseria gonorrhoeae) is the second most common bacterial STI in Ireland and is found most frequently in young people under the age of 25 and in MSM. Infection may involve the genitals, mouth, or rectum. Infected men may experience pain or burning with urination, discharge from the penis, testicular pain, and epididymitis. Symptoms in women can include vaginal discharge, intermenstrual bleeding, post coital bleeding, and PID. Rectal infection can lead to proctitis. Diagnosis can be made on first-void urine in males and vulvovaginal or endocervical swab in females. In MSM, pharyngeal and rectal sites should also be tested. Gonorrhoea is a notifiable disease.

The Nucleic Acid Amplification Test (NAATs)/PCR is the gold standard for chlamydia and gonorrhoea testing. The type of test may vary at different laboratories.

Genital herpes is a viral infection caused by the herpes simplex virus (HSV). There are two types: HSV-1 and HSV-2. Type 2 is most commonly associated with genital infection. Type 1 has also been found to cause genital infection, but is more commonly associated with oral herpes (cold sores). Genital herpes is common in Ireland and is mostly diagnosed in young women. The diagnosis can be made clinically, but should be confirmed with a HSV NAAT swab of the lesions to determine if HSV-1 or HSV2. Genital herpes is a notifiable disease.

Hepatitis B is a viral infection that infects the liver and is a major cause of serious liver disease, including cirrhosis and liver cancer. It affects millions of people worldwide. Hepatitis B is vaccine preventable. Hepatitis C is a viral infection that can cause long-term liver disease such as liver cirrhosis and liver cancer. There is currently no vaccination against hepatitis C. Most cases of hepatitis C are found in people who inject drugs, however, the number of cases of sexually-transmitted hepatitis C diagnosed in MSM in Ireland has increased. Many cases have been in MSM who are also infected with HIV. Hepatitis C virus (HCV) testing should be considered part of routine sexual health screening for MSM; people living with HIV; commercial sex workers, and people who inject drugs (PWID). Partners should also be considered for HCV testing. Trichomoniasis (TV) is an STI caused by a protozoan parasite – Trichomonas vaginalis. Most cases are found in women, and although it can affect both men and women, infection in men is uncommon. TV can infect the vagina and cervix in women and the urethra and underneath the foreskin in men. In women it usually presents with a vaginal discharge, which may be offensive with an associated vulvitis/vaginitis. Men usually present as sexual contacts of women with infection and may present with symptoms of urethritis, including dysuria and urethral discharge. TV is a notifiable disease.

Syphilis is an STI caused by a bacterium called Treponema pallidum. There were 611 cases reported in Ireland in 2020. The highest rate (2020) in males and females was in the 30-34-year age group, 75.6 per 100,000 population and 6.9 per 100,000 population, respectively. Most new cases of syphilis are among MSM. While the number of STI notifications decreased in Ireland in 2020, most likely due to the impact of the Covid-19 pandemic, early infectious syphilis (EIS) is on the increase, with a 43 per cent increase (498 cases) reported by HPSC in 2021 between 01/01/2021 and 21/08/2021, compared to the same time-period in 2020 (349 cases).

Unlike other STIs, such as chlamydia, gonorrhoea, and genital herpes simplex, cases of syphilis tend be in older age groups. The proportion of syphilis cases each year are highest in those aged 25-29 and 30-34 years, while for chlamydia the proportion of cases each year is highest in those aged 20-24 years. This trend continued in 2021, with 18 per cent of syphilis cases notified from 01/01/2021 to 21/08/2021 in those aged 25-29 years, 26 per cent of cases were aged 30-34 years, and 15 per cent of cases were aged 35-39 years, compared to 8 per cent of cases who were aged 20-24 years. Presenting symptoms of a syphilis infection depend on the phase of the infection at evaluation. Symptoms can be broken down by primary, secondary, latent, and tertiary phases. Early recognition and treatment of syphilis is critical to preventing avoidable morbidity for

Clinical Virology THE MEDICAL INDEPENDENT | 19 MAY 2022 26
TABLE 1: Eligibility for PrEP (HIV pre-exposure prophylaxis in Ireland) (HSE guidance) Continued on p28 ▸

THE FASTEST GROWING ORAL REGIMEN FOR PLHIV 1*

For your patients living with HIV, make DOVATO a part of their healthy future.

DURABLE AND ROBUST 2,3

PART OF HEALTHY LIVING WITH HIV WITHOUT TDF, TAF AND ABC

DOVATO is indicated for the treatment of HIV-1 in adults and adolescents above 12 years weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

Abridged Prescribing Information

Dovato (dolutegravir 50mg/lamivudine 300mg) tablets

See Summary of Product Characteristics (SmPC) before prescribing. Presentation: Film-coated tablet containing dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine debossed with “SV-137” on one face. Indication: HIV-1 in adults & adolescents above 12 years of age weighing >40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. Dosing: One tablet once daily with or without food. Use an additional 50mg tablet of dolutegravir approximately 12 hours after the dose of Dovato when co-administered with efavirenz, nevirapine, tipranavir/ritonavir, etravirine (without boosted PI), carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John’s Wort or rifampicin.

Elderly: Limited data in 65+ yrs. Renal impairment: Not recommended in patients with creatinine clearance < 30 mL/min. For patients with a sustained creatinine clearance between 30 and 49 mL/min see SmPC section 4.4. Hepatic impairment: Caution in severe hepatic impairment (Child-Pugh grade C). Contraindications: Hypersensitivity to any ingredient. Co-administration with substrates of OCT-2 with narrow therapeutic windows, such as fampridine. Special warnings/precautions: Risk of hypersensitivity reactions. Discontinue dolutegravir and other suspect agents immediately. Risks of osteonecrosis, immune reactivation syndrome. Monitor LFTs in Hepatitis B/C co-infection and ensure effective Hepatitis B therapy. Caution with metformin: monitor renal function and consider metformin dose adjustment. Use with etravirine requires boosted PI or increased dose of dolutegravir. Use with Mg/Al-containing antacids requires dosage separation. Use with calcium, multivitamins or iron also requires dosage separation if not taken at the same time with food. Use with cladribine or emtricitabine not recommended. When possible, avoid chronic co-administration of sorbitol or other osmotic acting alcohols (see SmPC

section 4.5). If unavoidable, consider more frequent viral load monitoring. Fertility, pregnancy and lactation: Human fertility - no data; animal fertility - studies indicate no effects. Women of childbearing potential (WOCBP) should be counselled about the potential risk of neural tube defects including consideration of effective contraceptive measures. If a woman plans pregnancy, the benefits and the risks of continuing treatment should be discussed with the patient. The safety and efficacy of a duel regime has not been studied in pregnancy. If a pregnancy is confirmed in the first trimester while on Dovato, the benefits and risks of continuing Dovato versus switching to another antiretroviral regimen should be discussed with the patient taking the gestational age and the critical time period of neural tube defect development into account (see SmPC section 4.6). There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues. Do not breast-feed. Side effects: See SmPC for full details. Headache, GI disturbance, insomnia, abnormal dreams, depression, anxiety, dizziness, somnolence, rash, pruritus, alopecia, fatigue, arthralgia, myalgia, hypersensitivity, completed suicide, suicidal ideation or suicide attempt, panic attack, hepatitis, blood dyscrasias, acute hepatic failure, pancreatitis, angioedema, rhabdomyolysis, lactic acidosis, peripheral neuropathy. Elevations of bilirubin, ALT, AST and CPK. MA Nr: EU/1/19/1370/001. MA holder: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands. Legal Category: POM A. Date of preparation of API: February 2022. Code: PI-6305. Further information available from GlaxoSmithKline, 12 Riverwalk, Citywest, Business Campus, Dublin 24. Tel: 01-4955000.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

*From November 2020 through October 2021, over 39 markets and territories with data sources available.

References: 1. Data on file. Regimen market share growth November 2020-October 2021. REF-146400. ViiV Healthcare group of companies. Research Triangle Park, NC. 2. Cahn P, Sierra Madero J, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-naïve adults with HIV-1 infection. AIDS. 2022;36(1): 39-48. doi:10.1097/QAD.0000000000003070 3. Osiyemi O, De Wit S, Ajana F, et al. Efficacy and safety of switching to dolutegravir/lamivudine (DTG/3TC) versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with HIV-1: results through week 144 from the phase 3, non-inferiority TANGO randomized trial. Clin Infect Dis. 2022;ciac036 and suppl 1-18. doi:10.1093/cid/ciac036

DOVATO is owned by or licensed to the ViiV Healthcare group of companies. ©2022 ViiV Healthcare group of companies or its licensor.

Date of preparation: March 2022 PM-IE-DLL-JRNA-220001

Virological suppression is the first step to achieving
DOVATO

Continued

those infected and onward transmission to others. Safer sex practices and regular testing among at-risk groups, such as HIV-positive MSM and those with multiple partners, are key to prevention.

The screening test for syphilis is  T. pallidum EIA (enzyme immunoassay), which checks for antibodies to  T. pallidum. In individuals with syphilis, this test remains positive regardless of treatment or risk of reinfection. Syphilis is a notifiable disease.

Human immunodeficiency virus (HIV) is a virus that attacks the human immune system and weakens its ability to fight infection and disease. Over 6,000 people are estimated to be living with HIV in Ireland and approximately 15 per cent of people with HIV in Ireland are unaware they have the condition, because they have either not been tested or developed HIV since their last test. Approximately half of new cases of HIV in Ireland are among MSM, the other half being mostly heterosexual men and women, and PWID. HIV is diagnosed with a blood test and HIV testing is available in many healthcare settings including STI clinics, GPs, and student health clinics. Many NGOs offer HIV testing in Ireland, including rapid HIV testing in community venues; HIV self-test kits are also now available on the Irish market, both commercially and free-of-charge through https://selftest.hivireland.ie/. HIV is a notifiable disease.

HIV prevention: PrEP and PEP/PEPSE

Pre-exposure prophylaxis (PrEP) is the use of oral antiretroviral therapy in HIV-negative people to reduce the risk of HIV infection. PrEP is taken by HIV-negative people prophylactically before having sex (pre-exposure) and after sex to prevent HIV. The window period for HIV is 45 days. PrEP is available free-of-charge through the HSE to people who meet the clinical eligibility criteria and who are deemed to be at substantial risk of acquiring HIV.

Post-exposure prophylaxis (PEP) is shortterm antiretroviral treatment to reduce the likelihood of HIV infection after potential exposure, either occupationally or through sexual intercourse. PEP may prevent infection with HIV developing. A full course of PEP (two or three antiretroviral HIV drugs) is for 28 days (four weeks). The medication must be started within 72 hours of possible exposure to HIV infection to be effective. The term PEPSE is sometimes used and stands for PEP after Sexual Exposure.

U=U 'undetectable' equals 'un-transmittable'

HIV can be treated effectively with antiretroviral medications, which stops HIV reproducing in the body. When taken properly, HIV treatment reduces the chance of a person living with HIV passing it on to someone else. When a person living with HIV is on treatment and the viral load in the body is 'undetectable', HIV cannot be transmitted to sexual partners. This is known as 'undetectable' equals 'un-transmittable' (U=U).

Window period

The window period can vary for different STIs, and is the time that elapses between encountering an STI, and when a false-negative result may occur. Sexual partners may

have a false-negative test result in this time. Sexual partner(s) of someone with a confirmed STI in this window period should be tested and treated empirically and follow-up testing should be arranged.

Partner notification

Partner notification is the process of providing advice, testing, and treatment to sexual contacts of an individual diagnosed with an STI. Testing and treatment of sexual partners is important to prevent reinfection and onward transmission. Partner notification is an important part of the management and control of STIs and a look-back period of three-to-six months should be considered. Patients who have been diagnosed with an STI should be encouraged to inform their sexual partners of the need for testing. For complex cases, referral to a GUM clinic should be considered.

STI screening. What happens at an STI clinic?

The clinician will start the consultation by taking a sexual health history with the patient and asking questions about the person's symptoms, sexual and past-history, risks, and general health. If female, risk of pregnancy will be discussed (see Table 2). Personal sexual health questions are only asked for the purposes of assessing the patients’ health and to guide the provider to take the appropriate tests, depending on what risks the person has been exposed to. A physical examination will then be carried out and the type of tests depend on the patient's symptoms. If a patient prefers a fe-

male or male provider this should be mentioned at registration and the request will be provided where possible. A chaperone can be provided if necessary and sometimes the patient may bring their own.

Males: The skin and testicles are examined for any rashes, lumps, bumps, and discharge. A swab may be taken from the penis, anus and/or throat, if required. A urine sample will be taken, and males need to hold their urine for at least two hours before testing. Blood tests will be taken for HIV, hepatitis B, and syphilis as well as any other infections the clinician considers necessary.

Females: The clinician will examine the skin and genitals for any rashes, lumps and bumps, and discharge. Vaginal swabs will be taken and sent for testing. Sometimes the vaginal swab may be taken by the patient themselves. Depending on the history, swabs may also be taken from the throat and anus. Blood tests will be taken for HIV, hepatitis B and syphilis as well as any other infections the clinician considers necessary.

Treatment

Bacterial vaginosis, vaginal candidiasis and trichomoniasis

Abnormal vaginal discharge can include STI and non-infectious causes. Three possible infections associated with abnormal vaginal discharge are bacterial vaginosis, vaginal candidiasis, and trichomoniasis.

Quick reference guide for vaginal discharge can be found at: www.antibioticprescribing.ie

Treatment of chlamydia

Treatment of uncomplicated anogenital chlamydia: Azithromycin therapy should only be considered if doxycycline is contraindicated. Doxycycline is effective in treatment of C. trachomatis infections of urogenital, rectal, and oropharyngeal sites, whereas azithromycin is less efficacious than doxycycline in the treatment of pharyngeal and rectal chlamydia. Azithromycin therapy is also associated with macrolide resistance in Mycoplasma genitalium and high-level azithromycin resistance in gonorrhoea. If azithromycin therapy is indicated, single-dose azithromycin is not recommended and a three-day course is required. See Table 3.

Treatment of gonorrhoea

Empiric treatment with oral cefixime is inappropriate. See Table 4

Treatment hepatitis B

There are two main phases of hepatitis B: acute (short-term) and chronic (longterm). Approximately 90 per cent develop an acute version of hepatitis B. They can clear the virus naturally from their bodies within six months and usually develop immunity to hepatitis B for life. About 10 per cent of people do not clear HBV from their bodies naturally and go on to develop a long-term chronic infection. In some people the virus progresses quickly and can result in cirrhosis, cancer, liver failure, and even death.

Treatment is available for hepatitis B.  Chronic hepatitis B infection is usually

Clinical Virology THE MEDICAL INDEPENDENT | 19 MAY 2022 28
from p26 ▸
TABLE 3: Treatment of chlamydia (HSE guidance) TABLE 2: Treatment of trichomoniasis (HSE guidance)

treated with alpha/pegylated interferon to help prevent further liver damage, however, not everyone can take interferon due to serious side-effects. Treatment usually lasts a number of months during which time the patient will be carefully monitored. If alpha/pegylated interferon is not suitable, antiviral medications, such as tenofovir or entecavir, will be tried instead.

Hepatitis B is a vaccine-preventable illness. PEP emergency treatment is also available within 72 hours for anyone who has been exposed to hepatitis B. PEP can prevent HBV establishing itself in the blood stream. It is available in most emergency departments and sexual health clinics.

Treatment of hepatitis C

Hepatitis C is now treated using direct-acting antiviral (DAA) medication. Two pangenotypic regimens are available on the Irish market – sofosbuvir/velpatasvir (Epclusa) and glecaprevir/pibrentasvir (Maviret). Treatment is extremely effective and consists of an eight-to-12-week course of oral tablets, although some people may need a 24-week course. Treatment is free under the National Hepatitis C Treatment Programme and cure rates exceed 95 per cent.

Treatment of syphilis

Parenteral penicillin is first-line treatment for syphilis and the dose, duration, and

route (IV versus IM) is determined by the clinical circumstances. Oral doxycycline is the second-line option – the dose and duration are determined by the clinical circumstances. Decisions around treatment should be made by a clinician with expertise and experience in managing syphilis. Patients with newly-diagnosed syphilis should be referred to a GUM clinic for further management and treatment.

Treatment of HIV

There is no cure for HIV, but the current treatment options (HAART, highly active anti-retroviral therapy), mean people with HIV can live a normal lifespan. There are more than 30 antiretroviral medications

in six drug classes. Each class of drug attacks HIV in a different way. Most people start HIV treatment on two drugs from the nucleoside/nucleotide reverse transcriptase inhibitors class combined with either one integrase inhibitor, one non-nucleoside reverse transcriptase inhibitor, or one protease inhibitor – hence the name, ‘triple therapy’.

It is important that people infected with HIV adhere to the treatment schedule, as HIV can become resistant to the medication if it is not taken properly. People living with HIV who have an undetectable viral load and take their HIV medications properly, will not pass on HIV to sexual partners.

Current situation and outlook

More than one million STIs occur worldwide every day. The economic and social cost of STIs places a large strain on healthcare systems. Adolescents, young adults, and MSM are disproportionately affected by STIs, and at high-risk due to behavioural, biological, social, and cultural factors.

The timeliness of treatment for STIs can have consequences for the individual and increase the likelihood of infecting others. Given the high burden of STIs and the risk of medical complications associated with these infections, screening, accurate diagnosis, and timely and appropriate treatment are critical. The testing and treatment of sexual partners is important in preventing the spread of STIs, decreasing the rate of reinfection, and preventing medical complications of asymptomatic infections.

Aside from the pandemic-related infectious disease drop, the continuing rise in STIs annually in Ireland is a worrying trend. The key message from the HSE HPSC is for people to get tested regularly and reduce their risks through using condoms for vaginal, oral and anal sex, and being mindful of other risks. People should get tested for STIs if they have symptoms of an STI, change their sexual partner, have multiple or overlapping partners, or their partner has an STI.

Stigma causes many people to avoid seeking STI-related services because of negative experiences such as discrimination, indifference, and overt hostility in healthcare settings. In addition to effective public health infrastructures and the technologies needed for diagnosis and treatment, global STI prevention and control efforts require renewed commitment to systematic programmatic approaches to prevent or reduce STI-related stigma.

The HSE has a number of dedicated programmes and strategies to improving sexual health activities and services. Sexual health is an essential component of overall health. Effective STI prevention and control emerges from a holistic, sexual health perspective involving many levels of society and a variety of approaches. An integrated approach is required that involves taking action throughout the entire population and at all levels of the prevention and care continua. Further advancement in technology, specifically the development of rapid, sensitive and specific point-of-care testing, will provide additional tools for STI diagnosis and control. These actions can lead to better prevention, screening, and treatment.

References on request

Virology Clinical THE MEDICAL INDEPENDENT | 19 MAY 2022 29
TABLE 5: Treatment of genital herpes (HSE guidance) TABLE 4: Treatment of gonorrhoea (HSE guidance)

Let there be LIGHT in inflammation

Attendees at UCD’s Charles Institute Seminar Series heard a presentation by Dr Mario Manresa on the concept of fibroblasts as regulators of chronic inflammation and LIGHT as a promising novel disease target

The Charles Institute, Ireland’s national dermatology research and education centre, hosts a range of guest speakers who cover a variety of topics ranging from skin cancer to psoriasis, among many others. The series, which is sponsored by RELIFE (part of the A.Menarini group), is designed to provide expert advice from a range of distinguished national and international experts in their respective fields and 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 broadcast to attendees with a special interest in dermatology and cutaneous science in other locations, who access the talks remotely via an audio-visual link.

The seminars are held using a hybrid model, combining in-person attendance with interactive online access.

Attendees heard a presentation by Dr Mario Manresa, Principal Investigator at UCD’s Conway Institute in Dublin. Dr Manresa has previously conducted important work with UCD’s Prof Cormac Taylor to gain insights into the role that hydroxylase inhibitors, which modulate the activation of the hypoxia-inducible factor pathway, play in mucosal inflammation and fibrosis. Some of his later work included study of the novel regulators of fibroblast diversity and their potential therapeutic applications in eosinophilic oesophagitis (EoE). Much of his current work in UCD is focused on investigating the mediators that define fibroblast diversity and the role of distinct fibroblast populations in chronic inflammation.

Dr Manresa addressed the seminar on the topic, ‘Fibroblasts as Regulators of Chronic Inflammation: The ‘LIGHT’ Goes On’. Fibroblasts, he explained, are the most abundant component of the stroma that sustains tissues in the skin, intestines and oesophagus. Previously, the main role of fibroblasts in homeostasis and disease was commonly linked to their ability to promote wound-healing and how when overactivated, can cause fibrosis. However, some novel evidence from various clinical studies indicates that fibroblasts may in fact co-ordinate tissue homeostasis and inflammatory responses. However, the mediators promoting fibroblast functional diversity remain poorly understood, he explained. Dr Manresa provided an overview of his findings, which included research into a putative role for a TNFSF member known as LIGHT as a type of ‘switch’ that regulates fibroblast plasticity in the oesophagus. Dr Manresa discussed how structural cells with inflammatory functions may contribute to immune cell infiltration, and the potential activation of the applications of these findings to the treatment of chronic inflammatory skin diseases.

Fibroblasts

Dr Manresa provided a brief overview of fibroblast diversity in terms of what is currently known compared to what is yet to be discovered, and spoke about the factors that define fibroblast diversity. “We now know that we can have fibroblasts that look like inflammatory cells – chemokines, cytokines, other factors involving inflammation –but we also see that in normal tissue, there are fibroblasts that probably have a role in maintaining homeostasis.”

He also gave a brief synopsis of the specific functions of each subtype of FBL in homeostasis and disease. “One of the biggest questions in the field of fibroblasts is, where do these cells come from?” This question can be broken down into three areas, said Dr Manresa: What factors define fibroblast diversity; what is the origin of different populations; and what are the specific functions of each subtype of FBL in homeostasis and disease.

He discussed EoE, which he described as a chronic, antigen/allergen-driven Th2 eosinophilic disease. “Abnormal remodelling due to fibrosis is a common, severe complication of EoE,” said Dr Manresa. “Histologic changes include LP deposition of ECM (collagen), basal zone hyperplasia (BZH), and endoscopic changes include rings, strictures, narrowing, furrows, rigidity and loss of compliance” in the oesophagus, he explained. “The symptoms include food impactions, dysphagia, early satiety and sometimes anorexia.”

Novel target

He then told the attendees that TNFSF14/LIGHT is a promising novel target in fibrotic disease, and cited research showing the effects of this therapy in models of asthma and atopic dermatitis. “LIGHT promotes a unique pro-inflammatory profile in oesophageal FBL,” said Dr Manresa. He also discussed IBS, and how FBL diversity in IBD has potential similarities with EoE, and showed examples of how “LIGHT is a key regulator of the oesophageal FBL phenotype”. He also addressed FBL diversity in IBD and showed research that raises the possibility of TNFSF molecules acting as drivers in this diversity.

“LIGHT is present in the oesophagus and is produced by T-cells during inflammation,” Dr Manresa told the attendees. “LIGHT promotes inflammatory responses on oesophageal fibroblasts and is a potential modulator of intestinal fibroblast activation,” he continued. “EoE

fibroblasts display a transcriptional profile that is consistent with that promoted by LIGHT, and an imbalance between fibroblast populations is found in EoE.”

Dr Manresa also discussed how inflammatory fibroblasts may be implicated in the regulation of the immune response, and presented laboratory work to show that ICAM-1+ FBL abundance correlates with eosinophilia.

“Markers of inflammation on fibroblasts show a positive correlation with EoE,” Dr Manresa explained. “Fibroblasts are potential hubs for eosinophil adhesion in an ICAM1-dependent manner,” he told the attendees. “In addition, stromal cells are found in proximity to degranulating eosinophils in active EoE.” He told the seminar: “This work shows potential applications to skin diseases, as there is evidence of structural-immune cell networks in ACD via regulation of the HIF pathway.”

He concluded by saying: “Keratinocytes contribute to the recruitment of neutrophils in murine ACD, and targeting the HIF pathway may block neutrophil recruitment, at least in part, by dampening chemokine production by keratinocytes.”

Inflammatory process

During an interactive Q&A and clinical discussion, Prof Tobin asked, in the context of EoE: “In EB, there is a very high risk of carcinogenesis in the tissue due to the fibrotic, prolonged, chronic inflammatory response. But what is it like in the oesophagus?” he asked Dr Manresa. “You mentioned the timeline in children, where there is an inflammatory phase, moving into a fibrotic phase – does it burn-out eventually, like some other inflammatory conditions, or is there a chronic underlying inflammation that continues?”

Dr Manresa responded: “It’s a great question but difficult to answer, because we only have follow-up observations from perhaps the past 20 years now…. My thoughts would be that this disease [EoE] is maybe not so prone to becoming cancer, with irritation, etc… in any inflammatory condition, you may have different inflammatory components,” and in a reasonably newly-described disease, it would be interesting to see how subsequent research develops, he said.

Prof Tobin concluded by adding: “It’s interesting to look at the chronicity of a wound, be it either keloid or hypertrophic scarring. This is a really difficult area, because the tissue becomes almost like a tumour, although it’s not a carcinogenic change,” he commented. “So surgeons try to cut it out, and that wound then triggers another iteration of this inflammatory situation, so we don’t get the normal resolution of myofibroblasts either apoptosing, or becoming something else – it just keeps on going,” he said.

“It would be interesting in those conditions [to study this] because typically, you have a pherum-stimulated hyperplasia, because the pherum fills out into the tissue and all the serum proteins induce the fibroblasts to proliferate. But in normal intact skin, you should not have that type of ‘indulgent’ environment for those fibroblasts to proliferate, so it would be very interesting to see whether the number of these cells are changing, or just their secretome is changing. In the double-cells you spoke about, where you have the fibroblasts binding to the eosinophils, it would be interesting to see whether a conditioned medium, the secretome of the fibroblasts, is influenced by the eosinophil, or even vice-versa. It would be interesting to see whether you need direct contact, or whether there is something else that is continuously keeping this [process] very active.”

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

Clinical Dermatology THE MEDICAL INDEPENDENT | 19 MAY 2022 30
Article and series in association with UCD CHARLES INSTITUTE SEMINAR SERIES
Dr Mario Manresa
The mediators promoting fibroblast functional diversity remain poorly understood

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TESLA MODEL 3: NO DRAMA, NO FUSS

As GPs we’re used to arguing with patients. Any GP will tell you the initial response many of us get when we tell a patient they have high blood pressure is “I’ve white coat hypertension”, or “That’s not right” or “I had trouble parking” or “the traffic was crazy”. They can be more interested in winning the argument than listening to what the truth is.

I say this because, when I talk about electric cars, there are three types of people. The first are happy. It is the way forward. The second have all sorts of arguments: What if you run out of charge and there’s a snow blizzard (in Ireland?). Or you go to a charger point and there’s none free? The type that likes to just win the argument. The third are sitting on the electric fence and waiting to see what the future holds.

I could not have predicted a new car company would become the most valued company in the world economy, nor can I tell you what the future holds for future fuels. I know there are alternative fuels out there. I know hydrogen is promising, in particular, for public transport. For the near future, there are no readily available commercially available alternatives. So unless there’s an alternative….

Which brings me back to electricity.

Electric cars are by no means a modern invention. It is just that the internal com-

bustion engine (ICE) took over the sector with its rapid refuelling process and readily available fuel supply. But, as it is causing an environmental problem, we have to look at viable alternatives.

So, to those in groups one and three as above, I have an excellent alternative. And maybe some of group two will be impressed too.

I have been looking forward to testing the Tesla Model 3 for some time. I have been a fan of the Model S, but it was too big for me. I have to admit I was not gone on the looks of the Model 3, especially the front end. The Model S has a lovely front, with a beautifully proportioned glass line and a relatively narrow roof. Let’s say the proportions of the Model 3 are engineered and designed for maximun passenger capacity and safety, as well as min-

imising aerodynamic drag.

Getting into the car I was shown the two balls on each side of the steering wheel. In order to drive the Model 3 properly, you will need to buy into the Tesla operating system. This is much bigger than a switch from Mac to Windows. Normally, on a test car, I have most of the bits figured out on the drive home. They’re designed that way for simplicity. But Tesla has a simpler presentation and they want to minimise the use of all buttons and switches. Even the glovebox opens by a control on the touch screen. Or by pushing the button on the right side of the wheel and saying: “Open glovebox.” As was shown to me, if you can’t find the menu settings, just push the button and tell the car what to do. Overall, the voice recognition is incredibly good, but it took me three attempts to tell it to

turn off the seat heaters.

The safety features are wonderful. I heard a story that it had failed to get five stars on an American safety test. Tesla’s CEO Mr Elon Musk was concerned and had a team work on the problem. Within one week there was an “over the air” safety update for the Tesla, the car was retested and got its five stars.

I found the adaptive cruise control brilliant, slowing down to stop following the car in front. There is a collision avoidance system, which just chirped at me at a dodgy manoeuvre I tried. I didn’t push it to see what else it would do.

There is a lot to access and change on the tablet screen. After a week I am certain I still don’t know how to access everything available.

Now this Model 3 is not one of the ‘Performance’ types. Tesla has said the 0-60mph time is about 4.4 seconds. The Performance option is capable of 0-60mph in 3.3 seconds. I don’t have equipment to test it, but Gerry, my friend, thinks my test car accelerates faster than a fairground ride. We were leaving his house, with Gerry in the passenger seat. He saw a car coming. Naturally he expected me to wait, but I had already driven the Model 3 and unlike him, knew what to expect. So I floored it. Poor Gerry wasn’t right for hours afterwards. He said his eyeballs sank to the back of his head and all the blood left them. And

THE MEDICAL INDEPENDENT | 19 MAY 2022 32 Read more at www.mindo.ie
Power is there all the time. There is no wind up. It just goes. And it is so aerodynamic
Life Motoring
DR ALAN MORAN

this was on a wet muddy country road, one guaranteed to leave the wheels of a conventional car spinning or flashing its traction control lights. Without a gearbox, with direct drive, the car simply took off. In reality the car is simply, amazingly, fast and just keeps going. Power is there all the time. There is no wind-up. It just goes. And it is so aerodynamic. There is minimal wind and road noise. Many have commented on the central ‘tablet’ display. I thought not seeing dials in front of me would be an issue, but I managed very well.

Up front the seats are comfortable and multi-adjustable, as is the steering column (with heated steering wheel). I could not find any memory settings for individual drivers. The front screen is very low, and in contrast the rear view is restricted with the high boot. However, the rear cameras (three!) and sensors make manoeuvring easy. There is even a dog mode, which keeps the air con on when you’re at the shops and the dog is in the car. There is an overnight mode, again keeping the air condition ticking over when you choose

to sleep in the car. An internet search will reveal all to you.

On day two I decided to charge the Model 3 at home via a standard household plug. The battery was at about 80 per cent and it said it would take six hours to charge. The following morning, I couldn’t get the plug out. Contacting Tesla, they said to simply push the button and tell the car to disconnect. It did in a second. Later the app told me I was leaving the air con on too long. I used the app to switch it off, yet it reminded me again I had it on too long. Maybe

that needs a bit of work.

Would I buy one? Maybe. Probably. Two of my local colleagues have one each. I’m a petrol head at heart and love the need to “work” when driving a car and hear it responding to my input. In the old days, I could do the minor servicing; oil, filters, and the like. There’s absolutely no way I will be doing anything in the Tesla apart from filling the washer fluid and checking the tyre pressures. To me it is like the empty nest syndrome of cars. I’m used to pushing the car, and feeling I’m getting to

the limits (on a track, of course). I love adjustability. The Tesla needs much less input. It goes, it hangs on very well on corners, and there’s no drama, no fuss. Like an empty nest at home. These are the bits I miss. But I love the performance, the silence, and the equipment.

Think of it this way: If any car manufacturer created a petrol car producing 450bhp with a 3.3 second 0-100kph time in a fourdoor family car for €66,000, it would be headlines. Never mind the safety features. I think I’ve nearly talked myself into one….

Motoring Life THE MEDICAL INDEPENDENT | 19 MAY 2022 33
Overall, the voice recognition is incredibly good, but it took me three attempts to tell it to turn off the seat heaters

Promotion hopes remain alive as Dublin Hospitals’ resurgence continues

Dublin Hospitals Football Club’s (DHFC) return to form following the Christmas break, sees the doctors well seated for a dramatic late drive for promotion. Five league games and one cup game have DHFC in the running with four league games left to play. The match highlights are available to view on www.dublinhospitalsfc.com

Dublin Hospitals 4-1 Dunboyne AFC

Friday, 11 February 2022

Leinster Senior League (LSL)

Pearse Park, Crumlin

On a blustery day in Crumlin, DHFC were guilty of another slow start. An early long ball caught in the wind allowing Dunboyne to take the lead in the opening minutes of the game. After the early setback, it was one-way traffic in favour of DHFC with Gaffney, Daly, and Wrynn in particular causing all kinds of trouble for the opposition. It was full-back Barra Neary who opened the scoring for the medics, following some neat play down the left flank. Neary sent a teasing cross shot into the Dunboyne area, which evaded the outreaching hands of the goalkeeper and found the bottom corner. That was Neary’s first of the season and just reward for a string of solid performances of late from the gastroenterology registrar. Substitute David Gildea then doubled the scoring for DHFC. The industrious Ian Daly burst into the Dunboyne penalty area, only to see his low drive parried into the path of Gildea, who made no mistake from six yards. Gildea doubled his own tally with a delightful finish early in the second-half. This was a goal of the highest quality. Daly again won possession on the halfway line. GP Daly’s perfectly weighted through pass left Gildea one-on-one against the Dunboyne centre-back. The unfortunate defender was left bamboozled by the footwork of Gildea, who smashed home from close range. A goal definitely worth the watch on the highlights reel. With the score 3-1 and the medics in cruise control, Ian Daly completed the rout. Player of the match Eddie Wrynn continued his bombardment of the Dunboyne backline and his pull-back found Daly on the edge of the box and his powerful effort crashed in off the underside of the crossbar. It was a well-deserved 4-1 victory for the Hospitals.

Matchday squad: P Schütze, F Nally, B Neary, C Kirby (Capt), R Winters, D Kennedy, E Wrynn, I Daly, R Durand, B Gaffney, G Cheevers.

Subs: A McGrath, M Berkley, E O’Connor, D Gildea.

Goal scorers: B Neary, D Gildea (2), I Daly. Player of the match (POTM): E Wrynn.

Dublin Hospitals 0-3 Leixlip United FC

Friday, 19 February 2022

LSL

Leixlip Amenities Centre

With two wins from two in the post-Christmas games, DHFC travelled to Leixlip for a game that the medics will want to forget. This Leixlip side are one of the in-form teams in the league and will be cursing their early season form. Based on this performance, they could well have been in the run for a top three finish. A combination of intelligent midfield players and an abundance of pace and strength in the frontline caused the doctors continuous problems, in particular in dealing with the long diagonal balls to the left-wing. The firsthalf ended with Leixlip 1-0 to the good. DHFC rallied early in the second-half, creating a number of chances, but were

caught on the counterattack to go two down. In the dying minutes, whilst chasing the game, DHFC conceded a third from the penalty spot and the game finished 3-0. Despite the result, the effort and work rate could not be faulted. We go again, as they say.

Matchday squad: P Schütze, C Kirby (Capt), B Neary, C Cosgrove, R Winters, A Delany, E Wrynn, I Daly, D Gildea, G Cheevers, A McGrath.

Subs: M Berkley, C Ward, C Vaughan, K Keane, J O’Grady, E Daly, R Durand.

POTM: P Schütze.

Dublin Hospitals 2-1 Skerries Town FC

Friday, 5 March 2022

LSL

Pearse Park, Crumlin

Following a humbling 3-0 defeat in Leixlip, DHFC welcomed Skerries Town to Crumlin. To put the game into context, Skerries have been the runaway league leaders and required just a point in this fixture to secure the league title. The last time these sides met, Skerries put DHFC to the sword convincingly with a 5-0 win. Clearly Durand and Cosgrove had analysed that performance and prepared the troops. Eoghan Daly, currently in Res year at UCD, made his first start for the club and put in a player of the match performance. Rheumatologist Colm Kirby repeatedly outmuscled the Skerries target man who had caused so much danger in the away fixture and the wily Colm Cosgrove was continuously alert to danger. Again, David Gildea found the net with a clinical finish in the first-half as DHFC dominated proceedings. As the second-half started the medics continued to take the game to the champions elect and it was a trademark John Cosgrove long distance effort that doubled the lead for the Hospitals. A consolation goal for Skerries was not enough to earn them the title, but over the course of the season they have been good value for the position that they find themselves in and hopefully DHFC will see them in the Major 1 division next season. Matchday squad: P Schütze, E Daly, J O’Grady, C Kirby (Capt), C Cosgrove, A Delany, E Wrynn, R Durand, D Gildea, I Daly, C Ward.

Subs: D O’Donnell, E O’Connor, R Colbert, J Cosgrove.

Goal scorers: D Gildea, J Cosgrove.

POTM: E Daly.

Life Sport THE MEDICAL INDEPENDENT | 19 MAY 2022 34
David Gildea has been relentless in front of goal this season. His second against Dunboyne is a must see on the match highlights at www.dublinhospitalsfc.com Neary opened his account for the season in the 4-1 win over Dunboyne, nailing down a regular left back spot in the process

Dublin Hospitals 3-2 St Paul’s Artane

Friday, 11 March 2022

Lanigan Cup Round of 32 Pearse Park, Crumlin

With some good league form, despite an unfortunate series of injuries to key players, DHFC took on St Paul’s Artane in the last 32 of the Lanigan Cup. In a physical affair, it was the medics who came off best in a convincing 3-2 win. David Gildea, who can’t seem to stop scoring at the moment, opened DHFC’s account on the day. Gildea’s record in front of goal is remarkable and this took him to nine goals in just 10 starts in all competitions this season. Suffice to say, the ophthalmology registrar has an eye for goal. St Paul’s had arrived in Crumlin prepared for a battle and took the game to the medics. Their physical approach and long ball tactics were met with resolute defending from DHFC. With Andy Delany and Ian Daly leading the charge, the Northsiders were met with a zero-tolerance policy and any efforts to breach the DHFC defence was strongly resisted. It was Ian Daly who made it two for the medics, with a clinical finish after some neat play down the left-wing. With 20 minutes remaining, Durand completed the scoring for DHFC with an outside of the boot swerving effort from 25 yards. At three goals to the good, this should have been plain sailing for the Hospitals; however, instead of doing things the easy way, two fortuitous goals from St Paul’s in the dying minutes meant DHFC had to hold on for a 3-2 win. They all count, especially in the cup, and a mouth-watering tie against Crumlin United is next on the cards in the last 16 for the team.

Matchday squad: P Schütze, E Daly, R Winters, C Kirby (Capt), C Cosgrove, J Cosgrove, R Durand, A Delany, D Gildea, I Daly, C Vaughan.

Subs: D Kennedy.

Goal scorers: D Gildea, I Daly, R Durand.

POTM: A Delany.

Dublin Hospitals 2-2 Killester Donnycarney FC

Friday, 25 March 2022

LSL

Pearse Park, Crumlin

Having comfortably defeated Killester Donnycarney in the reverse fixture only a few weeks previously, DHFC hosted the Northside outfit at Pearse Park, with a completely changed team. It also seemed that Killester arrived with a number of reinforcements compared to the previous game. It was the team from Killester that opened the scoring in bizarre circumstances. With only 10 players on the pitch and the DHFC goalkeeper not yet between the posts, the referee blew the whistle to kick-off. Killester duly responded with a direct

from the kick-off halfway line effort into an empty goal to open the scoring. Less than three seconds, surely a record for the quickest goal scored in league history! That set the tone for the first-half, with the stunned medics spending long periods chasing, harrying, closing down, and working their way into the game. Time and again, Dublin Hospitals have called upon their ‘never say die’ attitude this season and somehow managed to keep themselves in games when the going gets tough. When teams pull together like this, all it takes is a moment of inspiration from a talented individual. Eddie Wrynn was that man. Like a Speedy Gonzalez cartoon, the difference in pace between Wrynn and other players is laughable at times. Midway through the second-half, with the Hospitals losing 2-0, someone fired up the afterburners and brought the game to life. Driven on by Daly, Wrynn began to work his magic and laid off Durand and Nally for simple tap-ins to finish the game at 2-2. DHFC even had chances to win the game in the dying minutes, but it wasn’t to be and a draw was probably a fair result in the end.

Match squad: P Schütze, R Winters, B Neary, J O’Grady, C Kirby (Capt), M Berkley, E Wrynn, I Daly, R Durand, R Colbert, F Nally.

Subs: R Trueick, K Keane.

Goal scorers: R Durand, F Nally.

POTM: E Wrynn.

Dublin Hospitals 3-3 Finglas United FC

Friday, 9 April 2022

LSL

Larney Park, Finglas

With the Leinster Senior League season approaching its finale, DHFC travelled north to Finglas, where they met one of their fellow promotion hopefuls, Finglas United. On a glorious spring afternoon, it was the home team who started brighter, controlling possession as the Hospitals took some time to get to grips with the Finglas wing-back system. It was the medics who opened the scoring midway through the first-half. After a period of relentless closing down, the Finglas goalkeeper, under immense pressure from Durand and Ward, flapped at a clearance, leaving Durand with an unmissable opportunity. Finglas levelled the scoreline with a well worked move midway through the second-half. DHFC grew into the game as the half wore on. Some positive play resulted in a corner for the Hospitals. A clearance fell to Kennedy at the edge of the box, who volleyed to Cosgrove, who was still on the right wing having taken the corner kick. He unleashed a curled left-footed effort that found the net via the far top stanchion of the goal to make it 2-1 just before half-time. That makes it 12 for the season for Cosgrove and another goal of the season contender. With UCD hav-

ing beaten Rosemount in the earlier fixture, this game had turned into a huge opportunity for Finglas or DHFC to take a step towards third place. However, it ultimately led to a cagey second-half. Cian Ward, who had worked hard to pressurise the Finglas defence throughout the game, managed to jink past his marker on 70 minutes and sent a teasing delivery across the Finglas six-yard line. It found Durand, who scored his second of the day, making it four goals from three games for the St James’s cardiology registrar. With the score at 3-1, it looked to be enough to secure another win for the Hospitals. However, two penalties awarded to the home team, including one deep in the depths of injury time resulted in a 3-3 draw. An opportunity missed perhaps, but a result that saw Dublin Hospitals, Rosemount, and Finglas all in the running for promotion, with four games to play.

Matchday squad: P Schütze, E Daly, J O’Grady, A Delany, C Kirby (Capt), J Cosgrove, E Wrynn, D Kennedy, R Durand, I Daly, C Ward.

Subs: C Grant, C Vaughan, L Sheerin-Purcell, M Berkeley, K Keane.

Goal scorers: R Durand (2), J Cosgrove.

POTM: J Cosgrove.

PS

Dublin Hospitals FC would like to thank our kind sponsors Medisec Ireland for continuing to support the club for the past year. You can keep up to date with all things DHFC at www.dublinhospitalsfc.com

Sport Life THE MEDICAL INDEPENDENT | 19 MAY 2022 35
In a physical battle, Ian Daly was dominant throughout against St Paul’s Artane Eddie Wrynn has been in scintillating form for Dublin Hospitals in recent weeks A captain’s performance from Colm Kirby put Skerries Town’s title celebrations on hold

SPORTS QUIZ WIN €50 19 May 2022

Q1 Who won the first Formula One Miami Grand Prix staged earlier this month?

Q2 Which county knocked Mayo out of the 2022 Connacht football championship?

Q3 Katie Taylor overcame her toughest opponent to date in defeating Amanda Serrano recently. In which iconic venue did the bout take place?

Q4 Name the Spanish teenager who defeated both Nadal, Djokovic, and Zverev en route to winning the Madrid Open singles title?

Q5 Who will captain Europe in next year’s Ryder Cup?

Q6 Who will contest this year’s European Rugby Champions Cup Final later this month?

CROSSWORD COMPETITION

19 May 2022

The winner of the 28 April 2022 Sporting Quiz Competition is Dr Conor Higgins, Co Kerry

The winner of the 28 April 2022 Crossword is Dr Jeremiah Walsh, Co Cork

Q1 Who was sacked as manager of Premier League strugglers Burnley? A: Sean Dyche

Q2 Who was recently named as the new head coach of Munster Rugby, from next season onwards? A: Graham Rowntree

Q3 Name the winning horse of the Irish Grand National? A: Lord Lariat

Q4 The 2022 All Ireland Football championships are under way. Who are the defending senior champions? A: Tyrone

Q5 Who holds the WBC heavyweight championship belt after last weekend’s bout in Wembley? A: Tyson Fury

Q6 The fixtures for the 2023 Six Nations were announced last week. Which two nations face off in the opening fixture of the tournament? A: Wales v Ireland

Life Mindo Quizzes THE MEDICAL INDEPENDENT | 19 MAY 2022 36 Solution to Crossword Competition
Answers to Sports Quiz Competition Solution to Sudoku S U B S T A N T I A L P N E C E R A A I V O T E R G A P R I F L E U M U P T O R A S H E E R N O R M A L L Y O E M L A S P R E N G I N E E R S T O R M E R S I H C O E P A S T A I C E V I D E O I T P A I L R O E I N T E R E S T I N G 7 2 6 1 5 3 9 4 8 5 3 9 8 6 4 7 1 2 8 4 1 9 7 2 5 3 6 6 7 4 5 8 1 2 9 3 3 1 5 6 2 9 4 8 7 9 8 2 4 3 7 6 5 1 4 5 7 3 1 6 8 2 9 2 9 3 7 4 8 1 6 5 1 6 8 2 9 5 3 7 4 2 9 9 3 8 4 1 8 4 7 9 5 1 8 9 7 6 5 1 8 4 5 7 6 SUDOKU SCRIBBLE BOX 28 APRIL 2022 ANSWERS, SOLUTIONS, AND WINNERS WIN €50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Across 7 - Roughly (13) 8 - Unwelcome intrusion (8) 9 - Repudiate (4) 10 - Pugilist (7) 12 - Reasoned judgement (5) 14 - Put into use (5) 16 - Scientific study of life (7) 19 - Be at a ___ : be puzzled (4) 20 - Right to self-government (8) 22 - Presentation on how to use something (13) Down 1 - Revolve (4) 2 - Deliver a sermon (6) 3 - Exhilarated (7) 4 - In the company of (5) 5 - Workroom of a painter (6) 6 - Mapping out in advance (8) 11 - Made better (8) 13 - Agitate; bother (7) 15 - Period of instruction (6) 17 - Measurement of extent (6) 18 - Part of the human body (5) 21 - Emotional state (4) ACROSS 7 Roughly (13) 8 Unwelcome intrusion (8) 9 Repudiate (4) 10 Pugilist (7)
Reasoned
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Scientific study of life (7)
Be at a
Be puzzled (4)
Right to self-government (8)
Presentation on how to use something (13)
12
judgement
14
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Emotional state (4) OUR NEW ADDRESS Post your answers to: Mindo Quizzes, The Medical Independent , Greencross Publishing Ltd, 1 Mortons Lane, Wicklow Town, A67RX38 Closing date for entries is 31 May 2022
DOWN 1 Revolve (4) 2 Deliver a sermon (6) 3 Exhilarated (7) 4 In the company of
5 Workroom of
6 Mapping
11 Made better
13 Agitate;
15 Period of
17 Measurement of extent
18 Part
21

ABBVIE RECOGNISED AS A GREAT PLACE TO WORK AT 2022 AWARDS CEREMONY

Ireland’s best workplaces 2022 demonstrates these organisations’ commitment to improving their culture and putting their people first, whatever challenges they face. Ireland’s best workplaces can be very proud of their achieve-

ment in this particular year and have shown once again that working on the basics and with committed leadership dialled in on improving their culture will reap rewards when it comes to talent attraction and retention.”

GSK SHINGLES VACCINE NOW AVAILABLE IN IRELAND

GlaxoSmithKline Ireland recently announced that Shingrix, a vaccine to help protect adults against shingles, is now available in Ireland.

Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800-244-255.

The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.

Shingrix is not indicated for the prevention of chickenpox.

monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

AbbVie, the global biopharmaceutical company, which has eight sites across Ireland, has been listed as one of the best places to work in Ireland at the 20th annual Great Place to Work 2022 Awards.

It is the ninth consecutive year that the company has featured on the list, and first time since it acquired Allergan in 2020, that all the company’s Irish sites took part in the anonymous workplace experience survey. AbbVie, which employs approximately 2,600 people across eight sites in Ireland, was ranked 12th best large company in Ireland at the awards.

The Great Place to Work Institute assesses the policies and practices in place in organisations under nine key areas, including employee development, hiring practices, employee achievement recognition, and communication. It then benchmarks these against other organisations in each country.

The Institute also recognised AbbVie as a best workplace for women for the fourth successive year. AbbVie is one of just 27 companies in Ireland to receive this accolade in 2022. The programme recognises organisations that create a positive and supportive work environment for women to develop personally and professionally.

AbbVie’s Country HR Director, Ms Samantha Commons, said: “I’m very proud that AbbVie has been included in this

prestigious list again this year and delighted that this recognition includes our new AbbVie sites in Dublin and Westport. I’m equally delighted that AbbVie has also been awarded best workplaces for women certification, reflecting our commitment to empower female colleagues to reach their full potential.

“A big thank you to our dedicated employees working at our sites across Ireland for their ongoing commitment to develop and grow our business.

They continue to demonstrate the very best of our inclusive company culture and ensure an uninterrupted supply of vital medicines for patients around the world.”

The Great Place to Work Institute publishes three different lists at its annual awards, including the best large workplaces in Ireland (>301 employees). AbbVie was joined by 30 other companies on this roll-call.

Companies are largely ranked in order on these lists using information confidentially supplied by employees. Two-thirds of each workplace’s score comes through this trust index employee survey, with up to one-third of the remaining marks based on a company-wide culture audit undertaken by the Great Place to Work Institute.

Commenting on the awards, CEO at Great Place to Work Ireland, Mr Cathal Divilly, said: “Being recognised as one of

The vaccine is licensed to prevent shingles in adults aged 50 years and older as well as in adults 18 years of age or older who are at increased risk of shingles. It also prevents post-herpetic neuralgia (PHN), a common complication of shingles.

This vaccine is available privately for eligible adults from pharmacies* and general practice.

Ms Eimear Caslin, General Manager, GSK Ireland, said: “The launch of Shingrix is an important addition to our local portfolio of vaccines. The importance of adult immunisation has never been clearer, and we are pleased that healthcare professionals in Ireland will now have access to Shingrix to help reduce the burden of this painful disease.”

Dr Eavan Daly (PhD), Director of Medical Affairs, GSK Ireland, said: “The risk and severity of shingles increases with age as a person’s varicella zoster virus-specific immune response gradually becomes less effective. Shingrix was developed specifically to overcome this decline in immune function and to help protect people as they get older.”

According to the company: “The launch of Shingrix for private vaccination of eligible adults in Ireland is part of GSK’s ongoing commitment to ensure more people can benefit from our innovative vaccines. Over the coming years, GSK expects to increase supply of Shingrix globally and make the vaccine available to even more people who can benefit from it.”

About shingles

Shingles is a painful condition caused by the reactivation of varicella zoster virus (VZV), the same virus that

causes chickenpox. Most adults have had chickenpox so will have VZV dormant in their nervous system.

The risk of VZV reactivating and causing shingles increases with advancing age, particularly in adults 50 years of age or older. This is because as we get older there is a decline in our VZV-specific immunity, thereby allowing reactivation of dormant VZV. The lifetime risk of developing shingles is approximately one-in-three.

Shingles typically presents as a painful rash that develops on one side of the body and usually lasts for several weeks. While most people recover fully, shingles can potentially lead to serious and long-lasting complications. PHN is the most common complication of shingles, occurring in around 20 per cent of all shingles cases. PHN is prolonged nerve pain in the area affected by shingles that can last for months or even longer.

About Shingrix

Shingrix [Herpes Zoster vaccine (recombinant, AS01B adjuvanted)] is a non-live, recombinant subunit vaccine. The vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01B. The vaccine is administered intramuscularly. The vaccination schedule consists of two doses.

In two separate phase III studies published in the New England Journal of Medicine – ZOE-50 and ZOE-70 – Shingrix demonstrated efficacy of more than 90 per cent in all age groups studied (non-immunocompromised adults aged over 50).

Important safety information

Please review the summary of product characteristics (SmPC) for all safety information for Shingrix. Adverse events should be reported directly to the Health Products Regulatory

• This medicinal product is subject to additional

*Can be administered in pharmacies without the patient presenting a prescription [per prescriber definition in Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011 (S.I. No. 525 of 2011)].

BLACKROCK HEALTH FORMS STRATEGIC PARTNERSHIP WITH CLEVELAND CLINIC

Blackrock Health and Cleveland Clinic have agreed on a partnership, which will provide the Irish hospital group with access to Cleveland Clinic’s expertise in clinical and operational excellence, patient safety, quality, patient experience, and employee engagement. This is the first time that the US medical centre has formed such a relationship with a hospital in the European Union. Blackrock Health, which includes Blackrock Clinic, Galway Clinic, Hermitage Clinic and a diagnostic centre Limerick Clinic, has recently been launched with Dr Caroline Whelan (PhD) appointed as CEO. Cleveland Clinic is a “global leader in healthcare” and operates from a number of locations in the US, Canada, and United Arab Emirates. Earlier this year, Cleveland Clinic opened a hospital in London.

As part of the new partnership, Cleveland Clinic and Blackrock Health have formed a strategic advisory council combining experts from both organisations, “with the goal of sharing best practices and identifying opportunities to improve patient care in Ireland”. As a first collaborative step, Blackrock Health and Cleveland Clinic will review data and practices relating to safety, patient experience, employee engagement and clinical outcomes at Blackrock, Galway, and Hermitage Clinics.

Blackrock Health consultants will now be able to consult with specialists at Cleveland Clinic on complex patient cases as part of the relationship. They will also have access to Cleveland Clinic’s clinical education and professional

development programmes, as will nursing and allied healthcare professionals.

Dr Whelan said: “Blackrock Health and Cleveland Clinic are founded on the shared principle of putting patients first. That goal forms the foundation of our partnership to sustain our delivery of world-class clinical care across all of our clinics. For our staff, this also offers many exciting opportunities to learn and collaborate with their counterparts from one of the leading medical centres in the world.”

A team of clinical and operational leaders from Cleveland Clinic has recently visited the Blackrock, Galway, and Hermitage Clinics to engage with senior management, clinicians, and staff from all parts of the hospitals.

“Cleveland Clinic has a 100-year history of collaboration and innovation,” said Dr Curtis Rimmerman, Cleveland Clinic Chair of International Operations. “We look forward to working with Blackrock Health to learn from each other and share best practices. Our goal is working with like-minded organisations to promote excellent patient care and positively impact patients no matter the location.”

Chair of Blackrock Health, Mr Bryan Harty, said: “Our partnership with Cleveland Clinic will build on the ethos of continuous improvement that all of our staff and the consultants we work with pride themselves upon. This will also underline for all of our patients that their doctor and private hospital places the highest emphasis on excellence in quality, patient safety, and patient experience.”

Product Focus RXDX THE MEDICAL INDEPENDENT | 19 MAY 2022 37
Employees from AbbVie’s Citywest office pictured celebrating the company being recognised as one of Ireland’s best places to work for the ninth year in a row. Pictured from L-R: Ms Orla Lynch, Ms Karine Egan, Mr Basil Blakeney, Ms Deirdre Moran, Ms Iarlaí Duggan, and Mr Andres Rodrigo. Photo credit: Conor Healy/Picture It Photography

GP EDUCATIONAL WEBINAR ON PVFS AND ME/CFS

Dr Ros Vallings, a New Zealand GP who is an expert on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), will present a free talk entitled Key messages for primary care on the diagnosis and management of post viral fatigue syndrome and ME/chronic fatigue syndrome followed by a Q&A session on Monday, May 30 at 7:30pm.

Approved for 1 CPD point by the ICGP

For more info, contact CPD@irishmecfs.org

GP REQUIRED

Permanent/temporary/locum –Kilkenny/Tipperary/Waterford Border

 GP required for a growing two-centre practice

 6–8 sessions available with attractive package

 Immediate start available with long-term potential

 Partnership opportunity for the right person

 Established, well-located, busy practice with huge potential to grow

 Fully computerised using Socrates

 Excellent nurse and admin support – fully resourced for chronic disease management

 Member of CareDoc

 MICGP/MRCGP or equivalent essential Email: piltownhc1@eircom.net

MATCH MEDICS GP RECRUITMENT TEAM ARE HEADING TO SPAIN AND PORTUGAL IN JUNE!

We are meeting GPs and Family Medicine Doctors who are interested in making the move to Ireland to live and work. Would you like us to tell them about your practice? What it is like to live and work in your part of Ireland?

Would you like me to find a full-time doctor to fill your staffing needs?

FULL-TIME PRACTICE NURSE REQUIRED

Full-time practice nurse required for a busy friendly GP practice in Athlone. Must be registered with the Nursing and Midwifery Board of Ireland. GP practice experience would be an advantage but training will be provided. Duties would include phlebotomy, cervical smears, blood pressure and ECG monitoring, and immunisations.

Please email your CV to info@towncentresurgery.ie

GP REQUIRED

Well-established group practice in East Galway requires a full-time GP with view to partnership.

Fully computerised with Socrates and great practice support.

Contact Dr John Kilraine or Dr Cathal Nugent at 091 842144 or send your contact details to admin@mainstreetclinic.net and we will get back to you

GP LOCUM REQUIRED

Locum required in Tallaght, Dublin 24

Dates:

April: 19th, 20th, 21st, 22nd/28-29th

May: 20th

June: 10th, 13th, 14th, 15th, 16th, 17th Full Month of July and August

15 min appointments  No house calls  Excellent practice nurses and helpful administration staff and well organised  Nice mix of GMS/private  Flexibility with session times  Potential for ongoing work throughout the year if desired

Please contact Celina on celinamtmc@gmail.com /085 1034 397

EXCELLENT GP LOCUM OPPORTUNITIES

Outstanding earnings potential

 18 hrs @ weekend = 75K p/a.

 20 hrs overnight = 93K p/a.

 8 hrs evening (Earning top up) = 30K p/a.

 Day time GP opportunities for qualified GPs.

Contact us on 046 924 1533

Email: info@medsource.ie

Visit our website: www.medsource.ie

Classifieds & Recruitment THE MEDICAL INDEPENDENT | 19 MAY 2022 38
YOUR
shirley.osullivan@matchmedics.com or
REGISTER
INTEREST TODAY:
call me for a chat: 086 803 0891

GP LOCUM REQUIRED GP REQUIRED

A GP is required for 3-7 sessions for a busy, dynamic practice with a great team of people in East Cork.

We are a GP training practice with three other doctor colleagues and two nurses.

Fully computerised practice with administrative support.

We operate a 15-minute appointment system and use Socrates practice management system.

Out-of-hours work is optional. The practice covers indemnity and has competitive rates.

Informal enquiries can be made to Dr Mark Buckley at  mark_f_buckley@hotmail.com

GP ASSISTANT REQUIRED

GP assistant required for friendly, long-established, single-handed practice in Clogherhead, Co Louth.

Bright modern premises, fully computerised (Socrates) with excellent administration and nursing support. Good access to motorway and

MICGP/MRCGP QUALIFIED DOCTOR SOUGHT

Limerick City. Short- and long-term positions available to join 4 doctors and 2 nurses. GP training practice with strong commitment to teaching. No out-of-hours commitment. Flexible and attractive package for suitable candidate.

Expressions of interest to rmurraykimc@gmail.com

GP wanted, long-term, for the Cottage Surgery, Bailieborough.

We are looking for an enthusiastic GP to join our expanding team in the Cottage Surgery, Bailieborough, in South Cavan. An interest in female health preferable, but

Fancy a summer GP locum job in West Cork?

Would you like to work and enjoy the summer in West Cork near the sea?

GP locum sessional or full-time work available in a GP group practice. On-call commitment optional. Very supportive nursing and admin staff.

Please email any queries and cv to: westcorkmedical@gmail.com

Classifieds & Recruitment THE MEDICAL INDEPENDENT | 19 MAY 2022 39
www.medilearning.ie Free, independent CPD for doctors, nurses, and pharmacists… all under one roof
GP REQUIRED ilearning

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

Unravelling the mystery of why 80 years old

is a ‘tipping point'

The genetic conundrum of why the chances of our demise increase after the age of 80 has been tackled by researchers at the Wellcome Sanger Institute in Cambridge, UK, who were keen to examine the role DNA errors play in humans compared to other animals.

in our longevity

As is often the case, they approached the topic with a great many 'unknowns'. It is known that both animals and humans die having accumulated a roughly similar number of genetic mutations, which suggests an important role for the speed of DNA errors in determining our life span.

If you have anything you would like to share, please email: info@mindo.ie

Of course, sheer size has been acknowledged as a factor, with larger animals typically living longer than smaller ones, although obviously with humans, lifestyle factors play a larger part than in non-smoking, tee-totalling giraffes, for example. But generally, it's accepted that smaller mammals will not do so well in the longevity stakes as some whales, for instance, that can live for hundreds of years. Smaller animals burn-up energy more quickly and require a faster cell turnover, which causes a faster decline, according to the received wisdom.

The research published recently in Nature suggests that the speed of DNA errors is pivotal to determining the life span of a species. The authors say regardless of their size, longer-living animals manage to slow down their rate of DNA mutations. This, they say, explains in part why the naked mole rat can have a similar life expectancy as a giraffe, for instance, at approximately 25 years. The amazing naked mole rat may not be a great example, as it is something of an anomaly in nature. Because of its longevity and remarkable physiology, this remarkable bald little creature is much-loved by translational medical researchers and deserves a Dorsal View of its own in another issue.

But back to the researchers: They found that naked mole rats show 93 mutations per year, compared to giraffes at 99 mutations. Mice, on the other hand, undergo approximately 796 somatic mutations per year, whilst humans have around 47 mutations per year at age 83.6 years (the average age of the study participants). They found that the average number of mutations at the end of lifespan across species was approximately 3,200. This would suggest, they wrote, that there is a 'tipping point' of critical mass somatic errors beyond which the body loses its ability to function.

Senior author Dr Inigo Martincorena commented: “Ageing is a complex process, the result of multiple forms of molecular damage in our cells and tissues. Somatic mutations have been speculated to contribute to ageing since the 1950s, but studying them has remained difficult. With the recent advances in DNA sequencing technologies, we can finally investigate the roles that somatic mutations play in ageing and in multiple diseases.”

The researchers looked at genetic errors in the stem cells from the intestines of 16 species of mammal. They concluded that the longer the lifespan of a species, the slower the rate at which mutations happen.

First author Dr Alex Cagan added: "To find a similar pattern of genetic changes in animals as different from one another as a mouse and a tiger was surprising."

“But the most exciting aspect of the study has to be finding that lifespan is inversely proportional to the somatic mutation rate. This suggests that somatic mutations may play a role in ageing.”

With a continued growth in the ageing population worldwide, the research hopefully opens the door to more study on the mechanics of the ageing process and the predictability of death.

treatment of major depressive episodes in adults

Job number: IE-BRIN-0372.

Date of preparation: April 2022.

Cyber-security is front-and-centre of everybody's mind these days, particularly since GDPR, so the days of 'ABCD' passwords are long gone. Right?

Not according to a survey conducted recently in the UK to coincide with World Password Day (yes, that's apparently a thing). Across all countries where the research was conducted, the most common password generally used was '123456'. This was followed by '123456789'. In third place was 'picture1' and fourth was 'password'.

The list was compiled from research conducted in 2021, when we were all pretty much doing everything online, which makes the results all the more startling. The list is also country-specific, and Ireland does not cover itself in glory. On our little isle, the most common password was also '123456', followed by 'password' in second place. In third place was 'liverpool', followed by '123456789' in fourth, and '12345' in fifth, 'password1' in sixth, and 'qwerty' in seventh.

In case you're wondering, the typical average time it took for hackers to crack a password was less than one second for any of the passwords in the top-20 list.

The Dorsal View THE MEDICAL INDEPENDENT | 19 MAY 2022 40
Prescribing information is available in the Brintellix SPC on https://www.medicines.ie/medicines/brintellix-10-mg-filmcoated-tablets-34817/spc Legal category: POM, for non-renewable supply. Further information is available on request from Lundbeck Ireland Ltd. 4045 Kingswood Road, Citywest Business Park, Co. Dublin, D24V06K. Tel 01 4689800.
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