The Medical Independent 21st March 2023

Page 32

Need for retention focus

Legacy of a troubling past

Next month marks the 25th anniversary of the Good Friday Agreement, but the mental health consequences of ‘the Troubles’ continue, writes David Lynch

Rotunda to upgrade ‘inadequate’ emergency lighting and fire detection systems


The Rotunda Hospital in Dublin has gone to tender to address its “completely inadequate and sub-optimal” emergency lighting and fire detection systems, the Medical Independent (MI) has learned.

“The current emergency lighting system and fire detection alarm system in the hospital is completely inadequate and sub-optimal to meet statutory requirements,” according to a Rotunda business case dated August 2021, which was obtained from the HSE under Freedom of Information law.

A Rotunda spokesperson told MI that the project has recently gone to tender and will be fully funded by the HSE.

The Rotunda commissioned an independent fire safety report after a fire in the neonatal intensive care unit in 2017. The hospital has since been addressing risks and engaging with the HSE on funding to undertake the full works.

According to the business case: “The safety implications of not responding to a fire in a timely manner could result in patients being unsafely compromised or harmed and unnecessarily evacuations [sic] from the building where a horizontal compartmentation strategy could have avoided such disruption.”

It continued: “In the event of a fire in the wards where the lighting was affected the current emergency lighting system would not provide a safe passage to a place of safety.”

Furthermore, the possible delay in identifying “the precise location of an activated device due to the current radial network system may result in harm to patients and staff and greater damage to the hospital”.

Fire detection devices were found to age from new to over 25 years, noted the document. “It is recommended the asset life for such devices should not exceed 10 years.

The inspection identified 273 devices over

Finding common ground

Some descriptions of patients should be consigned to history, according to Dr Muiris Houston

XELJANZ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

XELJANZ in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.

XELJANZ in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

XELJANZ is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.


Date of preparation: June 2022

20 years with 235 of these ionisation devices requiring certified disposal.”

The estimated overall cost for the project was €2,658,842, stated the business case.

The Rotunda’s spokesperson said all fire detection devices will be replaced as part of the project, but “they are still operationally sound and are tested quarterly”.

In regard to a reference in the business case that in the event of a fire in the wards where the lighting was affected, the current emergency lighting system would not provide a safe passage, the spokesperson said: “This will be addressed as part of the project, however, the back-up generator would start up in the event of a mains failure and this is tested every month.”

On the possible delay in identifying the precise location of an activated device due to the radial network system, the spokesperson said: “There is a fully addressable system in place and a full graphics system now to identify precise location of activation alarms.”

DoH and HSE disagree on RHA funding options


There is disagreement between the HSE and the Department of Health on the funding model for the six new regional health areas (RHAs), the Medical Independent (MI) can report.

The issue was raised during a general discussion on RHAs at the December meeting of the HSE people and culture committee.

The minutes noted: “The Department of Health has suggested that funding would go directly to RHAs from the Department, but HSE not in favour of this approach.”

A HSE spokesperson told MI that no final decision has been made on the “funding mechanism”.

They added that the RHA implementation plan will require Government approval prior to publication and “is currently under review by the HSE and the Department of Health”.

“The HSE and the Department of Health are working collaboratively on the delivery of the RHA implementation plan, which includes the funding mechanisms and progressing a plan for population-based healthcare resource allocation,” said the spokesperson.

“The funding mechanism for RHAs is under discussion and a number of options are currently being considered. The preferred model has not yet been finalised, but will be considered further over the coming months, and a decision made in advance of the RHA implementation.”

The “full implementation and benefits realisation of the RHAs” will take a number of years, they added.

was the recipient of the 2023 RCSI Cameron Award for Population Health. The award recognises Prof Morris’s lifelong commitment to promoting data and informatics in population health.

Legal Category: S1A. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at
| PsA | JIA |
Legal Category S1A. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions. PP-CIB-IRL-0014 Date of preparation: July 2022
CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.
NEWS 1-16 ● OPINION 18-26 ● MCQ s 26 ● CLINICAL 28-34 ● CONFERENCE 36 ● LIFE DIARY 38 ● QUIZZES 39 ● MOTORING 40-41 ● BOOK REVIEW 42 ● GALLERY 43&44 ● PRODUCTS 45
Prof Andrew Morris, inaugural Director of Health Data Research UK, President of the Medical Council Dr Suzanne Crowe speaks to Catherine Reilly about some of the prevailing issues facing the regulator and health service


The recommended dose is 100 mg administered by intravenous infusion every 12 weeks.1

Legal Category: POM.

Marketing Authorisation Holder: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.

Further information from: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals and patients are asked to report any suspected adverse reactions to the HPRA via or to Lundbeck on 01 468 9800 Email:

1. Vyepti® Summary of Product Characteristics. Available at

Prescribing information:

VYEPTI®▼ (eptinezumab) 100 mg concentrate for solution for infusion

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See below on how to report adverse reactions.

Please refer to the full Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to side effects, precautions and contraindications.

Presentation: Eptinezumab 100 mg concentrate for solution for infusion. 1 vial of 100 mg/ml.

Indication: The prophylaxis of migraine in adults who have at least 4 migraine days per month. Treatment should be initiated by a healthcare professional (HCP) experienced in the diagnosis and treatment of migraine. The infusion should be initiated and supervised by a HCP.

Dosage: The recommended dose is 100 mg administered by intravenous infusion every 12 weeks. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 12 weeks.

Assess need for dose escalation within 12 weeks after initiating treatment. When switching dosage, the first dose of the new regimen should be given on the next scheduled dosing date. Assess overall benefit and continuation of treatment 6 months after initiation. Elderly: No dose adjustment is required. Patients with renal/hepatic impairment: No dose adjustment required. Paediatric: The safety and efficacy of VYEPTI in children aged 6 to 18 years has not yet been established.

Route of administration: Intravenous infusion, after dilution of the vial content in 100 ml sodium chloride (0.9%) solution for injection. Following dilution infuse over approximately 30 minutes. Observe or monitor patients during and after the infusion in accordance with normal clinical practice. Do not administer as a bolus injection. See full SmPC for further details on administration.

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Warnings & Precautions: Traceability: To improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Cardiovascular risk: Patients with a history of cardiovascular disease (e.g. hypertension, ischaemic heart disease) were excluded from clinical studies. No safety data are available in these patients. Limited safety data are available in patients with cardiovascular risk factors such as diabetes, circulatory diseases and hyperlipidaemia. Neurological or psychiatric conditions: Patients with a history of neurological diseases or patients with psychiatric conditions that were uncontrolled and/or untreated were excluded from the clinical studies. Limited safety data are available in these patients.

Serious hypersensitivity: Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion. Most hypersensitivity reactions occurred during infusion and were not serious. If a serious hypersensitivity reaction occurs, administration of VYEPTI should be discontinued immediately and appropriate therapy initiated. If the hypersensitivity reaction is

Date of preparation: February 2023

Job Code: IE-VYEP-0154

not serious, continuation of further treatment with VYEPTI is up to the discretion of the treating physician, taking into account the benefit-risk for the individual patient.

Hereditary Fructose Intolerance (HFI): VYEPTI contains sorbitol. Patients with HFI must not be given this medicinal product unless strictly necessary.

Interactions: Interactions by eptinezumab with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are considered unlikely.

Fertility, pregnancy and lactation: Limited data, as precautionary measure it is preferable to avoid VYEPTI during pregnancy. No data on the presence of eptinezumab in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterward; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, use of eptinezumab could be considered during breast-feeding only if clinically needed. The effect of eptinezumab on human fertility has not been evaluated.

Undesirable effects: Common (≥1/100 to <1/10): nasopharyngitis, hypersensitivity reactions, infusionrelated reaction, fatigue. Uncommon (≥1/1,000 to <1/100): anaphylactic reaction. Prescribers should consult the full SmPC in relation to other side effects.

Overdose: Symptomatic treatment with supportive measures instituted as required.

Legal category: POM, for non-renewable supply.

Marketing Authorisation Holder:

H. Lundbeck A/S, 9 Ottiliavej, 2500 Valby, Denmark.

Marketing Authorisation Number: EU/1/21/1599/001 (1 vial).

Further information is available from:

Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin. Tel. +353 1 468 9800.

Date of Revision: September 2022.

Reference: IE-VYEP-0018

VYEPTI® is a Registered Trade Mark.

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Lundbeck on: 01 468 9800 Email:

Focused • Passionate • Responsible

Medical Council seeks exemptions from ‘One Person One Salary’ rule


The Medical Council has highlighted to the Department of Health the “heavy workload” of Council members and has sought an exemption from the ‘One Person One Salary’ policy for affected members.

The request was made during a governance meeting with the Department in December, according to minutes obtained under Freedom of Information law.

Earlier this month, a spokesperson for the Medical Council told the Medical Independent (MI) there were 10 members subject to the rule and as a result they could not receive the €7,696 annual stiped.

“They can claim for vouched expenses such as travel and subsistence. The number of members expected to be exempted from the One Person One Salary policy will depend on the changeover of Council, however, we expect a minimum of eight members will be impacted based on previous Council membership.

Ongoing concern about format of Human Tissue Bill


Ongoing concern has been expressed at an expert clinical group about the potential for the current format of the Human Tissue Bill to negatively impact organ donation.

At a meeting on 2 December of the HSE’s national organ donation and transplantation advisory group (NODTAG), Dr Alan Gaffney, Intensive Care Consultant at Beaumont Hospital in Dublin, “noted that the way the Bill is currently drafted there is a risk it will decrease donation, which is at odds with the Minister’s press statements that it will increase donation. Members have been clear on this in formal correspondence.”

The Bill was published on 20 December.

The Medical Independent (MI) previously reported on concerns that the inclusion of organ donation and transplant provisions in the same Bill that addresses the separate area of post-mortem practice could undermine public sentiment on donation.

In a comment to MI in December, a HSE Organ Donation and Transplant Ireland (ODTI) spokesperson stated: “Conflating [the] organ donation and transplant section of the Bill with post-mortem, particularly organ retention, poses a risk of undermining the ethos of organ donation as it exposes organ donation to being adversely affected should there be shortcomings in handling of human tissue in the future.”

Asked about the ongoing concerns, a Department spokesperson said the Bill was drafted following “extensive consultation” that involved the HSE, ODTI, and NODTAG.

“The Human Tissue Bill introduces a system of soft optout consent, which is a longstanding policy commitment of Government,” said the spokesperson. “Under the legislation, all adults in Ireland will be considered to have agreed to be an organ donor when they die unless they have recorded a decision not to donate on an opt-out register or are in one of the excluded groups.”

Where a person has not registered their wish to opt-out, consent will be deemed, but their family members will continue to be consulted before a donation can take place.

“While there is a possibility that the register may initially reduce the donor pool at the margins, the majority of people in Ireland are in favour of organ donation and the proposed system changes the default assumption to one that matches the prevailing public attitudes regarding organ donation.”

The Government has “committed to a communications campaign” on organ donation to support the legislation.

“Regarding workload, there are four governance Council meetings per year and monthly regulatory meetings. There are also several extraordinary Council meetings held per year. In addition, Council members are expected to participate in one or two committees. The preparatory work for Council meetings and committee meetings can be significant.”

A Department spokesperson told MI it is considering the matter and the outcome will be communicated to the

Council when a decision has been made.

The objective of the One Person One Salary policy is to restrict payment of extra remuneration from additional public service sources to public sector employees.

Additional payment may be made for undertaking other work in the public sector under certain conditions. Sanction is considered where departments submit a business case to the Department of Public Expenditure and Reform and where a number of conditions are met.

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Medical Council President calls for focus on retention


Dr Suzanne Crowe, a Consultant Paediatric Intensivist and Anaesthesiologist, was elected as Medical Council President in 2021. She became only the second female to hold this position after predecessor Dr Rita Doyle.

Speaking to the Medical Independent (MI), Dr Crowe recalled an initial feeling of “imposter syndrome” after her election. She said she soon realised “I just needed to be myself and do the best that I could in my own style.”

Dr Crowe, noting that the Council was “very clearly stating” that doctors did not feel valued in the healthcare system.

She believes retention should be the prevailing focus. “We need more doctors and we need doctors to stay in the country, and I think there is probably less reason to increase our numbers in medical school at the moment, we are probably better off working on the retention side of things, so encouraging people to stay.

“We need more training places – funded training places – that will keep people in our country after intern year and keep them on training schemes and gaining experience, and hopefully putting down roots in the community and considering staying in Ireland in the longer term.

“Obviously that has to be matched then by funded consultant posts. There are a lot of locum posts out there in a variety of different hospitals throughout the country and transitioning locum posts to substantive posts would be very important. Because for patient care, the service works much better when it is run by people who are in substantive posts rather than locum posts....”

“I think if we improve working conditions for doctors and all healthcare workers in the system, the recruitment side will almost take care of itself.”

Dr Crowe has been an engaged President and is active on social media. She has highlighted the excessive working hours for doctors, the importance of patient advocates, gender inequality in medicine, and the need for greater diversity in the profession, among other issues.

She is a candidate in the current elections to select four registered medical professionals to sit on the Council. Voting closes at midday on 21 March and all candidate bios are on the Council’s website.

If enabled to stay on as President, Dr Crowe said one of her priorities is ensuring a “much greater focus” within the Medical Council on the majority of registered doctors who “work hard to reach the standards that are applied”.


In autumn 2022, the Council released its latest Medical Workforce Intelligence Report for 2021, which explicitly stated that the risks it identified had serious patient safety implications. These risks included the growth of doctors in the general division and their lack of access to supervision and training; the high proportion of non-training NCHDs relative to both trainees and consultants/specialists; excessive working hours and non-compliance with the European Working Time Directive; and acute doctor shortages especially at specialist level.

“I think that was noticed [by stakeholders], I feel it was noticed at the time,” said

General division

The Medical Workforce Intelligence Report highlighted that 34.9 per cent of clinically active doctors in Ireland were on the general division of the register. The Council stated that this presents “an unacceptable risk to patient safety” as the number of general-registered doctors has been increasing while many consultant/specialist posts are not being adequately filled. It noted a lack of appropriate supervision and training opportunities for doctors in the general division, which comprises a majority of international medical graduates.

Dr Crowe said several factors, including insufficient training access, had led to a “swelling” of the general division.

“Part of the concern around that is that we know very little about the doctors who are on the general register and what they are doing in terms of training opportunities, career progression,” she said. “But we do know doctors come back to us… and tell us one of the reasons they are leaving is they have not had adequate access to training opportunities and to career progression.

“So about 50 per cent of international graduates spend six, seven, eight years on the general division, have come into our country perhaps believing that they were going to be able to access a long-lasting, maybe long-term career, and then discover in fact that those training opportunities haven’t been there, and so they then leave.

“From our point of view, that is a terrible shame because they take six, seven, eight years of experience with patients in Ireland away with them and go to other countries where their progression is perhaps more supported.”

Dr Crowe said more precise information is required about doctors on the general division and the nature of their work. “And then I think the Council needs to work with the Department of Health to prepare a policy on the doctors on the general register with immediate access or improved access to places on the training schemes. And that has been supported by [Minister] Stephen Donnelly already. But what we haven’t really seen yet is the required increase in terms of funded training places.

“So there is a lot of work to be done there and I think we do have to tackle it because when we look at our complaints against doctors, that come in against all doctors, there is a disproportionate number of complaints against doctors on the general division. So the Council very rightly is concerned about this because this is a patient safety issue, and we need to understand why that is.

“Many doctors who come in from other countries perhaps haven’t received the level of induction information that they needed and the amount of training that they needed to work in a different culture and perhaps even a different language.

“In many ways, when you think of the challenges for a doctor coming in from another country, who has graduated in medicine from another country, now being asked to work through English in a very different cultural environment with different

prescribing practices and some different clinical practices, it can be no surprise that this would generate an increased number of complaints, and each one of those complaints has the potential to reflect on a poor patient experience or a safety incident, so we are very concerned about this. I think any changes we make or that we suggest for the general register, we have to be really careful that we are also making sure that they factor into the overall workforce.”

The Council has been strongly advocating the development of an overarching health workforce strategy that encompasses education through to practice. Dr Crowe said such a plan would need to set out the numbers and types of healthcare posts required, recognise retirement patterns and preferences for flexible working, as well as the required regional distribution.

“I am certainly not suggesting it would be an easy task to do a workforce plan like that, but I do think it is what is needed; everyone would benefit from that,” she said.

According to the Department of Health, it is developing a health and social care workforce planning strategy and projection model. This project forms a key part of what the Medical Council has been calling for regarding medical workforce planning, said a spokesperson.

Council powers

As well as regulating the individual practise of doctors, the Medical Council is responsible for quality assuring medical education and training in Ireland in accordance with the Medical Practitioners Act 2007. Clinical training sites where intern and specialist training is delivered are required to meet

of the Medical Council Dr Suzanne Crowe speaks to Catherine Reilly about some of the prevailing issues facing the regulator and wider health service Dr Suzanne Crowe

standards set by the Council. Inspection reports, as well as data from Your Training Counts surveys, have identified recurring issues, such as excessive working hours, alleged bullying, a lack of respect shown to trainees, and lack of protected training time for trainees and trainers.

MI asked Dr Crowe how the Council could better use its powers to help address issues, such as excessive working hours and doctor burnout.

Dr Crowe noted that the Council has the statutory powers to inspect training sites and issue recommendations, or if necessary, remove accreditation for a training site. The legislation does not specifically provide for placing restrictions on a site, but this could be negotiated with key stakeholders.

“Now, that has never been done by the Medical Council; that is our only statutory power in terms of targeting hospitals or services that have particular workplace issues,” she said. “We haven’t done it yet, but we are coming closer to doing so, because we are so concerned about the training environment in some hospitals that if that is the only statutory power we have open to us, we may be forced to restrict or reduce accreditation for a particular training site.”

That would be “a major decision” for the Medical Council.

Council but also within the wider regulatory environment.…”

Restrictions for a training site could involve the number of trainees it receives or a stipulation of the particular training hours.

“We are just exploring this at the moment,” stated Dr Crowe. “As I say, it hasn’t been done before, so we need to carry out a risk-benefit analysis and try and understand what it would mean for patient care as well. It is difficult, because our remit as a regulator is to protect the patient, but we also have a duty of care to the doctors who are working on a site.”


The regulator’s accreditation duties also extend to clinical sites operating in a deeply constrained political environment in Bahrain, where the RCSI offers a medical degree programme. Controversy has surrounded the Medical Council’s accreditation of the RCSI Bahrain medical degree programme due to allegations of breaches of medical neutrality and human rights at affiliated clinical training sites in the Gulf country, where human rights organisations say freedom of expression is tightly controlled by the ruling monarchy.

The RCSI Bahrain degree programme was first granted approval by the Council in 2014. This approval was unconditional despite the misgivings of some members due

arrangements, but for the moment the inspection teams are well briefed in terms of the challenges they will face and all of those issues – political and cultural – are taken into account when the reports are being written and the recommendations are being issued.”

She said the Council has regular meetings with Irish medical schools and these meetings include representatives from the overseas medical programmes. “So they are very much part of the whole system approach to medical students and I think that is very helpful.…”

Fitness to practise

Since the beginning of the Covid-19 pandemic to date, the Council has predominantly held fitness to practise hearings remotely. A recent report by RTÉ Investigates stated that the family of a woman who died shortly after giving birth had voiced disappointment at having to learn via an online hearing that a hospital consultant was found guilty of professional misconduct in her case.

MI asked Dr Crowe if the Council was examining the proportion of hearings that it held remotely.

“The remote platform was brought in during the pandemic, as it was across the coroners court and the court system in general,” she said. “Now, at present, we are holding about 10 per cent of inquiries in person, which means about 90 per cent are online. And for many of the more straightforward cases the online platform works very well. It actually improves the accessibility for witnesses to attend the inquiries, because sometimes we have witnesses, for example, a colleague in training, who might actually no longer be living in Ireland, so trying to bring that witness over to attend a hearing in person is really difficult. And then patients as well – our patients or complainants come from all around the country and asking them to travel is a big thing.…


social prescribing services are funded by the HSE across the country, 19 of which are located in Sláintecare Healthy Communities sites.

613 admitted patients were waiting for beds on the morning of Thursday 9 March, according to the Irish Nurses and Midwives Organisation’s Trolley Watch figures.

1,000,000+ GP appointments a year could be eliminated through a minor ailment or triage service in community pharmacy, thereby freeing up GP capacity, the Irish Pharmacy Union told the joint Oireachtas committee on health this month.

“Because if we withdraw or restrict training accreditation for a particular site, we have to be very careful that we are not actually in any way reducing or compromising patient care. So it is a very difficult line for us to walk – I think that helps me understand why it has never been done before within the Medical Council. But at the same time, I feel we can’t ignore really obvious issues within training sites at this stage.”

This issue is being examined as part of a wider move within the regulatory environment towards ‘right touch’ regulation, according to Dr Crowe.

“…. Where we use the information we get, we triangulate it with data that we receive from other bodies within healthcare – for example, the postgraduate training bodies – and we zone in in a much more focused way in sites where there is an issue, rather than doing much more blanket inspection and accreditation and gathering a huge amount of information that isn’t necessarily meaningful.

“We are going to move to the form of regulation that allows us to focus on the problems, understand the problems, and let the rest of the training happen as it should. So, it is part of a bigger move. That is a big cultural change, both within the

to allegations related to clinical sites. A virtual re-accreditation exercise in 2021 recommended unconditional approval subject to a confirmatory in-person inspection visit in 2022. The latter report is due before the Council’s education and training committee this month.

The Global Legal Action Network (GLAN), an organisation of human rights lawyers and activists, has contended that granting unconditional approval is inconsistent with the standards that the Council is bound in law to apply, particularly in regard to appropriate clinical experience and patient safety. The RCSI has stated that the Council’s virtual accreditation report, which is on the regulator’s website, provided feedback and recommendations for the university “to maintain the high-quality medical education it offers to its students”.

MI suggested to Dr Crowe that in a very challenged political environment, such as Bahrain, it is difficult for clinical sites to meet the necessary standards in the way an Irish site would.

“I think that is definitely a challenge,” she said. “It is something that may need to be addressed and viewed in a different way as the years go by. I couldn’t comment on, I suppose, the longevity of these

“So, in general, there are good reasons and similar to lots of other meetings we can actually improve attendance. We do have a difficulty in terms of delays of hearing fitness to practise complaints, so keeping hearings online predominantly will hopefully reduce the delays that doctors and complainants are facing when going through this really stressful process....

“But I think we also have to accept that it might not always be appropriate and for more complex cases it may be appropriate for the hearing to take place in person. However, it is important that both complainant and doctor understand it is an inquiry, this is not a court case; there isn’t a prosecution, it is an inquiry to understand what happened and to make findings about the conduct of the doctor.”

However, Dr Crowe said she acknowledged that the process “is a really traumatic experience” for families, “so I can understand how there would be a lot of emotion expressed around the hearing, either in person or online. It is very difficult.”

Dr Crowe added that the Council is working on improving its communications to doctors and the public around the complaints process and the outcomes that may arise. It will be appointing liaison officers to assist parties going through the complaints process as part of this work.

5 interdisciplinary teams are being established to support the treatment of endometriosis in each of the maternity networks for patients whose care cannot be managed at primary care level.

2 supra-regional endometriosis specialist centres are being developed for patients with more complex cases.


per cent reduction in hospital waiting lists is targeted through funding allocated to the HSE and National Treatment Purchase Fund under the 2023 Waiting List Action Plan.

THE MEDICAL INDEPENDENT | 21 MARCH 2023 5 Interview News
Part of the concern around that is that we know very little about the doctors who are on the general register and what they are doing in terms of training opportunities, career progression

Department developing health and social care workforce planning strategy


The Department of Health is receiving technical support under the European Commission Technical Support Instrument (TSI) to develop a health and social care workforce planning strategy and projection model based on international best practice, according to a spokesperson.

A key outcome of the project is that the Department will have the “tools, processes, and technical capacity” to produce rolling health and social care workforce planning action plans and implement targeted policy measures for health and social care workforce reform.

The Department spokesperson said work on this project forms a key part of what the Medical Council has been calling for regarding medical workforce planning. The project is due to be completed in the third quarter of 2023.

“The Department of Health is currently focused on the development of the health and social care workforce strategy and action plan,” outlined the spokesperson. “Extensive work has been completed in relation to inputs to the strategy and action plan.”

These inputs include assessment of the maturity of current health and social care workforce planning processes; data source mapping; a research review to inform technical specifications of a planning projection model; and stakeholder engagement with the HSE; Department of Further and Higher Education, Research, Innovation, and Science; Department of Children, Equality, Disability, Integration, and Youth; Deans of medical schools; Forum of Irish Postgraduate Medical Training Bodies; and professional regulators.

“The policy dialogue was further enhanced by an

international online workshop to learn from best practice across other jurisdictions including representatives from Scotland, the Netherlands, Sweden, New Zealand, Spain, and Italy,” added the spokesperson.

The first key project output is a health and social care workforce planning strategy and action plan. The strategy provides technical detail regarding workforce modelling based on international best practice and recommendations regarding the governance structures and data collection protocols required for health and social care workforce planning.

Extensive work is also underway on the development of health and social care workforce planning models, scenario building, projections, and gap analysis. The main challenge concerns unanticipated delays on data access and constraints on data coverage, according to the Department.

Protected trainer time raised by Faculty of Radiologists and Radiation Oncologists



There were almost 500 ‘vacant’ consultant posts at the end of last year, according to HSE figures supplied to this newspaper.

There were 3,571 consultant posts filled across the HSE system at the end of December, according to the Executive’s quarterly consultant workforce report for the end of the year. This represents an increase of 30 consultant posts filled from the figures for the end of September.

The new quarterly consultant workforce report has undergone a redesign and does not include the number of vacant posts. However, a HSE spokesperson told the Medical Independent there were “just under 500 vacant posts in December 2022”.

This compares to 479 consultant posts vacant at the end of September, which is 55 fewer than at the end of June.

The IMO and IHCA have previously stated there are over 800 consultant posts unfilled on a permanent basis. The HSE figures designate posts filled by temporary or locum doctors as ‘filled’ and these posts are not included in the number of vacancies.

Asked about the changes to the quarterly consultant workforce report design, the spokesperson said: “The volume and variety of demands for data from DIME [Doctors Integrated Management E-system] has resulted in us streamlining and improving the quality of reports we produce.”

Separately, earlier this month, consultant and NCHD members of the IMO voted to reject the new Sláintecare consultant contract proposed by the Department of Health and the HSE. Some 57 per cent of current contract holders indicated they would not switch to the new contract, while 64 per cent of NCHDs said they would not take up the contract.

Nearly three-quarters of IHCA members were “not confident” the new Sláintecare contract would address the consultant recruitment and retention crisis, found a recent survey conducted by the Association.

The RCSI Faculty of Radiologists and Radiation Oncologists wrote to hospital CEOs and managers “to remind them of the necessity for protected training time” for trainers to ensure ongoing accreditation for the sites, according to a spokesperson.

The correspondence followed Medical Council accreditation exercises in 2021 for the programmes of specialist training in radiology and radiation oncology. One of the conditions of approval placed on both programmes was that the Faculty advocate to stakeholders on the need for protected trainer time. Both of the programmes were approved for five years.

The Council’s accreditation report for the radiology programme noted: “The trainees stated that the trainers do not always have adequate time for training due to the shortage of consultant radiologists. They reported that although informal tutorials might be cut short, the formal lectures that they get every week are well protected.”

The accreditation report for radiation oncology referred to the Faculty’s statement that workload was increasing due to rising cancer cases and radiotherapy treatments becoming more complicated. The situation had a “marked impact” on both trainees and trainers.

The Faculty stated that there were times when clinical service demands encroached on protected time for trainers. There was no stipulated protected time each week.

“The trainers stated that the main challenge was to obtain protected training time while maintaining the number of working hours within the acceptable limit, because they did not want to exceed the number of working hours for the trainers and trainees.”

Another condition arising from both accreditation exercises was the need for the Faculty to develop a disability policy.

An RCSI spokesperson said: “The Faculty of Radiologists and Radiation Oncologists, RCSI, fosters diversity and is dedicated to preventing discrimination in the organisation and function of the Faculty.”

“The Faculty reaffirms its commitment to these principles and formalises a framework to be followed for persons indicating a disability at the time of application to, or during completion of, one of the training schemes of the Faculty. The Faculty also underlines its commitment to the principles of inclusive training and assessment, supporting the rights of trainees to a work environment that is accessible and free from discrimination.”

A disability policy was formulated and is available on the Faculty’s website.


Pictured are Transplant Team Ireland members Ms Sheila Gregan (kidney recipient) from Nenagh, Co Tipperary; and Mr Bryan Duignan (kidney recipient) from Palatine, Co Carlow; supported by former Olympian triathlete Mr Gavin Noble, as they prepare for the World Transplant Games in Perth, Australia, next month (15-21 April). Transplant Team Ireland’s participation at the Games is managed by the Irish Kidney Association. Ranging in age from 36 to 75 years, the current Transplant Team Ireland panel comprises

of 10 men and four women. They will be among over 1,200 participants from more than 50 countries honouring their gift of life and donors through sport. Each of the Irish athletes is funding their participation in the Games (through fundraising in the name of the Irish Kidney Association/ Transplant Team Ireland and using their own funds). The team kit has been sponsored by the Health Services Staffs Credit Union.

To find out more about the Games, visit www. worldtransplantgames. org. To follow the Irish team’s progress, visit www.

‘Just under’ 500 consultant posts vacant – HSE figures
Picture: Conor McCabe Photography


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HIQA commences replacement of ‘unstable’ IT system

HIQA has contracted the firm Codec-DSS to deliver its digitally enabled regulation (DER) project, which is being undertaken due to the instability and unsustainability of the existing system.

The issue was discussed at a meeting of HIQA’s board in December 2022.

HIQA CEO Ms Angela Fitzgerald stated that the DER project was commenced prior to her appointment in June 2022. Funding had since been secured and the procurement process finalised.

“In recent weeks there has been significant and detailed discussions with the preferred vendor [Codec-DSS] to ensure that the project is delivered within a fixed price contract using agile methodology,” according to the minutes.

Board member Ms Lynsey Perdisatt told the meeting that HIQA’s current information system, PRISM, was no longer supported, was at end-of-life, and was “unstable”. The

PRISM system is used to support all regulatory activities.

“It is also not fit-for-purpose in terms of meeting the requirements associated with planned new commencements,” according to the meeting minutes.

Mr Pat Millar of Clarion Consulting, who attended the meeting virtually, also stated that the existing system was not sustainable and “carries significant risk”.

He explained that following a “rigorous procurement process”, he was satisfied that HIQA was in a position to proceed with the contract and the relationship with the proposed vendor was now “on a firm footing”.

Ms Perdisatt added that HIQA’s resource oversight committee, which met before the board meeting, had emphasised that strong governance arrangements and oversight would be required over the course of the project.

Following its discussion, the committee agreed to recommend that the board approve the contract with Codec-DSS.

In response to queries from board members, it was clarified that the current system would be kept operational

External radiology service required at University Hospital Kerry


The HSE is seeking to appoint an external provider to assist with radiology services in University Hospital Kerry (UHK). The tender document cites “year-on-year growth in demand for diagnostics” at the hospital for the decision.

The tender states that a consultant radiologist will need to be on site for two days during normal working hours.

There is also an off-site requirement for remote radiology services for three days a week.

The on-call consultant radiologist requirement will be one-in-five weekends.

A spokesperson for the South/South West Hospital Group told the Medical Independent (MI) that radiology services across the Group’s hospitals, including UHK, “utilise external supports to meet the ongoing demands and ensure clinical requirements for diagnostics are met.”

In response to a question from MI on the number of consultant radiologists at the hospital and the number of related vacancies, the spokesperson said: “The radiology services in UHK are funded for five consultants and UHK continues in its activities to recruit with an

active campaign currently ongoing to fill the permanent vacancies.”

The tender document states that in 2021, some 74,020 radiological examinations were performed within UHK and the local Caherciveen Community Hospital, excluding multi-disciplinary meetings and MRI scans.

The tender document also outlines that there was recent significant capital investment in UHK with the provision for the replacement of a fluoroscopy in plain film imaging system, and a new and additional CT scanner.

In November 2022, the President of the European Society of Radiology, Prof Aidan Brady, told this newspaper that the Irish health service was “vastly underserved” in terms of the number of radiologists being trained and employed.

“There is a lot of talk in the press about expanding access to diagnostic tests in Ireland, which is a good idea,” said Prof Brady, a Consultant Radiologist at Mercy University Hospital, Cork.

“But there is very little talk about where those people who are going to interpret those diagnostic tests are going to come from.”

while the new system was being developed.

“Risks to the existing system are being addressed by upgrading hardware, processing only essential changes requested by the business, outsourcing 24/7 security monitoring, upgrading firewalls, and managing threat,” according to the minutes.

“From the business perspective, it will be important to plan for new commencements so that the technical functionality can be managed carefully and in a way that does not increase risks to the current system.”

The meeting heard that a change management lead had been assigned to the project, “given that this will be an important aspect to… successful delivery.”

The CEO also proposed to include an external change management expert on the project steering group.

A spokesperson for HIQA told the Medical Independent the contract was awarded following approval by the board. “It is a two-year project and it has commenced,” they added.

€5 million budget for ultrasound services


The HSE has requested expressions of interest for the provision of ultrasound services to manage GP referrals and hospital waiting lists.

The annual cost of the services will be approximately €5 million annually.

According to a recent tender document, an authorisation scheme is to be established to secure “suitable suppliers” located in Ireland to meet the requirements of patients to access community ultrasound through their GPs.

“The services will be delivered using service providers’ equipment with radiologists and radiographer sonographers provided by the service provider completing exams and reporting back to the referring GP,” according to the document.

The tender is divided into two ‘lots’: ‘Lot 1’ is for patient access to community ultrasound through GPs; and ‘lot 2’ is for ultrasound services to support

hospital GP waiting lists.

The value of ‘lot 1’, which will have an initial term of three years, will be €3.5 million annually.

The value of ‘lot 2’, which will have an initial term of one year, will be €1.5 million annually.

The document states that lot 2 is required “to deal with a substantial waiting list backlog of approximately 12,000 ultrasounds”.

GP access to community ultrasound is available to adult patients (16 years of age and over) with a medical card, GP visit card, or Health Amendment Act card unless locally specified.

The ultrasound scheme to support hospital GP waiting lists (also known as the US backlog scheme) commenced in January 2021. The scheme aims to support hospital sites with waiting list management for GP-referred ultrasound patients.

It is separate from the GP access to community ultrasound in that GPs do not refer directly to the scheme.

A statement by the IHCA on 7 March concerning the results of its recent survey. It found 73 per cent of respondents were not confident that the new consultant contract would address the recruitment and retention crisis.

Prof Matthew Sadlier, IMO consultant committee Chair, announcing on 7 March that IMO members had voted to reject the new contract. According to the ballot, 57 per cent of current contract holders indicated they would not switch to the new contract.

There remain significant risks, assumptions, and dependencies that will require effective mitigation to successfully deliver the 2023 plan.
Minister for Health Stephen Donnelly following the publication of the 2023 Waiting List Action Plan on 7 March.
While the employer has moved to talk-up its significance, those of us grappling with the system day-to-day can be forgiven for having reservations.
The new contract will not address the critical shortage of consultants that we face in the Irish health services and that is shocking news for every present and future patient.

The NSAC and the work of expanding the newborn screening programme

Paul Mulholland examines minutes of the national screening advisory committee’s recent meeting on possible additions to the newborn bloodspot screening programme

The final review of the implementation of recommendations from the scoping inquiry into the CervicalCheck screening programme, which was published in November 2022, was positive about the formation of the national screening advisory committee (NSAC). The creation of such a group was one of the recommendations in Dr Gabriel Scally’s original scoping inquiry report.

“The committee’s formation happened speedily, and its operation is transparent and a great credit to its Chair, its members, and all the staff involved in supporting and informing the committee,” according to Dr Scally’s final review.

The document noted it was “particularly commendable” to see the publication of the minutes of the committee’s meetings. These minutes give an important insight into the work of the committee and how it comes to its decisions. The meeting in December 2022 focused largely on the national newborn bloodspot screening (NBS) programme and the minutes highlight the various considerations involved in adding conditions to the programme.


At the meeting, Dr Laura Comber, Senior Health Technology Assessment (HTA) Analyst, HIQA, presented on the Authority’s final HTA of the addition of a group of conditions known as severe combined immunodeficiency (SCID) to the NBS programme.

SCID is a group of rare, but serious inherited conditions that are almost uniformly fatal in the first year of life without appropriate treatment. The estimated prevalence of diagnosed SCID in Ireland is relatively high at one-in-39,760 births, with 27 patients diagnosed from 2005-to-2020. The HTA found that national and international evidence consistently suggests that the implementation of T-cell receptor excision circles (TREC)-based analysis would enable the earlier detection of infants who would otherwise present clinically and such screening should allow appropriate care to be provided soon after diagnosis.

“The committee noted that TREC-based screening is not specific to SCID,” according to the minutes.

“Other T-cell lymphopenias (TCLs) would also be identified, and it is likely that the incidence of these non-SCID TCLs would be higher than that of SCID. These findings may vary in terms of clinical implications for babies, but it is important that specific clinical pathways are in place for those babies who will inevitably be detected with non-SCID TCLs.”

The committee stated that “significant communications issues” exist for parents and guardians and health professionals relating to newborn screening, particularly concerning false positive or false negative results.

“A plan should be in place for communication, dialogue, and reassurance to parents and guardians should they receive a false positive or false negative result,” according to the minutes.

As the equipment required for screening for SCID is not currently used in Ireland, planning is required to procure and implement the test by the NBS laboratory.

“Key operational challenges exist, and consideration must be given to the timing of implementation, given the scheduled move of the national NBS laboratory to the New Children’s Hospital.”

The committee decided to recommend to the Minister for Health Stephen Donnelly that screening for SCID should be added to the programme.

Other conditions

At its December meeting, the committee recognised the need for a transparent process to enable the preliminary pri-

oritisation of the 35 conditions that may be considered for assessment for potential addition to the NBS programme. These include 30 conditions identified from clinical advice from the HSE’s NBS programme governance group, as well as additional conditions proposed via the committee’s first annual call, which was made in December 2021. The committee selected five conditions following the consideration of the preliminary prioritisation.

Spinal muscular atrophy (SMA) should be considered as the next priority condition to undergo an in-depth HTA by HIQA for addition to the NBS programme, according to the committee.

“This advice is based on the clinical urgency arising from the prevalence in Ireland, the severity of the condition, the recent availability of curative treatments, and an existing diagnostic and treatment pathway in Ireland,” the minutes state.

“It was also noted, in terms of testing platform, that the same testing kits used for SCID would also enable testing for SMA.”

It was agreed the Chair of the committee, Prof Niall O’Higgins, would write to HIQA to request a HTA on the potential for the condition to be added to the programme.

The committee agreed that sickle cell disease should also be considered for more in-depth assessment, noting it was commonly screened for in many other countries.

“The group noted that the changing demographic in Ireland would likely increase prevalence, and that a full treat-

ment pathway (including bone marrow transplant) is not yet available in Ireland. Treatment is complex and evolving,” the minutes state.

The group advised that further information, including current opportunistic testing in Ireland, would be needed in evaluating screening for sickle cell disease in Ireland.

In-depth assessment of tyrosinaemia type I is also under consideration. The group advised that the longer list of conditions should be reviewed with a view to considering whether it would be more efficient to assess a cluster of conditions (including tyrosinaemia), which could be implemented simultaneously.

Another condition which should be considered for indepth assessment was biotinidase deficiency. The group noted that while it was relatively rare in Ireland, it was treatable, and the testing kit required would be available in Ireland in the near future. The group advised that glycogen storage disease type II (POMPE) was “not appropriate to include in the priority shortlist at present as there is currently very limited screening carried out for this condition internationally”.


In January 2023, Minister Donnelly announced the approval of the recommendation for SCID screening, bringing to 10 the number of conditions screened under the programme. It was also announced that HIQA will carry out a HTA on SMA and is expected to deliver its recommendation later this year.

The importance of ‘feasibility’

The inaugural annual call of the national screening advisory committee (NSAC) in 2021 for proposals for new screening programmes, or changes to existing programmes, received a significant response with over 50 submissions. The committee gave each submission consideration and recently published its work programme, which includes evaluation of proposals on cancer, non-cancer conditions, as well as the priority workstream on the expansion of newborn bloodspot screening.

The committee’s second annual call was launched on 30 November 2022 and ran until 27 January 2023. A total of 19 applications were received and will be reviewed by the committee at its scheduled meetings this year.

Speaking to the Medical Independent (MI) at the end of last year, NSAC Chair Prof Niall O’Higgins said “feasibility” around implementation is an important consideration for the committee when making its recommendations.

“We have to have an idea about the health economics and the feasibility of [a proposal], particularly with a new programme where you are starting from the very beginning and all ramifications of that for a health service, not least of which is the struggle the screening programmes have had as a consequence of the pandemic,” according to Prof O’Higgins.

“So we have to be careful not to recommend a whole slew of things that are going to be impossible to implement.”

Prof O’Higgins said it was worth noting that the UK national screening committee, which was established

in 1996, does not put forward recommendations for implementing many of the proposals it receives.

“That is because the criteria for recommending are fairly strict,” he said.

“And we are going to be fairly strict and rely on the existing criteria for recommending populationbased screening. We have to try to get across the message – when we don’t recommend something, it isn’t because the condition isn’t worthy of intensive management or treatment; it is just population-based screening is a whole new dimension to care and it is quite important it is considered as a public service rather than an individual patient care issue. It is not always easy to get that across.”

Prof O’Higgins also said there was a need for the evidence assessment team in place in HIQA, which supports the work of the NSAC, to be expanded given the committee’s growing workload.

“We have been supported in our endeavours and what we asked for to date,” he said.

A spokesperson for the Department of Health told MI it has sanctioned additional and permanent posts, which will increase the HIQA team to nine permanent posts.

“Recruitment is under way and it is expected that the new posts will be filled in the coming months,” the spokesperson added.

Also, at the end of last year, the Department sought expressions of interest for appointments of members to the NSAC. The spokesperson confirmed appointments have been made in the areas of communications/journalism; cancer; medico-legal; and diagnostic imaging.


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The mental health legacy of a troubling past

Next month marks the 25th anniversary of the signing of the Good Friday Agreement, but the mental health consequences of ‘the Troubles’ continue, writes David

The mental health impact caused by ‘the Troubles’ is still felt in Northern Ireland, the Creative Brain Week 2023 in Trinity College Dublin heard earlier this month (7 March).

Dr Ciaran Mulholland, Consultant Psychiatrist with the Northern Health and Social Care Trust and Senior Lecturer in the Centre for Medical Education at Queen’s University of Belfast, addressed the conference.

Dr Mulholland was one of a number of speakers addressing the issue of the impact of conflict and its enduring effects on the health of civilians and combatants. He outlined that the level of violence had fallen significantly since the Good Friday Agreement in 1998, but had not ceased. The last 25 years had also witnessed continued political instability with the local governmental structures in Belfast operating “only 50 per cent of the time... so within the Agreement, there have been disagreements”.

“My subject is the Troubles in Northern Ireland, the conflict, and violence. It is an emotive subject, it affected everyone who lived through that period of time, north and south,” Dr Mulholland told attendees.

“I know when I give these talks my heart rate increases. I do not get nervous about public speaking; it does not bother me. It’s the topic that touches on something dramatic from the past... and it’s important for me to acknowledge that myself; it is something in me and my brain, how it has affected me and marked me.”

Dr Mulholland noted we are “only beginning to have a greater understanding of the neuroscience of what actually happens to the psychologically injured brain.... We have to be realistic, we are not going to change everything, we are not going to change world politics through neuroscience, but understanding what happens is very important.”

He added that over recent years “a number of surveys have shown more or less the same thing, which is about 40 per cent of the [Northern Ireland] population had a

very direct experience of the conflict, they were personally injured or somebody close to them was injured or died. But the other 60 per cent did not emerge unscathed from the experience....

“Most people in Northern Ireland kind of discount the minor [experience], or kind of play it down. So if they are asked ‘did the Troubles affect you’, they will say, ‘oh no, not really.’ But in reality it might have impacted them in a number of ways.”

Speaking to the Medical Independent (MI) following his speech, Dr Mulholland said some positive initiatives have occurred in cross-border cooperation on mental health issues arising out of the Troubles. However, progress slowed due to a range of factors including suspensions of political institutions north of the border.

“We have had conversations with HSE colleagues on several occasions over the last number of years in regards cross-border efforts and we agreed in principle that there ought to be something in the south of Ireland which mirrors what we are doing in the north of Ireland,” Dr Mulholland told MI. “But because everything has moved so slowly, we have not pushed forward with that agenda.”

Dr Mulholland noted that cross-border work is “a conversation that we need to reengage with”. He said community groups have been working together and “some of those groups work across the border, so they would have clients in the border counties in particular”.

“So we have to come up with creative solutions, but we are just in the early days of trying to make that happen.”

During his address, Dr Mulholland mentioned large population movements that had occurred in the north of Ireland during the Troubles. Is there much known about the mental health legacy of those who left

during the conflict and moved to the UK, the US or elsewhere?

“There isn’t, but there might be soon,” he told MI, noting the development of the socalled ‘Troubles pension’.

Disablement payment

The Troubles Permanent Disablement Payment (TPDP) scheme has been designed to provide those who suffered permanent disablement (either physical or psychological) as a result of an injury caused through no fault of their own in a Troubles-related incident. The payments are made primarily in acknowledgement of the acute harm which they have suffered. Dr Mulholland said the TPDP scheme was launched 18 months ago, and 3,800 applications had been made so far.

“It is open to anyone in the world who was impacted by what happened in Northern Ireland, if at the time when it happened they were a citizen of the United Kingdom,”

Dr Mulholland told MI. “So we have received several applications from people from Northern Ireland who now live in Australia, America, Europe, mostly in England, Scotland, and Wales,” he said.

“It is early days and it’s a pension scheme, so we haven’t brought a research gaze to that yet, but we will in time. We might now actually get some information on those who left and the long-term [mental health] consequences. This has not existed before now and that is very important.

“So in two or three years’ time, maybe as early as that, we might be able to say something about that. Maybe we will perhaps have 1,000 people who left Northern Ireland and now live somewhere else and we will see the long-term psychological consequences.”


The Omagh bombing of 1998 marked a

“turning point in the mental health response” of the health system to violence. Dr Mulholland outlined that the aftermath of the Omagh bomb “changed everything” in the area, with new landmark therapeutic studies into the trial use of trauma-focused cognitive behavioural therapy (CBT) for victims. Dr Mulholland said such studies “demonstrated very strong evidence... that trauma-focused CBT is effective treatment for PTSD [post-traumatic stress disorder] in civil conflict”.

Eight years ago, he was also involved in the foundation of the regional trauma network north of the border. Dr Mulholland noted progress had been slow partly because of the political difficulties in the north.

“Everything is so sensitive and so tentative, it is difficult to make the strides forward we would like to make,” he said.

“But, nevertheless, today we have a developing network, which means the statutory services work very closely with our colleagues in the community and voluntary sector.” The network currently works with over 40 voluntary groups.

A series of studies have indicated the scale of the local mental health challenge. Dr Mulholland pointed to World Health Organisation figures that indicate the continuing existence of significant mental health challenges in Northern Ireland.

“We do see relatively high rates of common mental health disorders,” he said, listing PTSD, addiction, depression, and anxiety as examples. A study from a decade ago showed high PTSD levels compared to many other countries. A separate study from three years ago indicated one-in-20 young people in Northern Ireland had a stress-related mental health disorder.

“One of the things I find very interesting about our history is that the experience of the Troubles meant that Northern Ireland became a world leader in physical trauma care and there are techniques and approaches established in Belfast that have become embedded in trauma care and disaster responses all around the world now,” Dr Mulholland outlined in his talk. However, in contrast, the mental health services in Northern Ireland had “unfortunately, not led the world”.

“Why is that? Well, it’s complex. It’s not that mental health services did not respond. Mental health services and GPs were at times overwhelmed, but in general they held the line during the course of the 1970s and 1980s. Primarily, that meant the prescribing of medication. Psychological therapies were not well-developed and the scale of the problem was just too difficult. So what did we do? Well, we prescribed a lot.” Dr Mulholland said there were “high rates” of benzodiazepine prescription “especially in the 1970s”.

He noted that “today in the 2020s” Northern Ireland “has one of the highest rates of anti-depressant prescribing in the entire world”.

In the provision of wider mental health services, voluntary community groups did step in, “especially towards the end of the conflict and after the Good Friday Agreement.”

Looking at the impact on healthcare staff during the conflict, Dr Mulholland recalled that “we were not immune to the violence, there was violence everywhere. There was violence in the hospital setting... shootings and killings in hospitals.”

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The weaponisation of aid and healthcare


The aftermath of the earthquakes in Turkey and Syria highlighted the life-saving work of aid workers. However, in the broader context, humanitarian aid is increasingly exploited as a weapon of war and doctors and other aid workers face intimidation, attacks and threats to their lives.

The “weaponisation” of humanitarian aid and healthcare in conflict zones takes many forms, including bombing medical centres and killing healthcare workers; and the starvation of people by withholding food aid to one side in a conflict and diverting it to the other side.

Human rights groups and researchers say such weaponisation of medical and other humanitarian aid is imperilling the lives of huge numbers of people.


According to Dr Peter Gleick, founder of the Pacific Institute water expert group: “Of special concern is civil unrest over water scarcity and the control of local water resources, and a growing number of attacks on civilian water infrastructure during conflicts and war around the world.”

An update to the group’s Water Conflict Chronology in 2022 provided information on events related to water and conflict. On 4 January 2022, for example, Israeli military forces demolished Palestinian-owned agricultural facilities in Ibziq, West Bank, including a water tank. A few days earlier, in Somalia, Al Shabaab militants killed 10 people and injured 15 in an attack on a water tank. At the start of its war in Ukraine last year, Russian troops destroyed a Ukrainian dam that had blocked water to Crimea, which Moscow had annexed in 2014.

The weaponisation of aid can also occur following natural disasters. Amid the additional suffering in his wartorn country after the 6 February earthquakes, Syrian President Bashar al-Assad took a week to agree to border crossing points being used for humanitarian aid to reach a rebel-held province.

Human rights groups have also denounced the trial in January 2023 of 24 humanitarian workers, including Irishman Mr Seán Binder, who participated in migrant rescue operations in Lesbos, Greece. The prosecution alleged that smuggling offences were committed. The defendants denied all charges.

Amnesty International and other organisations have criticised the Greek authorities for using “farcical” and “baseless” charges to make an example of humanitarian workers. Some charges have since been dropped, but Amnesty International has called on the Greek authorities to drop all charges against the workers.


In a statement on 13 January, the UN human rights office said the case had a chilling effect on humanitarian organisations in the region. “Trials like this are deeply concerning because they criminalise life-saving work and set a dangerous precedent,” said Ms Elizabeth Throssell of the UN’s Office of the High Commissioner for Human Rights. “Indeed, there has already been a chilling effect with human rights defenders. We reiterate our call for charges against the 24 to be dismissed.”

The aid workers were affiliated with the Emergency

Response Centre International, a non-profit search and rescue group operating in Lesbos from 2016 to 2018. The island was then on the frontline of Europe’s refugee crisis with scores of asylum seekers arriving daily on its shores. “Saving lives and providing humanitarian assistance should never be criminalised or prosecuted,” Ms Throssell said. “Such actions are, quite simply, a humanitarian and human rights imperative.”

In 2023, according to the United Nations Office for the Coordination of Humanitarian Affairs (UNOCHA), a record 339 million people will need humanitarian assistance and protection. This is a significant increase from 274 million people at the beginning of 2022. The UN and partner organisations aim to assist 230 million people most in need across 68 countries, which will require €58.5 billion.

In July 2022, it was announced the European Investment Bank (EIB) agreed to disburse €1.6 billion to Ukraine. This was the second package of support for Ukraine under the EIB Ukraine solidarity urgent response developed in close cooperation with the Euro -

pean Commission. It followed an emergency support package of €668 million fully disbursed within a month of the war's beginning. In addition, the Ukraine regional response in 2023 will combine both a humanitarian and refugee response plan, aiming to support 13.6 million people with a total requirement of €5.3 billion.

A resolution on “Safety and security of humanitarian personnel and protection of United Nations personnel” was adopted at a meeting of the UN General Assembly in New York on 6 December 2022. It condemned all acts of violence, attacks and threats against humanitarian workers, as well as UN and associated personnel. It also called on states to explore and scale up measures for more systematic monitoring, reporting and investigation of attacks against humanitarian and medical personnel.

The Head of the EU delegation, Mr Björn Olof Skoog, said member states were committed to protecting humanitarian space and deterring violations of international humanitarian law (IHL). Continued violations was preventing vital assistance from reaching those in need, he said. “Humanitarian actors and medical workers must never be targets, perpetrators must be held accountable.”


The weaponisation of healthcare in Syria was highlighted in a report for The Lancet – American University of Bei-

aid and healthcare are increasingly exploited as weapons of war. Bette Browne reports
Humanitarian actors and medical workers must never be targets, perpetrators must be held accountable
Continued on p16 ▸
Mr Björn Olof Skoog Ms Elizabeth Throssell

For patients not adequately controlled on dual therapy with moderate to severe COPD


Significant protection against exacerbations*

TRIXEO Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.1

*Significant reductions in the rate of moderate or severe exacerbations vs LAMA/LABA (24%, n=2137 vs n=2120, annual rates 1.08 vs 1.42, 95% CI 0.69–0.83; p<0.001) and ICS/LABA (13%, n=2137 vs n=2131, annual rates 1.08 vs 1.24, 95% CI 0.79–0.95; p=0.003).1,2 COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist. In the clinical trial programme for TRIXEO, LAMA/LABA refers to glycopyrronium/formoterol fumarate and ICS/LABA refers to budesonide/formoterol fumarate. ©AstraZeneca

Consult Summary of Product Characteristics (SmPC) before prescribing.

Indication: Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Presentation: Pressurised inhalation, suspension. Each single actuation (delivered dose, ex-actuator) contains 5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2 micrograms of glycopyrronium and budesonide 160 micrograms.

Dosage and Administration: The recommended and maximum dose is two inhalations twice daily (two inhalations morning and evening). If a dose is missed, take as soon as possible and take the next dose at the usual time. A double dose should not be taken to make up for a forgotten dose. Special populations: Elderly: No dose adjustments required in elderly patients.

Renal impairment and Hepatic Impairment: Use at recommended dose in patients with mild to moderate renal impairment, and patients with mild to moderate hepatic impairment. Can also be used at the recommended dose in patients with severe hepatic impairment, severe renal impairment or endstage renal disease requiring dialysis, only if expected benefit outweighs the potential risk. Patients with severe hepatic impairment should be monitored for potential adverse reactions. Paediatric Population: No relevant use in children and adolescents (<18 years of age). Method of administration: For inhalation use. Patient’s inhaler technique should be regularly reviewed by physician or other healthcare professional. Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer.

Contraindications: Hypersensitivity to the active substances or to any of the excipients.

Warnings and Precautions: Not for acute use: Not indicated for treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. Paradoxical bronchospasm: Administration of formoterol/glycopyrronium/budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life threatening. Treatment should be discontinued immediately. Assess patient and institute alternative therapy if necessary. Deterioration of disease: Recommended that treatment should not be stopped abruptly. If patients find the treatment ineffective, continue treatment but seek medical attention. Increasing use of reliever bronchodilators indicates worsening of the underlying condition and warrants reassessment of the therapy. Sudden and progressive deterioration in the symptoms of COPD is potentially life threatening, patient should undergo urgent medical assessment. Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol. Use with caution in patients with clinically significant uncontrolled and severe cardiovascular disease. Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval. Systemic corticosteroid effects: May occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Potential effects on bone density should be

considered particularly in patients on high doses for prolonged periods that have co existing risk factors for osteoporosis. Visual disturbances: May be reported with systemic and topical corticosteroid use. If patient presents symptoms such as blurred vision or other visual disturbances, consider ophthalmologist referral for evaluation of possible causes. Transfer from oral therapy: Care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Clinical features of such infections can overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia: Potentially serious hypokalaemia may result from ß2-agonist therapy. This has potential to produce adverse cardiovascular effects. Caution is advised in severe COPD as this effect may be potentiated by hypoxia. Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics. Hyperglycaemia: Inhalation of high doses of ß2adrenergic agonists may produce increases in plasma glucose. Blood glucose should be monitored during treatment following established guidelines in patients with diabetes.

Co-existing conditions: Use with caution in patients with thyrotoxicosis. Anticholinergic activity: Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop. Co-administration with other anticholinergic containing medicinal products is not recommended. Drug Interactions: Co-treatment with strong CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products, are expected to increase the risk of systemic side effects and should be avoided unless the benefit outweighs the increased risk, in which case patients should be monitored for systemic corticosteroid adverse reactions. This is of limited clinical importance for short-term (1-2 weeks) treatment. Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms. Other antimuscarinics and sympathomimetics: Coadministration with other anticholinergic and/or long-acting ß2-adrenergic agonist containing medicinal products is not recommended as it may potentiate known inhaled muscarinic antagonist or ß2-adrenergic agonist adverse reactions. Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects, therefore caution is required when prescribed concomitantly with formoterol. Medicinal product-induced hypokalaemia: Possible initial hypokalaemia may be potentiated by xanthine derivatives, steroids and non potassium sparing diuretics. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. ß-adrenergic blockers: ß-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concurrent use should be avoided unless the expected benefit outweighs the potential risk. If required, cardio-selective ß-adrenergic blockers are preferred. Other pharmacodynamic interactions: Concomitant treatment with quinidine,

disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong QT interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics. Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. Elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.

Pregnancy and Lactation: Administration to pregnant women/women who are breast-feeding should only be considered if the expected benefit to the mother justifies the potential risk to the foetus/child.

Ability to Drive and Use Machines: Dizziness is an uncommon side effect which should be taken into account.

Undesirable Events: Consult SmPC for a full list of side effects. Common (≥ 1/100 to < 1/10): Oral candidiasis, pneumonia, hyperglycaemia, anxiety, insomnia, headache, palpitations, dysphonia, cough, nausea, muscle spasms, urinary tract infection. Uncommon (≥ 1/1,000 to < 1/100): Hypersensitivity, depression, agitation, restlessness, nervousness, dizziness, tremor, angina pectoris, tachycardia, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles), throat irritation, bronchospasm, dry mouth, bruising, urinary retention, chest pain. Very Rare (< 1/10,000): Signs or symptoms of systemic glucocorticosteroid effects, e.g. hypofunction of the adrenal gland, abnormal behaviour. Not known: Angioedema, vision blurred, cataract, glaucoma.

Legal Category: Product subject to prescription which may be renewed (B)

Marketing Authorisation Number: EU/1/20/1498/002 120 actuations

Marketing Authorisation Holder: AstraZeneca AB, SE-151 85, Södertälje, Sweden.

Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, College Business and Technology Park, Blanchardstown Road North, Dublin 15 Tel: +353 1 609 7100. TRIXEO and AEROSPHERE are trademarks of the AstraZeneca group of companies.

Date of API preparation: 05/2022

Veeva ID: IE-3823

Adverse events should be reported directly to; HPRA Pharmacovigilance, Website: Adverse events should also be reported to AstraZeneca Patient Safety on Freephone 1800 800 899

1. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. Summary of Product Characteristics. Available at

2. Rabe KF et al. Triple inhaled therapy at two glucocorticoid doses in modeate-to-very-severe COPD. N Engl J Med. 2020;383:35–48. doi: 10.1056/ NEJMoa1916046 COPD. N Engl J Med. 2020;383:35–48. doi: 10.1056/NEJMoa1916046

Veeva ID: IE-4094 Preparation Date: September 2022
All rights reserved. ABRIDGED PRESCRIBING INFORMATION TRIXEO AEROSPHERE® 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension (formoterol fumarate dihydrate/ glycopyrronium/ budesonide)

rut Commission on Syria in 2017. “The weaponisation of healthcare – a strategy of using people’s need for healthcare as a weapon against them by violently depriving them of it – has translated into hundreds of health workers killed, hundreds more incarcerated or tortured, and hundreds of health facilities deliberately and systematically attacked. Evidence shows use of this strategy on an unprecedented scale by the Syrian Government and allied forces, in what human rights organisations described as a war-crime strategy, although all parties seem to have committed violations.”

It described this war-crime strategy as multi-dimensional. “It includes practices such as attacking healthcare facilities, targeting health workers, obliterating medical neutrality, and besieging medicine. Through large-scale violations of international humanitarian laws, weaponisation of healthcare amounts to what has been called a war-crime strategy.

“The pattern of attacks on health facilities suggests intention to target, which is a war crime. Targeting of health workers, largely by pro-government forces, has continued and takes many forms in attacks on health facilities, executions, imprisonment or threat of imprisonment, unlawful disappearance (ie, kidnapping), abduction, and torture sometimes leading to death. As a consequence of the targeting of health workers, hundreds of health workers have been killed.”

Physicians for Human Rights (PHR) has verified more than 600 attacks on 400 health facilities in Syria and the killing of at least 945 medical staff since the start of the conflict in March 2011.

According to the global health reporting site Health Policy Watch , Russia’s invasion of Ukraine has also sparked a global health crisis.

“Russia’s war in Ukraine has sparked a global health crisis – from the death, suffering and displacement of people in the country to the global food and fuel insecurity, and diminished donor funds to support other health issues.” Health Policy Watch quoted Ms Ulana Suprun, a former Ukrainian health minister, as highlighting the fact that the UN High Commissioner for Refugees estimated that about 17.6 million Ukrainians, which is about 43 per cent of Ukraine’s population of 41 million, will need humanitarian assistance in 2023.

“It is very nice to say that healthcare is not political or that global health doesn’t get involved in politics,” Ms Suprun said. “But we can see today that global health is being impacted by the war that Russia started in Ukraine.”

International Rescue Committee

The CEO of the International Rescue Committee (IRC), Mr David Miliband, emphasised in an essay in March 2022 for Time magazine that there was a need for vigilance about violations of international humanitarian law around the world.

“It is… vital that civilians also suffering in other places don’t pay the price in loss of attention and resources,” he said. “The opposite should be the case. Support for Ukrainians should not come at the expense of Afghans, Yemenis, Ethiopians, or Syrians who face equally brutal tactics and disregard for the laws of war.

“Too often, violators of international humanitarian law face no consequences. The IRC is calling for an end to an era in which laws intended to protect civilians are

Basic rules of international humanitarian law (IHL)

 The parties to a conflict must at all times distinguish between the civilian population and combatants in order to spare the civilian population and civilian property. Neither the civilian population as a whole, nor individual civilians, may be attacked. Attacks may only be made against military objectives.

 People who do not or can no longer take part in hostilities are entitled to respect for their lives and for their physical and psychological wellbeing. They must in all circumstances be protected and treated with humanity, without distinction. It is forbidden to kill or wound an enemy who surrenders or who can no longer take part in the fighting.

 Neither the parties to the conflict nor members of their armed forces have an unlimited right to choose methods and means of warfare. It is forbidden to use weapons or methods of warfare that are likely to cause unnecessary losses or excessive suffering.

 The wounded and sick must be collected and cared for by the party to the conflict which has them in its power. Medical personnel and medical facilities and vehicles may not be attacked. Personnel wearing the distinctive emblem of the Red Cross, Red Crescent or Red Crystal on white backgrounds, and facilities and vehicles bearing the emblems, must be respected.

Ireland’s role in IHL

The core of modern IHL is set out in the four Geneva Conventions of 1949 and their additional protocols

and amendments.

Every state in the world has adhered to the Geneva Conventions and although not all states are yet parties to the two additional protocols of 1977, many of the rules set out in these instruments enjoy the status of customary international law applicable to all states.

Ireland was one of a core group of states that promoted the development of a new instrument of IHL on cluster munitions that culminated in the adoption of the Convention on Cluster Munitions at a conference in Dublin in May 2008.

Ireland signed and ratified the Convention on 3 December 2008. The Convention entered into force on 1 August 2010.

Ireland also participated in the Initiative of the International Committee of the Red Cross (ICRC) and the Swiss government to develop proposals to enhance the effectiveness of mechanisms to ensure compliance with international humanitarian law.

The Initiative was one of the principal outcomes of the 31st International Conference of the Red Cross and Red Crescent in 2011. Proposals to improve compliance with IHL were presented at the 32nd international conference of the ICRC in 2015. A resolution was adopted mandating the continuation of the process.

(Sources: Irish Department of Foreign Affairs, Irish Red Cross, UN)

seen as optional.

“We have also called for more support for humanitarian workers who need to reach the most vulnerable people in crisis areas, but are hindered by parties to a conflict.”

Mr Miliband also called for these efforts to be supported worldwide with the establishment of an Organisation for the Protection of Humanitarian Access, a body that would highlight the “strangulation and weaponisation of humanitarian aid” in conflict zones.

Others had shown little has been done to halt such attacks. “The international community has left these violations of international humanitarian and human rights law largely unanswered, despite their enormous consequences,” according to The Lancet – American University of Beirut Commission inquiry on Syria. “There have been repeated denunciations, but little action on bringing the perpetrators to justice. This inadequate response challenges the foundation of medical neutrality needed to sustain the operations of global health and humanitarian agencies in situations of armed conflict.”

International humanitarian law

IHL forbids intentional attacks on civilians. It stipulates that targeting civilians or critical civilian infrastructure, such as hospitals, could constitute a war crime. It also prohibits attacks on military objectives that do not take adequate precautions to avoid collateral harm to civilians.

“IHL plays an important part in protecting those of us who travel to dangerous places on humanitarian grounds,” the Irish Red Cross states on its website. “Our many aid workers need knowledge of IHL to protect themselves and those they assist. For Irish Defence Forces on peacekeeping missions with the UN and EU, IHL is often a critical aspect of their mandate. Respect for IHL saves lives, reduces human suffering and ensures protection of human dignity.”

Efforts for greater accountability have gained momentum in ensuring community engagement and accessible systems for feedback into operations, according to the UN. For example, in the Central African Republic (CAR), community consultations are helping humanitarian responders to understand how affected people experience the crisis as well as the response. The CAR humanitarian fund is also prioritising funding for projects that focus on collective accountability to affected people.

Ireland has ratified a large number of IHL treaties and in 2008 helped to broker an agreement on the Convention on Cluster Munitions adopted by 107 states in Dublin.

In a speech marking the 60th anniversary of the Geneva Conventions on human rights in 2009, the then Minister for Foreign Affairs, and current Tánaiste, Micheál Martin said the four Geneva Conventions of 1949 remained at the centre of modern international humanitarian law.

“It is a tribute to the power of the ideas represented by these Conventions that they are now universally applicable, that is that every state in the world has either ratified or acceded to them. This is a very rare distinction for any multilateral treaty. The four Conventions have been supplemented by two additional protocols concluded in 1977 and a third in 2005. Between them, these instruments constitute a very significant body of law that has played a vital – and continuing – role in limiting the horrors of warfare.”

He also stressed that accountability was important when humanitarian laws were breached.

While Ireland was prepared to join with other countries to develop the law if necessary, he suggested it was more a question of respecting the existing rules which “by and large were neither insufficient nor obsolete”.

“But where they are not followed there must also be accountability,” he stressed. “Successive Irish governments have consistently advocated the effective investigation and prosecution of violations of international humanitarian law. Ireland has also been a consistent and strong supporter of the International Criminal Court, recognising it as an essential means of ending a culture of impunity and of ensuring respect for international humanitarian law at the highest levels.”

Continued from p14 ▸
Too often, violators of international humanitarian law face no consequences
Ms Ulana Suprun
Centre for Women’s Health Mater Private Network | Cork Mater Private Network | Cork tel: 021 601 3387 · 021 201 0764 Ireland’s first, hospital-based Centre for Women’s Health
Dr. Alex O’Brien General Practitioner in Women’s Health Dr. Susan Wilson Gynaecology Fellow (SPR Obs & Gynae) Elaine Dilloughery Specialist Nursing, CNMII Michelle O’Brien Specialist Nursing, CNMI Prof. Barry O’Reilly Consultant Obstetrician & Gynaecologist
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The campaign for universal access to safe, timely and affordable hearing and ear care

Many non-complex ENT conditions can be treated in primary care, but this requires education and training

Unaddressed hearing loss has a detrimental impact on an individual’s quality-of-life. It may result in limiting educational potential, impede socioeconomic advancement, and negatively impact social engagement.

The World Health Organisation (WHO) cites lack of access to ear and hearing care as the third largest cause of global disease burden. Currently, more than 1.5 billion people experience some degree of hearing loss. This number could potentially double over the next 25 years.

In order to address these issues, the WHO is campaigning for universal access to safe, timely and affordable hearing and ear care by integration of these services within primary care.

The WHO estimates that 60 per cent of ear conditions are non-complex and could be safely evaluated and managed by primary care. It proposes achieving these goals through the introduction of targeted clinical ear, nose, and throat (ENT) education, and skills training and capacity building, at the community level.

World Hearing Day 2023 aimed to “highlight the importance of integrating ear and hearing care within primary care, as an essential component of universal health coverage”.

On 3 March 2023, the WHO launched a Primary ear and hearing care training manual aimed at community healthcare providers.


To address this deficit, we developed a novel ENT educational and training Fellowship programme for GPs who wish to deliver community-based ENT care in an Irish setting. The 12-month programme is delivered at the urgent care ENT department in the Royal Victoria Eye and Ear Hospital, Dublin, by the Programme Director Prof Camilla Carroll. The Fellowship is funded by the HSE National Doctors Training and Planning (NDTP) Aspire Fellowship pathway and the curriculum is accreditation by the RCSI.

The concept of integrating non-complex ENT care into a universal healthcare model is in keeping with the Otolaryngology Head and Neck Surgery: A Model of Care for Ireland launched in February 2019 and based on Sláintecare principles and WHO guidelines.

In the Republic of Ireland, ENT conditions account for a significant number of adult primary care visits (30-to-50 per cent). ENT referrals from general practice represent the third largest group of patient referrals to secondary care. However, Ireland has the lowest number of ENT consultant specialists in the EU, with one consultant per 82,000 population, compared to an EU average of one consultant per 19,500.

In the Irish setting, age-related ENT conditions occur in approximately 60 per cent of patients over 65 years. Simple conditions, such as cerumen impaction, in this cohort of patients are linked to the progression of cognitive impairment and left untreated can place a significant burden on the Irish healthcare system.

Currently, over 42,000 patients are waiting for a public ENT outpatient appointment, according to the latest National Treatment Purchase Fund data.

The ENT outpatient waiting numbers represent one of the largest group of patients waiting for a specialist opinion. This has been further compounded by the impact of the Covid-19 pandemic.

Almost 11,000 patients are now waiting more than 18 months for an ENT specialist. Waiting list validation has identified that approximately 33 per cent of these patients have non-complex ENT conditions, which are amenable to safe and effective treatment in primary care. However, there is limited ENT education and skills training in postgraduate primary care programmes. Many GPs are, therefore, not currently in a position to offer non-complex ENT care to their patients and have to refer the patient to the secondary care setting.

The inaugural Fellow Dr Cristina Warren, appointed in 2021, has now established a Community ENT service in Grangegorman, Dublin. This community ENT clinic is the first of its kind nationally providing a patient-to-specialist GP ENT service. The service has been very well received by patients to date.

PG Cert

To address capacity building for the provision of primary ear and hearing care in the community setting in Ireland, we have also developed and deliver a micro-credentialing postgraduate certificate (PG Cert) programme at the RCSI. The PG Cert in the ‘Management and care of the ENT patient’ is aimed at the multidisciplinary ENT healthcare team, working in a commu-

nity primary care setting.

This unique education and skills programme consists of three modules covering ear, nose, and throat conditions commonly encountered in primary care practice. The postgraduate ENT programme will equip the course participant with the necessary knowledge, skills, and professional attributes required to work as part of the multidisciplinary ENT team, tasked with the delivery of high-quality patient care. We have successfully graduated 25 practitioners from this programme, who are now delivering ENT care in a community setting.

The WHO has emphasised the need to raise awareness of ear conditions and hearing loss as a global healthcare priority. In the Irish setting, the 2019 implementation of the ENT model of care was the first step in policy development at national level towards the integration of ear and hearing care service delivery into the primary care environment.

The provision of educational funding by the NDTP in 2021 to facilitate the delivery of a targeted primary care ENT Fellowship has enabled skilled GP ENT specialists to enter the Irish healthcare workforce.

Scaling up to provide a significant number of skilled GP ENT specialists in primary care is possible through initiatives such as the PG Cert in ENT. It is now time to introduce probably the most important aspect of the ear and hearing care programme and focus on public engagement. The education of young people and adults of all ages about the importance of ear and hearing care and knowing when to seek medical attention will have a beneficial impact on maintaining a good quality-of-life and a meaningful contribution to society now and into the future.

PROF CAMILLA CARROLL , Consultant ENT Surgeon, Royal Victoria Eye and Ear Hospital, Dublin; and DR CRISTINA WARREN , Community ENT GP Specialist Dr Cristina Warren in community ENT practice PG Cert ear simulation training Pictured L-to-R: Prof Michael Walsh, Clinical ENT Advisor, HSE National Clinical Programme in Surgery; Prof Camilla Carroll, Consultant ENT Surgeon, Royal Victoria Eye and Ear Hospital, Dublin; Prof Tom O’Connor, Faculty of Nursing, RCSI; and Prof Nash Patil, Consultant ENT Surgeon, Saolta University Health Care Hospital Group

Genuair®-has it ‘clicked’ yet?

The ONLY prefilled inhaler with visual and audible feedback for confirmed dose delivery1-4

Genuair - a simple to use inhaler for patients with COPD4

Abbreviated Prescribing Information

Eklira® Genuair® 322 micrograms inhalation powder. Please consult the Summary of Product Characteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a white inhaler with an integral dose indicator and a green dosage button. Each delivered dose contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium. Also, contains lactose. Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Dosage: For inhalation use. Recommended dose is one inhalation of 322 micrograms aclidinium twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to aclidinium bromide or to any of the excipients. Warnings and Precautions: Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Use with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma. Do not use in patients with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption. Interactions: Do not administer with other anticholinergic-containing medicinal products. No other interactions expected. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Risk to newborns/infants cannot be excluded. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Sinusitis, nasopharyngitis, headache, cough, diarrhoea, nausea. Uncommon (0.1-1%): Dizziness, blurred vision, tachycardia, palpitations, dysphonia, dry mouth, stomatitis, rash, pruritus, urinary retention. Rare (0.01-0.1%): hypersensitivity. Not known: angioedema, anaphylactic reaction. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing Authorisation Number: EU/1/12/778/002

Marketing Authorisation holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: February 2020

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website:, e-mail: medsafety@ Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744.

Date of item: November 2020. IR-BRI-09-2020

Abbreviated Prescribing Information Brimica® Genuair® 340 micrograms/12 micrograms inhalation powder. Please consult the Summary of Product Characteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a white inhaler with an integral dose indicator and an orange dosage button. Each delivered dose contains 396 µg aclidinium bromide (equivalent to 340 µg of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate. Also, contains lactose. Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage: For inhalation use. Recommended dose is one inhalation of 340 µg/12 µg twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Do not use in asthma. Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Discontinue if increases in pulse rate, blood pressure or changes in ECG occur. Use with caution in patients with a history of or known prolongation of the QTc interval or treated with products affecting the QTc interval. Use with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma. Hypokalaemia may occur, is usually transient and supplementation not needed. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment. Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Do not use in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Interactions: Do not administer with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products. Caution in use with methylxanthine derivatives, steroids, non-potassium-sparing diuretics, β-adrenergic blockers or medicinal products known to prolong the QTc interval. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Nasopharyngitis, urinary tract infection, sinusitis tooth abscess, insomnia, anxiety, headache, dizziness, tremor, cough, diarrhoea, nausea, dry mouth, myalgia, muscle spasms, peripheral oedema, increased blood creatine phosphokinase. Uncommon (0.1- 1%): Hypokalaemia, hyperglycaemia, agitation, dysgeusia, blurred vision, tachycardia, electrocardiogram QTc prolonged, palpitations, angina pectoris, dysphonia, throat irritation, stomatitis, rash, pruritus, urinary retention, increased blood pressure. Rare (0.01-0.1%): Hypersensitivity, bronchospasm, including paradoxical. Not known: anaphylactic reaction, angioedema. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing

Authorisation Number: EU/1/14/963/001 Marketing Authorisation holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: October 2019

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:; E-mail: medsafety@ Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744. References: 1 MIMS Ireland November 2020 2. Eklira® Genuair® Summary of Product Characteristics, last updated November 2019 3 Brimica® Genuair® Summary of Product Characteristics, last updated August 2019 4 Magnussen, H et al. COPD. 2019 Apr;16(2):196-205

Reducing air pollution for the sake of our health

Air pollution has been linked to a wide range

It must be stated that Ireland has relatively clean air; internationally, Ireland is ranked as having some of the lowest levels of air pollution. That does not mean that our levels of air pollution are safe. Estimates show that Ireland loses about 1,300 people to air pollution annually in the form of premature mortality, and the city of Dublin loses €431.5 million a year in social costs related to air pollution. Even at the relatively lower levels of pollution that Ireland has, there is still a large health and economic loss. Globally, things are much more dire.

Air pollution kills people: Nearly nine million people, and half a million in Europe, each year. It is the single most significant environmental risk factor in Europe. Globally, nearly double the population of Ireland dies every year from breathing unclean air before they would have otherwise if they had clean air. In their streets, in their schools, in their workplaces and in their homes. The bulk of these deaths are in low- and middle-income countries, mainly China and India, where it is estimated up to 30 per cent of all deaths are related to air pollution (above the global average of 20 per cent). To put it simply: One-third of all deaths in China and India, and onefifth of all deaths on the planet are due to unclean air.


Air pollution has been linked to a wide range of conditions: Heart disease; high blood pressure; diabetes; stroke; multiple cancers; leukaemia in children; neonatal heart malformation; asthma; and acute and chronic lung disease. Some of these effects are immediate: Breathing in gases can cause acute breathing difficulties. Others show a lag; when air pollution levels rise, hospital admissions for stroke and heart attack rise over the next few days, as analysis in Dublin has shown. But many of these health effects can lag years, such as the effect on unborn babies. Children in general suffer the impacts a lot more, and will carry previous exposure risk through their lives, suffering outcomes up to decades later. This happens wherever air pollution is present; no level of air pollution exposure is safe.


Air pollution comes in two main categories: Gases and aerosols. Gases such as nitrogen oxides, sulphur dioxide, and ozone, arise from transport, industry, soil, agriculture, coal burning, volcanoes, and environmental conditions. Aerosols make up the rest of pollution and include dusts, carbon compounds, metals and other organics, and come largely from industry, transport, cars (including brake pads and tires), and burning wood, coal and fossil fuels. Aerosols are sorted by size (particulate matter (PM)) and most air pollution reports focus on the very small particles (those smaller than 2.5µm (PM2.5)). The smaller the particle, the deeper into the lungs it can settle, be absorbed and enter the body’s cells. Once inside the cells, these small particles set off inflammation, where the body mounts an attack against the foreign matter. A prolonged state of inflammation, especially in blood vessels, can start the chain leading to heart attack and stroke.


Recent local and international reports have given valuable insights into the origin of Irish air pollution. With Dublin being the largest city and capital, most reports have focused on the city and its air quality. A European Commission report in 2021 looked at PM2.5 in European cities, and their sources, to help guide cities in fighting pollution. The Dublin analysis showed the major sources of sulphur dioxide and small particles (PM2.5) levels in the city were industry and homes. In the homes, small particles come from burning coal, wood, and peat. The main source of nitrogen oxide gases was traffic, and this was the finding of a recent Environmental Protection Agency (EPA) report on air quality in Dublin in response

to the exceedance of the safe EU limit for these gases in 2019. The traffic density in and around Dublin was the main cause of the exceedance. This is quite significant; 13 per cent of new asthma globally is from NO2 gas exposure, and 92 per cent of these new asthma events occurred in areas where levels were below the previous World Health Organisation (WHO) guidelines. The air in Dublin is likely fuelling new cases of childhood asthma.

The EPA recommended that traffic be reduced in and around Dublin through designating low emissions zones, provision of public transport, and encouragement and support of active transport, such as walking and cycling.


Ireland has successfully tackled air pollution-related harm before. The Smoky Coal Ban, which was introduced in 1990, dramatically improved the air quality in Ireland, and has been estimated to have saved 8,000 lives in Dublin alone. Currently, we are awaiting the Clean Air Act from the Government, which it is hoped will set ambitious targets, guidelines and initiatives to reduce the harm done in Ireland from air pollution.

On the international front, the WHO has recently revised its air quality guidelines, in many cases reducing the threshold of acceptable risk for pollutants. It is expected that the EU will follow this with revising its air quality guidelines in the coming years, mandating lower acceptable levels of air pollution in the name of public health. While these changes may be difficult, they will help build a cleaner society and protect the health of people who breathe air, which is all of us. Initiatives to reduce air pollution often work to reduce carbon di-

oxide emissions, and the fight against climate change is also a fight against air pollution.

Locally, we can do a lot to improve the air quality and protect the people around us; choosing active and public transport options over private car use is a part of the solution and a way to cleaner air. Although cyclists in urban areas are forced to sit in the fumes of idling cars at traffic lights, cycling has been shown to outweigh the health effects of air pollution exposure along the cycle, and the more people do this, the safer it will continue to become. Reducing burning of solid fuels in our homes can greatly reduce the strain on local air and hospitals.

There is also a role for changes in the urban environment to help improve air quality. Measures that reduce the speed and density of cars decrease the pollutants put into urban environments. Designating zones of low traffic, putting a charge on commuting by car and reducing speed limits all have a role to play. Berlin recently reduced traffic speed limits, which decreased nitrogen oxide levels – as nitrogen oxides are Dublin’s main air pollution source, reducing speed limits could do the same. More green spaces would interrupt the flow of air pollution and help absorb air pollution by filtering it from the air.

Cleaner industries, cleaner energy production and cleaner agriculture will contribute to cleaner air, both in urban and rural settings, and across borders, as air pollution does not stay fixed to its origin point, but moves around freely, untied to the local environment.

However, these changes rarely happen without significant public pressure. Citizens and residents voicing their support for measures to reduce air pollution, such as reducing traffic and promoting public and active transport, help enable changes to be enacted and effective. Supporting moves for cleaner industries, transport and policies puts pressure on polluters to improve, and governments to act.

Air pollution is an incredibly significant health issue. While having relatively clean air on a regional and global scale, Ireland does still experience harm from air pollution. Individual, organisational and government initiatives to reduce air pollution, improve air quality, and decrease the health and social burden posed by air pollution will pay off.

References available on request

of conditions, but action can be taken to tackle the problem
The EPA recommended that traffic be reduced in and around Dublin

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It is fair to say the reaction from doctors to the new Sláintecare consultant contract has been far from positive. Both the IHCA and the IMO revealed the extent of this dissatisfaction on Thursday 7 March. Early that afternoon, the IHCA released the results of a survey of its members on the issue.

According to the survey, 73 per cent of respondents were not confident the new contract would address the consultant recruitment and retention crisis.

Also, 67 per cent of specialist trainee respondents said they were “less likely or not influenced” to stay in Ireland to take up the contract.

Of those practising abroad, 77 per cent indicated they were “less likely or not influenced” to return to Ireland based on the contract.

“Under this new contract, we face being stretched even further with no clarity on how it will attract and retain the additional consultants our patients need,” according to a statement from the Association.

Later in the day, the IMO announced that its consultant and NCHD members voted to reject the contract.

According to the ballot results, 57 per cent of current contract holders and 64 per cent of NCHDs would not take up the new contract.

Also, 59 per cent of consultants currently working overseas said they would not return to Ireland to take up the contract.

The Organisation called on the Government to re-engage on key points around hours of work, rostering arrangements and location, and work with the representative bodies to secure “a contract that works for all”.

“The Government took the unilateral decision to conclude negotiations on a new contract and to present a final


document on a take-it or leave-it basis without the agreement of the IMO,” said Prof Matthew Sadlier, Chair of the IMO consultant committee.

“While we accept there was progress on some issues, we were very clear at the negotiations that a lack of safeguards around rostering, location, and sufficient number of medical and other staff would make the terms unworkable in practice and create huge uncertainty and inequity.

“The Irish health services desperately need more consultants and while we hope this contract will achieve that, there are valid concerns amongst doctors.”

Also on 7 March, after the IHCA and the IMO released their statements, the Minister for Health Stephen Donnelly announced the publication of the 2023 Waiting List Action Plan

Under the plan, €363 million has been allocated to reduce and reform hospital waiting lists and waiting times.

The plan refers to the importance of the Sláintecare contract and how it would allow for “a significant expansion of consultant numbers and availability”.

“The new contract doubles the normal working week, extending the working day late into the evenings and on weekends,” according to the document.

Given the negative initial response to the contract, however, it is unlikely to offer a significant contribution to addressing the health service’s chronic waiting list problem, at least in the short-term.

Meanwhile, I am pleased to announce the Medical Independent has developed a new app. It marks another step in our commitment to expand our digital offerings and deliver high-quality journalism to our readership in a dynamic way that suits them. The app is available to download on both IOS and Android devices.


“Essential reading @DonnellyStephen."

Dr Shane Corr, @ShaneCorr3, 8 March


“Seems like a good idea to ask why they are leaving and (hopefully) to use that information to inform retention strategies locally or nationally."

Dr Niamh Humphries, @humphries_niamh, 6 March

“Was it not the norm before? Find out how to improve the work environment, the positives etc?" Hilary Cullinan, @hilo_hughes, 6 March


“Ultimately, its ability to meaningfully address record patient waiting times, fill the 900 vacant consultant posts, and improve the daily working experiences of all consultants will be the acid tests." Dr Nóirín Russell, @russellnoirin, 8 March

“73 per cent working in Ireland said they are more likely to remain on their current contract than take up the new one. 77 per cent of those currently working abroad are less likely or not influenced to return to Ireland now. Frustrated, deflated, demoralised. Job done, @HSELive." Dr Irwin Gill, @IrwinGill, 7 March

“@slaintecare contract that is being steam rolled through seems to be having the exact opposite effect to improve recruitment and retention and thus clinical services. Bizarre action from @HSELive@DonnellyStephen."

Dr Sorca O'Brien, @HerNameIsSorca, 7 March


“The speed at which the public health medicine recruitment process has been conducted has been really impressive, despite some bumps in the road. But hopefully, we’ll get some more posts in regional public health units, where we’re very understaffed and dealing with huge workload."

Dr Niall Conroy, @NICU_doc_salone, 8 March

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Negative reaction to contract should give health management cause for concern

Managing different types of challenging patients

Dr Emma Davies offers some tips on managing challenging situations with patients

The majority of patients are likely to be appreciative and have realistic expectations. However, there will always be a small number of patients who take up a disproportionate of time and energy for reasons outside disease management.

Whether it is frequent complaints, misuse of the system, unrealistic expectations leading to inappropriate demands, unwanted attention/stalking or even aggressive or violent behaviour, these situations can have significant impact on you and your team’s patience, morale, ability to focus, and sometimes you and your team’s wellbeing and safety.

Below is some guidance to doctors and staff on navigating these tricky situations.

When you receive a complaint

Getting it right first time can be helpful in closing down a complaint early on. We urge you to contact your medical defence organisation for advice in identifying the elements of the complaint and assisting with wording comprehensive responses. Many complaints can be resolved at a local level, with careful handling by the practice or hospital and good complaints procedures, as well as an offer to meet with the complainant to discuss the issues further and offer an apology, where appropriate can prevent matters from escalating.

The Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners advises doctors that patients are entitled to honest, open, and prompt communication about any adverse events that have caused them harm and outlines that doctors should:

 Acknowledge that the event happened;

 Explain how it happened;

 Apologise, if appropriate; and

 Assure patients… that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.

However, sometimes a complaint can become repetitive or vexatious. A patient may even decide to make a complaint directly to the Medical Council, and they may also choose to take this course of action should they remain dissatisfied with the practice or hospital’s response to a complaint. It is therefore important to get any complaint response right, first time, if this is possible.

ly on in the consultation. Asking “is there anything else you want to discuss”? after the opening conversation can be a simple, but useful tool.

If a patient comes with a shopping list, after consideration of any issues that require urgent attention (such as chest pain), asking “which of these is the most important one to look into today” and then gently suggesting that a further appointment is made for the other concerns can help. This way they feel heard and accept that you are in a position of wanting to help within the timeframes given.

2) Patients with unacceptable behaviour

iour from a patient or their relative, and if your personal safety allows, ask yourself if their behaviour is a manifestation of an illness or stress.

Being sworn at or threatened by a person who is obviously responding to external auditory hallucinations may also be very distressing and, depending on the physical power of the patient presenting these symptoms, may be a real threat to your safety. In both situations there may be a different level of risk to the practitioner, but also a need to ultimately ensure the patient gets the right treatment. The bottom line is your and your staff safety comes first.

able behaviour is not the manifestation of an illness the following options are open to you:

• Ignore it – this is a personal choice and different practitioners will have different thresholds for what they feel is tolerable.

• Try to de-escalate the situation – unacceptable behaviour is often a result of unmet needs. If we can ascertain what these needs are, and we can realistically meet them, that may defuse the situation. Sometimes explaining the effect of their behaviour on your own wellbeing can assist, as patients may genuinely not have appreciated the effect of their behaviour.

• Write a warning letter – they should clearly describe the behaviour that was unacceptable and the impact it had on the staff member(s) concerned. For example, rather than saying “you were very rude on the phone and it is not acceptable” a description may be: “You raised your voice and talked over the member of staff who was trying to explain the situation to you and used language which the staff member found offensive. This led to the staff member feeling intimidated.”

• Consider a behavioural agreement that outlines what the patient can expect from the practice and vice versa.

• As a last resort, you may wish to consider removal of the patient from the practice list – however, this action may well trigger a complaint or an allegation of discrimination, so it would be important that other options are fully explored first.

3) Patients who are stalking

Some doctors are subject to unprompted and unwanted attention, either in the form of negative attention or inappropriate declarations of feelings from patients. This is a very particular type of behaviour that warrants a robust approach. Again it is important to consider if the behaviour is a manifestation of an illness and consider if the patient needs referral to mental health services.

The Royal College of Psychiatrists in the UK has produced some helpful guidance on how to deal with stalking (www.


Patients who have unrealistic expectations

It is not uncommon to meet the patient with the ‘shopping list’ of issues that they want to explore in a single consultation. We would caution against a blanket ‘one concern per consultation’ approach and advise doctors from the outset to explore a patient’s expectations and concerns so that they can then best manage these ear-

Everyone has a different threshold for what they personally deem to be unacceptable; for example, some people may be more tolerant than others when patients swear or become angry – but what matters is how a patient’s behaviour impacts the staff member. Remember, the safety of you and your staff should be paramount.

When faced with unacceptable behav-

If you feel that your personal or staff wellbeing is at risk, consider calling the gardaí. The care and treatment of the patient then takes priority once it is safe to do so.

There will be patients we encounter who display unacceptable behaviour that is not a manifestation of a treatable physical or mental health illness.

If it is deemed that the unaccept-

The principles are equally applicable in Ireland. In essence, this involves telling the patient clearly what behaviour they have demonstrated; that this is unacceptable; describing the effect this has had on the recipient; and a statement that if the behaviour does not stop, there will be consequences, such as removal from the practice or even referral to the gardai, depending on the severity of the behaviour.

If you are struggling to manage a challenging patient, please contact your medico-legal defence organisation for further advice.

THE MEDICAL INDEPENDENT | 21 MARCH 2023 23 Medico-Legal Opinion
It is therefore important to get any complaint response right, first time, if this is possible

A plea for inclusivity

Don’t call me ‘your own’ because you think I am like you, especially if you share my skin colour, accent, religion, or sex

supposed kinship turned nasty. There was no talk of being one of them then.

“Wherever this flag is flown, We take care of our own.”

We should look after our own first!”

“We hear that a lot lately, but never from Brother Kevin, or Sister Stan or those who actually look after people. There is a type of social commentator who has decided that ‘our own’, as they call them, are now in need of some kind of priority. Not that they themselves will be out with the soup and the sleeping bags, or even calling for a tax increase, but somebody should do something about it. About our own. And a populist politician cloaked it well, but still came out with it in the Dáil. She knew who she was talking to, and why she said it.

When I first came back to this town as a doctor, after many years away, there were those who were keen to claim me.

“Sure aren’t you one of our own,” they would say. It was nice until I came to realise what they meant. If I was their own then it meant somebody else was not and, furthermore, it implied an obligation to give them special treatment. It was not long before they wanted the sleepers and painkillers and sick certs, and the

I have been on the lifesaving courses; most doctors have. There is usually a simulated crashed car and a team of instructors. You have a man with head injury, the unresponsive woman, the injured child. Their age and vital signs are given, and maybe their coma score. What is not given is their ethnicity, colour or religion. We are trained to respond to need, and nothing else.

So don’t call me ‘your own’ because you think I am like you, especially if you share my skin colour, accent, religion, or sex. ‘My own’ don’t bawl out hateful rebel songs, and cover up sexual assault, and defend gangsters and murderers. ‘My own’ don’t legislate for women to stay pregnant, and lock migrant children in cages.

‘My own’ don’t ignore climate experts, and public health experts and they don’t troll and vilify and bully those who speak the truth.

‘My own’ don’t try to stir up hatred between the city and the town, and pretend that because a bus service has been set up in a village that the shower above in Dublin want to take away your cars.

‘My own’ don’t roll their eyes at me when they see a Traveller. ‘My own’ don’t turn their backs on suffering and say they brought it on themselves, and sure they are only economic migrants anyway. They don’t go to church and do the opposite to what their religion preaches .

Bruce Springsteen has a song We Take Care of Our Own . Like much of his work it delves deep into the title –it is kind of an anti-MAGA song.

The flag “from sea to shining sea” means that the poor, the unfortunate, the immigrant is protected. In Ireland, there are those who would misinterpret and abuse the Tricolour, that revolutionary symbol of a new country, to bully and disenfranchise anyone they see as different; not Irish enough, not one of us. “Ooh Ah.”

Who are ‘my own’, if not these jingoistic, nationalistic heroes? Well, I will tell you. The little boy who has left his toys and Dad behind and is living in a hotel room. The girl on her own at break-time because she looks a bit different and has no friends. The grey-haired GP who is only still working by a colossal act of determination and loyalty, who has served their dues in a thousand ways and continues to care. The working-class politician who has used his talents to serve the people without cunning or artifice and endures the sneers and traps of the cynical on a daily basis. The girl who was maimed in an explosion before her life properly began, and still bears the scars and disability, and turns on the televisions to see a would-be Minister bawling out rebel songs and saying “Why don’t you lighten up, sure it’s only a bit of fun.”

These are my own: The exhausted nurse; the mother who sings to her children in a direct provision centre to drown out the hate chants of the mob; the Palestinian Jew who walks the streets unseen. Take care of them, and finally apologise for your wrongdoing, and you can claim me as one of you, but not beforehand, do not expect my vote or loyalty.

Why I was worried about Navan Hospital

A divergence on the future of the emergency services is growing between health officials and national politicians

Read more by Dr Christine

So, there I was last summer, worrying away about Our Lady’s Hospital, Navan. Navan’s emergency department (ED) is too small and must close; critically-ill patients need a large ED like Our Lady of Lourdes Hospital, Drogheda. It’s all so familiar from our experience in the mid-west, but here’s the really bad bit. To support the change, two ICU beds and 10 extra ward beds will open in Drogheda. Let’s do some maths. The average patient stays a week in hospital, so those new beds allow for two extra admissions per day to Drogheda. That is ridiculously optimistic. In fact, it’s downright scary and indicates nothing has been learnt from the tragedy unfolding in the mid-west.

So I was very worried about Navan Hospital, and the damage that would be done to Drogheda. The key issue for me is the medical ward patients.

Back in the mid-west, we were told that the majority of patients could continue in Nenagh General Hospital after reconfiguration. Maybe it’s true for outpatients or day cases, but it’s not true for inpatients. The surgical wards closed completely, but we were supposed to continue admitting selectively to the medical wards. We tried and this is what we found: Large numbers of medical patients could no longer be admitted to Nenagh. University Hospital Limerick (UHL) is a very fine hospital,

but it got no extra wards. Sadly, since reconfiguration UHL is best known for topping the league table of trolleys. Overcrowded EDs have a higher mortality rate, so it’s a serious patient safety issue.

The closure of an ED isn’t the immediate problem, but that’s where the trouble begins. Once the critically ill patients are supposedly “diverted” to a larger hospital, other acute services get whittled away. So, Nenagh lost on-call laboratory, staff on the wards were reduced and, worst of all, the coronary care unit (CCU) was shut. On paper, there was no need for a CCU or high dependency unit in Nenagh, but real life is different. The unit was staffed by CCU-trained nurses and fully equipped for monitoring ill patients and it was our clinical safety-net. It turns out that closing an ED does not remove the critically ill patients. Some patients appear “low-risk”, but turn out to be extraordinarily ill. Others deteriorate on the wards and need critical care. Without our unit, the only way to stay safe was to divert any patient who might need critical care and that is most medical cases.

So there I was, worrying about Navan and Drogheda, and something interesting happened. Actually, two things happened. Consultants in Drogheda wrote to Minister for Health Stephen Donnelly. Here’s a quote: “The transfer of risk from an unsafe ED in Navan to an under-resourced Our Lady of Lourdes Hospital in Drogheda will lead to poorer clinical outcomes for patients.” I agree. That is what we experienced in the midwest. I hope it is not done to the patients and staff of the hospitals in the north-east. And then the Health Minister “overruled” the closure. I was astonished and relieved. Yes, I know it’s a temporary reprieve – the reconfiguration juggernaut is revving up again.

Fast forward to this year and interesting things are happening in the mid-west too. Some 87 UHL consultants wrote an open letter stating that “withdrawal of direct emergency hospital care at Ennis, Nenagh, and St John’s was detrimental without the required capacity at UHL” and called for resourcing of all four hospitals. In February, Taoiseach Leo Varadkar visited Limerick. Before the visit, he said it would be “impossible” to re-open former emergency departments in Ennis, Nenagh, and St John’s. But surprisingly, during the visit he said “nothing is ruled out”. He added that Covid taught him never to rule anything out. That’s right: During Covid, impossible stuff was done all the time.

What is going on? I see a divergence between health officials and national politicians and it’s new.

Also, consultants have spoken out about EDs, and it’s not the usual voices. For years, ED consultants have called for bigger EDs with more consultants. Unfortunately, this does nothing for the ED trolley counts. When the INMO or the HSE say there are “50 patients on trolleys in an ED” they only count admitted people who are no longer under the ED doctors. Some trolley patients are under the care of urologists, gynaecologists, and orthopaedic surgeons. Most, however, are medical patients being treated by cardiologists and respiratory physicians, neurologists and geriatricians. It’s great to hear from them for a change.

I wonder what will happen next. Hospital campaign groups want EDs to re-open. Everyone seems to want more medical patients treated in the smaller hospitals. But our experience is that the same acute services needed for an ED are also needed for acute medical admissions. Closing a hospital service is tough; re-opening is much harder.

Read more by Dr Pat Harrold at @drpatharrold

Sondelbay® Awarded as a Best Value Medicine (BVM) Teriparatide

The Medicines Management Programme recommends Sondelbay® as a BVM for teriparatide.

Prescribe SONDELBAY® by Brand Name

Abbreviated Prescribing Information

Please refer to the Summary of Product Characteristics (SmPC) before prescribing Sondelbay ▼ (teriparatide) 20 micrograms/80 microlitres solution for injection in pre- lled pen.

Presentation: One pre- lled pen of 2.4 ml contains 600 μg of teriparatide. Each dose contains 20 μg of teriparatide in 80 μL. Indications: Indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a signi cant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated; Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Dosage and Administration: Recommended dose of Sondelbay is 20 μg administered once daily. Maximum total duration of treatment should be 24 months. The course should not be repeated over a patient’s lifetime. Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate. Following cessation of Sondelbay therapy, patients may be continued on other osteoporosis therapies. Elderly: Dosage adjustment is not required. Renal impairment: Must not be used in patients with severe renal impairment but should be used with caution in patients with moderate renal impairment. No special caution is required for patients with mild renal impairment. Hepatic impairment: Should be used with caution as no data are available. Paediatric population and young adults with open epiphyses: Should not be used in paediatric patients (<18 years), or young adults (>18 to 29 years) with open epiphyses due to lack of safety and e cacy data. Method of administration: Sondelbay should be administered once daily by subcutaneous injection in the thigh or abdomen. Patients must be trained to use the proper injection techniques.

Contraindications: Hypersensitivity to the active substance or to any of the excipients; Pregnancy and breast-feeding; Preexisting hypercalcaemia; Severe renal impairment; Metabolic bone diseases other than primary osteoporosis or glucorticoidinduced osteoporosis; Unexplained elevations of alkaline phosphatase; Prior external beam or implant radiation therapy to the skeleton; Patients with skeletal malignancies or bone metastases. Warnings and Precautions: Traceability: The name and batch number of the administered product should be clearly recorded. Serum and urine calcium: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent teriparatide injection. Routine calcium monitoring during therapy is not required.


strength for independence

SONDELBAY® is indicated in adults for treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.2

Urolithiasis: Sondelbay should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. Orthostatic hypotension: In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. Renal impairment: Caution should be exercised in patients with moderate renal impairment. Younger adult population (>18 to 29 years): Experience is limited (including premenopausal women). Treatment should only be initiated if the bene t clearly outweighs risks in this population. Excipient: Contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”. E ects on ability to drive and use machines: No or negligible in uence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided. Fertility, Pregnancy & Lactation: Women of childbearing potential: E ective methods of contraception should be used during use of teriparatide. If pregnancy occurs, Sondelbay should be discontinued. Pregnancy and breast-feeding: Contraindicated for use. It is not known whether teriparatide is excreted in human milk. Fertility: The e ect on human foetal development has not been studied. The potential risk for humans is unknown. Adverse Events include: Adverse events which could be considered serious: Common: Syncope, dyspnoea, hiatus hernia. Uncommon: tachycardia, nephrolithiasis. Rare: anaphylaxis, renal failure/impairment. Other Very Common adverse events: Pain in limb. Other Common adverse events: Anaemia, hypercholesterolaemia, depression, dizziness, headache, sciatica, vertigo, palpitations, hypotension, nausea, vomiting, gastro-oesophageal re ux disease, sweating increased, muscle cramps, fatigue, chest pain, asthenia, mild and transient injection site events. See SmPC for details of other adverse events. Shelf Life: Unopened vial – 2 years. Pack size: available in pack sizes of 1 pre- lled pen or 3 pre- lled pens. Each pre- lled pen contains 28 doses of 20 micrograms (per 80 microliters). Marketing Authorisation Numbers: EU/1/22/1628/001-002. Marketing Authorisation Holder: Accord Healthcare S.L.U. World Trade Centre, Moll de Barcelona s/n, Edi ci Est, 6ª Planta, 08039, Barcelona, Spain. Legal Category: POM. Full prescribing information including the SmPC is available on request from Accord Healthcare Ireland Ltd, Euro House, Little Island, Co. Cork, Tel: 021-4619040 or Adverse reactions can be reported to Medical Information at Accord Healthcare Ltd. via email: or Tel: +44(0)1271385257.

Date of Generation of API: February 2023. IE-02019

1. Best Value Medicines Accessed February 2023

2. SONDELBAY® Summary of Product Characteristics

February 2023 | IE-01873
Prescribing Sondelbay® to your patients will lead to significant savings for the health service.1

Time to find common ground

It would be for the best that some descriptions doctors give patients are consigned to history


Read more by Dr Muiris Houston at

We all have pet hates, don’t we? Leaving our personal ones to one side, what are the pet peeves in your professional life?

Structured history-taking has many merits, but it is not a perfect tool. And the reporting of the patient’s history throws up some curved balls, I reckon.

One of the things that annoys me is the habit of presenting cases with the phrase “patient denies smoking or drinking”. The glaring implication is that the doctor doesn’t believe the patient and neither should those listening to the presentation. How about “the patient reports not drinking and not smoking”? There is no judgement if we do it this way.

A bugbear that annoys some doctors is the use of the term “poor historian”. Writing in STAT recently, two US doctors asked colleagues to consider the following questions:

“Should we pity the ‘poor historians’ – the individuals or family members who can’t give a clear accounting of their illness or symptoms – or embrace them? They have important stories to offer their clinicians, but can’t tell them. Who is really to blame here? And should the term poor historian ever be part of an individual’s permanent record?”

A poor historian designation has at least two functions,


Question 1

Question 2

Question 3

Question 4

Question 5

they add: It’s an expression of frustration at a lack of diagnostic clarity and a solicitation of forgiveness from their colleagues for lingering clinical ambiguities in the case.

Back in the 1960s and 1970s, the term “poor historian” was widespread enough in medicine that some doctors began to advocate against its use. In 1961, a Kentucky physician suggested that the term implied that the doctor was “himself a poor observer”. A 1970s textbook was far more blunt: “Too often the excuse is made ‘The patient is a poor historian,’ when in fact the physician is at fault.”

But the term continues to be passed down, from one generation of clinicians to the next, and is still alive today.

The STAT authors would like to see the term retired: “We don’t seek to assign blame to individuals on either side of these conversations: Patients offer the stories they can offer, and not getting sufficient information is generally not a sign that clinicians aren’t doing enough, or aren’t effective information gatherers.”

In response to the article one reader said: “A reason I don’t like the label is that the person writing the history is the doctor, hence the doctor is the historian, and as a historian is able to consult many primary sources, such as family members, primary care physicians, nursing home staff… etc.”

In other words, the patient is not the only source of historical information and doctors need to tap all these resources before deciding to use the poor historian label.

In another related piece recently, my narrative-based medicine colleague John Launer, writing a pre-Christmas column in the British Medical Journal , asked: “Which words or phrases would you like to see disappear from doctors’ vocabulary?”

Calcaneal apophysitis (Sever’s disease)

A. Occurs more often in girls than boys.

B. Pain is localised to the plantar and posterior side of the heel.

C. Will cause redness of the heel.

D. Main diagnostic tool is the ‘squeeze’ test.

E. Would not be expected to create any long-term disability.

Chalazion (internal hordeolum)

A. Swelling is normally secondary to blepharitis.

B. Swelling is at the eyelid margin.

C. When newly developed, antibiotics are the treatment of choice.

D. May be treated by local injection of a steroid.

E. Virtually all resorb over two years.

Features suggesting that a sore throat is streptococcal rather than viral in origin include

A. Palatal petechiae.

B. Associated sneezing and runny nose.

C. Tender cervical lymphadenopathy.

D. ‘Strawberry tongue’.

E. Temperature 38 degrees.

In the management of epilepsy in adults, carbamazepine (Tegretol)

A. Is indicated for myoclonic seizures.

B. Starting dose is 200mgs BD.

C. Peak plasma concentrations occur about an hour after consumption.

D. Recognised side-effects include diplopia.

E. Never give rise to idiosyncratic reactions.

Migraine would be a reasonable diagnosis to suspect in a patient

A. With neurological symptoms on the same side as the headache.

B. Over 60 years of age with a continuous headache.

C. With occipital headache present on waking.

D. Under 50 years of age with scalp hypersensitivity noticed while combing the hair.

E. With cough headache.

He picked out three: “Lacking insight,” “in denial,” and “manipulative.” For him, they all smack of moral judgment masquerading as diagnosis.

Of “lacking insight,” he says that, although it carries a vague impression of psychiatric precision, it often means simply that the patient isn’t seeing things the same way as their doctor.

Doctors who use the phrase “in denial” usually have in their mind an imagined set of emotional responses that everyone is meant to feel in a given situation (anger when thwarted, prescribed stages of grief after loss, etc.).

“Doctors seem to apply this kind of thinking especially in the context of bereavement,” he writes. “In these and other circumstances, they may ignore any personality quirks or varieties of human psychology that lead some people to react in their own unique way. The lazy use of the term ‘denial’ also appears to exculpate doctors from – God forbid – demonstrating curiosity about exactly how a particular individual is responding and what’s made them do so.”

As for “manipulative”, Launer says he scarcely knows where to begin: “When doctors describe someone as ‘manipulative’ what they really mean is that a patient wants something that the doctor, rightly or wrongly, believes they don’t deserve. Whether the patient’s request arises from distress, a misunderstanding, or any other cause, it’s no more or less manipulative than the doctor’s disinclination to say yes.”

He concludes with the following: “Please can we retire all these expressions and just talk about having different perceptions, expectations, or wishes from some of our patients – and about finding some common ground when we do?”

E. FALSE. 50 per cent have no obvious disease, but some have a posterior fossa tumour.

D. TRUE. Also noticed while washing the face.

C. FALSE. Consider cervical spondylosis or raised intracranial pressure.

B. FALSE. Consider spondylotic or tension headache, cranial arteritis or Paget’s disease.

A. TRUE. If these occur on opposite sides possible causes include cerebral tumours and vascular anomalies.


E. FALSE. Up to 10 per cent may get a rash.

D. TRUE. Also headaches, dizziness, nausea, and vomiting.

C. TRUE. Use controlled release formulation to reduce side-effects.

B. FALSE. 200mgs a day, then increase by 200mgs a day every two weeks.

A. FALSE. Partial and generalised tonicclonic seizures.


D. TRUE. Also if circumoral pallor.

C. TRUE. More likely to be streptococcal.

B. FALSE. Suggests viral infection.

A. FALSE. Suggests glandular fever.


E. TRUE. So worth waiting before instigating treatment.

D. TRUE. Or surgical incision and curettage.

C. FALSE. Normally granuloma rather than abscess so would not respond to antibiotics.

B. FALSE . Red swelling away from the margin.

A. FALSE. Styes are often secondary to blepharitis.


E. TRUE. Symptoms resolve quickly with decreased activity.

D. TRUE. Pain on mediallateral compression of the calcaneus in the area of the growth plate.

C. FALSE. External appearance of the heel is almost always normal.

B. TRUE. Over the calcaneal apophysis.

A. FALSE. Commoner in boys. Average age at onset 9-11 years.

E. TRUE. Tonsillar exudate and lack of cough also suggestive.


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Implementing a nurse-led pathway for cardiac monitoring post-stroke

A nurse's experience with the stroke patient care pathway and the development of cardiac monitoring at UHL

Each year 1.4 million people have a stroke across Europe. The majority of all strokes are ischaemic, which means that they occur as a result of an obstruction, such as a blood clot, within the blood vessel. However, in around 25 per cent of cases, the cause of the stroke cannot be determined. This is what is known as a cryptogenic stroke.

About 25-to-30 per cent of these strokes are the result of atrial fibrillation (AF), the most common sustained cardiac arrhythmia worldwide, which can cause blood clots and increases the risk of stroke significantly. The incidence and prevalence of AF increases with age, and approximately one-in-four European adults over the age of 55 will develop AF. Prevalence data from the Irish Longitudinal Study on Ageing (TILDA) estimate the prevalence of AF at 3.2 per cent in Irish people over the age of 50, and using national population projections, this number is expected to significantly increase in the coming decades.

University Hospital Limerick (UHL) was one of the first hospitals to implement long-term cardiac monitoring for patients, post-stroke. Patients with potential AF need to be further investigated and closely monitored in order to determine the most suitable management and treatment option. This process is also critical to the prevention of secondary strokes.

Each year UHL admits over 430 stroke and 200 transient ischaemic attack (TIA) patients. Yet, despite the European Society of Cardiology (ESC) and European Stroke Organisation (ESO) guidelines both advocating the use of implantable loop recording devices, there is still very little awareness around cryptogenic stroke and clinicians are often not considering loop recording devices as a viable treatment option. This, combined with gaps in the referral process and a lack of patient compliance, means that loop recording devices have remained relatively under-utilised.

The implantable loop recorder monitors a patient’s heart rate and rhythm for up to four-and-a-half years, and provides the most reliable picture of the health of patients who have experienced strokes or loss of consciousness.

Without such data, clinicians are unable to reliably determine the cause of a stroke or a loss of consciousness in patients. Long-term monitoring enables the cause to be determined and treated effectively.

Patients with the implant are monitored at home, and can contact the nursing team for advice if they experience symptoms. If an abnormal rhythm is detected, nurses will contact the patient to organise a management and treatment plan.

Assessing the existing stroke pathway

The existing stroke patient pathway at UHL meant stroke patients would be referred directly to cardiology after their stay on the acute ward, where they would then have a loop recording device implanted. This procedure was carried out in a catheterisation laboratory (cath lab) and required a full cath team. Each procedure took 45 minutes and patients were then required to recover post implantation for another one-to-two hours.

Due to the busy nature of cardiology departments, and despite the procedure being short and minimally invasive, there were several inefficiencies in this approach. Appointments were regularly cancelled and patients often had to wait for long periods before being seen by the cath team. In response to these challenges, the stroke and cardiology departments carried out

an audit to identify areas for improvement. The audit highlighted that there was an eight-month waiting period from hospital discharge to the implantation of a patient’s loop recording device. This process was overseen by the cardiology service. UHL recognised that acute care and patient follow-up within the patient pathway could be streamlined within stroke departments, reducing anxious waiting periods, and freeing up vital cardiologist resources.

A new stroke patient pathway was born

In 2018, I helped develop a nurse-led pathway to streamline the implantation of loop recording devices, and set up an implantable loop recording list where patients would be directly admitted to the rapid access medical unit. Patients would be selected on the basis of a referral, post-inpatient cardiac monitoring, for between 24to-72 hours, an echocardiogram, an MRI, and full blood work. When the service began, nurses only had access to the use of a small hospital room once a month, for a

pathway more broadly. We highlighted the benefit of the time and costs saved by moving the procedure from a cath lab into a specialist room, which would enable more urgent procedures such as the implantation of pacemakers or implantable cardioverter-defibrillators (ICDs) to be carried out, while ensuring stroke patients’ appointments remained on time, without risk of cancellation.

Evidence to support the standardisation of implantable loop recording devices

There is significant evidence in support of the application of implantable loop recording devices for stroke patients. In 2016, the ESC released guidelines regarding the management of AF, calling for the urgent involvement of a specialised AF service in hospitals. This view is also supported by the American Hospital Association (AHA), and the ESO.

There has been much success with UHL’s new stroke care pathway. This includes an AF detection rate increase of approximately 26 per cent and, a mean time of implantation to detection of 54.3 days with no cases of complications to date. Additionally, a minority of patients have been implanted before discharge and this management option has been extended to combine stroke, cryptogenic stroke, and transient loss of consciousness (TLoC) referrals.

Adapting to implantable loop recording devices

It is important that teams are trained to overcome potential challenges that may arise with implantable loop recording devices. Often nurses have very little exposure to surgical procedures. Consequently, to prepare for device implantation, they are usually required to embark on surgical training, scrubbing up on incision techniques and learning how to suture. Post the Covid-19 pandemic there is already immense pressure on the HSE and surgeons may not have enough time or the correct resources to be able to support the training of nurses.

couple of hours. The procedure, inclusive of recovery, lasted up to 35 minutes and patients were given a specific appointment where there was minimal danger of cancellation. The loop recorder was implanted by an advanced practice provider (AAP), and often patients were treated and supported by nurses who had met them at the doors of the emergency department on admission.

Once discharged, the nurse would then follow up with the patient within 24 hours, making sure they were comfortable. The nurse later follows up with the patient a further two times at three and six months. If AF was detected, the nurse would contact the patient and talk them through the diagnosis, organising their coagulation prescription without the patient having to visit a hospital. UHL’s monitoring is managed externally and each week nurse practitioners are alerted with a traffic light system with red, amber, or green notifications. A report is then generated and sent directly to the nurse who would look over it in more depth and identify the most suitable management option. The patient has access to the practitioner nurses Monday to Friday, 9am to 5pm, which is the same access that they would have had with a cardiologist.

I had the full support of the stroke and cardiology departments and, alongside my team, we put together a business case for hospital management to implement this

Younger patients can often be more complicated to treat and, prior to having their loop recording devices implanted, may go on to have a trans-oesophageal echocardiogram (TOE) carried about by a cardiologist, a process which can take up to six weeks. In more complex cases, UHL would be required to raise concerns regarding the patient’s treatment at their multidisciplinary meetings, which are held monthly in order to discuss such patients, and a combined consensus would be made to ensure the most appropriate line of care is delivered - delaying the implantation of the loop recording device.

It is incredibly important to have the full support from the hospital with all stakeholders onboard with the revised pathway. Implantable loop recording devices require input from a wide range of medical professionals including acute care staff, cardiologists, and stroke specialists. In order for the care pathway to be most effective, all stakeholders need to align and advocate for the use of implantable loop recording devices not only during a patient’s stay in hospital, but also post-discharge. It is when patients are reintegrated back into the community that they are likely to feel most vulnerable and will require ongoing follow up support from the nurse-led pathway.

Our team of specialised nurses at UHL have demonstrated our invaluable roles in developing and implementing a new cardiac monitoring pathway for stroke patients. It is clearly a pivotal time to be working within cardiology and stroke services, and this pathway has brought to light the essential role that nurses have within the HSE and in supporting patient care.

THE MEDICAL INDEPENDENT | 21 MARCH 2023 28 Clinical Cardiology
In order for the care pathway to be most effective, all stakeholders need to align and advocate for the use of implantable loop recording devices not only during a patient’s stay in hospital, but also post-discharge

Significantly improves exercise duration and reduces angina frequency1

Abbreviated Prescribing Information: Ranexa (ranolazine). Please consult the Summary of Product Characteristics (SPC) for full prescribing information. Presentation: Prolonged-release tablets containing 375 mg, 500 mg or 750 mg of ranolazine. 750 mg tablet contains E102 and lactose. Use: Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). Dosage and administration: Oral administration. Patients should be instructed to list their medication to their health care professional at each visit. Adults: Initial dose is 375 mg twice daily. After 2-4 weeks, dose should be titrated to 500 mg twice daily and, according to patient’s response, further titrated to 750 mg twice daily. Concomitant treatment with moderate CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended. Renal impairment: Careful dose titration is recommended in mild to moderate renal impairment, and contraindicated in severe renal impairment. Hepatic impairment: Careful dose titration is recommended in mild hepatic impairment, and contraindicated in moderate to severe hepatic impairment. Elderly: Dose titration in the elderly should be exercised with caution. Low weight: Dose titration in patients with low weight should be exercised with caution. Congestive Heart Failure (CHF): Dose titration in moderate to severe CHF should be exercised with caution. Paediatric patients: No data in children below the age of 18 years. Ranexa tablets should be swallowed whole and not crushed, broken or chewed. They may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Severe renal impairment. Moderate or severe hepatic impairment. Concomitant administration of potent CYP3A4 inhibitors. Concomitant administration of Class Ia or Class III antiarrhythmics other than amiodarone. Warnings and Precautions: Caution should be exercised when prescribing or up titrating ranolazine to patients in whom an increased exposure is expected. QT prolongation: Caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval. Interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy. Renal impairment: Check renal function at regular intervals during treatment. Interactions: CYP3A4 inhibitors: Increase plasma concentrations of ranolazine. Combining ranolazine with potent CYP3A4 inhibitors is contraindicated. CYP3A4 inducers: Avoid initiation with Ranexa during administration of CYP3A4 inducers. CYP2D6 inhibitors: May increase plasma concentrations of ranolazine. Effect of ranolazine on other medicinal products: Dosage adjustment of sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range may be required. Lower doses of CYP2D6 substrates may be required. Caution with CYP2B6 substrates. Monitor digoxin levels following initiation and termination of Ranexa. Limit dose of simvastatin to 20mg once daily in patients taking Ranexa. Limit dose of atorvastatin and consider clinical monitoring in patients taking Ranexa. Monitor blood levels of tacrolimus when coadministering with Ranexa and adjust tacrolimus dose accordingly. Also recommended for other CYP3A4 substrates with a narrow therapeutic range. Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin increased in subjects with type 2 diabetes mellitus when co-administered with Ranexa. The exposure of other OCT2 substrates may also be affected. Theoretical risk that concomitant treatment with drugs known to prolong the QTc interval may increase the possible risk of ventricular arrhythmias. Pregnancy and lactation: Ranexa should not be used during pregnancy unless clearly necessary. Ranexa should not be used during breast-feeding. Effect on fertility unknown. Side-effects: Generally mild to moderate in severity and often develop within the first 2 weeks of treatment. Common (1-10%): dizziness, headache, constipation, vomiting, nausea, asthenia. Uncommon (0.1–1%): anorexia, decreased appetite, dehydration, anxiety, insomnia, confusional state, hallucination, lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paraesthesia, blurred vision, visual disturbance, diplopia, vertigo, tinnitus, hot flush, hypotension, dyspnoea, cough, epistaxis, abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort, pruritus, hyperhydrosis, pain in extremity, muscle cramp, joint swelling, muscular weakness, dysuria, haematuria, chromaturia, fatigue, peripheral oedema, increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight. In a long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients. Rare (0.1-0.01%): hyponatremia, disorientation, amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia, impaired hearing, peripheral coldness, orthostatic hypotension, throat tightness, pancreatitis, erosive duodenitis, oral hypoaesthesia, angioedema, allergic dermatitis, urticaria, cold sweat, rash, acute renal failure, urinary retention, erectile dysfunction, elevated levels of hepatic enzyme. Not known: myoclonus. Increased incidence of congestive heart failure and transient ischaemic attacks seen in patients with history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention and treated within 2 weeks with ranolazine (1000 mg twice daily [dose not approved in Europe]) in a placebo-controlled post-PCI trial. Elderly, renal impairment and low weight: In general, adverse events occurred more frequently among elderly patients and patients with renal impairment. Adverse events in patients with low body weight were similar to those of patients with higher weight. Please consult the SPC for further information.Pack size: 60 tablets. Legal category: POM. Marketing authorisation numbers: EU/1/08/462/001, 003, 005 Marketing Authorisation holder: Menarini International Operations Luxembourg S.A. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SPC. Last updated: October 2020

Date of item: November 2020. IR-RAN-12-2020

References: 1. Chaitman, B.R., et al. JAMA, 2004; 291(3): p. 309-16.

Advancing a prevention agenda for cardiovascular care in Ireland

Anew report by the National Institute for Prevention and Cardiovascular Health (NIPC) and the National CVD Prevention Council (NIPC and the Irish Heart Foundation) has identified significant gaps in Ireland’s cardiovascular healthcare services.

The report outlines that cardiovascular disease (CVD) kills nearly 9,000 in people in Ireland every year, despite an estimated 80 per cent of premature CVD being preventable. Long waiting times for hospital-based services are a recognised issue in Ireland as a major barrier to effective prevention and treatment. It has been reported that waiting times for diagnostic services, such as echo and angiography, can exceed a year in some public hospitals. Even before the Covid-19 pandemic, waiting times for a first consultation with a cardiologist were as long as 14 months. Conversely, people with private insurance are often able to access diagnostic services rapidly – within a few days – driving inequalities in healthcare access and outcomes.

While Ireland has made good progress in CVD prevention and management, notes the report, the most recent national CVD strategy, which expired in 2019, has not been evaluated and is yet to be replaced. This means there is currently no overall national approach to preventing and managing this set of conditions. Furthermore, while many aspects of CVD care are being addressed through the National Clinical Heart and Stroke Programmes in the acute, community and primary care settings, there is a lack of a national co-ordinated multidisciplinary approach.

Commenting at the launch of the report earlier this month, Dr Angie Brown, Medical Director of the Irish Heart Foundation, said: “We face a groundswell of rising CVD risk factors from population ageing, obesity, to new environmental threats from climate change. These challenges will result in a growing burden of disease and pressure on our healthcare system. To avoid this, we must identify any gaps in CVD prevention and management and ensure all patients requiring services to treat CVD should have access to timely, preventive care through the development of an annually reviewed national strategy that supports our healthcare system whilst saving lives.”

Key findings

While there is a myriad of gaps in how the Irish healthcare system detects signs of CVD, notable issues outlined in the report include Ireland having the lowest rate of detection of high blood pressure in Western Europe. This is particularly worrying when considering that in 75 per cent of those that had a heart attack between 2017-2020, the heart attack was the first manifestation of CVD.

Likewise, more than 1,200 people that suffered an ischaemic stroke in 2020 were found to also have atrial fibrillation (AF). However, AF was not identified in 40 per cent of patients until they suffered the stroke. In

2015, HIQA published a health technology assessment of opportunistic AF screening in primary care, which concluded that opportunistic screening of men and women aged 65 and over in primary care, via pulse check followed by electrocardiogram, was likely to be cost-effective. Pulse checks are now included in the HSE's Chronic Disease Management Programme (CDMP), so AF is likely to be detected more frequently as part of this programme. However, most people aged under 70 years are ineligible for the CDMP, so alternative strategies are needed to ensure more cases of AF are detected and treated before they cause a stroke, the report states.

As well as Ireland having the lowest hypertension detection rate in Western Europe, there is no specific case-finding approach for familial hypercholesterolaemia, a genetic condition which causes

dangerously high cholesterol levels from birth, and an important cause of premature cardiovascular death, the report points out. FH affects around 20,000 people in Ireland, but only a very small proportion of cases have been identified. FH is not addressed in the CDMP, and detection is sporadic and generally depends on opportunistic identification of high cholesterol or awareness of family history of premature CVD death. For lipid disorders more broadly, there are very limited specialist resources (eg lipid clinics) across the country and GPs may need more support to manage lipids in primary care.

Prof Bill McEvoy, NIPC’s Research and Medical Director, commented: “The report recommends a screening programme for FH.... FH affects around one-in-200-to-250 people in Ireland, however, the majority of this goes undetected. Childhood FH screening programmes are commonplace throughout Europe.”

The report notes that Slovenia introduced an FH screening programme in 1995, making it the first country to implement such an initiative nationwide. Cholesterol levels are assessed during scheduled visits to primary care paediatricians, and children found to have elevated cholesterol are referred to a dedicated lipid clinic for genetic testing. The programme has been identified as an EU Public Health Best Practice example for FH screening by the European Commission, alongside similar initiatives in the Czech Republic, Italy, the Netherlands, Norway, Spain, and the UK.

Key clinical recommendations from the report

Boost biomarker usage by ensuring direct GP access and adequately resourcing laboratories

 As part of the Enhanced Community Care initiative, GPs in Ireland can now order NT-proBNP testing for people who: Are enrolled in the CDMP with diagnosed type 2 diabetes; ischaemic heart disease or AF; or have suspected new or worsening heart failure. This is a welcome development, which should help to detect possible heart failure in people with certain risk factors and which may also improve efficiencies by avoiding unnecessary referrals for echo among people with normal NT-proBNP levels. It is crucial that this plan is fully implemented and resourced in the long-term to support early detection of heart failure and reduce avoidable hospitalisations.

Increase access to echo for people who need it

 Following preliminary investigations, such as electrocardiogram or NTproBNP testing, people requiring echo must be able to access the service rapidly to support timely diagnosis

of heart failure or valvular heart disease and to help reduce healthcare inequalities. Plans to provide echo in community ambulatory hubs are very welcome, but this must be supported by greater investment in an adequately trained workforce, including cardiac physiologists and cardiologists with a special interest in imaging.

Support detection and management of heart valve disease in primary care through existing programmes

 A heart murmur, indicating possible heart valve disease, can quickly and easily be detected with a stethoscope check in primary care. Stethoscope checks should be performed opportunistically during GP visits, along with the other opportunistic checks included in the CDMP.

 People who have heart valve disease, but are not yet suitable candidates for surgery, require routine monitoring and care. This should be provided in the community care hubs or primary care by expanding the CDMP to include heart valve disease, with specialist support where needed.

Initiating or escalating prevention in the acute setting

The report also details issues in the treatment and discharge of patients following the detection of CVD. These issues include long waiting times in public hospitals and the lack of tailored discharge plans for patients.

Data from Sweden show that, in the year following a heart attack, nearly one-in-five people die from a cardiovascular cause or experience a repeat heart attack or stroke. Similarly, data from Norway suggest that nearly one-in-five people will be readmitted to hospital within 90 days of discharge following an ischaemic stroke and that two-in-five will be readmitted within a year. Readmission rates in Europe for acute heart failure are over 40 per cent within one year of discharge.

For people who have been hospitalised with CVD, standardised prevention of repeat events and hospitalisations should clearly be a priority, yet many lack access to vital services in Ireland.

In hospitals, initiation of preventive services is inconsistent across regions and often falls short of national targets, and dedicated heart failure units are unequally distributed across the country, the report points out.

In addition, while access to cardiac rehabilitation is paramount to the recovery of those post-cardiac events, it has significantly declined in Ireland. A 2017 study previously identified that there was national capacity to meet only 39 per cent of the need for cardiac rehabilitation while in 2021 there was a waiting list of more than 2,800 people, with 40 per cent waiting at least three months following hospital discharge to access a programme.

The report also outlines the requirement for investment in data collection and analysis to inform the strategy, the need to expand the role of nurses and allied health professionals, and to increase access and care to disadvantaged groups. Dr Brown added that the implementation of electronic health records is a critically-important key to integration of services required for effective prevention in clinical practice.

Next steps

In response to the urgent needs identified by the report, NIPC and the National CVD Prevention Council are calling on the Government to develop a national strategy to tackle CVD.

Prof McEvoy said: “We know that there is real ambition to transform the Irish healthcare system. With Ireland’s ageing population, making the prioritisation of CVD prevention part of that transformation is more important than ever. The lack of a national strategy for what is society’s greatest killer is a significant and worrying gap. CVD is a preventable disease, yet it kills nearly 9,000 people per year. We have previously demonstrated national leadership in the space through lasting actions such as the smoking ban; we now need to recognise that more needs to be done to tackle CVD.”

The full report can be accessed at:

Dr Angie Brown





GFR mL/min/1.73m2


Once daily

No titration required except in patients with severe hepatic impairment

*The DAPA-CKD study was an international, multicentre, randomised, double-blind, placebo-controlled study. In DAPA-CKD, the primary endpoint showed that FORXIGA in conjunction with other CKD therapies reduced the relative risk of the composite endpoint of ≥50% sustained decline in eGFR, reaching ESKD, and renal or CV death by 39% (5.3% ARR) vs placebo with other CKD therapies in 4304 adult patients with CKD with an eGFR of 75 to 25 mL/ min/1.73m2 and albuminuria (UACR ≥ 200 and ≤ 5000 mg/g) (median follow-up of 2.4 years; 9.2% vs 14.5%; HR 0.61; 95% CI (0.51 - 0.72; p<0.001).1 ESKD defined as sustained eGFR < 15 mL/min/1.73m2, chronic dialysis treatment or receiving a renal transplant. DAPA-CKD was stopped early due to efficacy benefit, because of the unplanned early stop, the secondary endpoints are considered nominally significant; Secondary endpoints showed that FORXIGA in conjunction with other CKD therapies reduced the relative risk of the composite of CV death or hHF by 29% (1.8% ARR: HR 0.71; 95% CI, 0.55 to 0.92; nominal p=0.009) and also reduced the relative risk of all-cause mortality by 31% (2.1% ARR; HR 0.69; 95% CI, 0.53 to 0.88; nominal p=0.004) vs placebo with other CKD therapies. There were comparable rates of the individual component of CV death, FORXIGA vs placebo (3.0% vs 3.7%; HR 0.81; 95% CI, 0.58, 1.12)1

The overall safety profile of dapagliflozin in patients with chronic kidney disease was consistent with the known safety profile of dapagliflozin.2

©AstraZeneca 2022. All Rights Reserved.



Consult Summary of Product Characteristics (SmPC) before prescribing.

Indications: Adults and children aged 10 years and above: Type 2 diabetes mellitus: For the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance, or in addition to other medicinal products for the treatment of type 2 diabetes.

Adults: Heart Failure: Indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease: Indicated in adults for the treatment of chronic kidney disease.

Presentation: Film-coated tablets. 5mg or 10mg of dapagliflozin (as propanediol monohydrate). Each 5mg tablet contains 25mg of lactose. Each 10mg tablet contains 50mg of lactose.

Dosage and Administration: Adults: Type 2 diabetes mellitus: The recommended dose is 10mg once daily. Consider a lower dose of insulin or insulin secretagogue such as a sulphonylurea when used in combination with dapagliflozin to reduce the risk of hypoglycaemia. Children and adolescents: No dose adjustment in children aged 10 years and above. No safety and efficacy data available for children below 10 years of age. Heart Failure: The recommended dose is 10mg once daily. Chronic kidney disease: The recommended dose is 10 mg once daily. Children and adolescents: <18 years: Safety and efficacy not yet established.

Elderly: ≥65 years: No dose adjustment is recommended based on age. Renal impairment: No dose adjustment is required based on renal function. Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. If GFR falls below 45 mL/min, additional glucose lowering treatment should be considered in patients with diabetes mellitus if further glycaemic control is needed. Mild or moderate hepatic impairment: No dose adjustment. Severe hepatic impairment: Starting dose of 5mg is recommended, if well tolerated, dose may be increased to 10mg. Method of administration: Forxiga can be taken orally at any time of day with or without food. Tablets should be swallowed whole.

Contraindications: Hypersensitivity to dapagliflozin, or excipients. Warnings and Precautions: Dapagliflozin should not be used in patients with type 1 diabetes mellitus. Renal impairment: Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. The glucose lowering efficacy of dapagliflozin is dependent on renal function, and is reduced in patients with GFR < 45 mL/min and is likely absent in patients with severe renal impairment. Hepatic impairment: Exposure is increased in patients with severe hepatic impairment. Use in patients at risk of volume depletion and/or hypotension: Dapagliflozin increases diuresis which may lead to a modest decrease in blood pressure, it may be more pronounced in patients with very high blood glucose concentrations. Exercise caution in patients for whom a dapagliflozin induced drop in blood pressure could pose a risk, such as patients on anti hypertensive therapy with a history of hypotension or elderly patients. Careful monitoring of volume status and electrolytes is recommended in conditions leading to volume depletion, such as acute gastrointestinal illness. In volume depleted patients temporary interruption of dapagliflozin is recommended until volume depletion is corrected. Diabetic ketoacidosis (DKA): Rare cases of DKA, including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin. In a number of cases, the presentation of the condition was atypical with only moderately

increased blood glucose values, below 14mmol/L (250mg/dL). The risk of DKA must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level. In patients where DKA is suspected or diagnosed, dapagliflozin treatment should be stopped immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised. Before initiating dapagliflozin, factors in patient history that may predispose to ketoacidosis should be considered. Patients who may be at higher risk of DKA include patients with a low beta cell function reserve (e.g. patients with low C peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse. SGLT2 inhibitors should be used with caution in these patients. Restarting SGLT2 inhibitor treatment in patients experiencing a DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved. Dapagliflozin should not be used for treatment of patients with type 1 diabetes mellitus. Necrotising fasciitis of the perineum (Fournier’s gangrene): Postmarketing cases have been reported in female and male patients taking SGLT2 inhibitors. Urgent surgical intervention and antibiotic treatment is required. Advise patients to seek medical attention if they experience a combination of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Either uro-genital infection or perineal abscess may precede necrotising fasciitis. If suspected, discontinue Forxiga and institute prompt treatment (including antibiotics and surgical debridement). Urinary tract infections: Temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis. Elderly (≥65 years): No dose adjustment is recommended based on age. Elderly patients are more likely to have impaired renal function, be treated with medicines such as anti-hypertensives or diuretics, and be at a greater risk of volume depletion. Cardiac failure: Experience with dapagliflozin in NYHA class IV is limited. Infiltrative cardiomyopathy: Patients with infiltrative cardiomyopathy have not been studied. Chronic kidney disease: There is no experience with dapagliflozin for the treatment of chronic kidney disease in patients without diabetes who do not have albuminuria. Patients with albuminuria may benefit more from treatment with dapagliflozin. Lower limb amputations: Counsel patients with diabetes on routine preventative foot care as an increase in cases of lower limb amputation (primarily of the toe) has been observed in long term, clinical studies in type 2 diabetes mellitus with SGLT2 inhibitors. Urine laboratory assessments: Patients will test positive for glucose in the urine due to mechanism of action. Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Forxiga.

Drug Interactions: Diuretics: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues: Consider a lower dose of insulin or insulin secretagogue when used in combination with dapagliflozin to reduce the risk of hypoglycaemia. Interference with 1,5 AG assay: Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5 AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors. Alternative methods

should be used. Interference with lithium: Dapagliflozin may increase renal lithium excretion and the blood lithium levels may be decreased. Serum concentration of lithium should be monitored more frequently after dapagliflozin initiation and dose changes. Please refer the patient to the lithium prescribing doctor in order to monitor serum concentration of lithium.

Pregnancy and Lactation: Not recommended during the second and third trimesters of pregnancy. Treatment should be discontinued when pregnancy is detected. Do not use whilst breast-feeding.

Ability to Drive and Use Machines: Alert patients on the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea or insulin.

Undesirable Events: Consult SmPC for full list of side effects. Very common (≥1/10): Hypoglycaemia (when used with SU or insulin).

Common (≥1/100 to <1/10): Vulvovaginitis, balanitis and related genital infections, urinary tract infection, dizziness, rash, back pain, dysuria, polyuria, haematocrit increased, creatinine renal clearance decreased during initial treatment, dyslipidaemia. Uncommon (≥1/1,000 to < 1/100): Fungal infection, volume depletion, thirst, constipation, dry mouth, nocturia, vulvovaginal pruritus, pruritus genital, blood creatinine increased during initial treatment, blood urea increased, weight decreased. Rare (≥ 1/10,000 to < 1/1,000): Diabetic ketoacidosis (when used in type 2 diabetes mellitus).

Very Rare (< 1/10,000): Angioedema, necrotising fasciitis of the perineum (Fournier’s gangrene), Tubulointerstitial nephritis.

Legal Category: Product subject to prescription which may be renewed (B).

Marketing Authorisation Number: EU/1/12/795/002; EU/1/12/795/007.

Marketing Authorisation Holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden.

Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, College Business and Technology Park, Blanchardstown Road North, Dublin 15. Tel: +353 1 609 71 00.

FORXIGA is a trademark of the AstraZeneca group of companies.

Date of API preparation: 02/2023 Veeva ID: IE-4664


Adverse events should be reported directly to: HPRA Pharmacovigilance, Website:

Adverse events should also be reported to AstraZeneca Patient Safety on Freephone 1800 800 899

1. Heerspink HJL et al. N Engl J Med. 2020;383(15):1436–1446.

2. FORXIGA 10 mg film-coated tablets. Summary of product characteristics.

ARR = absolute risk reduction; CKD = chronic kidney disease; CV = cardiovascular; DAPA-CKD = Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease; eGFR = estimated glomerular filtration rate; ESKD = end-stage kidney disease; hHF = hospitalisation for heart failure; HR = hazard ratio. HFrEF = heart failure with reduced ejection fraction; T2D = type 2 diabetes

Veeva ID: IE-4695 Date of Prep: February 2023

Hypertension in focus

The Irish population has one of the highest rates of high blood pressure internationally, but the country ranks among the lowest in terms of diagnosis, treatment, and control of the condition

Hypertension is the most common cause of cardiovascular disease (CVD) and the leading risk factor for premature death worldwide. Approximately 55 per cent of ischaemic heart disease, 50 per cent of ischaemic stroke, 58 per cent of haemorrhagic stroke, and 58 per cent of other cardiovascular diseases including rheumatic and hypertensive heart disease, cardiomyopathy, rhythm disorders, aortic aneurysms, and peripheral vascular disease have been attributed to hypertension.1

The Global Burden of Disease study (2015) identified that non-optimal blood pressure (BP) continues to be the single greatest risk factor contributing to the global burden of disease and to ‘all-cause mortality’ worldwide, leading to 9.4 million deaths and 212 million healthy life years lost (8.5 per cent of the global total) each year.2 More than one billion adults worldwide have hypertension with up to 45 per cent of the adult population affected. The high prevalence of hypertension is consistent across all socio-economic and income strata, and the prevalence rises with age accounting for up to 60 per cent of the population above 60 years of age. Recent estimates suggest the number of patients with hypertension could increase by as much as 15-to-20 per cent, and reach close to 1.5 billion by 2025.3

The Irish population has one of the highest rates of high blood pressure internationally, but the country ranks among the lowest in terms of diagnosis, treatment and control of the condition, according to a study carried out at Imperial College London. The study looked at 123 national surveys conducted over 40 years, involving more than 525,000 people aged 40-to-80.

A study of people from 12 high-income countries found that men and women from Ireland were least likely to have been diagnosed with high blood pressure, given medication to treat the condition, or have it controlled. Irish men ranked second at 56 per cent and Irish women ranked fourth at 43 per cent, according to the study, which was published in The Lancet 6 A separate study by the Irish Longitudinal Study on Ageing (TILDA), published in the Journal of Public Health in 2016, reported that 64 per cent of the over-50s, equivalent to 797,000 people in Ireland had high BP.8


The aetiology of hypertension involves the complex interplay of environmental and pathophysiological factors that affect multiple systems, as well as genetic predisposition.4

The pathogenesis of essential hypertension is multifactorial and complex. The kidneys are both the contributing and the target organ of the hypertensive processes, and the disease involves the interaction of multiple organ systems and numerous mechanisms of independent or interdependent pathways. Factors that play an important role in the pathogenesis of hypertension include genetics, activation of neuro-hormonal systems such as the sympathetic nervous system and renin-angiotensin-aldosterone system, obesity, and increased dietary salt intake.5 Primary hypertension involves multiple types of genes. Some allelic variants of several genes are associated with an increased risk of developing primary hypertension and are linked in almost all cases to a positive family history. Malfunction or disruption of factors involved in BP control can directly or indirectly lead to increases in mean BP, BP variability, or both, over time resulting in target organ damage and negative CVD outcomes.7

Guidelines BP is commonly expressed as the ratio of the systolic and the diastolic BP. While normal values can vary geographically, blood pressure is measured in mmHG. The European Society of Cardiology/European Society of Hypertension (ESC/ESH) 2018 guidelines express the normal BP value as <120 systolic over <80 diastolic.11

In 2017, new guidelines from the American Heart Association (AHA), the American College of Cardiology (ACC), and nine other health organisations lowered the numbers for the diagnosis of hypertension to 130/80mm Hg and higher for all adults. The new guidelines stem from the 2017 results of the Systolic Blood Pressure Intervention Trial (SPRINT), which studied more than 9,000 adults aged 50 and older who had systolic blood pressure of 130mmHg or higher and at least one risk factor for cardiovascular disease.9

In 2019, the UK’s National Institute for Health and Care Excellence (NICE) published a new clinical guideline on the diagnosis and management of hypertension in adults. The threshold for diagnosing and treating hypertension remained unchanged, at 140/90mmHg for clinic readings or 135/85mmHg for daytime ambulatory blood pressure monitoring (ABPM) or for home blood pressure measurement (HBPM). The definition for stage 2 hypertension remained the same at 160/100mmHg, but stage 3 or severe hypertension changed to a new diastolic cut-off of 180/110mmHg. NICE continues to recommend that BP should be measured in both arms at the time of diagnosis, but suggests a difference of 15mmHg should now be considered significant, compared to the previous 20mmHg.10 Another notable change in the NICE guideline is to offer people <80 years of age with stage 1 hypertension treatment using a 10-year cardiovascular risk (QRISK2) threshold of 10 per cent instead of the previous 20 per cent.

The ESC/ESH classification guidelines were issued in 2018 for use in all individuals ≥16 years of age.11

 Normal: SBP <120mmHg and DBP <80mmHg.

 Pre-hypertension: SBP 120-to-139mmHg and DBP 80-to-89mmHg.

 Stage 1 hypertension: SBP 140-to-159mmHg and DBP 90 to 99mmHg.

 Stage 2 hypertension: SBP ≥160mmHg and DBP ≥100mmHg.

The ESC/ESH guidelines recommend that when BP-lowering medications are used, the first objective should be to lower BP to less than 140/90mmHg in all patients. Provided treatment is well-tolerated, treated BP values should be targeted to 130/80mmHg or lower in most patients. In patients over 65 years of age, systolic BP should be targeted to between 130-and-140mmHg, and diastolic BP to less than 80mmHg. The European target for hypertension in special situations such as diabetes, coronary artery disease (CAD), and TIA is BP 120-130/70-79mmHg for 18-to-65 year-olds, and 130-139/70-79mmHg for 65-to >80-year-olds. In CKD, the systolic target is <140-to-130mmHg, if tolerated.11

Symptoms, diagnosis, and evaluation

Essential or primary hypertension is usually asymptomatic, and hypertension is most commonly-diagnosed based on repeated BP measurements in a clinical office setting. Investigation is based on clinical history, physical examination, and routine laboratory investigations. Medical history assesses current and past BP measurements and antihypertensive medications if relevant. A history of pregnancy-related hypertension is an important factor in the assessment

of women with hypertension. Physical examination aims to establish the diagnosis of hypertension and screen for target organ damage and secondary causes.

The patient should sit quietly for five minutes before a BP reading is taken and the BP cuff should be positioned at heart level. An average of three BP measurements obtained on two-to-three separate occasions provides an accurate basis for estimation of BP.7 BP should be measured on both arms, and differences in SBP >20mmHg and/or in DBP >10mmHg should initiate investigations of vascular abnormalities. Careful attention should be paid to choosing an appropriately-sized cuff, particularly for patients with obesity. BP should be measured in both sitting and standing positions to rule out orthostatic hypotension, and this is particularly important in older patients.7

Investigation should include auscultation of the carotid arteries, heart, and renal arteries. Detection of murmurs should lead to further investigations including carotid ultrasound, echocardiography, and renal ultrasound. An irregular pulse frequently indicates atrial fibrillation, which should be confirmed by an electrocardiogram. Laboratory-investigations are used to detect additional risk factors, to confirm or exclude secondary hypertension, to detect clinical or subclinical target organ damage and to estimate CVD risk.7 Blood workup includes FBC, ESR, creatinine, eGFR, electrolytes, HbA1c, thyroid profile, blood cholesterol levels, and serum uric acid.4

Accurate measurement and recording of BP is essential to categorise the level of BP, ascertain BP-related CVD risk and guide management.7 HBPM is the measurement of BP at regular intervals by an individual at home or outside the clinic setting. Ambulatory blood pressure measurement is the most accurate method to diagnose hypertension and also aids in identifying individuals with masked hypertension as well as white coat effect.4 ABPM consists of an ambulatory device worn by the patient that measures and records the BP at regular intervals usually every 20-to-30 minutes, typically for a 24-hour period, while the individual goes about their daily activities.7

Evaluation of a patient with hypertension requires more than the diagnosis of elevated BP. It should also include assessment of the CVD risk, target organ damage, and concomitant clinical conditions that may affect the BP or related target organ damage as well as recognition of features suggestive of secondary hypertension. Secondary hypertension should be considered in cases of a sudden worsening of hypertension, poor BP response to medication, or severe target organ damage, which is out of proportion to the duration and severity of hypertension.7

Treatment and management

The treatment and management of hypertension can be divided into pharmacological and non-pharmacological interventions. Non-pharmacological and lifestyle management are recommended for all individuals with raised blood pressure regardless of age, gender, comorbidities or cardiovascular risk status. Lifestyle changes alone can account for an up to 15 per cent reduction in all cardiovascular-related events. Reducing blood pressure in adults with a high normal BP provides the potential to directly reduce CVD risk and to prevent or slow the age-related tendency for individuals to develop hypertension. Patient education is important for effective management and should include information regarding physical activity, weight management, salt restriction, and alcohol reduction and smoking cessation if applicable.4,7 Pharmacological therapy consists of angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARBs), diuretics – usually thiazides, calcium channel block-

Clinical Cardiology THE MEDICAL INDEPENDENT | 21 MARCH 2023 32
Continued on p34 ▸
THERESA LOWRY-LEHNEN, RGN, GPN, RNP, BSc, MSc, PG Dip Ed (QTS), M Ed, PhD, Clinical Nurse Specialist and Associate Lecturer, South East Technological University
FIGURE 1: ESC/ESH 2018 hypertension guidelines11 BLOOD PRESSURE CLASSIFICATION SBP mmHg DBP mmHg Normal <120 and <80 Pre-hypertension 120-139 or 80-89 Stage 1 hypertension 140-159 or 90-99 Stage 2 hypertension ≥160 or ≥100 SBP = Systolic blood pressure, DBP = Diastolic blood pressure


Therapeutic Indications: Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH) - Suvezen is indicated as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia in adult patients who are not appropriately controlled with statin alone, who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products. Prevention of Cardiovascular Events - Suvezen is indicated as substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently, at the same dose level as in the fixed dose combination, but as separate products to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS).

Prescribing Information: Suvezen (rosuvastatin/ ezetimibe) film-coated tablets

Please refer to the Summary of Product Characteristics (SmPC) for full prescribing details.

Presentations: Suvezen 10mg/10mg, 20mg/10mg and 40mg/10mg: Each film-coated tablet contains 10mg; 20mg or 40mg of rosuvastatin (as rosuvastatin calcium) respectively, and 10mg ezetimibe. Indication:

Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH) - Suvezen is indicated as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia in adult patients who are not appropriately controlled with statin alone, who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products. Prevention of Cardiovascular Events - Suvezen is indicated as substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently, at the same dose level as in the fixed dose combination, but as separate products to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS). Dosage and Administration: The patient should be on and continue, an appropriate lipid-lowering diet, during treatment with Suvezen. Suvezen is not suitable for initial therapy. When Suvezen is indicated for patients not controlled by statin alone, the dose of Suvezen should be individualized according to the target lipid levels and the patient’s response. When Suvezen is indicated for patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate product, treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. The recommended dose is one Suvezen tablet daily. To be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water. If co-administered with bile acid sequestrant (BAS), administration of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a BAS. Special populations: Paediatric (<18 years): Safety and efficacy has not been established. Elderly (>70 years): Starting dose of 5 mg rosuvastatin is recommended. The combination is not suitable for initial therapy. Hepatic impairment: Mild: No dosage adjustment is required. Moderate/Severe: Treatment with Suvezen is not recommended. Renal impairment: Mild: No dose adjustment is necessary. Moderate (creatinine clearance <60 ml/min): The recommended start dose is rosuvastatin 5mg. Race: The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry due to increased systemic exposure. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Suvezen 40 mg/10 mg tablets are contraindicated in these patients. Genetic polymorphisms: In patients who are known to have specific types of genetic polymorphisms that can lead to increased rosuvastatin exposure, a lower daily dose of Suvezen is recommended. Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5mg in patients with pre-disposing factors to myopathy. Suvezen 40 mg/10 mg tablets are contraindicated in some of these patients. Concomitant therapy: The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir). Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where co-administration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered. Contraindications: Hypersensitivity to the active substances or excipients.

Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures. Active liver disease or any serum transaminase elevations which are unexplained, persistent or exceeding 3x the upper limit of normal (ULN). Severe renal impairment (creatinine clearance <30ml/min); myopathy or receiving concomitant ciclosporin. 40mg/10mg dose contraindicated in patients with predisposing factors for myopathy/rhabdomyolysis; such factors include: Moderate renal impairment (creatinine clearance <60ml/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels of rosuvastatin may occur, Asian patients, concomitant use of fibrates.

Precautions and Warnings: Skeletal muscle effects: have been reported in rosuvastatin-treated patients with all doses and in particular with doses >20mg. As with other HMG-CoA reductase inhibitors, reporting rate for rhabdomyolysis is associated with use at doses >40mg. Post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. If myopathy is suspected based on muscle symptoms or is confirmed by a creatine phosphokinase (CPK) level, Suvezen and any of these other agents that the patient is taking concomitantly should be immediately discontinued. All patients starting therapy with Suvezen should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, particularly if associated with malaise or fever. Creatine kinase (CK) measurement: CK should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase. If CK levels are significantly elevated at baseline (>5x ULN) a confirmatory test should be carried out within 5 – 7 days. If the repeat test confirms a baseline CK >5x ULN, treatment should not be started. Patients with predisposing factors for myopathy/rhabdomyolysis: Caution should be exercised in these patients. Risk: benefit of treatment should be considered and clinical monitoring is recommended. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5x ULN) or if muscular symptoms are severe and cause daily discomfort. If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing treatment at the lowest dose. Immune-mediated necrotising myopathy (IMNM): Clinically characterised by proximal muscle weakness and elevated serum CK, has been reported very rarely during or after treatment with statins, including rosuvastatin, despite discontinuation of statin treatment. In clinical trials an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives. Suvezen should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Liver effects: In controlled co- administration trials in patients receiving ezetimibe with statin, consecutive transaminase elevations ≥3x ULN have been observed. It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminases is >3x ULN. The reporting rate for serious events is higher at the 40mg dose. In patients

with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome, the underlying disease should be treated prior to initiating therapy with rosuvastatin. Liver disease and alcohol: As with other HMG-CoA reductase inhibitors, rosuvastatin should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. Renal effects: Proteinuria has been observed in patients treated with higher doses of rosuvastatin and was transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40mg. Diabetes mellitus: Some evidence suggests that statins raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (fasting glucose 5.6 – 6.9mmol/l, BMI >30kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. Interstitial lung disease: Exceptional cases have been reported with some statins, especially with long term therapy. Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected, statin therapy should be discontinued. Severe cutaneous adverse reactions: Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be life-threatening or fatal, have been reported with rosuvastatin. If signs and symptoms suggestive of this reaction appears, Suvezen must be discontinued immediately and an alternative treatment should be considered. Treatment with Suvezen must not be restarted at any time. Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors in combination with ritonavir. Consideration should be given both to the benefit of lipid lowering by use of Suvezen in HIV patients receiving protease inhibitors and the potential for increased rosuvastatin plasma concentrations when initiating and up titrating rosuvastatin doses in patients treated with protease inhibitors. The concomitant use with certain protease inhibitors is not recommended unless the dose of rosuvastatin is adjusted. Fibrates: The safety and efficacy of ezetimibe administered with fibrates have not been established. If cholelithiasis is suspected in a patient receiving Suvezen and fenofibrate, gallbladder investigations are indicated and therapy should be discontinued. Anticoagulants: If Suvezen is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalised Ratio (INR) should be appropriately monitored. Fusidic acid: Suvezen must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re- introduced seven days after the last dose of fusidic acid. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e.g., for the treatment of severe infections, the need for coadministration of Suvezen and fusidic acid should only be considered on a case by case basis and under close medical supervision. Suvezen contains lactose and sodium: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine is essentially ‘sodium-free’. Interactions: Contraindicated combinations: Ciclosporin. Not- recommended combinations: Fibrates and other lipid-lowering products, protease inhibitors, transporter protein inhibitors and fusidic acid. Other possible interactions: Cytochrome P450 enzymes, antacids, colestyramine, anticoagulants, Vitamin K antagonists, clopidogrel, ticagrelor, erythromycin, oral contraceptive/ hormone replacement therapy. When co- administering rosuvastatin with other medicinal products known to increase exposure to rosuvastatin, doses should be adjusted (see SmPC for full details). The maximum daily dose should be adjusted so that the expected rosuvastatin exposure would not likely exceed that of a 40mg daily dose of rosuvastatin taken without interacting medicinal products. Fertility, Pregnancy and Breastfeeding: No clinical data are available on the use of ezetimibe during pregnancy. Potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. If a patient becomes pregnant during use of Suvezen, treatment should be discontinued immediately. Animal studies have shown excretion of medicinal product through breast milk. However, there are no data in humans. No clinical trial data on the effects of fertility in humans. Adverse Reactions: Adverse drug reactions previously reported with one of the individual components (ezetimibe or rosuvastatin) may be potential undesirable effects with Suvezen. Common: diabetes mellitus, headache, dizziness, constipation, nausea, abdominal pain, diarrhoea, flatulence, myalgia, ALT and/or AST increased, asthenia and fatigue. Uncommon: decreased appetite, paraesthesia, hot flush, hypertension, cough, dyspepsia, gastroesophageal reflux disease, nausea, dry mouth, gastritis, pruritus, rash, urticaria, arthralgia, muscle spasms, neck pain, back pain, muscular weakness, pain in extremity, ALT and/or AST increased, blood CPK increased, gamma-glutamyltransferase increased, liver function test abnormal, chest pain, pain, asthenia, oedema peripheral. Rare: thrombocytopenia, hypersensitivity reactions including angioedema, pancreatitis, increased hepatic transaminases, myopathy (including myositis), rhabdomyolysis, lupus-like syndrome and muscle rupture. Very rare: polyneuropathy, memory loss, jaundice, hepatitis, arthralgia, haematuria, gynaecomastia. Not known: thrombocytopenia, hypersensitivity (including rash, urticaria, anaphylaxis and angioedema), depression, peripheral neuropathy, sleep disturbances (including insomnia and nightmares), dizziness, paraesthesia, cough, dyspnoea, diarrhoea, pancreatitis, constipation, hepatitis, cholelithiasis, cholecystitis, Stevens Johnson syndrome, erythema multiforme, drug reaction with eosinophilia and systemic symptoms, immune-mediated necrotising myopathy, tendon disorders (sometimes complicated by rupture), myalgia, myopathy/rhabdomyolysis, oedema, asthenia. Prescribers should consult the SmPC in relation to other adverse reactions. Legal Category: POM. Marketing Authorisation Numbers: 10mg/10mg: PA0540/193/001; 20mg/10mg: PA0540/193/002; 40mg/10mg: PA0540/193/003. Marketing Authorisation Holder: Sanofi-Aventis Ireland Ltd. T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland. Further information is available from: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact Date of Preparation: February 2023 (MAT-IE-2300051 v1.0)

Adverse events should be reported. Reporting forms and information can be found at; email: Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to

20 mg /10 mg Rosuvastatin + Ezetimibe 10 mg /10 mg Rosuvastatin + Ezetimibe 40 mg /10 mg Rosuvastatin + Ezetimibe
MAT-IE-2101261 (v5.0) | March 2023 * LDL-C: Low-density lipoprotein Cholesterol. Reference: 1. Suvezen
of Product Characteristics.
High intensity statin single pill combination for LDL-C reduction1
12467_Suvezen_A4_Ad_JAN23_API_Sizing_06.indd 1 13/03/2023 10:37

▸ Continued from p32 ers, and beta-blockers, taking into account age, race, and comorbidities such as the presence of renal dysfunction, LV dysfunction, heart failure, and cerebrovascular disease.4 NICE recommends starting with monotherapy treatment, however, high BP cannot be controlled with monotherapy in many patients, particularly those with severe hypertension, and polypharmacy is common. There are two main approaches to pharmacological therapy; initiating two or more drugs such as an ACEi or an ARB with a thiazide diuretic and calcium channel blocker simultaneously, or a stepwise titration approach with single therapy being titrated up

to maximum dosage before initiating a second drug. Both are successful in improving patient outcomes, provided there is adequate patient compliance and treatment adherence.4,7

Patients must be aware of the possibility and monitored closely for side-effects, especially in the early stage of therapy. Side-effects of anti-hypertensive medication include hypotension, electrolyte imbalances, pedal oedema, and renal dysfunction. Renal dysfunction and electrolyte imbalance especially hyponatraemia and hyperkalaemia are common with ACE inhibitors and ARBs, and electrolytes must be monitored closely. Angioedema is a lifelong contraindication for ACEi or ARB usage. For patients with severe side-effects such as symptomatic hyperkalaemia or hyponatraemia, syncope,

and acute kidney injury (AKI), treatment needs to be discontinued, nephrologist and cardiologist opinions sought, and inpatient management considered. Once settled, treatment needs to be re-initiated slowly and cautiously with careful monitoring and frequent follow-up.4

Prognosis and outlook

Although there is regional variability in the outlook for hypertension over the next five-to-10 years, it is clear that the prevalence and associated global burden attributable to hypertension will increase, with 1.5 billion people expected to be affected by 2025. Global population growth and ageing will largely contribute to this increase. However, adverse trends in disease burden may invariably be offset by improvements in prevention, awareness, and treatment. Improving the efficacy of drug treatment holds promise for reducing the associated disease burden of hypertension, and the greatest effect could be achieved by the delivery and distribution of affordable, effective single-pill combinations of two or three drugs to low-income and middle-income countries where the burden of hypertension is considerable and where such therapies are currently either unavailable or unaffordable. Efforts to drive public health policy towards encouraging more healthy lifestyles must be encouraged, and scientific research to allow precision medicine to be developed and applied continued. Hypertension is a chronic disorder that requires long-term care and management and a multidisciplinary approach. Patient education and information regarding lifestyle modification and pharmacological therapy is the key to success for improved control and to prevent complications. Weight management, increased physical activity, limiting alcohol, and smoking cessation are important factors to address, to decrease cardiovascular risk. All patients with hypertension should have an evidence-based care plan that ensures the achievement of treatment and self-management goals, effective management of comorbid conditions and timely follow-up with the healthcare team.


1. Van Kleef M, Spiering W. Hypertension: Overly important, but undercontrolled. Eur J Prev Cardiol 2017 Jun 16; 24(3)

2. GBD 2015 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: A systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8; 388 (10053):1659-1724

3. Iqbal A, Jamal S. Essential hypertension. In StatPearls. 2021 Available at:

4. Oparil S, Acelajado, MC, Bakris GL, Berlowitz DR, Cífková R, Dominiczak AF, et al. Hypertension. Nature reviews. Disease primers. 2018 Mar 22; 4(18014)

5. Hamrahian S, Batuman V. Pathophysiology of Hypertension. Medscape. Drugs and diseases; nephrology. 2017 May 19. Available at: article/1937383-overview

6. Cullen P. Irish blood pressure problem revealed in international study. The Irish Times. 2019 Sept 11. Available at: www.irishtimes. com/news/health/irish-blood-pressureproblem-revealed-ininternationalstudy-1.4013974

7. Acelajado M, Bakris G, Berlowitz D, Cífková R, Dominiczak A, Grassi G, et al. Hypertension. Nature reviews. 2018 Mar 22. 4: 18014

8. Murphy C, Kearney P, Shelley E, Fahey T, Dooley C, Kenny R. Hypertension prevalence, awareness, treatment, and control in the over-50s in Ireland: Evidence from the Irish Longitudinal Study on Ageing. Journal of Public Health. 2015 Apr 8; 38(3):450-458

9. Harvard Health Publishing. Reading the new blood pressure guidelines. 2021. Available at: reading-the-new-blood-pressure-guidelines

10. National Institute for Health and Care Excellence. Hypertension in adults: Diagnosis and management: NICE guideline 136. 2019. Available at:

11. European Society of Cardiology. 2018 ESC/ESH Clinical Practice Guidelines for the Management of Arterial Hypertension. European Society of Cardiology. 2018 Aug 25. Available at: Arterial-Hypertension-Management-of

Clinical Cardiology THE MEDICAL INDEPENDENT | 21 MARCH 2023 34

ATTR-CM=transthyretin amyloid cardiomyopathy; CV=cardiovascular.

References: 1. Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016.

2. VYNDAQEL Summary of Product Characteristics. Vyndaqelq 61 mg soft capsules (tafamidis) Prescribing Information: Before prescribing Vyndaqel please refer to the full Summary of Product Characteristics. Presentation: Vyndaqel 61 mg soft capsules. Each soft capsule contains 61 mg tafamidis. Uses: Vyndaqel is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Dosage: Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. When there is a suspicion in patients presenting with specific medical history or signs of heart failure or cardiomyopathy, etiologic diagnosis must be done by a physician knowledgeable in the management of amyloidosis or cardiomyopathy to confirm ATTR-CM and exclude AL amyloidosis before starting Vyndaqel, using appropriate assessment tools such as: bone scintigraphy and blood/urine assessment, and/or histological assessment by biopsy, and transthyretin (TTR) genotyping to characterise as wild-type or hereditary. The recommended dose is one capsule of Vyndaqel 61 mg (tafamidis) orally once daily. Vyndaqel 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine, tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Vyndaqel should be started as early as possible in the disease course when the clinical benefit on disease progression could be more evident. Conversely, when amyoid-related cardiac damage is more advanced, such as in NYHA Class III, the decision to start or maintain treatment should be taken at the discretion of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. There are limited clinical data in patients with NYHA Class IV. If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible. If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual. There are no recommended dosage adjustments for elderly patients or patients with renal or mild and moderate hepatic impairment. Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min). Tafamidis has not been studied in patients with severe hepatic impairment and caution is recommended. There is no relevant use of tafamidis in the paediatric population. Method of Administration: The soft capsules should be swallowed whole and not crushed or cut. Vyndaqel may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1 of SPC. Warnings and Precautions: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis and for one month after stopping treatment. Tafamidis should be added to the standard of care for the treatment of patients with transthyretin amyloidosis. Physicians should monitor patients and continue to assess the need for other therapy, including the need for organ transplantation, as part of this standard of care. As there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued in patients who undergo organ transplantation. Increase in liver function tests and decrease in thyroxine may occur. This medicinal product contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of

sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Pregnancy and Lactation: Tafamidis is not recommended during pregnancy and in women of childbearing potential not using contraception.Available data in animals have shown excretion of tafamidis in milk.A risk to the newborns/infants cannot be excluded. Vyndaqel should not be used during breastfeeding. Interactions: In a clinical study in healthy volunteers, 20 mg tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4. In vitro tafamidis inhibits the efflux transporter BCRP (breast cancer resistant protein) at the 61 mg/day tafamidis dose with IC50=1.16 μM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib). In a clinical study in healthy participants, the exposure of the BCRP substrate rosuvastatin increased approximately 2-fold following multiple doses of Page 2 of 2 2020-0065522 61 mg tafamidis daily dosing. Likewise, tafamidis inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 μM and IC50=2.36 μM,respectively,and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine). Based on in vitro data, the maximal predicted changes in AUC of OAT1 and OAT3 substrates were determined to be less than 1.25 for the tafamidis 61 mg dose, therefore, inhibition of OAT1 or OAT3 transporters by tafamidis is not expected to result in clinically significant interactions. No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis. Undesirable Effects: The following adverse events were reported more often in 176 ATTR-CM patients treated with tafamidis meglumine 80 mg compared to placebo: flatulence [8 patients (4.5%) versus 3 patients (1.7%)] and liver function test increased [6 patients (3.4%) versus 2 patients (1.1%)]. A causal relationship has not been established. Safety data for tafamidis 61 mg are not available as this formulation was not evaluated in the double-blind, placebo-controlled, randomised phase 3 study. Legal category: S1A. Marketing Authorisation Numbers: EU/1/11/717/003– 61mg (30 capsules). 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 For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500. Last revised: 04/2021 q This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Ref: VY 61MG 2_0

PP-VYN-IRL-0159. Date of Preparation: September 2022. © 2022 Pfizer Inc. All rights reserved. Rare Disease ATTR-CMIS LIFE-THREATENING1
The first and only treatment indicated to reduce:
• all-cause mortality
Further information available upon request.
• frequency of CV-related hospitalisations in patients with wild-type or hereditary ATTR-CM.1
ORAL VYNDAQEL 61MG SOFT CAPSULES 12509_Vyndaqel_V_A4_AD_SEPT22_01.indd 1 23/09/2022 15:23
Indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). 2

European Association of Urology, Annual Congress, Milan, Italy, 10-13 March 2023

New technique reduces postoperative complications in prostate cancer surgery

Surgeons in Germany have shown a small technical change to keyhole surgery for prostate cancer can more than halve one of the most common post-operative complications – where lymphatic fluid collects in the pelvis.

The technique, presented at the 2023 European Association of Urology (EAU) Annual Congress in Milan, involves creating a small flap in the peritoneum and attaching this flap down into the pelvis. This creates a route for lymphatic fluid to escape from the pelvis into the abdomen where it can be more easily absorbed.

Around 10 per cent of patients whose prostate cancer and lymph nodes are removed through robot-assisted keyhole surgery require treatment for symptoms caused by lymphatic fluid collecting in the pelvis, known as lymphocele. Lymphocele can also be seen in nearly a third of patients when they are systematically checked, without them reporting symptoms. Symptoms include superinfection, pain in the pelvis, pressure on the bladder, and swollen legs due to compression of the veins. If left untreated, symptomatic lympho-

cele can lead to serious infections or deep vein thrombosis. Draining a lymphocele can take from three days to three weeks.

Urology specialist Manuel Neuberger from University Medical Centre Mannheim and Heidelberg University said: “If drainage doesn’t cure the problem, then – in rare cases – the final treatment is to create an artificial opening in the peritoneum, which provides a route out for the lymph so it’s no longer stuck in the pelvis. As it’s such a simple step, why not create a flap as standard, to prevent the condition in the first place? Previous studies of the technique have been inconclusive, so we designed a larger, more robust trial to ensure our findings were statistically significant.”

The trial involved over 550 patients and four different surgeons working at University Medical Centre Mannheim. During the six month follow-up period, only 10 patients in the peritoneal flap group had developed a symptomatic lymphocele, compared to 25 in the control group. At the time of discharge, 20 patients in the flap group had lymphocele with no symptoms, compared to 46 in the control group. During

the follow-up, this had risen to just 27 in the flap group, but 74 in the control group.

Prof Philip Nuhn, Professor of Urology at University Medical Centre Mannheim, who led the research, said: “Using the peritoneal flap reduced the incidence of lymphocele from 9 per cent to less than 4 per cent. We now use this as the new standard in Mannheim, and hope that – following these results – it will become common practice elsewhere as well.”

Prof Jochen Walz, from the EAU Scientific Congress Office and the Institut PaoliCalmettes Cancer Centre in Marseille, said: “Most problems in these operations are linked to the lymph node removal, rather than the prostate surgery itself. Removal of the lymph nodes allows us to see if the cancer has spread, so it’s important to do, particularly as surgery is now mainly used in higher-risk patients. Creating a peritoneal flap is a simple, small, easy and quick procedure that takes about five minutes to complete. It is totally safe and this trial has shown it can substantially reduce complications, so there’s no reason why surgeons should not now do this as standard.”

Testing for genetic mutations in urine can detect bladder cancer years before the disease shows clinical symptoms, new research presented at the EAU 2023 Annual Congress in Milan has shown.

Bladder cancer is the fifth most common cancer in the European Union (EU), with over 200,000 cases each year. Only around half of those diagnosed with the disease will survive more than five years, mainly due to late diagnosis and recurrence. By contrast, if their cancer is detected at an early stage, more than 80 per cent of patients survive for at least five years.

The new study, by researchers from France, Iran, and the US, identified mutations across 10 genes that were able to predict the most common type of bladder cancer up to 12 years in advance of diagnosis.

The study was based on the UroAmp test, a general urine test that identifies mutations in 60 genes. Drawing on previous research to identify genetic mutations linked to bladder cancer, the research team narrowed the new test down to focus on mutations within just 10 genes.

The researchers trialled the potential new test using samples from the Golestan Cohort Study, which has tracked the health of more than 50,000 participants over 10 years, all of whom provided urine samples at recruitment. Forty people within the study developed bladder cancer during that decade, and the team were able to test urine samples from 29 of them, along with samples from 98 other similar participants as controls. Of the 29 participants who

had developed bladder cancer within the Golestan cohort, the test was able to accurately predict future bladder cancer in 19 (66 per cent) of them, even though urine samples had been taken up to 12 years before clinical diagnosis. Fourteen of these participants were diagnosed with bladder cancer within seven years of urine collection, and the test was able to predict cancer in 12 (86 per cent) of these. The test was accurately negative in 94 of the 98 participants (96 per cent) who would not develop cancer in the future. Among those where the test was negative, but who did eventually develop bladder cancer, no cancer was diagnosed until at least six years after the urine collection.

The test was also trialled with colleagues from Massachusetts General Hospital and Ohio State University using samples from 70 bladder cancer patients and 96 controls, taken prior to a cystoscopy. In contrast with the Golestan study, some of these samples were provided by cancer patients on the day they were diagnosed, rather than many years before. Mutations were found in urine samples from 50 of the 70 patients (71 per cent) whose tumours were visible during the cystoscopy. Some of these were new diagnoses and others involved a cancer recurring. Mutations were not found in 90 of the 96 (94 per cent) patients with a negative cystoscopy.

Lead researcher Dr Florence Le Calvez-Kelm, from the International Agency for Research on Cancer (IARC) in Lyon, believes these results demonstrate the potential of a genetic urine test for early detection of bladder cancer.

Active monitoring of prostate cancer has the same high survival rates after 15 years as radiotherapy or surgery, reports the largest study of its kind. The latest findings from the ProtecT trial were presented at the EAU 2023 Annual Congress in Milan and published in the New England Journal of Medicine

Although men on active monitoring were more likely to see it progress or spread than those receiving radiotherapy or surgery, this didn’t reduce their likelihood of survival. The trial also found that the negative impacts of radiotherapy and surgery on urinary and sexual function persist much longer than previously thought – for up to 12 years.

The findings show that treatment decisions following diagnosis for lowand intermediate-risk localised prostate cancer do not need to be rushed, according to lead investigator, Prof Freddie Hamdy from the University of Oxford. “It’s clear that, unlike many other cancers, a diagnosis of prostate cancer should not be a cause for panic or rushed decision-making,” he said. “Patients and clinicians can and should take their time to weigh up the benefits and possible harms of different treatments in the knowledge that this will not adversely affect their survival.”

The trial, funded by the National Institute for Health and Care Research, was led by researchers at the Universities of Oxford and Bristol in nine UK centres and is the longest running study of its kind. It is the first to fully evaluate three major treatment options: Active monitoring, surgery (radical prostatec-

tomy), and radiotherapy with hormones for men with localised prostate cancer.

Between 1999 and 2009, 1,643 men aged 50-to-69 years across the UK, who were diagnosed with localised prostate cancer after a PSA blood test, agreed to be randomised to active monitoring (545), radical prostatectomy (553), or radical radiotherapy (545). The research team followed the men over an average of 15 years, to measure mortality rates, cancer progression and spread, and the impact of treatments on quality-of-life.

They found that around 97 per cent of the men diagnosed with prostate cancer survived 15 years after diagnosis, irrespective of which treatment they received. Around a quarter of the men on active monitoring had still not had any invasive treatment for their cancer after 15 years. Patients from all three groups reported similar overall quality-of-life, in terms of their general mental and physical health. But the negative effects of surgery or radiotherapy on urinary, bowel, and sexual function were found to persist much longer than previously thought.

In earlier findings released in 2016, the researchers found that, after 10 years follow-up, men whose cancer was being actively monitored were twice as likely to see it progress or metastasise than those in the other groups. The assumption had been that this might lead to a lower survival rate for men on active monitoring over a longer time period. However, the results from the 15-year follow-up show that this isn’t the case and that survival rates remain similarly high across all groups.

THE MEDICAL INDEPENDENT | 21 MARCH 2023 36 Conference Coverage
Urine gene test can predict bladder cancer years before diagnosis
Delaying treatment for localised prostate cancer does not increase mortality risk, trial shows

50mgs once daily

BETMIGA 25 mg prolonged-release tablets & BETMIGA 50 mg prolonged-release tablets.

Her 10th shopping trip since the day she started BETMIGA1

Prescribing Information: BETMIGA™ (mirabegron)

For full prescribing information, refer to the Summary of Product Characteristics (SPC). Name: BETMIGA 25 mg prolonged-release tablets & BETMIGA 50 mg prolonged-release tablets. Presentation: Prolongedrelease tablets containing 25 mg or 50 mg mirabegron. Indication: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Posology and administration: The recommended dose is 50 mg orally once daily in adults (including elderly patients). Mirabegron should not be used in paediatrics for OAB. A reduced dose of 25 mg once daily is recommended for special populations (please see the full SPC for information on special populations). The tablet should be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed. The tablet may be taken with or without food. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC. Severe uncontrolled hypertension defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg. Warnings and Precautions: Renal impairment: BETMIGA has not been studied in patients with end stage renal disease (eGFR < 15 ml/min/1.73 m2 or patients requiring haemodialysis) and, therefore, it is not recommended for use in this patient population. Data are limited in patients with severe renal impairment (eGFR 15 to 29 ml/min/1.73 m2); based on a pharmacokinetic study (see section 5.2 of the SPC) a dose of 25 mg once daily is recommended in this population. This medicinal product is not recommended for use in patients with severe renal impairment (eGFR 15 to 29 ml/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors (see section 4.5 of the SPC).

Hepatic impairment: BETMIGA has not been studied in patients with severe hepatic impairment (ChildPugh Class C) and, therefore, it is not recommended for use in this patient population. This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving strong CYP3A inhibitors (see section 4.5 of the SPC). Hypertension: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients. Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg). Patients with congenital or acquired QT prolongation: BETMIGA, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies (see section 5.1 of the SPC). However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown. Caution should be exercised when administering mirabegron in these patients. Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB: Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medicinal products for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. A

controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with BETMIGA; however, BETMIGA should be administered with caution to patients with clinically significant BOO. BETMIGA should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB. Interactions: Caution is advised if mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised by CYP2D6. Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. In patients with mild to moderate renal impairment or mild hepatic impairment, concomitantly receiving strong CYP3A inhibitors, the recommended dose is 25 mg once daily. For patients who are initiating a combination of mirabegron and digoxin (P-gp substrate), the lowest dose for digoxin should be prescribed initially (see the SPC for full prescribing information). The potential for inhibition of P-gp by mirabegron should be considered when BETMIGA is combined with sensitive P-gp substrates. Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate. Pregnancy and lactation: BETMIGA is not recommended in women of childbearing potential not using contraception. This medicinal product is not recommended during pregnancy. BETMIGA should not be administered during breast-feeding. Undesirable effects: Summary of the safety profile: The safety of BETMIGA was evaluated in 8433 adult patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received BETMIGA for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for adult patients treated with BETMIGA 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections. The frequency of tachycardia was 1.2% in patients receiving BETMIGA 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving BETMIGA 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving BETMIGA 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving BETMIGA 50 mg. Serious adverse reactions included atrial fibrillation (0.2%). Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies. Adverse reactions: The following list reflects the adverse reactions observed with mirabegron in adults with OAB in the three 12-week phase 3 double blind, placebo controlled studies. The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be established from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse events are grouped by MedDRA system organ class. Infections and infestations:

Common: Urinary tract infection, Uncommon: Vaginal infection, Cystitis. Psychiatric disorders: Not known (cannot be estimated from the available data): Insomnia*, Confusional state*. Nervous system disorders:

Common: Headache*, Dizziness*. Eye disorders: Rare: Eyelid oedema. Cardiac disorders: Common: Tachycardia, Uncommon: Palpitation, Atrial fibrillation. Vascular disorders: Very rare: Hypertensive crisis*. Gastrointestinal disorders:

Common: Nausea*, Constipation*, Diarrhoea*, Uncommon: Dyspepsia, Gastritis, Rare: Lip oedema. Skin and subcutaneous tissue disorders: Uncommon: Urticaria, Rash, Rash macular, Rash papular, Pruritus, Rare: Leukocytoclastic vasculitis, Purpura, Angioedema*. Musculoskeletal and connective tissue disorders: Uncommon: Joint swelling. Renal and urinary disorders: Rare: Urinary retention*. Reproductive system and breast disorders: Uncommon: Vulvovaginal pruritus. Investigations: Uncommon: Blood pressure increased, GGT increased, AST increased, ALT increased. * signifies adverse reactions observed during post-marketing experience. Prescribers should consult the SPC in relation to other adverse reactions. Overdose: Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended. Basic NHS Cost: Great Britain (GB)/Northern Ireland(NI): BETMIGA 50 mg x 30 = £29, BETMIGA 25 mg x 30 tablets = £29. Ireland (IE): POA. Legal classification: POM. Marketing Authorisation number(s): (GB): PLGB 00166/0415-0416. NI/IE: EU/1/12/809/001-006, EU/1/12/809/008-013, EU/1/12/809/015018. Marketing Authorisation Holder: GB: Astellas Pharma Ltd., 300 Dashwood Lang Road, Bourne Business Park, Addlestone, United Kingdom, KT15 2NX. NI/IE: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands. Date of Preparation of Prescribing information: January 2023. Job bag number: MAT-IE-BET-2023-00001. Further information available from: GB/NI: Astellas Pharma Ltd, Medical Information: 0800 783 5018. IE: Astellas Pharma Co. Ltd., Tel.: +353 1 467 1555. For full prescribing information, please see the Summary of Product Characteristics, which may be found at: GB:; NI:; IE:

United Kingdom (GB/NI)

Adverse events should be reported. Reporting forms and information can be found at or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Astellas Pharma Ltd. on 0800 783 5018. Ireland

Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Website: or Astellas Pharma Co. Ltd. Tel: +353 1 467 1555, E-mail:

January 2023 References: 1. Freeman R, et al. Current Medical Research and Opinion 2017. MAT-IE-BET-2023-00002
Date of preparation:
12259_Betmiga_SHOPPING_A4_JAN23_01.indd 1 16/01/2023 16:48



30th International Meeting on Advanced Spine Techniques (IMAST) Convention Centre, Dublin. The IMAST, organised by the Scoliosis Research Society (SRS), will see leading spine surgeons and researchers come together to demonstrate and discuss recent advances in spine surgery. IMAST focuses on innovative and new methods/techniques for spinal pathology. Educational content includes instructional course lectures, four-minute paper presentations, case discussions, E-point presentations, and industry workshops, all led by a multidisciplinary and international faculty. Visit


Blackrock Health Galway GP Study Day, Galway Bay Hotel, Galway. The event is organised by Investnet Healthcare Ltd.


Irish Nurses Cardiovascular Association 25th Jubilee event, Trinity College Dublin. The Association will hold its scientific meeting and cardiac excellence awards. The objective of the Association is to keep members informed of new developments relating to cardiovascular disease, to promote ongoing research and education for nurses, and enhance the standards of nursing care and research. Visit


Society of British Neurological Surgeons (SBNS) Spring Meeting, Clayton Hotel Silver Springs Conference Centre, Tivoli, Cork. The meeting will be hosted by SBNS colleagues at Cork University Hospital. Visit


14th World Congress on Brain Injury, Convention Centre, Dublin. Organised by the International Brain Injury Association (IBIA), the World Congress on Brain Injury is the largest gathering of international professionals working in the field. This year it is being held in partnership with Acquired Brain Injury Ireland. Visit


College of Psychiatrists of Ireland Spring Meeting. The College is the professional body for psychiatrists in the Republic of Ireland. Its mission is to promote excellence in the practice of psychiatry. Visit



Tackling long Covid in Ireland – priorities for services, strategy development, and research. This online conference will assess priorities and next steps for addressing the impact of long Covid in Ireland. Areas for discussion include developing and implementing research into the condition, the state of specialised services in Ireland, and progress on the Model of Care, which recommended the creation of eight post-acute and six long Covid clinics. It will be an opportunity to discuss Ireland’s strategy for tackling long Covid following analysis, which suggests that almost 340,000 people in Ireland could have been affected. It also follows a motion forwarded by a regional group of TDs calling for swifter action to support those with long Covid, which secured unanimous Dáil Éireann support.

With the HSE now implementing the Model of Care and developing an epidemiological survey

to gauge long Covid numbers in Ireland, delegates will assess progress so far, priorities for recruitment and the workforce, and next steps for research and data.

Keynote sessions will involve: Dr Siobhán Ní Bhriain, Consultant Psychiatrist and National Clinical Director, Integrated Care, HSE; Prof John Lambert, Consultant in Infectious Diseases, Mater and Rotunda Hospitals; and Full Clinical Professor, UCD School of Medicine; Prof Corinna Sadlier, Consultant in Infectious Diseases, Cork University Hospital Ireland; and Clinical Professor (Honorary), University College Cork; and Prof Daniel Altmann, Department of Immunology and Inflammation, Imperial College London.

Overall, sessions in the agenda will look at integrating responses with Sláintecare reforms and waiting list strategies. Visit


European Society of Gastrointestinal Endoscopy (ESGE) Days 2023, Convention Centre, Dublin. The ESGE Days meeting is organised by the ESGE and provides a platform where endoscopy professionals can meet and exchange education, innovation, and inspiration. Visit


56th Annual Meeting of the Association for European Paediatric and Congenital Cardiology (AEPC) 2023, Convention Centre, Dublin. The AEPC is hosted by the local organising committee from Children’s Health Ireland and the Royal Belfast Hospital for Sick Children. Visit



Irish Society for Rheumatology (ISR) Spring Meeting, Hotel Kilkenny. The ISR is an organisation of doctors and scientific specialists working in the field for rheumatology. The Society organises and hosts regular platforms and conferences allowing members to present clinical and scientific material. Visit


Irish Head and Neck Society Annual Conference, Lyrath Estate Hotel, Kilkenny. The Society is a multidisciplinary platform of professionals managing patients with head and neck cancer and promoting interdisciplinary collaboration in research and education to improve patient care. Speakers will include: Prof Ralph Gilbert (reconstructive surgery) University of Toronto, Canada; Dr Snehal Patel (surgery), Memorial Sloan-Kettering Cancer Center, New York, US; Dr Davide Lombardi (surgery), University of Brescia, Italy; Dr Justin Roe (speech and language therapy), Royal Marsden and Imperial College, London, UK; Dr Martin Forster (medical oncology), UCL Cancer Institute, London, UK; Prof Kevin Harrington (radiation oncology and cancer biology), Institute for Cancer Research/ Royal Marsden, London, UK; and Dr Hilda Stambuk (radiology), Memorial Sloan-Kettering Cancer Centre, New York, US.


Joint Meeting of the Irish Institute of Clinical Neuroscience’s Irish Neurological Association and the Association of British Neurologists, International Convention Centre, Belfast. The meeting will see an exciting and wide programme of neurology education and presentations on new developments. Visit


World Association for Disaster and Emergency Medicine (WADEM) Congress on Disaster and Emergency Medicine, Killarney Convention Centre. The theme for the conference is ‘Complexity and continuity: Caring, coping, and overcoming in an increasingly challenging world’. The WADEM meeting brings together global experts to exchange knowledge and best practices on disaster medicine, prehospital care, and the health aspects of emergency management and complex humanitarian crises. Visit


European and International Congress on Obesity, Convention Centre, Dublin. The ECO is the annual scientific congress of the European Association for the Study of Obesity. It brings together colleagues from every area of obesity research, prevention and management. Visit


Irish College of Ophthalmologists (ICO) Annual Conference, Great Southern, Killarney. The College is the recognised training and professional body for medical and surgical eye doctors in Ireland. The ICO’s goal is to provide and support education and learning for ophthalmologists and those who work alongside them delivering care to patients. Visit



22nd World Congress on Paediatric Neurology and Neuropathology, Convention Centre, Dublin. The theme for this conference is ‘A step forward in paediatric neuro and mental hygiene’. Visit https://



European Congress of Pathology (ECP), Convention Centre, Dublin. The congress is being staged by the European Society of Pathology (ESP) and RCPI Faculty of Pathology. The theme for the ECP 2023, ‘Pathology – a bridge between science and medicine’, acknowledges the significant changes that practising pathologists have made and continue to make to their daily practice so as to ensure that new diagnostic and technological advancements are embraced and integrated into everyday practice. The meeting will reflect the dynamic developments in the field of pathology and update on these advancements through the programme prepared by the ESP working groups, ESP-affiliated societies, education and trainee subcommittees. Visit


Irish Society for Rheumatology (ISR) Autumn Meeting, Fitzpatrick’s Castle Hotel, Killiney, Co Dublin. Visit



Irish Cardiac Society (ICS) Annual Meeting, Killashee Hotel, Naas, Co Kildare. The ICS is the professional society in Ireland for those whose primary interest is in the practice of cardiology, cardiovascular surgery, and cardiovascular research. Visit

MI 39 MINDO QUIZ Test your knowledge and win €50 40 MOTORING Giving tyres the respect they deserve 42 BOOK REVIEW Dr Naomi Smith reviews Women in White Coats by Olivia Campbell 43 GALLERY Bon Secours Hospital, Glasnevin, GP study evening 45 GALLERY Faculty of Public Health Medicine Winter Scientific Meeting, RCPI 44 GALLERY Launch of Irish Liver Foundation, RCPI

SPORTS QUIZ WIN €50 21 March 2023

Q1 Name the winning horse of the 2023 Cheltenham Gold Cup?

Q2 Who finished as the leading try scorer in the Six Nations championship?

Q3 Name the Irish athlete who just missed out on a medal in the European indoor athletics championships, finishing fourth in the 3,000 metres?

Q4 Who is the manager of League of Ireland side Derry City?

Q5 The GAA National League is in full swing at the moment. Who are the defending men’s football champions?

Q6 Who will captain the United States team in this year’s Ryder Cup?


21 March 2023

The winner of the 21 February 2023 Sporting Quiz Competition is Ms Sorcha Glynn, Co Galway

The winner of the 21 February 2023 Crossword is Ms Martina Foley, Co Kilkenny

Q1 Which golf course will host the Horizon Irish Open 2023?

A: The K Club

Q2 Who was named Superbowl LVIII most valuable player?

A: Patrick Mahomes

Q3 Which team will Daniel Ricciardo work with in 2023 as reserve team driver? A: Red Bull

Q4 Who is the new manager or Premier League strugglers Southampton Football Club? A: Rubén Sellés

Q5 Who will Katie Taylor defend her undisputed lightweight titles against on 20 May in Dublin? A: Amanda Serrano

Q6 How many host countries will there be in the 2026 World Cup and what are they? A: USA, Mexico, and Canada


8 Relating to a company (9)

9 One circuit of a track (3)

10 Not at all (5)

11 Have (7)

12 Permission (7)

13 Among (4)

17 Tilt to one side (4)

18 Greatest amount possible (7)

16 - Organic nutrient (7)

19 - Support; help (6)

20 - Compact (5)

21 - Impress on paper (5)

23 - Prod (4)

Mindo Quizzes Life THE MEDICAL INDEPENDENT | 21 MARCH 2023 39 Solution to Crossword Competition
Answers to Sports Quiz Competition Solution to Sudoku C I V I C B R E A T H E O E I A U O M R R N S T O R Y M U S I C I A N H S I I U N H O N E Y T R O P I C A L R E T N T P M S E F P L E A S A N T E N T R Y A S N E I E O U T S I D E R A G R E E N A A D H Z C G T A S T R E T C H E N E M Y 7 9 4 5 7 9 6 3 7 2 3 5 8 4 7 3 6 1 2 2 9 4 3 6 SUDOKU SCRIBBLE BOX 21 FEBRUARY 2023 ANSWERS, SOLUTIONS, AND WINNERS WIN €50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Across 8 - Relating to a company (9) 9 - One circuit of a track (3) 10 - Not at all (5) 11 - Have (7) 12 - Permission (7) 13 - Among (4) 17 - Tilt to one side (4) 18 - Greatest amount possible (7) 22 - Convey a thought in words (7) 24 - Later (5) 25 - Put a question to (3) 26 - Doubt about someone's honesty (9)
1 - Perfume (5) 2 - Prior (8) 3 - Activity of travelling for pleasure (7) 4 - Occur (6) 5 - Wild animal (5) 6 - Primary colour (4) 7 - One event in a sequence (7) 14 -
Large pile of something (8) 15 - Forbidden by law (7)
24 Later (5) 25 Put a question to (3) 26 Doubt
someone’s honesty (9) DOWN 1 Perfume
pleasure (7) 4 Occur (6)
(7) 19 Support;
Compact (5) 21 Impress on
(5) 23 Prod (4) OUR NEW ADDRESS
4 5 7 3 1 2 8 9 6 1 8 6 9 5 7 2 4 3 9 2 3 6 4 8 1 5 7 8 1 4 2 3 5 6 7 9 6 7 2 4 9 1 3 8 5 5 3 9 7 8 6 4 2 1 2 6 8 5 7 3 9 1 4 7 4 1 8 6 9 5 3 2 3 9 5 1 2 4 7 6 8
a thought in words (7)
(5) 2
(8) 3
of travelling for
7 One event in a sequence
14 Large pile of something
15 Forbidden by law
your answers to: Mindo Quizzes, The Medical Independent Greencross Publishing Ltd, 1st Floor Ebony House, Main St, Wicklow Town, A67R272. Closing date for entries is 4 April 2023


Tyres keep you alive, hence they need tender loving care.

But you’d never know to look at the state of tyres on the nation’s cars. A recent survey by Continental showed there was, in their words, “woeful levels of disregard for tyre safety regulations.” Some tyre dealers reported up to 80-to-90 per cent of tyres replaced were illegal. Which is fair enough, looking at any sample size you have to look at the source of data. When you turn up at a tyre dealer you already know you’ve a problem. But data from the UK show that about 27 per cent of their MOT (our NCT equivalent) failures are due to tyres. And I don’t know of anyone who goes for a car test expecting it to fail.  Continental’s tyre study was performed at 12 tyre retailers during August 2022. They were able to demonstrate that 50 per cent of tyres replaced were at, or below, the legal limit of 1.6mm tread depth. At this limit they are described as “effectively bald and dangerous to drive”.

A sample of the survey results shows the widespread nature of the problem:

 At Sean McManus Tyres in Drogheda, Co Louth, tyres worn to below 1.6mm made up 90 per cent of the tyres that staff replaced.

 Loughrea Tyres in Co Galway reported that 80 per cent

of the tyres they replaced were at, or below, the legal tread depth level.

 Newbrook Tyres in Mullingar, Co Westmeath, found that 70 per cent of tyres taken off customer vehicles were below the 1.6mm limit.

 For JW Tyres in Graiguecullen, Carlow, some 40 percent of tyres replaced were excessively worn so as to be illegal and, thus, highly dangerous.

 As evidence of a seemingly better level of tyre care in urban areas, BestDrive in Swords, Co Dublin, reported a figure of 18 per cent of replaced tyres at, or below, the legal tread depth limit.

Local celebrity, Julie McManus of Sean McManus Tyres in Drogheda, who participated in the month-long survey said: “I regularly see tyres like this on vehicles coming into our depot and in a lot of cases the owner is totally oblivious either to the condition of the tyres or to the potential impact they could have on the safety of their family who may even be in the vehicle with them in the depot.”

When the drivers were interviewed, they did not know they were breaking the law driving on illegal tyres. Tyres at, or below, the 1.6 limit can attract an €80 fine plus up to four penalty points. In the UK the fine can be up to £2,500. And that’s per tyre.

To this end all tyre dealers in the country provide free tyre checks using ramps to inspect the cars’ tyres.

Tyresafe is a UK charity dedicated to raising awareness of the importance of correct tyre maintenance and the dangers of defective and illegal tyres. I was on a Zoom talk with them recently and they were discussing the problems in the UK.

They referred to a case where a woman died as a result of under-inflated run-flat tyres. The problem with run-flat tyres is that they don’t look under-inflated until it is too late. Another incident was when a young man was killed just before Christmas. When the policeman called to break the news to the family, he was told there was a full new set of tyres in the garage waiting for him for Christmas.

Tyresafe are pushing for more data to be collected at road traffic collisions as tyres are often noted to be “contributory” without further information. UK Department for Transport figures show 153 people are killed or seriously injured due to tyre-related incidents annually, but the figure could be higher.

It is worth noting new tyres can displace enough water to fill a bucket every seven seconds. However, as tyres wear, the amount of water tyres can displace decreases. Even at or close to the legal limit of 1.6mm, water dis -


placement is significantly lower than on a newer tyre. Tyres become much more likely to ‘aquaplane’ with a tread depth of less than 3mm, meaning it is advisable to look at the tyres regularly. Aquaplaning is making the car into what’s effectively a boat, with the tyre skimming over the water surface. You’ll know when it happens. You’ve no control over the car.

Key messages

 Under-inflated tyres reduce vehicle control, reduce tyre life, and increase fuel consumption.

 57 per cent of cars in the UK are at least 4psi under the recommended limit.

 Car drivers should check their tyres once per month, every month, and before a long journey.

 Motorcyclists should check at least once per week.

 Tyre pressure monitoring systems have been mandatory since 2014. Pay attention to them, but also recognise they can fail. You won’t beat a visual inspection.

 My motorbike mechanic swears by the pencil-type tyre pressure reader.

 You can use a coin to check for tyre tread depth. Our €2 coin has a 3mm border. If the tyre tread is half that it needs replacing.

 Since 2018, the NCT can fail a car with less than 1.6mm tread as a dangerous fail. That means the car can’t be driven and has to be collected.

 You might only need a good set of tyres once.

Motoring Life THE MEDICAL INDEPENDENT | 21 MARCH 2023 41
Some tyre dealers reported up to 80-to-90 per cent of tyres replaced were illegal


Title: Women in White Coats: How the First Women Doctors Changed the World of Medicine

Author: Olivia Campbell

Publisher: Park Row, HarperCollins

Reviewer: Dr Naomi Smith

Stepping foot in a modern hos pital, it is hard to imagine the journey that was undertaken by the first women doctors to earn their place as medics. Women in White Coats: How the First Women Doc tors Changed the World of Medicine is a marvellous account of these trailblazing women in the mid-1800s. Its author, Olivia Campbell, is a journalist, essayist, and au thor focusing on the intersections of med icine, women, history, and nature.

While women had worked as healers in many capacities before the 1800s, none had been allowed to enter into a medical degree. It was deemed inappropriate for a lady to be exposed to the butchery and horror of clinical medicine at the time –and surely would prevent them from obtaining a suitable husband.

The Lancet , in response to the proposed arrival of female medical students, decried: “We anticipate an almost unanimous condemnation of the effort to introduce young women into the classes of medical students at our hospitals.”

Western medicine in the mid-1800s was a very different venture to modern day practice. The hygiene theory had not come into being and antibiotics were many decades away from crossing any cell membranes. The four humors reigned supreme and purging, bloodletting, and blistering were top of your choice of treatment options. And, of course, all the doctors were men. Often these men were deemed unsuitable for other courses of study.

dream of becoming a doctor as a child, and had no interest in it at all as a young adult. Her life took an unexpected turn when her dying friend remarked on how different her final months could have been had a female doctor been caring for her.

Elizabeth, an English woman who moved to the US as a child, became the first woman to undertake a medical degree. This book carefully constructs a clear picture of Elizabeth’s experiences throughout this time, moving from her childhood through her training and beyond. After years of preparation, she was admitted to a medical college in New York after a vote was put to the other medical students, who were happy to take her in, assuming that it was a practical joke. The students soon came to learn she was anything but a joke. She was scorned by local woman as a ‘bad’ woman, separated from male students and routinely ridiculed for her interest in medicine. Elizabeth was persistent and felt that, by not rising to the ridicule, they may come to see her as their equal. She ended up graduating first in her class – a huge honour to this day. Upon graduation, she could only find postgraduate training opportunities in France, with no hospitals in the US willing to facilitate her.

Elizabeth would later travel to England to deliver lectures entitled ‘Medicine as a profession for ladies’. She argued that women being doctors was a natural extension of the caring responsibilities they

spired England’s first female doctor to take up her journey into medicine, but inspired other upper class women in different ways – some ended up playing a role in securing the right to vote, stirred by the power of her ideas. Elizabeth developed a friendship with Florence Nightingale, who believed that women should be content to be nurses and not bother with medical school. This drove a wedge between them.

The British Medical Journal stated: “It is indeed high time that this preposterous attempt of one or two highly strong-minded women to establish a race of feminine doctors should be exploded.”

Women in White Coats introduces the women who would go on to become the first female doctors in the UK. The histories are richly fleshed out to encompass the full lives of these women thanks to

letters and diaries kept, combined with much social history from the time. The book covers the Edinburgh Seven, a group of pioneering women who had matriculated into medicine in the University of Edinburgh. The female students had been segregated, taught, and examined separately. The Edinburgh Seven faced threatening behaviour from male students with riots erupting on one occasion. A few professors supported the students, but only if they confined themselves to obstetrics and gynaecology. Four years into their term, the university attempted to remove the students due to the uproar that had resulted. A legal battle ensued, which ultimately failed and the women were left to find their own way to complete their education.

Interestingly, the Royal College of Physicians of Ireland (which at the time was the King and Queen’s College of Physicians in Ireland (KQCPI)) features heavily in the lives of many of the women featured. The KQCPI permitted women who had been educated abroad to undertake its licentiate examinations. A few of the Edinburgh Seven took advantage of the liberality of the RCPI and undertook examinations in Dublin. They successfully obtained their medical licences, allowing them to practice medicine in the UK. And yet, even with these examination passed, the women faced further ridicule – with English newspapers falsely claiming that a modified exam had been set for the women candidates. The Royal College of Physicians in London did not facilitate women until 1909.

They were brave, persistent, and tenacious in their efforts to complete their education to put that education into practice and work as a doctor. The variety of barriers they faced, from within the medical profession, academia, and society were remarkable. They did meet occasional enthusiastic male supporters who did their best to support their efforts, but the system was largely in opposition.

“No woman of true delicacy would be willing in the presence of men to listen to the discussion of the subjects that come under the consideration of the student of medicine. We object to having the company of any female forced upon us,” read a written protest by the senior class at Harvard University in the US. Harvard’s subsequent policy forbidding women students remained in effect until 1945.

Having read this book, I am left with a tremendous amount of gratitude to these inspiring women. They took a lonely path with seemingly insurmountable and relentless obstacles and emerged as champions for women’s health whom we must not forget. This book comes highly recommended to all medics and social historians.

Life Book Review THE MEDICAL INDEPENDENT | 21 MARCH 2023 42
Having read this book, I am left with a tremendous amount of gratitude to these inspiring women
Dr Naomi Smith is a GP registrar based in Ballyfermot. Olivia Campbell
Photos: Brendan Lyon Bon Secours Hospital, Glasnevin, GP study evening, 1 March 2023 Pictured L-to-R: Mr Tony Stafford, General Surgeon, Bon Secours; Prof Frank Murray, Consultant Gastroenterologist, Bon Secours; and Dr David Reilly, GP, Swords Dr Hassonn Al-Sarraf, GP, Clontarf; and Dr Ben Dafalla, GP, Dundalk Dr Dolores Rafter, GP, Hartsown; and Dr Ronan Cahill, Dental Surgeon Dr Zlatina Nikolova, GP, Skerries; and Dr Alice Conlon, GP, Chapelizod Dr Anne Flanagan, GP, Portmarnock; and Dr Rashid Ibrahim, GP, Donaghmede Mr Tony Stafford

Launch of Irish Liver Foundation, RCPI, No 6 Kildare St, Dublin, 13 December 2022

Life Gallery
Photos: David Coleman - Bobby Studio Pictured L-to-R: Ms Sonya Grandison; Ms Amy Power; Dr Emer Fitzpatrick; Dr Annemarie Broderick; and Ms Laura Feeney Ms Anne Brennan; Ms Michelle Bourke; Ms Aoife Coffey; and Dr Caroline Conlon Dr Aoife Moriarty; Dr Navneet Ramlaul; and Dr Paul Armstrong Prof John Ryan; Prof Frank Murray; and Ms Hannah Loughlin Prof John Ryan Dr Zita Galvin; Prof Stephen Stewart; Prof John Ryan; and Mr Christopher Neilson Dr Stephanie Annett and Dr Yinshuang Chen Dr Niamh Mehigan and Dr Aoife Moriarty Prof Frank Murray; Prof Stephen Stewart; and Prof Colm O’Morain Dr Paul Armstrong and Dr Bill Shanahan


AbbVie has announced the availability of upadacitinib (45mg [induction dose] and 15mg and 30mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent and as a subsequent line of therapy following treatment with a lower cost biological disease modifying anti-rheumatic drug (bDMARD).

“I welcome the HSE’s decision to support patient access to our innovative oral medicine, RINVOQ, which treats the symptoms of patients suffering from moderate to severe ulcerative colitis,” said Mr Andres Rodrigo, General Manager of AbbVie in Ireland. “This disease has a considerable impact in Ireland. Many patients diagnosed with ulcerative colitis, particularly the young and the active, face negative consequences on their quality-of-life. The availability of this new treatment option reflects AbbVie’s wider commitment to develop, manufacture and bring innovative medicines to patients in need in Ireland.”

The EC approval is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance. Statistical significance was achieved for the primary endpoint and all secondary endpoints with upadacitinib 45mg in the two induction studies and both upadacitinib 15mg and 30mg in the maintenance study.

Clinical remission

 During the U-ACHIEVE and U-ACCOMPLISH induction trials, 26 and 33 per cent of patients treated with upadacitinib 45mg achieved clinical remission at week eight, the primary endpoint, compared to 5 and 4 per cent of patients who received placebo.

 During the U-ACHIEVE maintenance trial, 42 and 52 per cent of patients treated with upadacitinib 15mg or 30mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 per cent of patients who received placebo.

 Additionally, 57 and 68 per cent of patients receiving upadacitinib 15mg or 30mg, respectively, achieved corticosteroid-free remission, defined as clinical remission (per Adapted Mayo Score) and corticosteroid free for ≥90 days immediately preceding week 52 among patients who achieved clinical remission at the end of the induction treatment, compared to 22 per cent of patients on placebo.

Clinical response and mucosal healing

 73 and 74 per cent of patients treated with upadacitinib 45mg achieved clinical response (per Adapted Mayo Score) at week eight compared to 27 and 25 per cent of patients receiving placebo during the U-ACHIEVE and U-ACCOMPLISH induction trials, respectively.

 In both trials, a significantly greater proportion of patients experienced clinical response per partial Adapted Mayo Score (symptomatic response) as early as week two (U-ACHIEVE: 60 vs 27 per cent and U-ACCOMPLISH: 63 vs 26 per cent).

 Mucosal healing was observed in 36 and 44 per cent of patients treated with upadacitinib 45mg in U-ACHIEVE and U-ACCOMPLISH, respectively, at week eight, compared to 7 and 8 per cent of patients, respectively, who received placebo.

 In the maintenance study at week 52, mucosal healing was observed in 49 and 62 per cent of patients treated with upadacitinib 15mg and 30mg, respectively, compared to 14 per cent who received placebo.

“I’m very excited by the recent HSE approval for the reimbursement for RINVOQ/upadacitinib for ulcerative colitis,” said Dr Eoin Slattery, Consultant Gastroenterologist and Honorary Personal Professor at University Hospital Galway. “It adds another important tool to the

gastroenterologists’ armamentarium in the management of this extremely debilitating and often silent disease that affects between 20-30,000 people in Ireland. RINVOQ’s potential to bring rapid and sustained relief via an oral formulation is the reason I look forward to introducing it in my daily clinical practice.”

In the placebo-controlled ulcerative colitis induction and maintenance clinical trials, the overall safety findings were generally consistent with the known safety profile of upadacitinib; no new important safety risks were observed. The rates of overall adverse events (AE), serious AEs, and AEs resulting in treatment discontinuation were lower with upadacitinib compared to placebo.

The most commonly reported adverse reactions (≥5 per cent of patients) with upadacitinib 45mg, 30mg, or 15mg were upper respiratory tract infection, blood CPK increased, acne, neutropaenia, and rash. In the overall clinical programme, major cardiovascular events, thrombotic events, malignancy excluding non-melanoma skin cancer, and gastrointestinal perforation were reported infrequently (all <1.0 cases per 100 patient-years in patients who received at least one upadacitinib dose).


biospecific, which means that its properties or activities vary according to the specific biological molecule with which it interacts. It will have enhanced adhesion to cardiac tissue and is made of a degradable biomaterial that would be administered to the patient through an intravenous, endocardial catheter.

This EU funding recognises the importance of tackling economic and personal health burdens and adds to the €70 million in EU investment generated by CÚRAM researchers during its first eight years.

The European Union has awarded a European consortium €4.5 million for the ELR-Scar project to validate a novel hydrogel biomaterial that will aim to prevent scar tissue from forming in the heart following a myocardial infarction (MI).

MI happens as a result of ischaemic heart disease (IHD). Europe has the highest rates of IHD worldwide, equalling almost 26.5 million patients. In the days and weeks following a heart attack, the damaged cells of the heart are replaced by scar tissue. This scarring or ‘remodelling’ of the heart tissue can cause further dysfunction and complications for the patient.

Prof Abhay Pandit, Scientific Director of the CÚRAM SFI Research Centre for Medical Devices at University of Galway, said: “There is a clear medical need for new treatment solutions that can prevent scar tissue formation and irreversible cardiac remodelling. Our hope is that this hydrogel will do exactly that to fundamentally improve clinical practice, reducing the enormous burden that a heart attack and its leading cause, ischaemic heart disease, places on society and the individual patient.”

Prof Pandit leads the ELR-Scar consortium and recently received the prestigious George Winter Award 2022 from the European Society for Biomaterials. The consortium includes seven industry and academic partners from Ireland, Spain, Belgium, Germany, Lithuania, Poland, and the Netherlands.

ELR-Scar draws on collaborations across western and eastern European countries to work on the project’s regulatory, manufacturing, and clinical needs.

The hydrogel solution being developed by the team is

The Nursing and Midwifery Board of Ireland (NMBI) has launched a public consultation on its draft digital health competency standards and requirements for undergraduate nursing and midwifery education programmes.

The draft document aims to ensure that digital health is incorporated into education programmes which lead to registration to ensure nurses and midwives learn about digital tools as part of their education. The draft standards aim to align with national and international evidence-based practice in a changing digital health environment.

NMBI CEO Ms Sheila McClelland said: “The provision of healthcare is evolving and it is essential that how we educate future generations of nurses and midwives evolves to meet these challenges. The Report of the Expert Review Body on Nursing and Midwifery (2022), Sláintecare Implementation Strategy and Action Plan 2021–2023 , Health Service Executive (HSE) service plan, and the Health Services People Strategy 2019–2024 all set digital health as a key enabler to support the significant redesign of services required to implement the Sláintecare model of care.

“These draft standards and requirements aim to ensure digital health skills and competencies are embedded within nursing and midwifery school curricula, training, and continuing professional development activities.”

NMBI has developed the draft digital health competencies following extensive consultation with nurses and midwives, and in collaboration with an expert working group to align with national and international evidence-based practice.

NMBI’s Director of Education, Policy and Standards, Ms Carolyn Donohoe, said: “The draft standards and requirements have been developed with input from key stakeholders to ensure undergraduate nursing and midwifery students are equipped with the digital health competencies required to support and enable person-centred connected care.

“We now want to hear feedback from registered nurses and midwives, recent graduates, those working in education bodies, people using services and those with further expertise in the field of digital health. All feedback received will be analysed and used to inform the final standards and recommendations, which will be published following approval by NMBI’s board.”

To take part in the consultation visit . The process closes at 5pm on Tuesday 11 April 2023.



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

Detecting anxiety through blood biomarkers

What else is there to say about anxiety, apart from the fact that it appears to be roaming the streets and striking with impunity at unprecedented levels? No doubt Covid-19 exacerbated the problem and I feel confident that you will have seen your share of presentations that illustrate some of this free-floating angst.

It was the Latin and Greek physicians of old who identified and classified anxiety as a standalone disorder. The word itself derives from the Latin substantive angor and the corresponding verb ango (to constrict), whilst a cognate

word is angustus (narrow). Appropriate, as many people describe their anxiety as manifesting in their throats.

Closer to home, according to Mental Health Ireland, our little island has one of the highest rates (out of 36 countries) of mental health illness in Europe. Some 18.5 per cent of the Irish population were recorded as having a mental health illness, such as anxiety, bipolar disorder, depression, or alcohol/drug use in 2016.

According to the National Institutes of Health in the US, at any given time, approximately 10.7 per cent of the global population suffer with some type of mental health disorder.

Iron deficiency in cardiology 2022

Authors: Dr Robert M Evans, SpR in Cardiology, and Dr Patrick O’Callaghan, Consultant Cardiologist, University Hospital Waterford

Anxiety disorder is at the top of this league table, at 3.4 per cent of the population, which equates to 284 million people (2.7 per cent males, 4.1 per cent females).

As you might expect, depression is a close second, at 3.4 per cent (264 million people; 2.7 per cent males, 4.1 per cent females).

However, these figures were compiled in 2017. With lifestyles becoming more stressful, and of course Covid, lockdowns, and general fear an epidemic in itself, it's fairly safe to assume that these figures are now considerably higher. So the need to spot anxiety early and deal with it appropriately has never been more pressing.

This was the motivation behind the development of a blood test that can, it appears, detect anxiety by examining blood biomarkers. Researchers at the University of Indiana, US, have devised the test that can not only predict a person's risk of developing anxiety, but can also determine their current level of anxiety and help to suggest which therapies might work best for them. The test has been validated and is currently being developed for wider use.

Of course, biomarkers can change over time, so the test is useful as a predictive tool and to monitor hormonal changes that might affect a person's mental health.

According to Prof Alexander Niculescu, Professor of Psychiatry at the University of Indiana: "Many people are suffering from anxiety, which can be very disabling and interfere with daily life. The current approach is to talk to people about how they feel to see if they could be on medications, but some medications can be addictive and create more problems. We wanted to see if our approach to identify blood biomarkers could help us match people to existing medications that will work better and could be a non-addictive choice."

Prof Niculescu has a previous track record in novel blood tests – he previously led research which resulted in blood tests for post-traumatic stress disorder, depression, bipolar disorder, and pain. In the current research, published in Molecular Psychiatry recently, participants completed a blood test every three-to-six months if there was a hospital admission due to mental health issues. Study of the blood biomarkers helped the team to identify a person's current level of anxiety and matched them with different therapy options.

"In addition to medications, there are other methods to treat anxiety, such as cognitive behavioural therapy or lifestyle changes," said Prof Niculescu. "But having something objective like this where we can know what someone's current state is as well as their future risk and what treatment options match their profile is very powerful in helping people."

He continued: "This is something that could be a panel test as part of a patient's regular wellness visits to evaluate their mental health over time and prevent any future distress. Prevention is better in the long run, so our goal is to be able to provide a comprehensive report for patients and their physicians using simply one tube of blood."

It's a novel development for sure and may help non-psychiatry physicians to shed light on the severity of a patient's anxiety. However, it's unlikely that it will fully replace the clinical judgement of the modern-day psychiatrist or referring GP.

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