The Medical Independent 20 May 2021

The universal quest Experts say developing a universal coronavirus vaccine is not only possible, but could be realised in the coming years.

Bette Browne reports

‘Storm-proofing’ healthcare infrastructure

The HSE is investigating the ability of healthcare buildings to cope with extreme weather events, writes

Paul Mulholland

PAGE 14

The flying doctor

Emergency medicine and flight medic

Dr Lisa Cunningham, speaks to Niamh Cahill about her exceptional working life

PAGE 16

Mending the system

Frontline innovation shows that the Irish health service can change for the better, writes

Dr Gabrielle Colleran

PAGE 20

Doctors tax compliance drive yields €83.5 million

CATHERINE REILLY

Over €83,500,000 has been yielded under Revenue’s medical consultants tax compliance programme since 2013, involving the closure of 733 cases, the Medical Independent (MI) can report.

According to figures released to MI, the total yield comprises €46,370,231 in tax; €21,521,740 in uplift; €9,848,828 in interest; and €5,762,205 in penalties. Uplift relates to the estimated tax receipts that have been saved, or will be collected in future, as a result of the intervention.

Overall, some €5,937,163 was yielded in 2020, compared with €3,518,764 in the previous year. The highest amounts have been yielded in 2015 (€21,608,125) and 2016 (€16,935,519).

“Revenue is satisfied that the medical consultants compliance programme has identified, addressed and is continuing to address relevant risks in respect

of the tax affairs of medical consultants,” a spokesperson told MI. “This is an ongoing sectoral programme in the context of Revenue’s overall compliance framework and strategy.”

By the end of 2020, Revenue had opened 774 interventions under this programme, with 41 open interventions at various stages of completion. Some 49 cases had been published in the quarterly list of tax defaulters.

Last year, 34 cases were closed, down from a peak of 197 cases concluded in 2016 and 170 finalised cases in 2015.

At the end of 2020, there were appeals relating to 16 consultants ongoing at the Tax Appeals Commission, an independent statutory body that adjudicates and determines appeals against decisions and determinations of the Revenue Commissioners concerning taxes and duties.

In 2010, Revenue initiated a review of the tax affairs of consult-

ants in the Dublin region following concerns about a tax planning strategy that was being promoted to the medical profession.

The project was expanded to the tax affairs of consultants nationally in 2013.

In May 2013, correspondence issued by Revenue’s Dublin Regional Office outlined that it was reviewing the tax affairs of “medical consultants” in the region, with a special focus on those who had incorporated their business or part thereof. In Dublin, this had been an area of attention “for some time” and the work was being expanded in the region and nationally.

At the time, Revenue said it had identified areas where considerable tax loss was at risk and stated its intention to write to taxpayers not already under enquiry and their agents. In cases of failure to respond or where matters were not addressed, Revenue said it would escalate to full audit.

The main focus of the programme

The RCPI recently announced that 2,700 doctors, from 38 countries, have taken its written membership examinations for postgraduate medical qualifications during the past year using advanced remote examination invigilation technology developed by TestReach.

TestReach, an Irish company that provides an innovative solution to create and deliver exams, was co-founded by Ms Louella Morton (pictured left) and Ms Sheena Bailey (right). The photo was taken before the Covid-19 pandemic.

has been to address the tax issues arising from the incorporation of consultants’ businesses.

Revenue’s concerns surround-

ed the manner in which some standard accounting practices associated with incorporation were applied.

mg) and type 58 (20 mg). INDICATIONS Gardasil 9 is a vaccine for use from the age of 9 years for the prevention of premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV-types and genital warts (condyloma acuminata) caused by specific HPV types. The indication is based on the demonstration of efficacy of Gardasil 9 in males and females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil 9 in children and adolescents aged 9 to 15 years. The use of Gardasil 9 should be in accordance with official recommendations. DOSAGE AND ADMINISTRATION Individuals 9 to and including 14 years of age at time of first injection: Gardasil 9 can be administered according to a 2-dose schedule. The second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered. Gardasil 9 can be administered according to a 3-dose (0, 2, 6 months) schedule. The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. Individuals 15 years of age and older at time of first injection: Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule. The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. It is recommended that individuals who receive a first dose of Gardasil 9 complete the vaccination course with Gardasil 9. The need for a booster dose has not been established. Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for Gardasil 9. Subjects previously vaccinated with a 3dose regimen of quadrivalent HPV types 6, 11, 16, and 18 vaccine (Gardasil or Silgard), hereafter referred to as qHPV vaccine, may receive 3 doses of Gardasil 9. The use of Gardasil 9 should be in accordance with official recommendations. Paediatric population (children <9 years of age): The safety and efficacy of Gardasil 9 in children below 9 years of age have not been established. No data are available. The vaccine should be administered by intramuscular injection. The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh. Gardasil 9 must not be injected intravascularly, subcutaneously or intradermally. The vaccine should not be mixed in the same syringe with any other vaccines and solution.

CONTRAINDICATIONS Hypersensitivity to any component of the vaccine including active substances and/or excipients. Individuals with hypersensitivity after previous administration of Gardasil 9 or Gardasil /Silgard should not receive Gardasil 9. PRECAUTIONS AND WARNINGS In order to improve traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. The vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. Syncope, sometimes associated with falling, can occur before or after vaccination with Gardasil 9 as a psychogenic response to the needle injection. Vaccinees should be observed for approximately 15 minutes after vaccination; procedures should be in place to avoid injury from faints. Vaccination should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is

not a contraindication for immunisation. As with any vaccine, vaccination with Gardasil 9 may not result in protection in all vaccine recipients. Gardasil 9 will only protect against diseases that are caused by HPV types targeted by the vaccine. The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease. The vaccine has not been shown to have a therapeutic effect and is not indicated for treatment of cervical, vulvar, vaginal and anal cancer, high-grade cervical, vulvar, vaginal and anal dysplastic lesions or genital warts. It is also not intended to prevent progression of other established HPV-related lesions. Gardasil 9 does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination. Vaccination is not a substitute for routine cervical screening. There are no data on the use of Gardasil 9 in individuals with impaired immune responsiveness. Safety and immunogenicity of a qHPV vaccine have been assessed in individuals aged from 7 to 12 years who are known to be infected with human immunodeficiency virus (HIV). Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may not respond to Gardasil 9. Long-term follow-up studies are currently ongoing to determine the duration of protection. There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil 9 with bivalent or quadrivalent HPV vaccines. PREGNANCY AND LACTATION There are insufficient data to recommend use of Gardasil 9 during pregnancy; therefore vaccination should be postponed until after completion of pregnancy. The vaccine can be given to breastfeeding women. No human data on the effect of Gardasil 9 on fertility are available. SIDE EFFECTS Very common side effects include: erythema, pain and swelling at the injection site and headache. Common side effects include: pruritus and bruising at the injection site, dizziness, nausea, pyrexia and fatigue. The post-marketing safety experience with qHPV vaccine is relevant to Gardasil 9 since the vaccines contain L1 HPV proteins of 4 of the same HPV types. The following adverse experiences have been spontaneously reported during post-approval use of qHPV vaccine and may also be seen in post-marketing experience with Gardasil 9: urticaria, bronchospasm, idiopathic thrombocytopenic purpura, acute disseminated encephalomyelitis, Guillain-Barré Syndrome and hypersensitivity reactions, including anaphylactic/anaphylactoid reactions. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. PACKAGE QUANTITIES Single pack containing one 0.5 millilitre dose pre-filled syringe with two separate needles. Legal category: POM Marketing authorisation number: EU/1/15/1007/002 (pre-filled syringe with two separate needles). Marketing

HSE examining extent of delayed diagnosis of endometrial cancer

CATHERINE REILLY

The HSE’s Chief Clinical Officer has commissioned work to determine “the extent to which and if delayed diagnosis of endometrial cancer is prevalent in other hospitals” after failings identified in an external review of gynaecology services at Letterkenny University Hospital (LUH).

A HSE spokesperson told the Medical Independent that “this work is ongoing”.

An external review into LUH’s gynaecology service was commissioned by Saolta University Health Care Group in response to eight instances of delayed diagnosis in women with endometrial cancer. The review, which was presented to Saolta in May 2020, had a particular focus on post-menopausal bleeding pathways.

The review referred to “suboptimal triage and administrative practices, suboptimal follow-up practices, and limited fail safes, underpinned by ineffective communication” as factors in delayed diagnoses.

In July 2020, in an addendum to the review, the external team expressed dissatisfaction that LUH

Large decrease in GP co-op treatment visits

NIAMH CAHILL

and Saolta did not inform them that a histology audit was occurring in parallel, which examined endometrial cancers diagnosed at LUH between 2010 and 2019. This audit referred to 133 women diagnosed with endometrial cancer and 38 women waiting longer than 100 days from initial referral to diagnosis.

Correspondence from Saolta stated that 25 of the women had a delay in diagnosis with a potentially serious consequence.

The review authors stated that consideration must be given to whether issues at LUH were replicated in other hospitals.

The review also highlighted the absence of national standards for women who present with post-menopausal bleeding, with no clear timelines for assessment, investigation, and treatment on presentation.

Interim national clinical guidance on the timeframe for investigation was developed by the National Women and Infants Health Programme in August 2020.

The Programme is currently leading on the development of a new national clinical guideline.

Indefinite contracts reflect ‘serious’ recruitment issues

DAVID LYNCH

Contracts of indefinite duration (CIDs) for consultants are “not best employment practice”, but reflect serious recruitment problems in certain specialties, the HSE’s National Director of Human Resources has told the consultant applications advisory committee (CAAC).

In October, Ms Anne Marie Hoey informed CAAC Chairperson Prof Áine Carroll that approximately 100 consultants were employed on these contracts.

“While CIDs potentially impact on the employer’s ability to provide opportunities for doctors to apply to vacant consultant posts, a recent analysis of the number of consultant CIDs across the HSE shows it to be approx 100,” wrote Ms Hoey in correspondence seen by the Medical Independent (MI) following a Freedom of Information request.

Treatment visits at out-of-hours GP co-ops have reduced by an average of 65 per cent compared to last year, according to Mayo GP and Chairperson of the National Association of GP Co-ops, Dr Ken Egan.

The drop relates to data for 2021 compared to treatment visits recorded in 2020, at one co-op, but is largely representative of the national picture, Dr Egan said.

Triage of calls received by co-ops has increased significantly since the pandemic began and is continuing to increase, data shows.

At one co-op, the number of calls triaged rose by almost 84 per cent to date in 2021 compared to the same time period in 2020, he said.

In January, when Covid-19 cases soared nationally and co-ops came under immense strain to meet pa-

tient demand, one co-op received some 3,600 calls in a 12-hour period.

Commenting on the current situation at out-of-hours services, Dr Egan remarked that co-ops were “starting to get busier and normal, non-Covid work is beginning to return again”.

He added that financial supports for out-of-hours services, which are currently at 100 per cent of 2019 funding, would continue until 30 June.

Talks on extending supports have yet to take place. Heretofore, supports have been negotiated with the Department of Health by the IMO on behalf of the National Association of GP Co-ops.

But according to Dr Egan, representatives from the national association plan to meet with the Department directly to negotiate supports before the June deadline expires.

“This is circa 3 per cent of employment contracts held by consultants and is due in part to the ongoing effort in managing non-permanent employment contracts.”

Last year, MI reported on concerns expressed by CAAC members about the number of applications for CIDs that were coming before the committee. The CAAC’s Chairperson wrote to Ms Hoey in February 2020 regarding the issue.

“From an employer and governance perspective, there are shared concerns as to how a CID is obtained given that the post does not go through a rigorous competitive process,” wrote Ms Hoey in her reply to the CAAC.

“As a result, other qualified candidates and senior trainees are not given the opportunity to apply for the post.”

Ms Hoey stated that she would bring the CAAC’s views “to the attention of HSE senior managers”.

Ms. Liza McLornan Consultant Urological Surgeon

Mr. Girish Nama Consultant Urologist

Mr. Nicholas Hegarty Consultant Urologist

When healthcare goes wrong…

This year is set to witness significant developments in the area of open disclosure. David Lynch looks at imminent changes and what impact they will have on the way doctors engage with patients

Open disclosure has been front and centre of medical debate in Ireland since the 2018 report of the scoping inquiry into the CervicalCheck screening programme. That report recommended the introduction of mandatory open disclosure.

Despite the ongoing Covid-19 pandemic, developments in open disclosure have continued. Legislation is progressing, a HSE policy review is underway, and a national training programme for staff is ongoing across the country. The coming months could transpire to be pivotal in terms of how doctors communicate with patients into the future.

A Department of Health spokesperson told the Medical Independent (MI) it “continues to progress work on the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019”. The legislation is part of the current Programme for Government and is due to go to Dáil committee stage.

This is an “interim revision” and it will require further revision “when the Patient Safety Bill is enacted”.

The HSE’s draft revised policy “will be circulated to HSE services and... to a number of external stakeholders”. These external bodies include patient representative groups, the RCSI, RCPI, IMO, IHCA, and the State Claims Agency.

But some of the practical implications of the looming legislation have raised concerns among doctors and representative bodies.

Prof Sean Tierney, Dean of Professional Development and Practice at the RCSI, informed MI the College “fully supports” the principle of disclosure of health-related harm to individual patients.

“In the vast majority of cases, healthcare-related harm is a complication of treatment and such explanations are a normal feature of good healthcare,” said Prof Tierney.

“The provisions of the Patient Safety Bill relating to open disclosure appear to be intended to deal with harm that occurs as a result of failings in the quality of healthcare provided to patients, as distinct from ‘expected’ complications.” Where the process set out in the Bill is followed, an apology cannot be used as evidence in civil proceedings

taken against providers.

“The definition in the Bill of these events is very broad and imprecise and the boundaries between expected and unexpected complications is unclear.”

Prof Tierney added that the RCSI supports the Forum of Irish Postgradu -

ate Medical Training Bodies’ proposal that the categorisation be aligned with the list of “serious reportable events” which includes specifications, such as wrong site surgery, instruments retained after surgical procedures, etc.

“This would align the requirement

Healthcare harms and the law of the land

The Bill provides for significant new measures including mandatory open disclosure of specified serious patient safety incidents. The provisions also include notification of these serious incidents externally to HIQA, the Chief Inspector of Social Services and the Mental Health Commission in order to “contribute to national learning and system-wide improvements”.

These measures will apply to the public and private health services. The Bill will extend HIQA’s remit to the private hospital sector and contains provisions supporting the conduct of clinical audit in the health service.

However, in this period before the final passage of the Bill, the HSE is also reviewing its own open disclosure policy.

A revised policy was discussed at the November meeting of the HSE national open disclosure steering committee, according to the minutes. A HSE spokesperson told MI the policy “is now revised and due to go out for consultation”.

An expert group was established by the Government in June 2018, chaired by Mr Justice Charles Meenan, to examine the law in relation to personal injuries arising in the healthcare context.

The group also set out to explore alternative mechanisms by which claims could be managed more effectively, particularly from the perspective of the person on whose behalf a claim has been made. The Government noted the contents of the final report and agreed to its publication on 16 December 2020.

“The report contains seventeen recommendations for change, eleven of which relate to the Department of Health. The Department is currently considering these recommendations,” a spokesperson told the Medical Independent (MI)

Doctors will watch these developments with interest.

The upcoming open disclosure legislation is emerging into a

medico-legal environment that many doctors regard as problematic and highly litigious.

As reported in MI last month, a survey of trainees’ perception of medico-legal practice in surgery, published in the February edition of the Irish Medical Journal, found 33 per cent of trainees had already received medico-legal correspondence and 96 per cent expected to be sued in the future. Two-thirds stated the issue had made them more risk adverse.

Retired Consultant Gastroenterologist Prof Seamus O’Mahony spoke to MI recently on the publication of his third book, The Ministry of Bodies

While discussing the broad issue of error in medicine, Prof O’Mahony said Ireland was “supposed to be heading into a world of open disclosure, but the reality is, doctors still don’t want to talk about their mistakes because

they are so heavily punished for them, because they are so stigmatised about them, and because we operate in a medico-legal environment in this country that is no longer fit for purpose.... I think there is a consensus within both the medical and legal professions that is the case.”

The IMO’s 2019 AGM debated the proposed open disclosure legislation. Consultant Rheumatologist at Connolly Hospital, Dublin, Prof Trevor Duffy, told the meeting that “open disclosure is something we as a profession want to feel that we do naturally. We perhaps don’t always do it as well as we should.

“I think the principal reason we don’t do it is because of the highly litigious environment in Ireland. And the reason I say this [open disclosure] legislation is cock-eyed is because it is legislation to protect us from a dysfunctional legal environment. And I think we should be tackling the legal environment first.”

The definition in the Bill of these events is very broad and imprecise and the boundaries between expected and unexpected complications is unclear

Prof Sean Tierney

to report such events to the CMO [Chief Medical Officer] with the requirement to fully inform patients about what has happened. Of course, patients involved in safety incidents which don’t reach this threshold should still be informed as set out in the HSE open disclosure policy and as part of good medical practice.”

Looking at the process set out in the proposed legislation, Prof Tierney described it as “very complex, bureaucratic and legalistic”. It was a system that “has been rarely used”.

“Making the use of the process mandatory in this setting, including the structured minuted meetings, the complex forms, and the intrusion into the patient-doctor encounter... is in stark contrast to the far more appropriate empathic format that we teach in our human factors communications courses and that outlined in the HSE open disclosure policy,” he said.

“Under the draft Bill, failing to complete all the forms would be an offence even where the incident had been fully disclosed to the patient.”

Prof Tierney also said there was “confusion” in the legislation as to where the responsibility will lie, as the Bill refers to “registered” providers “but registration only applies to individual healthcare providers”.

“It is inappropriate and impractical to have the burden of compliance fall on individuals when it should lie with provider organisations.”

Prof Tierney further highlighted a “risk” that clinical audit, especially local audits, could be made more difficult when the legislation is enacted.

“The National Office of Clinical Audit have made submissions to ensure that national audits that publish their reports are covered by the legislation,” he said. “The national review group on clinical audit included some recommendations to ensure that we can continue to audit and improve the care that we provide to our patients.”

As the legislative process advances in the coming months, Prof Tierney said the RCSI believes “the process of open disclosure of health-related harm can be facilitated by appropriate legislation”.

The College was “committed to engaging with the process to ensure that legislation that is introduced will improve the transparency and quality of healthcare delivered to patients”.

Training

Despite the pandemic and the continuing passage of the Bill, open disclosure training continues across the HSE, including among doctors.

Has the wait for new legislation made this training exercise more difficult?

“That’s a good question,” said GP Dr Philip Crowley, the HSE Director of the National Quality Improvement Team and Chair of the national open disclosure steering committee.

Dr Crowley said “in many ways the basic core of what we are trying to teach and get across is irrelevant to the Bill, and the

Open disclosure training goes virtual

Open disclosure training is mandatory but the pandemic has forced much of it online.

“It’s a very mixed picture to be honest with you,” Dr Philip Crowley, HSE Director of the National Quality Improvement Team, told the Medical Independent

“Some aspects are definitely better delivered face-to-face where you can do role play... and engage people. Online that is not as easy. We use a lot of videos now that would try to do that… we have put a huge amount of effort into developing our online materials.

“There are upsides and downsides. The upside is it’s very accessible now. It’s way more efficient for us. We previously would have done training travelling all over the country with a small team. So now with the training it is not geographically limited at all. We can deliver training at any time.”

Dr Crowley described the numbers of HSE staff accessing open disclosure training as “very heartening”.

“When we get back to the norm

though — I suppose like with many aspects of life — it will be a blended approach, where we will have stuff online, but we will have face-to-face training as well.”

Dr Crowley said he was happy with the progress made on uptake of the training by doctors in the last two years.

A HSE spokesperson said it has been working on a number of initiatives to improve the access to and uptake of training by doctors.

The spokesperson said these initiatives included offering external continuing professional development points for attendance at the open disclosure workshop; training of doctors including consultants as open disclosure trainers; collaboration with the Medical Council on the inclusion of open disclosure in the Safe Start programme for new registrants; and working in collaboration with the national doctors’ training programme on the inclusion of open disclosure as mandatory training for NCHDs.

68 wastewater catchment areas, covering each county in Ireland, have been selected for a national Covid-19 wastewater surveillance programme.

1,600 patients in Ireland suffer major trauma injuries each year. Minister for Health Stephen Donnelly recently announced the designation of the Mater Hospital in Dublin as the major trauma centre in a new central trauma network.

€5.7 million has been provided in Budget 2021 to allow for the commencement of phase one of the development of the major trauma centre for the central trauma network.

Bill is irrelevant to it in many ways”.

“The Bill will be making some particular events mandatory and there will be some process around that, it will be a more detailed process that will change [once the Bill is passed].”

But Dr Crowley said the “overall core” of what the HSE training is trying to teach is empathetic engagement with a person and patient “whatever degree of loss they are dealing with”.

“The eventual legislation will have some impact on the detail of what we teach, some of it is predictable so we can flag it. But the training will be ongoing, so we will adapt the training as the legislative framework adapts as well.”

Therefore, despite the slow pace of legislative change, Dr Crowley said “we are not finding that too much of a difficulty”.

In April, this newspaper reported that from February 2019 until December 2020 some 3,827 doctors accessed open disclosure training.

Dr Crowley told MI the updated figures for doctors who have received training since February 2019 has now risen to over 4,500 out of a total of approximately 96,000 HSE staff who have undertaken the training in that period.

Open disclosure training uptake by doctors was discussed at the Novem -

ber 2020 meeting of the HSE national open disclosure steering committee. According to minutes, there was “an update on the action taken to improve the level of uptake of training by doctors and… further feedback on how this could be improved further”.

Has the HSE seen any hesitancy among doctors compared to other healthcare workers in taking up the training?

“I remember being in the Oireachtas committee, there was a great focus on medical uptake of training,” said Dr Crowley.

“The truth about it is, as we know, everyone is very busy. And training is there as a benefit, but also a potential additional demand on [a member of staff’s] time….

“What are we doing with doctors?

Well, we are doing everything we can to make the training readily available to doctors and the result has been that in the last two years I think it [uptake] has certainly improved.

“It’s much improved, and we are going to continue to work on that (see panel). Making it [the training] mandatory is good, but we want people to want to do it as well of course,” said Dr Crowley. “We want people to want to do it empathetically and to want to do it right.”

62,300 people have had a Covid-19 test in one of the HSE’s walk-in centres as of 7 May.

2,048 positive cases of Covid-19 were detected in people who used the walk-in service.

1.2 million children under 15 become ill with tuberculosis (TB) every year and an estimated 67 million are infected with TB, placing them at risk of developing future disease, according to the World Health Organisation.

The eventual legislation will have some impact on the detail of what we teach, some of it is predictable so we can flag it

Dr Philip Crowley

Inadequate ‘link-up’ between hospitals and GPs – Sláintecare Council

DAVID LYNCH

The “lack of link-up” between hospitals and GP practices has been cited by members of the Sláintecare Implementation Advisory Council (SIAC) as a “key priority”.

During a discussion on e-health at the December meeting of the SIAC, members said better link-up was needed “to improve patient care, through more timely discharge summaries and sharing of information”.

“Members stated that it was very difficult to manage complex care of patients without timely hospital discharge summaries,” according to the minutes.

“This is a key Sláintecare reform initiative, to ensure there are the same pathways of communication between acute and community across the country. This is important for patient care, safety, and equity and will reduce/ eliminate significant repeat data entry, within the acute system, into multiple systems, which wastes clinical and administrative time.”

The minutes stated that Ms Laura Magahy, Executive Director of the Sláintecare programme implementation office (SPIO), “agreed that the linkage between hospital and GP practice IT systems should be a key priority and indicated that she is establishing a working group between the ICGP, HSE

and SPIO/e-health to work on this.”

Asked by the Medical Independent about progress to date, a Department of Health spokesperson said “regular meetings have been taking place, with monthly national general practice information technology (GPIT) group meetings to progress both the adoption and development of GP practice systems and their links with hospital systems, such as e-referral.

“A group has also been established to oversee the work of the GP Research Hub, funded through Sláintecare, which is considering research topics spanning GP practice and hospital care.”

PAUL MULHOLLAND

The National Office of Clinical Audit (NOCA) has recommended that all public patients treated under the National Treatment Purchase Fund (NTPF) joint arthroplasty programme are monitored as part of the Irish National Orthopaedic Register (INOR).

The INOR is a patient safety initiative, which aims to improve the quality of services and care provided to patients having joint replacement surgery through the analysis of clinical and patient reported outcomes and to monitor the safety of implants.

It is one of 13 national audits managed or governed by NOCA.

The HSE’s safety and quality committee was briefed on the register on 16 March by Joint INOR National Clinical Lead Mr Paddy Kenny and INOR Manager Ms Suzanne Rowley.

The committee discussed the importance of developing a “comprehensive, nationwide or-

thopaedic register” considering that all private hospitals were not part of INOR.

“It supported NOCA’s view that it would be appropriate that all public patients treated under the NTPF joint arthroplasty programme are monitored as part of INOR, thereby offered the same degree of quality assurance in private hospitals, as if treated within the public sector,” according to minutes of the meeting.

Currently eight of 12 ‘elective’ public hospitals and one private hospital are on the register. Phase 2 will include roll-out to hospitals that perform emergency as well as elective surgery.

“It was agreed that NOCA would provide the first national report from INOR to the committee when published later this year and that the [National Director of Quality and Patient Safety] work with NOCA and INOR to improve reporting on private hospital activity.”

Public patients treated in private hospitals under joint arthroplasty programme should be monitored – NOCA

Ms Laura Magahy

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Talks ongoing on area medical officer pay dispute

NIAMH CAHILL

The IMO is engaged in talks with the HSE on obtaining improved pay and conditions for area medical officers (AMOs) on a par with senior medical officer (SMO) colleagues.

According to Mr Thomas Smyth, Manager of IMO Member Advisory Services, discussions are ongoing with the HSE.

The talks follow a decision in early 2020 by a Workplace Relations Commission (WRC) adjudication officer against the IMO in a case where the union argued an AMO was denied a promotion to SMO due to indi -

rect age discrimination.

The IMO referred the matter to the WRC for conciliation and talks between the IMO and the HSE began late last year.

“We hope to come to agreement on this matter, but failing this we would then look to refer the matter to the Labour Court for a recommendation. We are looking at different options and are still engaged in a conciliation process,” Mr Smyth told the Medical Independent

There are currently between 16 and 20 AMOs, or community health doctors, some of whom work on a part-time basis. AMOs work in various HSE community health services nationally.

Increase in part-time posts approved by consultant committee

DAVID LYNCH

An increasing number of half-time consultant positions have been approved by the consultant applications advisory committee (CAAC), according to a report presented at one of its meetings.

The report, seen by the Medical Independent (MI) following a Freedom of Information request, outlined the number of posts approved on a 0.5 whole-time equivalent (WTE) basis between January 2018 and October 2020.

In 2018, only four half-time posts were approved; the figure rose to 15 in 2019; and last year (until October) 14 such posts were approved. Of these 14 posts, 10 were described as ‘new’, three as ‘restructure’, and one as ‘replacement’.

Of the 15 approved in 2019, five were described as ‘new’, nine as ‘restructure’ and one as ‘replacement’.

In total, the CAAC has approved 33 posts on a 0.5 WTE basis between January 2018 and October 2020.

Seven were in general medicine; six in surgery; five in pathology; four in anesthesiology; four in psychiatry; two in obstetrics and gynaecology; two in radiology; two in paediatrics; and one in intensve care medicine.

The number of half-time posts being presented before the CAAC was raised by members at its meeting in October.

The CAAC Chair Prof Áine Carroll had

When I graduated from medical school in 2005, there were 4,000 acute mental health beds in Ireland. That number has now decreased to 1,000. In real terms, what that means is that for every four patients we would have admitted to hospital in 2005, we would only admit one today.”

requested a report on the number of posts involved and it was brought before the meeting in December.

Meanwhile, the IHCA has warned it is increasingly urgent that additional consultant staffing and extra capacity is put in place in hospitals if waiting lists are to be reduced.

IHCA President Prof Alan Irvine said: “Minister [for Health Stephen] Donnelly must engage with the Association on record and growing waiting lists, including the solutions at his disposal to fill the 728 permanent consultant posts that are vacant and the opening of additional hospital facilities. If these twin deficits are not addressed without delay, the structural mismatch between capacity and demand will continue to increase rather than decrease waiting times.”

Our profession is committed to supporting public vaccination that is safe and delivered to our citizens as soon as possible. This also opens the door for optometrists to play a greater role in public vaccination programmes into the future.”

Since 2003, the number of AMOs has been dwindling and some community medical departments are already without any AMOs.

New structures were introduced in 2004 resulting in no further AMO recruitment. The restructuring process led to an inequality between AMO and SMO positions. Despite both posts involving similar duties in immunisation and child health services, SMOs are paid more than AMOs.

The salary scale for an AMO, based on October 2020 figures, begins at €70,000 to a maximum of €82,728. For SMOs, the salary scale begins at €83,796, increasing to a maximum of €97,370.

Audit into PPE sourcing yet to be completed

PAUL MULHOLLAND

The audit into the sourcing and management of personal protective equipment (PPE) is currently ongoing, according to the HSE.

A meeting of the HSE’s audit and risk committee on 13 November 2020, the minutes of which were seen by the Medical Independent (MI), discussed the audit before it had gone to tender.

The committee suggested that the date on which the report would be made available should be included in the “scope of services”document.

The National Director of Procurement

Mr Sean Bresnan said it was expected the audit report would be available at the end of the first quarter of 2021.

When questioned by MI about the progress of the audit, a HSE spokesperson said: “Government approved a €923 million spend on PPE for 2020 and given the scale of expenditure involved, it is entirely appropriate to conduct a thorough audit of the systems and controls in relation to the sourcing, the management and the usage of PPE. This audit is currently ongoing and any recommendations that are made by the audit team will be actioned by the HSE.”

The committee has also recommended that adherence to relevant occupational health standards should be considered as part of the review.

Separately, the HSE has confirmed it is using a stock management system in regard to storage and distribution of PPE.

Last year, internal audit findings on storage and distribution of PPE at a Dublin warehouse found that the receipting process used at that point was “inherently limited” and recommended the introduction of a stock management system to reduce data errors and improve efficiency.

The need to move to such a system had been discussed by the audit and risk committee.

“This involved expanding our existing stock management system and putting a team together to implement,” said the HSE’s spokesperson, who confirmed such a system was now in use.

“Efficiencies gained are electronic record of stock movements, cycle counting, improved stock management including slow moving stock and expiry dates.”

Covid can be a long-term, debilitating illness. People need to know where they stand, medically and in terms of work. The HSE need to lead the charge on this and implement the measures that our members are calling for.”

Dr Anne Doherty, Consultant Liaison Psychiatrist at the Mater Hospital, Dublin, speaking on behalf of the IHCA about the low number of adult mental health beds in Ireland.

Irish Nurses and Midwives Organisation General Secretary Ms Phil Ní Sheaghdha, commenting at the union’s virtual annual delegate conference, which heard nurses and midwives with long Covid are not getting the medical and employment supports they need.

Association of Optometrists Ireland President Mr John Weldon, who was one of the first optometrists in Ireland to administer a Covid-19 injection recently at the Aviva mass vaccination centre in Dublin.

NEW POS T- COVID CLINIC

Beacon Hospital’s Post - Covid Clinic was established in March 2021 in response to increasing numbers of patients presenting with lingering complaints long after their initial Covid-19 infection.

This highly specialised MDT clinic, the first of its kind in Ireland, o ers much needed care and support to these patients as they continue in their post-covid recovery journey.

Led by Prof Seamus Linnane, the Post-Covid Clinic has the support of the full service acute hospital including Ireland’s most technologically advanced radiology and diagnostics equipment.

For more information please see the Post-Covid Clinic section of our website - www.beaconhospital.ie or call 01 650 4860.

Patients can be referred by emailing covid.recovery@beaconhospital.ie

The quest for a universal coronavirus vaccine

Vaccines against Covid-19 were developed at record speed and now the global search for a universal vaccine against all variants of coronavirus is intensifying, especially in the UK and the US.

The focal point of current British research is the University of Nottingham, where scientists are working on a vaccine that would target the core of the virus instead of the spike protein on which current vaccines focus.

Successfully targeting the core of the virus would lessen, and ultimately eliminate, the need to adjust existing vaccines as the virus mutates. Proteins found in the core of the virus are far less likely to mutate so a universal vaccine would protect against all current variants.

Working with scientists from the University of Nottingham, the UK company Scancell is targetting a protein in the core of the virus called the nucleocapsid or ‘N’ protein, as well as the spike protein. “It is hoped that the N protein component of the vaccine will stimulate cells to recognise and kill virus-infected cells,” according to details published by the University of Nottingham on its website.

“The N protein is highly conserved among coronaviruses, therefore this new vaccine has the potential to generate protection not only against Covid-19 but also against new strains of coronavirus that may arise in the future.”

Prof Lindy Durrant, Chief Scientific Officer of Scancell and Professor of Cancer Immunotherapy at the University of Nottingham, commented: “Vaccines are the long-term solution and we believe our combined high avidity T-cell and neutralising antibody approach has the potential to produce a second-generation vaccine that will generate an effective and durable immune response to Covid-19.”

Prof Jonathan Ball, Director of the Centre for Research on Global Virus Infections at the university, added: “Focusing the antibody responses on the receptor binding domain of the SARSCoV-2 virus should ensure the generation of high-titre antibodies that prevent infection. A similar DNA vaccine has already been shown to be safe and effective

in cancer patients and so should rapidly translate into the clinic for prevention of Covid-19.”

Scancell’s Chief Medical Officer, Dr Gillies O’Bryan-Tear, told Britain’s Daily Telegraph: “We don’t necessarily claim it will be a pan-coronavirus vaccine, but it has got the potential to be so simply because of where it is targeted.”

Nanoparticle

In the US, scientists at Caltech (California Institute of Technology) have engineered a prototype all-in-one vaccine using a nanoparticle to hold fragments of the spike protein from multiple known coronaviruses.

This was found to trigger the production of antibodies against several coronaviruses in pre-clinical testing in February. It not only protected against the coronavirus antigens in the vaccine, but also against related strains, suggesting an immune response had recognised common features across coronaviruses. This approach could thus protect against newly emerging coronaviruses in the future.

Much of the work at Caltech is being led by the lab of Prof Pamela Bjorkman and details on progress towards a universal coronavirus vaccine were published in February in the journal Science

The US National Institute of Allergy and Infectious Diseases (NIAID) announced as far back as November 2020 that it would fund a number of projects to advance work on pan-coronavirus vaccine candidates.

“With multiple promising SARSCoV-2 vaccine candidates now under development, NIAID is looking ahead

to potential pan-coronavirus (pan-CoV) vaccine candidates capable of providing broad protective immunity to multiple CoV strains,” the agency announced.

“Getting there necessitates highly collaborative, multidisciplinary programme projects to incorporate understanding of CoV virology and immunology, immunogen design, and innovative vaccine and adjuvant platforms and technologies.”

As work intensified this year, NIAID Director Dr Anthony Fauci underscored the need for such a vaccine. Speaking at the virtual annual meeting of the American Association for the Advancement of Science on 8 February, Dr Fauci called the rapid development of Covid-19 vaccines the “success story” of the pandemic. “Something that would have taken years to do was accomplished in a matter of months, less than a year,” he declared. “This is purely a reflection of scientific advances and the work that was put in for the prior decade for the development of this platform technology.”

Universal flu vaccine

Dr Ted Ross (PhD), the Director of the Centre for Vaccines and Immunology at the University of Georgia, has been developing a universal flu vaccine for the past 15 years. In 2019, his team was awarded a contract worth $130 million (€109 million) to develop such a vaccine. It was one of the largest contracts ever issued

by the National Institutes of Health (NIH).

But in March of 2020, when it became clear that Covid-19 was becoming rampant across the globe, Dr Ross’s team switched to working on a universal coronavirus vaccine. The approach focuses on regions of the SARS-CoV-2 virus which are important for stimulating antibodies. Algorithms are used to analyse the important parts of multiple virus strains and assemble them into a single vaccine.

“Now that we're starting to see more variants come up, it starts to give us a chance to really test against a more broad reaction of strains, which is what's going to be needed to know if it's actually universal or not,” Dr Ross told Wired magazine. The plan is to start the first trials in the summer of this year.

Back in a pre-Covid world it was rare for a vaccine to be developed in fewer than about seven years. Therefore, the idea that one could emerge against Covid-19 within 12 months had been met with some scepticism. Yet it took less than a year to get a vaccine into the arms of frontline healthcare workers and now there are over half a dozen in use around the world. Some 23 others are in phase 3 large-scale efficacy tests. It has been a monumental achievement for science and medicine. But most breakthroughs do not happen overnight – usually careful work has been ongoing for a considerable time. This was the case with the Covid-19 vaccines and now the search for a pan-coronavirus vaccine is benefitting from some aspects of that work.

The extraordinary speed at which current vaccines have emerged was due to decades of previous work, including research on the original SARS virus and HIV. But it was also thanks to a team of Chinese scientists led by Prof Yong-Zhen Zhang of Fudan University in Shanghai, who on 10 January 2020 uploaded the genetic sequence of the coronavirus to a public site. “Once we got the sequence, we pulled the trigger to ask how fast we could go,” Dr Barney Graham, the Deputy Director of the US National Institutes of Health’s Vaccine Research Centre, told Stat News

SARS vaccine

Many of the research teams seeking to develop vaccines for SARS-CoV-2 had worked on vaccines for the SARS virus, which caused a 2003 outbreak, and MERS, which first emerged in 2012.

The earlier projects had identified the spike protein component of the coronaviruses as a key target for a vaccine,

Experts suggest that developing a universal coronavirus vaccine is not only possible, but could be realised in the coming years.

Bette Browne reports

Prof Lindy Durrant

Dr Gillies O’Bryan-Tear

Dr Ted Ross

Genuair®-has it ‘clicked’ yet?

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

Genuair - a simple to use inhaler for patients with COPD4

Abbreviated Prescribing Information

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

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

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

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

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

Abbreviated Prescribing Information

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

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

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

LAMA + LABA

LAMA

which aided scientists in developing potential vaccines. “What really helped was the knowledge gained from the SARS-1 infection,” US immunologist and researcher Prof Rama Rao Amara at Emory University in Atlanta, Georgia, US, told Stat News

Previous strategies for developing vaccines – obtaining the virus and weakening or inactivating it – are protracted processes. However, newer approaches meant scientists only needed to know the virus’s genetic sequence.

Less than 10 weeks after publication of the SARS-CoV-2 sequence, a team from the US NIAID and Massachusetts-based Moderna had a vaccine ready for a phase 1 trials.

One way scientists discovered so much about the spike protein was by applying methods developed over many years. “Traditionally, vaccines can take an average of up to 10-to-20 years to go through this process. The fastest we have been able to develop a vaccine is the mumps vaccine in four years and the Ebola vaccine in five years,” according to Dr Maria Elena Bottazzi, Associate Dean of the National School of Tropical Medicine at Baylor College of Medicine and Co-Director of the Centre for Vaccine Development at Texas Children’s Hospital, Houston, US.

“We have learned from this pandemic that prior research and development knowledge and the advent of new technologies can be leveraged and change the way we discover, produce and evaluate vaccines – leading to an acceleration of the process.”

But sometimes potential breakthroughs can go unrecognised. In 2016, for example, Dr Bottazzi and her colleagues applied for support from the US government to develop a pan-coronavirus vaccine, but did not receive it, she told The New York Times. “They (the government) said there’s no interest in pan-corona.”

Her team lost funding for developing a SARS vaccine despite demonstrating it worked in mice. They also showed it was not toxic to human cells and could be manufactured at scale. With no funding to start clinical trials, the scientists moved on to other research. Subsequently, Dr Bottazzi and her colleagues used the technology to develop a vaccine for Covid-19.

Another factor in the speedy development of coronavirus vaccines was advances in computational immunology. Understanding the immune system is a tall order, according to Prof Margaret Ackerman, an immunologist at Dartmouth College, in Hanover, New Hampshire, US. That is why so many scientists have turned to computational and informatics approaches.

Mathematical models have become so advanced it is possible to predict the parts of a novel pathogen that will be recognised by B-cells and T-cells or cre -

ate targeted immunotherapies against tumour cells. “These approaches offer incredible speed at getting from genetic sequence to a candidate vaccine. Nothing can compete with that,” Prof Ackerman told the journal Nature Medicine

Human Vaccines Project

“Collectively, studies now suggest that developing a universal coronavirus vaccine is scientifically feasible,” Dr Wayne Koff, CEO of the Human Vaccines Project, and Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, wrote in February in the journal  Science

The Human Vaccines Project is a non-profit public-private partnership aimed at accelerating development of vaccines and immunotherapies against major infectious diseases and cancers by decoding the human immune system. Gavi, the Vaccine Alliance, has a similar mission and is also working to increase access to immunisation in poor countries as a co-leader of the WHO’s COVAX project.

“The recent convergence of technological advances in biomedical, computing, and engineering sciences has ushered in a new era in antigen and vaccine discovery,” Dr Koff said. “High-performance supercomputing and machine learning, coupled with structural

priority. We can either invest now or pay substantially more later.”

Finance is an essential factor. The US, UK and a number of other countries, have provided billions in support to companies working on developing vaccines.

The budget for the US Warp Speed vaccine development programme under former President Donald Trump was as high as $18 billion (€15 billion). The New York Times reported that US agencies provided $2.5 billion to Moderna to assist in the development of its vaccine and to buy doses. The UK spent £12 billion (€14 billion) to help develop and secure vaccines. Many scientists and medical experts now say the focus must be on speeding up the search for a universal vaccine against coronavirus and backing the effort with substantial funding.

Dr Kayvon Modjarrad, Director of the Emerging Infectious Disease Division at the US Walter Reed Army Institute of Research in Silver Springs, Maryland, US, is one of many scientists who for years have called for one vaccine against all coronaviruses.

Global effort

Other scientists and doctors agree. Among them are Prof Eric Topol, a Professor of Molecular Medicine at the Scripps Research Institute in San Die -

ogen evolution and resistance to antibodies. They ask why this approach has not been widely applied already.

“Generating very broad, very potent neutralising antibodies can be difficult. But research to find the best antibodies and improve them has been highly successful in recent years. It might not always be possible to obtain the ideal breadth of responses across a whole family of viruses. But compromises can be made, and methods for delivering cocktails of antibodies and vaccines are becoming feasible.”

Unlike a reactive programme, the doctors say their projects could begin on a large scale immediately. “Thanks to work already done on other viruses, particularly HIV and influenza, the approaches are understood and the infrastructure is in place.

“Investments made so far in basic science – including virology, genomics, immunology and structural biology – have afforded us a remarkable opportunity to get ahead of further SARS-CoV-2 evolution and put us in a powerful position of readiness for new viral pathogens.”

They estimate the investment per virus from bench to phase I trials is likely to be between $100-200 million over several years, with the costs borne by public–private partnerships between governments, philanthropy, and industry.

“Organisations such as CEPI (Coalition for Epidemic Preparedness Innovations), the COVAX facility and GAVI, the Vaccine Alliance, could help to convene the expertise and initiate the negotiations needed to deliver the types of vaccine we propose.”

modeling, have the potential to greatly accelerate identification of common antigenic targets shared across coronaviruses. Databases of genetic sequences of animal isolates of coronaviruses can be used to model the evolutionary emergence of the viruses.”

Both doctors stressed this must be a “worldwide effort”. A roadmap is needed to set out the core scientific issues and a framework for funding and sharing of information, data, and resources.

“Although this pandemic is far from over, we now have the tools to end it, with the largest and most rapid global deployment of vaccines under way. That we got this far so quickly is remarkable, but next time we might not be so lucky. More virulent and deadly coronaviruses are waiting in the wings. Thus, the world needs a universal coronavirus vaccine.”

None of that can happen until all stakeholders across governments, industry, academia, and nongovernmental organisations, recognise that a universal coronavirus vaccine is a global public health priority, they emphasised.

“If we choose to wait for the next coronavirus to emerge, it may be too late, as it was with Covid-19. Creating the tools for preventing the next coronavirus pandemic is within our means and should be considered a global health

go, US, and cardiologist Dr Dennis Burton. They have called upon scientists to come together in another large-scale vaccine-creation project. They want an international effort, backed up by hundreds of millions in funding.

“Such pan-virus vaccines could be made in advance and deployed before the next emerging infection becomes a pandemic. We call for an investment now in basic research leading to the stockpiling of broadly effective vaccines,” they declared in February in the journal Nature

“As we’ve seen for influenza, one virus strain can cause more deaths than a world war and result in trillions of dollars of economic damage. Surely, global governments that together spend $2 trillion (€1.7 trillion) a year on defence can find a few hundred million dollars to stop the next pandemic?”

Dr Topol and Dr Burton acknowledge the difficulties inherent in the development of a pan-coronavirus vaccine, but reject the scepticism expressed by some critics. “What do the fiercest critics of our proposals argue? They point to the difficulties of isolating neutralising antibodies with sufficient potency and breadth to be effective. They note the complexities of rational vaccine design. They underscore concerns about path-

The Norwegian-based CEPI, launched in 2017 to develop vaccines to stop future epidemics, gave the current search for pan-coronavirus a significant boost on 31 March when it announced $200 million in funding will be allocated for development of vaccines that provide broad protection against SARS-CoV-2 and betacoronaviruses.

“CEPI aims to build on the technological advances that have been made in response to Covid-19 to develop an all-encompassing vaccine that could work against known Betacoronaviruses, including SARS, MERS, and COVID-19, and could potentially be used to quickly suppress future outbreaks of other novel coronaviruses that might jump into the human population,” said Dr Melanie Saville, Director of Vaccine Research and Development at CEPI, in announcing the pan-coronavirus project.

While work to develop such a vaccine would be extremely challenging, it would bring major rewards, she said. “This will be an incredibly challenging area of work, but one with tremendous benefits. A broadly protective coronavirus vaccine could help avert another Covid-19-like pandemic, reduce the need to continually update vaccine components, and ultimately reduce virus circulation.

“The emergence of a coronavirus combining the transmissibility of Covid-19 with the lethality of SARS or MERS would be devastating to civilisation. Finding solutions to mitigate the threat posed by coronaviruses is thus an issue of the greatest global urgency.”

Dr Maria Elena Bottazzi

We have learned from this pandemic that prior research and development knowledge and the advent of new technologies can be leveraged

For patients with wet AMD

1

THEIR VISION IS A WORK OF ART

NOW AVAILABLE

In two head-to-head trials vs aflibercept, Beovu®1:

• Demonstrated robust vision gains and non-inferiority vs. aflibercept in mean BCVA change from baseline to week 482*

• Outperformed aflibercept with superior fluid resolution at Weeks 16 and 482†

• Maintained a majority of patients on a q12w interval immediately after loading through Week 481

• Exhibited an overall welltolerated safety profile3

STUDY DESIGN: The safety and efficacy of Beovu was assessed in 2 randomized, multicenter, double-masked, active-controlled Phase III studies (HAWK and HARRIER) in patients with wet AMD. A total of 1817 patients were treated for 2 years (Beovu [N=1088]; aflibercept [N=729]). Patients were randomized to either Beovu (6.0 mg [n=360; n=372], q12w/q8w in HAWK and HARRIER, respectively; 3.0 mg [n=358], q12w/q8w in HAWK only) or aflibercept (2.0 mg, q8w). For patients on Beovu, after 3 initial monthly doses (Weeks 0, 4, and 8), disease activity assessments (DAAs) were conducted at Weeks 16 and 20. Patients selected for q12w received first treatment at Week 20 and continued on q12w unless disease activity (DA) was identified at any subsequent DAA visit (Weeks 20, 32, 44, 56, 68, 80, and 92). Patients identified with a q8w need at Week 16 and Week 20 were switched to q8w for the remainder of the study. Additional assessments and potential dosing interval adjustments occurred at Weeks 28, 40, 52, 64, 76, and 88 in HARRIER only. Aflibercept was administered every 8 weeks after 3 initial monthly doses. There was no hypothesis testing after Week 48.1,3,4 AMD=age-related macular degeneration; BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Study; q12w/q8w=treatment every 12/8 weeks.

ABBREVIATED PRESCRIBING INFORMATION

Beovu▼ (brolucizumab) 120 mg/ml solution for injection in pre-filled syringe. Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: Each pre-filled syringe contains 19.8 mg of brolucizumab in 0.165 mL solution. This provides a usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab. Indication: Beovu is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). Administration and Dosage: Single-use pre-filled syringe for intravitreal use only. Each pre-filled syringe should only be used for the treatment of a single eye. Beovu must be administered by a qualified ophthalmologist experienced in intravitreal injections.

Adults: Posology: The recommended dose is 6 mg brolucizumab (0.05 ml solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. Thereafter, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. A disease activity assessment is suggested 16 weeks (4 months) after treatment start. In patients without disease activity, treatment every 12 weeks (3 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) should be considered. The physician may further individualise treatment intervals based on disease activity. If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued. Special populations: Renal and Hepatic impairment: No dose adjustment is required. Elderly: No dose adjustment is required in patients aged 65 years or above. Pediatric patients: Safety and efficacy have not been established. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Patients with active or suspected ocular or periocular infections. Patients with active intraocular inflammation. Warnings and precautions: Traceability: the name and the batch number of the administered product should be clearly recorded. Intravitreal injection-related reactions: Intravitreal injections, including those with Beovu, have been associated with endophthalmitis, intraocular inflammation, traumatic cataract retinal detachment, retinal vasculitis, and/or retinal vascular occlusion (see section 4.8 of the SPC). Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Beovu (see sections 4.3 and 4.8). In patients developing these events, treatment with Beovu should be discontinued and the events should be promptly managed. Proper aseptic injection techniques must always be used when administering Beovu. Patients should be instructed to report any symptoms suggestive of the above-mentioned events without delay. Transient increases in intraocular pressure have been seen within 30 minutes of injection, similar to those observed with intravitreal administration of other VEGF inhibitors. Special precaution is needed in patients with poorly controlled glaucoma (do not inject Beovu while the intraocular pressure is ≥30 mmHg). Both intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately. The safety and efficacy of brolucizumab administered in both eyes concurrently have not been studied. As this is a therapeutic protein, there is a potential for immunogenicity with brolucizumab (see section 4.8). Patients should be instructed to inform their physician if they develop symptoms such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in their vision, or increased sensitivity to light (see section 4.8). There are no data available on the concomitant use of Beovu with other anti-VEGF medicinal products in the same eye. Brolucizumab should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular). In intravitreal anti-VEGF treatments, the dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity; a retinal break; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage

is ≥50% of the total lesion area; performed or planned intraocular surgery within the previous or next 28 days. Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD include a large and/or high pigment epithelial retinal detachment. When initiating brolucizumab therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears. Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 macular holes. Systemic adverse events, including non-ocular haemorrhages and arterial thromboembolic events, have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition. There are limited data on safety in the treatment of patients with AMD with a history of stroke, transient ischaemic attacks or myocardial infarction within the last 3 months. Caution should be exercised when treating such patients. Interactions: No formal interaction studies have been performed. Pregnancy, Lactation, and Fertility: ♦Women of child-bearing potential: should use of effective contraception during treatment with brolucizumab and for at least one month after last dose when stopping treatment. ♦Pregnancy: brolucizumab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus. ♦Breast-feeding: Brolucizumab is not recommended during breast-feeding. Breast-feeding should not be started for at least one month after the last dose when stopping treatment with brolucizumab. ♦Fertility: Based on the mechanism of VEGF inhibitors, there is a potential risk for female reproduction and to embryofoetal development. Adverse Reactions: Common (1 to 10%): Hypersensitivity (including urticaria, rash, pruritus, erythema) Visual acuity reduced, retinal haemorrhage, uveitis, iritis, vitreous detachment, retinal tear, cataract, conjunctival haemorrhage, vitreous floaters, eye pain, intraocular pressure increase, conjunctivitis, retinal pigment epithelial tear, vision blurred, corneal abrasion, punctate keratitis. Uncommon (<1%): Endophthalmitis, blindness, retinal artery occlusion, retinal detachment, conjunctival hyperaemia, lacrimation increased, abnormal sensation in eye, detachment of retinal pigment epithelium, vitritis, anterior chamber inflammation, irirodyclitis, anterior chamber flare, corneal oedema, vitreous haemorrhage. There is a potential for an immune response in patients treated with Beovu. There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors. Not known: Retinal vascular occlusion and Retinal vasculitis. Please refer to SmPC for full listing of all undesirable effects. Pack Size: Beovu is supplied in packs containing one pre-filled syringe. Legal category: POM. Marketing authorisation number: EU/1/19/1417/001. Marketing authorisation holder: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland. Full prescribing information is available upon request from: Novartis Ireland Limited, Vista Building, Elm Park Business Park, Elm Park, Dublin 4. Tel: 01-2601255 or at www.medicines.ie. Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu. Prescribing Information last revised: September 2020.

▼ This medicinal product is subject to additional monitoring. Reporting suspected adverse reactions of the medicinal product is important to Novartis and the HPRA. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported via HPRA Pharmacovigilance, website www.hpra.ie. Adverse events could also be reported to Novartis preferably via www.report.novartis.com or by email: drugsafety.dublin@novartis.com or by calling 01 2080 612.

REFERENCES 1. Beovu Summary of Product Characteristics. Novartis; 2020. 2. Dugel PU, Koh A, Ogura Y, et al; on behalf of the HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, multicenter, randomized, doublemasked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-123. 3. Data on file. RTH258-C002 Clinical Study Report. Novartis; 2018. 4. Data on file. RTH258-C001 Clinical Study Report. Novartis; 2018.

*The primary efficacy endpoint for the studies was the change from baseline in BCVA at Week 48 as measured by the ETDRS Letter Score, with the primary objective to demonstrate noninferiority of Beovu vs aflibercept.1

† Secondary endpoint in HAWK and HARRIER, confirmatory analysis in HAWK only (1-sided P values for superiority of Beovu).3,4 February 2021 | IE103131

‘Storm-proofing’ Ireland’s healthcare infrastructure

The HSE is investigating how well-braced the country’s healthcare buildings are to cope with extreme weather events. Paul Mulholland reports

Before Covid-19, one of the major shocks to healthcare delivery experienced in recent years were the effects of severe weather events.

In March 2018, Storm Emma and the ‘Beast from the East’ proved a huge challenge to hospitals, with many healthcare staff staying overnight at their workplaces or in nearby hotels to ensure the continuation of services.

In our 25 October 2018 issue, the Medical Independent (MI) published a feature detailing correspondence from a senior HSE manager showing how hospitals and emergency services had struggled to cope with the snowfall and cold weather during that time, as temperatures fell to -7 in some parts of the country.

Aside from the impact on staff and transport, there were also references to the effect the weather had on hospital infrastructure. According to a severe weather report for Hospital Groups, prepared on 2 March 2018, there was a fire incident in the maternity service area in Midland Regional Hospital, Portlaoise, due to an electrical fault in the sluice room. Fire services attended the scene and no patients were affected, it was reported.

Also, in the previous issue of this newspaper (10 May 2021), we published a story on how damage at the Rotunda Hospital’s colposcopy/administration building represents a “major” infrastructural risk as it houses the main IT server room. It is flat roof structure which is prone to "water damage and egress when there is major rainfall”, according to a spokesperson.

The challenges experienced during 2018 prompted the HSE to investigate the preparedness of the health infrastructure for such severe events. The need to upgrade infrastructure has been of increasing concern to the Executive. Early in 2020, the HSE’s Emergency Management Division had started work on a ‘critical infrastructure resilience’ report. Recently (8 March 2021), MI reported on how ‘capital infrastructure and critical equipment’ was one of the 26 risks included on the HSE’s corporate risk register (CRR), dated October 2020 and approved by the HSE board at its meeting in December.

in advance of the completion of this survey.

During its 13 November meeting, the committee noted a briefing paper on the critical infrastructural resilience report. The committee heard that while the report had been drafted, its approval was impacted by Covid-19.

“The critical infrastructure has been identified and includes all acute hospitals and other facilities providing 24/7 services, the national emergency operations centre, the national distribution centre, data centres, and designated primary care centres,” according to the meeting minutes.

The report recommended that leadership and oversight arrangements should be put in place “to ensure critical infrastructure resilience translates into effective actions”.

Critical infrastructure resilience measures and controls should be “continually built upon”, according to the report. It also called for review arrangements to be embedded across delivery systems by service owners “to ensure contingency exists for the provision of existing services”.

The report also cites the importance of the survey of health infrastructure resilience in relation to extreme weather events and states this piece of work needs to be progressed.

At a meeting of the Executive’s audit and risk committee on 26 August 2020 it was recommended that infrastructure and critical equipment should be included on the CRR and on the risk registers of all Community Health Organisations and Hospital Groups.

According to the minutes of the meeting, the HSE National Director of Estates Mr Jim Curran “informed that committee that the vast majority of HSE infrastructure is critical and hard to replace, particularly within a short timeframe”. It was agreed that “a paper on fire/flood/disaster assessments” of capital buildings would be brought to a future meeting of the committee.

At its meeting on 9 October, the audit and risk committee noted that a “major survey of health infrastructure resilience to severe weather events” had been delayed as a result of Covid-19.

However, it was stated that the survey document was being prepared and would be provided to the committee in the first quarter of 2021.

The committee requested that Mr Curran provide a list of infrastructure that was critical to “business continuity within the HSE”,

“The committee was informed that the HSE will now be conducting a survey of all identified health-critical locations, developing a costed plan to address deficiencies and commencing the project management of initial critical infrastructure resilience works. This report is expected to be ready in early March 2021.”

When questioned about the status of the survey, a spokesperson for the HSE told MI: “The survey was put on hold due to Covid and has not been completed.”

According to the CRR, risks associated with building infrastructure include: “Inadequate built infrastructure, ageing critical clinical equipment, including ambulances, failure to comply with regulatory requirements.”

“Additional requirements” emerging from the Covid-19 pandemic, in terms of new service locations and physical distancing requirements, were also noted.

The National Development Plan 2018-2027 included the provision of €10.9 billion for health-related capital projects.

Dr Brian Turner (PhD), Department of Economics, Cork University Business School, University College Cork told this newspaper in February: “Given the likely final cost of the NCH [National Children’s Hospital], as well as ongoing construction tender price inflation, this figure may not be sufficient to provide all of the planned additional capacity.”

The need to upgrade infrastructure has been of increasing concern to the Executive

PAUL MULHOLLAND paul@mindo.ie

The doctorflying

Emergency medicine and flight medic Dr Lisa Cunningham speaks to Niamh Cahill about her exceptional working life, Mayo roots, and love for the Irish language

Dr Lisa Cunningham became a volunteer with the Order of Malta, one of the country’s largest pre-hospital voluntary organisations, when she was just 13 years old.

The association ignited what would turn out to be a lasting passion for pre-hospital care and emergency medicine.

In 2010 the Mayo native graduated from University College Dublin (UCD). From there she completed her internship in counties Galway and Mayo before commencing an advanced emergency medicine training scheme.

While completing training Dr Cunningham had three children, Cathal (7), Cuán (5), and Féile (2).

During this time pre-hospital emergency medicine was developing as a specialty. As her training progressed, it gradually became an area she was keen to learn more about.

There is currently no structure in Ireland to study pre-hospital emergency medicine. This took the 35-year-old to the UK last year, where she is currently finishing her fellowship in pre-hospital emergency medicine with the Essex and Hertfordshire Air Ambulance Service.

She is part of the Helicopter Emergency Medical Service (HEMS) team that provides life-saving time-critical interventions in the pre-hospital environment.

Her work involves performing rapid sequence intubation (RSIs), blood transfusions, patient extrications, thoracotomies, thrombolysis, and pre-hospital major incidents, among other life-saving tasks.

Dr Cunningham regularly posts information and images about her work to her more than 41,000 followers on Instagram.

She left for England after the Covid-19 pandemic began and will complete her training in July, when she will return to the West to work in emergency medicine.

Travel restrictions have made coming home more difficult in 2021. She has only been back twice since Christmas.

“That’s very hard when you have three young kids and a husband. Up until that point I was able to isolate. We knew that this period might happen so it’s not unprecedented, but it doesn’t make it easier,” she said.

“Everyone is going through something similar. We’ll get through it and we’ll take it day by day and week by week and we’ll be grand.”

Gender

According to a 2017 emergency medicine medical workforce report, just one-quarter of emergency medicine consultants working in public hospitals in Ireland were female.

“It has been a difficult time throughout the rotation trying to rotate around the country not being able to get parental leave.

I had to go through the IMO to get parental leave at one stage,” according to the Ballina local.

The lack of access to leave was not due to the specialty in which she was training, but because of hospital structures and a lack of focus on work/life balance for trainees.

This is changing with more flexible rotas, focused on the needs of trainees, now in place, both in Ireland and in the UK, believes Dr Cunningham.

However, she points out that the inflexible nature of trainee work structures had to be highlighted before changes were introduced.

“St Vincent’s [hospital] was one of the places that was definitely very accommodating for me in terms of parental leave.”

She hopes these positive changes will encourage more females into previously male-dominated training specialties, such as emergency medicine.

“I get so many female medical students asking me about work/life balance. There is a huge amount that have the interest in it.”

Volunteering

Dr Cunningham is Chief Medical Officer of the Order of Malta Ambulance Corps. She also holds the rank of Commandant and is the youngest and first female to ever hold the position.

The charity, which has over 5,000 volunteers, teaches first aid, provides ambulance cover at large events, medical aid, patient transport and community and nursing services.

Her introduction to the role in January last year was “a baptism of fire”, as just weeks later the country was plunged into crisis.

“We had our first meeting at the end of January and then everything went awry in February, as all of a sudden we were thrown into Covid.”

Along with the chief nursing officer and chief paramedic, Dr Cunningham set up a Covid team and twice weekly meetings were held.

The charity quickly adapted its community service activities to meet the needs of

those impacted most by the virus.

Volunteers picked up prescriptions for ‘cocooning’ older patients and implemented Covid-19 guidance.

Now the charity is assisting individuals with transport to and from vaccination centres and hospital appointments. Its volunteers are helping at vaccination centres with paperwork, car parking, and any potential anaphylaxis events.

The Order has more than 420 Pre-hospital Emergency Care Council (PHECC) recognised practitioners including emergency medicine technicians (EMTs), paramedics and advanced paramedics.

When she returns to Ireland, Dr Cunningham plans to volunteer with the Irish Community Air Ambulance (ICAA), a flying doctor service made up of volunteers, including fellow Mayo resident Dr Jason Horan, Consultant in Emergency Medicine at Mayo University Hospital.

The charity responds to emergency calls involving critical injuries and works with the HSE National Ambulance Service.

Football

Last month, Dr Cunningham was approached to take up the role of team doctor with the Mayo Ladies GAA Football Team.

As an avid Mayo GAA supporter, she was delighted to get the opportunity and despite being abroad, has had one meeting with the team to-date.

“I’ve a huge GAA interest and would have went to many ladies matches in the past. To do it and see the amateur professional set up of the team has spurred me on so much. It is a privilege.”

She hopes to introduce learnings from her time with the team to her work in emergency medicine.

“We take an awful lot from aviation into the emergency departments so why not introduce the sports structure and what happens there and bring that into the pre-hospital or emergency department.”

Gaeilge

Dr Cunningham did not grow up in a Gaeltacht area but due to a “really good teacher” developed a love for the Irish language from a young age. Going to the Gaeltacht as a teen also helped.

“I went to the Gaeltacht out in Belmullet six years in a row. The first year I thought it

was going to be the worst time of my life but after two or three days I absolutely loved it and kept going back.”

She speaks Irish at home with her children, who all attend Gaelscoils, and even speaks the odd word of Irish to her sometimes bemused colleagues in the UK.

“There are some people over here that didn’t realise Irish was a language. So I’ve done my bit for the Irish language by telling someone that it exists.”

She has featured on TG4 and Raidió na Gaeltachta numerous times in her capacity as doctor, commenting on topical issues such as Covid-19 vaccinations.

She recently appeared in a TG4 television programme titled Mayo Day – Ár Bpobal , celebrating the culture and traditions of Co Mayo.

Future

After her training finishes in July, Dr Cunningham said “there’ll be no gallivanting”. Instead, she is determined to develop the specialty of pre-hospital care in the west of Ireland.

“You could count on one hand the number of doctors in Ireland with an interest in developing pre-hospital emergency medicine.

“I’ve reached a point in my career that I want to give my input to pre-hospital care in the West of Ireland. If I need to go abroad to develop my skillset, that’s an option, but at the moment no gallivanting. I want to develop and increase what we have in the West.”

“You can’t replicate what we have in Ireland anywhere else; it’s the same in other systems. You can’t take what they do in Sweden and just lob it into Ireland. There has to be ways we can develop it for ourselves. Our population and geography is quite unique to others.”

Several Irish-born doctors are studying the specialty abroad but may return to Ireland shortly, boosting expertise here, she hopes.

She welcomed publication of the new national trauma strategy for Ireland, which underlines the need for enhanced pre-hospital care.

But Dr Cunningham was keen to stress that trauma and pre-hospital care are quite distinct and emphasised that she will remain solely focused on pre-hospital emergency care in the time ahead.

Dr Lisa Cunningham

The Institute of Medicine –one year on

The Institute of Medicine was launched in the RCPI on 23 January 2020. Ireland’s newest medical training body, the Institute of Medicine, is the national professional and training body for clinical postgraduate medicine, dedicated to advancing the oversight and practice of 18 medicine specialties through education, advocacy, and quality improvement. We now represent the largest spectrum of medical specialties in Ireland, with over 1,000 trainees and 1,000 consultant trainers.

Our mission is to unify the many voices of Irish doctors practising in medicine and its specialties for the benefit of our patients, our members, and our profession. Over the past year, I have been really encouraged by the engagement and dedication of our members and here at the Institute of Medicine, we look forward to continuing to support you in your lifelong medical career.

The year since we launched the Institute of Medicine, as you know, has been a challenging time.

It has been the toughest year in living memory, bringing many frontline workers to their very limits. But we have held firm, united by a drive to provide the best possible care for our patients, young and old, and a very real feeling of ‘this is what we did our training for’. In the first wave, many medical trainees stepped up to give much-needed support, and throughout the year, trainees have had to juggle their all-important training and exam commitments and their invaluable work in treating seemingly endlessly increasing numbers of Covid-19 patients.

Towards a ‘new normal’ for physician training

As we come to grips with the pandemic and anticipate society slowly reopening, the priority must be rest and recuperation for all frontline workers who have contributed so much in the response to Covid-19. This is especially true for trainees, who have worked incredibly hard to play their part and on whom the entire effort relied upon so heavily. Wellbeing is a critical issue, but also ensuring that training remains on track and is as uninterrupted as possible – this is the key priority for RCPI. The incredible work of our outstanding community of trainers has also been of crucial importance during this period of uncertainty and challenge. Trainers play a crucial role in the delivery of our basic specialist training (BST) and higher specialist training (HST) programmes. They guide trainees along the path to becoming a specialist and help the next generation of medical leaders reach their full potential.

Reimagining professional exams

Despite Covid-19, we have been able to

support career progression with innovative approaches to end-of-year assessments, interviews, and in particular, examinations.

The RCPI was the first college to utilise remote invigilation, which allowed written examinations to continue. Our general medicine clinical examinations resumed last winter with adjusted protocols and procedures to ensure the safety of all participants, including personal protective equipment, use of surrogates/actors, social distancing, and a pre-examination questionnaire.

During the course of these exams, 100 BST trainees completed the clinical examination in time for interview for HST, and another 100 in March across five dif-

A ‘digital first’ approach to learning and development

One year ago, virtual events seemed like a temporary fix to keep "business as usual" for a few months. By leveraging the power of online events to reach and connect with our members during a time of lockdowns, we found a way to successfully drive our educational programmes and events and provide a great experience to those who needed it.

Within a week of the pandemic, we commenced the Covid-19 webinar series in March 2020 adapting the way we deliver education and reached thousands of clinicians with rapidly evolving information

of scientific and educational content, prepared by industry leaders and experts, ensuring you stay up-to-date with the latest developments in various specialties.

Summer Symposium 2021

The Covid-19 pandemic brought on new challenges and new opportunities for the organisation of meetings and events. As we move into 2021, online events are where we can meet, share, and exchange insights relating to health innovations, new technologies and tools, and the latest topics and trends in patient experience that are transforming healthcare.

The first annual Institute of Medicine

Summer Symposium is being held online on Thursday 1 July. The event will consist of a rich mixture of symposia, award conferrals, forums, presentations, and lectures from eminent international physicians.

As the postgraduate system grapples with Covid-19 and its impact, this year’s symposium will focus on how the pandemic will interact with trends in healthcare for those on the frontline of medicine.

The theme of the 2021 Summer Symposium will be a celebration of achievements in medicine and our graduating HST trainees. As part of the online event, we have invited prestigious guest speakers to deliver the inaugural Prof John Stearne and Dr Eliza Dunbar lectures. Among the speakers are Dr Mike Ryan, Executive Director of the World Health Organisation's Health Emergencies Programme and Prof Jeff Drazen, immediate past Editor of the New England Journal of Medicine. Prof Drazen will also receive an honorary fellowship from the RCPI in a special online ceremony.

The symposium will also include a recognition of key members of the Institute of Medicine and their contribution to its mission. Participants will have the opportunity to actively participate in the sessions and also network with colleagues during what I am sure will be an unmissable event.

ferent days in Dublin and Galway. I want to sincerely thank everyone involved and especially the examiners and exam sites for their support.

This year will see the highest ever numbers of trainees within the Institute of Medicine following the intake of 61 additional doctors to BST and a 10 per cent increase in trainees in higher specialist training. This increase in part reflects Covid-19 and we will work closely with the HSE National Doctors Training and Planning to determine intake numbers for 2022. Last year, we also welcomed 120 new members in the specialty of general medicine to the College.

and experience from across the world.

We subsequently launched the hugely popular acute medicine series. The sixth online event in this series, 'Hot Topics in Rheumatology,' took place on 21 April. Audience numbers and feedback throughout the year have been inspiring. I have been particularly delighted that the Institute was able to partner with many specialist societies in the presentation of our webinar series.

RCPI’s webinar, events and masterclass recordings are available on the online platform Panopto for you to save, create an online library, and watch back anytime. The webinar library is a great source

Bringing together key figures from across the healthcare sector, our first Summer Symposium will be an important event for those working in the field in 2021. Wherever you are in the world, you can expect to hear insights and experiences from experts and leaders sharing their visions on healthcare management, best practices, and ways to improve the care we deliver to our patients.

For more information on the Institute of Medicine Summer Symposium 2021, including the agenda and speakers’ bios, and to book your place, visit www.rcpi.ie

You can find out more about the Institute of Medicine’s work as the national professional and training body for clinical medicine in Ireland by visiting www.rcpi.ie/faculties/ institute-of-medicine

Prof Anthony O’Regan, Dean of the Institute of Medicine at the RCPI, reflects on the year since the Institute was founded and what vital lessons must be learned from Covid-19

It has been the toughest year in living memory, bringing many frontline workers to their very limits

Pictured at the launch of the RCPI Institute of Medicine (IOM) on 23 January 2020 are (L-R): Dr Terry McWade, CEO, RCPI; Prof Anthony O’Regan, Foundation Dean, IOM; Prof Mary Horgan, President, RCPI; and Prof Ed McKone, Director of Training, IOM

When should Ministers stay quiet and let

the

experts speak?

The Minister for Health Stephen Donnelly came in for some criticism recently when it was revealed that he asked Department of Health officials why he was not being mentioned in tweets from the Department’s feed. According to a story in The Irish Times in April, an analysis of the feed was completed for the Minister in mid-January. It showed no references were made to Minister Donnelly during the period in question. In contrast, Chief Medical Officer Dr Tony Holohan was referenced in 21 tweets. Other national public health emergency team members were also mentioned. Minister Donnelly’s predecessor and current Minister for Higher Education Simon Harris was mentioned 10 times in his Department’s feed, which was “more than any other person or entity”.

The criticism of Minister Donnelly was entirely predictable in the current context. Many people maintained he should be more concerned about the not insignificant matter of the pandemic, rather than how often he is mentioned on social media. But the story also brings to mind the question, namely: Does overtly linking a policy with a particular Minister, party or Government, sometimes harm its reception regardless of the policy’s merit?

The introduction of any new policy is invariably accompanied with a press release that begins with the Minister in question being ‘delighted to launch’, etc. Often initiatives are established as a result of the ideological disposition of the Government, of course. Sometimes these policies have been ‘pet projects’ of individual Ministers. But other times they have been in process long before the Minister came into office.

Minimum unit pricing (MUP) for alcohol has been talked about for many years. An RCPI policy group on alcohol was established in 2012. One of the

recommendations made by the group was the introduction of MUP. The measure was subsequently contained in section 11 of the Public Health (Alcohol) Act 2018, which was recently commenced by the Government.

The public reaction to the move has not been the most positive, if Twitter is a barometer of these things. The measure has been labelled ‘classist’ and one that will most adversely affect the poorest in society and those struggling with addiction.

It is seen by many on social media as symptomatic of successive administrations, which have allowed a housing crisis and homelessness to spiral. Introducing the legislation during a pandemic has also been criticised.

Have the voices of public health doctors been loud enough to counter these arguments? Has the evidence of the effect of MUP in Scotland been sufficiently explained? The introduction of the measure has been welcomed by doctors’ groups, such as the RCPI and the IMO, but these voices have been somewhat peripheral in online debate.

The important role of public health doctors and other experts during the Covid-19 crisis has been rightly praised for explaining why social distancing and other measures are essential to control the spread of the virus. Such input is even more important to inform and legitimise the response to the pandemic during a time when a fragile coalition is in power. While the Government ultimately decides and is responsible for policy direction, the population’s opinion of a given administration determines how these policies are received.

When it comes to healthcare, doctors have become increasingly vocal in their role as advocates. Perhaps governments and Ministers need to recognise when it is the right time for them to stay quiet and let these voices be heard.

MINDO CARTOON

READER COMMENTS

REACTION TO DR SARAH FITZGIBBON'S COLUMN, 'GETTING OVER THE STIGMA HURDLE', 10 MAY

"Beautifully written piece from @SarahFitzWiMIN." Dr Julie Reidy, @hedgehogtweets, 12 May

"What a courageous article Sarah, I am humbled by your honesty, there’s a stigma in saying I don’t feel well, when it applies to mental health #leadership."

Maeve Hurley, @HurleyMaeve, 12 May

"@SarahFitzWiMIN nails it again!!! Love your writing. I’m in awe of how you manage work, kids, etc and still have energy to co-ordinate self reflective thoughts. Take a bow." Dr Grainne Pinaqui, @docmum, 12 May

"Such a beautiful piece of writing with a really important message by @SarahFitzWiMIN." Dr Brenda Moran, @BrenGMoran, 12 May

REACTION TO OUR NEWS FEATURE, 'COVID-19 AND THE GP IT REVOLUTION', 10 MAY

"As always, GPs see an issue and create a practical, working solution with their own expertise. In terms of IT, general practice is so far ahead of secondary care."

Claire Shanahan, @ClaireShanaha10, 10 May

REACTION TO OUR BREAKING NEWS STORY, 'IMO PUBLIC HEALTH SPECIALISTS VOTE TO ACCEPT “LANDMARK” AGREEMENT', 7 MAY

"Extremely overdue and welcome news."

Aaron, @BabyMonsterGoon, 7 May

"This is long overdue good news for public health in Ireland." Dr Sara Burke, @sburx, 7 May "Good news." Dr Niall Conroy, @NICU_doc_salone, 7 May

REACTION TO OUR NEWS STORY, 'WRC RULES AGAINST SHO SEEKING PREMIUM PAY', 19 APRIL

"This is a shameful outcome that should not be allowed stand. ED doctors work on constantly alternating rotas with shifts starting anytime from eight and to midnight and finishing anytime. This is destructive to health and personal life, but we do it as it is necessary for EDs to work. Shift premium paid for the ability to be rostered at any time 24/7 not to necessarily work 24/7. That this hospital decided their junior doctors weren't entitled to shift premium because they finished at 6am instead of 8am as the hospital decided they weren't needed is wrong. ED shift patterns are gruelling, that is why they have a premium attached. This abuse of junior doctors will drive them out of emergency medicine and out of Ireland. That this needed to be challenged is wrong. This ruling is wrong and should be reversed!" Dr Paddy Hillery, @PaddyHillery, 4 May

"So SHO emigrates and then HR dept bemoans the premium locum rates they have to pay. Treat them fairly from the start." Dr Michael Quirke, @quirkemi, 4 May

"I can't believe that doctors still do 24 hours on-call. It's bloody mediaeval." Langrishegodown, @MikadoofJapan, 4 May

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PAUL MULHOLLAND

Now is the time to fix our healthcare system

Frontline innovation shows that the Irish health service can change for the better DR

GABRIELLE COLLERAN

Read more by Dr Gabrielle

at www.mindo.ie

Colleran

Ireland started this pandemic with the longest waiting lists in Europe and the lowest number of specialist consultants in post. But Covid-19 is not to blame for these problems. In fact, the pandemic has shone a light both on the deficits in the system and on the speed and ease at which they can be overcome when consultants are given the space to implement changes.

In 2020 hospitals across Ireland were able to revolutionise the ways they care for patients.  We were able to set up new respiratory assessment units, enhance NCHD and consultant numbers, change emergency department admission pathways, and move stable patients to off-site facilities, allowing for improved patient flow. Consultants also provided in-person consultant care in local nursing homes to help with Covid and infection control, and outsourced outpatient scans and phlebotomy for vulnerable patients to decrease waiting times. Within Children’s Health Ireland innovative use of the City West facility as a “pop-up” food challenge clinic led to 474 children being seen at this collaborative, interdisciplinary clinic, some of whom had been waiting since 2017. These successes highlight the potential when the frontline is empowered and resourced.

Of course, there have been challenges that individual or even groups of hospitals cannot easily overcome, regardless of Covid. As a country, we remain short on beds and short on specialist consultants. Many of our hospitals need refurbishment and infrastructural upgrades. We

still do not have a unified electronic record system. These issues require concerted national action orchestrated by the Government in collaboration with medical staff.

While these issues cannot be solved overnight, the pandemic has shown us that where there is a will to fix and solve, there is a way to make it happen. Consultants, medical staff, and hospital management boards across the country, despite the immense pressure of the last year, have been able to effect change for patients and staff, resulting in better health outcomes and more efficient care delivery.

The question now is: Are we going to amplify this smallscale pandemic-era culture of innovation and make it work on a country-wide scale? Is Ireland’s health service to return to its pre-pandemic inefficiencies and chronic resourcing issues, or will we all move forward constructively and build a fair health service fit for a growing 21st Century population?

That any of this innovation occurred at all is a testament to the skill, character, and endurance of Ireland’s consultants. Even before the pandemic, most senior doctors shouldered a very challenging workload, and low numbers in posts and tight call rosters continue to lead to burnout.

In fact, recently published work by Prof Anne Doherty shows levels of burnout in Irish consultants at 77 per cent. This is not sustainable. As we start to think about moving on from the pandemic and dealing with a backlog of care, Government decision-makers need to decide whether they want to help meaningfully deliver for Irish patients in the long-term or simply to control Irish consultants.

Every leadership course I have ever attended has talked about the importance of the “view from the balcony”, of stepping back and taking in the broad panorama. Deci-

High time for a change

DR PAT HARROLD

“Is there any evidence that he was using drugs or had been drinking?,” the psychiatry SHO on the other end of the line asked me. I looked at the scruffy young man in front of me. There was no sign of any kind of drunkenness, but there was a faint scent of weed in the air. I doubt if he had gone a day in the last four of his 20 years without skinning up, but that was not the issue right now.

“In that case, he will have to go to the emergency department to be medically cleared,” intoned the SHO. He rang off before I could tell him the story about the hospital on the ‘busy road’. The hospital was on a fast and dangerous stretch of road, famous for crashes. Every year the emergency department, the ambulance service, the orthopaedics service were upgraded and the survivors of the crashes were afforded treatment which was second to none. Eventually some wise person asked would it not be cheaper to make the road safer.

I was reminded of this by the recent recommendation by some doctors that marijuana remains banned, as if the current system was holding back the floodgates. Maybe it should, maybe it shouldn’t, but it brings to mind Father Ted: “Down with this sort of thing.”

Years ago, when tenements were full and the country was full of depressed bachelors, every now and then well-meaning people would deplore that the common people were drinking too much. Oscar Wilde riposted with “work is the curse of the drinking classes” and Oliver St John Gogarty suggested that the reason men who slept on floors in crowded hovels drank, was to sleep.

It is now 10 years since Love/Hate graced our screens and not much has changed. Youngsters see their only chance to earn money is by working for drug dealers and crime bosses, living hectic, often short, lives. If they die or are imprisoned a worse thug promptly takes their place. The courts are backlogged and the gardaí spend an inordinate amount of resources chasing marijuana. If a youngster gets a conviction, they are stuck firmly in the circumstances that led to it, without even the hope of emigration.

sion-makers are often stuck at this level. There is value in this, of course, but there is also value in listening to those on the ground, at the frontline, where the action happens.

It is the frontline staff who deliver care, and as we have seen with Covid-19, when obstacles are removed, they can and do innovate and deliver. It is important that consultants in Ireland can speak up and act when there are deficits in care; in fact, the Medical Council mandates that we do this.

This means we should be vocal in our advocacy and, where problems exist, we should call them out. Our silence would not benefit our patients. There are some things consultants can change, but there are many other things they cannot. That is why it is important that we are truly listened to by decision-makers and given the opportunity to shape the service we deliver and experience every day, not have it dictated to us. Orders from the top are rarely effective and often work only as imagined, not in reality.

Prior to Covid-19, many thought the agility and innovation seen in response to the pandemic in our health service was an impossible feat. Now is our chance to fix our system so that we have capacity to meet the needs of our growing population.

Patients are waiting too long to be seen, and some of them will have worse outcomes as a result of the delays in access. In the words of Prof John Crown, care delayed is care denied. We don’t need to re-invent the wheel, just to copy what works in countries like Australia and New Zealand that recruit and retain well. Doctors want to work in a system that works for patients.

We must move forward bravely together, embed the changes that have worked for patients and finally work together as a team to deliver the accessible public health system that the people need and deserve.

In my working life the profile of marijuana and those who smoked it has changed. Before the Gulf War cannabis resin was imported. Some regular smokers lost motivation and probably a few IQ points, but it was not much of a psychiatric issue. After the ill-conceived Iraq invasion cannabis herb, a mutant GM crop, high in tetrahydrocannabinol without any natural modificants, became the norm. Users became psychotic, paranoid, and disturbed.

Among the many losers in all this are those with multiple scleosis, epilepsy, and terminal cancer, who could have their lives completely changed by small doses of a herb that has been used medicinally for thousands of years.

But what would happen if we legalised cannabis in Ireland? If we followed the example of the state of Colorado cannabis production would immediately become the preserve of ‘big agriculture’. Huge factory farms would spring up, growing the strongest possible product under lights, drenching it with noxious chemicals. The product would be similar to the noxious weed currently on the streets. The drug dealers would lose out, but few would gain, apart from agricultural corporations.

Willie Nelson said that it did not matter to him if cannabis was legal or not. He smoked it when it was banned and he smoked it when it was legal. Prohibition inevitably means that quality suffers. The stuff that Willie smokes is as far removed from the joints smoked daily in small-town Ireland as a fine Champagne and a bottle of home-made poteen.

The psychiatry services are deplorably underfunded. Every day I get parents coming to me asking for a referral to child and adolescent mental health services. Very few of those children will be seen at all. The lost souls who misguidedly self-medicate are treated first as criminals and second as patients.

We should, instead of pretending that the present ban works, take a cool look at a system that has failed generations. We should ask what is wrong with our way of life that so many children want to get out of their heads .

The young man went to the emergency department to be “medically cleared” as if neither I nor the SHO were not practising doctors. After a few hours he left. Nobody had ever showed him how to sit in a room quietly by himself. Nobody in all his years at school had talked about drugs and their dangers, or mental health or exercise that was not a team sport. Nobody asked why he had such a need to blot it all out and what he was running from.

Blame the drug: Alcohol, coke, weed, rock’n’roll, whatever you like. It’s easier.

Instead of pretending that the present drug policy works, we should take a cool look at a system that has failed generations

Read more by Dr Pat Harrold at www.mindo.ie @drpatharrold_

Youngsters see their only chance to earn money is by working for drug dealers and crime bosses, living hectic, often short, lives

The 1st polypill licensed for secondary prevention of cardiovascular events in Ireland

Thanks to you...

Aspirin Atorvastatin Ramipril

6 Available Formulations

Reduce pill burden by 730 pills per year*

Capsules shown are not actual size. Capsules are Size 0. Please refer to SmPC before prescribing.

*The calculation of a reduction of 730 pills per year is based on a patient taking the three individual components of Trinomia (aspirin, atorvastatin, ramipril) on a daily basis for 365 days compared to a patient taking a Trinomia capsule once daily for 365 days.

Trinomia 100 mg/20 mg/10 mg, 100 mg/20 mg/5 mg, 100 mg/20 mg/2.5 mg hard capsules (acetylsalicylic acid, atorvastatin (as atorvastatin calcium trihydrate) and ramipril) and Trinomia 100 mg/40 mg/10 mg, 100 mg/40 mg/5 mg, 100 mg/40 mg/2.5 mg hard capsules (acetylsalicylic acid, atorvastatin (as atorvastatin calcium trihydrate) and ramipril) Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Hard capsules containing: two 50 mg acetylsalicylic film-coated tablets, two 10 mg atorvastatin film-coated tablets and one 10 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic filmcoated tablet, two 10 mg atorvastatin film-coated tablets and one 5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 10 mg atorvastatin film-coated tablets and one 2.5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablets, two 20 mg atorvastatin film-coated tablets and one 10 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 20 mg atorvastatin film-coated tablets and one 5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 20 mg atorvastatin film-coated tablets and one 2.5 mg ramipril film-coated tablet. Uses: Secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses Dosage: Oral administration. 1 capsule per day, preferably after a meal. Swallow with liquid. Do not chew or crush. Avoid grapefruit juice. Patients currently controlled with equivalent therapeutic doses of acetylsalicylic acid, atorvastatin and ramipril can be directly switched. Treatment initiation should take place under medical supervision. Cardiovascular prevention, target maintenance dose of Ramipril is 10 mg once daily. Daily dose in renal impairment based on creatinine clearance - ≥ 60 ml/min, maximum daily dose is 10 mg ramipril; 30-60 ml/min, maximum daily dose is 5 mg ramipril. Contraindicated in hemodialysis and/or with severe renal impairment (creatinine clearance <30 ml/min). Administer with caution with hepatic impairment. Perform liver function tests before initiation of treatment and periodically thereafter. Maximum daily dose is 2.5 mg ramipril and initiate treatment under close medical supervision. Contraindicated in severe or active hepatic impairment. Start treatment in very old and frail patients with caution. In patients taking elbasvir/grazoprevir concomitantly with atorvastatin, the dose of atorvastatin should not exceed 20 mg/day. Contraindications: Hypersensitivity to any component, to other salicylates, to NSAIDs, to any other ACE inhibitors, tartrazine, soya or peanut. History of previous asthma attacks or other allergic reactions to salicylic acid or other NSAIDs. Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, other kinds of bleeding. Haemophilia and other bleeding disorders. Severe kidney and liver impairment. Hemodialysis. Severe heart failure. Concomitant treatment with methotrexate at a dosage of 15 mg or more per week. Concomitant use with aliskiren-containing products with diabetes mellitus or renal impairment. Nasal polyps associated with ashma induced or exacerbated by acetylsalicylic acid. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy, lactation and in women of child-bearing potential not using appropriate contraceptive measures. Concomitant treatment with tipranavir, ritonavir, ciclosporin, glecaprevir/pibrentasvir,sacubitril/valsartan therapy. Trinomia must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. History of angioedema. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. Hypotensive or haemodynamically unstable states. Children and adolescents below 18 years of age. Warnings and Precautions: Only for use as a substitution therapy in patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses. Special populations requiring particularly careful medical supervision: Hypersensitivity to other analgesics/antiinflammatory/antipyretic/antirheumatics or other allergens. Other known allergies, bronchial asthma, hay fever, swollen nasal mucous membranes and other chronic respiratory diseases. History of gastric or enteric ulcers, or of gastrointestinal bleeding. Reduced liver and/or renal function. Particular risk of hypotension: strongly activated renin-angiotensin-aldosterone system, transient or persistent heart failure post MI, risk of cardiac or cerebral ischemia, in case of acute hypotension medical supervision including blood pressure monitoring is necessary. Deterioration of cardiovascular circulation. Glucose 6 phosphate dehydrogenase deficiency. Risk of elevated levels of uric acid. Consumption of substantial quantities of alcohol and/or have a history of liver disease. Diagnosed pregnancy, stop treatment immediately, and, if appropriate, start alternative therapy. ACE inhibitors cause higher rate of angioedema in black patients than in non-black patients. The blood pressure lowering effect of ACE inhibitors is somewhat less in black patients than non-black patients. Monitoring during treatment is required for: Concomitant treatment with NSAIDs, corticosteroids, SSRIs, antiplatelet drugs, anticoagulants, ibuprofen. Signs or symptoms suggestive of liver injury. Stop treatment temporarily prior to elective major surgery and when any major medical or surgical condition occurs. Particularly careful monitoring is required in patients with renal impairment, risk of impairment of renal function, particularly with congestive heart failure or after a renal transplant. Serum potassium: ACE inhibitors can cause hyperkalemia in patients with impaired renal function and/or in patients taking potassium supplements (including salt substitutes), potassium-sparing diuretics, trimethoprim or co-trimoxazole and especially aldosterone antagonists or angiotensin-receptor blockers, hyperkalemia can occur. Potassium-sparing diuretics and angiotensin-receptor blockers should be used with caution in patients receiving ACE inhibitors, and serum potassium and renal function should be monitored. Other situations that may increase the risk of hyperkalaemia are: age >70 years, uncontrolled diabetes mellitus, dehydration, acute cardiac decompensation or metabolic acidosis.Specific side-effects: Perform liver function tests before use and monitor periodically and with liver injury or increased transaminase levels. Use with caution with substantial alcohol use or history of liver disease. Potential risk of hemorrhagic stroke. May affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, ask patients to promptly report skeletal muscle effects (muscle pains, cramps or weakness) especially if accompanied by malasie or fever and measure CK levels, stop treatment if significantly elevated or if severe muscular symptoms occur. Prescribe with caution in patients with pre-disposing factors for rhabdomyolysis. Benefit/risk of treatment should be considered and clinical monitoring recommended. Do not measure CK following strenuous exercise or in presence of plausible alternative cause of CK increase. If CK levels significantly elevated at baseline, re-measure levels 5 to 7 days later to confirm the results. Risk of rhabdomyolsis with use of potent CYP3A4 inhibitors, transport proteins or HIV protease inhibitors. Consider alternative treatments if risk of myopathy. Consider lower starting or maximum dose and appropriate clinical monitoring with potent CYP3A4 inhibitors and medicinal products that increase the plasma concentration of atorvastatin respectively. The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, antivirals for the treatment of hepatitis C (HCV) (boceprevir, telaprevir, elvasvir/grazoprevir), erythromycin, niacin or ezetimibe. Do not co-administer with systemic fusidic acid or within 7 days of stopping fusidic acid. Where use of systemic fusidic acid considered essential, discontinue statin treatment during fusidic acid treatment. Reports of rhabdomyolysis in patients receiving fusidic acid and statins in combination. Where prolonged systemic fusidic acid needed, consider need for co-administration of Trinomia and fusidic acid on case by case basis with close medical supervision. Discontinue statin treatment if interstitial lung disease occurs. Monitor patients at risk of diabetes mellitus. Discontinue treatment if angioedema occurs and initiate emergency treatment promptly. Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated. due to the increased risk of angioedema. Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of Trimomia. Caution should be used when starting racecadotril, mTOR inhibitors and vildagliptin in a patient already taking an ACE inhibitor as there is an increased risk of angioedema. Concomitant use of ACE-inhibitors and angiotensin II receptor blockers or aliskiren is not recommended and should not be used in patients with diabetic nephropathy. Anaphylactic reactions during desensitization, consider temporary discontinuation of Trinomia during desensitization. Monitor white blood cells for neutropenia/agranulocytosis and more regularly in the initial phase of treatment, impaired renal function, concomitant collagen disease and other medicines that can change the blood picture. Cough. Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Acetylsalicylic acid: other platelet aggregation inhibitors, other NSAIDs, and antirheumatics, systemic glucocorticoids, diuretics, alcohol, SSRIs, uricosuric agents, metamizole, anticoagulant and thrombolytic therapy, digoxin, antidiabetic agents including insulin, methotrexate, valproic acid, antacids, ACE inhibitors, ciclosporin, vancomycin, interferon , lithium, barbiturates, zidovudine, phenytoin, laboratory tests. Atorvastatin: CYP3A4 inhibitors, CYP3A4 inducers, transport protein inhibitors, gemfibrozil/fibric acid derivatives, ezetimibe, colestipol, fusidic acid, colchicine, digoxin, oral contraceptives, warfarin. Ramipril: potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances, antihypertensive agents and other substances that may decrease blood pressure, vasopressor sympathomimetics and other substances, allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count, lithium salts, antidiabetic agents including insulin. Monitor as appropriate. Consider lower maximum dose of atorvastatin with potent CYP3A4 inhibitors. Pregnancy and Lactation: Contraindicated in pregnancy and breast-feeding. Women of child-bearing potential should use effective contraception during treatment. Side Effects: Ramipril: Common (≥1/100, <1/10): dyspepsia, nausea, diarrhoea, vomiting, digestive disturbances, abdominal discomfort, gastrointestinal inflammation, non-productive tickling cough, bronchitis, sinusitis, dyspnoea, headache, dizziness, rash in particular maculo-papular, blood potassium increased, myalgia, muscle spasms, chest pain, fatigue, hypotension, orthostatic blood pressure decreased, syncope. Atorvastatin: Common: dyspepsia, nausea, diarrhoea, constipation, flatulence, pharyngolaryngeal pain, epistaxis, nasopharyngitis, headache, allergic reactions, hyperglycaemia, myalgia, muscle spasms, pain in extremity, joint swelling, back pain, arthralgia, liver function test abnormal, blood creatine kinase increased. ASA: Very Common (≥ 1/10): Gastrointestinal complaints such as heartburn, nausea, vomiting, stomach ache and diarrhea, minor blood loss from the gastrointestinal tract (micro-bleeding). Common: Paroxysmal bronchospasm, serious dyspnoea, rhinitis, nasal congestion. For less frequent side effects see SmPC. Pack Sizes: Blister containing 28 hard capsules. Legal Category: POM. Product Authorisation Numbers: PA 1744/002/001-006 Product Authorisation

DR LUCIA GANNON

Teaching new dogs old tricks

Leaving my GP training scheme role has prompted me to reflect on education in general practice

“Education is an admirable thing, but it is well to remember from time to time that nothing worth knowing can be taught.”

Oscar

When I first started teaching GP registrars

17 years ago, I used to ask GPs at the end of their career how they had learned their craft. I doubted my ability to teach and wanted to compile a list of tips and tricks. One wise man asked me if I had ever seen anyone teach a hen to lay eggs. “You can teach medicine,” he said, “but you can’t teach anyone how to be a GP. You either have it, or you don’t.” Now, as my role as Assistant Programme Director (APD) in the south-east GP training scheme comes to an end, I am grateful to this man for being honest and forthright. His words have helped me to stay curious and humble, and offer encouragement and support when I feared that my teaching was not effective.

In 2018, the transfer of the GP training schemes from the HSE to the ICGP began. This process is near completion. Many long-term programme directors (PDs) and APDs have chosen to retire, creating opportunities for new teachers. My decision to retire was not taken lightly, as it means an end to an important part of my life’s work. Reflecting on this work, I know that I have not taught any medicine beyond what is contained in textbooks, guidelines, and journals. I have not created new knowledge or published any cutting-edge re-

MULTIPLE CHOICE QUESTIONS

search (or any research at all for that matter) and I have no evidence of the effectiveness of my endeavours. Do I, and others like me, make a difference? Do we teach doctors to become GPs?

My imminent departure has created a sense of urgency to impart every piece of my hard-earned wisdom to the groups that I facilitate on Zoom every Wednesday. I imagine that when I leave, I will remember all the things I should have said; crumbs to guide these young doctors through the forest. But then, I remind myself that the birds ate the crumbs and Hansel and Gretel had to find their own way in the end. General practice is a forest that is growing denser year by year. While general surgeons and physicians have been replaced by urologists, breast and vascular surgeons, respiratory physicians, old age consultants, and many other specialists, the GP is still the general practitioner with responsibility for all diseases, treatments, and drugs, alongside certification, vaccination, contraception, screening, and every opportunistic intervention imaginable, for all the patients on their list.

The curriculum for general practice is endless and perhaps this is why my friend said it could not be taught. But I suspect his words held more profound meaning. As I prepare to leave, I have noticed how often I see, hear or read something that I mentally file as “useful for teaching”. I have incorporated much of my own learning, reading, and life experiences into the teaching modules that line my bookshelves. As I begin to cull these modules, I remember the hours of thinking and preparation that went into each one

and the many times I shared them with registrars. Workshops on communication skills, “finding flow,” “character strengths”, “positive identity”, “art observation and medicine”, effective listening, and others that would be unlikely to be included in a medical curriculum. I recall how each teaching session was different, depending on the group, how well they participated and how curious they were about the subject. Each workshop was tweaked every time it was shared, depending on what worked well and what did not. But most of all, I remembered how discussions such as these only worked in a group that felt safe, valued, and respected, and how they helped us feel part of a profession that was as rewarding as it was challenging.

I always thought of these Wednesday meetings as a cauldron, where week after week, ingredients were added and, little by little, doctors became GPs. I will miss being an ingredient in the mix, where, from time to time, magic happened – though I have no evidence of this. The pandemic meant a swift segue to online teaching. As a facilitator, I did not feel as safe and connected as previously and some of the magic disappeared.

But it is time to move on. There is now an empty space on my bookshelves that mirrors the space I feel within myself, that, for the moment, I am reluctant to fill. I am grateful to have been part of this community of GP teachers and registrars. I have learned a lot and had many laughs, even if I am still wondering if I managed to impart “anything worth knowing”.

Wishing all retired and soon-to-be GP teachers every best wish for the future.

In roseola infantum

A. Cause is human parvovirus.

B. Rash is preceded by upper respiratory tract symptoms.

C. Two-to-five-year-olds are typically affected.

D. As fever ends, a morbilliform rash appears.

E. Erythematous papules on the soft palate and uvula are observed in the majority of cases.

Question 2

Tinnitus

A. Of moderate severity affects about 8 per cent of adults.

B. Is more likely to occur in patients who have been exposed to noise over a long period of time.

C. Never has a serious cause.

D. May be helped by correcting any associated hearing loss.

E. Symptoms may be alleviated by improving the ambient sound.

Question 3

Recognised symptoms of acute hyperventilation include

A. Paraesthesia of fingers.

B. Tremor.

C. ‘Air hunger’ or suffocation.

D. Chest pain.

E. Feelings of unreality.

Question 4

Lateral epicondylitis (tennis elbow)

A. Is thought to result from overuse of the extensor carpi radialis brevis.

B. Will have no effect on the range of movements at the elbow.

C. Pain may occur when gripping small objects, eg, a pen.

D. Mainstay of treatment is eccentric (lengthening only) exercises.

E. Cortisone injections may be beneficial in the short-term (six weeks).

Question 5

Carcinoma of the stomach

A. Is commoner in patients with pernicious anaemia.

B. Predominant tumour type is lymphoma.

C. Most common presentation is ‘recent dyspepsia’ in over 40-year-olds.

D. May cause supraclavicular lymph node enlargement.

E. Average five-year survival rate if diagnosed and treated before it has spread outside the stomach is nearly 70 per cent.

E. TRUE. But only 30 per cent if has already spread.

D. TRUE. Troisier sign.

C. TRUE. Though less than 2 per cent of patients with dyspepsia have carcinoma.

B. FALSE. 95 per cent are adenocarcinomas.

A. TRUE. Or previous partial gastrectomy.

ANSWER 5

E. TRUE. But harmful in the longer term (more than three months), so should be avoided in most people.

D. TRUE. And addressing any exacerbating factor.

C. TRUE. Or when twisting the forearm or fully extending the arm.

B. TRUE. The elbow joint itself is not affected.

A. TRUE. And the extensor digitorum communis.

ANSWER 4

E. TRUE. Important to reassure and explain why symptoms occurring. Rebreathing from a paper bag is widely prescribed.

D. TRUE. Palpitations, sickness, faintness, dizziness.

B. TRUE. As with other symptoms, is from hypocapnia from fast rate and increased depth of breathing.

A. TRUE. Or mouth. Initiated by anxiety, panic.

ANSWER 3

E. TRUE. Eg, play low levels of easy-listening music at bedtime.

D. TRUE. Brain, then doesn’t pay as much attention to the tinnitus.

C. FALSE. If sudden onset, unilateral or associated with unilateral deafness, think of acoustic neuroma.

B. TRUE. Also if infections in childhood, previous ear surgery.

A. TRUE. Interferes with getting to sleep.

ANSWER 2

E. TRUE. Known as Nagayama spots.

C, for three-tofive days, then rash for one-to-two days.

D. TRUE. Fever, up to 40 degrees

C. FALSE. Under 18 months in most cases.

symptoms.

B. FALSE. No

C. TRUE. And shortness of breath or wheezing.

Wilde

In the management of type 2 diabetes

THE POWER TO ACCOMPLISH MORE

Multiple benefits * Proven protection

JARDIANCE is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise 1 - as monotherapy when metformin is considered inappropriate due to intolerance

- in addition to other medicinal products for the treatment of diabetes

The most prescribed SGLT2i in Ireland

* In addition to glucose lowering, JARDIANCE demonstrated reduction in weight and blood pressure vs placebo; JARDIANCE is not indicated for weight loss or reduction of blood pressure.1

† EMPA-REG OUTCOME® was a randomised, double-blind, placebo-controlled cardiovascular outcomes trial. Patients were randomised to receive either JARDIANCE 10 mg once daily, JARDIANCE 25 mg once daily or placebo, on top of standard of care. Primary endpoint was 3-point MACE: Time to first occurrence of cardiovascular death, non-fatal MI, non-fatal stroke. 14% relative risk reduction for combined endpoint of cardiovascular death, non-fatal MI, or non-fatal stroke (ARR 1.6%). 2

References

1. JARDIANCE (empagliflozin) Summary of Product Characteristics 2019. Available at: http://www.medicines.ie/medicine/16081/SPC/Jardiance+10+mg+and+25+mg+Film-Coated+Tablets

2. Zinman B, Wanner C, Lachin JM et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373:2117-2128. (& Supplementary Appendix)

3. Data on File. Boehringer Ingelheim

Prescribing Information (Ireland) JARDIANCE® (empagliflozin)

Film-coated tablets containing 10 mg or 25 mg empagliflozin. Indication: Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance; in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, refer to the Summary of Product Characteristics. Dose and Administration: The recommended starting dose is 10 mg once daily. In patients tolerating empagliflozin 10 mg once daily who have eGFR ≥ 60 ml/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg. When used with sulphonylurea or insulin a lower dose of these may be considered to reduce the risk of hypoglycaemia. Renal impairment: The glycaemic efficacy is dependent on renal function. No dose adjustment is required for patients with an eGFR ≥60 ml/min/1.73 m2 or CrCl ≥60 ml/min. Do not initiate in patients with an eGFR <60 ml/min/1.73 m2 or CrCl <60 ml/min. In patients tolerating empagliflozin whose eGFR falls persistently below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily. Discontinue when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min. Not for use in patients with end stage renal disease (ESRD) or on dialysis. Hepatic impairment: No dose adjustment is required for patients with hepatic impairment. Not recommended in severe hepatic impairment. Elderly patients: No dose adjustment is recommended based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account. Not recommended in patients 85 years or older. Paediatric population: No data are available. Method of administration: The tablets can be taken with or without food, swallowed whole with water. If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including empagliflozin. Consider the risk of DKA in the event of nonspecific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness and assess patients for ketoacidosis immediately, regardless of blood glucose level. In patients where DKA is suspected or diagnosed, treatment should be discontinued immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with empagliflozin may be restarted when the ketone values are normal and the patient’s

condition has stabilised. Before initiating empagliflozin, consider factors in the patient history that may predispose to ketoacidosis. Use with caution in patients who may be at higher risk of DKA. Jardiance should not be used for treatment of patients with type 1 diabetes. Renal impairment: See under Dose and Administration; Monitor renal function prior to initiation and at least annually. Cases of hepatic injury have been reported with empagliflozin in clinical trials. A causal relationship between empagliflozin and hepatic injury has not been established. Haematocrit increase was observed with empagliflozin treatment. Osmotic diuresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure. Therefore, caution should be exercised in patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75  years and older. In case of conditions that may lead to fluid loss (e.g. gastrointestinal illness), careful monitoring of volume status and electrolytes is recommended. Temporary interruption of treatment with empagliflozin should be considered until the fluid loss is corrected. Elderly: See under Dose and Administration; special attention should be given to volume intake of elderly patients in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE-inhibitors). Temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections. Cases of necrotising fasciitis of the perineum (Fournier’s gangrene), have been reported in patients taking SGLT2 inhibitors. This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment. Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis. If Fournier’s gangrene is suspected, Jardiance should be discontinued and prompt treatment should be instituted. An increase in cases of lower limb amputation (primarily of the toe) has been observed in long-term clinical studies with another SGLT2 inhibitor, counsel patients on routine preventative footcare. Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with empagliflozin in NYHA class III-IV. Due to its mechanism of action, patients taking Jardiance will test positive for glucose in their urine. The tablets contain lactose and should not be used in patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Interactions: Use with diuretics may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues may increase the risk of hypoglycaemia therefore, a lower dose of insulin or an insulin secretagogue may be required. The effect of UGT induction (e.g. induction by rifampicin or phenytoin) on empagliflozin has not been studied. Co-treatment with known inducers of UGT enzymes is not recommended due to a potential risk of

decreased efficacy. If an inducer of these UGT enzymes must be co-administered, monitoring of glycaemic control to assess response to Jardiance is appropriate. Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by coadministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide. Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives. Fertility, pregnancy and lactation: There are no data from the use of empagliflozin in pregnant women. As a precautionary measure, it is preferable to avoid the use of Jardiance during pregnancy. No data in humans are available on excretion of empagliflozin into milk. Jardiance should not be used during breast-feeding. No studies on the effect on human fertility have been conducted for Jardiance. Undesirable effects: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data). Very common: hypoglycaemia (when used with sulphonylurea or insulin). Common: vaginal moniliasis, vulvovaginitis, balanitis and other genital infections, urinary tract infection (including pyelonephritis and urosepsis), thirst, pruritus (generalised), rash, increased urination, serum lipids increased. Uncommon: urticaria, volume depletion, dysuria, blood creatinine increased/glomerular filtration rate decreased, haematocrit increased. Rare: DKA. Not known: necrotising fasciitis of the perineum (Fournier’s gangrene), angioedema. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 10 mg; 28 tablets, 25 mg: 28 tablets. Legal category: POM. MA numbers: 10 mg/28 tablets EU/1/14/930/013; 25 mg/28 tablets

EU/1/14/930/004. Marketing Authorisation

Holder: Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Crescent Building, Northwood, Santry, Dublin 9. Prepared in October 2020

Adverse events should be reported. Reporting forms and information can be found at https://www.hpra.ie/homepage/about-us/report-anissue. Adverse events should also be reported to Boehringer-Ingelheim

Drug Safety on 01 2913960, Fax: +44 1344 742661, or by e-mail: PV_local_UK_Ireland@boehringer-ingelheim.com

Unlocking the secrets of longevity and disease tolerance

Attendees at UCD’s Charles Institute Seminar Series heard a presentation by Prof Emma Teeling on how the unique physiology of bats is being investigated to potentially help humans to live longer and healthier

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

Attendees heard a presentation from Prof Emma Teeling, an international expert in the cross-cutting fields of comparative genomics and mammalian phylogenetics. Prof Teeling has a special interest in bat biology and is founder of the UCD Laboratory of Molecular Evolution and Mammalian Phylogenics, as well as Founding Director of the genome consortium Bat1K and Head of Zoology at UCD. Much of the focus of Prof Teeling’s integrative research work with her colleagues is on mammalian adaptations, particularly extended life span and viral tolerance.

Describing bats as “the most fascinating of all the mammals,” Prof Teeling told the seminar that bats have gotten a “bad press”, particularly as some have suggested a potential link between bats and Covid-19. She also outlined bats’ anti-ageing mechanism and unique immunity and explained that studying bats can help to promote healthy ageing in humans and protect against infectious diseases in the context of the worldwide ageing population.

Immune system

One-in-five living mammals on earth are bats and there are more than 1,400 species, Prof Teeling explained. “Bats seem to be able to tolerate many pathogens and viruses that are typically lethal to other mammals,” she said. “They have a unique immune system that allows them to live with [a wide range of] pathogens, rather than die from them.” Much of Prof Teeling’s research is focused on the Myotis myotis, or the greater-mouse-eared bat , which is one of the longest-living bat species. “I wanted to study bats in a different way and create an alternative model system that would allow us to uncover the molecular pathways that underlie extraordinary ageing and disease tolerance in mammals,” she said.

In common with naked mole rats, bats’ extended longevity provides an advantage over other laboratory models and “bucks the trend” of the smallest mammals having shorter life spans than their larger counterparts, she added.

Among other aspects, Prof Teeling and her colleagues looked at the gene expression profile of different tissues in bats compared to other mammals. “There was a differential expression of genes involved in DNA repair mechanisms in bats when compared with other mammals,” she told the seminar. “There was no relationship between telomere length and age in the longest-lived bats [Myotis species] and this is not as a result of telomerase expression, because we could not find any such expression. Also, genomic and transcriptomic analyses implicated an enhanced DNA repair in the evolution of exceptional longevity in Myotis bats. Potentially, there is alternative telomere lengthening

as a maintenance mechanism and we are taking that [hypothesis] into the laboratory right now to try to validate it.”

Prof Teeling also looked at the damage that was induced in bats due to oxidative stress. “We found absolutely no evidence of a higher level of oxidative damage in bats as they age, despite their high metabolic rate and high production of free radicals. This means that bats have potentially evolved a mechanism to repair or remove this damage,” she postulated.

In addition, between young, middle-aged and older bats, there was no change in their microbiome and they are able to tolerate highly pathogenic bacteria, exhibiting a form of homeostasis as they age. Prof Teeling and her team sequenced the entire blood transcriptome to see which genes are up- or down-regulated. “What we found was extraordinary,” she told the attendees. “Bats actually increase the maintenance of their DNA as they age. Mice do not do this… mice show a huge increase in their inflammatory transcripts as they age, which is not seen in bats.”

“We found that bats show a similar expression with age of genes that are already known to extend the life span of model organisms,” she continued. “If you want to extend the life span of lab mice, you knock-in a second copy of PTEN, but bats have naturally such a gene expression profile. This means that we can uncover the mechanisms that bats have evolved in order to slow-down ageing. We found 23 genes that showed a completely different expression with age in bats compared to other mammals, and these genes are typically not implicated with ageing pathways directly — these are the targets that we need to work on. However, we also found a number of microRNAs which bats have, where we do have homologues in humans, that can potentially regulate these anti-longevity mechanisms, and these need to be our targets moving forward.”

Prof Teeling provided a brief overview of a range of other research she and her colleagues conducted in an effort to uncover the mysteries of bats’ extraordinary longevity and pathogen resistance, one of which was qPCR assessment for inflammatory and anti-inflammatory cytokines. “At the beginning of a simulated infection, there is a very aggressive antiviral response, but they dampen that very quickly with an equally aggressive anti-inflammatory response,” she told the seminar. “It has been argued that when patients go into hospital, they test the inflammatory-to-anti-inflammatory cytokine signature in an individual and if they have a higher ratio of anti-inflammatory to inflammatory cytokines, they typically have a better outcome. So, bats seem to have evolved a unique immune response that allows them to tolerate pathogens. This could explain why they can be reservoirs for so many zoonotic diseases — when you look at their immune response, their antiviral mechanisms are switched on all of the time and potentially, this is a selective factor that causes the viruses to be compelled to evolve and make them much better at

jumping between species.” Prof Teeling also that bats are missing the entire family of genes that make inflammasomes, combined with an expansion of the APOBEC antiviral gene family, compared to other mammals.

Sterile inflammation

In terms of why bats have these unique antiviral and longevity mechanisms, she hypothesised : “The theory is that flight is very costly metabolically. Bats are constantly suffering from sterile inflammation. This has necessitated an adaptation of their immune system to help them dampen that constant sterile inflammation and evolve mechanisms to deal with it. This has resulted in unexpected longevity, because inflammation drives ageing, as well as diseases like cancer… this means that there is also a unique tolerance to pathogens — they potentially deal with pathogens in the same way that they deal with the constant sterile inflammation, so they have had to evolve anti-inflammatory mechanisms, as well as DNA repair mechanisms.”

Prof Teeling summarised: “Studying bats in the way we do allows us to uncover the basis of how mammals can age more healthily. Also, we are now trying to uncover how we can live with infectious diseases by looking at how bats have evolved to allow them to switch on antiviral mechanisms and then switch them off just in time to prevent them becoming ill due to different pathogens. This is something we can learn from — it’s not a vaccine, but could be a way to treat people who are sick due to infectious diseases.”

Fecundity

During a Q&A session that saw a great deal of interest and clinical curiosity among the attendees, Prof Tobin noted that there are many areas of interest in Prof Teeling’s work that would appeal to researchers in other specialties of mammalian biology and asked: “Over 40 years, for example, would you see [in bats] the typical mammalian changes, such as reduced fecundity, or menopause — do you see any other changes in some organs in terms of their proclivity to show that the first signs of ageing, e.g., in the heart, for instance, where one may expect that it would be one of the first organs to become ‘worn out’. So, do they exhibit any of those other similar features [of ageing], such as sex steroid changes or different organs failing at different rates?”

Prof Teeling responded: “We don’t have access to that physiological data yet… typically, in the long term studies, the bats are not killed as they are protected species. We are now starting to work more with zoos — fruit bats do very well in zoos, because they eat fruit and they mate, hence we are able to feed them readily and the population can gorw,” she continued. “We are now working with Copenhagen Zoo, whereby we may be able to access to data like that. While we don’t have the physiological data, the ecological data shows that they exhibit no reduction in their fecundity and there is no menopause,” said Prof Teeling. “The longest-lived females keep having babies into their oldest ages…

“When you catch them, it’s very difficult to age them because there are no obvious outward signs of their age; a two-year-old can have broken teeth if they have eaten the wrong thing, for example. However, with collaborators have done a methylation study. There is potentially a methylation clock [in the bats], so we may be able to age bats that way but when you look at the overall epigenomic changes, you find that in the longest-living bats, their ‘clock’ ticks at a much slower rate, so this is something that we are also working on. But those questions are really important and we need to think now about how we can address them.”

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

Prof Emma Teeling

Picture: Olivier Farcy

DRY & ROUGH SKIN UNDER CONTROL, FROM HEAD TO TOE

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(three 100 mg/40 mg tablets), taken orally, once daily at the same time with food. Treatment

Duration: Patients without prior HCV therapy (GT 1, 2, 3, 4, 5, 6): No cirrhosis: 8 weeks.

Cirrhosis: 8 weeks. Patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin: GT 1, 2, 4-6: No cirrhosis: 8 weeks. Cirrhosis: 12 weeks. GT 3: No cirrhosis: 16 weeks. Cirrhosis: 16 weeks. Special Populations: HIV-1 Co-infection: Follow the dosing recommendations as above. For dosing recommendations with HIV antiviral agents, refer to SmPC for additional information. Elderly: No dose adjustment required. Renal impairment: No dose adjustment required. Hepatic impairment: No dose adjustment recommended in patients with mild hepatic impairment (Child-Pugh A). Maviret is not recommended in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Liver or kidney transplant patients: 12 weeks in liver or kidney transplant recipients with or without cirrhosis, with 16 week treatment duration to be considered for GT 3-infected patients who are treatment experienced with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin. Paediatric Population: No dose adjustment required in adolescents aged 12 to <18 years. The safety and efficacy of Maviret in children aged less than 12 years have not yet been established. Diabetic Patients: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating

College Green SuffolkStreet

phenobarbital, phenytoin, and primidone). SPECIAL WARNINGS AND PRECAUTIONS: Hepatitis B Virus reactivation: HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines. Hepatic impairment: Maviret is not recommended in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor: GT 1-infected (and a very limited number of GT 4-infected) patients with prior failure on regimens that may confer resistance to glecaprevir/pibrentasvir were studied in the MAGELLAN-1 study. The risk of failure was, as expected, highest for those exposed to both classes. A resistance algorithm predictive of the risk for failure by baseline resistance has not been established. Accumulating double class resistance was a general finding for patients who failed re-treatment with glecaprevir/pibrentasvir in MAGELLAN-1. No re-treatment data is available for patients infected with GT 2, 3, 5 or 6. Maviret is not recommended for the re-treatment of patients with prior exposure to NS3/4A- and/or NS5A-inhibitors. Lactose: Maviret contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. INTERACTIONS:

Dabigatran etexilate, carbamazepine, phenytoin, phenobarbital, primidone, rifampicin, ethinyloestradiolcontaining products, St. John’s wort, darunavir, efavirenz, lopinavir/ digoxin, pravastatin, Digoxin, Monitor INR with Losartan, valsartan, sofosbuvir, raltegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, levonorgestrel, norethidrone or norgestimate as contraceptive progestogen. FERTILITY, PREGNANCY AND LACTATION: Maviret is not recommended in pregnancy. It is not known whether Maviret and its metabolites are excreted in breast milk. No human data on the effect of glecaprevir and/or pibrentasvir on fertility are available. SIDE EFFECTS: See SmPC for full details. Very common side effects (≥1/10): headache, fatigue. Common side effects (≥1/100 to <1/10): diarrhoea, nausea, asthenia. Frequency not known (cannot be estimated from the available data): pruritus. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie. Suspected adverse events should also be reported to AbbVie Limited on 01-4287900.

LEGAL CATEGORY: POM(S1A) MARKETING AUTHORISATION NUMBER/PRESENTATIONS: EU/1/17/1213/001 – blister packs containing 84 (4 x 21) film-coated tablets. MARKETING

AUTHORISATION HOLDER: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany. Further information is available from AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. DATE OF REVISION: January 2020. PI/1213/008.

Hep C: Latest treatment guideline updates

An outline of the latest national and international guidelines on the diagnosis and management of HCV

Hepatitis C virus (HCV) is a major cause of chronic liver disease worldwide, with approximately 71 million people chronically infected worldwide, leading to 400,000 deaths annually due to cirrhosis complications and liver cancer (hepatocellular carcinoma).

In Ireland, the Health Protection and Surveillance Centre (HPSC) estimates that between 20,000 and 30,000 people are infected with hepatitis C, and of those, approximately 10,000 have been diagnosed, though this figure is disputed by some of the hepatology clinical community.

In 2016, the World Health Organisation (WHO) adopted the first Global Health Sector Strategy on Viral Hepatitis, calling for its elimination as a public health threat. The strategy presented a target for 2030 – of reducing new HCV infections by 80 per cent and mortality by 65 per cent. All WHO Member States, including Ireland, have approved this strategy.

One of the major difficulties in eradicating HCV is that significant numbers of patients are unaware of their infection and remain undiagnosed.

Thus key to the eradication goal is actively seeking out undiagnosed HCV cases; healthcare providers should screen individuals with risk factors, and providing free, widely available access to direct acting antivirals (DAAs), which can cure more than 95 per cent of cases and dramatically reduce long-term complications, like liver failure and hepatocellular carcinoma, with minimal side-effects.

In June 2019, the European Association for the Study of the Liver (EASL) published the EASL Policy Statement on Hepatitis Elimination. In so doing, EASL called on all European countries to implement a six-step action plan based on the WHO’s 2030 elimination targets, to develop a national strategy to increase public awareness, provide robust education to care providers at all levels, offer testing, and provide links to care.

At the end of 2019, EASL and three other health associations also joined forces in a call-to-action initiative: Calling to simplify HCV testing and access to treatment, integrating them with primary care and other disease programmes.

The call-to-action document outlines four clinical strategies that liver disease associations and their constituents can use in their continuing HCV elimination efforts, including simplifying diagnostic and treatment algorithms, integrating HCV treatment with primary care and other disease programmes, decentralising HCV services to local level care and task-sharing care with primary care clinicians and other healthcare practitioners.

The call-to-action also highlights the efficacy of existing screening and treatments, including accurate rapid HCV antibody screening and confirmatory viral load testing that can be accomplished in a single clinical visit and pan-genotypic DAAs that are available in fixed dose combinations.

In 2018, EASL first published comprehensive clinical practice guidelines, EASL Recommendations: Treatment of Hepatitis C, to assist physicians and other healthcare providers, as well as patients and other interested individuals, in the clinical decision-making process, by describing the current optimal management of patients with acute and chronic HCV infections.

These recommendations were updated in September 2020 (final update of the series), and can be summarised as follows:

What is new in this final version of the EASL recommendations?

First of all, there are clear recommendations for the diagnosis of the infection, as well as for screening in order to link-to-care as many infected subjects as possible.

Classically, the diagnosis of the HCV infection is based on the detection of anti-HCV antibodies followed by confirmation of the presence of the virus by a molecular, generally polymerase chain reaction (PCR)-based, technique. HCV core antigen testing can be used as an alternative to RNA testing by PCR. For screening, the classical serum or plasma ELISA can be replaced by a whole-blood ELISA on dried blood spots, or by a rapid diagnostic test performed on serum, plasma, whole blood, or even saliva. Reflex testing for confirmation of replication is recommended to simplify and shorten access to treatment.

Once the diagnosis has been made, all subjects with recently acquired or chronic hepatitis C who are naïve to treatment or treatment-experienced (interferon, ribavirin and/or sofosbuvir) should be treated without delay.

Pangenotypic combinations of two direct-acting antivirals (sofosbuvir/velpatasvir or glecaprevir/pibrentasvir) should be preferred in the therapeutic indication.

Today, the majority of patients should have access to a simplified treatment, without prior determination of the HCV genotype and subtype.

What is required to start antiviral therapy of hepatitis C?

Only three pieces of information are necessary for treatment initiation, according to the revised guidelines: Proof of viral replication (presence of RNA or core antigen), determination of the presence or absence of cirrhosis by a non-invasive test (possibly APRI or FIB4, which are easily accessible), and the study of possible drug-drug interactions.

In this case, patients may be treated with sofosbuvir/velpatasvir for 12 weeks, or with glecaprevir/pibrentasvir for eight weeks if they have no cirrhosis or if they have cirrhosis and are treatment-naïve and 12 weeks if they have cirrhosis and a history of treatment failure. “This simplified approach results in very high sustained virological response rates and, above all, easy access to treatment for a very large number of patients. It is a key option for achieving the WHO elimination targets,” said EASL.

In specialised departments, it remains advisable to perform HCV genotype and subtype determination in order to offer cirrhotic subjects infected with HCV genotype 3 an enhanced treatment to optimise their response rates, the revised guidelines note. HCV genotype and subtype determination is also very important in regions where HCV subtypes inherently resistant to NS5A inhibitors are frequently found in infected subjects, or in industrialised countries in subjects originating from these regions. However, such determination should be based on sequence analysis (because hybridisation-based assays cannot discriminate these subtypes), which is not available in many places. In the absence of reliable data with the most recent ‘pangenotypic’ dual therapies for most of these subtypes, it is recommended to treat them with the triple combination sofosbuvir/velpatasvir/voxilaprevir as first-line therapy (subtypes 1l, 4r, 3b, 3g, 6u, 6v or any other subtype that naturally harbours polymorphisms conferring reduced susceptibility to NS5A inhibitors).

What is new on the treatment of patients who failed previous antiviral therapy?

Retreatment of patients who failed to achieve viral eradication after an NS5A or protease inhibitor-containing regimen is based on a triple combination of sofosbuvir, velpatasvir and voxilaprevir. In the most difficult-to-cure patients (advanced cirrhosis, multiple treatment failures, presence of complex resistance-associated substitution profiles), the use of the combination of sofosbuvir plus glecaprevir/ pibrentasvir provides a better barrier to resistance to NS5A inhibitors. Treatment can also be reinforced by adding ribavirin and/or extending its duration to 16 or 24 weeks in the most problematic subjects.

What do the updated recommendations mean for the treatment of particular patient groups?

The treatment of many particular HCV-infected groups has been updated in this final version of the recommendations. An important novelty concerns paediatric treatments for which clear indications are given, pending the approval of the corresponding drug formulations. The treatment of adolescents is identical to that for adults. The treatment of HCV during pregnancy is also discussed (but not recommended in the current state of knowledge). Other special groups that are discussed

include patients with decompensated cirrhosis, those with hepatocellular carcinoma, solid organ (including liver) transplant recipients, patients who inject drugs and subjects under opioid substitution, and incarcerated subjects. The specific problem of certain co-morbidities (manifestations of HCV related to the formation of immune complexes, patients with renal impairment, co-infection with the hepatitis B virus, hemoglobinopathies and coagulation disorders) is also covered.

Source: https://easl.eu/publication/easlrecommendations-on-treatment-ofhepatitis-c-2020/

Ireland: National Hepatitis C Treatment Programme

The HSE’s National Hepatitis C Treatment Programme (NHCTP) was established in 2015, and is supported by a Clinical Advisory Group (CAG) and a Programme Advisory Group (PAG). All prescribing clinicians are entitled to membership of the CAG, which concurs with international guidelines and adopts the recommendations as best-practice in the Irish setting. Almost 6,000 people with HCV have been successfully treated with DAAs through the programme to-date.

Offered through designated hospital clinics initially, in 2017 DAA treatment was successfully expanded to the drug treatment service with on-site dispensing. In 2019 a community prescribing and dispensing pilot programme (GPs and pharmacists) was initiated, with new guidelines published by the ICGP and updated in July 2020.

Although the preferred treatment route remains through one of the eight hospital-based treatment centres, community treatment may be preferred if patients find it difficult to attend the hospital based services for logistical, social or psychological reasons, the guidelines note. For the present, community treatment is restricted to low-risk patients. Patients with cirrhosis, organ transplantation, HIV and recurrent HCV infection should be referred to a hospital treatment centre. It is expected that these criteria may change over time.

Speaking in 2020, Clinical Director of the Programme, Prof Aiden McCormick, Consultant Hepatologist, St Vincent’s University Hospital, Dublin, said Ireland had achieved the interim WHO elimination targets for 2020, and appeared “to be on target to achieve the 2030 elimination targets. More robust metrics will be required to confirm we are achieving this. The targets will only be achieved if we can identify the majority of infected patients in the country, which requires buy-in from all healthcare providers. Eradication will also require intensification of public health preventative measures, including needle exchange, etc, to prevent new infections and re-infections. It is a goal which can and should be achieved in Ireland.”

For more information, visit www.hse.ie/ hepc Any GPs wishing to become involved in treatment should contact the NHCTP at nhctp@hse.ie

Figure 1: Number of people with HCV treated with DAAs through the HSE National Hepatitis C Treatment Programme  *End of March 2021

HIV pre-exposure prophylaxis (PrEP): An overview

The goal of PrEP is to reduce the risk of HIV infection and the resulting morbidity, mortality and costs

Human immunodeficiency virus (HIV) is spread through body fluids, such as blood, semen, vaginal and rectal fluids, and breast milk. The infection is transmitted by sexual intercourse, blood-to-blood contact and from mothers to babies. The virus depletes the CD4 cells of the immune system leaving the patient vulnerable to other infections. The final stages of HIV infection occur when the immune system is no longer able to prevent opportunistic infections. The patient is then described as having developed acquired immunodeficiency syndrome (AIDS).

Approximately 9,000 cases of HIV have been recorded in Ireland by the Health Protection Surveillance Centre (HPSC) since the early 1980s with 536 notifications made in 2019. Although no effective cure for HIV has been developed, the treatment of the virus has made significant advances in the last few decades. In the mid-1990s those who were diagnosed with HIV would have progressed to AIDS in a few years. Now those diagnosed with HIV may live almost as long as someone without the disease as a result of treatment with anti-retroviral drugs. The latest progress in the fight against HIV takes the form of preventative treatment – HIV pre-exposure prophylaxis (HIV/PrEP).

PrEP usage

PrEP for HIV is a combination tablet containing tenofovir disoproxil 245mg and emtricitabine 200mg. It is available in the original or generic form.

PrEP is recommended for those individuals at high risk of HIV infection, including those who have sex without a condom and those who share needles or equipment to inject or use drugs. Individuals may also be at a higher risk of HIV if their sexual partner is HIV positive with a detectable viral load, if they have recently had a sexually transmitted infection (STI) or are using recreational drugs (eg, crystal meth, mephedrone) for sex (also known as ChemSex). PrEP is usually not necessary if the individual’s partner has HIV, but is undergoing ongoing anti-retroviral treatment and has an undetectable viral load (U=U).

The goal of PrEP is to reduce the risk of HIV infection and the resulting morbidity, mortality and costs that can accompany the infection. The treatment has been shown to be highly effective at reducing the risk of HIV transmission if it is taken correctly. Studies have shown that when taken correctly PrEP can reduce the risk of HIV transmitted via sex by about 99 per cent, and the risk from injecting drugs by about 74 per cent when taken consistently. PrEP does not protect against other STIs, such as syphilis, chlamydia, and gonorrhoea.

Before starting PrEP

There are several tests that must be carried out before a person is started on

PrEP. These include:

1. A fourth generation HIV test – PrEP is not appropriate for those who already have HIV, and patients who have been directly exposed to HIV must be treated with post-exposure prophylaxis (PEP). If PrEP is taken by a HIV-positive patient, drug resistance can develop. Therefore, before PrEP is started, a HIV negative status must be confirmed. A fourth generation test can detect if a person has been infected with HIV four weeks after exposure and uses both antibodies and p24 antigens from blood samples. Third generation tests have a greater window of exposure of approximately three months. These tests use HIV antibody-only detection. Most current rapid HIV tests are third generation tests and they include self-testing kits. Those wishing to start PrEP should have a fourth generation HIV test performed. Patients should be advised to report any flu-like illness (tiredness, fever, muscle aches, headache) four weeks before starting PrEP, as this could be an indication of HIV infection.

2. Test for hepatitis B – hepatitis B status must be confirmed before starting PrEP. There is a risk of severe acute exacerbation of hepatitis when individuals with hepatitis B infection stop taking PrEP. Those who have infected with the hepatitis B virus (HBV) must be closely monitored for several months when PrEP is discontinued. Those who are not infected with HBV should be offered vaccination. For those who have been previously vaccinated, a booster may be required.

3. Renal function tests – although not a common adverse effect, PrEP medication can cause renal dysfunction and in rare cases, renal failure. Creatinine clearance should be checked before commencing therapy. Throughout treatment renal function (creatinine clearance and serum phosphate) should be assessed regularly (after two-to-four weeks of treatment, after three months of treatment, and every three-to-six months thereafter in patients without renal risk factors.)

4. Test for other STIs – other STIs, such as syphilis, chlamydia, and gonorrhoea should be tested for as these infections can make it easier to be infected with HIV.

5. Pregnancy test – If there is a chance that the patient may be pregnant they should have a pregnancy test before starting PrEP.

Dosing regimens

PrEP needs to be present in the body at the highest concentrations at the time when HIV exposure occurs. There are two possible regimens for PrEP – daily dosing or event based dosing (EBD).

1. Daily PrEP – one tablet is taken daily. It is preferable for it to be taken with food. For PrEP to be effective adherence to therapy is essential. When commencing PrEP therapy drug levels must be high enough to prevent infection. To ensure this:

• For anal sex, at least two tablets must be taken 24 hours before sex and one tablet taken daily thereafter.

• For vaginal sex, PrEP must be taken for seven days before sex and one tablet taken daily thereafter.

Patients should be advised that missing doses of the drug can increase their chances of becoming infected with HIV.

If a dose is missed within 12 hours of the time it is usually taken, the dose should be taken straight away and the next dose at the usual time. If the tablet is taken over 12 hours from the usual time, the dose should be disregarded and the next dose taken at its usual time.

2. EBD – this regimen is only suitable for anal sex, not vaginal sex. Two tablets are taken two-to-24 hours before anal sex and a single tablet taken at 24 and 48 hours following sex. Although less studies have been carried out on this dosing regimen, the iPERGAY study has shown this as an effective method of protection from HIV. EBD is an option for people who: Do not want to take PrEP all the time; only occasionally have sex without condoms; can plan for sex in advance.

at roughly the same time each day.

• The importance of adherence to the medication – this has been demonstrated by measurable drugs levels in the blood. Even though this education piece will most likely be delivered by the prescriber on initiation of PrEP, it is advised that the importance of adherence is highlighted with each dispensing of the medication.

• Advise the patient on what to do if a dose is missed.

• Advise the patient what to do if they vomit – if vomiting occurs less than one hour after taking PrEP they should take another tablet. A second tablet is not required if they vomit more than one hour after taking PrEP.

Although PrEP has been shown to be highly effective if taken correctly, patients are recommended to also use a condom during sex. This not only reduces the risk of HIV infection further, but also protects against other STIs. Full screening for STIs should be carried out every three months. Individuals should be encouraged to find out the HIV status of their partners.

Patients should be reminded about the importance of ongoing monitoring whilst taking PrEP. Testing for HIV and STIs is carried out every three months. Renal function and testing for hepatitis C may be carried out every six-to-12 months.

PrEP in pregnancy

Adverse effects

Emtricitabine/tenofovir is generally well-tolerated. Commonly reported adverse effects include headache, diarrhoea and nausea. These usually subside after a few weeks of taking the medication. More seriously, renal failure, renal impairment and elevated creatinine have been reported following used of PrEP. For this reason carefully monitoring is required. The effects have been shown to reverse when the medication is stopped. Those over 40 years are most likely to be affected. Concurrent administration with nephrotoxic drugs should be avoided. There have been some reports of reduced bone mineral density by 1-to-2 per cent in uninfected individuals receiving PrEP. This adverse effect has also been shown to reverse when PrEP is stopped.

Advice for those taking PrEP

Individuals taking PrEP should be counselled on the following:

• The dose of PrEP, which in most cases will be one tablet once daily, to be taken

If asked about taking PrEP during pregnancy, advise that there is limited information available for taking PrEP during pregnancy. However, there has been no indication of PrEP-related complications in pregnancy to date. For a pregnant woman whose risk of HIV infection is high and therefore has potential to pass the virus to the foetus, it may be appropriate to take PrEP. A risk assessment would have to be carried out by the prescriber and an informed decision made by the individual before taking PrEP during pregnancy.

Reimbursement

Since November 2019, PrEP has been reimbursed by the HSE for people who are considered to be at substantial risk of contracting HIV through sex and who meet the clinical eligibility criteria. PrEP is thus available free of charge in Ireland to those who are prescribed the treatment by clinicians on the approved list of sexual healthcare clinics, which can be viewed at: www.sexualwellbeing. ie/sexual-health/prep/where-to-get-prep/ (Many public PrEP services are facing service restrictions due to Covid-19. This may result in longer waiting times for new appointments).

References on request

Further information can be found at: www. sexualwellbeing.ie and www.hivireland.ie

Most current rapid HIV tests are third generation tests and they include self-testing kits

NADIRA CALLACHAND, Pharmacist

POWER REIMAGINED

AN INNOVATIVE NEW TREATMENT FOR YOUR PATIENTS LIVING WITH HIV

POWERFUL, DURABLE EFFICACY1,2

HIGH BARRIER TO RESISTANCE1,2

TDF,

TAF AND ABC FREE1-3

GEMINI-1 and GEMINI-2 96-week data in treatment-naïve patients: DOVATO 86.0% (n=716) vs DTG + TDF/FTC 89.5% (n=717) (Proportion of patients with HIV-1 RNA <50 copies/mL)

WHY USE 3 IF 2 IS ALL HE NEEDS?

DTG 50 mg + 3TC 300 mg used in the GEMINI studies.

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

Abridged Prescribing Information

Dovato (dolutegravir 50mg/lamivudine 300mg) tablets

See Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Film-coated tablet containing dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine debossed with “SV-137” on one face. Indication: HIV-1 in adults & adolescents above 12 years of age weighing >40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. Dosing: One tablet once daily with or without food. Use an additional 50mg tablet of dolutegravir approximately 12 hours after the dose of Dovato when co-administered with efavirenz, nevirapine, tipranavir/ritonavir, etravirine (without boosted PI), carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John’s Wort or rifampicin. Elderly: Limited data in 65+ yrs. Not recommended in patients with creatinine clearance < 50 mL/min. Caution in severe hepatic impairment. Contraindications: Hypersensitivity to any ingredient. Co-administration with substrates of OCT-2 with narrow therapeutic windows, such as fampridine. Special warnings/precautions: Risk of hypersensitivity reactions. Discontinue dolutegravir and other suspect agents immediately. Risks of osteonecrosis, immune reactivation syndrome. Monitor LFTs in Hepatitis B/C co-infection and ensure effective Hepatitis B therapy. Caution with metformin: monitor renal function and consider metformin dose adjustment. Use with etravirine requires boosted PI or increased dose of dolutegravir. Use with Mg/Al-containing antacids requires dosage separation. Use with calcium, multivitamins or iron also requires dosage separation if not taken at the same time with food. Use with cladribine or emtricitabine not recommended. When possible, avoid chronic co-administration of sorbitol or other osmotic acting alcohols (see SmPC section 4.5). If unavoidable, consider more frequent viral load monitoring. Fertility, pregnancy and lactation: Human fertility - no data; animal fertilitystudies indicate no effects. Women of childbearing potential (WOCBP) should be

P et al. J Acquir Immunde Defic Syndr. 2020;83(3):310-318.

Characteristics. June 2020.

counselled about the potential risk of neural tube defects including consideration of effective contraceptive measures. If a woman plans pregnancy, the benefits and the risks of continuing treatment should be discussed with the patient. The safety and efficacy of a duel regime has not been studied in pregnancy. If a pregnancy is confirmed in the first trimester while on Dovato, the benefits and risks of continuing Dovato versus switching to another antiretroviral regimen should be discussed with the patient taking the gestational age and the critical time period of neural tube defect development into account (see SmPC section 4.6). There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues. Do not breast-feed. Side effects: See SmPC for full details. Headache, GI disturbance, insomnia, abnormal dreams, depression, anxiety, dizziness, somnolence, rash, pruritus, alopecia, fatigue, arthralgia, myalgia, hypersensitivity, suicidal ideation or suicide attempt, hepatitis, blood dyscrasias, acute hepatic failure, pancreatitis, angioedema, rhabdomyolysis, lactic acidosis, peripheral neuropathy. Elevations of ALT, AST and CPK. MA Nr: EU/1/19/1370/001. MA holder: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands. Legal Category: POM A. Date of preparation of API: January2021. Code: PI-6305. Further information available from GlaxoSmithKline, 12 Riverwalk, Citywest, Business Campus, Dublin 24. Tel: 01-4955000.

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

THERESA LOWRY-LEHNEN, National PRO Irish General Practice Nurses Educational Association, CNS, GPN, RNP and Associate Lecturer at Institute of Technology Carlow

Infectious mononucleosis: An overview

Infectious mononucleosis, commonly known as glandular fever, characterised by fatigue, fever, pharyngitis, and lymphadenopathy is an infection usually caused by the Epstein–Barr virus (EBV), (human herpesvirus 4) a member of the herpes virus family. It can affect people of any age, but is most common in young adults and teenagers aged 15-to-24 years. The infection is primarily spread through saliva, by kissing or exposure to coughs and sneezes and objects, such as eating and drinking utensils and toothbrushes. Following exposure, EBV infects epithelial cells of the oropharynx and salivary glands. B lymphocytes may become infected through exposure to these cells or may be directly infected in the tonsillar crypts. B-cell infection allows viral entry into the bloodstream, which systemically spreads the infection. The host immune response involves cytotoxic T-cells reacting against the infected B lymphocytes, resulting in enlarged, atypical lymphocytes.8 Infectious mononucleosis can also rarely be spread through other bodily fluids such as blood or semen. EBV can remain in saliva for up to 18 months post infection, and a few individuals may continue to have the virus present in their saliva intermittently for years. There is no vaccine for EBV, however, most individuals develop immunity after the initial infection.1,4,6

Infectious mononucleosis accounts for approximately 1 per cent of all patients who present with a sore throat. In those aged 16-to-20 years, however, it is the cause of about 8 per cent of throat infections. EBV causes approximately 90 per cent of cases of infectious mononucleosis, with the remainder due largely to cytomegalovirus, human herpesvirus 6, toxoplasmosis, HIV, and adenovirus. Because their management is much the same, it is not always necessary to distinguish between EBV mononucleosis and cytomegalovirus infection. However, in pregnant women, differentiation of mononucleosis from toxoplasmosis is important, since it is associated with significant consequences for the foetus.

After an incubation period of four-toeight weeks, EBV infection of adolescents or adults results in infectious mononucleosis in up to 70 per cent of cases. Most symptoms tend to resolve in two-to-four weeks, although approximately 20 per cent of patients continue to complain of a sore throat after one month. 3,4,8

Before puberty, the illness typically produces symptoms similar to those of common throat infections. In adolescence and young adulthood, the disease presents with a characteristic triad of fever, sore throat and lymphadenopathy. Other symptom include fatigue, headaches, nausea, vomiting, and abdominal pains. The most prominent sign is pharyngitis accompanied by enlarged tonsils with exudate similar to strep throat. In approximately 50 per cent of cases petechiae can be seen on the roof of the mouth. Spleen enlargement is common in the second

and third weeks, although this may not be apparent on physical examination. Rarely, in approximately 1 per cent of cases, the spleen may rupture. There may also be some enlargement of the liver.2,3 When adults over the age of 40 develop the illness, they display less characteristic symptoms and are more likely to develop prolonged fever, fatigue, malaise, and body pains with liver enlargement and jaundice.3,4

Diagnosis

Infectious mononucleosis should be suspected in patients who present clinically with the classic triad of fever, pharyngitis, and cervical lymphadenopathy. Lymphadenopathy may be prominent in both

monospot test results may be negative early in the course of EBV infectious mononucleosis. Positivity increases during the first six weeks of the illness. Patients who remain heterophile-negative after six weeks with a mononucleosis illness are considered to have heterophile-negative infectious mononucleosis and should be tested for EBV-specific antibodies. Patients who are heterophile-positive, but specific antibody-negative, should be considered for testing for possible causes of false positive heterophile antibodies. A real-time polymerase chain reaction (PCR) test identifying infectious mononucleosis DNA may be useful in cases of diagnostic doubt or where rapid diagnosis

infectious mononucleosis cases.7,8 ESR is elevated in most patients with infectious mononucleosis, but is not elevated with group A streptococcal pharyngitis. Abdominal ultrasound may be required to assess for splenomegaly and other investigations may be required to differentiate from other possible diagnoses, for example, lumbar puncture for meningism.9

CAEBV

Chronic active Epstein–Barr virus (CAEBV) infection is a rare condition characterised by severe, chronic, or recurrent infectious mononucleosis-like symptoms after a well-documented primary infection with EBV in a previously healthy person. The disease is progressive with markedly elevated levels of EBV DNA in the blood and infiltration of organs by EBV-positive lymphocytes. Patients often present with fever, lymphadenopathy, splenomegaly, EBV hepatitis, or pancytopaenia. Over time, these patients develop progressive immunodeficiency and, if untreated, develop infections, haemophagocytosis, multi-organ failure, and EBV-positive lymphomas. The only proven effective treatment for chronic active EBV is hematopoietic stem cell transplantation. 2,3

Complications

the anterior and posterior triangles of the neck, which distinguishes infectious mononucleosis from bacterial tonsillitis where the lymphadenopathy is usually limited to the upper anterior cervical chain. Other common physical signs include palatal petechiae, splenomegaly, hepatomegaly, and jaundice. Diagnosis of infectious mononucleosis is primarily based on symptoms, but should be confirmed by the heterophile antibody monospot test. Sensitivity is 85 per cent and specificity is 100 per cent. The heterophile antibody

is helpful, such as in patients with a high risk of splenic rupture. 9 White blood cell count and differential can be useful in establishing a diagnosis. A typical finding is increased blood lymphocytes. Liver function tests (LFTs) are also abnormal in more than 90 per cent of patients with infectious mononucleosis. Serum transaminase and alkaline phosphatase levels are usually moderately elevated. The serum bilirubin may be increased in approximately 40 per cent of patients, but jaundice typically only occurs in approximately 5 per cent of

Infectious mononucleosis usually resolves over a period of weeks, but occasionally can be exacerbated by complications. While uncommon, complications can be serious when they occur. Complications include secondary infection of the brain or nervous system, breathing difficulties as a result of inflamed tonsils and ruptured spleen. Airway obstruction may develop in patients with severe inflammation and swelling of the tonsils and adenoids. This complication may occur in one of every 100-to-1,000 cases and most often occurs in younger patients with infectious

EBV causes approximately 90 per cent of cases of infectious mononucleosis, with the remainder due largely to cytomegalovirus, human herpesvirus 6, toxoplasmosis, HIV, and adenovirus

Infectious mononucleosis should be suspected in patients who present clinically with the classic triad of fever, pharyngitis, and cervical lymphadenopathy

mononucleosis.4,8 Neurological disorders may occur in 1-to-5 per cent of patients. These include encephalitis, meningoencephalitis, seizures, optic neuritis, sudden sensorineural hearing loss, idiopathic facial palsy, and Guillain-Barré syndrome. 2,3 Haematological complications are more common, particularly haemolytic anaemia and thrombocytopaenia and rarely, aplastic anaemia, pancytopaenia, and agranulocytosis. Other rare acute complications include myocarditis, pericarditis, pancreatitis, interstitial pneumonia, rhabdomyolysis, and psychological complications. 3 There is evidence that a history of infectious mononucleosis significantly increases (doubles) the risk of multiple sclerosis. 3 Severe abdominal pain is uncommon in patients with infectious mononucleosis, and should prompt immediate reaction to the possibility of splenic rupture.8

Treatment

Infectious mononucleosis can be treated in most cases with rest, hydration, analgesia, and antipyretics. Paracetamol and NSAIDs, such as ibuprofen, may be used to reduce fever and pain. Antibiotics are not effective in treating infectious mononucleosis, because they have no effect on viral infection. Antibiotics may be prescribed if a secondary bacterial infection of the throat occurs, however, ampicillin and amoxicillin are not recommended during acute EBV infection, as a diffuse itchy maculopapular rash may develop. 3,4,5

Although antivirals are not usually recommended for people with simple infectious mononucleosis, they may be useful in the management of severe EBV manifestations, such as EBV meningitis, peripheral neuritis, hepatitis, or haematologic complications. Antiviral treatment with acyclovir has been shown to significantly decrease

diseases/herpesviruses/infectious-mononucleosis

2. Balfour H, Dunmire S, Hogquist K. (2015). Infectious mononucleosis. Clinical Translation Immunology. 4(2), Feb. doi: 10.1038/cti.2015.1 PMCID: PMC4346501

3. Lennon P, Crotty M, Fenton J. Infectious Mononucleosis. BMJ 2015. Education Clinical Review. doi: 10.1136/ bmj.h1825. Available at: www.bmj.com/bmj/sectionpdf/895012?path=/bmj/350/8005/Clinical_Review.full.pdf

4. HSE (2018). Glandular Fever. Health Service Executive. Available at: www.hse.ie/eng/health/az/g/ glandular-fever/treating-glandular-fever.html

5. Bennett J, Dolin R, Blaser M. (2014). Principles and Practice of Infectious Diseases. Elsevier Health Sciences. p.1760. ISBN 9781455748013

6. Rezk SA, Zhao X, Weiss L. (2018). Epstein-Barr virus (EBV)-associated lymphoid proliferations, a 2018 update. Human Pathology. 79: 18–41. doi:10.1016/j. humpath.2018.05.020. PMID 29885408

7. BMJ (2018). Infectious Mononucleosis. BMJ Best Practice. Available at: https://bestpractice.bmj. com/topics/en-gb/123?gclid=Cj0KCQjwy97qBRD oARIsAITONTK-4evuG9PmZxU8NL5pHlILFWFGk_ Oieeo4wg6wLUY7A7weEA0Eup4aAvtyEALw_wcB

8. Medscape (2019). Infectious Mononucleosis (IM) in Emergency Medicine. Available at: https:// emedicine.medscape.com/article/784513-overview

9. Knott L. (2016). Infectious Mononucleosis. Patient Information. Available at: https://patient. info/doctor/infectious-mononucleosis

doctorCPD.ie

Latest module

Cardiac amyloidosisOverview, Diagnosis and Management

the rate of oropharyngeal EBV shedding. There is insufficient evidence to recommend steroid treatment for symptom control in infectious mononucleosis, however, short courses of corticosteroids are beneficial for haemolytic anaemia, central nervous system involvement or extreme tonsillar enlargement. 9 The need for rest and return to usual activities after the acute phase of the infection should be based on the person's general energy levels. However, to decrease the risk of splenic rupture, avoidance of contact sports and heavy physical activity is advised for the first three-to-four weeks or until enlargement of the spleen has resolved. Alcohol should be avoided for the duration of the illness. 3,4,5

Resolution of the acute illness is usually followed by a lifelong latent infection. Once the acute symptoms of an initial infection resolve, they usually do not reoccur, however, the virus remains dormant in B lymphocytes in the body and the person is a carrier for the rest of their life. Independent infections of mononucleosis may be contracted, regardless of whether the person is already carrying the dormant virus. Occasionally, the virus can reactivate, during which time the person is again infectious, but usually without any symptoms of illness. However, in susceptible hosts the virus can reactivate causing vague physical symptoms, and during this phase the virus can spread to others.7

References

1. MSD (2019). Infectious Mononucleosis. MSD Manual Professional Version. US. Available at www.msdmanuals.com/professional/infectious-

Learning objectives of this module:

• Understand the principal causes (AL amyloidosis and ATTR) and underlying pathophysiology of cardiac amyloidosis

• Identify patients to screen for cardiac amyloidosis and the subsequent diagnostic process

• Develop insight into the management of cardiac amyloidosis and its underlying causes

Most symptoms tend to resolve in two-to-four weeks, although approximately 20 per cent of patients continue to complain of a sore throat after one month

Challenges and opportunities in managing perioperative iron deficiency anaemia

Consultant anaesthetist Dr Hugh Gallagher speaks with Pat Kelly about the role of the anaesthetist in managing perioperative iron deficiency anaemia

NICE blood transfusion quality standard [QS138]1

States that patients undergoing major surgery and who have preoperative anaemia and iron deficiency should be offered iron therapy.

NICE Guidance [NG24]2

Alternatives to blood transfusion for patients having surgery

 Offer oral iron before and after surgery to patients with iron-deficiency anaemia.

 Consider intravenous iron before and after surgery for patients who:

 Have iron-deficiency anaemia and cannot tolerate or absorb oral iron, or are unable to adhere to oral iron treatment.

 Are diagnosed with functional iron deficiency.

 Are diagnosed with iron-deficiency anaemia, and the interval between the diagnosis of anaemia and surgery is predicted to be too short for oral iron to be effective.

1. NICE Quality Standard [QS138] available at: https://www. nice.org.uk/guidance/qs138/chapter/Quality-statement-1Iron supplementation [accessed online May 2021].

2. NICE GUIDANCE [NG24] available online at: https://www.nice.org.uk/guidance/ng24/chapter/ Recommendations#alternatives-to-blood-transfusion-forpatients-having-surgery-2 [accessed online June 2020].

The management of perioperative anaemia in Irish patients can sometimes be fragmented, and whether or not a patient suffers with perioperative anaemia can depend on the surgical site and type of surgery. Sometimes, patients may only be recognised as being iron-deficient if the deficiency is very pronounced and a multidisciplinary approach is required to screen patients and treat them accordingly. While it can sometimes be unclear who is responsible for the management of these patients’ haemoglobin following discharge, iron deficiency and anaemia can have a significant impact on patients’ quality of life.

Dr Hugh Gallagher, Consultant Anaesthetist at St Vincent’s Private Hospital in Dublin, spoke with the Medical Independent (MI ) about the role of the anaesthetist in managing pre- and perioperative anaemia and iron deficiency and the opportunities and challenges in this area. “There is increasing awareness and interest in preoperative anaemia; the role of the anaesthetist starts at the preoperative assessment stage of the patient’s journey,” he said. “For example, many cancer patients in particular will have slow, steady blood loss in their bowels and anticipating that situation by investigating and looking at their low blood count is important. Some centres now give intravenous (IV) iron and follow-up with iron therapy, because most of these anaemias would be due to iron deficiency.”

One of the main difficulties, Dr Gallagher explained, is that sometimes physicians do not have the facilities to admit patients for IV infusion and to deal with any potential complications of administering IV iron, such as allergic reactions or low phosphate levels that are associated with some IV iron preparations on the market. “In terms of the perioperative/interoperative role, we [anaesthetists] would be the ones who monitor the blood loss and blood count, and organise transfusion

and the right blood products,” said Dr Gallagher, adding that the surgeon generally manages these issues postoperatively at ward level.

‘Red flags’

There are certain surgeries that raise ‘red flags’ in terms of major blood loss and potential iron deficiency anaemia, he said. “In some surgeries, by their nature, there is little that can be done to prevent major blood loss and this is often in the older population, where there are a number of medical conditions. The frail elderly in particular can take a long time to recover from surgery and the effects of anaesthesia, on top of anaemia and the knock-on effects on their wellbeing.”

Pre-Covid, Cappagh National Orthopaedic Hospital in Dublin ran an effective programme of preoperative ownblood donation and iron supplementation to help address these issues. “It’s logistically difficult to do that in the current climate, said Dr Gallagher. “Also, a lot of cancer care is centralised, so if you were coming from Donegal to the Mater Hospital for work-up and evaluation, for example, the logistics of coming back to give blood or receive iron several times before a major cancer operation is unfortunately difficult to organise.” Orthopaedic surgery, such as hip and knee, are the two main procedures that result in major blood loss over the course of the surgery, he added, as well as liver and sometimes bowel surgery, and also aortic aneurism repairs and gynaecology cancers and hysterectomies.

In terms of an oral versus IV approach to administering iron, Dr Gallagher said: “[Oral] iron doesn’t tend to be tolerated particularly well in people and they can get a lot of stomach upsets and constipation. There may also be insufficient time to get iron levels up with oral supplementation, given that most of these are for patients with cancer or for people who have been waiting a long time and have a very narrow window of opportunity to have their surgery,” he said. “Waiting for oral supplementation to build-up your iron stores and consequently improve your haemoglobin is challenging. Given that some people are called at the last minute and might have been on a standby list for cancellation, they may not have the appropriate amount of iron stores replaced by the time their call for surgery comes, so it’s difficult to plan it.

“In the private sector, it may be a little easier because you can schedule an operation day for most people and work around that and if the date is far enough away, you can use oral supplements. But in the public sector, where every bed is very precious, especially at the moment, it can be very difficult to organise that,” he continued. “Also, if someone is losing blood through their gut because of their cancer, and you get them toppedup and then [they catch] Covid and miss their surgical date, they lose the benefit [of oral iron]. With the constipation and stomach upsets that go with oral supplements, it’s not straightforward.”

Even pre-Covid, given the general lack of beds in the public sector, even with the national cancer strategies and time-frames for referral and surgery, “patients may have a bed in a hospital but not an ICU bed for postoperative care,” said Dr Gallagher.

Ideal service

In terms of what he would see as the ideal service for perioperative blood management in Ireland, and the anaesthetists’ role in that, Dr Gallagher said: “That would be linked in with a well-functioning preoperative assessment service,” he told MI. “That would be not just anaesthesia-provided, but also with medicine for the elderly and haematology in particular being the two services that would be most desired, with all the resource implications that would have.

Also, [we need] the appropriate time to investigate someone’s anaemia and the time and facilities to administer the necessary therapy, whether that be oral or intravenous.”

Such therapy would often involve infusion, therefore an ideal service would also include scheduling, sufficient nursing staff, sufficient trolleys and an adequate number of beds, he added. “In an ideal world, once a diagnosis of anaemia is made, we would have a suite available and that patient would enter into an ‘anaemia pathway’ and have a full assessment done for iron or other deficiencies and be given the appropriate supplementation — folic acid, vitamin B12 or iron, for example — and have the opportunity to be re-tested before entering the surgical pathway,” said Dr Gallagher. “At the moment, just getting the appropriate people together [to treat iron deficiency] is very difficult.”

He added that it can be problematic to achieve 100 per cent unanimity among physicians on a process, “but everyone wants good outcomes. The misery that anaemia causes is substantial, and that’s why the parenteral IV route would be the desired one in a pressurised health system to get iron levels up and get anaemia under control as early as possible”.

National programme

Dr Gallagher also commented on the role of the anaesthetist in managing perioperative care in the context of the national programme for model of care in elective surgery. “Everything in the model of care is designed for good-quality outcomes for each interaction with the patient and each operation, given that the nature of anaesthesia is generally closely aligned to that of surgeons,” he said.

“More and more, we are operating as independent physicians, if you like, in doing assessments and scheduling care and liaising with the surgeons to arrange optimum operating time. The model of care is in some senses an aspirational document in the ideal world — it is a very, very good document and it is the framework for most of our policy formulation in our individual hospitals,” he said. “When it comes to the patient awaiting surgery, the main drivers in supplementation would be anaesthesia specialists, rather than surgeons, who would be focusing on investigations, such as scanning, MRI, CT, planning surgery and so on… anaesthetists are generally more focused on the limitations imposed by kidney function, low haemoglobin, clotting status, and so on.

“We are in a slightly awkward situation, whereby we are providing a service to another service; we are not admitting specialists and we don’t have inpatient hospital beds in the way that most of our colleagues would,” he continued. “We have to liaise with surgery and we have to recognise that there are other pressures, in particular time and resources… we can always express our opinion if we think someone is not optimised for surgery, but disease progression and resectability, for example, are also important factors.

“We are collegial and co-operative but as with many other things in healthcare, it’s a compromise between minimising risk and trying to improve outcomes and get the best end result for the patient,” said Dr Gallagher. “At the moment, and even before Covid, our main shortfall is in intensive and critical care bed capacity. That’s more labour-intensive than other areas that we work in, so looking for resources for what is essentially an outpatient clinic at the moment is difficult to achieve, both in terms of space and nursing care.”

This editorial has been sponsored by Vifor Pharma UK Ltd. Commissioned by the Medical Independent and independently written, Vifor Pharma UK Ltd has had input in to the topic, suggested authors and performed a pre-publication review for compliance purposes.

IE-FCM-2100039

Help patients get back to what matters

Scan/hover your camera here to sign up to receive content from Vifor Pharma UK Ltd, including future information about webinars. This will include promotional content.

Ferinject® (ferric carboxymaltose)

Prescribing Information - Ireland

For full prescribing information refer to the Summary of Product Characteristics (SmPC)

Active ingredient: Ferric carboxymaltose (50mg/mL). Presentation: Solution for injection/infusion. Available as a 10mL vial (as 500mg of iron) and 20mL vial (as 1000mg of iron). Indication: Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used or if there is a clinical need to deliver iron rapidly. The diagnosis must be based on laboratory tests. Dosage and Administration: The posology of Ferinject follows a stepwise approach: Step 1: Determination of the iron need; The individual iron need for repletion using Ferinject is determined based on the patient’s body weight and haemoglobin (Hb) level. The table in the SmPC should be used to determine the iron need. Step 2: Calculation and administration of the maximum individual iron dose(s); Based on the iron need determined, the appropriate dose(s) of Ferinject should be administered: A single Ferinject administration should not exceed: • 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion). The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL Ferinject) per week. Administration rates for intravenous injection:

For iron doses of 100mg to 200mg, there is no prescribed administration time. For doses >200mg to 500mg, Ferinject should be administered at a rate of 100mg iron/min. For doses >500mg to 1,000mg, the minimum administration time is 15 min. Administration of intravenous drip infusion:

For iron doses of 100mg to 200mg, there is no prescribed administration time. For doses >200mg to 500mg, Ferinject should be administered in a minimum of 6 mins. For doses >500mg to 1,000mg, the minimum administration time is 15 mins. Ferinject must be diluted in 0.9% m/V NaCl but not diluted to concentrations less than 2 mg iron/mL. Step 3: Post-iron repletion assessments. Contraindications: Hypersensitivity to Ferinject or any of its excipients. Known serious hypersensitivity to other parenteral

References: 1. Ferinject® Summary of Product Characteristics.

Code: IE-FCM-2100039 Date of preparation: April 2021

iron products. Anaemia not attributed to iron deficiency. Iron overload or disturbances in utilisation of iron. Special warnings and precautions: Parenterally administered iron preparations can cause potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune or inflammatory conditions. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). Ferinject should only be administered in the presence of staff trained to manage anaphylactic reactions where full resuscitation facilities are available (including 1:1000 adrenaline solution). Each patient should be observed for 30 minutes following administration.

If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention has been reported. Patients should be asked to seek medical advice if they experience symptoms. Serum phosphate should be monitored in patients who receive multiple administrations at higher doses or long-term treatment, and those with existing risk factors. In case of persisting hypophosphataemia, treatment with ferric carboxymaltose should be re-evaluated. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Careful monitoring of iron status is recommended to avoid iron overload. There is no safety data on the use of single doses of more than 200mg iron in haemodialysis-dependent chronic kidney disease patients. Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies. It is recommended that treatment with Ferinject is stopped in patients with ongoing bacteraemia. In patients with chronic infection a benefit/risk evaluation has to be performed. Caution should be exercised to avoid paravenous leakage when administering Ferinject. Special populations: A single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease

patients. The use of Ferinject has not been studied in children. A careful risk/benefit evaluation is required before use during pregnancy. Ferinject should not be used during pregnancy unless clearly necessary and should be confined to the second and third trimester. Foetal bradycardia may occur during administration of parenteral irons, as a consequence of hypersensitivity. The unborn baby should be carefully monitored during administration to pregnant women. Undesirable effects: Common (≥1/100 to <1/10): Hypophosphataemia, headache, dizziness, flushing, hypertension, nausea, injection/infusion site reactions. Rare (≥1/10,000 to <1/1,000): Anaphylactoid/anaphylactic reactions. Frequency not known: Kounis syndrome, hypophosphataemic osteomalacia. Please consult the SmPC in relation to other undesirable effects.

Legal category: POM

MA Number: PA0949/004/001

Date of Authorisation: 19.07.2007

MA Holder: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

Ferinject® is a registered trademark

Document number: IE-FCM-2000137

Date of preparation: 10/20

Ferinject® is indicated for the treatment of iron deficiency when: oral iron preparations are ineffective oral iron preparations cannot be used there is a clinical need to deliver iron rapidly

The diagnosis of iron deficiency must be based on laboratory tests.1

SPORTS QUIZ WIN €50 20 May 2021

Q1 Which Irish golfer will defend his British Open title, two years after he won it, later in the summer?

Q2 Who will captain the British and Irish Lions squad on their upcoming tour of South Africa?

Q3 Which Irish international footballer won his case for wrongful dismissal against his club Derby County in 2019?

Q4 Rafael Nadal will defend his French Open title which commences later this month. How many times has he won this grand slam event?

Q5 Who will the Irish rugby team play in two summer test matches in the coming weeks?

Q6 Which county play GAA home fixtures in MacHale Park?

CROSSWORD COMPETITION

20 May 2021

The winner of the 29 April 2021 Sporting Quiz Competition is Dr Linda Lee, Co Offaly

The winner of the 29 April 2021 Crossword is Dr Michael Cushen, Co Offaly

Q1 Who was sacked as manager of Tottenham Hotspur? A: Jose Mourinho

Q2 Who will Limerick open their Munster Hurling Championship defence against? A: Cork

Q3 Who will coach the British and Irish Lions in their summer tour of South Africa? A: Warren Gatland

Q4 Who recently stepped down as Chairman of World Snooker and the Professional Darts Corporation? A: Barry Hearn

Q5 Which city in the United States will hold its first ever Grand Prix from 2022? A: Miami

Q6 Name the Irish lightweight rowers who won gold at the recent European Championships? A: Paul O’Donovan and Fintan McCarthy

ACROSS

1 Evaluate (6)

7 Ritual (8)

8 Four-wheeled road vehicle (3)

9 Stifle (anag) (6)

10 Noisy (4)

11 Sense experience (5)

13 Two-wheeled vehicle (7)

15 Person talking (7)

17 Stadium (5)

21 Large washing bowl (4)

22 Ball-shaped object (6)

23 Small truck (3)

6 Yearly (6)

14 Communication; note (7)

16 Celestial body (6)

18 Ten plus one (6)

19 Business organisation (6)

20 Garment with sleeves (5)

14 - Communication; note (7)

16 - Celestial body (6)

18 - Ten plus one (6)

19 - Business organisation (6)

20 - Garment with sleeves (5)

A thorough, well-timed, if flawed, meditation on euthanasia

TITLE: The Inevitable: Dispatches on the Right to Die

AUTHOR: Katie Engelhart

PUBLISHER: Atlantic Books 2021

REVIEWER: Prof Denis Gill

Let me state at the outset that ‘dying with dignity’ is no more than a euphemism for mercy killing. The people involved in ‘rational suicide’ are being killed by themselves, by a pro-euthanasia group, or by a sympathetic doctor. We all wish for a timely, peaceful death, preferably in our own home, surrounded by our family, and followed by a wake (with the coffin open), and a ceremonial funeral. There is no fundamental right to a peaceful death at the time and method of our choosing. Is there?

The author of The Inevitable is Katie Engelhart, a Canadian journalist and TV documentary producer. Engelhart seems to be an adventurous, industrious, driven investigative reporter, who has traversed the world to research her first book. The Inevitable had a long gestation of five years and was published earlier this year. The book runs to 280 pages. It has a helpful timeline on ‘assisted death’ from1942 to Sept 2019, and 46 pages of detailed notes. However, annoyingly, it has no index, which is a serious deficit in a story with so many characters, so much detail, and numerous acronyms. This must be corrected in future reprints. For those who would like to research the topic better acronyms to Google include: MAID (Medical Aid in Dying); SOARS (Society for Old Age Rational Suicides); VERF (Voluntary Euthanasia Research Foundation); DWD (dying with dignity); PAD (physician-assisted death); FEN (Final Exit Network); and AVD (assisted voluntary death).

“Dying with dignity” is due to become one of the most tortured medical topics now and in the immediate future. I never dreamt on graduation in 1968 that in 2021 doctors would be asked to cause the deaths of a select number of their ill patients at varying ages. Increases in life-expectancy have been accompanied by more years of age-induced disability. So this is a prescient book, which should be of interest to GPs, geriatricians, palliative care doctors, and psychiatrists.

Engelhart asks the relevant questions: Do people have the right to die on their own terms and conditions? Should doctors be involved in social suicide? Should doctors be putting down people as vets put down dogs? This analogy is intrinsically false comparing cognitive beings to animals. Who should decide who is eligible for ‘rational suicide’? Being a Hippocratic follower of the “ first do no harm” philosophy, I would believe that doctors should stay out of this. Doctors have long been ethically disbarred from active involvement in judicial homicide (capital punishment).

Engelhart centres her story on the US, but visited the UK, The Netherlands, Australia, and other countries to assemble her material. The Inevitable is primarily a collection of stories, conversations, and ideas. She focuses on six personal stories (of four suicidal people and two doctors providing euthanasia). These are told in six long chapters. The people’s stories are well told,

Engelhart asks the relevant questions: Do people have the right to die on their own terms and conditions? Should doctors be involved in social suicide?

but much too lengthy, and could do with editing and abbreviation. The two doctors are a Californian physician Dr Lonny Shevelson and an Australian Dr Philip Nitschke, who lost his medical licence for teaching people how to ‘exit’ at ‘DIY death’ seminars. Nitschke and his organisation Exit International gave a seminar in Dublin.

Engelhart eschews politicians and priests, who oppose assisted death on theological grounds. There is no reference to religious belief or faith. Engelhart provides little philosophical or ethical discussion in the text. It received a very positive review in The Economist . My favourite book on old age is Atul Gawande’s thoughtful Being Mortal . In it, Gawande writes that old age “is not a medical diagnosis”.

This is an important text covering an urgent problem confronting the medical profession. A peaceful, pain-

free death is everyone’s aspiration. No one wants to hear of people shooting themselves; hanging; walking into the sea with stones in their pockets; self-suffocating; overdosing with prescribed medicines; and so on. However, medically-assisted suicide is a very slippery slope. If societies and states legislate for social suicide, they should be prepared to train ‘terminators’ to do it. But who would want the job?

Compliments to Engelhart for her initiative, energy, reportage, and compelling stories. Despite its flaws (no index making review very difficult; over-long stories), it is thorough and well-timed. Doctors must think more carefully about the dying process. As Philip Roth put it “old age is not a battle, old age is a massacre”. It is ahead of us all. Amen.

Dr Philip Nitschke

Day-to-day banking: what are the options?

Mr Paul Redmond outlines how customers can respond to recent changes in the banking market

In February 2021, the announcement came that Ulster Bank, a popular high street bank, with branches in every town and city in Ireland and Northern Ireland, had decided to exit the Irish market. Following on from that in early March, Bank of Ireland decided to close 103 branches and last week KBC, a recent entry to the Irish banking world, also announced their imminent departure from Ireland.

Although customers are being told to remain using these banks and their facilities for the immediate future, as the wind down of these banks will be gradual and take some time, at some point in the next year we will have to decide how best to carry out our day-to-day banking.

For products such as mortgages, these banks have already clarified that there is no need to switch, the banks in question will forward on their loan books to another bank and everything will remain the same as what is in place currently.

However, it is not quite the same story for our everyday banking; we all tend to use the one bank for all our banking needs, such as current accounts, credit cards, some savings, and maybe some personal lending. We have the apps on our mobile phones, making it all convenient and under the one roof.

With the banks closing up, we will be instructed, with plenty of notice to begin the process of moving these banking products to another bank. This can create apprehension and questions: What are our options? Do we have only the three main high street banks available? What are their costs? And more generally, what is involved?

Current accounts

We all need a regular bank account that we can use daily, we need a Visa debit card that we can take out cash at the ATM machines, tap for our purchases if below €50 or pay with the card if the purchase exceeds this amount. In particular, within the last year as a result of Covid-19, we have never used our current accounts more, as we shopped online and tried to avoid using cash.

So, what should we look for when deciding? The first factor is to consider the monthly cost of operating a regular current account? The website www.CCPC.ie is an excellent impartial site that compares all the costs of every provider, breaking it down into the monthly cost and what you get for that fee. Some banks offer a one-off monthly fee and within that all direct debits, standing orders, ATM withdrawals, transactions etc, are included. Others will charge you a small fee for each tap. It is worth looking at how you bank. Is the one-off monthly fee a better option as you tap regularly or do you hardly avail of that?

Another option to consider is how adaptable the bank account will be to digital facilities. With the recent connections to Apple and Google pay, are these important to how you bank? Many of these transactions are free so should be considered when comparing.

The most obvious reason most people rarely switch their bank accounts is the actual switching process. Most of us have regular direct debits, payments; salaries are lodged, along with social welfare payments etc. It can be a daunting task to have to inform and co-ordinate these through the creation of a new account.

With the Central Bank switching code, the new bank will provide a switching service to you. They will help you with the entire pro-

cess and will agree a time when activity on your account is less frequent to avoid any missed payments. The switching packs from the new bank will cover all areas. It is also a good time to review all the direct debits on your account and decide if they are still live and active or can be deleted.

Credit cards

Again, most of us have our credit card with our current account provider. It helps payments stay on track and accounts can be viewed online within the same site. Changing credit cards is not so daunting as current accounts and many providers offer great enticement to switch. Pay particular attention to introductory rates, balance transfers, the APR rate, and the cost of taking out cash on credit cards.

Savings accounts

As with all the products above, now is a time to look for a better home for your savings. Banks are not giving good rates on regular savings. There has even been talk of introducing negative rates for those with cash in savings accounts. If you have substantial savings, do you need access to it all immediately? Can you separate it into an emergency cash fund and diversify into other savings areas where the return is better?

With the departure of these high street banks and branches closing, it is clear that the future for banking is changing considerably. The need for a local branch is lessening and the digitalisation of all retailer’s services allow us to perform all our banking on our mobile phones or through the bank’s website. Remember, there is no immediate need to close accounts. You will be given sufficient time, so take that time to choose wisely.

Mr Paul Redmond (CPA,QFA, FAIA) is Managing Partner of RDA Accountants Limited. He is a member of the Institute of Certified Public Accountants. He is also a Fellow of the Association of International Accountants and a qualified financial advisor.

The most obvious reason most people rarely switch their bank accounts is the actual switching process. Most of us have regular direct debits, payments; salaries are lodged, along with social welfare payments etc. It can be a daunting task to have to inform and co-ordinate these through the creation of a new account

24/7 BLOOD PRESSURE MONITORING SYSTEM LAUNCHED

Aktiia, an automated 24/7 blood pressure monitoring system, which collects data during the day and while sleeping, is now available in Ireland.

This medical innovation provides people and their doctors with comprehensive insights into blood pressure patterns that can better inform diagnosis and management of hypertension.

The wearable bracelet has been validated in multiple clinical studies and received its CE mark as a class IIa medical device.

Aktiia is the first product to automatically measure blood pressure over the course of hours, days and weeks with minimal effort required by the wearer. The data is gathered over 100 times per week – day and night – and then displayed in a free app. The information can also be shared with a doctor or family member to detect concerning blood pressure changes.

Untreated or uncontrolled hypertension threatens the health of millions of people worldwide. Increased night-time blood pressure in particular is

closely linked to cardiovascular diseases that can lead to strokes or heart attacks.

A number of peer-reviewed studies – including the Dublin Outcome Study – emphasise how more frequent blood pressure measurement allows for more personalised treatment.

By understanding each patient’s individual pattern, a doctor has additional information to provide a more accurate diagnosis and to create a tailored plan.

“As the principal investigator of Aktiia’s pivotal clinical trial, I am pleased that the result of our study shows that the Aktiia solution is accurate and allows patients and physicians to track their blood pressure daily,” said Dr Gregoire Wuerzner, President of the Swiss Society of Hypertension. “I believe the Aktiia solution has the potential to change the management of hypertension.”

“Hypertension is the number one cause of cardiovascular disease and premature death worldwide,” noted Prof Neil Poulter, Professor of Preventive Cardiovascular Medicine at Imperial College London, UK.

€4.7M AWARDED TO IRISH UNIVERSITIES IN GLOBAL DRIVE TO TRAIN DATA ANALYSTS FOR NEUROSCIENCE

NeuroInsight, a new research training programme led by RCSI University of Medicine and Health Sciences, has been awarded a Marie Skłodowska-Curie Actions (MSCA) COFUND worth €4.7 million. The programme will see scientists from around the world working in Ireland to develop advanced data skills for research into neurological conditions including motor neuron disease, epilepsy and Parkinson’s disease.

The NeuroInsight Fellowship programme has been established by RCSI-hosted FutureNeuro, the Science Foundation Ireland (SFI) Research Centre for Chronic and Rare Neurological Disease, in partnership with Insight, the SFI Research Centre for Data Analytics.

The two centres will deliver an integrated and applied training programme for research fellows, building upon respective health and data analytics expertise available across the two SFI centres. Collectively, FutureNeuro and

will work on projects across the FutureNeuro and Insight centres. The programme will equip this future generation of research leaders with competencies in fields such as precision medicine and artificial intelligence.

NeuroInsight Programme

Lead Prof Gianpiero Cavalleri, Deputy Director of FutureNeuro and Professor of Human Genetics at RCSI School of Pharmacy and Biomolecular Sciences, said: “As a society, and particularly in our healthcare systems, we are generating more and more data, insights from which can help us better understand and treat neurological disease. This programme is about training and equipping the next generation of researchers to safely and effectively engage with these datasets in a manner that positively impacts on the lives of people with neurological conditions.

“NeuroInsight is a significant programme that

will bring together Ireland’s leading researchers in the fields of neurosciences, e-health and data analytics. Partnering with the Insight Centre, we will work to create a culture of patient-centric entrepreneurship that will ultimately transform the patient journey for people with chronic and rare neurological conditions.”

Prof Alan Smeaton, Academic Lead for NeuroInsight from the Insight Centre, said: “Data analytics and artificial intelligence are now at the core of much of our work, our leisure and our health activities though it is not always obvious and apparent that they are being used in our day-to-day lives. There is huge opportunity to work with our colleagues in FutureNeuro and with patient organisations to apply such techniques to improve the lives of people living with neurological conditions and we look forward to meeting the challenges and making an impact.”

NUI GALWAY LEADS GLOBAL CLINICAL TRIAL TO IMPROVE HEALTH OUTCOMES FOR MANTLE CELL LYMPHOMA PATIENTS

nosis with an average survival rate of less than three years from diagnosis.

“Ireland’s standard of care treatment offered to newly diagnosed, physically fit MCL [mantel cell lymphoma] patients at present include an intensive chemotherapy regime coupled with an autologous transplant,” said Dr Hayat.

“Two targeted therapy drugs called bendamustine and rituximab are offered to patients who are less physically fit. This trial proposes a new experimental drug called zanubrutinib coupled with existing drug rituximab, which may be more efficient at treating MCL and hopefully, prolonging survival rates.

“Zanubrutinib differs from previous treatments as it blocks substances found in the body that help cancerous mantel cell lymphoma cells to grow and

survive. By blocking these substances, zanubrutinib could essentially slow the growth of these cells and may improve symptoms of MCL.”

Dr Hayat concluded: “In 2019, the Food and Drug Administration in the United States approved this drug for use on mantel cell lymphoma patients with continued clinical trials and approximately 1,500 patients having received the drug to date. As recruitment opens, we look forward to seeing what the results will bring for patients.”

Patients and family members wishing to enquire about this clinical trial and other clinical trials taking place at the advanced therapies and cancers group can visit the website at www.nuigalway. ie/hrbcrfg/research/advancedtherapiescancers/

RCSI AND BRUIN BIOMETRICS EXTEND STRATEGIC PARTNERSHIP TO INNOVATE IN PRESSURE ULCER PREVENTION

Insight already support over 500 researchers working on a new generation of neuroscience and data analytics technologies.

The voice of people living with neurological conditions will be at the core of the programme, with all projects under the scheme designed with input from patients at the outset. The researchers will also be seconded to hospital and industry settings during their fellowships, to ensure their findings are transferable to devices, diagnostics or treatments that can improve the lives of people impacted by neurological disease.

NeuroInsight will offer 24-month fellowships to 33 experienced researchers from around the world who

A leading haematologist at Galway University Hospital and the advanced therapies and cancer group at the School of Medicine in NUI Galway are looking at improving health outcomes for patients with mantle cell lymphoma by conducting a clinical trial of a new treatment drug, which aims to improve survival rates.

The trial is being overseen in Galway by Consultant Haematologist Dr Amjad Hayat, who has led many previous clinical trials in this area. The advanced therapies and cancer group research group, previously known as the cancer clinical trials unit, has been in operation since 2002 and has extensive experience in oncology and haematology research.

Dr Hayat said: “Participating in this trial is very important for the future

of mantel cell lymphoma treatments and its patients. The trial is expected to continue for seven years, which will include a treatment period and a follow-up period, giving the researchers as much information as possible about the efficacy and safety of the drug.”

Galway University Hospital is one of 150 sites globally to take part in this clinical trial, with an estimated 500 participants to be recruited on a voluntary basis across each site.

Dr Hayat said the team is now looking to recruit patients newly diagnosed with mantel cell lymphoma. It is a rare and aggressive type of non-Hodgkin’s lymphoma equating to about 7 per cent of all patients diagnosed with non-Hodgkin’s lymphoma each year. Currently the condition has a poor prog-

The Skin Wounds and Trauma (SWaT) Research Centre at RCSI University of Medicine and Health Sciences and Bruin Biometrics LLC have announced the extension of their strategic research partnership. The extension will see further collaboration in wound healing and tissue repair, with a specific emphasis on innovation in pressure ulcer prevention. This collaboration continues at a time when patient wound care outcomes and healthcare costs are being scrutinised across the globe.

Established in 2014, this long-standing academic-industry partnership will continue to explore innovative solutions that will ultimately prevent pressure ulcers through the integration of efficient patient-focused modernised care pathways into varying care settings.

Through this partnership, and in collaboration with RCSI’s Office for Research and Innovation, Bruin Biometrics has supported a comprehensive research programme at the SWaT Research Centre, including eight PhD scholars and two research Master’s students leading to significant clinical data in the area of pressure ulcer prevention, as well as multiple peer-reviewed pub -

lications and conference presentations.

This latest demonstration of support by Bruin Biometrics, through a philanthropic donation to RCSI, will see this research programme extend beyond 2021 and support a number of new and ongoing research initiatives within the SWaT Research Centre, under the leadership of Director Prof Zena Moore and Deputy Director Prof Declan Patton.

Commenting on this partnership extension, Prof Moore said: “Person-centred care and improved patient outcomes are at the heart of our research in the SWaT Research Centre. Partnering with Bruin Biometrics since 2014 has supported the RCSI SWaT Research Centre to lead translational research, demonstrating that pressure ulceration can be identified before it is visible on the skin surface, and that early identification can lead to effective preventative interventions which reduces pressure ulcer incidence and improves patient outcomes and service efficiency.

“We are delighted to extend this strategic research partnership with Bruin Biometrics and to receive continued endorsement from this internationally recognised innovative company.”

Prof Gianpiero Cavalleri

Dr Amjad Hayat

GP REQUIRED

Custom House Square Medical Centre is seeking a full-time salaried general practitioner to join a young(ish) dynamic team. The remuneration package is best in class and the working hours and conditions are most attractive.

Have a gander at our website www.custommedical.ie and if interested forward your CV to practicemanager@custommedical.ie

For informal enquiries please phone Dr Peter Killeen at 087 131 4139

GP REQUIRED

GP with view to succession/partnership wanted for single GP medical practice in Cork City. Initially 2 to 2½ days required, but this is flexible and open to discussion.  Excellent remuneration.

The practice has a well-established GMS and private patient base and it is supported by excellent experienced nursing and administrative staff. Enquiries to sfrawley@alphaprimarycare.com

GP POSITION AVAILABLE

GP position available in Galway. Seapoint Medical Centre located in Barna, Co Galway is a thriving 3 GP practice. We require an established compassionate, friendly, and energetic Assistant General Practitioner to join our team in a permanent capacity. Special interest in women’s health among your other interests would be an advantage. The successful GP will be required for 6 sessions per week.

Our practice is fully computerised using Socrates software and is appropriately supported by nursing, admin, and management. We have an attractive remuneration package for the suitable GP and some negotiable terms and conditions. Learn more about us at www.seapointmedical.com and express your interest or inquire further to Ronan at  ronan@seapointmedical.com

or 086 419 2470

GP LOCUM REQUIRED

Short-term/long-term GP locum needed for Skibbereen Medical Centre in beautiful West Cork. Supportive and friendly practice. Excellent administrative and nursing staff. Email enquiries and CV to westcorkmedical@gmail.com

LOCUM REQUIRED

Locum GP required in North Inishowen area to cover leave for months of July, August, and September.

Group practice/fully computerised, full ancillary staff in a purpose-built primary care centre.

For further information on this position contact Dr Seamus Kelly via email skelly@millbraesurgery.ie

Millbrae Surgery, Carndonagh, Co Donegal

GP POSITION AVAILABLE

GP position available in friendly, proactive practice in West Clare. Fully computerised with excellent administration and young enthusiastic nursing staff.

• There are 2 other GPs in the practice.

• Ideally 6-8 sessions (flexible) per week.

• No out-of-hours commitment.

• Long-term opportunity if desired.

• Competitive remuneration including Medical Indemnity. Please respond to mary.okmc@outlook.com

GP LOCUM REQUIRED

We are looking for GP locum cover for the following weeks. 5th July until 27th August (8 weeks)

Location: Inishowen Medical Clonmany and Buncrana (mixed urban and rural practice).

Work: 8-9 sessions per week as part of a multi-doctor team. No out-of-hours requirements.

Practice fully computerised (HPM) and practice offering a very generous pay package.

Contact mmcgowanardaravan@gmail.com for further information

GP REQUIRED

Rush Co Dublin

Share running of a single practice with a view to succession, in 2-to-3 years.

Public and private patients. Socrates computer software. Tel – 086 861 0692

GP REQUIRED

GP required in Killarney. Six sessions per week. Immediate start. Modern surgery. Sessions flexible. Rapid progress to own GMS list.

For more information or enquiries contact Laura at info@killarneygp.ie or 087 990 1108

CLINIC CONSULTING ROOM AVAILABLE

Looking for a consulting room in the Galway Clinic to rent on a sessional basis? 1-8 sessions available weekly in a quiet, furnished ground floor suite.

Also, if you need a separate office full-time for your medical secretary or as a clinical room for a nurse or physiotherapist, there is a smaller office available to let full-time in the same suite.

Please phone 086 804 9891 for further information

PRACTICE NURSE REQUIRED

An innovative practice in Abbeyfeale, Co Limerick, requires an additional practice nurse.

Part-time position, approximately 2-3 days per week, sharing the week with our established practice nurse.

Candidates must be a Registered General Nurse with An Bord Altranais.  Previous experience in general practice is ideal, but not essential. Candidates will be welcomed into a very supportive environment. Induction and training will be offered to the successful candidate. Please forward CV and cover letter to cedarvillesurgery@gmail.com

MEDICAL GP SURGERY EQUIPMENT FOR SALE

Entire contents of two treatment rooms, reception area, fridges, autoclave, etc, from closing down sale in Galway area.

Contact for list etc anseomra@gmail.com

Phone 085 725 4566

MEDICAL CENTRE AVAILABLE

Seafront Medical Centre available to rent from 1st July, Main St, Blackrock, Co Louth.

Existing medical practice in this building since 1989. Superb location, prestigious building, at bus stop, free parking. Three doctor’s consulting rooms, nurses room, receptionist and secretarial area, fine reception area and back office and toilets. All rooms have plenty of natural light and windows. Terrific opportunity for enthusiastic young doctors to set up practice in under-doctored population in sought after area in perfect location.

Contact  rockdoc89@gmail.com  or 086 829 4445 for further information

MAY EDUCATIONAL EVENTS FOR GPS

20 |Thurs

DUBLIN CARDIOVASCULAR RESEARCH FORUM, WEBINAR SERIES

The Cardiovascular Research Institute Dublin at Mater Private Network is delighted to host Dr Luis Scott, Chair of the Dept of Cardiovascular Diseases, Mayo Clinic, AZ, US, for a presentation and discussion on ‘Athletes and worrisome cardiovascular findings: What should I test to allow for athlete participation’? This takes place on Thursday 20th May from 6pm to 7pm. CPD applied for. To register, email mary.ryan@materprivate.ie or the CVRI Dublin team at cvri@materprivate.ie. See also www.cvridublin.ie

24 | Mon

GP WEBINAR – UROLOGY UPDATE FOR PRIMARY CARE, FROM MATER PRIVATE NETWORK

Ms Lisa McLornan, Mr Nicholas Hegarty, and Mr Girish Nama from Mater Private Network Dublin and Cork will present on ‘Benign Prostate Hyperplasia (BPH), Prostate Cancer, and Prostatitis’, and other related topics. This webinar takes place on Monday 24th May from 7pm to 8.30pm. CPD applied for. For full details and to register, visit www.materprivate.ie [News and Events section] or email events@materprivate.ie for registration link

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

A fond and funny farewell from the inimitable ‘ginger god of surgery and shenanigans’

There are obituaries and there are obituaries. An then there are obituaries about doctors with a unique and wonderful sense of humour. Who write their own obituaries.

Such was the case with Dr Thomas Lee Flanigan, US surgeon, army veteran, and many more things besides, who passed away recently at age 48. Before he died, he wrote his own colourful obituary, which was posted on legacy.com . Rather than pad this out with my nonsensical musings, I invite you to enjoy Dr Flanigan’s marvellous parting words first-hand:

“Well, that’s it. I have completed my shift as the great American cliché. In the spirit of what turned out to be my last New Year’s letter, my wild and crazy life has again taken a new, unexpected turn with my shocking and unexpected, yet fabulous, exit. Yes, I have joined the likes of Princess

Diana, John Belushi, and Steve Irwin the Crocodile Hunter, in leaving while still at the top of my game as an iconic superhero who seemed almost too good to be true.

“It was a good run. No, a great run, but I can’t take all the credit. Northern Michigan University and my Lambda Chi Alpha brothers, Wayne State University Medical School, The United States Army, colleagues, various celebrities, random cartoon characters, people who make memes, Russians and other friends and family all contributed. As you know, my wife, Amy, and my kids Joey (14), Evelyn (13), and Sylvia (10) are the absolute best. Please take good care of them like the priceless treasures they are.

HEALTHY DATA MEANS TRUE INTEROPERABILITY AND MORE INFORMED CARE.

“I will admit that I originally got married for the husband jokes and had kids for the dad jokes. It did not disappoint. The jokes I mean, but Amy and the kids were pretty good too. Going to school events, dance competitions, and

eight zillion hockey practices at the crack of dawn really makes a man’s life worthwhile. I also saw some other delightful things in my time here –Hawaiian volcanoes, Egyptian pyramids, and even the advent of air fryers. I will say, it was magical, all of it.

HEALTHY DATA MEANS TRUE INTEROPERABILITY AND MORE

HEALTHY DATA MEANS TRUE

InterSystems makes your data healthy so it’s accessible, useable, and ready for action. HealthyData.com

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“In case you’ve heard the rumours, I did dabble in a few other things along the way during my 48 years, like serving my country in combat on two separate tours, earning the rank of Lieutenant Colonel and saving countless lives as an accomplished surgeon and MD. Oh, there was also that whole, fulfilling, ‘cosmetic and reconstructive surgery’ stint too. Yada, yada, yada. Let’s talk about my real legacy, though... the dad jokes, the New Year’s letters, the Facebook memes. What was I to this world, if not a beacon of light shining upon those who couldn’t scan the Internet for their own hilarious and entertaining comic relief? I guess what I am trying to say is that you’re welcome and you owe me big time.

“I know it’s impossible to believe, but I, the Ginger God of Surgery and Shenanigans, have fought my last cow (you’re welcome Tim) and ridden off into the glorious sunset after re-enlisting with a new unit. Due to the unknown and cosmic nature of my next mission, this will be our last communication. It will self-destruct in five minutes. My whereabouts are now top secret, but let’s just say I have made some new friends by the names of Elvis and Kenny. The Church of Tom is closed for business, but please continue to worship me, light candles, and send

RIP Dr Thomas Lee Flanigan, 31/10/1972-27/4/2021.

Dr Flanigan was not alone in his desire to leave his loved ones with a laugh. Here are just a couple of gems from like-minded people before their demise.

“He travelled where he wanted to travel, laughed inappropriately at every chance, learned what he wanted to learn, fixed what he wanted to fix, and loved who he wanted to love. Cremation will take place at the family’s convenience and his ashes will be kept around as long as they match the

“She liked four-letter words as much as she loved her rock garden and trust us, she LOVED to weed that garden with us as her helpers, when child Mary ‘Pat’

“Clod’, as he was called even by those who knew his name, lived such a boring life that watching paint dry caused him to hyperventilate. His accomplishments will be published at a later date, if any are Philip Dayton Thorpe, 1934-2018

“What’s not to love about a woman who loved her children and grandchildren – almost as much as she loved the Boston Red Sox, cold Budweiser, room-temperature Budweiser, cigarettes, airplane Jan Lois Lynch, 1945-2018

“Danny Lloyd was a generous man – giving away many of his possessions in the months before he died. He even left his car to 12 different friends….” Danny Lloyd, aka ‘Rooster’, aka Winston, aka ‘Pizza Pop’, 1953-2018.

Dr Thomas Lee Flanigan