The Medical Independent – 16 September 2021

The seal of approval

The lack of a licensing system in Ireland has prompted Beaumont Hospital’s decision to prepare for independent accreditation.

Catherine Reilly reports

PAGE 10

Health remains most lobbied public policy area

DAVID LYNCH

Health remains the area of public policy where the greatest amount of lobbying takes place in Ireland, according to data from the lobbying register maintained by the Standards in Public Office Commission (www.lobbying.ie).

As of 8 September, the statistics showed health as the policy area with the highest number of registered incidences of lobbying, with 6,001 registrations. The next largest area was ‘economic development and industry’, with 3,451 registered incidences, while in third place was agriculture with 2,861.

These are the same top three policy areas as when the Medical Independent last reported on the statistics in February 2018. The figures include all registrations since the website was launched in 2015.

The Department of Health remains the most lobbied Government department, with 3,870 registered incidences over the same time period. The Department of Fi-

nance is next with 3,102.

In late June, the Standards in Public Office Commission published its 2020 annual report under the Regulation of Lobbying Act 2015.

During 2020, the total number of registrants on the register increased to 2,089, almost a 7 per cent increase on 2019. In the first returns period of January to April 2020, the number of returns submitted was 3,324. However, the number of returns increased quite significantly for the second and third returns periods of the year, bringing the total number of returns to just over 11,600.

“The increase in returns submitted likely reflects lobbying due to the pandemic,” according to the Standards Commission.

“Returns submitted for 2020 include 1,378 specifically referencing the pandemic (using the terms ‘Covid-19’, ‘Covid 19’ or ‘coronavirus’), across most public policy areas.”

The Regulation of Lobbying Act 2015 was signed into law in March 2015 and the Act commenced in September 2015.

A day never forgotten

Dr Muiris Houston’s memories of experiencing 9/11 in Canada are tinged with the surreal

PAGE 19

SSWHG and Saolta have most

‘non-specialist’ consultants

DAVID LYNCH

General medicine, psychiatry and surgery are the specialties with the most consultants employed by the HSE who are not on the specialist register of the Medical Council, the Medical Independent (MI) can report.

South/South West Hospital Group (SSWHG) and Saolta University Health Care Group are the two Hospital Groups with the highest number of consultants who are not on the specialist register.

MI recently reported that there were 109 consultants employed by the HSE at the end of April who were not on the specialist register. This newspaper has since received a breakdown of the specialties and the healthcare regions involved.

In terms of specialties, general medicine leads the way with 35; psychiatry comes next with 20; and surgery with 18. Anaesthesiology has 11; emergency medicine has nine; obstetrics and gynaecology has six; radiolo -

gy has five; paediatrics has three; and pathology two.

In terms of locations, SSWHG has the highest number of consultants who are not specialist-registered, at 25, followed by Saolta, which has 20. Dublin Midlands Hospital Group is next with 13; RCSI Hospitals has 11; and Ireland East Hospital Group has nine.

The data provided was extracted from the Doctors Integrated Management E-system (DIME) as of 30 April.

“DIME is dependent on clinical sites inputting details on their consultant workforce and therefore there may be variances and gaps in the data supplied to that held within clinical sites,” said a HSE spokesperson.

“Due to the recent HSE cyberattack and the data backlog outstanding it is not possible to provide data after this date.”

The 109 consultants not on the specialist register represent a 29 per cent reduction over the last two years, noted the spokesperson.

duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.1

Pictured L-R are Ms Lauren Fagan from Trim, Co Meath and Ms Méabh Ní Chaithail from Letterkenny, Co Donegal, who graduated with BSc Degrees in Biomedical Health and Life Sciences at University College Dublin on 2 September.

An uncertain winter

David Lynch examines how seasonal influenza combined with the continuing impact of the Covid-19 pandemic could lead to a particularly demanding winter

Skudexa ® 75 mg/25 mg film-coated tablets (tramadol hydrochloride/dexketoprofen).

Abbreviated Prescribing Information

Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.

Presentation: Film-coated tablets containing tramadol hydrochloride 75 mg and dexketoprofen 25 mg. Excipients with known effects: croscarmellose sodium and sodium stearyl fumarate

Use: Symptomatic short term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen. Dosage:

Adults: 1 tablet (75 mg tramadol hydrochloride/ 25 mg dexketoprofen), additional doses as needed with a minimum dosing interval of 8 hours. Maximum daily dose 3 tablets/day. Use lowest effective dose for the shortest duration necessary to control symptoms. Maximum duration of use is 5 days. Patients with mild-moderate hepatic dysfunction or mild renal dysfunction: maximum daily dose is 2 tablets/day. Elderly: initial dose is 2 tablets/day can be increased to a maximum of 3 tablets/day after good tolerance established. Use with caution in patients over 75 years. Contra-indications: Hypersensitivity to any component or other NSAID or excipients. NSAID induced attacks of asthma, bronchospasm, acute rhinitis, or nasal polyps, urticaria or angioneurotic oedema. Known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active peptic ulcer/gastrointestinal/ haemorrhage or any history of gastrointestinal bleeding, ulceration or perforation, chronic dyspepsia, other active bleeding or bleeding disorders, Crohn’s disease or ulcerative colitis, severe heart failure, moderate-severe renal dysfunction, severe hepatic dysfunction, haemorrhagic diathesis and other coagulation disorders, severe dehydration. Acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products. Concomitantly with MAO inhibitors or within 14 days of having taken them. Inadequately controlled epilepsy. Severe respiratory depression. Pregnancy and lactation. Warnings and precautions: Dexketoprofen: Caution in allergic conditions. Avoid use with concomitant other NSAIDs including COX-2 selective inhibitors. Gastrointestinal bleeding, ulceration or perforation which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs withdraw treatment. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in older people. Ensure cure of oesophagitis, gastritis and/or peptic ulcer before starting treatment. Consider combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors), and in patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk. Monitor patients with a history of gastrointestinal toxicity, particularly when elderly, for unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages. Caution in patients receiving oral corticosteroids, anticoagulants, SSRIs or anti-platelet agents. Caution in patients with impairment of renal function, receiving diuretic therapy or those who could develop hypovolaemia. Ensure adequate fluid intake. Caution in liver impairment. Appropriate monitoring and advice required with history of hypertension and/or mild to moderate heart failure. Special caution in patients with cardiac disease, especially episodes of previous heart failure. Only treat patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease after careful consideration. Similarly for risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Caution in haematopoietic disorders, systemic lupus erythematosus, connective tissue disorders, impairment of hepatic and/or renal functions, history of hypertension and/or heart failure, diuretic therapy, the elderly. Older people are more likely to be suffering from impaired renal, hepatic and cardiovascular function. Serious skin reactions (some of them fatal), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis were reported very rarely. Particular caution is required in patients with congenital disorder of porphyrin metabolism, dehydration, directly after major surgery. Severe acute hypersensitivity reactions have been observed on very rare occasions. Discontinue treatment at the first signs of severe hypersensitivity reactions. Can cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs. Avoid use in case of varicella. Do not use with warfarin, other coumarins or heparin. Can mask the symptoms of infectious diseases. Tramadol: Use with particular caution in patients with an addiction, head injury, shock, reduced level of consciousness of uncertain origin, disorders of respiratory centre or function or increased intracranial pressure. Use with caution in patients sensitive to opiates. Care should be taken in treating patients with respiratory depression, with concomitant CNS depressant drug administration or significant excess of the recommended dose as resulting respiratory depression cannot be excluded. Convulsions have been reported with recommended doses of tramadol, this risk may increase when exceeding the recommended upper daily dose limit (400mg). Seizure risk increases in patients taking other seizure threshold lowering medications. Only treat patients susceptible to seizures with tramadol if circumstances are compelling. Tolerance, psychic and physical addiction may develop. For patients with abuse/dependence potential only treat for short periods under strict medical supervision. Consider tapering dose gradually when discontinuing treatment to prevent withdrawal symptoms. CYP2D6 deficiency may reduce the analgesic effect, whereas ultra-rapid metabolisers of CYP2D6 incur risk of opioid toxicity even at commonly prescribed doses. Extreme caution and close monitoring for opioid toxicity required when administering tramadol to children for post-operative pain relief. Not recommended in children with compromised respiratory function. Skudexa: Not for use in children and adolescents. Concomitant use with sedative medicines such as benzodiazepines or related drugs should be reserved for patients with no alternative treatment options, using the lowest effective dose and an as short as possible treatment duration while following them closely for signs of respiratory depression and sedation. Interactions:

Dexketoprofen: Other NSAIDs, anti-coagulants, heparins, corticosteroids, lithium, methotrexate, hydantoines and sulphonamides, diuretics, ACE inhibitors, antibacterial aminoglycosides and angiotensin II receptor antagonists, pentoxyfilline, zidovudine, sulfonylureas, betablockers, cyclosporin and tacrolimus, thrombolytics, anti-platelet agents and SSRIs, probenecid, cardiac glycosides, mifepristone, quinolone antibiotics, tenofovir, deferasirox, pemetrexed.

Tramadol: MAOIs, coumarin derivatives (e.g. warfarin), mixed agonists/antagonists opioid receptors (e.g. buprenorphine, nalbuphine, pentacozine), SSRIs, SNRIs, tricyclic antidepressants, antipsychotics and other seizure threshold-lowering medication (e.g. bupropion, mirtazapine, tetrahydrocannabinol), sedative medicines such as benzodiazepines, centrally depressant medications or alcohol, cimetidine, carbamazepine, ondansetron (5-HT3 antagonist) and substances inhibiting CYP3A4 (e.g. ketoconazole, erythromycin). Pregnancy and lactation: Contra-indicated during pregnancy and lactation. Do not use in women attempting to conceive. Side-effects: Skudexa: Common (≥ 1/100, <1/10): dizziness, nausea, vomiting. Uncommon (≥ 1/1000, <1/100): thrombocytosis, laryngeal oedema, hypokalaemia, psychotic disorder, headache, somnolence, periorbital oedema, vertigo, tachycardia, hypertensive crisis, hypotension, abdominal distension, constipation, dyspepsia, raised LFTs, face oedema, hyperhidrosis,urticaria, haematuria, asthenia, chills, discomfort, feeling abnormal, BP increased, increased alk phos, increased LDH. For less frequent side effects and side effects associated with the individual constituentssee SmPC. Pack size: 15 tablets. Legal category:

POM A Marketing authorisation number: PA 865/20/1 Marketing authorisation holder:

Menarini International Operations Luxembourg S.A., 1 Avenue de la Gare, L-1611 Luxembourg.

Marketed by: A.Menarini Pharmaceuticals Ireland Ltd. Further information is available on request to A Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Co. Dublin Co. Dublin, Ireland A96 T924 or may be found in the SmPC. Date of preparation: January 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 via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@ hpra.ie. Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744.

75mg/25mg film coated tablets

Fixed Dose Combination for Moderate to Severe Acute Pain1

CENTRAL & PERIPHERAL ACTION2

LONG LASTING PAIN RELIEF3*

FAST ACTING

EFFICACY 3

Multimodal analgesia with central and peripheral action.2,4

* In a model of acute pain (third molar extraction) Skudexa demonstrated a median duration of action of 8.1 hours post-dose3

Concerns mounting over potential severity of winter influenza season

DAVID LYNCH

Concerns have been raised within the HSE that a reduction in people’s “genetic memory” of seasonal influenza may lead to a more problematic winter season.

Meeting minutes of the HSE’s flu planning steering group on 23 June noted that “people’s genetic memory of flu is now likely to be significantly reduced so if flu circulates, the severity of illness could have increased”. The minutes were seen by the Medical Independent (MI) following a Freedom of Information request.

The discussion took place in the context of the lack of a

Consultancy for Values in Action ‘culture change’ project has ceased – HSE

CATHERINE REILLY

There are “no plans” to issue another external contract to support the Values in Action (ViA) staff ‘culture change’ initiative, the HSE has informed the Medical Independent (MI)

However, ViA and other “culture improvement work” will continue under the auspices of the “capability and culture function”, which was established in March 2021 in the National HR Division and is led by an Assistant National Director of HR.

The HSE’s board also has a people and culture committee that oversees culture change issues.

UK company The Chalfont Project, headed by “organisational architect” Dr Leandro Herrero, was engaged to assist in developing ViA, which began as a pilot in the mid-west in 2016.

ViA is a staff ‘culture change’ project based around nine behaviours voluntarily promoted by ‘champions’ who attend bootcamps to learn more about the process. The behaviours include asking colleagues how you can help them and doing “an extra, kind thing”.

According to HSE literature: “Values in Action is led by staff from across the health service, from all grades and disciplines, who are working together to create a grassroots movement to spread the behaviours that reflect our values. The behaviours are visible units of action that can be universally understood and adopted by everyone.”

In 2017, The Chalfont

significant influenza season in 2020-21.

The meeting also “noted the importance of continuing flu messaging with the general public and the importance of respiratory etiquette as a first barrier to flu”.

At a prior meeting in May, a report from the acute section of the health service noted there was “a common emerging question”, which was outlined in the minutes as follows:

“Why not ‘piggy-back’ flu vaccination onto the Covid-19 vaccination programme and centres?”

A HSE spokesperson told MI it was “in the advanced stages of planning the 2021-22 influenza vaccination

programme. It is anticipated immunisations will begin in early October and will be available free of charge to adults and children (from two years old) at risk of flu and its complications.”

Separately, some doctors have raised concerns that the planned easing of Covid-19 restrictions – especially measures around mask wearing – could lead to a particularly challenging winter season. Government plans for late October include the easing or removal of rules on physical distancing and mask wearing in many circumstances. However, masks will still be required on public transport, in healthcare settings, and shops. See news feature, p4-5.

Dr Leandro Herrero

Project won a three-year contract “to provide behaviour-based culture change implementation support” for ViA following a competitive tender process, according to the HSE.

The value of the threeyear contract was for a maximum of €250,000 per annum with an option to extend for one year.

The last tranche of fees to The Chalfont Project amounted to €209,668 covering the period July 2019 to July 2020 “when the planned cessation of the contract took place”.

Currently six HSE staff members are assigned to ViA and there are “no plans to wind down the initiative”.

“Values in Action has been rolled out in Community Healthcare Mid-West, University of Limerick Hospitals Group, Community Healthcare Dublin North City and County, Community Healthcare East, and Tallaght University Hospital.”

Covid-19 had impacted on the project’s implementation “as staff were redeployed for long periods to other areas to support the pandemic effort. Since the recent return of redeployed staff, plans have been re-ignited to implement the project in new areas.”

of treatment for inflammatory bowel disease

Authors: Dr Jayne Doherty, SpR in Gastroenterology, and Dr Garret Cullen, Consultant Gastroenterologist, Centre for Colorectal Disease, St Vincent’s University Hospital, Dublin

DAVID LYNCH david@mindo.ie

Facing an uncertain winter

The arrival of flu season combined with continuing impact of the Covid pandemic could lead to a winter of unique challenges for the Irish health service. David Lynch reports

Last winter was an unusual one for the Irish health system. This was because of what was present – the Covid-19 pandemic – and what was essentially absent – the seasonal influenza virus.

What will happen this winter is uncertain. It remains to be seen what effect the lifting of Covid restrictions, both at home and abroad, will have on the spread of the virus, even with vaccination. And without a national lockdown, seasonal influenza is likely to be more of a factor than it was at the end of 2020.

In August 2020 the phrase ‘twindemic’ was used in The New York Times, referring to the potential of a severe winter influenza season alongside Covid-19. Ultimately, the worst fears did not come to pass because of the low level of influenza. But already the international easing of Covid-19 restrictions has led to concerns about the possibility of such an occurrence at the end of this year and the early months of 2022.

In the UK earlier this year, the Academy of Medical Sciences issued a stark warning regarding the potential challenges posed by the combined difficulties of Covid and influenza in the coming months.

According to the British Medical Journal, the warning stated that urgent action was needed to stop a “lethal triple mix” of Covid-19, influenza and respiratory syncytial virus (RSV) “pushing an already depleted NHS to breaking point this winter”.

Similar concerns have been raised in this country. In early August, speaking on RTÉ Radio One’s Morning Ireland , IMO President and Specialist in Public Health Medicine

Dr Ina Kelly warned of a “challenging winter ahead for acute hospitals and general practitioners”.

sions taking place around the possibility that the severity of illness from influenza could be higher this year because people’s “genetic memory” may have reduced. There has also been mention of potentially “piggy-backing” the influenza vaccination system onto the Covid vaccination infrastructure (see panel).

Uncertain picture

“Flu starts of in southeast Asia every year, then goes to places like Australia, New Zealand and it comes to our part of the world in winter,” Consultant in Emergency Medicine at Sligo University Hospital and President of the Irish Association for Emergency Medicine (IAEM), Dr Fergal Hickey, told the Medical Independent (MI) last month.

“So they are typically six months ahead of us. They saw a significant reduction in flu last year, which was as a result of the social distancing, mask wearing, hand washing and so on. Because we had a significant lockdown, we essentially saw no real influenza last year, which was just as well, because we were struggling with Covid.”

Looking forward to this winter, the IAEM President warned that an absence of influenza was not now guaranteed. Speaking before the Government announced the further easing of Covid-19 restrictions, Dr Hickey predicted that the loosening of lockdown measures may lead to increased influenza levels.

“Because many of the lockdown measures have been lessened – I’m not saying they shouldn’t be, but I’m just saying some of the things that protected us last winter are not going to protect us this winter.”

Dr Hickey said that emergency departments were already experiencing significant crowding with high numbers of patients in August (see interview, page 12).

At the end of last month, the Government announced its aim for the final easing of public health restrictions by 22 October. The plans from late October include the easing or removal of rules on physical distancing and mask wearing in many cir-

response to the timetable for the easing of Covid restrictions.

In response, Dr Oisin O’Connell, Respiratory Consultant at Bon Secours in Cork, and senior medical lecturer at University College Cork, tweeted: “Just an FYI, by not using near universal face covering/masks this winter, it is going lead to the biggest emergency department and hospital bed crisis in Irish history for winter 2021/spring 2022 – mainly due to influenza and RSV [respiratory syncytial virus] as opposed to Covid!”

‘Naive’

Echoing comments made at the HSE’s national flu planning steering group (see panel on page 5), Dr O’Connell warned that “the significant reduction in influenza cases in 2020 could mean a particular highly susceptible population towards influenza this winter 2021”.

Looking back on last winter, he said that the impact of the absence of influenza throughout society has been seen within respiratory care.

“The learning curve of the benefits in mask use and social distancing in the winter of 2020, resulted in a particularly low number of both viral and bacterial chest infections across multiple respiratory patient cohorts,” he said.

“We were spared... an influenza outbreak last winter because the closure of society in a lot of ways protected us from Covid, but also from influenza,” she said. “This winter we’re not going to have that protection, so we’re going to potentially have many respiratory viruses and it will be harder to diagnose whether it’s Covid-19 or what else it is.”

HSE preparations for the influenza season are underway, with internal discus-

cumstances. However, masks will still be required on public transport, in healthcare settings and shops.

The easing and removal of some of the face covering restrictions has caused unease among some doctors.

On 31 August, former Minister for Health and current Minister for Further and Higher Education, Research, Innovation and Science, Simon Harris, tweeted the phrase “progress and hope” in

Dr O’Connell’s tweet received over 260 likes and nearly 80 retweets, including by many doctors.

Speaking to MI, Dr O’Connell highlighted that even Covid patients who are not acutely unwell still require single-room occupancy.

“This will only be added to by other highly transmissible respiratory viruses requiring isolation rooms and wards in the hospital setting, resulting in segregating patients and not having isolation beds for other vulnerable patients this winter,” said Dr O’Connell.

He said this included “vastly reduced exacerbations” in chronic obstructive pulmonary disease (COPD) and asthma and bronchiectasis “and other underlying respiratory conditions”.

Dr O’Connell said it is well established that viral infections can trigger “secondary bacterial pneumonias” and “the mitigating strategies used in Covid, like mask wearing, pragmatic social distancing, and hand washing all vastly reduced these other common viral infections and hospitalisations in the winter of 2020”.

Dr Ina Kelly

The significant reduction in influenza cases in 2020 could mean a particular highly susceptible population towards influenza this winter 2021

Dr Oisin O’Connell

According to Dr O’Connell, it was “naive timing to stop some of these measures”.

“The benefits of mask-wearing in reducing respiratory viral transmission especially with any respiratory symptom, such as coughing, has been very well recognised in Asian countries for decades pre-Covid,” he said.

“The transition to indoor living in Ireland’s cold, wet winters can be a breathing ground for other respiratory viral infections.” These infections included influenza, rhinovirus, parainfluenza, and RSV.

“Ireland’s health system has already been stretched, even in summer and autumn 2021, from a combination of delayed presentations and increased waiting lists,” he said.

What could be done to help mitigate these challenges this winter? Dr O’Connell returns to the Government easing plan. He said that the “mask relaxation measures coming into effect on 22 October pre the annual winter healthcare crisis seems to be an unnecessary risk currently being proposed in the current roadmap to easing restrictions”.

He said that this “needs to be re-assessed as a priority”.

Vaccination

The relationship between the pandemic, the Covid-19 vaccination process and the plans for this year’s influenza vaccine campaign has sparked some interest in recent months.

Last year saw increased uptake of the influenza vaccination. How this was influenced by the pandemic was the subject of a paper published in the Irish Medical Journal (IMJ) in February.

The study, titled ‘The impact of the Covid-19 pandemic on the uptake of the seasonal influenza vaccine’, was based on a

12-item cross-sectional survey distributed to 465 patients in an urban GP practice over a two-week period in October 2020.

It found that there was a 27.4 per cent increase in uptake of the seasonal influenza vaccine in 2020 relative to 2019. Some 233 patients (76 per cent) were more likely to take the vaccine this year due to the Covid-19 pandemic.

“Considering the poorer clinical outcomes in elderly Covid-19 patients, compared to younger patients, it is unsurprising that age had a strong influence on whether the Covid-19 pandemic had made patients more inclined to take the seasonal influenza vaccine (SIV),” according to the paper.

“With regards SIV uptake, the 13-to-30 year-old age group was 3.2 times less likely than the other age groupings to have been positively influenced by the Covid 19 pandemic.”

The IMJ paper also found that the pandemic had a higher impact on people’s decision to take the influenza vaccine than the fact that the vaccine was free of charge.

“I anticipate that flu vaccine uptake will be lower in 2021 relative to 2020, largely due to declining levels of anxiety around both flu and Covid as we move out of the emergency phase of the pandemic,” Dr Niall O’Sullivan, GP at the Douglas Medical Centre in Co Cork, and an author of the IMJ article, told MI.

“I expect, however, that uptake in 2021 will be higher than in 2019 and previous years.”

The Cork GP added that “if [the] flu vac-

cine is linked to a Covid booster this should positively influence flu vaccine uptake”.

“There is also a significant cohort that got the flu vaccine for the first time last year who had no adverse reaction and one would expect will be less hesitant about getting the vaccine again.”

So what lessons from the paper could the HSE’s national flu planning steering group incorporate for the coming winter?

“One of my take home learnings from the paper is that the primary factor influencing flu vaccine uptake is preventing illness for the individual in question,” said Dr O’Sullivan.

“In the height of the Covid-19 pandemic last winter, there was an increased recognition of the risks posed by flu and the importance of the flu vaccine.

“There is no guarantee this will be sustained this year and beyond, especially with low levels of circulating flu last year.”

Dr O’Sullivan said that he believed it was “incumbent on public health to reinforce the message of the risks of serious illness and death from flu” to maintain uptake. “This will require a concerted public education campaign.”

According to the World Health Organisation, influenza is an acute viral infection that primarily attacks the upper respiratory tract, including the nose, throat, bronchi and, less frequently, the lungs.

“The disease occurs worldwide and spreads very quickly in populations, especially in crowded circumstances. In the northern hemisphere, annual influenza epidemics occur during autumn and winter affecting approximately 5-to-15 per cent of the population.”

The impact of Covid-19 measures on the spread of influenza this winter is sure to be a subject of future analysis and healthcare planning.

Behind the scenes of a flu campaign

The first meeting of the HSE’s national flu planning steering group for the 2021-22 season took place on 11 May.

According to the minutes, seen by the Medical Independent (MI) following a Freedom of Information request, the meeting began with Dr Kevin Kelleher, HSE Assistant National Director, Strategic Planning and Transformation, Public Health and Child Health, noting that the 2020-21 influenza season “was very successful” with “high rates” of vaccination.

The minutes noted that 72 per cent of those over 65 years were vaccinated (based on CSO 2020 population estimate) and this equated to “almost 80 per cent of this age group who are registered with the GMS [General Medical Services]”.

“The national and EU target for this age group was 75 per cent. Healthcare worker (HCW) worker vaccination update also increased. Circa 280,000 children were vaccinated....”

The May meeting heard discussion around how the influenza vaccination programme was implemented in the HSE. Minutes stated that “the need for stronger structures have been agreed by

CCO [Chief Clinical Officer], COO [Chief Operations Officer] and Community Operations”.

A report at the meeting from HSE acute services noted that there was “a common emerging question”.

“Why not ‘piggy-back’ flu vaccination on to the Covid-19 vaccination programme and centres?”

At the next meeting, held on the 23 June, it was noted that the “first deliveries for the flu vaccine are expected late September, and at regular intervals thereafter”.

The meeting also heard that there were no supply issues anticipated.

The Health Protection Surveillance Centre (HPSC) reported to the meeting that there was “no flu circulating” in Ireland at that time (June).

In regards the lack of influenza circulating last winter, the meeting discussed that “people’s genetic memory of flu is now likely to be significantly reduced so if flu circulates, the severity of illness could have increased”.

The meeting “noted the importance of continuing flu messaging with the general public and the importance of

respiratory etiquette as a first barrier to flu”.

MI asked the HSE a series of questions regarding the plans for this year’s influenza season. The Executive said that because preparations were still underway, it was not in a position to provide details at this time.

“The HSE is in the advanced stages of planning the 2021-22 influenza vaccination programme,” a HSE spokesperson told this newspaper.

“It is anticipated immunisations will begin in early October and will be available free of charge to adults and children (from two years old) at risk of flu and its complications.”

Asked whether this year’s HSE winter plan will make any contingency for the possible emergence of influenza alongside Covid-19, the spokesperson said that it is “currently preparing our plan for managing increased demand across community and acute health services that will arise over the winter period”.

“This plan will include hospital avoidance, patient flow and patient egress measures using the learnings of the pandemic period.”

MINDO NUMBERS

73,023 donors gave 123,304 whole blood donations in 2020, with the pandemic significantly impacting new donor recruitment, according to the Irish Blood Transfusion Service annual report.

55 per cent of whole blood donors were male, the 2020 annual report stated.

4,663 new donors joined the bone marrow registry during the year.

60

Irish patients received a stem cell transplant in 2020.

250,000 Covid-19 vaccines had been administered in pharmacies as of 1 September, according to the Irish Pharmacy Union.

55 million people worldwide are living with dementia, according to the World Health Organisation (WHO).

78 million will be living with dementia by 2030 and 139 million by 2050, stated the WHO’s projections.

Dr Niall O’Sullivan

Confidentiality statements required of HSE pandemic group

CATHERINE REILLY

Members of the HSE national health protection pandemic incident control team (PICT) are required to sign confidentiality statements, a spokesperson has confirmed.

“Confidentiality is an integral part of working in the health services and inherent in all employee roles,” outlined the spokesperson. “It is not unusual to ask groups/committees to agree confidentiality as part of the TORs [terms of reference] or through confidentiality agreements/statements as an addendum to the meeting proceedings.

“This request is likely to occur when we have cross-sector membership groups working with sensitive, commer-

cially sensitive information and/ or when guidance material and reports are under deliberation. We are unaware of any breaches of the confidentiality statements.”

PICT is accountable to the HSE Chief Clinical Officer through the National Clinical Director for Health Protection as Chairperson.

“We are aware that the national standing oversight committee on cases and outbreaks of Covid-19 in highrisk settings [such as] food processing and construction industry sectors also signed confidentiality agreements,” added the spokesperson.

Confidentiality statements were introduced for members of the national public health emergency team

HIQA report imminent on gynae services at Letterkenny

CATHERINE REILLY

HIQA’s review of governance arrangements for gynaecology services at Letterkenny University Hospital (LUH) is “almost complete” and due to be published in the coming weeks, a spokesperson informed the Medical Independent (MI) on 6 September.

The Authority declined to provide any further comment in advance of the review’s completion and publication.

In April 2021, HIQA announced it was commencing the review to ensure that the HSE, Saolta University Health Care Group and LUH were implementing recommendations of an external review into gynaecology service failures at Letterkenny.

Speaking at the time, Mr Sean Egan, HIQA’s Head of Healthcare, said: “It is essential that women accessing gynaecology services are assured that the service is safe and that they are being protected and safeguarded. This review will assess the effectiveness and sustainability of the governance and oversight arrangements to ensure that high-quality gynaecology services are provided at Letterkenny University Hospital.”

In response to eight instances of delayed diagnosis in women with endometrial cancer at LUH, Saolta had commissioned an independent review led by Consultant Obstetrician/Gynaecologist Dr John Price.

The review, which was provided to Saolta in May 2020, referred to “suboptimal triage and administrative practices, suboptimal follow-up practices, and limited fail-safes, underpinned by ineffective communication” as factors in delayed diagnoses.

“LUH is beset with large and worsening waiting lists for both inpatient, day case and outpatient services and there is evidence that insufficient effort is being made to improve the situation.”

Last January, MI reported on a discussion at a Saolta board meeting in September 2020, where the prospect of initiating an independent hospital-wide review of LUH was raised. At the meeting, it was suggested that HIQA could be approached to conduct such an exercise.

Recently, MI reported on 20 consultant vacancies at LUH, where consultant recruitment has been noted as especially problematic within the Saolta Group.

(NPHET) in November 2020 following a review of procedures. A Department of Health spokesperson said the requirement to respect the principle of confidentiality had applied since the establishment of the NPHET in January 2020.

A HIQA spokesperson said members of all expert advisory groups (EAGs) advising the Health Technology Assessment Directorate – including the Covid-19 EAG – are asked to complete confidentiality declarations. “Taking action to deal with a breach in confidentiality has not been required to date,” said the spokesperson.

“The approach in the event of a breach in confidentiality would depend on the circumstance and would range from a conversation between the Chair of the EAG and the member to clarify responsibilities up to and including exclusion from the EAG if deemed necessary.”

Several conditions could be added to bloodspot screening programme

DAVID LYNCH

Members of the national screening advisory committee (NSAC) have highlighted “several” conditions that could be considered for addition to the new-born bloodspot screening (NBS) programme, the Medical Independent can report.

At its meeting on 20 May, the NSAC approved a new standardised application process and procedure for modifications to existing population-based screening programmes.

“This builds on the progress made at our February meeting where we approved the process for applications for new population-based screening programmes,” the NSAC’s Chairperson Prof Niall O’Higgins wrote in his official note of the meeting.

It is anticipated the application process will open in the coming months, with a first annual call for proposals planned for this autumn.

Prof O’Higgins also wrote that “in order to inform the expansion of the national NBS programme, the committee requested HIQA to conduct a review of processes in use interna-

tionally to inform the expansion of NBS programmes”.

“The committee is supported by a specialist, dedicated evidence team in HIQA. The draft report of the findings from this review was considered by the committee at our meeting on 20 May and a wide-ranging discussion, facilitated by the HIQA team, ensued.”

Prof O’Higgins noted that the draft report “provided a comprehensive review” of the experience and approaches of other countries in expanding NBS programmes, including the ethical, legal, and societal issues that arise when planning “an enduring population-based programme of this nature”.

“This evidence-base will greatly help to inform our future decision-making on this important topic.”

The committee concluded there were “several potential conditions that could be selected for consideration for addition to the NBS programme in Ireland and could therefore be subjected to formal assessment by HIQA in the coming months”.

‘Increased usage’ of enhanced Employee Assistance Programme – HSE

PAUL MULHOLLAND

A total of 184 medical and dental staff contacted the HSE Employee Assistance Programme (EAP) counselling service last year and in the first four months of 2021, according to figures obtained by the Medical Independent (MI)

The HSE stated that 143 staff contacted the service in 2020 and 41 between January and April 2021. These figures include calls made to external providers.

As the national EAP data collection system was implemented in 2020, standardised data was not available prior to last year.

In 2020, the HSE provided additional funding to increase the staffing in the internal EAP service by 40 per cent. A new national EAP phone line with a single point of contact for all services was launched, based on feedback from staff

The programme moved to a blended model of service delivery, using telehealth solutions as well as face-to-face delivery.

There were a number of temporary breaks in face-toface delivery based on public health and HSE occupational health Covid-19 guidance and direction.

“The majority of HSE staff access the internal service because of its in-depth organisational knowledge and understanding of the structures and culture of the HSE,” a spokesperson for the Executive told MI

The HSE also changed to a new external contractor for the service.

“The previous Staffcare contract allowed for an EAP external counselling service only and referred to the

contact line for this service as the ‘Staffcare helpline’,” according to the spokesperson.

“In fact, this service was always a counselling only contract. There was never any variation in this contract at any stage or point in time in terms of scope.

“Inspire won the 2020 contract and consequently operate the current counselling only external partner service. It is identical in operation to the Staffcare contract, where each caller is spoken with and triaged to help them access the external counselling service.”

In December 2020, the HSE launched a national EAP awareness campaign that “has successfully increased usage rates, helped to normalise the seeking of psychological support, and improved staff understanding of all the EAP services including counselling”, according to the spokesperson.

The HSE EAP can be reached at 0818 327 327. For further information, visit https://healthservice.hse.ie/staff/benefits-services/benefits/counselling.html

Mater Private Network

Cancer Masterclass for Primary Care

Saturday, 2nd October | 9 am – 12:30 pm

Speakers

Agenda

Session 1 | 9 am – 10:10 am

Breast & Gynaecological Cancer

Introduction – Dr. Jerome Coffey

Recent Advances in Breast Cancer Surgery

– Ms. Siun Walsh

Breast Cancer – Hormones, Chemotherapy & Beyond

– Dr. Sarah Picardo

Improving Outcomes in Ovarian Cancer Care

– Dr. Claire Thompson

Session 2 | 10:10 am – 11:15 am

Genitourinary Cancer

Big Changes in Prostate Cancer Diagnostics

– Prof. Martin O’Connell

Prostate Cancer: Radiation Treatment Options

– Dr. Richard Moore

Systemic Therapy of Prostate Cancer in 2021

– Prof. John McCaffrey

Session 3 | 11:15 am – 12:30 pm

Patient Access & New Developments

Evolving Role and Benefits of Stereotactic Radiation

– Dr. Daniel Cagney

Lung Cancer: Rapid Access leading to Greater Success

– Dr. Dermot O’Callaghan

GI Endoscopy Optical Advances Looking vz Seeing

– Dr. Alan Bohan

Each session to be followed by Panel Discussion / Q&A. Questions can be submitted in advance to events@materprivate.ie or online during the live webinar.

Registration on www.materprivate.ie/news-events/events/ For more information, email events@materprivate.ie

Dr. Jerome Coffey Consultant Radiation Oncologist & Head of Mater Private Cancer Centre

Prof. Martin O’Connell Consultant Radiologist

Ms. Siun Walsh Consultant Breast Surgeon

Dr. Richard Moore Consultant Radiation Oncologist

Dr. Sarah Picardo Consultant Medical Oncologist

Dr. Daniel Cagney Clinical Director Radiation Oncology

Dr. Claire Thompson Consultant Gynaecological Oncologist

Dr. Dermot O’Callaghan Consultant Respiratory & General Physician

Prof. John McCaffrey Consultant Medical Oncologist

Dr. Alan Bohan Consultant Gastroenterologist & Hepatologist

Online event only. CPD applied for.

Maintaining new supply route for medical radioisotopes ‘under discussion’

PAUL MULHOLLAND

It has yet to be decided whether to continue with the new delivery route for medical radioisotopes, which was “deemed necessary” as a result of Brexit, the Medical Independent (MI) can report.

The Department of Health together with the National Cancer Control Programme (NCCP), HSE Acute Strategy and Planning, HSE Acute Operations, the Health Products Regulatory Authority (HPRA) and other stakeholders worked together to put in place measures to prevent and alleviate any acute supply issues of medical radioisotopes in Ireland due to Brexit.

One such measure was the avoidance of transiting supplies through the UK, mainly East Midlands Airport. In 2020, it was agreed that a new delivery route from Leipzig to Dublin would commence in January 2021 for an initial six-month period.

Homeless hospit al discharge programme to be ev aluated

PAUL MULHOLLAND

An independent evaluation of the homeless hospital discharge programme is being planned, the Medical Independent can report.

The programme, funded by HSE Social Inclusion, Sláintecare and the Service Reform Fund is an interagency service for the delivery of healthcare to people experiencing homelessness.

The work incorporates inclusion health services at St James’s Hospital, Dublin, and the Mater Misericordiae Universiy Hospital, Dublin.

It includes pilot implementation and evaluation of a Dublin homeless hospital discharge protocol at St James’s and the Mater, with subsequent adaptation and implementation at other sites; the development of a homeless health peer advocate service and integration within broader clinical services across hospital and community services.

The programme, which commenced in 2018, aims to improve access to care and health and social outcomes for homeless and other marginalised patients at St James’s and the Mater through an integrated approach across primary care and mental health services.

VOX BOX

Director of Public Health at the HSE National Immunisation Office, Dr Lucy Jessop, announcing that people who received a first dose of Vaxzevria (AstraZeneca’s Covid-19 vaccine) can now choose to receive an mRNA (Pfizer/Moderna) vaccine as their second dose.

“This direct route has associated increased costs that were deemed necessary as a mitigation measure for the supply of medical radioisotopes for the initial Brexit period,” according to a letter from the National Director of the NCCP, Prof Risteárd Ó Laoide, to Hospital Group CEOs and other senior HSE management on 31 March, seen by MI through Freedom of Information (FoI) law.

Prof Ó Laoide said the HSE would seek funding from the Department of Health to offset these additional costs.

“In order for hospitals to receive additional funding to offset these costs, the HSE require data on the costs incurred per hospital,” according to the letter.

The HSE/NCCP also planned to obtain the details of additional costs directly from the supplier (Perlamar), thus minimising the work at hospital level.

When questioned on whether the change had led to any supply issues, a NCCP spokesperson said: “There

was no service disruption in the first six months of the year due to the change in route.”

The spokesperson said it was currently under discussion whether the new arrangement would be continued. “The cost for the first six months is being finalised and any additional funding will be allocated to the hospitals.”

According to meeting minutes of the NCCP’s executive management team in January 2021, obtained through FoI law, “Brexit work is ongoing. There have been a number of issues escalated in terms of supply chain challenges to the Brexit ops team…. The residual risk items, radiopharmaceuticals and chemotherapy supply, remain a focus point for the Brexit ops team and there have been a number of escalations to resolve chemotherapy deliveries from the UK.”

“The NCCP continue, as required, to monitor any Brexit-related issues relating to cancer and radiopharmaceuticals and chemotherapy supply.”

It also seeks to ensure planned, coordinated and timely discharges from acute hospitals with appropriate onward referral to health and social supports, including access to suitable accommodation and stable housing.

Another aim is to reduce hospital utilisation by enhancing alternative community pathways.

The procurement process for the independent evaluation is being undertaken by the board of St James’s.

The tenderers must submit a proposal for conducting an evaluation of the programme, specifying the approach and methodology to be employed.

The successful tenderer will be expected to monitor and evaluate the implementation of the homeless hospital discharge protocol from the perspective of key stakeholders, as well as monitor and analyse data on key performance indicators and other data sources.

They would also submit a final evaluation report and related dissemination materials “to ensure that the learning from [the] homeless hospital discharge programme can inform other systems change initiatives”.

The deadline for submissions is 29 September 2021.

DAVID LYNCH

Areas of the country “experiencing average levels of deprivation” are least well served by general practice, new research has found.

A recent Economic and Social Research Institute (ESRI) research bulletin on the use and supply of GP services found they were “most abundant in areas with the highest and lowest levels of deprivation”, while areas experiencing average levels of deprivation were least well-served.

In addition, people residing in more deprived communities had a strong, statistically significant positive association with having seen a GP within the last four weeks.

The research, titled ‘Use and supply of general practitioner services in Ireland by area-level deprivation’, examined the supply and use of GP services by Irish adults according to levels of deprivation in their residential area.

The authors noted that the so-

cio-economic makeup of an area may be relevant to “decisions about how to allocate primary care resources”, particularly in the context of the Government’s Sláintecare strategy.

“In Ireland, those living in areas with highest levels of deprivation make significantly more use of GP services, even after controlling for many factors affecting the need for GP care and GP supply,” the authors stated.

“Higher demand for GP care likely reflects worse health status among many individuals in deprived areas. We also found that the most deprived areas had a relatively good supply of GP services on average, as did the best-off areas.”

The authors noted that the determinants of GP supply were “complex, reflecting historical patterns of population growth, incentives in the medical card system, and ability-to-pay among those not covered by medical cards”.

For the small number of people who have not had a second dose of AstraZeneca, they now have the option to receive an mRNA Covid-19 vaccine dose instead if it is suitable for them, which will mean they are fully vaccinated.”

Areas with ‘average’ deprivation have least access to GPs

This has been another very challenging year for hospital staff, as well as for patients and their families. Now, more than ever, it is vital that we develop our understanding of patients’ experiences in Irish hospitals.”

The IBTS had to respond quickly to a rapidly evolving situation, introducing an appointments system for donors virtually overnight and maintaining the national blood supply by continuing to operate donation clinics throughout the country….”

Irish Blood Transfusion Service (IBTS) CEO Ms Orla O’Brien on the “significant” impact of the Covid-19 pandemic. She was commenting as the IBTS launched its annual report for 2020.

Ms Rachel Flynn, HIQA’s Director of Health Information and Standards and Director of the National Care Experience Programme, on the launch of the new national patient experience survey.

The Evolution of Precision Science

The E volution of Precision Science

Contains a unique combination of two clinically researched synergetic strains

Contains a unique combination of two clinically researched synergetic strains.

Calcium: Contributes to the normal function of digestive enzymes.

Pantothenic Acid, Vitamin B6: Contribute to the reduction of tiredness and fatigue.

✝Calcium: Contributes to the normal function of digestive enzymes.

Pantothenic Acid, Vitamin B6: Contribute to the reduction of tiredness and fatigue.

ScientificallyStudied

ScientificallyStudied

CATHERINE REILLY catherine@mindo.ie

Beaumont seeks ‘the gold seal’ of JCI approval

The website of Joint Commission International (JCI) states that earning 'the gold seal of approval' demonstrates dedication to improving healthcare quality and safety.

The ‘gold seal of approval’, which is a registered trademark, is emblematic of JCI’s global prominence in healthcare accreditation – a process that has both its supporters and sceptics.

According to a JCI brochure, each new edition of standards “reflects the most current thinking in patient safety practices and concepts to help accredited and nonaccredited organisations uncover their most pressing safety risks and advance their goals for continuous quality improvement”.

“Through interviews, observations, and interactions with your organisation, our JCI survey team evaluates the effectiveness of your organisation’s patient safety and quality system. The survey process accommodates and respects specific legal, religious, and cultural factors within a country.”

JCI accreditation can be achieved by different types of health and social care organisations, including hospitals, academic medical centres, laboratories, and longterm care facilities.

Ireland

Currently, there are 31 health and social care organisations in the Republic of Ireland holding JCI accreditation including 17 (mainly private) hospitals.

MI understands the drive for independent accreditation in the private hospital sector was precipitated by a contractual requirement by Vhi, and subsequently, other private health insurance providers. There is no such requirement on public hospitals, however.

Only two of the 17 JCI-accredited hospital programmes in Ireland are publicly-funded – the Royal Victoria Eye and Ear Hospital (RVEEH) in Dublin, which has been accredited as a “hospital programme” since 2014; and St Vincent’s University Hospital (SVUH) in Dublin, accredited as an “academic medical centre hospital programme” since 2010 (St Vincent’s Private Hospital has been accredited since 2009).

Beaumont Hospital in Dublin is now advancing plans to apply for site accreditation with JCI.

In recent months it advertised for a “hospital accreditation manager” – reporting to the Director of Quality and Patient Safety – who will co-ordinate the process from application through to inspection by JCI. The advertisement indicated that Beaumont would seek accreditation as an academic medical centre hospital programme. The accreditation manager will “co-ordinate and work with hospital accreditation teams to determine a baseline level of compliance with the JCI standards and develop and implement quality improvement plans to address any identified gaps”.

In March 2021, hospital management informed the board of its intent to pursue JCI accreditation. The decision arose from the “lack of a licensing system in Ireland”, stated board minutes obtained by MI through Freedom of Information law.

The meeting minutes indicated that the decision was not put to the board for prior approval.

Chairperson Ms Gillian Harford sought fundamental information on the matter, including whether the process would only involve specific departments; whether funding had to be sought; and the length of the process. CEO Mr Ian Carter advised that hospital accreditation would be pursued. He reported that the hospital would fund the “endeavour” directly and the process would take about 12 months (MI understands the process leading up to the application will take approximately 12 months).

RCSI Hospitals Group (where Mr Carter is also CEO)

informed MI that, in April 2021, HSE Acute Operations granted funding for the progression of three quality and safety initiatives within the Group –falls prevention; accreditation; and management of the deteriorating patient. “The required funding in each instance is a Clinical Service Project Manager (grade VII or equivalent).”

A key benefit of accreditation was “externally validated achievement of key internationally recognised patient safety goals”, according to the RCSI Hospitals spokesperson. Currently it is planned “to move this accreditation initiative on a hospital-by-hospital basis commencing with Beaumont Hospital”.

Drivers

Health Care Informed (HCI) works with health and social care organisations to provide patient safety, regulatory compliance, and quality improvement intelligence and support. It has assisted healthcare organisations in preparing for JCI accreditation.

CEO of HCI Mr John Sweeney told MI there are two factors that have driven hospital accreditation in Ireland – one was the requirement on private hospitals initiated by Vhi; the other was organisations’ desire for an overarching quality and safety framework.

The JCI process for site accreditation is widely acknowledged as intensive. Therefore, for a public hospital in a pressurised system, are there risks inherent in taking on this endeavour?

“It is a fair point,” acknowledged Mr Sweeney. “It does require time and energy, there is no question. It is a challenge and it is an investment.”

However, he added: “The organisations, be they public or private, that have gone down the road say yes, certainly the first 12 months – the first 18 months – is challenging, it is difficult, it is time-consuming, but the benefits are there. That is evidenced by the organisations continuing to do it and not just the ones that have to. The initial development work is always a challenge, but it is an investment in what they are doing and the benefits are trying to evaluate and improve the overall systems they are providing.”

The “return on investment” is an organisation that is “better structured, that has clear governance, and has systems in place that have actually been considered and evaluated internally, which is not always the case because people are so busy”. A major benefit from the process is “peer review” as the organisation is assessed by independent experts who are senior professionals in medicine, nursing and administration.

Internationally “accreditation is just growing and growing significantly over the last 10 years”, added Mr Sweeney.

“That is because it is giving these hospitals this framework that helps them to prioritise the areas [required] and helps them see how all of these areas interact with one another.”

RVEEH and SVUH

According to a statement to MI from Mr Patrick Dowling, President of the RVEEH, the hospital has achieved JCI accreditation on three occasions through the “hard work and dedication” of staff.

“Each time it takes a huge amount of effort and time to make sure the hospital passes the rigorous checks JCI requires on inspection. On all occasions the hospital has achieved the standards required on first inspection. We have found that the accreditation process galvanises our staff, brings a greater focus on standards and processes, and ensures that we remain up to date with best practice internationally.

“The fee for this [most recent] accreditation process to JCI for RVEEH was US$26,084. There was discussion, sup-

port, and full approval at board level to seek JCI accreditation. We do not receive specific funding for JCI accreditation from the HSE.”

Ms Angela Smyth, Director of Quality and Patient Safety, SVUH, commented: “Our commitment to quality and patient safety led to us choosing to be independently inspected against international hospital accreditation standards. This promotes a commitment to continued sustained quality improvement for our patients, visitors, and staff within the services we provide.”

SVUH did not disclose the costs associated with maintaining accreditation, but confirmed these are incurred by the hospital.

Benefits of the exercise included the fostering of a culture of safety throughout the hospital and preparing SVUH for future licensing by HIQA.

A healthcare professional who experienced several JCI inspections at a private hospital (who did not wish to be named) said the process potentially instigated positive changes at the hospital, but they maintained this was not the case in their department. The last inspection when they worked at the private hospital was in 2014.

They said the department would alter certain practices during the inspection to comply with the prior advisories of the JCI team. For example, the established practice for a short theatre list was that the anaesthesiologist and anaesthetic nurse laid-out the drugs for each patient in advance.

However, the JCI inspectors advised that the drugs should only be drawn-up when each patient arrived in the anaesthetic room. “[The change in practice] delayed things and caused confusion,” said the healthcare professional. “As soon as they [the inspectors] were gone, everything changed back.”

The entire department was on ‘the same page’ on such issues. The consultants considered such changes in practice as “malarkey” and feared it would lead to “nothing getting done”.

There would also be “surprise questions” that were sometimes directed at staff who would not be qualified to respond (for example, questions on theatre practice directed at recovery room nurses).

Oversight

According to HCI’s Mr Sweeney, in previous years, some organisations saw the process as an exam and the main goal seemed to be the generation of new policies and copious paperwork. He believed the approach of organisations had substantially moved forward.

It is crucial the process is clearly managed with close oversight from the senior management team, he underlined. “[Another] big risk is that this meanders along and starts soaking up people’s time and pulls them away. That is where we come in. Where our role is very much involved is to make clear that when people are allocating this time, be it an hour a month or two hours a month… that they are focusing on what is important.”

Mr Sweeney said he was unaware of any other developed country that did not have either accreditation or regulation across the hospital sector. Prior to the Covid-19 pandemic, there was “a lot of interest” within public sector organisations regarding independent accreditation.

A healthcare licensing system has been planned by Government for many years. The Patient Safety (Licensing) Bill is currently with the Attorney General’s Office for drafting to be undertaken. The licensing body under the proposed system would be HIQA.

MI asked the Department of Health if any other licensing bodies would be permitted under the system; and whether independent accreditation by an international organisation (such as JCI) would be recognised as an alternative to the HIQA process.

According to the Department, HIQA “will be the licensing authority under the Bill”.

The lack of a licensing system in Ireland has prompted Beaumont Hospital’s decision to prepare for independent accreditation. Catherine Reilly reports

Mr Ian Carter

Mr John Sweeney

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

In a time of emergency

Dr Fergal Hickey, President of the Irish Association for Emergency Medicine, talks to David Lynch about positive developments in emergency medicine, despite the significant challenges faced by the specialty

When outlining the challenges facing emergency medicine (EM) and emergency departments (EDs) in Ireland, President of Irish Association for Emergency Medicine (IAEM), Dr Fergal Hickey, paused for a moment.

“Look, the irony is despite what I’m saying about recruitment and other issues, there is a huge interest among medical students in emergency medicine,” Dr Hickey, Consultant in Emergency Medicine at Sligo University Hospital, told the Medical Independent (MI)

However, the difference now is there “are more organised training programmes to accommodate” and develop this interest.

“There are very active student emergency medicine groups in the six universities. There are significant numbers applying for basic training in emergency medicine... [training] posts are oversubscribed.”

In Irish EM, there is “a huge amount of dynamism and enthusiasm and a lot of good research work”, as well as a “huge amount of good work done in our EDs”.

The IAEM has been busy and recently published a new policy document titled Strategic Objectives for the Irish Association for Emergency Medicine

“It was a fairly comprehensive process arriving at that strategy,” Dr Hickey told MI “That process got complicated by Covid... and then the cyberattack. It [the document] represents our view of what needs to happen both for emergency medicine and for the IAEM. The next step is that the IAEM executive will need to come up with an implementation plan” for the coming years.

Dr Hickey said he would not describe the enthusiasm of trainees for EM as “growing”, but as something that was “always there”. He pointed out that this interest has been facilitated by new training pathways.

Dr Hickey noted that in the US, EM “has always been in the top two” most popular specialties for medical students and “we would have a similar experience in Ireland”.

“Medical students like EM because of its dynamic nature; the fact that you can make a difference to patients. Some people don’t want to be responsible for continued care. They are happy to treat a patient when they have a crisis and then discharge them or move them on to another specialty. So we know that there is a high level of interest that has always been there.”

“There is a clear pathway from internship through to becoming a consultant. The challenges are because they [successive governments] haven’t addressed issues that are outside the control of emergency departments.”

According to Dr Hickey, issues such as the consultant salary, crowding and capacity are hindering the supply of consultants in the Irish system.

Some of the challenges facing EM and EDs nationally are longstanding, but others have emerged more recently. While aspects of the fallout from the devastating cyberattack on the HSE in May have been addressed, the impact can still be felt in the country’s hospitals.

enduring issues that the IAEM has raised.

“Over the last six-to-eight weeks, most emergency departments around the country have set new records for attendances within a 24-hour period,” said Dr Hickey, speaking to MI in August. “That’s a cause for concern, particularly as the number of patients on trolleys is climbing and the level of the [Covid-19] Delta variant in the community is rising.”

Looking towards the winter period, Dr Hickey warned that “we have elements of a perfect storm”.

He also stated that EDs were “short of registrars, there seems to be a national shortage and many EDs have been fairly badly hit”.

“And many, if not most, are short some of their normal complements... so nurse recruitment and retention is challenging.

and Department of Health reports that confirm the bed problems. “The bed capacity report makes fairly optimistic predictions about the impact of Sláintecare, which are unlikely to be fully realised. So in effect [what is needed] is far more than the 2,000 [beds specified in the report].”

“At the same time demand for healthcare is going up, the capacity to deliver it is not going up to meet our demands five years ago, much less our demands currently.”

With these combined difficulties in the hospital system, “the pressure tends to be felt in the emergency department.”

“If you can’t move people out of the other end of the hospital system... they have nowhere to go, they end up being retained in the emergency department, it becomes a warehouse for admitted inpatients. But it’s also expected to function as an emergency department. It’s not possible to do two of those things together.

“That is one of the reasons that we are losing nursing staff who are finding it increasingly intolerable and if they are being replaced, they are often being replaced with people with less experience.”

Consultant recruitment

As noted, the recruitment challenge also extends to consultants across specialties, who have been impacted by the 2012 salary cut imposed on ‘new-entrants’.

“Emergency medicine is hit as hard, if not harder, than any other speciality [in respect of consultant recruitment]”. According to Dr Hickey, many consultant posts are vacant and filled by locums.

“And ironically many of the locums have not had formal emergency medicine training and are being paid more than those [doctors] who have had formal emergency medicine training, but who are subject to the so called new-entrants salary... so it makes no sense economically or from a service provision point of view. We have significant numbers of vacancies and we have hospitals that have more than one vacancy in a workforce that is relatively small.”

Most IT systems are back up and running, acknowledged Dr Hickey. “But the functionality of what has returned is often not as good as the functionality we had previously. So, many of the systems have far more steps that need to be taken to use them... there are huge frustrations as a result of that; it takes longer to do things than it used to.

“This is happening at a time we are seeing record number of patients with fewer staff than we need, so this is just one more [problem] that causes difficulty.”

Overcrowding

Overcrowding in EDs and the annual problems at winter are among the more

Medical recruitment is challenging, and at the same time, we have an increased number of attendances and we have a large number of patients on trolleys. And this is a concern given that you and I are having this discussion in August, it’s not winter.”

The pressure on capacity in the hospital system is a matter the IAEM has been highlighting for years.

“We get a huge amount of lip service paid to it. People accept that we are 2,000 acute hospital beds short of where we need to be, and yet the rate in the improvement of bed capacity is glacial. It is not for the want of us pointing out the issues.”

The IAEM President said there are HSE

Dr Hickey estimated there were “roughly 100 consultants in emergency medicine at the moment” and about 20 unfilled consultant posts. He noted he could see the impact of the contract issues on the decisions made by EM graduates.

“A lot of people are saying ‘I don’t want to take up a consultant post, because of the salary cut’ or ‘my skills or expertise are better regarded in Australia or New Zealand or Canada, or US’. People are voting with their feet,” he warned.

“That is a sad reflection of something that was brought in 2012 during the financial crisis and proved to be very detrimental, and rather than fix the problem they have continued with a very flawed policy, which is causing major difficulties in every specialty in the country. It’s bizarre.”

Dr Fergal Hickey

david@mindo.ie

Medical recruitment is challenging and, at the same time, we have an increased number of attendances and we have large number of patients on trolleys

Enabling people with depression to feel, think

Brintellix is indicated for the treatment of major depressive episodes in adults1

Brintellix® (vortioxetine) film-coated tablets

Prescribing information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing, particularly in relation to side effects, precautions and contraindications. Presentation: Tablets containing 5, 10, 15 or 20mg vortioxetine. Indication: Treatment of major depressive episodes in adults. Dosage: 10mg once daily. May be increased to a maximum 20mg daily or reduced to 5mg if necessary. After symptoms resolve, treatment recommended for at least 6 months. Can be taken with or without food. Elderly (≥65 years): Initial dosage is 5mg once daily. Caution advised if using doses above 10mg daily. Children (7-11 years): Not recommended. Adolescents (12-17 years): Not recommended in major depressive disorder; efficacy not established. Cytochrome P450 inhibitors and inducers: Consider a dose reduction of vortioxetine if a strong CYP2D6 inhibitor is added. Consider a dose adjustment if a broad CYP450 inducer is added to treatment. Renal or hepatic impairment: No dose adjustment; subpopulations are vulnerable and data on the use of Brintellix are limited. Contraindications: Hypersensitivity to the active substance or excipients. Concomitant use with nonselective, monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (e.g. moclobemide).

Fertility, pregnancy and lactation: Limited data; should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus. Animal studies showed reproductive toxicity. Use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Potential risk of postpartum haemorrhage following exposure to an SSRI or SNRI within the month prior to birth. Excreted into human milk, risk to the breastfeeding child cannot be excluded. Animal data showed no effect on fertility, sperm quality or mating performance. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed. Please refer to SPC for more detail.

Warnings & Precautions: Closely supervise patients, especially those at high risk for suicide-related behaviours during first few weeks of treatment and during dose changes. Use with caution in patients: at risk of hyponatraemia; with a history of mania/hypomania; aggression/agitation; undergoing ECT; with unstable epilepsy (discontinue if seizures begin for the first time or increase in frequency); with bleeding tendencies/disorders, taking anticoagulants or medicines affecting platelet function; in patients on lithium or tryptophan; with increased intraocular pressure, or those at risk of acute narrow angle glaucoma. Monitor patients for appearance of serotonin syndrome or neuroleptic malignant syndrome and discontinue if occurs. Patients may experience feelings of aggression, anger, agitation and irritability. Patients/caregivers should seek medical advice if such behaviour emerges or aggravates. SSRIs/SNRIs may increase the risk of postpartum haemorrhage. Brintellix tablets contain sodium (<1mmol/tablet).

Drug interactions: Alcoholic drinks not advisable. Vortioxetine is extensively metabolised in the liver.

Potential for interactions with: MAOIs, MAO-A and MAO-B inhibitors; serotonergic medicines; St John’s wort; products which may lower the seizure threshold, e.g. antidepressants, neuroleptics, mefloquine or bupropion. Lower dose may be considered if strong CYP2D6 inhibitor is added to treatment depending on patient response, these effects may be greater in patients who are poor metabolisers of CYP2D6. Dose adjustment may be considered if a broad cytochrome P450 inducer is added to treatment. Reports of false positive results in urine enzyme immunoassays for methadone in patients taking vortioxetine. Exercise caution in interpreting positive drug screen results. Effects on ability to drive and operate machines:

No or negligible influence, dizziness has been reported; use caution at the start of treatment or when the dose is changed. Adverse events: Most common adverse reaction is nausea, usually mild or moderate, transient and occurs within first two weeks of treatment. The following have been reported in clinical trials and during post-marketing use: Very common (≥1/10 patients): nausea. Common (≥1/100 to <1/10): abnormal dreams, dizziness, diarrhoea, constipation, vomiting, pruritus, including generalised pruritus. Uncommon (≥1/1,000 to <1/100): flushing, night sweats. Rare (≥1/10,000 to <1/1,000): mydriasis (which may lead to acute narrow- angle glaucoma). Not known: anaphylactic reaction, hyponatraemia, insomnia, agitation, aggression, serotonin syndrome, haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding), angioedema, urticaria, rash. Sexual dysfunction: 20mg dose was associated with increase in sexual dysfunction. Class effect: Studies in patients ≥50 years of age, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. Not known if relevant to vortioxetine. Paediatrics: Higher incidences reported in adolescents for abdominal pain-related events and suicidal ideation. Prescribers should consult the full SPC in relation to other side effects. Overdose: Management consisting of treating clinical symptoms and relevant monitoring. Legal category: POM, for non-renewable supply. Brintellix Tablets, blisters of: 5mg (EU/1/13/891/002) 28 tablets. 10mg (EU/1/13/891/010) 28 tablets. 15mg (EU/1/13/891/019) 28 tablets. 20mg (EU/1/13/891/028) 28 tablets. Further information available from: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co. Dublin. Tel: 01 468 9800. Date of last revision of PI: November 2020. Reference: IE-BRIN-0254. Brintellix® is a Registered Trade Mark.

Job number: IE-BRIN-0262

Date of preparation: March 2021

Reference: 1. Brintellix Summary of Product Characteristics. Available at https://www.medicines.ie/medicines/brintellix-10-mg-film-coated-tablets-34817/smpc

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Lundbeck on: 01 468 9800 Email: SafetyLuIreland@lundbeck.com

and do better1

Menopause – The need to open up the conversation

Following extensive coverage of the menopause on RTÉ Radio 1’s Liveline programme in May, GPs are reporting an increase in women seeking advice and support with symptoms, writes

Niamh Cahill

Menopause affects all women, but it is an issue often spoken about in hushed tones.

This changed in May when Ms Sallyanne Brady, founder of The Irish Menopause, took to the airwaves to inform listeners about her own experiences.

Ms Brady told the Medical Independent (MI) that she appeared on RTÉ Radio 1’s Liveline after writing to presenter Mr Joe Duffy urging him to “give women a voice”.

“I lost four to five years of my life from this…. I was told I was too young to have the menopause. I became suicidal and ended up in Pieta House because I couldn’t get treatment. GPs didn’t have the information and my symptoms were dismissed and ignored.”

Despite her unpleasant experience and the sub-standard treatment of some women as elucidated on Liveline , Ms Brady holds no ill-will towards doctors, whom she said “don’t always join the dots”.

“Nobody wants to talk about it and that’s what has us in this mess. How can medicine and science address the issue if they don’t know it’s a problem?”

Ms Brady established The Irish Menopause in 2019 to “inform, support, and guide women”. The group now has 22,000 Facebook members.

A petition to Government for greater education, investment, and GP training in respect of menopause has been signed by almost 20,000 people to date.

Definition

The menopause is defined as the last day of the last menstrual period, but the term is also used to describe the many months or years before that day, when the ovaries transition from producing large amounts of reproductive hormones to producing almost none, according to menopause specialist and GP at Bray

Women’s Health Centre, Dr Deirdre Lundy. There are up to 100 symptoms associated with the menopause, but around 40 are seen most commonly.

Mood changes, anxiety and depression can be experienced. Early perimenopausal symptoms such as hot flushes, sweating (especially at night), poor sleep, and mood and cognitive changes can have a significant impact.

According to Dr Lundy, who appeared on Liveline to address issues raised by women, the radio discussion marked a turning point.

“My own practice has had to stop accepting menopause consults as we cannot care for the amount of women seeking help. Thankfully there are many Irish GPs who still have capacity, but it is a struggle for some women, especially medical card holders, to get access to those doctors,” Dr Lundy told MI

Despite the impact of Covid-19 on healthcare, which Dr Lundy said had “set us back 18-to-24 months”, she welcomed the fact that greater resources are being invested in women’s health.

“There is funding out there now that was never available before. Another great innovation is the promise of the establishment of gynaecology OPD in hospital. They will be co-serviced by GPs with specialist gynaecology skills as opposed to first year SHOs.”

Treatment In a recent column in MI , Tipperary GP Dr Lucia Gannon addressed why doctors hesitate to prescribe hormone replacement treatment (HRT) for women experiencing menopause.

Up until 2002, HRT was commonly prescribed internationally. However, prescriptions declined substantially after a US study prompted concern about a possible link between HRT and breast cancer.

According to Dr Lundy, the study did not suggest causation but that there was a slight association in some older women over time. The authors chose to pause that part of the study until more information was gathered.

But an article by some of the study authors, later published in the Journal of the American Medical Association (JAMA), led to international concern that HRT may cause breast cancer after it was picked up by the media.

“Those of us able to actually read a scientific paper and question the claims continued to advise and prescribe, but we were a minority,” wrote Dr Lundy in an article published in MI ’s sister publication, Nursing in General Practice

How can medicine and science address the issue if they don’t know it’s a problem?

“No matter how much we tried to reassure patients about the real relationship between HRT and breast cancer there were just as many other doctors warning patients to avoid it at all costs! This still happens today and is inexcusable.”

Guidance published in 2015 by the UK National Institute for Health and Care Excellence has helped to change perceptions and increase confidence in HRT treatment. However, only 10 per cent of women experiencing menopause in the UK are on HRT.

According to Ms Brady, women who have had breast cancer are generally excluded from receiving HRT in Ireland. She said this was not the case in the UK.

“It is just a blanket ‘no’ here and it shouldn’t be,” she maintained. Ms Brady added that much research on the topic, even today, is “fluffy and scanty”. She is calling on the HSE to design information leaflets on the menopause for GPs and healthcare clinics to ensure women have “evidence-based information”.

Since the Liveline coverage, Dr Gannon has noticed “that it is much easier to persuade women to do something about their symptoms”.

“It seems as if the symptoms have been validated by hearing others describe them and whether it is lifestyle measures or HRT, or both, the women I talk to

are much more receptive to doing something positive about them,” according to Dr Gannon.

“I used to find that even after going through a full menopause consultation and examination and explanation, and coming to a shared decision to prescribe HRT for some, they would stop it prematurely as there was a lot of fear around the side-effects and ambivalence about taking medication for a ‘condition’ that was a natural consequence of ageing. This has changed.”

Ultimately, she hopes greater awareness will lead to increased resources for women’s health and improve information on this “complex” subject.

“It is encouraging that the ICGP have appointed a Women’s Health lead recently and this should lead to the development of guidelines and education for GPs. There are so many things demanding resources and attention that it is difficult to keep abreast of everything and of course Covid and the cyberattack did nothing to help.

“It has taken a long time for doctors and patients to forget the headline warnings about HRT, but it may be happening now thankfully.”

A women’s health taskforce was established in 2019 and Budget 2021 saw €5 million allocated to a “women’s health fund” to help deliver taskforce targets.

GPs

Another positive development is the desire among GPs to learn more about menopause in order to help patients.

More than 1,500 GPs attended a recent ICGP webinar to hear a talk by Dr Caoimhe Hartley, who has launched a dedicated women’s health and menopause clinic in Dalkey, Co Dublin.

Speaking to MI , Dr Hartley said she regularly receives emails and referrals from other GPs about challenging cases.

“There has been a definite increase in the level of interest among both GPs and women in the last month,” she said.

“There has been more media coverage of menopause and HRT also. This is in part, I believe, due to the increasing evidence that menopause is a time of medical importance for women – it is when we see changes in our cardiovascular, neurological, musculoskeletal and psychological health.”

Against the background of a lack of accessible evidence-based information, Dr Hartley believes it is incumbent on healthcare providers to “interpret the research and translate the benefits and risks to women”.

“It is our job to recognise menopause as a possible (and treatable) cause of symptoms that can impact quality-of-life for some women. On a society level, we are totally youth obsessed so some of the barriers to discussion on this topic may be due to stigma around ageing. There is also a cultural disinterest in targeting ‘older’ women.

“I think as a GP who is specialising in this area and is passionate about women’s health in general, the responsibility is on us to start the conversation and to provide accurate, reliable information for the women we care for.”

Dr Deirdre Lundy

Dr Lucia Gannon

Dr Caoimhe Hartley

peripheral, dyspnoea, abdominal pain, constipation, stomatitis, oral disorder, hyperbilirubinaemia, Palmar-plantarerythrodysaesthesia syndrome, rash, alopecia, pruritus, dry skin, proteinuria, pyrexia, oedema, mucosal inflammation, malaise, hepatic enzyme increased, blood alkaline phosphatase increased, weight decreased. Uncommon Septic shock, enteritis infectious, lung infection, biliary tract infection, influenza, urinary tract infection, gingivitis, herpes zoster, tinea pedis, candida infection, bacterial infection, infection, neutropenic sepsis, upper respiratory tract infection, conjunctivitis, cancer pain, pancytopenia, granulocytopenia, monocytopenia, erythropenia, leukocytosis, monocytosis, dehydration, hyperglycaemia, hyperkalaemia, hypokalaemia, hypophosphataemia, hypernatraemia, hyponatraemia, hypocalcaemia, gout, anxiety, insomnia, neurotoxicity, dysaesthesia, hyperaesthesia, hypoaesthesia, syncope, paraesthesia, burning sensation, lethargy, dizziness, headache, visual acuity reduced, vision blurred, diplopia, cataract, dry eye, vertigo, ear discomfort, angina pectoris, arrhythmia, palpitations, embolism, hypertension, hypotension, flushing, pulmonary embolism, pleural effusion, rhinorrhoea, dysphonia, oropharyngeal pain, epistaxis, cough, enterocolitis haemorrhagic, gastrointestinal haemorrhage, pancreatitis

Chronic neglect means it’s right to be apprehensive about winter

In this issue of the Medical Independent (MI), our main feature focuses on the uncertainty of the coming winter period. This uncertainty is driven by the reopening of society after more than a year of restrictions to limit the spread of Covid-19.

While Ireland’s high vaccination rate offers encouragement, the greater transmissibility of the Delta variant remains a cause for concern as people are allowed to gather more freely. Also, one of the side benefits of lockdown last winter was that influenza was notable only by its absence. The measures taken to contain Covid (physical distancing, mask wearing, etc) had the consequence of containing more traditional seasonal threats.

While health services last year struggled in the face of Covid, at least they were spared the usual impact of influenza. This is unlikely to be the case this winter as restrictions lift. And some doctors are worried.

In an interview with MI , Respiratory Consultant at Bon Secours in Cork, and senior medical lecturer at University College Cork, Dr Oisin O’Connell, warned that it was “naïve” on the part of the Government to lift some measures, such as mask-wearing, at this point.

“The transition to indoor living in Ireland’s cold, wet winters can be a breathing ground for other respiratory viral infections,” according to Dr O’Connell. He said this was worrying given the health system has already been under increasing pressure in recent months. The Government’s plan needs to be reassessed as a “priority”, he contended.

One of the primary reasons for our prolonged lockdown was the very fragile state of our health service, which has suffered from overcrowding and long waiting lists for years as a result of chronic capacity and staffing deficits.

In the midst of a pandemic, Ireland’s health service requires a greater layer of protection than those in many other European countries. This is not to say that restrictions should not be lifted. It is just stating that our health service has been made vulnerable as a result of years of under-investment, mismanagement, and shortterm thinking.

The next number of months require careful navigation by the Government, health management, and other stakeholders, to ensure the healthcare system does not become overwhelmed on the road back to ‘normality’.

The continued success of the vaccination programme is a genuine source of hope. But serious questions need to be asked before this crisis is fully over as to why the chronic problems that beset the health service have been allowed to fester for so long.

Uncertainty is inevitable at a time such as this. Few countries have emerged from the pandemic without serious scars and most will view the coming winter with understandable apprehension.

However, we would be on surer ground had the longstanding deficits in the community, acute, and public health sectors been adequately addressed by successive governments.

READER COMMENTS

REACTION TO DR SARAH FITZGIBBON'S COLUMN, 'NEVER TOO LATE TO CHANGE', 6 SEPTEMBER

"Best of luck, Sarah. Am sorry that general practice is losing you, but totally get the desire to do something new. CervicalCheck are lucky to have you. Keep us posted. Always like to hear how people navigate new challenges… a great column as always!" Dr Lucia Gannon, @LuciaGannon, 8 September

"Thanks for all the good wishes about my career change! I’d love to hear any tips and hints from others who have resigned or retired from general practice on how best to hand over patients. Leave lots and lots of meticulous notes? Or verbally hand over the most complex?" Dr Sarah Fitzgibbon, @SarahFitzWiMIN, 5 September

"Best of luck in the new job. Really enjoyed reading your article. You’ll bring great perspective and insight to the new role from general practice!"

Patrick Kelly, 4 September

"Best wishes Sarah in your new role – you are an inspiration to all women and have no doubt the CervicalCheck team are delighted to have you join them. I always enjoy your writing." Dr Mairead Fagan, @HealthcareRout1, 2 September

"A lot of people do a leadership course and then make a change! I’m doing the RCSI one now." Dr Keith Perdue, @Keith6perdue, 2 September

"Change transformed my outlook… embrace... life is too short not to take opportunities presented #rightplace #righttime."

Dr Rose McCullagh, @rmcc182, 2 September

"'I am proud to have joined an organisation that has overcome a huge amount of difficulty and is consistent in its goal to provide a world-class screening service to the people of Ireland' #CervicalCheck Delighted to have you join our team!" Dr Nóirín Ní Rùiséil, @russellnoirin, 2 September

"Sarah, so well written and has a sense of the loss and opportunity that change often brings. Thanks for your honest sharing, I am sure you will make a great contribution in CervicalCheck and be missed by many in general practice."

Maeve Hurley, @HurleyMaeve, 2 September

REACTION TO OUR NEWS STORY, 'EMERGENCY MEDICINE "HIT HARD" BY CONSULTANT RECRUITMENT PROBLEMS', 6 SEPTEMBER

"'Many of the locums have not had formal emergency medicine training and are being paid more than those [doctors] who have had formal emergency medicine training.'" Dr Gerard Crotty #CareCantWait, @gmcrotty, 4 September

"Emergency medicine consultants continue to be stretched thin due to chronic recruitment and retention crisis #CareCantWait for emergency patients. Solutions needed now @DonnellyStephen @davidcullinane @mmcgrathtd @LeoVaradkar." IHCA, @IHCA_IE, 3 September

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MINDO CARTOON

Fictional patient, for illustrative purposes only

*A worsening of symptoms or a history of exacerbation treated with antibiotics or oral corticosteroids in the past 12 months

It’s the

TRELEGY Ellipta provides your patients with statistically superior improvements in lung function and health-related quality of life, and reduction in annualised rate of moderate/ severe exacerbations** vs. budesonide/formoterol***1–3

Moderate exacerbation is a worsening of symptoms or a history of exacerbation treated with antibiotics or oral corticosteroids. A severe exacerbation is a worsening in symptoms that required hospitalisation.

TRELEGY Ellipta (FF/UMEC/VI) 92/55/22 mcg OD is indicated for maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of a LAMA and a LABA1

▼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.

Co-primary endpoints were change from baseline in trough FEV1 and SGRQ at week 24 (n=1810). A subset of patients (n=430) remained on blinded study treatment for 52 weeks. Trelegy showed an improvement in trough FEV1 of 171mL versus budesonide/formoterol (p < 0.001, 95% CI 148,194) at week 24. Trelegy showed an improvement in health-related quality of life (SGRQ) of 2.2 units (p <0.001, 95% CI 3.5, 1.0) at week 24. At week 52 in a subset of patients Trelegy showed a 44% reduction in annualised rate of moderate/severe exacerbations versus budesonide/formoterol (95% CI 15,63, p=0.006, Absolute difference 0.16).

TRELEGY Ellipta is generally well tolerated. Common adverse reactions include: pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain1

FF, fluticasone furoate; ICS, inhaled corticosteroid; LABA, long-acting ß2-agonist; LAMA, long-acting muscarinic antagonist; OD, once-daily; UMEC, umeclidinium, VI, vilanterol

References: 1. TRELEGY Ellipta SmPC 2019. 2. Lipson DA et al. Am J Respir Crit Care Med 2017; 196:438–446. 3. Lipson DA et al.N Engl J Med 2018; 378:1671–1680.

Trelegy▼ Ellipta (fluticasone furoate/umeclidinium/vilanterol [as trifenatate]) Prescribing information.

Please consult the full Summary of Product Characteristics (SmPC) before prescribing Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of fluticasone furoate (FF) 100 micrograms (mcg), umeclidinium bromide (UMEC) 62.5 micrograms and vilanterol as trifenatate (VI) 25 mcg provides a delivered dose of 92 mcg FF, 55 mcg UMEC and 22 mcg VI. Indications: Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting ß2-agonist (LABA) or a combination of a LABA and a long acting muscarinic antagonist. Dosage and administration: One inhalation once daily at the same time each day. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate). Precautions: Paradoxical bronchospasm, unstable or life-threatening cardiovascular disease or heart rhythm abnormalities, convulsive disorders or thyrotoxicosis, pulmonary tuberculosis or patients with chronic or untreated infections, narrow-angle glaucoma, urinary retention, hypokalaemia, patients predisposed to low levels of serum potassium, diabetes mellitus. In patients with moderate to severe hepatic impairment patients should be monitored for systemic corticosteroid-related adverse reactions. Eye symptoms such as blurred vision may be due to underlying serious conditions such as cataract, glaucoma or central serous chorioretinopathy (CSCR); consider referral to ophthalmologist. Increased incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroids. Risk factors for pneumonia include: current smokers, old age, patients with a history of prior pneumonia, patients with a low body mass index and severe COPD. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Trelegy. Acute symptoms: Not for acute symptoms, use short-acting inhaled bronchodilator. Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases. Therapy should not be abruptly stopped without physician supervision due to risk of symptom recurrence. Systemic effects: Systemic effects of ICSs may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Interactions with other medicinal products: Caution should be exercised with concurrent use of ß-blockers. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products), hypokalaemic treatments or non-potassium-sparing diuretics. Co-administration with other long-acting muscarinic antagonists or long acting ß2-adrenergic agonists is not recommended. Pregnancy and breast-feeding: Experience limited. Balance risks against benefits. Side effects: Common (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, arthralgia, back pain. Uncommon (≥1/1,000 to <1/100): viral respiratory tract infection, supraventricular

tachyarrhythmia, tachycardia, atrial fibrillation, dysphonia, dry mouth, fractures. Rare (≥1/10,000 to <1/1,000): Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, and rash. Not known (cannot be estimated from the available data): vision blurred. Marketing Authorisation (MA) Holder: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA No. [EU/1/17/1236/002]. Legal category: POM B. Last date of revision: September 2020. Code: PI-6725. Further information available on request from GlaxoSmithKline, 12 Riverwalk, Citywest Business Campus, Dublin 24. Tel: 01-4955000.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

MR NIALL ROONEY

The pitfalls of treating colleagues and family members

Doctors are frequently asked to provide medical advice or treatment to their family members or colleagues. Although it can seem like getting free or rapid medical advice or treatment is an assumed or expected perk of the relationship, it is often problematic for the doctor, may not be in the best interests of the patient and certainly requires careful consideration of the potential risks and challenges that can arise.

It is undoubtedly difficult to refuse to provide advice or treatment to a colleague, particularly where there has been a long-established culture in the hospital or practice of prescribing an occasional antibiotic or pain medication when the risks appear minimal. However, difficult it may be, for the reasons set out below, best practice is to advise your colleague to seek medical advice or treatment from their own doctor.

Not all relationships are created equally

Having a close personal relationship with a patient can make it difficult to maintain clinical objectivity, and can impact the normal doctor-patient relationship. For example, might a doctor feel pressurised to sign a prescription requested by another doctor they work with or to provide treatment they would not usually provide to an employee where they may otherwise be left short-staffed?

When considering whether to treat those with whom you have a personal relationship with, doctors should be aware of the relevant section of the Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners (the ‘Ethical Guide’).

Treatment of relatives

60.1 You should not treat or prescribe for members of your family or others with whom you have a close personal relationship except in emergencies. You must not prescribe controlled substances for them or issue sick certificates or reports for them except in emergencies.

Anecdotal evidence suggests the practice of informal prescribing for friends and colleagues is not uncommon. However, it is clear from the Ethical Guide that prescribing for a family member or those with whom a doctor has a close personal relationship should be avoided save in the emergency situations. Doctors who prescribe medication on an informal basis, often without a full clinical examination, are putting themselves at significant professional risk and may be subject to criticism. In addition, doing so may have implications for patient safety and continuity of care of the patient not least when in the absence of the full clinical records

or examination, the doctor must rely entirely on the patient to relay clinically relevant information.

If you decide to prescribe for colleagues or others with whom you have a close personal relationship with, you should make a clear record of the treatment provided as well as why no alternative was available at that time. It is important not only for continuity of care but also has potential legal implications if evidence is required for defending a claim or regulatory complaint. Where possible, any such prescribing should be conditional upon the person agreeing to you notifying their own doctor of the treatment provided or medication prescribed.

Confidentiality

Whilst it is always important to keep patient information confidential, treating other doctors or members of staff can give rise to additional considerations such as who can access their records. If it is necessary to treat your colleagues, special consideration should be given to ensuring their information is kept strictly confidential. For example, many software packages include a facility to lock or limit access to some or all patient notes.

It should be explained to the other doctor or employee when accepting him/her as a patient that other members of staff may require access to their records in the ordinary course or may inadvertently see their records despite you taking all steps reasonably practicable to preserve patient confidentiality. All staff would ordinarily be expected to sign a confidentiality statement/agreement to safeguard against inappropriate access to records or use of confidential information, but it is worth ensuring such agreements are in place and to provide regular reminders/training to staff in relation to their obligations around patient confidentiality.

Disputes over treatment

It is always a challenge to appropriately deal with a patient who is dissatisfied with the treatment or care they have received. Complaints or dissatisfaction coming from a colleague can complicate matters further and impact not only the doctor-patient relationship, but also wider relationships within the hospital or practice setting.

Take the example of a doctor’s receptionist who is taken on as a patient and then suffers an adverse reaction to prescribed medication or a fainting episode after administration of the winter flu vaccine. We have seen time and again where these types of adverse events escalate into complaints or formal claims for compensation. It can be extremely difficult to avoid the issue becoming personal to one or both parties and there is significant potential for long established relationships to be damaged.

Conflict of interests

It can be particularly difficult to avoid actual or perceived conflicts of interests when treating patients who are also colleagues in the hospital or practice. Clear conflicts of interest can exist from an employment law perspective when clinicians wear two hats: One as a treating doctor and the other as the employer or someone in a management role.

Typical issues we have advised on in Medisec include:

 The difficulty of staff who may be reluctant to talk openly and discuss personal issues with the doctor, knowing that they are also their employer and thus hampering the doctor-patient relationship.

 The significant challenges that can arise if the treating doctor becomes aware of confidential information by virtue of having treated a colleague that can affect job performance, such as a health condition

or social/family circumstances, or information that can have patient safety implications such as where the colleague sought advice regarding drug or alcohol misuse.

 The dilemma of whether to issue a sick certificate to a colleague arises frequently. A refusal, even on strong clinical grounds, could lead to an accusation of prioritising the needs of the hospital or practice over the patient’s best interests. Equally a doctor who provides a sick certificate to a colleague or employee may come under pressure or have a perception of pressure from the practice or hospital management who may want the employee back at work.

No other alternative

Whilst it is preferable to have a policy against treating colleagues or members of staff, there may be scenarios where providing treatment is necessary or unavoidable. Such scenarios include cases of emergency where delay can have severe consequences to a patient’s health. Equally, there will be occasions where colleagues or staff do not have easy access to an alternative doctor due to the geographical location of the practice or hospitals, in particular in remote rural communities. In such scenarios, treating colleagues or staff may be unavoidable and the treating doctor will have to take practical steps to safeguard confidentiality and to maintain clinical objectivity. Although not always possible, assigning the clinical care of the colleague or staff member to another employed doctor can be a practical step to address any actual or perceived issues around clinical objectivity.

Conclusion

 Best practice is to avoid treating colleagues or family members. Instead they should be advised to attend their own doctor where possible.

 In emergency situations, it is appropriate to provide all necessary care to make the patient safe until further help can be sought from their own doctor(s).

 Where it is necessary to provide treatment or advice to colleagues, it is important to avoid any actual or perceived conflicts or interests such as clinical decisions being influenced by any business needs of the doctor or practice.

 Follow guidance from the Medical Council on treating those with whom the doctor has a close personal relationship, as well as guidance on maintaining adequate patient records.

If you have any concerns in relation to the treatment of colleagues or family, you should contact your indemnifier for advice and guidance specific to your circumstances.

Mr Niall Rooney, Consultant Lead Counsel in Medisec, outlines why best practice dictates that treating colleagues or family members should be avoided

A day the world will never forget

My memories of experiencing 9/11 in Canada are tinged with the surreal

The 20th anniversary of 9/11 was reached a few days ago. The recent suicide bombings at Kabul airport were a horrible reminder of the activities of Al Qaeda and their equally extreme successors, the Islamic State (ISIS).

The anniversary of 9/11 brings back some vivid memories for me. I was in Toronto, on assignment for The Irish Times, to research a series on the Canadian health system. By 11 September 2001 I had spent a day with the Ontario air ambulance service and a day with an innovative private radiotherapy service, contracted to carry out treatments for the overstretched public health system.

Canada has a decentralised, universal, and publicly-funded health service. Largely run by each province, it is funded by both provincial and federal taxation. And while private health services do exist, they are nowhere near as ubiquitous as here in Ireland. On a visit to a cardio thoracic unit I met two men sharing a ward who were post-CABG; one was a retired university professor and the other a relatively deprived First Nations individual from the far north of the province. The cardiac surgeon told me, somewhat proudly, that both were operated on purely on the basis of clinical need and without any consideration for social status or ability to pay.

I had an early morning appointment to interview the Ontario Minister for Health on 9/11. I arrived at the Ministry at about 8am and was brought to a waiting area outside his office. There was an air of calm urgency about the place, with a multiplicity of aides darting in and out of a confer-

ence room. No one interacted with me apart from the receptionist – it was a case of serious, head-down scurrying for the rest of the office staff. Thirty minutes lapsed with this intensity of activity around me. Eventually, about 45 minutes after my appointment time, an aide emerged and said she was sorry, but the Minister wasn’t going to be able to see me that day. She referred rather obliquely to the activation of an emergency plan and a rush to empty burns units across the province for a mass casualty event. There was no mention of New York, however.

Could I possibly be standing next to Jack Nicholson?

Toronto film festival, plush downtown hotel… was this really happening?

The offices were downtown, in an area with lots of plush hotels. I had seen posters for the annual Toronto film festival earlier in my visit. It was time for a nice pot of tea, I reckoned, while I regrouped and reorganised my schedule for the day.

The bar of the hotel was surprisingly busy for early on a weekday morning. Everyone’s focus was on the TV screen above the bar. The image was of a skyscraper, billowing smoke. The news anchors referred to the north tower, and were speculating about a commercial airliner that had

gone off course and crashed into it.

“What am I looking at,” I asked the man beside me. “World Trade Centre, New York,” he spat back tersely. Then as we watched, a second plane hit the south tower. The news anchors were stunned, no longer speculating about an accident, but unable to think of a narrative that would explain why two airliners had just taken out one of New York’s most famous landmarks.

The terrible saga continued as I stood transfixed in front of the screen, all thoughts of tea banished by the unfolding horror. A third plane had hit the Pentagon. Then another crashed in a field near Washington.

I glanced at the man beside me. His face was contorted with anger. A scene from One Flew over the Cuckoo’s Nest flashed in front of me. Could I possibly be standing next to Jack Nicholson? Toronto film festival, plush downtown hotel… was this really happening?

It was and he was about to exit the scene. He brought his fist down on the countertop while staring even more intently at the TV. “Nuke the bastards,” he snarled before rushing from the room.

By now, my world had turned upside down, normality swept aside by a new and surreal reality. American airspace had been closed indefinitely, the news anchors said. All planes in the air to the US had been diverted, with Gander airport in Newfoundland rapidly filling up with jets belonging to a smorgasbord of European flag carriers. Was I going to be able to get home on schedule in three days time? I rang my wife – we even discussed the possibility of a transatlantic sailing as a means of repatriation. Did the QE2 still do a regular run from New York to Southampton?

The surreal was now laced with feelings of deep shock. I was fortunately staying with a good friend from medical school and her husband. My final memory of 9/11 is late evening, nervously reliving the day’s events on TV, while wrapped under a blanket in their basement recreation room.

In praise of face-to-face meetings

DR NEASA CONNEALLY

Read more by Dr Neasa Conneally at www.mindo.ie

@neasaconneally

So much has changed in our lives since March 2020 that at this point it is now almost impossible to remember how we once used to live. Things evolved so rapidly overnight that I didn’t even really register it when I was first directed to a computer programme called ‘Zoom’ for a hastily reorganised teaching session back in those first scary, uncertain days. Like face masks and the now ubiquitous yellow signs, it has now become a staple of our lives, particularly in the spheres of medical education and conferences.

There are many great things about Zoom (and the other video conferencing software platforms available that haven’t succeeded in achieving such brand recognition). It has brought about great convenience and ease of accessibility to attending events, particularly if you live outside of the capital or have busy family commitments at home. It may not always have been as easy to travel to a Dublin teaching hospital or a hotel conference room before, now we have the ability to attend a Saturday morning or midweek evening seminar delivered by experts in their fields all over the world from the comfort of our own homes. Many of the postgraduate colleges have really pivoted towards this new means of delivery, with the ICGP in particular now running very popular weekly webinars and online learning events

much more regularly than they did previously. Although Zoom webinars and meetings are a great new way of communicating, I would hate to see these becoming the only way of delivering medical education and training in the future. Although we are now all much more attuned to the new etiquette of muting and unmuting yourself than we were back at the start of all of this, it is still a much more tiring, unnatural way for human beings to communicate. Much as we didn’t realise how much we all lip-read until face masks came in, we didn’t realise how much we rely on non-verbal communication until so many of its cues were lost. ‘Zoom fatigue’ is a real phenomenon and adaptions need to be made in how material is delivered, as trying to do it in the same way as you would if you were in a room with an audience just does not work. It’s also difficult to sit staring at a screen after a long day of work and these days there really is no limit to the amount of worthy, educational webinars that one could be improving themselves with.

Surely I can’t be the only one who feels ‘Zoom guilt’ when I don’t have the energy or motivation to sit at my laptop screen when I’d far rather be out getting some fresh air or watching mindless television of an evening.

I know that Zoom is not going away any time soon, but I would be sorry if the old ways were completely done away with. Of all the many things that I missed when they were taken away from us, I was surprised that medical conferences and events were something that I was nostalgic for from the pre-Covid times. I miss the lanyards and the bad coffee and the free tote bags. I miss trying to balance a cup and saucer and a mini croissant in one hand as you shake hands with someone that you vaguely know as you desperately try to remember their name. I miss meeting new people and never knowing what interesting person you might get talking to. I even miss the reminders that medicine in Ireland is very small and that you’re only one degree of separation from somebody at all times. In particular, I still have incredibly fond memories of the last DotMD conference in Galway in 2019, a self-styled ‘Electric Picnic of medical conferences’ and I will be the first to book a ticket for its return in 2022, provided that we don’t make our way through the entire Greek alphabet of variants in the meantime.

As soon as it is truly safe do so, I hope that one day we will get back to the stuffy hotel function rooms and mass catering events. I also hope that I will still have the ability to attend educational sessions in my pyjamas from my sofa on a Saturday morning. By offering people a blend of online and in-person options, we will hopefully be able to prevent the dreaded Zoom fatigue and continue to use this brilliant, revolutionary tool for what it’s truly good for.

Although Zoom is a great communication tool, I would hate to see it become the only way of delivering medical education

DR MUIRIS HOUSTON

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

I was surprised that medical conferences and events were something that I was nostalgic for from the pre-Covid times

The right to treatment, social care, and liberty

The Mental Health Commission annual report 2020 provides important detail on recent trends in involuntary admission

Involuntary admission to psychiatric inpatient care is governed by the Mental Health Act, 2001, which was introduced incrementally between 2001 and 2006. At the time, there was broad acceptance of the need to update existing legislation in order to better protect patients’ rights and increase adherence to the United Nations’ Principles for the Protection of Persons with Mental Illness and the Improvement of Mental Health Care (1991)

There were, however, clear gaps in the new legislation, which did not address in detail the process of voluntary admission; did not establish a minimum standard of care to which patients were entitled; and did not allow for shorter periods of detention explicitly for assessment purposes. These deficits remain today.

In fact, the 2001 Act was quite crisply focussed on two key issues: Revised procedures for involuntary admission, and strengthened governance mechanisms, especially mental health tribunals and changes to inspection processes. Its overarching aim was to enhance protections of the human rights of the mentally ill, especially those who receive involuntary care.

Fifteen years after full implementation of the legislation, much has changed in mental health services, with additional changes over the past year owing to Covid-19. Against this background, the Mental Health Commission (MHC) recently provided an update on mental health services in Ireland during the first year of the pandemic in its 2020 annual report.

The Commission’s Chief Executive, Mr John Farrelly, notes

MULTIPLE CHOICE QUESTIONS

Question 1

Question 2

Question 3

Question 4

that, “in the peak months of April and May, services came under severe and relentless pressure. The collaborative, flexible and committed effort of all involved contributed significantly to protecting the life, health, and welfare of patients and residents.” As usual, the Commission’s report provides a wealth of useful information about mental health services over the course of 2020, a year in which some 1,946 mental health tribunal hearings took place.

Mr Farrelly draws particular attention to the increased involvement of gardaí in involuntary admissions: “It is even more concerning that this occurred during Covid-19 when persons requiring treatment might have been even more vulnerable and intervention by the gardaí could have caused more distress.”

Mr Farrelly’s concerns are well-founded. Garda involvement should be a last resort and, in my experience, usually occurs only when there is no other alternative admission pathway. That said, it is worth noting that Ireland’s rate of involuntary psychiatric admission (“sectioning”) is low by international standards, at approximately half the rate in England. Rates vary considerably across countries, but Ireland’s rate is notably low at present.

This was not always the case. In 1838, the ‘Dangerous Lunatic Act’ permitted the transfer of an individual to an “asylum” if they were considered dangerous and either mentally ill or intellectually disabled. This soon became the admission pathway of choice, partly because it gave the police full responsibility for transporting the individual.

The “dangerous lunacy” procedure was widely used, and

Breath-holding attacks

A. Affect about 15 per cent of children.

B. Can be provoked by fright.

C. May cause cyanosis or pallor.

D. Never lead to loss of consciousness.

E. Are followed by a brief period of confusion.

Nonexudative age-related maculopathy

A. Is responsible for some visual loss in 60 per cent of all 70-year-olds.

B. Affects both distant and near vision.

C. Patients can improve their vision for some tasks by viewing eccentrically.

D. Patients may benefit greatly by using some form of magnification.

E. Treatment of choice is laser photocoagulation.

Olecranon bursitis (student’s elbow)

A. Bursa is located over the distal part of the humerus.

B. Most common cause is infection.

C. May present bilaterally.

D. Management should start with simple RICE.

E. If aspirated, injection of corticosteroids helps prevent recurrence.

Recognised complications/side-effects of local anaesthetic injection with lidocaine include

A. Depigmentation in dark skin.

B. Pain along the distribution of a nerve.

C. Tinnitus.

D. Infection.

E. Ischaemia and gangrene.

Question 5

Trigeminal neuralgia

A. Affects females more than males.

B. Is as likely to be bilateral as unilateral.

C. Pain characteristically occurs in the ear and back of the mouth.

D. Pain occurs in brief paroxysms.

E. May be secondary to multiple sclerosis.

Irish “mental hospitals” soon housed more people per capita than any other country in the world, before or since. Services have changed considerably since then, but continuous monitoring is needed in order to ensure that involuntary admission is as infrequent and patient-focussed as possible.

Despite the best efforts of many excellent gardaí today, their involvement in what is already a difficult process can increase stigma. Alternative approaches, involving “authorised officers” of the health service, are available. Upcoming legislative changes will likely prioritise these pathways more.

Mental health law is, however, complex to draft and challenging to implement. In addition to the concerns outlined above, some of the issues that patients raise in relation to the Mental Health Act, 2001 include difficulty understanding how the involuntary admission system works, problems knowing precisely what to expect from mental health tribunals and a feeling that the appeals process in the courts is unlikely to produce the result they seek.

Ultimately, reducing rates of involuntary admission requires not only legislative reform, but also more extensive community mental health services, enhanced social supports, and political determination to protect the rights of people with mental illness and their families – the right to treatment and social care, as well as the right to liberty.

Brendan Kelly is Professor of Psychiatry at Trinity College Dublin and author of The Science of Happiness: The Six Principles of a Happy Life and the Seven Strategies For Achieving It (Gill Books, 2021)

E. TRUE. Strongly suspect this is in a young patient.

D. TRUE. Though may occur so rapidly in succession as to appear prolonged.

C. FALSE. This would be glossopharyngeal neuralgia.

B. FALSE. Rarely bilateral.

A. TRUE. Onset usually after 50.

ANSWER 5

E. FALSE. Only a risk if used in combination with adrenaline for anaesthesia of fingers, toes, penis or ears.

D. TRUE. Small risk of this from any injection into a joint.

C. TRUE. Would indicate toxicity.

B. TRUE. Stop injection, withdraw needle and re-site it.

A. TRUE. Warn patient that this is possible.

ANSWER 4

Tubigrip may help prevent rapid reaccumulation of fluid.

E. FALSE. If aspirated, application of a

D. TRUE. And avoidance of exacerbating factors.

C. TRUE. As part of gout, pseudo-gout or RA.

A. FALSE. Over extensor aspect of proximal part of ulna, allowing skin to glide freely over the olecranon process.

ANSWER 3

E. FALSE. No such treatment will help.

D. TRUE. Best possible glasses and simple hand magnifiers.

C. TRUE. Peripheral vision is unaffected.

B. TRUE. Patients notice a slow, relatively symmetrical decrease in vision.

A. FALSE. 30 per cent of all 70-year-olds.

ANSWER 2

E. TRUE. Then the child fully recovers.

D. FALSE. They may be associated with tonic posturing and clonic movements of the hands and arms.

C. TRUE. The typical sequence is of crying, expiratory apnoea, cyanosis or pallor and loss of consciousness.

B. TRUE. Or by anger.

A. FALSE. About 5 per cent.

ANSWER 1

B. FALSE. Most often idiopathic, but may be traumatic, inflammatory or infective.

PROF BRENDAN KELLY

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The fascinating functions of follicles

Attendees at UCD’s Charles Institute Seminar Series heard a presentation by Prof Ralf Paus on how human scalp hair follicles are in fact chemosensory ‘mini-organs’

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 Ralf Paus, Professor of Dermatology at the University of Miami Miller School of Medicine in the US and Professor of Cutaneous Medicine at the University of Manchester, who addressed the seminar on the topic, ‘The Hair Follicle (HF) as a Chemosensory Organ’. Prof Paus described human hair scalp follicles as ‘mini-organs’ that are highly innervated sensory organs, as well as operating as major chemosensors. They contain a complex repertoire of fully-functional chemosensory receptors that range from vanilloid and cannabinoid, to olfactory and even pheromone and taste receptors, their latest research has shown.

Stimulation of certain of these receptors by endogenous or exogenous ligands regulates a wide range of HF functions, explained Prof Paus, ranging from hair cycle control, proliferation and apoptosis in the hair matrix and bulge stem cell functions to the HF immune system and the HF microbiome.

He discussed some examples of what he described as the “astounding chemosensory activity” of human scalp HFs, particularly how HFs’ ‘smell’ and ‘taste’ activity is important in regulating human scalp hair growth. Prof Paus provided an overview of the evolutionary and clinical significance of HF chemosensation biology and he discussed how expanding our knowledge of this research frontier may lead to the development of new non-drug therapeutics in dermatology that go beyond the management of hair diseases.

Introducing Prof Paus, Prof Tobin referred to his “extraordinary research output,” which includes authoring more than 680 papers on PubMed, and he cited Prof Paus as an example for students on how to build a strong career in research.

Receptors

Prof Paus specifically discussed three chemosensory receptors — taste receptors, olfactory receptors, and TRP ion channels. “Taste and olfactory receptors are the most obvious ones, but TRP ion receptors also permanently contribute to our sense of taste, and even others, such as cannabinoid receptors, can in the widest sense be subsumed under the term ‘chemosensory receptors’,” said Prof Paus. HFs are the most densely innervated peripheral organs in the human body, with the possible exception of the cornea, Prof Paus explained. “The function of this very dense innervation is only now becoming better understood. We know that the follicle innervation does a lot more than send sensory signals to the sensory cortex — for example, when an insect hits the hair shaft, it thereby excites action potentials in the sensory neurons, but these nerve endings around the hair follicles, which are particularly dense around the stem cell region of the hair follicle, are also secreting neuropeptides, neurotrophins, neurotransmitters and neurohormones that are ‘talking’ to the hair follicle epithelium,” he told the attendees.

“They may also be interacting with the hair follicle microbiome, the most interesting microbiome in your skin and

much richer than the skin surface microbiome. If you are under psycho-emotional stress, neuropeptides released from these nerve endings will release perifollicular neurogenic inflammation, which inhibits your hair growth and may even damage your stem cells.”

Aside from these classical neuro-physiological aspects of hair biology, hair follicles also engage in chemosensation, independent of peripheral innervation, said Prof Paus. Among his findings, Prof Paus and colleagues found that the hair growth cycle regression phase or catagen is promoted if signalling is blocked through the receptor, either by an antagonistic odorant or by silencing RNA, and is prolonged by an odorant such as sandalore that agonises the receptor. “IGF-1 was increased and probably, most of the mechanistic explanation for this effect is due to up-regulation of IGF-1,” he said. “There was also a minor stimulation of hair shaft formation, but the main effect was on hair follicle cycling — the key finding was that continued stimulation of this one olfactory receptor is actually required for the scalp hair follicles to remain ‘happy’.”

Prof Paus gave an overview of TRP ion channels, focusing particularly on TRPM5, which he described as a “promiscuous” receptor that can be stimulated by multiple signals, such as odorants, acidic pH and gustatory agents, for example. “But the most interesting stimulants are bona fide pheromones, which can stimulate the receptor,” he said. This represents the first evidence that pheromones can manipulate human organ remodelling, said Prof Paul. “That is exciting, because several perfumes contain pheromones… if you can use an odorant like pheromone that ‘talks’ to a well-defined receptor to effect changes in organ remodelling, you are basically impacting dramatically on human tissue function without using any drugs.”

Wound-healing

Prof Paus touched on the implications for influencing hair growth and wound-healing, among other potential applications as a result of these findings. “Stimulating the 2AT4 (OR2AT4) stimulates the proliferation and migration of human keratinocytes and actually promotes wound-healing, the re-epithelialisation of excrementally-induced wounds in organ cultured human skin,” he told the attendees. “That’s interesting enough in itself, but it’s even more interesting that a simple odorant that is found in many cosmetics, particularly in aftershaves and perfumes, the synthetic sandalwood-like odorant sandalore specifically stimulates this receptor and has all of these keratinocyte effects.”

Whenever there is a substance that promotes wound-healing, the chances are very high that the same agent or receptor system can promote hair growth, and vice-versa, added

Prof Paus. “There is not a lot of interaction between these two fields, but they are so closely related,” he said.

“Our working hypothesis is that olfactory receptors in the human hair follicle are perhaps actually primarily there not so much to regulate the growth of the hair follicle, but to ‘smell’ the hair follicle microbiome and to manage it by differential AMP peptide production,” he told the attendees. “If that is true, then sandalore may be used as a cosmetic agent in the adjuvant therapy of bacterial or fungal infections.”

He concluded by telling the seminar: “Human hair follicles do, very prominently, engage in chemosensation, for example via vanilloid, cannabinoid, olfactory and taste receptors to regulate their own growth,” said Prof Paus. “But also, they do multiple other things, such as regulating the hair follicle microbiome, as we are beginning to understand in our olfactory receptor research. They are all doing the same things — the olfactory and pheromone receptors we looked at were hair growth-promoting, and the bitter taste receptor was hair growth-stimulatory.

“What I find fascinating is that this work opens up an entire new microcosm of dermatological research,” continued Prof Paus. “I would call it ‘chemosensation dermatology’, where we use non-drugs to exert powerful growth- and microbiome-modulatory effects by modulating potent growth factors. This is an area that dermatologists should be really excited to exploit, because it greatly expands our therapeutic armamentarium. A few of these examples of chemosensation dermatology I have presented invite you to explore an entire microcosm of evolutionarily ancient, but until now in the human system conserved, chemosensory activities that are just waiting to be targeted by drug-free strategies. This new therapy, beyond capsaicin and menthol and other TRP ion channel agonists that dermatologists have used for a long time, is perhaps one of the most exciting new frontiers that I have come across in the past two decades in dermatology.”

Apoptosis

During an interactive Q&A session and discussion, Prof Tobin described Prof Paus’s work as potentially representing a “paradigm shift” in how therapeutic dermatology is approached. “A lot of your initial work was done using mice, and as you rightly point out, we need to be very careful in extrapolating from the mouse model to the human,” commented Prof Tobin. “The data you present now is based on findings in humans, in particular the human scalp. The examples you have shown today are not really about stimulating proliferation of cells or rapidly-dividing cells; it’s more about the apoptosis or catagen checkpoint; either delaying or stimulating either of those. That seems to me to be nature’s ‘sweet spot’ for modulating tissue dynamics and remodelling, and even potentially as a contribution to wound-healing. So, what is it about the follicle that makes its target keratinocyte in particular constrained for proliferation, but wide open in the context of apoptosis?”

Prof Paus replied: “It’s a brilliant point — industry has been barking up the wrong tree for far too long. They try to clobber an already maximally-growing follicle to grow even more, while instead, they should be targeting the switch from a highly proliferative state, to a pro-apoptotic state,” he said. “This switch is what clinically matters most, so this is what we really need to attack with whatever therapy we develop. Apoptosis is possibly a more economical way of regulating the system than stimulation of proliferation, so it’s probably more energy-saving to use apoptosis control as the main form of regulation.”

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

Prof Ralf Paus

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Atrial fibrillation: An overview

Atrial fibrillation (AF) is the most common cardiac arrhythmia diagnosed in clinical practice and affects more than 33 million people worldwide. Characterised by the rapid and irregular beating of the atrial chambers of the heart, episodes of which may become longer or continuous over time, AF is associated with a significant risk of transient ischaemic attack, ischaemic stroke, systemic embolism, and death. While not immediately life-threatening like some cardiac arrhythmias, AF carries a five-fold higher risk of stroke caused by the formation of blood clots in the heart and blocked blood vessels in the brain. The percentage of people with AF increases with age with 0.1 per cent under 50 years, 4 per cent between 60-to-70 years and 14 per cent over 80 years of age being affected. Due to increased lifespan, AF is on the rise and predicted to affect 14-to-17 million people in Europe by 2030, with 120,000-to215,000 new cases per year (estimated incidence 0.23-0.41 per 1,000 person/years). A further estimated 280,000-to-340,000 new ischaemic strokes, 3.5-to-four million hospitalisations for AF and 100-to-120 million outpatient visits can also be added to these figures. AF constitutes a significant public health challenge with high comorbidity and increased mortality risk and is a significant cause of increasing healthcare costs globally. An estimated 1.4 per cent of all adults over 65 years are living with undiagnosed AF, which means more cases of unmanaged AF will create even further economic strain on our healthcare systems.

Aetiology

AF is multi factorial in nature. Abnormalities or damage to the heart’s structure are the most common causes. AF is more common with increased age and affects certain groups of people more than others. While it can sometimes affect people who are physically very fit, AF is more common in people with other heart conditions such as hypertension, atherosclerosis, cardiomyopathy, pericarditis, heart valve and congenital heart disease. A family history of AF may also increase the risk. AF is also asso-

ciated with other medical conditions, such as pneumonia, lung cancer, pulmonary embolism, sarcoidosis, obstructive sleep apnoea, hyperthyroidism, and obesity. A number of triggers are associated with the condition, including smoking, excessive alcohol and coffee consumption. When no other medical conditions are associated with it, it is called lone AF.

Symptoms

AF is often asymptomatic, especially in the elderly, but many patients experience palpitations, rapid and irregular heartbeat, vague chest discomfort or symptoms of heart failure, such as weakness, light-headedness, and dyspnoea, particularly when the ventricular rate is very rapid (140 to 160 beats/ minute). Patients may also present with signs and symptoms of acute cerebrovascular accident (CVA) or other organ damage due to systemic emboli.

Diagnosis and screening

Diagnostic investigation of AF typically includes a complete medical history and physical examination, ECG, full blood count, urea and electrolytes, and serum thyroid stimulating hormone level. All patients who present with symptoms of AF should have at minimum their pulse checked for irregularities as well as a 12-lead ECG.

First diagnosed AF Every patient who presents with AF for the first time irrespective of the duration or the presence and severity of AF-related symptoms

Paroxysmal AF AF that terminates spontaneously, usually within 48 hours, although AF paroxysms may continue for up to seven days. After 48 hours spontaneous conversion is low and anticoagulation must be considered

Persistent AF Continuous AF sustained for more than seven days or requires termination by cardioversion, either with drugs or by direct current cardioversion

Longstanding persistent AF Continuous AF of greater than 12 months duration. It is usually decided to adopt a rhythm control strategy at this stage

Permanent AF Permanent AF is said to exist when the presence of the arrhythmia is accepted by the patient and physician. Rhythm control interventions, by definition, are not pursued in patients with permanent AF

Table 1: ESC AF classification

Reference: Taskforce for the Management of Atrial Fibrillation of the European Society of Cardiology

ECG findings for AF indicate the absence of P waves, irregularly irregular R-R intervals and the presence of F (fibrillatory) waves between the QRS complexes. Fibrillatory waves are irregular in timing and morphology with baseline undulations at rates up to or >300/minute, best seen in lead V1 and not always apparent in all leads.

Other diagnostic tests for AF include CXR and echocardiogram. Echocardiography is carried out to assess for structural heart defects such as left atrial enlargement, left ventricular wall motion abnormalities suggesting past or present ischaemia, valvular disorders and cardiomyopathy, and to identify additional risk factors for stroke such as atrial blood stasis, thrombus or complex aortic plaque. Atrial thrombi are more likely in the atrial appendages, where they are best detected by transoesophageal rather than transthoracic echocardiography.

AF is a progressive disorder. The exact electro-pathological mechanisms underlying persistence of AF are at present unknown and none of the available recording techniques can determine the degree and extensiveness of atrial electro-pathology or determine the stage of the condition at any time in the process. Identifying individuals at risk of developing AF is important, however, as there is strong evidence that early detection and treatment of modifiable risk factors can reduce morbidity and mortality.

Classification of AF

The European Society of Cardiology (ESC) distinguishes five types of AF based on presentation and duration of arrhythmia (Table 1).

Complications of AF

The absence of atrial contractions in AF predisposes the patient to thrombus formation.

Risk of stroke is higher in older patients and in those with mechanical heart valves, rheumatic valvular disease, hyperthyroidism, hypertension, diabetes, left ventricular systolic dysfunction, or previous thromboembolic events. Systemic emboli can also cause malfunction or necrosis of other organs. AF may impair cardiac output. Loss of atrial contraction can lower cardiac output at normal heart rate by about 10 per cent. Such a decrease is usually well tolerated except when the ventricular rate becomes too fast (>140

beats/minute), or when patients already have borderline or low cardiac output. In such cases, cardiac failure may develop.

Treatment

Treatment of AF varies from person to person and depends on the type of AF, symptoms, treatment of any underlying cause, age, and overall health. The first step is to try to find the cause of the AF. For example, hyperthyroidism can sometimes be the underlying cause of AF and medication to control the condition can correct the symptoms of AF. If no underlying cause is found, treatment of AF is usually aimed at either rhythm or rate control. Since AF induces electrical, structural, and contractile remodelling, therapy aimed at prevention or restoration of remodelling and consequently restoration of sinus rhythm should be the first choice strategy. The different AF treatment modalities include pharmacological therapy, electrical cardioversion, pacemaker implantation combined with His bundle ablation or surgical isolation of the pulmonary veins with or without additional linear lesions/substrate modification.

Anti-arrhythmic medication can control AF by restoring normal heart rhythm and controlling the rate at which the heart beats. The choice of anti-arrhythmic depends on the type of AF, comorbidities, side-effects of the medicine chosen and response to therapy. Some patients may need more than one anti-arrhythmic to control AF and a variety of medications are available to restore normal heart rhythm. The aim is to reduce the resting heart rate to <90 beats per minute, however, in some people the target is <110bpm.

First-line medications include beta blockers, such as propranolol or atenolol and nondihydropyridine calcium channel blockers such as diltiazem or verapamil, which slow the conduction of impulses to the ventricles. Digoxin may be added to control the heart rate further. Digoxin is usually only effective for controlling the ventricular rate at rest and should therefore only be used as a monotherapy in predominantly sedentary patients.

Anti-arrhythmic drugs can be classified clinically into those that act on supraventricular arrhythmias (eg, verapamil), both supraventricular and ventricular arrhythmias (eg, amiodarone), and those that act on ventricular arrhythmias (eg, lidocaine). They can also be classified according to their effect on the electrical behaviour of myocardial cells during activity (Vaughan Williams Classification). Class I anti-arrhythmic medications are membrane stabilising drugs, eg, lidocaine and flecainide. Class II are beta blockers. Class III include amiodarone and sotalol and Class IV are calcium channel blockers, including verapamil, but not dihydropyridines. The negative inotropic effects of anti-arrhythmic drugs tend to be additive. Special care should be taken if two or more are used, especially if myocardial function is impaired. Many medications that are effective in countering arrhythmias can also provoke them in some instances. Patients

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

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

must be monitored closely as common side-effects of anti-arrhythmic medications include hypotension, fatigue, nausea, vomiting, possible issues with liver, kidneys, thyroid or lungs, and heart rhythm disorders. Amiodarone causes sensitivity to sunlight and skin changes are common, therefore, sun protection is important when taking this medication.

Aspirin is not recommended to prevent strokes caused by AF. Patients with a high or moderate level of risk of stroke or thrombus formation due to AF are usually prescribed an anticoagulant, such as the vitamin K antagonist warfarin or a novel oral anticoagulant (NOAC), also called direct oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban or edoxaban. There are fewer dietary and medication interactions with the newer agents and less need for monitoring. NOACs are at least as effective or superior to warfarin for stroke prevention in patients with non-valvular AF, and are at least as safe or safer in terms of bleeding risk, according to three large clinical trials. NOACs have major pharmacologic advantages over warfarin, including rapid onset/offset of action, few drug interactions and predictable pharmacokinetics.

Practical advantages of NOACs over warfarin include fixed once- or twice-daily oral dosing without the need for coagulation monitoring.

Potential drawbacks include a risk of bleeding that might be increased in patients over 75 years of age, the lack of a routine laboratory test to reliably measure anticoagulant effect and previously the lack of an antidote for reversal. Choice of NOAC is influenced by the patient’s individual characteristics, including risk of stroke or VTE, risk of bleeding, and comorbidity, in particular renal dysfunction. It is also recommended that one of the bleeding risk scores, such as the HAS-BLED score, be used to help risk-assess patients. The choice of agent should take into consideration the patient’s age, weight and creatinine clearance, as dose adjustment may be required.

Cardioversion is a medical procedure carried out in a hospital setting by which a tachycardia or other cardiac arrhythmia is converted to a normal rhythm using an electric current or pharmacology. Synchronised electrical cardioversion uses a therapeutic dose of electric current to the heart at a specific moment in the cardiac cycle, restoring the activity of the electrical conduction system of the heart. Electrical cardioversion has success rates of between 65-to-90 per cent and can be performed safely as a day case procedure. The likelihood of success can be further improved by the co-administration of anti-arrhythmic drug therapy.

Pharmacologic cardioversion, also referred to as chemical cardioversion, uses anti-arrhythmic medication instead of an electrical shock. Pharmacological cardioversion is often used for the treatment of AF of recent onset. Flecainide, ibutilide, propafenone, and vernakalant can be used in patients with no structural heart disease. Where structural heart disease is present, intravenous amiodarone is the drug of choice. Flecainide administered intravenously in patients with AF of recent onset has been shown to restore sinus rhythm in 72-to-95 per cent of patients, with greatest success rates in those who receive treatment within 24 hours of AF onset. When AF has persisted for >48

hours, pharmacological cardioversion is much less likely to be effective. Amiodarone appears to be the most effective agent for restoring sinus rhythm in patients with persistent AF. For patients who have been in AF for longer than 12-to-24 hours, or in whom the duration of the arrhythmia is not clear, a minimum period of anticoagulation of three weeks is recommended before cardioversion. Even if echocardiography has demonstrated no thrombus before cardioversion, patients should be anticoagulated for at least one month post cardioversion, since mechanical atrial function may return slowly after cardioversion.

the atria beat irregularly. In atrial flutter, the atria beat regularly, but faster than usual and more often than the ventricles, and there may be four atrial beats to every one ventricular beat. During atrial flutter, unlike AF, electrical activity in the atria is coordinated. The atria do contract, but at a very rapid rate of 250 to 350 times per minute. This rate is too fast to allow every impulse to be conducted through the atrioventricular node to the ventricles. Because the AV node cannot usually conduct at this rate, typically half of the impulses get through (2:1 block), resulting in a regular ventricular rate of 150 beats/minute. The diagnosis of atrial flutter

prevalence of AF is rising and approximately 600 men and 375 women per 100,000 population are affected. In the 2017 report Burden of Stroke in Europe, the Stroke Alliance for Europe signalled a possible 58 per cent increase in the absolute number of strokes in Ireland over the next decade. Much of this can be accounted for by increasing numbers of AF-related stroke as our population ages. The population aged 65 years and over in Ireland is increasing at the rate of 4 per cent annually. The CSO predicts that people aged over 65 will represent between 21.5-to-27.9 per cent of the Irish population by 2046. As a result AF is a growing public health concern.

Screening for AF in general practice

Projections show that the number of people living with stroke as a chronic condition will rise from 3,718,785 in 2015 to 4,631,050 in 2035, representing an increase of 25 per cent or almost one million people across Europe. There are approximately 8,000 strokes in Ireland annually, a third of which are associated with AF.

In 2015, HIQA published a health technology assessment (HTA) of a national screening programme for AF in primary care. The HTA announced that a national screening programme for AF for over-65s in primary care would be cost-effective. HIQA’s Director of Health Technology Assessment Dr Máirín Ryan, said: “Based on the best available evidence, annual opportunistic pulse palpation for those aged 65 and older is expected to lead to reductions in the incidence and severity of AF-related strokes assuming that those detected by screening have a comparable risk of stroke as those detected through routine care.”

Analysis estimated that screening would result in the detection of one additional AF case for every 22 people screened from age 65 onwards, and one stroke avoided for every 270 people screened over the same period. The total incremental cost to the HSE was estimated at €3.7 million over the first five years. This included the additional costs associated with screening, ECGs and AF drug therapy in diagnosed cases, as well as the cost savings resulting from a gradual decrease in stroke incidence over a period of five years.

Catheter ablation has emerged as an important rhythm-control strategy and is an increasingly used option if medical treatment for AF has not been successful. The procedure restores the heart’s normal rhythm by electrically isolating the left atrium from the pulmonary veins where most abnormal electrical activity that promotes AF originates. The procedure destroys or ablates the diseased area of the heart and interrupts abnormal electrical circuits.

The principal reason to place a pacemaker in a patient with AF is to treat symptomatic bradycardia, especially due to sick sinus syndrome (tachycardia-bradycardia syndrome). This tends to be mainly used in people aged 80 or over.

Differentiation between atrial flutter and AF

Atrial flutter is much less common than AF, but its causes and haemodynamic consequences are similar. About a third of people with atrial flutter also have AF. Both conditions carry increased risk of stroke. In AF,

is by electrocardiography. In typical flutter, ECG shows continuous and regular atrial activation with a saw tooth pattern, most obvious in leads II, III, and aVF.

Carotid sinus massage can increase AV block and better expose the typical flutter waves. A similar response may follow pharmacologic AV nodal blockade, example with adenosine, but such therapy does not terminate atrial flutter. Treatment of atrial flutter focuses on ventricular rate control, rhythm control, and prevention of thromboembolism. Patients with chronic or recurrent atrial flutter require an oral anticoagulant. The choice among the therapies is based on the same considerations as for AF. Patients often require cardioversion or atrial flutter substrate ablation.

AF is associated with one-in-three strokes in Ireland

AF is the most common cardiac arrhythmia affecting at least 3 per cent of Irish adults over 60 and is associated with almost onein-three strokes in Ireland. Globally the

Almost 11 per cent of Irish adults aged 65 years and over attending general practice have AF. The HSE (2015) study on atrial fibrillation screening in general practice also concluded that “opportunistic screening for an irregular pulse in general practice to assist in the detection of AF is both feasible and beneficial”. This multi-site prospective observational study found that approximately 8,415 new cases of AF could be identified by opportunistic screening in general practice each year. Each GP could expect to diagnose 17 new cases per 1,000 patients annually through opportunistic screening in practice. General practice is well placed to opportunistically screen older patients and is ideal in terms of the pathway for treatment for those identified. Opportunistic screening for an irregular pulse carried out by GPs and general practice nurses (GPNs) “has the potential to be an extremely important stroke prevention strategy, capable of saving society and the health service significant social and economic costs”.

References on request

Risk of stroke is higher in older patients and in those with mechanical heart valves, rheumatic valvular disease, hyperthyroidism, hypertension, diabetes, left ventricular systolic dysfunction, or previous thromboembolic events

Life-threatening, underrecognized, and underdiagnosed, ATTR-CM is a rare condition found in mostly older patients in which misfolded transthyretin proteins deposit in the heart.1-7 It is vital to recognize the diagnostic clues so you can identify this disease.

References

heart failure with preserved ejection fraction in patients typically over 60 years old5-7

to standard heart failure therapies (ACEi, ARBs, and beta blockers)8-10

between QRS voltage and left ventricular (LV) wall thickness11-13

of carpal tunnel syndrome or lumbar spinal stenosis3,8,14-20

showing increased LV wall thickness6,13,16,21,22

H FpEF I NTOLERANCE DISCORDANCE DIAGNOSIS E CHO N ERVOUS SYSTEM

—autonomic nervous system dysfunction-including gastrointestinal complaints or unexplained weight loss6,16,23,24

1. Sipe JD, Benson MD, Buxbaum JN, et al. Amyloid fibril proteins and amyloidosis: chemical identification and clinical classification International Society of Amyloidosis 2016 Nomenclature Guidelines. Amyloid. 2016;23(4):209-213.

2. Maurer MS, Elliott P, Comenzo R, Semigran M, Rapezzi C. Addressing common questions encountered in the diagnosis and management of cardiac amyloidosis. Circulation. 2017;135(14):1357-1377.

3. Connors LH, Sam F, Skinner M, et al. Heart failure due to age-related cardiac amyloid disease associated with wild-type transthyretin: a prospective, observational cohort study. Circulation. 2016;133(3):282-290.

4. Pinney JH, Whelan CJ, Petrie A, et al. Senile systemic amyloidosis: clinical features at presentation and outcome. J Am Heart Assoc. 2013;2(2):e000098. 5. Mohammed SF, Mirzoyev SA, Edwards WD, et al. Left ventricular amyloid deposition in patients with heart failure and preserved ejection fraction. JACC Heart Fail. 2014;2(2):113-122. 6. Maurer MS, Hanna M, Grogan M, et al. Genotype and phenotype of transthyretin cardiac amyloidosis: THAOS (Transthyretin Amyloid Outcome Survey). J Am Coll Cardiol. 2016;68(2):161-172. 7. González-López E, Gallego-Delgado M, Guzzo-Merello G, et al. Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction. Eur Heart J. 2015;36(38):2585-2594. 8. Narotsky DL, Castano A, Weinsaft JW, Bokhari S, Maurer MS. Wild-type transthyretin cardiac amyloidosis: novel insights from advanced imaging. Can J Cardiol. 2016;32(9):1166.e1-1166.e10. 9. Brunjes DL, Castano A, Clemons A, Rubin J, Maurer MS. Transthyretin cardiac amyloidosis in older Americans. J Card Fail. 2016;22(12):996-1003. 10. Castaño A, Drach BM, Judge D, Maurer MS. Natural history and therapy of TTR-cardiac amyloidosis: emerging disease-modifying therapies from organ transplantation to stabilizer and silencer drugs. Heart Fail Rev. 2015;20(2):163-178. 11. Carroll JD, Gaasch WH, McAdam KP. Amyloid cardiomyopathy: characterization by a distinctive voltage/mass relation. Am J Cardiol. 1982;49:9-13. 12. Cyrille NB, Goldsmith J, Alvarez J, Maurer MS. Prevalence and prognostic significance of low QRS voltage among the three main types of cardiac amyloidosis. Am J Cardiol. 2014;114(7):1089-1093. 13. Quarta CC, Solomon D, Uraizee I, et al. Left ventricular structure and function in transthyretin-related versus light-chain cardiac amyloidosis. Circulation. 2014;129(18):1840-1849. 14. Connors LH, Prokaeva T, Lim A, et al. Cardiac amyloidosis in African Americans: Comparison of clinical and laboratory features of transthyretin V122I amyloidosis and immunoglobulin light chain amyloidosis. Am Heart J. 2009;158(4):607-614. 15. Nakagawa M, Sekijima Y, Yazaki M, et al. Carpal tunnel syndrome: a common initial symptom of systemic wild-type ATTR (ATTRwt) amyloidosis. Amyloid. 2016;23(1):58-63. 16. Rapezzi C, Merlini G, Quarta CC, et al. Systemic cardiac amyloidoses: disease profiles and clinical courses of the 3 main types. Circulation. 2009;120(13):1203-1212. 17. Sperry BW, Reyes BA, Ikram A, et al. Tenosynovial and cardiac amyloidosis in patients undergoing carpal tunnel release. J Am Coll Cardiol. 2018;72(17): 2040-2050. 18. Westermark P, Westermark GT, Suhr OB, Berg S. Transthyretin-derived amyloidosis: probably a common cause of lumbar spinal stenosis. Ups J Med Sci. 2014;119(3):223-228. 19. Yanagisawa A, Ueda M, Sueyoshi T, et al. Amyloid deposits derived from transthyretin in the ligamentum flavum as related to lumbar spinal canal stenosis. Mod Pathol. 2015;28(2):201-207. 20. Sueyoshi T, Ueda M, Jono H, et al. Wild-type transthyretin-derived amyloidosis in various ligaments and tendons. Hum Pathol. 2011;42(9):1259-1264. 21. Phelan D, Collier P, Thavendiranathan P, et al. Relative apical sparing of longitudinal strain using two-dimensional speckle-tracking echocardiography is both sensitive and specific for the diagnosis of cardiac amyloidosis. Heart. 2012;98(19):1442-1448. 22. Ternacle J, Bodez D, Guellich A, et al. Causes and consequences of longitudinal LV dysfunction assessed by 2D strain echocardiography in cardiac amyloidosis. JACC Cardiovasc Imaging 2016;9(2):126-138. 23. Coelho T, Maurer MS, Suhr OB. THAOS - The Transthyretin Amyloidosis Outcomes Survey: initial report on clinical manifestations in patients with hereditary and wild-type transthyretin amyloidosis. Curr Med Res Opin. 2013;29(1):63-76.

New ESC guidelines on HF management

The European Society of Cardiology (ESC) has launched new guidelines for the diagnosis and treatment of acute and chronic heart failure (HF), which have been published online in the European Heart Journal. This was the first ESC guideline to include patients as full members of the taskforce.

Approximately 2 per cent of adults worldwide have HF. Prevalence increases with age, from 1 per cent in those under 55 years to more than 10 per cent in people aged 70 and above.

These new ESC guidelines on HF have revised the format of the previous 2016 version to make each phenotype of HF stand-alone in terms of its diagnosis and manage -

COMBINING POWER AND CONFIDENCE

ment. The therapy recommendations mention the treatment effect supported by the class and level of evidence and are presented in tables.

For HF with reduced ejection fraction (HFrEF), the tabular recommendations focus on mortality and morbidity outcomes.

For diagnostic indications, the guidelines suggest investigations that all patients with HF should receive, and investigations that can be targeted to specific circumstances. As diagnostic tests have rarely been subject to randomised controlled trials (RCTs), most of the evidence would be regarded as level C. However, that does not mean that there has not

been appropriate rigorous evaluation of diagnostic tests.

In this guideline, the ESC decided to focus on the diagnosis and treatment of HF, not on its prevention.

Regarding diagnosis, when there is a suspicion of chronic HF, the guidelines recommend measuring the level of natriuretic peptides. If levels are normal the patient can be reassured that HF is very unlikely. If high, this should prompt referral for an echocardiogram to detect the underlying heart problem.

All HF patients are normally treated with diuretics to reduce breathlessness and ankle swelling. For HFrEF, there are many drug treatments that improve survival, namely angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor neprilysin inhibitors (ARNIs), beta-blockers and mineralocorticoid receptor antagonists (MRAs). In addition, the guidelines recommend sodium-glucose co-transporter-2 (SGLT2) inhibitors, also called gliflozins, as both dapagliflozin and empagliflozin reduce the risk of cardiovascular death and/or hospitalisations for HF when added to standard treatment. Some patients with HFrEF may also benefit from devices such as defibrillators and cardiac resynchronisation therapy pacemakers.

The guidelines state that no treatment has been shown to reduce mortality and morbidity in patients with HF with preserved ejection fraction (HFpEF) to date.

Exercise is recommended for all capable chronic HF patients to improve quality-of-life and reduce HF-related hospitalisation. In those with more severe disease, frailty, or comorbidities, a supervised, exercise-based, cardiac rehabilitation programme should be considered.

Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia1

Indication: Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia.

should be on and continue, an

suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. The recommended dose is one Suvezen tablet daily. To be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water. If co-administered with bile acid sequestrant (BAS), administration of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a BAS. Special populations: Paediatric (<18 years): Safety and efficacy has not been established. Elderly (>70 years): Starting dose of 5 mg rosuvastatin is recommended. The combination is not suitable for initial therapy. Hepatic impairment: Mild: No dosage adjustment is required. Moderate/Severe: Treatment with Suvezen is not recommended. Renal impairment: Mild: No dose adjustment is necessary. Moderate (creatinine clearance <60 ml/ min): The recommended start dose is rosuvastatin 5mg. Race: The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry due to increased systemic exposure. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Suvezen 40 mg/10 mg tablets are contraindicated in these patients. Genetic polymorphisms: In patients who are known to have specific types of genetic polymorphisms that can lead to increased rosuvastatin exposure, a lower daily dose of Suvezen is recommended. Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5mg in patients with pre-disposing factors to myopathy. Suvezen 40 mg/10 mg tablets are contraindicated in some of these patients. Concomitant therapy:

The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir).

Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where co-administration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered. Contraindications: Hypersensitivity to the active substances or excipients.

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

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

HMG-CoA reductase inhibitors, rosuvastatin should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. Renal effects: Proteinuria has been observed in patients treated with higher doses of rosuvastatin and was transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40mg. Diabetes mellitus: Some evidence suggests that statins raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (fasting glucose 5.6 – 6.9mmol/l, BMI >30kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. Interstitial lung disease: Exceptional cases have been reported with some statins, especially with long term therapy. Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected, statin therapy should be discontinued. Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors in combination with ritonavir. Consideration should be given both to the benefit of lipid lowering by use of Suvezen in HIV patients receiving protease inhibitors and the potential for increased rosuvastatin plasma concentrations when initiating and up titrating rosuvastatin doses in patients treated with protease inhibitors. The concomitant use with certain protease inhibitors is not recommended unless the dose of rosuvastatin is adjusted. Fibrates: The safety and efficacy of ezetimibe administered with fibrates have not been established. If cholelithiasis is suspected in a patient receiving Suvezen and fenofibrate, gallbladder investigations are indicated and therapy should be discontinued. Anticoagulants: If Suvezen is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalised Ratio (INR) should be appropriately monitored. Fusidic acid: Suvezen must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination.

The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of fusidic acid. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e.g., for the treatment of severe infections, the need for co-administration of Suvezen and fusidic acid should only be considered on a case by case basis and under close medical supervision. Suvezen contains lactose monohydrate and sodium: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Interactions: Contraindicated combinations: Ciclosporin.

Not-recommended combinations: Fibrates and other lipid-lowering products, protease inhibitors, transporter protein inhibitors and fusidic acid. Other possible interactions: Cytochrome P450 enzymes, antacids, colestyramine, anticoagulants, Vitamin K antagonists, erythromycin, oral contraceptive/hormone replacement therapy. When co-administering rosuvastatin with other medicinal products known to increase exposure to rosuvastatin, doses should be adjusted (see SmPC for full details). The maximum daily dose should be adjusted so that the expected rosuvastatin exposure would not likely exceed that of a 40mg daily dose of rosuvastatin taken without interacting medicinal products. Fertility, Pregnancy and Breastfeeding: No clinical data are available on the use of ezetimibe during pregnancy. Potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. If a patient becomes pregnant during use of Suvezen, treatment should be discontinued immediately. Animal studies have shown excretion of medicinal product through breast milk. However, there are no data in humans. No clinical trial data on the effects of fertility in humans. Adverse Reactions: Adverse drug reactions previously reported with one of the individual components (ezetimibe or rosuvastatin) may be potential undesirable effects with Suvezen. Common (≥1/100 to <1/10): diabetes mellitus, headache, dizziness, constipation, nausea, abdominal pain, diarrhoea, flatulence, myalgia, ALT and/or AST increased, asthenia and fatigue. Uncommon (≥1/1,000 to <1/100): decreased appetite, paraesthesia, hot flush, hypertension, cough, dyspepsia, gastroesophageal reflux disease, nausea, dry mouth, gastritis, pruritus, rash, urticaria, arthralgia, muscle spasms, neck pain, back pain, muscular weakness, pain in extremity, ALT and/or AST increased, blood CPK increased, gamma-glutamyltransferase increased, liver function test abnormal, chest pain, pain, asthenia, oedema peripheral. Rare (≥1/10,000 to <1/1,000): thrombocytopenia, hypersensitivity reactions including angioedema, pancreatitis, increased hepatic transaminases, myopathy (including myositis), rhabdomyolysis, lupus-like syndrome and muscle rupture. Very rare (<1/10,000): polyneuropathy, memory loss, jaundice, hepatitis, arthralgia, haematuria, gynaecomastia. Not known: thrombocytopenia, hypersensitivity (including rash, urticaria, anaphylaxis and angioedema), depression, peripheral neuropathy, sleep disturbances (including insomnia and nightmares), dizziness, paraesthesia, cough, dyspnoea, diarrhoea, pancreatitis, constipation, hepatitis, cholelithiasis, cholecystitis, Stevens Johnson syndrome, erythema multiforme, immune-mediated necrotising myopathy, tendon disorders (sometimes complicated by rupture), myalgia, myopathy/rhabdomyolysis, oedema, asthenia. See SmPC for full

“The vast majority of drug treatments that improve survival and reduce hospitalisations also have beneficial effects on quality-of-life and symptoms,” said guidelines taskforce chairperson Prof Theresa McDonagh of King’s College Hospital, London, UK. “There are some interventions that do not impact survival, but do improve quality-of-life and symptoms – for example exercise rehabilitation – that should also be offered to patients with chronic heart failure.”

The guidelines recommend that all patients have access to a multidisciplinary HF disease management programme to ensure that their HF is correctly diagnosed and managed. In addition, patients with HF should be encouraged to be actively involved in managing their condition. Self-care includes adopting healthy habits, such as physical activity, avoiding excessive salt intake, maintaining a healthy body weight, avoiding excessive alcohol consumption, and not smoking.

As patients with HF are at increased risk of infections, which may worsen symptoms and be a precipitant factor for acute HF, the guidelines state that influenza, pneumococcal and Covid-19 vaccination should be considered in patients with HF.

The guidelines also provide general advice on how to prevent HF. This includes regular physical activity, not smoking, healthy diet, no/light alcohol intake, influenza vaccination, and treatment of high blood pressure and high cholesterol.

Recommendations are also given on how to manage patients with HF who have co-existing conditions, such as atrial fibrillation and valvular heart disease.

“It is crucial to treat the underlying causes of heart failure and its comorbidities,” said guidelines taskforce chairperson Prof Marco Metra of the University of Brescia, Italy.

“Proper treatment of high blood pressure, diabetes and coronary artery disease can prevent the development of heart failure. Atrial fibrillation, valvular heart disease, diabetes, chronic kidney disease, iron deficiency, and other comorbidities frequently co-exist with heart failure and the adoption of specific treatments may have a major impact on the clinical course of our patients.”

Significantly improves exercise duration and reduces angina frequency1

Abbreviated Prescribing Information: Ranexa (ranolazine). Please consult the Summary of Product Characteristics (SPC) for full prescribing information. Presentation: Prolonged-release tablets containing 375 mg, 500 mg or 750 mg of ranolazine. 750 mg tablet contains E102 and lactose. Use: Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). Dosage and administration: Oral administration. Patients should be instructed to list their medication to their health care professional at each visit. Adults: Initial dose is 375 mg twice daily. After 2-4 weeks, dose should be titrated to 500 mg twice daily and, according to patient’s response, further titrated to 750 mg twice daily. Concomitant treatment with moderate CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended. Renal impairment: Careful dose titration is recommended in mild to moderate renal impairment, and contraindicated in severe renal impairment. Hepatic impairment: Careful dose titration is recommended in mild hepatic impairment, and contraindicated in moderate to severe hepatic impairment. Elderly: Dose titration in the elderly should be exercised with caution. Low weight: Dose titration in patients with low weight should be exercised with caution. Congestive Heart Failure (CHF): Dose titration in moderate to severe CHF should be exercised with caution. Paediatric patients: No data in children below the age of 18 years. Ranexa tablets should be swallowed whole and not crushed, broken or chewed. They may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Severe renal impairment. Moderate or severe hepatic impairment. Concomitant administration of potent CYP3A4 inhibitors. Concomitant administration of Class Ia or Class III antiarrhythmics other than amiodarone. Warnings and Precautions: Caution should be exercised when prescribing or up titrating ranolazine to patients in whom an increased exposure is expected. QT prolongation: Caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval. Interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy.

Renal impairment: Check renal function at regular intervals during treatment. Interactions: CYP3A4 inhibitors: Increase plasma concentrations of ranolazine. Combining ranolazine with potent CYP3A4 inhibitors is contraindicated. CYP3A4 inducers: Avoid initiation with Ranexa during administration of CYP3A4 inducers. CYP2D6 inhibitors: May increase plasma concentrations of ranolazine. Effect of ranolazine on other medicinal products: Dosage adjustment of sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range may be required. Lower doses of CYP2D6 substrates may be required. Caution with CYP2B6 substrates. Monitor digoxin levels following initiation and termination of Ranexa. Limit dose of simvastatin to 20mg once daily in patients taking Ranexa. Limit dose of atorvastatin and consider clinical monitoring in patients taking Ranexa. Monitor blood levels of tacrolimus when coadministering with Ranexa and adjust tacrolimus dose accordingly. Also recommended for other CYP3A4 substrates with a narrow therapeutic range. Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin increased in subjects with type 2 diabetes mellitus when co-administered with Ranexa. The exposure of other OCT2 substrates may also be affected. Theoretical risk that concomitant treatment with drugs known to prolong the QTc interval may increase the possible risk of ventricular arrhythmias. Pregnancy and lactation: Ranexa should not be used during pregnancy unless clearly necessary. Ranexa should not be used during breast-feeding. Effect on fertility unknown. Side-effects: Generally mild to moderate in severity and often develop within the first 2 weeks of treatment. Common (1-10%): dizziness, headache, constipation, vomiting, nausea, asthenia. Uncommon (0.1–1%): anorexia, decreased appetite, dehydration, anxiety, insomnia, confusional state, hallucination, lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paraesthesia, blurred vision, visual disturbance, diplopia, vertigo, tinnitus, hot flush, hypotension, dyspnoea, cough, epistaxis, abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort, pruritus, hyperhydrosis, pain in extremity, muscle cramp, joint swelling, muscular weakness, dysuria, haematuria, chromaturia, fatigue, peripheral oedema, increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight. In a long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients. Rare (0.1-0.01%): hyponatremia, disorientation, amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia, impaired hearing, peripheral coldness, orthostatic hypotension, throat tightness, pancreatitis, erosive duodenitis, oral hypoaesthesia, angioedema, allergic dermatitis, urticaria, cold sweat, rash, acute renal failure, urinary retention, erectile dysfunction, elevated levels of hepatic enzyme. Not known: myoclonus. Increased incidence of congestive heart failure and transient ischaemic attacks seen in patients with history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention and treated within 2 weeks with ranolazine (1000 mg twice daily [dose not approved in Europe]) in a placebo-controlled post-PCI trial. Elderly, renal impairment and low weight: In general, adverse events occurred more frequently among elderly patients and patients with renal impairment. Adverse events in patients with low body weight were similar to those of patients with higher weight. Please consult the SPC for further information.Pack size: 60 tablets. Legal category: POM. Marketing authorisation numbers: EU/1/08/462/001, 003, 005 Marketing Authorisation holder: Menarini International Operations Luxembourg S.A. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SPC. Last updated: October 2020

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

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

ESC Congress 2021 round-up

Priscilla Lynch presents a round-up of some of the most topical research presented at the European Society of Cardiology (ESC) 2021 Congress, which took place virtually from 27-30 August.

Flu jab after heart attack should become standard care

Influenza vaccination reduces the risk of all-cause death, myocardial infarction, or stent thrombosis at 12 months in hospitalised patients with myocardial infarction or high-risk coronary disease, according to late breaking research presented in a Hot Line session at the ESC 2021 Congress.

During influenza epidemics more people die from cardiovascular causes than during non-epidemic periods, the researchers noted. Observational studies have suggested a protective effect from influenza vaccination on cardiovascular events, and single-centre randomised trials have supported these findings. Influenza vaccination is recommended for patients with heart disease, but is not part of standard hospital care following an acute myocardial infarction.

The IAMI trial was the largest randomised trial to date to evaluate whether influenza vaccination improves outcomes following myocardial infarction or percutaneous coronary intervention in high-risk patients with coronary artery disease. The trial was conducted at 30 hospitals in eight countries (Sweden, Denmark, Norway, Latvia, the UK, Czech Republic, Bangladesh, and Australia) over four

influenza seasons spanning October 2016 through February 2020.

Participants were randomly assigned in a 1:1 ratio to receive either the influenza vaccine or placebo within 72 hours of an invasive coronary procedure or hospitalisation. The primary endpoint was a composite of all-cause death, myocardial infarction, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary outcomes of all-cause death, cardiovascular death, myocardial infarction, and stent thrombosis.

The trial was halted prematurely on 7 April 2020 by the data safety and monitoring board due to the Covid-19 pandemic after the enrolment of 2,571 patients (58 per cent of the target). The average age of participants was 60 years and 18 per cent were women.

The primary composite endpoint occurred in 67 patients (5.3 per cent) in the vaccine group and 91 (7.2 per cent) in the placebo group (HR 0.72; 95% CI 0.52–0.99; p=0.040). Regarding secondary endpoints, death from any cause occurred in 37 patients (2.9 per cent) in the vaccine group

Intensive blood pressure lowering benefits older patients with hypertension

Aggressive blood pressure treatment in older hypertensive patients lowers the incidence of cardiovascular events compared to standard therapy, without increasing adverse outcome, according to research presented in a Hot Line session at ESC Congress 2021 and published in the New England Journal of Medicine

The overall prevalence of hypertension in adults is around 30-to-45 per cent, rising to more than 60 per cent of people over 60 years of age. As populations age, adopt more sedentary lifestyles, and increase their body weight, the prevalence of hypertension worldwide will continue to rise. Elevated blood pressure was the leading global contributor to premature death in 2015, accounting for almost 10 million deaths.

Trials of blood pressure lowering in older adults with hypertension have yielded mixed results and guidelines recommend different target levels. The STEP study was conducted to provide new evidence on the benefits of blood pressure lowering in older patients with hypertension. Specifically, it examined whether intensive treatment targeting a systolic blood pressure (SBP) below 130mmHg could reduce the risk of cardiovascular disease compared with a SBP target below 150mmHg.

The study enrolled 8,511 older essential hypertensive patients from 42 clinical sites in China. All participants were aged 60-to-80 years, with an SBP of 140-190mmHg during three screening visits or taking antihypertensive medication. Patients with prior stroke were excluded.

Participants were randomly assigned to either intensive treatment (SBP target below 130mmHg, but no lower than 110mmHg); or standard treatment (SBP target 130150mmHg). The primary outcome was a composite of acute coronary syndrome, stroke, acute decompensated heart failure, coronary revascularisation, atrial fibrillation, or death from cardiovascular causes. Secondary outcomes included the components of the primary endpoint, major artery stiffness, and a decline in renal function or development of end-stage renal disease. All participants were scheduled for follow-up at one, two, and three months, and every three months thereafter until month 48 or until the close-out visit. The same validated office blood pressure measurement device was used at all collaborating hospitals, which minimised investigator bias in deter-

mining blood pressure during the follow-up clinic visits.

One important strength of the trial was that home blood pressure was monitored as an adjunct to office measurements via a smartphone-based application (app). At study entry, all participants were provided with the same validated automatic home blood pressure monitor. The monitor’s Bluetooth function enabled patients to upload readings to a data centre via the app. If blood pressure was not measured regularly and transmitted to the data centre, the app sent reminders via WeChat. A monthly report on home measurements was sent to doctors to improve the efficiency of blood pressure control during the trial.

During a median 3.34-year follow-up period, the average decrease in SBP from baseline was 20.4mmHg in the intensive treatment group and 10.8mmHg in the standard treatment group. Average SBP reached 125.6mmHg and 135.2mmHg in the intensive and standard groups, respectively, with an average between-group difference of 9.6mmHg.

A total of 196 primary outcome events were documented in the standard treatment group (4.6 per cent) compared to 147 events in the intensive treatment group (3.5 per cent), with a relative risk reduction of 25 per cent (HR with intensive treatment 0.75; 95% CI 0.60–0.92).

Regarding secondary outcomes, intensive treatment was associated with a 34 per cent lower relative risk of stroke (95% CI 0.46-0.95) and a 32 per cent lower relative risk of acute coronary syndrome (95% CI 0.48–0.95). The progression of arterial stiffness evaluated by brachial-ankle pulse wave velocity was significantly slower in the intensive treatment group. Rates of serious adverse events and renal outcomes did not differ between the two groups except hypotension, which occurred in 146 (3.4 per cent) and 113 (2.6 per cent) patients in the intensive and standard treatment groups, respectively (p=0.03).

Principal investigator Prof Jun Cai of the Chinese Academy of Medical Sciences, Beijing, China said: “Active control of SBP to below 130mmHg in older hypertensive patients, as compared with below 150mmHg, resulted in a lower incidence of major cardiovascular events, with no increase in renal injuries. Home blood pressure monitoring more accurately reflected long-term fluctuations in blood pressure than office measurements.”

and 61 (4.9 per cent) in the placebo group (HR 0.59; 95% CI 0.39–0.89, p=0.010). Rates of cardiovascular death were 2.7 per cent and 4.5 per cent, respectively (HR 0.59; 95% CI 0.39–0.90, p=0.014). There was no difference between groups in the rate of myocardial infarction, which occurred in 25 (2.0 per cent) and 29 (2.4 per cent) patients in the vaccine and placebo groups, respectively (HR 0.86; 95% CI 0.50–1.46; p=0.57).

Serious adverse events were rare and of similar type and incidence in both groups. injection site reactions like pain, redness, swelling, and hardening were reported significantly more often in patients assigned to influenza vaccine.

Principal investigator Prof Ole Fröbert of Örebro University, Sweden said: “The IAMI trial found that in patients with myocardial infarction or high-risk coronary disease, early influenza vaccination resulted in a lower risk of the composite of all-cause death, myocardial infarction or stent thrombosis at 12 months compared with placebo. Our findings suggest that influenza vaccination should be considered as part of in-hospital treatment after myocardial infarction.”

During the ESC 2021 Congress, Dr Andreas Karwath from the team of Prof Dipak Kotecha (University of Birmingham, UK) reported on the use of a novel artificial intelligence (AI) pipeline to identify clusters of patients with heart failure (HF) and reduced left ventricular ejection fraction (LVEF) that respond to beta-blocker therapy.

Including 15,659 patients from nine double-blind placebo-controlled randomised trials, the study used a combination of neural network-based variational autoencoders and hierarchical clustering, with objective determination of the number of clusters and dimensions. All-cause mortality was assessed during a median of 1.3 years of follow-up, and stratified by heart rhythm into sinus rhythm and atrial fibrillation (AF).

Among 12,822 patients in sinus rhythm, most of the six clusters identified demonstrated a consistent overall mortality benefit from beta-blockers, with odds ratios (ORs) ranging from 0.54 to 0.74, including in those at the highest mortality risk. However, there was no significant efficacy in one cluster of 2,537 patients who were on average older, with less impairment of LVEF and a lower baseline heart rate.

Among 2,837 patients with AF, four of five clusters were consistent with the overall neutral effects of beta-blockers vs placebo (OR 0.92; 95% CI 0.77 to 1.10; p=0.37). The fifth cluster, on average younger AF patients with lower rates of prior myocardial infarction but similar LVEF, had a statistically significant mortality reduction with beta-blockers (OR 0.57; 95% CI 0.35 to 0.93; p=0.023). The robustness and consistency of clustering was confirmed for all models (p<0.0001 vs random) and cluster membership was externally validated across the nine independent trials.

This AI-based approach may provide a useful, unbiased tool to estimate prognostic response to beta-blocker therapy in patients with HF and reduced LVEF, and across other therapies and conditions. Further details can be seen in the paper to be published in The Lancet

More than 39,000 health professionals from 169 countries registered to tune into live and on-demand scientific presentations covering the full spectrum of cardiovascular medicine during the ESC 2021 Congress. The 20 Hot Line sessions showcased the most highly anticipated clinical trial results, and scientists from over 88 countries presented their research in nearly 3,700 abstracts.

A novel machine learning approach redefines beta-blocker response in patients with HF

For all that matters in medicine

Low-sodium salt prevents stroke – new study

Replacing salt with a low-sodium alternative lowers the risk of stroke in people with high blood pressure or prior stroke, according to major new research presented in a Hot Line session at ESC Congress 2021 and published in the New England Journal of Medicine

Both elevated sodium intake and low potassium intake are associated with high blood pressure and an increased risk of cardiovascular disease and premature death. Salt substitutes, which replace part of the sodium chloride in regular salt with potassium chloride, have been shown to lower blood pressure but their effects on heart disease, stroke, and death had been uncertain. In addition, there had been concerns about causing hyperkalaemia in people with chronic kidney disease leading to cardiac arrhythmias and sudden death.

The Salt Substitute and Stroke Study (SSaSS) compared the effect of reduced sodium salt substitute versus regular salt on stroke, cardiovascular events, mortality and clinical hyperkalaemia. SSaSS was an open, cluster-randomised, trial that enrolled participants between April 2014 and January 2015. Participants were adults with either previous stroke or age 60 years and above with poorly controlled blood pressure.

The trial was conducted in 600 villages in rural areas of five provinces in China. Two counties within each province were chosen that represented the socioeconomic development level of rural counties in that province. Ap-

proximately 35 individuals were recruited from each village – for a total of 20,995 participants. Participants were cluster-randomised by village in a 1:1 ratio to provision of salt substitute or continued use of regular salt.

Participants in intervention villages were given free salt substitute (about 75 per cent sodium chloride and 25 per cent potassium chloride) as a replacement for regular salt and advised to use it for all cooking, seasoning and food preservation. They were also encouraged to use the salt replacement more sparingly than they previously used salt to maximise their sodium reduction. Sufficient salt substitute was provided to cover the needs of the entire household (about 20g per person per day). Participants in control villages continued their usual habits.

The average age of participants was 65.4 years and 49.5 per cent were female. Some 72.6 per cent had a history of stroke and 88.4 per cent had a history of hypertension.

During an average follow-up of 4.74 years, more than 3,000 people had a stroke, more than 4,000 died, and more than 5,000 had a major cardiovascular event. The risk of stroke was reduced with salt substitute compared to regular salt (29.14 versus 33.65 per 1,000 patient-years; rate ratio [RR] 0.86; 95% CI 0.77–0.96; p=0.006).

Regarding secondary outcomes, major cardiovascular events (non-fatal stroke, non-fatal acute coronary syndrome, vascular death) were reduced with salt substitute (49.09 versus 56.29 per 1,000 patient-years; RR 0.87; 95% CI 0.80–0.94;

p<0.001) as was total mortality (39.27 versus 44.61 per 1,000 patient-years; RR 0.88; 95% CI 0.82–0.95; p<0.001).

Regarding safety, there was no increased risk of serious adverse events attributed to clinical hyperkalaemia with salt substitute compared to regular salt (3.35 versus 3.30 per 1,000 patient years; RR 1.04; 95% CI 0.80–1.37; p=0.76). Neither were any other risks identified.

Principal investigator Prof Bruce Neal of the George Institute for Global Health, Sydney, Australia said: “This study provides clear evidence about an intervention that could be taken up very quickly at very low cost. A recent modelling study done for China projected that 365,000 strokes and 461,000 premature deaths could be avoided each year in China if salt substitute was proved to be effective. We have now showed that it is effective, and these are the benefits for China alone. Salt substitution could be used by billions more with even greater benefits.”

He added: “The trial result is particularly exciting because salt substitution is one of the few practical ways of achieving changes in the salt people eat. Other salt reduction interventions have struggled to achieve large and sustained impact.’’

“Importantly, salt substitute is very easy to manufacture and it is not expensive…. It is primarily lower-income and more disadvantaged populations that add large amounts of salt during food preparation and cooking. This means that salt substitute has the potential to reduce health inequities related to cardiovascular disease.”

There has been little information on the safety of direct-acting oral anticoagulants compared with vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) following successful transcatheter aortic valve implantation (TAVI).

In a Hot Line session at the ESC 2021 Congress, Prof George Dangas (Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, US) presented results from the multi-centre, open-label ENVISAGE-TAVI AF study, in which patients with AF and an anticoagulation indication were randomised to receive edoxaban or the locally available VKA (warfarin or its analogues), each administered between 12 hours and five days following TAVI.

The primary efficacy endpoint was the incidence of net adverse clinical events (NACE), a composite of allcause death, myocardial infarction, ischaemic stroke, systemic thromboembolism, valve thrombosis, and major bleeding (as defined by the International Society on Thrombosis and Haemostasis [ISTH]). The primary safety endpoint was the incidence of ISTH-defined major bleeding.

The average age of the 1,426 participants was 82 years and 47.5 per cent were women. Comorbidities were common: 83-to-87 per cent had congestive heart failure, 39-to-42 per cent had coronary artery disease, and approximately 17 per cent had a previous stroke or transient ischaemic event.

At an average follow-up of 18 months, edoxaban demonstrated non-inferiority to VKAs for the primary efficacy endpoint, with NACE rates of 17.5 per cent per year in the edoxaban group and 16.5 per cent per year in the VKA group (HR 1.05; 95% CI 0.85 to 1.31; p=0.01 for non-inferiority).

However, there was a higher risk of major bleeding in the edoxaban group compared with the VKA group (HR 1.40; 95% CI 1.03 to 1.91), with rates of 9.7 per cent per year and 7.0 per cent per year, respectively. The higher risk was mainly due to gastrointestinal bleeding. In secondary analyses, patients in the edoxaban group who required a downward dose adjustment and those not prescribed oral antiplatelet therapy had a similar rate of major bleeding as those in the VKA group.

Summarising the findings, Prof Dangas commented: “ENVISAGE-TAVI AF suggests that treatment with edoxaban can be valuable in the management of this high-risk population of patients with AF after TAVI. We need to be attentive to the higher bleeding risks with edoxaban. Based on secondary analyses, it seems that lowering the edoxaban dosage when indicated and avoiding patients on mandatory antiplatelet therapy is reasonable safety advice from a clinical point of view. We will be conducting a detailed analysis on specific types of bleeding in the near future.”

During the ESC 2021 Congress, new ESC and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the management of valvular heart disease (VHD) were presented in a session chaired by Prof Alec Vahanian (University of Paris, France; ESC Taskforce Chair) and Prof Friedhelm Beyersdorf (University of Freiburg, Germany; EACTS Taskforce Chair).

“VHD is too often undetected, and the new guidelines begin with a section that stresses the importance of clinical examination as the initial step in diagnosis,” said Prof Vahanian. “Modern non-invasive evaluation using two- and three-dimensional echocardiography first – with other cardiac imaging techniques applied when needed – is essential to assess severity.” He added: “Catheterisation should only be used when imaging is inconclusive.”

Interventions (transcatheter or surgical) are indicated in symptomatic patients if there is an expected benefit. For asymptomatic patients, the guidelines emphasise that decision-making must weigh the risk of intervention against the expected natural history of VHD – if rapid symptom progression is predicted, intervention may be justified if the procedural risk is low. In elderly patients, the estimated impact of treatment on life expectancy and quality-of-life should be considered.

“Patients’ expectations and values are an important part of the decision-making process,” said Prof Beyersdorf. “Patients and their families should be thoroughly informed and assisted in their choices. Symptom relief on its own may justify intervention if it is a priority for the patient. However, treatment is considered futile when it is not expected to prolong life or relieve symptoms.”

Regarding surgery, increased experience and

procedural safety have led to expanded indications toward earlier surgery in asymptomatic patients with aortic stenosis, aortic regurgitation or mitral regurgitation. The guidelines emphasise the need for more comprehensive evaluation and earlier intervention in patients with tricuspid regurgitation to avoid irreversible heart damage.

Regarding transcatheter techniques, new information from randomised studies comparing transcatheter aortic valve implantation (TAVI) vs surgery in low-risk patients with a follow-up of two years has led to a need to clarify which types of patients should be considered for each mode of intervention. Transcatheter edge-to-edge repair is increasingly used in secondary mitral regurgitation and has been evaluated against optimal medical therapy, resulting in an upgrade of the recommendation. The larger number of studies on transcatheter valve-in-valve implantation after failure of surgical bioprostheses served as a basis to upgrade its indication. Finally, the encouraging preliminary experience with transcatheter tricuspid valve interventions suggests a potential role for this treatment in inoperable patients, although this needs to be confirmed by further evaluation.

For antithrombotic management, new evidence has led to recommendations in patients with surgical or transcatheter bioprostheses for bridging during perioperative periods and over the long-term. The recommendation for non-vitamin K antagonist oral anticoagulants has been reinforced in patients with native valvular disease, except for significant mitral stenosis and in those with bioprostheses.

The full 2021 ESC/EACTS Guidelines for the management of VHD are now published in the European Heart Journal

Edoxaban is non-inferior to VKAs in patients with AF after TAVI

2021 ESC/EACTS clinical practice guidelines for the management of valvular heart disease

SPORTS QUIZ WIN €50 16 September 2021

Q1 Which county won the All Ireland Senior Ladies Football Championship for the first time in their history earlier this month?

Q2 How many medals did Team Ireland win at the 2021 Paralympic Games?

Q3 What team will Formula One driver Valtteri Bottas drive for in the next season?

Q4 Who scored the goal for Ireland in the defeat to Portugal in the recent World Cup qualifiers?

Q5 Who won the US Open Ladies Singles title in Flushing Meadows last weekend?

Q6 Primož Roglič won the Vuelta España last week, but how many Vuelta titles has he now won?

CROSSWORD COMPETITION

16 September 2021

The winner of the 26 August 2021 Sporting Quiz Competition is Dr Kathleen Murtagh, Co Kilkenny

The winner of the 26 August 2021 Crossword is Dr Patricia McCarthy, Co Waterford

Q1 Mayo will take on either Kerry or Tyrone in this year’s All Ireland Football Final. How many finals have Mayo lost since they last won Sam Maguire back in the early 1950s? A: 10

Q2 Kellie Harrington’s Olympic boxing gold medal is the third boxing gold Team Ireland have ever won. Katie Taylor won in 2012, but who was the other gold medallist from 1992? A: Michael Carruth

Q3 Which Formula 1 driver won his maiden Grand Prix at the recent Hungarian Grand Prix? A: Esteban Ocon

Q4 Who won the 2021 FA Community Shield? A: Leicester City

Q5 The British and Irish Lions went down to South Africa’s Springboks in their summer tour. What year did the Lions last win a test series against the Springboks? A: 1997

Q6 Who stepped down as Tipperary Hurling manager earlier this month? A: Liam Sheedy

7 Mayhem (5)

8 Taken as a whole (7)

9 Apparel (5)

12 Eg, Iceland (6)

DOWN

2 Evident (7)

3 Discovering; finding out (8)

4 Solid and firm (4)

5 Vital content (7)

6 In the fresh air (7)

7 Assert

The Japanese art of ‘less-is-more’

Mazda’s 100th anniversary edition CX-30 crossover was festooned with commemorative markings to celebrate the marque’s century in the business. My test car had a lovely burgundy interior with the aforementioned ‘1920-2020’ markings in the headrests. There were also ‘100 years’ logos on the 18” bright silver alloy wheels and the floor mats. As it’s a special edition, Mazda threw the kitchen sink at the car’s spec list, with the Bose sound system, 360 view cameras, and driver monitoring system, to name just a few.

Mazda are keen to shine a light on more than just the limited-edition specs on this car, as the CX-30’s e-Skyactiv-X engine has received some updates in both power and efficiency. The motor is now producing 186 metric horsepower, which is an increase of 6hp, as well as 240nm of torque at 4,000rpm, which is another increase of 16nm. Those torque levels are in the range you would expect from a diesel engine, which is quite a feat from this impressive motor. The e-Skyactiv-X motor’s fuel economy has improved by 0.2l/km while it produces -5g less CO 2 . So, all in all, it’s faster, leaner and greener.

I enjoy the feeling of that surge of torque you get from most turbos, so it takes a little getting used to the feeling of the normally aspirated e-Skyactiv X-engine. The CX30 has a surprisingly wide power band and the snappy gearbox means it’s enjoyable to drive throughout the rev band. I normally prefer an automatic gearbox in crosso -

ver SUVs, but in this instance I’d make an exception. As the car shares its chassis with the Mazda-3 hatchback it also handles rather nicely, for a crossover, which adds to the fun of driving it.

The CX-30 is very sleek, inside and out. In my opinion, it is one of the best-looking crossovers on the market. Its design prowess, according to Mazda, showcases the latest developments in the company’s Kodo, ‘Soul of Motion’ design language. According to the Japanese marque, Kodo now targets greater styling prestige through the elegance and rigor of a minimalist, ‘less-ismore’, aesthetic inspired by the purest traditions of Japanese art and the beauty of space between objects.

The only drawback is the infotainment system, which I’m afraid I just don’t get. It was fine in the MX-5, where you have too much driving to be doing to be worrying about it. But in a family-focused crossover, when some of the competition can play Disney videos and Angry Birds games on the touchscreen infotainment system, I think Mazda is falling behind a little.

However, this infotainment system is attached to, dare I say, one of the best sound systems I’ve come across in a while. The system in my test car was so good I featured it in a collection of Instagram stories on my 928dublin page. My test car had the 12-speaker Bose system custom-tuned set up. It uses a newly devised BassMatch system, which combines two 115mm high-excursion woofers, each housed in a 3-litre low-frequency enclosure placed in the front cowl-sides near the kick panels

in the driver and passenger footwells, with a third bass source, a 130mm Richbass woofer in an 8-litre custom-engineered enclosure in the spare-tyre well at the rear of the car.

According to the experts at Mazda: “Placing the front enclosures near the kick panels instead of typical integration into the doors minimises speaker buzz and vibration – even when playing music at high volume. In addition, this configuration generates more acoustic energy because the BassMatch enclosures are positioned near the forward cabin corners, producing a similar effect to placing home speakers in the corners of a room to create more powerful bass response through sound reflection off the walls and back toward the listener.”

The CX-30 will be offered with three engine options, the first two option are part of the e-Skyactiv-G engine series. The first produces 122hp, gets milage figures of 6.9-5.9 l/100km and has CO 2 emissions of 156-134g/ km. The second, 150hp option offers up fuel consumption of 6.9-5.9 l/100km with CO 2 emissions of 156-134g/ km. Finally, the all-important, revolutionary 186hp e-Skyactiv-X, with its bells, whistles, and mild hybrid system gets milage of 6.6-5.7 l/100km with CO 2 emissions of 149-128g/km.

The Mazda CX-30 100th Anniversary Edition I was testing will set you back €39,165 (rrp), compared to the base model starting price of €29,145. It’s a lovely car to spend time in and like all Mazdas it will suit a keen driver more than someone who just wants to get from A to B.

MAZDA CX-30 100TH

ANNIVERSARY EDITION

Engine: 2.0 Skyactiv-X Mazda M Hybrid

Power: 186ps/6,000rpm (+6ps)

Torque: 240nm @ 4000rpm (+16nm)

0-100km/h: 8.3 seconds

Fuel economy (WLTP): 5.7 l/km (-0.2l)

Top speed: 204km/h

Spec: 100th Anniversary Special Edition

Colour: Snowflake White (Metallic)

Transmission: Manual

Drive: FWD

CO2 (WLTP): 128g/km (-5g)

Price: €39,165 RRP

CX-5 Starting price: €29,495

MAZDA CX-30 STANDARD EQUIPMENT

 16” Alloys

 LED Headlights

 Bluetooth and Mazda MZD Connect

 High beam control

 Mazda radar cruise control

 Lane keep assist with lane

departure warning

 Blind spot monitoring

 Rear cross traffic alert

 Rear parking sensors

 Alarm and Immobiliser

 Multifunction leather steering wheel

 Heated auto folding power door mirrors

 8.8” Colour centre console display and multimedia commander

 7 Inch TFT digital dashboard

 Apple Car Play and Android Auto

 Dynamic stability control

(DSC) with traction control system (TCS)

 USB ports (X2)

 Emergency break assist (EBA)

 Electronic brake-force distribution (EBD)

 Tyre pressure monitoring system

 Airbags (driver, passenger, side & curtain)

 ISOFIX brackets

 Hill hold assist

 Automatic rain sensing wipers

 Automatic dusk sensing lights

 Electronic handbrake

 Integrated satellite navigation

 i-stop/engine start stop button

 Window projection active driving display

 Traffic sign recognition

 G-Vectoring control plus

 Smart city brake support (front) with pedestrian recognition

 Ecall with GPS

UPGRADE FEATURES

(IN ADDITION) [GS-L ADDS:]

 Auto dimming outer mirror

 Auto dimming inner mirror

 Smart keyless entry

 Power liftgate

 Rear digital camera

 Front seat heaters

 Dual automatic air conditioning

 Front parking sensors

 CD player

[GT ADDS:]

 18” Alloy wheels

 Mirror and head up display memory

 Driving position memory

 Black leather seats

 Power driver seat (8 way and lumbar)

 Heated steering wheel

[GT Sport adds:]

 Adaptive LED Headlights

 Front and rear LED signature LED lights

 Rear privacy glass

 Frameless auto dimming rear view mirror

 Piano black front grille and sail garnish

 Piano black B pillar

 BOSE Sound System with 12 speakers

[100TH ANNIVERSARY EDITION ADDS:]

 100 Years 1920-2020 exterior badging

 18” bright silver alloys with 100 years logo

 Burgundy leather seat trim with 100 year logo embossing

 100 Years burgundy floor mats

 Stone leather centre and door trim

 360° view parking monitor

 Driver monitoring system

 Front cross-traffic alert

 Rear smart brake support

 Snowflake White Pearlescent paint

 Power tilt and slide sunroof

According to the Japanese marque, Kodo now targets greater styling prestige through the elegance and rigor of a minimalist, ‘less-is-more’, aesthetic inspired by the purest traditions of Japanese art

PROF GAYE CUNNANE Consultant Rheumatologist, St James’s Hospital, Dublin

Charlie – a love story

The strong bond that developed between Prof Gaye Cunnane and her new dog was a source of great surprise

They say that owners begin to resemble their dogs after a period of time. Over the years while out walking around the streets of Dublin or elsewhere, I might take a moment to observe the connections between canine and human and, frequently, I would silently agree. There might be pointed features, or a dishevelled appearance, or (and this might be a reason to cross the road) an aggressive stance, with the leash acting as the real and metaphorical connection between the two.

So, when Charlie arrived, in a whirlwind of fluff and unpredictable bodily functions, into my ordered existence, I was sure that no-one would ever make such an analogy. Even the bond that I thought would be there from the beginning was questionable in the rude awakenings, typically at 3.25am, when insistent barking and whining would portend an unpleasant mess. At those times, when I would carry him into the garden to finish off what he had started, I would look up at the gloomy sky and ask myself how I had gotten into this situation and, more importantly, how I would get out of it again. In those dark moments, I would have happily handed him over to a stranger, along with the copious toys and comfy doggy blankets I had bought for him. Even as a doctor, I had never seen so much pooh, especially in unpredictable places. One early morning, after a particularly dramatic night, I noticed lumps of it stuck to a kitchen cupboard and wondered if he’d actually fired them from his crate because I couldn’t think how they could otherwise have reached such far-flung locations.

But several hours later, he would greet me with delight, cuddling, licking, and sighing with contentment to have been reunited with his human, even if it wasn’t long since our previous, less happy, interaction.

It was easy to name Charlie, because he just looked like one. There were no long hours of debate over other choices. And the chance to give a precious, living creature his identity felt special. I loved holding his little body, feeling his heartbeat and his vulnerability, kissing the top of his soft, curly head and promising to give him the best life possible.

It soon became obvious that Charlie was well-named – he’s a cheeky fellow who gets himself into trouble despite his best intentions. He has a hard time recognising that not everyone will love him – not all humans take kindly to canine ways and some dogs like their personal space to the extent that they will snarl if it’s compromised, even by an enthusiastic panting puppy with a wagging tail. It took me a while as an adult to remember these lessons too and like Charlie, I have

learned to hang back in new situations, to take it all in first, without landing myself in immediate trouble.

Charlie’s breed is uncertain and when his hair started to grow, he began to resemble a scruffy English sheepdog. He has bushy red/white eyebrows, circles of black hair around his eyes and a white muzzle with long whiskers. He arrived, as an eight-week old puppy, in April 2021, in the middle

sighed at the irony. It turned out to be much easier for him to get a grooming appointment, but the price of a haircut for each us ended up the same.

Charlie had been with me for about a month when we both became ill – I got a fever, cough, and breathlessness, and Charlie developed vomiting and diarrhoea. At least we couldn’t blame each other for our symptoms. I went to the GP and brought Charlie to the

febrile and lethargic for some weeks –my barking cough eventually resolved, but his bark, thankfully, became stronger with time.

of a prolonged lockdown of our third pandemic wave, where all but essential businesses were shuttered, and grooming could only be done, legally, in a self-styled way. One morning, just a few weeks after Charlie’s arrival, in an exhausted state of sleeplessness, I looked in the mirror to notice my overgrown shaggy locks in serious need of a trim, the dark circles under my eyes, not to mention the unkempt eyebrows, although thankfully no whiskers, and

vet. We both came home with antibiotics – I kept his on one side of the kitchen counter and I had mine on the other. He was on metronidazole, so even though, of course alcohol is out of the question for him – at least I wasn’t subject to the same restrictions. I was careful not to mix the tablets up and became appreciative of my degree that allowed me to tackle the complexities of the medications (some involved syringes) with ease. We both remained

I have a wonderful cousin whose intervention facilitated Charlie’s arrival in my life. She has an avid interest in genealogy and is always encouraging me to contribute my DNA to the family database. She bought me a kit for my birthday a few years ago that remains where I left it at the time. My heritage isn’t in question, so I didn’t see the point. However, Charlie’s parentage is the subject of conversation with random strangers almost every time I bring him for a walk. When I say I don’t know what type of dog he is, they start guessing – Cavalier, Bichon, Dalmatian, Terrier, with perhaps some Poodle characteristics. I saw him running the other day and he reminded me of a horse. He has very long legs and huge paws, so his ultimate size could be quite large. I had hoped for a small, quiet dog – and he is a rapidly growing, energetic fluffball. I decided I’d like to know exactly what he is, in order to estimate future size and to be prepared for possible illnesses, so, to my cousin’s surprise, I bought a DNA kit for him. Like the antibiotics, I kept it separate from my own –how ironic it would be to mix them up – Gaye Canine and Charlie Cunnane: Results awaited.

I had hoped for a small, quiet dog – and he is a rapidly growing, energetic fluffball

LAUNCH OF SOLFEROL VITAMIN D

to show that bioelectric cues contribute significantly in promoting tendon repair.”

Dr Biggs added: “This unique strategy of combining a device which is powered through body movement and which can induce accelerated tendon healing is expected to significantly impact the field of regenerative devices, specifically in the area of sports or trauma associated injuries.”

“These devices are cost-ef-

fective, relatively easy to implant and may pave the way for a whole new class of regenerative electrical therapies.”

The research was funded by SFI and, in particular, the SFI-Biotechnology and Biological Sciences Research Council Partnership Programme.

The full study in Advanced Materials can be read here: https://doi.org/10.1002/ adma.202008788

probability of success.

BioSimulytics, which has already secured its first commercial contract with a major pharma company in Europe, and signed evaluation agreements with several others for industrial evaluation, will use the funding to support the growth of its product development team and client base and plans to complete a series A funding round within the next 18-to-24 months.

Windzor Pharmaceuticals has announced the launch of Solferol vitamin D.

 Solferol Vitamin D 90

Soft Gel Capsules 1000IU

 Solferol Vitamin D 90

Soft Gel Capsules 2000IU

 Solferol Vitamin D 90

soft Gel Capsules 4000IU

 Solferol vitamin D is a

high-quality vitamin D3 to boost the immune system and assist with bone formation, muscles and teeth. Solferol is available from UD and Uniphar from 1 September 2021.

For more information, email info@windzorpharma.com or visit www.windzorpharma.com

NUI GALWAY CÚRAM RESEARCHERS

DISCOVER WAY TO SWITCH ON AND SPEED UP TENDON HEALING

Researchers at CÚRAM, the Science Foundation Ireland (SFI) Research Centre for Medical Devices at NUI Galway, have shown how walking can power an implantable stimulator device to speed up treatment of musculoskeletal diseases.

The results have been published in the journal Advanced Materials. The research establishes the engineering foundations for a new range of stimulator devices that enable control of musculoskeletal tissue regeneration to treat tendon damage and disease and sports injuries, without the use of drugs or external stimulation.

Lead researcher on the study, CÚRAM Investigator Dr Manus Biggs, said: “One of the most exciting parts of our study is that these implantable devices may be tailored to individual patients or disorders and may show promise in accelerating the repair of sport-related tendon injuries, particularly in athletes.”

The study investigated whether electrical therapy, coupled with exercise, would show promise in treating tendon disease or ruptures. It showed that tendon cell function and repair can be controlled through electrical stimulation from an implantable device, which is powered by body movement.

Dr Marc Fernandez, who carried out the principal research of the study at CÚRAM, said: “Successful treatment of tendon dam-

DR CAGNEY APPOINTED CLINICAL DIRECTOR OF RADIATION ONCOLOGY AT MATER PRIVATE NETWORK

Mater Private Network has strengthened its multidisciplinary team of consultants and specialists with the appointment of Dr Daniel Cagney as Clinical Director of Radiation Oncology.

age and disease represents a critical medical challenge. Our discovery shows that an electrical charge is produced in the treatment target area - the damaged or injured tendon - when the implanted device is stretched during walking. The potential gamechanger here is like a power switch in a cell – the electrical stimulus turns on tendon-specific regenerative processes in the damaged tendon.”

The stimulator device uses a fabric like mesh – known as a piezoelectric material – that produces electricity when stretched or put under mechanical pressure. It is made using a scaffold of nano-fibres, which are 1,000th of the thickness of a human hair.

Dr Fernandez added: “We presented an implantable, electrically active device capable of controlling tendon regeneration and healing. Importantly, our research improved the therapeutic performance of the device by enhancing its structure, piezoelectric characteristics, and biological compatibility.”

“We also evaluated the individual influence of mechanical, structural, and electrical cues on tendon cell function and were able

Joining from Dana-Farber Brigham and Women’s Cancer Centre in Boston, US, Dr Cagney has returned home to Ireland to take up the role at Mater Private Network having held several strategic positions at the world-leading cancer treatment and research facility over the past six years. These roles included Consultant Radiation Oncologist, Director of Stereotactic Radiation and Director of MRI Guided Radiation Programme.

Sharing his expertise across treatment centres in Dublin and Limerick, Dr Cagney will spearhead the further development of radiation oncology services at Mater Private Network. With a specialist interest in the field of stereotactic radiation, Dr Cagney previously identified an unreported pattern of intracranial failure in neuro-oncology and initiated the first trial of its kind to assess the safety and efficacy of combination stereotactic radiation and nanoparticles for patients with centrally locat-

ed non-small cell lung cancer and pancreatic cancer.

Dr Cagney said: “I am incredibly excited to work with the whole team in Mater Private Network. Our multidisciplinary group of doctors, nurses, therapists, physicists, and support staff deliver holistic, personalised care daily. I am humbled to join this group and will strive to continue to innovate and deliver patient-centric care.”

Dr Cagney received his medical degree from University College Cork. As a clinical researcher at Harvard Medical School and Dana-Farber/Brigham and Women’s Cancer Centre, he published more than 70 peer-reviewed manuscripts and book chapters in leading academic journals. He is a Diplomate of the American Board of Radiology and a Fellow of the Faculty of Radiologists of the RCSI.

BIOSIMULYTICS SECURES €595K IN SEED FUNDING

BioSimulytics (www.biosimulytics.ai), a University College Dublin (UCD) spin-out company, has secured €595,000 in initial seed funding from a number of strategic angel investors and Enterprise Ireland. The NovaUCD-headquartered company is focused on using artificial intelligence (AI) to digitise key steps in how new drug molecules are designed and developed.

The company has developed a software solution using a combination of AI, machine learning, computational chemistry, quantum physics and high-performance computing (HPC) to drive R&D processes in the design and development of new drugs. According to the company, its software enables the pharma industry to advance potential molecules to approved medicines quicker and with a greater

One of the complicating factors in the drug development process is polymorphism, the ability of a compound to exist in more than one stable crystalline structure. Drug molecules are complex compounds which can have hundreds of stable structures, and a polymorph may change to a more thermodynamically stable form hours, weeks and even years later depending on conditions.

Different drug polymorphs can have different properties such as solubility, toxicity and efficacy. It is therefore vital for pharma companies to fully understand the polymorphic landscape of their drug molecules, required also for regulatory compliance and patent protection, and to have certainty about identifying and reproducing the most stable crystal structure of any new drug before bringing it to market for patient use.

Experimental techniques, which are the current stateof-the-art for identifying the most stable polymorph of a new drug molecule, are slow and arduous manual processes that can take six months or more to complete and with potentially uncertain results.

According to BioSimulytics, its software solution

only requires the basic 2D structure of a molecule to accurately predict the full polymorphic landscape of that molecule and to rank the most stable crystal structures of the molecule, within a matter of weeks. This provides pharma companies with far greater accuracy and certainty in the development process of new drugs, avoiding potentially costly mistakes such as those cases in recent decades where polymorph problems have forced the pharma companies involved to pull their drugs from the market resulting in multi-million US dollar losses.

BioSimulytics was founded in 2019 by Prof Niall English, Dr Christian Burnham, and Mr Peter Doyle as a spin-out from the UCD School of Chemical and Bioprocess Engineering following the completion of Enterprise Ireland commercialisation funding.

Mr Doyle, CEO of BioSimulytics, commented: “We are delighted to have secured this seed funding which will help us to expand our team here in Ireland and grow our client base in the EU and US markets.”

“The successful development of Covid-19 vaccines over the last 18-months demonstrates the powerful role that new digital AI and HPC-based technologies play in dramatically transforming the pharma value chain. BioSimulytics’ goal is to be a key player in this rapidly expanding global market within the next few years.

“As a follow-on to this seed round, we plan to complete a multi-million euro series A funding round within the next 18-to-24 months following the full industrial validation of our technology.”

RCSI RETAINS POSITION IN TOP 250 UNIVERSITIES WORLDWIDE

RCSI University of Medicine and Health Sciences has been ranked among the top 250 universities worldwide in the 2022 Times Higher Education (THE) World University Rankings. It has achieved this status for the sixth consecutive year.

RCSI has maintained its worldwide position in the 201-250 category and ranks joint second out of the nine ranked institutions in the Republic of Ireland.

The THE World University Rankings 2022 includes 1,662 universities across 99 countries and regions, standing as the largest and

most diverse university rankings to date.

According to the RCSI, its “global focus and collaboration” has been recognised in this year’s league table, with the university rising to 45th in the world in the ‘International Outlook’ category of the ranking.

The result follows the RCSI’s “strong performance” in the THE Impact Ranking published in April. This saw the university ranked joint second in the world for its contribution to the United Nations Sustainable Goal 3 – ‘Global Health and Wellbeing’.

Dr Daniel Cagney

GP REQUIRED – EAST CORK

Up to 6 sessions per week with days negotiable. Flexible, friendly, computerised practice that aims to keep patient safety and to provide a caring and supportive work environment at its core.

Working with three other doctors, two practice nurses, three administration staff. 15-minute appointments. 30 minutes from Cork City. No house calls/nursing homes/admin. There would be an OOH commitment of approximately two evenings per month and four weekends per year.

Please contact Dr Mark Buckley mark_f_buckley@hotmail.com  or 086 025 6001

GP REQUIRED

(Full-time/sessions also available)

Riverwest Medical, Foynes, Co Limerick are looking for a GP to join our practice. We are a two GP practice and we are supported by an excellent nursing and administration team. We are fully computerised and our appointments are 15 minutes. We have an excellent package, paid professional indemnity, and there is no out-of-hours commitment.

Starting date is negotiable and we can accommodate a future start date for those in a current role.

Please contact us at dreileen@riverwest.ie or call Eileen on 087 296 6970 to arrange a meeting. See our website on www.riverwest.ie

GP POSITION AVAILABLE

Large mixed GMS/private practice, Newcastle West, Co Limerick, seeking a GP assistant to join our team with a definite view to partnership.

Fully computerised Health One and excellent practice nurse and clerical support.

No out-of-hours commitment. Excellent renumeration.

Ideally 9 sessions required and vocational training an advantage. Please contact via email boherbueclinic@hotmail.com with CV or further queries

GP POSITION AVAILABLE

GP opportunity to take over a thriving rural practice in West Limerick. Full rural practice allowance, purpose-built premises, computerised, full ancillary staff, appointment only, no on-call commitment, thirty minute drive to nearest university. This is a two-doctor practice. We are prepared to work part-time, to ease transfer. Very favourable terms for suitable candidate/s. Contact 087 253 2584 or email catgercorrigan@yahoo.com

GP REQUIRED

Cara Medical Centre, Newcastle West, Co Limerick are looking for a GP to join our practice, ideally for six sessions per week initially, open to negotiation.

We are a two GP practice and we are supported by an excellent nursing and administration team.

Fully computerised Health One software. Large mixed GMS/ private practice.

No out-of-hours commitment. Excellent renumeration. Please contact with your interest/CV to caramedical@gmail.com

GP REQUIRED

Well-established GP practice requires a GP for 6+ sessions per week with a view to full-time employment in Donegal Town. Group practice/fully computerised/full ancillary staff.

Email enquires to millrowfamilypractice@gmail.com

PRACTICE NURSE REQUIRED

Practice nurse required for North Dublin City practice. Experience helpful, but not essential for right candidate. Duties include, but not limited to, phlebotomy, ECG, vaccines, smears tests, and managing smear recall system, stock ordering, chronic disease management. Hours flexible. Salary negotiable.

Please email cv to practicenursevacancy@outlook.com

PRACTICE NURSE REQUIRED

Part-time practice nurse required in a busy GP practice in Stillorgan, Co Dublin for 3 sessions per week. Previous general practice experience desired, but not essential. Standard practice nurse duties. Negotiable sessions.

Please email michellehalpin1@hotmail.com to apply

PRACTICE NURSE REQUIRED

Full- or part-time practice nurse required for GP practice in Bettystown, Co Meath. Experience in general practice desirable, but not essential.

Responsibilities will include standard practice nurse duties, such as phlebotomy, childhood vaccinations, smears. Contact: Olivia Commons practicemanager@ bettystownmedicalpractice.ie

PRACTICE NURSE REQUIRED

Practice nurse required in Tipperary town. New build clinic.

4 doctor 4 nurse practice. Full-time position.

Previous GP experience required with skills in cervical check, vaccination, maternity, stock ordering etc.

P lease send CV to Tom Purcell at Tipperary Primary Care or email to jbsurgery@hotmail.com

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

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

Tee time: Swinging a ‘banana ball’ shot at the weird and wonderful origins of golf

As things stand when this is written, golf's PGA Tour 2021 is about to tee-off, while Ireland's Leona Maguire has just played a starring role on her Solheim Cup debut as Europe retained the cup on US soil. The professional golf circuit is of course a highly sophisticated machine that caters for the players' every physical, psychological and emotional need to ensure they are at 100 per cent peak performance. But it was a long road to get to this point.

While there is some discussion, it's generally accepted that golf originated near Edinburgh in Scotland. Its first incarnation would see players whack a pebble around tracks and over sand dunes with a bent stick – no doubt you will have played a round or two where you felt like that guy. All good fun, but in the 15th Century golf was actually banned for a time by the Scottish parliament of King James II, as its rising popularity was seen as a distraction from military training, in preparation for another attack on Scotland by the pesky English.

This material is for healthcare professionals only

NUTRAMIGEN WITH LGG®: PROVEN EFFICACY AT EVERY STEP*1

rapidly relieve cow’s milk allergy symptoms as quickly as 48 hours 2–4

successfully accelerate return to cow’s milk after 12 months of use**5

reduce the risk of future allergic manifestations by ~50%†6

For the management of cow’s milk allergy

**vs. eHCF without LGG ®, rice, soy or amino acids (p<0.001)

† During a period of 3 years vs. eHCF without LGG ® (p<0.001)

TRANSFORMING THE LIVES OF BABIES WITH COW’S MILK ALLERGY

References:

3. Baldassarre ME et al. J Pediatr 2010; 156:397–401. 4. Nermes M etal.ClinExpAllergy 2011; 41:370–377. 5. Canani RB et al. J Pediatr 2013; 163:771–777.

6. Canani RB etal.JAllergyClinImmunol 2017; 139:1906–1913.

Nutramigen with LGG ® is a food for special medical purposes for the dietary management of cow’s milk allergy and must be used under medical supervision. Nutramigen with LGG ® is not recommended for premature and immunocompromised infants unless directed and supervised by a healthcare professional.

IMPORTANT NOTICE: Breastfeeding is best for babies. The decision to discontinue breastfeeding may be difficult to reverse and the introduction of partial bottle-feeding may reduce breast milk supply. The financial benefits of breastfeeding should be considered before bottle-feeding is initiated. Failure to follow preparation instructions carefully may be harmful to your baby’s health. Parents should always be advised by an independent healthcare professional regarding infant feeding. Products of Mead Johnson must be under medical supervision.

Trademark of Mead Johnson & Company LGG © 2019 Mead Johnson & Company, LCC. All rights reserved. LGG ® and the LGG ® logo are registered trademark of Chr. Hansen A/S.

Date of Preparation: April 2020 (RB-M-04765)

However, in 1502, an official endorsement of the game by King James IV of Scotland led to a surge in the sport's popularity across Europe and made him the world's first 'Golfing Monarch'. Mary Queen of Scots introduced the game to France, where she was studying. Fun fact: The term ‘caddie’ originates from the name for her French military aides, who were referred to as 'cadets'.

One of the first incarnations of golf balls were made of leather and feathers. With these erratic spheres, manufacturers would wrap the feathers around the leather ball in an effort to keep them dry. If you think that's bad, the previous generation of golf balls were reputedly made from wood, specifically beech, and weren't always perfectly round.

Of course – pun unintentional – St Andrew's is a Mecca of golf and it was in fact the site of the first ever 18hole course, which was built in 1764 and set the tone for the courses we use to this day. Feathers were still in use though; the balls at this time were made from compressed feathers wrapped in a stitched horse hide. The clubs were generally made from beech with shafts of ash or hazel.

This really laid the foundations for the development of the modern game; however, the first official round of women's golf was not played until 1811, some 400 years after the sport was invented. And so here we are, with many landmarks in the development of the sport in between there and here, but just a couple of obscure facts for you to ponder while you watch the pros on the PGA tour.

Perhaps you will be lucky enough to see a hole-in-one, although it's not uncommon for a pro golfer to play their whole career without achieving one of these rare feats. The average golfer has a one-in-12,500 chance of making a hole-in-one. Tiger Woods made his first hole-inone when he was eight years old, but don't let that put you off – he was two years old when his father began his golf training.

The early originators of the sport probably could not have imagined that in 2021, golf has become a desirable option to maintain some level of activity for those of advanced age.

It would be appropriate to give the last word to Dr Benjamin Rush (1745–1813), physician and signatory to the United States Declaration of Independence: "Golf is an exercise which is much used by a gentleman in Scotland…. A man would live 10 years the longer for using this exercise once or twice a week.”

A brief golf-related joke as we head to the clubhouse with this issue's offering. Why not send your tuppence-worth to the above email address; readers' contributions are always welcome.

A priest, a doctor and an economist are playing a round of golf. They begin to become frustrated, stuck as they are behind a particularly slow group of players.

The angry economist is the first to crack: "What's wrong with these people? We must have been waiting for 20 minutes," he grumbles.

The doctor nods his head and says: "I don't know, but I've never seen such a terrible round of golf."

The priest chimes-in: "Here comes the greens-keeper – let's have a word with him." The priest asks: "Hello George, what's wrong with that group ahead of us, they're terribly slow." The greens-keeper replies: "Ah yes – that's a group of blind ex-firemen. They sadly lost their sight saving our clubhouse from a fire last year, so we let them play for free whenever they want."

The trio are chastened and after a few moments of awkward silence, the priest says: "That's tragic, I will say a special prayer for them tonight."

The doctor adds: "Yes, terribly sad, I will contact my ophthalmologist colleague and see if there is anything that she can do to help them."

The economist scratches his head and asks: "Why can't they play at night?"