The Medical Independent 6 September 2021

The health impact of direct provision

The health of protection applicants in the direct provision system continues to be negatively impacted.

Catherine Reilly reports

Healthcare in the crossfire

Attacks on medical facilities in conflict zones are of increasing concern, writes

PAGE 10-12

Saolta concerned about elective hospital proposal

The Sláintecare programme’s proposed elective hospital model “does not correlate” with the requirements of Saolta University Health Care Group as outlined in a 2019 options appraisal report, a board meeting heard.

“Further engagement and consultation with Sláintecare is required,” stated minutes of Saolta’s board meeting in April, which were obtained under Freedom of Information law. “It was agreed that the Group should also engage with local public representatives regarding same.”

A spokesperson for Saolta told the Medical Independent that, in 2019, it published the outcome of an options appraisal process undertaken to identify “the most appropriate way to proceed with the future development of hospital services in Galway”.

As part of the options appraisal process, a regional elective hospital scoping study was undertaken.

“This outlines capacity including the in-

frastructural requirements necessary to develop an elective hospital which will serve the wider region. We are currently engaging with Sláintecare (Department of Health) and the national team in relation to their proposed model.

“We recently made a submission to the elective hospitals site selection [process] for Merlin Park University Hospital to be the chosen site. It is our view that the Sláintecare elective model will deliver on phase one of our more comprehensive requirement as outlined in the elective hospital scoping study. We are going to continue to work with the national project team to develop a facility that adds the greatest value to patients in this region.”

The National Development Plan 20182027 stated that new dedicated ambulatory elective-only hospital facilities would be introduced in Dublin, Galway, and Cork.

“These facilities will provide high volume, low-complexity procedures on a day and outpatient basis, together with a range of ambulatory diagnostic services.”

Never too late to change Dr Sarah Fitzgibbon’s decision to leave her GP practice brought a certain sadness, but also a feeling of liberation

PAGE 20

‘Lone working’ risks highlighted at HPRA

The potential risks of hybrid working have been highlighted by a recent incident in the office of the Health Products Regulatory Authority (HPRA), the Medical Independent (MI) can report.

Staff working in the HPRA office at Earlsfort Terrace in Dublin have been asked to ensure they carry a mobile phone with them to alert other staff “should any assistance be required”.

The reminder was issued following an incident in April.

“There was an incident in the HPRA building... a brief overview of the accident and outcome was provided to the management committee,” according to minutes of the April meeting of the HPRA management committee. The minutes were seen by MI following a Freedom of Information request.

“The incident highlighted the need for a further reminder to staff about

Care at the heart of your community

The Medical Independent (MI) is delighted to announce the launch of our ‘Care at the heart of your community’ campaign in association with Fleming Medical.

The concept of this initiative is to invite doctors to nominate a local club or facility in their community to receive a bursary award of a Fleming Medical defibrillator. In spring 2022, MI readers will be asked to send a 200-word synopsis to suggest why their nominated club or facility should receive this bursary award.

The 2021 bursary has been awarded to All Over Fitness in Rathfarnham, Dublin 16. The gym owner Mr Damien Carey is delight ed to have this life-saving equipment on the premises for both members and resi dents in the community.

Next year, we will commence the campaign through the newspaper, website, and social media. The recipient will be announced in early summer. Mr Carey (left) is pictured with Managing Director of Greencross Publishing, Mr Graham Cooke.

the increased risk of lone working in the HPRA offices during the level five social restrictions,” read the minutes.

“It was proposed to encourage staff to carry their mobile phones at all times when on site during the pandemic. Further text will be added to the intranet and emailed to staff highlighting the procedures in place.”

A spokesperson for the HPRA told MI that the incident involved “an employee who cut their finger and has fully recovered”.

“Due to lower staff attendance in the office, as most staff work remotely in line with Government guidance in relation to Covid-19, a reminder to all staff was issued to be conscious that there may be very few other staff present in the office.”

The spokesperson added that HPRA staff in the office should “ensure” they carry a mobile phone with them “to alert other staff should any assistance be required”.

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

UNLEASH THE PROTECTION OF TRIXEO1,2

Significant protection against exacerbations*

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

*Significant reductions in the rate of moderate or severe exacerbations vs LAMA/LABA (24%, n=2137 vs n=2120, annual rates 1.08 vs 1.42, 95% CI 0.69–0.83; p<0.001) and ICS/LABA (13%, n=2137 vs n=2131, annual rates 1.08 vs 1.24, 95% CI 0.79–0.95; p=0.003).1,2 COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist. In the clinical trial programme for TRIXEO, LAMA/LABA refers to glycopyrronium/formoterol fumarate and ICS/LABA refers to budesonide/formoterol fumarate. ©AstraZeneca 2021. All rights reserved.

ABRIDGED PRESCRIBING INFORMATION

TRIXEO AEROSPHERE® 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension (formoterol fumarate dihydrate/ glycopyrronium/ budesonide) Consult Summary of Product Characteristics (SmPC) before prescribing. Indication: Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist. Presentation: Pressurised inhalation, suspension. Each single actuation (delivered dose, ex-actuator) contains 5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2 micrograms of glycopyrronium and budesonide 160 micrograms. This corresponds to a metered dose of 5.8 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 10.4 micrograms, equivalent to 8.2 micrograms of glycopyrronium and budesonide 182 micrograms. Dosage and Administration: The recommended and maximum dose is two inhalations twice daily (two inhalations morning and evening). If a dose is missed, take as soon as possible and take the next dose at the usual time. A double dose should not be taken to make up for a forgotten dose. Special populations: Elderly: No dose adjustments required in elderly patients. Renal impairment: Use at recommended dose in patients with mild to moderate renal impairment. Can also be used at the recommended dose in patients with severe renal impairment or end-stage renal disease requiring dialysis, only if expected benefit outweighs the potential risk. Hepatic impairment: Use at recommended dose in patients with mild to moderate hepatic impairment. Can also be used at the recommended dose in patients with severe hepatic impairment, only if expected benefit outweighs the potential risk. Paediatric

Population: No relevant use in children and adolescents (<18 years of age).

Method of administration: For inhalation use. To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient’s inhalation technique. Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Not for acute use: Not indicated for treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.

Paradoxical bronchospasm: Administration of formoterol/glycopyrronium/ budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life threatening.

Treatment should be discontinued immediately if paradoxical bronchospasm occurs. Assess patient and institute alternative therapy if necessary.

Deterioration of disease: Recommended that treatment should not be stopped abruptly. If patients find the treatment ineffective, continue treatment but seek medical attention. Increasing use of reliever bronchodilators indicates worsening of the underlying condition and warrants reassessment of the therapy. Sudden and progressive deterioration in the symptoms of COPD is potentially life threatening, patient should undergo urgent medical assessment.

Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol. Use with caution in patients with clinically significant uncontrolled and severe cardiovascular disease such as unstable ischemic heart disease, acute myocardial infarction, cardiomyopathy, cardiac arrhythmias and severe heart failure. Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males or > 470 milliseconds for females), either congenital or induced by medicinal products. Systemic corticosteroid effects: May occur with any inhaled corticosteroid, particularly at high doses prescribed

for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma. Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have co existing risk factors for osteoporosis. Visual disturbances: May be reported with systemic and topical corticosteroid use. If patient presents symptoms such as blurred vision or other visual disturbances, consider ophthalmologist referral for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR). Transfer from oral therapy: Care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia: Potentially serious hypokalaemia may result from β2-agonist therapy. This has potential to produce adverse cardiovascular effects. Caution is advised in severe COPD as this effect may be potentiated by hypoxia. Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics.

Hyperglycaemia: Inhalation of high doses ofβ2-adrenergic agonists may produce increases in plasma glucose. Blood glucose should be monitored during treatment following established guidelines in patients with diabetes. Co-existing conditions: Use with caution in patients with thyrotoxicosis. Anticholinergic activity: Due to anticholinergic activity, use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop. Co-administration of this medicinal product with other anticholinergic containing medicinal products is not recommended. Renal impairment: Patients with severe renal impairment (creatinine clearance of <30 mL/min), including those with end-stage renal disease requiring dialysis, should only be treated with this medicinal product if the expected benefit outweighs the potential risk. Hepatic impairment: In patients with severe hepatic impairment, use only if the expected benefit outweighs the potential risk. These patients should be monitored for potential adverse reactions. Drug Interactions: Co-treatment with strong CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products are expected to increase the risk of systemic side effects. Should be avoided unless the benefit outweighs the increased risk, in which case patients should be monitored for systemic corticosteroid adverse reactions. This is of limited clinical importance for short-term (1-2 weeks) treatment. Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms. Other antimuscarinics and sympathomimetics: Co-administration with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products is not recommended as it may potentiate known inhaled muscarinic antagonist or β2-adrenergic agonist adverse reactions. Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects. Caution required when prescribed concomitantly with formoterol. Medicinal product-induced

hypokalaemia: Possible initial hypokalaemia may be potentiated by xanthine derivatives, steroids and non potassium sparing diuretics. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. β-adrenergic blockers: β-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concurrent use of β-adrenergic blockers should be avoided unless the expected benefit outweighs the potential risk. If required, cardio-selective β-adrenergic blockers are preferred. Other pharmacodynamic interactions: Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong QT interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2sympathomimetics. Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. Elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.Pregnancy and Lactation: Administration to pregnant women/women who are breast-feeding should only be considered if the expected benefit to the mother justifies the potential risk to the foetus/ child. Ability to Drive and Use Machines: Dizziness is an uncommon side effect which should be taken into account. Undesirable Events: Consult SmPC for a full list of side effects. Common (≥ 1/100 to < 1/10): Oral candidiasis, pneumonia, hyperglycaemia, anxiety, insomnia, headache, palpitations, dysphonia, cough, nausea, muscle spasms, urinary tract infection. Uncommon (≥ 1/1,000 to < 1/100): Hypersensitivity, depression, agitation, restlessness, nervousness, dizziness, tremor, angina pectoris, tachycardia, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles), throat irritation, bronchospasm, dry mouth, bruising, urinary retention, chest pain. Very Rare (< 1/10,000): Signs or symptoms of systemic glucocorticosteroid effects, e.g. hypofunction of the adrenal gland, abnormal behaviour. Not known: Angioedema, vision blurred, cataract, glaucoma.

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

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

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

Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, Block B, Liffey Valley Office Campus, Dublin 22.

Tel: +353 1 609 7100. TRIXEO and AEROSPHERE are trademarks of the AstraZeneca group of companies.

Date of API preparation: 07/2021 Veeva ID: IE-2842

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

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

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

Seven cases of ‘high-risk’ occupational exposure to blood-borne viruses at Beaumont

CATHERINE REILLY

Beaumont Hospital in Dublin had seven cases of “high-risk” occupational blood exposures to patients known to be positive with a blood-borne virus – including three staff exposed to HIV – during 2020. Subsequent screening found that no seroconversions had occurred, according to minutes of a meeting of the infection prevention and control committee in February.

Details from the Annual Occupational Blood Exposure Report 2020 were outlined at the meeting by Specialist in Occupational Medicine Prof Blánaid Hayes.

According to the minutes, obtained by the Medical Inde-

pendent (MI) following a Freedom of Information request, there were 91 needlestick injuries as well as 22 mucocutaneous exposures reported in 2020. “While the number of needlestick injuries for 2020 is down on the 108 reported in 2019, it’s not clear what impact, if any, the Covid-19 pandemic from March 2020 had on the reporting of needlestick or other occupational blood exposure injuries.”

Prof Hayes reviewed performance against the goals of the needlestick working group in 2014. The goals were listed as elimination of all re-sheathing injuries; elimination of insulin pen injuries; reduction of injuries to non-clinical staff to less than five per annum; and reduction of phlebotomy-asso-

ciated injuries to fewer than 10 per annum.

Prof Hayes “noted a significant rise in phlebotomy-related injuries since 2018, many of which are associated with the use of the ‘butterfly needle’ device”, according to minutes. “The report recommends reconvening the needlestick working group to set new goals for 2021 and tackle the ongoing hazard of occupational blood exposure injuries.”

MI sent queries to Beaumont regarding occupational blood exposure injuries, but the hospital declined to comment.

In 2017, Beaumont had its first case of an occupationally acquired blood-borne viral infection since it began monitoring needlestick exposures in 1993.

It is expected that a CAR T-cell therapy service will be operational for both adult and paediatric patients by the end of this year, a HSE spokesperson has told the Medical Independent (MI)

The National Cancer Control Programme (NCCP) has formally designated the national stem cell transplantation unit at St James’s Hospital (SJH) in Dublin and the haematopoietic stem cell transplant unit at Children’s Health Ireland (CHI) at Crumlin as the initial sites to develop and deliver the service.

The establishment of the service will be financed through dedicated resource allocations and minor capital funding.

The NCCP has supported SJH and CHI at Crumlin in progressing the technical and service readiness elements required over the last 18 months and a patient pathway has been established.

The basis of a national CAR T review group has also been agreed. The group’s role will be to consider all patients who have been referred for discussion at the designated CAR T centre multi-disciplinary team meeting.

Several CAR T products have been licensed in the EU as medicines. One product, tisagenlecleucel, has now been approved for reimburse -

ment by the HSE in line with its licensed indications.

A number of additional applications for reimbursement for CAR T therapy are also currently being assessed in line with the standard HSE assessment process.

“Service planning discussions are ongoing with the NCCP, service providers and pharmaceutical companies to move forward on a CAR T service in Ireland. It is expected that the service will be operational for both adult and paediatric patients by end2021,” according to the spokesperson.

In the absence of access to the therapy in Ireland, “an exception was made in 2019 for patients to be allowed access to this drug treatment under the treatment abroad scheme.”

MI previously reported that the HSE spent €8.18 million on patients receiving the therapy in the UK in 2019 and 2020.

CAR T is a novel treatment for patients with cancer. It is a patient-specific, individualised cell therapy that involves genetically modifying the patient’s own T-lymphocytes.

CAR T-cell service to be operational before end of 2021

Direct provision’s enduring health impact

A Government commitment to end the direct provision system is likely to entail a long process, during which time the health of protection applicants will continue to be negatively impacted. Catherine Reilly reports

Mr Lucky Khambule is unequivocal about the greatest health challenge for residents in Ireland’s direct provision system, which currently accommodates over 7,000 applicants for international protection.

“Mental health,” he tells the Medical Independent (MI) “Mental health is the worst challenge people have and that is the most ignored part of the fate of people in direct provision.”

Mr Khambule is a former resident of this system and coordinator for the Movement of Asylum Seekers in Ireland (MASI).

“There is no formal situation whereby there is support, where you know on this particular day there will be this person who is coming into the centre and will offer their services, there is nothing like that. Nothing. People are left on their own.”

A spokesperson for the Department of Children, Equality, Disability, Integration, and Youth (DCEDIY) stated that applicants can access all health services through “the same referral pathways as Irish citizens”. They are also entitled to a medical card and a waiver on prescription charges.

“Recent tender competitions have required contractors to provide social supports to residents to assist them to integrate and have meaningful interaction with the local community, to meet their recreational needs, etc,” according to the DCEDIY, which took over responsibility for the International Protection Accommodation Services (IPAS) from the Department of Justice in 2020.

A vulnerability assessment pilot commenced in December 2020 and was extended to all new applicants for international protection from the beginning of February 2021. The Irish Refugee Council had highlighted that the State was legally required since 2018 to implement these assessments under the EU Reception Conditions Directive and it put legal pressure on Government regarding this matter. Notably, the statutory instrument to implement this Directive also includes a “right to healthcare” provision.

According to the DCEDIY, the vulnerability assessment pilot will continue until the end of 2021. “The purpose of these assessments is to determine if, by virtue of a particular category of vulnerability, an applicant is deemed to have special reception needs, what those needs are and what actions are required to address those needs.”

All applicants are advised they can contact IPAS to discuss their needs at any stage, even if a vulnerability assessment has previously been conducted.

A resident welfare team was established in

IPAS from the beginning of May to oversee the vulnerability assessment process.

System

As of 22 August, direct provision centres (including the Balseskin reception centre) had overall capacity for 7,163 people, with 7,056 accommodation places assigned. The Balseskin centre in Dublin, where applicants stay following quarantine and prior to leaving for an accommodation centre, has capacity for 537 residents, with 382 accommodation places assigned. A “comprehensive health screening process is afforded to each resident upon entry to Balseskin”.

The direct provision system has been in place since April 2000, when asylum applica-

€29.80 per child is provided. Since 2018, some applicants have had labour market access following a Supreme Court judgement. In early 2021, the Government widened access to applicants waiting for six months for a first-instance decision on their protection application. Previously, employment permission could only be sought after nine months.

Applications for international protection fell dramatically in 2020 (1,566) compared with 2019 (4,781) due to the pandemic. Most applicants last year were from Nigeria (208) followed by Somalia (167). In 2021(to 30 June) there were 728 applicants, with 173 from Nigeria and 70 from Afghanistan.

Over the years, mainstream support has slowly crystallised around scrapping the di-

ach Micheál Martin in the White Paper to End Direct Provision and to Establish a New International Protection Support Service, which was published in February. It sets out a policy to ‘phase out’ the current system over the next four years.

The white paper proposes that applicants will stay in a reception and integration centre for “no more than four months”. These centres will be “newly built to a high specification and will be operated by not-forprofit organisations on behalf of the State”.

During this “orientation period”, people will receive integration supports including English language tuition and “employment activation supports”.

After the first four months, people whose protection claims are still being processed will move to accommodation in the community. “This will be own-door or own-room accommodation, for which they will pay a means-tested rent.

“Applicants will be entitled to seek paid work after six months, and they will be encouraged and supported to do so. Integration supports will continue to be available to people who need them.”

The transition to the new system will be led by the DCEDIY, which envisages that it will be “fully operational by December 2024”.

The model is based on an assumed 3,500 new applicants per annum and applications being largely processed to decision at first instance within six months and on appeal within a further six months.

Delays

Currently, the application system is “fraught with administrative delays and a substantial backlog” despite the commencement of the International Protection Act 2015 and the introduction of a single application procedure in 2017, according to a recent report from the Irish Refugee Council.

Applications for international protection are made to the International Protection Office (IPO) in the Department of Justice, while appeals are handled by the International Protection Appeals Tribunal (IPAT), a statutory independent body.

tions were rising significantly. It principally involves provision of full board at accommodation centres run by private companies under State contracts. Most applicants do not have their own cooking facilities.

In 2018 the system cost €78 million and this increased to €175 million in 2020 to cover additional requirements, including provision of Covid-19 response centres for isolation and quarantine and personal protective equipment (PPE) for residents.

A weekly stipend of €38.80 per adult and

rect provision system. The Programme for Government included a commitment – instigated by the Green Party – to replace the system with a new international protection accommodation policy “centred on a notfor-profit approach”.

“The shortcomings of the current accommodation system for applicants for international protection in congregated settings have been widely recognised and developing a new long-term approach has been a key priority for this Government,” wrote Taoise-

The Covid-19 pandemic had “further slowed the decision-making process” with public health restrictions reducing the processing capacity of the IPO and IPAT, as well as family reunification decision-making, stated the Council’s report Hanging on a Thread: Delays in the Irish Protection Process

In 2020 the median processing time for international protection applications, processed to completion at first instance at the IPO, was 17.6 months, a Department of Justice spokesperson informed MI

The median processing time for all applications, processed to completion at first instance at the IPO in quarter two 2021, was 26.9 months. The median processing time for applications at appeal in 2020 was 31 weeks.

Last year the median processing time for

Staff and management ‘were ill-prepared as to what was going on. They didn’t know how to react to a person with symptoms or even a Covid test result’

cases decided in the Ministerial Decisions Unit (which processes recommendations from the IPO and decisions of the IPAT) was 1.6 months and seven days for cases processed to completion in quarter two 2021.

“The white paper proposes that the new system should be phased in and operational by 2024 and that the intervening period should provide an opportunity to progress improvements in the overall processing times for international protection,” the Department of Justice spokesperson stated.

“Work is under way in the Department towards identifying mechanisms which will assist with this. For example, additional ICT resources have been secured for this year, and detailed practical work, including the end-to-end review of relevant international protection processes by a multidisciplinary team from within the Department, has now been completed.”

Health in new model

The white paper states that a health assessment will be provided for all new international protection applicants in phase one of the process. A vulnerability assessment process will be in place “building on the current pilot vulnerability screening and assessment process with which the HSE is supporting DCEDIY”. Community healthcare teams will develop a “comprehensive and efficient model of care for applicants for international protection”.

Under the white paper, the DCEDIY has committed to developing wellbeing indicators for international protection applicants, to be assessed by an independent body at regular intervals.

The DCEDIY spokesperson said the development of wellbeing indicators will commence “at a later stage in the implementation process”. As set out in the white paper, “an independent body of experts will work with the Department to develop these indicators. The process to appoint this independent body of experts has not yet commenced.”

Pandemic

In the meantime, campaigners say the pandemic has exposed and exacerbated the impact of direct provision on people’s health.

Data from the Health Protection Surveillance Centre (HPSC) shows from August 2020 to December 2020, there were 19 reported outbreaks in direct provision centres.

According to Mr Khambule of MASI, the authorities responsible for managing and overseeing the system did not respond appropriately to the emergence of the Covid-19 pandemic.

“The issue of Covid in direct provision has been a concern from day one…. Our concern, even before the outbreaks, were the overcrowding and lack of opportunity for people to social distance in accordance with the health guidelines.

“All the health guidelines which we were seeing from the HSE were non-existent when it comes to direct provision…. Initially there was no plan in terms of the sanitisers, the gloves, masks, that was not provided.”

Staff and management “were ill-prepared as to what was going on. They didn’t know how to react to a person with symptoms or even a Covid test result.”

“Our calls at that time were simple, to reduce the number of people in the centres” to a maximum of two people per room “instead of three or four”.

MASI also advocated for people at high risk of Covid-19 to be identified and moved

from centres promptly, so as not to be exposed to overcrowding. He maintained these calls “fell on deaf ears” at the time, but he acknowledged there have been some improvements. “The longer this pandemic stayed with us, it meant that they also had to up their game. They now started to put the sanitisers in visible areas, which was good to see happening.”

However, overcrowding has remained a concern and social distancing is often not being managed by authorities when moving residents between different centres and locations, he maintained.

Aside from infection control, the close cohabitation of people from vastly different backgrounds can lead to interpersonal tensions.

“This question of mixing people of different races, religions, countries, they don’t really care about the fact that some of these people cannot get along because of the differences of countries people come from….

“IPAS is supposed to be the caring part of this whole process, but they care less, honestly they do care less.”

Mr Nick Henderson, CEO of the Irish Refugee Council, told MI that pandemic measures in the direct provision system “gradually improved, but there were still significant outbreaks”.

A report published by the Council in August 2020, titled Powerless, found 55 per cent of people in the system felt unsafe during the pandemic; 50 per cent were unable to socially distance from other residents; 42 per cent shared a bedroom with a non-family member; and 46 per cent shared a bathroom with a non-family member. One respondent to the survey commented: “We share the same canteen, a lot of people share bathrooms and toilets. The truth of the matter is we are at risk of dying more than anyone else.”

Mr Henderson said there were efforts by authorities to cocoon the vulnerable. “But I think the State never got away from the fact that people were ultimately in congregated settings, they were in close proximity to each other, and therefore there was always going to be a higher degree of risk of transmission”.

A pressing concern for support organisations is the “real deterioration in people’s mental health”, he added. The pandemic has impacted people’s health and wellbeing, in addition to the associated delays in processing applications.

“That manifests itself in drastic actions that includes suicidal ideation and actual suicide attempts as well.”

Mr Henderson said that, more generally, residents can face difficulties getting on GP lists, while access to dentistry has emerged as an issue. “People can get linked to really good health and appropriate support, but in our experience, people can also just be lost within a system.”

He noted wider problems around access to mental healthcare in Ireland. “If it is absent for mainstream society, it will definitely be absent for people in this process.”

‘High priority’

The DCEDIY spokesperson maintained that the health and wellbeing of all residents during the pandemic “remains the highest priority for this Department”.

“To that end, a wide range of measures have been put in place across the accommodation network to address any Covid-19 related issues, should they arise. These measures were implemented in collaboration with the HSE

and informed by regional public health officials and infection control teams.”

According to the Department, the measures are kept under regular review by a joint HSE/DCEDIY monitoring group. These measures include “provision for self-isolation facilities in centres and offsite self-isolation at HSE and IPAS isolation facilities”; increased capacity to support physical and social distancing; “enhanced” cleaning regimes and provision of PPE; regular communications on public health advice to residents and centre managers; provision of a free, confidential and independent support line for residents operated by the Jesuit Refugee Service; cocooning of all medically vulnerable residents and those aged over65; and the HSE accommodation scheme for healthcare workers.

The spokesperson said Covid-19 vaccination of residents was a matter for the HSE. “However, IPAS fully supports all information sessions and/or vaccination clinics where the HSE have chosen to implement a clinic on-site; supports access to GP/pharmacy vaccinations, and in many cases, supports residents’ transport requirements to national vaccination centres.”

As there are a number of routes by which residents can access vaccinations, the HSE had indicated it would not be able to measure vaccine uptake in an accommodation centre with accuracy.

Meanwhile, the DCEDIY spokesperson said it is engaged in consultations with the Department of Health and HIQA to establish an independent monitoring mechanism for IPAS accommodation centres, where overall conditions are often criticised by advocacy groups. “The aim is that HIQA will be able to commence roll-out of its monitoring strategy shortly. Centres will be required to address any issues arising from the inspections.”

According to Mr Henderson, HIQA inspections “will be really important because ending direct provision isn’t going to happen overnight”.

“If you read HIQA inspection reports [of health and social care services] and compare them to current inspection reports [of direct provision], they are chalk and cheese, so to have their teeth could really make an impact in the short-term.”

While an end to the direct provision system has been promised, Mr Khambule of MASI remains sceptical about whether it will be fully realised or just repackaged. Mr Henderson also acknowledged that this is a worry and that the Council, as a member of the programme board overseeing the process, shares a responsibility to ensure the full reforms are implemented.

“I think what they are trying to do is find a fancy term they are going to come with, but the operation will still be the same, from what I can see,” noted Mr Khambule. He said a core problem remains the length of time that people are required to stay under State care, whatever form that may take.

He underlined that the operators of accommodation centres were not financially impacted by the pandemic.

“They still overcrowd people, because overcrowding means money to them as they are paid per head, not per bed,” he maintained.

“During the pandemic, everyone, every sector, suffered, but I can tell you, any owners of direct provision did not suffer an inch in terms of their profits…. They are smiling all the way to the bank while everyone else is trying to recover.”

MINDO NUMBERS

61 people with Covid-19 were receiving critical care on 26 August, the highest number since 3 April.

1in-four Irish people say that their mental health deteriorated during the pandemic and one-in-five say their general health has declined, according to a survey published by the RCSI University of Medicine and Health Sciences.

73 per cent of survey respondents completely trust the information shared with them by healthcare professionals, up from 61 per cent in 2019 when this survey was last undertaken, according to RCSI findings.

7 per cent completely trust the health information they find online, and 3 per cent completely trust the heath information shared on social media.

5.4 per cent of the overall health budget is accorded to mental health, which is half the level of spending compared with other European neighbours, according to the IHCA, which recently launched its mental health pre-Budget 2022 submission.

doing

CATHERINE REILLY

The public believes the HSE is not “doing enough” to promote the services of the Office of the Confidential Recipient for Vulnerable Persons and doubt it is an “independent means of someone placing concern”.

The findings were identified in an anonymous email survey of people who had used the Office of the Confidential Recipient during 2018 and 2019.

A HSE spokesperson told the Medical Independent : “The HSE is committed to ensuring that people who use our services are aware of the Office of the Confidential Recipient. The communications team have developed a plan in conjunction with the Confidential Recipient to increase

the awareness, promotion and independence of the Office.”

“One component of this is the recent publication of the Annual Report 2019/ 2020 and video footage of the Confidential Recipient detailing her role and welcoming concerns within her remit to be notified to the Office.

“The HSE will continue to use a mixture of internal and external channels including traditional media (national and local) and social media channels to promote the Office of the Confidential Recipient.”

The Office was established in 2015 to receive concerns/ complaints about potential abuse, neglect or bad practice in care provided by the HSE or their providers in residential, day or home services.

The Office is funded by the HSE although it is “independ-

ent” in its functions.

Some 320 concerns/complaints were received during 2019 and 2020, with 282 related to disability and older persons services. Some 201 of the 320 concerns/complaints related to care issues.

In the annual report, Confidential Recipient Ms Leigh Gath noted that thousands of people with disabilities were on waiting lists for services and supports.

“Many people who do receive a service and are contacting my office receive less than an hour a day support – to get out of bed, wash, dress, shower, be fed – and be put back to bed before 8pm – as services cost more later in the evening. These people are told when someone will come to them and have no choices in their lives.”

Emergency medicine ‘hit hard’ by consultant recruitment problems

Recruitment and retention for consultants in emergency medicine (EM) is “hit as hard, if not harder than any other specialty” due to the pay cut for ‘new-entrant’ consultants imposed in 2012, the Medical Independent (MI) has been told.

Negotiations on the new Sláintecare consultant contract are due to begin this month. In a recent circular to members seen by this newspaper, the IMO said it expected these negotiations to be “particularly challenging”. The process will be chaired by Ms Marguerite Bolger, SC.

Speaking to MI on a range of EM matters, Consultant in Emergency Medicine at Sligo University Hospital and President of the Irish Association for Emergency Medicine (IAEM), Dr Fergal Hickey, said many consultant vacancies nationally were 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.”

Dr Hickey noted that the IAEM “are not a trade union... but clearly our basic objective is to ensure the best possible emergency care for the population of Ireland and visitors to Ireland and that’s impossible to do if you can’t recruit consultants”.

“The reason we feel it’s appropriate to speak about it is because it has implications for patient care. If you can’t get people to take consultant posts then patients will suffer as a result. We can’t just ignore the very large elephant in the room.”

A Department of Health spokesperson told this newspaper that engagement with the IMO and IHCA on the new contract was ongoing.

In the circular to members last month, the IMO said that “given the overwhelmingly negative response from both consultants and NCHDs to the Government’s [contract] proposals we expect these negotiations to be particularly challenging”.

The IMO will demand “contractual terms that are capable of dealing with the crisis of recruitment and retention of consultants” and “an equitable solution to the inequitable pay policy within the consultant body”.

The IMO said that “the importance of these negotiations cannot be overstated”.

Launching its recent pre-Budget submission on mental health funding, the IHCA said it was “unacceptable” that more than one-in-five approved consultant psychiatrist posts were vacant or filled on a temporary basis across the country.

“The Association has long pointed to the ongoing salary inequity (applied since 2012) as the root cause of Ireland’s consultant psychiatrist recruitment and retention crisis,” it outlined.

Meanwhile, the Sláintecare Implementation Advisory Council (SIAC) recently insisted that a letter be written directly to Minister for Health Stephen Donnelly raising the “importance” of recruitment and retention of staff within the health service.

Asthma*

KEEP ASTHMA TAMED

KEEP ASTHMA TAMED

Proactive asthma control that lasts1,2

Proactive asthma control that lasts1,2

RELVAR ELLIPTA (fluticasone furoate/vilanterol)

RELVAR ELLIPTA (fluticasone furoate/vilanterol)

* Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting β 2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting β 2-agonists or patients already adequately controlled on both inhaled corticosteroid and long-acting β 2 - agonist 2

* Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting β 2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting β 2-agonists or patients already adequately controlled on both inhaled corticosteroid and long-acting β 2 - agonist 2

For Healthcare Professionals only. Images used are for illustrative purposes only. Relvar is well tolerated. Most common adverse events are nasopharyngitis and headache2 PM-IE-FFV-ADVT-200005 December 2020

Relvar Ellipta was developed in collaboration with

For Healthcare Professionals only. Images used are for illustrative purposes only. Relvar is well tolerated. Most common adverse events are nasopharyngitis and headache2 PM-IE-FFV-ADVT-200005 December 2020

Relvar Ellipta was developed in collaboration with

References: 1. Bernstein DI et al. J Asthma 2015; 52: 1073-1083.

Relvar® Ellipta® (fluticasone furoate/ vilanterol [as trifenatate]) Prescribing information

2. Relvar Ellipta SmPC, 2019, available on www.medicines.ie

(Please consult the full Summary of Product Characteristics (SmPC) before prescribing) Relvar® Ellipta® (fluticasone furoate/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of fluticasone furoate (FF) 100 micrograms (mcg) and vilanterol (VI) 25mcg provides a delivered dose of 92mcg FF and 22mcg VI. Each single inhalation of FF 200mcg and VI 25mcg provides a delivered dose of 184mcg of FF and 22mcg of VI. Indications: Asthma: Regular treatment of asthma in patients ≥12 years and older where a long-acting β2-agonist and inhaled corticosteroid combination is appropriate and where patients are not adequately controlled on inhaled corticosteroids and ‘’as needed” short-acting inhaled β2-agonists, or where patients are already controlled on both inhaled corticosteroid and long-acting β2-agonist. COPD (Relvar 92/22mcg only): Symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy). Dosage and administration: Inhalation only. Asthma: Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. Prescribers should be aware that in patients with asthma, FF 100 mcg once daily is approximately equivalent to fluticasone propionate (FP) 250 mcg twice daily, while FF 200 mcg once daily is approximately equivalent to FP 500 mcg twice daily. Adults and adolescents ≥12 years: one inhalation once daily of: Relvar 92/22mcg for patients who require a low to mid dose of inhaled corticosteroid in combination with a long-acting β2-agonist. If patients are inadequately controlled then the dose can be increased to one inhalation once daily Relvar 184/22mcg. Relvar 184/22mcg can also be considered for patients who require a higher dose of inhaled corticosteroid in combination with a long-acting β2-agonist. Regularly review patients and reduce dose to lowest that maintains effective symptom control. COPD: one inhalation once daily of Relvar 92/22mcg. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose

Relvar® Ellipta® (fluticasone furoate/ vilanterol [as trifenatate]) Prescribing information (Please consult the full Summary of Product Characteristics (SmPC) before prescribing) Relvar® Ellipta® (fluticasone furoate/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of fluticasone furoate (FF) 100 micrograms (mcg) and vilanterol (VI) 25mcg provides a delivered dose of 92mcg FF and 22mcg VI. Each single inhalation of FF 200mcg and VI 25mcg provides a delivered dose of 184mcg of FF and 22mcg of VI. Indications: Asthma: Regular treatment of asthma in patients ≥12 years and older where a long-acting β2-agonist and inhaled corticosteroid combination is appropriate and where patients are not adequately controlled on inhaled corticosteroids and ‘’as needed” short-acting inhaled β2-agonists, or where patients are already controlled on both inhaled corticosteroid and long-acting β2-agonist. COPD (Relvar 92/22mcg only): Symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy). Dosage and administration: Inhalation only. Asthma: Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. Prescribers should be aware that in patients with asthma, FF 100 mcg once daily is approximately equivalent to fluticasone propionate (FP) 250 mcg twice daily, while FF 200 mcg once daily is approximately equivalent to FP 500 mcg twice daily. Adults and adolescents ≥12 years: one inhalation once daily of: Relvar 92/22mcg for patients who require a low to mid dose of inhaled corticosteroid in combination with a long-acting β2-agonist. If patients are inadequately controlled then the dose can be increased to one inhalation once daily Relvar 184/22mcg. Relvar 184/22mcg can also be considered for patients who require a higher dose of inhaled corticosteroid in combination with a long-acting β2-agonist. Regularly review patients and reduce dose to lowest that maintains effective symptom control. COPD: one inhalation once daily of Relvar 92/22mcg. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose

monohydrate & magnesium stearate). Precautions: Pulmonary tuberculosis, severe cardiovascular disorders, heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium. chronic or untreated infections, diabetes mellitus. Paradoxical bronchospasm – substitute alternative therapy if necessary. In patients with hepatic with moderate to severe impairment 92/22mcg dose should be used. 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. Asthma-related adverse events and exacerbations may occur during treatment. Patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Relvar. Systemic effects: Systemic effects of inhaled corticosteroids may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Possible Systemic effects include: Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract, glaucoma. More rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Increased incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. If a patient presents with visual disturbance they should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include: current smoking, older age, low body mass index and severe COPD. The incidence of pneumonia in patients with asthma was common at the higher dose of Relvar (184/22mcg). Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption

monohydrate & magnesium stearate). Precautions: Pulmonary tuberculosis, severe cardiovascular disorders, heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium. chronic or untreated infections, diabetes mellitus. Paradoxical bronchospasm – substitute alternative therapy if necessary. In patients with hepatic with moderate to severe impairment 92/22mcg dose should be used. 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. Asthma-related adverse events and exacerbations may occur during treatment. Patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Relvar. Systemic effects: Systemic effects of inhaled corticosteroids may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Possible Systemic effects include: Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract, glaucoma. More rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Increased incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. If a patient presents with visual disturbance they should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include: current smoking, older age, low body mass index and severe COPD. The incidence of pneumonia in patients with asthma was common at the higher dose of Relvar (184/22mcg). Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption

should not use Relvar. Interactions with other medicinal products: Interaction studies have only been performed in adults. Avoid β-blockers. Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products). Concomitant administration of other sympathomimetic medicinal products may potentiate the adverse reactions of FF/VI. Relvar should not be used in conjunction with other longacting β2-adrenergic agonists or medicinal products containing long-acting β2-adrenergic agonists. Pregnancy and breast-feeding: Experience limited. Balance risks against benefits. Side effects: Very Common (≥1/10): Headache, nasopharyngitis. Common (≥1/100 to <1/10): Candidiasis of the mouth and throat, pneumonia, bronchitis, upper respiratory tract infection, influenza, oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia, abdominal pain, arthralgia, back pain, muscle spasms, fractures, pyrexia. Uncommon (≥1/1,000 to <1/100): Hyperglycaemia, vision blurred, extrasystoles. Rare (≥1/10,000 to <1/1,000): Hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria; palpitations, tachycardia, tremor, anxiety, paradoxical bronchospasm. Marketing authorisation (MA) Holder: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Nrs: 92/22mcg 1x30 doses [EU/1/13/886/002]; 184/22mcg 1x30 doses [EU/1/13/886/005].

Legal category: POM B. Last date of revision: June 2019. Code: PI-2046. Further information available on request from GlaxoSmithKline, 12 Riverwalk, Citywest Business Campus, Dublin 24. Tel: 01-4955000.

should not use Relvar. Interactions with other medicinal products: Interaction studies have only been performed in adults. Avoid β-blockers. Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products). Concomitant administration of other sympathomimetic medicinal products may potentiate the adverse reactions of FF/VI. Relvar should not be used in conjunction with other longacting β2-adrenergic agonists or medicinal products containing long-acting β2-adrenergic agonists. Pregnancy and breast-feeding: Experience limited. Balance risks against benefits. Side effects: Very Common (≥1/10): Headache, nasopharyngitis. Common (≥1/100 to <1/10): Candidiasis of the mouth and throat, pneumonia, bronchitis, upper respiratory tract infection, influenza, oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia, abdominal pain, arthralgia, back pain, muscle spasms, fractures, pyrexia. Uncommon (≥1/1,000 to <1/100): Hyperglycaemia, vision blurred, extrasystoles. Rare (≥1/10,000 to <1/1,000): Hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria; palpitations, tachycardia, tremor, anxiety, paradoxical bronchospasm. Marketing authorisation (MA) Holder: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Nrs: 92/22mcg 1x30 doses [EU/1/13/886/002]; 184/22mcg 1x30 doses [EU/1/13/886/005].

Legal category: POM B. Last date of revision: June 2019. Code: PI-2046. Further information available on request from GlaxoSmithKline, 12 Riverwalk, Citywest Business Campus, Dublin 24. Tel: 01-4955000.

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

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

CPE national emergency status ‘will be stepped down’

CATHERINE REILLY

The national public health emergency status for the proliferation of carbapenemase-producing Enterobacterales (CPE) in Irish healthcare remains in place, but will be stepped down in “the coming months”.

A Department of Health spokesperson told the Medical Independent (MI): “Due to the circumstances related to the Covid-19 pandemic and the recent cyberattack, the national public health emergency team for CPE has not yet had the opportunity to hold a final meeting and therefore the status of the public health emergency remains unchanged.”

“Significant progress has been made in responding to CPE across the healthcare system and it is planned to step down this public health emergency in the coming months.”

A HSE spokesperson told MI: “We continue to monitor for CPE colonisation and infection in line with our established processes. The indications are the situation is stable.”

Asked about any extra measures planned to control CPE during the upcoming winter period, the spokesper-

son said: “The comprehensive process for monitoring CPE acquisition has been maintained. The HSE is continuing to promote adherence to infection prevention and control measures to manage the risk of transmission of CPE. HSE-AMRIC [antimicrobial resistance and infection control programme] is currently reviewing infection prevention and control guidance on the control of CPE to ensure it meets current needs.”

According to the HPSC data, the provisional total of new patients with CPE for the first 27 weeks of 2021 was 268. The total for the corresponding period in 2020 was 273.

The HPSC’s CPE report for June stated there were outbreaks reported at Tallaght University Hospital; St Luke’s General Hospital, Kilkenny; Beaumont Hospital, Dublin; Galway University Hospital; Sligo University Hospital; Cork University Hospital; and University Hospital Limerick.

Since late 2018, there has been an increasing recognition that, in addition to direct and indirect person-to-person spread, environmental reservoirs of these organisms in acute hospitals represents a significant source, noted the HPSC report. “Increasing numbers of hospitals are undertaking environmental testing in wards that are

Almost 20 consultant posts vacant at Letterkenny

CATHERINE REILLY

There are 19.3 whole-time equivalent (WTE) consultant posts vacant across “a range of medical and surgical specialties” at Letterkenny University Hospital (LUH).

“All posts are currently filled by [a] locum, apart from 3.8 WTE,” of which one WTE will be filled by a permanent consultant in forthcoming weeks, according to a spokesperson for Saolta University Health Care Group.

“There are ongoing consultant campaigns with the Public Appointments Services for the filling of permanent consultant positions in the following specialties: Orthopaedics; obstetrics and gynaecology; microbiology; anaesthetics; nephrology; radiology; and geriatric medicine.

“Local recruitment campaigns are also underway to fill vacant posts on a locum/ temporary basis across all specialties, as and when required.”

Sixty of the hospital’s consultants are on the Medical Council’s specialist register, while six doctors employed as consultants are not on the specialist register, Saolta’s spokesperson told the Medical Independent.

VOX BOX

Consultant Liaison Psychiatrist and Chair of the IHCA psychiatry committee, Prof Anne Doherty, on the IHCA’s mental health pre-Budget 2022 submission. The Association called on Government to set funding at “realistic levels”.

Difficulties recruiting consultants have been discussed at Saolta’s board meetings, with these challenges especially evident at LUH “due to location”.

Meanwhile, Saolta and the HSE have completed a mini-tender to recruit an “insourcing company” to provide additional endoscopy capacity within the Group in the evenings and at weekends.

“Dates will be scheduled until year-end to maximise the amount of patients to be seen,” according to Saolta’s spokesperson.

“Funding has been sanctioned for 2,734 patients initially; there is flexibility to increase this as required by each site. This increased access is very much welcomed considering the loss of activity and capacity due to Covid-19 and the disruption of the cyberattack over the last 18 months.

“The inclusion/exclusion criteria differs from site to site. Common inclusion criteria across model 3 and model 4 hospitals include diagnostic colonoscopy, gastroscopy, flexible sigmoidoscopy, and routine, urgent, and suspected cancer target. Common exclusion criteria include inpatients, paediatric patients, and therapeutic endoscopy.”

deemed potential high-risk areas. Moist areas, for example showers, sinks, and toilets are the most common locations from which CPE have been detected.” A low number of isolates of CPE detected in the hospital environment in 2020 was likely to be related to reduced sampling activity in the context of Covid-19, noted the report.

In October 2017, the rise of CPE in healthcare was declared a public health emergency by then Minister for Health Simon Harris. At the time, he described “a rapid and worrying increase in the incidence of CPE in Ireland” with a significant increase in numbers of cases of CPE in recent years. Known outbreaks had occurred in eight healthcare facilities in Ireland resulting in high costs and bed closures, he outlined.

Immunosuppressed patients are at particular risk of CPE infection, which carries a high mortality risk in the context of extremely limited antibiotic treatment options. Although treatment options are limited for all types of CPE, they are frequently even more limited for metallo-beta-lactamase-producing Enterobacterales, such as New Delhi metallo-beta-lactamase (NDM) and Verona Integron-encoded metallo-beta-lactamase (VIM), HSE guidance has noted.

HIQA strengthening IT security systems

A spokesperson for the Authority told the Medical Independent : “The underlying technology used on this system is going out of support by the technology provider, hence HIQA is replacing the system.”

As a result of the ongoing management of HIQA’s security, it identified and prioritised requirements to proactively monitor its systems.

A project related to the monitoring of HIQA’s IT systems was fast-tracked by the Authority as a result of the recent HSE cyberattack. Last year, HIQA’s external security consultants, BDO, completed a review of cyber security provisions at the Authority.

The security review identified items which needed to be improved or strengthened in respect of the systems utilised by HIQA.

The main finding of the review related to the replacement of the existing IT system PRISM. This is HIQA’s main IT system used to record and manage inspection and monitoring activities in regard to health and social care services.

When asked about the impact of the cyberattack on HIQA’s IT policy, the spokesperson said: “This project was fast-tracked in quarter two, 2021, and [a] 24/7 external security monitoring solution on our systems was implemented. A modern cyber security awareness training platform was also subsequently rolled out to our staff.”

After the BDO security review in 2020, HIQA undertook cost estimates required to cover its “critical” IT security needs. Subsequently a request for additional funding of €250,000 was made to the Department of Health.

“This funding was approved in early 2021, which allowed us to proceed with identified security initiatives,” according to the spokesperson.

We are at a pivotal moment and decision-making around this Budget is critical. It provides an opportunity to get it right, making a huge difference for our mental health patients.”

It is concerning to see an approved centre in 2021 receiving critical risk noncompliances, as patients did not have access to occupational therapy, sufficient social work support and that nursing resources were insufficient to provide safe care to the resident cohort.”

four critical and six high non-compliances at two inpatient mental health centres in Cork and Naas.

As a singularly focused health sciences university, we have a particular responsibility to use our knowledge to help people to make the small lifestyle adjustments that will enhance their physical and mental health as we emerge from the pandemic.”

Genuair®-has it ‘clicked’ yet?

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

Genuair - a simple to use inhaler for patients with COPD4

Abbreviated Prescribing Information

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

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

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

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

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

Abbreviated Prescribing Information

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

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

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

Healthcare in the crossfire

Despite the attempts of the United Nations to better protect healthcare staff and patients, attacks on medical facilities in conflict zones are of increasing concern. Bette Browne reports

“Stop bombing hospitals. Stop bombing health workers. Stop bombing patients.”

That was the plea to world leaders when the United Nations (UN) passed a resolution in 2016 to protect medical workers in conflict zones. But five years on, brutal attacks are continuing almost unabated and often with impunity.

“UN Resolution 2286 was prompted, in part, by the devastating US airstrikes on the Médecins Sans Frontières (MSF) trauma hospital in Kunduz, Afghanistan, in October 2015, which killed 42 people, and by subsequent aerial attacks in 2016 by states on hospitals in Syria and Yemen,” Ms Isabel Simpson, Executive Director of MSF Ireland, told the Medical Independent (MI)

“We saw the resolution as a political reassertion of the legitimacy and protected status of humanitarian medical action at a time when MSF was under deadly aerial attack from states, including member states of the United Nations Security Council or coalitions they backed.

“States were forced to publicly reassure the protection of medical activities and to stop the erosion of International Humanitarian Law (IHL). It further contributed to clarifying grey areas of IHL and acknowledging the legitimacy of our activities.” IHL, also known as the ‘laws of armed conflict’, regulate the conduct of war.

Impact

While world leaders were sufficiently shocked by the scale of attacks to support the passage of Resolution 2286, they appear to have done little to effect change, according to data from humanitarian agencies. Attacks have continued to deprive communities of health services as well as placing the lives of patients and healthcare workers in danger.

The International Committee of the Red Cross recorded 3,780 attacks on healthcare providers and patients from 2016 to 2020. Of the 231 reported attacks to date in 2021, most have occurred in Syria, Afghanistan, Yemen, and Myanmar, according to World Health Organisation (WHO) data.

This summer has seen a litany of shocking attacks. On 24 May, the International Rescue Committee (IRC) announced the death of Dr Louis Edward Saleh Ufew, an IRC staff member who died in Panyijiar County, South Sudan.

“We are deeply disturbed by these attacks and extremely saddened by the loss of our esteemed colleague. Following the horrific and tragic death of Dr Louis, IRC has suspended all its humanitarian operations in Ganyliel Payam with immediate effect because we are very concerned about the safety and wellbeing of our staff working on projects in the area,” said Ms Caroline Sekyewa, IRC South Sudan Country Director in a statement after the attack.

“Attacks on humanitarian staff constitute a severe breach of international humanitarian law. We urge the local authorities to provide a guarantee of staff security so that we can continue to provide life-saving humanitarian services to host and displaced communities in South Sudan.”

Ethopia, Afghanistan, and Gaza

One month later, on 24 June, three MSF aid workers were killed in Ethiopia's Tigray region. They were María Hernández, Yohannes Halefom Reda, and Tedros Gebremariam Gebremichael.

“No words can truly convey all our sadness, shock, and outrage over this horrific attack, nor can they soothe the loss and suffering of their families and loved ones,” said Ms Marta Cañas, MSF General Director, in a statement. “We condemn this attack in the strongest possible terms and will be relentless in learning what happened. Maria,

Yohannes, and Tedros were in Tigray providing assistance to people, and it is unthinkable that they paid for this work with their lives.”

They are among at least 12 aid workers reported killed since fighting broke out last year between Ethiopia's military and forces loyal to the region's former ruling party, the Tigray People's Liberation Front (TPLF). The conflict has resulted in the deaths of thousands of people and displaced more than two million.

Reports of rights abuses have been widespread in Tigray and the warring parties have been accused by human rights groups of occupying schools and attacking hospitals.

UN Secretary-General Mr Antonio Guterres also denounced the killing and emphasised that those responsible must be brought to justice. “This is totally unacceptable and an appalling violation of international humanitarian law. The perpetrators must be found and severely punished.”

children a year, had to close.

As recently as 5 August, the UN expressed its deep concern about the safety and protection of tens of thousands of people in Afghanistan, including those depending on hospitals and medical facilities. “There are reported increased civilian casualties, destruction or damage to civilian houses, as well as to critical infrastructure and hospitals,” UN spokesperson Mr Stephane Dujarric told reporters.

To coincide with the fifth anniversary of UN Resolution 2286, the Safeguarding Health in Conflict Coalition released its eighth annual report, documenting the global incidence of attacks and threats against health workers, facilities, and transport.

It cited 806 incidents of violence against, or obstruction of, healthcare in 43 countries and territories in wars and conflicts in 2020, ranging from the bombing of hospitals in Yemen to the abduction of doctors in Nigeria. The attacks included killings, kidnappings, and sexual assaults, as well as destruction and damage of health facilities and transport.

“The findings reveal that on the fifth anniversary of the UN Security Council's Resolution 2286 on protection of healthcare in conflict, acts of violence against healthcare have not been curbed and impunity for those who commit them has remains a constant,” the report emphasised.

The organisation’s Chairperson Mr Leonard Rubenstein said while the reasons for violence were sometimes complex, the explanation for impunity was not. “States have failed to fulfil their commitments to take action – individually or as part of an international effort – to prevent such violence or hold the perpetrators accountable.”

Action required

In 2019, a total of 483 aid workers were killed, kidnapped, or wounded, according to data from the Humanitarian Outcomes organisation. This was the highest number in the 20 years since it started keeping records. Of the 483 aid workers, 125 were killed, 234 were wounded and 124 were kidnapped.

In a particularly horrific and deadly attack on 12 May 2020 at the Dasht-e-Barchi Hospital – a facility supported by MSF in the Afghan capital Kabul – 24 people were killed when attackers killed mothers and pregnant women in their beds. MSF said the attack on a maternity ward had no precedent in MSF’s 50-year history.

On 16 May 2021, in Gaza, Israeli airstrikes damaged a MSF trauma and burns care clinic and killed at least 42 people in the vicinity. The clinic, which treats over 1,000

Ms Simpson also emphasised that the UN resolution was only a first step. She said it must be backed up with more concrete action by nations.

“Whilst the resolution was an important political assertion at the highest political level, it is nevertheless not sufficient or cannot be considered as a standalone solution. Our teams and patients continue to witness and face horrific and unacceptable attacks. There have been over 500 attacks on healthcare so far in 2021. This includes attacks on patients, medical staff, ambulances, hospitals, and supplies.

“Since 2015, we have marked the loss of 26 MSF staff who were killed while providing medical assistance in 10 separate

There have been over 500 attacks on healthcare so far in 2021. This includes attacks on patients, medical staff, ambulances, hospitals, and supplies

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Continued from p10 ▸

incidents in Afghanistan, South Sudan, Yemen, Central African Republic, Syria, and Ethiopia. This figure doesn’t account for the deaths of patients and care givers in these attacks, nor does it account for casualties in other attacks that have not been fatal.

“MSF has also witnessed numerous signals – from accusations and smear campaigns to intense harassment and arrests of staff – across varying contexts that demonstrate to us that the medical mission is being less and less respected. Words are not transforming into actions. Political leaders need to realise that Resolution 2286, as a political reassertion, was only the first step.”

Humanitarian organisations, including MSF, have already indicated the precise nature of the actions that could be taken. Ms Simpson told MI the steps should include the systematic inclusion of humanitarian exemptions in UN resolutions calling on states to implement counterterrorism and sanctions measures and the systematic inclusion of humanitarian exemptions in domestic counter-terrorism legislation.

“In fact, securitisation and anti-terror legislation further threaten the medical mission by impeding the provision of humanitarian relief, as protected and authorised by international humanitarian law. Political leaders need to call on states to take precise and concrete action to reassert the protection of the medical mission and explicitly upholding the rules of international humanitarian law.”

Another major concern for aid groups is the move by some countries to seek to criminalise humanitarian action in anti-terrorism measures. This concern was highlighted by Irish Ambassador Mr Brian Flynn at the UN Security Council in a speech on 16 July.

“There is now a greater awareness of the extent to which these measures can limit humanitarian access, criminalise the delivery of assistance, or curtail the ability of NGOs to finance humanitarian operations in areas under the control of sanctioned individuals and entities, including designated terrorist groups.”

He said Ireland, which now holds a seat at the Security Council, supports efforts to promote dialogue between donors, regulators, banks, and international NGOs. He also emphasised that UN bodies working on countering terrorism should engage systematically with humanitarian organisations.

“The Security Council also has a role to play in improving the protections for humanitarian actors in UN counter-terrorism and sanctions regimes, by including designation criteria sanctioning those that obstruct or harm humanitarian activity and actors, and providing for appropriate exemptions in sanctions regimes for humanitarian work.”

The Safeguarding Health in Conflict Coalition called on the UN Secretary-General to report on the actions and inactions of member states with respect to the commitments made five years ago. It recommended the appointment of a special rapporteur or representative to report on countries and themes as a step towards accountability.

While the direct loss of lives is tragic, the indirect impact of the loss of a medical facility to a given population is also devastating. Each attack on health facilities means that thousands of people are deprived of urgent access to medical care. The attacks can also affect the numbers volunteering with aid agencies.

Mr Jan Egeland, Secretary-General of the Norwegian Refugee Council, which employs some 15,000 aid staff globally, said the international community needed to do far more to protect medical staff including volunteer workers.

“I’m really worried that there will be even fewer aid workers able and willing to stay and deliver in the worst hit conflict areas in the future,” he told The Guardian last year.

“Already, we see fewer groups being able to stay and deliver in the worst areas and I fear it will be even thinner in the future. We need governments, donors, diplomats, military leaders, and politicians to do more to protect our humanitarian workers. There must be a higher price for those who can now attack with apparent impunity.”

With Ireland a member of the Security Council until 2022, it could play a constructive role in ensuring UN members live up to their responsibilities in enforcing Resolution 2286 and advocate for measures to reinforce the protection of medical workers.

“Since the Security Council adopted 2286 five years ago, we have seen increased recognition of the need to protect medical workers and facilities,” Ambassador Flynn, told a webinar in May. The webinar was organised by MSF Ireland, the Irish Red Cross, and DSA Ireland’s Humanitarian Action Study Group.

“Ireland has a long record of supporting the humanitarian and healthcare efforts around the world. And as members of the Security Council, we are deeply conscious of the need to protect those doing such vital work.

“Since the Security Council adopted 2286 five years ago, we have seen increased recognition of the need to protect medical workers and facilities. Notwithstanding this, we’ve also seen a continuation of horrific attacks on healthcare facilities and workers and violations (of the Resolution).

“These attacks have a devastating impact on populations of those already in extremely fragile situations. In the first five months of this year alone we've seen multiple attacks on medical workers, humanitarian staff, and health facilities.

“As a member of the Security Council, we have consistently highlighted (the need) to address these attacks. And, of course, we highlighted the violations in Gaza or damage to clinics and hospitals from airstrikes. Unfortunately, this is just to name a few instances.”

However, as Ambassador Flynn also stated, words and good intentions were not enough.

appropriate measures to avoid the destruction of healthcare facilities, is potentially a war crime.”

Ireland made its position clear at the UN Security Council meeting in July 2021 that when the Council fails to call for accountability for violations of international humanitarian law, a culture of impunity pervades from one conflict to the next.

“From Yemen to Syria to the Democratic Republic of the Congo, we continue to tolerate such impunity,” said Ambassador Flynn, urging the Council to ensure that clear measures should be in place to protect civilians and humanitarian missions.

He also pointed out that local medical and humanitarian staff – and notably women – were often at the forefront of humanitarian responses and they could face greater pressure than their international colleagues from local authorities, community members, and security forces. Such challenges must be factored into planning for the security of all staff, he stressed.

Ms Amina Mohammed, Deputy Secretary-General of the UN, told the meeting that attacks were making it ever more difficult to provide humanitarian aid.

“Since late June, just one convoy of aid has been able to enter Tigray, where an estimated two million people are displaced and 5.2 million are in need of humanitarian assistance.

“In Afghanistan, aid workers, particularly women, face increased attacks, harassment and interference in their work. And in Yemen, there were over 350 incidents involving restrictions on humanitarian organisations, personnel, and goods in just two months earlier this year.”

She reiterated the Secretary-General’s calls for the Security Council to take strong and immediate action to support its resolutions. To that end, she pointed out that the Council had access to an array of practical tools designed to foster greater respect for international humanitarian law.

“We need to find ways of making a real difference on the ground. This begins with speaking out where attacks take place. We've also endorsed a call for humanitarian action made by France and Germany this year, an initiative that aims to better fight impunity for attackers.”

He said the concerns of humanitarian workers must be included in drafting sanctions and anti-terror legislation. He acknowledged, however, that measures to hold those responsible for violations are often blocked by one or more UN members.

“It comes back to having to political will to take the steps necessary, we cannot simply look the other way.”

The Irish Ambassador emphasised this point by quoting the words of former MSF International President Mr James Orbinski: “We are not sure that words can always save lives, but we know that silence can certainly kill.”

Indeed, when Resolution 2286 was passed back in 2016, then MSF President Ms Joanne Liu charged that while the Security Council was responsible for maintaining peace and security, four of its five permanent members had been associated with coalitions responsible for attacks on health structures over the previous year.

War crimes

In the intervening years, that situation has changed little.

In a briefing to the UN Security Council regarding attacks on health facilities and personnel in Syria in July 2019, Ms Susannah Sirkin, Director of Policy with the US-based group Physicians for Human Rights, commented: “When hospitals are destroyed, the loss is far greater than the buildings. When medical workers are killed, the human toll is not just their lives, but also the exponential number of people who suffer and die without medical treatment.”

Physicians for Human Rights branded such attacks as potential war crimes.

“International humanitarian law requires special protections for medical personnel and facilities to ensure the functioning of healthcare throughout a conflict. International humanitarian law also prohibits the targeting of civilians, including wounded combatants receiving care. Any attack that deliberately targets healthcare facilities, or that does not take

These tools include facilitating the training of national militaries, applying diplomatic pressure and imposing sanctions when no other remedies remained viable. She also stressed that clear lines should be drawn between military operations, political objectives and humanitarian efforts, and that counterterrorism measures must explicitly ensure that humanitarian workers are not punished for doing their jobs.

Irish role

Ms Simpson told MI that “at this critical juncture, the UN Security Council must not be content to sit on their laurels” and she emphasised the role Ireland could play on the Council.

“As an elected member of the UN Security Council, Ireland now has the opportunity to highlight this as a priority issue and one that is necessary for the survival of impartial humanitarian and medical assistance. States must uphold the obligations that they have themselves undertaken to be bound by in order to protect fundamental humanitarian principles, including humanitarian and medical assistance for all.”

But attacks on the medical mission must be viewed more broadly than the string of aerial attacks on health facilities that triggered the adoption of Resolution 2286 in the first place, she said.

“Whilst this still constitutes a threat to humanitarian and medical assistance, today the medical mission is also menaced in less internationally visible ways. In situations where violence and conflict are permeated with a counter-terrorism element, or where states of emergency are declared, there is no longer any space for impartial humanitarian and medical assistance to all populations in need.

“Relief to populations in need present in areas controlled by non-state armed groups, designated as criminals or terrorists, is considered as financing or material support to terrorists or criminal groups.

“Simply put, anti-terrorism laws tacitly criminalise humanitarian action. As long as states do not clearly and unequivocally exempt humanitarian actors under these laws when they provide exclusively medical and humanitarian relief, then humanitarian and medical facilities and personnel will be endangered.

“International Humanitarian Law protection of medical care is intended to allow doctors, medical and humanitarian personnel to provide necessary medical treatment to all persons. Without this protection and with the constant fear of being attacked, pressured or harassed for the sole reason of providing medical care, doctors can simply not work.”

As an elected member of the UN Security Council, Ireland now has the opportunity to highlight this as a priority issue

Fictional patient, for illustrative purposes only

For COPD patients on treatment with ICS/LABA and at risk of exacerbation* 1

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

It’s the things you do today that

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.

▼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.

(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

patients on TRELEGY Ellipta

expect

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.

Start TRELEGY Ellipta was developed in collaboration with

How to practise self-compassion

In advance of an upcoming virtual masterclass on self-compassion and self-care – in partnership with RCPI – Co-Founder of the Rise Wellness Programme Mr Barry Lee reflects on how compassion for one’s self can benefit healthcare workers

We will start by acknowledging that the phrase “self-compassion” can sometimes be off-putting for some people.

Do you notice any of the following reactions as you read the phrase?

It is weak.

It is self-indulgent.

It will undermine my motivation to get things done. In fact, none of the above are true. Self-compassion is actually the key to resilience, strength in the face of failure and the ability to learn from mistakes. There is a significant body of evidence showing that practising self-compassion is strongly correlated with increased emotional resilience and wellbeing, in addition to reduced stress and anxiety.

A common trait shared by many of us is a tendency towards being very harsh and critical of ourselves. Without wishing to generalise, this may be especially true of doctors and others who work in caring professions. Research indicates that four out of five doctors find it easier to take care of their patients than themselves. This is not a good thing. In order to care for others without burning out, we must learn to care for ourselves. So perhaps some of us could really benefit from this practice?

The components of self-compassion and how to practise it

Compassion arises ‘when kindness meets suffering’.

In case you are put off by the word ‘suffering’, it is important to note that we all suffer at times: We might feel stressed or anxious; we might experience conflict with another person; we might feel overwhelmed or we might encounter physical pain. Caring for patients who are sick and who often expect so much is in and of itself challenging. Factor in a devastating global pandemic and the HSE cyberattack, which stretched our healthcare services to breaking point, and it is clear that the last year has been really hard.

It is not enough to simply acknowledge that there is suffering. For compassion to arise there must also be the sincere wish (at some level) to alleviate that suffering – kindness meets suffering. It is a very human quality we all share. We usually experience compassion in the heart. It is an open, warm, spacious feeling.

There are three ingredients to self-compassion (mindfulness, common humanity and kindness). A simple practice, which integrates each component, is the three step self-compassion break goes as follows.

Step 1 Mindfulness – ‘This is a moment of suffering’

First we must actually connect with the difficult experience without over-identifying with it or drowning in it. This is counter intuitive and it takes some courage. Normally when a difficult experience arises, our first instinct is to recoil and contract. Mindfulness means being aware of our present moment experience ‘as it is’. It gives us perspective. We can witness the physical sensations that go along with this difficult experience coming and going (the tension, the resistance, the contraction). We acknowledge the difficult experience, but do not have to over-identify with it and get lost in a spin cycle of thought. Mindfulness creates a little distance and gives us space to breathe.

Step 2 Common humanity – ‘Suffering is part of life’

Next we acknowledge that this difficult experience is part of an authentic human life. We are not alone in this. Even on my very worst day, I know that millions of others feel the same. Recognising this truth takes the magnifying glass off me and my experience. Again, acknowledging the common humanity of suffering gives

us perspective. This is just part of life. It is normal to feel anxious, angry, overwhelmed, frustrated, embarrassed or sad at times. We all make mistakes and we all fall short. I'm not alone and I do not have to beat myself up.

Step 3 Kindness – ‘In the midst of all this, without having to fix everything, can I be kind to myself?’ For the final step we offer ourselves some kindness. It is probably easy to do this for a good friend but perhaps not so easy to do this for yourself.

Now, without it feeling phony, can you offer some of this same kindness for yourself? What words do you need to hear? (ie, ‘This will pass’; ‘It will be okay’; ‘I'm doing the best I can’; ‘I'm not alone’; ‘This is hard, but I know I can be with this experience and I know I can learn from it’).

What would actually help right now? Maybe you can simply return your attention to the connection between your feet and the floor. There may be a sense of support there. Can you release some tension in the body or perhaps allow the breath to slow and deepen? Even one deep breath?

So that is the practice. It is very simple, but it is not always easy.

If it resonates with you and you would like to learn more, you can join Mr Barry Lee and Mr John Slattery for a self-compassion workshop in partnership with the RCPI on Thursday 9 September from 16.00 to 18.00 (Self-compassion – Create your self-care strategy). This special online event will help you create practical strategies to fuel sustainable self-care in your professional and personal lives.

Think for a moment about what you might say to a good friend who is going through this same difficult experience. Imagine that they are struggling right now. What is your facial expression as you sit with them? What is the tone of your voice? Are you rolling your eyes and telling them that it is all their fault? Are you getting up to leave the room? Are you telling them all about the worst-case scenario? Are you going to kick them while they are down? If you are not having a really bad day yourself, probably not. Without having to fix everything, in your better moments you might be able to offer your good friend some kindness and support.

• Mr Lee and Mr Slattery are Directors of Rise Wellness , a mindfulness and wellness programme empowering attendees to rise to the new challenges of life and work. Open to individuals and to organisations, Rise focuses on enhancing vibrancy, resilience and healthier team cultures.

• If you are interested in learning more about mindfulness and self-compassion, you can also check out the Mindfulness Teachers Association of Ireland for some free resources and a list of qualified mindfulness and self-compassion teachers.

• The RCPI Physician Wellbeing Programme aims to help doctors enhance their wellbeing and professional conduct throughout their working lives. It will do this by promoting better training practices and providing support for doctors who need it.

Research indicates that four out of five doctors find it easier to take care of their patients than themselves

Investment in mental healthcare more important than ever

In our last editorial, we wrote about how many of the problems within healthcare exposed by the Covid-19 pandemic have been known for a long time. The editorial chiefly focused on HIQA’s recent comments on infrastructural deficits, but also referred to waiting lists and recruitment difficulties.

While these are all significant issues within the general health service, they perhaps are felt even more acutely in mental healthcare. Our last issue also had a feature on child and adolescent mental health services. In recent years, the waiting list for the services has been a problem. Covid-19 has made a concerning situation even worse. Before the start of the second wave of the virus in October 2020, 93 per cent of all accepted referrals were offered a first appointment within 12 weeks. Of those, 96 per cent were seen within 12 weeks. However, at the end of December 2020, at the beginning of the third wave, only 79.1 per cent of referrals nationally were offered an appointment within 12 weeks. At that time, 1,556 young people were waiting less than three months for an appointment and 266 were waiting more than 12 months.

The IHCA recently published its mental health pre-Budget 2022 submission. According to the Association, while the 2021 mental health budget of €1,114.1 million is 9 per cent above the equivalent 2009 expenditure level, it does not account for the population growth over the last decade.

The IHCA points out the current mental health budget is €2,000 per 1,000 population, below the spend 13 years ago. At 5.4 per cent of the over-

all health budget, the mental health budget in 2021 is also half the level of spending compared with other European neighbours and is low by international standards. France allocates 13 per cent of government health spending to mental health. Germany, The Netherlands, and Sweden all spend approximately 11 per cent. Ireland also has the third lowest number of inpatient psychiatric care beds in the EU, at just 32.69 per 100,000 inhabitants. This is half the EU 27 average. Also, more than onein-eight inpatients spend six months or longer in an acute mental health bed, highlighting the lack of suitable alternative facilities. The IHCA says it is “unacceptable” that more than one-in-five approved consultant psychiatry posts are vacant or filled on a temporary basis across the country.

For Budget 2022, the IHCA urges the Government to increase capital expenditure for Ireland’s mental health services and for its allocation to be expedited to address the physical infrastructure deficits that have resulted from years of capital cuts and lack of investment. It calls for filling of posts with consultants on permanent contracts.

We hear a lot about the devastating impact Covid-19 has had on people’s mental health. It is unsurprising that the World Health Organisation has identified the mental health repercussions of the pandemic as a serious problem.

In Ireland, mental healthcare has received inadequate funding for decades and the past year has made investment in the area even more critical.

MINDO CARTOON

READER COMMENTS

REACTION TO OUR NEWS STORY, 'PROGRESS IN DEEP BRAIN STIMULATION SERVICE', 26 AUGUST

"Some good news on the development of deep brain stimulation services in Dublin's Mater Hospital for people with Parkinson's disease and other neurological conditions." Parkinson's Ireland, @ParkinsonsIre, 25 August

REACTION TO OUR BREAKING NEWS STORY, 'PROBLEM OF SLEEP DEPRIVATION IN SURGEONS HIGHLIGHTED IN NEW STUDY', 6 AUGUST

"Thanks to @med_indonews for the feature on my recent publication!"

Dale Whelehan, @Daleyfurter, 10 August

REACTION TO OUR BREAKING NEWS STORY, 'CONSULTANT POSTS FOR PUBLIC HEALTH DOCTORS DUE TO BE ADVERTISED', 29 JULY

"Good news back home." Dr Niall Conroy, @NICU_doc_salone, 29 July

"It’s great to see progress being made on recruiting consultants in public health medicine in Ireland." Dr Regina Kiernan, @KiernanRegina, 29 July

REACTION TO OUR BREAKING NEWS STORY, ‘"SEVERE" SHORTAGE OF CONSULTANTS IN SSWHG LEADING TO "UNACCEPTABLE DELAYS"', 22 JULY

"Seeing the impact of this every single day working as a GP in the south-west. Our patients are at a huge disadvantage." Laucullen, @laucullen1, 22 July

REACTION TO OUR NEWS STORY, '"COMPLEX" TRANSFER OF DISABILITY REMIT ONGOING', 22 JULY

"An article detailing the 'complex' transfer of policy and funding responsibility for specialist community-based disability services from the Department of Health to the Department of Children, Equality, Disability, Integration, and Youth (DCEDIY) and the impact of the pandemic." Inclusion Ireland, @InclusionIre, 20 July

REACTION TO DR MICHAEL CONROY'S COLUMN, 'THE MAYFLY EFFECT', 24 JUNE

"This is so relevant again this morning. First payday from my new job and hospital, emergency taxed to the hilt despite tax credits being sorted from my side. Paid a third of what I was due. A stressful two weeks ahead as I live off essentially nothing after rent and loans are paid." Dr Sarah Jane @sarahjane_oc, 29 July

"Replying to @sarahjane_oc. It's eight years since I was an NCHD, this was an issue throughout my training, I can't believe it is still an issue. And the timing is so brutal as many have to pay deposits after moving and often double rent/mortgage for the away rotation. Totally unacceptable." Dr Gabrielle Ní Challaráin, @GColleranMD, 29 July

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50mgs once daily

50mgs once daily

Her 10th shopping trip since the day she started BETMIGA1

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

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

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

products metabolized by CYP2D6 with a narrow therapeutic index such as thioridazine, Type 1C antiarrhythmics (e.g.flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. Inhibition of P-gp: Mirabegron is a weak inhibitor of P-gp. For patients who are initiating a combination of Betmiga and digoxin, the lowest dose for digoxin should be prescribed initially. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect. The potential for inhibition of P-gp by mirabegron should be considered when Betmiga is combined with sensitive P-gp substrates e.g. dabigatran. Fertility, pregnancy and lactation: The effect of mirabegron on human fertility has not been established. Betmiga is not recommended during pregnancy and in women of child-bearing potential not using contraception. Mirabegron should not be administered during breast feeding. Refer to SPC for full guidance. Driving and use of machines: Betmiga has no or negligible influence on the ability to drive and use machines.

Undesirable effects: Summary of the Safety Profile: the safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.

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

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

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

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

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

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

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

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

HPRA Pharmacovigilance Astellas Pharma Co. Ltd Earlsfort Terrace, IRL - Dublin 2 Tel: + 353 1 467 1555

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie E-mail: medsafety@hpra.ie.

E-mail: Irishdrugsafety@astellas.com

Teleconsulting: Keeping yourself and your patients safe

Since the start of the Covid-19 pandemic, Medical Protection has received numerous requests for advice on the risks involved in remote consulting, or telemedicine. If you are practising telemedicine, it is important that you are aware of the medico-legal pitfalls and how best to protect yourself against them.

According to the Medical Council, telemedicine is the delivery of healthcare services through information and communication technologies to promote the health of individuals and their communities.

Although the way doctors have practised has seen significant changes, the regulatory framework in Ireland remains mostly unchanged, and the Medical Council make it clear that the same standards of care apply to telemedicine as they do with face-to-face consultations. It is important to be familiar with the obligations outlined in the Guide to Professional Conduct and Ethics for Registered Medical Practitioners , as well as the ‘Telemedicine phone and video consultations guide for doctors’.

Medical Protection has produced a series of Digital Future webinars addressing various aspects of remote consulting. Here, some of the frequently asked questions will be addressed.

Prior to the appointment

 What issues do I need to consider around confidentiality?

In general, there are physical considerations such as who else is present in the virtual consultation, or physically in the room with the patient. It is also important that privacy is maintained from the doctor’s side and any disruptions minimised.

During a Medical Protection webinar on telemedicine in Ireland, 52 per cent of attendees said that they would not routinely ask a patient if anyone else was in the room with them when on a phone or video consultation. This can be an important question to raise; for example, if a patient cannot speak freely due to the presence of others, it may be appropriate to have a face-to-face consultation.

From a technological perspective, a secure system should be used, and the relevant data protection principles adhered to, in line with General Data Protection Regulation (GDPR) and Medical Council guidance. A drawback of remote consulting is the possibility of technological difficulties, so it is helpful to agree a contingency plan with the patient in advance should the consultation be interrupted, for example, due to lost internet connection.

 What if the patient states they want a family member present on the video call to act as an interpreter?

When this question was posed in our webinar, 33 per cent of attendees reported that they would decline and arrange for

an official interpreter. The ideal situation is to have an official interpreter to overcome any language barrier, and there are clinical and medico-legal risks in having a family member or friend take on this role. However, the clinical risk and urgency of the situation would need to be considered. If the delay in organising an interpreter might put the patient at risk, it may be appropriate to go ahead with this consultation with the intention of arranging a further appointment with an interpreter. Doctors should clearly document their reasons for making this decision.

It is essential, if you do choose to go ahead in such circumstances, that you bear in mind that the family member or friend may not be objective, you would not be able to guarantee that the translation is correct, and sensitive information may be withheld.

A record should also be made of any third parties present during a consultation, including interpreters, family members or friends.

 What if I become aware that the consultation is being recorded? There is no legal barrier in Ireland, which would prevent a patient from making a recording of a consultation if they are

at Medical Protection, advise on the growing field of telemedicine

face-to-face consultation in the right circumstances is key to ensuring that patient care is not compromised due to the method of consulting. The Medical Council guidance states that “you must satisfy yourself that the services you provide through telemedicine are safe and suitable for patients”. Doctors should explain to their patients that there are aspects of telemedicine that are different to traditional medical practice – for example, explaining that a teleconsultation does not involve a physical examination and any additional risks that may arise as a result.

The reasons behind the patient’s decision should be explored as the situation could perhaps be resolved. At the heart of this question, however, is the issue of informed consent – if the patient has capacity, their autonomy should be respected. However, their decision to attend or not must be appropriately informed.

You must therefore be satisfied that the patient understands the limitations of the assessment that can be carried out remotely, the rationale behind your advice to attend in person, and the risks of not attending in person. Your management plan and safety netting advice may need to be adjusted in light of this decision, perhaps advising a further remote consultation to review the situation, for example. Consent is dynamic, and people’s decisions may change as circumstances and risks change, and so it is important to revisit this discussion.

After the appointment

 What should I document following a remote consultation?

the subject of that consultation. This may make some doctors feel uncomfortable, especially if recording is initiated covertly. It is important that doctors remain professional during all interactions with patients whether they are being recorded or not.

If a doctor discovers that a patient is recording their consultation, it would be helpful to discuss this and explore the reasons. The patient may be worried about forgetting key information or would like to consider the content of the consultation further, especially in relation to decisions they may need to make. It may be that the patient is making a recording because they have concerns about the care provided; discussing these concerns at an early stage reduces the risk of a formal complaint arising and can assist in preserving the therapeutic relationship. A copy of the recording could be requested to be stored as part of the medical records, with the usual data storage and security requirements considered.

The consultation

 What if a patient declines an in-person physical examination that I believe to be clinically necessary?

Recognising the need to recommend a

Medical Council guidance says that you must follow the standards of good practice set out in their guide, whether your service is via telemedicine or face-to-face.

Its advice on record-keeping states the following:

“You must keep accurate and up-todate patient records either on paper or in electronic form. Records must be legible and clear and include the author, date, and, where appropriate, the time of the entry, using the 24-hour clock.”

As with all consultations, the management plan and any safety netting should be clearly documented, but additional conversations such as the need to convert to a face-to-face appointment may also need to be recorded.

If doctors are in doubt about the risks they face when consulting remotely, they should contact Medical Protection or their medical defence organisation for advice

For more resources on telemedicine, visit medicalprotection.org/ireland/hub/ telemedicine

Medical Protection’s consultant and GP conferences are on 11 and 25 September respectively. Free for members medicalprotection.org/ireland/ resources-training/events

From a technological perspective, a secure system should be used, and the relevant data protection principles adhered to, in line with General Data Protection Regulation and Medical Council guidance

Never too late to change

Deciding to leave my GP practice for a new role brings with it a certain sadness, but also a feeling of liberation

At the end of September, I will be leaving the practice where I have worked for the past 16 years. I arrived here in July 2005, an eager, wide-eyed GP registrar with an anti-hospital bias [see recent column] and pro-primary care enthusiasm. I loved having my own little room, with my own electronic diary and full electronic health record for each patient. I didn’t have to run around a huge hospital trying to find the right form for the right department only to be told that department actually now just accepts the blue forms, not the red ones. I was able to satisfy my need for control and order, with the luxury of extended consultation times and close supervision from my trainer.

Of course, things changed as time went on. After graduation, I was fortunate to be offered a locum position in the same practice (not before I had taken six weeks off to travel across Canada. Priorities, like.) Then I stayed on as a salaried assistant. The hours were great, with long lunchbreaks and defined finishing times. I was able to build up relationships with patients and get a feel for how a large practice operates. I was drawn towards the intricacies of management and was intrigued by the business of medicine almost as much as the medicine itself.

When the offer of a partnership arose, I don’t think I hesitated for a second. I was eager to get more involved in the nuts and bolts of maintaining, developing, and improving

the practice structures and was keen to have a greater involvement in the decisions that would affect my day-to-day life. I even embraced the “Gordian Knot” of practice support subsidies, determined that I would finally figure out how the hell they are calculated. I was keen to make changes that would hopefully improve the patient experience. As with all organisations, some changes were easier to incorporate than others, and my utopian vision of harmonious autonomy was sometimes dented. But life proceeded, as it does, and I never gave any thought to the possibility of starting somewhere new elsewhere. My professional future would be within these walls, and the opportunities and developments that I needed for personal fulfilment would all happen in the parameters of my ‘Job for Life’.

One day last summer, though, a sudden and stunning thought entered my head. I could leave. I could do something else.

I had been reading some of Nora Ephron’s essays and came across her famous quote, “Every 10 years or so,

there was a moment when I’d say, even subconsciously, ‘Is that all there is?’” She famously moved from journalism to screenwriting, writing the exquisite When Harry Met Sally in her mid-40s. It dawned on me that I had never even contemplated the notion of doing something different with my life. Of course, Covid played its part; the tumult that it induced was certainly a kick up the butt. It also brought opportunities for online learning and communication that had not previously existed. I applied for a Diploma in Leadership, which I would never have considered if it required regular trips to Dublin, as it would have done pre-pandemic. Once I had made the decision to up sticks, it was liberating. But of course there was a sadness and a sense of loss for what I would be leaving behind. The colleagues, friends, and patients that have been part of my life for most of my career so far. The joy of sharing good news with a patient and the bittersweet satisfaction of finally solving a diagnostic conundrum. While I expect to return to clinical practice in the future, for the moment I will be leaving behind the intimate relationships that I have built up with men, women, and children that know me as ‘The Doctor’. I know that some of them will struggle with building up that relationship with someone new and I feel guilty for leaving them in the lurch.

I am now working with CervicalCheck as Primary Care Clinical Advisor. After a few weeks of figuring out a whole new way of working, I think I might be getting the swing of it. 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, led by the indefatigable Dr Nóirín Russell.

Any regrets?

I still have no idea how practice support subsidies are calculated.

The problem of media misrepresentation

paring for press conferences they were often disappointed with the media portrayal of their message. A completely false social media report that one of the first volunteers in the Oxford vaccine trail had died was an especially low moment for the scientists.

there is a need for dialogue and deliberation to examine this highly complex problem from many different angles. “When we move beyond ‘us versus them’ we can come to better understand ourselves and be more likely to arrive at the best collective decisions.”

It has been interesting to be involved in the Covid-19 pandemic as a journalist and a doctor. Over the course of the last 18 months or so the playing pitch has changed. At the start of the pandemic, there was a striking sense of shared resolve and solidarity. People were largely united in their support of difficult measures to protect the vulnerable, safeguard our health system and sustain key workers.

More recently, there has been a polarisation into two camps: The ‘open up camp’ and the ‘not yet camp’. This divide has become especially acute in the UK, since the government there lifted Covid restrictions on 19 July.

Writing in The Conversation recently, two Oxford academics argued that it is time for the media “to rise above pitting scientists against each other – dealing with the pandemic requires nuance”. Profs Trish Greenhalgh and Dominic Wilkinson say that with the battle lines drawn sharply, media interviewers have set up head-to-head encounters between the ‘open ups’ and the ‘not yets’. “We have been in the ring for such debates on opposite sides and found that these formats add heat, but little light to public understanding.”

They are not the only scientists to express disquiet at the media handling of the pandemic. In their recently published book Vaxxers, Prof Sarah Gilbert and Dr Catherine Green – who were among those who developed the Astra Zeneca vaccine at Oxford University – say that despite carefully pre-

An example of the important, but complicated, relationship between science and the media was the completely untrue claim made in a German newspaper in late January (2021) that the new vaccine was only eight per cent effective in older people. As a result, Germany’s vaccine policymaking body announced that it would not authorise the use of the vaccine in the over 65s.

“Of course this isn’t just about my hurt feelings that my work was misrepresented,” Green said. “It’s not even about the importance of trust in journalism. This kind of information… will have cost lives. People who could have been vaccinated were not vaccinated, and some of those people will have died.”

Greenhalgh and Wilkinson put forward a possible solution to the media vs science soundbites. They say we need to recognise that this pandemic is a complex phenomenon unfolding in a complex system.

“Complex systems are non-linear. In other words, small things can have large effects (the Delta variant entered the UK, perhaps in just one infected person, and became dominant within weeks). And large things can have small effects (a huge, centralised test and trace system has proved inefficient and contributed little). Such dynamics make accurate prediction of the effect of interventions impossible. While scientists can estimate and speculate, none of us know for sure what will unfold,” they write.

In their view, complex systems must be handled in ways that embrace scientific and moral uncertainty. Crucially,

They want media hosts to rise above the catechism of both-sides journalism, which demands a superficial bare-knuckle fight between a “pro” and an “anti” voice. “Instead, they should acknowledge common ground (we all want to protect our young; we all yearn to return to work and social activities) and help scientists, ethicists and others with different perspectives to work through the possibilities and trade-offs, to find common ground, to accept reasonable disagreement, to seek compromise,” they say.

Taking the issue of giving children the Covid vaccine, there are arguments both for and against. Differences may be resolved partly by new data and partly by identifying sub-groups, such as high risk and low risk.

But Greenhalgh and Wilkinson argue the decision to vaccinate or not also requires moral deliberation on how to weigh up a putative risk to the child against a putative benefit to another household member. It also requires deliberation on how much a vaccine campaign in children would divert supplies or policy attention away from the increasingly difficult task of reaching every eligible adult that remains unvaccinated. These are important issues that need to be teased out calmly.

Ultimately, the rules, motivations and indicators of success in science are not the same as those obtaining in the media.

From my perspective, this is an important difference we should value. A media that cannot ask reasonable questions is of no use to science.

It dawned on me that I had never even contemplated the notion of doing something different with my life

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MULTIPLE CHOICE QUESTIONS

Question 1

In polycystic ovarian syndrome

A. Male pattern hair loss occurs.

B. There is an increase in malignancy in later life.

C. Patients should be advised to eat only two meals a day.

D. Vigorous exercise should be recommended.

E. Metformin has been shown to improve ovulation rates.

Question 2

Congenital hydrocoeles characteristically

A. Present in infancy.

B. Are unilateral.

C. Fluctuate in size.

D. Are confined to the scrotum.

E. Resolve spontaneously within 18-to-24 months of life.

Question 3

In a 30-year-old with an acute knee injury, the following would support a diagnosis of an anterior cruciate ligament rupture

A. At time of injury the patient heard a ‘pop’.

B. Swelling within two hours.

C. Injury from a rugby tackle.

D. Knee locking since injury.

E. Little or no pain.

Question 4

Advise patients with obesity trying to lose weight that

A. Weight loss of more than 5kg halves the risk of developing diabetes.

B. Try to have <30 per cent of your calorie intake from fat.

C. Take at least 30 minutes of moderate intensity physical activity two days a week.

D. Target weight loss would be 3-4kg per week.

E. Minimise alcohol intake.

Question 5

Budgerigar (bird) fancier’s lung

A. Like farmer’s lung, is a hypersensitivity pneumonitis.

B. May develop insidiously with progressive dyspnoea.

C. Characteristically causes finger clubbing.

D. Patients should be advised to ration exposure to their budgies.

E. Severe cases may be treated with prednisolone 30mgs/day until improvement occurs.

E. TRUE. But only with weight loss. NB: Use is unlicensed, but supported by wide body of opinion.

For others steroid inhalers can be effective.

E. TRUE. Then reduce slowly, but increase again if symptoms recur.

D. FALSE. Must cease all exposure and never resume it.

C. FALSE . Is uncommon.

B. TRUE. Or with symptoms similar to asthma.

A. TRUE. From exposure to organic dusts, eg, bird droppings.

ANSWER 5

E. TRUE. Reduces calories and loss of will power.

D. FALSE. 0.5-1kg a week is realistic.

C. FALSE . Exercise five or more times per week.

B. TRUE. This would be ideal.

A. TRUE. And every 1kg lost reduces LDL cholesterol by 0.02mmol/l.

ANSWER 4

E. FALSE. Likely to have a marked lump and significant amount of pain.

D. FALSE. Suggests meniscal tear or loose body.

C. FALSE. Most ACL injuries involve minimal to no contact.

B. TRUE. As will have caused a haemarthrosis.

A. TRUE. Or a loud crack.

ANSWER 3

E. TRUE. Operation should be delayed until child is at least two years old.

D. TRUE. Swelling does not extend into the groin.

C. TRUE. Present as a swelling surrounding the testis.

B. FALSE. Often bilateral.

A. TRUE. Usually noted at birth.

ANSWER 2

D. TRUE. Has an influence on insulin sensitivity vastly in excess of weight loss. Return of ovulation can occur with as little as 6kg loss.

C. FALSE. Small, regular, high fibre, low-fat meals to avoid excessively stimulating insulin production.

B. TRUE. And diabetes, dyslipidaemia, IHD, and hypertension.

A. FALSE . High circulating androgens cause hirsutism, greasy skin, acne, alopecia.

ANSWER 1

When a DPP-4 inhibitor is needed

Simplicity. Reinforced . for

a BROAD RANGE of adults with type 2 diabetes (T2D)

UNIQUE CONVENIENCE through always one dose, once daily 1 5mg once daily

Demonstrated CV AND KIDNEY SAFETY PROFILE 2,3

HbA1c

PROVEN EFFICACY VS PLACEBO for adults with T2D 1,4

References:

1. TRAJENTA® (linagliptin) Summary of Product Characteristics. Available at: https://www.medicines.ie/medicines/trajenta-5-mg- lm-coated-tablets-34014/

2. Rosenstock J, et al. JAMA. 2019;321:69–79

3. Rosenstock J, et al. Cardiovasc Diabetol. 2018;17:39

4. McGill JB, et al. Diabetes Care. 2013;36:237–44

Prescribing Information (Ireland) TRAJENTA® (Linagliptin)

Film-coated tablets containing 5 mg linagliptin. Indication: Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment; combination therapy in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control. Dose and Administration: 5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia. Renal impairment: no dose adjustment required. Hepatic impairment: pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking. Elderly: no dose adjustment is necessary based on age.

Paediatric population: the safety and efficacy of linagliptin in children and adolescents has not yet been established. No data are available. Take the tablets with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as possible but 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: Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin; a dose reduction of the sulphonylurea or insulin may be considered. Acute pancreatitis has been observed in patients taking

linagliptin. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Trajenta should be discontinued; if acute pancreatitis is confirmed, Trajenta should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Bullous pemphigoid has been observed in patients taking Linagliptin. If bullous pemphigoid is suspected, Trajenta should be discontinued. Interactions: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. It is not an inducer of CYP isozymes. Linagliptin is a P-glycoprotein substrate and inhibits P-glycoprotein mediated transport of digoxin with low potency. Based on these results and in vivo interaction studies, linagliptin is considered unlikely to cause interactions with other P-glycoprotein substrates. The risk for clinically meaningful interactions by other medicinal products on linagliptin is low and in clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, warfarin, digoxin or oral contraceptives (please refer to Summary of Product Characteristics for information on clinical data). Fertility, pregnancy and lactation: Avoid use during pregnancy. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. No studies on the effect on human fertility have been conducted for linagliptin. Undesirable effects: Adverse reactions reported in patients who received linagliptin 5 mg daily as monotherapy or as add-on therapies in clinical trials and from post-

marketing experience. 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) or very rare (<1/10,000). Adverse reactions with linagliptin 5 mg daily as monotherapy: Common: lipase increased. Uncommon: nasopharyngitis; hypersensitivity; cough; rash; amylase increased. Rare: pancreatitis; angioedema; urticaria; bullous pemphigoid. Adverse reaction with linagliptin in combination with metformin plus sulphonylurea: Very common: hypoglycaemia. Adverse reaction with linagliptin in combination with insulin: Uncommon: constipation. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 28 tablets. Legal category: POM. MA number: EU/1/11/707/003. 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 December 2019.

Adverse events should be reported. Reporting forms and information can be found at https://www.hpra.ie/homepage/about-us/reportan-issue. 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

For the treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years1

Prescribing Information:

Toujeo (insulin glargine 300 units/ml)

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

Presentation: Toujeo SoloStar and DoubleStar pre-filled pens. Each ml contains 300 units of insulin glargine. SoloStar pen contains 1.5ml (450 units) of solution for injection. DoubleStar pen contains 3ml (900 units) of solution for injection.

Indication: Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years. Dosage and

Administration: Toujeo is administered subcutaneously, by injection into the abdominal wall, the deltoid or the thigh, once daily, at any time of the day, preferably at the same time every day. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis. The dose regimen (dose and timing) should be adjusted according to individual response. Do not administer intravenously. In type 1 diabetes mellitus, Toujeo must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. In patients with type 2 diabetes mellitus, recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments. Toujeo can also be given together with other anti-hyperglycaemic medicinal products. Switch between insulin glargine 100 units/ ml and Toujeo: Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable. When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit to unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels. When switching from Toujeo to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%). Switching from other basal insulins to Toujeo: A change of dose and/or timing of the basal insulin and concomitant anti hyperglycaemic treatment may be required. Dose adjustments may also be required if the patient’s weight or lifestyle changes, the timing of insulin dose is changed or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia. Toujeo must not be mixed or diluted with any other insulin or other medicinal products. Close metabolic monitoring is recommended during a switch and in the initial weeks thereafter. SoloStar 1-80 units per single injection in steps of 1 unit and DoubleStar 2-160 units in steps of 2 units. When changing from Toujeo SoloStar to Toujeo DoubleStar, if the patient’s previous dose was an odd number then the dose must be increased or decreased by 1 unit. Toujeo DoubleStar prefilled pen is recommended for patients requiring at least 20 units per day. Special Populations: Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. Paediatric: When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimise the risk of hypoglycaemia. The safety and efficacy of Toujeo in children and adolescents below 6 years of age have not been established. Contraindications: Hypersensitivity to insulin glargine or any excipients. Precautions and Warnings: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Toujeo is not the insulin of choice for treatment of diabetic ketoacidosis. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at

® Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie; email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com

sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered. Hypoglycaemia: In case of insufficient glucose control or a tendency to hyper/hypoglycaemic episodes, the patient’s adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Particular caution should be exercised, and intensified blood glucose monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or who are elderly. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. Intercurrent illness: Requires intensified metabolic monitoring and often it is necessary to adjust the insulin dose. Insulin antibodies: administration may cause insulin antibodies to form. Use with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Medication errors: Insulin labels must always be checked before each injection to avoid errors between Toujeo and other insulins. Patients must be instructed to never use a syringe to remove Toujeo from the SoloStar or DoubleStar pre-filled pen, A new sterile needle must be attached before each injection. Needles must not be re-used. Pregnancy and lactation: There is no data from exposed pregnancies in controlled clinical trials. However, there is a large amount of data on use of insulin glargine 100 units/ml in pregnant women indicating no specific adverse effects on pregnancy and no specific malformative nor feto/neonatal toxicity. The use of Toujeo may be considered during pregnancy, if clinically needed. Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk. Interactions: Substances that affect glucose metabolism may require adjustment of insulin glargine. Adverse Reactions: Very common: Hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening. Common: Lipohypertrophy, injection site reactions, including redness, pain, itching, hives, swelling, or inflammation. Legal Category: POM. Marketing Authorisation Number: SoloStar 3 Pen pack: EU/1/00/133/034, DoubleStar EU/1/00/133/038. Marketing Authorisation Holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. Further information is available from: Medical Information, Sanofi 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of preparation: July 2020.

References: 1. Toujeo® Summary of Product Characteristics

Date of preparation: April 2021 | MAT-IE-2100614 (v1.0)

Diabetic foot disease in focus

A detailed overview of the prevention, diagnosis, and management of diabetic foot disease

Diabetic foot ulceration (DFU) is a vascular complication of diabetes mellitus and associated with extensive periods of hospitalisation and a high degree of morbidity and mortality. The pathogenicity of diabetic foot ulcers are multifactorial. Diabetic foot syndrome (DFS) is associated with neurologic abnormalities and peripheral arterial disease of the lower limbs of varied severity. DFS involves infection, ulceration, or destruction of deep tissues of the foot including bones in a patient with diabetes mellitus and is defined by the World Health Organisation (WHO) as an “ulceration of the foot (distally from the ankle and including the ankle) associated with neuropathy and different grades of ischemia and infection”.1,3

Diabetes mellitus is a disorder of glucose haemostasis, which causes hyperglycaemia. When high blood glucose levels persist, complications occur causing damage in the wall of blood vessels throughout the body systems. A combination of damage in both small and large blood vessels leads to the presence of DFS manifesting in DFU.

Neuropathy and vascular abnormalities are involved in the development of DFS. The underlying cause of DFS is the complex interaction between large vessel disease causing peripheral arterial disease (PAD) and small vessel disease leading to peripheral diabetic sensory neuropathy.2

Motor neuropathy results in atrophy of foot muscles, disturbing the flexor-extensor balance and leading to contractures. Sensory neuropathy including abnormal sensation of pain, temperature, and touch exposes the patient to repeated uncontrolled injuries, increasing the risk of ulcerations. Autonomic neuropathy results in the formation of arteriovenous fistulae and trophic changes and atherosclerosis of the lower extremities results in foot ischaemia. All these changes are associated with the development of local osteoporosis and may also lead to osteomyelitis, avascular necrosis, fractures, dislocations, and Charcot foot arthropathy.3

DFS affects nearly 6 per cent of individuals with diabetes, and round 0.5-to-1.5 per cent of patients with DFS require amputation. Most amputations start with ulcerations and can be prevented with good foot care and screening to assess the risk of foot complications. DFS is associated with neurologic abnormalities and peripheral arterial disease of the lower limbs of varied severity.3

All patients with diabetes should have an annual screen to identify their foot ulcer risk status. Those with any risk factors require specific foot care education as well as regular contact with a healthcare professional, usually a podiatrist. Most important in the identification of the high-risk neuropathic foot is good clinical observation and removal of the shoes and socks, with careful inspection of the feet as part of the routine follow up of all patients with diabetes.6

Risk factors for developing diabetic foot ulcers

All people with diabetes are at risk of developing foot ulcers. The trilogy of peripheral

ON DIAGNOSIS OF DIABETES AND AT ANNUAL REVIEW THEREAFTER:

Trained practice nurse will examine patient’s feet and lower limbs for risk factors, this should include:

 Testing vibration and 10g monofilament sensation

 Palpation of dorsalis pedis and posterior tibial pulses in both feet

 Inspection of any foot deformity

 Inspection of footwear

LOW RISK

AT RISK

ACTIVE FOOT DISEASE

CLINICAL FINDINGS

Normal sensation

 Intact pressure and vibration sensation

No peripheral arterial disease (PAD)

 All pedal pulses present

 No signs or symptoms of PAD, ie, claudication pallor, dependent rubor, poor tissue vitality

No previous ulcer or lower limb amputation

 No foot deformity

 Normal vision

MODERATE RISK

CLINICAL FINDINGS

Any one of the following:

 Loss of sensation/ peripheral neuropathy

 PAD:

 Absent pulses

 Signs or symptoms of PAD

 Previous vascular surgery

 Structural foot deformity

 Significant visual impairment

 Physical disability (eg, stroke or gross obesity)

MANAGEMENT PLAN

 Annual foot screening in primary care

 Practice nurse/primary care nurse to screen

 Clinical nurse specialist and/or podiatrist to provide education to practice nurse/public health nurse to provide screening

 Patient education/ smoking cessation

MANAGEMENT PLAN

 Annual foot examination by foot protection team and ongoing review by podiatrist member of the foot protection team based in either the hospital or the community

 Education in foot protection

 Vascular assessment, biomechanical, orthopaedic assessment and orthotics if indicated

 Referral to community podiatry for non-diabetic foot pathology

neuropathy, PAD and susceptibility to infection are the main predisposing factors for lesions on the foot. Other factors that increase the risk include poorly fitting or poor quality shoes, not washing regularly or thoroughly or not drying the feet well after washing, improper trimming of toe-

HIGH RISK

CLINICAL FINDINGS

PAD and sensory loss and/or previous diabetes-related foot ulcer or lower limb amputation and/ or previous Charcot neuroarthropathy

CLINICAL FINDINGS

Active foot ulceration and/or active Charcot neuroarthropathy

MANAGEMENT PLAN

 Called for formal review by foot protection team and routine ongoing review by GP/ practice nurse/hospital diabetes clinic

 Examination for deformity, neurological and vascular status, and footwear and orthotics as indicated.

 Education in foot protection

 If ulceration present then refer within 24 hours to multidisciplinary foot care service (Model 4 hospital)

nails, plantar calluses, elevated foot pressures, foot deformity, visual disturbance as a consequence of retinopathy, cardiac disease, renal disease, oedema, obesity, alcohol and tobacco use, ethnic and poor social backgrounds. It is the interaction and combination of risk factors working togeth-

MANAGEMENT PLAN

Referral with rapid access (within 24 hours/ next working day) to multidisciplinary foot care service in tertiary centre

 Access to vascular, orthopaedics, orthotics

 Access to vascular laboratory, radiology, microbiology, infectious disease

HEALED ULCER

 Once ulcer healed refer patient back to the foot care team in the referral Model 3 hospital

 If the healed ulcer belongs to a patient who originated from Model 4 hospital, they remain under the care of the specialist diabetes foot service in the Model 4 hospital

er that leads to skin breakdown.4,6 Of all the risk factors for DFU the most important is a past history of ulceration and/or amputation. DFU is most common in older men.   It is estimated that 19-to-34 per cent of

patients with diabetes are likely to be affected by DFU in their lifetime, and the International Diabetes Federation reports that 9.1-to-26.1 million people will develop DFU annually. A UK population-based cohort study demonstrated that the development of DFU is associated with a 5 per cent mortality in the first 12 months and a 42 per cent mortality within five years. Patients with DFU were also found to have a 2.5-fold increased risk of death compared with their diabetic counterparts without foot wounds.5

Effective glycaemic control reduces the incidence of DFU and decreases the risk of amputation. In assessing glycaemic control the HbA1c test should be performed routinely in all patients with diabetes.

HbA1c is an indirect measure of average glycaemia and has a strong predictive value for diabetes complications. A target of 53mmol/l (7 per cent) or below is recommended as the optimal target for diabetes patients.8 Self-monitoring of blood glucose (SMBG) allows real time measurement of blood glucose levels for individuals. It is important for patients who are self-monitoring to have a good understanding of glucose levels, what their targets are, how well they are achieving this and to play an active role in managing and tailoring their levels and preventing complications.2

Routine diabetes foot screening should ensure that all patients with diabetes are offered annual screening and regular foot examinations from early diagnosis. Foot review and screening is carried out by appropriately trained staff and foot care education is provided to individuals according to their clinical and personal needs. Patients are regularly assessed for their risk of DFU and classified as low, at risk (moderate or high risk), or with active foot disease.7

Foot care management in diabetes is based on three categories of risk7

1. Patients at low risk of diabetic foot disease are managed preventatively through annual screening and regular foot examinations by primary care nurses. A low-risk patient has normal foot pulses, normal vibration and sensation to 10g monofilament, no history of foot ulceration, no significant foot deformity, or no visual impairment.7

2 Patients at risk of diabetic foot disease may be classed as either moderate or high risk. All patients will be under regular surveillance by primary care nurses/GPs. Moderate-risk patients will be referred to the podiatrist, either in the community or in the hospital, for an annual review and these patients will remain under the clinical governance of the GP and podiatrist. The moderate-risk patient has either impaired peripheral sensation or impaired circulation or significant visual impairment or a structural foot deformity. High-risk patients will be reviewed at least annually by the diabetes foot protection team in one of the 16 designated centres and will be under the governance of the foot protection team for their foot care. The high-risk patient has an abnormality that predisposes them to foot ulceration. This can be impaired sensation and impaired circulation, or a previous foot ulcer, previous lower limb amputation or previous Charcot foot.7

3. Patients with active diabetic foot disease have an active foot ulcer (full thickness skin break) or a Charcot foot and will be actively managed by a multidisciplinary specialist foot care service, in conjunction with vascular surgery, orthopaedics, and orthotics input as required. This is available in the eight Model 4 indicative hospitals.7 The HSE National Model of Care states that patients with active DFU should be referred to the multidisciplinary diabetic foot team (MDFT) in the Model 4 hospital within one working day.

Diabetic foot care involves a multidisciplinary team approach including a wide range of professionals as well as patients and their carers. Central to diabetes foot care are patients, carers, podiatrists, general practice nurses and other primary care nurses, GPs, diabetes specialist nurses, diabetes consultants, orthoptist, vascular surgeons, and orthopaedic surgeons. Other groups with an important input into diabetes foot care are tissue viability nurses, physiotherapists, infectious disease service, radiology consultants, ward nurses, and emergency department (ED) staff.7

Screening and assessment

Low-risk foot: Patients previously classified as low risk or patients newly diagnosed with diabetes mellitus should receive annual foot screening as part of their general diabetes care and have the following foot examination:7

Moderate-risk foot: A patient at moderate risk of foot complications has either a reduction in vibration or 10g monofilament sensation or has absent foot pulses in either or both feet. There must be no history of ulceration and no significant foot deformity.7 Foot examination frequency requires ongoing review by GP/general practice nurse or primary care nurse or hospital diabetes clinic as part of routine follow-up. Annual podiatry review by the specialist podiatrist is based either in the community or in the hospital.7

Patients previously classified as moderate risk should have the following foot examination:

 Inspection for structural foot deformity.

 Skin and nail examination.

 Vibration perception testing (128 Hz tuning fork) and cutaneous pressure perception testing using the 10g monofilament.

 Palpation of foot pulses.

 A comprehensive vascular assessment where indicated, including Doppler waveform analysis, ankle brachial index, and toe brachial pressure index calculation.

 Examination of footwear.

Management

If there is loss of vibration and 10g monofilament sensation the patient should be educated on how to protect their feet. If there is intact sensation and absence of foot pulses in either or both feet, the patient may require further vascular assessment, particularly

quired by the members of the foot protection team or service where appropriate.7

Patients classified as high risk should have the following foot examination:7

 Inspection for structural foot deformity.

 A comprehensive neurological assessment.

 A comprehensive vascular assessment where indicated, including Doppler waveform analysis, ankle brachial and toe brachial pressure index calculation.

 Examination of footwear.

Management 7

 The diabetes foot protection clinic should take place on a monthly basis at minimum, within the Model 3 or Model 4 hospital and should have input from a diabetes specialist, podiatrist, and diabetes nurse with input where necessary from vascular, orthopaedics, and orthotics.

 Podiatrists within the foot protection team or foot care service should review the high-risk foot at least once every 12 months.

 If ulceration is present the patient should be referred within 24 hours or the next working day to the multidisciplinary foot care service (Model 4 hospital).

 The educational needs of the patient should be reviewed.

 If there is a problem with footwear, the patient should be referred to a podiatrist/ orthotist for footwear assessment and orthoses provision.

 The patient should be referred to vascular services.

 If there is other foot pathology such as nail conditions, corns, callus or verrucae, referral to a community podiatrist should be made.

 The hospital podiatrist will work closely with the community podiatrist in the joint care of high-risk foot patients.

 Foot care education as previously described should be provided for the patient.

 Inspection of skin, nails and for structural foot deformity.

 Vibration perception testing (128Hz tuning fork) and cutaneous pressure perception testing using the 10g monofilament.

 Palpation of foot pulses.

 Examination of footwear.

Foot care education involves:7

 Nail care.

 Emollient use.

 Footwear.

 Daily self-examination of the feet.

 Not walking in bare feet.

 Checking footwear and hosiery before putting them on.

 Breaking shoes in should never be attempted.

 No hot water bottles.

 Checking bath and shower temperature.

 Avoidance of home remedies, eg, corn plasters.

 What to do and the appropriate person to contact if foot problems develop.

 A low-risk foot information sheet should be provided.

A patient with low risk of diabetic foot disease does not routinely need to see a podiatrist for diabetes-related purposes.

if there are symptoms of vascular insufficiency. Foot deformity may not need any action, but if it is severe the patient should be referred for specialist assessment. Podiatry advice, biomechanical assessment and discussion of all treatment options including accommodative footwear and orthoses should be provided where required. In some cases orthopaedic surgery may be required. If there is other foot pathology such as nail conditions, corns, callus or verrucae, these can be dealt with during the examination by the podiatrist and a referral to a community podiatrist should be made.7 Foot care education as previously described should be provided for the patient.7

High-risk foot: A patient with high risk of foot complications has both a reduction in vibration and monofilament sensation and PAD –absence of foot pulses. If there is a previous history of ulceration, lower limb amputation or Charcot neuro-arthropathy then the foot is classified as high risk automatically and remains in the high risk category. Foot examination frequency requires ongoing review by GP/primary care nurse/hospital diabetes team. Patients will be called for formal annual review or more frequently as re-

Active foot disease: All diabetes patients with an active foot ulcer or active Charcot foot should be referred to the diabetes foot clinic urgently and patients should be seen within 24 hours or on the next working day by the diabetes multidisciplinary foot care service, and involve the appropriate specialties. Patients will be seen weekly by a member of the multidisciplinary foot care service until healing of the ulcer occurs and will be seen regularly in the specialist multidisciplinary foot care clinic until ulcer healing or the Charcot foot becomes stable and inactive.

Patients with active foot disease should have the following foot examination:

 Inspection for structural foot deformity.

 A comprehensive neurological assessment.

 A comprehensive vascular assessment where indicated, including Doppler waveform analysis, ankle brachial, toe brachial pressure index calculation and/ or radiological imaging of the lower limb vasculature.

 Radiology investigations where indicated including foot x-ray or MRI of the foot. Isotope bone scan may also be used in certain circumstances.

 Examination of footwear.

Management7

 The diabetes foot care clinic should take place on a monthly basis at minimum, with-

Diabetic foot care involves a multidisciplinary team approach including a wide range of professionals as well as patients and their carers

99.33% of 4SURE SMART DUO test results are within ± 0.83 mmol/L (low glucose levels) or ± 15% (high glucose levels) of laboratory reference method test results. 4

SMART

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in the Model 4 hospital and should have input from a diabetes consultant, senior podiatrist and diabetes nurse with input where necessary from vascular, orthopaedics, orthotics, tissue viability, physiotherapy, plastic surgery, and infectious disease.

 Podiatrist within the foot care service should review the active foot disease patient at least weekly until healing occurs.

 Review the educational needs of the patient.

 Referral to a podiatrist/orthotist for footwear assessment and orthoses provision if required.

 Refer to vascular and/or orthopaedics where necessary.

 If there is other foot pathology such as nail conditions, corns, callus or verrucae, referral to a community podiatrist should be made.

 If there are clinical signs of infection, antibiotics should be commenced immediately.

 If there are clinical signs of severe/ limb-threatening infection then the patient should be admitted urgently for intravenous antibiotic therapy.

 If there is evidence or suspicion of osteomyelitis the patient should be referred for radiological and orthopaedic review.

 Control vascular risk factors.

 Once the foot ulcer has healed and appropriate footwear organised for the patient, they can be moved back to the ‘highrisk group’ in the ‘at-risk’ category. However, if there is the likelihood of re-ulceration the patient should continue to attend the multidisciplinary foot care service in a Model 4 hospital.

 The high-risk foot information sheet should be given to the patient.

A comprehensive assessment of the patient’s general health, glycaemic control, extent of peripheral neuropathy and detailed dermatologic and musculoskeletal examination are included in the evaluation. Clinical evaluation of the foot wound should include a detailed description of the site, size, and depth of wound. Neuropathic ulcers typically occur in the warm but insensate foot, often under pressure-bearing areas, and are surrounded by callus. Ischaemic wounds tend to occur in the cool, poorly perfused foot and are often at lateral fifth metatarsal head regions or the medial first metatarsal head regions. Correct identification of the degree of ischaemia is of great importance when evaluating a wound.6

Classification

Ulcers are graded using the University of Texas Classification System (Figure 2), which is a validated tool specifically for diabetic foot ulcers. The Meggitt-Wagner grading system was regarded as the gold standard for many years. One problem with the Meggitt-Wagner grading system is that the ischaemic status of the wound is not included and therefore a number of new classification systems for diabetic foot wounds have been proposed and validated over the last 20 years. The University of Texas Classification System incorporates the Meggitt-Wagner grades, but also enables the practitioner to stage the wound with respect to the presence or absence of infection and/or ischaemia.6,9

Treatment and management

Depending on the primary underlying cause

of ulceration, the wound will be assessed and a management plan will be developed. The management of DFU is multifaceted and combines revascularisation, infection management, debridement of dead tissue and offloading of pressure in addition to hyperglycaemic treatment and wound care.2 Treatment of hyperglycaemia, ketoacidosis, renal insufficiency and other comorbidities that may coincide in the ulcerated patient should be treated simultaneously with the foot lesion. Debridement is important as it reduces devitalised tissue, promotes proliferation, granulation, and epithelialisation, eliminates potential pathogens, allows exudate drainage, reveals the true extent of ulceration and reduces pressure on subcutaneous tissue.9

DFU should heal if there is an adequate arterial inflow, infection is aggressively managed, and pressure is removed from the wound and its margins. Pressure reduction is essential for a patient who has just been treated for a diabetic foot and off-loading or reducing the pressure plays a significant role in managing the healing process. There are various off-loading modalities such as the total-contact casts (TCC), removable cast walkers (RCW) and half shoes, and studies have been conducted to compare their effectiveness to heal neuropathic foot ulcerations in diabetic individuals. Although less commonly used, results reveal that TCC is better and heals a comparatively higher number of wounds in a shorter duration of time. In the management of plantar neuropathic ulcers, offloading is critical and all efforts must be made to enhance patient understanding of the need for offloading.6,9

Identification of infection in wounds can be challenging and particularly so in DFU. In the presence of neuropathy and ischaemia, signs of infection can be diminished as the normal inflammatory response is impaired. The correct diagnosis of infection in the diabetic foot wound is critical as it is often the combination of untreated infection and PAD that lead to amputation in the diabetic foot. If osteomyelitis is suspected plain x-rays can assist diagnosis, however, initially reports may prove normal and evidence of osteomyelitis may not be apparent for 14 days. Antibiotic usage should be guided by clinical signs of infection and microbiologic analysis of deep tissue specimens.6,9

Most adjunctive therapies have little evidence to support their use, although recent trials suggest efficacy for a number of topical therapies including LeucoPatch and sucrose octasulfate. Negative pressure wound therapy has also been shown to be helpful in certain cases. There is currently no indication for hyperbaric oxygen usage, whereas recent studies suggest that topical oxygen therapies

may help wound healing.6,10

Wound dressings are important to keep the ulcer clean, but the placement of a large dressing on a wound may mislead the patient into believing that the dressing of an ulcer is curative. Although there has been much progress in the understanding and management of diabetic foot disorders over the last three decades, much of what we use in clinical practice today still lacks an evidence-base. This is particularly true for dressings and there is little evidence from randomised controlled trials (RCTs) that any dressing is superior to another.6

Prevention and recurrence

Prevention of diabetic foot disease can only be successful with the early identification of patients who have risk factors for foot ulceration. All patients with diabetes should, at whatever stage, be screened for evidence of complications at least annually. The principle aim of the annual review is to identify those with early signs of complications and provide appropriate management to prevent progression. The most important aspect of the annual foot review is the removal of shoes and socks with very careful inspection of both feet including between toes. Many neuropathic feet can be identified by this simple clinical observation, looking for features such as small muscle wasting, clawing of the toes, prominence of the metatarsal heads, distended dorsal foot pains, dry skin, and callus formation. For evidence of neuropathy, the perception of pressure using the 10g monofilament should be used at four sites in each foot. An additional test, which might include a vibrating 128Hz tuning fork, should also be used to confirm any abnormality. For the vascular assessment, foot pulse palpation is most important. The ankle brachial index may be falsely elevated in many patients with diabetic neuropathy and therefore listening to the Doppler signal may be more helpful.

Other simple devices developed for clinical screening that have been validated in clinical studies include the ‘Ipswich Touch Test’, which assesses the ability of the patient to perceive the touch of a finger on the toes and the ‘Vibratip’, a battery-operated disposable vibrating stylus used to assess vibration sensation. A number of studies are currently looking at ‘smart technology’ in the prevention of recurrent DFU. These include the use of sensors in socks or shoes to detect pressure change and also various devices to measure differentials in skin temperature. These technologies aim to alert patients in the pre-ulcerative phase with the hope of preventing the actual ulcer from developing.6

Recurrence is common after the healing of neuropathic or neuro-ischaemic foot ulcers,

and the patient is termed in remission rather than healed following an episode of DFU. While the symptoms may have resolved the underlying disease process remains and the symptoms of the disease will likely re-occur. Rates of DFU recurrence are up to 40 per cent one year following DFU. It is important that patients and their families are educated about the persistence of DFS even in the absence of DFU.2

All individuals with diabetes should receive regular screening and structured education to empower them to maintain their own foot health. Early identification of problems and rapid referral to the specialist multidisciplinary team can reduce the risk of DFU and unnecessary amputations.9 Foot care programmes accentuating preventive management can reduce the incidence of foot ulceration through modification of selfcare practices, appropriate evaluation of risk factors and formulation of treatment protocols directed at patient education/re-education, early intervention, limb preservation and prevention of new lesions.

References

1. Tuttolomondo A, Maida C, Pinto A. (2015). Diabetic foot syndrome: Immune-inflammatory features as possible cardiovascular markers in diabetes. World J Orthop. 2015 Jan 18; 6(1): 62–76.doi: 10.5312/wjo.v6.i1.62

2. Wilson P, Fu W, Doyle J. (2021). Joining the dots … Diabetes mellitus and foot disease. Irish Pharmacy News, Volume 13, Issue 7, pp 68-69. Available at: www.pharmacynewsireland.com/digital-magazines/

3. Rodríguez-Gutiérrez R, Quintanilla-Flores DL, Soto-Garcia AJ, Gonzalez-Gonzalez JG, Sieradzki J, Płaczkiewicz-Jankowska E. Diabetic foot syndrome. McMaster Textbook of Internal Medicine. Kraków: Medycyna Praktyczna. https://empendium.com/mcmtextbook/ chapter/B31.II.13.4.4

4. Healthline (2021). Diabetic Ulcers: Causes and Treatment. Available at: www. healthline.com/health/type-2-diabetes/ hyperglycemic-hyperosmolar-syndrome

5. Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan; 1411(1): 153–165. doi: 10.1111/nyas.13569

6. Boulton A, Whitehouse W. (2020). The Diabetic Foot. NCBI. Available at: www.ncbi.nlm.nih. gov/books/NBK409609/

7. HSE (2011). Model of care for the diabetic foot. HSE Available at: www.hse.ie/eng/ services/list/2/primarycare/east-coast-diabetes-service/management-of-type-2-diabetes/ foot-care/model-of-care-diabetic-foot.pdf

8. Diabetes Ireland (2021). Know your numbers and targets. Diabetes Ireland. Available at: www.diabetes.ie/are-you-at-risk-free-diabetestest/a-numbers-game/

9. NUI Galway (nd). Foot screening and education of the patient with diabetes. Discipline of Podiatry School of Health Sciences NUI Galway. Available at: www.hse.ie/eng/services/publications/clinical-strategy-and-programmes/foot-screening-and-education-of-the-patient-with-diabetes.pdf

10. Niederauer M, Michalek J, Liu Q, et al. (2018). Continuous diffusion of oxygen improves diabetic foot ulcer healing when compared with a placebo control: A randomised, double-blind, multicenter study. J Wound Care. 2018; 27 suppl 9:S30–S45

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

Thanks to you...

Aspirin Atorvastatin Ramipril

6 Available Formulations

Reduce pill burden by 730 pills per year*

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

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

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

Polycystic ovary syndrome (PCOS): An overview

Polycystic ovary syndrome (PCOS), a heterogeneous disorder characterised by hyperandrogenism and chronic anovulation, is a common endocrine, metabolic, and menstrual disorder in women. Depending on diagnostic criteria, PCOS affects 6-to10 per cent of women of reproductive age.

While the aetiology is not completely understood, PCOS is believed to be multifactorial in nature and a complex interaction of genetic and environmental factors. PCOS is exacerbated by obesity and has significant metabolic, reproductive, and psychological features, including an increased risk of type 2 diabetes mellitus with an earlier age of onset, subfertility, and an increased risk of depression and anxiety symptoms.

A family history confers a higher risk of developing PCOS and other contributing factors include low birth weight, premature pubarche, obesity, diabetes mellitus, and antiepileptic drug use.

Pathophysiology

The abnormal findings in PCOS are a result of ovarian hyperandrogenism and insulin resistance. Evidence suggests that the ovarian hyperandrogenism in PCOS is a result of primary ovarian dysfunction and is secondary to disordered gonadotropin activity. While not included in diagnostic criteria for PCOS, the elevated level of serum luteinising hormone (LH) in affected patients due to inappropriate secretion has long been recognised. In addition, PCOS pathophysiology appears to have a polygenic predisposition that is exacerbated by environmental factors, especially obesity

Diagnosis

The diagnosis of PCOS has lifelong implications, with increased risk for infertility, metabolic syndrome, type 2 diabetes mellitus, and possibly cardiovascular disease and endometrial carcinoma.

Typical clinical features include hirsutism, irregular menses, chronic anovulation, acne, obesity, insulin resistance, and infertility. Patients typically present with acne and menstrual irregularities. PCOS should be considered in any adolescent girl with hirsutism, treatment-resistant acne, menstrual irregularity, or acanthosis nigricans, and evidence of these signs and symptoms should be especially sought in patients being evaluated for obesity.

Three sets of diagnostic criteria; AES, Rotterdam (Figure 2) and NIH; are commonly used for PCOS and all require the exclusion of other known disorders. Among the different diagnostic criteria used to define PCOS, the Rotterdam criteria are the most widely used and recommended, and like the more liberal AES criteria they allow for different phenotypes of the disorder.

Diagnosis of PCOS requires the exclusion of other conditions, such as pregnancy, thyroid dysfunction, hyperprolactinaemia, Cushing’s syndrome, non-classical congenital adrenal hyperplasia, and androgen-secreting tumours. In women with signs or symptoms of androgen excess, serum total testosterone should be checked and the patient referred to a specialist for evaluation if the level is greater than two times the upper limit of normal. According to clinical findings, further tests may be neces-

SUGGESTED SCREENING TESTS

 Luteinising hormone

 Follicle-stimulating hormone

 Total testosterone, sex hormone binding globulin

 Lipid profile

 Fasting glucose with or without oral glucose tolerance test, glycated haemoglobin

 Serum prolactin

 Thyroid function

 Serum ferritin

 25-hydroxy vitamin D

IF CLINICALLY INDICATED

 17 hydroxyprogesterone

 1mg overnight dexamethasone suppression or 24 hour urine-free cortisol

 Sleep study

sary including beta-HCG, thyroid function, prolactin, 1mg overnight dexamethasone suppression and early morning serum 17OHP (17-hydroxyprogesterone) tests. Mild elevations in serum prolactin are common in PCOS, but after excluding macroprolactin, levels that are greater than twice the upper limit of normal warrants further investigation. High levels of anti-Müllerian hormone, a hormone produced by ovarian follicle granulosa cells, are also seen in PCOS and may be useful in the diagnosis of the condition.

As PCOS is associated with insulin resistance, all women with PCOS should be screened for diabetes or pre-diabetes, especially if they are planning to conceive, as poorly controlled diabetes is associated with adverse pregnancy outcomes.

Screening for coronary artery disease and obstructive sleep apnoea (OSA) should be considered in women who are at high risk.

Obesity increases the risk of endometrial cancer three-fold in women with PCOS. While routine screening for endometrial cancer using ultrasonography is not currently recommended, it is important to have a high level of suspicion for patients with prolonged oligomenorrhoea for more than three months between menses.

Iron deficiency is common in PCOS, and may contribute to fatigue and androgenic alopecia. Screening and treatment with iron if necessary is suggested, targeting serum ferritin in the upper quartile of the reference range. Vitamin D deficiency is also common in patients with PCOS and may have an additive adverse effect on fertility, insulin resistance, and glucose intolerance, therefore screening levels and replacing any deficiency may be helpful.

Psychological well-being due to the effects of PCOS on physical appearance, such as weight gain, acne, and hirsutism, is an important consideration as is being alert for mental health issues, such as depression, anxiety, and self-harm.

Treatment

Treatment for PCOS is multi-targeted and individualised to suit each patient’s phenotype, symptoms, goals and expectations, such as wanting to become pregnant. First-line therapy for women with PCOS and obesity is lifestyle modification in the form of diet and exercise. This is particularly important in women who are preparing for pregnancy, in order to

reduce the risk of complications, such as gestational diabetes, pre-eclampsia, pre-term delivery, macrosomia, birth defects, and stillbirth. Antiandrogens, such as spironolactone, should be stopped for three months before conception, and patients should be counselled about recurrence of androgen excess symptoms while preparing for fertility. Metformin may help, although it is unclear if this is independent of the weight loss benefit it confers. Ovulation induction with clomiphene citrate or letrozole is effective for fertility treatment.

Obesity is prevalent in 50-to-80 per cent of women with PCOS. Even modest lifestyle changes can have a significant impact and reducing body weight by 2-to-5 per cent has been shown to restore ovulation and increase insulin sensitivity in obese anovulatory women. Weight reduction has additional benefits, reducing the risk of diabetes, hypertension, cardiovascular disease, and certain malignancies.

To induce periods for those with menstrual irregularities, cyclical progesterone can be used every two months to ensure regular shedding of the endometrium. The oral contraceptive pill (OCP) is also effective in controlling menses, with the added benefit of providing contraception and improving androgenic symptoms. However, given many women with PCOS are obese this, together with the OCP, causes an increased risk of thrombosis, so patient selection is important. It is advisable to avoid OCPs with higher oestrogen doses or those containing 19-norprogesterone derivatives, as androgenic progestin may adversely affect the patient’s cardiovascular risk. Starting with low-dose ethinylestradiol combined with a third- or fourth-generation progestin is recommended, as these have the least intrinsic

androgenic activity. Metformin can also help to restore menstrual cyclicity.

Hyperandrogenism in PCOS is caused by insulin resistance, hypersecretion of luteinising hormone and ovarian androgens. Medications commonly used to treat androgen excess target these pathways. Spironolactone is an anti-androgen that blocks the effect of testosterone at the level of the androgen receptor. OCPs suppress LH secretion and reduce ovarian androgen production and metformin improves insulin resistance. If hirsutism is severe, all three medications may be used.

The OCP remains the first-line treatment for hirsutism because of its effect on androgen production. OCP use offers the additional benefit of reducing acne if present, and provides protection against endometrial cancer and menstrual cycle irregularity.

Patients need to be informed that the symptoms of androgen excess, particularly hirsutism takes at least six months to improve. Eflornithine can be applied topically for rapid control of facial hirsutism, although fastidious use is required for the treatment to be effective. Permanent laser hair removal can be an effective treatment and may be considered if the symptoms are causing severe distress. Metformin is beneficial for improving insulin sensitivity and can aid in weight loss, but it is ineffective in controlling hirsutism in the majority of women. Antibiotics and retinoic acid derivatives can also be used for acne treatment.

If first-line measures for cycle control or androgen excess are ineffective in controlling symptoms, then referral to an endocrinologist, gynaecologist or reproductive medicine specialist should be considered.

References on request

Post your answers to: Mindo Quizzes, The Medical Independent, Greencross Publishing Ltd, Top Floor, 111 Rathmines Road Lr, Dublin 6. Closing date for entries is 20 September 2021

SPORTS QUIZ WIN €50 6 September 2021

Q1 Which Irish golfer became the first Irish woman to be selected for the European Solheim Cup team?

Q2 Who won the British Open Snooker Championship last month?

Q3 Who did Limerick defeat in this year’s All Ireland Senior Hurling Final?

Q4 The final tennis major of the year, the US Open, is underway. Who won the ladies singles in 2020?

Q5 Which city will host next year’s Winter Olympics?

Q6 The NFL season will kick off next week. Who are the defending Superbowl champions?

CROSSWORD COMPETITION

6 September 2021

The winner of the 12 August 2021 Sporting Quiz Competition is Dr Patricia Day, Dublin

The winner of the 12 August 2021 Crossword is Dr Frank Leader, Cork

Q1 Who are the new 2021 Ulster Football champions? A: Tyrone

Q2 How many medals did Team Ireland win at the Olympics in Tokyo? A: Four

Q3 The Premier League will kick off this weekend. Name the three promoted teams for this upcoming season? A: Norwich, Watford, and Brentford

Q4 Formula One held its first sprint qualifying race recently. What track was it staged on? A: Silverstone

Q5 Name the Irish golfer who won his first PGA tournament last month? A: Seamus Power

Q6 Who are the new NBA Finals champions for 2021? A: Milwaukee Bucks

Getting it right with primary cicatricial alopecias

Attendees at UCD’s Charles Institute Seminar Series recently heard a presentation by Dr Matthew Harries on the topic of scarring alopecias

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 Dr Matthew Harries of the Centre for Dermatology Research at the University of Manchester and Manchester Biomedical Research Centre, who delivered a talk on the topic of ‘Scarring Alopecias’. Dr Harries discussed primary cicatricial alopecias (PCAs), a rare group of inflammatory disorders that cause permanent hair loss and are clinically characterised by loss of visible follicular ostia. PCAs are also associated with varying degrees of inflammation, and histologically by perifollicular inflammation, hair follicle destruction and eventual replacement of follicles with scarlike fibrous tissue.

Dr Harries explained that it is of “paramount importance” that clinicians who manage these patients with hair loss can accurately diagnose these disorders and he presented a pragmatic guide to the assessment, investigation, diagnosis and treatment of patients with PCA, with a particular emphasis on lichen planopilaris and frontal fibrosing alopecia (FFA). He also briefly discussed pathogenesis and highlighted hair follicle stem cell loss, immune privilege collapse and epithelial mesenchymal transition (EMT) as key processes in this permanent destruction of hair follicles.

Dr Harries presented the attendees with an overview of data and case studies to illustrate the challenges in treating scarring alopecia, as well as an overview of the general pathogenesis of these conditions. “There are various challenges when we are faced with patients with scarring alopecia,” he told the seminar. “We don’t really know the natural history of these conditions; they probably do spontaneously stabilise, so sometimes we are unclear whether the responses we see are due to treatment or spontaneous stabilisation. The clinical signs don’t correlate particularly well with hair loss progression and we struggle to accurately assess the changes in the hair over time.

“We also have poor outcome measures, which means that at present, the level of our evidence in the literature is really quite poor and it’s quite difficult to make any real informed therapeutic choices,” he continued. However, he added that in the past couple of

years, it has become clear that using vibrational therapies on the scalp skin helps to promote pain relief when injecting into the scalp. “This is quite a useful top-tip in reducing pain and discomfort when treating with intralesional steroid injections,” he said.

Main goals

Hair loss can be patchy or diffuse, said Dr Harries, “so often, there is an irregular pattern of hair loss, but sometimes there is a more diffuse pattern, and this can sometimes be confused with female pattern hair loss, so it’s important to closely inspect the scalp,” he explained. “Usually, the inflammation is at the periphery of the patches, which helps to differentiate this condition clinically.

“When we treat scarring alopecias, the main goals are to stop any symptoms from the scalp and stop progression of the hair loss, but realistically, we can’t regrow the hair because the follicles are damaged and destroyed, so we need to suppress the process for a reasonable period of time, so the treatments have to be safe in the medium-to-long term.”

He also provided an overview of FFA and told the seminar that it is characterised by a band-like recession of the frontal hairline and is also often associated with eyebrow hair and body hair loss. “When we look at the frontal hair margin, the morphology of the hair follicles looks quite similar to lichen planopolaris,” said Dr Harries. “There is loss of follicular ostia, there is perifollicular erythema and perifollicular scaling. We do see

skin. The difficulty in women patients is that there is a high background use of cosmetics anyway so it’s quite difficult to differentiate cases from controls. So to follow on from this, we looked at men with FFA,” said Dr Harries.

“Men with FFA are far less common, but we did manage to identify 17 men with FFA from the UK and Belgium, and from this we found that 71 per cent of the men with FFA, compared with 11 per cent of the controls, were applying sunscreen-containing products at least twice a week all year round, which was highly significant.”

However, further attention now needs to be placed on potential genetic factors, said Dr Harries: “What we really need to focus on going forward is finding out what the processes are that cause the divergence in the phenotypes that we see in our patients,” he said. “This is where we need to focus on looking at the pathogenesis of these conditions.”

FFA

scale

He also returned to a rhetorical question posed at the start of the presentation, which was: ‘What is the most important piece of equipment in a hair-loss consultation?’

“I think the answer is, a box of tissues,” said Dr Harries. “Anybody who deals with patients with hair loss will see that these conditions have quite dramatic emotional impacts on our patients. What interests me going forward is how the emotional impact affects the biology of these conditions,” he commented. “So, if you improve the emotional aspects of these patients’ care, does that improve their response to therapy? So, appreciating, understanding and addressing the emotional impact of hair loss is also important in the management of these patients.”

‘Lonely’ follicles

During an interactive Q&A session and discussion, Prof Tobin touched on the aforementioned so-called ‘lonely’ hair follicles. “To some extent, they seem to be ‘immune’ to what is happening all around them,” said Prof Tobin. “If you have ever biopsied these ‘lonely’ follicles, presumably they don’t show the same degree of injury, and potentially may not have immune privilege collapse to the same extent as the targeted follicles, but is there anything special about those follicles that could be reverse-engineered in understanding the targeted hair follicles?”

‘lonely hairs’, which are hairs that have been left behind by the receding hairline, which are quite typical in this condition. Lonely hairs, and lack of vellus hairs in the frontal margin, are useful clues to differentiating FFA from pattern hair loss or androgenetic alopecia is that in FFA, those hairs are often lost quite early on in the frontal hairline.”

The incidence of these conditions is increasing, he pointed out, which prompted Dr Harries and his colleagues to investigate why this is the case and if any environmental factors are implicated. “We did a questionnaire study of FFA patients and compared then with age-matched controls,” he told the attendees.

“We found a potential link with leave-on facial cosmetics, and particularly the use of sunscreens regularly and all year round, on the

In terms of efforts to achieve better outcome measures, Dr Harries explained that he and his team have produced a scale for FFA, which is titled the ‘FFA Severity Index’. Along with his colleagues, Dr Harries has also conducted research on what hair specialists do in their clinics, and at time of writing this research was due to be submitted for publication. “Most of them use a combination of measurements of the hairline and photography to try to determine if the hairline is moving,” he told the seminar.

Dr Harries summarised by saying: “The key to treatment of scarring alopecias is to try to prevent further hair loss and control symptoms, and to be really clear with our patients about what we can achieve with the therapy, with hair regrowth being unlikely,” he said. “The evidence for treatment in scarring alopecias is generally very poor; our outcome measures are also generally poor, but we are trying to improve those. A better understanding of the disease pathogenesis is required so that we can start to target therapies better, and hopefully the work that is currently going on will start to identify new therapeutic targets for these conditions.”

Dr Harries commented: “That’s a very interesting question — I have always wondered whether these are actually more resistant to the process, or if it’s just the conditions. These lonely hair follicles do eventually get destroyed if the process continues, so it may be the stage that they are at that impairs the cycle with the inflammatory process and that may explain why they have lasted longer than the other ones,” he said. “I’m not sure of the answer and I don’t think anyone has looked at this by examining these lonely hairs, but it would certainly be an interesting study to conduct to find out whether they actually have a more robust protective mechanism or immune privilege that helps to make them more resistant to the inflammatory process.”

Prof Tobin pointed to parallels, such as hairs that survive in alopecia universalis if they grow within a mole, or the robust hairs that are sometimes seen on a bald head, “so there is something about the autonomy of individual follicles that seems to crop-up in many clinical presentations of follicular change and follicular disorder that, presumably through receptor expression differences or some other level of immunosuppressive protein expression, for example, mark those follicles out to be able to push back against the pathological process, at least temporarily,” he concluded.

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

Further attention now needs to be placed on potential genetic factors, said Dr Harries

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FROM THE ARCHIVE (13 September 2018) RCSI Alumni Gathering Gala Dinner

Dublin Hospitals’ unbeaten run continues

Dublin Hospitals FC 1-1 Rosemount Mulvey

Game three of the Leinster Senior League (LSL) season for Dublin Hospitals FC (DHFC) pitted the doctors against Rosemount Mulvey. Rosemount have enjoyed plenty of success in recent seasons, securing consecutive promotions and winning the prestigious Noel Ryan cup along the way.

Pre-match preparations were interrupted by an earlier than usual kick-off time of 7pm being the excuse for a few late-arriving doctors. It was no surprise then that DHFC was slow out of the blocks. Rosemount, lining out with three at the back and wingbacks, were on top early, finding joy with direct balls into the centre forward’s feet who was able to hold onto the ball and bring their tricky number 10 into play.

Rosemount had a number of opportunities from set pieces, and it wasn’t long before they made one count. An in-swinging corner was not dealt with by the Hospitals’ defence and it fell kindly to the Rosemount centre-half who had come up for the corner. Presented with a complete sitter he made no mistake. 1-0 Rosemount.

Dublin Hospitals were still in warm-up mode at the 15-minute mark when they began to battle back into the game. This was not a great watch for the neutral, both teams had made an excellent start to the season and there was a tension in the air before the game. When the doctors finally woke from their slumber, this game turned into a battle, with very few chances. There were lots of heavy tackles leading to free kicks and disruptions to the flow of play and very few sustained periods of possession.

On the 30-minute mark, DHFC scored the equaliser. After Mat Berkley won the ball in midfield, he released John Cosgrove who was deputising at left-back for the evening. Cosgrove drove into the opposition’s half and found himself in space. What followed was truly spectacular. With the Rosemount goalkeeper barely 10 yards off his line, Cosgrove drove a dipping left-footed effort into the top right-hand corner of the net. The only place outside the goalkeeper’s reach. That spark of brilliance, reminiscent of a certain Brazilian effort against England in the 2002 World Cup quarter final, stood out in a game where both teams essentially cancelled each other out. The first-half ended with score at 1-1.

The teams re-entered the fray after the half-time break, with the DHFC looking somewhat livelier than they did in the opening minutes of the first-half. A rare period of sustained pressure led to a number of half chances for Dublin Hospitals, but the physical Rosemount defence remained resolute and didn’t allow much space for the typically boisterous Cillian Grant.

Dublin Hospitals have reaped the rewards of representing all hospitals in the county and a broader selection of players to attract to the club. This was most obvious when looking at the strength in depth and the substitutes available. Nally, Wrynn, Durand, and Gildea all potential matchwinners on their day and all confined to the substitutes bench at the start of this game.

Fionn Nally was the first to make an entrance. The skilful winger has recently returned from Australia to much excitement in the Dublin Hospitals camp. He immediately made an impact, injecting energy to the attack and causing havoc with his direct running and exquisite close control. Despite

the addition of Eddie Wrynn and later David Gildea in the attacking positions, Dublin Hospitals could not break the deadlock as the game continued with a midfield battle, featuring multiple 50-50 challenges and loose balls.

In the closing stages of the game, DHFC had one final chance to take the three points. After some intricate play involving Nally and Cosgrove on the left-flank, Aidan McGrath had a rare opportunity to get in behind the Rosemount defensive line; however, the goalkeeper closed his angles very well and forced the shot wide.

The game ended in a 1-1 stalemate, with both sides perhaps happy not to lose. Maybe this game came a little too early in the season for these teams and it will be an intriguing reverse fixture when they meet again at Rosemount.

For Dublin Hospitals FC the next game sees them take on Finglas United at home. Finglas are a team in form at present and it will be another important game for the team who have seven points from the first three games of this LSL season. The doctors have yet to be defeated in a competitive game

John Cosgrove has been in fine form in the opening games of the season and it was his typically creative effort that provided the equaliser for Dublin Hospitals since evolving from St Vincent’s FC to Dublin Hospitals FC and will hope to continue their good run of form.

Matchday squad: P Schütze, C Kirby (C), J Cosgrove, K Keane, A Delany, M Berkley, C Ward, I Daly, C Grant, B Gaffney, A McGrath. Subs: E Wrynn, R Durand, F Nally, D Gildea.

PS: We would like to thank our sponsors Medisec Ireland for their continued support throughout the season. We would also like to thank the Medical Independent for the excellent coverage of Dublin Hospitals FC activities. Supporters are welcome at Dublin Hospitals FC games. Weekly updated fixtures and results can be found at the club website www.dublinhospitalsfc.com

There were lots of heavy tackles leading to free kicks and disruptions to the flow of play and very few sustained periods of possession

Getting carried away by caraway

There are many benefits to gardening, not least of that it can afford a brief respite from the hurly burly of daily life, especially in these days of the pandemic when solitary pursuits have an added appeal. It can also introduce you to flavours that might be otherwise elusive.

I mean, when did you last see kohlrabi in an Irish supermarket? Or even the humble broad bean? There have been scattered outbreaks of globe artichokes, I realise. But generally speaking they would be a Fallon & Byrne kind of thing. We are lucky to have a forest of them here at home.

I suppose what non-gardeners are missing, in terms of taste, is the sheer, unadulterated joy of the home-grown tomato that, admittedly, requires growing under cover and, to some extent, careful selection of varieties. By and large your own tomatoes will taste 10 times better than any you can buy.

Anyway, speaking of gardening and flavours, I have a tendency to lose packets of seeds and then discover them again when it’s way past the appropriate sowing date. My latest experience of this was with caraway (Carum carvi), a herb that not many of us grow these days. I might just give it a go and see if I get anything before the days shorten and most annual plants give up the ghost.

Fergus Henderson, of the offal-centric London restaurant St John, has long maintained that caraway seed cake, taken with a glass of Madeira, is a wonderful pick-me-up and he advised that this combination should be ingested at 11 o’clock in the morning. He has never been a slave to fashion.

I’m not really up to Madeira before the

sun is well over the yard arm so I would postpone the dosage until the middle of the afternoon. Seedy cake and a glass of sweet Madeira will put a spring in your step. And the temptation to have another slice and another glass is hard to resist.

Now, caraway seeds, like Marmite and the gherkins in McDonald’s hamburgers, evoke strong emotions, mostly of distaste. I know very few people, apart from my wife Johann, who like that distinctive and frankly rather Mittel European flavour.

She was fortunate in that she was brought up in a caraway-tolerant household. I grew up hearing about this supposedly frightful natural substance, which should be avoided in much the same way as the News of the World and Maoist students. I have a feeling that caraway was pretty big in Edwardian times and that my Edwardian grandparents doted on the stuff. It has become bracketed in my mind with aspidistras and antimacassars and elderly ladies who treated headaches by bathing their temples in eau-de-cologne.

At the height of my adolescent gardening phase I enjoyed growing stuff that was unusual or hard to find and I tried caraway one year. It developed pungent foliage and, after a warm dry summer, fleshy green seeds which, when dried, could have gone into a basic sponge mixture to make “seedy cake”. Instead,

I munched them fresh and never looked back. I hope I’ll be able to revisit the experience in, say, late October.

Caraway is a great help to the digestion (which is why the liqueur Kummel is so good after over-indulging) and has a long history as a carminative (ie, it helps with flatulence). In large quantities it can induce hypoglycaemia and it has been suggested that, taken daily, it helps maintain a steady weight. As for me, I simply love its utterly distinctive smell and taste and am fortunate not to require its anti-flatulence qualities. Many do not love caraway and go so far as to suggest that it’s an emetic. I suppose it depends how much you hate it.

It’s deliciously fragrant and pungent, potent indeed, but is not like anything else that I can name. Is there the faintest suggestion of dill? Or do I think that because gripe water traditionally contained extracts of both of these very stomach-friendly herbs?

Caraway seed cake is delightful, but we often divide the sponge mixture, with its payload of what looks distressingly like desiccated mouse droppings, between bun cases. And we sometimes roast potatoes with caraway seeds, a very Germanic thing to do. As is adding a few to red cabbage as you cook it slowly for serving with goose or duck.

The caraway seed that I’ve been buying lately (for cooking, not sowing) has been slightly marred by the presence within it of interlopers. Cumin seed – it’s a first cousin – looks almost identical and every now and then I get a taste of curry in my seed cake. This is not quite as unpleasant as it sounds, but this is what prompted me to grow the stuff myself.

I have a theory that the anti-caraway tendency is dying out as people of my parents’ generation fade away. If you approach it without any prejudice there’s a fair chance that you may be seduced by the stuff. A Madeira cake fortified with caraway and further fortified by a glass of actual Madeira, as it goes down the little red lane, is certainly the afternoon pick-me-up of champions.

And just think of how much better it is if you grow it yourself. And, ideally, remember to sow it in good time.

But what to drink with caraway seed cake? The traditional answer is clearly Madeira and I have to say that Blandy’s Rainwater Madeira (€25, O’Briens, independents) hits the spot. Yes, it’s sweet, but the acidity is like a rapier and there’s a very distinctive tang that reminds me of the slightly burnt raisins on top of a good fruitcake. It’s a deliberately oxidised style so can be kept for ages after opening without going downhill.

It’s deliciously fragrant and pungent, potent indeed, but is not like anything else that I can name

MATER PRIVATE EDUCATIONAL EVENTS FOR GPS

September

02|Thurs

Dublin Cardiovascular Research Forum, Webinar Series

European Society of Cardiology 2021 Conference

| Update on Late Breaking Clinical Trials. The Cardiovascular Research Institute Dublin at Mater Private Network will host an online lecture on Thursday 2 September from 6-7pm. Presented by Prof Robert Byrne, Professor of Cardiovascular Research at RCSI University of Medicine and Health Sciences and Director of Cardiology at Mater Private Network.

For full details and to register, visit https:// bit.ly/3iBIOQV or www. cvridublin.ie

06|Mon

GP Webinar – Spine and Orthopaedics Virtual Clinic Mater Private Network, in association with MedCafé, will host a Virtual Clinic on Spine and Orthopaedics on Monday 6 September from 7-8pm. Speakers include Prof Joseph Butler, Mr Michael Leonard, and Ms Aoife Brogan. CPD applied for. For full details and to register, visit www.MedCafe.ie

20|Mon

GP Webinar – Stress Management in the Primary Care Setting

Mater Private Network will host an evening webinar on Stress Management in the Primary Care Setting on Monday 20 September from 7-8.30pm. CPD applied for. For full details and to register, visit www. materprivate.ie or email events@materprivate.ie

October

02|Sat

GP Webinar –Cancer Masterclass for Primary Care

Mater Private Network will host an online Cancer Masterclass for Primary Care on Saturday 2 October from 9am-12.30pm. Topics include breast cancer, gynaecological cancer, genitourinary cancer, patient access, and new developments.

Speakers include Prof John McCaffrey, Prof Martin O’Neill, Dr Daniel Cagney, Dr Alan Bohan, Dr Sarah Picardo, Ms Siun Walsh, Dr Claire Thompson, Dr Richard Moore, and others.

CPD applied for. For full details and to register, visit https://bit.ly/3yMrChi or www.materprivate.ie

IMPORTANCE OF PHARMACIES ‘HAS INCREASED THROUGHOUT PANDEMIC’ – IPU

The importance of community pharmacies has increased throughout the pandemic, according to new research from B&A. The study, published by the Irish Pharmacy Union (IPU), found that with overall visits to GPs decreasing during the pandemic, pharmacies have grown in importance.

Some 39 per cent of people now see their pharmacist as their most important healthcare professional, according to the research.

The 2021 edition of the Irish Pharmacy Index is the 15th annual study to quantitively measure public attitudes to pharmacy in Ireland.

Key findings of the 2021 study include:

 The number of people citing pharmacists as their most important healthcare provider has increased by almost a third.

 Just over half of people

ity of vaccines in pharmacies.

Commenting on the findings, IPU President Mr Dermot Twomey said: “The role of the community pharmacy has been expanding and increasing in importance for many years. This accelerated during the pandemic as pharmacies kept their doors open during each lockdown.

“With people visiting GPs less, or GPs favouring virtual appointments, the accessibility of pharmacies is driving healthcare in our communities.”

The report found 85 per cent of people find pharmacies accessible compared to 51 per cent for GPs and 13 per cent for hospitals.

Furthermore, the longer opening hours typically offered by pharmacies were recognised, with 75 per cent agreeing that pharmacies are available at a time that suits compared to just 31 per cent for GPs.

Mr Twomey welcomed the exceptionally high levels of trust (97 per cent) patients have towards their pharmacies. “Pharmacists pride themselves in their personal approach to healthcare and supporting patients. The direct personal interaction allows us to provide valuable

advice to patients in a quick and convenient way.”

Public support for expanding the role of pharmacies is very strong with 95 per cent favouring pharmacists being allowed to prescribe medications for minor ailments.

“The pharmacy profession stepped up during the pandemic in a big way. The sector has now administered more than 215,000 Covid-19 vaccines in just two months.

“Prior to that, when called upon and empowered to do so, we extended and repeated prescriptions for patients for up to nine months when other healthcare providers weren’t available, to ensure safe continuation of patients’ medication and to help manage their existing health conditions.

“Both are examples of how increasing the role of pharmacies can rapidly lead to successful results.”

Mr Twomey concluded by calling for a concerted Government effort to maximise the value of the pharmacy sector in post-pandemic healthcare: “We are all optimistic that the crisis of the pandemic will recede in the coming months. Now is the time to plan for how healthcare will operate in future.”

IRISH QUALITY IMPROVEMENT STUDIES ‘DEMONSTRATE HIGH REPORTING STANDARDS’

practitioners on performing cost analysis in healthcare.

“With appropriate educational guidance and resources, this awareness can be fine-tuned to support informative QI cost analyses.”

The study’s senior author and Director of the RCSI Healthcare Outcomes Research Centre, Prof Jan Sorensen, stated: “The RCSI is committed to providing the evidence base to support better decision-making about resource allocation in healthcare, and we expect this study will guide healthcare educational institutions, researchers and policy makers to more substantially in-

clude consideration of costs and outcomes in QI studies.”

The study Reporting standards, outcomes and costs of quality improvement studies in Ireland: a scoping review was commissioned by the HSE.

It was conducted by Dr McCarthy of the Graduate School of Healthcare Management, Dr Samira Barbara Jabakhanji (post-doctoral researcher), and Prof Sorensen of the Healthcare Outcomes Research Centre at the RCSI, in collaboration with Dr Jennifer Martin and Dr Maureen Flynn of the HSE National Quality Improvement Team.

NEW SCHOOL OF MEDICINE OPENS AT ULSTER UNIVERSITY

Ulster University recently opened a newly refurbished building to welcome the first 70 students to the new School of Medicine at its Magee campus in Derry.

The first cohort to enter the first graduate-entry medical school in Northern Ireland is comprised of students with a range of related and non-scientific/healthcare backgrounds from politics to investment banking, radiography, management consultancy, optometry, forensic science, nursing, and even a previous lecturer in Irish at Magee.

tion, as a pre-emptive part of the Derry and Strabane City Deal. Medical schools are sometimes located in a hospital setting, but I want our students to learn near the city’s GPs and the population they will go on to care for. The School of Medicine will act as their home, a welcoming place, for the future doctors who are embarking on a challenging yet hugely rewarding journey with us.”

(54 per cent) visited the GP less often throughout the pandemic period, “with many consulting with their pharmacist instead”.

• Pharmacists play a much greater role in the healthcare of younger adults. Someone under 25 is four times more likely to have been to the pharmacy in the past week than a GP.

 Up to half (48 per cent) of the adult population indicated that the pandemic has either had some or a significant impact on their health with the biggest impact being on younger adults.

 85 per cent of people see pharmacies as highly accessible and 57 per cent believe they are increasing in relevance.

 There is “clear support” for pharmacies expanding the range of services they provide, including 88 per cent favouring the availabil-

A review by RCSI University of Medicine and Health Sciences in collaboration with the HSE National Quality Improvement Team has found that quality improvement (QI) studies in Ireland over a five-year period “conformed to high reporting standards and enhanced multiple elements of healthcare quality”.

The review showed an increasing trend in the frequency of publication of QI studies in Ireland, with 43 studies published during the period 2015 to 2020.

Key findings from the review published in BMJ Open Quality were that most QI studies were conducted in hospitals and aimed to improve the effectiveness (65 per cent), efficiency (53 per cent), timeliness (47 per cent) and safety (44 per cent) of care. Fewer aimed to improve patient-centredness (30 per cent), value for money (23 per cent) or staff well-being (9 per cent).

The review found that costs and healthcare outcomes were understudied and require increased at-

tention to support better decision-making about resource allocation in healthcare. No study aimed to increase equity.

Dr Siobhán McCarthy, the study’s first author and Lecturer at the RCSI Graduate School of Healthcare Management, commented: “The review has, for the first time, profiled the characteristics of QI studies published in Ireland. It is encouraging to see that the studies meet high reporting standards with a focus on internationally recognised elements of healthcare quality.

“It is also pertinent that the review findings align with current international discussion about the need to promote equity-focussed quality improvement work.

“It is becoming increasingly acceptable to discuss costs in healthcare and the review points to an existing awareness of costs among QI practitioners in Ireland. Approximately half of studies discussed costs, but did not quantify these sufficiently, highlighting the need to provide greater guidance to QI

Over the past 12 months, Ulster University’s estates services team has worked alongside its design team led by architects McAdam Design and contractors P & K McKaigue Ltd to bring this project to fruition.

As part of the plan for the expansion of the Magee campus, a permanent home for the School of Medicine will be located on the Strand Road. It will act as a catalyst for an innovation corridor stretching out to Fort George.

Prof Louise Dubras, Foundation Dean at the School of Medicine, Ulster University, said: “I’m so excited to greet our new students on this momentous day which I have looked forward to for years. I hope that the school, the university and the city itself will encourage a sense of belonging and pride in our region’s future doctors.

“I am very proud of our new School of Medicine which in itself marks the continued transformation of the Magee campus into a hub for health and innova-

Dr Tom Black, BMA NI Council Chair, commented: “It is fantastic to see the years of lobbying and hard work come to fruition today with the opening of the new School of Medicine at Ulster University.

“BMA had for years said we needed to have another medical school as we need to train more doctors locally with the anticipated result being that they will chose to stay and work in Northern Ireland thereby increasing our workforce at a critical time.

“I am sure all of the students who start their medical career today will be warmly welcomed by colleagues across the health service once they begin their placements. I wish them every success in their studies. “

Western Health and Social Care Trust Medical Director, Dr Catherine McDonnell, added: “The medical school will play a truly transformative role in the region and will complement and support the existing positive work being carried out by the Clinical Translational Research and Innovation Centre and Cognitive Analytics Research Laboratory.”

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

GP required to join practice in Dundalk, Co Louth with a view to succession.

Mixed GMS/private. Student teaching attachment RCSI. Very little on-call (large group rota). Socrates software. Email CV to rodenct@eircom.net

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

PRACTICE NURSE REQUIRED

Practice nurse required two days a week –Southside Cork City practice. Apply to: jmrosslee@gmail.com

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

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

GP REQUIRED

Unique opportunity to live and work in the bustling and scenic town of Tralee.

Part-time GP required to work 4 to 6 sessions (flexible) per week in a friendly, flexible, well organised, training practice at Fairies Cross Medical Centre, Tralee.

Excellent rate of pay.

Please apply with CV or contact for further information if required to jennycrushell@hotmail.com

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

EVENT

BEACON HOSPITAL CARDIOLOGY AND SPINAL GP STUDY MORNING

Saturday 11th September 2021

This event will be a live streamed webinar. Topics include practical demonstrations, such as interpretation of ECG results and spinal examinations. Other topics cover referral pathways, adolescent back pain, cardiology updates, and more. Speakers include Dr David Burke, Prof Jonathan Lyne, Dr Rory O’Hanlon, Mr Seamus Morris, and Mr Marcus Timlin amongst others.

Register via the GP events section on our website. CME Accreditation applied for

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

They put their right foot in, their right foot out –a dance of death that puzzled doctors for centuries

Following on from the last issue's overview of the 'Laughter Epidemic' of Tanganyika, let's touch on another condition with bizarre and confusing symptoms that baffled doctors when it manifested in mainland Europe between the 14th and 17th Centuries.

'Dancing mania' – also known as 'dancing plague', 'choreomania', 'St John's Dance', 'tarantism' and 'St Vitus Dance' – was a social phenomenon whereby groups of people 'danced' erratically, sometimes thousands at a time. It affected both adults and children and these unfortunate individuals would involuntarily 'dance' until they

literally collapsed due to exhaustion, injuries, or some other related factor that would incapacitate them.

One of the first major outbreaks was observed in Aachen, Germany, in 1374, but the phenomenon quickly got a foothold in the rest of Europe.

Dancing mania was no joke – it utterly baffled the physicians of the time. As you might imagine, some of the 'remedies' of the time were based on spirituality and pure guesswork. It wasn't unusual to see groups of people plagued by the condition accompanied by musicians, as some doctors believed this would 'treat' the bizarre illness. However, this strategy backfired, as it often

prompted unaffected bystanders to join in.

This also paints the grotesque picture of multiple sufferers writhing in pain, screaming, and begging for help while the musicians and bystanders accompanied them.

The Lancet reported in 2009 that on one occasion in Maastricht in the Netherlands, some 200 people danced uncontrollably on the bridge over the Moselle River until it collapsed, drowning everyone involved.

In Strasbourg in 1518, authorities built a special stage and instructed the sufferers to continue dancing round the clock, as dancing was believed to be both the affliction and the cure.

There is still discussion over the real medical cause of dancing mania. Some have suggested that it may have been due to ingestion of a mould called ergot, which caused spasms, hallucinations, and tremors and was often the result of consuming contaminated flour. However, this would not fully explain why the sufferers were compelled to dance for days on end. It would also be a leap of logic to assume that ergot would cause exactly the same symptoms in everybody who ingested it.

Another hypothesis is that it was caused by Sydenham's chorea, an autoimmune disease that results from childhood infection with Group A beta-haemolytic Streptococcus and is characterised by writhing or explosive involuntary movements. One other likely cause was mass psychogenic illness, which was prevalent in those times and was fuelled by religious or spiritual fervour.

One thing is for sure – dancing mania was real. For a contemporary description, see the vivid accounts left to us by the Renaissance physician Paracelsus.

Comedy fans may be aware of the recent and untimely passing of Sean Lock, the deadpan stand-up comedian best known for his panel appearances on TV shows such as 8 out of 10 Cats does Countdown , QI, and Have I Got News for You , among others.

Sean died from cancer at age 58, but his comedy will no doubt live on for many years to come. As an homage, here are a few of his selected jokes to round-off this issue's offering.

• The Daleks: Devoid of all emotion except hate. They’re like Piers Morgan on wheels.

• Some people say the glass is half empty or half full, but to me that’s irrelevant, because I’m having another drink.

• ‘You got your bag for life?’ Too bloody right I have. Now fill it with vodka or fags. I’m ironic. Let’s see who goes first, me or the bag.

• I don’t like the Queen. I think it’s absurd that we have a queen. Basically what we’re saying is that we’re no more sophisticated than bees.

• I’m just organised – I always put a bit of butter on the knife before I go to bed.

• Interesting fact: A shark will only attack you if you’re wet.

• A bit of advice: Never read a pop-up book about giraffes.