A five-year plan for doctors
A conference in Dublin marked the launch of the new strategy for HSE National Doctors Training and Planning. David Lynch reports
Staff burnout in CAMHS Niamh Cahill speaks to Prof Fiona McNicholas about her research into the high levels of burnout in child and adolescent psychiatry
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The shattered lives in Donegal Creeslough used to be Dr Pat Harrold’s home and the recent tragedy has made him determined to visit as soon as he can
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CATHERINE REILLY
A Medical Council accreditation team declined an opportunity to interview witnesses of alleged abuses at training hospitals used by the RCSI in Bahrain, a Gulf country with a widely criticised record on human rights and freedom of expression.
Bahrain is described as “not free” in Freedom House's 2022 study of political rights and civil liberties worldwide.
Three witness statements were submitted to the Council by Global Legal Action Network (GLAN), an organisation of human rights lawyers and activists, in advance of the accreditation process at RCSI Bahrain and affiliated clinical sites. The accreditation process took place virtually in March 2021. The statements were “considered” as part of the team’s assessment, but it “did not consider it necessary” to in-
terview the witnesses, the Council informed GLAN in June 2021.
The training hospitals – Salmaniya Medical Complex, Bahrain Defence Force (BDF) Hospital, and King Hamad University Hospital – have been linked with alleged mistreatment of political activists and prisoners, and discrimination against Shia Muslims.
According to handwritten notes of the assessor team’s meetings with students, released to GLAN under Freedom of Information law, the student feedback was mostly positive. However, there was reference to a “fear factor” about reporting potential ethical concerns at clinical sites.
The Council assessor team noted a much lower than anticipated level of student participation in these meetings, according to the accreditation report.
A Bahraini doctor, who submitted a witness statement to GLAN, told this
newspaper that students would be afraid to speak out due to the political climate.
In late 2021, the Council granted RCSI Bahrain unconditional approval for five years. This is subject to a “confirmatory” site inspection under the hybrid process necessitated by Covid-19. The inspection of RCSI Bahrain and affiliated clinical sites took place in October 2022 and the report is being finalised.
The Council said the assessor team was “satisfied” with the information gathered from students during the virtual accreditation process and indicated that a lower level of student engagement was associated with the virtual process.
A spokesperson for the RCSI said the accreditation report provided feedback and recommendations for the university “to maintain the high-quality medical education it offers to its students”. See news feature, p4-6.
A group within the HSE “is coordinating plans” to mitigate the impact of any potential fuel shortages and power outages over the winter period, the Medical Independent (MI) has been told.
The issue was raised at the HSE audit and risk committee meeting in September in relation to a discussion on the national emergency plan.
According to meeting minutes, the committee discussed “the potential for significant shortages on fuel and electricity, which could lead to potential power cuts and the risks associated with same, and if there is a contingency plan in place”.
The meeting was assured that health services were “prioritised” in relation to supply of power.
A HSE spokesperson told MI that a planning sub-group of the HSE national crisis management team has now been established.
“The focus is on business continuity measures for this scenario focused on mitigation measures that may help reduce the potential impact of any fuel shortages and power outages should they arise.”
The spokesperson added that the HSE attended an oil emergency exercise in May at the National Emergency Coordination Centre.
“A second cross-Government exercise, ‘Exercise Dara’, was held on Friday 16 September to test plans to address different scenarios,” said the spokesperson. These scenarios included gas and electricity power generation reduction, emergency rota plans, and the impact on the public.
Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com
XELJANZ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
XELJANZ in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.
XELJANZ in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
XELJANZ is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.
For patients not adequately controlled on dual therapy with moderate to severe COPD
TRIXEO Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.1
*Significant reductions in the rate of moderate or severe exacerbations vs LAMA/LABA (24%, n=2137 vs n=2120, annual rates 1.08 vs 1.42, 95% CI 0.69–0.83; p<0.001) and ICS/LABA (13%, n=2137 vs n=2131, annual rates 1.08 vs 1.24, 95% CI 0.79–0.95; p=0.003).1,2 COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist. In the clinical trial programme for TRIXEO, LAMA/LABA refers to glycopyrronium/formoterol fumarate and ICS/LABA refers to budesonide/formoterol fumarate. ©AstraZeneca
Consult Summary of Product Characteristics (SmPC) before prescribing.
Indication: Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.
Presentation: Pressurised inhalation, suspension. Each single actuation (delivered dose, ex-actuator) contains 5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2 micrograms of glycopyrronium and budesonide 160 micrograms.
Dosage and Administration: The recommended and maximum dose is two inhalations twice daily (two inhalations morning and evening). If a dose is missed, take as soon as possible and take the next dose at the usual time. A double dose should not be taken to make up for a forgotten dose. Special populations: Elderly: No dose adjustments required in elderly patients.
Renal impairment and Hepatic Impairment: Use at recommended dose in patients with mild to moderate renal impairment, and patients with mild to moderate hepatic impairment. Can also be used at the recommended dose in patients with severe hepatic impairment, severe renal impairment or endstage renal disease requiring dialysis, only if expected benefit outweighs the potential risk. Patients with severe hepatic impairment should be monitored for potential adverse reactions. Paediatric Population: No relevant use in children and adolescents (<18 years of age). Method of administration: For inhalation use. Patient’s inhaler technique should be regularly reviewed by physician or other healthcare professional. Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer.
Contraindications: Hypersensitivity to the active substances or to any of the excipients.
Warnings and Precautions: Not for acute use: Not indicated for treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. Paradoxical bronchospasm: Administration of formoterol/glycopyrronium/budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life threatening. Treatment should be discontinued immediately. Assess patient and institute alternative therapy if necessary. Deterioration of disease: Recommended that treatment should not be stopped abruptly. If patients find the treatment ineffective, continue treatment but seek medical attention. Increasing use of reliever bronchodilators indicates worsening of the underlying condition and warrants reassessment of the therapy. Sudden and progressive deterioration in the symptoms of COPD is potentially life threatening, patient should undergo urgent medical assessment. Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol. Use with caution in patients with clinically significant uncontrolled and severe cardiovascular disease. Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval. Systemic corticosteroid effects: May occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Potential effects on bone density should be
considered particularly in patients on high doses for prolonged periods that have co existing risk factors for osteoporosis. Visual disturbances: May be reported with systemic and topical corticosteroid use. If patient presents symptoms such as blurred vision or other visual disturbances, consider ophthalmologist referral for evaluation of possible causes. Transfer from oral therapy: Care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Clinical features of such infections can overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia: Potentially serious hypokalaemia may result from ß2-agonist therapy. This has potential to produce adverse cardiovascular effects. Caution is advised in severe COPD as this effect may be potentiated by hypoxia. Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics. Hyperglycaemia: Inhalation of high doses of ß2adrenergic agonists may produce increases in plasma glucose. Blood glucose should be monitored during treatment following established guidelines in patients with diabetes.
Co-existing conditions: Use with caution in patients with thyrotoxicosis. Anticholinergic activity: Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop. Co-administration with other anticholinergic containing medicinal products is not recommended. Drug Interactions: Co-treatment with strong CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products, are expected to increase the risk of systemic side effects and should be avoided unless the benefit outweighs the increased risk, in which case patients should be monitored for systemic corticosteroid adverse reactions. This is of limited clinical importance for short-term (1-2 weeks) treatment. Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms. Other antimuscarinics and sympathomimetics: Coadministration with other anticholinergic and/or long-acting ß2-adrenergic agonist containing medicinal products is not recommended as it may potentiate known inhaled muscarinic antagonist or ß2-adrenergic agonist adverse reactions. Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects, therefore caution is required when prescribed concomitantly with formoterol. Medicinal product-induced hypokalaemia: Possible initial hypokalaemia may be potentiated by xanthine derivatives, steroids and non potassium sparing diuretics. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. ß-adrenergic blockers: ß-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concurrent use should be avoided unless the expected benefit outweighs the potential risk. If required, cardio-selective ß-adrenergic blockers are preferred. Other pharmacodynamic interactions: Concomitant treatment with quinidine,
disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong QT interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics. Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. Elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Pregnancy and Lactation: Administration to pregnant women/women who are breast-feeding should only be considered if the expected benefit to the mother justifies the potential risk to the foetus/child.
Ability to Drive and Use Machines: Dizziness is an uncommon side effect which should be taken into account.
Undesirable Events: Consult SmPC for a full list of side effects. Common (≥ 1/100 to < 1/10): Oral candidiasis, pneumonia, hyperglycaemia, anxiety, insomnia, headache, palpitations, dysphonia, cough, nausea, muscle spasms, urinary tract infection. Uncommon (≥ 1/1,000 to < 1/100): Hypersensitivity, depression, agitation, restlessness, nervousness, dizziness, tremor, angina pectoris, tachycardia, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles), throat irritation, bronchospasm, dry mouth, bruising, urinary retention, chest pain. Very Rare (< 1/10,000): Signs or symptoms of systemic glucocorticosteroid effects, e.g. hypofunction of the adrenal gland, abnormal behaviour. Not known: Angioedema, vision blurred, cataract, glaucoma.
Legal Category: Product subject to prescription which may be renewed (B)
Marketing Authorisation Number: EU/1/20/1498/002 120 actuations
Marketing Authorisation Holder: AstraZeneca AB, SE-151 85, Södertälje, Sweden.
Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, College Business and Technology Park, Blanchardstown Road North, Dublin 15 Tel: +353 1 609 7100.
TRIXEO and AEROSPHERE are trademarks of the AstraZeneca group of companies.
Date of API preparation: 05/2022
Veeva ID: IE-3823
Adverse events should be reported directly to; HPRA Pharmacovigilance, Website: 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
Preliminary business cases for new elective-only hospitals in Cork and Galway will be presented to the Government “very shortly”, this newspaper understands.
The business case for the site in Dublin will follow at a later date, a Department of Health spokesperson told the Medical Independent (MI)
In December 2021, the Government agreed a new national elective ambulatory care strategy. It involves the development of additional capacity through dedicated elective hospitals in Cork, Galway, and Dublin.
“A preliminary programme business case and individual project business cases have been developed for the new elective hospitals in Cork and Galway,” the Depart-
NIAMH QUINLAN
Formal discussions between GP representatives and the Department of Health on additional GP visit cards are not expected to take place before the end of the year, the Medical Independent (MI) has learned.
ment spokesperson told MI
“These have been subject to detailed internal and external assurance. These will now be presented to Government very shortly for approval-in-principle at decision gate one of the public spending code (PSC). Subject to passing through gate one, the projects can then move to gate two, a detailed project brief and procurement strategy.
“The preliminary project business case for Dublin will
follow the same process in due course. Only after approval-in-principle at gate one of the PSC has been given can the names of the emerging preferred sites at each location be confirmed.”
The assurance and planning process was “very detailed” and it was “difficult to be prescriptive about timelines”. However, “we hope that the hospitals will be open from 2027 and fully operational by 2028.”
Speaking to MI in October, IHCA President Prof Robert Landers raised concerns about the Government’s plans.
“What we are asking is for the Government instead to consider building and increasing the elective capacity on existing hospital sites, right across the country, not just Cork, Dublin, and Galway.”
Dr Denis McCauleySpeaking to MI, Chairperson of the IMO GP committee, Dr Denis McCauley, said: “There are preliminary discussions, but no substantive discussions as of yet.” He said some engagement would “naturally” be expected and “we would probably expect that there would be further discussions after Christmas”.
Measures announced as part of Budget 2023 included the extension of GP visit cards to people who earn the median household income of €46,000 or less from 1 April 2023. Budget 2023 also committed to extension of GP visit cards to all children aged six and seven by the end of 2022, a measure that was also included in Budget 2022, but without a timeframe.
These extensions would result in an additional 400,000 people having access to free GP care. GPs have warned that the measures will increase demand for appointments amid a workforce crisis.
The Department and HSE have “held several meetings with the IMO this year on separate GP-related issues including on the issue of expanding GP care without charges,” a Department spokesperson said.
The spokesperson continued: “A significant package of additional capacity supports to GP practices will be made available in respect of the expansion, and engagement with the GP representative organisation is to continue in this regard to determine how best to utilise these additional supports.”
Dr McCauley said the extension of GP visit cards must be done “in a planned way or else it's going to just affect capacity in general practice enormously”.
He added: “It is going to have an effect on waiting lists, on the attractiveness of general practice [for] older GPs who are going to stay or not, or young GPs coming in. [The Government] have got to be very careful they don't turn us into the UK in disguise.”
GPs in the UK are also facing a workforce crisis with patients struggling to access timely appointments.
An Irish Medical Council (IMC) assessor team did “not consider it necessary” to speak with witnesses of alleged breaches of medical neutrality at training hospitals used by RCSI in Bahrain – a Gulf country with a poor human rights record.
Three witness statements were submitted by the Global Legal Action Network (GLAN) prior to the reaccreditation process at RCSI Bahrain. A virtual accreditation process took place in March 2021 and a “confirmatory” in-person visit occurred in October 2022.
GLAN, an organisation of human rights lawyers and activists, offered to facilitate the Council’s assessor team to speak directly to the witnesses, where possible. However, in June 2021 the Council’s accreditation manager responded that the statements had been considered by the assessor team and it did “not consider it necessary to interview the witnesses”. In late 2021, the Council granted unconditional approval to RCSI Bahrain and its medical programme for five years subject to the “confirmatory” inspection.
The training hospitals – Salmaniya Medical Complex, Bahrain Defence Force (BDF) Hospital, and King Hamad University Hospital –have been linked with alleged mistreatment of political activists and prisoners, and discrimination against Shia Muslims.
A Bahraini doctor, who was one of the witnesses, told the Medical Independent (MI) that medical students in Bahrain would be afraid to speak out about concerns due to the political climate (Bahrain is rated as “not free” in Freedom House’s 2022 study of political rights and civil liberties worldwide).
The doctor told MI: “[The students] will be afraid of interrogation by the ministry of interior or simply they would be afraid of being dismissed from continuing their study in university by the ministry of education, which is interfering in all sorts of higher education in the country, including medical studies.
“No-one would be able to speak openly and freely in Bahrain without these fears in the back of their minds. It is very unfair for the Council to listen just to the students in Bahrain and ignoring anyone who worked in Bahrain or witnessed what they have seen there in the hospitals.”
The doctor said they trained and worked at BDF Hospital and Salmaniya Medical Complex, respectively, for several years post-2011. They reported being forced to discontinue training at the BDF Hospital due to alleged discrimination based on their Shia Muslim religion.
The doctor described witnessing police interference in medical treatment while working at Salmaniya Medical Complex.
This interference included police attendance at patient exams, interrogating patients, instructing the withholding of treatment, mistreatment of political detainees and injured protestors, and hospital staff reporting suspected protestors to the authorities
According to the doctor, they were tortured and imprisoned by authorities for treating injured protesters outside of the hospital system and they applied for asylum abroad. They are now working as a doctor in a European country.
In March 2021, the Council assessor team met virtually with groups of students from RCSI Bahrain. The student engagement process is confidential with no names noted in order to encourage participation. However, the assessor team was concerned about the low numbers of students who engaged in the process, according to Council documents released to GLAN through Freedom of Information (this issue was referenced in the Council’s published virtual accreditation report).
According to sparse handwritten notes of the assessor team’s meetings with students, the team asked most groups about patient dignity and specifically referenced prisoners. In one group, a “fear factor” was cited about reporting potential ethical concerns at clinical sites. Responses from an intern group referred to communication issues and barriers to care “due to diversity” which were “systemic”. The Council’s accreditation report stated interns raised the issue of language barriers impacting on care. There was no reference in the accreditation report to remarks about a fear factor or reference to the impact of the political climate on clinical sites.
Situated on the Persian Gulf, Bahrain has a population of 1.7 million people. The majority of citizens are Shia Muslims and yet the ruling monarchy, the House of Khalifa, profess Sunni Islam. The discrimination experienced by the Shia Muslim community and their under-representation in governmental and other state roles has been a key driver of political tensions. These tensions erupted into large pro-democracy and reform protests in early 2011.
RCSI Bahrain was established in 2004. The university invested in a multi-million-euro campus in Manama, the capital, where it
delivers medical and nursing programmes.
Currently, almost 900 students are enrolled in the undergraduate medicine programme, which has published fees of US$39,500 per annum for Bahraini nationals and US$41,475 for non-Bahrainis. Seventy-five per cent of medical students come from outside Bahrain.
In the early 2000s, Bahrain seemed to be pursuing political reforms. It has long since changed course. In the last decade, the authorities have “infringed upon human rights, curtailed civil society, banned political opposition parties and shuttered independent media”, stated Amnesty International ahead of parliamentary elections in November.
The IMC’s first accreditation process at RCSI Bahrain was delayed due to political unrest. The state’s brutal crackdown on activists and healthcare professionals in early 2011 made global headlines.
A report by Physicians for Human Rights (PHR), published in April 2011, documented the beating, abuse, and threatening of physicians and the obstruction of medical care through the “militarisation” of hospitals.
The Bahrain Independent Commission of Inquiry was commissioned by the Bahrain government to examine the events of February/March 2011 on foot of international pressure. The commission’s report had a chapter on incidents at Salmaniya Medical Complex and stated that security services “executed unlawful arrests” on the hospital premises and “attacked and mistreated some individuals, including medical personnel”. It also stated that some medical personnel had ties with the political opposition and “moved in and out of their roles as political activists and medical personnel”.
The Council’s accreditation visit proceeded in 2014 and it granted unconditional approval to RCSI Bahrain for the maximum period of five years. Prior to the Council’s vote, some members expressed concern about “insufficient consideration during the accreditation process of ethical and human rights concerns in Bahrain”, according to
meeting minutes. The accreditation report made no reference to abuses of medical neutrality and human rights at training sites or any recommendations on such matters.
Under statutory rules for accreditation, a medical programme must demonstrate that it incorporates the Council’s ‘eight domains of good professional practice’, the first of which is patient safety and quality of patient care.
The medical programme must also comply with the basic requirements of the World Federation of Medical Education (WFME) standards, which state that the medical school must facilitate “adequate clinical experience” and “organise clinical training with appropriate attention to patient safety”. The learning outcomes would include knowledge and understanding of human rights and medical ethics, according to the WFME standards.
The medical programme must also meet the requirements of an EU Directive on recognition of professional qualifications, which states that the programme must provide “suitable clinical experience in hospitals under appropriate supervision”.
In 2019, in advance of the reaccreditation process at RCSI Bahrain, GLAN Director Dr Gearóid Ó Cuinn (PhD) wrote to then Council President Dr Rita Doyle. He noted the WFME requirements adopted by the Council and the rules for accreditation under legislation. According to GLAN, the Council’s “failure” to consider submitted evidence on human rights abuses at clinical sites during the accreditation process in 2014, “amounted to a breach of the Council’s duty, as a public body, to have regard to relevant information prior to arriving at its decision.” The granting of unconditional approval was “inconsistent with the standards which the Council is bound in law to apply” during the accreditation process.
GLAN has noted a past example of the Council granting conditional (not full) approval to a medical school in Ireland due to deficits at a training site.
In his correspondence, Dr Ó Cuinn detailed that the human rights situation in Bahrain “remained a matter of serious concern”.
There is evidence of ongoing breaches of medical neutrality and denial of medical care in Bahrain. In 2018, the UN human rights committee noted “with concern” reports of an increase in use of violence by law enforcement officials during peaceful demonstrations and reports that injured demonstrators were questioned in medical facilities about their participation and denied medical assistance.
The most recent published communication from a UN Special Rapporteur to Bahrain authorities (July 2022) raised the alleged delayed access to medical care for political prisoners and alleged refusal of Salmaniya Medical Complex to release medical files to their families.
MI spoke to a former political detainee about an episode of inpatient treatment at
The Medical Council has reaccredited the medical programme at RCSI Bahrain following a virtual process, subject to a ‘confirmatory’ site visit. However, human rights activists are strongly critical of the process. Catherine Reilly reports
Salmaniya Medical Complex in 2019. This individual, who has a serious chronic condition, described long periods of denial of medical care by prison authorities. Medical appointments at Salmaniya were granted by authorities following the advocacy of a family member. At the hospital he remained handcuffed and shackled throughout almost all his treatment, which included a theatre procedure, he told MI
He described the healthcare team working under the close surveillance of police officers which restricted the standard of care they could provide. Doctors and nurses were “frightened” to ask the police officers to remove handcuffs and shackles. The doctor would “not even dare” ask the police to leave during consultations to offer privacy. “The nurses would not even come [due to] the way they were treated by the police as well. They will only see me once during the change of the shift… they wanted to avoid the police.”
This individual alleged they were “severely” beaten by police in front of healthcare staff, after attempting to flee the hospital in desperation. He stated he did not have access to the necessary post-surgical care when he was brought back to prison.
The accreditation renewal process at RCSI Bahrain was meant to take place in early 2020, but was delayed due to the Covid-19 pandemic.
In July 2020, a Council accreditation manager corresponded with the WFME to ascertain whether undertaking a virtual process for accreditations (due to the pandemic) would be sufficient to meet the standards.
President of the WFME, Prof David Gordon, said if an accreditation was a routine cyclical re-accreditation of a school in good standing, and there was “no reason to suspect any serious issues”, a virtual accreditation “should be adequate… provided a confirmatory site-visit is arranged once it becomes possible”.
The Council proceeded with this process at RCSI Bahrain.
On 12 March 2021, the Council contacted RCSI Bahrain’s Head of the School of Medicine, Prof Alf Nicholson, in regard to submissions by GLAN relating to concerns about clinical sites.
The Council’s accreditation manager asked Prof Nicholson if he had observations on whether such material was relevant in the context of the WFME standards and on the substance of the information.
Prof Nicholson responded that “to our knowledge, there is no precedent for such discussions being included as part of a formal accreditation visit in Ireland or other countries”.
He added: “I have been Head of School for the past 18 months and I can definitively state that I have not witnessed nor have I received reports from either staff or students to support these allegations.”
The virtual accreditation process proceeded on 23-24 March 2021. The assessor team comprised Prof Mary O’Sullivan (Chair of the Visiting Team and Medical Council member), Dr Tom Crotty (Medical Council member) and medical assessors Dr Ailís Ní Ríain, Prof Barry Lewis, and Prof Hisham Khalil.
The assessor team held 14 virtual meetings across 14 hours during the two days. The team spoke to RCSI Bahrain management and staff, students, and clinical site representatives. Videos of the university and clini-
cal training sites were also submitted.
The documents released to GLAN included handwritten notes of the assessor team’s meetings with these parties.
According to notes of the meeting with RCSI Bahrain management, whose names were listed, the assessor team asked questions “in relation to treatment of prisoners”. The notes indicated that Prof Nicholson considered the issues raised as unusual: “Unusual issues being raised during accred[itation] visit, no direct reports that would support third party reports.”
In the notes on the meeting with BDF Hospital representatives, whose names were listed, there was no reference to questions or responses on patient dignity. However, the Council’s published virtual accreditation report stated that when asked about their awareness of any mistreatment of patients, “no staff member had ever witnessed any form of mistreatment.”
In the notes of the meeting with representatives of King Hamad University Hospital, whose names were not listed, there was a question on “lack of respect and dignity”. One of the representatives said they “clinically worked here 10 years” and taught at BDF Hospital but had “never come across any incidents”. The “culture [was] very welcoming to all”, there was “no discrimination whatsoever” and “dignity always maintained”, according to responses.
Asked about a “formal policy to report”, there was reference to a “strict” policy on dignity, mission values, and the ethics committee and morbidity and mortality committee.
In the notes of the meeting with representatives of Salmaniya Medical Complex, whose names were not listed, there was a question on “lack of respect and dignity-patients”. A response stated, “a lot [of] help provided to prisoners, treated with extreme dignity, if couldn’t come to SMC consultant sent to prisoners.” Asked about a “clear process”, there was reference to a “process within hospital in higher authority”.
The assessor team asked a group of student representatives, “have any of you heard lack [of] respect in terms patients or prisoners.” The response was “all treated well and other vulnerable populations”.
A second student group was asked about “lack [of] respect to patient ie prisoners or are all treated equally respect and dignity”. A response stated, “early in careers not full experience in clinical setting,” but from what was known and/or experienced “respect heavily focused on” and “not seen or heard anything like that”.
Another group was asked about “interacting with patients” and whether prisoners were treated with a lack of dignity. A response referred to having “never picked up on particular group of people”. Some general examples of ethical concerns in regard to patient care were outlined in responses. A question was asked on whether students would know where to report potential ethical concerns. The responses stated, “don’t know who to go to” and “fear factor, don’t want to say anything”.
Interns were asked about “any incidents [involving] lack of respect for patients”. The responses were noted as follows: “Incidents – may have seen, miscommunication…”, “lack [of] communication” and “steps if issues arise”. There was “not intended malice – population diverse”. Another noted response was
“barriers to care – due to diversity. Systemic not from anything taught by med sch[ool].”
According to draft notes of a close-out meeting with RCSI Bahrain management (and noted in the virtual accreditation report), it was “both unfortunate and unusual for us as assessor team that of the eight meetings arranged with students and interns we had to cancel three of them across the two days because either one or no students attended”.
The students who it met were “very enthusiastic” and had provided “a very positive view” of the medical programme.
‘Serious reprisals’
Mr Sayed Ahmed AlWadaei is Director of Advocacy at the Bahrain Institute for Rights and Democracy (BIRD) in London. He was granted political asylum in the UK after participating in the pro-democracy protests in 2011.
Commenting on the Council’s process, Mr AlWadaei underlined that students and clinical staff would feel inhibited from raising concerns due to the oppressive political climate.
“No-one would dare to speak about any wrongdoing because they will face serious implications, serious reprisals, if they dare to do so,” according to Mr AlWadaei, who spoke to MI on 17 November.
“So the only way for this Council to really conduct proper due diligence and to really examine the places properly is they have to speak to political prisoners and hear from them directly about their experiences, what sort of treatment they are getting.”
Ordinarily, non-imprisoned human rights defenders and political activists can access medical services if they do not cause suspicion during their presentation.
“The problem is if someone is protesting against the government and gets an injury because the police shot them or used gunshot pellets or tear gas or anything that resulted in injury linked to protest. Then they would not be able to go to the hospital because they will end up being in prison themselves. And interrogated as well.”
People in Bahrain who challenged “the dictatorship” and called for democracy were routinely “thrown in prison after being tortured”, many serving life sentences and some on death row. Some were facing a “slow assassination through denial of medical treatment” in prison, including political prisoner Mr Hassan Mushaima, aged 74. Mr Mushaima is Secretary General of the Haq Movement, a banned oppositional party.
Mr AlWadaei said he spoke to Mr Mushaima on 7 November – “and he detailed how harrowing his situation is…. He is in remission from cancer and a man of this age with really serious medical issues would require proper treatment, and unfortunately he is not getting that.”
He noted that Bahrain had the highest rate of imprisoned people in the Middle East.
“And most of those prisoners in the country are political prisoners – we estimate 1,400 political prisoners; 500 of them are serving more than 20 years’ imprisonment. Many of them are in prison since 2011, simply because they took part in what we call the Arab spring revolution…. It is a situation where human rights defenders, peaceful opposition figures, are
89
per cent of women who accessed abortion care through the Irish Family Planning Association in 2020 and 2021 were less than nine weeks pregnant at the time of their abortion.
500,000+ Covid-19 bivalent vaccines have been administered since their introduction on 3 October, stated the Minister for Health on 21 November.
725,000
primary and booster Covid-19 vaccine doses have been administered since 15 August.
74
per cent of doses are being administered by GPs and pharmacies participating in the winter programme.
1
-in-eight deaths in 2019 were linked to bacterial infections, the second leading cause of death globally, according to new research in The Lancet.
behind bars simply because they wanted to challenge the dictatorship in the country.” Human rights defenders and activists were considered by the authorities as a “threat”.
“I am currently a stateless individual. Simply because I am a human rights defender working from exile. You would imagine what it would mean for those individuals who are human rights defenders who are in the country. Regrettably, one of the biggest names is Abdulhadi al-Khawaja – he is a dual Danish-Bahraini national and he is also serving life imprisonment. Recently they are just propping up new charges against him, some of them are because he protested the conditions in the prison and
one of the key issues is obviously access to medical care.
“A lot of the problems that Abdulhadi suffers today are because he suffered serious torture back in 2011 and he has to deal with the consequences of that torture.” (On 28 November, BIRD reported that a court had upheld “reprisal charges” against Mr Al-Khawaja following his protests).
In granting accreditation to RCSI Bahrain, which depended on allegedly compromised training sites, the IMC was “legitimising” the actions of the Bahrain government, he believed.
“They are legitimising the denial of the medical treatment to hundreds of political prisoners in the country.”
He said discrimination against the Shia majority was also “a huge problem in the entire country”, including in healthcare employment.
Mr Alwadaei said BIRD receives core funding from the Sigrid Rausing Trust and Joseph Rowntree Fund. It also receives funding from the European Commission to support its work on death penalty abolition in Bahrain.
‘Final approval’
The Council’s education and training committee approved the virtual accreditation report at its meeting on 17 November 2021 and “final approval” was received from the Irish Minister for Further Education on 21 December 2021. In line with WFME requirements, the approval was subject to a “confirmatory site inspection”.
This site visit took place in October 2022. “The report of this visit is still in the deliberative phase and will be put before the education and training committee for approval when finalised,” the Council informed MI. The site visit included in-person inspections “of all clinical training sites associated with RCSI Bahrain”.
The spokesperson confirmed a “lower than normal” attendance of students during the virtual accreditation. The assessor team was, however, “satisfied” with the information gathered. At the two virtual accreditations carried out during the pandemic, student attendance was “significantly lower” than in-person accreditations.
The Council “followed all accreditation procedures in relation to third-party submissions”. It did “not direct the questions to WFME in this instance”.
A spokesperson for RCSI said the accreditation report provided feedback and recommendations for the university “to maintain the high-quality medical education it offers to its students”.
“The Council commended the university for the strong presence of professionalism throughout the undergraduate medicine programme, the quality of facilities on campus and at teaching sites, the support provided by the research office to medical students and staff across the spectrum of research activities and the enthusiasm and commitment of RCSI Bahrain medical students to their education.”
They added: “Our primary responsibility is to contribute to our students’ high-quality education in a safe, supportive, and non-sectarian environment.
“To this end we are committed to ensuring we provide our students with access to clinical training in the affiliated teaching hospitals in a safe and non-sectarian environment where the principle of medical neutrality is absolutely respected.”
Bahrain authorities
MI contacted the communications directorate of Bahrain’s ministry of health and awaited a response at press time.
Commenting on 25 November, Bahrain ombudsman’s office (which receives complaints about the interior ministry) said it had received “some complaints about the delay in obtaining medical care by some inmates”.
The office’s spokesperson maintained there was “no intentional deprivation of any inmate of medical services”. Where necessary, “the ill inmate is immediately transferred through ambulance to an external hospital.”
In regard to the aforementioned cases of Mr Mushaima and Mr Al-Khawaja, “we are already following up on any complaints or assistance requests. We provide those who submit official complaints on their behalf (such as their families) with the necessary and updated information about their condition adhering to the principle of preserving the privacy of personal information.”
GLAN response
Ms Siobhan Allen, Senior Lawyer, GLAN, told MI: “In its assessment of whether to reaccredit RCSI Bahrain, the IMC appears to have given inadequate consideration to the human rights situation in Bahrain or the specific (and numerous) allegations of violations in the training hospitals used by RCSI Bahrain.
“These procedural breaches make the assessment process, and the IMC’s resulting decision to grant unqualified reaccreditation, unsound.” In the context of the “long running and severe situation involving the medical mistreatment and neglect of prisoners, protesters and pro-reform advocates it is unimaginable that these training environments could live up to Irish standards as they are required to do pursuant to the relevant standards the IMC purports to apply”.
AGENDA
Early Morning Session
Case
Session One
Cath Lab; What’s New & How Will it Bene t Your Patients?
Prof David Burke, Director of Cardiology, Beacon Hospital
The Role of CT in Cardiac Diagnostics
Dr Julie O’Brien, Consultant Radiologist, Beacon Limerick
Cardiology Referral Pathways - Rapid Access or ED?
Dr David Barton, Consultant Cardiologist
Congenital Heart Disease; Growing Field of Adult Congenital Cardiology
Prof Kevin Walsh, Consultant Cardiologist
Diagnosis,
Cardiac MRI Case Studies
Dr Rory O’Hanlon, Consultant Cardiologist
Cardiac Electrophysiology; Case Studies to Set Your Pulses Racing
Prof Jonathan Lyne, Director of Cardiac EP, Beacon Hospital
Cardio-Oncology in General Practice
Dr Theodore Murphy, Consultant Cardiologist
Cardiac Problems in Infants & Children; When to Worry & When to Refer
Dr Paul Oslizlok, Consultant Paediatric Cardiologist
Self-Care for the GP; Who Takes Care of You
Prof Robert Kelly, Consultant Cardiologist and Lifestyle Medicine Physician
6.5
CPD Points
The HSE has developed a new procurement plan to overhaul existing “fragmented” procurement processes.
The HSE Corporate Procurement Plan 2022-2024 notes that procurement spend on goods and services accounts for nearly €3.7 billion of the annual expenditure within the HSE budget (€21 billion in 2022).
“Procurement processes and systems are currently fragmented, which impacts on spend visibility, control, and compliance,” according to the document.
It states that public procurement is facing new challenges and is increasingly expected to demonstrate best value for public money in “ever-constricting budgetary environments”.
The challenges are compounded by continuing global supply chain disruption resulting from “pandemics, Brexit, and geo-political factors”.
“Further professionalising the procurement function, improving planning and driving compliance is essential to enable the HSE and funded agencies achieve greater value for money from the collective procurement activities (cash and non-cash benefits) to support reinvestment into providing high quality healthcare and personal social services,” according to the document.
A key priority is to coordinate and collaborate with all HSE organisations to agree a multi-annual procurement plan (MAPP). This would be aligned to the implementation of the HSE Corporate Procurement Plan and include agreement with
section 38 and section 39 health sector agencies.
The MAPP is intended to increase and maintain HSE “spend under management” (SUM) to a target of 68 per cent by the end of 2022 and a target of 85 per cent by the end of 2024. SUM is the amount of spend managed by procurement out of total company spend. It is also the aim to improve SME participation through the HSE MAPP pipeline of upcoming tenders that will be published each quarter (from quarter three 2022 onwards) to inform SMEs and “micro-enterprises” of upcoming opportunities in advance of tender publication.
The document notes that delivering on the plan, including achieving the compliance targets, requires collaboration with the Office of Government Procurement (OGP) to progress the execution of the MAPP for non-health categories for which the OGP is responsible.
Another priority is to apply appropriate procurement processes, award criteria, and weighting to support “innovation, social inclusion, economic, and environmental sustainability priorities into all procurement processes” with effect from the end of this year. “Deliverables” in the area for next year will be set out within the imminent HSE Climate Action Strategy
A bespoke corporate procurement plan/procurement compliance improvement programme is to be developed in collaboration with each participating health service organisation to assist them in becoming compliant with legal and regulatory policy and corporate governance obligations. Each organisation’s programme will be supported and managed using the available electronic toolset to support corporate procurement
CATHERINE REILLY
The HSE will advocate for development of a whole-of-government national strategy on foetal alcohol spectrum disorders (FASD), according to a new HSE position paper.
The paper, which was endorsed by the HSE executive management team and the board’s quality and safety committee in September, also commits to increasing public awareness and rolling out training in health and social care.
FASD is a group of disorders caused by prenatal alcohol exposure. The disorders are associated with a range of lifelong physical, mental, educational, social, and behavioural difficulties.
One of the long-term actions in the HSE paper is to develop a model of care for child neurodevelopmental disorders to include FASD.
Another action for the medium-term is expanding the availability of drug and alcohol liaison midwifery services, with access to the full range of services for patient support in pregnancy (eg, detoxification), as recommended by the national maternity strategy and drug and alcohol strategy.
The HSE will also support implementation of the Public Health (Alcohol) Act 2018 “in full”. The paper noted that the provisions on the content of advertising, broadcast watershed, and health warnings on all alcohol product labels, were not yet enacted.
According to the paper, the commercial interests of industry “act against the population’s health through aggressive market-
ing, lobbying against effective public health measures, corporate social responsibility strategies that can deflect attention, and extensive supply chains”.
Research conducted by the HSE to inform its ‘Ask about alcohol’ communications campaign found that women do not always receive clear and consistent information on the importance of avoiding alcohol during pregnancy, it noted.
FASD is preventable through avoiding alcohol during pregnancy. There is no evidence-based, defined, safe amount of alcohol that can be consumed during pregnancy to prevent a child being born with FASD.
A HSE spokesperson said: “An implementation plan for the delivery of the actions with associated timeframes is under development. Many of the actions being progressed will utilise existing resources. Business cases for actions requiring additional resources will be submitted through the HSE estimates process.”
The prevalence and epidemiology of FASD in Ireland is not known. A 2017 systematic review and meta-analysis estimating prevalence of alcohol use during pregnancy showed Ireland had one of the highest of all countries studied. It estimated that between 2.8 and 7.4 per cent of the population might have FASD. In Ireland, two-in-five pregnancies are unplanned, increasing the chance the embryo and foetus will be exposed to alcohol.
It is estimated that about 600 babies in Ireland are born each year with foetal alcohol syndrome, with a further nine-to-10 times this number born annually with other FASD.
planning (eCPP). The target is to achieve compliance of 100 per cent usage of the eCCP toolset for procurement planning by Hospital Groups and Community Healthcare Organisations by the end of this year, with continued roll-out across health organisations to take place in 2023.
It is also a priority to support “e-health and disruptive technologies to deliver a major programme of digital health system replacement” in the wake of last year’s cyberattack on the HSE.
As part of ongoing digital transformation efforts within the HSE, new systems, applications, and tools will be made available to support HSE staff in executing procurement activities. One example is the long-delayed integrated financial management system (IFMS). The HSE is currently implementing a finance reform programme, of which the IFMS forms a key part.
The current aim is for over 80 per cent of expenditure to be transacted through the IFMS by 2025. A target operating model to support the IFMS will include “self-service procurement for purchases below €25,000; and procurement shared services for strategic sourcing above €25,000”.
It is also important to ensure new systems that have procurement-related capabilities, such as the national estates information system, are fully aligned and consistent with a new finance operating model and the IFMS target operating model.
An oversight group will monitor and drive the implementation of the plan. The group is to consist of senior leaders from the HSE, representatives from section 38 and 39 organisations, the Department of Health, and the Department of Public Expenditure and Reform. Meeting quarterly, the group will monitor and report on progress in terms of delivering on the priorities identified.
“The significant pressure on services is acknowledged as a key risk,” according to the document.
This will be “mitigated” by additional supports, including the recruitment of 20 procurement compliance business analysts.
The HSE’s new Chief Operations Officer (COO), Mr Damien McCallion, highlighted the disability and mental health sectors were under “severe pressure” earlier this year.
Mr McCallion became interim COO in June after Ms Anne O’Connor left the HSE to take up a position with Vhi Health and Wellbeing.
A HSE spokesperson told the Medical Independent (MI) that Mr McCallion was appointed as COO on a permanent basis on 20 September.
At a meeting of the HSE performance and delivery committee in July, the then interim COO Mr McCallion was asked by committee members for an overview of his first two weeks within the role.
Overall, the performance of community services had been “stabilising”, but remained “challenged in a number of service areas”, Mr McCallion told committee members, according to meeting minutes.
“An additional challenge is being presented by the Ukraine situation with significant numbers of people seeking refuge and support in Ireland with a corresponding requirement for a range of health services.”
Mr McCallion noted that the rise in Covid-19 cases in the first three
months of 2022 would impact on the ability to deliver on the annual national service plan key performance indicators.
“He highlighted that there remains a lot of work in the area of disabilities and mental health as these services remain under severe pressure.”
In relation to acute services, the COO reported that activity this year until June had been “significantly impacted” by the surge in Covid-19 cases in the early part of this year.
Separately, the search for a new HSE CEO is continuing.
“The CEO recruitment process is underway and we hope for it to be completed by the end of the year,” the HSE’s spokesperson told MI
RINVOQ demonstrated in an integrated analysis of the MEASURE UP 1 & 2 monotherapy studies at Week 16:
• EASI 75 skin clearance rates of 76% and 65% for patients treated with RINVOQ 30 mg QD and 15 mg QD, respectively, vs 15% with placebo (p<0.001 for both comparisons)2
• Itch reduction (mean percent change from baseline in Worst Pruritus NRS) of –70% and –58% for RINVOQ 30 mg QD and 15 mg QD, respectively, vs –24% with placebo (p<0.001 for both comparisons)2
PRESCRIBING INFORMATION (PI)
RINVOQ® (upadacitinib) 15 mg and 30mg prolonged-release tablets. Refer to Summary of Product Characteristics (SmPC) for full prescribing information. PRESENTATION: Each 15 mg prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15mg of upadacitinib. Each 30mg prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 30 mg of upadacitinib. INDICATION: Treatment of moderate to severe active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate. Treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. Treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy. DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of conditions for which upadacitinib is indicated. Dosage: RA, PsA and AS: The recommended oral dose is 15mg once daily. Consideration should be given to discontinuing treatment in patients with AS who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. AD (adults): The recommended oral dose is 15 mg or 30 mg once daily based on individual patient presentation. 30 mg once daily dose may be appropriate for patients with high disease burden and for patients with an inadequate response to 15 mg once daily. The lowest effective dose for maintenance should be considered. For patients ≥ 65 years of age, the recommended dose is 15mg once daily. AD (adolescents from 12 to 17 years): The recommended oral dose is 15mg once daily for adolescents weighing at least 30 kg. Adults and adolescents 12 years and older: Upadacitinib can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used for sensitive areas such as the face, neck, and intertriginous and genital areas. Consideration should be given to discontinuing upadacitinib treatment in any patient who shows no evidence of therapeutic benefit after 12 weeks of treatment. Special Populations: Elderly: For AD, doses higher than 15mg once daily not recommended in patients aged 65 years and older. Limited data for patients aged 75 and older. Renal: No dose adjustment required in mild-moderate renal impairment. Upadacitinib 15mg once daily should be used with caution in patients with severe renal impairment. Upadacitinib 30 mg once daily is not recommended for patients with severe renal impairment. Upadacitinib has not been studied in subjects with end stage renal disease. Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Should not be used in patients with severe (Child Pugh C) hepatic impairment. Paediatric Population: No data available in the following paediatric patient populations: children with AD below the age of 12 years; children and adolescents with RA, PsA and AS aged 0 to less than 18 years. CONTRAINDICATIONS: Hypersensitivity to active substance or excipients. Active tuberculosis (TB) or active serious infections. Severe hepatic impairment. Pregnancy. SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. Immunosuppression: Combination use, with immunosuppressants e.g. azathioprine, ciclosporin, tacrolimus, and biologic DMARDs or other JAK inhibitors has not been evaluated in clinical studies and is not recommended as the risk of additive immunosuppression cannot be excluded. Serious infections: Serious and fatal infections have been reported. Caution when treating patients ≥65 years. Frequently reported – pneumonia and cellulitis. Bacterial meningitis has been reported. Opportunistic infections reported –TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis. Do not initiate treatment in patients with active, serious infection, including localised infections. Consider the risk/benefit of treatment in patients with: chronic or recurrent infection, history of serious or opportunistic infection, those exposed to TB, those who have resided or travelled in areas of endemic TB or endemic mycoses, those with underlying conditions that may pre-dispose patients to infection. Closely monitor patients and interrupt treatment if there are signs and symptoms of infection pre and post treatment. Tuberculosis: Pre-screen patients for active or latent TB. RINVOQ should not be given to patients with active TB. Consider anti-TB therapy in patients with previously untreated latent TB or in patients with risk factors for TB infection. Consult with a physician with experience in TB therapy to assess whether initiating anti-TB therapy is appropriate for an individual patient. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Viral reactivation: Cases of herpes virus reactivation have been reported e.g. herpes zoster. If herpes zoster is reactivated, consider interruption of upadacitinib therapy until the episode resolves. Screen for viral hepatitis and monitor regularly for reactivation before starting and during therapy with upadacitinib. Patients, positive for hepatitis C antibody/hepatitis C virus RNA and hepatitis B surface antigen/hepatitis B virus DNA were excluded from clinical studies. If hepatitis B virus DNA is detected while receiving RINVOQ, a liver specialist should be consulted. Vaccination: Use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunisations, including
prophylactic zoster vaccinations prior to starting therapy, in agreement with current immunisation guidelines.
Malignancy: Immunomodulatory therapies may increase the risk of malignancies including lymphoma and nonmelanoma skin cancer in RA patients. Malignancies were observed in clinical studies. Periodic skin examination recommended for patients who are at increased risk for skin cancer. See SmPC for full details. Haematological abnormalities: Do not start therapy if Absolute Neutrophil Count <1 x 109 cells/L, Absolute Lymphocyte Count <0.5 x 109 cells/L and Hb <8 g/dL. Monitor patients and temporarily stop therapy if abnormal haematological parameters as specified are detected during routine patient management. Diverticulitis: Events of diverticulitis have been reported in clinical trials and post-marketing. Upadacitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis to prevent gastrointestinal perforation. Cardiovascular Risk: RA patients have an increased risk for cardiovascular disorders. Manage patient’s risk factors for e.g. hypertension, hyperlipidaemia as per usual standard of care. Lipids: Monitor total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) at 12 weeks and thereafter according to international guidelines. Elevated LDL in clinical trials decreased to pre-treatment levels in response to statin therapy, although evidence is limited. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Hepatic transaminase elevations: Monitor liver enzymes at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. In such cases therapy should be interrupted until this diagnosis is excluded. Venous thromboembolism: Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAKi, including upadacitinib. Use therapy with caution in patients at high risk for DVT/PE. Risk factors should be determined by patients age, obesity and medical history of DVT/PE, patients undergoing major surgery and prolonged immobilisation. If clinical features of DVT/PE occur discontinue therapy, evaluate and treat promptly.
INTERACTIONS: Upadacitinib is metabolised mainly by CYP3A4 and plasma exposures may be affected by CYP3A4 inhibitors or inducers. Upadacitinib 15 mg once daily should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors. Upadacitinib 30 mg once daily dose is not recommended for patients receiving chronic treatment with strong CYP3A4 inhibitors. See SmPC for full details. FERTILITY, PREGNANCY AND LACTATION: Upadacitinib is contraindicated during pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of upadacitinib. Female paediatric patients and/or their parents/caregivers should be informed about the need to contact the treating physician once the patient experiences menarche while taking upadacitinib. Upadacitinib should not be used during breast-feeding. The effect of upadacitinib on human fertility has not been evaluated. ADVERSE REACTIONS: Refer to SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): upper respiratory tract infections, acne. Common adverse reactions (≥1/100 to <1/10): bronchitis, herpes zoster, herpes simplex, folliculitis, influenza, anaemia, neutropaenia, hypercholesterolaemia, cough, abdominal pain, nausea, urticaria, fatigue, pyrexia, increased blood CPK/ALT/AST, increased weight and headache. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie.
LEGAL CLASSIFICATION: POM (S1A). MARKETING AUTHORISATION NUMBER/ PRESENTATION: EU/1/19/1404/001 and EU/1/19/1404/006 – Calendar blister packs containing 28 prolonged-release tablets. MARKETING
AUTHORISATION HOLDER: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany. Further information is available from AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
DATE OF REVISION: December 2021. PI-1404-005
Abbreviations: EASI – eczema activity and severity index; NRS – numerical rating scale; QD – once daily; EU – European Union.
* The recommended dose of RINVOQ is 15mg once daily for adolescents weighing at least 30kg. The safety and efficacy of RINVOQ in children with atopic dermatitis below the age of 12 years have not been established. No data are available. No clinical exposure data are available in adolescents <40kg. The posology in adolescent patients 30kg to <40kg was determined using population pharmacokinetic modelling and simulation.2
Reference: 1. Langan S. et al. Atopic dermatitis. The Lancet. 2020;396(10247):345-360. DOI: https://doi.org/10.1016/ S0140-6736(20)31286-1.
2. RINVOQ Summary of Product Characteristics, available on www.medicines.ie
3. Baricitinib Summary of Product Characteristics, available on www.medicines.ie 4. Abrocitinib Summary of Product Characteristics, available on www.medicines.ie
RINVOQ, the first and only oral JAK inhibitor indicated for the treatment of both adults and adolescents ≥12 years* with moderate to severe Atopic Dermatitis in the EUDAVID LYNCH david@mindo.ie
Last month, a conference in Dublin marked the launch of the new strategy for HSE National Doctors Training and Planning. David Lynch reports
Innovation in data analysis and collection, increased part-time working arrangements, and greater training opportunities for doctors on the general division of the medical register are among the objectives of the new strategic plan of HSE National Doctors Training and Planning (NDTP).
The NDTP Strategic Plan 2022-2027 was launched in Dublin on 11 November at a conference which included delegates from all areas of the HSE, the Medical Council, the Department of Health, and international speakers.
Speaking at the event, Dr Philip Crowley, National Director of Strategy and Research, HSE, said the conference was an opportunity “to listen and learn from one another to further strengthen the HSE’s ongoing commitment to supporting the careers of our NCHDs”.
“There are significant challenges in recruitment and retention, and this conference will give us an opportunity to share thoughts and experiences on how we can build a sustainable workforce who feel fulfilled and safe in their work environment.”
Officially launching the new strategy, Medical Director of the NDTP Prof Brian Kinirons told delegates that the document “involves a huge number” of stakeholders.
“There is much that we do well,” Prof Kinirons said.
“We know that, for example, that we increase training [numbers] year on year... and every year despite the increase in the training programmes these training programmes are full. So it is fairly clear that there is huge demand for our doctors [and] for high-quality training... we deliver world-class training.”
However, he noted that he was “not saying there are not challenges”.
“What we are reaffirming in this strategy is our commitment to workforce planning. It is the foundation stone of who we are and what we do. In terms of our vision for the future, this is the roadmap that will guide our major decisions over the next five years.”
Prof Kinirons said it was the NDTP’s vision to “create a healthcare environment where patients receive the best care from the best medical workforce and to achieve the best outcomes and where doctors fulfill their full potential”.
Data Prof Kinirons added that the document noted the “importance” of data.
“The NDTP is a recipient of a huge volume of largely quantitative data, which we collaborate with our stakeholders in terms of generating. We spend a huge amount of energy ensuring that the data is clean, validating the data, and that data drives the de-
cision-making, informs positive change and also directs our workforce plans.”
He said that the NDTP is investing “in data analytics and we will actually broaden and commit to embracing and improving” the collection system.
The referenced system is the current DIME [Doctors Integrated Management E-system], and Prof Kinirons said this work is a “key part of our commitment” to the future.
Writing in the foreword of the strategy, Dr Colm Henry, Chief Clinical Officer, HSE, noted that “we know that planning for health services cannot succeed unless comprehensive data is gathered and transformed into useful information that generates actionable insights and recommendations.”
“This enables HSE and Government make the right decisions in planning for the medical workforce needs of our health service to deliver the best care to our population.”
Workforce planning is also a significant part of the new strategy. The NDTP Medical Director told conference delegates that the organisation is close to signing contracts with an external academic partner to allow the unit to increase the number of specialty specific reports it produces each year.
Prof Kinirons said that “training and development is a significant portion of our project – this is about investing in training and it is largely about being an advocate for training in the medical workforce”.
He outlined the roll-out in Children’s Health Ireland and South/South West Hospital Group of a network of clinical educators, who would “support the generic elements of the [training] curriculum”.
“This is again an example of a significant investment in grassroots education at a site level by NDTP.”
The new plan includes a commitment to “work with the clinical educator network to enhance mentorship for doctors” on the general division of the register.
Speaking to the Medical Independent (MI), Prof Kinirons said that these measures are about “recognising the fact that there are doctors who need support in terms of training... so it’s about trying to find measures to support them and recognising the fact that we have too many [doctors] on that [general] register and we need to reduce that number”.
More than one-third of all clinically active doctors in Ireland are on the general division of the register, according to the Medical Workforce Intelligence Report 2021, which was published by the Medical Council in September.
Doctors on the general division of the Medical Council register need “equal training opportunities” and legislative support, Dr Suzanne Crowe, President of the Medical Council, told the conference.
Prof Kinirons told delegates that none of the training and data developments “is [of] any benefit unless we have a robust retention strategy”.
“We believe we need to change the way we work in order to retain the doctors of the future,” he said.
“That includes less than full-time working and training.”
He added that “whilst we have a smaller number of doctors currently training less than full-time”, such part-time work would become more sought after.
Prof Kinirons told MI that “there are challenges” when it comes to flexible work arrangements.
“You can’t be what you can’t see,” he said.
“So we have to develop a culture [with]... trainees who are successfully training part-time and it is only when you see that, that it becomes the model for the future, and then people can consider that.
“…I think there is an unmet demand and we need to grow the current numbers. We currently have maybe 70 doctors [in training] working on a part-time basis or less than a full-time basis in the country and we need to grow that number. In the UK, 11-to-13 per cent of all their trainees are training less than fulltime. In Ireland, it’s less than 3 per cent, so we need to grow that.”
Although not a focus of his speech during the strategy launch, Prof Kinirons later told this newspaper that an agreed new consultant contract is “critical” to recruiting and retaining doctors.
Last month, the current negotiations between representatives bodies and the HSE and Department of Health were described as being “very close” to completion by the Minister for Health Stephen Donnelly.
Prof Kinirons told MI a new contract “does matter”.
“I think it is about creating an environment where people want to work in,” he said. “So the contract is critical. So we want to create a contract that is actually attractive that will actually bring people back to Ireland. We don’t want to create barriers to that.”
Last month’s conference also heard from Dr Consilia Walsh, Clinical Lead, NDTP, who said that the NDTP’s model 3 hospital network project is due to be finalised in the coming weeks. The project report and recommendations should be completed towards the end of the year. The NDTP will then fund a project manager to progress the recommendations.
In the NDTP strategy’s foreword, Dr Henry wrote that it was “essential that we utilise all of the clinical resources represented by our medical workforce, which includes supporting a variety of pathways through training and career progression, and continuing to create flexible working conditions so that our highly educated, motivated and passionate doctors can stay working within our healthcare system throughout their careers”.
The NDTP Strategic Plan 2022-2027 describes its mission as “ensuring that the needs of the health service and our population are provided for by data-driven medical workforce planning. The right doctor, with the right training, in the right place, at the right time.”
The document lists its “key mandates” as continuing to support the move to a consultant-delivered service, to create multiple pathways for career progression, encourage the medical workforce into training pathways, cultivate flexible working arrangements, and support a culture of excellence and innovation.
The same effective and stable plasma
levels are achieved
Intestinal
ABBREVIATED PRESCRIBING INFORMATION. Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel. 1 ml contains 20 mg levodopa, 5 mg carbidopa monohydrate and 20 mg entacapone. Presentation: Yellow or yellowish-red opaque viscous gel. Indications: Treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results. Dosage and administration: Adults/Elderly: Administration by a portable infusion pump directly into the duodenum or upper jejunum via a percutaneous endoscopic gastrostomy(PEG) tube or radiological gastrojejunostony tube. Please consult Summary of Product Characteristics (SmPC) for further information. Only pump Crono LECIG (CE 0476) may be used for the administration of Lecigon. The dose should be titrated to achieve the optimal clinical response in the individual patient, which involves maximising the functional ON-time during the day by minimising the number and duration of OFF episodes (bradykinesia) and minimising ON-time with disabling dyskinesia. Total dose/day of Lecigon is composed of three individually adjusted doses: the morning bolus dose, the continuous maintenance dose, and extra bolus doses. Treatment is usually limited to the patient’s awake period. If medically justified, Lecigon can be administered up to 24 hours/day. The maximum recommended daily dose is 100 ml (2000 mg levodopa, 500 mg carbidopa monohydrate and 2000 mg entacapone. Please consult SmPC for further information. Total morning dose is usually 5–10 ml (100–200 mg levodopa) but not exceeding 15 ml (300 mg levodopa). Continuous maintenance dose is usually 0.7–5.0 ml/hour (15–100 mg levodopa/hour). Extra bolus doses are given if the patient becomes hypokinetic and are normally less than 3ml. An increase in the continuous maintenance dose should be considered if the need for extra doses exceeds 5 doses per day. Please consult SmPC for further information. After initial titration, the morning dose and maintenance dose are fine-tuned over the course of a few weeks. Lecigon is initially given as monotherapy. If needed, other anti-Parkinsonian medicinal products can be taken concurrently. If treatment with other anti-Parkinsonian medicinal products is discontinued or changed, it may be necessary to adjust the doses of Lecigon. Sudden deterioration in response with recurring motor fluctuations may indicate that the tube has dislocated to the stomach. This needs confirmation by X-ray and may require repositioning. Please consult SmPC for further information. The cartridge is for single use only and should not be used for more than 24 hours. Children: There is no relevant indication for use in children and adolescents. Contraindications: Hypersensitivity to the active substances or any of the excipients, narrow-angle glaucoma, severe heart failure, severe cardiac arrhythmia, acute stroke, severe hepatic impairment. Non-selective MAO-inhibitors and selective MAO type A inhibitors are contraindicated and should be discontinued at least two weeks prior to initiating therapy with Lecigon. Conditions in which adrenergics are contraindicated. Previous neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis. Suspected undiagnosed skin lesions or a history of melanoma. Please consult SmPC for further information. Warnings and precautions: Not recommended for the treatment of drug-induced extrapyramidal reactions. Caution in ischaemic heart disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions, past or current psychosis, chronic wide-angle glaucoma, concomitant administration of antipsychotics with dopamine receptor blocking properties or with medicines which may cause orthostatic hypotension. In patients with a history of myocardial infarction who have residual atrial nodal or ventricular arrhythmias, cardiac function should be monitored with particular care during the period of initial dosage adjustments. Monitor all patients for mental changes, depression with suicidal tendencies, and other serious mental changes. Neuroleptic malignant like syndrome with secondary rhabdomyolysis may occur on abrupt dose reduction/discontinuation of Lecigon. Patients should be monitored for the development of impulse control disorders and review of treatment is recommended if such symptoms develop. Patients and caregivers are advised to monitor for melanomas on a regular basis when using Lecigon. Dose may need to be adjusted downwards to avoid levodopa-induced dyskinesia. Periodically evaluate hepatic, haematopoietic, cardiovascular and renal function during extended therapy. Lecigon contains hydrazine, a degradation product of carbidopa that can be genotoxic and possibly carcinogenic. Reported complications for levodopa/carbidopa in clinical studies include bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischaemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumoperitoneum and post-operative wound infection. Sudden or gradual worsening of bradykinesia may indicate an obstruction in the tubing system and should be investigated. Weight loss has been associated with the active substances contained in Lecigon, and caregivers should therefore be aware of weight loss. Monitoring of weight is recommended to avoid severe weight loss. Prolonged or persistent diarrhoea that appears during use of entacapone could be a sign of colitis. In case of prolonged or persistent diarrhoea, treatment with the medicinal product should be discontinued and other appropriate medical treatment and investigation considered. Replacement of Lecigon with either levodopa and a DDC inhibitor without entacapone or other dopaminergic therapy may be necessary and should be done slowly. For patients who experience progressive anorexia, asthenia and weight loss within a relatively short period of time, a general medical evaluation including liver function assessment should be considered. Please consult SmPC for further information. Interactions: Antihypertensives, antidepressants, anticholinergics, dopamine receptor antagonists, benzodiazepines, isoniazide, phenytoin, papaverine, sympathicomimetrics iron, protein-rich diet, amantadine and dopamine agonists (e.g. piribedil) may increase levodopa-related adverse events. Lecigon dose adjustment may be needed when used with these medicines. Lecigon can be taken with MAO type B inhibitors (e.g. selegiline) although serious orthostatic hypotension may occur and the dose of levodopa may need to be reduced. Lecigon may affect metabolism of medicinal products such as S-warfarin and patients should be monitored during initiation with Lecigon therapy when used with this medicine. Please consult SmPC for further information. Pregnancy and lactation: Lecigon is not recommended during pregnancy or in women of childbearing potential not using contraception unless the benefits for the mother outweigh the possible risks to the foetus. It is unknown whether carbidopa and entacapone or their metabolites are excreted in human milk. Breastfeeding should be avoided during treatment with Lecigon. Driving and operation of machinery: Caution; Lecigon can have a major influence on the ability to drive and use machines. Refrain if somnolence and/or sudden sleep episodes occur. Undesirable effects: Weight loss, anxiety, depression, insomnia, dyskinesia, Parkinson’s disease /exacerbation of parkinsonism (e.g. bradykinesia), orthostatic hypotension, nausea, constipation, diarrhoea, pain in muscles and tissues, musculoskeletal pain, chromaturia, fall. Complications of the device and surgery: Postoperative wound infection, abdominal pain, excessive granulation tissue, complication of device insertion, incision site erythema, post-procedural discharge, procedural pain, procedural site reaction. Refer to SmPC for other undesirable effects. Adverse events should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Special precautions for storage: Store in a refrigerator 2°C - 8°C. Do not freeze. Store in the original package in order to protect from light. For storage instructions after first opening of the medicinal product, refer to the summary of product characteristics. Pack size: 7 x 47 ml cartridges. Marketing authorisation holder: LobSor Pharmaceuticals AB, Kålsängsgränd 10 D, SE-753 19 Uppsala, Sweden. Distributed by Clonmel Healthcare Ltd, Clonmel, Co. Tipperary. Marketing authorisation number: PA23144/001/001. Medicinal product subject to medical prescription. A copy of the summary of product characteristics is available upon request or alternatively please go to: www.clonmelhealthcare.ie Last revision date: March 2022. Date of Preparation: October 2022. 2022/ADV/LEC/268H
A combination of three effective Parkinson’s therapies in one convenient gel formulation for intestinal infusion1
In late May of this year, the first case of monkeypox (which is being renamed mpox by the World Health Organisation (WHO)) was recorded in Ireland.
The WHO announced the global outbreak as a public health emergency of international concern (PHEIC) on 23 July.
As of 19 November, the HSE had been notified of 217 confirmed cases of monkeypox in Ireland. At the time of going to press, there were nearly 80,000 cases reported as part of a multi-country outbreak in countries where there has not historically been monkeypox, according to the US Centres for Disease Control and Prevention.
Monkeypox is a viral zoonosis (a virus transmitted to humans from animals), with symptoms similar to those seen in the past in smallpox patients, although it is clinically less severe.
The virus, which is part of the orthopoxvirus group, is endemic in Central and West Africa.
Progress
After the outbreak was announced as a PHEIC, the HSE established a monkeypox national crisis management team to coordinate a multidisciplinary health service response to the outbreak.
Experts from across the healthcare system contributed to this response, including the National Ambulance Service, infection control, the national immunisation advisory committee (NIAC), the Department of Health, NGOs and advocacy groups, and HSE communications, among others, according to the Irish Society of Specialists in Public Health Medicine (ISSPHM).
Strategy Lead for the Society, Dr Fiona Ciani told the Medical Independent (MI): “In particular, what worked very well was harnessing the existing, well-established relationships between the HSE and networks of community and advocacy groups and NGOs, as a result of work done on HIV and sexual health. These relationships have been really important in the management of this outbreak and we could learn a lot from how this is working for other programmes also.”
The Department of Health also established a strategic advisory group on monkeypox on 18 August, chaired by Chief Medical Officer Prof Breda Smyth. The group held its third meeting on 9 November and “will continue to hold regular meetings”, a spokesperson for the Department of Health told MI
According to the Department spokesperson, the advisory group “continues to provide oversight and advice on the surveillance and management of monkeypox at a national level, as well as the ongoing strategy to contain the outbreak”.
However, Dr Ciani highlighted the continuing gaps in the surveillance and management systems for infectious disease outbreaks.
She said the outbreak demonstrated “yet again that we urgently need a case and incident management system for public health”.
This system would comprise of “a nationally integrated IT system that will enable the recording, investigation, and control of all infectious disease hazards, incidents, and outbreaks”, according to Dr Ciani.
She also pointed to the need for a national immunisation information system.
Vaccines
A vaccine based on a modified attenuated vaccinia virus (Ankara strain) was approved for the prevention of monkeypox in 2019. This is a two-dose vaccine for which availability remains limited.
Given the current limited vaccine supply and following detailed clinical discussions, the HSE prioritised the vaccine for gay, bisexual or other men who have sex with men (gbMSM), and transgender people who have had a notification to the HSE’s infectious disease monitoring system (CIDR), of early infectious syphilis (EIS) between December 2021 and July 2022.
The vaccines are being rolled out in two phases: Phase I pre-exposure vaccination for gbMSM and transgender people who contracted EIS in the above timeframe; and phase II pre-exposure vaccination for the people at heightened risk of con-
tracting the virus.
The roll-out of vaccines for monkeypox began at the end of August for the prioritised populations. A spokesperson for the HSE told MI: “The current working model will be to utilise the Covid vaccination infrastructure to allow the rapid administration of vaccines to further agreed prioritised groups.”
On 25 October, Minister for Health Stephen Donnelly announced the purchase of 15,000 additional monkeypox vaccines. A total of 5,000 doses were to be delivered by the end of the year and the remaining 10,000 doses to be delivered in early 2023.
At the time of the purchase, the Department said: “Demand for the vaccine has been high and all currently available vaccine appointments have now been booked. A significant number of additional appointments will open for booking [in November].”
Originally, the HSE estimated that about 6,000 people were at heightened risk of exposure to monkeypox. The original plan was for 10 per cent of this population to be vaccinated in the first stages of roll-out. Then the European Medicines Agency (EMA) recommended that the monkeypox vaccine was to be given intradermally, rath-
Ireland will be in receipt of additional monkeypox vaccines “very soon”, the Director General of the EU Health Emergency Preparedness and Response Authority (HERA) has told the Medical Independent (MI)
Mr Pierre Delsaux was in Dublin on 24 November for a conference. Following the event, Minister for Health Stephen Donnelly said that HERA’s role in securing availability of medical countermeasures in the event of future public health crises would be “essential” in ensuring smaller EU member states had the resources to combat cross-border health threats.
HERA was established last year following Europe’s difficult experience in the early period of Covid-19.
Its aim is to ensure that the EU and member states are “better prepared to act” in the face of future cross-border health crises, by supporting the rapid development, manufacturing, procurement, and equitable distribution of “key medical countermeasures”.
Responding to some concerns over the pace at which monkeypox vaccines arrived in Ireland earlier this year, Mr Delsaux told MI that without the coordinated work of HERA across Europe, there would have been no
vaccines arriving at all.
He said the distribution system was agreed by member states.
The difficulty was that “available vaccines were in limited quantity, so there were only a limited number of vaccines that were available before the summer”, he said. “At HERA we purchased everything which was available at that time... then [the vaccines] were distributed to the member state. But of course, in such a case you need to be fair.”
He added: “That’s why… you [Ireland] got a limited number of vaccines – but more than you would have gotten without HERA.”
He said: “You could say it is not enough, but that is all that was there. Again, without HERA, without the work we have done, collectively nothing would have come to Ireland, and not only to Ireland, but other member states.”
Mr Delsaux said that “more monkeypox vaccines will be available in Ireland soon”.
“And when I say soon, I mean very soon, and that is the same for other member states,” he stated.
He added that HERA had made further agreements with the vaccine manufacturer and more monkeypox vaccine will be available next year.
er than into the subcutaneous tissue. This administration allows a smaller dose of vaccine to be used, thus allowing more people to be vaccinated, according to the EMA. NIAC reviewed the recommendation and approved it in the interim, while vaccine supplies are low.
The ISSPHM’s Dr Ciani highlighted that the global shortage of vaccines does not only affect the countries in which monkeypox was not historically recorded. Most cases of the virus are recorded in the Democratic Republic of the Congo and Nigeria, where the virus is endemic.
According to Dr Ciani: “We have to remember though that it is countries in sub-Saharan Africa that have been most affected by monkeypox since it was first identified. Unfortunately, once again, like for Covid, we have inequity in access globally to vaccines for this PHEIC.”
Many countries where monkeypox was not historically recorded are now seeing a decline in monkeypox transmission. The European Centre for Disease Prevention and Control (ECDC) reported 2,151 cases in the EU/EEA region in the third week of July; however, there were only approximately 42 new cases reported between 8 November and 22 November.
However, speaking in September, Prof Jack Lambert, Consultant in Infectious Diseases and Genitourinary Medicine, Mater Misericordiae University Hospital, Dublin, said the reduction in transmission was “despite [of] what we’re doing, not because of it”.
“I think our response, especially our vaccine response, has been quite slow,” he told MI. “We did have plans to vaccinate all the high-risk [gb]MSMs, but that vaccine plan was delayed, delayed, delayed, and now just starting.”
According to Prof Lambert, while fortunately the cases of monkeypox seemed to be subsiding, this delay could have been dangerous if the virus was as deadly as the first wave of Covid. “The bureaucracy and the crisis preparedness and the ability to operationalise plans in the middle of a crisis seems to be lacking in Ireland. We had the experience with Covid and now we’ve had the same experience with monkeypox.”
Information Prof Lambert added that more accurate information about the monkeypox virus should be published, particularly around the mortality rate associated with the virus. He noted that early coverage of the issue had caused fear in the gbMSM community.
A HSE spokesperson told this newspaper: “A significant element of the vaccination roll-out plan will involve the development of additional communication and community engagement initiatives.”
They also highlighted the monkeypox awareness campaign organised by the MPOWER programme, an initiative by HIV Ireland and Man2Man with oversight from the HSE. Primary care operations had also approved psychosocial supports for those affected, provided by HIV Ireland.
Shingrix powder and suspension for injection in vials
(Please refer to SmPC before prescribing)
Composition: After reconstitution, one dose (0.5 mL) contains: Varicella Zoster Virus glycoprotein E antigen1,2 50 micrograms. (1 adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms, 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms, 2 glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology). Therapeutic indications: Prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults 50 years of age or older and in adults 18 years of age or older at increased risk of HZ. The use of this vaccine should be in accordance with official recommendations. Posology and method of administration: For intramuscular injection only, preferably in the deltoid muscle. Primary Vaccination: Initial dose of 0.5 ml followed by a second 0.5 ml dose 2 months later. For flexibility the 2nd dose can be administered between 2 and 6 months after the first dose. For subjects who are or might become immunodeficient or immunosuppressed and whom would benefit from a shorter vaccination schedule, the 2nd dose can be given 1 to 2 months after the initial dose. Booster doses: need not established. Contraindications: Hypersensitivity to the active substances or any of the excipients. Special warnings and precautions for use: The name and the batch number of the administered product should be clearly recorded. Appropriate medical treatment and supervision should be readily available in case of an anaphylactic event. Administration of Shingrix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in deferral. A protective immune response may not be elicited in all vaccinees. Never administer intravascularly or intradermally; subcutaneous administration not recommended as it may lead to an increase in transient local reactions. Caution in individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration. Syncope can occur following, or before any vaccination as a psychogenic response. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. There are no data to support replacing a dose of Shingrix with another HZ vaccine. There are limited data to support the use of Shingrix in individuals with a history of HZ and in frail individuals including those with multiple comorbidities. The benefits and risks of HZ vaccination should be weighed on an individual basis. Interactions: Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23), 13-valent pneumococcal conjugate vaccine (PCV13) or reduced antigen diphtheria-tetanusacellular pertussis vaccine (dTpa). The vaccines should be administered at different injection sites. Fertility, pregnancy and lactation: There were no effects on male or female fertility in animal studies. It is preferable to avoid the use of Shingrix during pregnancy. The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied. It is unknown whether Shingrix is excreted in human milk. Effects on ability to drive and use machines: Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination. Undesirable effects: Very common (≥1/10): Headache, GIT symptoms, myalgia, injection site reactions, fatigue, chills, fever. Common (≥
to <1/10): injection site pruritus, malaise. Uncommon (≥1/1000 to <1/100): lymphadenopathy, arthralgia. Rare (≥1/1000 to <1/100): Hypersensitivity reactions. Legal
Niamh Cahill speaks to Consultant in Child and Adolescent Psychiatry
Prof Fiona McNicholas about her research into the high levels of burnout in the area
The long waiting lists for children referred to the HSE Child and Adolescent Mental Health Services (CAMHS) are well recognised.
The matter is often highlighted in the media, as experts call for greater investment in the service to help address the issue.
The spotlight, however, falls less regularly on the clinicians working within child and adolescent psychiatry and the challenges they face in trying to provide a quality patient service.
Consultants in psychiatry in Ireland can often suffer “moral injury” due to the nature of the services they work in.
In her academic work, Prof Fiona McNicholas, Consultant in Child and Adolescent Psychiatry at Children’s Health Ireland at Crumlin and the Lucena Clinic, Rathgar, has drawn attention to the issue and related factors.
Prof McNicholas and colleagues have published a number of studies on burnout in CAMHS and the adult mental health services.
Furthermore, data obtained from another larger study on stress levels among doctors in psychiatry during the Covid-19 pandemic is currently being analysed.
Prof McNicholas, who has worked in the Irish mental health service for the past 23 years, began the research to examine the wellbeing of her colleagues due to the concern they were working in an under-resourced environment with poor staffing levels and increasing referrals.
Since 2014, referrals to CAMHS have increased by about 30 per cent.
“These referrals have been increasing and this has not been met with significant investment in CAMHS,” Prof McNicholas told the Medical Independent (MI)
“There has been a little additional investment, but not much, and we started at a very low level.”
She spoke about the difficult experience of being aware of increasing numbers of children waiting to be seen, and struggling, but not having the capacity, to see them.
“That is damaging to yourself as a clinician trying to do a good job. We talk about that as ‘moral injury’. You want to do a good job, but you can’t for various reasons. It was in that context, where referrals were increasing, and we weren’t getting an increase in resources, that I decided to look at the level of burnout in consultants.”
One study, ‘Burnout in consultants in CAMHS in Ireland: A cross-sectional study,’ was published in BMJ Open in 2020.
The results showed that 75 per cent and 72.3 per cent of respondents were suffering from moderate or higher levels of work-re-
lated burnout, respectively.
Almost 70 per cent had seriously considered changing jobs and higher burnout scores were present in those who would not retrain in child psychiatry.
“The biggest shock of all was to see the amount of people who thought of not retraining in child psychiatry and that had thought of leaving their job. That’s a huge problem. That’s a bit of an emergency when you have that amount saying they seriously thought of changing jobs in the last six months,” said Prof McNicholas.
The study concluded that “urgent organisational intervention” was required to support the wellbeing of consultant psychiatrists.
Despite the results, Prof McNicholas said neither she nor her colleagues have been consulted by the HSE about their wellbeing in a meaningful way.
Job satisfaction is a major part of recruitment and retention, which is a significant problem within the specialty of psychiatry internationally.
“Recruitment and retention in child psychiatry is a big problem everywhere,” according to Prof McNicholas.
“It’s hard to get psychiatrists to stay in post and to get good job satisfaction. There are many reasons for this.”
These factors include remuneration (psychiatrists generally earn less than colleagues in other medical specialties because there is little private work); poorly resourced services and work environments; and the personal impact of dealing with mental illness.
Regarding the final point, Prof McNicholas said that “if you’re dealing with other people’s problems day-in, day-out, patients are depressed and distressed and have had awful things happen to them, then there is going to be a natural impact on you”.
“Also, sometimes your patients don’t always agree with you despite a helpful con-
sultation; they’re not always happy with you. Whereas if you were going to a cardiologist… they’re generally much happier with you. It’s a difficult practice.”
Other CAMHS staff
Prof McNicholas examined stress and burnout among all staff members in CAMHS in a study published in the Irish Journal of Psychological Medicine in April 2022. It was titled, ‘Occupational stress in clinical and non-clinical staff in CAMHS: A cross-sectional study.’
“The consultant is the leader of the team and absorbs a lot of the stress and has additional managerial and clinical governance responsibilities, but other members are equally exposed,” Prof McNicholas told MI
“We included secretaries and cleaners because they are often dealing with parents who are frustrated about being on a waiting list. Sometimes the secretaries aren’t properly supported in their role and have never been trained in how to deal with an angry parent.
“What was interesting about this study was that even non-clinical staff were just as stressed in the CAMHS setting.” She said these staff must not be forgotten and are also experiencing burnout.
The survey examined the view of 59 clinical and non-clinical staff. It concluded that “pre-pandemic levels of stress were high among clinical and non-clinical staff surveyed”.
“Given the anticipated increased demand on CAMHS post-Covid-19, urgent action is needed to protect all staff from intolerable levels of occupational stress and burnout”.
Further studies are underway to determine whether “the same stresses have been magnified” because of Covid-19, Prof McNicholas said. Stress levels among psychiatric medical professionals during Covid-19 will be examined in a large national study.
There will also be research undertaken on the stress levels of non-frontline clinicians. It is hoped this will raise HSE awareness of the need to “invest more in looking after staff in their services, because if they don’t, the staff will leave and they won’t have a service”.
According to Prof McNicholas, the problems highlighted in the research have worsened following the pandemic.
“I work in both the community and Crumlin hospital and we are continuing to see the huge increase in referrals,” she said.
“Our staff are getting sick with Covid-related illnesses, but you still have an increasing number of referrals. Whilst you’re able to do it in the beginning, this kind of active motivation where everybody was en-
ergised, now we’re all depleted as it’s been going on for two years-plus. We’re exhausted. The burnout is getting worse.
Prof McNicholas pointed out that before Covid-19, clinicians “derived solace” from meeting with colleagues at conferences. However, the pandemic saw a reduction in the number of face-to-face events.
“That’s still continued, even though it’s probably not necessary…. I think that’s very detrimental and sometimes you worry that organisations have gotten too lazy and they continue with online because it suits them and they’re not realising the negative side of that and what’s being missed.”
The increasing number of children seeking help for mental illnesses is an international trend, according to Prof McNicholas.
She attributes many reasons for the rise, including the use of social media, online bullying, changes in diet, and the fragmentation of families.
“Society has changed and social media has been mentioned as a particular risk factor for kids; the fact you’re continuously exposed to social media and there is no reprieve and adolescents are now wedded to their phones,” she said.
“And it’s all about peer comparison… there’s a lot of self-worth attached to other people’s ratings of you.”
Prof McNicholas also noted the “pervasive” nature of online bullying.
“Before, if you were bullied at school, you had a reprieve when you came home and you could build up resilience. But now the pervasive nature of social media means that’s not possible.”
Prof McNicholas called on the Government to make a commitment to child psychiatry through increased funding and the creation of a more “child-specific focus” in the management of services.
She argued the second priority should be for mental health services to begin to make wellbeing of their staff a priority.
“They should be evaluating that on a regular basis,” she emphasised.
Prof McNicholas pointed out that, despite the difficulties, working in child and adolescent psychiatry is still a very rewarding career.
“I am so passionately interested in the wellbeing of children’s mental health that, despite horrendous days, I still delight in being able to meet with the family of a child and feel I’ve made some small difference to the child’s outcome,” she said.
“Despite the hours I work, I love my job. I feel in order to provide a good service to my patients I’m often in the hospital for hours to do that. I give a lot of my time to trainees as well. You could do that 24 hours a day and still feel you haven’t given them enough support.”
The Medical University of Bialystok (MUB) is a modern, dynamically developing university, whose mission is to provide the best education of professional, responsible, modern medical staff, conduct research at the highest international level, implement innovative application solutions in cooperation with providers of medical services and act in response to social needs. Currently, 6,000 students study at 16 courses, including over 450 students studying in English, and over 30,000 graduates have already left the walls of the University.
The Medical University of Bialystok belongs to the most dynamic medical universities in Central and Eastern Europe and, for many years, it has been adopting an innovative scientific policy.
The University is continuously investing in the development of academic staff. Researchers benefit from numerous scholarships, internships, trainings, and study visits to the best scientific and educational centres in the world. The number of foreign scientists collaborating with our University, who represent dynamically developing world research centres is growing annually.
These activities result in the growing number of the University staff achievements. Medical University of Bialystok employees are experts in their fields of science, members of scientific committees, editorial offices. The dynamic, creative staff constitutes great potential for acquiring external funds, both research and EU grants and for commercialisation of research.
Medical University of Bialystok undertakes numerous scientific initiatives of significant importance for the region and the country. It is a precursor and leader in conducting work on artificial intelligence in medicine and contributing to the development of large-scale research on genomics, proteomics, metabolomics, radiomics and bioinformatics. It was here that the first, in this part of Europe, Centre for Artificial Intelligence in Medicine was founded, based on the generation of high-quality comprehensive data sets from patients with civilization diseases. The University also conducts a population-based study, unique in this part of Europe, covering 10,000 inhabitants of Bialystok (Bialystok Plus Study). Unique research programmes in the field of personalised medicine and lifestyle diseases are being implemented. One of them is a project to create a reference model of biobanking and a service supporting the diagnosis and treatment of early stages of non-small cell lung cancer.
The University has a state-of-the-art research and educational infrastructure, which includes, among others: A modern University Clinical Hospital; Euroregional Pharmacy Centre; Faculty of Health Sciences Didactic-Scientific Centre; Centre for Experimental Medicine; Centre for Clinical Research; Centre for Bioinformatics and Data Analysis; Laboratory of Molecular Imaging; and Centre for Medical Simulation.
The confirmation of the significant position of the University are the scientific categories awarded by the Ministry of Education and Science (in the evaluation of scientific activity for 2017-2021): The highest possible A+ category in the discipline of pharmaceutical sciences and category A in the disciplines: medical sciences and health sciences. This result is one of the best among all Polish universities.
In addition, MUB, as the only Polish university, has won a prestigious grant for conducting PhD studies in the COFUND competition as a part of the Marie Skłodowska-Curie Actions within the European Commission Framework Programme, Horizon 2020. In 2019, the University took eleventh place in the prestigious competition of the Ministry of Science and
Higher Education “Initiative of Excellence - Research University”, which selected 20 best Polish universities.
The Faculty of Medicine of the Medical University of Bialystok is the faculty with the longest tradition. It was established along with the creation of the Doctors Academy in Bialystok on 3 February 1950. In 1969, the University’s academic scope expanded by creating the Division of Dentistry. Over the course of the next few years the educational offer was expanded and the Faculty’s academic and research base was improved.
A six-year English-language MD programme was inaugurated in 2004 and was made available to the students. Currently, among the teaching staff, there are over 88 professors, 93 associate professors, and about 590 academic teachers. The academic, research, diagnostic and therapeutic programmes at this Faculty are executed by 44 clinics, 36 departments and four independent laboratories. Currently, there are about 2,600 students and over 17,000 graduates of the Faculty. The high level of teaching at Medical University of Bialystok is proven by the top positions obtained by our graduates in the Medical Final Examination and Medical-Dental Final Examination. In 2017, the learning facilities of the University was improved with the most modern Centre for Medical Simulation, where practical classes are held in the fields of medicine and dentistry.
In the academic year 2004-2005, the Faculty admitted the first group of 24 students to the six-year English-language MD programme. The English Division students benefit, both, from theoretical knowledge as well as practical experience of the academic staff. The teachers strive to provide the students with optimal conditions for studying and working, all in a friendly atmosphere and with the emphasis on the ethical principles. During its 18-year history, the English Division has granted medical doctor diplomas to 13 classes of graduates.
English-speaking students participate in the annual all-Poland Anatomical Knowledge Competition called Golden Scapula and they achieve very good results (multiple individual and team winners, many second and third places and other awards). Additionally, many English Division students represent the University in various disciplines in sports contests. The international community of English-speaking students is very active. They organize football tournaments, celebrate their national holidays and integrate very well into the local community.
It is noteworthy that the Medical University of Bialystok is situated in a region of outstanding tourist attractions. The region of Podlasie is home to various nationalities, languages, religions, traditions and cuisines. It is also an area exceptional
for its nature, as there are four national parks, three landscape parks and almost 90 nature reserves, which together form the area known as the Green Lungs of Poland.
Due to the activity of the International Cooperation Department, in 2022 MUB has been classified in the prestigious, global Times Higher Education World University Ranking. The University was placed in the range 1,001 - 1,200 position, which is the sixth result in Poland. This year’s ranking includes only six Polish medical universities. The University obtained a particularly good result in the Teaching category (second place in Poland). MUB is also distinguished by a high proportion of women (76:24 - second place in Poland). The MUB was also classified in the global US News Best Global Universities Ranking and U-Multirank (institutional and by-subject).
Fees at the Division of Medical Education in English for the academic year beginning 2023/2024 are €13,500. More information about Admission at the official website of the University: https://www.umb.edu.pl/en/admission
Internationalisation is one of the priorities of the Medical University of Bialystok. We have international students from 40 countries around the world, from the most distant places, such as India, China, Saudi Arabia, Canada, Germany, Ireland, the United States, Nigeria, and even Trinidad and Tobago.
The University attaches great importance not only to the high level of teaching, but also to the acclimatisation of their students by organising international events integrating the entire academic community. The Welcome Centre offers people from abroad comprehensive assistance. The University has created a complete internationalization infrastructure.
Examples of activities carried out by the International Cooperation Department include, among others, events for the entire academic community (e.g. International Cooking Workshops, International Sports Day, International Karaoke Night, International Sightseeing Day, etc.), intercultural training for employees, foreign promotional campaigns in social media, extension of the library’s electronic collection, coordination of short-term outgoing and incoming visits of domestic and foreign PhD students and academic employees, study visits, preparation and distribution of brochures and promotional leaflets and many other activities aimed at the development of internationalisation of the University.
The entire University campus has bilingual Polish-English signage. The University has a bilingual virtual walk around the University campus. International students can use the myMUB mobile application for smartphones, which facilitates life at the University and in the city. The content of the app includes also essential information about the University, admission and many tips for international students.
The University offers not only a high level of education confirmed by the presence in the Times Higher Education ranking, but also a warm and friendly welcome. If you want to become part of the international academic community of the MUB, they are waiting for you.
The article is financed by the Polish National Agency for Academic Exchange under the Welcome to Poland (2020) programme. Grant agreement no. PPI/WTP/2020/1/00017/U/00001.
There was much that was positive in Dr Gabriel Scally’s final review of the implementation of his scoping inquiry recommendations.
In the report, which was published last month, Dr Scally noted improvements made to the CervicalCheck screening programme. These included better governance, the move to HPV primary screening, and the quality assurance system put in place for laboratory services.
One of the most notable recommendations of the scoping inquiry in 2018 was that Ireland should have a committee of experts and lay people to advise the Minister for Health on all new screening proposals and revisions to existing programmes. Dr Scally praised the formation of the national screening advisory committee (NSAC). He said the formation of the NSAC “happened speedily, and its operation is transparent and a great credit to its Chair, its members, and all the staff involved”.
The scoping inquiry had found a disconnect between CervicalCheck and the National Cancer Registry Ireland (NCRI). It was also unacceptable that the NCRI did not have data-sharing agreements, contracts, or memoranda of understanding in place to govern the data transfers in which it engaged.
“These deficiencies have been addressed, for the most part – although improvement has been slower than might have been hoped,” according to the new report. “However, governance and staffing issues remain problematic.”
Dr Scally had particularly strong words for the lack of progress made as regards open disclosure or duty of candour.
While he acknowledged good work has been done in the area, the current policy within the HSE, in place since June 2019, was an ‘interim revision’ of the previous “deeply unsatisfactory policy”.
The Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 is currently be-
fore the Oireachtas. However, Dr Scally said it was hard to see how the legislation, as it was currently constituted, would progress the issue.
“The slow pace of movement in creating a framework that fully supports telling patients the truth about possible errors in their care can be explained partially by the unprecedented collective burden of the pandemic,” according to the new document.
“However, the underlying concern must be that there is no fully formed plan to fundamentally change how patients are dealt with and regarded within the health services.”
One of the scoping inquiry’s recommendations was that the Medical Council’s ethical guidance should state that doctors ‘must’ be open and honest with patients, rather than using the word ‘should’. To date, the Council’s guidance remains unchanged.
In relation to a culture of openness and patient rights, Dr Scally said it was “extraordinary” that the Health Act 2004 has a legal prohibition on anybody making a complaint to the HSE about the clinical judgement of a doctor or other health professional providing care funded by the Executive.
“An adequately constituted clinical complaints system is one thing that might help address the serious problem of patients being left with no choice but to take legal action if they are concerned that their clinical care may have been deficient,” according to Dr Scally.
In the report’s foreword, Dr Scally referred to the “courage, dignity, and determination” of patient advocate Ms Vicky Phelan, who died on 14 November.
“She pushed forward the whole arena of women’s health and highlighted the crucial issues of openness, truth and honesty in communication between health professionals and patients,” according to Dr Scally. “I am, as are we all, in her debt.”
REACTION TO OUR NEWS FEATURE, 'HOW TO STOP HEALTHCARE WORSENING A GLOBAL HEALTH EMERGENCY', 28 NOVEMBER
“Our very own @MaccannRachel and @thefamilycurse featuring in this great article in the @med_indonews. The message is simple: Sustainability strategies and emission targets are all well and good, but we need to see rapid tangible action!" Irish Doctors for the Environment, @IrishDocsEnv, 28 November
REACTION TO OUR BREAKING NEWS STORY, 'NWC WELCOMES SUBSTANTIAL PROGRESS IN CERVICAL SCREENING PROGRAMME', 23 NOVEMBER
“‘Women shouldn’t have to go to court to achieve the truth, an apology, or guarantees that what happened to them won’t happen again.' We've welcomed progress made in the #CervicalCheck programme since Dr Gabriel Scally's report." Womenscouncilireland, @NWCI, 24 November
REACTION TO OUR BREAKING NEWS STORY, 'HSE APPOINTS NEW CONFIDENTIAL RECIPIENT', 18 NOVEMBER
“Social worker appointed as independent Confidential Recipient by @HSELive –to ‘act as a voice for vulnerable people with a disability and vulnerable older people'. Via @CathyReilly at @med_indonews." IASW, @IASW_IRL, 18 November
REACTION TO OUR BREAKING NEWS STORY, 'IRISH FAMILY PLANNING ASSOCIATION RELEASES NEW DATA ON EARLY ABORTION SERVICE', 15 NOVEMBER
“‘We know as a healthcare provider that legal restrictions – such as the 12-week limit and three-day wait – exclude, delay, and cause harm to those seeking care.' @IrishFPA' #FreeSafeLegalLocal #RepealReview." Abortion Rights IE, @freesafelegal, 18 November
“‘We also know from our services that the mandatory three-day waiting period causes distress and delay to our clients. It has no health rationale and interferes with women’s ability to make autonomous decisions about their healthcare.' @IrishFPA" Kerry for Choice, @KerryForChoice, 16 November
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Much more to do to create culture of openness in the health service
Due to issues related to the Covid-19 pandemic, there has been a striking increase in GPs requesting advice on dealing with difficult patients and on how to remove a patient (or families) from their lists.
GPs are entitled to end their professional relationship with a patient, but removing any patient from the practice list can be emotive and result in criticism. It is always worth reviewing and adhering to the professional and ethical standards set out by the Medical Council in its Guide to Professional Conduct and Ethics for Registered Medical Professionals when considering removing a patient.
When a doctor feels unable to continue to care for a patient, either as an individual practitioner or as part of a team, they are advised by the Medical Council to: “…tell the patient(s) and make arrangements for another doctor or service to take over their care. Until care has been taken over by another doctor or service, you are responsible for your patients. This means that you must provide emergency services and any care or treatment that your patients may need. When alternative medical care is in place, you should facilitate the transfer of the patients’ medical records without delay.”
The Medical Council also advises that if you feel unable to continue to provide effective care for a patient because the therapeutic relationship has broken down, you should get the patient’s consent to send all of their medical records to another doctor of your or the patient’s choice. You should document this in their medical records.
This can be a challenging scenario and may involve a difficult conversation with the patient. However, honesty is important, and the Medical Council expects doctors to be co-operative with patients in arranging the safe transfer of their care to a new GP and providing care, especially in emergency situations, in the interim period.
Case study
Patient A telephoned his GP practice to make an appointment with Dr C. He was off work with anxiety and depression, having recently lost a family member to Covid-19. The practice was busy, and the phone line was jammed with calls trying to get through. Patient A was a healthcare worker himself and knew the pressure that was being put on clinics, so he decided to try the practice again later.
After an hour, he called the practice again a few times, but received no answer and became increasingly annoyed and anxious. By the time he got to speak with the receptionist, patient A had called eight times. He launched into an argument and asked to speak to Dr C. The receptionist Ms B remained calm and apologised to patient A for the delay. She confirmed first that he did not need emergency care, then explained that Dr C was consulting with another patient and would call patient A back in a few hours. Patient A calmly and quietly stated that “it was not good enough”, and slammed down the phone.
Ms B was upset with patient A’s manner and told the Practice Manager, Mrs D, what had happened. Mrs D then relayed the situation to Dr C in between consultations. Dr C had never experienced what appeared, from the retelling of the interaction, to be aggressive and abusive behaviour from the patient before.
Dr C decided that the patient’s behaviour warranted removal from his practice list, and he proceeded to write to the HSE, as the patient was a public patient, asking to have him reassigned to another GP’s practice list, and providing a description of the events leading to the request for removal from his list. He decided to inform patient A when he called him that afternoon.
Patient A was very upset to learn that Dr C had removed him from his list when he was still unwell and after the many years that he was a patient with him. He denied being aggressive towards Ms B and expressed disappointment that Dr C did not call to discuss the incident before taking action.
Four weeks later, the practice received a letter of complaint from patient A. He described being extremely upset by his conversation with Dr C and after reflection, he felt that he had not spoken to Ms B the way he should have. He asked Dr C to pass on his apology to Ms B. However, he had received a copy of Dr C’s correspondence to the HSE and felt that the account was exaggerated and incriminating of his interaction with Ms B. He asked Dr C to reconsider his removal from the list, since he felt that the account was inaccurate and that he had been removed unfairly. After seeking an account directly from Ms B, Dr C met with patient A to discuss his complaint and agreed that he could remain a patient of the practice.
As there is a lack of detail within the regulatory guidance in this area, it is interesting to note how the UK regulator, the General Medical Council (GMC), addresses the issue of ending a professional relationship with a patient fairly. Although the GMC has no jurisdiction in the Republic of Ireland, its guidance is sound and practical, and GPs might consider incorporating it when navigating such matters. Its guidance below offers a clearer step by step process when considering ending a doctor-patient relationship.
Before ending a professional relationship with a patient, clinicians should:
Warn that you are contemplating ending the professional relationship.
Consider what can be done to restore the relationship.
Explore alternatives to ending the professional relationship.
Discuss the matter with an experienced colleague, your employer, or contracting body.
You must be satisfied that your reasoning for wanting to terminate the relationship is fair and does not discriminate against the patient.
If the doctor-patient relationship cannot be salvaged, it is advisable to:
Inform the patient of your decision to end the professional relationship, and your reasoning and rationale for doing so. Ideally, the patient should be told in writing.
Follow the Irish Medical Council guidance and regulations.
Document your decision to end the professional relationship – any information recorded in the patient’s medical records must be factual and objective, and should not include anything that could unfairly prejudice the patient’s future treatment.
Make alternative arrangements promptly to ensure the patient’s continuity of care is not negatively impacted. This includes a swift transfer of records.
Learning points
This situation highlights the many pitfalls that can occur when there is an absence of detailed guidance and the practice does not have an appropriate and fair procedure in place.
Firstly, proactively communicating with patients regarding any potential issues, as and when they arise, is always a good first step. Dr C did not sufficiently investigate the incident between patient A and Ms B, and the situation appears to have been slightly over-dramatised by Mrs D. It is important to remember that there are several sides to every story. GPs should always consider whether there are reasonable grounds for removing the patient and decisions should not be made in haste.
It is also important for doctors to consider whether the patient’s behaviour may have been caused or exacerbated by their illness. It would not be appropriate to remove the patient for being difficult if they were likely suffering from their illness, in need of care, or if the health of the patient may be harmed if their care was interrupted.
On the other hand, it is equally important to recognise incidents and circumstances where immediate removal of a patient could be justified, such as circumstances where a patient may be threatening or violent, or where your staff members and other patients’ safety is at risk.
In a situation where you or team members feel or are unsafe, it would be justifiable to write to the patient, rather than engaging in face-to-face discussion, informing them of the practice’s decision and the steps they need to take. You may also consider contacting the gardaí for support should there be a risk to safety.
Be prepared to justify your decision.
Summary
In summary, before practitioners consider whether ending their professional relationship with a patient, it is important to consider whether a discussion with the patient or other steps can be taken to restore the relationship. Steps may include providing the patient with a warning, ideally followed up in writing, that they may be removed from the practice list if their behaviour persists; for example, if they are persistently rude to reception staff.
If this option has been considered and there is no alternative, ensure you follow the Medical Council guidance on ending your professional relationship. You should inform patients that you are unable to continue to provide care for them, the reason why, and transfer their medical records without delay once they have consented to this.
To help reduce the scope for criticism, it is important that practitioners document their reasons for ending their professional relationship and any actions taken to resolve this matter in detail, separately from the patients’ medical records. This will demonstrate that they have carefully considered this situation, reviewed the relevant guidance and have come to an informed decision.
These situations can be a very stressful and emotional experience to deal with. Above all, try to remain professional and rational, and continue to provide your patients with the best care possible – even when it is tough.
References available on request
You must be satisfied that your reasoning for wanting to terminate the relationship is fair and does not discriminate against the patient
@drpatharrold
You have probably heard the song The Homes of Donegal recently. The beautiful and haunting Paul Brady interpretation of an old song has taken on a new poignancy since that awful explosion. When I first moved to Creeslough 30 years ago, all I knew about the place was that it had inspired two well-known songs, one being The Homes of Donegal , which had been a worldwide hit for Creeslough native Bridie Gallagher. The other song, by Percy French, was about a young man on the emigrant boat who, among all the gaiety and hopefulness, said softly to himself: “They are cutting the corn in Creeslough today.”
I don’t know when, or indeed if, anyone cuts corn there anymore, but the turning of the year sometimes reminds me that they are spotting their first tourist, or the football is starting. I forget my surroundings while my mind flies to that lovely place, like the emigrant’s, and I think about what is happening in Creeslough.
The homes of Donegal. The smiling faces waiting at the door. The kitchen tables where we would sit and talk for hours with other young parents, while our little girls played on the swings with the McGinley, Friel, and Flynn children. Donegal. No song can capture those summer days with the great hills behind us, breathless in the still air, the sea reflecting sunlight into the far distance and the clink of glasses while the
adults softly talked and the weans played the endless games of childhood.
I had known and admired many Donegal people when I was in college in Galway. They were effortlessly cool and seemed way ahead of the rest of us when it came to clothes and music. Yet, they also had a strong sense of home and community and went back at every opportunity on O’Donnell’s bus.
When I moved there, I found that the more I knew of Donegal people the better I liked them. And they were as welcoming as the song. There was nowhere a young GP and his family could have fitted in so well. We made friends for life.
There were two GP offices: Little health board rooms where the waiting room was bigger than the rest of building. Corncrakes croaked endlessly in the field next door. This was a time when the house call was part of the work, not that I minded. It was a pleasure to drive around those boreens, with my boxer Susie sitting beside me on the passenger seat, steering the car between forest and beach, up hillsides, and across mountaintops.
I was going to a house somewhere on the mighty cliffs of Horn Head on that brilliant sunny Good Friday when it was announced on the car radio that agreement had been reached in the North. As I looked over the panorama of great sea cliffs stretching into the distance, I felt that I had reached the top of Ireland, and the future was glorious.
Before I came to Donegal I had lived and worked in Northern Ireland. There I had learned how a moment can ruin lives forever. I had experienced that strange stillness after a terrible event, as if the air itself is shocked into silence. The first time I passed through Barnesmore Gap it was as if I had left all that violence, which a minority had thought was justifiable, behind and now, on that Good Friday, the rest of the country would leave it behind too.
If I had only known I would have to leave Donegal before too long and go back through that same gap, through which more emigrants left than ever had returned. Creeslough was no longer my home.
Now another explosion has devastated a community. It is beyond cruel. As I looked at the familiar wee town on the news through tear-filled eyes, so many memories came to mind. And I have vowed to go back there at the first opportunity, to walk the beaches and have a pint in Roses’ Bar. I will call in to the striking white church that mirrors Muckish mountain and think of those who are no longer with us. And I will walk through the forest in Ards and remember all those welcoming faces and chats and home visits to the fine old people who were part of a GP’s life.
And I will stay in the lovely Arnold’s Hotel and sit by their bay windows and watch the terns and the gannets fishing in the sea and not leave it so long to just drop in and say hello.
Read more by Dr Christine O’Malley at
www.mindo.ie @DrChristineOMIvisited the island of Syros in October. The last time I visited the Cyclades Islands, we skipped Syros. I was one of a bunch of new medical graduates and we were heading for the fun islands – Paros, Naxos, Ios – before starting our intern year. Syros was the boring island where normal people lived and had jobs, so we stayed on the ferry.
This time, I spent a week there. It’s an unusual place, full of churches like all the Greek islands, but most are not Greek Orthodox. Surprisingly, Syros has a strong Catholic tradition, going right back to the time of the Crusades. The main town, Ermoupoli, has a history that resonates now. It was built 200 years ago by refugees who fled from the horrors of another war. They paved the streets of their new town with marble and filled them with interesting architecture.
We were visiting Jo, an Irish girl working in an animal shelter in Kini, a small resort village. Jo wanted to escape from lockdown Ireland so she did what any sensible girl would do. She googled “cats” and “Greek Islands” and volunteered for the place nearest to a beach. That brought her to Kini and now she’s running ‘Syros Cats’,
swimming in the Aegean, and learning Greek.
Don’t tell my dog, but at heart I’m a cat lady. I was thrilled to get a tour of this delightful sanctuary, a happy place for the 65 cats who have chosen to live there. Many have tricky medical issues from living on their wits on the streets. There are difficulties too from the constant sun exposure, especially for white cats. Because they lack protective pigment, they often develop disfiguring skin cancers of ears and nose, requiring surgery. Syros Cats relies on the work of volunteers, and on donations to pay for food and medical care, and adoptions.
As well as the cat shelter, the work includes 40 other cats who continue to “work” the tavernas, as Jo says, until they opt to “retire” up the hill to Syros Cats. I’ve seen plenty of scrawny feral cats on holidays abroad, scavenging for food and living short lives, in poor medical condition. In contrast, the cats of Kini are healthy, relaxed, and long-lived; sometimes they acknowledge us tourists and graciously accept offerings of food.
Kini is small, just a beach with a string of bars and restaurants. Visitors come from Athens on the ferry, for the summer, or for a weekend. When we were there, the weather was cool with autumn wind, the beach nearly empty, holiday houses closed up. Each day we ate delicious (and cheap) fresh food, but one by one the restaurants and bars were closing too. Soon it’ll be just the winter residents. That includes Jo, no longer a transient volunteer, and clearly a welcome addition to this small world.
Even though it’s on a Greek island, Kini felt familiar.
It’s a village and it reminded me of Dromineer.
Since my return, I’ve been swimming in the lake – yes, in winter. It’s cold now and the beach is empty, apart from us early morning swimmers. The Lake Café has shut for the season and we miss it. We’ve had the last of the sailing regattas; the final sail training event for kids; and the summer visitors have gone back to Dublin. It’s just Dromineer regulars now, the people who live and work here.
We will have new people soon in our tiny community, as several houses have sold, but will they be summer friends or winter residents? Change is good. When I moved here 20 years ago, there were no children in the village. This Halloween, there were plenty of mini ghouls and witches about, perhaps including some of our younger Ukrainians. Holiday homes turn into family houses and family homes turn into holiday houses. But until we know who the new owners are, it’s a bit unsettling.
There have been losses too. We’ve had funerals, some more timely than others. Recently, I watched a grave being prepared for a neighbour who died suddenly. He wasn’t young, but was still farming and sailing competitively to the end. His son was there, and 15 local men, armed with shovels, pick, measuring tape and of course, whisky, digging the grave. It’s a remarkable and enduring tradition, part of how Dromineer marks the passing of one of our own. After the burial, the family, and the same local men, set to work and filled in the grave, finishing it off neatly with the grass sods on top.
That’s life and death in our village.
Creeslough used to be my home and the recent tragedy has made me determined to visit as soon as I canRead more by Dr Pat Harrold at www.mindo.ie
I will call in to the striking white church that mirrors Muckish mountain and think of those who are no longer with us
1,2
* Nothing on the skin: Defined as 75% achievement of PASI90 at Week 16 and ≥50% achievement of PASI 100 at Week 52 in UltIMMa-1 and UltIMMa-2.1 High skin clearance matters to patients: Patients who achieve and maintain high levels of skin clearance (PASI 90-99 or PASI 100) have significantly better HRQoL than those with lower levels of skin clearance (PASI 75-89).2 Sustaining high skin clearance or complete skin clearance is associated with incremental and durable benefits in HRQoL and mental health of psoriasis patients.2
PRESCRIBING INFORMATION (PI). SKYRIZI®▼ (risankizumab) 75 mg solution for injection in prefilled syringe; Skyrizi 150 mg solution for injection in pre-filled pen and Skyrizi 150 mg solution for injection in prefilled syringe. Refer to Summary of Product Characteristics (SmPC) for full information before prescribing. PRESENTATION: Skyrizi 150 mg solution for injection in pre-filled pen/syringe: each prefilled pen/syringe contains 150 mg risankizumab in 1 mL solution. Skyrizi 75 mg solution for injection in pre-filled syringe: each pre-filled syringe contains 75 mg risankizumab in 0.83 ml mL solution. INDICATION: Plaque Psoriasis: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic Arthritis: alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis. Dosage: The recommended dose of Skyrizi is 150 mg by subcutaneous injection at weeks 0, 4, and every 12 weeks thereafter (either as two 75 mg pre-filled syringe injections or one 150 mg pre-filled pen or pre-filled syringe injection). Two 75mg pre-filled syringes should be injected for the full 150 mg dose. Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. Renal or hepatic impairment: No dose adjustment required. Paediatric Population: No data available. Overweight patients: No dose adjustment required. CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections (e.g. active tuberculosis). SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be evaluated for tuberculosis infection prior to initiating treatment. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Completion of all appropriate immunisations should be considered prior to initiating therapy. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. If a serious hypersensivity reaction occurs, administration of Skyrizi should be discontinued immediately and appropriate therapy initiated. Excipients with known effect (75
mg solution for injection only): Skyrizi contains 68.0 mg sorbitol and less than 1 mmol sodium (23 mg) per 150 mg dose. INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated. PREGNANCY AND LACTATION: Women of Childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure. Lactation: It is not known whether Skyrizi is excreted in breast milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. A decision should be made whether to discontinue/abstain from Skyrizi therapy, taking into account the benefit of breastfeeding to the child and the benefit of Skyrizi therapy to the woman. Fertility: The effect of Skyrizi on human fertility has not been evaluated. ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; Website: www.hpra.ie. Suspected adverse events should also be reported to AbbVie Limited on 01-4287900.
LEGAL CLASSIFICATION: POM (S1A). MARKETING AUTHORISATION NUMBERS/PRESENTATIONS:
Skyrizi 75 mg solution for injection in pre-filled syringe (Pack of 2 pre-filled syringes): EU/1/19/1361/001; Skyrizi 150 mg solution for injection in pre-filled pen: EU/1/19/1361/002; Skyrizi 150 mg solution for injection in prefilled syringe: EU/1/19/1361/003. Not all presentations may be marketed. Further information is available from: AbbVie Ltd., 14 Riverwalk, Citywest Business Campus, Dublin 24, D24XN32. DATE OF REVISION: November 2021 PI/1361/004
HRQoL, Health-Related Quality of Life; PASI, Psoriasis Area Severity Index.
REFERENCES: 1. Gordon KB, et al. Lancet 2018; 392: 650-661. 2. Ryan C et al. Poster presented at the 27th European Academy of Dermatology & Venerology (EADV) Congress 2018; September 12–16; Paris, France.
Skyrizi® Summary of Product Characteristics, available on www.medicines.ie.
Date of preparation: April 2022 | IE-RISN-220005
When it comes to your patient’s psoriasis treatment goals
Question 1
In an adult, features suggesting that an acute asthma attack is severe include
A. Bradycardia.
B. Patient unable to complete sentences.
C. Peak expiratory flow 25 per cent below predicted.
D. Wheezing.
E. Cyanosis.
Question 2
A. Are more likely to be found on the extremities rather than the trunk.
B. Characteristically itch.
C. Are intradermal.
D. Are nearly always a dull skin colour.
E. Should not be treated with liquid nitrogen.
Question 3
Patients with the following conditions would be likely to require a lower than normal dose of digoxin
A. Hyperthyroidism.
B. Hypercalcaemia.
C. Hepatic impairment.
D. Chronic heart failure.
E. Old age.
Question 4
For best results a patient with a long-term catheter fitted should
A. Have routine bladder washouts every two weeks or so.
B. Empty the drainage bag as infrequently as possible.
C. Have a bag with an effective one-way valve at the tubing end.
D. Use the largest (comfortable) catheter size possible.
E. Have a catheter change every two months.
Question 5
A. Cause is ‘catching’ of the atlantoaxial joints.
B. The left side is most often affected.
C. The face is turned away from the side of the contracture.
D. Gentle stretching exercises are indicated.
E. Persisting beyond six months should be operated on expeditiously.
12-to-14 if urine clear; 20-to-22 if there are clots and debris. E.
D. FALSE. If small, less reaction.
C. TRUE. And a convenient tap at the outflow to lessen risk of ascending infection.
B. FALSE. Frequent emptying more comfortable and reduces pressure from a heavy, hanging bag.
A. FALSE. Only wash out if clinical indication, eg, blockage.
ANSWER 4
E. TRUE. This reduces renal clearance and there is increased susceptibility to toxicity.
D. TRUE. This reduces renal clearance.
C. FALSE . Only a small preparation of digoxin is detoxified in the liver.
B. TRUE. Also hypokalaemia, hypomagnesaemia.
A. FALSE . This increases digoxin clearance.
ANSWER 3
E. FALSE. If need treatment, then can use curettage and cautery or liquid nitrogen cryotherapy.
D. FALSE. Vary from dull skin colour to dark black.
C. FALSE. Appear to be stuck onto the surface of the skin.
B. FALSE. Asymptomatic, though sometimes become inflamed or irritated.
A. FALSE. Mostly on trunk and face.
ANSWER 2
E. TRUE. Attack is lifethreatening.
D. FALSE. But if chest silent in attack, then is a serious sign.
C. FALSE. 50 per cent or less of predicted or best PEF.
B. TRUE. Or, in a child, unable to move around.
A. TRUE. Or exhaustion is a sign that the asthma attack is life-threatening. Before this, tachycardia >110 beats/min is a sign of a severe attack.
ANSWER 1
Dr Tom Barrett provides a detailed overview of the current monkeypox (mpox) outbreak, symptoms of the infection, and the vaccination programme in ireland
Monkeypox (which is being renamed mpox by the World Health Organisation (WHO)) was first recognised in 1958, when two outbreaks of a pox-like disease occurred in macaque monkeys in a research facility in Copenhagen. The first human case was recorded in 1970 in the Democratic Republic of the Congo (DRC), who was initially diagnosed with smallpox, as the two diseases can resemble one another. Both viruses are orthopoxviruses. Since then, the infection has been reported in a number of central and Western African countries. Monkeypox is endemic to tropical rainforest regions of Central and West Africa. Most cases are reported from the DRC and Nigeria.
Over the last few years, cases and the geographical extent of human monkeypox infection have been increasing. Extensive outbreaks of human monkeypox infection in Nigeria and DRC are not uncommon. Prior to 2017, Nigeria had registered no human monkeypox infection for almost 40 years. However, since 2017, an upsurge in human monkeypox disease was identified and is currently ongoing. Before 2022, cases had been reported in seven countries, and were rarely reported outside Africa. Those cases were generally related to international travel. Travellers infected in Nigeria have been identified in Israel in 2018, in the UK in 2018, 2019, 2021, and 2022, in Singapore in 2019, and in the US in 2021.
In 2003, monkeypox was recorded in the US when an outbreak occurred in humans and pet prairie dogs following importation of rodents from Africa. The human infections followed contact with an infected pet and all patients recovered. Monkeypox virus has been isolated from a number of animal hosts in sub-Saharan Africa, including small mammals such as rodents. A wide range of African mammals, including primates, can become infected with the monkeypox virus.
On 7 May, 2022, monkeypox was identified in the UK in a person with recent travel to Nigeria. Since then, hundreds of cases have been reported in non-endemic countries without a history of travel to Africa. On 23 July 2022, WHO declared the global monkeypox outbreak a public health emergency of international concern, with the vast majority of cases in the European region. The cases in Ireland are part of an ongoing multi-country outbreak of monkeypox in Europe, the Americas, and many other regions worldwide.
There are two clades (strains) of monkeypox; the Central African and West African strains. A recent systematic review reported a case fatality rate of 10.6 per cent for the Central African strain and 3.6 per cent for the West African strain in a Nigerian population. However, most of this data is from countries where access to healthcare might be variable. The West African lineage
is generally associated with milder disease and is responsible for the 2022 outbreak.
As of 26 November 2022, there were 81,107 confirmed cases of monkeypox globally reported from 110 countries and regions to the WHO. Nine-hundred and eighty-two of these cases were in the African countries that historically report monkeypox. Fifty-five deaths from monkeypox have been reported, five in Europe. No case linked to occupational exposure has been reported to date.
In Ireland, as of 19 November 2022, there were 217 cases reported, 215 were male and two were female, with a median age of 35 years. Twenty people have been hospitalised. Twelve cases were admitted for clinical care, three were admitted for isolation purposes, and the reason for admission for the remaining five remains unknown. Currently, data shows that gay, bisexual and other men who have sex with men (gbMSM) make up the majority of cases in this current monkeypox outbreak. However, anyone who has been in close personal contact with someone that has monkeypox is at risk. Sexual orientation is known for 194 people affected in Ireland, 193 of whom self-identified as gbMSM. The epidemiological picture to date in Ireland is similar to that seen in other countries, whereby cases are primarily in gbMSM populations.
In Africa, the majority of human monkeypox infection cases have traditionally been infected through direct contact with African wild mammals and consumption of bushmeat. In this current outbreak, human-to-human transmission of monkeypox virus is evident, through direct contact with lesion exudate, crust material, lesion scabs, body fluids or contaminated materials like bedding, clothing, and surfaces. The virus enters the body through broken skin, the respiratory tract or mucous membranes (eyes, nose, mouth, anus or vagina). It usually takes close physical contact with a symptomatic individual for transmission to occur. The incubation period is generally six-to-13 days, but can range between five-to-21 days.
1. Initial symptoms
Initial symptoms include sudden onset of fever (38.5-40.5oC), severe headache, profound weakness, back pain, myalgia, and generalised lymph node enlargement involving posterior auricular, cervical and axillary nodes. In more severe disease, the inguinal nodes may also be enlarged.
2. Rash
The rash appears within one-to-10 days of development of fever, usually within one-tothree days, beginning on the face and then spreading to other parts of the body. The lesions are initially maculopapular, pruritic and about 2-5mm in diameter. They then become vesicular, then pustular and painful, before ulcerating, crusting and scabbing. The lesions seen in monkeypox are similar to those of varicella, however, unlike varicella, the lesions in monkeypox infection evolve at the same time and do become pustular.
The rash was typically only seen on the face, palms of the hands, soles of the feet, and occasionally in the mouth. However, during the upsurge of human monkeypox infection cases seen in Nigeria since 2017, more than twothirds of cases developed genital infections, indicating the likelihood that monkeypox virus could be transmitted through close skinto-skin contact during sexual intercourse. In the current outbreak, genital lesions are also being seen. The entire cycle, from initial presentation until lesion desloughing and skin healing, takes between two and four weeks, depending on the severity of the disease. This evolution is shown in Figure 1
Monkeypox infection is usually a self-limiting illness and symptoms generally last for two-to-four weeks. The disease is more severe in young children, pregnant women, older persons, and those who are severely immunocompromised, especially if this is related to HIV. Secondary bacterial skin infection is not uncommon in monkeypox infection and requires early and aggressive intervention.
The HSE has established a Monkeypox Crisis Management Team (CMT) to co-ordinate the
multi-agency, multidisciplinary response to the outbreak in Ireland. The HSE also continues to actively monitor the evolving international situation. To assist in Ireland’s response, monkeypox has been made a notifiable disease. Any patient who presents with symptoms of monkeypox, or any close contacts of confirmed monkeypox cases, should be referred to the local Department of Public Health for follow-up.
There is no specific treatment for human monkeypox infection. The monkeypox vaccine distributed in the EU contains Smallpox Modified Vaccinia Ankara – Bavarian Nordic (MVA-BN). Imvanex, a third-generation smallpox vaccine, is authorised by the European Medicines Agency (EMA) for the prevention of smallpox, monkeypox, and disease caused by vaccinia virus in adults. It is marketed as Jynneos in the US, where it is authorised by the Food and Drug Administration (FDA) for the prevention of monkeypox. During the current monkeypox outbreak, both Jynneos and Imvanex are being used across the EU in line with EMA recommendations. The vaccine contains a non-replicating form of vaccinia virus that does not cause disease in humans, as it cannot replicate in human cells.
People who are considered part of a highrisk group can now book a pre-exposure vaccine through this HSE website: www2. hse.ie/conditions/monkeypox/vaccine/# They will receive the vaccine in a sexual health clinic or at a vaccination centre. Two doses of the vaccine are given intradermally or subcutaneously in the forearm, 28 days apart, as per the National Immunisation Advisory Committee immunisation guidelines. The vaccine is effective 14 days after the second dose. Vaccines may develop adverse reactions, similar to the prodromal symptoms of monkeypox infection, during the first 48 hours after vaccination. There may be erythema, induration or itching at the intradermal vaccine site, or mild injection site skin discoloration lasting six or more months. Any reported adverse events should be notified to the Health Products Regulatory Authority (HPRA).
Further information about monkeypox may be found at:
National Immunisation Advisory Committee immunisation guidelines, Monkeypox/smallpox (variola) chapter. Available at: www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/ch13a.pdf
Monkeypox in Ireland – latest update (HPSC). Available at: www.hpsc.ie/a-z/zoonotic/monkeypox/title-22106-en.html
CDC 2022 Outbreak Cases and Data. Available at: www.cdc.gov/poxvirus/monkeypox/response/2022/index.html.
Information for the public is available at: www2.hse.ie/conditions/monkeypox/
Both oral and genital herpes are mostly asymptomatic or unrecognised, but can cause painful blisters and ulcers, with more severe impacts in the immunocompromised
The herpes simplex virus (HSV), more commonly known as herpes, is categorised into two types: HSV-1 and HSV-2. Both are members of the Herpesviridae family, a group of double-stranded enveloped DNA viruses that cause various infections and certain diseases, and include Varicella Zoster virus (VZV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and Human Herpesvirus (HHV) 6, 7, and 8, which are common among humans. 2
HSV-1 is mainly transmitted via contact with the virus in sores, saliva or surfaces in or around the mouth and causes oral herpes (cold sores). HSV-1 can also be transmitted to the genital area through oral-genital contact and cause genital herpes. Oral herpes infection is mostly asymptomatic, but symptoms can include painful blisters or open sores in or around the mouth. Infected persons will often experience a tingling, itching or burning sensation around their mouth before the appearance of sores. These symptoms can recur periodically, and the frequency varies from person to person.1
HSV-2 is a sexually transmitted infection (STI) that causes genital herpes. HSV-2 is mainly transmitted through contact with genital or anal surfaces, skin, sores or fluids of a person infected with the virus. HSV-2 can be transmitted even if the skin looks normal, and is often transmitted in the absence of symptoms.1
An estimated 3.7 billion people under the age of 50 years (67 per cent) have HSV-1 infection globally, and an estimated 491 million people aged 15-to-49 years (13 per cent) worldwide have HSV-2 infection (WHO 2016 last available estimates). Infection with HSV-2 increases the risk of acquiring and transmitting HIV infection.1
Genital herpes can be caused by HSV-1 or HSV-2 and manifests as either a primary or recurrent infection. Most commonly, viral replication occurs in epithelial tissue and establishes dormancy in sensory neurons, reactivating periodically as localised recurrent lesions. HSV remains one of the most common STIs, but continues to be under-identified, given the vague presentation of its symptoms. When symptoms occur, genital herpes is characterised by one or more genital or anal blisters or ulcers. Symptoms of a new infection often include fever, body aches and swollen lymph nodes. After an initial episode, which can be severe, symptoms may recur. Genital herpes caused by HSV-1 typically does not recur frequently, but with HSV-2 infection, recurrent symptoms are common. However, recurrences are often less severe than the first episode and tend to decrease over time.1,2
Risk factors
Risk factors for HSV-1 infection differ depending on the type of HSV-1 infection. In the case of orolabial herpes (cold sores), risk factors include any activity that exposes an individual to an infected person’s saliva. A risk factor for herpetic sycosis includes close shaving with a razor blade in the presence of an acute orolabial infection. Risk factors for herpetic whitlow include thumb sucking and nail biting in the presence of orolabial HSV-1 infection in children, although HSV-2 most commonly causes herpetic whitlow in adults. 5
Risk factors for acquiring HSV-2 infection involve direct exposure to fluids from a seropositive individual containing viral products, most often during sexual intercourse. HSV-2 is mainly transmitted through sexual intercourse, attributing to its predominant rise starting at puberty. Both primary and recurrent HSV infections in pregnant women can lead to intrauterine transmission and resultant congenital HSV infection. 2
HSV-1 is typically spread through direct contact with contaminated saliva or other infected bodily secretions, as opposed to HSV-2, which is primarily spread by sexual contact. HSV-1 begins to replicate at the site of mucocutaneous infection and then proceeds to travel by retrograde flow down an axon to the dorsal root ganglia (DRG), where latency is established. The latency period allows the virus to remain in a non-infectious state for a variable amount of time before reactivation. 2
HSV-2 is transmitted through direct contact of secretions in a seropositive individual who is actively shedding the virus. The virus affects the skin and mucous membranes, invading epithelial cells on initial exposure and ultimately replicating intracellularly at that site. After initial exposure the symptoms resolve in 10-to-14 days, but the virus lies dormant in the periaxonal sheath of the sensory nerves of either the trigeminal, cervical, lumbosacral, or autonomic ganglia. In these locations, viral replication is often controlled by the patient's immune system and remains in a dormant state only to reactivate later in life. When reactivation occurs, the virus travels through the sensory nerves until it reaches the mucocutaneous sites where replication takes place, and leads to vesicular clusters at the dermatological site of that sensory neuron. 2
HSV-2 infection increases the risk of acquiring HIV infection. People with both HIV and HSV-2 infection are more likely to spread HIV to others. HSV-2 infection is
among the most common infections in people living with HIV. In immunocompromised people, including those with advanced HIV infection, herpes can have more severe symptoms and more frequent recurrences.1
Rare complications of HSV-2 include meningoencephalitis and disseminated infection. Rarely, HSV-1 infection can lead to more severe complications such as encephalitis or keratitis. Ocular HSV is a common cause of blindness when it manifests as keratitis or a branching dendritic corneal ulcer.1,5
Neonatal herpes can occur when an infant is exposed to HSV during delivery. Neonatal herpes is rare, occurring in an estimated 10 out of every 100,000 births globally. However, it is a serious condition that can lead to lasting neurologic disability or death. The greatest risk for neonatal herpes is when a mother acquires primary genital herpes in the third trimester of pregnancy, especially within six weeks of delivery, as the neonate will be unlikely to have acquired protective antibodies in this time.1
The major clinical manifestations of infection with HSV-1 or HSV-2 are oral, genital, and ocular ulcers. Less commonly, primary or recurrent HSV infections may also present at other sites with neurological, hepatic, or respiratory complications. The primary episode occurs during initial infection with HSV, in which the host lacks an antibody response. 8
HSV-1 infection is frequently asymptomatic. When symptoms do occur, there is a wide range of clinical presentations that can occur including orolabial herpes, HSV folliculitis, herpes gladiatorum, herpetic whitlow, ocular HSV infection, herpes encephalitis, Kaposi varicelliform eruption (eczema herpeticum), and severe or chronic HSV-1 infection. 5 HSV-1 is the most common cause of orolabial herpes. When symptoms occur, the most common manifestation is a ‘cold sore’ on the mouth/lips. 5
In children, symptomatic orolabial HSV-1 infections can present as gingivostomatitis that leads to pain, halitosis, and dysphagia. In adults, it can present as pharyngitis and a mononucleosis-like syndrome. 5 Symptoms of a primary orolabial infection occur between three days and one week after exposure. Patients will often experience a viral prodrome consisting of malaise, anorexia, fever, tender lymphadenopathy, localised pain, tenderness, burning, or tingling prior to the onset of mucocutaneous lesions. Primary HSV-1 lesions usually occur on the mouth and lips. Symptoms of recurrent orolabial infection are typically milder than those of primary infection, with a 24-hour prodrome of tingling, burning, and itch. Recurrent orolabial HSV-1 infections classically affect the vermillion border of the lip, as opposed to the mouth and lips as seen in primary infection. 5
Genital herpes can be caused by either HSV-1 or HSV-2. HSV-2 may present as a primary infection with painful genital ulcers, sores, crusts, tender lymphadenopathy, and dysuria. The classical features are of macular or papular skin and mucous membrane lesions, progressing to vesicles and pustules that often last for up to three weeks. Genital lesions can be especially painful, leading to swelling of the vulva in women, burning pain, and dysuria. Systemic symptoms can include fever, headache, and malaise and are often due to concurrent viraemia. 2
Diagnosis can be made clinically, but should be confirmed with an HSV NAAT swab of the lesions to determine if the cause is HSV-1 or HSV-2. If there is no obvious active infection, a HSV antibodies blood test may be carried out to screen for the virus. The HSV antibodies
HSV remains one of the most common sexuallytransmitted infections but continues to be underidentified, given the vague presentation of its symptomsFigure 1: HSV-1 on the face
These medications can be used in pregnancy where there is a clear clinical need
Aciclovir is less expensive than valaciclovir and famciclovir
People with symptoms of oral herpes should avoid oral contact with others, including oral sex and sharing objects that touched saliva. Individuals with symptoms of genital herpes should abstain from sexual activity while experiencing symptoms. Both HSV-1 and HSV-2 are most contagious when sores are present, but can also be transmitted when no symptoms are felt or visible. For sexually-active people, consistent and correct use of condoms is the best way to prevent genital herpes and other STIs. However, HSV infection can still occur through contact with genital or anal areas not covered by the condom. People with symptoms suggestive of genital herpes should be offered HIV testing. Pregnant women with symptoms of genital herpes should inform their healthcare providers. Preventing acquisition of HSV-2 infection is particularly important for women in late pregnancy when the risk for neonatal herpes is greatest.1,3
Once a person contracts HSV, it is a lifelong condition. There is no cure. Overall, most HSV-1 infections are asymptomatic, and if symptomatic; present with mild recurrent mucocutaneous lesions. The prognosis of HSV-1 infection varies depending on the manifestation and location of the HS-1 infection. Early identification of symptoms and prompt use of pharmacotherapy can lead to early suppression of viral replication. The key to treatment is starting the antiviral within 24 hours of symptoms. Abstinence from sex during known viral shedding can decrease the risk of transmission to a seronegative partner. The herpes viruses as a family are responsible for significant neurological morbidity, and HSV-2 persists in the seropositive individual for a lifetime. 2
Vaccinations
test is not as reliable as culturing a sample, but can help identify the recurrence of a previous infection. 8
As HSV-2 is an STI, individuals diagnosed with genital herpes should be offered testing for other STIs including HIV, hepatitis B, syphilis, chlamydia, and gonorrhoea. Testing for hepatitis C should be considered part of routine sexual health screening in men who have sex with men (MSM); people living with HIV; commercial sex workers; and people who inject drugs (PWID). Partners should also be considered for HCV testing.4
Pregnant women with a history of genital herpes should inform their obstetrician and referral to a GUM clinic should be considered, particularly if the patient is experiencing frequent recurrences. Patients presenting with genital herpes for the first time in pregnancy should have the diagnosis confirmed, treatment started, and be referred to a GUM clinic. Patients presenting with frequent recurrences (>/= one per month) should be offered suppressive therapy and may be best managed at a GUM clinic. Genital herpes is a notifiable disease.4
Although there is no cure for HSV, treatments can relieve the symptoms. Medication can decrease the pain related to an outbreak, shorten healing time, and can also decrease the total number of outbreaks. Antiviral drugs including acyclovir, famciclovir, and valacyclovir, are among the medications used to treat the symptoms of herpes. If given within 72 hours of symptom onset, antivirals can be effective in reducing the severity and duration of symptoms, however, early treatment of primary infection does not prevent recurrences.1,3
Treatment should be started based on clinical impression (See Table 1).4 Goals are to treat and prevent symptomatic genital herpes recurrences, and prevent transmission to sexual partners by supressing the virus.6
Topical antiviral medication is not as effective as oral antiviral medication.
Simple oral analgesia, eg, ibuprofen or paracetamol, and local anaesthetic cream, eg, EMLA cream.
Warm baths may help relieve the pain associated with genital sores.
Hospitalisation may be required for urinary retention, meningism or severe constitutional symptoms. 4
The latest HSE prescribing guidance on genital herpes is available at: www.hse.ie/eng/services/list/2/gp/ antibiotic-prescribing/conditions-and-treatments/genital/genital-herpes/genital-herpes.html
HSV vaccines are being researched and studied to reduce the severity of symptoms and help expedite visible lesion healing. By reducing shedding, severity may be reduced, as has been seen with the Varicella-zoster vaccination. HSV vaccines are being researched and developed with two broad focuses; preventative and therapeutic, and some with a dual use as both immunotherapeutic and prophylactic.7 Although several candidate HSV vaccines are in the pre-clinical and clinical phases of study and have been tested in humans, there are currently no licensed vaccines available against either HSV type.
References
1. WHO (2022). Herpes simplex virus. World Health Organisation, Geneva. Available at: www.who.int/ news-room/fact-sheets/detail/herpes-simplex-virus
2. Jacob M (2022). Herpes Simplex type 2. StatPearls Publishing. Available at: www.statpearls. com/ArticleLibrary/viewarticle/688
3. WebMD (2022). Herpes simplex virus: HSV-1 and HSV-2. Available at: www.webmd.com/ genital-herpes/pain-management-herpes#1
4. HSE (2021). Genital herpes. Available at: www. hse.ie/eng/services/list/2/gp/antibioticprescribing/conditions-and-treatments/genital/ genital-herpes/genital-herpes.html
5. Saleh D, Yarrarapu S, Sharma S (2022). Herpes simplex type 1. StatPearls Publishing. Available at: www.ncbi.nlm.nih.gov/books/NBK482197/
6. MIMS (2022). Herpes simplex virus infections. Available at: https://specialty.mims.com/herpes%20 simplex%20virus%20infection/treatment
7. WHO (2022). Herpes simplex virus. World Health Organisation: Immunisation, vaccines and biologicals. Available at: www.who.int/teams/immunizationvaccines-and-biologicals/diseases/herpes-simplex-virus
8. BMJ (2022). Herpes Simplex Virus Infection. BMJ Best Practice . Available at: https:// bestpractice.bmj.com/topics/en-gb/53
Infection with HSV-2 increases the risk of acquiring and transmitting HIV infection
The Gathering Around Cancer conference 2022 was held in the Croke Cark Conference Centre on 17 and 18 November. It saw a number of renowned national and international speakers converge to share their expertise and clinical updates in a range of cancer areas and sub-specialties. The Gathering covered a wide range of clinical themes of interest to cancer care professionals, with the input of the multidisciplinary team and patient representation high on the agenda.
It was the first time since Covid that the Gathering has been able to go ahead on a face-to-face basis.
“Our goal of gathering the Irish oncology diaspora and their mentors and friends to learn from each other and to share research ideas has never been as relevant,” said Prof John McCaffrey and Prof David Gallagher of the conference organising committee.
The meeting had a multidisciplinary flavour and featured sessions on ‘Specialty nursing in quality patient care’, and ‘Multidisciplinary approach to quality patient care’. As always, the Irish investigators abroad sessions generated great interested and featured an exceptional-
ly high quality of presentations, with thought-provoking and hypotheses-generating research.
The meeting also saw a plethora of presentations over the two days under the categories of gynaecology, breast, colon and genitourinary cancers, as well as specialty updates and a special address on ‘The patient journey’. The opening and closing remarks at the Gathering were delivered by Prof McCaffrey and Prof Gallagher, and Dr Tony Holohan delivered a talk at the close of the conference titled ‘Personal reflections’.
The attendees heard from Dr Niamh Peters of the Christie NHS Foundation Trust in Manchester, UK, who spoke on the rare but devastating disease penile cancer. Dr Peters outlined a descriptive study of penile cancer in north-west England, including epidemiology, risk factors and outcomes. There is an increasing incidence of the disease, she said, with 650 new cases and 150 new deaths per year in the UK. It remains a poorly researched area of cancer, she added.
The risk factors include phimosis (tightening of the foreskin), obesity and HPV, as well as a smoking history. However, this cancer is highly treatable when or-
gan-confirmed and there is a need to raise awareness to reduce the numbers of men presenting with nodal/metastatic disease, she said.
Following her presentation, Dr Peters spoke with the Medical Independent (MI) and expanded on some of her research.
“Penile cancer affects men of all ages from all walks of life,” she said. “In studies of penile cancer survivors, one of their main concerns was the lack of awareness/taboo amongst men and indeed primary care physicians, which I hope to try and improve myself in the future following my dissertation.
“Similar to women and breast cancer, I really would urge men to know what's normal for them and to seek medical advice if they notice any changes whatsoever, and not to feel embarrassed. A big factor in the development of this cancer, which I didn't get to discuss in my presentation, was poor penile hygiene – this can be poor as a result of phimosis – cleaning under the foreskin regularly is a simple task that could prevent the development of penile cancer in the future,” she told MI. “Although it is rare, it really can have devastating and deadly consequences.”
During the ‘Breast cancer update’ session at Gathering Around Cancer 2022, delegates heard presentations by Dr Elaine Walsh of Memorial Sloan Kettering Cancer Centre in New York, US, who delivered a talk on ‘Triple-negative breast cancer (TNBC)’; and Prof Roisin Connolly of Cork University Hospital, who delivered a presentation on ‘Her2+ breast cancer’. The opening comments for the session were delivered by Prof Risteárd Ó Laoide, Director of the National Cancer Control Programme.
Dr Walsh reviewed trial data from the FISH and KEYNOTE-355 and KEYNOTE-522 studies, and discussed antibody drug conjugates, among other therapeutic options. She also synopsised the treatment algorithm for TNBC.
Dr Walsh told attendees: “TNBC remains an area of unmet need, with a significant incidence of recurrence in the first one-to-three years after diagnosis. When we compare TNBC to other breast cancer subtypes, it continues to be associated with poorer survival. Thankfully, due to developments both in research and in therapeutics, we now have a number of current and potential targets in TNBC.”
Dr Walsh talked the delegates through the treatment algorithm and commented: “If they [tumours] are 2cm or greater or if there is lymph node-positive disease, I would certainly consider neoadjuvant chemotherapy. Now, the standard of care is the KEYNOTE-522 regimen… but as always, [more] clinical trials are greatly encouraged.”
Prof Connolly gave an overview of the historical development of trials in breast cancer and the evolution of drug development. She also reviewed data from the APT and CompassHER2 trials, among others, and discussed FDG-PET scans as a biomarker of response, but focused her talk on early-stage sHER2+ breast cancer.
She discussed strategies for adding and improving benefit – but potentially with increased toxicity – and stressed the need for a tailored treatment approach. Prof Connolly also touched on the role of imaging-based biomarkers, and said “there is a huge amount of work going on into liquid-based biopsies and tissue-based biomarkers, but prospective clinical
validation in well-designed trials is essential before we can change our practice”.
She explained: “Essentially, in patients who have lower-risk cancers T1N0, we recommend going to surgery first and then possibly considering the APT regimen if the patients have [tumours] under 3cm, which is associated with a lot less toxicity. If the patients have
larger or node-positive cancers, we recommend the neoadjuvant chemotherapy and we will be trying to enroll in clinical trials….”
“In the postoperative setting, we have the option of the T-DM1 or DESTINY 5 [Breast05] trial in residual disease,” Prof Connolly continued.
“I try to avoid anthracyclines as much as I can to avoid long-term toxicity for patients. We don’t traditionally give adjuvant therapy for the smaller T1a cancers.”
Prof Connolly explained that during the Covid-19 pandemic, she collaborated with researchers from Johns Hopkins in the US on a paper focused on the management of breast cancer.
She said: “I think more and more with the APT data and the opportunity to use less chemotherapy in the tumours under 3cm, I’m querying whether we should be considering the neoadjuvant therapy more for those cancers over 3cm. Because if we give neoadjuvant therapy, we end up giving a lot of therapy, and then giving T-DM1 postoperatively, so we need to consider that,” she said.
Prof Connolly concluded: “In the future, we will be able to tailor treatment more to the individual… there are radiation clinical trials that are being considered in the HER2+ space for omitting radiation in some of these lower-risk patients,” she told the conference.
“Could we see a time where we would just be using the HER2+ therapy? We are already using one chemotherapy with the HER2+ directed therapy in some patients and I’m sure there will be more and more novel approaches incorporating these ADCs, for example, in the higher risk patients. But really, we need to identify upfront who those patients are with robust biomarkers.
“So, we are achieving excellent outcomes with the use of HER2+ directed therapies, and I think the next generation of clinical investigation will be to optimise further this treatment decision-making so that we can give the same efficacy to the patient, but with less of the side-effects. It’s really miserable when these patients come in with side-effects of treatment, both short- and long-term. We need carefully designed clinical trials and biomarker development, and partnership is essential – partnership with patients as we design our trials; partnership with clinicians; basic and clinical investigators; industry; and with academia.”
Walsh
It’s really miserable when these patients come in with side-effects of treatment, both short- and long-term
2012, NASA successfully landed the Mars Curiosity Rover on the red planet. And thanks to the launch of INLYTA®,* George† had time to prepare the garden for summer.
Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine1
*INLYTA® offers patients time free from disease progression, as demonstrated by a significant 33% reduced risk of progression vs. sorafenib (mPFS was 6.8 months with INLYTA® vs. 4.7 months with sorafenib, HR: 0.67; 95% CI: 0.56–0.81; p<0.0001) in the AXIS trial. In this randomised, open-label, multicentre Phase III AXIS study, 723 patients with advanced RCC whose disease had progressed on or after treatment with one prior systemic therapy were randomised (1:1) to receive Axitinib (N = 361) or sorafenib (N = 362).1
†Patient names are fictional and used for illustrative purposes only. CI, confidence interval. HR, hazard ratio. mPFS, median progression-free survival. mRCC, metastatic renal cell carcinoma.
Reference: 1. INLYTA®. Summary of Product Characteristics. Pfizer.
PP-INL-IRL-0119 | November 2022
Inlyta (axitinib) Film-Coated Tablets. Please refer to the Summary of Product Characteristics (SmPC) before prescribing Inlyta 1 mg or 5 mg film-coated tablets.
Presentation: Each 1 mg and 5 mg film-coated tablet contains 1 mg and 5 mg of axitinib, respectively.
Indications: For the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. Dosage: Treatment should be initiated by a physician experienced in the use of anticancer therapies. The recommended oral dose is 5 mg twice daily (approximately 12 hours apart) taken with or without food. Dose increase or reduction is recommended based on individual safety and tolerability. Patients who tolerate the starting dose of 5 mg twice daily with no adverse reactions > Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) for two consecutive weeks may have their dose increased to 7 mg twice daily unless BP > 150/90 mmHg or patient is receiving anti-hypertensive medication. Subsequently, using the same criteria, patients who tolerate a dose of 7 mg twice daily, may have their dose increased to a maximum of 10 mg twice daily. Management of some adverse drug reactions may require temporary or permanent discontinuation and/or dose reduction. When dose reduction is necessary, the dose may be reduced to 3 mg twice daily and further to 2 mg twice daily. Co-administration with strong CYP3A4/5 inhibitors or inducers may increase or decrease axitinib plasma concentrations respectively. Selection of an alternative concomitant medicine with no or minimal CYP3A4/5 inhibition or induction potential is recommended. If a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of axitinib to approximately half the dose (e.g. from a starting dose of 5 mg twice daily to a reduced dose of 2 mg twice daily) is recommended. If co-administration of the strong inhibitor is discontinued, a return to the axitinib dose used prior to initiation of the CYP3A4/5 inhibitor should be considered. If a strong CYP3A4/5 inducer must be co-administered, a gradual dose increase is recommended with careful monitoring for toxicity. If co-administration of the strong inducer is discontinued the axitinib dose should be immediately returned to the dose used prior to initiation of the strong CYP3A4/5 inducer. No dose adjustment is required in elderly patients or patients with renal impairment or with mild hepatic impairment (Child Pugh class A). A dose decrease is recommended in patients with moderate hepatic impairment (Child-Pugh class B) (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily). Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population. Dose adjustment is not required on the basis of patient age, race, gender, or body weight. The safety and efficacy of axitinib in children (<18 years) have not been established.
Contra-indications: Hypersensitivity to axitinib or to any of the excipients. Special warnings and precautions for use: Signs or symptoms of cardiac failure should periodically be monitored throughout treatment. Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of axitinib therapy. Blood pressure should be wellcontrolled prior to initiation. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. In the case of persistent hypertension despite use of antihypertensive medicinal products, the axitinib dose should be reduced. For patients who develop severe hypertension, temporarily interrupt axitinib and restart at a lower dose once the patient is normotensive. If axitinib is interrupted, patients receiving antihypertensive therapy should be monitored for hypotension. In case of severe or persistent arterial hypertension and symptoms suggestive of posterior reversible encephalopathy syndrome (PRES), a diagnostic brain MRI should be considered. Thyroid function should be monitored before initiation of, and periodically throughout, treatment. Hypothyroidism and, to a lesser extent, hyperthyroidism were reported in clinical studies and should be treated as per standard medical practice to maintain a euthyroid state. Arterial embolic and thrombotic events (including transient ischaemic attack, myocardial infarction, cerebrovascular accident and retinal artery occlusion) and venous embolic and thrombotic events (including pulmonary embolism, deep vein thrombosis, and retinal vein occlusion/thrombosis) were reported in clinical studies and axitinib should be used with caution in patients at risk of or who have a history of these events. Increases in haemoglobin or haematocrit, reflective of increase in red blood cell mass may occur during treatment and should be monitored before initiation of, and periodically throughout, treatment and treated as per standard medical practice. An increase in red blood cell mass may increase the risk of embolic and thrombotic events. Haemorrhagic events (most commonly epistaxis, haematuria, rectal haemorrhage and gingival bleeding) were reported in clinical studies. Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. Temporarily interrupt treatment if any bleeding requires medical intervention. The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections. Before initiating axitinib, this risk should be carefully considered
in patients with risk factors such as hypertension or history of aneurysm. Events of gastrointestinal perforation and fistulas were reported in clinical studies and symptoms for these should be monitored periodically throughout treatment. Treatment with axitinib should be stopped at least 24 hours prior to scheduled surgery and the decision to resume therapy after surgery should be based on clinical judgment of adequate wound healing. Events of PRES (a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances; mild to severe hypertension may be present) were reported in clinical studies. MRI is necessary to confirm diagnosis. In patients with signs or symptoms of PRES, temporarily interrupt or permanently discontinue axitinib treatment. The safety of reinitiating therapy in patients previously experiencing PRES is not known. Proteinuria, including that of Grade 3 and 4 severity, was reported in clinical studies. Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended. In moderate to severe proteinuria reduce the dose or temporarily interrupt treatment. Axitinib should be discontinued if the patient develops nephrotic syndrome. Increases in ALT, AST and bilirubin have been reported. Liver function tests should be monitored before initiation of, and periodically throughout, treatment. Systemic exposure to axitinib was approximately two fold higher in subjects with moderate hepatic impairment (Child-Pugh class B) compared to subjects with normal hepatic function. In these patients dose decrease is recommended (see Dosage section). Axitinib has not been studied in patients with severe hepatic impairment (Child Pugh class C) and should not be used in these patients. Contains lactose and patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Other interactions: Axitinib is metabolised primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, CYP2C19, and uridine diphosphate-glucuronosyltransferase (UGT) 1A1. If a strong CYP3A4/5 inhibitor (e.g. itraconazole, clarithromycin, erythromycin) or inducer (rifampicin, dexamethasone phenytoin, and Hypericum perforatum [St. John’s wort]) must be co-administered, a dose adjustment of axitinib is recommended (see Dosage section). In patients taking strong inhibitors of CYP1A2 and CYP2C19 caution should be exercised due to the risk of increased axitinib plasma concentrations. Fertility, pregnancy and lactation: Axitinib may cause foetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity including foetal malformations. Axitinib should not be used during pregnancy unless the clinical condition of the woman requires treatment. Axitinib should not be used during breast-feeding and women of childbearing potential must use effective contraception during and up to 1 week after treatment. Fertility may be impaired during treatment. Driving and operating machinery: Axitinib has a minor influence on the ability to drive and use machines. Advise patients that they may experience dizziness and/or fatigue during treatment. Undesirable effects: TThe most important serious adverse reactions reported in patients receiving axitinib were cardiac failure events, hypertension, thyroid dysfunction, arterial thromboembolic events, venous thromboembolic events, elevation of haemoglobin or haematocrit, haemorrhage, gastrointestinal perforation and fistula formation, wound healing complications, PRES, proteinuria and elevation of liver enzymes. Very common (≥ 1/10) adverse events are hypothyroidism, decreased appetite, headache, dysgeusia, hypertension, haemorrhage, dyspnoea, cough, dysphonia, diarrhoea, vomiting, nausea, abdominal pain, stomatitis, constipation, dyspepsia, palmar-plantar erythrodysaesthesia (hand-foot syndrome), rash, dry skin, arthralgia, pain in extremity, proteinuria, fatigue, asthaenia, mucosal inflammation, weight decreased. Common (≥ 1/100 to < 1/10) reported adverse events are anaemia, thrombocytopenia, polycythaemia, hyperthyroidism, dehydration, hyperkalaemia, hypercalcaemia, dizziness, tinnitus, cardiac failure events, venous and arterial embolic and thrombotic events, oropharyngeal pain, upper abdominal pain, flatulence, haemorrhoids, glossodynia, gastrointestinal perforation and fistula, hyperbilirubinaemia, cholecystitis, pruritus, erythema, alopecia, myalgia, renal failure, thyroid stimulating hormone increased, lipase increased, and ALT, AST, alkaline phosphatase, creatinine and amylase increased. Refer to SmPC for information on other adverse effects. Legal Category: S1A.
Marketing Authorisation Number: EU/1/12/777/002 - 1 mg (56 tablets); EU/1/12/777/005 - 5 mg (56 tablets).
Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at EUMEDINFO@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 467 6500.
Last revised: November 2019.
Ref: IL 11_1.
10 years of milestones for your patients with mRCC.
The Gathering Around Cancer conference 2022 also heard an update by Dr Emmet Jordan of University Hospital Waterford on the topic of kidney cancer. In this genitourinary session, the delegates also enjoyed a talk by Dr Mike Morris of Memorial Sloan Kettering Cancer Centre (MSKCC), New York, US, who visited the conference to talk on ‘Systemic therapy for prostate cancer’. The genitourinary session of the conference also heard from a number of other renowned speakers, including Dr Dean Bajorin of MSKCC, Mr Greg Norman of the Mater Misericordiae Hospital, Dublin, and Dr Darren Feldman of MSKCC. Dr Jordan presented an overview of clinical trial data and a synopsis of therapies. “At present in kidney cancer, we have different drugs in our armamentarium… we are trying to move the field forward with combination therapies, such as triplets, some novel agents based on tumour cell metabolism and alpha inhibition, and as with any cancer, going forward [we need] better biomarkers so that we can escalate or de-escalate therapies.”
Dr Jordan presented trial data on different therapeutic approaches and touched on options for latestage treatments. “In advanced disease, the remaining questions include that there are a lot of options for therapy going forward, with different risk factors to be considered,” Dr Jordan told the meeting. “The role of triple therapy for advanced kidney cancer is unclear… in the adjuvant setting, many patients are cured by their surgery, but unfortunately, a proportion of these patients will relapse…. We need to balance trying to improve the overall survival against the side-effects of therapy and the cost of treatment,” he commented.
At the conference, Dr Morris spoke with the Medical Independent (MI) about how systemic therapy for cancer, and specifically prostate cancer, has advanced in recent years. “It’s hard to understate the revolution that prostate cancer treatment is undergoing right now,” he said. “There are several different trends, but they really all hinge on a greater under-
standing of the biology of the disease. Now, we use not just where the patient is in the distribution of the disease, but the genomics that underlie that disease and some of the targets that are present in the disease, in order to treat it.”
“As a result, we have many new drugs and we are learning how to best utilise those drugs,” he continued. “In the past, many of our best drugs were saved for late in the disease, but now we understand that if we bring those drugs in earlier and combine them and match the right drug with the right patient’s biology, it really substantially leverages the improvement to their survival and quality-of-life.”
In this regard, patient selection is vital and there are some challenges to implementing the optimum use of these therapies, Dr Morris explained. “There are always the challenges of better understanding what the biomarkers are to lead you to better select the right treatment for the right patient,” he explained. “There are always challenges in getting clinical trials done, and prostate cancer is a diverse disease with many different risks that patients have to face. We have to separate the high-, intermediate- and low-risk patients within a given disease state to make sure that we are not over-treating the lower-risk patients, or under-treating the higher-risk patients. It’s certainly not a one-size-fits-all approach,” he told MI
At Gathering Around Cancer 2022, the Medical Independent (MI) spoke with Consultant Medical Oncologist and Consultant Medical Geneticist at St James’s Hospital, Dublin, Prof David Gallagher – also one of the conference organisers – about the importance of sharing expertise for the benefit of patients.
“We are trying to make this a national meeting that appeals to a variety of healthcare professionals in healthcare, and that’s one of the central roles of the conference,” he said. “It’s not just strictly for physicians – it includes all healthcare professionals, but also patients and patient advocates who want to be more informed and that’s the reason we include this variety.”
He also touched on the increasing sub-specialisation in the field. “Oncology is becoming more sub-specialised and thankfully, we are getting more and more individuals with sub-specialty interests back to Ireland to allow that sub-specialty focus to grow here.
“It’s also lovely to have everybody back on a face-to-face basis,” Prof Gallagher told MI. “We started this 10 years ago to bring people together and to bring people from abroad back home. We wanted to grow research relationships and interaction and it’s very hard to do that remotely, so having everyone together again just makes that so much easier.”
Attendees at the Gathering Around Cancer
2022 heard a talk by Dr Karen Cadoo of St James’s Hospital in Dublin during the ‘Ovarian cancer update’ as part of the gynaecology session. Dr Cadoo provided an overview of PARP inhibitors and a synopsis of data from trials, including the SOLO1, SOLO2, ATHENA-MONO, and PRIMA studies, among others.
“We have had such great advances [in care] over the past five years and we have made huge progress, but this makes us pause and think… there are a few issues, and the data is complex and incomplete,” she said. “One of the issues is crossover, which makes it very difficult to define what’s happening.”
When some of the studies were done, PARP inhibitors were not available, so crossover was not an issue at that time, she explained.
“I have talked about how the duration of PARP inhibitor therapy may affect bone marrow robustness and ability to tolerate future therapy, and it may also impact on resistance to that therapy,” said Dr Cadoo. “The PARP inhibitor studies all looked at multiple endpoints and as we get more data over time on these sec -
ondary end-points, we will know more about the impact on future therapies.”
Dr Cadoo told attendees: “PARP inhibitors have been amazing and they have changed the landscape of ovarian cancer, but as some of this data emerges, we need to be cautious. I would say we don’t have overall survival data for a number of the PARP inhibitor maintenance studies…. I don’t think that this is necessarily specific to [a particular drug], but I think there may be class effect issues here that we need to be watching out for.”
She continued: “For women who have BRCA-associated ovarian cancer, PARP inhibitors have been absolutely revolutionary. We know with any oncology therapy, moving it to the frontline is likely the place to achieve the maximum benefit – it has the potential to cure these women, and that is unbelievable. But we also need to understand why in more women with BRCA-associated ovarian cancers, that curve doesn’t plateau more, and why do people get progression of disease or recurrence.
“The other question is around the magnitude of benefit with PARP inhibitors – when that decreases, we need to be mindful,” she told the conference. “We know that with BRCA, then HRD [homologous recombination de -
ficiency] then HRP [homologous recombination proficient], the magnitude of benefit declines. We know that part of this is because their HRD testing is not adequate and doesn’t sort things out properly, and we have work to do in that space. But if the absolute gains on modest recombination proficient tumours are small, we may have issues, even in the frontline setting.”
Dr Cadoo summarised: “For women with platinum-sensitive BRCA-associated ovarian cancer, I think they should be treated with a PARP inhibitor. I think that includes the new current platinum-sensitive space and includes somatic BRCA, and as I said, these are revolutionary. But I also think we need to understand the mechanism of resistance and how we can do better. For BRCA wild type, for these women who are on PARP inhibitors, and with this new data, we need to have a very clear conversation that includes updated data, updated international approval status, and the data limitations.
“I do understand that progression-free survival is important for women; this is a very morbid disease,” she continued. “There may be women who say they want to stay on their therapy, but they need to have the opportunity to make that decision for themselves.”
Lonsurf® (Trifluridine/ tipiracil): Abbreviated Prescribing Information: Please refer to the Summary of Product Characteristics before prescribing COMPOSITION*: Lonsurf 15 mg/6.14 mg: film-coated tablet containing 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride). Lonsurf 20 mg/8.19 mg: film-coated tablet containing 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride). INDICATION*: As monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. As monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease. DOSAGE AND ADMINISTRATION*: Recommended starting dose: 35 mg/m2/dose taken orally twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle, within 1 hour after completion of the morning and evening meals (20mg/m2/dose for patients with severe renal impairment). Dosage calculated according to body surface area, not exceeding 80 mg/ dose. Possible dosing adjustments based on individual safety and tolerability: permitted dose reductions to a minimum dose of 20 mg/m2 twice daily (15mg/m2/dose for patients with severe renal impairment), dose escalation not permitted after a dose reduction. CONTRAINDICATIONS*: Hypersensitivity to the active substances or to any of the excipients. WARNINGS *: Bone marrow suppression: Complete blood cell counts must be obtained prior to initiation of therapy, prior to each cycle and as needed. Treatment must not be started if absolute neutrophil count < 1.5 x 109/L, if platelet counts < 75 x 109/L, or if unresolved Grade 3 or 4 non-haematological clinically relevant toxicity. Patient should be monitored closely for infections, appropriate measures should be administered as clinically indicated. Gastrointestinal toxicity: anti-emetic, anti-diarrhoeal and other measures should be administered as clinically indicated, dose modifications should be applied as necessary. Renal impairment: not recommended if end-stage renal disease. Patients with renal impairment should be monitored closely; patients with moderate or severe renal impairment should be more frequently monitored for haematological toxicities. Hepatic impairment: not recommended if baseline moderate or severe hepatic impairment. Proteinuria: monitoring by dipstick urinalysis recommended prior to starting and during therapy. Excipients: contain lactose. INTERACTIONS*: Precautions: medicinal products that interact with nucleoside transporters CNT1, ENT1 and ENT2, inhibitors of OCT2 or MATE1, human thymidine kinase substrates (e.g. zidovudine), hormonal contraceptives. FERTILITY*. PREGNANCY AND BREASTFEEDING*: Not recommended. CONTRACEPTION*: For women and men, highly effective contraceptive measures must be used during treatment and for 6 months after stopping treatment. DRIVE & USE MACHINES*: Fatigue, dizziness or malaise may occur. UNDESIRABLE EFFECTS*: Very common: Neutropenia, leukopenia, anaemia, thrombocytopenia, decreased appetite, diarrhoea, nausea, vomiting, fatigue. Common: Lower respiratory tract infection, febrile neutropenia, lymphopenia, hypoalbuminaemia, dysgeusia, neuropathy peripheral, dyspnoea, abdominal pain, constipation, stomatitis, oral disorder, hyperbilirubinaemia, Palmar-plantarerythrodysaesthesia syndrome, rash, alopecia, pruritus, dry skin, proteinuria, pyrexia, oedema, mucosal inflammation, malaise, hepatic enzyme increased, blood alkaline phosphatase increased, weight decreased. Uncommon: Septic shock, enteritis infectious, lung infection, biliary tract infection, influenza, urinary tract infection, gingivitis, herpes zoster, tinea pedis, candida infection, bacterial infection, infection, neutropenic sepsis, upper respiratory tract infection, conjunctivitis, cancer pain, pancytopenia, granulocytopenia, monocytopenia, erythropenia, leukocytosis, monocytosis, dehydration, hyperglycaemia, hyperkalaemia, hypokalaemia, hypophosphataemia, hypernatraemia, hyponatraemia, hypocalcaemia, gout, anxiety, insomnia, neurotoxicity, dysaesthesia, hyperaesthesia, hypoaesthesia, syncope, paraesthesia, burning sensation, lethargy, dizziness, headache, visual acuity reduced, vision blurred, diplopia, cataract, dry eye, vertigo, ear discomfort, angina pectoris, arrhythmia, palpitations, embolism, hypertension, hypotension, flushing, pulmonary embolism, pleural effusion, rhinorrhoea, dysphonia, oropharyngeal pain, epistaxis, cough, enterocolitis haemorrhagic, gastrointestinal haemorrhage, pancreatitis acute, ascites, ileus, subileus, colitis, gastritis, reflux gastritis, oesophagitis, impaired gastric emptying, abdominal distension, anal inflammation, mouth ulceration, dyspepsia, gastrooesophageal reflux disease, proctalgia, buccal polyp, gingival bleeding, glossitis, periodontal disease, tooth disorder, retching, flatulence, breath odour, hepatotoxicity, biliary dilatation, skin exfoliation, urticaria, photosensitivity reaction, erythema, acne, hyperhidrosis, blister, nail disorder, joint swelling, arthralgia, bone pain, myalgia, musculoskeletal pain, muscular weakness, muscle spasms, pain in extremity, renal failure, cystitis noninfective, micturition disorder, haematuria, leukocyturia, menstrual disorder, general physical health deterioration, pain, feeling of body temperature change, xerosis, discomfort, blood creatinine increased, electrocardiogram QT prolonged, international normalised ratio increased, activated partial thromboplastin time prolonged, blood urea increased, blood lactate dehydrogenase increased, protein total decreased, C-reactive protein increased, haematocrit decreased. Post-marketing experience: interstitial lung disease. OVERDOSE* PROPERTIES*: Trifluridine is an antineoplastic thymidine-based nucleoside analogue and tipiracil hydrochloride is a thymidine phosphorylase (TPase) inhibitor. Following uptake into cancer cells, trifluridine, is phosphorylated by thymidine kinase, further metabolised in cells to a deoxyribonucleic acid DNA substrate, and incorporated directly into DNA, preventing cell proliferation. However, trifluridine is rapidly degraded by TPase and readily metabolised by a first-pass effect following oral administration, hence the inclusion of the TPase inhibitor, tipiracil hydrochloride.PRESENTATION* Pack of 20 or 60 film-coated tablets.
During Gathering Around Cancer 2022, Prof John McCaffrey, Consultant Medical Oncologist at the Mater Misericordiae Hospital, Dublin, and organiser of the conference, spoke with the Medical Independent (MI) about whether the broad mix of topics at the conference reflected a growing trend towards sub-specialisation in medicine. “We are trying to be reflective of what is happening in oncology each year, and that’s why we have
lasted so well for these 10 years – by reacting to what our audience wants,” said Prof McCaffrey. “We have had nursing specialty sessions in the past, but this is the first time we have had so many of them and that’s what the audience wanted, and they [disciplines] cross all areas of cancer care.
“We have also invited patients to be in the audience. What has been striking to me is that some areas are very well developed, such as in women’s health, although obviously, more
can be done there with breast and gynaecology, for example,” he continued.
“But there is a lot of men’s health [content], colorectal cancer, and patient advocacy groups are just beginning the journey. We always try to introduce more radiation and surgical aspects, but we would always ask people for their suggestions as to what we can do for the next 10 years.”
He also commented on the importance of returning to the face-to-face format and the benefits that brings. “It’s so much better than the virtual setting,” he commented. “The virtual system is convenient, but it took out the whole human aspect of the actual Gathering, where you get together and have a chat, exchange ideas, get people into educational programmes or Fellowships, so it is great to have all of that back.”
In terms of a health check for Irish oncology services generally, particularly in the context of disrupted appointments during Covid-19, Prof McCaffrey commented: “We definitely have a lot more late-stage presentations, and I think that is going to continue for the next five or 10 years,” he told MI. “A lot of the screening programmes suffered, so there were a lot of missed opportunities due to Covid that are going to come back to haunt us. There are also a lot of patients who did not have access to their GP or diagnostics, so the challenge is to keep doing what we have been doing well in the NCCP [National Cancer Control Programme], which is funding innovations like nurse specialties and empowering services with additional consultants. We are grateful that the HSE and NCCP have responded to the impact of Covid on cancer care.”
During a specialty session of Gathering Around Cancer 2022, the attendees heard a talk by Dr Derek Power of Cork University Hospital, who delivered a ‘Melanoma update’. Dr Power presented a synopsis of research on sentinel lymph node procedures and an overview of trial data, including the IMMUNED and CHECKMATE trials, among others.
Dr Power said: “As highlighted by Dr [Mike] Morris, when treatments come thick and fast and the evidence is increasing, it becomes more complex to decide the best algorithm for treatment.”
Dr Power explained that there are major efforts underway to look at the efficacy of neoadjuvant immunotherapy in melanoma.
ABBREVIATED PRESCRIBING INFORMATION
Please refer to the Summary of Product Characteristics (SmPC) before prescribing Pelgraz▼(peg lgrastim) 6 mg solution for injection in pre- lled syringe or prelled injector. Presentation: Each pre- lled syringe or pre- lled injector contains 6 mg of peg lgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**. *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/mL if the PEG moiety is included. Indications Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Dosage and Administration Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Posology: One 6 mg dose (a single pre- lled syringe or pre- lled injector) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. Safety and e cacy of Pelgraz in children and adolescents has not yet been established and no recommendation on a posology can be made. No dose change is recommended in patients with renal impairment, including those with end-stage renal disease. Method of administration: Pelgraz is for subcutaneous use. The injections should be given subcutaneously into the thigh, abdomen or upper arm. See SmPC for instructions on handling of the medicinal product before administration.
Contraindications Hypersensitivity to peg lgrastim or any of the excipients in Pelgraz.
Warnings and precautions To improve the traceability of biological medicinal products, the trade name of the administered product should be clearly recorded. The long-term e ects of peg lgrastim have not been established in acute myeloid leukaemia (AML); therefore, it should be used with caution in this patient population. Granulocytecolony stimulating factor (G-CSF) can promote growth of myeloid cells in vitro and similar e ects may be seen on some non-myeloid cells in vitro The safety and e cacy of peg lgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML. The safety and e cacy of peg lgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established. The safety and e cacy of peg lgrastim have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens. Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary in ltrates or pneumonia may be at higher risk. The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary in ltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of adult respiratory distress syndrome (ARDS). In such circumstances peg lgrastim should be discontinued at the discretion of the physician and the appropriate treatment given. Glomerulonephritis has been reported in patients receiving lgrastim and peg lgrastim. Generally, glomerulonephritis resolved after dose reduction
or withdrawal of lgrastim and peg lgrastim. Urinalysis monitoring is recommended. Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of peg lgrastim. Spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. Treatment with peg lgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia. Peg lgrastim in conjunction with chemotherapy and/or radiotherapy has been associated with development of myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) in breast and lung cancer patients. Patients treated in these settings should be monitored for signs and symptoms of MDS/AML. Sickle cell crises have been associated with the use of peg lgrastim in patients with sickle cell trait or sickle cell disease. Therefore, use caution when prescribing peg lgrastim in patients with sickle cell trait or sickle cell disease, monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vasoocclusive crisis. White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1% of patients receiving peg lgrastim. No adverse reactions directly attributable to this degree of leukocytosis have been reported. Such elevation in WBCs is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic e ects of this medicinal product. Consistent with the clinical e ects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 × 109/L after the expected nadir, this medicinal product should be discontinued immediately. Hypersensitivity, including anaphylactic reactions, have been reported with peg lgrastim. Permanently discontinue peg lgrastim in patients with clinically signi cant hypersensitivity. Do not administer peg lgrastim to patients with a history of hypersensitivity to peg lgrastim or lgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with peg lgrastim treatment. If the patient has developed SJS with the use of peg lgrastim, treatment must not be restarted at any time. As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against peg lgrastim is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present. Aortitis has been reported after lgrastim or peg lgrastim administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased in ammatory markers (e.g. C-reactive protein and WBC count). In most cases aortitis was
diagnosed by CT scan and generally resolved after withdrawal of lgrastim or peg lgrastim. The safety and e cacy of Pelgraz for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging ndings. This should be considered when interpreting bone-imaging results. The additive e ect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. Pelgraz contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free’. The needle cover contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Pregnancy and Lactation Peg lgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from peg lgrastim therapy taking into account the bene t of breastfeeding for the child and the bene of therapy for the woman. Adverse Events include: Adverse events which could be considered serious include: Common: Thrombocytopenia. Uncommon: Myelodysplastic syndrome, acute myeloid leukaemia, sickle cell anaemia with crisis, capillary leak syndrome, glomerulonephritis, hypersensitivity reactions (including angioedema, dyspnoea, anaphylaxis), splenic rupture (including some fatal cases), Sweet’s syndrome (acute febrile neutrophilic dermatosis), pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema and pulmonary brosis have been reported. Uncommonly cases have resulted in respiratory failure or ARDS which may be fatal. Rare: Aortitis, pulmonary haemorrhage, Stevens-Johnson syndrome. Other Very Common adverse events: Headache, nausea, bone pain. Other Common adverse events: Leukocytosis, musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain), injection site pain, non-cardiac chest pain. See SmPC for details of other adverse events. Shelf Life: 3 years. Store in a refrigerator (2∞C – 8∞C). Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded. Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely a ect the stability of Pelgraz. Keep the container in the outer carton in order to protect from light. Pack Size: One pre lled syringe or pre lled syringe injector with one alcohol swab, in a blistered packaging. Marketing Authorisation Numbers: Pre-
“We must remember that in melanoma, even in the adjuvant setting, there are significant numbers of patients who have recurrent disease and who die from their disease,” he said. “Even in the adjuvant studies, before being enrolled in the study, certainly in macroscopic disease that was resected, nearly 20 per cent of patients went on to develop progression of disease before even getting immunotherapy or targeted therapy.
“So we need neoadjuvant therapy in melanoma – survival is still poor; surgery can be morbid, and we need biomarkers, and we need to better understand why resistance develops, and I think the neoadjuvant platform has been very good for that.”
Dr Power discussed hypothesis-generating data on neoadjuvant immunotherapy and the potential for its practical application. He also outlined the advances in recent years in therapies for advanced disease, which he said has complicated the area of metastatic disease treatment.
“We have very difficult subsets of patients with advanced melanoma, and significant numbers of these patients do not do well,” said Dr Power.
He also discussed second-line treatments for the 70 per cent of patients who have disease progression after first-line PD-1 treatment and presented studies with data on this topic. “There are lots of emerging new pathways that are being looked at to overcome immune resistance,” he said. “Asymptomatic patients with brain metastases can do very well with immunotherapy alone, and symptomatic patients don’t do well, but they still do better than historic norms without immunotherapy.”
National Comprehensive Cancer Network® (NCCN®) now recognizes ribociclib (KISQALI®) + ET, a Category 1 preferred treatment option, for showing an OS BENEFIT IN 1L PATIENTS with HR+/HER2- mBC4
KISQALI is not indicated for concomitant use with tamoxifen 4 1L, first line; 2L, second line; ET, endocrine therapy; LHRH, luteinizing hormonereleasing hormone, aBC, advanced breast cancer.
ESMO - European society of medical oncology SABC - San Antonio Breast Cancer Conference ASCO - American Society of Clinical Oncology
1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival results from the phase III MONALEESA-2 trial of postmenopausal patients with HR+/HER2− advanced breast cancer treated with endocrine therapy ± ribociclib. Presented at: European Society of Medical Oncology; September 16-21, 2021.
2. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316.
3. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514-524.
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Published June 21, 2022. Accessed July 29, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
Kisqali (ribociclib) 200 mg film-coated tablets
Presentation: Film coated tablets (FCT) containing 200 mg of ribociclib and 0.344 mg soya lecithin.
Indications: Kisqali is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy
In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.
Dosage and administration:
Adults: The recommended dose is 600 mg (3 x 200 mg FCT) taken orally, once daily for 21 consecutive days followed by 7 days off treatment, resulting in a complete cycle of 28 days.
Kisqali should be used together with 2.5 mg letrozole or another aromatase inhibitor or with 500 mg fulvestrant.
When Kisqali is used in combination with an aromatase inhibitor, the aromatase inhibitor should be taken orally once daily continuously throughout the 28 day cycle.
Please refer to the Summary of Product Characteristics (SmPC) of the aromatase inhibitor for additional details.
When Kisqali is used in combination with fulvestrant, fulvestrant is administered intramuscularly on days 1, 15 and 29, and once monthly thereafter. Please refer to the SmPC of fulvestrant for additional details.
Treatment of pre and perimenopausal women with the approved Kisqali combinations should also include an LHRH agonist in accordance with local clinical practice.
Management of severe or intolerable adverse reactions (ARs) may require temporary dose interruption, reduction or discontinuation of Kisqali. Please see section 4.2 of SmPC for recommended dose modification guidelines.
Kisqali can be taken with or without food (see section 4.5).The tablets should be swallowed whole and should not be chewed, crushed or split prior to swallowing.
Special populations: ♦Renal impairment: Mild or moderate: No dose adjustment is necessary. Severe: A starting dose of 200 mg is recommended in patients with severe renal impairment. Kisqali has not been studied in breast cancer patients with severe renal impairment. Caution should be used in patients with severe renal impairment with close monitoring for signs of toxicity.
♦Hepatic impairment: Mild: No dose adjustment is necessary. Moderate or severe: Dose adjustment is required, and the starting dose of 400 mg once daily is recommended. ♦Elderly (>65 years): No dose adjustment is required.
♦Pediatrics(<18 years): Safety and efficacy have not been established.
Contraindications: Hypersensitivity to the active substance or to peanut, soya or any of the excipients.
Warnings/Precautions: ♦Neutropenia was most frequently reported AR. A complete blood count (CBC) should be performed before initiating treatment. CBC should be monitored every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, then as clinically indicated. Febrile neutropenia was reported in 1.4% of patients exposed to Kisqali in the phase III clinical studies. Patients should be instructed to report any fever promptly.Based on the severity of the neutropenia, Kisqali may require dose interruption, reduction, or discontinuation. ♦Hepatobiliary toxicity - increases in
transaminases have been reported. Liver function tests (LFTs) should be performed before initiating treatment. LFTs should be monitored every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, then as clinically indicated. If grade ≥ 2 abnormalities are noted, more frequent monitoring is recommended. Recommendations for patients who have elevated AST/ALT grade ≥ 3 at baseline have not been established. Based on the severity of transaminase elevations, Kisqali may require dose interruption, reduction, or discontinuation. ♦QT interval prolongation has been reported with Kisqali. The use of Kisqali should be avoided in patients who have already or who are at significant risk of developing QTc prolongation. The ECG should be assessed prior to initiation of treatment. Treatment with Kisqali should be initiated only in patients with QTcF values <450 msec. The ECG should be repeated at approximately Day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated. In case of QTcF prolongation during treatment, more frequent ECG monitoring is recommended Appropriate monitoring of serum electrolytes (including potassium, calcium, phosphorous, and magnesium) should be performed prior to initiation of treatment, at the beginning of the first 6 cycles, and then as clinically indicated. Any abnormality should be corrected before the start of Kisqali treatment. Based on the observed QT prolongation during treatment, Kisqali may require dose interruption, reduction, or discontinuation. Based on the E2301 study QTcF interval data, Kisqali is not recommended for use in combination with tamoxifen. ♦Critical visceral disease. The efficacy and safety of ribociclib have not been studied in patients with critical visceral disease. ♦Severe cutaneous reactions Toxic epidermal necrolysis (TEN) has been reported with Kisqali treatment. If signs and symptoms suggestive of severe cutaneous reactions (e.g. progressive widespread skin rash often with blisters or mucosal lesions) appear, Kisqali should be discontinued immediately. ♦Interstitial lung disease/pneumonitis ILD/pneumonitis has been reported with CDK4/6 inhibitors including Kisqali. Based on the severity of the ILD/pneumonitis, which may be fatal, Kisqali may require dose interruption, reduction or discontinuation as described in SmPC.
Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis which may include hypoxia, cough and dyspnoea and dose modifications should be managed in accordance with Table 5 (see section 4.2)
♦Blood creatinine increase ribociclib may cause blood creatinine increase – if this occurs it is recommended that further assessment of the renal function be performed to exclude renal impairment.
♦CYP3A4 substrates. ribociclib may interact with medicinal products which are metabolised via CYP3A4, which may lead to increased serum concentrations of CYP3A4 substrates (see section 4.5). Caution is recommended in case of concomitant use with sensitive CYP3A4 substrates with a narrow therapeutic index and the SmPC of the other product should be consulted for the recommendations regarding co administration with CYP3A4 inhibitors.
Pregnancy, Fertility and Lacation
♦Pregnancy: Pregnancy status should be verified prior to starting treatment as Kisqali can cause foetal harm when administered to a pregnant woman.
♦Women of childbearing potential who are receiving Kisqali should use effective contraception (e.g. double-barrier contraception) during therapy and for at least 21 days after stopping treatment with Kisqali. ♦Breast feeding: Patients receiving Kisqali should not breast feed for at least 21 days after the last dose. ♦Fertility: There are no clinical data available regarding effects of ribociclib on fertility. Based on animal studies, ribociclib may impair fertility in males of reproductive potential.
♦Effects on ability to drive and use machines Patients should be advised to be cautious when driving or using machines in case they experience fatigue, dizziness or vertigo during treatment with Kisqali.
Interactions:
♦Concomitant use of strong CYP3A4 inhibitors should be avoided, including, but not limited to, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir, ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, verapamil, and voriconazole. Alternative concomitant medicinal products with less potential to inhibit CYP3A4 should be considered. Patients should be monitored for ARs. If concomitant use of a strong CYP3A4 inhibitor cannot be avoided, the dose of Kisqali should be reduced (see section 4.2 of SmPC). ♦Grapefruit or grapefruit juice should be avoided. ♦Concomitant use of strong CYP3A4 inducers should be avoided, including, but not limited to, phenytoin, rifampicin, carbamazepine and St John’s Wort (Hypericum perforatum). An alternative medicinal product with no or minimal potential to induce CYP3A4 should be considered. ♦Caution is recommended when Kisqali is administered with sensitive CYP3A4 substrates with narrow therapeutic index (including, but not limited to, alfentanil, ciclosporin, everolimus, fentanyl, sirolimus, and tacrolimus), and their dose may need to be reduced. ♦Concomitant administration of Kisqali at the 600 mg dose with the following CYP3A4 substrates should be avoided: alfuzosin, amiodarone, cisapride, pimozide, quinidine, ergotamine, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam. ♦Caution and monitoring for toxicity are advised during concomitant treatment with sensitive substrates of drug transporters P-gp, BCRP, OATP1B1/1B3, OCT1, OCT2, MATE1 and BSEP which exhibit a narrow therapeutic index, including but not limited to digoxin, pitavastatin, pravastatin, rosuvastatin and metformin. ♦Co-administration of Kisqali with medicinal products with known potential to prolong the QT interval should be avoided such as anti-arrhythmic medicinal products (including, but not limited to, amiodarone, disopyramide, procainamide, quinidine and sotalol) and other medicinal products known to prolong the QT interval including, but not limited to, chloroquine, halofantrine, clarithromycin, ciprofloxacin, levofloxacin, azithromycin, haloperidol, methadone, moxifloxacin, bepridil, pimozide and intravenous ondansetron. Kisqali is not recommended for use in combination with tamoxifen.
Adverse reactions: ♦Very common: Infections, neutropenia, leukopenia, anaemia lymphopenia, decreased appetite, headache, dizziness, dyspnoea, cough, nausea, diarrhoea, vomiting, constipation, stomatitis, abdominal pain, dyspepsia alopecia, rash, pruritus, back pain, fatigue, peripheral oedema, asthenia, pyrexia, abnormal liver function tests. ♦Common:, thrombocytopenia, febrile neutropenia, hypocalcaemia, hypokalaemia, hypophosphataemia, vertigo, lacrimation increased, dry eye, syncope, dysgeusia, , hepatotoxicity, erythema, dry skin, vitiligo, dry mouth, oropharyngeal pain, blood creatinine increased, electrocardiogram QT prolonged. ♦Please refer to SmPC for a full list of adverse reactions.
Legal Category: POM
Pack sizes: Unit packs containing 21, 42 or 63 FCTs. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4 Ireland
Marketing Authorisation Numbers: EU/1/17/1221/003 & 005.
Full prescribing information is available on request from Novartis Ireland Ltd, Vista Building, Elm Park Business Park, Dublin 4. Tel: 01 2601255 or at www.medicines.ie
Prescribing information last revised: April 2022
Reporting suspected adverse reactions of the medicinal product is important to Novartis and the HPRA. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported via HPRA Pharmacovigilance, website www.hpra.ie. Adverse events could also be reported to Novartis preferably via www.report.novartis.com or by email: drugsafety.dublin@novartis.com or by calling 01 2080 612.
Novartis Ireland Ltd, Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, D04 A9N6
| IE253121 © 2022 Novartis
KISQALI—the only CDK4/6 inhibitor with statistically significant overall survival across all 3 phase III trials1–3
*Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1
Ryaltris™ 25 mcg/actuation + 600 mcg/actuation nasal spray, suspension.
Prescribing information
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.
Presentation: One delivered dose contains mometasone furoate monohydrate equivalent to 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to 600 mcg olopatadine. White, homogeneous suspension.
Uses: In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.
Dosage: For nasal use only. Adults and adolescents (12 years of age and over) two actuations in each nostril twice daily (morning and evening). Elderly: no dose adjustment required. Children under 12 years: not recommended. Renal and hepatic impairment: no dose adjustment expected.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. Recent nasal surgery or trauma until wound healing has occurred.
Warnings and Precautions: Instances of nasal ulceration and nasal septal perforation have been reported. Not recommended in case of nasal septum perforation. Patients using Ryaltris™ over several months or longer should be examined periodically for possible changes in the nasal mucosa and for evidence of Candida infection. Instances of epistaxis have been reported. Visual disturbance may be reported with systemic and topical corticosteroid use. Consider referral to ophthalmologist with symptoms such as blurred vision or other visual disturbances as cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported after use of systemic and topical corticosteroids. Hypersensitivity reactions, including wheezing, may occur - discontinue. Immunosuppression: use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex. Potential systemic effects of corticosteroids include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Hypercorticism and adrenal suppression may appear at higher than recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris™ in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system (CNS) depressants. Increased risk of antihistamine adverse effects with concomitant use of olopatadine or other antihistaminic drugs administered via nasal, ocular or oral route. Paediatric population: It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. Interactions: No interaction studies have been performed with Ryaltris™. Any interactions
from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination. Olopatadine: No interactions with other drugs expected. Mometasone Furoate: Cotreatment with CYP3A inhibitors should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects and patients should be monitored. Pregnancy and Lactation: Avoid use during pregnancy unless potential benefit to mother justifies potential risk to mother, foetus or infant. Assess before prescribing in lactating mothers.
Side Effects: Common: dysgeusia, epistaxis, nasal discomfort. Uncommon: dizziness, headaches, somnolence, nasal dryness, dry mouth, abdominal pain, nausea, fatigue. Rare: bacterial vaginosis, anxiety, depression, insomnia, lethargy, migraine, blurred vision, dry eye, eye discomfort, ear pain, nasal inflammation, nasal mucosal disorder, oropharyngeal pain, sneezing, throat irritation, constipation, sore tongue, laceration. Frequency not known: pharyngitis, upper respiratory tract infection, hypersensitivity (including anaphylactic reactions, angioedema, bronchospasm, dyspnoea), cataracts, glaucoma, increased intraocular pressure and nasal septum perforation.
Pack Sizes: One bottle containing 30ml suspension (240 actuations).
Legal Category: POM.
Product Authorisation Numbers: PA 1543/002/001
Product Authorisation Holder: Glenmark Pharmaceuticals s.r.o., Hvezdova 1716/2b, 140 78 Prague 4, Czech Republic.
Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.
Date of Preparation: June 2022.
ALL REPORTS PRISCILLA LYNCH
The 2022 Irish Society of Gastroenterology (ISG) Winter Meeting took place at the Grand Hotel, Malahide, Co Dublin, on 17-18 November, and was deemed a “great success”.
The two-day meeting was a celebration of the 60th anniversary of the Society’s formation and also honoured leading Irish Gastroenterologist Prof Diarmuid O’Donoghue with a lifetime achievement award.
ISG President Prof Deirdre McNamara, Consultant Gastroenterologist at Tallaght University Hospital, Dublin, and
Speaking to the Medical Independent, Prof McNamara said: “For me the highlight of the meeting was the quality of the speakers. They were fantastic. They covered a very diverse set of topics. I was particularly interested in all the new technologies, including AI [artificial intelligence], coming
through. And yet it was lovely to come back to the more clinical, functional element. So the speakers were fantastic, the crowd was super. At all of these meetings, it is the interaction between the speakers and the questions from the floor and the chairpersons [that is of such value].”
The meeting’s key thematic focus was how to provide less invasive gastroenterology diagnostics/procedures where possible and optimal personalised and tailored care, against a background of ever-growing demand, changing technology, and scarce resources.
“Gastroenterology is a very broad church, but a common theme – and one for all Irish medicine – is how we maximise our healthcare services… with [the] challenges that face us. We are duty bound to identify the best way of treating patients. It is a continuing theme from meeting to meeting, and at this meeting there were some advances in that – our paediatric colleagues spoke about new triage systems that might be adaptable in adult medicine. So it is that mix, that opportunity to hear other ideas, that is hugely beneficial.”
ONE
There was also “an excellent standard” of research and case studies produced by younger ISG members and their mentors, she said. “What I am always proudest of is the presentations from our young gastroenterologists. The future of gastroenterology is in good hands. You can see that at meetings like this, you can see their enthusiasm, but also the skills that they’re bringing.”
Prof McNamara’s own hospital, Tallaght, fared very well in the award winners at the meeting. “I suppose that is reflecting our ethos of clinical and translational research, which would have been instilled in us from my trainer [the renowned gastroenterologist and Professor] Colm O’Moráin, who has a great history in research, which we are continuing.”
MMX technology enables targeted release of budesonide throughout the entire colon.1,5–8
IN ULCERATIVE COLITIS:
• CORTIMENT, with low systemic bioavailability, has a comparable side e ect profile to placebo1,5–8
• Symptom resolution may be achieved with CORTIMENT in a median of 30 days9
• Real World Evidence and a randomised controlled trial demonstrate that CORTIMENT is an e ective add-on therapy in mild to moderate active UC patients9,10
Prescribe CORTIMENT 9 mg once-daily for up to 8 weeks for your flaring UC and Active MC patients.1 No dose tapering required.1
systemic e ects may occur (see SPC); current or history of severe a ective disorders (including first degree relatives). See SPC for full information on warnings and precautions. Interactions: No interaction studies have been performed. Inhibitors of CYP3A4 enzyme are expected to increase systemic exposure to budesonide several times and the risk of systemic side e ects. Combination should be avoided unless the benefi outweighs the increased risk. CYP3A4 inducers may reduce budesonide exposure. Please refer to the SPC for further information. Pregnancy, lactation and fertility: Cortiment should only be used during pregnancy if the potential benefi justifies the potential risk to the foetus. Lactation: data supports continued use, see SPC. Fertility: see SPC. E ects on ability to drive and use machines: No studies; occasional dizziness or tiredness may occur. Side e ects: Fromclinicaltrials:Common: insomnia, headache, nausea, abdominal pain upper, abdominal distension, abdominal pain, dry mouth, dyspepsia,
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie. Date of preparation: November 2021. IE-COR-2100013. References: 1. Cortiment 9 mg, Prolonged Release Tablets. SmPC. 2. Tillotts Pharma Budesonide 3 mg Capsules. SmPC. 3. Dr Falk Budesonide 3 mg Gastro-resistant Capsules. SmPC. 4. Dr Falk Budesonide 9 mg Gastro-resistant Granules. SmPC. 5. Brunner M, et al. Br J Clin Pharmacol. 2006;61(1):31–38. 6. Fiorino G, et al. Curr Med Chem. 2010;17(17):1851–1857. 7. Travis SPL, et al. Gut. 2014;63:433–441. 8. Sandborn WJ, et al. Gastroenterology. 2012;143:1218–1226. 9. Danese S, et al. J Crohns Colitis. 2019;13 (supplement 1):296–297. 10. Rubin D, et al. J Crohns Colitis. 2017;11(7):785–791. budesonide MMX 9 mg tablet once-daily for up to 8 weeks
Clinicians need to take irritable bowel syndrome (IBS) symptoms more seriously and take the time to better inform patients about the condition, the ISG 2022 Winter Meeting heard.
Prof Magnus Simrén, Professor of Gastroenterology, University of Gothenburg, spoke about the burden of IBS and optimum management strategies. He pointed out that IBS is one of the most common presentations in gastroenterology as well as general practice. Often patients can feel dismissed or their symptoms minimised despite the large negative impact IBS can have on their lives.
Prof Simrén said listening to patients is key, as is reassuring and educating them about IBS and potential triggers, as simple lifestyle changes and managing stress and dietary triggers can have a very positive impact.
Treatment-wise, he noted the importance of firstly correctly defining what the key symptoms are and the specific subtype of IBS, ie, constipation or diarrhoea predominant, bloating, etc, as defined under the Rome IV Diagnostic Criteria, and taking a multidisciplinary approach (stress management and dietetics) to optimise outcomes.
Speaking to the Medical Independent, Prof Simrén said the burden of disease for IBS is high globally, regionally, and nationally.
“It is important to optimise the management using different approaches, to address the different components of IBS… it is also important that we take their symptoms quite seriously as they impact their lives substantially. But we don’t always need to give them medication; just explanation, reassurance, and some general advice can be sufficient for many patients.”
‘IBS patients would benefit from more education and
of Cortiment tablets is likely to reduce the immune response to vaccines. Concomitant administration of ketoconazole or other potent CYP3A4 inhibitors, including grapefruit juice, should be avoided (see SPC for further information). Cortiment contains lecithin (soya oil). Avoid if hypersensitive to peanut or soya. Contains lactose. Warningsgenerallyidentifiedforcorticosteroids:adrenocortical suppression (transfer from systemic treatment); increased susceptibility to infections; surgery/other stresses – supplementary systemic corticosteroid treatment recommended; avoid exposure to chicken pox and measles, especially if not previously exposed;
Colon capsule endoscopy is a useful colonoscopysparing technology, which can help alleviate ever-growing diagnostic demand and offers a safer, less invasive alternative for many patients, the ISG Winter Meeting heard
Dr James Turvill, Consultant Gastroenterologist, York Teaching Hospital, UK, presented early NHS data on the rollout of colon capsule endoscopy (CCE) in England during a dedicated session on less invasive diagnostic approaches in gastroenterology. A pilot CCE programme was launched in England during the Covid-19 pandemic.
Outlining the English data so far, Dr Turvill said 3,624 capsules have been swallowed to date, with monthly rates of about 200 across the 48 participating sites.
Analysis of 3,257 comparative study participants shows a conclusivity rate of 71 per cent overall (87.9 per cent in left colon) in those who had a CCE.
“We’re seeing much more pathology [polyps] than we anticipated – 45-to-50 per cent of the total, when we expected 30 per cent.”
However, there are a lot of false positives and patient age and sex significantly impact CCE completion rate, with men more likely to have a successful completion rate, even at older ages, which needs to be addressed with further study, he said.
Results-wise “about 31 per cent go on to have a colonoscopy, 14 per cent stay on an urgent pathway. The reasons for onward activity are mostly down to the pathology we’ve found… so it [CCE] is doing its job.”
Dr Turvill also pointed out that colonoscopies are “very bad for the environment” and are “very carbon-wasteful”.
Speaking to the Medical Independent (MI), Dr Turvill said: “We have capacity and demand issues in the use of colonoscopy, and it is not risk-free, and when it is performed unnecessarily that is not ideal. Colonoscopy has the advantage of being a therapeutic intervention, but should be targeted when resources are limited. I think we are increasingly demonstrating an evidence-base for using colon capsules as a colonoscopy-sparing test.”
Colon capsules can also be taken directly to patients, and can increase uptake in hard-to-reach populations, he added.
Also speaking during this session was Prof Subrata Ghosh, Chair and Head of Medicine, University College Cork Medical School, who said that bowel ultrasonography should be a standard tool in all inflammatory bowel disease centres.
The many advantages of bowel ultrasonography include that it is non-invasive, easy to use, quick (seven-to-10 minutes), accurate, radiation free, cost-effective, well accepted by patients (particularly useful in paediatrics), and portable, he outlined.
Training and a lack of official guidelines have impacted the uptake of this diagnostic modality; however, scores are evolving and more training programmes are coming on stream.
“Ultrasonography is very easy to do and once you have the machine, it is very cheap to do,” Prof Ghosh told MI
“There seems to be a training issue at the moment. It must be introduced as part of training early on….
“For a patient having an ultrasonography, it takes seven minutes to do; it is completely painless, completely non-invasive.... For kids, this is the best thing to do.”
The final speaker in this session was Prof Maja Thiele, Professor of Hepatology at Odense University Hospital, Denmark, who looked at optimum non-invasive testing strategies in non-alcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD).
FibroScan remains the gold standard non-invasive liver disease test across Europe. It is widely available compared to MRI-E (elastography), which has a slightly higher diagnostic accuracy than FibroScan, Prof Thiele reported. For diagnosing steatosis, where indicated, ultrasonography or the controlled attenuation parameter (CAP) score are recommended.
However, Prof Thiele said CAP can be “inaccurate, is not prognostic, and is highly dynamic”, so she warned it should be used “with caution”.
Transient elastography is the reference non-invasive test for advanced fibrosis and prognosis, but it is more accurate in ALD than in NAFLD she noted, quoting supporting data.
There are now a number of commercial diagnostic fibrosis tests available, such as the ELF [enhanced liver fibrosis]
Entocort®CR Capsules are indicated for the induction of remission in patients with mild-to-moderate Crohn’s disease affecting the ileum and/or the ascending colon, and for the induction of remission in patients with active microscopic colitis.
test; however, they can be expensive.
FIB-4 (non-invasive biomarker score) can be somewhat useful as a ‘rule-out’ tool, but has false positive rates in excess of 50 per cent, while 20-25 per cent of results are false negatives, so it should only be used in primary care, Prof Thiele stressed.
The future is better biomarkers for liver disease monitoring and prediction, she concluded.
2 to 4 weeks. When discontinuing, reduce dose over the last 2 to 4 weeks. Entocort can be used for up to 3 months: 6 mg, once daily in the morning. Long-term use is not recommended. To replace prednisolone in steroiddependent patients, 6 mg once daily in the morning. Prednisolone dose should be tapered. To prevent recurrence after surgery in patients with high disease activity: 6 mg once daily in the morning. No benefit shown in post surgical patients with obstructive fibrostenotic Crohn’s disease.
Active microscopic colitis: 9 mg once daily in the morning for up to 8 weeks. Reduce dose for last 2 to 4 weeks. Use lowest effective dose.
Elderly: As for adults. Experience is limited. Children: Not recommended.
CONTRAINDICATIONS: Hypersensitivity to active or excipients.
PRECAUTIONS AND WARNINGS:
Systemic corticosteroid effects may occur, including glaucoma. Monitor for visual disturbance caused by e.g. cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).
Monitor for infections.
Caution in: patients with reduced liver function; patients with infections, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts or family history of diabetes or glaucoma or any condition where glucocorticosteroids may have unwanted effects; patients with severe affective disorders (or family history), including depressive or manic-depressive illness and previous steroid psychosis; patients not immune to chicken pox and measles. If exposed, consider immunoglobulin therapy, or antiviral agents. Contains sucrose. Caution when transferring from another glucocorticosteroid to Entocort® CR Capsules, monitor adrenocortical function and unmasked allergies. During surgery or other stress situations, supplementary glucocorticoid treatment is
recommended. On discontinuation, reduce dose over 2 to 4 weeks, monitor for withdrawal effects, adjust dose if necessary. Coadministration of CYP3A inhibitors is expected to increase side effects: avoid/monitor (see interactions). With chronic high doses, systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression may occur, and very rarely psychiatric/behavioural effects. Children: not recommended. If used monitor child’s growth, evaluate risk-benefit. Long-term studies have not been performed.
INTERACTIONS: CYP3A4 inhibitors (e.g. ketoconazole, itraconazole), HIV protease inhibitors and grapefruit juice can increase systemic budesonide, CYP3A4 inducers (e.g. carbamazepine) may reduce budesonide levels; adjust dose. Colestyramine may reduce Entocort uptake. Raised levels/effects of corticosteroids reported with oestrogens and contraceptive steroids. At recommended doses, omeprazole does not affect the pharmacokinetics of oral budesonide whereas cimetidine has a slight but clinically insignificant effect.
USE DURING PREGNANCY AND LACTATION: Pregnancy: Associated with foetal abnormalities in animals; consider risk-benefit. Breast-feeding: Budesonide is excreted in breast milk; at therapeutic doses, exposure to breast-fed infants anticipated to be low.
UNDESIRABLE EFFECTS: Common (≥1/100 to < 1/10): Cushingoid features, hypokalemia, behavioural changes such as nervousness, insomnia, mood swings, and depression, palpitations, dyspepsia, skin reactions (urticaria, exanthema), muscle cramps, menstrual disorders; Uncommon (≥ 1/1,000 to < 1/100): Anxiety, tremor; psychomotor hyperactivity. Rare (≥1/10,000 to <1/1,000): Aggression, blurred vision, glaucoma, cataract, ecchymosis. Very rare (< 1/10,000): Anaphylactic reaction, growth retardation. Systemic corticosteroid effects may occur depending on dose, duration and individual.
LEGAL CATEGORY: POM. MA No: 2018/003/001.
MA HOLDER: TILLOTTS PHARMA GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany.
DATE OF PREPARATION: May 2020. CODE: 2020/21 Full prescribing information available on request from the Marketing Authorisation holder or from Tillotts Pharma Ltd., 25 Sandyford Office Park, Dublin 18. Tel:(00 353 1) 294 2015. Entocort® is a trademark.
XELJANZ® (tofacitinib) Prescribing Information:
Please refer to the Summary of Product Characteristics (SmPC) before prescribing XELJANZ 5 mg or 10 mg film-coated tablets, XELJANZ 11 mg prolonged release tablets or XELJANZ 1 mg/mL oral solution. Presentation: Film-coated tablet containing tofacitinib citrate, equivalent to 5 mg or 10 mg tofacitinib. Prolonged-release tablets containing tofacitinib citrate, equivalent to 11 mg tofacitinib. Oral solution containing tofacitinib citrate, equivalent to 1 mg/mL tofacitinib. Indications: Please note not all presentations are licensed for all indications, please see dosage section for details: In combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. Can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. In combination with MTX for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy. For the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. For the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. For the treatment of active polyarticular juvenile idiopathic arthritis (JIA) (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis, and extended oligoarthritis), and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Can be given in combination with MTX or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Dosage: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of the condition for which tofacitinib is indicated. Tofacitinib is given orally, with or without food. RA, PsA and AS: The recommended dose is 5 mg twice daily or 11 mg once daily which should not be exceeded. Treatment with tofacitinib 5 mg film coated tablets twice daily and tofacitinib 11 mg prolonged release tablet once daily may be switched between each other on the day following the last dose of either tablet. Available data suggest that clinical improvement in AS is observed within 16 weeks of initiation of treatment. Continued therapy should be carefully reconsidered in AS patients exhibiting no clinical improvement within this timeframe. UC: The recommended dose is 10 mg twice daily for induction for 8 weeks. For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance. Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16. The recommended dose for maintenance treatment is tofacitinib 5 mg twice daily. Tofacitinib 10 mg twice daily for maintenance treatment is not recommended in patients with UC who have known venous thromboembolism (VTE) risk factors, unless there is no suitable alternative treatment available. For patients with UC who are not at increased risk for VTE, tofacitinib 10 mg twice daily may be considered if the patient experiences a decrease in response on tofacitinib 5 mg twice daily and failed to respond to alternative treatment options for UC such as tumour necrosis factor (TNF) inhibitor treatment. Tofacitinib 10 mg twice daily for maintenance treatment should be used for the shortest duration possible. The lowest effective dose needed to maintain response should be used. Polyarticular JIA and juvenile PsA: The recommended dose in patients 2 years of age and older: 10 kg - < 20 kg: 3.2 mg (3.2 mL oral solution) twice daily, 20 kg - < 40 kg: 4 mg (4 mL oral solution) twice daily, and ≥ 40 kg 5 mg (5 mL oral solution or 5 mg tablet) twice daily. Patients ≥ 40 kg treated with tofacitinib 5 mL oral solution twice daily may be switched to tofacitinib 5 mg tablets twice daily. Available data suggest that clinical improvement is observed in paediatric patients within 18 weeks of initiation. Continued therapy should be carefully reconsidered in a paediatric patient exhibiting no clinical improvement within this timeframe. Dose interruption and adjustment:
a
Tofacitinib treatment should be interrupted if a patient develops a serious infection until the infection is controlled. Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia. It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 0.75×10 9/L, an absolute neutrophil count (ANC) less than 1×10 /L or with haemoglobin less than 9 g/dL. It is recommended not to initiate dosing in paediatric patients with an absolute neutrophil count (ANC) less than 1.2×10 9/L or with haemoglobin less than 10 g/dL. Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. Patients with severe renal impairment the dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal renal function is 5 mg twice daily or 11 mg prolonged-release tablet once daily. Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal renal function is 10 mg twice daily. Patients with severe renal impairment should remain on a reduced dose even after haemodialysis. Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment. Patients with moderate hepatic impairment dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal hepatic function is 5 mg twice daily or 11 mg prolonged-release tablet once daily. Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal hepatic function is 10 mg twice daily. Tofacitinib should not be used in patients with severe hepatic impairment. Elderly: No dose adjustment is required in patients aged 65 years and older. Use with caution as increased risk and severity of adverse events. See also Warnings & Precautions for use in patients over 65 years of age. Paediatric population: The safety and efficacy of tofacitinib in children less than 2 years of age with polyarticular JIA and juvenile PsA has not been established. The safety and efficacy of tofacitinib in children less than 18 years of age with other indications (e.g. ulcerative colitis) has not been established. The safety and efficacy of tofacitinib prolonged-release formulation in children aged less than 18 years have not been established. Interactions: Tofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g. ketoconazole) and in patients receiving 1 or more products that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g. fluconazole). Coadministration with potent CYP inducers (e.g. rifampicin) may result in a loss of or reduced clinical response. Coadministration with potent inducers of CYP3A4 is not recommended. Contraindications: Hypersensitivity to any of the ingredients, active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections, severe hepatic impairment, pregnancy and lactation. Warnings and Precautions: Patients treated with tofacitinib should be given a patient alert card. Use in patients over 65 years of age: Considering the increased risk of serious infections, myocardial infarction, and malignancies with tofacitinib in patients over 65 years of age, tofacitinib should only be used in patients over 65 years of age if no suitable treatment alternatives are available. Combination with other therapies: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies. Tofacitinib should be avoided in combination with biologics and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporin and tacrolimus. Venous thromboembolism (VTE): Serious VTE events including pulmonary embolism (PE), some of which were fatal, and deep vein thrombosis (DVT), have been observed in patients taking tofacitinib. In a randomised post authorisation safety study in patients with rheumatoid arthritis who were 50 years of age or older with at least one additional
From the start of treatment with XELJANZ in patients with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. 3
XELJANZ 10 mg BID achieved higher rates of remission (primary endpoint) at week 8 vs placebo in OCTAVE Induction 1 (19% [88/476] vs 8% [10/122]; P=0.007) and OCTAVE Induction 2 (17% [71/429] vs 4% [4/112]; P<0.001) 1
XELJANZ 10 mg BID achieved higher rates of clinical response at week 8 vs placebo in OCTAVE Induction 1 (60% [285/476] vs 33% [40/122]; P<0.001) and OCTAVE Induction 2 (55% [236/429] vs 29% [32/112]; P<0.001) 1
In OCTAVE Sustain, for patients showing remission or clinical response following induction, XELJANZ 5 mg BID achieved higher rates of remission at week 52 (primary endpoint) vs placebo (34% [68/198] vs 11% [22/198]; P<0.001).1
Decreases in rectal bleeding and stool frequency Mayo subscores were observed as early as day 3 in patients treated with XELJANZ 10 mg BID 2
cardiovascular risk factor, a dose dependent increased risk for VTE was observed with tofacitinib compared to TNF inhibitors. In a post hoc exploratory analysis within this study, in patients with known VTE risk factors, occurrences of subsequent VTEs were observed more frequently in tofacitinib-treated patients that, at 12 months treatment, had D-dimer level greater than or equal to twice the upper limit of normal (2×ULN) versus those with D-dimer level <2×ULN. For patients with RA with known risk factors for VTE, consider testing D-dimer levels after approximately 12 months of treatment. If D-dimer test result is ≥ 2×ULN, confirm that clinical benefits outweigh risks prior to a decision on treatment continuation with tofacitinib. Tofacitinib should be used with caution in patients with known risk factors for VTE, regardless of indication and dose. Tofacitinib 10 mg twice daily for maintenance treatment is not recommended in patients with UC who have known VTE risk factors, unless there is no suitable alternative treatment available. Promptly evaluate patients with signs and symptoms of VTE and discontinue tofacitinib in patients with suspected VTE, regardless of dose or indication. Retinal venous thrombosis
(RVT): Patients experiencing symptoms suggestive of RVT should be advised to promptly seek medical care. Infections: Serious and sometimes fatal infections have been reported in patients administered tofacitinib. Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection. Patients should be closely monitored for infections, with prompt diagnosis and treatment. Treatment should be interrupted if a serious infection develops. As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. Tuberculosis: Patients should be evaluated for both active and latent TB prior to being treated with tofacitinib. Patients who test positive for latent TB should be treated with standard antimycobacterial therapy before administering tofacitinib. Viral Reactivation: Viral reactivation and cases of herpes zoster have been observed. Screening for viral hepatitis should be performed in accordance with clinical guidelines prior to starting therapy with tofacitinib. The impact on chronic viral hepatitis is not known. Major adverse cardiovascular events (MACE): MACE have been observed in patients taking tofacitinib. In a randomised post authorisation safety study in patients with RA who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of myocardial infarctions was observed with tofacitinib compared to TNF inhibitors. In patients over 65 years of age, patients who are current or past smokers, and patients with other cardiovascular risk factors, tofacitinib should only be used if no suitable treatment alternatives are available. Diabetes: Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycaemia occurs following initiation of tofacitinib. Vaccinations: Prior to initiating tofacitinib it is recommended that all patients, particularly pJIA and jPsA patients, be brought up to date with all immunisations in agreement with current immunisation guidelines. Live vaccines should not be given concurrently with tofacitinib. Malignancy and lymphoproliferative disorder: Tofacitinib may affect host defences against malignancies. In a randomised post authorisation safety study in patients with RA who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of malignancies excluding non-melanoma skin cancer (NMSC), particularly lung cancer and lymphoma, was observed with tofacitinib compared to TNF inhibitors. Lung cancers and lymphoma in patients treated with tofacitinib have also been observed in other clinical studies and in the post marketing setting. Other malignancies in patients treated with tofacitinib were observed in clinical studies and the post marketing setting, including, but not limited
References:
to, breast cancer, melanoma, prostate cancer, and pancreatic cancer. In patients over 65 years of age, patients who are current or past smokers, and patients with other malignancy risk factors tofacitinib should only be used if no suitable treatment alternatives are available. NMSCs have been reported in patients treated with tofacitinib; the risk of NMSC may be higher in patients treated with tofacitinib 10 mg twice daily than in patients treated with 5 mg twice daily. Periodic skin examination is recommended in patients at increased risk for skin cancer. Interstitial lung disease: Caution is recommended in patients with a history of chronic lung disease as they may be more prone to infection. Asian patients are known to be at higher risk of ILD, caution should be exercised with these patients. Gastrointestinal perforations: Tofacitinib should be used with caution in patients who may be at increased risk, e.g. history of diverticulitis or concomitant use of corticosteroids or NSAIDs. Hypersensitivity: Cases of hypersensitivity associated with tofacitinib administration have been reported. Allergic reactions included angioedema and urticaria; serious reactions have occurred. If any serious allergic or anaphylactic reaction occurs, tofacitinib should be discontinued immediately. Laboratory Parameters: Increased incidence of lymphopenia and neutropenia have been reported, and decreases in haemoglobin, which should be monitored in accordance with the SmPC. Monitor ANC and haemoglobin at baseline, 4-8 weeks and 3 monthly, ALC at baseline and 3 monthly. Tofacitinib has been associated with increases in lipid parameters, maximal effects were observed within 6 weeks. Monitoring should be performed 8 weeks after initiation and managed according to hyperlipidaemia guidelines. Tofacitinib has been associated with liver enzyme elevations; use caution if initiating in patients with elevated liver enzymes particularly in combination with potentially hepatotoxic products. Routine monitoring of liver tests and prompt investigation of any observed liver enzyme elevations are recommended to identify potential cases of drug-induced liver injury. Gastrointestinal obstruction with a non-deformable prolonged-release formulation: Caution should be used when administering tofacitinib 11 mg prolonged release tablets to patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic). Pregnancy & Lactation: Use of tofacitinib during pregnancy and breast-feeding is contraindicated. Undesirable Effects: RA, PsA and A: The most common serious adverse reactions were serious infections; pneumonia, herpes zoster, UTIs, cellulitis, diverticulitis, appendicitis and opportunistic infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical studies were headache, upper respiratory tract infections, diarrhoea, nausea and hypertension. UC: The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily were headache, nasopharyngitis, nausea, and arthralgia. Commonly reported adverse reactions (>1/100 to <1/10) across all indications were pneumonia, influenza, herpes zoster, urinary tract infection, sinusitis, bronchitis, nasopharyngitis, pharyngitis, lymphopenia, anaemia, headache, hypertension, cough, abdominal pain, vomiting, diarrhoea, nausea, gastritis, dyspepsia, rash, arthralgia, peripheral oedema, increased creatine phosphokinase. Refer to section 4.8 of the SmPC for further information on side effects, including description of selected adverse reactions. Legal Category: S1A. Marketing Authorisation Number: EU/1/17/1178/003 – 5 mg (56 film-coated tablets); EU/1/17/1178/007 – 10 mg (56 filmcoated tablets); EU/1/17/1178/012 – 11 mg (28 prolonged-release tablets); EU/1/17/1178/015 1mg/mL oral solution. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@ pfizer.com . For queries regarding product availability please contact: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, + 353 1 467 6500. Last revised: 09/2022.
Ref: XJ 18_0.
1. Sandborn WJ, Su C, Sands BE, et al; for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736.
2. Hanauer S et al. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019;17(1):139-147.
3. XELJANZ Summary of Product Characteristics.
Doctors are in no danger of being replaced by machines anytime soon and some so-called ‘game-changing’ technological advances have been overhyped and still require a lot of refinement, delegates attending the 2022 ISG Winter Meeting heard.
The continuing rise of new technologies, including artificial intelligence (AI), in gastroenterology was a key theme of the meeting. A number of leading international and local experts gave critical overviews of a number of new technologies
to assess if they are as useful as claimed.
‘AI in colonoscopy – polyp detection and characterisation: Is it safe to leave or resect and discard?’ was the title of a presentation by Prof Cesare Hassan, Associate Professor of Gastroenterology, Humanitas University, Milan, Italy, and a world expert on cancer screening.
Prof Hassan noted that humans were not designed to analyse 10,000 images in minutes like AI; are not good at spotting lesions (“we miss up to one-third of polyps”); or detecting changes in texture on flat mucosa (“we miss up to two-thirds
of SSL neoplasia”); or differentiating between an adenoma and hyperplastic polyps.
Prof Hassan and colleagues have tested the predictive diagnostic value of AI against standard histology for diagnosing colorectal polyps in a major non-randomised real-life study. He outlined the key findings, which included that AI was equivalent to clinicians in lesion detection and to histology in optical biology.
However, while its “standalone performance is outstanding” in assessing images and it is effective in a controlled setting, AI did not improve screening outcomes.
“Its value was marginal,” Prof Hassan said.
He added it is still very expensive, can be time-consuming, can create a false sense of confidence, and in real-life settings is simply not sufficiently impressive to date.
Prof Hassan said a lot of work remains to fine-tune its applicability. “AI is part of the solution to the problem of quality, but not the only one…. It helps you, it does not replace you.”
Another speaker in this session, Prof Jeanin Van Hooft, Consultant and Chair, Department of Gastroenterology and Hepatology, Leiden University Medical Centre, the Netherlands, spoke about ‘AI and digital medicine: From personalised medicine and improved risk stratification’.
Opening, she maintained that: “We need to remain critical. Garbage in, is garbage out, and that is very true about AI.”
Prof Van Hooft stressed the importance of “training, validation, and testing” in any AI-based technology, noting that deep-learning algorithms need “huge amounts of data to be successful”.
Prof Van Hooft showed how tiny images of different and unrelated items – chihuahuas and blueberry muffins – interspersed at random across a large grid look very similar to each other.
She also reported how a car safety system designed to brake upon detection of large animals, like deer running out quickly in front of the car, failed when rolled out in Australia where they were unable to identify and brake automatically for kangaroos. “If you train your system very narrowly, you cannot apply it to all,” Prof Van Hooft commented.
She noted that some AI studies have been performed in the same geographical areas, which raises questions on wider applicability. Prof Van Hooft pointed out there are a lot of population variations in relation to disease risk and prognosis, and queried how do we incorporate all the potential variables into AI.
She showcased the data to-date on the application of AI in the upper GI tract in detecting cancerous lesions, risk stratifying, and predicting outcomes.
There have been positive results in the use of AI deep-learning systems in detecting neoplasia in Barrett’s oesophagus and in clinical risk-scoring systems for upper GI bleeding. Speaking to the Medical Independent, Prof Van Hooft said AI “needs a lot of fine tuning”.
“In the beginning we were all very enthusiastic, but now I think we all see the pitfalls…. If we make guidelines and do articles, we really need to be critical. AI can really help us, but we have to stay very critical, look what’s behind, look what type of population it [algorithm] includes, did it really do the proper training and testing, and then it can really be of great help.”
The next speaker in this session was Prof Torsten Beyna, Head of Department of Gastroenterology and Therapeutic Endoscopy, Evangelisches Hospital, Düsseldorf, Germany, who discussed the viability of ‘Motorised spiral enteroscopy in gastrointestinal diagnostics and therapeutics’.
Motorised PowerSpiral enteroscopy (PSE) is a further development of spiral enteroscopy to facilitate a less invasive approach to the small bowel, which he said has proven to be “feasible, effective, and safe”.
Prof Beyna and colleagues have carried the first prospective clinical feasibility study into its usage.
It has demonstrated that PSE is effective for diagnostic and therapeutic antegrade enteroscopy and may compare favourably with traditional methods of deep enteroscopy in ease of use and procedural duration.
Idiopathic Parkinson’s disease (IPD) is a common, progressive, neurodegenerative disease which affects 1 per cent of the population over 60
There will soon be national guidelines and a formalised training pathway for robotic-assisted surgery in Ireland, the ISG 2022 Winter Meeting heard.
Mr Colin Peirce, Consultant Colorectal and General Surgeon, University of Limerick Hospitals Group, gave a presentation on the advent of robotic-assisted colorectal surgery in Ireland, and the latest developments in technology and usage in Ireland.
University Hospital Limerick was the first Irish public hospital to introduce the technology in 2016 following a philanthropic donation to cover the cost of its Da Vinci Xi dual console robotic system, which cost approximately €2.5 million.
Mr Peirce, who carried out his formal robotic surgical training in the US and Europe, confirmed that the RCSI is finalising work on a formal national surgical training pathway with competency exams, governance, and national guidelines for robotic-assisted surgery in Ireland. There is also a recognised need to publish national data on robotic-assisted surgical uptake and outcomes.
“This will now become part and parcel of how we train the surgeons of the future. They will be getting training from the very initial commencement of their training programmes. There will be robotic surgery incorporated into that. That is very important, as clearly we have seen the advances, the introduction of more robots into the country, which is something our trainees are very excited about in that regard and we need to train them appropriately,” Mr Peirce told the Medical Independent (MI)
He said that for current surgeons, who have a laparoscopic background, about 40 cases are needed to become competent in using robotic-assisted surgical systems, “so about two years, a reasonable workload.”
Robotic-assisted surgery is now available in seven of the eight rectal cancer centres.
The remaining centre, University Hospital Waterford, is due to get a robotic surgical system next year.
There is now a total of 12 robotic surgery platforms currently across the country, which are also used in gynaecological surgery, Mr Peirce said.
Addressing criticism from the meeting audience that the technology does not lead to better outcomes, he said, in his experience and from the literature, robotic-assisted surgery does lead to a shorter length of stay.
Mr Peirce added it also results in better patient experience, and better sexual and uro-genital outcomes, though not necessarily better oncological outcomes.
“We have clearly shown that the robotic platform is superior to the laparoscopic platform in terms for the functional outcomes for patients, especially in male patients….”
He also pointed out that obesity is on the rise.
As well as being a risk factor for earlier development of disease, obesity leads to more challenging surgical cases.
“The robot is good for these patients – you don’t lose a lot of blood doing it and it is also good for older patients.”
BEST CLINICAL ORAL ABSTRACT AWARDS
1st Fintan O’Hara Tallaght University Hospital, Dublin
Abstract 22W127
2nd Lakshman Kumar St Vincent’s University Hospital, Dublin Abstract 22W174
He acknowledged that robotic surgery systems are very expensive.
In addition to the original outlay, they also need maintenance, which costs about €100,000 a year.
However, as more manufacturers come on stream, it is hoped costs will stabilise.
On balance, Mr Peirce believes robotic surgery systems are worth the expense and are here to stay, with continuing refinements and applicability advancements.
“More and more we need to look at patient-related out-
comes,” he told MI
“What we are definitely seeing in the colorectal aspect is that these are improved [with robotic surgery], particularly in our younger patients. Unfortunately, it is younger patients that we are seeing a lot more colorectal cancer and disease in these days, so that is very important. We have also shown very good trends in terms of reducing length of stay for our patients, which is very important both for them and their families, and also for our under-pressure hospitals…. So you’re saving on that end.”
The only licensed treatment for the reduction in recurrence of episodes of overt hepatic encephalopathy ≥ 18 years1
BEST SCIENTIFIC ORAL ABSTRACT AWARDS
1st Thomas J Butler Trinity College Dublin
Abstract 22W132
2nd Caroline Walker Tallaght University Hospital, Dublin Abstract 22W156
See the full list of award winners at www.medicalindependent.ie
IE Prescribing Information: Targaxan 550mg (rifaximin-α)
REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING
Presentation: Film-coated tablet containing rifaximin 550 mg. Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age. Dosage and administration: Recommended dose: 550mg twice daily as long term treatment for the reduction in recurrence of overt episodes of overt hepatic encephalopathy. In the pivotal study, 91% of patients were using concomitant lactulose. TARGAXAN can be administered with a glass of water, with or without food. No dosage changes are necessary in the elderly or those with hepatic insufficiency. Use with caution in patients with renal impairment The safety and efficacy in paediatric patients (aged less than 18 years) have not been established. Contraindications: Contraindicated in hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients and in cases of intestinal obstruction. Warnings and precautions for use: The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis cannot be ruled out. The administration of rifaximin with other rifamycins is not recommended. Rifaximin may cause a reddish discolouration of the urine. Use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for End-Stage Liver Disease) score > 25. In hepatic impaired patients, rifaximin may decrease the exposure of concomitantly administered CYP3A4 substrates (e.g. warfarin, antiepileptics, antiarrhythmics, oral contraceptives). Both decreases and increases in international normalized ratio (in some cases
Long-term prophylaxis in hepatic encephalopathy (HE)2
with bleeding events) have been reported in patients maintained on warfarin and prescribed rifaximin. If co-administration is necessary, the international normalized ratio should be carefully monitored with the addition or withdrawal of treatment with rifaximin. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Ciclosporin may increase the rifaximin Cmax. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’. Pregnancy and lactation: Rifaximin is not recommended during pregnancy. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding. Side effects: Common effects reported in clinical trials are dizziness, headache, depression, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. Other effects that have been reported include: Clostridial infections, urinary tract infections, candidiasis, pneumonia cellulitis, upper respiratory tract infection and rhinitis. Blood disorders (e.g. anaemia, thrombocytopenia). Anaphylactic reactions, angioedemas, hypersensitivity. Anorexia, hyperkalaemia and dehydration. Confusion, sleep disorders, balance disorders, convulsions, hypoesthesia, memory impairment and attention disorders. Hypotension, hypertension and fainting. Hot flushes. Breathing difficulty, pleural effusion, COPD. Gastrointestinal disorders and skin reactions. Liver function test abnormalities. Dysuria, pollakiuria and proteinuria. Oedema. Pyrexia. INR abnormalities. Prescribers should consult the SmPC in relation to all adverse reactions.
IRELAND
Legal category: Prescription only Cost: €262.41 for 56 tablets Marketing Authorisation holder:
Norgine B.V. Antonio Vivaldistraat 150, 1083 HP, Amsterdam, Netherlands Marketing Authorisation number: PA 1336/009/001 For further information contact: Norgine Pharmaceuticals Limited Norgine House Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK Telephone: +44 (0)1895 826 606 E-mail: Medinfo@norgine.com Ref: IE-HEP-XIF-2100010
Date of preparation: April 2021
Ireland
Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance.
Website: www.hpra.ie. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on: Tel. +44 (0)1895 826 606 Email. Medinfo@norgine.com
References:
1. National Institute for Health and Care Excellence. Rifaximin for preventing episodes of overt hepatic encephalopathy: appraisal guidance TA337 for rifaximin. Available from: http://www.nice.org.uk/guidance/ta337
2. TARGAXAN® 550 Summary of Product Characteristics. Available for Ireland from: www.medicines.ie
Product under licence from Alfasigma S.p.A. TARGAXAN is a registered trademark of the Alfasigma group of companies, licensed to the Norgine group of companies. NORGINE and the sail logo are registered trademarks of the Norgine group of companies.
IE-HEP-XIF-2100002
Date of preparation: May 2021
At home they are still at risk; …TARGAXAN® rifaximin-α reduces the risk of recurrence of overt hepatic encephalopathy.2
Irish Society of Gastroenterology, Winter Meeting, Grand Hotel, Malahide, 17-18 November 2022
SIMPONI is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.1
Simponi 50 mg, 100 mg Solution for Injection in pre-filled pen
Simponi 50 mg Solution for Injection in pre-filled syringe (golimumab)
ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing PRESENTATION Simponi 50 mg solution for injection in pre-filled pen Simponi 50 mg solution for injection in pre-filled syringe Simponi 100 mg solution for injection in pre-filled pen INDICATIONS Rheumatoid Arthritis (RA): Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate; the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function; Psoriatic Arthritis (PsA): Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in adults when the response to DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Ankylosing Spondylitis (AS): Simponi is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-Axial SpA): Simponi is indicated for the treatment of severe, active nr-Axial SpA who have had an inadequate response to or are intolerant to NSAIDs Ulcerative colitis (UC): Simponi is indicated for treatment of moderately to severely active UC in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Polyarticular juvenile idiopathic arthritis (pJIA): Simponi 50mg in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX. DOSAGE AND ADMINISTRATION Simponi should be injected subcutaneously. Treatment should be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of RA, PsA, AS, nr-Axial SpA, UC or pJIA. After proper training in subcutaneous injection technique, patients may self-inject, if their physician deems it appropriate. RA: Simponi 50 mg given once a month, on the same date each month, concomitantly with MTX. PsA: Simponi 50 mg given once a month, on the same date each month, alone or in combination with MTX. AS and nr-Axial SpA: Simponi 50 mg given once a month, on the same date each month. Clinical response is usually achieved within 12-14 weeks of treatment (3 or 4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period. In patients weighing more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose.
UC: Patients weighing < 80 kg: Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2. Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter. Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter. Patients weighing ≥ 80 kg: Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks.
During maintenance treatment, corticosteroids may be tapered, following clinical practice guidelines. Clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses). pJIA: Simponi 50 mg administered once a month, on the same date each month, for children with a body weight of at least 40 kg. Clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Missed dose: If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers. The patient should be instructed not to inject a double dose. Older patients (≥ 65 years): no dose adjustment required. Paediatric patients (<18 years): For indications other than pJIA, Simponi is not recommended. Patients with renal and hepatic impairment: Simponi is not recommended. CONTRAINDICATIONS Patients with a hypersensitivity to golimumab or any of the excipients; Patients with active tuberculosis (TB) or other severe infection such as sepsis and opportunistic infections; patients with moderate or severe heart failure (NYHA class III/IV). PRECAUTIONS AND WARNINGS Infections: Patients must be monitored closely for infection before, during and for 5 months after cessation of treatment. Exercise caution when considering golimumab in patients with chronic infection or a history of recurrent infection including use of concomitant immunosuppressive therapy. Golimumab should not be given to patients with clinically important active infection. Patients should be advised of the potential risk factors. Bacterial infections (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported. The invasive fungal infection should be suspected if they develop a serious systemic illness. There was a greater incidence of serious infections, including opportunistic infections and TB, in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg. Serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infection. There have been reports of active TB in patients receiving golimumab, including patients previously treated for latent TB. Patients should be evaluated for active or latent TB before golimumab treatment. All such tests should be recorded on the Patient Reminder Card provided with the product. If active TB is diagnosed, treatment with golimumab should not be initiated. If latent TB is diagnosed, treatment with anti-TB therapy must be initiated before initiation of golimumab. Patients on golimumab should be monitored closely for signs and symptoms of active TB and advised to seek medical advice if signs and/or symptoms of TB appear. Hepatitis B (HBV) reactivation: Reactivation of HBV occurred in patients receiving golimumab who were chronic carriers. Some cases had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with golimumab Malignancies and lymphoproliferative disorders: Caution is advised when considering golimumab treatment in patients with history of malignancy or continuing treatment in patients who develop a malignancy, additional caution should be exercised in patients with increased risk for malignancy due to heavy smoking. A risk for the development of malignancies in children and adolescents cannot be excluded. Rare cases, usually fatal, of hepatosplenic T-cell lymphoma (HSTCL) have been reported, the majority of cases occurred in adolescent and young males nearly all on concomitant treatment with azathioprine (AZA) or 6-mercaptopurine (6–MP). The potential risk with the combination of AZA or 6-MP and golimumab should be carefully considered. A risk for the development for HSTCL in patients treated with TNF-blockers cannot be excluded. Colon dysplasia/carcinoma - Screen for dysplasia in all patients with UC who are at increased risk or had a prior history for dysplasia or colon carcinoma. In newly diagnosed dysplasia patients the risks and benefits of continued golimumab use should be carefully assessed. Melanoma and Merkel cell carcinoma (all TNF-blocking agents including golimumab) have been reported, periodic skin examination is recommended, particularly for patients with risk factors for skin cancer. Heart Failure: Golimumab should be used with caution in patients with mild heart failure (NYHA class I/II). Patients should be closely monitored and golimumab must be discontinued in patients who develop new or worsening symptoms of heart failure. Some cases had a fatal outcome. Neurological events: Use of anti-TNF therapy, including golimumab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders. Discontinuation of golimumab should be considered if
these disorders develop. Carefully consider the benefits and risks before initiation of therapy in patients with a history of demyelinating disorders. Surgery: Patients requiring surgery whilst on golimumab therapy should be closely monitored for infections. Autoimmune processes: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with golimumab and is positive for antibodies against double-stranded DNA, treatment should be discontinued. Haematological reactions: There have been post-marketing reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anaemia, and thrombocytopaenia in patients receiving TNF-blockers, including golimumab. Patients should be advised to seek medical attention if they develop signs and symptoms suggestive of blood dyscrasias. Discontinuation should be considered in patients with significant haematologic abnormalities. Vaccinations/therapeutic infectious agents: It is recommended that live vaccines or any therapeutic infectious agents should not be given concurrently. Allergic reactions: If an anaphylactic reaction or other serious allergic reaction occurs, administration of golimumab should be discontinued immediately, and suitable treatment initiated. The needle cover of the pre-filled pen contains latex and may cause allergic reactions in those sensitive to latex. Special populations: Older patients (≥ 65 years): Adverse events, serious adverse events and serious infections in patients aged ≥65 were comparable to those observed in younger patients. However, caution should be exercised when treating the elderly, particular attention should be paid to infections. There were no patients age 45 and over in the nr-Axial SpA study. Paediatric patients (<18 years): Vaccinations: it is recommended that prior to initiating golimumab therapy, paediatric patients be brought up to date with all immunisations in agreement with current immunisation guidelines. Excipients: Simponi contains sorbitol (E420). In patients with rare hereditary problems of fructose intolerance, the additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. INTERACTIONS Combination of golimumab and other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended. PREGNANCY AND LACTATION Administration of golimumab is not recommended during pregnancy or breast-feeding. Women of childbearing potential should use adequate contraception and continue its use for at least 6 months after the last golimumab treatment. SIDE EFFECTS Refer to SmPC for complete information on side effects Very Common (≥ 1/10): upper respiratory tract infection; Common (≥1/100): bacterial infections, lower respiratory tract infections, viral infections, bronchitis, sinusitis, superficial fungal infections, abscess, leukopenia (including neutropenia), anaemia, allergic reactions, autoantibody positive, depression, insomnia, dizziness, headache, paraesthesia, hypertension, asthma and related symptoms, dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders, stomatitis, alanine aminotransferase increased, aspartate aminotransferase increased, pruritus, rash, alopecia, dermatitis, pyrexia, asthenia, injection site reaction, chest discomfort, bone fractures were reported. Serious, including fatal adverse events have been reported including septic shock, lymphoma, leukaemia, melanoma, Merkel cell carcinoma, hepatosplenic T-cell lymphoma*, leukopenia, thrombocytopaenia, pancytopaenia, aplastic anaemia, agranulocytosis, serious systemic hypersensitivity reactions (including anaphylactic reaction), skin exfoliation, vasculitis (systemic), sarcoidosis, demyelinating disorders, congestive heart failure, arrhythmia, ischaemic coronary artery disease, thrombosis, interstitial lung disease and lupus-like syndrome. * Observed with other TNF-blocking agents. Paediatric population: pJIA: The safety of golimumab has been studied in a phase III study of 173 pJIA patients from 2 to 17 years of age. The average follow-up was approximately two years. In this study, the type and frequency of adverse events reported were generally similar to those seen in adult RA studies. PACKAGE QUANTITIES 1 x 50 mg pre-filled pen containing 50 mg of golimumab in 0.5
SIMPONI delivers long-term disease control, maintaining efficacy and safety profile over 4 years.2
Q1 Who is the manager of the current FIFA men’s World Cup champions?
Q2 Name the New Zealander who recently returned to number one spot of the women’s PGA Tour world rankings?
Q3 Who recently resigned as head of the Ferrari Formula 1 team?
Q4 MacCumhaill Park hosts intercounty GAA fixtures for which county?
Q5 Which tennis player has had his visa reinstated and can now participate in the Australian Open in January?
Q6: Name the manager of Premier League leaders Arsenal?
The winner of the 17 November 2022 Sporting Quiz Competition is Dr Claire Daniels, Co Waterford
The winner of the 17 November 2022 Crossword is Dr Safiya Elsheikh, Co Meath
Q1 Who are the Cricket T20 World Cup champions of 2022? A: England
Q2 Who is the new manager of Aston Villa football club? A: Unai Emery
Q3 The FIFA World Cup kicks off this weekend. Who are the defending champions? A: France
Q4 Which tennis player has finished the season as the men’s world number one? A: Carlos Alcaraz
Q5 Who do Ireland open their Rugby World Cup pool fixtures against next year? A: Romania
Q6 Name the Irish gymnast who recently won gold at the World Championships on the pommel horse? A: Rhys McClenaghan
Title: The year the world went mad: A scientific memoir
Author: Mark Woolhouse
Publisher: Sandstone Press
Reviewer: George Winter
Prof Mark Woolhouse’s main contention is that the UK’s Covid-19 lockdowns were mistakes. This is underlined in Viscount Ridley’s foreword, which enthuses that in addressing the defence of there being no alternative to lockdown, “Mark demolishes this in devastating and relentless fashion…” arguing that shielding the elderly and cocooning the vulnerable were superior strategies. Woolhouse’s demolition is indeed “devastating and relentless”, and he supplies genuinely useful and insightful analyses into Covid-19 being essentially a disease of old age; the folly of school closures; deficiencies in the response to Covid-19; and other well-argued points.
But undermining Woolhouse’s anti-lockdown arguments in a singularly “devastating and relentless” fashion is his own admission that: “At the SPI-M [SAGE’s modelling sub-committee] on the morning of 23 March [2020] I supported the committee’s recommendation of an immediate national lockdown.” Yet he told the Daily Telegraph in February 2022: “We knew from February [2020], never mind March, that the lockdown would not solve the problem. It would simply delay it.” And even knowing “that the lockdown would not solve the problem” Woolhouse nevertheless supported its establishment because “there was no other option on the table”. But other options, surely, must have occurred to – as Ridley avers – “one of the world’s most distinguished epidemiologists”. He could have advocated waiting for more accurate data to emerge. Or, since Woolhouse had “been studying the emergence of new viruses for more than 20 years, I knew what to look out for”, why didn’t he take the opportunity to deploy, as Prof Simon N Wood did, “a Bayesian inverse problem approach applied to UK data on first-wave Covid-19 deaths,” finding that “the disease duration distribution suggests that fatal infections were in decline before full UK lockdown” (Biometrics ; 2022: 78: 1127–1140).
Given Woolhouse’s support of a lockdown he knew would fail; given his “devastating and relentless” demolition of that very strategy; and given that the Scottish Covid-19 Inquiry is underway, could one speculate that self-justification – rarely the best course of action after a calamity – played a motivating role in this “scientific memoir”? With this perspective, Dr Dorothy H Crawford’s assessment at the front of the book that it comprises a “unique record of the pandemic year” is true; and emblematic of its uniqueness is the author’s skill at holding cards to his chest to avoid spilling beans. Thus, the flyleaf assures readers that in “this astonishing account, Mark Woolhouse shares his story as an insider…”, but flicking through the index raised the suspicion that
“this astonishing account” might reveal astonishingly little. For example, our insider is Professor of Infectious Disease Epidemiology at the University of Edinburgh and a Scottish Government advisor during the Covid-19 pandemic. Another insider, and Scotland’s best-known face and voice of Covid-19 advice, was National Clinical Director Prof Jason Leitch… who isn’t mentioned. Why not? Readers might have been interested in the extent to which two high-profile colleagues agreed/disagreed on policy issues.
Similarly, Ridley’s foreword is striking for what it omits. Thus, having written scathingly in May 2020 on how it had become commonplace for epidemiologists, inter alia , “to cite the output of mathematical models as if it was ‘evidence,’ [and asking].… Did we base one of the biggest peacetime policy decisions on crude mathematical guesswork?”, Ridley’s avoidance of the
“m” word contrasts with Woolhouse’s chapter endorsing the value of modelling.
Woolhouse reminds us how his expertise helped address the 2009 swine flu pandemic. So he must have read Dame Deirdre Hine’s 2010 independent review of the UK’s response where she notes that a number of interviewees were concerned that “SAGE advice focused on the academic scientific viewpoint – the modelling activity – to the exclusion of views from those involved in operational epidemiology, such as people dealing directly with clinical cases, who arguably were better able to understand the virulence of the epidemic.” Such concerns were seemingly forgotten by Woolhouse who criticises Covid-19 scientific advisory committees “dominated by clinicians and public health specialists who weren’t looking at the bigger picture…” (page 256).
The bibliography has a slovenly approach to citation: Incomplete references; absent websites; and clumsy constructions – “I and 12 colleagues” – abound. Woolhouse asserts that respiratory viruses are transmitted when we “exhale, cough, sneeze or vocalise” ignoring the welldocumented role of hands (see, for example, N Leung’s evidence in Nature Reviews Microbiology, 2021; 19: 528545), and his claim that there is “surprisingly little data on the transmission of respiratory viruses between humans” fails to acknowledge substantial pioneering work undertaken by, for example, Sir Christopher Andrewes and Dr David Tyrrell at Salisbury’s Common Cold Unit, where human volunteer trials began in July 1946, and Prof Caroline Breese Hall into agents like respiratory syncytial virus in the 1970s.
Perhaps the Scottish Covid-19 Inquiry will enable Prof Woolhouse to clarify his role in the Covid-19 pandemic beyond what readers are given access to in this book.
Perhaps the Scottish Covid-19 Inquiry will enable Prof Woolhouse to clarify his role in the Covid-19 pandemic beyond what readers are given access to in this bookProf Mark Woolhouse
It started with a simple question. A lady texted me and asked me to suggest a birthday present for her husband. Naturally, I suggested things I would like to do, as it might give someone I know and love a hint.
Now let’s say this lady is slightly nervous of her husband on a motorbike. But when I suggested off-road biking, she jumped at the idea. No cars, slow speed, full protection, what’s not to like?
Now let’s classify things a little: Dirt bikes are light, usually single-cylinder and simple. They’re not designed for speed, but for lightness. They must be easy to pick up if, sorry, when, you fall over, and can’t get a foothold on a slippery surface. No headlights, no screen, no taillights, not even a registration number. These are bits that can break and need replacing, as well as adding weight. And adding lightness is the key. Some even argue that they don’t need electric starters, or batteries, a simple kick-start would do nicely. I disagree, for reasons you’ll find out soon enough.
These are not adventure bikes, the likes of the BMWs
that Charlie and Ewan rode around the world (with full support), or the Yamaha Ténéré , famously used by Nick Sanders in his mad adventures (with no support). For example, Nick rode from the southernmost point of Ar-
gentina to the tip of Alaska and back in 50 days, a distance of about 50,000 miles. And these bikes need to be reliable. No point lying somewhere with a bike that won’t go and you can’t get a pick-up truck up the side of the mountain.
In Wales, there are plenty of opportunities for dirt bike riding. Ireland has much fewer option. The only one I could find was a four-hour drive (for me) to Donegal. Of course, I had to go with him.
So, we headed off there, and met Paul, the chief instructor. I had asked if there was a danger the weekend’s riding could be cancelled with the weather, and I was told “we’re not fair weather bikers”. Anyway, a day in Donegal without rain would be remarkable.
Bikes, protection, and sandwiches were provided. Now, when I say protection, it was from falling rather than from the weather.
We had a few basic rules, such as give each other space. As he said, “when” (not “if”) we fall off, best to give each other space and not to ride over a fallen biker, lest we turn a simple fall into a more complicated one.
Anyway, would I do it again? Yes, certainly. And I’d remember the most important rule: “Look where you want to go….”
Soon he took us across the slippery stuff. We were introduced to another rule, “stay off the brown stuff”. Of course, I didn’t, and I became the first to fall over into the wet with the bike on top and my left boot filling with water. And then I appreciated the relative lack of weight of the bike as I got going again. Then came rule three: “If you’re between a low spot and a higher spot, tend to lean to the higher spot because it’s easier to put a foot down there.” (Obvious now….)
Off we went to practise going across watery ditches, followed by rule four: “Use a higher gear and plenty of throttle, to keep the momentum up.” Fell there too.
Gravel lanes I managed well, despite the ruts and the water. Then came the slopes and rule five: “Just go down using engine braking, first gear. Don’t touch the throttle or brakes.” First time was fine, but I fell every time after that. By now I was starting to appreciate the electric starter and glad I didn’t have to kick-start the bike.
It was followed rapidly by rule six: “Look where you want to go.” If you look at the hole or the ditch, you’ll hit it. Also rule six: “The bike follows your nose.”
After lunch, we elected to go on more paths rather than up mountains. We were taken along a “path”, in the loosest sense of the word. We were told to stay away from the barbed wire fence and I managed to get stuck axle deep in the mud. Then I learned why it is best not to travel alone on dirt bikes. Paul lifted the bike and I lifted the front wheel, then manually rotated it to get out of the mud.
All of us made some mistake or other on this ‘path’, yet on the return journey not one of us made a mistake on the same surface. Maybe we were learning after all.
It was exhilarating, brilliant fun. I was exhausted at the end. I am not famous for my physique or upper body strength, and the day after my arms, quads, left calf, and left ankle were sore (not helped by a certain bike falling on my left leg). Nothing two aspirin wouldn’t cure. Paul videoed us several times along the way, and despite thinking we were brilliant, I couldn’t believe how slow we were. Maybe that’s why we fell off with no injuries.
Anyway, would I do it again? Yes, certainly. And I’d remember the most important rule: “Look where you want to go….”
And for those an interest in dirt bike riding and want to take it to the highest level, there’s the Trans Euro Trail, or TET. In their own words: “Comprising over 51,000km of dirt road, the Trans Euro Trail is an epic motorcycle journey through some of Europe’s most remote, diverse, and inspirational landscapes.”
“Influenced by the pioneering Trans America Trail, the TET encourages adventurous riders to travel light and experience the rich diversity of Europe’s land and culture.” Have a nice weekend.
international centre for excellence in medical education.
Prof Ronald Harden, AMEE General Secretary, said: “The ASPIRE to Excellence programme has an important role to play at a time of rapid change in education, when the value of a university’s teaching as well as their contributions to research are recognised.”
Prof Dara Byrne, Professor of Simulation Education, University of Galway and Director of Simulation for the Saolta University Health Care Group and at the ICAPSS, said: “This award is the first of its kind for a simulation facility in Ireland. It reflects our commitment to improving patient safety and the quality of care through our simulation activities that are translational and interprofessional, across the continuum of health professions education.
Clonmel Healthcare is launching Lecigon, a triple combination product with modern pump technology, for the treatment for advanced Parkinson’s disease.
Lecigon is a novel intestinal gel formulation of the three established Parkinson’s active ingredients: Levodopa, carbidopa, and entacapone.
Lecigon is indicated for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results. The intrajejunal infusion therapy is administered through the portable Crono LECIG pump, which can be programmed to deliver variable flow rates and bolus doses. The pump can be removed and patients can even bathe, shower or swim – if their overall condition permits. Both the intestinal gel and the pump are manufactured in Europe.
To accompany the launch of Lecigon in Ireland, Clonmel is offering a comprehensive package of support services for patients being treated in clinics and at home. As part of the global STADA Group, Clonmel brings extensive experience with injection and infusion treatments for Parkinson’s disease through its APO-go (apomorphine hydrochloride) pen injectors and pre-filled syringes.
Parkinson’s disease is the second most common neurodegenerative condition after Alzheimer’s, according to the Parkinson’s Association of Ireland. The incidence is 1-2:1,000 of the general population, and 1:100 of those aged over 80, leading to an estimated 12,000 people living with Parkinson’s in Ireland.
“Lecigon is a prime example of how Clonmel Healthcare is increasingly offering added value for patients and caregivers with differentiated specialty pharmaceuticals, alongside our extensive consumer healthcare and generic prescription portfolios,” explained Clonmel’s General Manager Mr Jim Hanlon.
Lecigon, to which STADA acquired rights in October 2020, has already been introduced in more than 15 European countries, including in Germany, Austria, and the Nordic countries, with hundreds of patients currently undergoing therapy with the drug-device combination. Real-world evidence from daily clinical practice is currently being generated through the ongoing ELEGANCE observational study.
The Association for Medical Education in Europe (AMEE) has awarded a team at University of Galway’s School of Medicine a prestigious ASPIRE to Excellence Award for their achievements in medical simulation education and research.
The award has been made to the School of Medicine’s Irish Centre for Applied Patient Safety and Simulation (ICAPSS).
The ICAPSS team is a collaborative group of researchers and academics from University of Galway and clinicians from the Saolta University Health Care Group who provide medical education training in a simulated environment. The special facility where they work, train, educate, and research was officially opened by Minister for Health Stephen Donnelly in March 2022.
The ASPIRE award identifies the School of Medicine as an
“Applying for an ASPIRE award challenges medical education and training providers to benchmark themselves against what is considered exemplary. This requires learners, staff, and other stakeholders to develop and demonstrate excellence in education. The collaborative process stimulates the School of Medicine’s focus on improving medical education.”
Dr Paul O’Connor, Senior Lecturer in General Practice at the University of Galway and Research Director for the ICAPSS, added: “Patient safety and patient safety research are our priority. As we now are members of the ASPIRE academy, we can collaborate with other centres for excellence and continue to improve our simulation activities, which support learners in the university and Saolta.”
The ASPIRE Award highlights medical schools which have demonstrated teaching excellence in one or more areas including assessment, curriculum development, faculty development, inspirational approaches to medical education, international collaborations, simulation, social accountability, student engagement, and technology enhanced learning.
The collaboration between University of Galway and Saolta was particularly commended by the international assessment team.
In its feedback on the award, the assessment team stated: “The work of the ICAPSS team is impressive and we also applaud their achievements in a relatively short period. We also note the success of the collaboration between a university and a healthcare service partner. These relationships are not always productive, so the achievements are even more impressive. We recommend sharing this model so others may benefit too, acknowledging that contextual factors may also be unique. In summary, the number of personnel at ICAPSS, many with considerable experience and qualifications in relevant domains, have created, implemented and evaluated a range of education programmes. The application reflects a well-developed organisational structure, which functions effectively, serving both the sponsoring organisations.”
New research from Pfizer Healthcare Ireland has found over a third of all adults are in some way worried about the possibility of a missed diagnosis due to the impact of Covid-19. The research also reveals that almost one-third (32 per cent) of people with an underlying condition are nervous about being in a hospital setting this winter.
The research, undertaken as part of the annual Pfizer Health and Science Index, asked respondents about their direct experience of Covid-19, their general health, and attitudes to science. Of the respondents who have had Covid-19 at least once, 80 per cent had it in 2022, with the highest incidence occurring between January and April 2022 (45 per cent). The research also revealed that 15 per cent of people with an existing health condition, who tested positive for Covid-19, feel that their health has deteriorated as a result, with this figure increasing to one-in-five people (21 per cent) amongst those aged 18-to-24.
In addition to the Covid-19 pandemic, this year’s Pfizer Index also asked the general public about the cost-of-living and its potential impact on access to healthcare: Three-in-10 adults say they are less likely to go to the doctor this winter specifically due to the cost-of-living crisis, with younger age groups aged 18-to-24 (49 per cent) more likely to put off a doctor’s visit because of these concerns. One-fifth of all respond-
ents confirmed they have already put off a trip to the doctor this year due to cost-of-living concerns.
While people in Ireland are generally quite positive about their health, scoring themselves 6.9 out of 10, the annual Pfizer Index has captured a gradual decline in this positive sentiment over a number of years. On average, Irish adults are concerned about developing illnesses as they age (more than four are mentioned on average), with cancer, heart disease, arthritis, and Alzheimer’s topping the list of concerns. More than half the adult population (56 per cent), and two-thirds of women, are concerned about developing a form of cancer.
Looking at attitudes to science, with 40 per cent of respondents studying science up to Leaving Certificate, and 20 per cent at third-level, more than three-quarters (77 per cent) believe there should be more focus on science subjects in primary school. There is general acknowledgement that STEM qualifications boost employability (56 per cent), but equally a growth in the perspective that STEM courses necessitate high Leaving Certificate points and are difficult third-level courses to get into (51 per cent). Four-in-10 (41 per cent) of younger adults (aged 18-to-24) feel that Ireland has more STEM opportunities in comparison to other countries.
Commenting on the research, Ms Deb Mangone, Country Manager, Pfizer Healthcare Ireland, said: “The research results showcase the impact of Covid-19, which is still being felt by the public and the health service. It’s really important for people to book their appointment for their booster this winter and if you get Covid-19, and are higher risk, it is especially important that you take action straight away and not ignore concerns. A worrying statistic from the Index shows that 36 per cent of people are concerned they may have missed a medical diagnosis – we strongly encourage people to attend healthcare appointments, particularly if they have been putting this off and ensure they take preventative action to stay well this winter.”
RCSI researcher Prof Killian Hurley has been awarded a European Research Council (ERC) starting grant to conduct innovative research into treatments for pulmonary fibrosis.
The project, called STAR-TEL, is one of 408 projects chosen out of almost 3,000 applications to receive ERC funding. A total value of €636 million has been awarded across all ERC starting grant projects.
Pulmonary fibrosis occurs when lung tissue becomes damaged and scarred. While existing medications can slow the progression of the disease, currently there is no known cure. Many patients die within three years of diagnosis as a result.
STAR-TEL will seek new personalised treatments for patients with pulmonary fibrosis by first investigating how the disease develops, and then generating new mRNA medications specifically designed for individual patients.
The treatments will be tested in innovative stem cell models, known as ‘lung-in-a-dish’ models, to ensure their effectiveness and understand potential side-effects prior to administering them to patients.
The drugs will be targeted at the lungs specifically, so that patients only get the treatment where they need it. It is hoped this will result in life-changing personalised treatments for patients with this devastating lung disease.
Prof Hurley, who is a Principal Investigator in RCSI’s Department of Medicine and Tissue Engineering Research Group and Consultant Respiratory Physician at Beaumont Hospital, commented: “I am delighted to receive an ERC starting grant to help STAR-TEL find new personalised treatments for patients with pulmonary fibrosis. By developing the ‘lung-in-a-dish’ models in the lab using adult stem cells, we can learn if medications work for individual patients and about the side-effects or toxicity of drugs before ever giving them to real-life patients. Our overall aim is to better understand how pulmonary fibrosis happens and to provide improved medications to patients, allowing them to live normal and healthy lives.”
Woods Surgery in Clane are currently recruiting for a vocationally trained GP to join our friendly and well-established practice on a long-term basis. Generous remuneration package on offer and paid medical indemnity.
There is also a progressive and transparent career pathway to include partnership for the right candidate. We are happy to facilitate a candidate getting a GMS list.
Please send CV to practice manager Niamh pmwoodssurgery@gmail.com
GP wanted to join country GP practice in Mountrath, Co Laois. Socrates in place. 4 sessions available.
Team includes practice nurse, 3 GPs, and admin team. CV to mountrathmp@gmail.com
Closing date 02/02/23
For some time now, interest has been growing around the potential for the common canine to sniff-out malignancy in the urine of patients with bladder cancer. According to the Cancer Council in the UK, the phenomenon first gained traction in 1989 when a physician reported that a woman presented with a mole, which her dog would continually sniff and try to bite. It turned out to be a malignant melanoma and the rest, as they say, is history
Once this bizarre form of 'cancer screening' showed up on people's radar, reports accumulated of dogs sniffing and nudging areas of their owner's body that turned out to contain a malignancy.
The basic science: In the early stages of a cancer, when the cells are furiously dividing, volatile organic compounds are released. With their almost supernatural sense of smell, dogs can easily pick up on the scent of these compounds, which
are released in sweat, breath, and urine.
Small-scale studies seem to suggest that dogs can be trained specifically for this purpose – small trials show our canine companions could identify the urine of patients with bladder cancer almost three times more often than would be expected by chance. In addition, two studies showed they could detect lung cancer in exhaled breath samples with very high accuracy. They could also pick up on ovarian and colorectal cancers by smelling breath samples. Ironically, this has led to some work on efforts to design screening instruments that have the same detection sensitivity as the common mutt.
And so to the less-cuddly locust, the talents of which have recently come to the attention of researchers. The folks at Michigan State University (MSU) in the US have found that locusts can also 'smell' cancer and have the ability to differentiate between cancer cells and healthy cells. Not only that, they seem to have the ability to differentiate between different cancer cell lines.
"Noses are still state-of-the-art," according to Prof Debajit Saha, Assistant Professor of Biomedical Engineering at MSU. "There's really nothing like them when it comes to gas sensing. People have been working on 'electronic noses' for more than 15 years, but they're still not close to achieving what biology can do seamlessly."
Using locusts for such a purpose is actually logical, as the researchers have been working to better understand their super-sensitive olfactory sensors and corresponding neural circuits. And, of course, using animal models in medical research is nothing new. Think mice, rats, zebrafish, bats, and so on.
In this particular endeavour, electrodes are attached to the locusts' brains and their responses are monitored as they smell gas that contains both healthy cells and cancerous ones.
Prof Christopher Contag, Professor in the Department of Biomedical Engineering and in the Department of Microbiology and Molecular Genetics at MSU, pointed out that in previous research, cells from mouth cancers had quite distinctive appearances when examined under microscopes and optical tools. The researchers subsequently found different metabolites in different cell lines and it transpired that some of those metabolites were volatile, meaning they could become airborne, and were therefore 'sniffed-out'.
"Early detection is so important, and we should use every possible tool to get there, whether it's engineered or provided to us by millions of years of natural selection. If we're successful, cancer will be a treatable disease," commented Prof Contag.
All of this may still be in the realm of 'pop science', but perhaps not for too much longer – experiments are also being conducted to assess the ability of dogs to detect Covid-19 and low blood sugar levels. The endgame is to develop devices with the same sensitivity as a dog's sense of smell although, so far, we are still way behind our canine companions in this regard. But some day, we may be able to mimic their talents to create a device that can detect early-stage cancer with the same sensitivity.
We already trust our trained dogs to sniff out drugs and explosives, and it's clear that we still have much to learn from nature's creatures. Even the humble locust.