Dr Lisa Hynes of Croí speaks with Pat Kelly about its digital cardiovascular disease prevention and recovery programme
Politicians in the EU and US are bidding to invigorate efforts to prevent and treat cancers. Bette Browne reports
PAGE 12-13
CATHERINE
REILLYDelayed transfers of care led to 3,132 lost bed days at the National Rehabilitation Hospital (NRH) in Dún Laoghaire last year at a cost of €4.4 million, which was equivalent to 38 full programmes of rehabilitation.
Bed days lost due to delayed transfers of care have averaged between 2,500 and 3,500 annually, according to a NRH spokesperson. The issues related primarily to availability of carers and home care supports for highly complex patients. “The NRH is actively working with the HSE to develop high complexity care pathways for patients with complex discharge planning
needs,” the NRH’s spokesperson informed the Medical Independent.
The average waiting period for inpatient admission to the NRH is 89 days. It is 66 days for outpatient consultant clinic appointments and 39 days for outpatient therapy appointments.
As of early March 2022, 178 adults were waiting for admission to inpatient programmes; 21 children awaited admission to the paediatric inpatient programme; 3,417 adults were waiting for admission to outpatient consultant clinics; 332 adults were waiting for outpatient therapy appointments; and 209 children awaited admission to paediatric outpatient clinics.
“Steps taken to reduce waiting
times include face-to-face review by NRH consultants in the major acute hospitals (particularly Beaumont Hospital as the national neurosurgical centre and the Mater Hospital as the national spinal injuries centre) where the local medical team then avail of expert advice on managing patients awaiting admission to a specialist programme of rehabilitation,” outlined the NRH’s spokesperson.
“The NRH clinical programmes also have dedicated liaison and outreach rehabilitation specialists who visit other hospitals around the country providing clinical guidance, education, and information to local medical teams, families, and community-based therapists
The recent retirement of her mentor has prompted Dr Gabrielle Colleran to reflect on the importance of resilience
PAGE 19
on managing patients awaiting admission to the NRH. Patients awaiting admission are also reviewed by consultant-led multidisciplinary teams in outpatient clinics depending on the patients’ clinical needs.”
The NRH also works in collaboration with rehabilitation facilities, such as the Royal Hospital Donnybrook and Peamount Healthcare, as part of managed clinical rehabili-
The selection process for the provision of an acute electronic health record (EHR) system for the New Children’s Hospital (NCH) is “still underway” more than two years after the process commenced, the Medical Independent (MI) can report.
In February 2021, the HSE informed MI that in line with Sláintecare, the EHR for the NCH would proceed first as part of the new national EHR system. Children’s Health Ireland (CHI) went out to the market for an acute EHR in December 2019.
More than two years later, a spokesperson for CHI told MI that the EHR vendor selection process for the NCH “is still underway” and “for legal reasons confidentiality must be maintained to ensure full integrity of the process”.
The spokesperson added that “while we have made great progress and are eager to share results, there are still a number of very important steps ahead among CHI and prospective vendors, as well as between CHI and Government departments involved in the review of the EHR business case”.
According to the HSE, the first acute deployment of a national EHR will be in the NCH. “The overall timeline of the deployment has been impacted by the pandemic. There is a maternal and newborn EHR in four of our maternity hospitals today.”
Forty per cent of Irish births are now recorded and managed on the maternal and newborn clinical management system, stated the spokesperson. See news feature, p4-6.
tation networks providing specialist input as the level one tertiary specialist rehabilitation centre.
“The NRH is actively working with the HSE to further develop in-reach services into hospitals and outreach services provided by dedicated outreach teams, for people whose access to rehabilitation services was affected due to the pandemic,” added the spokesperson.
Legal Category: S1A. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
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.
PP-XEL-IRL-0668
Date of preparation: September 2021
The ONLY prefilled inhaler with visual and audible feedback for confirmed dose delivery1-4
Genuair - a simple to use inhaler for patients with COPD4
Abbreviated Prescribing Information
Eklira® Genuair® 322 micrograms inhalation powder. Please consult the Summary of Product Characteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a white inhaler with an integral dose indicator and a green dosage button. Each delivered dose contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium. Also, contains lactose. Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Dosage: For inhalation use. Recommended dose is one inhalation of 322 micrograms aclidinium twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to aclidinium bromide or to any of the excipients. Warnings and Precautions: Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Use with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma. Do not use in patients with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption. Interactions: Do not administer with other anticholinergic-containing medicinal products. No other interactions expected. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Risk to newborns/infants cannot be excluded. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Sinusitis, nasopharyngitis, headache, cough, diarrhoea, nausea. Uncommon (0.1-1%): Dizziness, blurred vision, tachycardia, palpitations, dysphonia, dry mouth, stomatitis, rash, pruritus, urinary retention. Rare (0.01-0.1%): hypersensitivity. Not known: angioedema, anaphylactic reaction. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing Authorisation Number: EU/1/12/778/002
Marketing Authorisation holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: February 2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@ hpra.ie. Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744.
Date of item: November 2020. IR-BRI-09-2020
Abbreviated Prescribing Information Brimica® Genuair® 340 micrograms/12 micrograms inhalation powder. Please consult the Summary of Product Characteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a white inhaler with an integral dose indicator and an orange dosage button. Each delivered dose contains 396 µg aclidinium bromide (equivalent to 340 µg of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate. Also, contains lactose. Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage: For inhalation use. Recommended dose is one inhalation of 340 µg/12 µg twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Do not use in asthma. Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Discontinue if increases in pulse rate, blood pressure or changes in ECG occur. Use with caution in patients with a history of or known prolongation of the QTc interval or treated with products affecting the QTc interval. Use with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma. Hypokalaemia may occur, is usually transient and supplementation not needed. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment. Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Do not use in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Interactions: Do not administer with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products. Caution in use with methylxanthine derivatives, steroids, non-potassium-sparing diuretics, β-adrenergic blockers or medicinal products known to prolong the QTc interval. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Nasopharyngitis, urinary tract infection, sinusitis tooth abscess, insomnia, anxiety, headache, dizziness, tremor, cough, diarrhoea, nausea, dry mouth, myalgia, muscle spasms, peripheral oedema, increased blood creatine phosphokinase. Uncommon (0.1- 1%): Hypokalaemia, hyperglycaemia, agitation, dysgeusia, blurred vision, tachycardia, electrocardiogram QTc prolonged, palpitations, angina pectoris, dysphonia, throat irritation, stomatitis, rash, pruritus, urinary retention, increased blood pressure. Rare (0.01-0.1%): Hypersensitivity, bronchospasm, including paradoxical. Not known: anaphylactic reaction, angioedema. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing
Authorisation Number: EU/1/14/963/001 Marketing Authorisation holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: October 2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via
CATHERINE REILLY
HSE Estates has accepted the “full findings and recommendations” of an updated fire safety report commissioned by the Rotunda Hospital in Dublin, a hospital spokesperson has told the Medical Independent (MI). There is agreement “to fully fund the works to address report findings, which will be on a phased basis” likely to occur over two-to-three years, according to the Rotunda. In 2022 initial funding of €250,000 has been provided to procure a design team for fire safety works.
Substantive items that are outstanding from the report’s recommendations relate to the emergency lighting and fire detection systems. Both systems need to be “updated and modernised” to meet current fire safety standards. There is an ongoing programme to replace and upgrade all electrical boards since
the initial report was published, the Rotunda stated. As previously reported in MI, the Rotunda received a draft campus-wide fire risk assessment in November 2017, which highlighted serious deficits in emergency lighting throughout the hospital.
The report was undertaken following a fire at the neonatal intensive care unit in April 2017. The fire was caused by an electrical fault and all babies in the affected room were moved with no adverse effects.
NIAMH QUINLAN
While the number of people commencing hepatitis C virus (HCV) treatment declined markedly during the pandemic, activity in clinics is expected to return to 2019 levels this year, a HSE spokesperson has told the Medical Independent (MI)
Only 529 patients were treated for HCV infection in 2021, according to figures provided by the HSE. In 2020, some 532 patients began treatment compared to 1,196 in 2019.
The Department of Health and HSE noted that clinics have been significantly impacted during the pandemic.
“While hepatitis C treatment continued to be delivered during this time, it did so at a reduced capacity as infection prevention and control precautions to ensure patient safety were adhered to. However, clinics are returning to normal,” stated the HSE’s spokesperson.
According to a Department spokesperson, the National Hepatitis C Treatment Programme was “confident” it remained on target to make hepatitis C a rare disease in Ireland by 2026, and in alignment with World Health Organisation goals, to be eliminated by 2030.
However, Consultant in Infectious Diseases at the Mater Misericordiae University Hospital in Dublin, Prof Jack Lambert, expressed doubt about the scale of Ireland’s progress.
“You have to stay ahead of the curve if you want to meet your target,” he told MI. “I think we’re just kind of breaking even right now in terms of the numbers.”
According to Prof Lambert, while approximately 500 patients may have been treated last year, there were “probably 500 new infections” during that time. However, he highlighted a lack of comprehensive data in this regard.
“New drug-users continue to be infected and some of them are not accessing care,” he added.
Prof Lambert noted there were people who may have been cured of HCV infection who had “gone back to injecting” during the pandemic. “And I don’t think there is a systematic plan to go back and test all of those.”
Brintellix® (vortioxetine) film-coated tablets
Prescribing information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing, particularly in relation to side effects, precautions and contraindications. Presentation: Tablets containing 5, 10, 15 or 20mg vortioxetine. Indication: Treatment of major depressive episodes in adults. Dosage: 10mg once daily. May be increased to a maximum 20mg daily or reduced to 5mg if necessary. After symptoms resolve, treatment recommended for at least 6 months. Can be taken with or without food. Elderly (≥65 years): Initial dosage is 5mg once daily. Caution advised if using doses above 10mg daily. Children (7-11 years): Not recommended. Adolescents (12-17 years): Not recommended in major depressive disorder; efficacy not established. Cytochrome P450 inhibitors and inducers: Consider a dose reduction of vortioxetine if a strong CYP2D6 inhibitor is added. Consider a dose adjustment if a broad CYP450 inducer is added to treatment. Renal or hepatic impairment: No dose adjustment; subpopulations are vulnerable and data on the use of Brintellix are limited. Contraindications: Hypersensitivity to the active substance or excipients. Concomitant use with non-selective, monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (e.g. moclobemide). Fertility, pregnancy and lactation: Limited data; should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus. Animal studies showed reproductive toxicity. Use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Potential risk of postpartum haemorrhage following exposure to an SSRI or SNRI within the month prior to birth. Excreted into human milk, risk to the breastfeeding child cannot be excluded. Animal data showed no effect on fertility, sperm quality or mating performance. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed. Please refer to SPC for more detail. Warnings & Precautions: Closely supervise patients, especially those at high risk for suiciderelated behaviours during first few weeks of treatment and during dose changes. Use with caution in patients: at risk of hyponatraemia; with a history of mania/ hypomania; aggression/agitation; undergoing ECT; with unstable epilepsy (discontinue if seizures begin for the first time or increase in frequency); with bleeding tendencies/disorders, taking anticoagulants or medicines affecting platelet function; in patients on lithium or tryptophan; with increased intraocular pressure, or those at risk of acute narrow angle glaucoma. Monitor patients for appearance of serotonin syndrome or neuroleptic malignant syndrome and discontinue immediately if occurs. Patients may experience feelings of aggression, anger, agitation and irritability. Patients/caregivers should seek medical advice if such behaviour emerges or aggravates. SSRIs/SNRIs may increase the risk of postpartum haemorrhage. Brintellix tablets contain sodium (<1mmol/tablet). Drug interactions: Alcoholic drinks not advisable. Vortioxetine is extensively metabolised in the liver. Potential for interactions with: MAOIs, MAO-A and MAO-B inhibitors; serotonergic medicines (including opioids and triptans); St John’s wort; products which may lower the seizure threshold, e.g. antidepressants, neuroleptics, mefloquine or bupropion. Lower dose may be considered if strong CYP2D6 inhibitor is added to treatment depending on patient response, these
A hospital board meeting in February 2020 noted that an audit of the fire system found it was “technically end-of-life” and maintained by a “robust proactive maintenance programme, but needs to be updated to new technology”.
In early 2020, the Rotunda informed MI it had “continual engagement” with the HSE to fund recommendations from the fire safety report, “but funding outlay to date has been minimal.” However, the hospital was “working continually over the last number of years to address and mitigate fire safety issues”.
effects may be greater in patients who are poor metabolisers of CYP2D6. Dose adjustment may be considered if a broad cytochrome P450 inducer is added to treatment. Reports of false positive results in urine enzyme immunoassays for methadone in patients taking vortioxetine. Exercise caution in interpreting positive drug screen results. Effects on ability to drive and operate machines: No or negligible influence, dizziness has been reported; use caution at the start of treatment or when the dose is changed. Adverse events: Most common adverse reaction is nausea, usually mild or moderate, transient and occurs within first two weeks of treatment. The following have been reported in clinical trials and during post-marketing use: Very common (≥1/10 patients): nausea. Common (≥1/100 to <1/10): abnormal dreams, dizziness, diarrhoea, constipation, vomiting, pruritus, including generalised pruritus, hyperhidrosis. Uncommon (≥1/1,000 to <1/100): flushing, night sweats. Rare (≥1/10,000 to <1/1,000): mydriasis (which may lead to acute narrow- angle glaucoma). Not known: anaphylactic reaction, hyperprolactinaemia, hyponatraemia, insomnia, agitation, aggression, serotonin syndrome, headache, haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding), angioedema, urticaria, rash. Sexual dysfunction: 20mg dose was associated with increase in sexual dysfunction. Class effect: Studies in patients ≥50 years of age, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. Not known if relevant to vortioxetine. Paediatrics: Higher incidences reported in adolescents for abdominal pain-related events and suicidal ideation. Prescribers should consult the full SPC in relation to other side effects. Overdose: Management consisting of treating clinical symptoms and relevant monitoring. Legal category: POM, for non-renewable supply. Brintellix Tablets, blisters of: 5mg (EU/1/13/891/002) 28 tablets. 10mg (EU/1/13/891/010) 28 tablets. 15mg (EU/1/13/891/019) 28 tablets. 20mg (EU/1/13/891/028) 28 tablets. Further information available
from: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co. Dublin. Tel: 01 468 9800. Date of last revision of PI: December 2021.
Reference: IE-BRIN-0350 Brintellix® is a Registered Trade Mark.
Job number: IE-BRIN-0337
Date of preparation: January 2022
Reference: 1. Brintellix Summary of Product Characteristics. Available at https:// www.medicines.ie/medicines/brintellix-10-mg-film-coated-tablets-34817/smpc
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Lundbeck on: 01 468 9800 Email: SafetyLuIreland@lundbeck.com
Enabling people with depression to feel, think and do better1
Brintellix is indicated for the treatment of major depressive episodes in adults1Prof Jack Lambert Rotunda Hospital
Last month at the online National Health Summit, Dr Gabrielle Colleran, Consultant Paediatric Radiologist and Vice-President of the Irish Hospital Consultants Association, spoke about the rise in the use of telemedicine and e-health during the Covid-19 pandemic. Dr Colleran pointed out that the computer in one of the hospitals in which she works has Windows 7.
“It takes me approximately 25 minutes to log in,” she said. “It’s the first thing I do in the morning.”
As the Covid-19 pandemic in Ireland enters a new phase, Dr Colleran said she hoped there would be “dramatic changes in the investment in our IT infrastructure.”
“We really need to have a health identifier. We really need to have e-health across the system... the IT system is vulnerable and we need the investment in it.”
This is not solely the view of hospital consultants. A recent position paper on pandemic control by the Irish Society of Specialists in Public Health Medicine called on the State to “address longstanding and critical IT infrastructure gaps, including the lack of a case and outbreak management system, an integrated surveillance system, an immunisation reporting system”.
There have been developments in e-health in the last two years. During the initial roll-out of the Covid-19 vaccine programme early last year, there was talk from HSE leadership that it would be used to further integrate the individual health identifier (IHI) into the health service. Has that happened?
A HSE spokesperson told the Medical Independent (MI) the IHI “was utilised in the deployment” of the vaccine.
“Over 97 per cent of all people vaccinated have their IHI recorded on the vaccine database. All e-health programmes contribute to the development of e-health within healthcare and the vaccine programme was no exception.”
However, progress with the national electronic health record (EHR) has been slow. In February 2021, the HSE informed this newspaper that in line with Sláintecare, the EHR for the New Children’s Hospital would proceed first. Children’s Health Ireland (CHI) went to market for an acute EHR in December 2019.
More than two years on, a spokesperson for CHI told MI the EHR vendor selection process “is still underway” and, “for legal reasons, confidentiality must be maintained to ensure full integrity of the process”. The spokesperson added that “while we have made great progress and are ea-
ger to share results, there are still a number of very important steps ahead among CHI and prospective vendors, as well as between CHI and Government departments involved in the review of the EHR business case.”
The HSE said that the first acute deployment of EHR would be in the New Children’s Hospital. “The overall timeline of the deployment has been impacted by the pandemic,” the spokesperson said. “There is a maternal and newborn EHR in four of our maternity hospitals today. Forty per cent of Irish births are now recorded and managed on the maternal and newborn clinical management system (MN-CMS) and 45 per cent of neonatal intensive care cots are ‘live’ on the system, enabling seamless integration between maternity and neonatal service.”
There are also changes intended in relation to the HSE’s information and communication technology (ICT) leadership personnel.
The post-incident review of last May’s cyberattack recommended the creation of two additional senior posts – a Chief Informa-
tion Security Officer and Chief Technology and Transformation Officer (CTTO). The HSE intends to fill both positions this year.
Speaking last month at the National Health Summit, HSE CEO Mr Paul Reid said the health service has “a legacy network, not built by any design”.
“It was built by history... by voluntary hospital groups, statutory hospital groups, community services.” He said the service’s digital setup was “not a nationally designed network... we have a really big job to do”.
Regarding the new roles, Mr Reid said the CTTO will look at the design, architecture and weaknesses of the system.
He described the two roles as “key” but warned that “it’s always difficult to recruit in the public service. These are well sought-after roles and are well paid roles across the world.”
There have been some recent concerns
raised at HSE leadership level about funding for ICT projects. In January, MI reported that the HSE’s Chief Information Officer (CIO) Mr Fran Thompson told the Executive’s performance and delivery committee that it would be difficult to achieve completion of “all agreed” ICT projects this year.
“The CIO noted that the ICT and e-health capital funding available in 2022 is €130 million, an increase of €10 million on 2021,” according to meeting minutes. “It is less than what was requested to complete the planned projects for 2022 and it was noted balancing the investments across the demands of both the foundational and the transformational strategic imperatives simultaneously is the challenge of… 2022.”
According to the minutes, the CIO stated: “It will be difficult to achieve completion of all agreed projects while continuing to deliver on the multiple priorities that the organisation has articulated.”
Despite challenges of funding and implementation in Ireland and elsewhere, experts are agreed that the trend towards greater use of digital health will continue well beyond this phase of the pandemic.
Change
Ms Laura Maass is co-author of the paper ‘The dawn of digital public health in Europe: Implications for public health policy and practice’, which was published recently in The Lancet Regional Health (Europe). She is a steering committee member at the European Public Health Association – Digital Health Section and PhD student at the Leibniz ScienceCampus Digital Public Health Bremen, University of Bremen in Germany.
Ms Maass noted that the growing use of digital health in some European countries predates the pandemic.
“Countries like Estonia, Denmark, and the UK already had digital health tools implemented in their routine care long before the Covid-19 pandemic started and people were familiar with using digital health services,” she told MI. Ms Maass said that in her own country of Germany, interventions such as EHRs were planned since 2006 “and finally implemented in 2021”.
“What I think is safe to say is that the pandemic was an enabler to speed things up. The legal regulation sometimes takes up to several years and, therefore, might have been in the planning already before Covid hit Europe.”
She noted that Google trends graphs for searches for online consultation, health app, telemedicine, and telehealth during the pandemic displayed an “increase in the interest of the general population and health professionals to use digital health technology”.
“Obviously, the pandemic created a market for digital health interventions and the improvement of existing tools. These improvements will have an impact on our experience with those given tools.”
In a future ‘post-pandemic’ scenario, Ms Maass said she doubted “we will stop
The Covid-19 pandemic has had a major influence on the direction of e-health and digital health in Ireland and abroad. David Lynch looks at recent trends in t he area and challenges that lie ahead
What I think is safe to say is that the pandemic was an enabler to speed things up
The Covid tracker app was launched to some fanfare in July 2020, with Minister for Health Stephen Donnelly heralding its role as “vital to the continued momentum of the reopening of Irish society and business”.
The app was widely praised for the speed of its development and the huge initial interest generated in the general public. However, recently, more questions have been raised over its performance and continuing usefulness in the pandemic.
The Covid tracker app advisory committee was established in May 2020 and met three times that year and only twice last year. The Department of Health told this newspaper that another meeting is expected “in the coming weeks”.
It is “very common” for any digital health tool to go through a number of phases of public response, which can lead to some people no longer engaging with an app after initial interest, according to Dr Jack Banks (PhD), Trinity College Dublin. Dr Banks is the co-author of the paper ‘Covid Tracker Ireland: What is its function?’ published in the Irish Medical Journal (IMJ) in January.
At a certain point, if people do not consider that the app is making a “tangible difference” to their lives, they end up “not using it or leaving it”, he told the Medical Independent (MI)
He said that when the app was released in mid-2020 it was “heralded” almost “like this is how contact tracing was going to be done going forward, this lovely passive app is going to exist on your phone, all you need to do is enable the settings”.
“To be fair to the general public, the response was pretty outstanding. Close to two million people downloaded it.”
Dr Banks was then working on a PhD examining the attitudes of people living with epilepsy towards digital health tools when, with Prof Colin Doherty of Trinity Centre for Health Sciences, he began keeping an eye on the number of publicly recorded Covid cases and the data available through the app.
It became apparent to him that the number of people using the app for contact tracing purposes was “always really, really low”.
The resulting IMJ paper noted that from its launch until late November 2021, only 20,946 people had used the Government app for the purpose for which it was intended by uploading close contacts. There were 503,421 Covid cases reported over the period.
“[T]hat would indicate that over 2,013,684 people needed to be contact traced. Again, data available on the homepage of the app on 22 November told us that under 35,000 people had been contact traced as a result of information uploaded to the app” according to the IMJ paper.
“Compared to some other digital health tools such as for chronic disease management...this [the tracker app] is quite passive,” Dr Banks told MI. “It
functions on your phone in your pocket or in your hand. It does the work for you.”
He said the communication from the Government and HSE surrounding the app was focused on lauding its success, while at the same time being unclear on its actual function. This was potentially dangerous, he argued, because it risks undermining the general public’s trust in digital health.
“Digital health tools are going to be a very prominent feature of healthcare in the next decade and going forward... it really undermines trust if the general public... are not really sure what it [tracker app] is doing,” he said.
“If for the general public, their conceptualisation of digital health is based solely on this tracker app, which for a large portion of the population is the first time to use a digital health tool, it’s really going to create a problem going down the line; if everyone downloads an app and they are not really sure what it does.”
He added that from a “bird’s eye view” it was easy to form the impression “that this app was launched in 2020... and nothing much has happened since”. Or at least, we are “not entirely sure” what has happened since, he said.
Dr Banks said anecdotal evidence led him to believe that the “primary manner” in which the app was used last year was as a place to upload the digital Covid-19 vaccination certificate.
“So, if this extremely widely lauded contact tracing app is [primarily] being used as a passport to get into the pub, again it kind of undermines the message of digital health tools and the manner in which they are going to be used going forward.”
He added that although he was lacking data to prove it, he believed that a “large proportion” of those who have downloaded the app “don’t have the bluetooth enabled” or the contact tracer “set up correctly on their phone”.
“I think it is time for the HSE and the Government to explain exactly how the app is functioning at the moment and what the general public need to do in order for the contact tracing process to improve or for the app to be used optimally for that,” he said.
While granting the app was “developed extremely quickly”, Dr Banks believes there was “so much potential” to utilise it for health research and the collection of health data analytics. “I think they missed a trick on that,” he said.
A HSE spokesperson told MI in February that features of the app “are still being used by an average of 1.75m people”.
“In particular, the ‘check-in’ feature which stores the data on the phone is a useful aide-memoire if that person contracts Covid and the HSE ask them to recall when they first noticed the onset of symptoms and what symptoms they experienced.” The spokesperson added that the app provides a place to “store EU digital Covid vaccination certificates”.
But does the Executive still regard the app as a significant part of the response to Covid-19?
The HSE said the “app along with the existing public health measures will help us all stay safe when we meet up, socialise, work or travel”.
“There are no plans to discontinue usage of the app at this point, the app is still serving its purpose as a pandemic response app.”
The spokesperson said that €1,664,783 had been spent on the app to date. They pointed to media reports of significantly higher expenditure for similar apps in other European countries such as Germany, Norway, and Denmark.
In response to the concerns raised in the IMJ paper, the HSE said the app was “just one method of contact tracing employed”.
“Capacity in the contact tracing centres determined the need for and use of the Covid tracker app and the move from manual to automated collection of close contacts involved integrating and reorganising the close contact process, including the introduction of the ‘list your contacts’ portal,” continued the spokesperson.
“To give a sense of the scale of contact tracing overall, from 1 October 2020 to 7 February this year, 841,112 people were contact traced by the HSE using the various methods.” The HSE estimates that approximately 64,000 close contacts were notified via the app. “The Covid tracker is augmenting, not replacing, other testing and tracing channels.”
Ms Laura Maass, co-author of the paper ‘The dawn of digital public health in Europe: Implications for public health policy and practice’, recently published in The Lancet Regional Health (Europe), said “nearly all countries have developed surveillance and contact-tracing systems – mostly, these systems didn’t exist before the pandemic”.
Because of the mix of public health interventions over the last 24 months, she said it was difficult to specify one or two digital health responses that have proved particularly effective.
“From a gut feeling, I would say that contact tracing and surveillance are excellent supportive interventions, but should not be used as standalone interventions. But, I don’t have hard evidence on that,” she said. “Health and medical apps have proven to be effective and accepted for some population groups. Although we need to distinguish between those apps that provide evidence of their effectiveness and those that do not. We can say that apps were of great support as a response to the pandemic in all fields.”
For example “mental health apps to deal with the psychological burden of isolation, contact diaries, apps for physical activity at home and outside.... Public health apps have proven to be effective if developed based on evidence, tackle user needs and are responsible in the handling of the users’ data.”
300,000 plus dialysis treatments were delivered in 23 dialysis centres to 2,026 adult and paediatric patients in 2021, according to the HSE on World Kidney Day (10 March).
100,000 additional dialysis treatments were carried out by patients in their own homes last year.
137 people received a kidney transplant in 2021, adding to the total of 2,656 people living with a successful kidney transplant.
3 times as many people may have died worldwide, due to the pandemic, than official records suggest, according to an analysis published in The Lancet.
12 modifiable risk factors that could account for 40 per cent of worldwide dementia were recently identified in another Lancet paper.
64,000 people are living with dementia in the country and the number is forecast to more than double in the next 25 years, according to the HSE.
using health and medical apps, telemedicine, surveillance systems”.
“We will use the skills, infrastructure, and knowledge we gained and continue developing.”
Back in Ireland, Dr Jack Banks (PhD), School of Medicine, Trinity College Dublin, is the co-author of the paper ‘Covid Tracker Ireland: What is its Function?’ recently published in the Irish Medical Journal (IMJ)
In that paper, Dr Banks raised concerns that the Covid tracker app may not have performed as effectively as some of the claims made by the HSE and the Government (see panel).
However, he remains convinced that the tide towards digital will not be reversed.
“Digital health is here to stay and it’s only going to get bigger,” he told MI
“We have to convey to the public how they [digital health tools] are working in order for them to engage with them meaningfully and consistently.”
He added “digital health tools are going to be a very prominent feature of healthcare in the next decade and going forward”. But he warned that celebrating the tracker app as a “massive uniform success” risks undermining the general public’s confidence in future e-health initiatives.
Can all patients access this technology equally?
In an interview with MI in December, north Dublin GP and former IMO President Dr Ray Walley raised concerns about “digital exclusion”.
“Digital exclusion is a significant concern from the perspective of social interaction and access to important services,” he said. “Lack of IT skills or the lack of access to computers or smartphones will mean that some people will not be able to maintain the same level of connection to supports as they did pre-pandemic. Digital has its benefits, but it cannot replace face-to-face consultation.”
Taking a European perspective, Ms Maass said it was her “hope” that “we will implement digital public health tools in our health systems and ensure that no part of the population is left behind”.
She noted some recent research that showed “the digital divide and differences in digital health literacy” was increasing in Europe.
“It is, therefore, important to leave no one behind and reduce gaps rather than increasing them from a public health perspective,” she said.
“For the German case, this means that our e-prescriptions are actually paper-based with a QR code [so] that patients without a smartphone can bring to their pharmacist to scan and link to the prescription, which is already in the cloud.
“We can’t go from analogue to a completely digital system in just two or three years. It needs time, established digital infrastructure, and a lot of education.”
She added that recent reports into the digital health future highlight how we need to “talk about personal data, data security, and how to collect, store and process data ethically”.
According to the recently published HSE national service plan, some of the priority areas for action this year in e-health and ICT include:
Stabilise the operational environment and deliver foundational infrastructure and cyber technology resilience, while continuing to build and enhance the security operations centre which will protect the organisation from the threat of future cyberattacks.
Further deploy a corporateled cyber security education and communication programme to raise awareness of cyber security threats.
Advance the secure integration of Covid-19 applications and information environments, enabling the exchange of vaccination data across the healthcare system.
Deliver the core national programmes to advance the Sláintecare Implementation Strategy This area includes EHR, integrated financial management system, national estates information system, and e-Pharmacy and e-Prescribing.
NIAMH QUINLAN
The high-tech drugs payment scheme (HTDS) has become the highest costing scheme in State pharmaceutical expenditure, according to a spending review by the Department of Health (DoH) and Department of Public Expenditure and Reform (DPER).
The HTDS has been the area with the largest expenditure since 2018, with an average year-on-year increase of €62 million or 11 per cent between 2012 and 2020.
The Review of High-Tech Drug Expenditure, dated August 2021, showed that €794 million was spent on the HTDS in 2020, with €939 million forecasted to be spent last year. However, the HSE was unable to provide figures for 2021 when requested by the Medical Independent (MI)
A number of policy options for cost containment in the future were suggested in the report. A Department of Health spokesperson told MI that “detailed work is currently ongoing to examine the feasibility of particular options identified in the Irish context”.
For instance, the review recommended that improvements should be made to “existing agreements with industry which provide more favourable pricing terms”.
The Department spokesperson pointed out that, in December 2021, two new framework agreements on pricing and supply of medi-
cines for the period 2021 to 2025 were signed.
“The multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in reducing the cost of medicines and facilitating access to innovative new medicines for patients,” the spokesperson said. “It is estimated that the terms of the new agreements should contribute between €600 and €700 million towards the cost of medicines over the lifetime of the agreements.”
This agreement with IPHA “builds on” the 2016-2020 agreement, “with all provisions of that agreement being carried forward, but substantially enhanced in a number of key respects”, according to a press statement at the time.
“The new measures in the agreement include increased rebate contributions from on-patent medicines, closing loopholes in relation to hybrid medicines, changing the reference date for price cuts, and increased savings from off-patent medicines,” the statement said.
A parallel agreement with the MFI “provides for enhanced price cuts in the case of generic and biosimilar medicines”, according to the statement.
This measure aligns with the spending
review’s recommendation to create “policies to promote the usage of generic and biosimilar medicines, including chemical-based prescribing, mandatory generic substitution, gainshare initiatives and the publication of a biosimilar strategy”.
While expenditure on non-originator (‘biosimilar or generic’) pharmaceuticals has increased between 2012 and 2020, when compared internationally “Ireland lags significantly behind comparator countries for biosimilar penetration”, according to the review.
It stated 15 per cent of State expenditure on pharmaceuticals was on generic medications, compared to 24 per cent in the OECD. Also, in Ireland 40 per cent of medications prescribed are generic, compared to 52 per cent in the OECD and 85 per cent in the UK.
This “likely results in a higher than average spend on pharmaceuticals for the same clinical benefit”, the review noted.
The review also recommended “the State could consider measures to promote international cooperation in pharmaceutical policy, including greater information sharing on pharmaceutical pricing and… joint procurement”. During the Covid-19 pandemic, “the joint procurement of Covid vaccines through the EU demonstrates the potential application of this approach”.
The “forecasting of multi-year expendi-
ture commitments arising from potential allocations for investment in new medicines” should also be a policy consideration, according to the report.
“In general, the multi-year Exchequer impact of new drug introductions is not adequately taken into account when approval and reimbursement decisions are initially being made,” it stated. Cooperation between the DoH, HSE and DPER on budgeting multi-year level expenditure from newly approved drugs could remedy this, according to the report.
Changes to the quality adjusted life year (QALY) threshold (currently €45,000) were also recommended.
According to the review, the current QALY threshold lacks a formal basis. Therefore “the option exists to alter the threshold to achieve a stricter cost effectiveness criterion for new drug introductions.”
“This would have the effect of requiring at approval stage that new drugs provide better clinical benefits for their associated cost,” according to the review.
“This would further prioritise State expenditure towards drugs that are the most cost effective, producing an associated reduction in expenditure on less effective, more expensive pharmaceuticals.”
Digital exclusion is a significant concern from the perspective of social interaction and access to important services
For patients not adequately controlled on dual therapy with moderate to severe COPD
Significant protection against exacerbations*
TRIXEO Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.1
*Significant reductions in the rate of moderate or severe exacerbations vs LAMA/LABA (24%, n=2137 vs n=2120, annual rates 1.08 vs 1.42, 95% CI 0.69–0.83; p<0.001) and ICS/LABA (13%, n=2137 vs n=2131, annual rates 1.08 vs 1.24, 95% CI 0.79–0.95; p=0.003).1,2 COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist. In the clinical trial programme for TRIXEO, LAMA/LABA refers to glycopyrronium/formoterol fumarate and ICS/LABA refers to budesonide/formoterol fumarate. ©AstraZeneca 2021. All rights reserved.
TRIXEO AEROSPHERE ® 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension (formoterol fumarate dihydrate/glycopyrronium/budesonide)
Consult Summary of Product Characteristics (SmPC) before prescribing
Indication: Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.
Presentation: Pressurised inhalation, suspension. Each single actuation (delivered dose, ex-actuator) contains 5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2 micrograms of glycopyrronium and budesonide 160 micrograms.
Dosage and Administration: The recommended and maximum dose is two inhalations twice daily (two inhalations morning and evening). If a dose is missed, take as soon as possible and take the next dose at the usual time. A double dose should not be taken to make up for a forgotten dose. Special populations: Elderly: No dose adjustments required in elderly patients.
Renal impairment: Use at recommended dose in patients with mild to moderate renal impairment. Can also be used at the recommended dose in patients with severe renal impairment or end-stage renal disease requiring dialysis, only if expected benefit outweighs the potential risk. Hepatic impairment: Use at recommended dose in patients with mild to moderate hepatic impairment. Can also be used at the recommended dose in patients with severe hepatic impairment, only if expected benefit outweighs the potential risk. Paediatric Population: No relevant use in children and adolescents (<18 years of age). Method of administration: For inhalation use.
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient’s inhalation technique. Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product..
Contraindications: Hypersensitivity to the active substances or to any of the excipients.
Warnings and Precautions: Not for acute use: Not indicated for treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. Paradoxical bronchospasm: Administration of formoterol/glycopyrronium/budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life threatening. Treatment should be discontinued immediately if paradoxical bronchospasm occurs.
Assess patient and institute alternative therapy if necessary. Deterioration of disease: Recommended that treatment should not be stopped abruptly. If patients find the treatment ineffective, continue treatment but seek medical attention. Increasing use of reliever bronchodilators indicates worsening of the underlying condition and warrants reassessment of the therapy. Sudden and progressive deterioration in the symptoms of COPD is potentially life threatening, patient should undergo urgent medical assessment.
Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol. Use with caution in patients with clinically significant uncontrolled and severe cardiovascular disease such as unstable ischemic heart disease, acute myocardial infarction, cardiomyopathy, cardiac arrhythmias and severe heart failure. Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males or > 470 milliseconds for females), either congenital or induced by medicinal products. Systemic corticosteroid effects: May occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with
inhalation treatment than with oral corticosteroids. Systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma. Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have co existing risk factors for osteoporosis. Visual disturbances: May be reported with systemic and topical corticosteroid use. If patient presents symptoms such as blurred vision or other visual disturbances, consider ophthalmologist referral for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR). Transfer from oral therapy: Care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia: Potentially serious hypokalaemia may result from 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 ß2-adrenergic agonists may produce increases in plasma glucose. Blood glucose should be monitored during treatment following established guidelines in patients with diabetes.
Co-existing conditions: Use with caution in patients with thyrotoxicosis. Anticholinergic activity: Due to anticholinergic activity, use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop. Co-administration of this medicinal product with other anticholinergic containing medicinal products is not recommended. Renal impairment: Patients with severe renal impairment (creatinine clearance of <30 mL/min), including those with end-stage renal disease requiring dialysis, should only be treated with this medicinal product if the expected benefit outweighs the potential risk. Hepatic impairment: In patients with severe hepatic impairment, use only if the expected benefit outweighs the potential risk. These patients should be monitored for potential adverse reactions..
Drug Interactions: Co-treatment with strong CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products are expected to increase the risk of systemic side effects. Should be avoided unless the benefit outweighs the increased risk, in which case patients should be monitored for systemic corticosteroid adverse reactions.
This is of limited clinical importance for short-term (1-2 weeks) treatment.
Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms. Other antimuscarinics and sympathomimetics: 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. Caution required when prescribed concomitantly with formoterol. Medicinal product-induced hypokalaemia: Possible initial hypokalaemia may be potentiated by xanthine
derivatives, steroids and non potassium sparing diuretics. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. β -adrenergic blockers: ß-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concurrent use of ß-adrenergic blockers 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.
Product subject to prescription which may be renewed (B)
Legal Category:
Marketing Authorisation Number: EU/1/20/1498/002 120 actuations
Marketing Authorisation Holder: AstraZeneca AB, SE-151 85, Södertälje, Sweden.
Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, Block B, Liffey Valley Office Campus, Dublin 22. Tel: +353 1 609 7100.
TRIXEO and AEROSPHERE are trademarks of the AstraZeneca group of companies.
Date of API preparation: 10/2021
Veeva ID: IE-3166
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
NIAMH QUINLAN
The extensive use of personal protective equipment (PPE) by healthcare workers during the Covid-19 pandemic has contributed to a concurrent rise in contact dermatitis in this cohort, according to Dr Johnny Bourke, Consultant Dermatologist, South Infirmary Victoria University Hospital, Cork.
“Within a few weeks of shut-down, masks, gloves, and handwashing, we had a flood of staff with problems with their hands and with their face,” Dr Bourke told the Annual Meeting of the Primary Care Dermatology Society of Ireland (PCDSI), which was held virtually on 4-5 March.
Initially, there were concerns that components of the masks were causing allergic dermatitis, with some evidence internationally of allergic dermatitis due to components including nickel, foam and rubber.
However, from Dr Bourke’s experience and patch testing of staff, the “vast majority were not allergic dermatitis”, which was the finding nationally and internationally.
“Almost all of the dermatitis from the masks was irritant contact dermatitis,” said Dr Bourke.
Staff were not accustomed to wearing masks to the extent necessary in the pandemic and the stronger FFP2 and FFP3 masks contributed to this issue.
Severe irritant contact dermatitis was seen in those working in ICU, where erosions occurred on the nose. However, this
has lessened in recent times as people have become used to wearing masks, he noted.
Contact dermatitis was also seen on the hands of other workers and while there was some allergy to gloves, and fragrances and preservatives in soaps, “the vast majority” of cases were contact dermatitis from increased handwashing with soap and water, according to Dr Bourke.
The issue proved difficult to treat as increased handwashing was mandatory in healthcare settings. “We could not get them to use emollients to wash their hands with at work,” said Dr Bourke.
He was successful in getting staff to use emollients at other times, such as nighttime, and encouraged them to use alcohol gels instead of soap and water.
“It is an ongoing problem and we still are seeing a good bit of it,” he added. For full coverage of the PCDSI Annual Meeting, see p30.
It is hoped the “development phase” of a ‘potential donor audit’ will commence in quarter two of this year, with “scoping” currently underway, according to the National Office of Clinical Audit (NOCA).
NOCA’s Potential Donor Audit Feasibility Study Report , which was commissioned by HSE Organ Donation and Transplant Ireland, has recommended the development of a potential donor audit starting with implementation in one hospital in each of the six Hospital Groups and expanding to all acute hospitals, including paediatric hospitals, as organ donation nurse manager resources increase.
Evidence from other countries suggested that a potential donor audit was a key driver of improvement in organ donation rates. Current data collection in Ireland “does not provide the necessary information to identify all missed organ donation opportunities”, stated NOCA.
The rate of organ donation in Ireland was 18 per million population (PMP) compared to 25 PMP in the UK and more than 45 PMP in Spain, noted the report.
In the forward to the report, Dr Beatriz Domínguez-Gil, Director General of Spain’s Organización Nacional de
A proposal for a breast implant registry is being progressed, according to the HSE.
An expert advisory group (EAG) on breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is “actively working” with stakeholders including the Health Products Regulatory Authority (HPRA) and National Office of Clinical Audit to “progress a proposal for the Department of Health on the development of a breast implant registry”.
“Regarding the cost of setting up and running of a breast implant registry, operational funding, and the question of inclusion of historic breast implants, the proposal is still under development,” the HSE’s spokesperson informed the Medical Independent
Breast implant registries have been established in several countries. Such registries aim to facilitate tracing of patients in the event of a product recall or safety concern relating to a type of implant. They also allow for the identification of possible trends and complications relating to specific implants.
In the UK, a breast implant registry was established in 2016 on foot of an independent report setting out recommendations to protect people who have cosmetic surgery. This followed
the recall of the Poly Implant Prothèse breast implants in 2010.
The HSE’s EAG was formed in 2021 in response to the emergence of BIA-ALCL, a rare type of non-Hodgkin’s lymphoma associated with breast implants. Internationally, most cases of BIA-ALCL have been linked with Allergan textured implants, which have been recalled from the market. In Ireland, “less than five” reports of BIA-ALCL have been received by the HPRA.
As well as scoping the development of a breast implant registry, the EAG is performing an up-to-date literature review on the evidence for surgery and radiology interventions relating to BIA-ALCL.
Internationally, implant removal in non-symptomatic patients for the purpose of BIA-ALCL prophylaxis has not been recommended.
Trasplantes – a world leader in the areastated that the key to improving deceased organ donation rates was “the exquisite management of a multidisciplinary process of high complexity – the deceased donation pathway”. This involved appointing the “right professionals, providing them with appropriate guidance and continuous training, and assessing performance”. She wrote that “without precise data, we cannot succeed”.
Dr Domínguez-Gil also cautioned about “magic bullets”, such as promotional campaigns or reforming the existing legislation towards an ‘opt-out’ system, noting that these measures have never proven to result in “sustained improvements in organ donation”.
According to the HSE, there are six funded clinical lead in organ donation posts, which are all filled. There are nine organ donation nurse manager posts, of which five are in the recruitment process. Four further organ donation nurse manager posts are planned under the HSE National Service Plan 2022
A Human Tissue Bill, which has been in development for several years, intends to introduce an ‘opt out’ organ donation system. The consent of families would still be required.
The Health Products Regulatory Authority (HPRA) has not received any applications for e-cigarettes to be regulated as medicinal products, it has informed this newspaper.
Recently the national clinical effectiveness committee released guidelines to help healthcare professionals assist adults to stop smoking. The guideline development group was chaired by Specialist in Public Health Medicine Dr Paul Kavanagh.
E-cigarettes are mentioned in the guidelines as “consumer products”, but they are not included in the recommendations. Speaking to the Medical Independent (MI) last month, Dr Kavanagh said that in other jurisdictions, such as the UK, medicines regulators were “increasingly interested” in taking on a role in regulation of e-cigarettes. He said if the HPRA was to regulate e-cigarettes in the future, the considerations of the guideline development group may be different.
A HPRA spokesperson told MI
there had been no authorisations of e-cigarettes as medicinal products in Ireland and no applications had been received to date.
Separately, last month the HSE highlighted that 1,300 referrals had been made to a programme supporting pregnant women in the south-east to quit smoking since it launched in January 2020.
The programme takes referrals of pregnant women (in addition to partners and family members) from the four maternity departments of acute hospitals in the south-east and from primary care and community services in counties Carlow, Kilkenny, South Tipperary, Waterford, and Wexford.
“Nearly half of pregnant women who set a quit date with their stop smoking service go on to quit successfully,” said Ms Kate Cassidy, Health and Wellbeing Officer in the HSE south-east community healthcare services. “No matter what stage you or your partner are at in your pregnancy, it is never too late to stop smoking.”
Dr Lisa Hynes, Head of Health Programmes at Croí, speaks with Pat Kelly about a new way to deliver care and improve clinical outcomes in cardiac disease prevention and recovery
Areport was published recently that focused on the outcomes of an innovative digital cardiovascular disease prevention and recovery programme developed by Croí, the Irish heart and stroke charity. The programme, titled 'Croí MySláinte', was delivered virtually due to Covid restrictions and saw the development of a new interactive platform that enabled participants to access it from their own homes. People were also able to access pre-recorded videos, weekly live Zoom sessions, and other resources.
The core components of the programme included lifestyle advice and modifications (such as smoking cessation, food choices and exercise), risk management of blood pressure, cholesterol and glucose control, and electronic prescribing of cardioprotective medications. The participants comprised 105 people aged between 35 and 84 years who had suffered a cardiac event and were referred from cardiac centres across the West of Ireland, including Galway, Mayo, Limerick, and Donegal.
A number of health improvements resulted, arising from 423 consultations over a 12-week period. Among these, the authors of the report noted that physical activity levels increased almost six-fold: Blood pressure control improved from 24 to 68 per cent; achievement of LDL cholesterol targets increased from 14 per cent to 41 per cent; 57 per cent of participants lost more than 2 per cent of their body weight (with 23 per cent losing 5 per cent or more); and anxiety and depression levels were reduced by more than 50 per cent. In addition, many of the participants were also living with comorbidities such as diabetes, arthritis, chronic kidney disease and cancer, and benefits were also seen with these conditions as a result of the programme.
Croí is a purpose-built centre constructed in 2012 and is the first of its kind as an accredited cardiovascular risk management and prevention centre, which is aligned with University Hospital Galway and linked with primary care and community-based services.
New tool
and concluded with assessments of risk factors and other clinical information. As exercise is a core component of cardiac rehabilitation, fitness assessments were also conducted. Steps were taken to ensure that exercise could be managed remotely in patients who had already had a cardiac event, and Dr Hynes explained that one hour of exercise was followed by a group discussion on Zoom around the different topics of interest to patients.
The programme was complemented by the Moodle learning technology platform interface, which contains a range of learning resources. Nurse prescribing and medicines optimisation features were also included in the programme. This gave patients ‘protected’ time with their healthcare providers to discuss medications and potential concerns or side-effects. Nurses in the programme would then liaise with the patient’s GP, who would decide whether the dosing or regimen needed to be changed.
Covid, cardiac rehabilitation was in serious trouble,” she told MI. “There was a survey published in 2021 that showed how big the gaps in cardiac rehabilitation services were before Covid. For example, it showed that only one-third of people who were eligible actually completed a [rehabilitation] programme. So we were starting off from a bad place in terms of staffing levels and access, for example, and that has all been compounded since Covid. Cardiac rehab providers are working so hard to address these issues and to lobby for investment into cardiac rehabilitation and also to address the waiting lists that are now happening because of Covid,” she continued.
“But nobody really knows what’s coming down the line in terms of cardiovascular disease and stroke and really, it’s all about time. There is huge concern that people who have had symptoms for a long period of time have struggled to get to see their GP or other healthcare professional… we would strongly advocate for more investment in cardiac rehabilitation in all forms and we very much believe that digital cardiac rehab has a major role to play in addressing some of these barriers.
“For example, we had a man who lived on a tidal island in Mayo who completed Croí MySláinte, and other [remote] people with caring responsibilities – there is no way these people would have been able to attend a hospital, Covid or not,” said Dr Hynes. “So we believe this is a really important complement to in-person cardiac rehab.”
Whilst the value of the programme has been widely acknowledged, including by Minister for Health Stephen Donnelly, Dr Hynes acknowledged that in an ideal world, every patient would be seen face-to-face. “Overall, the benefits outweigh the drawbacks,” said Dr Hynes. “There are things that we have learned from the programme that will benefit future [initiatives], and which we can feed on to our healthcare colleagues.” Some of the impediments ranged from people not having access to devices, to people not having good enough broadband. “That’s so important, to nationally provide 100 per cent reliable broadband access for everybody,” said Dr Hynes.
As part of the programme, participants were encouraged to manage their own health, stress, and emotional eating habits. Lifestyle advice was also offered, including in the areas of sexual health, sleep hygiene and returning to work following illness. The patients were also given a Fitbit device to measure their daily exercise and blood pressure monitors for home measurement, as well as being encouraged to maintain food and exercise diaries. The healthcare teams included a cardiovascular nurse prescriber, physiotherapist and a dietician, all overseen by a consultant cardiologist.
Dr Lisa Hynes
Dr Lisa Hynes, Head of Health Programmes at Croí, spoke with the Medical Independent (MI) in more detail about the programme and how the results may point the way towards a new tool in the armament of healthcare professionals to help prevent cardiac events and aid recovery. “The Croí MySláinte programme is based on cardiac rehabilitation protocols; cardiac rehabilitation is normally something that is delivered in hospital settings – it’s a hugely effective and really important part of a patient’s recovery from a cardiac event,” said Dr Hynes. “But as we know, with [the onset of] Covid-19, in-person hospital-based cardiac rehab was simply not available in a lot of places, as staff were redeployed and some units closed and capacity went down.”
In response to these circumstances, Croí MySláinte was developed to operate digitally to offer cardiac rehabilitation during Covid-19 and bring it from hospital-based in-person delivery to online delivery. The service was delivered to the same protocols, such as health promotion sessions that covered a range of areas, including cardio-protective medications and the benefits of exercise, to emotional wellbeing and a heart-healthy diet. The 12-week programme started
“The digital skills and confidence side of things are also important,” she continued. “That would have been important for healthcare providers who aren’t necessarily tech people… it’s also important to risk-stratify people to identify those who should be seen in person and those who can be seen remotely. I think these are the conversations we will be having.” Technical support and advice were offered to participants, she added. “It does of course take time [to establish a digital platform],” Dr Hynes added. “Some people think digital health approaches are the easiest ones, but it’s just different and there is a lot to cover – you want to make sure everyone is engaged, that the cameras are on, etc. Sometimes of course it would be better to see people face-to-face, but overall, the benefits have the potential to outweigh the drawbacks, as long as it is done carefully and everybody engages.”
‘Serious trouble’
Dr Hynes also addressed the potential surge of undiagnosed cardiac disease as a result of the massive disruption to the health service since the onset of Covid-19. “Even before
“So many sectors in the health service are now having these conversations about digital health,” said Dr Hynes. “It does seem to be a priority and the chronic disease management integrated care programme, among other programmes, are talking about digital health in the context of ‘right care, right place, right time’. Now that we have launched the report, we are open to conversations about who is interested in this and who we can support to try it.
“… We are open to talking about how we can support teams within the health service, whether that’s in a new integrated care hub or hospital-based settings, to add a digital delivery plan to what they are doing, because it has such potential to complement the wonderful in-person work they are doing,” Dr Hynes concluded. “We would love to see the integration of Croí MySláinte – or digital cardiac rehab in whatever form that works within those services – and we want to be part of supporting the health service to do that.
“It’s all very much about including stakeholders and we have collected data on people who have referred to the service, such as the cardiac team in hospitals, on how they found it and what they think should happen next. It’s important to remember that this is a process that involves consultation and matching the tech infrastructure and skills within the service.”
Konverge Plus is indicated for the treatment of essential hypertension as an add on therapy in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. Konverge Plus is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine).
Legal Category: POM. Marketing Authorisation Number: PA 865/19/1-5. Marketed by: A. Menarini Pharmaceuticals Ireland. Further information: Available on request from A. Menarini Pharmaceuticals Ireland Ltd, Castlecourt, Monkstown Farm, Monkstown, Co. Dublin or may be found in the SmPC available at www.medicines.ie Date of Item: March 2021 Item Code: IR-KON-06-2021
European and US politicians are bidding to invigorate efforts to prevent and treat cancers. Bette Browne reports
“We can end cancer as we know it,” declared US President Joe Biden at the re-launch in February of his ‘cancer moonshot’, which aims to halve the US death rate from cancer over the next quarter of a century.
The US programme’s goals, which are similar to those approved by the European Parliament, involve earlier diagnosis, prevention, addressing inequities in treatment and targeting the right treatments to the right patients.
When President Biden first announced the initiative in 2016, he was former President Barack Obama’s Vice-President. But now as President he promised to “supercharge” the cancer moonshot and has announced the establishment of a ‘cancer cabinet’ to focus on implementing his goals.
“I committed to this fight when I was Vice-President. It’s one of the reasons why, quite frankly, I ran for President. Let there be no doubt: Now that I am President, this is a presidential White House priority – period,” he said during the re-launch at the White House in early February. “Let's end cancer as we know it. I refuse to believe this is beyond our capacity. I refuse to believe it.”
“Let's show the world what's possible. Let’s show the world that we're committed. Let's show we can do big things,” he declared. “The goal is to cut the cancer death rate in half in the next 25 years – at least by 50 per cent – and to turn more cancers from death sentences into chronic diseases that people can live with; to create a more supportive experience for patients and their families; and by doing these things and more, to end cancer as we know it.”
In 2021, the European Commission presented a new strategy in relation to the disease titled Europe’s Beating Cancer Plan. In December the European Parliament’s special committee on beating cancer (BECA) adopted final proposals on how to strengthen the EU’s role in the fight against cancer.
MEPs said that the implementation of Europe’s Beating Cancer Plan was a first step towards “a real European Health Union”. The comprehensive strategy addressing cancer at EU level should “serve as a model for other non-communicable diseases”, MEPs add.
Ireland was represented on BECA by Ms Deirdre Clune MEP. The committee was created in June 2020 and ended its mandate in December 2021. The adoption of the committee’s report by the Parliament was hailed by MEPs as a major step in addressing “the biggest killer of our times”.
They said implementing Europe’s Beating Cancer Plan would advance the struggle against the disease on several fronts by laying out a co-ordinated EU strategy. BECA’s Chair Mr Bartosz Arlukowicz MEP commented: “If we can co-finance building bridges, roads, and museums together, as a Union, then we can surely start fighting the biggest killer of our times, cancer. If we work together, if we pool our resources, we can really beat cancer.”
In 2020, cancer killed almost 10 million people worldwide, according to World Health Organisation figures.
In the EU, 2.7 million people were diagnosed with cancer and 1.3 million people lost their lives to the disease. The American Cancer Society projects about 1.9 million new cancer cases and 609,360 deaths in 2022.
With an estimated 40 per cent of all cancers now preventable, MEPs called for effective prevention measures at national and EU level, based on independent scientific expertise. Europe’s Beating Cancer Plan includes funding programmes that encourage people to stop smoking and measures to promote actions to reduce and prevent alcohol-related harm as part of a revised EU alcohol strategy. MEPs were
also concerned that patients still faced problems when accessing healthcare services and participating in clinical trials in other EU countries.
They called for the existing legislative framework to be reformed to allow for mobility and access to highly specialised equipment and care. There should be a single set of rules to authorise and reimburse cross-border healthcare, including a right to a second opinion.
Multi-national cooperation and the way cross-border clinical trials are run also needed to be more effective, they said. “We cannot allow the unequal access to diagnosis and treatment to persist,” Mr Arlukowicz stressed. “A woman with breast cancer in one country should not have 25 per cent less chance of surviving cancer than a woman with the
same cancer in another country.”
To counter shortages and make cancer treatments more accessible and affordable at EU level, MEPs strongly advocated extending joint procurement procedures, especially for rare, paediatric, and novel cancer medicines and treatments. They also want to diversify the cancer drugs supply chain, monitor shortages more closely and create a strategic stockpile of critical cancer medicines.
A key recommendation in the BECA report, which the parliamentarians approved, was to guarantee to all EU patients the ‘right to be forgotten’. Under this right, insurers and banks would not be allowed to consider the medical history of people affected by cancer 10 years after the end of their treatment and up to five years for patients who were diagnosed before the age of 18.
The Parliament heard that people affected by cancer were over three times more likely to have difficulty purchasing insurance than the general population, and over twice as likely to experience problems in getting a mortgage.
France, Portugal, Belgium, Luxembourg, and the Netherlands have already ensured that cancer survivors can use their right to be forgotten when, for instance, applying for a mortgage 10 years after the end of their treatment, if there has been no relapse.
But no such right exists in Ireland. Nearly a quarter of people affected by cancer in Ireland said they could not get a quote for a range of financial products and services due to a diagnosis at some point in their lives, according to a survey published in February by the Irish Cancer Society.
The Covid-19 health crisis affected cancer research considerably, leaving facilities with financial and logistical challenges
Other significant recommendations, approved by the EU Parliament, included adding other cancers, besides breast, cervical and colorectal cancer, to the updated EU cancer screening scheme. At present, this scheme aims to help EU countries ensure that 90 per cent of the EU population who qualify for breast, cervical, and colorectal cancer screenings are offered screening by 2025.
“Twelve years after the last European strategy to beat cancer, the one we are now presenting is historic, both in terms of its ambition and its objectives, and in terms of the resources we will provide,” said BECA Rapporteur, Ms Veronique Trillet-Lenoir (MEP).
“We will finally be able to fight effectively, together, against the health inequalities that persist within the European Union and respond to the needs of millions of Europeans affected by this disease.”
Lessons learnt by the committee on the impact of the Covid-19 pandemic on cancer care have also been incorporated. “Healthcare services face multiple challenges in providing essential care to their patients in the midst of Covid-19 restrictions across the EU,” the BECA report emphasised.
“Cancer care services have endured significant delays or cancellations leading to backlogs of patients furthering the already existing strains on healthcare systems and healthcare professionals. The Covid-19 health crisis affected cancer research considerably, leaving facilities with financial and logistical challenges.”
Nonetheless, it said “the pandemic sparked the use of innovative health technologies, for example telemedicine, in the mitigation of the detrimental effects on all cancer-related services and research and fuelled the drive to restructure existing health systems and make them more resilient for future health crises.”
US expenditure
For Americans, Biden’s moonshot initiative recalls President John F Kennedy’s pledge in 1961 to conquer space by sending a man to the moon and safely returning to Earth – a goal that took almost a decade to achieve.
In 2016, the US Congress authorised $1.8 billion (€1.6 billion) in funding for the cancer moonshot over seven years. The National Cancer Institute, which oversees the initiative, says it has already spent $1 billion on more than 240 research projects. There is an estimated $410 million (369 million) left for the next two fiscal years.
The financial support was facilitated by the 21st Century Cures Act, which has provided new funding for cancer research in several areas including cancer disparities, new clinical trial networks to drive drug discovery, and childhood cancer.
The Act, signed into law in December 2016, streamlined cancer-related decision-making at the US Food and Drug Administration through the formation of an Oncology Center of Excellence so that treatments could be approved faster and patients could have more direct access to information about the regulatory process.
In many ways, fighting cancer has been a personal mission for President Biden and his wife Dr Jill Biden. Her advocacy for cancer education and prevention began back in 1993, when four of her friends were diagnosed with breast cancer. She subsequently launched the Biden Breast Health Initiative to inform high school girls about the importance of cancer prevention.
As First Lady she has continued her work, which has emphasised early detection efforts. She stressed the importance of cancer screenings, especially those delayed due to the Covid-19 pandemic, and has urged government partners, the business community, and non-profit sectors to help make screenings more accessible and available.
As Vice-President, Biden brought together a taskforce and urged the public and private sectors to unite to progress measures against the disease.
Companies, patient groups, universities and foundations, worked together to forge new partnerships and programmes.
At the time, the cancer moonshot initiative was ambitious and it achieved progress on a number of fronts. Its three overarching goals were to accelerate progress in cancer research, encourage greater collaboration, and improve the sharing of data.
Under the initiative, the National Cancer Institute funded two groups of research teams focused on immunotherapeutic approaches in adults and children. The Immuno-Oncology Translational Network, which included 31 principal investigators at 19 different institutions, investigated the mechanisms by which tumours in adults interact with the immune system, developed new immune-based therapies and created approaches aimed at minimising the risk of side-effects.
Because most paediatric cancers are biologically different from adult cancers, a separate network of research teams was established to focus on identifying immune targets and treatments specific to paediatric cancers and developing laboratory models for testing immunotherapies against these cancers. A data management centre was also built into the immunotherapy component, which allowed researchers to share their work and facilitate collaboration.
Another area in which significant progress is being made is in cancer prevention and early detection. Some of the research being funded in this area is making extensive use of implementation science – taking evidence-based interventions and testing ways to apply them in real-world settings. For example, several research teams tested methods to improve efforts to encourage people to stop smoking. Similarly, there were initiatives to improve the uptake of colorectal cancer screening.
it’s completely doable.”
To help make it “doable”, President Biden is calling on scientists to explore the lessons learned from the development of the Covid vaccines to see if mRNA vaccine technology could also be used to stop cancer cells when they first emerge.
“To target the right treatments to the right patients, we’re learning more about how to use genetics, immune response, and other factors to tell which combinations of treatments are likely to work best for a particular individual,” the President said.
“To address inequities, we can target prevention, detection, and treatment efforts so that all Americans – whether they’re urban, rural, or Tribal communities – have equal access to cancer diagnostics, therapeutics, and clinical trials.
President Biden announced the formation of a new ‘cancer cabinet’. The cabinet will coordinate the work of multiple government agencies. It has representatives from the Departments of Health and Human Services, Veterans Affairs, Defence, Energy, and Agriculture, as well as the Environmental Protection Agency, the National Institutes of Health, the National Cancer Institute, and other agencies across the executive branch.
The President has also called on Congress to fund his proposed Advanced Research Projects Agency for Health (ARPA-H), which will be a new entity within the National Institutes of Health to drive what he described as “unprecedented progress” in biomedicine. “ARPA-H will have a singular purpose – to drive breakthroughs to prevent, detect, and treat diseases, including cancer, Alzheimer’s, and diabetes, and other diseases. I’m also calling on the scientific and medical communities to bring the boldest thinking to this fight.”
He said harnessing the private sector will be key to progress. “I’m calling on the private sector to develop and test new treatments, make drugs more affordable, and share more data and knowledge that can inform the public and benefit every company’s research.”
Cancer screening should also be stepped up: “Americans have missed more than nine million cancer screenings in the last two years because of Covid. We have to get cancer screenings back on track and make sure that they are accessible to all.”
However, just a year after Vice-President Biden launched the initiative, a new US administration took over under President Donald Trump in January 2017 and there was far less focus on the moonshot. Funding cuts to the National Institutes of Health followed and inevitably impacted cancer research within the agency.
Propelled by concerns about the fate of the cancer moonshot, the President and his wife, Dr Biden, decided to launch a private sector Biden Cancer Initiative in June 2017, under the auspices of the Biden Foundation. The goal was to give momentum to the cancer moonshot and push for faster progress in new treatments, prevention, and detection.
But in 2019, when President Biden announced a presidential run, it meant the foundation had to close for political reasons, although the work of the Biden Cancer Initiative continued independently. The Vice-President of the Biden Cancer Initiative was Dr Danielle Carnival.
Dr Carnival, who spoke with the Medical Independent (MI) in a lengthy interview in 2019, has now been tapped to oversee the “supercharged” version of the moonshot announced by President Biden. Dr Carnival told MI in 2019 that she believed the moonshot was bringing a greater sense of urgency to cancer prevention and treatment, both nationally and internationally.
President Biden also spoke about that same sense of urgency in his re-launch of the initiative in February. “The cancer moonshot brought the country and the world closer together on this issue. Our goal was to bring a new sense of urgency to the system of prevention, research, and patient care to take advantage of the 21st Century science and technology.
“And that’s why I’m proud to announce our plan to supercharge the cancer moonshot as a central effort of the Biden-Harris administration. It’s bold, it’s ambitious, but
But a major obstacle to improving access to preventive measures, like early detection and treatment, is the continued lack of health insurance for millions of Americans. Despite gains in health insurance coverage following the implementation of President Obama’s 2010 Affordable Care Act, some 30 million Americans aged between 18 and 64 are still uninsured, according to the US National Health Interview Survey by the Centres for Disease Control and Prevention (CDC).
The President has also called on the medical profession and scientists to examine the efficacy of their practices. “Take a hard look at your practice. Ask yourself, am I practising perfectly or am I practising to make the old way permanent? Old practices created data silos, minimised the role of patients, fostered the wrong kind of competition instead of the right kind of collaboration. My plea to you scientists is (to) share data as best you can.”
He said too little was known about why treatments worked for some patients, but not others. He added that patients often wanted to share their data to help more people.
The President called on companies to develop mobile units and pop-up clinics to make screening more accessible and he urged members of Congress to “fund this particular programme and focus on it until we beat cancer”.
President Biden’s launch of the moonshot initiative came just a year after his son Beau had died at age 46 of glioblastoma. Beau’s doctor was at the moonshot relaunch event. The President pointed to him and spoke emotionally about how cancer patients often asked their doctors for two more weeks to see their daughter’s wedding or six more months to see their baby born.
He added: “For survivors and caregivers, who carry the physical and mental scars of treatments and recovery, and for those who have lost, and for the ones we can save: Let’s end cancer as we know it.”
Old practices created data silos, minimised the role of patients, fostered the wrong kind of competition instead of the right kind of collaboration
Lack of access to safe, affordable, and timely surgical care can have a significant negative impact on the patient, their family and the wider community. Access to safe surgical care can save lives and alleviate life-long disabilities. Access to timely surgical care can improve the individual patients’ economic activity and potential and have a beneficial impact on their family and community.
The Republic of Ireland, a high-income country (HIC), has weathered the storm of the Covid-19 pandemic cycle over the past two years and the enormous disruptive impact of the cyberattack on the HSE. The professionalism and resilience of the Irish healthcare workforce ensured that acute patient care was delivered during these challenging times. However, immediate action to address the unacceptably high waiting lists for scheduled care must now be the urgent health priority for 2022. Minister for Health Stephen Donnelly has allocated the biggest
ever investment in Ireland’s health and social care services in Budget 2022, with a spend of €21 billion.
A 2022 waiting list action plan of €350 million has been committed by the Minister to stabilise and reduce waiting lists and waiting times for elective surgical care in Ireland, aimed at bringing about significant and lasting change in waiting list numbers.
Currently, it is projected that over 1.5 million patients will be added to active waiting lists in 2022. Minister Donnelly has stated: "While this plan focuses on significant numbers and targets, it is fundamentally about ensuring people receive the right care in the right place, at the right time – reforming our health service through the fundamental principles of Sláintecare."
The focused spend on scheduled surgical care is on 15 high volume inpatient day case procedures, with the intent that every person waiting for over six months, who is clinically ready, will receive an offer of treatment.
Addressing these treatable surgical diseases in a timely fashion will have a significant impact in reducing the burden of surgical disease experienced by a wide cross-section of Irish patients ranging from the young child requiring tonsillectomy for obstructive sleep apnoea, to the older patient with impaired vision waiting for cataract surgery.
The global burden of treatable sur-
Ireland has acknowledged the need to provide improved and equitable surgical care to the world’s population by developing a strategic collaborative partnership with the College of Surgeons of East Central and Southern Africa (COSECSA). The aim of this collaboration is to “improve the standards of surgical care, education, training, and examinations in the east, central, and southern Africa region”. A memorandum of understating was entered into in 2007 by COSECSA and RCSI, with funding from Irish Aid to help drive forward this partnership. The key individuals who enabled the development of the collaborative programme were the then President of COSECSA Prof Krikor Erzingatsian, a RCSI School of Medicine graduate (class of 1969), and the then President of RCSI Prof Gerry O’Sullivan (2006-2008).
Table 1: Public and trainee costs at different staged of surgical training. MRCS: Membership of Royal College of Surgeons diploma; BSS: Basic curgical skills course; CCrISP: Care of the critically ill surgical
gical disease is staggering. The World Health Assembly, the decision-making body of the World Health Organisation, estimates that treatable surgical disease accounts for 11 per cent of the global burden of disease. Low- and middle-income countries (LMICS) are disproportionately disadvantaged through a lack of access to surgical and anaesthesia care.
Over five billion people lack access to safe, affordable and timely surgical care globally. Over 15,000 children are dying every day because of unmet surgical need in sub-Saharan Africa and southeast Asia.
At the time of the signing of the memorandum of understanding in 2007, there were approximately 500 surgeons in the east central sub-Saharan Africa (ECSA) region, serving a population of 230 million. That number has grown to over 1,690 surgeons practising in the region, which represents a figure of 0.53 per 100,000 population. By way of comparison Ireland has a total of 16.74 per 100,000 population practising surgeons.
COSECSA is now involved in delivering surgical education and training in over 125 accredited hospital sites. (Figure 1) Each hospital site has a designated programme director, who oversees and delivers a validated surgical curriculum. The surgical trainees utilise an electronic
Women surgeons now represent 14 per cent of COSECSA graduates and 23 per cent of COSECSA traineesPROF CAMILLA CARROLL Opinion
surgical logbook, which has been developed and adapted by COSECSA in partnership with RCSI. This records individual trainee data, including the number and complexity of surgical cases observed and carried out by the surgeon in training.The collection of robust data sets using a validated electronic logbook has been shown to assist in mapping trainee performance and progression. It also acts as a tool to analyse quality of individual training sites.
The surgical training programme involves two years of core surgical training with exposure to general surgery and orthopaedics with a membership examination upon completion of year two. The surgeon in training can then progress to specialised surgical training and exposure to the eight specialties that are currently offered by COSECSA. These include: General surgery; orthopaedics; urology; otolaryngology; cardiothoracic surgery; neurosurgery; plastic and reconstructive surgery; and paediatric surgery. Upon completion of three to four years for specialist training, the surgeon can then undertake the specialty COSECSA Fellowship examination.
A strategic goal of COSECSA to train 500 surgeons by 2020 has been achieved. It is planned to scale-up between 20212025 with 1,000 surgeons to be trained in the coming five years.
Irish Aid has provided over € 5 million to the COSECSA-RCSI collaboration programme, since 2008. Through the collaboration programme, over the past 13 years, 530 surgeons have been trained and graduated with a Fellowship qualification from COSECSA. These Fellows have become part of the specialist surgical workforce in sub-Saharan Africa. This represents a cost of approximately €9,400 per specialist surgeon to the Irish State.
The cost of training a surgeon in Great Britain and Ireland far exceeds this number.
When the RCSI-COSECSA collaboration programme was established in 2007, a position statement from the Association of Surgeons in Training (ASIT) of Great Britain and Ireland outlined the costs of training a surgeon in 2007 to be in the region of £413,205. (Table 1)
Retention of surgeons in the ECSA region having completed surgical training is 88.13 per cent. The majority of COSECSA trained surgeons were retained within Africa (93.4 per cent). Research carried out at the RCSI by Dr Avril Hutch and published in the World Journal of Surgery in 2017 concluded: “High surgical graduate retention rates across the region indicate that the expansion of national surgical training initiatives is an effective solution to addressing the surgical workforce shortage in East, Central, and Southern Africa and counters long-held arguments regarding brain drain in this region.” (Figure 2)
This is in stark contrast to the findings of a longitudinal medical career tracking study by the health workforce research group at the RCSI led by Prof Ruairi Brugha. They concluded: “Medical workforce stressors continue to under-
mine Ireland’s ability to achieve medical workforce sustainability and compliance with the WHO Global Code on international recruitment of health personnel. These include i) high rates of emigration among Irish medical school graduates attracted by working conditions, training, and career opportunities in other English-speaking countries; ii) the need to be compliant with the European Working Time Directive, which restricts hospital doctors working week.”
Global health research has identified the ever-increasing trend that healthcare is being delivered by women. Some 75 per cent of the global health workforce are women, with a representation of over 90 per cent in nursing and midwifery.
The recruitment of women into the surgical workforce in the ECSA region has been slow. The RCSI published data in 2016 on the specialist surgeon workforce in the ECSA region and identified
that only 9 per cent of the surgical workforce was provided by women surgeons. Women’s under-representation in surgical roles frequently is as a result of societal norms, lack of educational and training pathways, which support women’s careers and visible role models. Motherhood and surgery may not be compatible in societies, where there is no affordable childcare and the burden of domestic work and caregiving is borne by the woman.
Recognising that women were under-represented in the numbers of surgeons being trained in the ECSA region, Women in Surgery Africa (WiSA) was established in 2015. The aim of WiSA is to encourage women to enter surgical training and to support and mentor them during their training. The programme is delivered as a collaborative venture with support from the RCSI and the American College of Surgeons (ACS). The ACS also
offer WiSA funded scholarships for training and professional exam fees. WiSA mentoring has had a positive impact on increasing the numbers of women choosing surgery as a career in sub-Saharan Africa. Women surgeons now represent 14 per cent of COSECSA graduates and 23 per cent of COSECSA trainees.
The WHO Global Health 50/50 report seeks to advance action and accountability for gender equality in global health: “Gender equality in health means, that women and men, across the life-course and in all their diversity, have the same conditions and opportunities to realise their full rights and potential to be healthy, contribute to health development, and benefit from the results.” Collaborative trusted partnerships between LMICs and HICs have been the cornerstone of significant advances in global surgery. The COSECSA-RCSI collaboration has been one of the most successful programmes delivering surgical education, training, and assessment, with the end result being an expansion of the surgical workforce in Africa. This success has been enabled by the development of mutual trust between the two organisations, an ethical and culturally sensitive approach to surgical training and education, with institutional leadership locally and nationally. COSECSA is now a well-established surgical training institution offering internationally recognised qualifications. COSECSA works closely with the Colleges of Medicine of South Africa, the west African College of Surgeons, all of the Royal Surgical Colleges in the UK and Australia, the ACS and the Japanese Surgical Society. The strategic plan for COSECSA 2020-2025 is to continue to “scale-up” the number of appropriately trained, well-qualified surgeons and support the development of the anaesthesia, perioperative nursing and obstetrical workforce. A key enabler to surgical workforce expansion is to deliver continuous professional development for the trained surgeons and to this end COSECSA plan to establish a surgical simulation skills centre in Lakilaki Land, Arusha, Tanzania. This exciting project will be the first of its kind in Africa. The location has been carefully selected. Arusha is a multicultural city, a diplomatic hub hosting the UN and the African Court of Human and People’s Rights and home to a number of universities. COSECSA will launch this project and seek donor funding in the coming months.
It is a privilege and honour to collaborate with my friends and surgical colleagues from COSECSA and witness at first hand the impact that building sustainable partnerships in global surgery can have on delivering safe, effective, and affordable surgical care in Africa.
It is important to thank and acknowledge the commitment of Irish Aid on behalf of the people of Ireland in funding this very important work, which has significantly increased the surgical workforce in the ECSA region.
The run-up to the March bank holiday weekend saw the return of familiar pleas we hoped were behind us for now. On Tuesday 15 March, the HSE appealed to the public to only attend hospitals in the case of emergencies due to the pressure Covid-19 was putting on staff and resources.
According to Ms Anne O’Connor, HSE Chief Operations Officer: “Anyone who suspects they may be facing an emergency situation should of course come to the emergency department (ED) and they will be seen and treated. However, we would ask those who may be in a non-urgent situation to help our staff through a challenging time by looking at other healthcare options where possible.”
At the time, validated figures showed there were 101 Covid-19 outbreaks across hospitals and a further 595 outbreaks across community care services, including nursing homes. These were resulting in bed and ward closures and delays in patient discharge from hospital care.
While the number of patients requiring ICU care remained stable, the HSE said it was important to note that the impact of the recent steady rise in admissions was “extremely challenging, placing significant pressure on emergency departments and patient waiting times for admission to hospitals”.
These words were echoed by a statement from the Mater Misericor-
diae University Hospital on the same day, which appealed to the public to avoid its ED where possible.
“Hospital services are under extreme pressure due to a combination of large numbers of people contracting Covid, high numbers of presentations at the ED and high levels of staff absences due to Covid-19,” according to the statement.
“Patients who are presenting at our ED with non-urgent conditions are unfortunately experiencing lengthy waiting times to be seen. Where possible, the Mater advises patients with non-emergency conditions to seek assistance from other parts of the health service, such as minor injury units or their GP. However, any patient who is in need of emergency hospital care will of course be seen and the Mater would urge such patients not to delay and to seek care.”
This year the traditional St Patrick’s Day holiday was extended, with a further bank holiday held on 18 March to recognise the efforts of the country during the Covid-19 pandemic and to remember those who lost their lives.
The rise in cases and pleas regarding ED attendances are a reminder, if one was needed, that Covid-19 has not gone away. While it is right to recognise the toll the pandemic has taken over the past two years, Covid is still very far from being consigned to history. It is a very real public health threat and is likely to remain so for some time to come.
REACTION TO PROF BRENDAN KELLY’S BOOK REVIEW OF "I WON’T KEEP YOU A MINUTE, DOCTOR": TALES FROM AN IRISH GENERAL PRACTICE BY DR VIVIAN BRENNAN, 7 MARCH
“Great to see this wonderful collection of stories from Galway GP Dr Vivian Brennan getting such a positive review." dotMD, @DotMDConf, 10 March
“This looks good." Anne, @AnnePM4, 10 March
REACTION TO OUR NEWS STORY, 'HSE TO PUBLISH DOCUMENTS UNDER "TRUST" PLAN', 7 MARCH
“Having trouble getting basic weekly data from HSE – it used to be automatic, but now very difficult. Sorry, but must fly the patients flag!"
Irish Patients Assoc, @IrishPatients, 8 March
REACTION TO DR SARAH FITZGIBBON'S COLUMN, 'WHEN THE "SHOCKING" IS NOT SURPRISING', 24 FEBRUARY
“Ireland has failed and continues to fail so many of its children – shame on Ireland. For many years as a GP I felt as if I needed to apologise for these inadequacies, but then realised it's not my fault and it's only politicians who can resolve it."
Dr Ray Walley, @WalleyRay, 24 February
“Many people who have worked in hospitals will identify with this piece by @SarahFitzWiMIN." Ciara Scott, @ciaramsc, 24 February
“You are correct @SarahFitzWiMIN, seems to be in freefall – I have so many examples that it would take a book to record them! Medication reconciliation a major one! Absence of discharge letters another and as you say CAMHS and adult psychiatry –we need patient-centred care." Dr Rita Doyle, @ritakj, 24 February
“Brilliant as ever Dr F." Dr Madeleine Ní Dhálaigh, @Madser2002, 24 February
REACTION TO OUR NEWS FEATURE, 'PHYSICIAN ASSOCIATES: A SOLUTION TO DOCTOR BURNOUT?', 7 MARCH
“Sounds like a great idea." Michael Cushen, @michael_cushen, 12 March
“Physician Associates: A solution to doctor burnout? Advocates say they are an integral part of multidisciplinary teams working to deliver patient-centered care." RCSI, @RCSI_Irl, 7 March
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Involvement in patient safety incidents can significantly affect the professional and personal lives of healthcare professionals. Understanding this ‘second victim’ phenomenon and seeking appropriate support is key to achieving a healthy recovery.
Every day healthcare professionals strive to deliver safe and effective patient care in challenging, stressful, and highly complex environments. Despite their best intentions, unexpected complications and unintentional patient safety incidents occur due to the nature of human fallibility and complex socio-technical systems, such as healthcare. Although not all errors are life-threatening, they can significantly compromise a patient’s quality-of-life. When a medical error or patient harm occurs, the patient is understandably the first victim and a key priority for clinicians is to provide them with truthful information, appropriate care, and emotional support.
According to the HSE Patient Safety Strategy 2019-2024, unexpected events occur to approximately 13 per cent of patients using healthcare services. These can have traumatic effects on others, including clinicians and staff involved in the incident, ie, they become second victims. Prof Albert Wu first coined the term in 2000, to describe clinicians who were traumatised by their own errors. Scott SD et al (2009) expanded the term to describe second victims as:
“…healthcare providers who are involved in an unanticipated adverse patient event, in a medical error and/or a patient related injury and become victimsed in the sense that the provider is traumatised by the event.”
It is estimated that all clinicians, at some stage in their professional life, will become a second victim (Laue von N et al 2012).
The pronounced psychological strain experienced by second victims, if unsupported, can pose a further threat to patient safety and can be detrimental to organisational culture; therefore, it needs to be taken seriously.
What effect does this have on clinicians?
In the aftermath of an incident, the clinicians involved may be left feeling unsupported and experience feelings of blame, anger, shame, failure, depression, inadequacy, and distress.
A UK survey by Harrison R et al (2014) highlighted the professional and personal impact of adverse events on clinicians: 74 per cent reported stress, 68 per cent anxiety, 60 per cent sleep disturbance, and 63 per cent lower professional confidence.
On a positive note, 80 per cent of respondents reported a determination to improve following an adverse event. However, 81.5 per cent were anxious about the potential for future errors, which the authors suggested may lead to clinicians exercising greater caution.
A clinician’s response to adverse outcomes can depend on various factors, including the seriousness of the circumstance, the person’s role and perception of responsibility, the patient’s outcome, and organisational response. In some cases, clinicians might experience minor stress or anxiety that dissipates in the days and weeks following an incident. A study of anaesthesiologists, involved in difficult airway management, by Samuels JD et al (2020) illustrated that second victim symptoms persisted in 26 per cent of participants up to weeks, 8 per cent for half a
year, and 5 per cent for over a year. Others may suffer from strong emotional reactions and symptoms akin to those of post-traumatic stress disorder.
A 2016 study by Panella M et al suggested that: “Being a second victim is the strongest predictor of practising defensive medicine.” Practising defensive medicine exposes patients to the risk of unnecessary examinations and increases the costs of care. Providing effective support to second victims, together with a systematic use of evidence-based clinical guidelines, is also recognised as a key recommendation for reducing defensive medicine.
by the Covid-19 pandemic
Healthcare professionals have been facing exceptional circumstances during the current Covid-19 pandemic. A recent publication by Lobão MJ et al suggests that, “longterm stressors and risks to clinicians’ physical, mental, and emotional wellbeing are real and represents predisposing factors for adverse outcomes for their own health as well as adverse events during patient care.” These factors include: Fear of contracting Covid-19; fear of infecting family members; social isolation; growing number of cases with a severe and lethal course; caring for colleagues who got sick; increased workload; working with new and frequently changing protocols; and feeling out of control and unappreciated. There is a risk that healthcare professionals, in either primary and secondary care, could become second victims due to the impact of the pandemic.
By acknowledging and proactively addressing the patient safety incident-stress-error cycle, clinicians can work toward effectively managing the situation. The following tips may be helpful when dealing with the stress associated with an adverse patient outcome.
1. Be open and honest with the patient/family (open disclosure)
When things go wrong, healthcare providers have an ethical responsibility to disclose unanticipated patient outcomes, in accordance with the Civil Liability (Amendment) Act 2017. The Act provides the legal framework to support voluntary open disclosure; it applies to all patient safety incidents including near misses and no-harm events. It is essential to investigate, explain and apologise to the patient. Whilst clinicians may feel uncomfortable and anxious discussing adverse outcomes with patients and/or families, when done properly, disclosure can reduce the negative impact of adverse outcomes and support a culture of transparency and safety.
2. Participate in peer review meetings
An adverse patient outcome, whilst unfortunate, can present an ideal learning opportunity to reflect on personal performance and to identify potential risks within your healthcare setting. To maximise learning during this reflection, it is important to adopt a ‘systems thinking’ approach. This will provide a more meaningful analysis and understanding as to why the adverse event occurred. It does not seek to blame.
3. Adopt an organisational safety culture
Establish a culture of safety that encourages transparency, respect and honesty. Punitive policies and measures in relation to adverse outcomes can create barriers to disclosure of incidents and emotional coping. Consider developing written policies and procedures for second victim support and resources. Disseminate to all staff and leaders.
4. Emphasise people skills
If you feel anxious, fearful, or dissatisfied, you may find it challenging to relate well to patients. These feelings can impair the doctor/patient relationship, which may adversely affect mutual trust, critical to effective communication and good outcomes. Acknowledging these emotions and working to connect and engage with patients can help relieve such stress.
5. Identify your support systems
Your personal relationships may also suffer because of emotional distress. To address this, identify your support systems, ie, those with whom you can share your feelings and concerns without sharing specific information about the adverse patient outcome. Expressing your personal feelings and concerns to one of your support systems, such as your spouse, a trusted friend, or a colleague, can help re-establish your emotional equilibrium.
6. Maintain a healthy work/life balance
Most people realise the benefits of maintaining a work/ life balance. However, maintaining a “balanced” lifestyle is even more critical in this situation. At the very least, try to take care of your physical health. Consider how your eating habits, medication and alcohol intake, physical activity, sleep schedule, etc, might affect a balanced lifestyle.
7. Stay connected with colleagues
Working remotely, particularly due to the pandemic, may have increased the sense of clinical isolation. Consider setting up peer networks to ensure a connection with others.
8. Seek professional help
Managing stress on your own is not always possible. If you have been involved in an adverse event do contact your indemnifier, eg, Medisec, who provide professional support, legal guidance, and counselling. Whilst there is a widely recognised stigma amongst doctors around admitting the need for self-care and asking for help, you may need to seek help from another healthcare professional if you find you are struggling, eg, your own GP. Talking with a professional in a confidential setting can help with processing the perfectly normal reactions of being involved in an adverse/critical event.
Regardless of how the second victim phenomenon manifests, it can have a serious impact on healthcare providers’ personal and professional lives and, consequently, can be detrimental to patient safety and organisational culture. For these reasons, healthcare organisations should consider the systems they have in place to support staff involved in adverse outcomes. Bullying, blaming, and belittling those involved should not be tolerated. Asking for support is not a sign of weakness; it evidences a sense of responsibility towards patients.
Second victims need to
Be heard and to have distress acknowledged. Asking for support is not a sign of weakness.
Be supported by colleagues and the organisation.
Make sense of what happened.
Have opportunities to transform experience into learning.
References available on request
There are many occasions that mark significant beginnings and endings in the seasons of life. These moments when they happen often give us a chance to pause, reflect and take stock. I had one such occasion recently when my mentor retired. Although not unexpected, it was sooner than anticipated and unlike I had hoped: She elected (as is her right!) to retire completely rather than stay on in part-time capacity as she had previously considered. I found myself feeling somewhat bereft and somewhat embarrassed at the impact her moving on to the next stage in her life was having on me.
To better explain why, I’ll go back to the beginning of our mentor/mentee relationship. I was nearing the end of my radiology SpR scheme. I had already set up Fellowships in North America; two years of neuroradiology followed by two years of neuro-intervention, which would set me up for eligibility for a full licence and board examinations in that State. It was 2012, I was the generation of SpR who felt the 2012 pay cut to be a slap in the face by the Irish Government and I was keen to respond to it by taking myself elsewhere permanently. Cut in haste, repent at leisure was the message I hoped to convey, if you will.
I was in the last group in my year to rotate to paediatrics. Before I started, I pleaded with my husband to reason with me if I decided to change my path from neuroradiology to paediatrics.
“What would be wrong with that?,” he asked.
“They do lots of call and it’s a way harder job. It would be a foolish move,” I responded.
“Why would you change, so?”
“Well one of the consultants there is really brilliant, she gives great lectures and she’s very funny. She clearly loves her job.”
As I’d predicted, I was quickly won over. She was a wonderful teacher, delighted in sharing her knowledge. I ran after her to theatre where we injected botox into muscles that were too tight, on from there to the NICU in the Rotunda where she scanned the tiniest of babies with the greatest of care and back to Temple Street where she taught me the differentials of common brain tumours in children. In the ultrasound room, her warmth and patience with children and their parents really moved me. She taught me that when you look after a child, you care for the whole family. If you focus only on getting the diagnosis right, but you miss the opportunity to support the parents by listening to them and addressing their concerns, then you miss the chance to provide great care and a patient-centred experience to the whole family. Each day learning from her was a masterclass in professionalism and vocational care.
As a result, at that late stage, I found myself rushing to change my Fellowships to paediatric radiology. I was really lucky to secure further training in Boston Children’s Hospital where I went soon after completion of the SpR scheme. She stayed in touch. Little emails from home reminded me of updates of the New Children’s Hospital; she was keen to impress on me that it was expected to open by 2017-18. She knew that I still planned to stay in the US, but she also knew that life has a way of changing the best laid plans.
As it happened, my mother-in-law sadly became unwell while we were away and my husband was keen that we return home at the end of the Fellowship. I struggled with this as I was very happy in the US. I was working in a great hospital with brilliant staff, ample capacity, and protected research time each week with administrative support. I knew that any role I returned to in Ireland would be clinically busier, with much more on-call and less (or rather as
it turned out, no) academic time. But the pull of family is strong and we made the decision to move home.
Ego can make one want to amplify one’s achievements, but getting a consultant post was very easy for me due to ample vacancies in my specialty. I was one of two applicants for two available posts as a consultant paediatric radiologist and was duly appointed. The other candidate was also appointed, but ultimately decided to stay abroad. Ten years previously one would have seen at least five or six eligible excellent candidates. But most of my peers who followed the same training path in the US have elected to stay there.
When I took up my post in Ireland, I approached my mentor and asked her would she be my mentor “officially”. I explained how the mentor/mentee relationship had worked in Boston and she was intrigued by the concept and took to it with gusto. Like many things in her career she managed to maintain the enthusiasm of the beginner, with the skill of the expert. We had regular meetings. She advised me on everything from filling in on-call forms, to continuing professional development, to filing tax returns. She was unwaveringly supportive and an absolute champion of me and everyone she trained.
When she retired last October, the retirement party was somewhat muted due to Covid-19, social distancing, masks, and no food or beverages. But the hospital gave her a very warm send-off in spite of this, with wonderful speeches from many clinical colleagues who had benefitted from her skill and support over the years. For once, I was speechless. I was just too choked up to put words to what she meant to me and how she had shaped me as a professional.
In her speech, she spoke of how, as she was cleaning out her office she found multiple letters that she had written over the years. They were to management, to fundraising,
to various politicians, pleading for more staff and better infrastructure. She spoke with such passion about the frustration of having spent a career asking for adequate resources to provide care to the nation’s children and her disbelief that, even as she retired, we are still writing those same letters. What she was too modest to say was how many of those efforts made a difference to how we provide care to children in Ireland. An example is the funding secured for dedicated radiographer posts to support Ireland’s only paediatric MRI service on-call, and later CT on-call, which are essential to the timely provision of the neurosurgical service in Temple Street. She also was instrumental in the hospital acquiring replacement fluoroscopy, ultrasound, and gamma camera equipment. All of these were crucial investments in staffing and infrastructure, which enabled us to do our jobs better and provide the highest quality of care to our patients.
As you drink your chosen beverage today, please raise a toast to this amazing woman, Dr Stephanie Ryan – Ní bheidh a leithéid ann arís.
Many of you may have expected this column to be an update on the status of the consultant contract talks. In one rather glum respect, there is sadly nothing to report. Talks are stalled since mid-December 2021 and, as of yet, no new Independent Chair has been appointed to allow the process to resume. The Government decision to exclude consultants from the final round of FEMPI reversals has served only to damage relations further at a critical juncture for the health service. In another respect, thinking about Dr Ryan’s impact has given me cause to think about resilience, a quality those of us involved in the talks have had to call upon again and again, both individually and collectively. Ultimately, the strength to stay the course is what delivers enduring benefits for our patients and our health service.
The recent retirement of my wonderful mentor has caused me to think about the importance of resilience and other values
DR GABRIELLE COLLERAN
Read more by Dr Gabrielle Colleran at www.mindo.ie
For once, I was speechless. I was just too choked up to put words to what she meant to me and how she had shaped me as a professionalDR MICHAEL
As a second year house officer, I had a short stretch in my hospital’s ICU. My college, optimistically, imagined the medical trainees picking up the nonchalance of an intensivist when faced with chaos. I had a creeping admiration for the way they yawned in the face of turmoil and shrugged off despair. But in reality, you can’t be a little bit of an intensivist, in the same way you can’t be a little bit pregnant: It is a binary situation. Nobody wants an almost-right intubation.
Still, they gave me their best shot, involving me like any other ICU trainee in arterial lines, central lines, and worsening caffeine dependence. It turned out to be one of my favourite rotations. Unfortunately, I had a lifetime of sports coaches and one scared woodwork teacher to testify that ‘hands-on’ was never my strong point.
I still remember being called to a respiratory arrest one afternoon in the unit. One of my friends, then the senior trainee, had already started the rhythmic ritual of resuscitation with the bag-valve mask over the motionless body. Squeeze, relax. Squeeze, relax. This being as routine as ironing his clothes, he was conversational. A friend of his had recently started in radiology.
“My worst nightmare. Could you imagine it?” Squeeze, relax. “Your name, sitting at the bottom of that scan report, for the rest of time! What if you missed something?” Squeeze, relax. “I could not deal with that
Question 1
Question 2
Question 3
Question 4
Question 5
pressure. The stress!” Squeeze, relax.
Most people would find the idea of performing breaths for someone who cannot breathe to be absurdly stressful, but for my friend it was bland. Similarly, a radiologist who is kept up all night by the possibility that they made a mistake will not remain a radiologist for long. In oncology, I find delivering bad news and dealing with death are the two features most likely to jar that week’s medical student. For most people working in cancer care, however, delivering bad news sensitively is not a drag, but an important part of caring and a skill as structured as inserting a chest drain. And once you recognise dying as an inevitability that you can support people through either well or badly, it loses some of its taboo.
Unusual strains of every flavour are part of the condition of being a doctor, from GPs to epidemiologists, and it’s hard to escape them entirely. This should not come as a surprise to anyone: We’re different people, it is natural that we vary in what pressures we best tolerate. But why is it important?
As we (probably) emerge from the miasma of the pandemic and look at our raw new world, we’re all a bit more sceptical about work. One of Covid’s few gifts has been a sense of perspective, and people’s expectations from their jobs are more exacting than before, with fulfilment now the star of the show. Fulfilment can be
In acute ischaemia of the lower limb
A. Most patients are in atrial fibrillation or flutter.
B. Pain is not a prominent feature.
C. Mottled, purple-coloured skin is a good prognostic sign.
D. The limb is cold.
E. The patient should be admitted to hospital as soon as the diagnosis is suspected.
Characteristic features of tension headaches include
A. A feeling of a tight band or constriction round the head.
B. Nausea and vomiting.
C. Aggravated by alcohol.
D. Worse in the morning, getting better as the day goes on.
E. Prodromal yawning and fatigue.
Balanitis xerotica obliterans
A. Has no effect on erection.
B. May cause spraying of urine.
C. On examination shows circumferential bluish-red scarring of the distal foreskin.
D. Initial treatment of choice is an anticandidal cream applied three-to-four times daily.
E. Has a very small risk of progression to malignancy.
A. Risk factors include low socioeconomic class.
B. Typical age at presentation is 10-to-15 years.
C. Affected child limps intermittently.
D. Is bilateral in 80 per cent of cases.
E. Expected recovery is better the younger the child is at presentation.
Barring contraindications, anti-depressants are first-line treatment for depressive episodes when
A. The depression is mild-to-moderate.
B. The patient has weight loss.
C. There is a history of positive response to medication.
D. CBT has not helped.
E. The symptoms, if severe enough, are not an understandable reaction to adverse circumstances.
elusive, though. “Choose a job you love and you’ll never have to work a day in your life” is one of the most readily falsifiable statements you’ll hear all week. Our lives are full of people working in an area they love, but who are utterly exhausted. “Choose a job you love, but keep a reasonable balance” takes you one step closer, but it’s still not quite right.
I think what my unfazed friend’s experience shows is that we also need to consider which pressures we can best manage. We may all have a vague understanding of what’s demanding and draining, but this actually means something different to everyone. For some of us, giving public health advice for a million people would be unbearably stressful. For me, bringing sharp metal objects near the temporal lobe would be a step too far.
It can take time and the grind of experience to find out which work builds us up and which wears us down. Sometimes, the dividing lines can be blurred. But if your dream job has pressures that are a lead weight around the waist, then your career won’t stay afloat.
Maybe, then, we need to bring a little more nuance to advice when speaking to the doctors of the future. Alongside being energised by something they love, they should have some sober thoughts about what stresses they can shoulder and when they’ll unwind. We can all tolerate some squeeze for a while, but then we need to relax.
E. TRUE. Though could still treat with anti-depressants if depression was an understandable reaction to adverse circumstances.
D. TRUE. In moderate cases consider medication at a follow-up visit if CBT/psychological therapies not helpful.
C. TRUE. Also if the patient requests medication.
B. TRUE. Or psychotic features or atypical features, such as overeating, oversleeping.
A. FALSE. Moderate or severe.
ANSWER 5
E. TRUE. And girls have worse prognosis than boys, probably because affected at a later age.
D. FALSE. Unilateral in 85 per cent of cases.
C. TRUE. Gradual onset of pain; range of hip movement reduced.
B. FALSE. Four-to-10 years.
A. TRUE. Also male sex, low birth weight.
ANSWER 4
E. TRUE. Is a form of lichen sclerosis.
D. FALSE. Is not caused by thrush.
C. FALSE. White scar.
A. FALSE. Makes them painful.
ANSWER 3
E. FALSE . In a person with migraine, prodromal symptoms may allow early treatment.
D. FALSE. Usually worse in the evenings when the patient is tired.
C. FALSE. May well be temporarily alleviated, unlike migraine, which may be aggravated.
B. FALSE. Or increased sensitivity to light or sound suggests migraine.
A. TRUE. Or a weight on the vertex are virtually diagnostic.
ANSWER 2
E. TRUE. Muscle necrosis may occur within two hours of the initial block, so the condition should be treated as an emergency.
D. TRUE. And pale with loss of pulses.
C. FALSE. This means the limb is no longer viable and amputation is inevitable.
B. FALSE. Normally there is sudden onset of severe pain.
A. TRUE. With thrombus in the left atrium, which embolises.
B. TRUE. And in later stages, urinary retention.
ANSWER 1
2 CPD Hours
Authors: Dr Patrick Owens and Prof Deborah McNamara
2 CPD Hours
Authors: Theresa Lowry-Lehnen GPN, RNP, PhD, Clinical Nurse Specialist and Associate Lecturer at IT Carlow. Member of the Irish General Practice Nurses Educational Association (IGPNEA)
2 CPD Hours
Authors: Dr Jayne Doherty, SpR in Gastroenterology, and Dr Garret Cullen, Consultant Gastroenterologist, Centre for Colorectal Disease, St Vincent’s University Hospital, Dublin
Accord Healthcare has announced the launch of another high-tech medicine to its already extensive range of high-tech medicines: Lenalidomide
Accord 5mg, 10mg, 15mg, 20mg and 25mg, which come in pack sizes of 21 hard capsules.
Accord Healthcare Ireland has teamed up with HealthBeacon to create an online portal for pharmacists to order and administer Lenalidomide. Pharmacists can register their pharmacy, review the risk management materials, complete the risk management paperwork and order Lenalidomide Accord via the HealthBeacon Lenalidomide portal. To register on the portal, visit www.patientsafetyhub.ie Once registered and logged in, demonstration videos explaining how to use the portal are also available.
Auditing requirements are the responsibility of Accord Healthcare Ireland.
Lenalidomide Accord is indicated for treatment of multiple myeloma
Lenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone, is indicated for the treatment of adult patients with previously un-
treated multiple myeloma who are not eligible for transplant. Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Myelodysplastic syndromes
Lenalidomide Accord as monotherapy is indicated for the treatment of adult patients with transfusion dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
Mantle cell lymphoma
Lenalidomide Accord as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Follicular lymphoma
Lenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).
Please refer to the Summary of Product Characteristics (SPC) for further information. The SPC is available at www.hpra. ie and for healthcare professionals at www.accord-healthcare.ie
For further information, contact Accord in Cork on 021 461 9040 or visit www. accord-healthcare.ie .
CYSTIC FIBROSIS IRELAND CALLS FOR INCREASED FUNDING FOR FERTILITY ASSESSMENT AND TREATMENT FOR PEOPLE LIVING WITH THE CONDITION
Cystic Fibrosis Ireland (CFI) is encouraging people to support 65 Roses Day on Friday 8 April by taking part in a 65 Roses Challenge, donating online at 65Roses.ie or by purchasing a purple rose in participating Dunnes Stores, shopping centres and other outlets nationwide.
This year, the annual fundraising flag day is
lesser-known side-effects of CF is infertility. Without IVF treatment many people with CF would never have the joy of starting a family of their own. CFI provided over €83,000 for fertility treatment to people with CF in Ireland in 2021 – we really need your support to provide similar funding in 2022.
“About one-quarter of adults with CF now have children of their own, but many cannot afford the IVF treatment to make the dream of having a family of their own a reality. Ireland remains one of the last countries in the European Union that does not
provide financial support towards IVF treatment, which can cost up to €12,000 and more. Please tell your TDs that the Government needs to support those that need fertility treatment in Ireland, including those with CF.”
The CFI fertility grant scheme provides financial support to people with CF and their respective partners wishing to undergo treatment. In 2021, some 33 couples received financial support for fertility assessment and treatment via the grant.
For further information visit www.65Roses.ie
A clinical trial conducted by researchers from RCSI University of Medicine and Health Sciences and Beaumont Hospital, Dublin, has indicated an effective treatment for critically ill Covid-19 patients.
The study published in Med investigates the effects of using an anti-inflammatory protein, alpha-1 antitryspin (AAT), to treat Covid-19 patients who have progressed to acute respiratory distress syndrome (ARDS).
ARDS is a highly inflammatory state hallmarked by airway damage, respiratory failure and increased risk of death. Treatment options for Covid-19 patients who have ARDS are particularly limited.
AAT is a naturally occurring human protein produced by the liver and released into the bloodstream which normally acts to protect the lungs from the destructive actions of common illnesses.
a potentially important role for AAT in the treatment of ARDS and other inflammatory diseases associated with Covid-19.
The study’s co-lead author, Dr Oliver McElvaney from the RCSI Department of Medicine and Beaumont Hospital, commented: “We know that patients who are critically ill with Covid-19 are more prone to developing severe inflammation throughout the body, with a disproportionately high rate of progression to ARDS and other serious respiratory issues. We think AAT might be able to provide some protection against the more harmful types of inflammation that arise in severe Covid-19 and other conditions with a similar inflammatory profile.”
to determine if new treatments are effective and safe in critically-ill patients with Covid-19. This study is the first Irish-led clinical trial of a medicine for Covid-19. The rationale for the study, its design and the recruitment of critically-ill patients was all carried out by researchers from RCSI, Beaumont Hospital and St James’s Hospital on patients here in Ireland.”
Prof Gerry McElvaney, RCSI Department of Med-
icine and Beaumont Hospital, and senior author on the paper, commented:
“These early results are encouraging, and will we hope form the basis for a larger trial to see how much of an effect reducing inflammation using AAT has on clinical outcomes such as mortality.”
The study was a collaboration between the RCSI University of Medicine and Health Sciences, Beaumont Hospital and St James’s Hospital.
HSE APPROVES ADTRALZA▼ (TRALOKINUMAB) FOR REIMBURSEMENT IN IRELAND FOR ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS WHO ARE CANDIDATES FOR SYSTEMIC THERAPY
LEO Pharma has welcomed news that the HSE has approved tralokinumab for reimbursement in Ireland via the high-tech scheme. This approval makes tralokinumab the first reimbursed biologic that specifically targets the IL-13 cytokine alone, a driver of atopic dermatitis signs and symptoms, for use within Ireland.
seeking to raise €350,000 to provide support and services for people with cystic fibrosis (CF), including funding for the CFI fertility grant scheme.
CFI is also pledging to provide €1 from every €10 raised from 65 Roses Day towards support for the estimated 1,000 people with CF in Ukraine.
CEO of CFI, Mr Philip Watt, said: “One of the
In this randomised controlled trial, AAT that had been purified from the blood of healthy donors was administered to patients with Covid-19-associated ARDS, with the aim of reducing inflammation.
The results indicated that treatment with AAT led to decreased inflammation after one week. The study also found the treatment was safe and well-tolerated and did not interfere with patients’ ability to generate their own protective response to Covid-19.
This discovery suggests
Ms Natalie McEvoy, Senior Clinical Research Nurse in the RCSI Department of Critical Care and Anaesthesia and Beaumont Hospital, and the paper’s co-lead author, commented: “This study is the first randomised control trial of AAT for acute respiratory distress syndrome, the first randomised control trial of AAT in the intensive care unit and the first such trial of a Covid-19 therapeutic in Ireland.”
Senior author on the paper, Prof Ger Curley from the RCSI Department of Anaesthetics and Critical Care and Beaumont Hospital, noted the national significance of the study: “It is only through clinical trials we will be able
Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Tralokinumab is available in a 150mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600mg followed by 300mg every other week. Tralokinumab can be used with or without topical corticosteroids (TCS).
“The HSE approval is a significant milestone for LEO Pharma, offering a new treatment option to help alleviate the unmet need for people living within atopic dermatitis in Ireland. We hope this approval will bring new optimism for those living with the condition. Thank you to all the LEO Pharma employees who have supported the approval process,” said Ms Sarah Kleinpeter, Vice President and General Manager for UK and Ireland at LEO Pharma.
“I am delighted that patients with moder -
ate-to-severe atopic dermatitis in Ireland will now have access to tralokinumab, an important new treatment option for these patients. Atopic dermatitis is much more than a skin condition, it can have a profound effect on the emotional and psychological wellbeing of patients, as well as on their physical health,” said Prof Alan Irvine, Consultant Dermatologist, School of Medicine, Trinity College Dublin.
The evidence supporting the efficacy and safety of tralokinumab comes from four randomised, multicentre, double-blind, placebo-controlled, phase III studies: ECZTRA 1, ECZTRA 2, ECZTRA 3 in patients with moderate-to-severe atopic dermatitis and ECZTRA 7 in patients with severe disease.
Tralokinumab was approved by the European Commission (EC) for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy in Europe and by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in June 2021. The MHRA and EC decisions are valid in the UK and all European Union Member States, Iceland, Norway, and Liechtenstein. Tralokinumab is also approved for use in Canada and the United Arab Emirates and was approved by the US Food and Drug Administration on 27 December 2021.
yperlipidaemia is characterised by an increase in one or more of the plasma lipids, including cholesterol, cholesterol esters, triglycerides, phospholipids and/or plasma lipoproteins including very low-density and low-density lipoprotein along with reduced high-density lipoprotein levels.1
Hyperlipidaemia, in particular elevated LDL cholesterol (low-density lipoprotein), is one of the most prevalent risk factors contributing to atherosclerosis and consequent vascular disease. In contrast, high-density lipoprotein (HDL) cholesterol assists in regulating cholesterol levels to prevent imbalances. Atherosclerosis is a pathologic process characterised by the accumulation of lipids, cholesterol and calcium and the development of fibrous plaques within the walls of large and medium arteries.
Hypercholesterolaemia and hypertriglyceridaemia are the main cause of atherosclerosis, which is strongly related to ischaemic heart disease (IHD).1,2 Atherosclerosis often remains asymptomatic until plaque stenosis reaches 70-to-80 per cent of the vessel's diameter. It originates after underlying endothelial damage occurs, which stems from loss of nitric oxide within the endothelium. This process leads to increased inflammation directly around the dysfunctional site, permitting the accumulation of lipids within the innermost layer of the endothelial wall. The lipids are
then engulfed by macrophages, leading to the establishment of 'foam cells' or debris.
Cholesterol build-up within the foam cells causes subsequent mitochondrial dysfunction, apoptosis, and necrosis of the underlying tissues. Smooth muscle cells encapsulate the pack of foam cells, which produces a fibrotic plaque that inhibits underlying lipids from being destroyed.2
Cholesterol is naturally produced within the body and can also be obtained from animal fats in food. Cholesterol is absent in plant-based foods, however, plant products such as flax seeds may contain cholesterol-like compounds called phytosterols which are beneficial in the body. Cholesterol is an essential substance in the body necessary for the production of cell structures and plasma membranes, energy expenditure and bile formation and it is important for the synthesis of steroids, hormones, vitamin D and other substances.3 Adults typically synthesise about 1g of cholesterol per day and the total body content is approximately 35g. The liver is the primary organ that synthesises cholesterol. About 20-to-25 per cent of total daily cholesterol production occurs in the liver. It is also synthesised to a smaller extent in the adrenal glands, intestines and reproductive organs. The predominant route of cholesterol elimination from the body is by excretion into the bile. Cholesterol from cells is transported from the plasma membranes of peripheral cells to the liver HDL-mediated pro-
cess termed reverse cholesterol transport.3
Major dietary sources of cholesterol include cheese, egg yolks, beef, pork, poultry, and shrimp. Saturated and trans saturated fats in food raise blood cholesterol. Saturated fats are present in full fat dairy products, animal fats, and several types of oil and chocolate. Trans saturated fats are present in hydrogenated oils, which are found in many fast and snack foods and fried or baked products.3
Hyperlipidaemia can be subdivided into two broad categories: primary (familial) or secondary (acquired). Familial hypercholesterolaemia (FH) is an inherited genetic defect that may lead to early development of atherosclerosis and IHD. Homozygous FH is rare; affecting 1:160,000 people, while heterozygous FH is more common; affecting approximately 1:250 people.4 Familial combined hyperlipidaemia may occur as
ing by a patient’s GP or general practice nurse conducting a cardiovascular risk assessment. Regularly, patients presenting with underlying hyperlipidaemia remain asymptomatic, therefore obtaining a thorough history is essential. It is important to assess a patient’s family history of cardiovascular disease, hyperlipidaemia, and/or familial hypercholesterolaemia, the patient’s diet and exercise habits, tobacco, alcohol or drug use, the presence of coronary artery disease (CAD), risk factors or history of CAD; and/or symptoms of peripheral arterial disease or angina.2
A focused physical exam is very important, including accurate blood pressure measurements, observing the patient's skin for xanthomas, listening for carotid and femoral bruits for evidence of stenosis, listening for an S4 heart sound, and palpating for intact peripheral pulses in all four extremities. Bloods including a lipid profile (fasting) will be carried out which routinely includes LDL, HDL, triglycerides and total cholesterol. Other blood tests may include LFTs, HbA1c and TFTs. Urinalysis can be collected to screen for albuminuria.2
The treatment of hyperlipidaemia involves both primary and secondary prevention. Primary prevention concerns people with high cholesterol at risk of CVD with comorbidities, such as high blood pressure, type 1 and 2 diabetes, or kidney disease, who do not yet have established CVD. Secondary prevention involves treating individuals with established CVD.4
The European Society of Cardiology and European Atherosclerosis Society (ESC/EAS) 2019 guidelines for the management of dyslipidaemia outline the risk categories and patient groups in each of these categories (Figure 1), and intervention strategies for primary and secondary prevention as a function of total cardiovascular risk and untreated low-density lipoprotein cholesterol levels.5
an interaction of multiple genes and the person’s environment, and occurs in 1:100 to 1:200 people. Secondary hyperlipidaemia accounts for up to 40 per cent of hyperlipidaemia cases and typically originates from an alternate aetiology, such as an unhealthy diet, medications including amiodarone, and glucocorticoids, hypothyroidism, uncontrolled diabetes, and/or a poor lifestyle.2,4
For most patients, hyperlipidaemia is polygenic and influenced by factors such as obesity, saturated fat intake and the cholesterol content within the person's diet. Another mechanism involves elevated levels of ‘apo B-100’ lipoproteins within the plasma, which may lead to atherosclerotic disease, even when the patient has no other risk factors. There is often a combination of genetic and environmental factors involved that contribute to a person's risk of developing hyperlipidaemia and cardiovascular disease.2
The diagnosis of hyperlipidaemia is often an incidental finding following a routine screen-
Initial treatment modalities are focused on diet and lifestyle modification, with the addition of lipid-lowering medications if needed. Patients with mild hyperlipidaemia and low CVD risk should focus on a low fat, low carbohydrate diet, and moderate to high-intensity physical activity. Heart health diets are low in saturated and trans fats, sodium, added sugars and refined grains. Weight loss and regular exercise do not result in significant LDL reduction; however, they play an important part in good cardiovascular health and are associated with reduced triglyceride levels. Smoking cessation, lowering blood pressure, and losing weight are beneficial to lowering vascular disease risk. For patients at moderate-to-high CVD risk, the above lifestyle modification applies and lipid-lowering statin medications should be added. There is a clear and proven benefit to statin therapy for the vast majority of patients from low-risk to high-risk, therefore these drugs' side-effects and costs should be weighed against the individual patient's potential benefit from taking the medication.2,6
The ESC/EAS 2019 guidelines for the management of dyslipidaemia also outline target plasma LDL cholesterol levels according to the patient’s risk level (Figure 2).4,5 Statins are associated with a 30-to-60 per cent reduction in LDL cholesterol; a reduction
The diagnosis of hyperlipidaemia is often an incidental finding following a routine screening by a patient’s GP or general practice nurse conducting a cardiovascular risk assessment
Continued from p23 ▸ of 20-to-40 per cent in triglyceride levels; and an increase in HDL cholesterol levels of approximately 3-to-12 per cent.4 Statins are the first-line pharmacological intervention for abnormal lipid profiles. They work by inhibition of the enzyme HMG-CoA reductase, which is involved in the production of mevalonic acid in the cholesterol biosynthesis pathway. By preventing the endogenous production of cholesterol, the expression of LDL receptors in liver cells is up-regulated, enhancing the clearance of the circulating LDL-C particles from the blood.6 Five statins are marketed for use in Ireland – atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin. Atorvastatin is the preferred statin for the treatment of hypercholesterolaemia and prevention of cardiovascular events under the HSE's Medicine Management Programme (MMP) guidance.6
The usual starting dose of atorvastatin is 10mg once daily, and the dose can be adjusted at intervals of four weeks or more to achieve the target LDL cholesterol level. In secondary prevention, 30mgs daily should be initiated after diagnosis.4
Prior to commencing cholesterol-lowering therapy, baseline cholesterol, LDL and HDL, and triglycerides must be measured. TFTs should also be checked and hypothyroidism treated if present before commencing cholesterol-reducing medication. LFTs should be measured and statins should not be commenced if liver transaminases are ≥3 times the upper normal limit.4
Ezetimibe, co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as an adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercho-
lesterolaemia who are not appropriately controlled with a statin alone.8 PCSK9 inhibitors, evolocumab and alirocumab, are monoclonal antibodies administered subcutaneously, which have shown an LDL cholesterol-reducing effect of up to 60 per cent when used alone and up to 70 per cent when used in conjunction with a statin. They can lower triglycerides by over 25 per cent. PCSK9 inhibitors are associated with reductions in the risk of heart attack and stroke. Evolocumab and alirocumab are both indicated for use in adults over the age of 18 years, and evolocumab is indicated for use in patients over the age of 12.4
Patient education and information regarding lifestyle modification and pharmacological therapy is the key to success for improved cholesterol control and to prevent complications. Weight management, proper diet, increased physical activity, and smoking cessation are important factors to address, to decrease cardiovascular risk. If pharmacological therapy is required, discussion of the risks and benefits of each medication should be explained to the patient before initiation. Primary care clinicians and pharmacists have a duty to educate the patient on medication compliance, side-effects, interactions, and overall risks versus the benefits of the medications prescribed. The patient must also understand the potential risks related to not taking the medication and what alternatives they may have as treatment options.
Potential statin medication complications include myopathy, renal injury, arthralgia, extremity pains, nausea, myalgia, elevated liver enzymes/hepatotoxicity, diarrhoea, and rhabdomyolysis. Up to 5-to-20 per cent of patients taking a
statin medication report experiencing a muscle-related intolerance. A lower dose of the statin should be tried or a transition to another lipid-lowering medication such as ezetimibe or a PCSK9 inhibitor such as evolocumab or alirocumab attempted. 2
Benefits and monitoring
Based on a 20-year follow up of the West of Scotland Coronary Prevention Study, patients who received statin therapy for five years demonstrated improved survival rates and a clinically significant reduction in CVD over the 20 year period. This data and numerous other studies and clinical trials have shown a significant cardiovascular risk reduction when statin therapy is used appropriately.7
Patients should be monitored regularly in practice to prevent hyperlipidaemia
progression and improve patient outcomes. Patients receiving lipid-lowering medications should be reviewed after three months of initiating treatment and then at least once yearly. In those receiving statin therapy, liver function needs to be assessed three months after commencing therapy and again at 12 months. Patients should be monitored for medication compliance, tolerance, adherence, and adverse effects. If hyperlipidaemia is left untreated or undertreated, the condition is progressive and can lead to severe CVD, which can be fatal.
1. Shattat, G. A review article on hyperlipidemia: Types, treatments, and new drug targets. Biomed Pharmacol J 2014; 7 (2)
2. Hill M, Bordoni B. (2021). Hyperlipidemia. StatPearls Publishing. Available from: www. ncbi.nlm.nih.gov/books/NBK559182/
3. Mandal A. (2019). Cholesterol Physiology. In News, Medical Life Sciences. Available at: www.news-medical.net/health/Cholesterol-Physiology.aspx
4. Bermingham M. (2022). Managing cholesterol in the community setting. Irish Pharmacy News. January 2022
5. ESC/EAS (2019). Guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk: The taskforce for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). European Heart Journal, Volume 41, Issue 1, 1 Jan 2020, Pages 111–188, https://doi. org/10.1093/eurheartj/ehz455
6. HSE (2020). Medicines Management Programme Preferred Drugs. Statin monotherapy for the treatment of hypercholesterolemia and prevention of cardiovascular events in adults. Health Service Executive. Available at: www. hse.ie/eng/about/who/cspd/ncps/medicines-management/latest-updates/statin-preferred-drug-report-july-2020.pdf
7. Ford I, Murray H, McCowan C, Packard C. Long-term safety and efficacy of lowering low-density lipoprotein cholesterol with statin therapy: 20-Year follow-up of West of Scotland coronary prevention study. Circulation. 2016 Mar 15; 133(11):1073-80
8. EMC (2022). Ezetimibe 10mg tablets. Medicines.org. UK. Available at www.medicines.org. uk/emc/product/8618/smpc#gref
Vyndaqel 61 mg is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)2
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. Refer to section 4.8 of the SmPC for how to report adverse reactions.
Vyndaqelq 61 mg soft capsules (tafamidis) Prescribing Information: Before prescribing Vyndaqel please refer to the full Summary of Product Characteristics. Presentation: Vyndaqel 61 mg soft capsules. Each soft capsule contains 61 mg tafamidis. Uses: Vyndaqel is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Dosage: Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. When there is a suspicion in patients presenting with specific medical history or signs of heart failure or cardiomyopathy, etiologic diagnosis must be done by a physician knowledgeable in the management of amyloidosis or cardiomyopathy to confirm ATTR-CM and exclude AL amyloidosis before starting Vyndaqel, using appropriate assessment tools such as: bone scintigraphy and blood/urine assessment, and/or histological assessment by biopsy, and transthyretin (TTR) genotyping to characterise as wild-type or hereditary. The recommended dose is one capsule of Vyndaqel 61 mg (tafamidis) orally once daily. Vyndaqel 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine, tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Vyndaqel should be started as early as possible in the disease course when the clinical benefit on disease progression could be more evident. Conversely, when amyoid-related cardiac damage is more advanced, such as in NYHA Class III, the decision to start or maintain treatment should be taken at the discretion of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. There are limited clinical data in patients with NYHA Class IV. If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible. If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual. There are no recommended dosage adjustments for elderly patients or patients with renal or mild and moderate hepatic impairment. Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min). Tafamidis has not been studied in patients with severe hepatic impairment and caution is recommended. There is no relevant use of tafamidis in the paediatric population. Method of Administration: The soft capsules should be swallowed whole and not crushed or cut. Vyndaqel may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1 of SPC. Warnings and Precautions: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis and for one month after stopping treatment. Tafamidis should be added to the standard of care for the treatment of patients with transthyretin amyloidosis. Physicians should monitor patients and continue to assess the need for other therapy, including the need for organ transplantation, as part of this standard of care. As there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued in patients who undergo organ transplantation. Increase in liver function tests and decrease in thyroxine may occur. This medicinal product contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose.
Further information available upon request.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Pregnancy and Lactation: Tafamidis is not recommended during pregnancy and in women of childbearing potential not using contraception. Available data in animals have shown excretion of tafamidis in milk. A risk to the newborns/infants cannot be excluded. Vyndaqel should not be used during breastfeeding. Interactions: In a clinical study in healthy volunteers, 20 mg tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4. In vitro tafamidis inhibits the efflux transporter BCRP (breast cancer resistant protein) at the 61 mg/day tafamidis dose with IC50=1.16 μM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib). In a clinical study in healthy participants, the exposure of the BCRP substrate rosuvastatin increased approximately 2-fold following multiple doses of Page 2 of 2 2020-0065522 61 mg tafamidis daily dosing. Likewise, tafamidis inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 μM and IC50=2.36 μM, respectively, and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine). Based on in vitro data, the maximal predicted changes in AUC of OAT1 and OAT3 substrates were determined to be less than 1.25 for the tafamidis 61 mg dose, therefore, inhibition of OAT1 or OAT3 transporters by tafamidis is not expected to result in clinically significant interactions. No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis. Undesirable Effects: The following adverse events were reported more often in 176 ATTR-CM patients treated with tafamidis meglumine 80 mg compared to placebo: flatulence [8 patients (4.5%) versus 3 patients (1.7%)] and liver function test increased [6 patients (3.4%) versus 2 patients (1.1%)]. A causal relationship has not been established. Safety data for tafamidis 61 mg are not available as this formulation was not evaluated in the double-blind, placebo-controlled, randomised phase 3 study. Legal category: S1A. Marketing Authorisation Numbers: EU/1/11/717/003– 61mg (30 capsules). Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at 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 4676500.
Last revised: 04/2021 q This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
Ref: VY 61MG 2_0
Hypercholesterolaemia is one of the principle modifiable risk factors for the development of coronary artery disease (CAD). Studies have consistently proven that low-density lipoprotein cholesterol (LDL-C), which is the principal lipoprotein transporting cholesterol in the bloodstream, is directly associated with the development of cardiovascular disease. Evidence for the pathogenic importance of serum cholesterol has largely been determined by randomised trials which have proven that reductions in total cholesterol and LDL-C levels reduce coronary events and mortality when used in the setting of both a primary and secondary preventative strategy. The mainstay of treatment in the reduction of LDL-C over the last number of decades has been statin therapy. The most frequently used currently-available statins include atorvastatin, rosuvastatin, simvastatin and pravastatin. These agents vary in their dosing and potency, but share the mechanism of action as competitive inhibitors of hydroxymethylglutaryl (HMG) CoA reductase, which is the rate-limiting step in cholesterol biosynthesis. They occupy a portion of the binding site of HMG CoA, which blocks access of the substrate to the active site on the enzyme. Although statins are the mainstay of treatment, this article will also outline lifestyle measures and other therapeutic options to reduce LDL-C.
Lifestyle measures
When high cholesterol levels are detected, initial recommendations to patients should centre around undertaking lifestyle modifications (particularly those with elevated LDL-C) in an effort to lower cholesterol levels. The HSE has published a list of recommendations which can help patients:
Eating a healthy and balanced diet that is low in saturated fat can help to lower cholesterol.
Smoking cessation is also recommended for general health, but alters cholesterol levels. High-density lipoprotein cholesterol (HDL-C) is often referred to as ‘good’ cholesterol because it helps to remove other forms of cholesterol from the bloodstream. Studies have shown that nicotine causes a decrease in HDL-C with a subsequent increase in LDL-C and also an increase in VLDL cholesterol, with an accumulation of lipids in the arterial wall.
Regular physical activity has also been shown to increase HDL-C while offsetting increases in LDL-C and triglycerides. At least 150 minutes of moderate-intensity exercise each week is the current HSE recommendation.
Guidelines also recommend that patients avoid excessive alcohol intake, and avoid binge drinking.
Lowering LDL as primary prevention
Evidence from randomised trials that evaluated the impact of lowering LDL-C has demonstrated a reduction in subsequent cardiovascular events in the short- and long-term, irrespective of the pre-therapy LDL-C level. Multiple meta-analyses have been performed to assess the effects of lipid-lowering therapy as a form of primary prevention. For example, a recent meta-analysis published in JAMA found that statin therapy was associated with decreased risk of all-cause mortality, cardiovascular mortality, stroke, and myocardial infarction (MI). Relative benefits appeared consistent in demographic and clinical subgroups, including populations without marked hyperlipidaemia. It was also concluded that greater absolute benefits occurred in patients who had a greater baseline risk. Therefore, recent meta-analyses have demonstrated that lowering LDL-C with statin therapy for primary prevention is effective at reducing cardiovascular disease (CVD) events such as MI and stroke (over a wide range of baseline LDL-C levels and lipid profiles).
However, despite the fact that there is a benefit from LDL-C lowering with statins at virtually all levels of cardiovascular risk, it is worthwhile to remember that medications come with side-effect burdens and cost, and these need to be reasonably balanced with the potential benefits. Our approach to decide when statin therapy should be recommended is often guided by the assessment of CVD risk. Patients with documented atherosclerotic CVD, familial hypercholesterolaemia (FH), type 1 or type 2 diabetes mellitus, or chronic kidney disease are gener-
ally considered to be at higher risk for the development of CVD.
Risk assessment systems have been developed to assist in quantifying an individual risk of developing CVD typically over the course of the next 10 years. The European Society of Cardiology (ESC) recently published an updated SCORE (Systematic Coronary Risk Estimation) system, which estimates the 10-year cumulative risk of a first fatal atherosclerotic event occurring, based on large European cohort data sets. Risk assessments have been produced for high- and lowrisk regions in Europe. Although these scores can provide a helpful guide, they should be used simply as one part of the overall decision making process.
Current ESC recommendations for treatment goals for LDL-C are as follows:
In individuals at low-risk, an LDL-C goal of <3.0mmol/L may be considered.
In individuals at moderate-risk, an LDL-C goal of <2.6mmol/L should be considered.
In individuals at high-risk, an LDL-C reduction of >50 per cent from baseline and an LDL-C goal of <1.8mmol/L are recommended.
In primary prevention for individuals at very high-risk (with or without known familial hypercholesterolaemia), an LDL-C reduction >50 per cent from baseline and an LDL-C goal of <1.4mmol/L are recommended.
In primary prevention when the decision is made to treat, treatment is usually commenced with a moderate dose of a statin such as atorvastatin 20mg or rosuvastatin 5-10mg.
Patients who have known CVD are at high-risk for future cardiovascular events. Therapy to reduce the risk of subsequent events is known as secondary prevention. LDL-C plays a key role in the pathogenesis and perpetuation of atherosclerotic CVD. For patients with known CVD (independent of the baseline LDL-C level), a meta-analysis of >40,000 patients concluded that treatment with a high-intensity statin is recommended (such as atorvastatin 40-80mg or rosuvastatin 20-40mg).
High-intensity statin therapy reduces the risk of non-fatal events, and likely also has a role in reducing mortality.
After the initiation of a high-intensity statin, LDL-C should be rechecked after six-to-eight weeks. For patients who have not achieved the expected 50 per cent reduction in LDL-C or if LDL-C remains >1.8mmol/L, possible non-adherence should be considered (given that non-adherence with statin therapy is quite frequent). If non-adherence is not an issue, at this point we consider the addition of a second medication to further lower the LDL-C. In most cases, when a second agent is required the most commonly used additional agent is ezetimibe.
Current ESC recommendations for treatment goals for LDL-C as secondary prevention are as follows:
In secondary prevention for patients at very high-risk, an LDL-C reduction of >50 per cent from baseline and an LDL-C goal of <1.4mmol/L are recommended
For patients with atherosclerotic CVD who experience a second vascular event within two years (not necessarily of the same ‘type’ as the first event) while taking maximally tolerated statin-based therapy, an LDL-C goal of <1.0mmol/L may be considered.
These are obviously aggressive targets and in reality can be difficult to achieve in the majority of patients without pushing to maximal statin dosing with additional agents. As we are aware, the likelihood of adverse effects grows substantially at these levels.
Patients who present with an acute coronary syndrome (ACS) are at an increased risk of experiencing recurrent cardiovascular events. LDL-C levels tend to decrease during the first days of ACS and therefore a lipid profile should be obtained as soon as possible after a patient is admitted with ACS. Initiation of a high-intensity statin is recommended (in patients previously taking a low- or moderate-intensity statin, dose should be optimised). Lipid profile should be rechecked in four-to-six weeks
and if treatment goals (LDL-C reduction of >50 per cent from baseline and LDL-C goal of <1.4mmol/L) are not achieved, then combination with ezetimibe is recommended. If the LDL-C goal is not achieved after another four-to-six weeks despite maximal tolerated statin therapy and ezetimibe, the addition of a PCSK9 inhibitor should be considered.
The mechanism by which lipid-lowering therapy is beneficial is incompletely understood. Mechanisms thought to be involved include the stabilisation of coronary plaques, reduction of inflammation, reversal of endothelial dysfunction and decreased thrombogenicity. Coronary artery plaque rupture is a central component in most patients who present with ACS. Patients may have plaque build-up in multiple coronary arteries. Therefore, intervention aimed only at the culprit lesion is not likely to be optimal and plaque stabilisation with statins has the potential to play a key role. Statin therapy is thought to maintain the integrity of the fibrous cap of plaque, thereby protecting against plaque rupture. This effect appears to be mediated by inhibition of macrophage proliferation, reduced expression of matrix metalloproteinases and tissue factor by macrophages (which promotes thrombus formation).
Familial hypercholesterolaemia
FH is a genetic condition caused by a mutation of one or more genes critical for LDL-C catabolism. It is the most common autosomal dominant genetic disorder. The syndrome is characterised by extremely elevated levels of LDL-C and a propensity to early-onset CVD. FH may be diagnosed if there is evidence of mutation in either the LDLR, PCSK9 or APOB genes (each of these genes influence LDL-C levels). In terms of presentation, previously undiagnosed heterozygous FH patients tend to present with symptoms or signs of CVD in early middle age. Many patients are identified by the detection of an LDL-C >90th percentile for their age and sex. When a patient is diagnosed with FH, all first-degree relatives should be advised to get routine bloods done to assess their lipid profiles. In terms of prevalence, homozygous patients are rare and have an estimated prevalence of 1:300,000 to 1:400:000 in the general population. A recent meta-analysis in 2020 involving more than seven million people found that the prevalence of heterozygous FH was 1:311 in the general population. This study also found that the prevalence of atherosclerotic CVD was 18fold higher in these patients, driven mainly by CAD.
Ezetimibe
Although statins are the first-line treatment for patients with hypercholesterolaemia, other agents are available (with varying levels of evidence for clinical benefits). In patients who do not achieve the targeted LDL-C reduction with statin monotherapy, or certainly in patients who are deemed statin intolerant, ezetimibe is the most common additional agent.
Ezetimibe inhibits intestinal uptake of dietary and biliary cholesterol at the level of the brush border of the intestine. Ezetimibe therefore reduces the amount of cholesterol, which is delivered to the liver via the bloodstream, by inhibiting cholesterol absorption. In response to reduced cholesterol delivery, the liver reacts by upregulating LDLR expression, which subsequently increases the clearance of LDL from the blood. A meta-analysis by Pandor et al including 2,722 cases showed an 18.58 per cent reduction in LDL-C in the ezetimibe monotherapy group verses placebo. The recommended dose of ezetimibe is 10mg/day.
Within the last decade, a new class of drugs called PCSK9 inhibitors have become available, which target a protein (PCSK9) involved in the control of the LDL receptor. Proprotein convertase subtilisin/kexin type 9 is an enzyme, which is produced in the liver. PCSK9 binds to the LDL receptor on the surface of hepatocytes, which leads to its degradation and increased LDL-C levels. Alirocumab and evolocumab are monoclonal antibodies that bind free plasma PCSK9, and hence act as
Ginkgo biloba is a traditional herbal medicinal product used to alleviate the symptoms of poor blood flow in conditions such as cold hands and feet. To get the desired effects, it is essential that you choose a product with a documented content of active compounds.
A thermo-graphic camera can be used to test ginkgo biloba's ability to improve circulation in the hands. When the test subject takes ginkgo biloba, their hands become significantly warmer in the minutes right after they have been cooled down in very cold water.
Your bloodstream carries oxygen and nutrients to every single part of your body – from head to toe – to ensure that all your body functions work properly. However, the flow of blood through the smallest capillaries can decrease for various reasons, and that may cause problems like cold fingers and toes.
Without Ginkgo-Biloba Pharma Nord:
After 10 minutes, the skin temperature increased from 12.6° to approx. 20.0° C.
With Ginkgo-Biloba Pharma Nord:
After 10 minutes, the skin temperature increased from 13.8° to approx. 30.9° C.
This problem may be a result of having poor blood circulation, and the solution could be tablets with ginkgo biloba.
Every inch of the body depends on a wellfunctioning blood supply that delivers oxygen and nutrients to the cells. As we humans age, our blood circulation becomes less efficient, leading to problems like cold hands and feet.
Supports your blood circulation
It stands to reason that ginkgo biloba is so popular among older people. The active compounds in the extract dilate your blood vessels, helping your blood to flow more easily through them.
What is ginkgo biloba?
Ginkgo biloba is a plant extract made from the leaves of ginkgo biloba, an ancient temple tree that is also known as maidenhair tree. The extract contains a variety of biologically active compounds. Two specific compounds – ginkgoflavone glycosides and terpene lactones – are particularly well-documented and have been shown to support good blood circulation and good cognitive function. Today, thanks to scientific research that has delved into
the underlying mechanisms of these active ingredients, it is possible to manufacture high-quality extracts that deliver the exact same amount of active compound with each tablet. Ginkgo-Biloba Pharma Nord represents this new generation of pharmaceutical-standard ginkgo biloba products that have become increasingly popular, namely among the elderly.
Ginkgo-Biloba Pharma Nord has a high content of active compounds: The high content of active compounds makes it possible to obtain the desired effect with 1 tablet twice a day.
Traditional herbal medicinal product used to alleviate the symptoms of poor blood flow in conditions such as cold hands and feet, exclusively based upon long-standing use. Always read the leaflet.
Continued from p26 ▸
PCSK9 inhibitors. The mechanism of action relates to the reduction of the plasma level of PCSK9, which in turn is not available to bind to the LDL receptor. Their use is associated with lower rates of MI and stroke. Alirocumab in addition to intensive statin therapy has the potential to reduce death after acute coronary syndrome, particularly if treatment if maintained for >three years.
PCSK9 monoclonal antibodies are approved for use in many parts of the world. They are highly effective at lowering LDL-C and are administered via a once-or-twice-monthly subcutaneous injection. The barrier to widespread use of these medica-
AGAINST LDL-C* IN THE TREATMENT OF HYPERCHOLESTEROLAEMIA
tions at this stage remains their high cost. Evolocumab was made available under the HSE High Tech Arrangement from July 1 2019. For a patient to qualify for reimbursement of evolocumab, their LDL-C must be persistently ≥4mmol/L. If the patient has a history of FH, they qualify for reimbursement if LDL-C is persistently elevated with or without known atherosclerotic cardiovascular disease. However, patients must have confirmed atherosclerotic CVD to qualify for reimbursement if they do not have a history of FH. Atherosclerotic CVD in this context is defined as a prior diagnosis of MI (with or without revascularisation procedures) or having undergone coronary artery bypass grafting.
When an application for reimbursement is made, two
LDL-C levels must be provided to demonstrate that the LDL-C is persistently above the threshold. The current level must be taken within 30 days of the application for PCSK9 reimbursement. The other level must be taken within the previous three-to-six months.
For patients to meet the criteria for PCSK9 reimbursement, elevated LDL-C level must be reflective of:
Adherence to treatment with optimised lipid-lowering therapy for a minimum of three months; or
Statin intolerance; or
Contra-indication to statin therapy.
Optimised lipid-lowering therapy is defined as confirmed adherence for a minimum of three months to treatment with ezetimibe 10mg daily, and atorvastatin ≥ 40mg daily or rosuvastatin ≥ 20mg daily.
If the patient qualifies for reimbursement, the dose of evolocumab is 140mg every two weeks. Reimbursement is supported for a maximum of 26 evolocumab 140mg pre-filled pens per year.
Reimbursement for evolocumab is not considered in certain patients who meet exclusion criteria. The following listing gives some examples, but is not exhaustive:
Patients with NYHA Class 3 or 4 symptoms, or those with known LVEF of <30 per cent.
Patients with uncontrolled hypertension (defined as sitting systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg).
Patients with untreated (or inadequately treated) hyperthyroidism or hypothyroidism, as defined by thyroid stimulating hormone less than the lower limit of normal or greater than 1.5 times the upper limit of normal, or free T4 levels that are outside the normal range.
Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia1
and 40mg/10mg: Each film-coated tablet contains 10mg; 20mg or 40mg of rosuvastatin (as rosuvastatin calcium) respectively, and 10mg ezetimibe. Indication: Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia. Dosage and Administration: The patient should be on and continue, an appropriate lipid-lowering diet, during treatment with Suvezen. Suvezen is not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. The recommended dose is one Suvezen tablet daily. To be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water. If co-administered with bile acid sequestrant (BAS), administration of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a BAS. Special populations: Paediatric (<18 years): Safety and efficacy has not been established. Elderly (>70 years): Starting dose of 5 mg rosuvastatin is recommended. The combination is not suitable for initial therapy. Hepatic impairment: Mild: No dosage adjustment is required. Moderate/Severe: Treatment with Suvezen is not recommended. Renal impairment: Mild: No dose adjustment is necessary. Moderate (creatinine clearance <60 ml/ min): The recommended start dose is rosuvastatin 5mg. Race: The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry due to increased systemic exposure. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Suvezen 40 mg/10 mg tablets are contraindicated in these patients. Genetic polymorphisms: In patients who are known to have specific types of genetic polymorphisms that can lead to increased rosuvastatin exposure, a lower daily dose of Suvezen is recommended. Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5mg in patients with pre-disposing factors to myopathy. Suvezen 40 mg/10 mg tablets are contraindicated in some of these patients. Concomitant therapy: The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir). Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where co-administration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered. Contraindications: Hypersensitivity to the active substances or excipients.
Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures. Active liver disease or any serum transaminase elevations which are unexplained, persistent or exceeding 3x the upper limit of normal (ULN). Severe renal impairment (creatinine clearance <30ml/min); myopathy or receiving concomitant ciclosporin. 40mg/10mg dose contraindicated in patients with predisposing factors for myopathy/rhabdomyolysis; such factors include: Moderate renal impairment (creatinine clearance <60ml/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels of rosuvastatin may occur, Asian patients, concomitant use of fibrates.
Precautions and Warnings: Skeletal muscle effects: have been reported in rosuvastatin-treated patients with all doses and in particular with doses >20mg. As with other HMG-CoA reductase inhibitors, reporting rate for rhabdomyolysis is associated with use at doses >40mg. Post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. If myopathy is suspected based on muscle symptoms or is confirmed by a creatine phosphokinase (CPK) level, Suvezen and any of these other agents that the patient is taking concomitantly should be immediately discontinued. All patients starting therapy with Suvezen should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, particularly if associated with malaise or fever. Creatine kinase (CK) measurement: CK should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase. If CK levels are significantly elevated at baseline (>5x ULN) a confirmatory test should be carried out within 5 – 7 days. If the repeat test confirms a baseline CK >5x ULN, treatment should not be started. Patients with predisposing factors for myopathy/rhabdomyolysis: Caution should be exercised in these patients. Risk: benefit of treatment should be considered and clinical monitoring is recommended. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5x ULN) or if muscular symptoms are severe and cause daily discomfort. If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing treatment at the lowest dose. Immune-mediated necrotising myopathy (IMNM): Clinically characterised by proximal muscle weakness and elevated serum CK, has been reported very rarely during or after treatment with statins, including rosuvastatin, despite discontinuation of statin treatment. In clinical trials an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives. Suvezen should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Liver effects: In controlled co-administration trials in patients receiving ezetimibe with statin, consecutive transaminase elevations ≥3x ULN have been observed. It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminases is >3x ULN. The reporting rate for serious events is higher at the 40mg dose. In patients with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome, the underlying disease should be treated prior to initiating therapy with rosuvastatin. Liver disease and alcohol: As with other
Single-pill combination of rosuvastatin and ezetimibe available in 3 doses*
HMG-CoA reductase inhibitors, rosuvastatin should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. Renal effects: Proteinuria has been observed in patients treated with higher doses of rosuvastatin and was transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40mg. Diabetes mellitus: Some evidence suggests that statins raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (fasting glucose 5.6 – 6.9mmol/l, BMI >30kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. Interstitial lung disease: Exceptional cases have been reported with some statins, especially with long term therapy. Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected, statin therapy should be discontinued. Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors in combination with ritonavir. Consideration should be given both to the benefit of lipid lowering by use of Suvezen in HIV patients receiving protease inhibitors and the potential for increased rosuvastatin plasma concentrations when initiating and up titrating rosuvastatin doses in patients treated with protease inhibitors. The concomitant use with certain protease inhibitors is not recommended unless the dose of rosuvastatin is adjusted. Fibrates: The safety and efficacy of ezetimibe administered with fibrates have not been established. If cholelithiasis is suspected in a patient receiving Suvezen and fenofibrate, gallbladder investigations are indicated and therapy should be discontinued. Anticoagulants: If Suvezen is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalised Ratio (INR) should be appropriately monitored.
Fusidic acid: Suvezen must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination.
The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of fusidic acid. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e.g., for the treatment of severe infections, the need for co-administration of Suvezen and fusidic acid should only be considered on a case by case basis and under close medical supervision. Suvezen contains lactose monohydrate and sodium: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Interactions: Contraindicated combinations: Ciclosporin. Not-recommended combinations: Fibrates and other lipid-lowering products, protease inhibitors, transporter protein inhibitors and fusidic acid. Other possible interactions: Cytochrome P450 enzymes, antacids, colestyramine, anticoagulants, Vitamin K antagonists, erythromycin, oral contraceptive/hormone replacement therapy. When co-administering rosuvastatin with other medicinal products known to increase exposure to rosuvastatin, doses should be adjusted (see SmPC for full details). The maximum daily dose should be adjusted so that the expected rosuvastatin exposure would not likely exceed that of a 40mg daily dose of rosuvastatin taken without interacting medicinal products. Fertility, Pregnancy and Breastfeeding: No clinical data are available on the use of ezetimibe during pregnancy. Potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. If a patient becomes pregnant during use of Suvezen, treatment should be discontinued immediately. Animal studies have shown excretion of medicinal product through breast milk. However, there are no data in humans. No clinical trial data on the effects of fertility in humans. Adverse Reactions: Adverse drug reactions previously reported with one of the individual components (ezetimibe or rosuvastatin) may be potential undesirable effects with Suvezen. Common (≥1/100 to <1/10): diabetes mellitus, headache, dizziness, constipation, nausea, abdominal pain, diarrhoea, flatulence, myalgia, ALT and/or AST increased, asthenia and fatigue. Uncommon (≥1/1,000 to <1/100): decreased appetite, paraesthesia, hot flush, hypertension, cough, dyspepsia, gastroesophageal reflux disease, nausea, dry mouth, gastritis, pruritus, rash, urticaria, arthralgia, muscle spasms, neck pain, back pain, muscular weakness, pain in extremity, ALT and/or AST increased, blood CPK increased, gamma-glutamyltransferase increased, liver function test abnormal, chest pain, pain, asthenia, oedema peripheral. Rare (≥1/10,000 to <1/1,000): thrombocytopenia, hypersensitivity reactions including angioedema, pancreatitis, increased hepatic transaminases, myopathy (including myositis), rhabdomyolysis, lupus-like syndrome and muscle rupture. Very rare (<1/10,000): polyneuropathy, memory loss, jaundice, hepatitis, arthralgia, haematuria, gynaecomastia. Not known: thrombocytopenia, hypersensitivity (including rash, urticaria, anaphylaxis and angioedema), depression, peripheral neuropathy, sleep disturbances (including insomnia and nightmares), dizziness, paraesthesia, cough, dyspnoea, diarrhoea, pancreatitis, constipation, hepatitis, cholelithiasis, cholecystitis, Stevens Johnson syndrome, erythema multiforme, immune-mediated necrotising myopathy, tendon disorders (sometimes complicated by rupture), myalgia, myopathy/rhabdomyolysis, oedema, asthenia. See SmPC for full
Patients with active liver disease or hepatic dysfunction (defined as aspartate aminotransferase or alanine aminotransferase >three times the upper limit of normal)
Patients with creatinine kinase levels greater than five times the upper limit of normal.
Summary
All patients who have an elevated LDL-C should be counselled on lifestyle measures. Eating a healthy and balanced diet, reducing alcohol intake, smoking cessation, and regular physical activity are all lifestyle measures that should be adhered to when a patient is diagnosed with hypercholesterolaemia.
Our approach to decide when statin therapy should be recommended is often guided by the assessment of cardiovascular disease risk.
LDL-C targets are largely determined by the overall cardiovascular risk.
In primary prevention when the decision is made to treat, treatment is usually commenced with a moderate dose of a statin such as atorvastatin 20mg or rosuvastatin 10mg.
For patients with known CVD (independent of LDL-C level), lifelong high-intensity statin therapy is recommended. Examples include atorvastatin 40-80mg or rosuvastatin 20-40mg.
In secondary prevention for patients at very high-risk, an LDL-C reduction of >50 per cent from baseline and an LDL-C goal of <1.4mmol/L are recommended.
FH is an autosomal dominant syndrome, which is characterised by extremely elevated levels of LDL-C and a propensity to early-onset cardiovascular disease.
FH may be diagnosed if there is evidence of mutation in either the LDLR, PCSK9 or APOB genes.
In patients who do not achieve the targeted LDL-C reduction with statin monotherapy, or with statin intolerance, ezetimibe is the most common additional agent.
In ACS, if LDL-C reduction of >50 per cent from baseline and LDL-C goal of <1.4mmol/L are not achieved after four-to-six weeks, then combination with ezetimibe is recommended.
PCSK9 inhibitors are a recent development in terms of lowering LDL-C. Alirocumab and evolocumab are monoclonal antibodies that bind free plasma PCSK9, and hence act as PCSK9 inhibitors.
There are various criteria which need to be met for reimbursement to be considered for PCSK9 inhibitors.
References on request
Abbreviated Prescribing Information: Ranexa (ranolazine). Please consult the Summary of Product Characteristics (SPC) for full prescribing information. Presentation: Prolonged-release tablets containing 375 mg, 500 mg or 750 mg of ranolazine. 750 mg tablet contains E102 and lactose. Use: Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). Dosage and administration: Oral administration. Patients should be instructed to list their medication to their health care professional at each visit. Adults: Initial dose is 375 mg twice daily. After 2-4 weeks, dose should be titrated to 500 mg twice daily and, according to patient’s response, further titrated to 750 mg twice daily. Concomitant treatment with moderate CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended. Renal impairment: Careful dose titration is recommended in mild to moderate renal impairment, and contraindicated in severe renal impairment. Hepatic impairment: Careful dose titration is recommended in mild hepatic impairment, and contraindicated in moderate to severe hepatic impairment. Elderly: Dose titration in the elderly should be exercised with caution. Low weight: Dose titration in patients with low weight should be exercised with caution. Congestive Heart Failure (CHF): Dose titration in moderate to severe CHF should be exercised with caution. Paediatric patients: No data in children below the age of 18 years. Ranexa tablets should be swallowed whole and not crushed, broken or chewed. They may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Severe renal impairment. Moderate or severe hepatic impairment. Concomitant administration of potent CYP3A4 inhibitors. Concomitant administration of Class Ia or Class III antiarrhythmics other than amiodarone. Warnings and Precautions: Caution should be exercised when prescribing or up titrating ranolazine to patients in whom an increased exposure is expected. QT prolongation: Caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval. Interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy.
Renal impairment: Check renal function at regular intervals during treatment. Interactions: CYP3A4 inhibitors: Increase plasma concentrations of ranolazine. Combining ranolazine with potent CYP3A4 inhibitors is contraindicated. CYP3A4 inducers: Avoid initiation with Ranexa during administration of CYP3A4 inducers. CYP2D6 inhibitors: May increase plasma concentrations of ranolazine. Effect of ranolazine on other medicinal products: Dosage adjustment of sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range may be required. Lower doses of CYP2D6 substrates may be required. Caution with CYP2B6 substrates. Monitor digoxin levels following initiation and termination of Ranexa. Limit dose of simvastatin to 20mg once daily in patients taking Ranexa. Limit dose of atorvastatin and consider clinical monitoring in patients taking Ranexa. Monitor blood levels of tacrolimus when coadministering with Ranexa and adjust tacrolimus dose accordingly. Also recommended for other CYP3A4 substrates with a narrow therapeutic range. Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin increased in subjects with type 2 diabetes mellitus when co-administered with Ranexa. The exposure of other OCT2 substrates may also be affected. Theoretical risk that concomitant treatment with drugs known to prolong the QTc interval may increase the possible risk of ventricular arrhythmias. Pregnancy and lactation: Ranexa should not be used during pregnancy unless clearly necessary. Ranexa should not be used during breast-feeding. Effect on fertility unknown. Side-effects: Generally mild to moderate in severity and often develop within the first 2 weeks of treatment. Common (1-10%): dizziness, headache, constipation, vomiting, nausea, asthenia. Uncommon (0.1–1%): anorexia, decreased appetite, dehydration, anxiety, insomnia, confusional state, hallucination, lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paraesthesia, blurred vision, visual disturbance, diplopia, vertigo, tinnitus, hot flush, hypotension, dyspnoea, cough, epistaxis, abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort, pruritus, hyperhydrosis, pain in extremity, muscle cramp, joint swelling, muscular weakness, dysuria, haematuria, chromaturia, fatigue, peripheral oedema, increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight. In a long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients. Rare (0.1-0.01%): hyponatremia, disorientation, amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia, impaired hearing, peripheral coldness, orthostatic hypotension, throat tightness, pancreatitis, erosive duodenitis, oral hypoaesthesia, angioedema, allergic dermatitis, urticaria, cold sweat, rash, acute renal failure, urinary retention, erectile dysfunction, elevated levels of hepatic enzyme. Not known: myoclonus. Increased incidence of congestive heart failure and transient ischaemic attacks seen in patients with history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention and treated within 2 weeks with ranolazine (1000 mg twice daily [dose not approved in Europe]) in a placebo-controlled post-PCI trial. Elderly, renal impairment and low weight: In general, adverse events occurred more frequently among elderly patients and patients with renal impairment. Adverse events in patients with low body weight were similar to those of patients with higher weight. Please consult the SPC for further information.Pack size: 60 tablets. Legal category: POM. Marketing authorisation numbers: EU/1/08/462/001, 003, 005 Marketing Authorisation holder: Menarini International Operations Luxembourg S.A. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SPC. Last updated: October 2020
Date of item: November 2020. IR-RAN-12-2020
References: 1. Chaitman, B.R., et al. JAMA, 2004; 291(3): p. 309-16.
Primary Care Dermatology Society of Ireland, Annual Meeting, 4-5 March 2022
Benign lesions are one of the most common skin presentations in primary care and can be mostly dealt with locally, but knowing when to refer for further investigation is vital, the 2022 Primary Care Dermatology Society of Ireland (PCDSI) Annual Meeting heard.
During his presentation to the meeting, Dr David Buckley, PCDSI co-founder and Medical Director of
the Kerry Skin Clinic, discussed the 10 most common benign lesions in primary care, of which benign moles, viral warts, molluscum contagiosum, and seborrhoeic keratosis are the four “big ones”.
“These are the most common benign lesions that we see pretty much every day in general practice,” said Dr Buckley.
When a practitioner cannot make a complete, competent and named diagnosis, “then that lesion is by definition sus-
picious,” Dr Buckley said.
In this case, he advised considering referral of the patient to a colleague with more experience in dermatology as the patient may require a biopsy.
✓ IBUGEL has been proven to be as effective as 400 mg ibuprofen tablets t.i.d. (1200mg) in soft tissue injuries.1
✓ IBUGEL has been shown to achieve up to 4 times greater skin penetration compared to other contemporary 5% ibuprofen gel formulations.2
Prescribe ALL REPORTS NIAMH QUINLAN
Uses: For backache, rheumatic and muscular pain, sprains, strains and neuralgia. Also for relief of pain due to non-serious arthritic conditions.
Directions: Adults, the elderly and children over 12 years (only on medical advice if under 12 years). Gently massage into and around the affected areas until absorbed, up to 3 times daily. Do not use excessively. Contra-indications, warnings, side effects etc: Please refer to SPC for full details before prescribing. Do not use on broken skin, during pregnancy or lactation, or if sensitive to any of the ingredients, particularly in patients with asthma known to be hypersensitive to aspirin or other NSAIDs. Susceptible patients may experience hypersensitivity, renal impairment and gastrointestinal side effects. Concurrent use of NSAID tablets including aspirin may increase possibility of side-effects. This product should not be used with occlusive dressings. Mild skin rashes, itching or irritation and photosensitivity reactions at the site of application, frequency unknown. Keep away from eyes and mucous membranes. Package quantity, trade price and MA number: 100g tube, €8.29, PA23128/011/001.
Legal category: Prescription only, PCRS Code: 28862.
Further information is available from: Dermal Laboratories (Ireland) Ltd,
Head Office Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. Date of preparation: June 2021. ‘Ibugel’ is a trademark.
References: 1. Whitefield M. et al. Comparative efficacy of a proprietary topical ibuprofen gel and oral ibuprofen in acute soft tissue injuries: a randomized, double-blind study. Journal of Clinical Pharmacy and Therapeutics; Vol 27, No. 6, December 2002. 2. Hadgraft J, Whitefield M, Rosher P.H. Skin penetration of topical formulations of ibuprofen 5%: An in vitro comparative study. Skin Pharmacology and Applied Skin Physiology. 2003; 16: 137-142.
www.dermal.ie
Over 55 years’ experience in topical formulations.
“It’s having the confidence of diagnosing the common benign skin conditions and then having the knowledge that if you can’t recognise lesions, you can’t put a name on it and you’re not quite sure, then it’s probably malignant until proven otherwise,” he continued. “Especially in adults and in the elderly.”
Dr David Buckley
When a patient has symptoms that seem not severe enough to warrant a hospital referral, GPs may refer the patient to their colleagues who have a special interest in dermatology. This model is replicated in England, Australia, and other countries, according to Dr Buckley.
“And that model has never been formalised [in Ireland],” he added, “but perhaps it should be encouraged, supported, and funded.”
One example of this is dermatoscopy and the use of a dermatoscope (a hand-held magnifying device used to visualise features of pigmented and non-pigmented skin lesions) in primary care. While it is not available to every GP in Ireland, “hopefully in every region or town there might be one GP who has an interest and experience within dermatoscopy,” Dr Buckley commented.
Dermatoscopy is no longer optional “for anyone who has an interest in dermatology, especially in lesion recognition, and particularly if they’re going to be treating… low-risk skin cancer”, said Dr Buckley. “In my view it is compulsory.”
After conducting a dermatoscopy or taking a focused history from a patient where there has not been a change in size, shape and colour, the mole can be defined as benign.
Dr Buckley said clinicians should be “highly suspicious” of new moles developing when a patient is over the age of 40. He also recommended using a handout (Warning signs to look for in a mole) to visually show patients how to detect a change in mole size, shape, and colour, available on the Kerry Skin Clinic website (www.kerryskinclinic.ie).
For warts, treatment options included topical salicylic acid, cantharidin, cryosurgery, “traditional cures/placebos” or no treatment. “Probably the treatment of choice in children is no treatment at all because the vast majority of warts in children go away anyway,” he said.
However, in elderly patients, “the index of suspicion goes up if there’s an isolated warty-lesions or a warty lesion on an unusual location, like the face.”
Molluscum contagiosum is very common in children and “again, treatment in children is to do nothing”, as the lesion tends to clear after a few months. The lesion is associated with dry skin, so applying a “greasy moisturiser” twice daily for about three months can help.
Seborrhoeic keratosis is more common in older patients and can be treated with cryosurgery or by scraping the skin. “Everything we scrape, we send for biopsy,” said Dr Buckley. “You have to be sure of your clinical diagnosis.”
The other most common benign skin lesions are dermatofibroma, pyogenic granuloma, sebaceous cyst, skin tags, sebaceous gland hyperplasia, and haemangiomas.
Dr Buckley also highlighted the importance of context when identifying a benign skin lesion, including age, gender, location on the body and family history.
“I think more and more GPs are left dealing with skin problems because of [issues] accessing hospital-based dermatologists, both privately and publicly,” said Dr Buckley. “The vast majority of skin problems we see in primary care can be managed… in primary care, [if] the GP has the knowledge and the skills and the experience. And hopefully, the book will help them to build on their knowledge and skills.”
Dr Buckley published his Textbook of Primary Care Dermatology late last year, and formally launched it at the PCDSI meeting, which aims to further educate and upskill healthcare professionals in primary care and help them to become more comfortable and confident in dermatology. Dr Paula Pasquali, Consultant Dermatologist in Pius Hospital de Valls, Tarragona, Spain, aided Dr Buckley in writing the textbook.
“It’s very useful to have both the GP and the consult-
ant dermatologist involved because you get to see it from both points of view,” Dr Buckley said. He praised Dr Pasquali as “an excellent person to work with” and “very helpful”.
A textbook written specifically for GPs, it fills “that gap of dealing with common dermatology problems as they would present in mild and moderate fashion to GPs”, with helpful flow charts, tables, and diagrams for practitioners to refer to easily and as needed. Dr Buckley highlighted that the information in the textbook can also be useful for nurses, pharmacists, students, trainees, and allied healthcare professionals working in primary care.
“[Dermatology] makes up a large part of a GP’s workload…, yet it’s kind of grossly neglected in both undergraduate and postgraduate training,” said Dr Buckley. “So again this will hopefully address that imbalance.”
“The demand for skin, hair, and nails [care] is ever increasing but hopefully so are the skills of GPs,” Dr Buckley added, “and maybe they could manage more and more skin problems in primary care, then obviously that would free up the dermatology clinics for looking after people with very severe or refractory skin conditions that we can’t manage in primary care.”
Although there are side-effects to cryosurgery, practitioners should not be deterred from using the technique, as it is a quick and successful treatment for a broad range of skin lesions, the 2022 PCDSI Annual Meeting heard.
Dr Paula Pasquali, Consultant Dermatologist, Pius Hospital de Valls, Tarragona, Spain, spoke about expectations in cryosurgery, possible side-effects and how to avoid them. “I think that every surgical procedure [can have] complications,” said Dr Pasquali. “And that you should be aware of them.”
Communication with patients is important, to inform them of issues with hyper- or hypo-pigmentation, and any scarring or pain that may occur.
“Depressed scars can happen especially and mostly when you do cryosurgery that are very deep. This happens if you’re
treating skin cancer,” said Dr Pasquali. The hair follicle can also be destroyed in this instance and hair will no longer grow in the area.
Cryosurgery can be painful, it should be acknowledged. “When you do cryosurgery, you have a first peak of pain and then it starts coming down. And then suddenly, you have a second peak,” Dr Pasquali said. If a patient is sent out of the office before the second peak of pain has occurred, there is a risk of a patient fainting later on.
Liquid nitrogen spattering can contribute to pain and other complications.
Performing cryosurgery around the eye may result in liquid nitrogen spraying into the conjunctiva so caution and care are needed. “It usually heals very well,” Dr Pasquali added. She recommended protecting the eye using
a plastic or wooden piece.
There is also a risk of insufflation of the subcutaneous tissue, where liquid nitrogen spray can get under the skin tissue after a lesion has been curetted. This is harmless and can be identified by a “crunching” noise under the skin, which can alarm patients.
Dr Pasquali recommended using a probe or a rubber cone to “fix it on the area very closely so that you seal around the area, and then you can freeze”.
After curetting a lesion and performing cryosurgery, Dr Pasquali advised to let the site thaw fully before letting a patient leave, as bleeding can occur afterwards.
Other common after-effects that can occur after cryosurgery include oedema, bullae, and mummification of the lesion.
Genital psoriasis often goes under-reported and under treated in primary care, the 2022 PCDSI Annual Meeting heard.
HSE National Clinical Lead for Dermatology Prof Anne Marie Tobin, Consultant Dermatologist, Tallaght University Hospital, spoke about diagnosis and treatment of psoriasis in primary care, including more unusual sites.
She said GPs should recognise that genital psoriasis “can have a significant impact on their [patients’] quality-of-life". She also recommended that when a patient presents with scalp psoriasis, to “always remember to ask: ‘Do you have psoriasis anywhere else?’ And ‘do you have it in your groin?’”. It can be treated with “mild-mid” potency steroids, such
as hydrocortisone or clobetasone (Eumovate), the latter of which she would start with.
Prof Tobin also covered psoriasis of the scalp and the need to descale using an emollient before applying a potent topical steroid.
She also spoke about palmo-plantar psoriasis, marked by thickening of the skin with erythema, which can cause fissuring. This should be treated with “thick, greasy emollients” to prevent cracking. Prof Tobin noted that palmo-plantar psoriasis “is difficult to treat with topical treatment and often patients will require treatments in secondary care”.
Nail psoriasis causes lifting of the distal nail plate, and where nail psoriasis is aggressive, a fungal infection is “very common”, Prof Tobin added. Psoriasis at the nail site
Education on dermatology not only aids primary care practices, but also secondary care, according to Clare GP and committee member of the PCDSI, Dr Finbar Fitzpatrick.
The PCDSI’s Annual Meeting took place virtually (4-5 March) with over 200 attendees logging in to access presentations from leading national and international dermatology experts on a wide range of topics. However, the PCDSI Annual Meeting 2023 is set to go ahead in person. “At this stage in the post-Covid environment we’re missing a little bit of the human interaction to keep the society thriving,” Dr Fitzpatrick said. “And there is an educational element that you get from meeting in person that you don’t get online. So we’re looking forward to having that in addition to the education next year.”
When asked about the importance of healthcare profes-
sionals in primary care being able to properly diagnose and treat dermatological issues, Dr Fitzpatrick highlighted that 10 per cent of presentations in general practice involve “some dermatology or skin disease”, which rises to 20 or 30 per cent if that GP has a special interest in dermatology.
“There [are] also occasionally inappropriate referrals to secondary care for skin conditions that could be very easily managed in general practice,” he added. “There’s a lot of
can be aided by keeping the nails clipped short and treated by a clobetasol propionate (Dermovate) or Betnovate scalp application overnight or Xamiol gel for two days a week for six months.
Dr Tobin also highlighted the importance of informing patients that “psoriasis isn’t curable, but it can be controlled and we can control it so it has minimal impact on your life”.
“All patients with psoriasis should use an emollient,” she added. “It reduces the scaling and the fissuring of the cracks. Because when the cracks fissure, they’re incredibly painful and itchy.”
In a separate presentation at the meeting, Prof Tobin spoke about rashes involving the flexures and their treatment in primary care.
very common skin conditions that are most appropriately managed in general practice. We’re trying to improve education on that front.”
Similarly, the PCDSI is aiming to improve recognition of rarer conditions so that those are referred on appropriately to secondary care with a clarification on the likely diagnosis.
“There is difficulty accessing secondary care, publicly, primarily and to an extent privately,” said Dr Fitzpatrick. He added this can cause issues regarding waiting lists for issues that do require secondary care.
“It’s really educating in dermatology and primary care that improves the quality of care in general practice and also improves the rate of appropriate referrals to secondary care.”
Dr Fitzpatrick also highlighted the high standard of primary care in Ireland when compared internationally.
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
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
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 EU
Primary Care Dermatology Society of Ireland, Annual Meeting, 4-5 March 2022
During the PCDSI 2022 Annual Meeting, Dr Alana Durack, Consultant Dermatologist, University Hospital Waterford, gave her “pearls of wisdom” for encountering bacterial skin infection in primary care.
“Common things are common,” said Dr Durack. “But it’s important to swab so you’ve got something to back up if the antibiotics aren’t working or the patient’s not getting better.”
For example, with an impetigo, a superficial skin infection that occurs in bullous and non-bullous form, the latter of which can form a crust. “When there’s a lot of crusting it’s very easy to miss an underlying [herpes simplex virus] HSV infection,” said Dr Durack. “With those kind of things I think it’s always sensible to think about taking a swab for HSV as well as bacterial swab.”
Her second pearl was about the importance of considering underlying viral infections, including HSV and
varicella zoster virus (VZV), using the “red swabs” when conducting PCR tests.
“Give the full clinical details on the request to microbiology,” she advised. “The more information you give, the better advice that you get back.” She advised including details like where on the body the sample is from, if the wound is surgical or not, or if the wound is contaminated.
While Panton-Valentine leukocidin (PVL) staph infection is not common, it is important to consider the condition, according to Dr Durack. PVL staph is a “highly pathogenic staph strain”, that’s “often recurrent and… not so easy to clear”.
“Microbiology are always available for advice if needed,” she said in her last point. “So it’s always helpful sometimes to just pick up the phone and get an opinion.”
“The most common infections, globally, regardless of age or geographical location are staph and strep[tococcal] infections,” said Dr Durack.
There was a rise in dermatological infestations (scabies, lice, etc) during the pandemic, and also increased research around treatment, according to Dr Fiona Browne, Consultant Dermatologist, Children's Health Ireland (CHI) at Crumlin, and CHI at Temple Street, Dublin.
“We’ve learned that infestations love a pandemic,” according to Dr Browne.
This spike in scabies and other infestations was not anticipated, but was also seen internationally.
“It really highlights the opportunity for these infestations to take over when we are in enclosed environments, when people are not able to isolate,” said Dr Browne. When compared to Crumlin there were more of these cases recorded in Temple Street in Dublin city centre, according to Dr Browne.
Talk of “super-infestation” of scabies raised concerns that a resistance had been built up against permethrin, however, a study published in December 2021 in Dermatologic Therapy (‘Is there a really resistance to scabies treatment with permethrin?’) showed that there was no evidence for this.
“Rather then, the likelihood is that patients are just not treated appropriately,” said Dr Browne.
Authors: Prof Anne-Marie Tobin, Consultant Dermatologist, Tallaght University Hospital, Clinical Associate Professor at Trinity College Dublin, and HSE Clinical Lead in Dermatology
A study published recently in The Journal of Paediatrics (‘Comparison of permethrin-based treatment strategies against scabies in infants and young children’) showed a higher cure rate in patients treated with permethrin on their full body overnight on days one, eight, and 15 of treatment, with an added application of permethrin on the patients’ hands and feet every second day during this period. “At the moment we ask to apply and leave overnight and then repeat the treatment one week later [days one and eight],” said Dr Browne.
She said by adding the extra treatment days to the hands and feet alone "you can achieve almost twice the cure [rate]".
Ivermectin, which is currently licensed for children “over the weight of 15 kilos and in adults”, is also suitable for children under 15 kilos, according to two large studies referenced by Dr Browne: One published in 2021 in The Australasian Journal of Dermatology (‘A narrative review of the roles of topical permethrin and oral ivermectin in the management of infantile scabies’); and another published in 2019 in The British Journal of Dermatology (‘Ivermectin safety in infants and children under 15kg treated for scabies: A multicentric observational study’).
“It’s not licensed [for this indication], but it does appear to be safe,” said Dr Browne.
As outlined in this module, treatments for psoriasis have advanced such that patients can expect to have clear or nearly clear skin, with a broad range of effective therapies to treat mild to moderate to severe disease.
Oilatum
Dublin Hospitals FC 4
Hadden Park, Clontarf West, Killester, Co Dublin
Saturday, 5 February 2022
On a blustery Saturday afternoon, Dublin Hospitals
FC’s (DHFC) Leinster Senior League (LSL) campaign got back on track, after a three month hiatus due to Covid postponements and the winter break.
Killester can thank their ground-people for maintaining one of the best grass surfaces in the league. Unfortunately for the Northsiders, it was a perfect fit for the counter-attacking doctors on the day.
Both sides started well, with an even share of possession in the opening 30 minutes. Killester’s central midfield, drafted in from the higher echelons of intermediate football for the day, kept possession well and found some neat forward passes; however, their play in the final third let them down. As the half wore on, the Galway combination of Gaffney and Cheevers began to influence proceedings. Time and again Cheevers got behind Killester’s back three with overloads created on the left side in combination with Durand and the unpredictable Brian Gaffney. The searing pace of Wrynn on the opposite flank stretched and exposed the Killester back three on this vast pitch on the counter-attack.
It was the team from Killester who opened the scoring. Chambers, playing in centre midfield for the home team, had been causing all kinds of trouble for the doctors, with probing forward passes early in the game. He picked up the ball after a loose pass from a DHFC defender 30 yards out and wasted no time in dispatching a powerful effort towards the top right corner. Berkeley, standing in for Schutze for the day, had no chance. Within five minutes of the restart, DHFC had a glorious opportunity to level matters. A perfectly weighted through ball from the industrious Ian Daly saw Rory Durand clean through on goal. Durand neatly rounded the oncoming keeper, but hit the side netting from a tight angle. Despite an evenly matched and enjoyable first-half for the spectators, DHFC trudged off at half-time a goal down and with the prospect of a mountain to climb in the second-half. It was an all too familiar feeling for this group of players.
As the action restarted, the doctors seemed to have taken a level-headed view on things, despite the scoreline and picked up where they left off at the end of the first-half. On the 55-minute mark, DHFC finally got the goal that their play deserved. The move started with a clearance from Colm Cosgrove, who had been a colossus at the heart of the DHFC defence all day. Wrynn, as he
had done on numerous occasions in the first-half, picked up the ball just outside his own box and drove forward at pace, before releasing Durand down the outside channel. After reaching the byline he cut the ball back to the penalty spot. Then a neat dummy from Cheevers left Gaffney with a simple finish. It was a scintillating break involving ev-
ery member of the DHFC attacking quartet.
Within five minutes DHFC took the lead. John Cosgrove split the Killester defence in half with a perfectly weighted through pass. In a mirror image of his first-half opportunity, Durand broke clear of the Killester Donnycarney defence. This time no chances were taken and Durand squared the ball to Cheevers who had an open goal to pass the ball into.
Unfortunately, for DHFC, the lead was short-lived. A dangerous inswinging corner led to a wrestling match between Kirby and Keating, resulting in a penalty being awarded against the centre-half. Keating dusted himself off and duly dispatched the spot kick with minimal fuss, levelling the scoreline.
As the second-half wore on, the doctors began to take control of the game. Only a man of the match performance from White in goal for Killester kept the scores
level until the 80th minute. It was the left foot of John Cosgrove that proved to be decisive again. After some good build-up play, a blocked shot from Kirby, fell to the feet of Cosgrove, 30 yards from goal. It was an opportunity too tempting to turn down and the midfield playmaker slammed a spectacular effort into the top left corner. A carbon copy of many of Cosgrove’s goals in the past, this was fit to win any football match and appropriately marked his 50th club goal.
With a slender lead intact, DHFC continued to be proactive and search for the goal to put the result beyond reasonable doubt.
Brian Gaffney, who had tormented the opposing defence all afternoon, was able to effortlessly dribble his way into Killester’s 18-yard box. As he looked sure to double his tally for the day, he was brought down inside the box in desperation. The outcome was never in doubt as Cosgrove made it four for DHFC.
A 4-2 win sees DHFC in mid-table with nine games left to play in the LSL season. An outside chance for promotion is still on. Next up for DHFC will be a crucial home fixture against the familiar faces of Dunboyne AFC. There really is nothing quite like the doctors in green under Friday night lights at Pearse Park.
Matchday squad: M Berkeley, D Kennedy, B Neary, C Cosgrove, C Kirby, J Cosgrove, I Daly, B Gaffney, E Wrynn, G Cheevers (C), R Durand.
Subs: C Ward (Cheevers), C Vaughan (Durand), F Nally (Wrynn), E Daly (Kennedy).
DHFC goals: B Gaffney, G Cheevers, J Cosgrove, J Cosgrove (pen).
PS: Dublin Hospitals FC would like to thank our kind sponsors Medisec Ireland for continuing to support the club for the past year. You can keep up to date with all things DHFC at www.dublinhospitalsfc.com
As the second-half wore on, the doctors began to take control of the gameBrian Gaffney strides clear A 4-2 win saw DHFC put their poor preChristmas form behind them
Post your answers to: Mindo Quizzes, The Medical Independent , Greencross Publishing Ltd, 1 Mortons Lane, Wicklow Town, A67RX38 Closing date for entries is 7 April 2022
Q1 Name the Irish boxer who was knocked out in the final round of his recent WBA world featherweight title bout?
Q2 Who was the leading jockey at this season’s Cheltenham festival?
Q3 Who won golf’s Players Championship at TPC Sawgrass?
Q4 Which League of Ireland team play at Tolka Park?
Q5 Who was named Six Nations player of the tournament?
Q6 Who won the ladies singles at the prestigious Indian Wells Masters tournament this month?
The winner of the 7 March 2022 Sporting Quiz Competition is Dr Joan Hutchinson, Dublin 15
The winner of the 7 March 2022 Crossword is Dr Kevin Quinn, Co Donegal
Q1 Name the Liverpool goalkeeper who scored the winning penalty in the Carabao Cup final? A: Caoimhin Kelleher
Q2 Which Irish golfer finished in the runner-up spot at golf’s Honda Classic last month? A: Shane Lowry
Q3 Kellie Harrington and Aoife O’Rourke both won gold for Ireland last month. Which boxing tournament did this occur in?
A: The Strandja Tournament
Q4 Who was recently sacked as manager of Leeds United?
A: Marcelo Bielsa
Q5 Name the full-back who made a try-scoring debut for Ireland against Italy in this season’s Six Nations? A: Michael Lowry
Q6 Who was named as US captain for the next Ryder Cup?
A: Zach Johnson
GP ASSISTANT REQUIRED
GP assistant required in North Inishowen with a view to partnership. Short-term position also considered. Group practice/ fully computerised, full ancillary staff (APN, practice nurses, medical technicians and administration staff) in a purpose-built primary care centre.
For further information on this position contact Dr Seamus Kelly via email skelly@millbraesurgery.ie
Millbrae Surgery, Carndonagh, Co Donegal
SHANE O’TOOLE
Specialist Medical Accountant, RCSI Lecturer and author of Fit moneythe key to financial freedom
Now offering:
• Monthly Profit Growth Model
• Annual Accounts and Tax Returns
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Contact 01 801 3116 for help and support
Tipperary Primary Care is looking for a GP to join our team. We will facilitate your needs and time available.
For a salaried or partner GP please contact Tom Purcell 062 51657
www.tipperaryprimarycare.ie
Fancy a summer GP locum job in West Cork?
Would you like to work and enjoy the summer in West Cork near the sea?
GP locum sessional or full-time work available in a GP group practice.
On-call commitment optional.
Very supportive nursing and admin staff.
Please email any queries and cv to: westcorkmedical@gmail.com
Part-time general practice nurse sought for Rathgar Medical Practice, Dublin 6. Competitive rates and flexible hours for the right candidate. Friendly working environment. Previous practice nurse skills desirable, but not essential. Training can be provided. Position available immediately. Interested applicants please contact osullym@yahoo.ie with your CV
Dr Ros Vallings, a New Zealand GP who is an expert on myalgic encephalomyelitis/chronic fatigue syndrome (ME/ CFS), will present a free talk entitled “Key messages for primary care on the diagnosis and management of post viral fatigue syndrome and ME/chronic fatigue syndrome” followed by a Q&A session on Monday, May 30 at 7:30pm. Accreditation applied for from the ICGP.
For more info, contact CPD@irishmecfs.org
Louth, Meath, Cavan, and Monaghan
GP out-of-hours (NEDOC) and daytime surgery jobs
Great rates available
Contact us on 046 924 1533, Email: info@medsource.ie
Visit our website: www.medsource.ie
IN DUBLIN 2
Medical Suites available at 26 Clare Street, Dublin 2. Adjacent to the National Gallery.
Suitable for a range of medical uses including GP practice - Private or GMSOut-of-hours service or walk-in clinic – physio clinic – beauty clinic, etc. Full medical planning permission.
These suites would suit many uses due to the high footfall passing the door every day. The suites are 5 minutes walk from Grafton Street with several amenities close by.
There is direct access from all areas of Dublin to the suites via the Dart and bus and the Luas runs to Dawson Street, 5 minutes walk away. There is a big concentration of new businesses in the area. Trinity College, Merrion Square, and Pearse Street are on the doorstep. Very favourable and flexible terms.
2 Suites available ● self-contained ● bathroom/waiting room/consulting rooms 440sq feet and 690sq feet both newly renovated ● high speed broadband, etc
Please contact Mr Aidan Ringrose on +353 87 951 9786 or mornwill26@gmail.com for further information or to arrange viewing
Cara Medical Centre, Newcastle West, Co Limerick is looking for a GP to join our practice, ideally for six sessions per week initially, open to negotiation. We are a two GP practice and we are supported by an excellent nursing and administration team.
Fully computerised Health One software. Large mixed GMS/private practice. No out-of-hours commitment. Excellent renumeration.
Please contact with your interest/CV to caramedical@gmail.com
When: Sat 2nd April
Time: 8.30am
Location: Now Online Webinar Only
This event will feature speakers from Rheumatology, Respiratory, Neurosurgery, Cancer, Cardiology, Orthopaedics, Urology and General Surgery.
Recognised for 6 CPD Points / 1 Day GMS Study Leave.
To register for this event please go to our website or email events@beaconhospital.ie
This webinar is free of charge but pre-registration is essential.
share, please email: info@mindo.ie
A round-up of news and oddities from left field by Dr Doug Witherspoon
Ever the optimists, we must assume (in hope rather than expectation) that the onset of spring will bring with it warmer weather. Along with that, of course, comes the usual flood of allergies and skin inflammations. But there is a strange and parallel world of rare allergies, the symptoms of which could baffle even the most scrupulous doctor.
Aquagenic urticaria – or 'water allergy' – is possibly the
Patients seen within 24 hours of GP referral or next working day
best known of these very rare conditions. Like many other rare allergies, aquagenic urticaria is mysterious in terms of its causes and possible place within a larger syndrome. Because it is so rare, research into it is scant, but it is characterised by small, raised bumps surrounded by larger, red areas that may be itchy. They usually manifest on the neck, the upper arms, and the trunk.
A 'water challenge test' involving a wet compress on
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the chest for 20 minutes can help with the diagnosis and some of the treatment options include using alcohol-based cleansers, antihistamines, skin barriers or UV light therapy.
Exercise-induced urticaria (or 'exercise allergy') is a very rare allergic reaction to physical exercise and causes large welts on the skin that may be itchy and appear in response to physical exercise. The identification of exercise allergy is painstaking and involves meticulously ruling out any foods that may be interacting with the body to trigger the allergy upon physical exertion. The usual symptoms include hives, itchy skin, flushing, stomach cramps, headache, and possibly swelling of the face, tongue or hands.
Most of us have known somebody who seems allergic to putting their hand in their pockets to pay for a round, but if you wanted to be kind, you could assume they suffer with nickel allergy. This is one of the more common allergies and is a reaction to nickel, one of the ingredients with which coins are made. This condition can be problematic on a wider scale, as it often occurs due to contact with jewellery, zippers, the frames of eyeglasses, watchbands, buckles, buttons, snaps, and hooks.
To complicate the situation, nickel is also widely used in the manufacture of cellphones, meaning that people who suffer with a nickel allergy may also be allergic to their mobile phones (even phones with cases).
Perhaps 'coming soon to a bush near you' is the pine processionary caterpillar. This fuzzy leaf-crawler is most found in North Africa, southern Europe and the Middle East, but has slowly been crawling its way northwards and has been spotted as far north as Paris, Switzerland, and Hungary. In a study in The Scientific World Journal, the authors stated that this bug "causes dermatological reactions in human by contact with its irritating larvae hairs". It's not even necessary to touch the bug, as its hairs travel through the breeze, making the cause of this allergy even more difficult to establish.
The condition vibratory urticaria is so rare that the number of sufferers has not been established, but for those affected, the consequences can be baffling and extremely inconvenient. As the name suggests, vibratory urticaria causes swelling, itching, headaches, and blurry vision when the sufferer comes into contact with anything that vibrates. This includes lawnmowers, motorcycles, and almost anything else you can think of that vibrates. Headaches, fatigue, faintness, blurry vision, and a metallic taste in the mouth comprise other common symptoms and the unfortunate sufferer can experience several episodes each day, lasting for up to an hour each time.
Finally, in a slightly cruel twist of fate, some people are actually allergic to their antihistamines. This is thought not to be an allergic reaction to the active ingredients themselves, but rather to the dyes and additives contained in the medication.
People who are 'allergic to work' is a topic for another day, but the symptoms include excessive texting, extended lunch and coffee breaks, inability to complete paperwork, a systemic lack of enthusiasm, and a severe allergy to showing up. The literature is sparse, but the anecdotal evidence is strong.
