Catherine Reilly speaks to doctors about the need for flexible training and the obstacles that are hampering progress
Concerns over new Covid variants have reignited the argument over vaccine equity and access across the globe, writes David Lynch
The cyberattack on the HSE earlier this year “significantly” impacted the longstanding recruitment challenges faced by the health service, the Medical Independent can report.
According to the HSE’s corporate risk register (CRR), which was approved by the HSE’s executive management team in September, “workforce and recruitment” is noted as one of the 18 red risks out of a total of 28 risks listed.
The impact of the cyberattack on recruitment was added to the long-standing workforce planning difficulties.
“There is a risk to effectiveness of health services potentially leading to a prolonged, widespread reduction in the quality and consistency of care and repeated failure to achieve standards as a result of, challenges related to the scale of recruitment outlined under
the Winter Plan,” reads the CRR. Other reasons noted by the HSE’s risk register for the recruitment problems include: The current shortage of critical staff, in particular clinical staff who have the required skills and professional qualifications and “the high reliance on agency staff”; the shortage of qualified candidates both nationally and internationally; “consultants not on the specialist division register”; challenges relating to the recruitment and retention of medical, clinical, and other critical workforce grades; and Covid-19 related absence leading to a reduced workforce.
The CRR also noted that the “cyberattack impacted recruitment significantly in 2021 from the perspective of attracting, recruiting, and retaining candidates both nationally and internationally in a non-digital environment”.
The healthcare sector has an important role to play in combatting the climate crisis, argues Dr Neasa Conneally
PAUL MULHOLLAND
A number of major issues were identified regarding the operation of the systemic therapy programme at the meeting of the National Cancer Control Programme’s (NCCP) executive management team in September.
According to the minutes of the meeting, released to the Medical Independent through Freedom of Information, work was ongoing on seeking “a short- to medium-term resolution to systemic anti-cancer therapy treatment capacity and waiting lists”.
There was also a backlog in the drugs approval process, with the HSE drugs group due to meet on the issue.
“The cyberattack has impacted on the cytogenetics testing service,” according to the minutes. “All adult cytogenetics, bar CLL [chronic lymphocytic leukaemia], are now being outsourced.”
St James’s Hospital, Dublin, and Children’s Health Ireland at Crumlin were to re-
vert with a proposed job description for a cytogenetics oversight post in the near future.
The cyberattack was also continuing to have an impact with “notable data gaps” and paper records still to be uploaded to patient files.
The July meeting had heard that “clinical risk” as a result of the cyberattack was still an issue.
“[D]ata availability, which informs decision making is intermittent,” the minutes state. “MDMs [multidisciplinary meetings] continue to run in the absence of data, or with limited data.”
In July, continuing problems were noted regarding the recruitment of appropriately trained staff.
“It is difficult to get staff who are appropriately trained,” according to the minutes.
“Funding does not always solve the problem where there is a shortage of appropriately trained staff. This may impact on the delivery of clinical trials in the west of Ireland.”
For more information, call freephone 1800 923 404 or visit www.nutricia.ie
Available in Retail and Pharmacy outlets
Reference: 1 Rosen R et al. J. Pediatr. Gastroenterol. Nutr. 2018; 66(3): 516-554.
IMPORTANT NOTICE: Breastfeeding is best. Aptamil Anti-Reflux is a food for special medical purposes for the dietary management of frequent reflux and regurgitation and must only be used under medical supervision.
Date of preparation: February 2021
Nutricia Ireland, Deansgrange, Co. Dublin
A global study co-led by NUI Galway into causes of stroke has found that one-in-11 survivors experienced a period of anger or upset in the one hour leading up to the event. One-in-20 patients had engaged in heavy physical exertion. The suspected triggers have been identified as part of the global INTERSTROKE study – the largest research project of its kind, which analysed 13,462 cases of acute stroke, involving patients with a range of ethnic backgrounds in 32 countries, including Ireland.
Pictured L-R at the Health Research Board (HRB) Galway facility are study co-authors: Dr Michelle Canavan, Consultant Stroke Physician at Galway University Hospitals; and Prof Andrew Smyth, Professor of Clinical Epidemiology at NUI Galway, Director of the HRB-Clinical Research Facility Galway, and a Consultant Nephrologist at Galway University Hospitals.
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
Brintellix® (vortioxetine) film-coated tablets
Prescribing information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing, particularly in relation to side effects, precautions and contraindications. Presentation: Tablets containing 5, 10, 15 or 20mg vortioxetine. Indication: Treatment of major depressive episodes in adults. Dosage: 10mg once daily. May be increased to a maximum 20mg daily or reduced to 5mg if necessary. After symptoms resolve, treatment recommended for at least 6 months. Can be taken with or without food. Elderly (≥65 years): Initial dosage is 5mg once daily. Caution advised if using doses above 10mg daily. Children (7-11 years): Not recommended. Adolescents (12-17 years): Not recommended in major depressive disorder; efficacy not established. Cytochrome P450 inhibitors and inducers: Consider a dose reduction of vortioxetine if a strong CYP2D6 inhibitor is added. Consider a dose adjustment if a broad CYP450 inducer is added to treatment. Renal or hepatic impairment: No dose adjustment; subpopulations are vulnerable and data on the use of Brintellix are limited.
Contraindications: Hypersensitivity to the active substance or excipients. Concomitant use with nonselective, monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (e.g. moclobemide). Fertility, pregnancy and lactation: Limited data; should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus. Animal studies showed reproductive toxicity. Use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Potential risk of postpartum haemorrhage following exposure to an SSRI or SNRI within the month prior to birth. Excreted into human milk, risk to the breastfeeding child cannot be excluded. Animal data showed no effect on fertility, sperm quality or mating performance. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed. Please refer to SPC for more detail.
Warnings & Precautions: Closely supervise patients, especially those at high risk for suicide-related behaviours during first few weeks of treatment and during dose changes. Use with caution in patients: at risk of hyponatraemia; with a history of mania/hypomania; aggression/agitation; undergoing ECT; with unstable epilepsy (discontinue if seizures begin for the first time or increase in frequency); with bleeding tendencies/disorders, taking anticoagulants or medicines affecting platelet function; in patients on lithium or tryptophan; with increased intraocular pressure, or those at risk of acute narrow angle glaucoma. Monitor patients for appearance of serotonin syndrome or neuroleptic malignant syndrome and discontinue if occurs. Patients may experience feelings of aggression, anger, agitation and irritability.
Patients/caregivers should seek medical advice if such behaviour emerges or aggravates. SSRIs/SNRIs may increase the risk of postpartum haemorrhage. Brintellix tablets contain sodium (<1mmol/tablet).
Drug interactions: Alcoholic drinks not advisable. Vortioxetine is extensively metabolised in the liver.
Potential for interactions with: MAOIs, MAO-A and MAO-B inhibitors; serotonergic medicines; St John’s wort; products which may lower the seizure threshold, e.g. antidepressants, neuroleptics, mefloquine or bupropion. Lower dose may be considered if strong CYP2D6 inhibitor is added to treatment depending on patient response, these effects may be greater in patients who are poor metabolisers of CYP2D6. Dose adjustment may be considered if a broad cytochrome P450 inducer is added to treatment. Reports of false positive results in urine enzyme immunoassays for methadone in patients taking vortioxetine. Exercise caution in interpreting positive drug screen results. Effects on ability to drive and operate machines:
No or negligible influence, dizziness has been reported; use caution at the start of treatment or when the dose is changed. Adverse events: Most common adverse reaction is nausea, usually mild or moderate, transient and occurs within first two weeks of treatment. The following have been reported in clinical trials and during post-marketing use: Very common (≥1/10 patients): nausea. Common (≥1/100 to <1/10): abnormal dreams, dizziness, diarrhoea, constipation, vomiting, pruritus, including generalised pruritus. Uncommon (≥1/1,000 to <1/100): flushing, night sweats. Rare (≥1/10,000 to <1/1,000): mydriasis (which may lead to acute narrow- angle glaucoma). Not known: anaphylactic reaction, hyponatraemia, insomnia, agitation, aggression, serotonin syndrome, haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding), angioedema, urticaria, rash. Sexual dysfunction: 20mg dose was associated with increase in sexual dysfunction. Class effect: Studies in patients ≥50 years of age, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. Not known if relevant to vortioxetine. Paediatrics: Higher incidences reported in adolescents for abdominal pain-related events and suicidal ideation. Prescribers should consult the full SPC in relation to other side effects. Overdose: Management consisting of treating clinical symptoms and relevant monitoring. Legal category: POM, for non-renewable supply. Brintellix Tablets, blisters of: 5mg (EU/1/13/891/002) 28 tablets. 10mg (EU/1/13/891/010) 28 tablets. 15mg (EU/1/13/891/019) 28 tablets. 20mg (EU/1/13/891/028) 28 tablets. Further information available from: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co. Dublin. Tel: 01 468 9800. Date of last revision of PI: November 2020. Reference: IE-BRIN-0254. Brintellix® is a Registered Trade Mark.
Job number: IE-BRIN-0261
Date of preparation: March 2021
Reference: 1. Brintellix Summary of Product Characteristics. Available at https://www.medicines.ie/medicines/brintellix-10-mg-film-coated-tablets-34817/smpc
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Lundbeck on: 01 468 9800 Email: SafetyLuIreland@lundbeck.com
Enabling people with depression to feel, think and do better1
A recommendation for the scoping of a comprehensive review of future primary care centre requirements taking account of geographical coverage, population and service needs, and other relevant factors, has been approved by the HSE board.
Following an assessment, carried out to establish whether the appropriate approvals were in place, it emerged that a total of 47 primary care centre developments required and sought additional approval from the board.
More than 300 doctors have signed a petition calling for the Irish Government to support the TRIPS (Trade Related aspects of Intellectual Property Rights) waiver.
The TRIPS waiver is a motion put to the World Trade Organisation (WTO) to temporarily waive intellectual property rights for health technologies needed to prevent, contain, or treat Covid-19.
The Irish group Doctors for Vaccine Equity is running an online petition in support of the waiver, as well as an “urgent” global redistribution of current vaccine supplies.
One of the founding members of the group, Dr Christine Kelly, SpR in Infectious Diseases and Clinical Fellow in Public Health Virology, told the Medical Independent (MI) “the US supports the TRIPS waiver, but unfortunately the EU has not joined them. We strongly believe that Ireland must advocate for the support of the TRIPS waiver at EU level.”
On the TRIPS waiver, a Department of Foreign Affairs spokesperson told MI that “Ireland supports the EU commitment to an open dialogue with all WTO members to explore how to support universal and equitable access to Covid-19 vaccines and treatments, while also focusing on initiatives to facilitate broad industry cooperation to build production capacity, based on transfers of technology and know-how through voluntary licensing agreements”. See news feature, p12.
CATHERINE
Targets are required for flexible training and a broader scope of specialties should be involved, the Chair of the IMO NCHD women in medicine working group has told the Medical Independent
Dr Rachel McNamara, who is also a member of the union’s NCHD committee, added that flexible working arrangements should be available for NCHDs in both training and service posts.
Currently, one of the few means of accessing flexible training is through the HSE national supernumerary flexible training scheme. However, it provides for only 32 places annually and has a number of restrictive conditions.
Dr McNamara noted: “There is a responsibility there with departments, the training bodies, and with NDTP [National Doctors Training and Planning], to promote and facilitate less than full-time training among a wider variety and large number of departments.”
She said many hospitals and teams believed it would be difficult to accommodate a doctor who is training flexibly or job sharing.
“But that has to change from the IMO point of view. We are heading into year three of a pandemic, there are going to be more and more people that will feel the effects of the last two years and they will either need to take career breaks or we have to give them some sort of a flexible option to retain our workforce.” See news feature, p4-6.
According to minutes of the September HSE board meeting, the assessment had been completed in terms of primary care centres which were operational, in progress or planned. It also considered whether there was adequate primary care centre coverage across the country.
This process had identified that 10 of the primary care centres, within the 292 total which were operational or being progressed, had not been previously approved by the board.
These included four locations that were replacements for previously approved locations.
A further 37 primary care locations required approval for changes made subsequent to their initial board approval due to issues, such as size and/or rental cost.
The board approved both the recommendation by the HSE audit and risk committee of additional approval for the 47 primary care centres identified in the assessment, and the scoping for a more comprehensive review.
For the treatment of active rheumatoid arthritis, severe recalcitrant disabling psoriasis & severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate
For the treatment of active rheumatoid arthritis, severe recalcitrant disabling psoriasis & severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate
Nordimet (methotrexate) Solution for injection in pre-filled pen
Please refer to the Summary of Product Characteristics (SmPC) for full prescribing information. Further information is available on request.
Presentation: Pre-filled pen containing 7.5 mg (in 0.3 ml), 10 mg (in 0.4 ml), 12.5 mg (in 0.5 ml), 15 mg (in 0.6 ml), 17.5 mg (in 0.7 ml), 20 mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in solution for injection. Indications: Active rheumatoid arthritis in adult patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. Dosage and administration: Nordimet should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Nordimet should be performed under direct medical supervision. Nordimet is injected once weekly, administered subcutaneously. Rheumatoid arthritis:
Recommended initial dose is 7.5 mg of methotrexate once weekly.
Depending on the individual activity of the disease & patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Polyarthritic forms of severe, active juvenile idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20mg/m² BSA per week. Use in children < 3 years of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to
ml), 10 mg (in 0.4 ml), 12.5 mg (in 0.5 ml), 15 mg (in 0.6 ml), 17.5 mg (in 0.7 ml), 20 mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in solution for injection. Indications: Active rheumatoid arthritis in adult patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. Dosage and administration: Nordimet should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Nordimet should be performed under direct medical supervision. Nordimet is injected once weekly, administered subcutaneously. Rheumatoid arthritis: Recommended initial dose is 7.5 mg of methotrexate once weekly. Depending on the individual activity of the disease & patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Polyarthritic forms of severe, active juvenile idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20mg/m² BSA per week. Use in children < 3 years of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to
Date Of Preparation: Aug 2021 IE/21/NOR/011-00
initiation of therapy is recommended. Recommended initial dose 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate. Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose. In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate. Crohn’s disease (adult patients): 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Maintenance treatment: 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission. Renal impairment, hepatic impairment or elderly patients: Please refer to SmPC. Note: When switching from oral to parenteral use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.
initiation of therapy is recommended. Recommended initial dose 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate. Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose. In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate. Crohn’s disease (adult patients): 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Maintenance treatment: 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission. Renal impairment, hepatic impairment or elderly patients: Please refer to SmPC. Note: When switching from oral to parenteral use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.
Contraindications: Hypersensitivity to methotrexate or to any of the excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency. Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis. Ulcers of the oral cavity and known active gastrointestinal ulcer disease. Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines. Special warnings and precautions: Patients must be clearly advised that the therapy is to be administered once a week, and not every day.
Patients receiving therapy should be appropriately monitored. Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. The possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with male and female patients of childbearing potential.
Methotrexate contact with skin and mucosal membranes is to be avoided; in cases of contamination rinse the area with plenty of water. Interactions: Consult SmPC for detailed information on interactions. Undesirable
Contraindications: Hypersensitivity to methotrexate or to any of the excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency. Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis. Ulcers of the oral cavity and known active gastrointestinal ulcer disease. Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines. Special warnings and precautions: Patients must be clearly advised that the therapy is to be administered once a week, and not every day. Patients receiving therapy should be appropriately monitored. Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. The possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with male and female patients of childbearing potential. Methotrexate contact with skin and mucosal membranes is to be avoided; in cases of contamination rinse the area with plenty of water. Interactions: Consult SmPC for detailed information on interactions. Undesirable
effects: See SmPCs for full list of undesirable effects. Very common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. Abnormal liver function tests (increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache. Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis. Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic events. Pulmonary fibrosis. Pneumocystis carinii pneumonia. Shortness of breath and bronchial asthma. Pleural effusion. Acute hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. Lymphoproliferative disorders. Severe courses of bone marrow depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative disorders). Legal classification:
effects: See SmPCs for full list of undesirable effects. Very common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. Abnormal liver function tests (increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache. Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis. Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic events. Pulmonary fibrosis. Pneumocystis carinii pneumonia. Shortness of breath and bronchial asthma. Pleural effusion. Acute hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. Lymphoproliferative disorders. Severe courses of bone marrow depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative disorders). Legal classification: POM. MA numbers: EU/1/16/1124/001 – 008. Further information available from: Nordic Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin. Date of Prescribing Information: July 2021. Item code: IE/21/NOR/008-00.
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Nordic Pharma Ireland; info@ nordicpharma.ie or +353(0)1 4004141
As the diversity of the medical profession increases, and retention becomes ever more critical, the need for flexible training for doctors is paramount. However, as Catherine Reilly heard, doctors face considerable barriers in this area
Flexible training in Irish medicine is “still unusual”, noted the authors of a recent study in the Irish Medical Journal (IMJ) examining trainee knowledge and perceptions of less than full-time (LTFT) training.
Some revealing comments were made by trainee respondents in the study, which was conducted by doctors from RCPI’s Faculty of Paediatrics. One trainee described LTFT training as “culturally frowned upon”. Another said they feared being seen as “less able” for full-time work or “less committed” to their career if they sought flexible training.
The authors concluded that “a cultural shift within training bodies and with trainers should be encouraged to recognise LTFT training as an acceptable pathway for all trainees”. It was noted that LTFT training “has been recognised as an important tool for the creation of better work-life balance and avoidance of burnout in the medical workforce”.
The HSE’s national supernumerary flexible training scheme is one of the few routes to flexible medical training. It provides 32 places annually for a workforce of over 4,800 trainees (and not all are eligible). The scheme has several limitations including an emphasis on providing half-time posts and these issues were raised by respondents to the IMJ study (see panel on page 6).
But inflexibility extends far beyond the HSE scheme and deep into the conventions of medical training.
A number of trainees who spoke to the Medical Independent (MI) highlighted a lack of creative solutions for doctors with caring responsibilities or health concerns. A rigidity in training structures was causing major personal and financial hardships for some trainees, heard MI
There were doctors, for example, who wanted to work full-time (often out of financial necessity), but whose rotations removed them from essential support networks (including childcare), with considerable financial and personal implications and indiscernible benefits to training outcomes.
Another theme that emerged was a divergence between the public statements of training bodies in support of flexible training – and the difficult and delicate process for some trainees when making requests for greater flexibility.
The doctors who spoke to MI under condition of anonymity were not suggesting that trainees should never have to move during training, but that more flexibility was achievable and necessary – for the wellbeing of the doctors themselves and the health system that needs them.
A trainee in the early stages of their scheme, who has a young toddler, told MI she was sent to a far part of the country at approximately three months’ notice (although she was advised of her subsequent locations for an 18-month
period). This is an experience typical of many schemes and, as the trainee noted, not a family-friendly process.
“Trying to find a house and a creche with only a few months’ notice, in this day and age, is just impossible,” according to the trainee, who described training structures as traditionally designed around single males.
The trainee, who came through a graduate-entry medical degree programme, had an established family life. She said this was not considered in the allocation of rotations.
The trainee and her family made the move to the new location, over 250km from their home, with limited childcare support for the initial months. Childcare is “very hard to find and lots of places are saying ‘we have no toddler spaces, but if you are thinking of having another baby let us know and we will put your name down’. That is the level of preparedness you need for childcare.”
As matters stand, the trainee is facing the same challenges for their upcoming rotation. The trainee, who is happy to work full-time, is considering the possibility of continuing their training in the UK, which would involve being based in one region.
“I will look at applying to the UK. If it is between that and moving around every corner of Ireland, I’d rather go to the UK and have some sort of a base. We will see.”
She added: “The training bodies have to offer some acknowledgement of the
difficulties posed by this and justify why they are not willing to offer flexibility or start thinking of ways that training can be done with reduced rotations or better compensations.” As an example, the maximum amount that trainees can claim from the HSE in relocation expenses is just €500 per annum.
The trainee concluded: “I don’t know how they are going to change it, but it does need to change, especially if you are looking at more graduate-entry doctors and female doctors qualifying. We are already losing doctors to abroad for better opportunities anyway. It would be nice if they acknowledged the ones who are still here.”
The reasons for the slow roll-out of flexible working and training arrangements were “multifactorial” and included a ‘cultural’ resistance within medicine and the health service, according to Dr Rachel McNamara, Chair of the IMO NCHD women in medicine working group and a member of the union’s NCHD committee. In regard to NCHDs, she said flexible working should be an option for trainees and NCHDs in service posts, who number over 7,700 combined (including interns).
Many hospitals and teams consider that it would be difficult to accommodate a doctor who is training flexibility or job sharing – or it would not fit into how things are usually done.
“But that has to change from the IMO point of view. We are heading into year three of a pandemic, there are going to be more and more people that will feel the effects of the last two years and they will either need to take career breaks or we have to give them some sort of a flexible option to retain our workforce.”
There needs to be buy-in from “multiple stakeholders” including training schemes, hospitals, departments, and the HSE. In the UK “there are targets [for flexible training] in each deanery and at the moment they are sitting anywhere between 5 and 20 per cent”.
Dr McNamara said there must be a variety of flexible training posts available and these posts should be accessible throughout training. She also noted one of the difficulties was ensuring flexible trainees do not end up working fulltime, given that unrostered overtime is “commonplace”. Additionally, the concept of job-sharing needed to be developed and promoted.
She told MI flexible training cannot be discussed without reference to the fact many trainees are required to move multiple times during their schemes.
Dr McNamara said retention of doctors will be enhanced by recognising that their lives “outside of work do matter and are important”. She noted that an increasing number of doctors have entered medicine through graduate-entry degree programmes and are more likely to have long-term partners (with their
own established careers), mortgages, and children enrolled in creches, which have long waiting lists.
“If you want to move up the ladder towards consultant, you are expected to up sticks and move, whether it be [every] six months or every year. I have known colleagues of mine who have commuted two hours to and from work every day just so they could stay at the house where their kids are…. They have to do it because they are not in a position to pay mortgage and rent, their partner or spouse is not able to up and move their career across the country.
“I know a good few colleagues who do need to live apart from their families for a time and that is additional rent, forcing people to make very difficult decisions. If the system can be kinder in that scenario, it could be more beneficial to all….
“The system is still very much suited to somebody with no attachments and no external responsibilities and ultimately we are losing out on a very rich diversity of people within the workforce.”
She knew of doctors for whom training structures had dictated their specialty choice; for others it has contributed to major difficulties in relationships and living conditions. In a broader sense, NCHDs are working in an “unyielding system” with consistent overcrowding. The “additional difficulties” placed on doctors by lack of flexible working “certainly doesn’t help”.
10-year strategy included a clear commitment to support flexible training.
“But you do run into difficulties,” he continued. “The main one is if you do less than full-time training, it is going to prolong your training. That is obvious. If you take something like surgery, for instance, where you have an eight-year training programme, and you do less than full-time training, then you are going to extend that training to make it 10 or 12 years. That is a huge challenge for trainees. Some of the other training programmes wouldn’t be as long, but it is a huge dilemma.”
He agreed that greater availability of flexible posts above half-time (eg, 0.6, 0.8 whole time equivalent [WTE]) would be helpful in this regard. Mr Mealy believed the training bodies were open to considering such posts.
Combining professional training with having a family or taking time out for personal or health reasons was a challenge, said Mr Mealy. In surgery, as across medicine, there are increasing numbers of females (comprising 56 per cent of all trainees in 2020/21). Currently, in year one of core surgical training, the percentage of females is 40 per cent; in year two it is 44 per cent, and
need periods of time off, remembering most of these individuals are very, very driven, very competitive, and tend to look for short periods of time for support when they need it. I don’t believe there is any ideological block to this among the training bodies.”
For trainees who want or need to work full-time, and who have family responsibilities and supports in a particular area, is there room for more flexibility in their rotations?
Mr Mealy said most training schemes, as he understood it, attempted to give trainees as much advance notice as possible for their rotations. “Certainly in surgery, they try and tell trainees where the next two or three years will be, so they have some sort of security. Yes, they try and take into account where your partner may be, but it really is challenging. Take for instance, you have a couple who are both doctors, one training in surgery and one training in internal medicine, psychiatry, or general practice, to find alignment between the two training programmes so both can go to Galway for a year or two years, or to co-ordinate that, is a challenge.
“There has been a commitment from the training bodies to try and address that to the best of their ability. There is an understanding this is a big problem for trainees and there is a commitment to try and address those [issues] in the coming years by the training bodies working closer together.”
Greater regionalisation in surgical training is being explored, according to Mr Mealy. He added that service commitments are a factor in surgical rotations as well as exposure to the required range of procedures.
Asked about consultants’ views on flexible training, Mr Mealy said “you will always have individuals who will say ‘this is very disruptive to my practice’”. However, he believed most were “delighted” to have trainees and would do their best to ensure they were accommodated.
42
per cent of children who are deaf or hard of hearing have clinically significant socio-emotional difficulties, according to a report commissioned by Chime, the national charity for deafness and hearing loss.
14
per cent of these children are currently receiving mental health or counselling supports, found the report.
1
-in-four African healthcare workers are fully vaccinated against Covid-19, leaving most of the workforce on the frontlines unprotected, a preliminary analysis by World Health Organisation (WHO) has shown.
Dr McNamara also noted there were “a good few disciplines” where it appeared flexible training was not really “entertained”.
“We need a broader scope of specialties involved, we need to be setting targets, we need to start increasing the amount of people on flexible training year on year….
“We need to work with departments to identify what are the barriers to implementation of flexible training in this workplace and just start working through them. There is a responsibility there with departments, the training bodies, and with NDTP [National Doctors Training and Planning], to promote and facilitate less than full-time training among a wider variety and large number of departments.”
Dr McNamara underlined that the system needed more doctors and “we will be able to attract more staff if we are showing a bit of humanity”.
Forum
Former RCSI President Mr Ken Mealy, Chair of the Forum of Irish Postgraduate Medical Training Bodies, told MI the Forum’s new
in higher specialist surgical training it is 34 per cent.
In regard to female trainees who wish to have children, Mr Mealy said he was encouraged by the number who have done so during their surgical training. He said these trainees are “determined young individuals who want their family, but also want a career, [and] they find ways to work around it”. Nevertheless, Mr Mealy said he was “not trying to pretend for a moment there are simple solutions around all of this”.
Mr Mealy confirmed that female surgical trainees generally took a small amount of maternity leave. They usually took “a couple of months out” and completed a further six-to eight weeks at the end of their training scheme, “but that is the sort of commitment many of our trainees have.”
He commented: “There is a considerable body of opinion in the professional bodies that we have to accommodate young trainees, whether they be male or female, to support them having families during their training period and accommodate [them] – do they need an extension to their training period, or do they
He added: “We have further to go, but there has been a sea change in our understanding that we need to be trainee-centric in terms of the training programmes.… This whole concept comes up at Forum meetings all the time, that it is a ‘buyer’s market’ out there. We have to support trainees to have satisfying training careers, otherwise we won’t have trainees and we won’t have consultants.”
In terms of greater financial support for trainees in rotating around the country, Mr Mealy said this was an issue for the employer rather than training bodies, although the latter could advocate for such measures. The HSE provided some support for training costs, but it was not enough, he added. “One would advocate that the true costs of training are covered more appropriately.”
This newspaper contacted several training bodies on the issue of flexibility during training.
Mr Martin McCormack, CEO of the College of Anaesthesiologists (CAI), told MI the postgraduate training environment in Ireland “must adapt to trainee
150,400+
Covid-19 infections in healthcare workers have been reported to WHO by countries in the African region, since March 2020.
900
more doctors were working in the HSE by the end of 2020, compared to the end of 2019, according to the report ‘Health in Ireland – Key Trends 2021’, published by the Department of Health.
We have further to go, but there has been a sea change in our understanding that we need to be trainee-centric in terms of the training programmesMr Ken Mealy
needs” and this would require “meaningful improvement in training structures and trainee experience and outcomes”.
“While the CAI will continue to prioritise the educational aspects of training, it is committed to working with the other stakeholders to meet the challenges of more flexible and family friendly contracts, to provide flexible training and career paths, to eliminate any gender, age, or ethnic bias in training, and to care for the health and wellbeing of our trainees.”
There are three main categories in which the College offers flexible training: Sharing a (full-time) training post; a LTFT training post; and a supernumerary post under the HSE scheme.
“Our College policy on flexible training makes it explicit that individual circumstances will be considered,” he added.
In the CAI’s current cohort of 242 trainees, just three doctors are availing of LTFT flexible training. There are also seven doctors in training “who have expressed a wish to stay within a particular region due to childcare responsibilities (or other exceptional circumstances) and, in each case, this has been accommodated”, stated Mr McCormack.
The CAI, the RCSI, and the ICGP are undertaking research investigating the challenges facing trainees who require flexibility during training and attitudes from trainees and consultants to LTFT work practices. In addition, the CAI is trialling a pilot LTFT project across two major academic teaching hospitals this year “to provide further support to such
trainees for whom the traditional model of LTFT training is inadequate”.
The doctors wishing to avail of the pilot are a mixture of trainees on the scheme and NCHDs working in the same department, but not on the training scheme. The College is accommodating “flexibility within the pilot” with some doctors electing to work 0.2, 0.6 or 0.8 WTE posts, for example.
Since the introduction of ‘run-through training’, the CAI has endeavoured to give at least two years prospective rotations to each trainee. Where possible, it tries to limit moves during the six years to two different regions.
Mr McCormack noted that not all clinical sites were approved for anaesthesiology training and each Hospital Group/Community Healthcare Organisation did not have the “full range of quality training opportunities” to be self-sufficient as an independent training scheme/deanery model.
The College of Psychiatrists of Ireland (CPsychI) has 330 trainees in total, comprising 280 basic specialist trainees (BSTs) and 150 higher specialist trainees (HSTs).
Three psychiatry trainees are on the HSE flexible training scheme; one trainee is in a permanent part-time HST post; four trainees are job sharing; and four trainees are in LTFT working, eg, four-day week.
In cases where trainees wished to stay within a region due to childcare responsibilities (or other circumstances), was this accommodated?
“Yes, in general all our BST schemes operate on a regional basis and all our
HST trainees may base themselves in a particular region,” according to Dr Aoibhinn Lynch, the College’s Dean of Education. “Even in HST, where there is a requirement for HSTs to spend one year outside their main training base (usually in a city), we try to allocate a post which is within commuting distance so the trainee should not need to move residence. All trainees get the opportunity to make a choice on their training posts and to change their mind. All trainees are given multi-year allocations of training posts so they have notice of where their posts will be over the course of the training scheme.
“With the exception of a small number of sub-specialty areas which operate on a national basis (eg, forensic psychiatry) it is possible for all trainees to complete their training in a particular region. The only limitation is the number of training posts available in a geographical area, and this is the only reason why a trainee may be allocated to a post outside the region where they live – but this happens very rarely.”
Attrition rates in psychiatry training were “very low”. In higher training it averaged at one trainee per year. The College asks trainees for their reasons for leaving the scheme and, where this information is disclosed, it has included personal reasons, a change in specialty, and moving abroad to continue specialist training.
According to Dr Lynch, “once aware of
The HSE national supernumerary flexible training scheme is one of the few means of accessing flexible medical training, but there are a number of limitations on who can apply. The scheme is not open to firstyear basic specialist trainees and “not recommended” for final year trainees (although “this is at the discretion of the relevant training body”).
Currently, participation is restricted to a maximum of two years and will only be extended by HSE National Doctors Training and Planning (NDTP) in “exceptional circumstances”.
According to HSE literature, the most common reasons for trainees applying to the scheme include responsibility for caring for others (eg, children or older relatives); physical and mental health; personal family circumstances.
In July 2016, the number of whole time equivalent (WTE) funded places on the scheme rose from 12 to 16 and there have been no further increases. The number of trainees engaged in the scheme at any given time is set at a maximum of 32.
The scheme’s flexible training posts
have generally been set at 50 per cent of full-time, but the HSE’s guidance document for the 2022 application process stated that “provisions can be made to facilitate arrangements outside of 50 per cent of full-time, depending on circumstances”.
Overtime is paid at a rate of single time extra until WTE hours are reached, ie, 39 hours per week.
According to HSE data for 2018 to 2020, psychiatry had the largest number of participants at 25. This was followed by paediatrics at 14 and histopathology at eight. The following specialties had no listed participants in these years: Cardiology, gastroenterology, general surgery, neurology, and respiratory medicine.
A recent study in the Irish Medical Journal (‘Trainee knowledge and perceptions of less than full-time training’, Howard et al) reported on trainees’ perceived barriers to less than full-time (LTFT) training. The main issues identified were post availability; potential impact on career progression; and availability of only 0.5 posts. Trainees noted lack of
flexibility in the HSE scheme, including availability only from July to July and participation restricted to a maximum of two years.
“Trainees felt applications would be rejected if they were not a parent. Some reported perceptions from teams that LTFT trainees are less committed and that trainees can find it difficult to integrate.”
For female trainees who had children, the key concerns were salary (ie, loss of earnings), delay in date for certificate of satisfactory completion of specialist training, impact on career progression, and childcare costs.
Male trainees were most concerned about impact on career progression and availability of LTFT posts.
“Trainees mentioned salary difference as an issue and in particular noted that the policy of overtime pay at single time extra rate until WTE hours are reached, ie, 39 hours per week, puts LTFT trainees who contribute to a 24-hour call rota at a significant disadvantage in their salaries compared to full-time colleague.”
Suggested recommendations from
any particular needs that a trainee has, [the College] will try to accommodate these needs where possible. Trainees with disabilities have regularly been accommodated (for example in exams or continuous assessment). The CPsychI Vice Deans, tutors, educational supervisors and HST mentors play a vital role in supporting and advocating for particular trainees’ needs. Also, the trainee committee regularly bring trainees’ issues to the Dean or to the postgraduate training committee where they can be discussed and solutions explored.”
“During the Covid-19 pandemic, there have been particular difficulties for those trainees with underlying medical conditions who cannot work face-to-face. The College has allowed virtually all training activities to be carried out by distance and, to date, each of these trainees has been able to progress in training.”
Dr Lynch said issues, such as salary, overtime payments, pension contributions, or other contractual matters relating to the terms and conditions of employment for part-time trainees, were “dealt with by the employer and not by the training body”.
“The CPsychI requirement of training sites is that all trainees should receive the terms and conditions of the current HSE NCHD employment contract. Of note, there is no reference to job sharing in the HSE NCHD contract, nor are there any specific HSE guidelines for HR departments in implementing job sharing for trainees (or consultants for that matter).”
Comment from the RCPI and the RCSI (in regard to surgical training) was awaited at press time.
the study were as follows: Training bodies and the HSE/NDTP should issue “strong statements” of support for LTFT training; expansion of LTFT training options; time limits on the duration of LTFT training should be removed; LTFT training should be open to all trainees; “better engagement” with trainees at all levels; awareness campaigns to highlight positive experiences of LTFT trainees and to give accurate information on potential impact on salary, pension etc; teams should receive education on working with LTFT trainees; a central hub for the coordination of LTFT training options should be considered (possibly through the NDTP).
Meanwhile, the number of consultants working LTFT in 2020/21 stood at 13 per cent, according to an NDTP medical workforce report. A higher proportion of females (17 per cent) worked LTFT compared to males (11 per cent).
The HSE was contacted for comment on the flexible training scheme, but no response was received by press time.
The Department of Agriculture, Food and Marine (DAFM) is “currently following up with other agencies” to begin the process of formulating a national action plan on verocytotoxin-producing Escherichia coli (VTEC) infection in Ireland. The Covid-19 pandemic has stalled efforts to hold an inter-agency workshop as a means of commencing the process. A DAFM spokesperson told the Medical Independent (MI) it is seeking to arrange a suitable date to hold the workshop virtually “at the earliest possible opportunity in 2022”.
As previously reported by MI, in 2019 the DAFM termed the level of human VTEC infection as “unacceptable” and warned that “a large outbreak in the future is a real threat”. In a briefing note shared with the Department of Health, the DAFM stated that a Government-wide approach was
needed to make “meaningful progress in addressing this public health threat”.
When two or more individual human cases of VTEC infection are linked and likely to have arisen from the same source, they are described as an ‘outbreak’.
“VTEC outbreaks can involve large numbers of people and the consequences can be catastrophic,” outlined the DAFM briefing note in 2019. “In Canada in the year 2000, VTEC contamination of the Walkerton town drinking water supply resulted in over 2,000 people becoming ill and six deaths….”
“Over the period 2004 to 2017, 830 VTEC outbreaks are known to have occurred in Ireland. Thankfully to date, these have been limited to a small number of individuals – with 86 per cent of all VTEC outbreaks confined to families in private dwellings. However, the next-most com-
Some 136 patients received care at the Rotunda Hospital’s teenage pregnancy service last year, with around one-third being from the Roma community, according to the hospital’s annual report. This was a small increase from 126 patients in 2019.
The service, headed by Consultant Obstetrician and Gynaecologist Dr Geraldine Connolly, provides antenatal care to teenagers up to the age of 19. The clinic may also be attended by other vulnerable patients, including teenage multiparous mothers, as they may benefit from the continuity of care and specialised approach provided.
In 2020 some 59 per cent of attendees at the service were Irish, including 10 per cent from the Travelling community. Roma patients accounted for 32 per cent of attendees.
The report noted that one patient from a Roma background “delivered at home with no medical or midwifery input due to fear of Covid-19 infection in the hospital”.
In terms of pregnancy outcomes for the 121 patients who delivered during the year, there were 79 spontaneous vaginal deliveries, 21 operative vaginal deliveries, five elective Caesarean deliveries, and 16 emergency Caesarean deliveries.
The overall Caesarean delivery rate
I welcome NIAC’s continuous review of all international evidence relating to booster doses. I am accepting and authorising these latest recommendations on the basis that a significant amount of planning will be required to operationalise these booster doses.”
in the teenage population was 17 per cent, which was “consistent with prior years’ experience”.
“It remains reassuring to see a low Caesarean section rate in this young population,” outlined the report. “The excellent attendance rate for routine antenatal care visits during the Covid-19 pandemic was also notable, with 71 per cent of patients accessing supports from the Medical Social Work Service. Our Clinical Midwife Specialist became qualified in examination of the newborn, thereby providing continuity of care in the postnatal ward.”
However, the report also noted that “cancellation of some in-person postnatal clinics due to Covid-19 caused some challenges to continuity of care for this group of patients. Additionally, poor attendance at virtual antenatal classes was also noted.”
The service had several complex cases where patients had significant mental health issues. Three homeless patients also required additional service supports.
“A number of late hospital registrations were noted in patients with very poor English, with an increased requirement for translation services,” added the report.
It was also noted that increased dietician input would be required for this “vulnerable, poorly nourished population” with ferritin levels to be checked routinely at booking.
As GPs we cannot diagnose Covid without a PCR test and it is really important that everyone with any symptoms, even mild ones, self-isolate and await the results of a PCR test. Antigen tests have their place, but where symptoms are present you need a PCR.”
mon setting in which VTEC outbreaks have occurred in Ireland is in childcare facilities, with significant practical and emotional implications for all involved.”
In Ireland, the most common reported transmission route for human VTEC infection is person-to-person spread. As regards primary human infection, water-borne transmission (associated with untreated or poorly-managed private water supplies) and animal contact are the most frequently reported transmission routes.
While VTEC infection is usually uncomplicated, it can cause haemolytic uraemic syndrome (HUS) in 5-to-10 per cent of cases and lead to kidney failure. Five per cent of people who develop HUS may die.
Nationally there were 826 VTEC notifications in 2020, compared with 878 in 2019 and 1,113 in 2018, according to data from the Health Protection Surveillance Centre.
Demand for European Health Insurance Cards (EHICs) has fallen significantly during the period of the Covid-19 pandemic, the Medical Independent (MI) has been told.
A HSE spokesperson also told MI that the impact of the cyberattack on the EHIC service has been resolved.
“There was some initial disruption as applicants could not apply online in the immediate aftermath of the attack,” said the spokesperson. “However, arrangements were made to ensure applications were facilitated throughout the period of loss of the online system and this was coordinated through EU Regulations National Office, Limerick. The online application system has been operating normally since the summer.”
According to figures provided to this newspaper, there were 509,578 EHICs issued by the HSE in 2019. This number fell by over half to a total of 204,031 last year. MI asked how many have been issued so far in 2021, but that figure was not provided.
“Demand for the EHIC has been greatly reduced over the period of the
pandemic,” the spokesperson added. The EHIC annual report figure for the number of valid cards in circulation in 2020 was 1,611,474.
“There is an annual reporting of official figures to the EU and the 2021 figures will be reported next spring,” added the spokesperson. The EHIC allows a patient receive healthcare in another EU or European Economic Area (EEA) state for free, or at a reduced cost. Currently, the EEA comprises of the 27 member states of the European Union together with Iceland, Norway, and Liechtenstein.
The HSE has previously told this newspaper that it does not have a yearly target for the number of EHICs to issue and that the number of cards issued per year “varies considerably” and is “heavily influenced by events in Europe”.
We know that the news of the Omicron variant is causing some concern. However, we also know how to break the chains of transmission of Covid-19 – these measures have worked against previous variants of Covid-19, they can successfully supress transmission of the Delta variant and we are optimistic that they will work against the Omicron variant.”
Lipertance® (Atorvastatin,perindopril,amlodipine): Abbreviated Prescribing Information: Please refer to the Summary of Product Characteristics before prescribing. COMPOSITION*: Lipertance 10mg/5mg/5mg, 20mg/5mg/5mg, 20mg/10mg/5mg, 20mg/10mg/10mg, 40mg/10mg/10mg film-coated tablets contain 10 mg atorvastatin (ator)/5 mg perindopril arginine (per)/5 mg amlodipine (amlo), 20mg ator/5 mg per/5 mg amlo, 20mg ator/10 mg per/5 mg amlo, 20mg ator/10 mg per/10 mg amlo, 40mg ator/10 mg per/10 mg amlo. Contains lactose as excipient. INDICATIONS*: Substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in association with primary hypercholesterolaemia or mixed hyperlipidaemia, in adult patients adequately controlled with atorvastatin, perindopril and amlodipine given concurrently at the same dose level. DOSAGE AND ADMINISTRATION*: One tablet once daily before a meal in the morning. Lipertance is not suitable for initial therapy. If a change of posology is required, the dose could be modified or individual titration with free combination may be considered. Co-administration: with elbasvir/grazoprevir or letermovir, the dose of atorvastatin should not exceed 20 mg/day. Lipertance not recommended when letermovir co-administered with ciclosporin. Elderly and patients with renal failure: frequent monitoring of creatinine and potassium. Clcr < 60 ml/min: not suitable. Hepatic impairment: should be used with caution. Lipertance is contraindicated in patients with active liver disease. Children and adolescents: should not be used. CONTRAINDICATIONS*: Hypersensitivity to the active substances or to any other ACE inhibitor or dihydropyridine derivatives or statin or to any of the excipients, active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal, during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures (see section PREGNANCY* and BREASTFEEDING*), concomitant use with the hepatitis C antivirals glecaprevir/pibrentasvir, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g., hypertrophic obstructive cardiomyopathy and high grade aortic stenosis), haemodynamically unstable heart failure after acute myocardial infarction, history of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy, hereditary or idiopathic angioedema, concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m²) (see section INTERACTIONS*), concomitant use with sacubitril/valsartan (see WARNING* and INTERACTIONS*), extracorporeal treatments leading to contact of blood with negatively charged surfaces (see INTERACTIONS*), significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (see WARNINGS*). WARNINGS*: Special warnings and precaution for use: Liver effects: liver function tests should be performed periodically and in case of transaminase levels increased, the patient should be monitored until resolution. Stop treatment if jaundice or marked elevations of hepatic enzymes (serum transaminases exceeding 3 times the upper limit of normal) and in patients with active liver disease. Use with caution in patients with hepatic impairment, who consume alcohol and/or have history of liver disease. Skeletal muscle effects: stop treatment if elevation of CK levels > 10 x ULN or muscular symptoms with elevation of CK level > 5 x ULN occur, or if rhabdomyolysis is suspected. Caution should be exercice when Lipertance is used with certain medicinal products that may increase the plasma concentration of atorvastatin and then the risk of rhabdomyolysis such as potent inhibitors of CYP3A4 or transport proteins (e.g ciclosporine, ketoconazole, letermovir, ritonavir…). Increased risk of myopathy with concomitant use of gemfibrozil and other fibric acid derivatives, antivirals for the treatment of hepatitis C, erythromycin, niacin and ezetimibe. Co-administration with systemic fusidic acid or within 7 days of stopping the treatment is not recommended. If use essential, Lipertance should be discontinued during fusidic acid treatment. Interstitial lung disease: if suspected, treatment should be discontinued. Diabetes Mellitus: In diabetic patients, glycaemic control should be closely monitored during first month of treatment. Patients with cardiac failure: use with caution. Hypotension: monitor blood pressure, renal function and potassium in patients at high risk of symptomatic hypotension (volume depleted or who have severe renin-dependent hypertension) or with symptomatic heart failure (with our without renal insufficiency), or with ischaemic heart or cerebrovascular disease. A transient hypotensive response is not a contraindication to further doses once the blood pressure has increased after volume expansion. Aortic and mitral valve stenosis/hypertrophic cardiomyopathy: use with caution and see CONTRAINDICATIONS. Kidney transplantation: no experience in case of recent transplantation. Renovascular hypertension: Increased risk of hypotension and renal insufficiency in patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients with unilateral renal artery stenosis. Renal impairment: monitor potassium and creatinine; individual dose titration with the monocomponents recommended if Clcr < 60 ml/min. In patients with renal artery stenosis, blood urea and creatinine may increase; with renovascular hypertension, risk of severe hypotension and renal insufficiency. Amlodipine may be used at normal doses in patients with renal failure. Amlodipine is not dialysable. Haemodialysis patients: use with caution.
Hypersensitivity/Angioedema: stop treatment and monitor until complete resolution of symptoms. Angioedema associated with laryngeal oedema may be fatal. Combination with sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/ valsartan must not be initiated until 36 hours after taking the last dose of perindopril therapy. Perindopril therapy must not be started until 36 hours after the last dose of sacubitril/valsartan. Concomitant use of other NEP inhibitors (e.g. racecadotril) and ACE inhibitors may also increase the risk of angioedema. Concomitant use of mTOR inhibitors: Increased risk for angioedema. Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis: rarely, patients have experienced life-threatening anaphylactoid reactions, temporarily withhold treatment prior to exams. Anaphylactoid reactions during desensitisation: temporarily withhold treatment prior to exams. These reactions reappeared upon inadvertent rechallenge. Neutropenia/agranulocytosis/thrombocytopenia/anaemia: extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treated with allopurinol or procainamide, periodic monitor of white blood cell counts advised. Race: perindopril may be less effective and cause a higher rate of angioedema than in non-black. Cough: resolves after discontinuation. Surgery/Anaesthesia: stop treatment one day prior to surgery. Hyperkaliemia: frequent monitoring of blood potassium if renal insufficiency, worsening of renal function, age (>70 years), diabetes mellitus, dehydration, acute cardiac decompensation, metabolic acidosis, and concomitant use of potassium-sparing diuretics and potassium salts or supplements. Combination with lithium. not recommended Dual blockade of the renin-angiotensin-aldosterone system (RAAS): concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS is therefore not recommended. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Primary aldosteronism: Use not recommended in patients with primary hyperaldosteronism (not responding to drugs acting through inhibition of reninangiotensin system). Galactose intolerance/glucose- galactose malabsorption/total lactase deficiency: should not be taken. Sodium: ‘sodium-free’. INTERACTIONS*: Contraindicated: Aliskiren (in diabetic and impaired renal patients), Extracorporeal treatments, Sacubitril/valsartan, Glecaprevir/pibrentasvir. Not recommended: CYP3A4 inhibitors, aliskiren, concomitant therapy with ACE inhibitor and angiotensin-receptor blocker, estramustine, lithium, Co-trimoxazole (trimethoprim/sulfamethoxazole), potassium- sparing diuretics (e.g. triamterene, amiloride, eplerenone, spironolactone), potassium salts, dantrolene (infusion), grapefruit or grapefruit juice. Precautions: CYP3A4 inducers, digoxin, ezetimibe, fusidic acid, gemfibrozil / fibric acid derivatives, transport inhibitors, warfarin, antidiabetic agents (insulins, oral hypoglycaemic agents), baclofen, non-steroidal anti- inflammatory medicinal products (NSAIDs) (including aspirin ≥ 3 g/day), racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus), colchicine, colestipol, oral contraceptives, gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin), sympathomimetics, tricyclicantidepressants/antipsychotics/anesthetics, gold, digoxin, atorvastatin, warfarin or ciclosporine, tacrolimus, antihypertensive agents and vasodilators. PREGNANCY AND BREASTFEEDING*: Lipertance is contraindicated during pregnancy and lactation. FERTILITY*: Reversible biochemical changes of spermatozoa in some patients treated by calcium channel blockers. DRIVE AND USE MACHINES*: May be impaired if dizziness, headache, fatigue, weariness or nausea. Caution is recommended especially at the start of treatment. UNDESIRABLE EFFECTS*: Very common: Oedema. Common: nasopharyngitis, hypersensitivity, hyperglycaemia, somnolence, dizziness, headache, dysgeusia, paraesthesia, vertigo, visual impairment, diplopia, tinnitus, palpitations, hypotension (and effects related to hypotension), flushing, pharyngolaryngeal pain, epistaxis , cough , dyspnoea, nausea, vomiting, abdominal pain upper and lower, dyspepsia, diarrhoea, constipation, change of bowel habit, flatulence, rash, pruritus, joint swelling, ankle swelling, pain in extremity, arthralgia, muscle spasms, myalgia, back pain, asthenia, fatigue, liver function test abnormal, blood creatine kinase increased. Uncommon: Rhinitis, eosinophilia, hypoglycaemia, hyponatraemia, hyperkalaemia reversible on discontinuation, anorexia, insomnia, mood altered (including anxiety), sleep disorder, depression, nightmares, tremor, syncope, hypoaesthesia, amnesia, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vision blurred, tachycardia, vasculitis, bronchospasm, dry mouth, pancreatitis, eructation, hepatitis either cytolytic or cholestatic, urticaria, purpura, skin discolouration, hyperhidrosis, exanthema, alopecia, angioedema, pemphigoid, photosensitivity reactions, neck pain, muscle fatigue, micturition disorder, nocturia, pollakiuria, renal failure, erectile dysfunction, gynecomastia, chest pain, pain, malaise, oedema peripheral, pyrexia, blood urea increased, blood creatinine increased, weight increase, white blood cells urine positive, weight decrease, fall. Rare: Thrombocytopenia, confusional state, neuropathy peripheral, cholestasis, psoriasis aggravation, stevens-johnson syndrome, toxic epidermal necrolysis, erythema multiforme, myopathy, myositis, rhabdomyolysis, muscle rupture, tendinopathy sometimes complicated by rupture, hepatic enzymes increased, blood bilirubin increased. Very rare: Leucopenia/neutropenia, agranulocytosis or pancytopenia, haemolytic anaemia in patients with a congenital deficiency of g-6pdh, haemoglobin decreased and haematocrit decreased, anaphylaxis, hypertonia, hearing loss, myocardial infarction secondary to excessive hypotension in high-risk patients, angina pectoris, stroke possible secondary to excessive hypotension in high-risk patients, eosinophilic pneumonia, gastritis, gingival hyperplasia, jaundice, hepatic failure, exfoliative dermatitis, lupus-like syndrome, renal failure acute. Not known: immune-mediated necrotizing myopathy, extrapyramidal disorder (extrapyramidal syndrome), Raynaud’s phenomenon. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) can be considered as a very rare complication associated with ACE inhibitor therapy. OVERDOSE*. PROPERTIES*: Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. PRESENTATION*: Box of 30 film-coated tablets for Lipertance 10mg/5mg/5mg, 20mg/5mg/5mg, 20mg/10mg/5mg, 20mg/10mg/10mg, 40mg/10mg/10mg. FOR BOTH LIPERTANCE AND LIPERCOSYL: MARKETING AUTHORISATION HOLDER Les Laboratoires Servier, 50 rue Carnot, 92284 Suresnes cedex France. www.servier.com. Marketing Authorisation number: PA0568/028/001-005 (LPT) PA0568/032/001-006 (LPC). Legal Classification
The 2020 annual report of Community Healthcare West contains valuable insights into how additional infection prevention and control supports were rolled out across the organisation in response to the Covid-19 pandemic.
Acentral part of the 2020 annual report of Community Healthcare West, which was recently published by the HSE, concerns the service’s response to the Covid-19 pandemic. The report charts how “expeditious work” occurred to ensure that Covid test centres and assessment hubs were established and that personal protective equipment (PPE) was secured and deployed. Services were fast tracked to detect cases, to support GPs in managing people at home where appropriate, and to ensure admission pressures were minimised within the Saolta University Healthcare Group. As with elsewhere in the country, facilities and services were developed while existing services were altered and redesigned to ensure that the needs of patients continued to be met in the most challenging of circumstances.
Infection control
The annual report contains important insights into infection control and prevention (IPC) and highlights the lack of IPC resources that existed in the Community Healthcare Organisation (CHO). At the start of the Covid-19 pandemic, Community Healthcare West only employed one IPC Specialist Nurse.
In the initial stages of the pandemic, activities focused on contingency planning and preparedness in a rapidly evolving situation.
“Staff and service users’ safety was paramount. Business continuity, in a safe and effective environment, was prioritised,” the report states.
“Preparedness planning involved sourcing emergency accommodation solutions to facilitate staff members who had high risk persons within their household. Some staff left their homes, moved to temporary accommodation, to protect their families and support the continuity of service delivery.”
As the situation evolved and the need for support for IPC increased exponentially, the CHO reached out to the Saolta University Healthcare Group.
“The response was prompt and led to a hugely successful joint response across acute and community sectors," according to the report.
“This ongoing collaboration consolidated relationships and bodes well for the future.”
Specialist IPC support was provided on a seven-day basis throughout 2020. Interventions included providing Covid-19, PPE and hand hygiene education on site to services. It also included providing education to service users in Direct Provision sites, and Traveller services in residential addiction facilities. Site visits were also undertaken to review current practices and advise on actions required for nursing homes, as well as mental health and disability services. Two self-isolation units for mental health services use were developed in Castlebar and Tuam. IPC support was also provided to sheltered employment/training centres within the mental health service, and in relation
to the launch of the CAMHS [child and adolescent mental health service] e-hub in Castlerea, Co Roscommon.
The gap in IPC knowledge and expertise was acknowledged as a risk across services.
“The emerging IPC team provided innovative systems to build confidence and capacity to address the crisis in the short-term, much of the work included directing service managers to relevant sources of information and explaining the application of same, advice on cleaning resources and advising the management of facilities to enhance/ ensure the safe isolation of persons with possible or confirmed Covid-19 infection,” according to the report.
The IPC team was supported professionally by the nursing team within antimicrobial resistance and infection control (AMRIC) and later from the newly appointed IPC unit within quality and patient safety, community operations.
“Providing advice, support, and education to staff to give them confidence in managing the situation evolving was critical,” the report states.
There was also the need to respond to the rapid development and release of guidelines by AMRIC/Health Protection Surveillance Centre. These guidelines were disseminated and implementation supported by IPC staff.
IPC membership on the Covid response team and representation on the outbreak control team, chaired by public health, was pivotal in the management of outbreaks across all sectors, particularly in relation to older people services.
After a brief respite towards the end of summer, the second wave followed in the third quarter of 2020. Again the IPC team was mobilised and worked in a manner similar to how it operated at the beginning of the pandemic. The team worked in a “synergistic way”, according to the report. Some members who had returned to their substantive posts were once again released to respond to the need for IPC staff and specialist support.
“The impact and importance of IPC expertise is recognised and acknowledged and by the end of 2020 an Assistant Director of Nursing and a Clinical Nurse Specialist had been appointed with further posts to follow. This development will ensure our CHO continues to deliver safe and quality services.”
Paul Mulholland reports
The emerging IPC team provided innovative systems to build confidence and capacity to address the crisis in the short-term
Respimat® is a soft-mist inhaler - not a DPI or a pMDI.1,2
Respimat® is also reusable - using one Respimat® inhaler with six cartridges can reduce its carbon footprint by 71% vs using the inhaler with one cartridge every month for six months.3
Respimat® is a soft-mist inhaler - not a DPI or a pMDI.1,2 Respimat® (tiotropium) achieved greater lung deposition compared with tested DPIs.3* Respimat®
Concerns over new Covid variants have reignited the argument over vaccine equity and access across the globe, writes David Lynch
The recent emergence of the Omicron variant of Covid-19 has made the calls for greater global vaccine equality even more intense from public health experts. They argue the lack of access to sufficient vaccines in many developing countries is both unfair and dangerous to the future direction of the pandemic.
Recently, a number of Irish doctors founded Doctors for Vaccine Equity. The group's aim is "to highlight the vast inequities in Covid-19 vaccine access worldwide". Specifically, it supports the ‘TRIPS (Trade Related aspects of Intellectual Property Rights) waiver’ to allow vaccine production in the ‘Global South’. The group also calls for an "urgent" global redistribution of current vaccine supplies and to ensure that “any strategy for booster vaccines is ethical within a global context". More than 300 doctors have signed an online petition supporting these measures (see https://globalhealth. ie/doctors-for-vaccine-equity/)
The group wants the Irish Government to support the TRIPS waiver. However, for months there have been calls for the Government to support the WHO Covid-19 Technology Access Pool (C-TAP) and the waiver. Is there any hope such action will be undertaken now?
"I am cautiously hopeful as I think the time may now be right for our Government to reflect on its policy towards Covid-19," Prof Susan Smith, Professor of Primary Care Medicine and GP, Inchicore, Dublin, and one of the founder members of Doctors for Vaccine Equity, told the Medical Independent (MI)
"Understandably, we have been focused on protecting our own population and trying to minimise the impact of this virus in terms of serious illness and deaths but also on our wider society and economy.
"I think we all hoped that the Covid-19
vaccines would represent a path out of the pandemic but it is clear that as long as the SARs-CoV-2 virus continues to circulate it can mutate and continues to threaten our health and wellbeing."
She added that "a Professor of Virology has pointed out that if we were to design an experiment to increase viral mutation globally, our current unbalanced approach to vaccination would be it".
At the end of last month, the Department of Health and Department of Foreign Affairs (DFA) announced that a consignment of 500,000 Covid-19 vaccines donated by Ireland arrived in Nigeria. It was the first part of Ireland's commitment to donate 1.3 million vaccine doses through the COVAX (Covid-19 Vaccines Global Access) facility.
On the issue of the C-TAP, a spokesperson for the DFA told MI that while a number of EU countries had joined the in-
With over 300 Irish doctors supporting the Doctors for Vaccine Equity goals online (see https://globalhealth.ie/ doctors-for-vaccine-equity/), why is the role of medical doctors particularly important for this campaign?
"We've been on the frontline of this pandemic for nearly two years," according to GP Prof Susan Smith.
"We have seen the impact it has had within our own clinical practice and communities."
She told the Medical Independent (MI) that doctors know that their colleagues in the ‘Global South’ "face the same challenges and we want to support them".
"We also hope that we are trusted by our patients and communities and believe that the most effective way to
end the pandemic is to ensure global vaccination to reduce transmission and reduce opportunities for viral mutations."
Dr Christine Kelly, SpR in Infectious Diseases, told MI global access to vaccines is essential in order to bring the pandemic to an end.
"The higher the global SARS-CoV-2 viral load, the more replication, the more transmission and the more opportunity for viral mutation. Vaccination helps decrease transmission, but it also helps the immune system limit opportunities for the evolution of new variants," she said.
"It is essential that we stop approaching this pandemic from a nationalistic viewpoint. It is only by approaching Covid-19 from a global viewpoint that will we get this virus under control."
itiative, "there has not been consensus around this." The spokesperson made no comment on Ireland joining. "Ireland will continue to promote the sharing of technology and has fully shared the intellectual property behind the Covid Tracker App to assist other countries in their contact tracing efforts."
On the TRIPS waiver, the DFA spokesperson noted that "Ireland supports the EU commitment to an open dialogue with all WTO members to explore how to support universal and equitable access to Covid-19 vaccines and treatments...".
Another founding member of the group, Dr Christine Kelly, SpR in Infectious Diseases and Clinical Fellow in Public Health Virology, told MI that "we believe that the most important path to an effective global vaccination campaign is through empowering economically disadvantaged countries to access vaccine production technology".
"The protection of intellectual property rights and technology processes by a handful of pharmaceutical companies is blocking a successful global pandemic strategy. We urgently need to do everything we can to facilitate generic production of Covid-19 vaccines so that an adequate vaccine supply can be manufactured and so regions are able to adjust vaccines to respond to variants as they emerge".
She added that the TRIPS waiver is a motion put to the World Trade Organisation to temporarily waive intellectual property rights for health technologies needed to prevent, contain, or treat Covid-19. This waiver would remain in place “until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity”.
"The US supports the TRIPS waiver, but unfortunately the EU has not joined them. We strongly believe that Ireland must advocate for the support of the TRIPS waiver at EU level."
Dr Ciara Conlan, Registrar in Medical Virology, added that the TRIPS waiver complements the WHO's C-TAP.
"In February 2020, Access to Medicines Ireland made a submission on the C-TAP to the Joint Oireachtas Committee on Foreign Affairs and Defence," she told MI
"The committee were unanimous in their conclusion that Ireland should endorse the C-TAP; however, the Government did not follow through on this recommendation.
"We are now at a critical point as the WTO are due to meet shortly to discuss the TRIPS waiver. Ireland should advocate for support for the waiver at EU level, and add our name to the list of 120 countries who support the waiver, including the United States and our Irish Aid partner countries."
But considering the small size of Ireland, does our stance matter significantly?
"We may be small, but the advantage of being within the EU is that we have a voice and we have used this well in recent years," Dr Kieran Harkin, GP and Access to Medicines Ireland co-founder, told MI
"It just takes one firm voice to demand an ethical approach and, if done carefully, this would put great pressure on other countries to follow suit. Ireland has successfully taken a global lead in the past on issues, such as plastic bags, smokeless fuel, and banning of cigarette advertising etc. We also have an important international role through our seat on the security council [of the UN]."
There is an understandable push for booster vaccines. But should 'first world' governments, such as the Irish Government, take into account vaccine global inequality when making decisions on boosters?
"We understand that our patients and colleagues want the best protection they can get but we don’t think this is an ‘either-or’ situation," said Prof Smith.
"We can support countries in the Global South to produce their own vaccines. One area where governments can address global vaccine supply is to avoid vaccine hoarding and wastage. There are estimates that up to 1.2 billion vaccine doses could be wasted in high income countries by the end of this year as they will not be used before they expire. Countries need transparent systems of managing excess doses with adequate timelines to donate or give excess doses to COVAX, which can then redistribute them globally."
Dr Harkin said that there "are hundreds" of pharmaceutical companies who are willing and able to manufacture mRNA vaccine "but they are prevented doing so by the patent holder".
Valerie Ryan speaks to founder of ExWell Medical Dr Noel McCaffrey about the importance of exercise regimens for people with chronic illnesses
Dr Noel McCaffrey is the founder and CEO of ExWell Medical, a social enterprise targeting secondary prevention through ongoing medically-led exercise programmes for patients with chronic illnesses referred by healthcare professionals.
According to a summary of the programme: “The rationale behind ExWell Medical is that a large proportion of the disability and unwellness that comes with any longterm illness is caused by becoming deconditioned. At ExWell we can improve or reverse this with appropriate exercise thereby greatly enhancing a person's quality-of-life.”
ExWell Medical was established in 2019 by Dr McCaffrey, a Consultant in Sports and Exercise Medicine in the National Orthopaedic Hospital Cappagh.
portant as the physical.
“We all get less active as we get older, but it's worse in people with chronic illness for a number of reasons. They become either afraid of physical activity or perhaps specifically afraid of experiencing breathlessness, or they are told to be less active by us, all of which is a very bad idea.
“We can have an enormous impact on quality-of-life without fixing the illness, which is not fixable anyway, by appropriate exercise programmes and it has an absolutely transformative impact on people and on their families, because there is a lot of hidden distress around caring for people with chronic illness.
“What exercise does is very simple: It's accessible; it empowers people to restore the joy of exercise and mobility; it restores hope and facilitates social engagement,” added the former Dublin GAA football player and All-Star.
The programme has its origins in a pre-existing service based in Dublin City University (DCU) called MedEx, which had offered community-based chronic illness rehabilitation – on medical referral – to people with chronic illnesses though structured exercise classes.
Dr Noel McCaffrey“I started off with a phase 4 cardiac rehab programme at DCU,” Dr McCaffrey told the Medical Independent (MI). “It quickly spread to become pulmonary, diabetes, then chronic pain, cancer, Parkinson’s disease and MS [multiple sclerosis]. What became clear to us over time, with some exceptions, was that everybody needs the same intervention; it’s not really different for cardiac or pulmonary or other conditions.
“That insight led to our innovation, which was to bring all chronic illness cohorts into the same programme. Over time, we started offering our programmes based more on the functional capacity of the patient rather than the illness,” he said.
The MedEx centre has developed into the biggest centre of its kind in Europe, hosting 700 participant visits weekly and receiving up to 1,000 new referrals annually. It became clear there was an increasing need to offer the service outside DCU.
A decision was made by DCU not to become involved in the national roll-out. What followed was the formation of a new corporate entity, ExWell Medical CLG, in January 2019 with the aim of bringing the medically-led service to all parts of Ireland.
Three years after establishing the ExWell Medical initiative, Dr McCaffrey has just received a joint National Innovation Award at the recent Future Health Summit. Extensive partnerships have evolved with State agencies, the HSE, sports bodies, GPs, local Government organisations, and busi-
nesses under a wide-ranging series of pilots across the country.
The HSE has funded two centres: In Citywest in Dublin and in Athlone for the Dublin Midlands Hospital Group.
With the roll-out of the chronic disease management programme, Dr McCaffrey said ExWell Medical aimed to position itself as an aid to the ambulatory care hubs and integrated care programmes in community settings.
The ExWell Medical programme has been exploring the needs of specific groups with chronic illnesses; the role of exercise in preparing pre-operative cohorts for surgery; a ‘moving on’ programme for cancer survivors, teenage cancer survivors, and hard-toreach cohorts; and it was hoping to extend other services to children and adolescents in a new project called ExWell Junior.
Dr McCaffrey explained that most chronic illnesses are included in the programme. He said it also provides benefits in other areas. For example, clinical exercise has a huge role to play in preparation for elective surgery and cancer surgery because “it prepares people physically and mentally for surgery and enhances recovery”.
Mental illness and chronic pain are other
areas where the programme can make positive impacts. Regarding the latter, Dr McCaffrey noted there has been a “huge shift away” from medical treatments towards movement-based interventions.
“We surveyed participants to see how many had pain on a regular basis, four days a week, and the answer was 65 per cent. We then asked them, ‘What happened to your pain since you started on this programme’, which would have been four weeks earlier. The answer was, in 95 per cent of cases, the pain either got better or did not change. In 5 per cent of cases, it got worse. There are two messages there: The presence of pain in itself is not a barrier to take part and it might actually get better.”
Dr McCaffrey said the components of fitness are aerobic capacity; strength; flexibility; and balance.
“The thing is that all of those elements of fitness have a fundamental impact on your quality-of-life. Once they fall below certain thresholds, you’ll notice it,” he said.
“The net effect of all of that, in the context of chronic illness, is social isolation, immobility and loneliness. Layered on top of everything else, you get the mental unwellness element, which is just as im-
The benefits of exercise are assessed by measuring strength, aerobic capacity, flexibility balance, and quality-of-life using validated measures. In a recent study carried out at a HSE-funded centre in Citywest, it was found that all key measures improved within six weeks.
“The extent of the improvement for some exceeded what is called the ‘minimally clinical important difference’, which is the level of meaningful difference on clinical impact. The final thing is the biggest impact is seen in those people who start off the worst. We knew that anyway, but it is nice to have it in black and white. In that context, nobody gets turned away. All we need is a little information about the person and their medication and off you go.”
Dr McCaffrey, who continues to personally deliver classes, highlighted that the programme was not aimed at primary prevention. “What we do is secondary prevention so we are dealing with rehabilitation of established illness.”
The programme has made a number of adaptations to ensure safety during the pandemic including online and outdoor activities and smaller group pods.
ExWell Medical accepts referrals from all healthcare professionals including GPs, consultants, nurses, physiotherapists, occupational therapists, and dieticians. Referrals are by Healthmail only and details and forms are provided on the programme website.
Dr McCaffrey paid tribute to the “fantastic team” running the programme as well as the input from undergraduates in healthcare disciplines involved in ExWell.
He was optimistic that the programme is on target to have 22 centres in 2022. “At the moment we have five in Dublin, four outside Dublin. We’re opening up two more outside Dublin in the near future and another five or six in Dublin. There’s interest from lots of places and I think we will easily make that target.”
What exercise does is very simple: It's accessible; it empowers people to restore the joy of exercise and mobility; it restores hope and facilitates social engagementParticipants at ExWell Medical's CityWest facility
Dr Peter Lachman outlines why the RCPI has developed a certificate in leadership for new consultants
Medical education often focuses on ensuring future consultants have the skills and knowledge relevant to their specialty. However, the consultant role is complex, involving far more than the management of clinical conditions. The first three years of the consultant role can be stressful as a newly appointed consultant suddenly must become a leader, working within a multidisciplinary team and interacting with the complexity of healthcare management.
The RCPI has recognised the need to develop programmes that can equip consultants with the additional knowledge and skills that they need to be effective consultants leading a team to deliver safe and effective care.
Recently burnout has become a focus in healthcare, and it has been exacerbated by the Covid pandemic. The Irish Medical Journal , highlighting the challenge of burnout, recommended that preventive measures be undertaken to protect doctors. This is supported by the work undertaken at the National Academy of Sciences, which published a review of burnout and identified the non-clinical components of the job of doctors to be a major contributing factor. We believe that by equipping doctors with the leadership and management skills for their role, we can help to prevent burnout from occurring. In addition, the increasing demands of the health service to deliver safe, effective and efficient care within budgetary constraints implies that we need not only look after the wellbeing of the consultants, but also equip them with the skills to deliver the service.
Leadership
The Medical Council has identified eight domains of professional practice, which describe what a consultant must do to act professionally. At the RCPI, we have identified key leadership components for the consultant and have developed the Certificate in Essential Leadership for New Consultants around these themes – the how to achieve professional practice. This will assist the new consultant in delivering on the domains of professional practice.
Often, leadership for a consultant is learnt behaviour – what has been observed during training. Leadership skills vary and the aim is to develop consultants who know how to be compassionate and humble leaders, at times transactional but mostly transformational, by bringing in the theories of leadership. All these different facets of leadership are required at different times and we will expose the consultants to leaders in the field, who
can discuss how they have managed to be successful leaders.
Professionalism is a core component of being a doctor. The Medical Council states that “doctors must always be guided by their primary responsibility to act in the best interests of their patients, without being influenced by any personal consideration. They should act independently in the service of their patients and have a responsibility to advocate with the relevant authorities for appropriate healthcare resources and facilities.”
Yet the concept of professionalism has been evolving, with the changing demographics of patients with chronic disease, the need to work within teams, to be part of a collective responsibility, and working within a digital age and changing technologies. Ability has changed over the years and this has been highlighted in the pandemic. Doctors and
especially consultants were faced with new demands and the requirement to work differently, make difficult choices and balance competing needs. A recent editorial in The Lancet concluded that we need to ensure that “we as a profession support our doctors and promote ways of working that incorporate the doctor, the patient, teams, healthcare organisations, workplace environment, and health systems.” In addition, with the growth of patient-centred care, the consultant role has changed to become one of partnership with patients rather than one of simply acting upon them. The learners on the course will focus on what it means to be a doctor and how the consultant balances the needs of the individual patient with the greater demands of the health service as a whole.
An essential part of the consultant role is reflective practice and, if done well,
can help to protect the wellbeing of the consultant, the clinical team and the people receiving care. This is a key foundation for developing psychological safety, to understand one’s fallibilities and to be humble and respectful to generate a culture in which everyone is working for each other to deliver safecare. Reflective practice is at the core of being a modern doctor and learners will have the opportunity to hone their skills on the course.
Management skills for consultants are needed on numerous levels. The successful consultant needs to know how to manage teams, work with people from different professions, manage a budget, develop business cases, and appraise trainees to ensure they develop into future leaders. All of this requires a different type of skill to that of diagnosing and managing clinical conditions. In addition, a high preforming organisation will have close working relationships between healthcare management and the clinical leadership. Consultants will need to know how to work with management to use the scarce resources effectively, while advocating for the needs of the patients. This is even more important as we come out of the pandemic and need to manage healthcare differently to achieve the outcomes all desire.
Quality and patient safety are now essential elements of healthcare. Whereas it was once thought to be part of being a professional, the need to understand the theories and methods of improvement science and patient safety science has become apparent over the past 20 years. Consultants are essential leaders for patient safety and quality and learners will learn about the challenges of keeping people safe, human factors, climate change and equity. These are vital skills that are often overlooked in clinical training.
As we look at the increasing demands of healthcare, we must build a workforce that is focused on delivering high quality care to all. This will require clinical leaders at every level. The consultant is a key component for the success of Irish health care services and by investing in them at the start of their careers, we will reap the benefit for many years to come.
The Certificate in Essential Leadership for New Consultants is designed for recently-appointed consultants or those who wish to apply for consultant roles. The programme will commence in January and run until June 2022. The closing date for applications is 17 December 2021.
Reflective practice is at the core of being a modern doctor and learners will have the opportunity to hone their skills on the course
DR PETER LACHMAN
International Lead Faculty, Leadership Quality Improvement and Patient Safety, RCPI
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.
ABRIDGED PRESCRIBING INFORMATION
TRIXEO AEROSPHERE® 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension (formoterol fumarate dihydrate/ glycopyrronium/ budesonide)
Consult Summary of Product Characteristics (SmPC) before prescribing. Indication: Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist. Presentation: Pressurised inhalation, suspension. Each single actuation (delivered dose, ex-actuator) contains 5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2 micrograms of glycopyrronium and budesonide 160 micrograms. This corresponds to a metered dose of 5.8 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 10.4 micrograms, equivalent to 8.2 micrograms of glycopyrronium and budesonide 182 micrograms. Dosage and Administration: The recommended and maximum dose is two inhalations twice daily (two inhalations morning and evening). If a dose is missed, take as soon as possible and take the next dose at the usual time. A double dose should not be taken to make up for a forgotten dose. Special populations: Elderly: No dose adjustments required in elderly patients. Renal impairment: Use at recommended dose in patients with mild to moderate renal impairment. Can also be used at the recommended dose in patients with severe renal impairment or end-stage renal disease requiring dialysis, only if expected benefit outweighs the potential risk. Hepatic impairment: Use at recommended dose in patients with mild to moderate hepatic impairment. Can also be used at the recommended dose in patients with severe hepatic impairment, only if expected benefit outweighs the potential risk. Paediatric
Population: No relevant use in children and adolescents (<18 years of age).
Method of administration: For inhalation use. To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient’s inhalation technique. Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Not for acute use: Not indicated for treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Paradoxical bronchospasm: Administration of formoterol/glycopyrronium/ budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life threatening.
Treatment should be discontinued immediately if paradoxical bronchospasm occurs. Assess patient and institute alternative therapy if necessary.
Deterioration of disease: Recommended that treatment should not be stopped abruptly. If patients find the treatment ineffective, continue treatment but seek medical attention. Increasing use of reliever bronchodilators indicates worsening of the underlying condition and warrants reassessment of the therapy. Sudden and progressive deterioration in the symptoms of COPD is potentially life threatening, patient should undergo urgent medical assessment.
Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol. Use with caution in patients with clinically significant uncontrolled and severe cardiovascular disease such as unstable ischemic heart disease, acute myocardial infarction, cardiomyopathy, cardiac arrhythmias and severe heart failure. Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males or > 470 milliseconds for females), either congenital or induced by medicinal products. Systemic corticosteroid effects: May occur with any inhaled corticosteroid, particularly at high doses prescribed
for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma. Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have co existing risk factors for osteoporosis. Visual disturbances: May be reported with systemic and topical corticosteroid use. If patient presents symptoms such as blurred vision or other visual disturbances, consider ophthalmologist referral for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR). Transfer from oral therapy: Care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia: Potentially serious hypokalaemia may result from β2-agonist therapy. This has potential to produce adverse cardiovascular effects. Caution is advised in severe COPD as this effect may be potentiated by hypoxia. Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics.
Hyperglycaemia: Inhalation of high doses ofβ2-adrenergic agonists may produce increases in plasma glucose. Blood glucose should be monitored during treatment following established guidelines in patients with diabetes. Co-existing conditions: Use with caution in patients with thyrotoxicosis. Anticholinergic activity: Due to anticholinergic activity, use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop. Co-administration of this medicinal product with other anticholinergic containing medicinal products is not recommended. Renal impairment: Patients with severe renal impairment (creatinine clearance of <30 mL/min), including those with end-stage renal disease requiring dialysis, should only be treated with this medicinal product if the expected benefit outweighs the potential risk. Hepatic impairment: In patients with severe hepatic impairment, use only if the expected benefit outweighs the potential risk. These patients should be monitored for potential adverse reactions. Drug Interactions: Co-treatment with strong CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products are expected to increase the risk of systemic side effects. Should be avoided unless the benefit outweighs the increased risk, in which case patients should be monitored for systemic corticosteroid adverse reactions. This is of limited clinical importance for short-term (1-2 weeks) treatment. Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms. Other antimuscarinics and sympathomimetics: Co-administration with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products is not recommended as it may potentiate known inhaled muscarinic antagonist or β2-adrenergic agonist adverse reactions. Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects. Caution required when prescribed concomitantly with formoterol. Medicinal product-induced
hypokalaemia: Possible initial hypokalaemia may be potentiated by xanthine derivatives, steroids and non potassium sparing diuretics. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. β-adrenergic blockers: β-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concurrent use of β-adrenergic blockers should be avoided unless the expected benefit outweighs the potential risk. If required, cardio-selective β-adrenergic blockers are preferred. Other pharmacodynamic interactions: Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong QT interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2sympathomimetics. Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. Elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.Pregnancy and Lactation: Administration to pregnant women/women who are breast-feeding should only be considered if the expected benefit to the mother justifies the potential risk to the foetus/ child. Ability to Drive and Use Machines: Dizziness is an uncommon side effect which should be taken into account. Undesirable Events: Consult SmPC for a full list of side effects. Common (≥ 1/100 to < 1/10): Oral candidiasis, pneumonia, hyperglycaemia, anxiety, insomnia, headache, palpitations, dysphonia, cough, nausea, muscle spasms, urinary tract infection. Uncommon (≥ 1/1,000 to < 1/100): Hypersensitivity, depression, agitation, restlessness, nervousness, dizziness, tremor, angina pectoris, tachycardia, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles), throat irritation, bronchospasm, dry mouth, bruising, urinary retention, chest pain. Very Rare (< 1/10,000): Signs or symptoms of systemic glucocorticosteroid effects, e.g. hypofunction of the adrenal gland, abnormal behaviour. Not known: Angioedema, vision blurred, cataract, glaucoma.
Legal Category: Product subject to prescription which may be renewed (B)
Marketing Authorisation Number: EU/1/20/1498/002 120 actuations
Marketing Authorisation Holder: AstraZeneca AB, SE-151 85, Södertälje, Sweden.
Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, Block B, Liffey Valley Office Campus, Dublin 22.
Tel: +353 1 609 7100.
TRIXEO and AEROSPHERE are trademarks of the AstraZeneca group of companies.
Date of API preparation: 07/2021 Veeva ID: IE-2842
Adverse events should be reported directly to; HPRA Pharmacovigilance, Website: www.hpra.ie Adverse events should also be reported to AstraZeneca Patient Safety on Freephone 1800 800 899
1. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. Summary of Product Characteristics. Available at www.medicines.ie
2. Rabe KF et al. Triple inhaled therapy at two glucocorticoid doses in modeate-to-very-severe COPD. N Engl J Med. 2020;383:35–48. doi: 10.1056/ NEJMoa1916046 COPD. N Engl J Med. 2020;383:35–48. doi: 10.1056/NEJMoa1916046
REACTION TO OUR LEAD STORY, 'IT AND STAFFING DEFICITS CONTINUE TO IMPACT PUBLIC HEALTH'S RESPONSE TO COVID-19', 29 NOVEMBER
On 29 November, in a joint statement, the Department of Health and the Department of Foreign Affairs announced that a consignment of 500,000 Covid-19 vaccines donated by Ireland arrived in Nigeria.
The Minister for Health Stephen Donnelly noted that this is Ireland’s second significant vaccine donation in recent months following a recent delivery to Uganda.
However, the delivery to Nigeria was the first consignment of vaccines donated by Ireland through the COVAX process. COVAX is co-led by the Coalition for Epidemic Preparedness Innovations, Gavi and the World Health Organisation (WHO), alongside UNICEF. Its aim is to accelerate the development and manufacture of Covid-19 vaccines and to guarantee fair and equitable access for every country in the world.
“This significant donation of 500,000 vaccines to Nigeria represents Ireland’s continued commitment to universal access to Covid-19 vaccines and their fair and equitable distribution as we work together to bring this global pandemic under control,” according to Minister Donnelly.
So how committed is Ireland to vaccine equity? A feature in this edition of the Medical Independent explores the issue.
The day after the donation announcement, People’s Vaccine Alliance Ireland staged a protest outside Leinster House. According to the group, the reason for the protest was that Ireland and the EU are “blocking” efforts to expand vaccine
production at ongoing World Trade Organisation (WTO) talks. The organisers argue a waiver of WTO trade-related intellectual property barriers (a so-called ‘TRIPS’ waiver) would help to facilitate sustainable production and supply of vaccines, treatments and diagnostic tests essential to ending the global pandemic. Ireland has not committed to the waiver, nor the WHO Covid-19 Technology Access Pool (C-TAP). C-TAP provides a global one-stop-shop for developers of Covid-19 therapeutics, diagnostics, vaccines, and other health products to share their intellectual property, knowledge, and data, with quality-assured manufacturers through public health-driven voluntary, non-exclusive, and transparent licenses.
In April, we reported that Government departments had “noted” the Joint Committee on Foreign Affairs and Defence recommendation that Ireland fully endorses C-TAP. However, months later, no such commitment has been made. While the delivery of vaccines to Uganda and Nigeria is welcome, broader action is required to stop the spread of Covid-19 globally. If solidarity or altruism fails to motivate countries like Ireland to act, will self-interest? The emergence of the Omicron variant shows the consequence of allowing the coronavirus to continue to spread, more or less unchecked, in other parts of the world. But supporting the TRIPS waiver and C-TAP would require standing up to powerful commercial forces and this does not seem to be a decision the Irish Government wishes to make right now, if ever.
”'We still have no national electronic case and outbreak management system'. Why is someone depriving our specialist public health doctors of a critical work tool?" Joe Noonan @NoonanJoe, 30 November
REACTION TO OUR NEWS FEATURE, 'PUBLIC HEALTH: FACING DOWN ANOTHER WAVE', 29 NOVEMBER
"Nice piece." Dr Niall Conroy, @NICU_doc_salone, 1 December
REACTION TO OUR NEWS FEATURE, 'COVID CONTROL: WHAT NEXT FOR HEALTHCARE STAFF', 18 NOVEMBER
"Health Divisional Organiser, Kevin Figgis, underlined that the HSE must fulfil its duties 'as an employer and not just as a health provider'."
SIPTU Health Division, @siptuhealth, 17 November
REACTION TO OUR NEWS FEATURE, 'COVID RESEARCH IN IRELAND: THE STORY SO FAR', 18 NOVEMBER
"Thanks to @med_indonews and @wedderburn_anna for including ESI in this story on #Covid-19 research in Ireland (which we did in collaboration with many, including @hrbtmrn @CochraneIreland @nuigalway)."
Evidence Synthesis Ireland, @EvidSynIRL, 16 November
REACTION TO DR EOIN KELLEHER'S CARTOON, 18 NOVEMBER
"Instead of using the Sláintecare contract as a rare opportunity to improve the damaged relationship between doctors and the health service, the Department seems determined to use it as a means to drive those of us remaining away. My cartoon for @med_indonews #slaintecarecontract." Dr Eoin Kelleher, @EoinKr, 18 November
REACTION TO OUR BREAKING NEWS STORY, 'DOCTORS' ORGANISATIONS DEEPLY CONCERNED ABOUT WINTER PERIOD', 18 NOVEMBER
"Winter Plan from @HSELive provides no clear investment or actions to recruit the consultants required to fill beds with patients and treat them in timely fashion, the IHCA warns @med_indonews." IHCA, @IHCA_IE, November 17
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Will self-interest motivate Ireland to be stronger on vaccine equity?
Staff shortages, overcrowding and exceptional patient demand are some of the factors that have contributed to a pressure cooker atmosphere in many healthcare settings, which is taking its toll on staff and patients alike. Sadly, one consequence of this is a growing number of violent incidents and assaults on healthcare staff.
According to figures from HSE’s National Incident Management Scheme, which were obtained by the Irish Nurses and Midwives Association, more than 8,667 staff reported physical, verbal, and sexual assault in the workplace in 2020. This compares with more than 1,000 reported assaults in 2019 and 948 in 2018. These alarming figures are likely to under-represent the actual number of incidents.
Of course, this is not an exclusively Irish problem. The World Health Organisation (WHO) has noted that between eight per cent and 38 per cent of health workers worldwide suffered physical violence at some point in their careers, largely from patients and visitors. The WHO commented that this “not only had a negative impact on the psychological and physical wellbeing of healthcare staff, but also affects their job motivation. As a consequence, this violence compromises the quality of care and puts healthcare provision at risk. It also leads to immense financial loss in the health sector.” And in May 2021, The Guardian reported that “hundreds of healthcare workers treating Covid patients around the world have experienced verbal, physical, and sometimes life-threatening attacks during the pandemic” citing cases in India, Italy, Mexico, and the US.
While most patients and their families appreciate their skill and dedication, the possibility of encountering violence, intimidation or verbal abuse during their shift is an additional strain on healthcare professionals, who are already working long hours in difficult conditions.
Every healthcare organisation has a responsibility to protect frontline staff, but is there anything that doctors and other healthcare professionals can do to help themselves?
Situational awareness
The first step is to be alert to factors that might make you more vulnerable. The Health and Safety Authority’s guidance on managing the risk of violence and aggression in healthcare includes examples of employees that are at greater risk, including those who:
Provide care and advice for service users with risk factors, such as a history of alcohol or drug misuse or a physical or mental illness, which may cause them to behave unpredictably;
Tell people something they don’t want to hear;
Work alone or work in the community;
Carry, handle or are believed to car-
ry money, valuables (such as expensive equipment) or medication;
Work after normal working hours;
Are new, inexperienced or have not received the necessary training or developed the required skills.
Other typically high-risk situations include Friday and Saturday night in the emergency department, long waiting times, or cases of street violence, which have the potential to spill over.
Recognising high-risk situations at an early stage means you can request additional support and security measures, in line with the Medical Council’s ethical guidance. This says that “you should also take all reasonable steps to protect yourself and your colleagues when treating patients who may be violent or pose other risks to the health or safety of
Patient aggression may seem to come out of the blue if you have missed clues such as body language. This can escalate from restlessness and agitation/irritability to verbal aggression, gestures and threats, and potentially damage to objects and physical assault.
For this reason, it is important for doctors and other healthcare professionals to observe a patient’s manner as much as what they say (this applies to any relatives or friends in attendance).
If you notice warning signs early enough it may be possible to take steps to calm the situation. The HSA guidance recommends training for employees at risk in how to recognise the early signs of aggression, manage difficult situations and de-escalation techniques. If you have not been
may help you find a solution.
Maintain eye contact, but not prolonged.
Aim to position yourself between the patient and the exit, keep away from corners and know how to raise the alarm in an emergency.
If the patient has a weapon, ask them to put it down. Don’t ask them to hand it over.
Use the panic button or call for help.
Leave the room and call security or the police.
If possible, move the patient to an area away from public view.
Even if a patient has been aggressive or you fear they may become violent, they cannot be denied necessary treatment as the Medical Council states that you can only consider refusing treatment in ‘exceptional circumstances’ (39.1). However, it may be reasonable and necessary to consider alternative arrangements for providing treatment, such as with hospital security or gardaí in attendance or close by.
If you have been assaulted
If the worst happens and someone attacks you during a shift or you witness an assault on a colleague or patient, you should raise the alarm immediately. Hospital security should respond to any immediate threat, but it would usually be appropriate to report assaults to the gardaí. They could ask you or the staff member concerned to be examined by a forensic physician so that injuries are fully recorded and necessary samples taken.
Even if you do not want to notify the gardaí, you should still follow your organisation’s reporting procedures to ensure that the incident is properly recorded and investigated. As mentioned above, employers have a legal responsibility to protect staff from harm. The HSA says that organisations must have clear procedures for employees to follow in the event of an aggressive or violent incident and that “employees should be encouraged to report all incidents of violence and aggression, however minor”.
Hospitals should investigate violent incidents to determine the cause, learn lessons and identify trends. If a healthcare professional is unable to work for more than three days as a result, it must be reported to the HSA.
those caring for them” (paragraph 5.5).
Under the Safety Health and Welfare at Work Act 2005 employers also have a duty to ensure, so far as is reasonably practicable, employee safety, health, and welfare at work, including putting in place appropriate control measures to protect employees from violence and aggression.
The HSA guidance calls on organisations to have a policy to address workplace violence and includes examples of safety measures, such as a prominently displayed zero-tolerance and acceptable behaviour policy; restricted access to treatment rooms and staff areas; a visible security presence; and the issue of personal alarms.
trained or are not confident in how to handle a particular situation, you should seek immediate support.
If you can, try to defuse the situation
As implied above, dealing with an aggressive patient takes care, judgement and self-control. The advice of the Medical Defence Union (MDU) is as follows:
Remain calm, listen to what they are saying, ask open-ended questions.
Reassure them and acknowledge their grievances.
Provide them with an opportunity to explain what has angered them. Understanding the source of their frustration
Finally, do not underestimate the effect a violent episode can have on those who experience it, especially when the initial shock has begun to wear off. Take advantage of any counselling services your organisation may offer and seek professional support if you are concerned about your mental health.
MDU members can contact us for further support and advice if encountering difficulties with aggressive or abusive patients.
MDU membership is open to consultants and doctors not currently in training posts working in public hospitals. To find out more information, visit www.themdu.com/ireland or follow us on Twitter @the_mdu
If you notice warning signs early enough it may be possible to take steps to calm the situation
Ican’t be the only one who is increasingly feeling the growing gnawing dread of environmental anxiety in recent times. Even ignoring the damp squib that was the outcome of the recent COP26 conference, the simultaneous news stories of floods and fires across Europe and North America, or even just the unseasonably mild autumn we’ve been having, would have all but the most staunch climate change denier realise that we’re definitely in a new phase of climate change and maybe even at a point of no return.
Such anxiety can overwhelm into paralysis. It’s easy to ask why should one person even bother when countries and large corporations are doing the bare minimum. However, it is thought that healthcare contributes to 4 per cent of Ireland’s greenhouse gas emissions alone. Even making small changes in how we do our jobs could have a significant impact on our future. There is now a greater movement in medicine towards green prescribing and the concept of ‘planetary health’. It seems logical that the health of the planet and the health of its people are inextricably linked. Living in a more inhospitable world is, of course, going be detrimental to our health.
As doctors, even something as simple as changing what inhaler we prescribe can make a difference. It is estimated that the mostly commonly prescribed inhaler in Ireland, the well-known ‘blue inhaler’, Ventolin, with its hydrocarbon emitting spray mechanism releases 28kg of carbon per inhaler per year compared to the new dry powder devices,
which only release 1kg of carbon. Another push factor is that clinical guidelines are now suggesting that we should move away from the reliever inhalers alone towards the combination dry powder formulations. We do, however, also have to consider that the newer inhalers are many times more expensive and can represent a significant cost burden to patients when many have to pay for the full cost of inhalers themselves. If asthma was recognised as a longterm illness, with the subsequent funding of all prescribed medication, such as inhalers, this would be a valuable state intervention that could allow doctors and patients to make better choices for both themselves and the planet, rather than putting all the onus on the individual.
There is also medicine’s contribution to the vast generation of single-use non-recyclable plastic waste. Even an afternoon of administering Covid vaccines generates a bin full-to-bursting with syringe and needle wrappers. It staggers the mind to think of this being replicated across the world as we try to vaccinate ourselves out of this mess. Of course, this is certainly not an argument to not vaccinate
against Covid, but we have to consider whether there is anything that can be done to combat this huge amount of waste that goes to landfill. Perhaps consumer pressure can be put on the companies, which make the syringes and needles, to no longer supply them in packaging coated in plastic that makes it impossible for the individual to recycle.
Single-use instruments are used extensively in all healthcare settings and their benefits for convenience and infection control are obvious. However, all that plastic, metal, and packaging that goes into the yellow bin is incinerated, which has clear environmental impacts. Perhaps we should consider going back to the old days of the autoclave machine and reusable instruments where possible.
Maybe we need to examine whether we are careless about throwing things in the expensive yellow clinical waste bins that don’t need to be incinerated or specially disposed. Simple things like making a bigger effort to recycle nonclinical waste in healthcare settings, shredding and recycling paper, turning off lights, and switching off computers completely at the end of the day would seem obvious to a child, but are very easy to do if we make the effort to think of them.
More significant reform on an institutional and organisational level can also be made. If the roasting hot hospitals and nursing homes of Ireland would only turn down their heat by a couple of degrees, we would probably get several decades more out of the polar ice caps at least.
There is no one perfect answer or solution to this. But many little changes that seem infinitesimally small in the grand scale of things can make a difference. Yes, we do need the worst emitting countries and corporations to get on board. While we wait for them, rather than giving up, we as individuals can try our best to make a difference and hopefully protect our planet for future generations.
The contributions of the late Dr Des McGrath to the specialty of psychiatry in this country were enormous
Read more by Prof Brendan Kelly at www.mindo.ie
Iwas deeply saddened to read of the death of Dr Sean Desmond (Des) McGrath, a distinguished psychiatrist who will be familiar to many readers. McGrath was Medical Director of St John of God Hospital in Stillorgan, where he first took up a post in the mid1950s. He retired in the 1990s and died in September 2021, in his 100th year.
McGrath was a remarkable person. Over the course of his long career, psychiatry in Ireland changed dramatically, and McGrath was a key part of that shift over several decades.
To appreciate the context, it is useful to remember that these were times of radical transformation in the Irish mental health system. At national level, the number of inpatients across the country fell from 19,801 in 1963, to a relatively low total of 4,256 in 2001. The nature of service provision also changed, not least because the independent sector developed considerably from the middle of the 20th Century onwards. St John of God Hospital and McGrath were key agents of that change.
St John of God Hospital has a long, distinguished history. The Brothers of St John of God first established a private psychiatric hospital in Stillorgan, Co Dublin in 1882. The Order already had an extensive history of assisting the mentally ill in France and elsewhere, so this was not an entirely new departure for them.
The Stillorgan hospital progressed well from the outset.
It was recognised by the Royal Medico-Psychological Association (RMPA) in 1926. In 1950, the hospital hosted a prestigious three-day psychiatric congress, including an official RMPA meeting. Six years later, it became the first psychiatric hospital in Ireland to introduce the “open-door system”. This involved according greater liberty to patients, expanding occupational and recreational therapies, and increasing group activities. The new system met with notable success.
When McGrath took up a post at St John of God in 1955, the hospital had just 132 admissions per year. McGrath, however, proved to be an outstanding clinician, trainer, and service developer, and he consolidated St John of God Hospital as a pioneer in teaching and developing psychiatry in Ireland and beyond. By the time McGrath retired in the 1990s, the hospital had approximately 1,750 admissions per year.
By 1997, there were 210 beds at the hospital, including inpatient provision for the innovative Cluain Mhuire community mental health service. The Inspector of Mental Hospitals noted that “the quality of inpatient accommodation at St John of God was very high and continuous improvements were being made”. The hospital developed speciality services in addictions, adolescent mental health, eating disorders, psychiatry of later life, psychosis, stress management, wellness and recovery programmes, and programmes for mindfulness and relaxation.
McGrath was central to many of these changes, but his contributions to the development of psychiatry extend well beyond the hospital that he led so skilfully. I would like to draw attention to a book that he co-edited in 1963, titled The Priest and Mental Health, as just one example of his broader contributions. Published by Alba House in New York, this remarkable volume was edited by the Reverend E F O’Doherty, UCD Professor of Logic and Psychology, and McGrath. It richly merits renewed attention today.
The volume opens with an introduction by John C McQuaid, Archbishop of Dublin and Primate of Ireland. McQuaid points out that “St Thomas, in dealing with the passions, treats them as passiones animae, the passions of the soul. That, I submit, is the most fundamental concept of true psychotherapy”.
Further contributions to the book focus on “the priest and mental health” (O’Doherty), “diseases of the mind” (Professor John Dunne), “early symptoms of psychological disorders” (McGrath), and “child psychiatry” (Dr John J Stack). There is a strong religious dimension to certain chapters, looking at “psychoanalysis, psychotherapy, and spiritual direction”, “confessional problems of the mentally ill”, and “the mental hospital chaplain”. There are also considerations of “marriage problems”, “alcoholism”, and “the problem of scruples”, among other issues.
Perhaps the most interesting contribution comes from McGrath himself, where he explores “current developments in psychiatry”. McGrath writes in detail about novel physical and pharmacological treatments, as well as the “open door system” and day hospitals. He finishes by drawing attention to the centrality of the patient, who lies at the very heart of care: “If the individual and his personal problems are lost sight of, no amount of physical or pharmacological treatment will be effective.”
This sentiment is a fitting reflection of a life that was devoted to caring for the mentally ill, training a new generation of psychiatrists, and improving our understanding of mental ill-health. McGrath’s contributions were enormous. Irish psychiatry is profoundly in his debt.
Prof Brendan Kelly is Professor of Psychiatry in Trinity College Dublin and author of Hearing Voices: The History of Psychiatry in Ireland (Irish Academic Press).
The healthcare sector has an important role to play in combatting the climate crisis
As doctors, even something as simple as changing what inhaler we prescribe can make a difference
Question 1
A. With grass pollen allergy typically get symptoms from early April.
B. Ideally should have their diagnosis confirmed by skin prick and RAST testing.
C. Should begin medication as soon as their symptoms get troublesome.
D. Should use oral antihistamines to relieve all nasal symptoms.
E. With asthma symptoms, may find them reduced with use of nasal corticosteroids.
Question 2
Characteristic features of a simple ankle strain (with damage to a few fibres of a ligament only) include
A. Slight swelling.
B. Bruising.
C. Joint irritability.
D. Discomfort over the ligament.
E. Dramatic pain relief with cold compresses.
Question 3
A. Predominantly affects men.
B. Recognised symptoms include non-restorative sleep.
C. Patients have an elevated creatine kinase.
D. Treatment of choice is NSAIDs.
E. Patients should be advised to avoid all exercise.
Question 4
A. Is taken twice weekly.
B. Should be started the day before travel.
C. Is contraindicated if breast feeding.
D. May cause neuropsychiatric adverse events.
E. Should be taken for four weeks after leaving a malaria area.
Question 5
E. FALSE. Bilateral field loss and may affect central vision.
D. TRUE. Transient loss as can also occur in retinal embolic events.
C. FALSE. Retinal artery loss is not transient, like retinal detachment and retinal vein occlusion.
B. TRUE. May cause transient, unilateral loss often without associated headache.
A. FALSE. Established lost vision, usually with pain on eye movement.
ANSWER 5
Recognised causes of transient, sudden, painless loss of vision include
A. Optic neuritis.
B. Migraine.
C. Vitreous haemorrhage.
D. Raised intracranial pressure.
E. CVA.
E. TRUE. To suppress parasites as they emerge from the liver.
D. TRUE. Contraindicated in depression, recent history of mental illness or a history of seizures.
C. TRUE. Is found in breast milk.
B. FALSE. Two-to-three weeks before travel.
A. FALSE. Weekly.
ANSWER 4
D. FALSE. No evidence of effectiveness. Amitriptyline has been the most consistently effective drug in trials.
C. FALSE. This would be raised in myopathy. In fibromyalgia blood tests and x-rays are normal.
B. TRUE. Reduction in REM sleep leads to fatigue and non-restorative sleep.
A. FALSE. Female to male ratio is up to 9:1.
E. FALSE. Modest exercise, perhaps water-based initially, is likely to give some benefit.
ANSWER 3
E. FALSE. May help reduce swelling, but usually increase pain.
A.
D. TRUE. See answer
C. FALSE . Would need major damage with a macroscopic rupture of the ligament to produce this.
B. FALSE. This occurs with a true or severe sprain.
A. TRUE. With pain develops immediately, but settles to a large extent within a few hours.
ANSWER 2
E. TRUE. First-line for moderate-to-severe allergic rhinitis as relieve nasal congestion and sneezing and reduce bronchial hyperresponsiveness.
D. FALSE . Poor for nasal congestion.
C. FALSE. Ideally three weeks before start of season.
B. FALSE. If any tests needed, do skin prick.
A. FALSE. May onwards.
Iron deficiency anaemia is a major cause of morbidity and burden of disease worldwide, but can generally be diagnosed by blood testing and remedied by iron replacement therapy using the oral or intravenous route
Iron deficiency anaemia (IDA) is a major cause of morbidity and burden of disease. It affects approximately two billion people worldwide, is a global health concern and a common comorbidity in multiple medical conditions.3,9 Iron deficiency in the absence of anaemia occurs more frequently. Particularly affecting growing children, pre-menopausal and pregnant women, IDA is increasingly a clinical condition that can also affect older people and those with chronic conditions.1,2 Several chronic diseases are frequently associated with IDA, notably chronic kidney disease, chronic heart failure, cancer, and inflammatory bowel disease.3
Anaemia can be defined as a haemoglobin (Hb) concentration below the lower limit of normal for the relevant population and laboratory performing the test.6 The World Health Organisation (WHO) defines anaemia as a haemoglobin concentration below 130g/L in men over 15 years of age, below 120g/L in non-pregnant women over 15 years of age, and below 110g/L in pregnant women in the second and third trimester.6 IDA, according to the Global Burden of Disease Study 2016, is one of the five leading causes of years lived with disability burden and is the first cause in women.2,7 Globally, IDA has medical and social impacts, accounting for impairment of cognitive performance in young children, adverse outcomes of pregnancy for both mothers and new-borns, decreased physical and working capacities in adults, and cognitive decline in older people.2
The aetiology of IDA is variable and attributed to several risk factors; decreasing iron intake and absorption or increasing demand and loss, with multiple aetiologies often coexisting in an individual patient.1 There are multiple physiological, environmental, pathologic and genetic causes of iron deficiency that lead to IDA. The many causes of iron deficiency include poor dietary intake and malabsorption of dietary iron, as well as a number of significant gastrointestinal pathologies.6 The multiple aetiologies and non-specificity of symptoms can challenge the diagnosis, and the availability of different formulations of iron supplementation can complicate treatment decisions.1
Iron homeostasis involves a number of important processes, including the regulation of intestinal iron absorption, the transport of iron to the cells, the storage of iron, the incorporation of iron into proteins, and the recycling of iron after red blood cell degradation. As there is no active iron excretion mechanism, under normal physiological conditions iron homeostasis is strictly controlled at the level of intestinal absorption.9
Iron deficiency occurs in two main forms: absolute or functional. Absolute iron deficiency arises when total body iron stores are low or exhausted. Absolute iron deficiency may occur in instances of increased demand, decreased intake, decreased or malabsorption, or chronic blood loss.1 Functional iron deficiency is a disorder in which total body iron stores are
normal or increased, but the iron supply to the bone marrow is inadequate. Absolute and functional deficiencies can coexist.3
Iron, a micronutrient, is essential for life. It is an essential component of haemoglobin in red blood cells and of myoglobin in muscles, which contain around 60 per cent of total body iron. Iron is also necessary for the functioning of various cellular mechanisms, including respiration, enzymatic processes, DNA synthesis, and mitochondrial energy generation. In adults, the body contains 3-to5g of iron and 20-to-25mg is needed daily for production of red blood cells and cellular metabolism. Because dietary intake is limited (1-to-2mg per day), other sources are needed for iron homoeostasis including recycling of ageing erythrocytes in macrophages, exchange of iron in iron-containing enzymes, and iron stores. About 1-to-2mg of iron is lost daily as a result of menstrual bleeding, sweating, skin desquamation, and urinary excretion.3 Iron does not have an excretion regulation pathway, and dietary intake, intestinal absorption, and iron recycling have to be finely regulated.3
ulatory hormone controlling the amount of iron in the body. In inflammation, hepcidin levels rise causing iron to be trapped within macrophages and liver cells, therefore, serum iron levels fall. This typically leads to anaemia due to an inadequate amount of serum iron being available for developing red cells. This leads to functional iron deficiency, which develops under conditions where the demand exceeds iron availability.9
The maximum absorption of iron from the diet is less than the body's requirements for iron, resulting in a risk of iron deficiency. In infants and young children aged 0-to-15 years, rapid growth consumes the iron stores that accumulated during gestation, which can lead to an absolute deficiency. Adolescent girls and women of childbearing age are particularly at risk of IDA, because of menstrual iron losses. During pregnancy, iron needs are tripled because of expansion of maternal red cell mass and growth of the foetus and placenta. Anaemia is the most common medical disorder in pregnancy. Pregnancy causes a two- to three-fold increase in the requirement of iron, and a 10- to 20-fold increase in folate
Symptoms
Symptoms of IDA include lethargy, fatigue, dizziness, shortness of breath, palpitations, and pale skin. Less common symptoms include headache, tinnitus, pruritus, sore tongue, hair loss, pica, dysphagia, angular stomatitis, spoon shaped nails, and restless leg syndrome.4
Investigations and diagnosis
Investigations for IDA are guided by a complete history of the presenting symptoms, physical examination and assessment for risk factors. IDA is diagnosed by blood tests that include a full blood count (FBC), and additional tests may be ordered to evaluate the levels of serum ferritin, iron, total iron-binding capacity, and/or transferrin.8 Haemoglobin normal range values for males is 13.8-17.2g/ dL and for females is 12.1-15.1g/dL. If the FBC result shows a low haemoglobin and mean cell volume (MCV – normal range 80-100fL), ferritin levels should be checked. Ferritin levels may be less reliable in pregnancy.8 Serum ferritin (SF) level is considered to be a reliable indicator of iron deficiency in the first trimester of pregnancy in the absence of infection or inflammation, however, in the second and third trimesters it is of limited use, as SF levels fall independently of iron stores.8
Serum markers of iron deficiency include low ferritin, low transferrin saturation, low iron, raised total iron-binding capacity, raised red cell zinc protoporphyrin, increased serum transferrin receptor (sTfR), low reticulocyte Hb (Retic-Hb), and raised percentage hypochromic red cells. SF is the most specific test and useful marker of IDA, but other blood tests, such as transferrin saturation, can be helpful if a false-normal ferritin is suspected.6
Dietary iron is available in two forms; haem and non-haem iron. Haem iron is estimated to contribute 10-to-15 per cent of total iron intake in meat-eating populations, but because it is generally better absorbed than non-haem iron, it can account for more than 40 per cent of total absorbed iron. Foods which include haem iron are liver, beef, lamb, pork, chicken, and oily fish such as salmon and sardines. Some components of diet directly affect iron bioavailability. Non-haem iron is found mainly in non-meat foods such as fortified breakfast cereals, bread, broccoli, cabbage, peas, beans, lentils, eggs, and nuts. Eating foods which contain vitamin C at the same time as eating non haem iron helps with its absorption. Vitamin C can be found in berries, fruit juices, vegetables, and salads. Phytates, found in cereals and vegetables, polyphenols found in vegetables, fruits, some cereals and legumes, tea, coffee, wine, calcium, and proteins inhibit iron absorption. By contrast, ascorbic acid and muscle tissue enhance iron absorption.3 Hepcidin plays a crucial role in the control of iron availability to tissues. High expression of hepcidin decreases plasma iron concentrations and low expression increases concentrations.3 Hepcidin is a naturally occurring protein, secreted by the liver. It acts as a reg-
requirement. Daily iron supplementation is significantly associated with reduced risk of anaemia at term.9
Both pregnancy and lactation place heavier demands on the body for the use of iron and iron stores, particularly as the baby develops and when the body responds to the demands to nurture the baby during feeding. In addition, there are greater physical demands on the body when caring for a newborn, with the change in sleep and dietary patterns of the mother.8
There are, however, many other recognised causes of IDA including blood loss, malabsorption, poor dietary intake, chronic disease, genetic alterations, and the use of non-steroidal anti-inflammatory drugs (NSAIDs).6
Regular blood donors are also at increased risk of iron deficiency.3 Blood loss is the most common cause, especially from the digestive tract. The most common causes of iron malabsorption are coeliac disease, gastrectomy, bypass gastric surgery and Helicobacter pylori colonisation.1 Anaemias caused by genetic defects are a large group of rare, heterogeneous disorders including haemolytic anaemias, and anaemias arising from mutations in genes that control duodenal iron absorption.3 A ferritin deficiency can deplete iron stores quickly and lead to IDA.5
An SF less than 15µg/L is highly specific for iron deficiency (specificity 0.99). A cut-off of 45µg/L provides a respectable specificity of 0.92, and figures below this may warrant consideration of GI investigation, especially in the context of a chronic inflammatory process with anaemia.6
Vitamin B12 and folate levels should be considered if the person is anaemic and the anaemia is normocytic with a low or normal ferritin level; vitamin B12 or folate deficiency is suspected; if there is inadequate response to iron supplements in proven IDA; and in elderly patients.8
Initial investigation of confirmed IDA should include urinalysis or urine microscopy, screening for coeliac disease and in appropriate cases, endoscopic examination of the GI tract.6
Once a diagnosis of IDA has been established, every effort must be made to determine the pathogenesis of the disease. Coeliac disease should be considered in all patients, particularly those with a history of IDA refractory to oral iron.11
The treatment of IDA aims to restore normal circulating Hb levels, replenish body iron
Symptoms of IDA include lethargy, fatigue, dizziness, shortness of breath, palpitations and pale skin
stores, and improve quality-of-life and physiological function.6
Oral iron supplements
Oral iron supplements should be considered for all people diagnosed with iron deficiency to help correct anaemia and replenish iron stores. However, there are some instances when it is inappropriate to take oral iron, particularly if the person has inflammatory bowel disease that is active, has an oral iron intolerance, or is taking erythropoiesis-stimulating agents. There are several iron compounds available as tablets including ferrous sulphate, ferrous fumarate, and ferrous gluconate. Oral iron preparations contain varying amounts of ferrous iron and the frequency of gastrointestinal side-effects related to each different preparation tends to be directly related to the content of ferrous iron. When people are able to take and tolerate iron supplements effectively, haemoglobin should rise by 2g/l every three weeks.9 British Society of Gastroenterology 2021 guidelines for the management of IDA in adults suggest that a good response to iron therapy (Hb rise ≥10g/L within a twoweek timeframe) in anaemic patients is highly suggestive of absolute iron deficiency, even if the results of iron studies are equivocal.6
There are several limitations to taking iron supplements. Only a small amount is actually absorbed, particularly if there is inflammation. Between 10-to-40 per cent of people taking oral iron supplements experience gastrointestinal side-effects, including diarrhoea or constipation, and do not fully adhere to the prescribed course.9
Regular Hb monitoring is recommended to ensure a satisfactory response and FBC and iron levels should be checked monthly until the Hb is in the normal range. Once Hb is normal, oral iron is continued for three months, but may need to be continued for longer. The patient should be advised of potential GI side-effects including constipation and dark stools and that taking ascorbic acid (vitamin C) can help with iron absorption.9 After the restoration of Hb and iron stores with iron replacement therapy (IRT) the blood count should be monitored periodically, every six months initially to detect recurrent IDA.6
Traditional oral iron salts, ferrous sulfate, ferrous gluconate and ferrous fumarate are inexpensive, effective, safe and readily available, and remain the standard therapies for IDA.6 Iron supplements should be taken either two hours before or four hours after administration of antacids. Iron as a ferrous salt is more easily absorbed. Iron salts should not be taken with food, because the phosphates, phytates and tanates in food bind to the iron and affect absorption. Other factors that can affect absorption of iron salts include antacids, H2 receptor antagonists, proton pump inhibitors, antibiotics; for example, quinolones and tetracyclines, and food and drinks containing calcium.11 The most economic iron preparation is ferrous sulphate. Each tablet contains 325mg of iron salts, of which 65mg is elemental iron. Adverse effects occur in the digestive tract, and include abdominal discomfort, nausea/ vomiting, diarrhoea and/or constipation and are directly related to the amount of elemental iron ingested.11
Intravenous iron is given when there is an
oral iron intolerance/poor adherence, or if there is a poor response to oral iron. It needs to be given in a specialist environment. The intravenous route for iron replacement therapy (IRT) may be preferable from the outset in those with ongoing significant bleeding, malabsorption due to GI disease, the combination of iron deficiency and anaemia of inflammation, or issues with administration such as severe dysphagia or compliance.6 However, there are a number of contraindications including known hypersensitivity to intravenous iron, anaemias not caused by iron deficiency, iron overload, and first trimester of pregnancy. Precautions to take into account include asthma, eczema or other atopic allergy, liver dysfunction, acute or chronic infection, and hypotension.9
Parenteral IRT preparations are more expensive than traditional oral iron preparations, and there are additional associated costs relating to the facilities, staffing, and equipment required for administering infusions.6 All IV iron preparations should be administered in a setting where resuscitation facilities are available and appropriately trained staff are present. The patient should be observed for adverse effects for at least 30 minutes following each administration.9
Although intravenous iron is more reliably and quickly distributed to the reticuloendothelial system than oral iron, it does not provide for a more rapid increase in haemoglobin levels. The most common adverse effect of intravenous iron is nausea. While rare, anaphylaxis may occur with intravenous iron infusions.12 Infusion-related reactions are uncommon with modern intravenous iron preparations, but hypersensitivity-type and infusion reactions (approximate incidence –0.5 per cent) are more common than with oral iron. Serious adverse reaction rates are low, however, and similar for oral and parenteral iron preparations.6 Hypophosphataemia has been reported with all parenteral iron preparations. This relates to the molecules complexed to the iron, rather than the iron itself.6
While most oral iron supplements are cheap, they are not always well-tolerated, often due to GI side-effects. Intravenous IRT is often necessary for patients with comorbidities which impair iron absorption. While there are several studies reporting the cost-effectiveness of intravenous iron preparations in comparison to oral IRT for specific conditions such as chronic kidney disease, chronic heart failure and inflamatory bowel disease, it is the associated comorbidity which accounts for the improved cost-effectiveness of intravenous iron in these circumstances.6
Blood transfusion
Red blood cell transfusions may be given to patients with severe iron-deficiency anaemia who are actively bleeding or who have significant symptoms, such as chest pain, shortness of breath, or weakness. Transfusions are given to replace deficient red blood cells and will not completely correct the iron deficiency. Red blood cell transfusions will only provide temporary improvement. It is important to find and treat the cause as well as the symptoms.10
Dietary recommendations
In general, a broad range of foods should be incorporated in the diet to prevent iron deficiency. A normal balanced diet contains a total of 12-to-18mg of iron per day. However, only a small amount of iron ingested is absorbed (3-to-5mg per day).9 Iron in the diet
comes in two forms: haem iron and nonhaem iron. Haem iron is found in animal derived foods and non-haem iron in plant derived foods. Non-haem iron is less easily absorbed therefore a balanced diet with iron enhancers is recommended. Foods that enhance iron intake include lean red meat, oily fish, vitamin c in fresh fruit and juices, and fermented products, such as soy sauce and bread. Foods that inhibit iron absorption include calcium, particularly from milk and dairy products, phytates present in cereal brans, grains, nuts and seeds, and polyphenols and tannin in tea and coffee.9
Iron deficiency anaemia in the elderly Anaemia is common in older people, affecting more than 20 per cent over the age of 85 years, and more than 50 per cent of residential/nursing home residents. Aetiologies responsible for anaemia in this age group are complex and often multiple. Iron deficiency is a contributory factor in about half of cases, sometimes associated with deficiencies of vitamin B12 and/or folate. Anaemia in older patients has been shown to contribute to worsening of physical performance, cognitive function and frailty.6 Iron deficiency in the elderly has many potential contributory causes including poor diet, reduced iron absorption, occult blood loss, medication, and chronic disease. Blood loss from mucosal lesions may be compounded by concurrent antiplatelet/anticoagulant therapy.
Older patients are more likely than younger people to have more than one contributing cause. The diagnosis can be confirmed by measurement of ferritin and transferrin saturation, although the former may be difficult to interpret in the presence of coexisting inflammatory conditions.6 The potential risks and benefits of invasive investigation should be carefully weighed up in older adults, particularly those who are frail, have significant comorbidities or reduced life expectancy.
Outlook
Although iron deficiency is one of the oldest and most common medical disorders, the condition has still not received adequate clinical attention and evaluation. IDA presents in primary care and across a range of specialties in secondary care, and because of the insidious nature of the condition it has not always been optimally managed despite the considerable burden of disease, with investigation sometimes being inappropriate, incorrectly timed or incomplete. Many children, elderly patients, and pregnant women continue to have undiagnosed IDA or remain under-treated. IDA is a significant global public health concern that can cause debilitating clinical consequences across age groups, genders, geographies and clinical conditions. Early diagnosis and effective management is required to avoid associated sequelae. Although effective means for iron supplementation exist, making the right and timely choice of treatment is essential to avoid unnecessary delays in iron repletion and correction of anaemia. This can be achieved with increased awareness of the prevalence and causes of IDA, as well as the benefits of treatment, amongst all healthcare professionals in secondary and primary care settings. Primary care healthcare providers especially GPs and general practice nurses (GPNs) play a pivitol role and are often the first to investigate and treat the presence of IDA in patients. Other practitioners
involved in IDA include laboratory technologists, haematologists and pharmacists.
Patient education, improving health literacy and health awareness is an important intervention in the prevention and treatment of IDA. The role of the clinician is to provide ongoing assessment, management, support and education. Key roles are to establish a therapeutic relationship with the patient, assess their understanding of the condition, establish goals and expectations for successful management of the condition and evaluate the patient's physical, emotional, and psychological wellbeing. By implementing person-centred care, monitoring and evaluating symptoms, outcomes and responses to therapy, clinicians play a pivotal role in managing IDA and improving the patient’s quality-of-life.
The design and implementation of preventative and therapeutic interventions to combat disorders of iron metabolism, most commonly IDA, are greatly aided by a clearer understanding of the precise mechanisms regulating iron metabolism. Pharmaceutical companies are actively developing hepcidin agonists and antagonists to combat iron overload and anaemia. Ongoing research in science and medicine to better understand iron metabolism and the role of hepcidin as a diagnostic tool and treatment target could bring advances and more novel diagnostic and therapeutic interventions for IDA in the future.
1. Cappellin M, Mussalam K, Taher A. (2020). Iron deficiency anaemia revisited. Journal of Internal Medicine. doi: 10.1111/joim.13004
2. Camachella C. (2019). Iron Deficiency: Iron metabolism and its disorders. Blood. doi: 10.1182/blood-2018-05-815944
3. Lopez A, Cacoub P, MacDougall, I, PeyrinBiroulet L. (2015). Iron deficiency anaemia. Lancet Available at: www.thelancet.com/journals/lancet/ article/PIIS0140-6736(15)60865-0/fulltext
4. HSE (2021). Iron deficiency anaemia. Health Service Executive, Ireland. Available at: www.hse. ie/conditions/iron-deficiency-anaemia/
5. Gastrolife (2020). Ferritin and iron. Available at: https://gastrolife.ie/ferritin-and-iron/
6. BSG (2021). British Society of Gastroenterology guidelines for the management of iron deficiency anaemia in adults. www.bsg.org.uk/wp-content/ uploads/2011/05/Iron-Deficiency-Aneamia-inAdults-gutjnl-2021-325210.pdf
7. GHDx (2016). Global burden of disease study 2016 (GBD 2016) data resources. Available at: http://ghdx.healthdata.org/gbd-2016
8. NICE (2021). Anaemia-iron deficiency: What investigations should I arrange to confirm iron deficiency anaemia? National Institute of Clinical Excellence. UK. Available at: https://cks. nice.org.uk/topics/anaemia-iron-deficiency/ diagnosis/investigations/
9. RCN (2019). Iron deficiency and anaemia in adults. Royal College of Nursing. UK. Available at: www.rcn.org.uk/professional-development/ publications/pub-007460
10. American Society of Haematology (2021). Irondeficiency anaemia. Available at: www.hematology. org/education/patients/anemia/iron-deficiency
11. Science Direct (2015). Iron deficiency anaemia. Available at: www. sciencedirect.com/science/article/pii/ S0185106315000918#bib0335
12. Warner M, Kamran M. (2021). Iron deficiency anaemia. StatPearls Publishing; 2021. Available at: www.ncbi.nlm.nih.gov/books/NBK448065/
(DARATUMUMAB)
Remarkable PFS benefit
>79% RRR* in disease progression or death vs Vd of patients with 1PL of therapy2
Meaningful response 3x
DVd complete response (CR) or better vs Vd2
Unlocking hope
≥5x increase in rate of MRD negativity 2
Transform the treatment of multiple myeloma
DARZALEX® in combination with Velcade® (bortezomib) + dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. See DARZALEX® SmPC for full indication, including its use as a monotherapy.1
* Recorded Response Rates
DARZALEX® 20 mg/ml Concentrate for Solution for Infusion and 1 800 mg Solution for Injection
PRESCRIBING INFORMATION. ACTIVE INGREDIENT(S): Daratumumab. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Newly diagnosed multiple myeloma: in combination with lenalidomide/dexamethasone or bortezomib/melphalan/prednisone in adults, ineligible for autologous stem cell transplant; in combination with bortezomib, thalidomide and dexamethasone in adults, eligible for autologous stem cell transplant. Relapsed/Refractory multiple myeloma: Monotherapy for adults whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on last therapy. In combination with lenalidomide/dexamethasone or bortezomib/dexamethasone in adults who have received ≥ one prior therapy. Darzalex SC: in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. AL Amyloidosis: Darzalex SC in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. DOSAGE & ADMINISTRATION: Administration by healthcare professional where resuscitation facilities are available, intravenous (IV) infusion or subcutaneous (SC) injection. For SC injection, resuscitation facilities required only for first dose. Adults: Recommended IV dose: 16 mg/kg body weight. Dilute with sodium chloride 0.9% solution for injection and administer by IV infusion using incremental escalation of infusion rate, only if previous infusion well-tolerated. SC dose: inject 15 mL (1 800 mg) Darzalex solution for SC injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes according to dosing schedule. Patients > 120 kg, flat-dose 1 800 mg SC, efficacy not established. SC injection: no dose adjustments based on body weight recommended. Darzalex solution for SC injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars, rotate injection site. During treatment with Darzalex SC injection, do not administer other medicinal products for subcutaneous use at the same site as Darzalex. Check the vial labels to ensure that the appropriate formulation (IV or SC formulation) and dose is being given as prescribed. For dose and schedule of medicinal products administered with DARZALEX, refer to SmPC 4.2 and the corresponding SmPC for other products. Administer pre- and post -injection medicinal products to reduce the risk of infusion related reactions (IRRs). Recommended concomitant medications for management of infusion/injection-related reactions (IRRs): administer pre-IV infusion/SC Injection medicinal products to all patients 1-3 hours prior to every infusion (corticosteroid, antipyretics and antihistamine). For SC injections, premedications can be given orally from the first dose. When dexamethasone is background regimen specific corticosteroid, this dose will serve as pre medication on infusion days. If dexamethasone given on infusion day, do not take additional background regimen specific corticosteroids (e.g. prednisone). Post-IV infusion/SC injection medicinal products should be administered to reduce the risk of delayed IRRs: administer oral corticosteroid. SC injections: if the patient experiences no major IRRs after the first three SC injections, post-injection corticosteroids (excluding any background regimen corticosteroids) may be discontinued. Consider short/long acting bronchodilators and inhaled corticosteroids in patients with history of chronic obstructive pulmonary disorder. IV Infusion: Any grade/severity IRRs, interrupt Darzalex immediately and manage symptoms. Re-starting Darzalex IV infusion: reduce infusion rate (refer to SmPC); Grade 4 IRRs (or third occurrence of Grade 3) – permanently discontinue. For haematological toxicity dose delay may be required to allow recovery of blood cell counts. No dose reductions of Darzalex recommended. Consider anti viral prophylaxis for prevention of herpes zoster virus reactivation. Children: No data available. Elderly/ Renal impairment/Hepatic impairment: No dose adjustments. CONTRAINDICATIONS: Hypersensitivity to active substance or excipients. SPECIAL WARNINGS & PRECAUTIONS: IRRs: can cause serious IRRs including anaphylactic reactions. Majority occurred following first IV infusion/SC injection. Fatal outcomes have been reported with IV infusion. IV infusion: monitor for IRRs throughout the IV infusion, continue monitoring post-IV infusion until symptoms resolve. For SC injection, median time to onset of IRRs was 3.7 hours following injection, monitor IRRs especially in the first and second
SC injection. IV infusion: interrupt Darzalex for any severity IRRs. Institute medical management/ supportive treatment as needed. For both IV and SC Darzalex if an anaphylactic reaction or life threatening (Grade 4) IRR occurs, initiate appropriate emergency resuscitation immediately and discontinue Darzalex immediately and permanently. Neutropenia/Thrombocytopenia: Darzalex may increase neutropenia and thrombocytopenia induced by background therapy; monitor for infections & periodic complete blood cell counts (refer to relevant SmPCs); consider supportive care. Indirect Antiglobulin Test (Indirect Coombs Test): Daratumumab binds to CD38; may mask detection of antibodies to minor antigens; ABO and Rh blood typing not impacted. Interference may occur up to 6 months post-treatment. Type and screen patients prior to starting daratumumab; consider phenotyping; red blood cell genotyping not affected by daratumumab. Inform blood transfusion centres when appropriate. If emergency transfusion required, give non-cross-matched ABO/RhDcompatible RBCs. Hepatitis B virus (HBV) reactivation: Fatal cases reported in patients treated with Darzalex. Perform HBV screening before initiation of treatment. Suspend treatment in patients who develop reactivation of HBV while on Darzalex. Patient’s with body weight >120 kg receiving SC injection, potential for reduced efficacy. IV infusion contains sodium. SC injection contains sorbitol.
SIDE EFFECTS: Very common: IRRs, pneumonia, bronchitis, upper respiratory tract infection, anaemia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, decreased appetite, peripheral sensory neuropathy, paraesthesia, headache, hypertension, cough, dyspnoea, nausea, diarrhoea, constipation, vomiting, back pain, muscle spasms, fatigue, pyrexia, oedema peripheral, asthenia. SC only: insomnia, arthralgia, rash. Common: urinary tract infection, influenza, sepsis, cytomegalovirus infection, hypogammaglobulinemia, hyperglycaemia, hypocalcaemia, dehydration, fainting, atrial fibrillation, pulmonary oedema, pancreatitis, chills. SC only: dizziness, musculoskeletal chest pain, pruritus, injection site reactions. Other side effects: HBV reactivation (uncommon), anaphylactic reaction (rare). Refer to SmPC for other side effects. LEGAL CATEGORY: Prescription only medicine. PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S): 5 ml vial (100mg daratumumab), X 1, EU/1/16/1101/001; 20 ml vial (400mg daratumumab), X 1, EU/1/16/1101/002; 15 ml vial (1 800 mg daratumumab), X 1, EU/1/16/1101/004. MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL – Co. Cork P43 FA46. Prescribing information last revised: October 2021
Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance, Website: www.hpra.ie. Adverse events should also be reported to, Janssen Sciences Ireland UC on 1800 709 122 or at dsafety@its.jnj.com.
References: 1. Darzalex® SmPC. Available at www.medicines.ie/medicines/darzalex-1-800-mg-solution-forinjection-34971/patient-info. 2. Weisel K et al, Castor Four Year Update. Ash 2019, Poster 3192.
Date of Preparation: November 2021 | CP-273392 | Janssen Sciences Ireland UC 2021
ALL REPORTS PRISCILLA LYNCHNew international clinical practice guidelines have been published for the diagnosis and management of von Willebrand disorder (VWD).
Despite being the most common inherited bleeding disorder, with approximately onein-1,000 of the population being affected, VWD is underdiagnosed, undertreated and under-recognised, and in many countries the proportion diagnosed stands at between 10 and 20 per cent.
The new VWD guidelines aim to improve diagnosis and treatment of VWD and were drawn up by the American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), the US National Hemophilia Foundation (NHF), and World Federation of Hemophilia (WFH), and are published in the journal Blood Advances
Two expert panels made up of international haematologists, people living with VWD and scientists with expertise in appraising clinical evidence developed the guidelines.
They started by identifying the most important clinical questions about VWD diagnosis and treatment through an international survey and panel discussions. This was combined with a systematic review of all available evidence about VWD, conducted by the University of Kansas Medical Center, US, which the panel referred to when making its recommendations.
The finalised guidelines detail 19 recommendations on diagnosis and management of VWD.
Key recommendations include the role of bleeding-assessment tools in the assessment of patients suspected of VWD, diagnostic assays and laboratory cut-offs for type 1 and type
2 VWD, how to approach a type 1 VWD patient with normalised levels over time, and the role of genetic testing vs phenotypic assays for types 2B and 2N. Future critical research priorities are also identified.
For the first time, it is recommended that VWD patients who suffer from frequent, severe bleeding that decreases their quality-of-life should receive routine VWD prophylaxis, an injectable concentrate of clotting protein, several times a week.
Specific regimes are recommended for the treatment of heavy menstrual bleeding with tailored treatment depending on whether or not the woman may wish to conceive.
The establishment of multidisciplinary clinics to include a haematologist and gynaecologist to optimally diagnose and treat women with VWD is also recommended.
The guidelines also call for the classification of VWD to be more inclusive of patients who experience bleeding, but whose blood tests do not meet currently accepted thresholds for diagnosis.
Dr Martin Tallman, from Memorial Sloan Kettering Cancer Center, US and 2021 ASH President, said: “While VWD is a common bleeding disorder, it is also complex, presenting challenges in the timely diagnosis and appropriate management of bleeding for patients.
“Because diagnosis is not straightforward and symptoms range in severity, there is a need for trustworthy guidelines to help improve the quality of care for patients.”
Dr Leonard Valentino, President of NHF, added: “These guidelines are an extremely important step in our quest to address the difficulties individuals go through to obtain an accu-
rate, timely diagnosis, and appropriate treatment.
“The challenge ahead will be for us to educate both those living with VWD and healthcare professionals on the guideline recommendations.”
The guidelines are accompanied by tools and educational resources to help patients, haematologists and other healthcare providers understand and implement the recommendations.
The most common warning sign of VWD for women is heavy menstrual bleeding. One-in-five women will have heavy menstrual bleeding and, of these, up to one-in-five may have an underlying bleeding disorder.
Many people with VWD have suffered through years of frequent nosebleeds, bleeding post dental care, easy bruising or heavy menstrual bleeding prior to diagnosis.
There is thus a need to raise awareness among the general public and among GPs that frequent nosebleeds or heavy menstrual bleeding are not normal and may require investigation via referral to a specialist coagulation centre, according to the Irish Haemophilia Society.
Mr Brian O’Mahony, Chief Executive, Irish Haemophilia Society, said: “Von Willebrand disorder is massively underdiagnosed in many countries, including Ireland. There are currently 1,643 people in Ireland diagnosed with VWD of whom 618 are male and 1,025 are female. We would expect to have 4,900 diagnosed if all those with VWD were identified.”
In April, the Society launched a VWD patient information booklet, series of animated and personal videos and host two webinars to mark World Haemophilia Day. Further information is available at https://haemophilia.ie/
The American Society of Hematology (ASH) recently announced the publication of its 2021 Guidelines for sickle cell disease: Stem cell transplantation. The guidelines are the final instalment of the Society’s five evidence-based clinical practice guidelines on sickle cell disease (SCD).
While rare, SCD is one of the most common inherited red blood cell disorders and can cause severe pain, joint and organ damage, and stroke.
Allogeneic hematopoietic stem cell transplant (HSCT) is currently the only potentially curative therapy for SCD. The new guidelines, published in ASH’s journal Blood Advances, inform how to use HSCT in clinical practice, including through weighing of risks and benefits of transplantation rather than disease-modifying therapies or potential curative therapies still under development, such as gene therapy.
Together, the guidelines in the SCD collection provide evidence-based recommendations for emergency medicine physicians, primary care, haematologists, and patients about how to manage SCD and how to individualise care to help individuals with SCD and their providers make shared and informed decisions. The collection of SCD guidelines covers care topics for which there has been significant uncertainty or variation in clinical practice:
“We have known for decades that transplantation is indeed curative for sickle cell disease, but we have never before had a set of comprehensive recommendations about how the therapy fits into the treatment options for this disease,” said Dr John Tisdale, guideline co-chair and Chief of the Cellular and Molecular Therapeutics Branch at the National Heart, Lung, and Blood Institute (NHLBI). “It is important that discussions about transplantation begin at a young age for all individuals with sickle cell disease as one possible treatment option available over their lifetime. These guidelines inform the continued discussions and
risk-benefit analyses between patients and providers.”
In partnership with the Evidence-Based Practice Research Programme at Mayo Clinic, US, the ASH Guidelines on SCD were developed using the GRADE methodology to ensure the highest standards for trustworthiness. ASH brought together 61 clinical experts, five methodologists, and 10 patient representatives to identify best practices for the management of acute and chronic complications of SCD and ways to improve the quality of care for patients.
Highlights of the ASH guideline recommendations for SCD: Stem cell transplantation:
HSCT should be considered over standard of care (transfusion) in individuals with SCD who have experienced a stroke or are at very high risk of stroke. Further, transplantation should be considered for all patients with neurologic injury who have a matched, related sibling donor. Recommendations point to evidence suggesting that children under age 13 who receive HSCT from a matched sibling donor have better outcomes than those older than age 13.
For patients with frequent pain, as well as those with recurrent episodes of acute chest syndrome, the ASH guidelines suggest transplantation from a matched sibling donor over the standard of care.
For individuals with an indication for HSCT who lack a matched sibling donor, the ASH guideline panel suggests transplantation from alternate donors only in the context of a clinical trial.
In patients with an indication for transplant, the ASH guideline panel suggests transplantation with cells from a matched donor earlier in life due to the risk of irreversible SCD-related damage to the body that increases with age.
Conclusions
ASH notes that the use of HSCT for SCD is evolving. The
evidence for all the aforementioned recommendations is of low or very low certainty because of the lack of randomised controlled trials for HSCT in SCD, the lack of universal end points used in HSCT trials, and the lack of direct comparative therapies. The conditional nature of the recommendations for all questions results from the short duration of accumulated data and the reliance on evaluation of noncomparative data.
Matched sibling donor (MSD) HSCT should be considered for all individuals at risk of neurologic injury or with recurrent vaso-occlusive pain crises or a history of recurrent ACS. Furthermore, when feasible, the panel agreed HSCT should be undertaken at the earliest age possible. However, given the benefits and burdens of HSCT, the panel expressed strong views that all patients (even those without an MSD) with severe complications of SCD (indications for transplantation as above) should receive information about transplantation as an option. For adults with SCD, undergoing HSCT with an MSD and nonmyeloablative therapy is recommended.
Overall, alternative donor HSCT and newer nonmyeloablative regimens should be undertaken in the context of a clinical trial to better evaluate the efficacy and outcomes for future recommendations
ASH also notes that there are new potentially disease-modifying medications (eg, L-glutamine, crizanlizumab, and voxelotor) that have recently been approved in the US for SCD and ongoing development of additional therapies both for new medical treatments and for HSCT (eg, gene therapy). It is unclear how these newer therapies will affect SCD outcomes, including organ complications, and if broader access to a curative therapy will alter the trajectory of SCD outcomes. It is possible that new recommendations will be needed once long-term data are assembled on these newer agents, ASH acknowledged.
Visit www.hematology.org/SCDguidelines for more information about the ASH guidelines on SCD.
Results of a new study indicate patients with lymphoma are more likely to develop post-vaccination Covid-19 infection compared to patients with other blood cancers, highlighting the need for additional precautions
People with haematological malignancies (HM) are at a higher risk than healthy individuals for severe and life-threatening Covid-19 illness; furthermore, research suggests that they do not always achieve optimal protection from vaccination.
A new study, the first to report on post-vaccination Covid-19 cases in patients with HM, offers preliminary findings about the incidence of breakthrough infection in this vulnerable population.
The study, published in Blood, drew data from an open online registry, EPICovidEHA, which was set up in April 2020 by the European Haematology Association – Infectious Diseases Working Party (EHA-IDWP) to describe the epidemiology, risk factors, and mortality rates of HM patients. Overall, 3801 valid cases were collected with an overall mortality rate of 31 per cent.
As of 31 August, 2021, out of the 3,801 total cases, there were 113 reported cases of Covid-19 occurring after vaccination. The majority of these patients were males (61.1 per cent) and over 50 years of age (85.8 per cent). More than 80 per cent of the HM patients who contracted Covid-19 had underlying lymphoproliferative malignancies (chronic lymphoid leukaemia [CLL], non-Hodgkin lymphoma [NHL], acute lymphoblastic leukaemia [ALL], Hodgkin’s lymphoma [HL], and multiple myeloma [MM]). Seventy-eight (68.1 per cent) patients received active treatment for underlying HM at the time of Covid-19 infection or within the prior three months.
Eighty-seven patients (77 per cent) were considered fully vaccinated, while the remaining 26 (23 per cent) had been partially vaccinated.
Within the group of breakthrough cases, 79 patients experienced severe or critical Covid-19 infection, with 75 needing to be hospitalised. After a follow up of 30 days post-Covid-19 diagnosis, 14 (12.4 per cent) patients died, and Covid-19 was deemed the cause of death for all but one of those individuals.
The study researchers emphasise that although the mortality rate in patients with breakthrough Covid-19 cases was high, it was still much lower than before vaccines were available.
Previous studies using the registry’s data reported that during the pre-vaccination period of the pandemic, people with HM and Covid-19 had mortality rates ranging from 30-to-50 per cent (depending on type of underlying HM).
“Before vaccination, if our patients with haematologic malignancies developed Covid-19, they died in a lot of cases,” said study author Dr Livio Pagano, of the Università Cattolica del Sacro Cuore in Italy. “With these preliminary data, we showed that vaccination is not able to completely protect, but surely it has a strong role in reducing the mortality for Covid-19 for people with blood cancers.”
Post-vaccine IgG levels against SARS-CoV-2 spike protein were analysed in 40 (35.4 per cent) fully vaccinated HM patients, two-to-four weeks from the last vaccine dose. Among these patients, only 13 (32.5 per cent) presented an antibody response to vaccine (optimal: 8; weak: 5), whereas the remaining 27 (67.5 per cent) were considered non responders (binding antibody units, BAU 30/ml).
The study also found that the level of Covid-19 vaccine response was associated with the type of underlying HM. People with myeloproliferative disorders were the least likely to develop Covid-19 after vaccination, and people with lymphoproliferative disorders were the most likely.
Of the 113 breakthrough Covid-19 cases, 80 per cent occurred in people with lymphoproliferative conditions such as CLL, NHL, HL, and MM.
“Unfortunately, people with lymphomas are more likely to have suppressed immune systems and to develop infections, and it is no different for Covid-19,” said Dr Pagano. “In future studies we will look at the efficacy of additional vaccine doses to understand if they can reduce infection in our patients, especially those with lymphoproliferative disorders.”
Notably, the type of Covid-19 vaccine did not affect the risk of breakthrough cases. Approximately 70 per cent of the patients in this study received an mRNA vaccine, and the remain-
ing patients received the AstraZeneca vector-based vaccine or the Sinovac inactivated vaccine.
“The key message is that we must make a great effort to vaccinate as many people as we can,” said Dr Pagano. “We can’t only vaccinate our patients with haematologic malignancies;
it is also important to vaccinate their caregivers so we can form a barrier of protection around them, because their own immunity from the vaccine is not enough.”
Reference on request
Authors: Ms Laura Fahey, Orthopaedic Specialist Registrar and Prof Paul O’Grady, Consultant Orthopaedic Surgeon, Department of Trauma and Orthopaedic Surgery, Mayo University Hospital.
The main learning outcome for this module is that patients should have an individualized approach to thromboprophylaxis for the prevention of venous thromboembolism.
Irish endocrinology trainees are highly trained, in great demand abroad, and it must be made attractive for them to return to Ireland and remain in the country, Prof Hilary Hoey, Director of Professional Competence, RCPI, told the 45th Annual Meeting of the Irish Endocrine Society (IES), which took place on 19-20 November on a virtual basis.
Prof Hoey, who delivered the IES’s keynote McKenna Lecture, said the future of Irish medicine depends on its doctors, pioneers and health professionals.
She believes there are many opportunities for young doctors in Ireland.
“Doctors in Ireland are respected and greatly trusted by the public,” she said.
“Irish consultants are highly trained, and they have international experience and are innovative.”
An elected member of the RCPI Council and Emeritus Professor at Trinity College Dublin (TCD), Prof Hoey described Ireland as a small country where things could get done quickly.
“We're a very agile country and this was demonstrated by Covid-19 in terms of the agility and willingness to adapt to the rapidly changing situation and deliver excellent patient care, education and research despite Covid-19 and the cyberattack,” she added.
She highlighted the current major challenges facing healthcare professionals including managing emergencies such as
Covid-19, and the recent cyberattack; the increased number of people with chronic conditions and disabilities; keeping up to date with diagnostics, therapeutics and digital skills; patient empowerment and public expectations; prevention with avoidance of complications; and access to integrated services regardless of socio-economic group and residence.
Turning to opportunities available today, Prof Hoey said recent research has made it possible to successfully treat many previously untreatable conditions and improve health and wellbeing.
“Genetic aspects have been clearly shown,” she said, referring to Swedish twin studies.
She also highlighted recent concern about the effects of obesity on pregnancy.
Prof Hilary HoeyIn her view, continuing professional development (CPD) provides an opportunity to reduce stress, increase personal development, and to reflect on practice pressures and what resources are required.
“CPD should be self-directed unlike in many other countries where it's much more prescriptive,” she said.
It should reflect the scope and stage of practice with the individual doctor and was “not a one-size-fits-all” as “people learned differently”.
“It is a great privilege to work as a doctor in Ireland and follow in the footsteps of our esteemed ancestors who met many challenges, rose to many opportunities, and made long lasting innovations,” Prof Hoey told the Annual Meeting.
During the lecture, she gave a history of medicine in this country, continuing to the current major challenges faced by health services.
Nevertheless, serious global challenges included obesity and nutrition. The complications of obesity, such as “type 2 diabetes, cancer, pregnancy with the complications of microsomia, and adult diabetes”, were enormous, according to Prof Hoey. Obesity and type 2 diabetes were increasing, she stated.
“It's been now labelled the double pandemic with a 10-fold increase in the US annually in relation to this.
“In Ireland 60 per cent of adults are obese and 20-to-25 per cent of children are overweight or obese.
“Obese children become obese adults and the proportion with severe obesity is increasing. Obesity, as you know, is a complex biochemical and hormonal interaction between genetic and environmental lifestyle factors.”
She underlined that calorie intake exceeded energy expenditure and pointed to the reported levels of exercise as being below World Health Organisation recommended ranges. If one parent was obese, there was a 50 per cent chance for the child to become obese.
Where both parents were obese, there was a 75 per cent chance for the child to become obese, noting that the condition was not only the result of lifestyle.
Prof Hoey underscored the difficulties in the management of obesity. Prevention was key at all ages, but particularly in the first 1,000 days of life.
“It’s very difficult to change established lifestyle; it requires motivation, empowerment, and an expert multidisciplinary team. Wellbeing is important to avoid shame and stigma. As Prof Donal O'Shea says: ‘Nobody chooses to be obese’.”
Findings from a recent patient survey of people with type 2 diabetes by Diabetes Ireland showed that while patients had a care plan, they had poor understanding of it.
“They had great difficulty changing lifestyle with a large emotional impact. Many feel that diabetes is a stigma and poorly managed, consider themselves a failure, and live in a negative psychological state. Now I think this applies to many type 1 diabetes and obese patients as well.”
Prof Hoey stressed the need for ongoing patient support and empowerment and highlighted the role of the use of language. “In terms of dealing with people with diabetes it's important to avoid shame, blame, and stigma and have a supportive relationship.”
The most important criteria for the diagnosis of hypogonadism are symptoms, comorbidities and low serum testosterone levels, Prof Eberhard Nieschlag, University of Münster, Germany, reminded participants at the 45th Annual Meeting of the IES.
Described as the world’s foremost authority on testosterone, he gave two presentations online to the Society. As a keynote speaker, he delivered this year’s IES Hadden Lecture on ‘The cultural and medical history of testosterone and the testes’.
He also gave a detailed summary on ‘Testosterone substitution: For whom, when and how'?
In his presentation at the opening of the conference, he highlighted that testosterone replacement was available in intramuscular, transdermal, and oral preparations and the patient could, more or less, decide what they preferred. Regular monitoring after three, six, and 12 months – then at least annually – was mandatory, he stressed.
The most important parameters were the haematocrit, prostate specific anti-
gen (PSA) and bone density. Testosterone substitution had positive effects on the following: Anaemia; osteoporosis; obesity; metabolic syndromes; diabetes; and erectile dysfunction. After a disease-free year, he added that patients with prostate carcinoma may receive testosterone replacement if
they had low testosterone levels.
In delivering the 2021 Hadden Lecture on Friday afternoon, he outlined the history of testosterone, which was identified in 1935 and was synthesised in the same year.
Looking to the future of testosterone substitution, Prof Nieschlag anticipated it would be modified according to pharmacogenetic findings, which could be used for better adaptation for the patient. He expected improved modes of application would also be introduced, eg scrotal implants with controlled release responding to physiologic needs would be a great advantage.
Another benefit would be the regulation of complex interactions of the endocrine and other systems by computers and by artificial intelligence.
Selective androgen receptor modulators would have little impact on clinical practice because they had the same history as the anabolic steroids, he believed.
He predicted – and hoped – that the male hormonal contraceptive, based on testosterone, would become available.
Prof Nieschlag was convinced that
moderate testosterone substitution for athletes would become accepted as part of sports medicine and sports endocrinology.
Finally, he added, transplantation of Leydig cells, possibly derived from stem cells, would make pharmacologic substitution superfluous.
The meeting heard from a second prestigious international speaker, Prof Mehul Dattani, as part of this year’s paediatric lecture on novel insights into management of congenital hypopituitarism.
Prof Dattani, Great Ormond Street Hospital for Children, University College London Hospitals, and Institute of Child Health, highlighted the many issues affecting children with the condition. He spoke on hypopituitarism in children and focused particularly on congenital hypopituitarism.
In children the main causes seen were congenital, in contrast to adult patients with hypopituitarism. Hypopituitarism in children may be genetic or associated with structural defects of the brain – midline defects mainly – Prof Dattani told the Annual Meeting.
Looking to the future of testosterone substitution, Prof Nieschlag anticipated it would be modified according to pharmacogenetic finding
The 1st polypill licensed for secondary prevention of cardiovascular events in Ireland
Reduce pill burden by 730 pills per year*
Capsules shown are not actual size. Capsules are Size 0. Please refer to SmPC before prescribing.
*The calculation of a reduction of 730 pills per year is based on a patient taking the three individual components of Trinomia (aspirin, atorvastatin, ramipril) on a daily basis for 365 days compared to a patient taking a Trinomia capsule once daily for 365 days.
Trinomia 100 mg/20 mg/10 mg, 100 mg/20 mg/5 mg, 100 mg/20 mg/2.5 mg hard capsules (acetylsalicylic acid, atorvastatin (as atorvastatin calcium trihydrate) and ramipril) and Trinomia 100 mg/40 mg/10 mg, 100 mg/40 mg/5 mg, 100 mg/40 mg/2.5 mg hard capsules (acetylsalicylic acid, atorvastatin (as atorvastatin calcium trihydrate) and ramipril) Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Hard capsules containing: two 50 mg acetylsalicylic film-coated tablets, two 10 mg atorvastatin film-coated tablets and one 10 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic filmcoated tablet, two 10 mg atorvastatin film-coated tablets and one 5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 10 mg atorvastatin film-coated tablets and one 2.5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablets, two 20 mg atorvastatin film-coated tablets and one 10 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 20 mg atorvastatin film-coated tablets and one 5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 20 mg atorvastatin film-coated tablets and one 2.5 mg ramipril film-coated tablet. Uses: Secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses Dosage: Oral administration. 1 capsule per day, preferably after a meal. Swallow with liquid. Do not chew or crush. Avoid grapefruit juice. Patients currently controlled with equivalent therapeutic doses of acetylsalicylic acid, atorvastatin and ramipril can be directly switched. Treatment initiation should take place under medical supervision. Cardiovascular prevention, target maintenance dose of Ramipril is 10 mg once daily. Daily dose in renal impairment based on creatinine clearance - ≥ 60 ml/min, maximum daily dose is 10 mg ramipril; 30-60 ml/min, maximum daily dose is 5 mg ramipril. Contraindicated in hemodialysis and/or with severe renal impairment (creatinine clearance <30 ml/min). Administer with caution with hepatic impairment. Perform liver function tests before initiation of treatment and periodically thereafter. Maximum daily dose is 2.5 mg ramipril and initiate treatment under close medical supervision. Contraindicated in severe or active hepatic impairment. Start treatment in very old and frail patients with caution. In patients taking elbasvir/grazoprevir concomitantly with atorvastatin, the dose of atorvastatin should not exceed 20 mg/day. Contraindications: Hypersensitivity to any component, to other salicylates, to NSAIDs, to any other ACE inhibitors, tartrazine, soya or peanut. History of previous asthma attacks or other allergic reactions to salicylic acid or other NSAIDs. Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, other kinds of bleeding. Haemophilia and other bleeding disorders. Severe kidney and liver impairment. Hemodialysis. Severe heart failure. Concomitant treatment with methotrexate at a dosage of 15 mg or more per week. Concomitant use with aliskiren-containing products with diabetes mellitus or renal impairment. Nasal polyps associated with ashma induced or exacerbated by acetylsalicylic acid. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy, lactation and in women of child-bearing potential not using appropriate contraceptive measures. Concomitant treatment with tipranavir, ritonavir, ciclosporin, glecaprevir/pibrentasvir,sacubitril/valsartan therapy. Trinomia must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. History of angioedema. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. Hypotensive or haemodynamically unstable states. Children and adolescents below 18 years of age. Warnings and Precautions: Only for use as a substitution therapy in patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses. Special populations requiring particularly careful medical supervision: Hypersensitivity to other analgesics/antiinflammatory/antipyretic/antirheumatics or other allergens. Other known allergies, bronchial asthma, hay fever, swollen nasal mucous membranes and other chronic respiratory diseases. History of gastric or enteric ulcers, or of gastrointestinal bleeding. Reduced liver and/or renal function. Particular risk of hypotension: strongly activated renin-angiotensin-aldosterone system, transient or persistent heart failure post MI, risk of cardiac or cerebral ischemia, in case of acute hypotension medical supervision including blood pressure monitoring is necessary. Deterioration of cardiovascular circulation. Glucose 6 phosphate dehydrogenase deficiency. Risk of elevated levels of uric acid. Consumption of substantial quantities of alcohol and/or have a history of liver disease. Diagnosed pregnancy, stop treatment immediately, and, if appropriate, start alternative therapy. ACE inhibitors cause higher rate of angioedema in black patients than in non-black patients. The blood pressure lowering effect of ACE inhibitors is somewhat less in black patients than non-black patients. Monitoring during treatment is required for: Concomitant treatment with NSAIDs, corticosteroids, SSRIs, antiplatelet drugs, anticoagulants, ibuprofen. Signs or symptoms suggestive of liver injury. Stop treatment temporarily prior to elective major surgery and when any major medical or surgical condition occurs. Particularly careful monitoring is required in patients with renal impairment, risk of impairment of renal function, particularly with congestive heart failure or after a renal transplant. Serum potassium: ACE inhibitors can cause hyperkalemia in patients with impaired renal function and/or in patients taking potassium supplements (including salt substitutes), potassium-sparing diuretics, trimethoprim or co-trimoxazole and especially aldosterone antagonists or angiotensin-receptor blockers, hyperkalemia can occur. Potassium-sparing diuretics and angiotensin-receptor blockers should be used with caution in patients receiving ACE inhibitors, and serum potassium and renal function should be monitored. Other situations that may increase the risk of hyperkalaemia are: age >70 years, uncontrolled diabetes mellitus, dehydration, acute cardiac decompensation or metabolic acidosis.Specific side-effects: Perform liver function tests before use and monitor periodically and with liver injury or increased transaminase levels. Use with caution with substantial alcohol use or history of liver disease. Potential risk of hemorrhagic stroke. May affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, ask patients to promptly report skeletal muscle effects (muscle pains, cramps or weakness) especially if accompanied by malasie or fever and measure CK levels, stop treatment if significantly elevated or if severe muscular symptoms occur. Prescribe with caution in patients with pre-disposing factors for rhabdomyolysis. Benefit/risk of treatment should be considered and clinical monitoring recommended. Do not measure CK following strenuous exercise or in presence of plausible alternative cause of CK increase. If CK levels significantly elevated at baseline, re-measure levels 5 to 7 days later to confirm the results. Risk of rhabdomyolsis with use of potent CYP3A4 inhibitors, transport proteins or HIV protease inhibitors. Consider alternative treatments if risk of myopathy. Consider lower starting or maximum dose and appropriate clinical monitoring with potent CYP3A4 inhibitors and medicinal products that increase the plasma concentration of atorvastatin respectively. The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, antivirals for the treatment of hepatitis C (HCV) (boceprevir, telaprevir, elvasvir/grazoprevir), erythromycin, niacin or ezetimibe. Do not co-administer with systemic fusidic acid or within 7 days of stopping fusidic acid. Where use of systemic fusidic acid considered essential, discontinue statin treatment during fusidic acid treatment. Reports of rhabdomyolysis in patients receiving fusidic acid and statins in combination. Where prolonged systemic fusidic acid needed, consider need for co-administration of Trinomia and fusidic acid on case by case basis with close medical supervision. Discontinue statin treatment if interstitial lung disease occurs. Monitor patients at risk of diabetes mellitus. Discontinue treatment if angioedema occurs and initiate emergency treatment promptly. Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated. due to the increased risk of angioedema. Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of Trimomia. Caution should be used when starting racecadotril, mTOR inhibitors and vildagliptin in a patient already taking an ACE inhibitor as there is an increased risk of angioedema. Concomitant use of ACE-inhibitors and angiotensin II receptor blockers or aliskiren is not recommended and should not be used in patients with diabetic nephropathy. Anaphylactic reactions during desensitization, consider temporary discontinuation of Trinomia during desensitization. Monitor white blood cells for neutropenia/agranulocytosis and more regularly in the initial phase of treatment, impaired renal function, concomitant collagen disease and other medicines that can change the blood picture. Cough. Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Acetylsalicylic acid: other platelet aggregation inhibitors, other NSAIDs, and antirheumatics, systemic glucocorticoids, diuretics, alcohol, SSRIs, uricosuric agents, metamizole, anticoagulant and thrombolytic therapy, digoxin, antidiabetic agents including insulin, methotrexate, valproic acid, antacids, ACE inhibitors, ciclosporin, vancomycin, interferon , lithium, barbiturates, zidovudine, phenytoin, laboratory tests. Atorvastatin: CYP3A4 inhibitors, CYP3A4 inducers, transport protein inhibitors, gemfibrozil/fibric acid derivatives, ezetimibe, colestipol, fusidic acid, colchicine, digoxin, oral contraceptives, warfarin. Ramipril: potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances, antihypertensive agents and other substances that may decrease blood pressure, vasopressor sympathomimetics and other substances, allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count, lithium salts, antidiabetic agents including insulin. Monitor as appropriate. Consider lower maximum dose of atorvastatin with potent CYP3A4 inhibitors. Pregnancy and Lactation: Contraindicated in pregnancy and breast-feeding. Women of child-bearing potential should use effective contraception during treatment. Side Effects: Ramipril: Common (≥1/100, <1/10): dyspepsia, nausea, diarrhoea, vomiting, digestive disturbances, abdominal discomfort, gastrointestinal inflammation, non-productive tickling cough, bronchitis, sinusitis, dyspnoea, headache, dizziness, rash in particular maculo-papular, blood potassium increased, myalgia, muscle spasms, chest pain, fatigue, hypotension, orthostatic blood pressure decreased, syncope. Atorvastatin: Common: dyspepsia, nausea, diarrhoea, constipation, flatulence, pharyngolaryngeal pain, epistaxis, nasopharyngitis, headache, allergic reactions, hyperglycaemia, myalgia, muscle spasms, pain in extremity, joint swelling, back pain, arthralgia, liver function test abnormal, blood creatine kinase increased. ASA: Very Common (≥ 1/10): Gastrointestinal complaints such as heartburn, nausea, vomiting, stomach ache and diarrhea, minor blood loss from the gastrointestinal tract (micro-bleeding). Common: Paroxysmal bronchospasm, serious dyspnoea, rhinitis, nasal congestion. For less frequent side effects see SmPC. Pack Sizes: Blister containing 28 hard capsules. Legal Category: POM. Product Authorisation Numbers: PA 1744/002/001-006 Product Authorisation
Irish Endocrine Society, Annual Meeting, virtual, 19-20 November 2021
This year’s 45th Annual Meeting of the Irish Endocrine Society (IES) received more than 150 submissions for the poster and oral presentation sections of the meeting.
A total of 19 oral presentations were finally selected and six invited posters were also chosen for the meeting, in addition to 131 abstracts featured in the 2021 poster virtual exhibition.
In the end, the winner of the 2021 Montgomery Medal was Dr Clare Miller, St James’s Hospital, Dublin, and colleagues, for her poster presentation entitled ‘Hy-
poglycaemia in a metastatic gastrin secreting pancreatic NET [neuroendocrine tumour] on insulin pump therapy’.
The case presented highlighted the potential for gastrin secreting pancreatic neuroendocrine tumours to change biological activity with disease progression.
The presentation noted polysecreting NET was typically associated with multiple endocrine neoplasia syndrome or in rare cases an advanced sporadic disease. This was the second published case of metastatic insulinoma in a patient on insulin pump therapy, according to the authors.
The 2021 O’Donovan medal was awarded to Dr Lucy Kayes and colleagues from Queen’s University Belfast for her oral presentation entitled ‘Forty years experience of neonatal thyroid stimulating hormone screening in Northern Ireland’.
Northern Ireland was one of the first participating sites in the UK national screening programme for congenital hypothyroidism (CHT) 40 years ago. Their study aimed to explore any changing patterns in incidence.
Their findings revealed a significant increase in incidence (p<0.00001)
Researchers have highlighted increases in vitamin D levels during the pandemic in a number of presentations at this year’s IES annual meeting.
Vitamin D levels increased and deficiency decreased between 2015-20 and 2020-21 in a study population in the west of Ireland, the meeting heard in an oral presentation by Ms Caoimhe Moran, School of Biological and Health Sciences, Technological University Dublin, and colleagues.
Vitamin D may reduce the risk and severity of infection with the SARS-CoV-2 virus, but the effects of lockdown on population vitamin D status in Ireland were unknown.
Following their cross-sectional study ‘Changes in vitamin D concentration and deficiency in the West of Ireland during the Covid-19 lockdown’, she added that it remained unknown whether this trend related to lockdown or to changes in diet and supplementation practices.
This study compared wintertime serum 25 OHD in 16,725 samples analysed between October and February 2015-20 (13,449 samples) and between October 2020 and February 2021 (3,276 samples) at University Hospital Galway (UHG).
Vitamin D deficiency was defined at the IoM ((<30nmol/L) and Endocrine Society (<50nmol/L) thresholds. Mean total serum vitamin D and mean serum vitamin D3 concentrations were higher in 2020-21 (65.7nmol/l and 61.7nmol/l respectively) than in 2015-2020 (59.9nmol/l and 55.6nmol/l respectively) (p<0.001).
Prevalence of deficiency decreased at the <30nmol/L threshold from 18.2-to-14.6 per cent, and at 50nmol/L threshold from 43.6-to-34.6 per cent, between 2015-20 and 2020-21. Deficiency at both thresholds was more common in females (p<0.001).
Deficiency was higher in inpatients and nursing home residents than in outpatients and GP patients, with a trend towards greater deficiency in younger adults.
During the Q & A following her presentation, Ms Moran agreed the importance of good public health advice directing the public to appropriate levels of supplementation.
Another cross-sectional study: ‘Sex, sunshine, and sample-origin – predictors of emerging spring and summertime vitamin D deficiency trends amongst Irish adults during the Covid-19 lockdown’ by Ms Maria O’Sullivan, School of Biological and Health Sciences, Technological University Dublin, and colleagues found, overall, vitamin D deficiency was more prevalent in males, hospital inpatients, and nursing home residents.
The divergent trends in vitamin D status between males and females between 2015-19 and 2020 suggested possible sex-specific differences in the effects of lockdown, and of diet and supplementation changes, on vitamin D status.
A further study by Mark Kilbane and colleagues at St Vincent’s University Hospital in Dublin, detailed how they had conducted a laboratory-based trend analysis of serum 25-hydroxyvitamin D (25OHD) comparing yearly average concentration in the 12 months prior to the pandemic with the first 12 months of the pandemic.
In a large sample, they noted the average yearly 25OHD increased by 2.8nmol/L in combination with a lower percent of low vitamin D status and a higher per cent of high vitamin D status. The yearly increase was almost threefold higher than the yearly increase in average 25OHD based on two similar trend analyses that they conducted between 1993 and 2016.
This indicated “that caution should be exercised about blanket recommendations for vitamin D supplementation in favour of maximising low dose daily supplementation in at-risk groups and clinically vulnerable patients”.
They advised strongly in favour of targeted supplementation policies.
Following an audit of serum (25OHD) measures in the Irish population during the 2019-21 Covid-19 pandemic, Ms Katrina Hutchinson, Eurofins Biomnis, and colleagues found vitamin D mean concentrations had increased annually since 2019, particularly in 2020. They suggested this was probably due to lifestyle changes in Ireland because of lockdowns, which might have allowed more outdoor activity.
They added in their poster that further audits in 2022 would enable them to fully examine changes in vitamin D status in Ireland when lockdown had finished.
in Northern Ireland. There was an increased incidence of CHT with 26 cases/100,000 livebirths in 1981 vs 71/100,000 in 2019 (p<0.00001).
They added results were similar to recent Republic of Ireland data (65/100,000).
The conference was organised this year by Prof Siobhán McQuaid, Department of Endocrinology, Mater Misericordiae University Hospital, Dublin.
Society President Prof Brendan Kinsley formally opened the meeting and Prof James Gibney acted as Chair to the oral and poster presentation sessions.
Separate research teams from University Hospital Kerry, Tipperary University Hospital, Tallaght University Hospital and Beaumont Hospital in Dublin have reported on cases of thyroiditis post-vaccination for SARS-CoV-2 to this year’s IES Annual Meeting.
In an oral case report of ‘Subacute thyroiditis post-viral vector vaccine for Covid-19', by Dr Caoimhe Casey and Dr Tom Higgins at University Hospital Kerry, Dr Casey said there were a growing number of published case reports of thyroiditis post-Covid-19 vaccination.
The mechanism of development of thyroiditis post-vaccination was unclear, but it was thought that cross recognition of virus and healthy thyroid cell antigens may play a role.
Knowledge of this potential adverse effect would lead to earlier diagnosis and appropriate management “as we continue to battle the Covid-19 pandemic worldwide”, the authors added.
Subacute viral thyroiditis was a recognised cause of thyrotoxicosis, which usually presented as neck pain and hyperthyroidism after an acute viral illness, according to researchers from the Academic Department of Endocrinology and Diabetes, Beaumont Hospital and the RCSI, Dublin in their study on ‘Subacute thyroiditis following Covid-19 mRNA vaccine’.
Several viruses including SARS CoV-2 had been implicated. The occurrence of thyroiditis had also been reported following hepatitis B and influenza vaccination.
Thyroiditis had only been very rarely reported following mRNA Covid-19 vaccination. However, with the very high volume of primary and booster vaccine dose administration, both at present and in the future, they recommended it should be considered in all patients who presented with thyrotoxicosis following vaccination; particularly when TRAb was negative.
From Tallaght University Hospital, Dublin, researchers reported details on a case of ‘Subacute Thyroiditis following Sars-CoV-2 Infection’.
They noted that the first case of subacute thyroiditis following Sars-CoV-2 infection had been described in Italy in July 2020. Since then, there had been approximately 22 cases reported in the literature.
Also, a report from researchers at Department of Endocrinology, Tipperary University Hospital, Clonmel, added that it was well established that subacute thyroiditis may be associated with Covid-19 infection. They outlined a case of subacute thyroiditis following Pfizer vaccination for Covid-19.
Ozempic® provided a significant 26% risk reduction of MACE# in people with type 2 diabetes* and cardiovascular disease.1,2,§
This includes a 39% relative risk reduction in non-fatal stroke.1,2,‡
Ozempic® also has superior blood glucose and weight-loss efficacy across all head-to-head clinical trials in the SUSTAIN program.1-9,†,‡
* 26% CV risk reduction in patients with type 2 diabetes and high CV risk, compared to placebo, in addition to standard treatment.
# Major Adverse Cardiovascular Events
† Results apply to Ozempic® across SUSTAIN trials, which included placebo, sitagliptin, dulaglutide, canagliflozin, exenatide PR and glargine U100.1-9 § p=0.02 for superiority ‡ p<0.05
Ozempic® is recommended by the ADA/EASD Consensus Report for people with type 2 diabetes who have established atherosclerotic cardiovascular disease10
PR = Prolonged Release; ADA = American Diabetes Association; EASD = European Association for the Study of Diabetes.
SUSTAIN = Semaglutide Unabated Sustainability in treatment of Type 2 Diabetes.
*SUSTAIN was the phase 3 clinical trial programme investigating the effects of once weekly semaglutide versus other anti-diabetic agents.
ABBREVIATED PRESCRIBING INFORMATION
Ozempic®t semaglutide
Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Ozempic® 0.25 mg solution for injection in pre-filled pen. Ozempic® 0.5 mg solution for injection in pre-filled pen. Ozempic® 1 mg solution for injection in prefilled pen. One ml of solution contains 1.34 mg of semaglutide (human glucagon-like peptide-1 (GLP-1) analogue). Indication: Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 of the Ozempic® SmPC. Posology and administration: Administered once weekly at any time of the day, with or without meals. Injected subcutaneously in the abdomen, thigh or upper arm. Starting dose: 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control. When Ozempic® is added to existing metformin and/or thiazolidinedione therapy or to an SGLT2 inhibitor, the current dose of metformin and/or thiazolidinedione or SGLT2 inhibitor can be continued unchanged. When Ozempic® is added to a sulfonylurea or insulin, a reduction in dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia. Blood glucose selfmonitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Ozempic® is started and insulin is reduced. A stepwise approach to insulin reduction is recommended. Children: No data available. Elderly: No dose adjustment required, therapeutic experience in patients age ≥75 is limited. Renal impairment: No dose
adjustment is required for patients with mild, moderate or severe renal impairment. Experience in patients with severe renal impairment is limited. Not recommended for use in patients with end-stage renal disease. Hepatic impairment: No dose adjustment is required for patients with hepatic impairment. Experience with severe hepatic impairment is limited. Caution should be exercised when treating these patients with semaglutide. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Not a substitute for insulin. Diabetic ketoacidosis has been reported in insulin-dependent patients whom had rapid discontinuation or dose reduction of insulin. There is no experience in patients with congestive heart failure NYHA class IV and is therefore not recommended in these patients. Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function as nausea, vomiting, and diarrhoea may cause dehydration which could cause a deterioration of renal function. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, semaglutide should be discontinued; if confirmed, semaglutide should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Use of semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia, therefore consider reducing the dose of sulfonylurea or insulin when initiating treatment with Ozempic®. In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Caution should be exercised when using semaglutide in patients with diabetic retinopathy treated with insulin. These patients should be monitored closely and treated according to clinical guidelines. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded. When
semaglutide is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines. Fertility, pregnancy and lactation: Women of childbearing potential are recommended to use contraception when treated with semaglutide. Should not be used during pregnancy or breast-feeding. Discontinue at least 2 months before a planned pregnancy. Effect on fertility unknown. Undesirable effects: Very common (≥1/10): Hypoglycaemia when used with insulin or sulfonylurea, nausea, diarrhoea. Common (≥1/100 to <1/10): Hypoglycaemia when used with other oral antidiabetic medications, decreased appetite, dizziness, diabetic retinopathy complications, vomiting, abdominal pain, abdominal distension, constipation, dyspepsia, gastritis, gastro-oesophageal reflux disease, eructation, flatulence, cholelithiasis, fatigue, increased lipase, increased amylase, weight decreased. Uncommon (≥1/1,000 to <1/100): Hypersensitivity, dysgeusia, increased heart rate, acute pancreatitis, injection site reactions. Rare (≥1/10,000 to <1/1,000): Anaphylactic reaction. Not known (cannot be estimated from available data): Angioedema. The SmPC should be consulted for a full list of side effects. MA numbers: Ozempic® 0.25 mg pre-filled pen EU/1/17/1251/002. Ozempic® 0.5 mg prefilled pen EU/1/17/1251/003. Ozempic® 1 mg pre-filled pen EU/1/17/1251/005. Each pre-filled pen delivers 4 doses and includes 4 disposable NovoFine® Plus needles. Legal Category: POM. For complete prescribing information, please refer to the SmPC which is available on www.medicines.ie or by email from infoireland@novonordisk.com or from the Clinical, Medical and Regulatory Department, Novo Nordisk Limited, 1st Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9. Date last revised: March 2021.
tAdverse events should be reported to the Health Products Regulatory Authority. Information about adverse event reporting is available at www.hpra.ie. Adverse events should also be reported to Novo Nordisk on Tel: 1850 665 665 or complaintireland@novonordisk.com
References: 1. Ozempic® Summary of Product Characteristics www.medicines.ie 2. Marso SP, et al; Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. (SUSTAIN 6) N Engl J Med. 2 2016;375:1834-1844. 3. Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(suppl1):S1-S108. 4. Lingvay et al, Once weekly Semaglutide vs Canagliflozin in type 2 diabetes (SUSTAIN 8) : a double blind phase 3 randomised control trial: Lancet Diabetes Endocrinol 2019; 7: 834–44. 5. Ahmann AJ et al. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care 2018;41:258-266. 6. Aroda VR et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol 2017;5: 355–66. 7. Sorli C et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol 2017; 5: 251–60. 8. Ahrén B et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol 2017; 5: 341–54. 9. Pratley RE et al. Semaglutide versus dulaglutide once-weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6275-286. 10.Buse JB et al. 2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2020 Feb; 43(2):487-493.
Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the SmPC.1 tThis medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Novo Nordisk Limited, First Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9, D09 X8W3, Ireland. Tel: 01 8629 700, Fax: 01 8629 725, Lo call: 1 850 665665. infoireland@novonordisk.com
Ozempic® and the Apis bull logo are registered trademarks owned by Novo Nordisk A/S.
Date of preparation: October 2021. IE21OZM00098
www.novonordisk.ie
Referrals of differentiated thyroid cancer to the endocrinology unit at St James’s Hospital in Dublin have increased more than five-fold over 15 years, with increasing case complexity, the Irish Endocrine Society Annual Meeting heard. Details of a retrospective review conducted by the unit
were presented to the meeting by Mr James Gibney. The aim of this was to determine temporal changes in referral patterns of differentiated thyroid cancer (DTC), pathological stage at diagnosis and radio-iodine utilisation.
Over 1,000 patients with differentiated thyroid cancer had been managed by the endocrinology service at St
James’s Hospital since 2005.
In the first analysis of a large cohort of patients with differentiated thyroid cancer greater than 1cm managed in a single centre in Ireland, the researchers found referral rates were high and continued to climb, reflecting worldwide trends.
The endocrinology unit provided a fully integrated management pathway for patients with DTC including administration of radio-iodine where appropriate, year one surveillance and lifelong follow-up.
Management of thyroid cancer had changed markedly over the past two decades, particularly following the revision of the American Thyroid Association guidelines in 2015 advocating a more conservative approach to treatment, and specifically advising that radio-iodine (RAI) be reserved for high-risk patients.
Although RAI remained central to the management of high-risk patients, increasing numbers of patients were no longer receiving RAI and required longitudinal follow-up. Radio-iodine utilisation was reserved for 30 per cent of patients deemed high-risk. By 2019, patients triaged to receive radio-iodine represented less than 50 per cent of patients referred.
He added that the number receiving radio-iodine had stabilised at 38 to 40 patients per year.
Further examination of the cohort was to include reflection on treatment outcomes in both higher and lower risk patients with and without RAI utilisation.
The study was entitled ‘The endocrine management of differentiated thyroid cancer at St James’s Hospital 2005-2020’.
Early identification of pre-frailty in employees with and without diabetes, and implementation of tailored workplace interventions, may improve the self-perception of ability to work and prevent early retirement, according to Dr Duygu Sezgin, School of Nursing and Midwifery, National University of Ireland Galway (NUIG) and colleagues at NUIG and University College Cork.
In a European overview of ‘Pre-frailty in working middle-aged and older adults with and without diabetes and its association with fear of health limiting their ability to work and early retirement plans’, the researchers noted diabetes mellitus was associated with increased frailty risk, resulting in loss of working days.
Authors: Dr Michael Lockhart, Endocrinology SpR, and Prof Diarmuid Smith, Consultant Diabetologist and Endocrinologist, Academic Department of Diabetes and Endocrinology, Beaumont Hospital and RCSI Medical School
A significant proportion of middle-aged and older adults sought early retirement, potentially due to pre-frailty caused by health issues limiting their ability to work. Dr Sezgin underlined that this could be detected before frailty had an impact on people’s lives.
As a concept, pre-frailty was a multi-dimensional state. Identification of frailty at early (pre-frailty) stage could prevent this negative outcome. She told the IES meeting that factors leading to frailty status could be managed and tailored interventions based on people’s needs were needed.
The study investigated the prevalence of pre-frailty in working adults and reported the association between diabetes, pre-frailty, fear of health limiting ability to work, and plans for early retirement.
They combined data from 29 European countries using waves 1-8 of the Survey of Health, Ageing and Retirement in Europe (SHARE, 2004-2020).
Participants aged 50 years or over, with data on employment (including self-employment), frailty and diabetes status, were included in the descriptive and logistic regression analyses. A total of 38,220 participants (mean age 55.7±3.8) were analysed. Of these, 13,909 were pre-frail (36 per cent), 2,264 (6 per cent) had diabetes, 17,614 (46 per cent) sought early retirement, and 11,406 (30 per cent) were afraid that their health limited their ability to work.
Monitoring glucose levels frequently helps patients to achieve more intensive glycaemic control. This module will summarise the evidence for CGM and its current role in the management of patients with T1DM.
Early identification of pre-frailty may improve self-perception and
Toujeo
Shared features with Toujeo ® SoloStar
• Pen size
• 5-second hold time5,6
• 42-day shelf life after first use1
• Same technical platform
*Toujeo ® DoubleStar™ is recommended for patients requiring at least 20 units of basal insulin per day1
Prescribing Information: Toujeo (insulin glargine 300 units/ml)
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
Presentation: Toujeo SoloStar and DoubleStar pre-filled pens. Each ml contains 300 units of insulin glargine. SoloStar pen contains 1.5ml (450 units) of solution for injection. DoubleStar pen contains 3ml (900 units) of solution for injection.
Indication: Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years. Dosage and Administration: Toujeo is administered subcutaneously, by injection into the abdominal wall, the deltoid or the thigh, once daily, at any time of the day, preferably at the same time every day. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis. The dose regimen (dose and timing) should be adjusted according to individual response. Do not administer intravenously. In type 1 diabetes mellitus, Toujeo must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. In patients with type 2 diabetes mellitus, recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments. Toujeo can also be given together with other anti-hyperglycaemic medicinal products. Switch between insulin glargine 100 units/ml and Toujeo: Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable. When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit to unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels. When switching from Toujeo to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%). Switching from other basal insulins to Toujeo: A change of dose and/or timing of the basal insulin and concomitant anti hyperglycaemic treatment may be required. Dose adjustments may also be required if the patient’s weight or lifestyle changes, the timing of insulin dose is changed or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia. Toujeo must not be mixed or diluted with any other insulin or other medicinal products. Close metabolic monitoring is recommended during a switch and in the initial weeks thereafter. SoloStar 1-80 units per single injection in steps of 1 unit and DoubleStar 2-160 units in steps of 2 units. When changing from Toujeo SoloStar to Toujeo DoubleStar, if the patient’s previous dose was an odd number then the dose must be increased or decreased by 1 unit. Toujeo DoubleStar prefilled pen is recommended for patients requiring at least 20 units per day. Special Populations: Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. Paediatric: When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimise the risk of hypoglycaemia. The safety and efficacy of Toujeo in children and adolescents below 6 years of age have not been established. Contraindications: Hypersensitivity to insulin glargine or any excipients. Precautions and Warnings: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Toujeo is not the insulin of choice for treatment of diabetic ketoacidosis. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection
® Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie; email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com
site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered. Hypoglycaemia: In case of insufficient glucose control or a tendency to hyper/hypoglycaemic episodes, the patient’s adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Particular caution should be exercised, and intensified blood glucose monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or who are elderly. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. Intercurrent illness: Requires intensified metabolic monitoring and often it is necessary to adjust the insulin dose. Insulin antibodies: administration may cause insulin antibodies to form. Use with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Medication errors: Insulin labels must always be checked before each injection to avoid errors between Toujeo and other insulins. Patients must be instructed to never use a syringe to remove Toujeo from the SoloStar or DoubleStar pre-filled pen, A new sterile needle must be attached before each injection. Needles must not be re-used. Pregnancy and lactation: There is no data from exposed pregnancies in controlled clinical trials. However, there is a large amount of data on use of insulin glargine 100 units/ml in pregnant women indicating no specific adverse effects on pregnancy and no specific malformative nor feto/neonatal toxicity. The use of Toujeo may be considered during pregnancy, if clinically needed. Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk. Interactions: Substances that affect glucose metabolism may require adjustment of insulin glargine. Adverse Reactions: Very common: Hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening. Common: Lipohypertrophy, injection site reactions, including redness, pain, itching, hives, swelling, or inflammation. Legal Category: POM. Marketing Authorisation Number: SoloStar 3 Pen pack: EU/1/00/133/034, DoubleStar EU/1/00/133/038. Marketing Authorisation Holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. Further information is available from: Medical Information, Sanofi 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of preparation: July 2020.
References: 1. Toujeo® Summary of Product Characteristics.
Date of preparation: November 2021 MAT-IE-2101574 (v1.0)
® DoubleStar™ holds more units per pen than any other basal insulin pen on the market1-4
Toujeo ® is available in two pre-filled insulin devices allowing you to choose the most suitable device for your patients
Irish Thoracic Society, Annual Scientific Meeting, virtual, 19 November 2021
Diffuse cystic lung diseases (DCLDs) are not as rare as commonly believed and are probably underdiagnosed in Ireland, thus increased clinician vigilance is needed, the 2021 Irish Thoracic Society (ITS) Scientific Meeting heard.
Prof Cormac McCarthy, Consultant Respiratory Physician, St Vincent’s University Hospital, Dublin, who is an expert on DCLDs, spoke in detail on this diverse group of disorders characterised by multiple cysts and outlined a number of interesting case studies to showcase how they can present.
DCLDs are often multisystem diseases and can be broadly categorised based on underlying pathophysiology into neoclassic, genetic, developmental, lymphoproliferative, infectious, inflammatory, or smoking-related, and overlap. The major ones include lymphangioleiomyomatosis (LAM); pulmonary Langerhans cell histiocytosis (PLCH); Birt-Hogg-Dubé syndrome (BHD); and lymphoid interstitial pneumonia (LIP)/ follicular bronchiolitis (FB), “but there are a lot of mimics” and infections that must be ruled out, hence laboratory tests and a detailed family history are key.
Prof McCarthy noted that recurrent spontaneous pneumothoraces are common in DCLDs so clinicians should be vigilant about the possibility of underlying DCLDs when evaluating patients with a spontaneous pneumothorax. He advised offering pleurodesis following the first episode of pneumothorax rather than waiting for a recurrent event, explaining that the patient’s scans will look like a normal lung “so you need a high-res CT; you won’t pick these up on chest x-ray”.
Prof McCarthy pointed out that spontaneous pneumothorax is not rare – the incidence rate is approximately 22.7 per
100,000 population, and recurrence is high; at about 70 per cent . “This is a huge burden on the health service – the median length of stay when admitted is seven days and a quarter of these will need some sort of intervention.”
BHD accounts for approximately 5-10 per cent of patients with spontaneous pneumothorax, while it is estimated that in women aged between 25-50 years, LAM accounts for 5 per cent of cases, he reported.
Looking at Irish data, Prof McCarthy said there are about 1,160 reported cases of pneumothorax a year here.
“So there are probably a high number of undiagnosed cystic lung diseases out there. We estimate that about 40-to-50 cases a year are present with pneumothorax. That’s not saying they all have severe underlying disease, but they may have underlying cystic lung disease that is not being screened for,” he said, citing US data that shows screening all patients presenting with a spontaneous pneumothorax with a high-res CT is cost effective, and improves quality-of-life.
Discussing LAM, a rare systemic neoplastic disease due to tuberous sclerosis complex mutations, he said it almost exclusively affects females, particularly in the reproductive years, and a biopsy is not needed in most cases for diagnosis – serum VEGF-D (≥800pg/ml), non-contrast CT or MRI of the abdomen/pelvis, relevant family history, and positive cytology are usually sufficient to diagnose.
Treatment advances in recent years have led to the approval of mTOR inhibitors, including sirolimus, which was licensed by the US FDA in 2015 and subsequently in the EU, for the treatment of LAM. Oestrogen-containing therapies (eg, HRT) and, where possible, pregnancy should be avoided in women with LAM, while immunotherapy is now being explored as a potential treatment, Prof McCarthy said.
Looking at BHD, he explained that it is an autosomal dominant disorder characterised by formation of fibrofolliculomas, renal tumours (27-to-34 per cent prevalence) and pulmonary
cysts, and is more common in older patients, and family screening and neoplastic monitoring is indicated.
Moving on to PLCH, Prof McCarthy said it is rare and heavily smoking-related, featuring irregular, bizarrely shaped cysts (sometimes ‘Cheerio nodules’), with patients often having emphysema, bronchial wall thickening and centrilobular nodules, and it is associated with BRAF mutations. In terms of diagnosis, a transbronchial or tissue biopsy is usually needed, with core PLCH management involving smoking cessation and stopping marijuana inhalation. Screening for pulmonary hypertension is indicated and cladribine has been tried in PLCH with some success, while targeted treatment with BRAF and/or MEK inhibitors may be useful, he reported.
With regards to LIP, he said it is commonly associated with auto-immune conditions, especially Sjögren syndrome, and while it can sometimes follow a benign course, monitoring is important as “there is a high risk of lymphoma transformation”.
“There are no effective treatment options for the cysts. Sometimes ground glass changes are steroid-responsive in these autoimmune conditions, but the effects of the steroids are unclear.”
Prof McCarthy said while there are no clear guidelines on repeating imaging in LAM, he probably does it every two years and “if you get changes in the ground glass cysts or they get bigger they need to be biopsied”.
Summarising, Prof McCarthy said he hoped he had explained why it is so important to distinguish individual DCLDs rather than just saying the patient has diffuse cysts. “We know treatments are available for LAM. Family screening is important in BHD and you need neoplastic monitoring that takes a different course depending on the underlying cause,” he commented, adding that lifestyle modifications and prognosis is also different for the individual diseases.
Lung cancer screening with lowdose CT (LDCT) in high-risk populations has been proven to save lives, is cost effective and should be rolled out in Europe without further delay, the 2021 ITS Scientific Meeting heard from a renowned international expert in the area.
Prof Harry de Koning, Professor of Public Health and Screening Evaluation, Erasmus University Medical Centre, Rotterdam, gave a detailed presentation on the role and value of lung cancer screening, citing data from a number of trials and real world experiences.
Lung cancer currently kills more people worldwide than any other type of cancer, being responsible for 18.4 per cent of all cancer-related mortality. This is partly because 70 per cent of diagnoses are made at an advanced stage, with five-year survival of only 15 per cent.
In Ireland, lung cancer is the fourth most commonly diagnosed cancer, with approximately 2,750 cases diagnosed annually.
Average life expectancy for lung cancer patients upon diagnosis is 200 days, but with appropriate LDCT screening this could be increased to 12.5 years, he said.
Prof de Koning designed and is principal investigator of the Dutch-Belgian NELSON trial, Europe’s largest randomised lung cancer screening trial, which confirmed that regular screening for lung cancer would significantly reduce overall lung cancer mortality in current and former smokers (24 per cent in men and 33 per cent in women [up
to 48 per cent in women in the earlier years]).
He said the roll-out of LDCT screening in Europe could save at least 22,000 lives annually, and has now been shown to be cost-effective, with the benefits outweighing the potential harms (over-diagnosis/-treatment). Quoting data from the NELSON trial, Prof de Koning said that in the control arm, 46 per cent of lung cancers were diagnosed at stage 4 while in the screening arm, particularly in the first five/six years, 60 per cent were detected at stage 1, while 10 per cent were detected at stage 4.
“So it works,” he said.
Prof de Koning also compared the NEL-
SON results to the US NSLT lung cancer screening trial, which showed similar results in improved mortality rates, but had a much higher referral and false-positive rate. “Whereas the NSLT trial referred about 20 per cent or more, we referred about 2 per cent for suspicious lesions. That has to do with the volumetrics that we use, with having a completely different health system [in Europe]….”
He pointed out that the Covid-19 pandemic has significantly impacted lung cancer diagnosis and screening in countries where it exists, such as the US, which is already having a negative impact on outcomes.
Optimal screening intervals for lung cancer are also an important consideration with yearly, two years, and 2.5 years among those studied, with current trial results and modelling supporting annual screening, Prof de Koning reported. He noted that the US has recently changed its lung cancer screen-
ing recommendations – the US Preventive Services Task Force (USPSTF) now recommends annual screening for lung cancer with LDCT in adults aged 50-to-80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years, though Australia is preparing to roll-out a two-year screening interval programme for high-risk individuals.
However, annual lung cancer screening in high-risk individuals across Europe would probably mean some 142 million CT scans in the next 10 years, he noted, so it is being examined if the interval can be successfully lengthened without significantly impacting early detection rates. He added that coronary artery calcium scoring is a useful additional potential marker, which is also being studied in lung cancer screening.
Concluding, Prof de Koning said LDCT lung cancer screening has been shown to be at least as effective (and more in some scenarios) as longer established cancer screening programmes, and called for it to be rolled out across Europe as a priority, adding that “collaboration in the next few years would help come up with the best strategies”.
“It is not necessary to delay initiating screening until all answers are in. You can always find an argument to postpone; that is not the issue. It is actually unethical to withhold potentially beneficial treatment from people who are likely to benefit, even if all the exact best approaches are not known.”
It is actually unethical to withhold potentially beneficial treatment from people who are likely to benefit, even if all the exact best approaches are not knownProf Harry de Koning
The virtual 2021 Irish Thoracic Society (ITS) Scientific Meeting was a great success, comprising of themed poster discussions, oral presentations and five ‘state-of-the-art’ guest lectures from leading national and international experts.
Prof John Cryan, Professor and Chair, Department of Anatomy and Neuroscience, University College Cork, whose research is focused on understanding the interaction between brain, gut, and microbiome and how it applies to stress, psychiatric and immune-related disorders at key time-windows across the lifespan, gave a very interesting presentation, which addressed how the microbiome can impact respiratory health.
Prof Cryan pointed out that human genes are “99 per cent microbial”. “The one thing I want to tell you all is that we are living in a microbial world. Microbes were here long before humans so it is important that we frame all of medical research within this evolutionary context and that will help us going forward.”
Discussing early life microbiome and disease risk, he noted that many different factors, such as the mode of birth delivery, diet (breastfeeding versus formula feeding), antibiotic, animal, and smoking exposure can influence children’s
microbiomes and their chances of developing many different conditions such as allergies, asthma, type 1 diabetes, etc.
Prof Cryan also highlighted the impact of the Covid-19 pandemic on people’s microbiome (increased stress and hygiene, less social contact and exposure to other viruses, etc).
Looking at the latest cutting-edge research in the field, on how we can influence the microbiome/brain to prevent/treat respiratory illness, Prof Cryan commented: “It is early days in this field, but it is very exciting to be able to see whether we can target what is going on in the gut to affect the brain, to affect the lungs in that way. That is something we will see a lot more of, also in translational studies as we move forward. The good thing about the microbiome is its potential to be modifiable. That allows then for ways to go in with certain dietary or other interventions that could switch or tinker with cardiorespiratory control centres within the brain stem and that could lead to better outcomes across the lifespan.…”
As in previous years, there was a very high standard of research entries showcased at the meeting. The 2021 winners were as follows:
ORAL AWARD
Donal Cox, Trinity College Dublin, for ‘Lactate alters me-
tabolism in human macrophages and improves their ability to kill mycobacterium tuberculosis’.
POSTER AWARDS
Patrick Coghlan, Cork University Hospital (CUH), for ‘Computed tomography morphometric analysis of patients with idiopathic inflammatory myopathy related interstitial lung disease correlates with forced vital capacity’.
Kevin Brown, St James’s Hospital, Dublin, for ‘Differential gene expression in the immunometabolic response of human macrophages in tuberculosis and HIV infection’. Laura Walsh, CUH, for ‘A study to assess the impact of airway virus on asthma control in non-exacerbating patients’. Kate O’Brien, St James’s Hospital, Dublin, for ‘The effects of a six-week virtual Covid-19 recovery programme on exercise capacity, fatigue scores, and quality-of-life in individuals recovering from Covid-19’.
JEAN NORTON AWARD FOR BEST PAPER IN CHRONIC RESTRICTIVE PULMONARY DISEASE
Patrick McFadden, University College Dublin, for ‘Characterisation of exosomes from Lymphangioleiomyomatosis (LAM) patients’.
Pulmonary rehabilitation should be made more widely available for respiratory patients, the 2021 ITS Scientific Meeting heard.
Noted expert in the area, Prof Thierry Troosters, Professor in Rehabilitation Sciences, KU Leuven, Belgium, provided an update on pulmonary rehabilitation and its beneficial role in many respiratory conditions.
He pointed out that pulmonary rehabilitation has been shown beyond any doubt to be effective: Research has demonstrated that it improves exercise capacity (6MWD), quality-of-life and symptoms, brings an improvement in mood status, a reduction of utilisation of healthcare resources, and a reduction of postural balance and risk of falling.
“In terms of programme components, we all agree that endurance and resistance exercise training are absolutely crucial, but also other components are important [eg, smoking cessation].”
Prof Troosters outlined the main scenarios for pulmonary rehabilitation, which include stable patients with conditions such as chronic obstructive pulmonary disease, interstitial lung disease and pulmonary arterial hypertension, where it can help improve muscle function, exercise tolerance, symptoms and quality-of-life; rehabilitation post severe exacerbation, where it has been shown to reduce readmission risk and increase survival (it may be easier to start four weeks post-discharge rather than immediately, but uptake and referral remain a problem); and rehabilitation during an exacerbation
(resistance training; lifting weights), with a focus on blocking deleterious effects on skeletal muscle function.
“If you catch patients with COPD in a stable phase then one of the best things you can offer these patients is a pulmonary rehabilitation programme. It will improve exercise tolerance and quality-of-life in these patients, way beyond what we call a minimal difference in these patients.... The evidence is there, we know it works, for now it is time to implement this in our clinical routine across the different lines of healthcare.”
A properly designed multidisciplinary pulmonary rehabilitation programme will also improve anxiety and depression in patients with these issues, which is about a third of patients with chronic lung diseases, he added.
It is important to note, however, that exercise training programmes need to be adapted to the exercise limitation of patients to maximise effects and comfort, Prof Troosters stressed.
Enhancing physical activity is not a given after pulmonary rehabilitation and requires a behavioural intervention, and methodology to assess physical activity is now standardised and a framework for interventions is available, he said.
New exercise platforms (eg, telemedicine, step counters, smart phone applications) for pulmonary rehabilitation are now being explored, which should help address access and referral issues, Prof Troosters said. “We can’t just offer rehabilitation in tertiary centres very far from where our patients live so they have to travel half a day to get there. We need to get these programmes closer to the patient.”
Innovative bronchoscopic treatments for respiratory patients are continuing to evolve and can bring significant additional benefits for appropriate patients, the 2021 ITS Annual Scientific Meeting was told.
Prof Dirk-Jan Slebos, Professor of Interventional Pulmonology, University Medical Centre Groningen, Netherlands, who has extensive knowledge and research in the area, gave a comprehensive overview of bronchoscopic interventions for chronic obstructive pulmonary disease (COPD), emphysema, and chronic bronchitis.
He quoted data showing a median survival of 5.7 years versus 8.4 years in COPD patients not offered bronchoscopic lung volume reduction; “so we know that reducing hyperinflation works”.
Endobronchial valves are increasingly being used to treat hyperinflation in COPD, but about 20 per cent of patients are not eligible; “so there is a big need for additional treatments,” which include coils and lung volume reduction surgery. Disadvantages of valves include the risk of a pneumothorax (10-33 per cent), and the fact that revision bronchoscopies can be needed to prolong the effect of treatment or address longterm complications. Moreover, it is a complex treatment with respect to patient selection, intervention and follow-up, and should be performed in specialised centres only, Prof Slebos told the meeting.
Targeted lung denervation (TLD) is a 60-minute outpatient procedure performed under general anaesthesia, and fluoroscopy guided, which aims to decrease the release of acetylcholine, which regulates smooth muscle tone and mucus production, by ablating the parasympathetic nerves running alongside the main bronchi. It leads to sustained airway dilation, with studies showing a decrease in COPD exacerbations following the procedure, he said. In COPD, TLD is intended for symptomatic and at-risk patients, ie, persistent exac-
erbation history, and persistent high symptom burden (CAT). There is an unmet need in patients with maximal guideline based pharmacotherapy (COPD Gold D), Prof Slebos said.
Looking at emphysema, he cited numerous studies showing that prompt treatment with valves in carefully selected patients achieves good outcomes. “Outcomes depicted over a year are an increase in six minute walk distance, improvement in the St George’s Respiratory Questionnaire, which is a quality-of-life measurement, on top of maximum medical management and pulmonary rehabilitation, so this is really additional benefit.”
New developments for emphysema include new types of coils, airway bypass, and fissure closing.
Moving on to chronic bronchitis, Prof Slebos noted that in the past decade there has been significant developments in bronchoscopic treatments. These include liquid nitrogen metered cryospray (RejuvenAir), bronchial rheoplasty and balloon desobstruction, which all aim to destroy the hyperplastic goblet cells and excess submucous glands using different strategies.
Explaining the RejuvenAir technology, where the metered cryospray is delivered via a bronchoscope through a radial spray catheter, he said it is a well-tolerated outpatient procedure, with early signals of a quality-of-life improvement, stable lung function parameters, but durability and effect on exacerbations are not yet known (trial ongoing).
TLD is another option; however, confirmation of the benefit in improvement in chronic bronchitis symptoms is still needed as this treatment is not specifically aimed at chronic bronchitis, but at COPD in general.
Concluding, Prof Slebos said that bronchoscopic interventions for COPD and chronic bronchitis are additional to standard treatment (COPD), “bronchoscopic lung volume reduction is a guideline treatment,” phenotyping patients is key, and new developments are ongoing.
Pulmonary rehabilitation should be more widely availableIrish Thoracic Society, Annual Scientific Meeting, virtual, 19 November 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
OUR
Q1 Who is the manager of the Ireland women’s senior football team?
Q2 Who recently won snooker’s first Triple Crown event of the season, the UK championship?
Q3 Formula One sadly lost a former car manufacturer team principal when he passed away last month. Can you name the racing legend?
Q4 Who won this year’s FAI Cup?
Q5 Name the former British ladies No 1 tennis player and Grand Slam semi-finalist who announced her retirement from professional tennis last week?
Q6 Which county play their intercounty home fixtures at O’Moore Park?
The winner of the 18 November 2021 Sporting Quiz Competition is Dr Lucy Smith, Co Dublin
The winner of the 18 November 2021 Crossword is Dr Tracey Brennan-Moran, Co Kildare
Q1 Which nation won cricket’s Twenty20 international this month?
A: Australia
Q2 Snooker’s first Triple Crown event, the UK Championships, cues off next weekend. Who is the defending champion?
A: Neil Robertson
Q3 Who has replaced Steve Bruce as Newcastle United manager?
A: Eddie Howe
Q4 Which golf course will host the 2022 Irish Open?
A: Mount Juliet
Q5 Who became boxing’s undisputed Super Middleweight World Champion after claiming the WBC belt earlier this month?
A: Saúl Canelo Álvarez
Q6 Who will face off in this season’s FAI cup final?
A: Bohemians V St Patrick’s Athletic
DOWN
1 Firmly fixed (6)
2 Manner of giving a speech (8)
3 Keen (5)
5 Not spiritual or sacred (7)
6 Wicked (4)
7 Religious act of petition (6)
8 Serving to enlighten; instructive (11)
13 Make; produce (8)
14 A particular item (7)
15 Second of two (6)
16 Be present at (6)
17 Subject of a talk (5)
19 Metal fastener (4)
TITLE: A State of Fear: How the UK government weaponised fear during the Covid-19 pandemic
AUTHOR: Laura Dodsworth
PUBLISHER: Pinter & Martin, London
REVIEWER: George Winter
“Acentral tenet of this book”, writes journalist, photographer, and filmmaker Laura Dodsworth, “is that the use of fear to create compliance is ethically dubious, and at the very least, warrants public debate.” I agree. I also agree with Dodsworth’s call “for a specific inquiry into the use of behavioural science by government”. Although the focus of A State of Fear is on the UK government, Dodsworth helpfully not only refers to the New Zealand government’s delivery of a “masterclass in propaganda” since the emergence of Covid-19, but highlights how Ireland’s independent scientific
advocacy group was instructed “to look for ways to increase insecurity, anxiety, and uncertainty”, with a reminder that “people hurt faster than institutions”. But A State of Fear has left me in a state of annoyance. This is because even if the author had not revealed that it had taken her a year to write this book, there’s no doubt that it is a rush-job with more padding than a kapok factory. My irritation is further fuelled by the knowledge that this book has some valid critiques of how the UK government and many of its advisors frightened the UK popu-
lation, and Dodsworth’s insights could have made interesting contributions to a retrospective analysis of the pandemic. Unfortunately, they are undermined by a sloppy approach that erodes one’s trust in the author.
Before I had finished reading the first page of the introduction I was in a state of puzzlement because it was clear that the author does not know the difference between a pandemic and an epidemic. Although Dodsworth – when not quoting primary sources – uses the word “pandemic” correctly some 22 times throughout the book, she favours “epidemic” incorrectly on at least 67 occasions. But even more concerning, on page 26 she misquotes a primary source by substituting “pandemic” with “epidemic”. Thus, according to
Dodsworth a Press Gazette poll had asked, “Do you think trust in journalism has increased since the Covid-19 epidemic?” In a state of curiosity, I checked the original article (written by Charlotte Tobitt on 14 April 2020), and the question was, “Do you think trust in journalism has increased since Covid-19 pandemic?” Given Dodsworth’s blunder, one wonders how many other contributors who talk of the “epidemic” may have been misquoted by her.
In a state of exasperation, I went back to the start to find that at the end of the introduction’s first paragraph “we were one of the most frightened countries in the world”, yet three pages later “[w]e were the most frightened population in the world.” Equally poor copy-editing stalks the text. For instance, Matt
Hancock is variously the Minister for Health (page 24) and the Secretary of State for Health and Social Care (page 48); it is Emily Maitlis not Emily Maitliss (page 23); and the apparently random selection of “Covid”/“Covid-19”/ “COVID-19” throughout the text signals inconsistency.
As for padding, consider chapter 3, titled ‘Frightful Headlines’. Throughout the pandemic, those of us able to read were all too aware of the diverse headlines generated by mainstream media, so I’m in a state of bemusement as to why this self-evident point must be rammed down the reader’s throat by including six pages on which 55 newspaper/website/broadcast headlines are reproduced without comment. Similarly, it is right – indeed imperative – that the havoc wrought by the pandemic on our lives and those of our fellow citizens should be documented. But is a book on how governments and behavioural scientists manipulated populations an appropriate forum in which to include 15 first-hand accounts by anonymous contributors on how they felt?
The fact that Dodsworth is not a scientist in no way disqualifies her from writing a book such as this. After all, the current pandemic has exposed the fact that the gulf in competence and knowledge between many so-called experts is deep and wide. But it hardly inspires confidence in the reader to learn (page 9) that “I had done my best to qualify as an armchair virologist by mid-March 2020, and inhaled articles and YouTube videos about viruses, Wuhan, and the Diamond Princess”. The articles and videos that Dodsworth “inhaled” had led her to believe that the causative agent of Covid-19 “would inevitably behave as all other respiratory viruses before it. Why would it not?” To learn why it would not necessarily have behaved “as all respiratory viruses before it”, would have required Dodsworth to have spent many weeks in her armchair inhaling a lot more articles and videos. But this would have meant less time both for writing and – bafflingly – arranging a rendezvous with Steve. Steve wore camouflage gear, drove an olive-green Land Rover, and the author met him in a B&Q car park, where she asked, “Did he believe aliens might be involved in controlling governments?” Dodsworth further interrogated Steve to determine whether he thought a Covid-19 conspiracy might be “operated by the Masons or Illuminati”?
Writing a negative review of a hastily written book with well-intentioned aims is no more enjoyable than stamping on a box of chocolates, but A State of Fear makes me despair at the state of journalism.
A State of Fear has left me in a state of annoyance. This is because even if the author had not revealed that it had taken her a year to write this book, there’s no doubt that it is a rushjob with more padding than a kapok factory
Unfortunately, while testing the Ford’s new Fiesta mHEV, I had to get my mum to a certain South Dublin private hospital’s emergency room before it closed at 6pm. This plucky little Fiesta rose to the challenge of becoming a makeshift ambulance and proved, as the Fiesta has time and again, that it isn’t the size of the dog in the fight, it’s the size of the fight in the dog.
Having fallen in love with the Fiesta mHEV’s hardcore cousin, the full fat, 200hp Fiesta ST, two years ago, I was sceptical about this ‘mild hybrid’ Fiesta, but boy was I pleasantly surprised. My test car was a five-door ST-Line, with a 1.0-litre turbocharged engine, pushing 125hp through a rather sweet six-speed manual gearbox. Utilising the new mild hybrid system, this Fiesta was fun to drive in a way that many supposed sporty cars would dream of. It was powerful, responsive, and accelerated smoothly throughout the gear range. It was a handsome little so-and-so, painted in metallic black with 17” alloy wheels and slightly tinted rear windows, for that sleek, black-on-black look. It also boasted some nice ST-Line body panels, such as the grille and spoiler.
Available in 125hp or 155hp, this turbocharged, mHEV Fiesta features a belt-driven integrated starter/generator (BISG) in
place of the standard alternator, enabling recovery and storage of energy usually lost during braking and coasting, to charge a 48-volt lithium-ion air-cooled battery pack. The BISG also acts as a motor, integrating with the engine and using the stored energy to provide torque assistance during normal driving and acceleration, as well as running the vehicle’s electrical ancillaries. Finally, this clever system also shuts down one of the engine’s cylinders, when it detects it’s not needed, to enhance
fuel efficiency and save the planet.
According to Mr Roelant de Waard, Vice-President, Marketing, Sales and Service at Ford of Europe: “Adding EcoBoost Hybrid technology to Fiesta’s best-inclass driving dynamics means customers can have even more power and still go further on a tank of fuel.”
The Fiesta is festooned with tech, like FordPass Connect, which allows the driver to unlock their doors, start the car, locate the vehicle and check on the fuel
level, alarm status, tyre pressures and oil life, through the FordConnect app, on their smartphone. My test car also had adaptive cruise control, which the driver can now use in stop start traffic, as well as motorway driving, and a terrific Fiesta SYNC 3 infotainment system with Android Auto and Apple CarPlay. Also available are park assist, cross traffic alert, with active braking and a phenomenal B&O sound system with a subwoofer built into the wheel arch.
The four-door Fiesta is a perfect example of less is more. I packed up the boot with shopping on three occasions, as well as bags, boxes, and four adult humans, and despite what the crossover SUV propaganda would tell you, nothing went wrong, it was perfectly fine. So, do you really need a small SUV for your family of three when a good hatchback will do the job? I don’t think so.
The entry-level Fiesta costs €18,949, but I don’t believe in promoting entry-level cars, as they’re usually lacking. My test car, the ST-Line, 1.0-litre, 125hp, EcoBoost-Hybrid starts at €23,947. However, once you add the optional extras that price rises to €25,015. That’s not bad at all, in a world where people spend €45k on a Nissan Qashqai.
I can’t recommend this little bargain enough, especially if you’re looking for a family car that doesn’t feel cheap and won’t let you down in an emergency.
FORD FIESTA
MHEV ST-LINE
1.0T 125PS MHEV EcoBoost
Hybrid
Six-speed manual
Five-door
CO 2 Emissions: 116g/km
(WLTP)
Colour: Agate Black
metallic paint
Registration: 211 D 8915
Standard features include:
Rock Metallic Light 17”
5x2-spoke alloy wheels
ST-Line front fog lamps with cornering lights
Black headlining
LED night signature to
rear lights
Keyless start with Ford power starter button
Rear privacy glass
Cruise control including ASLD
(Active speed limiter device)
Rear parking sensors
Rainsensing wipers and autodimming mirror
Sensico wrapped
flat-bottom steering wheel with centre console with opening armrest, 2 x cupholders, red
stitching 12v and USB
Ford SYNC 3 navigation with 8’’ touchscreen
Electric rear windows
DAB radio, Emergency
Assistance, Apple CarPlay and Android Auto, 2 x USB sockets, Six speakers and FordPass Connect** (Embedded modem)
Unique ST-Line upper grille and full body styling kit with ST-Line wing badges
Large body coloured
rear spoiler
Sports tuned suspension
Additional options on this model:
Driver assistance pack –incl 4.2” TFT instrument cluster; (AEB) Autonomous emergency braking – incl pedestrians
AEB, auto high beam, speed sign recognition, driver alert, intelligent adaptive cruise control (ACC), door edge protectors, BLIS (Blind spot information system), advanced auto park includes front parking sensors and advanced auto park assistance, rear view camera = €1,068
Price for Ford Fiesta
ST-Line 1.0 125PS EcoBoost
Hybrid from €23,947 = plus optional extras = €25,015
Entry price for Ford Fiesta from €18,949 (Prices exclude delivery and related charges)
The Fiesta is festooned with tech, like FordPass Connect, which allows the driver to unlock their doors, start the car, locate the vehicle... through the FordConnect app, on their smartphone
THREE DIFFERENT SERUM BIOMARKERS OF SELENIUM STATUS ARE INVERSELY ASSOCIATED WITH ALL-CAUSE MORTALITY FOLLOWING BREAST CANCER DIAGNOSIS – STUDY
A study recently published in Redox Biology investigated three complementary serum selenium status biomarkers in relation to overall survival and recurrence following diagnosis of primary invasive breast cancer in a large prospective cohort study.
The new study, titled ‘Serum selenium, selenoprotein P and glutathione peroxidase 3 as predictors of mortality and recurrence following breast cancer diagnosis: A multicentre cohort study’, identified “a group of patients with breast cancer diagnosis with exceptionally high mortality risk” by assessing the selenium (Se) deficit via a compound biomarker consisting of the three serum parameters.
According to the authors, trace element Se is of prime importance for the biosynthesis of a limited set of selenoproteins implicated in antioxidative protection, thyroid hormone metabolism, tumour growth and cell proliferation. Accordingly, Se intake and status have been discussed as potentially affecting breast cancer development.
The researchers from the University of Lund in Sweden conducted the research in collaboration with researchers from various universities in Germany. They measured levels of selenium in the blood of 1,996 women who had a new diagnosis of primary invasive breast cancer.
They looked specifically at total selenium, selenoprotein P, and glutathione peroxidase (GPx3). All three selenium markers were inversely correlated with cancer survival and recurrence. Notably, using all three
parameters of Se status, a “triple deficient” patient group was identified with highest mortality risk of close to 50 per cent after eight years of follow-up.
“The composite biomarker of Se status outperformed three of the most important tumour characteristics, ie, Nottingham histologic grade, tumour size and number of lymph nodes involved, in predicting mortality. We conclude that the Se status constitutes an important prognostic parameter in breast cancer.”
The authors concluded that “the stringent and surprisingly strong association between Se deficiency and poor overall survival after breast cancer diagnosis supports the notion on the essential importance of a sufficiently high Se status for human health”.
They noted that “as seen before, populations residing in Europe are insufficiently supplied, and a profound Se deficit is associated with worst chances of survival”.
“Our study has identified a group of patients with breast cancer diagnosis with exceptionally high mortality risk by assessing the Se deficit via a compound biomarker consisting of three serum parameters. In contrast to genetic predisposition, Se status is amenable to correction via simple dietary or supplemental means.
“Hence, a solid and sufficiently powered intervention study stratified for baseline Se deficiency is needed and appears highly promising in order to test whether correcting a diagnosed Se deficit confers survival benefits in breast cancer.”
The Blackrock Clinic is providing a new type of scan for prostate cancer. The PSMA (protein specific membrane antigen) is labelled with F-18 and the PET/CT scan is used to detect the F-18 PSMA within the body. PSMA provides the most accurate staging evaluation for men
with prostate cancer. The scan is most commonly used for patients who have previously had prostate cancer and are re-presenting with concern of disease recurrence, most frequently with elevated prostate-specific antigen (PSA). PSMA can also be used as a stag-
ing tool to more accurately detect the spread of prostate cancer in a newly diagnosed patient. Due to difficulties accessing this scan in Ireland, some Irish patients go overseas to the UK or Europe.
The PSMA PET/CT scan uses nuclear isotopes in fluorine-18 to detect certain proteins in the body by attaching to and ‘lighting up’ on a scan when they come into contact with cancerous growths.
Prof Stephen Connolly, Consultant Urologist at the Blackrock Clinic, said: “This is very good news for men with prostate cancer. This simple and effective scan will help to quickly and accurately evaluate prostate cancer, which in turn will lead to better precision in treatment and improvements in outcome.”
CEO of the Blackrock Clinic Mr James O’Donoghue welcomed the development, saying: “At the Blackrock Clinic we strive to provide the most advanced
care to all of our patients. The PSMA PET/CT scan using the fluorine-18 radioisotope is the latest technology we have introduced specifically to improve men’s health and wellbeing.”
According to Blackrock Clinic, it is the only private hospital in the country offering such a scan and agreement has been reached with the VHI to fund this diagnostic test for members on certain plans. If a patient’s insurer does not cover the cost of this scan, “it is available on a self-pay basis.”
Internationally, use of these scans is widespread in the evaluation of prostate cancer. PSMA PET/CT is now considered the best staging tool for the most common cancer affecting men.
However, in Ireland, only one public hospital is currently providing PSMA PET/CT scanning, which means there are long delays in accessing this diagnostic tool.
Researchers at Trinity College Dublin have made a major discovery in understanding motor neurone disease (MND). The research team has found that MND has four distinct patterns of changes in electrical signals that can be identified using electroencephalography (EEG).
According to the College, this breakthrough will be extremely valuable in identifying patients for clinical trials and will assist in finding new treatments for this disease.
The study was published online in the journal Brain The paper, ‘Resting-state EEG reveals four subphenotypes of amyotrophic lateral sclerosis’, can be read in open access here: https://academic.oup. com/brain/advance-article/doi/10.1093/brain/ awab322/6430106
While trials of new drugs are being undertaken, MND is known to be very heterogeneous with different patterns of disability and life expectancy. Predicting the pattern of disability and life expectancy is one of the major challenges in designing modern clinical trials.
The world class electrical signal analysis research developed within Trinity College has discovered dif-
body of work. A major barrier to providing the right drug for the right patient in MND is the heterogeneity of the disease. This breakthrough research has shown that it is possible to use patterns of brain network dysfunction to identify subgroups of pa-
tients that cannot be distinguished by clinical examination. The implications of this work are enormous, as we will have new and reliable ways to segregate patients based on what is really happening within the nervous system in MND.”
The recent innovation week at Tallaght University Hospital (TUH) saw the introduction of an electronic patient record (EPR) called Synergy. It will replace some of the hospital’s legacy end-of-life ICT systems and paper-based records and processes, enabling staff to access a single, reliable and integrated source of clinical information.
According to TUH, Synergy is another example of the hospital’s “overall innovative approach to supporting the delivery of healthcare with digital technologies” known as Digital Enabled Care, a core pillar of the hospital’s corporate strategy.
Once the Synergy roll-out is complete, there is potential for it to be accessible within the community, general practices, and other services.
Mr David Wall, Chief Information Officer at TUH, paid tribute to all the staff involved in the EPR programme: “TUH staff have approached the implementation of Synergy with energy, commitment and focus which has directly contributed to the success of the programme.”
ferent patterns of brain network disruption reflect the underlying disease process. The Trinity researchers have now shown that these patterns of brain network disruptions in MND cluster into four distinct subtypes that are predictive of how the disease progresses. The team’s findings move the Trinity researchers one step closer to building better and more effective treatments for different sub-categories of the disease.
The work was performed by Mr Stefan Dukic, a PhD student within the Academic Unit of Neurology at Trinity, under the supervision of Dr Bahman Nasseroleslami, who is the ‘Fr Tony Coote Assistant Professor in Neuroelectric Signal Analysis’.
Dr Nasseroleslami said: “Understanding how brain networking is disrupted in MND has been the focus of our research for the past 10 years. This work shows that we are on the right track, and that the technologies we have developed to capture electrical activity in the brain can identify important differences between different patient groups.”
Prof Orla Hardiman, Professor of Neurology and a world leader in MND research, said: “This is a very important and exciting
“This is the most significant change the hospital has introduced in its 23-year history and has been years in planning,” according to a statement from TUH. “The hospital has a number of legacy ICT systems requiring replacement and identified a number of information gaps. Coupled with this was the hospital’s use of its own clinical specific ICT systems as well as national HSE ICT systems.”
According to the hospital, there was also the sustainability of an increasing manual paper record to be considered. Having reviewed all the options, it decided to implement an interfaced EPR, utilising some of the existing ICT systems and interfacing them through an EPR platform to create a single view of the patient record (‘Synergy’).
Ms Lucy Nugent, CEO at the hospital, added: “Synergy will improve TUH’s service delivery, clinical processes, informatics capabilities and work flow efficiencies, improving patient outcomes for those who attend TUH.
Chief Clinical Information Officer Dr Jason Carty said Synergy offered TUH a major opportunity to transform the way it delivered care to patients. “An additional benefit is that it will streamline workflows and processes which support care delivery and facilitate service user communication and information sharing between staff anytime anywhere and in time on any device.”
Ms Ciara Blair, Synergy Programme Manager, commented: “A strategic project of this scale is always challenging but the clinical, technical and project management skill mix within the Synergy team has been a critical success factor.”
Long-established two-doctor GP training practice North Meath area seeks assistant. Flexible options available. Fully computerised, supported by excellent nursing and administrative staff. Excellent package including genuine partnership opportunity if desired.
Please email cv to drjameskeenan@gmail.com or phone 086 814 0136 for informal enquiries
GP required for a well-established practice in East Galway (6-8 sessions).
20-minute commute from Oranmore.
Fully computerised with Socrates and great practice support.
Generous remuneration available to the right candidate.
Contact our Practice Manager Mary on 091 842144 or 087 2035825 or email your CV to maryhoran.mh@gmail.com
Well-established GP practice requires a GP for 6+ sessions per week with a view to full-time employment in Donegal Town. Group practice/fully computerised/full ancillary staff. millrowfamilypractice@gmail.com
match medics are working with a number of south african GPS ON THEIR JOURNEY TO IRELAND
CONTACT GRAHAM TODAY TO KICK START THE PROCESS
Call: 087 758 4592 or Email: graham.cosgrave@matchmedics.com
From 24th of December to 3rd of January
With added bonuses for taking 5 sessions or more
VISIT: www.medsource.ie
CALL: 046 924 1533
EMAIL: info@medsource.ie
Modern medicine: What’s new in 2022
WHEN: Saturday 22nd January
WHERE: Live streamed webinar
This live-streamed webinar will feature consultants from a number of specialties giving us an update on the latest treatments and techniques available for patients. Topics will include: Clinical trails and research, cancer, cardiology, orthopaedics, long Covid, plastic and reconstructive surgery, patient rehabilitation, and more. For further information or to register to attend, please visit the events page in the GP section of beaconhospital.ie CME Accreditation has been applied for.
Link for online: www.beaconhospital.ie/ information-for-gps/study-events/januarygp-educational-webinar-2022/
If you have anything you would like to share, please email: info@mindo.ie
Only in recent years has the issue of concussion and head injuries in professional sport been taken seriously. Along with almost everything else, focus on this issue has taken a back seat to Covid-19, but a new study from researchers in Durham University in the UK, along with colleagues in Aus-
tralia and New Zealand, has shed some new light on the topic.
The study, published recently in Sports Medicine, showed that there appear to be significant mental health implications for rugby players who suffered concussions during their playing careers. Specifically, the authors found that retired professional rugby players are more prone to anxiety,
For the treatment of active rheumatoid arthritis, severe recalcitrant disabling psoriasis & severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate
For the treatment of active rheumatoid arthritis, severe recalcitrant disabling psoriasis & severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate
depression and irritability than their non-contact or amateur counterparts.
Participants comprised former top professional rugby players who had suffered more concussions than their counterparts in the aforementioned other groups. They found that players who had suffered five or more concussions were twice as likely to potentially suffer with mental health problems. It was also concluded that these ex-players also have to deal with deep-seated feelings of anger and irritability.
The number of concussions is a factor – they found that 50 per cent of those who had three or more concussions showed these signs of poor mental health, compared to one-third of those who had suffered less than three concussions. The participants were compared to other former sports people, including runners and cricketers, in the UK. Another longterm implication was identified as sleep disturbances in those who had suffered multiple concussions.
“Our study shows that elite-level rugby players disclosed more adverse mental health issues following retirement from the sport, compared to those who had played amateur level rugby, or a non-contact sport," commented Dr Karen Hind of Durham University’s Department of Sport and Exercise Sciences. “This was particularly the case for those players who had experienced three or more concussions. These findings add to a growing body of evidence that can inform strategies to support player welfare and they shed further light on risks of repeated concussions.”
Overall, during the course of a professional rugby career, three concussions is a low threshold and it's reasonable to expect that between training and competition, the average player will experience more than three of these injuries. A quick search will yield plenty of videos of how rugby was played in the ‘old days’, before there was such a heavy emphasis on the crash-bang-wallop approach to modern professional rugby, where the players are bigger and stronger and the hits are incomparably heavy.
initiation of therapy is recommended. Recommended initial dose 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.
Nordimet (methotrexate) Solution for injection in pre-filled pen
Please refer to the Summary of Product Characteristics (SmPC) for full prescribing information. Further information is available on request.
Presentation: Pre-filled pen containing 7.5 mg (in 0.3 ml), 10 mg (in 0.4 ml), 12.5 mg (in 0.5 ml), 15 mg (in 0.6 ml), 17.5 mg (in 0.7 ml), 20 mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in solution for injection. Indications: Active rheumatoid arthritis in adult patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.
Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. Dosage and administration: Nordimet should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Nordimet should be performed under direct medical supervision. Nordimet is injected once weekly, administered subcutaneously. Rheumatoid arthritis:
Recommended initial dose is 7.5 mg of methotrexate once weekly.
Depending on the individual activity of the disease & patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Polyarthritic forms of severe, active juvenile idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20mg/m² BSA per week. Use in children < 3 years of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to
12.5 mg (in 0.5 ml), 15 mg (in 0.6 ml), 17.5 mg (in 0.7 ml), 20 mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in solution for injection. Indications: Active rheumatoid arthritis in adult patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. Dosage and administration: Nordimet should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Nordimet should be performed under direct medical supervision. Nordimet is injected once weekly, administered subcutaneously. Rheumatoid arthritis: Recommended initial dose is 7.5 mg of methotrexate once weekly. Depending on the individual activity of the disease & patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Polyarthritic forms of severe, active juvenile idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20mg/m² BSA per week. Use in children < 3 years of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to
Date Of Preparation: Aug 2021 IE/21/NOR/011-00
initiation of therapy is recommended. Recommended initial dose 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate. Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose. In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate. Crohn’s disease (adult patients): 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Maintenance treatment: 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission. Renal impairment, hepatic impairment or elderly patients: Please refer to SmPC. Note: When switching from oral to parenteral use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.
Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose.
In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate. Crohn’s disease (adult patients): 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Maintenance treatment: 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission. Renal impairment, hepatic impairment or elderly patients: Please refer to SmPC. Note: When switching from oral to parenteral use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.
Contraindications: Hypersensitivity to methotrexate or to any of the excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency.
Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis.
Ulcers of the oral cavity and known active gastrointestinal ulcer disease.
Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines.
Contraindications: Hypersensitivity to methotrexate or to any of the excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency. Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis. Ulcers of the oral cavity and known active gastrointestinal ulcer disease. Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines. Special warnings and precautions: Patients must be clearly advised that the therapy is to be administered once a week, and not every day.
Special warnings and precautions: Patients must be clearly advised that the therapy is to be administered once a week, and not every day.
Patients receiving therapy should be appropriately monitored. Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. The possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with male and female patients of childbearing potential.
Methotrexate contact with skin and mucosal membranes is to be avoided; in cases of contamination rinse the area with plenty of water. Interactions: Consult SmPC for detailed information on interactions. Undesirable
effects: See SmPCs for full list of undesirable effects. Very common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. Abnormal liver function tests (increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache. Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis. Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic events. Pulmonary fibrosis. Pneumocystis carinii pneumonia. Shortness of breath and bronchial asthma. Pleural effusion. Acute hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. Lymphoproliferative disorders. Severe courses of bone marrow depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative disorders). Legal classification: POM. MA numbers: EU/1/16/1124/001
Patients receiving therapy should be appropriately monitored. Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. The possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with male and female patients of childbearing potential. Methotrexate contact with skin and mucosal membranes is to be avoided; in cases of contamination rinse the area with plenty of water. Interactions: Consult SmPC for detailed information on interactions. Undesirable
effects: See SmPCs for full list of undesirable effects. Very common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. Abnormal liver function tests (increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache. Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis. Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic events. Pulmonary fibrosis. Pneumocystis carinii pneumonia. Shortness of breath and bronchial asthma. Pleural effusion. Acute hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. Lymphoproliferative disorders. Severe courses of bone marrow depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative disorders). Legal classification: POM. MA numbers: EU/1/16/1124/001 – 008. Further information available from: Nordic Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin. Date of Prescribing Information: July 2021. Item code: IE/21/NOR/008-00.
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Nordic Pharma Ireland; info@ nordicpharma.ie or +353(0)1 4004141
That's all well and good, as long as the players' health and safety are not compromised, so perhaps this new research will kick-start that conversation once again.
Sticking with sports, another new study has found that men and women athletes react and perform differently when there is no crowd to perform in front of.
The pandemic has given rise to many eerie scenarios where sports events are held in empty or almost-empty stadia, and the bright sparks at Martin Luther University (MLU) Halle-Wittenberg in Germany decided to examine the performance implications more closely.
In short, they found that without an audience, men run slower and women run faster. Women were also found to perform better in complex tasks, such as shooting, when an audience was present compared to men. The athletes studied performed at the 2020 Biathlon World Cup: "To our knowledge, this is the first time that a study was able to show a different effect of the audience on men and women," said Dr Oliver Stoll, head of the sports psychology section at MLU. "Our study raises questions about the generalisability of the social facilitation theory and indicates there might be a previously unknown difference between men and women."
If you want to check out the full findings, the study was published recently in Psychology of Sport and Exercise