The Medical Independent 25th August 2022

Examining the role of the HSE Confidential Recipient

Enhancing emergency medicine

PAGE 16-18

‘World-leading' genomics expert declined post

The absence of a genomics strategy and multi-annual budget led to a “world-leading expert in genomics” declining the role of Director of the planned national genetics and genomics medicine network (NGGMN), this newspaper has been told.

The first search for a Director began in September 2020 and was unsuccessful. A second campaign in 2021 resulted in an identified candidate being offered the role, which they did not take up.

“A multi-annual budget can be allocated based on business case development and having a strategy in place, and the absence of these was a contributing factor that led to the identified candidate’s decision to not leave their prominent position and relocate to Ireland to take up the role of Director of the NGGMN at that time,” a HSE spokesperson told the Medical Independent (MI)

“It is also understood that the absence of

a national testing infrastructure contributed to their decision.”

In his report to the March meeting of the HSE safety and quality committee, Chief Clinical Officer Dr Colm Henry said that although “there are some pockets of excellence in the country, Ireland lags considerably behind other countries in harnessing the power of genomic data and research to inform clinical decision-making”.

Dr Henry told committee members that the average waiting time for a routine genetics appointment was two years, according to the minutes.

The committee stated it was “very disappointed” to learn that the position of NGGMN Director was still vacant.

In May, the HSE commenced work on a national genetics and genomics strategy for Ireland, which is due to be published by the end of the year.

Commenting at the time, Dr Henry said: “A number of previous reviews have shown that

Testing the personalities of surgeons

Incorporating personality testing into the selection of surgical trainees needs further study, writes Dr Muiris Houston

PAGE 26

there is a large and increasing disparity between genomic medicine services offered in Ireland and internationally, and medical genetics in Ireland is under-resourced for both clinical and laboratory services.

“As a result, patients here do not currently have timely access to genetic opinions or to genetic testing, resulting in delays in diagnosis, treatments, and interventions. This new strategy will allow our health service to tackle these shortcomings and realise the benefit of genomic medicine for patients in Ireland.”

The HSE’s spokesperson told MI that the strategy “is considered crucial to the recruitment of any leadership post with the appropriate level of expertise”.

“The strategy will make recommendations relating to the establishment of a national structure and the roles required for that entity, taking into consideration unfilled posts already in receipt of funding and those that would require additional funding,” said the spokesperson.

“The recruitment for all roles associated with the establishment of this national structure will be part of the implementation of the strategy and will commence, subject to funding, in 2023.”

‘Lack of engagement’ on status of occupational medicine specialists

CATHERINE REILLY

The establishment of consultant status for occupational medicine specialists will not be discussed during Sláintecare consultant contract negotiations, the Department of Health has stated.

It is understood specialists are on a range of contracts which incorporate certain elements of the consultant contract. Some new entrants were also put on a “defunct” pay scale, according to the IMO.

An IMO spokesperson commented: “It’s immensely frustrating that the HSE and the Department of Health have yet to properly engage on the status of those occupational health physicians recruited onto a defunct salary scale. Everyone agrees that this issue needs to be resolved, and there is no dispute as to the avenue that will be used for that resolution, but the lack of engagement from the State side is almost total.”

The IMO said it has “included the position of occupational health physicians within the sectoral bargaining process under Building Momentum. In particular, we are seeking to have those specialist physicians who were placed on a defunct salary scale removed from that scale and placed instead on a pay scale already in payment, ie, that which applies to consultants appointed post-October 2012. Discussions in that respect remain delayed on the State side.

“We do note that occupational medicine is no different from any other specialty in that one is required to hold specialist registration in order to practice as a specialist.”

XELJANZ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

XELJANZ in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.

XELJANZ in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

XELJANZ is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.

KEYTRUDA® (pembrolizumab)

ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. PRESENTATION KEYTRUDA 25 mg/mL:

One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. INDICATIONS KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection. KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.

KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. KEYTRUDA as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1. KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy.

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. KEYTRUDA, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. KEYTRUDA as monotherapy is indicated for the first line treatment of metastatic microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults.

KEYTRUDA as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with (a) unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy, (b) advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation, (c) unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.

KEYTRUDA, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 10. KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. DOSAGE AND ADMINISTRATION See SmPC for full details. Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. The recommended dose of KEYTRUDA as monotherapy in paediatric patients aged 3 years and older with cHL is 2 mg/kg bodyweight (up to a maximum of 200 mg), every 3 weeks administered as an intravenous infusion over 30 minutes. For use in combination, see the Summary of Product Characteristics (SmPC) for the concomitant therapies. KEYTRUDA must not be administered as an intravenous push or bolus injection. When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first. Treat patients until disease progression or unacceptable toxicity (and up to maximum duration of therapy if specified for an indication). For the adjuvant treatment of melanoma or RCC, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year. Refer to the SmPC for dosing in neoadjuvant and adjuvant treatment of locally advanced, or early stage triple-negative breast cancer at high risk of recurrence. KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued (a) For Grade 4 toxicity except for: endocrinopathies that are controlled with replacement hormones; or haematological toxicity, only in patients with cHL in which KEYTRUDA should be withheld until adverse reactions recover to Grade 0-1; (b) If corticosteroid dosing cannot be reduced to ≤10 mg prednisone or equivalent per day within 12 weeks; (c) If a treatment-related toxicity does not resolve to Grade 0 1 within 12 weeks after last dose of KEYTRUDA; (d) If any event occurs a second time at Grade ≥ 3 severity. Patients must be given the Patient Alert Card and be informed about the risks of KEYTRUDA. Special populations Elderly: No dose adjustment necessary. Renal impairment: No dose adjustment needed for mild or moderate renal impairment. No studies in severe renal impairment. Hepatic impairment: No dose adjustment needed for mild hepatic impairment. No studies in moderate or severe hepatic impairment. Paediatric population: Safety and efficacy in children below 18 years of age not established except in paediatric patients with cHL. CONTRAINDICATIONS Hypersensitivity to the active substance or to any excipients. PRECAUTIONS AND WARNINGS Assessment of PD-L1 status When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations. Immune-related adverse reactions Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab. Most immune related adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care. Immune related adverse reactions have also occurred after the last dose of pembrolizumab. Immune-related adverse reactions affecting more than one body system can occur simultaneously. Immune-related adverse reactions are immune-related pneumonitis, immune-related colitis, immune-related hepatitis, immune-related nephritis, immune-related endocrinopathies (including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoaci-

(pembrolizumab) Infusion 25mg/ml

dosis, hypothyroidism, and hyperthyroidism), Immune-related skin adverse reactions (also including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)), Refer to SmPC for more information and management of immune-related adverse reactions. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT): Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with classical Hodgkin lymphoma undergoing allogeneic HSCT after previous exposure to pembrolizumab. Infusion-related reactions: Grades 1, 2, 3 or 4 infusion reactions including hypersensitivity and anaphylaxis, could be seen with pembrolizumab treatment. Refer to SmPC for more information and management of infusion-related reactions. Overdose: There is no information on overdose with pembrolizumab. In case of overdose, monitor closely for signs or symptoms of adverse reactions and treat appropriately. INTERACTIONS No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. No metabolic drug drug interactions are expected. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. Corticosteroids can be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions. FERTILITY, PREGNANCY AND LACTATION Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Pregnancy No data on use in pregnant women. Do not use during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. Breast-feeding It is unknown whether pembrolizumab is secreted in human milk. A risk to newborns/ infants cannot be excluded. Fertility No clinical data available. SIDE EFFECTS Refer to SmPC for complete information on side effects. Pembrolizumab is most commonly associated with immune-related adverse reactions. Most of these reactions resolved with appropriate medical treatment or withdrawal of pembrolizumab. The most serious adverse reactions were immune-and infusion-related adverse reactions. When pembrolizumab is administered in combination with axitinib or lenvatinib, refer to the SmPC for axitinib or lenvatinib prior to initiation of treatment. For additional lenvatinib safety information related to advanced RCC see the SmPC for Kisplyx and for advanced EC see the SmPC for Lenvima. Monotherapy: Very Common: anaemia, hypothyroidism, decreased appetite, headache, dyspnea, cough, abdominal pain, nausea, vomiting, constipation, musculoskeletal pain, arthralgia, asthenia, oedema, pyrexia, diarrhoea, pruritus, rash, fatigue. Common: pneumonia, thrombocytopenia, neutropenia, lymphopenia, hyponatraemia, hypokalaemia, hypocalcaemia, insomnia, neuropathy peripheral, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, hyperthyroidism, insomnia, dizziness, dysgeusia, pneumonitis, colitis, dry mouth, severe skin reactions, vitiligo, dry skin, alopecia, eczema, dermatitis acneiform, erythema, dermatitis, myositis, pain in extremity, arthritis, influenza like illness, chills, AST and ALT increases, increase in blood alkaline phosphatase, hypercalcaemia, blood bilirubin increased, blood creatinine increased, infusion related reaction. In combination with chemotherapy: Very Common: neutropenia, anaemia, thrombocytopenia, leukopenia, hypothyroidism, hypokalaemia, decreased appetite, insomnia, neuropathy peripheral, headache, dizziness, dysgeusia, dyspnoea, cough, nausea, diarrhoea, vomiting, abdominal pain, constipation, alopecia, rash, pruritus, arthralgia, musculoskeletal pain, myositis, pyrexia, fatigue, asthenia, oedema, ALT increase, AST increased.

Common: pneumonia, febrile neutropenia, lymphopenia, infusion related reaction, adrenal insufficiency, thyroiditis, hyperthyroidism, hyponatraemia, hypocalcaemia, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, pneumonitis, colitis, gastritis, dry mouth, hepatitis, severe skin reactions, erythema, dermatitis acneiform, dermatitis, dry skin, eczema, pain in extremity, arthritis, acute kidney injury, influenza-like illness, chills, blood creatinine increased, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased. In combination with axitinib or lenvatinib: Very Common: urinary tract infection, anaemia, hypothyroidism, decreased appetite, headache, dysgeusia, hypertension, dyspnoea, cough, diarrhoea, abdominal pain, nausea, vomiting, constipation, rash, pruritus, arthralgia, musculoskeletal pain, myositis, pain in extremity, fatigue, asthenia, oedema, pyrexia, lipase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased. Common: pneumonia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, infusion-related reaction, adrenal insufficiency, hyperthyroidism, thyroiditis, hyponatraemia, hypokalaemia, hypocalcaemia, insomnia, dizziness, neuropathy peripheral, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), pneumonitis, colitis, pancreatitis, gastritis, dry mouth, hepatitis, severe skin reactions, dermatitis, dry skin, erythema, dermatitis acneiform, alopecia, arthritis, nephritis, influenza like illness,

NJ, USA and its affiliates.. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin, D18 X5K7 or from www.medicines.ie. II109_II117_II110 Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to MSD (Tel: 01-2998700)

Reference

1. Keytruda Summary of Product Characteristics, June 2022, available at www.medicines.ie.

J Med 2016, 375(19)1823-1833. ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; mNSCLC=metastatic non–small cell lung carcinoma; PDL1=programmed death ligand 1. Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7, Ireland.

Rent the most common expense under RCSI student assistance fund

NIAMH QUINLAN

Rent was the most commonly funded expense for RCSI students accessing the student assistance fund (SAF) in 2020/2021, with overall funding rising by over €35,000 compared with the previous academic year.

Some €59,931 was provided through the SAF in 2020/2021 and €22,978 was allocated in 2019/2020.

The rise of €36,953 was “mainly” pandemic-related, according to a response from RCSI under Freedom of Information (FoI) law.

“A number of applicants reapplied for the SAF during the year as they or their family had lost income due to Covid,” the FoI response stated.

Funded by the Irish Government with assistance from the European Social Fund, the SAF is aimed at “tackling educational disadvantage by providing financial support” to enable students to fully participate in third-level education. The SAF is operated by student services and open to full-time EU students at RCSI.

There were 12 applicants in 2018/2019; 20 in 2019/2020;

‘Ideal time’ to expand HSE Confidential Recipient role

CATHERINE REILLY

The HSE should consider appointing a confidential recipient for vulnerable persons in each of the six planned regional health areas, according to Confidential Recipient Ms Leigh Gath.

The Confidential Recipient is “an independent person appointed by the HSE” to receive concerns and complaints about HSE and HSE-funded services that are accessed by older people and people with a disability.

Speaking to the Medical Independent (MI), Ms Gath said it is “an ideal time” for the HSE to examine expanding the office. She said the service was “well established” and “respected” in the HSE.

As of 2021, the office had managed over 1,200 formal concerns/complaints and hundreds of informal queries since its inception in late 2014. However, the HSE informed MI it was not planning to make “any additional confidential recipient appointments”. The Executive is currently in the process of recruiting a new Confidential Recipient, with Ms Gath due to step down from the role in September.

Meanwhile, Ms Gath expressed dissatisfaction with the operation of a memorandum of understanding (MoU) with HIQA. Under the agreement, the Confidential Recipient reports concerns/complaints received about private nursing homes to the Authority.

Ms Gath said HIQA does not provide her with information on the actions taken when she has relayed these reports. This was unsatisfactory as she has been unable to follow-up with families and individuals who have raised the issues.

According to HIQA, it has received one piece of information from the Confidential Recipient over the last 18 months. This information was “passed to the relevant inspector” and the Confidential Recipient was informed of this. “We have an MoU with the Confidential Recipient and we will be arranging a meeting for her with our new CEO and Chief Inspector,” stated HIQA’s spokesperson.

Ms Gath said when families or individuals contact her about private nursing homes, she now advises them to outline the concern/complaint in a registered letter to the private nursing home and copy this correspondence to HIQA. If they do not receive a prompt or adequate response, she advises them to contact the ombudsman’s office where the concern/ complaint meets its remit. See news interview, p12-14.

and 24 in 2020/2021.

While no applicants were rejected in 2018/2019, five were turned down in 2019/2020. However, 22 of the 24 applicants in 2020/2021 were accepted.

In 2020/2021, rent was the most commonly funded expense. Some 39 rent-related payments were made to 35 students from 2018 to 2021. General living expenses and costs accounted for 24 payments, while travel and transport needs were funded 10

times. Childcare and food costs were funded three times each.

The highest amount allocated to one student in 2020/2021 was €6,000, which comprised one payment towards rent and two payments towards living expenses.

RCSI stated that students may also seek financial support from the student hardship fund, which is open to EU and nonEU students. Some €13,901 was provided in 2018/2019 and this figure rose to €28,120 in 2020/2021.

Diagnosis and management of depression

Fault lines in occupational safety of healthcare workers

In advance of autumn and winter, the HSE is being urged to enhance Covid-19 control measures, which some unions and medical specialists have regarded as inadequate throughout the pandemic. Catherine Reilly reports

As of mid-August, the HSE had not published detailed profile reports on Covid-19 infections in healthcare workers since December 2021. But the risks for staff have not so abruptly disappeared.

The consequences of Covid-19 infections and reinfections, and the potential emergence of further variants less susceptible to vaccines, pose significant ongoing threats to the health workforce and to the delivery of care.

While the recommendation by the national immunisation advisory committee (NIAC) for a second booster vaccine for healthcare workers has been welcomed by unions and medical bodies, there remains ongoing concern about the robustness of control measures in healthcare.

Occupational medicine experts

During the pandemic, these concerns have been expressed at the very highest levels of medical expertise on occupational health and safety in Ireland, the Medical Independent (MI) understands.

In late 2021 an expert working group of occupational medicine specialists, which was convened by the RCPI Faculty of Occupational Medicine, concluded that certain control measures outlined in HSE guidance at the time were inadequate in maximising staff safety and inconsistent with the employer’s duty of care to their staff. Specifically, the specialists strongly advised that there should be much greater use of respirator masks. These views were provided in the context of a predicted imminent surge in Covid-19 cases and were communicated to the HSE, this newspaper understands.

Since the beginning of the pandemic, a number of occupational medicine specialists have internally expressed concern that HSE guidance was not consistent with health and safety law and not taking a pragmatic approach to best available evidence.

Under law, where it is not technically possible to prevent exposure to a biological agent, employers must apply measures to ensure that “as far as technically practicable” exposure is reduced to “as low a level as necessary” in order to adequately protect employees’ health and safety.

HSE infection prevention and control (IPC) guidance is published by the Antimicrobial Resistance and Infection Control (AMRIC) division, with input predominantly from microbiology, IPC, and public health.

The Irish Nurses and Midwives Organisation (INMO) has repeatedly advocated for additional control measures in healthcare settings. In recent weeks, these communications have been continuing with HSE Chief Clinical Officer Dr Colm Henry.

“We are dealing with a droplet and airborne pathogen circulating in an environment which is not designed to deal with anywhere like the number of people that are presenting,” Dr Edward Mathews

(PhD), INMO Deputy General Secretary, told this newspaper.

According to Dr Mathews, the HSE is “extremely resistant to the recognition of the nature of the airborne transmission of the virus”.

Ventilation remains a key area of concern. “We have very many enclosed spaces with poor ventilation and no appropriate mechanical ventilation and… we are seeing overcrowding not only in our emergency departments but also in many inpatient areas in our acute system. We have many of those [areas] that have no effective ventilation system, and we are asking for supplementary ventilation to be put in place. We are asking for monitoring of ventilation to be put in place and we are asking for the release of a report that the HSE has commissioned into ventilation and matters related to their estates.”

Dr Mathews said it appeared that prior to taking any action, the HSE seeks certainty that a measure is either completely or pre-

dominantly effective.

“But that is totally contrary to the precautionary principle. The precautionary principle was well established at the time of the Sars [one] outbreak where employers and state authorities waited for scientific certainty before taking action, as a result of which both patients and staff became infected, became seriously ill and some paid the ultimate price.

“What the HSE are doing here is a classic example of what the [Sars Commission] report said following the Sars outbreak in Canada, for example, which was that you should not wait for scientific certainty and act where there is evidence in support [of the fact] that this is an important strategy.”

The union has informed the HSE of studies that “confirm the benefits” of air filtration units and provided an example of research conducted in Addenbrookes Hospital, UK, on surge wards. The advice and instruction from the HSE at national level to healthcare facilities in respect of airflow is “open to too much interpretation and unlikely to result in risk reduction”, according to the INMO.

The Organisation has also been seeking “immediate reintroduction” of Covid screening for all unscheduled care presentations and has asked the HSE to promote

the benefits of mask wearing in the community. In regard to healthcare staff, Dr Mathews said a respirator mask was “more effective” than a surgical mask in preventing infection and “should be available for any member of staff” as required.

PPE

HSE guidance on personal protective equipment (PPE), updated in June, removed a requirement for use of FFP2 respirator masks for “all care” (this stipulation was added in late December 2021). The HSE guidance currently states that respirator masks should be used for care of patients with suspected or confirmed Covid-19. It also advises that respirator masks should be worn in settings where the IPC team indicates there is a high risk that patients with “unsuspected Covid-19” are likely to be present.

The Faculty of Occupational Medicine expert working group noted the “compelling” nature of evidence supporting an airborne risk of transmission. It referred to the established superiority of FFP masks for protection against airborne hazards as part of a hierarchy of control measures.

The expert working group examined HSE IPC guidance dated 5 July 2021. In line with the current guidance, this HSE document recommended use of FFP2 masks when in contact with possible or confirmed Covid-19 cases and contacts, rather than for all care.

The opinion of the expert working group was that the guidance should clearly state that FFP2 masks are recommended for all staff working in clinical areas “where Covid-19 cases may present or arise at all times, irrespective of an individual patient’s status”. Furthermore, this recommendation should be extended to “all staff” in admitting hospitals at times of high community incidence. In areas where close contact with known Covid patients was required, the higher grade FFP3, powered air purifying respirators or elastomeric cartridge respirators, were preferred.

The specialists also stated that an additional and “very important benefit” of healthcare workers wearing respirator masks was in reducing the risk of transmission to patients, who may be vulnerable and not necessarily vaccinated. As with all occupational health matters, they advised that decisions regarding the most appropriate PPE should be properly integrated into the hierarchy of controls with due emphasis on engineering and administrative controls.

There was a subsequent change in HSE guidance in favour of recommending wider use of FFP2 masks, but this has since been revised.

Occupational disease

In May, the EU’s advisory committee on safety and health at work reached an agreement on the need to recognise Covid-19 as an occupational disease in health and social care. The committee supported an update of the

We are dealing with a droplet and airborne pathogen circulating in an environment which is not designed to deal with anywhere like the number of people that are presenting

Dr Edward Mathews (PhD)

EU list of occupational diseases and this was agreed by the European Commission.

According to a Commission statement: “The aim is that member states adapt their national laws according to the updated recommendation. If recognised as an occupational disease in a member state, workers in relevant sectors, who have contracted Covid-19 at the workplace, may acquire specific rights according to national rules, like the right to compensation.”

Mr Kevin Figgis, Divisional Organiser, Siptu Health, noted the EU committee’s opinion as well as a recent case at an employment tribunal in Scotland, which determined that long Covid was a ground for disability under equality legislation.

“The unions are very clearly of a view that healthcare workers being infected in the workplace is an injury in their workplace and we are very clearly of a view that there are responsibilities for that on the employer, there are responsibilities on the independent bodies that are established in order to provide oversight... and there is also a role for Government,” he stated.

Dr Mathews of the INMO expressed a similar view: “The Irish State should recognise the situation in relation to Covid-19, according to the European recommendation, and apply the same rigor to managing the safety of healthcare workers in healthcare facilities as it does to caring for the health and safety of other workers in our society.”

Worker representative organisations are legally entitled to data from the HSE on the ongoing healthcare worker infections, he added. “We can say that 29 per cent of all absences in June for nursing and midwives were as a result of Covid-19,” according to Dr Mathews, who also referred to a “very large number of clusters of infection arising from healthcare settings”.

He said the Health and Safety Authority (HSA) needs to apply greater focus to the “considerable risk” for healthcare workers and monitor and direct improvements “in the same way as they would in other areas”.

“It cannot be regarded that it is an occupational hazard of the health services to be injured by pathogens in the course of work. And very serious attention is required by the Health and Safety Authority to the work environment and the work systems, not just exits and egress and matters like that, but work systems and work environment in relation to how they are contributing to or taking away from the risk faced by healthcare staff.”

Meanwhile, the health worker unions are seeking an adequate replacement to the Covid-19 special leave with pay scheme for the public service (beyond the self-isolation period), which was wound-up on 30 June. The HSE, in consultation with the Department of Public Expenditure and Reform (DPER), has issued a circular on a replacement temporary scheme for healthcare workers with restrictive terms.

“The terms that were sought to be introduced unilaterally were essentially to ensure that no-one else, no matter how they were infected or how long they were ill as a result of Covid-19 in the health service, would be able to benefit going forward from an occupational injury scheme,” said Dr Mathews.

“We have established occupational injury schemes which deal with things like MRSA infection, and infection with a blood-borne pathogen, and we are seeking the implementation of a similar scheme in

relation to Covid-19, which is a workplace risk and people should not have to use up their very valuable allocation of sick leave because of something that they acquired in the workplace. We have not made progress with the employer on that as yet, but that is working its way through the industrial relations machinery of the State,” added Dr Mathews, speaking to MI on 9 August.

Mr Figgis of Siptu noted that unions had sought engagement with the HSE and Department of Health from early April about the scheme. However, this engagement was not forthcoming. “When the special leave with pay was ceasing there were people contacting us telling us they literally would not be able to pay their bills. I have spoken to people who told me they are suffering from such chronic fatigue that they spend 15 to 18 hours a day in bed.

“I have spoken to people who have told me of chronic effects of memory loss, they were working in certain jobs in the health service that they would never be allowed to go back to if those symptoms were prevailing....”

An IMO spokesperson told MI: “The IMO, in common with other health sector unions, are of the view that an occupational injuries scheme for healthcare workers with long Covid is the appropriate method to support such workers. Those healthcare workers who sacrificed their own health to protect the health of the nation should be recognised and supported by the HSE.”

In regard to control measures in healthcare, the IMO’s spokesperson said: “Public health advice and infection control measures must continue to be adhered to in healthcare settings. In relation to particular measures or additional measures, these are clinical decisions that should be taken having regard to the public health advice at any given time and the trajectory of this disease.”

HSA

The HSA made no definitive comment on current HSE guidance and control measures. “We have engaged with the HSE and employers in the sector around risk assessment requirements and the controls to protect workers; we will continue to engage with them,” said a spokesperson.

Since November 2020 under the biological agents regulations, employers are required to report cases of occupationally-acquired Covid-19 to the HSA (although comparisons with HSE data suggest there has been significant under-reporting to the HSA).

From 1 January to 30 June 2022, the HSA received 1,069 reports covering 1,748 cases of Covid-19 infection from the health and social care sector (public and private). The Authority was also aware of 23 reports of healthcare workers who had reportedly died with Covid-19.

“All fatalities that are reported as being occupationally related are investigated by the Authority. Arising from the investigation a determination on whether the fatality has arisen from an occupational-related matter is made based on the facts and evidence gathered when an investigation has been initiated. Of the 23 investigations initiated by the Authority, 12 investigations have been completed,” according to the HSA spokesperson.

From 1 January to 30 June 2022, the Authority conducted 235 inspections in the health and social care sector, resulting in 189 written advices, seven improvement

notices, and one prohibition notice being issued. “The Authority does not discuss or comment on any matters that relate to individual workplaces or investigations,” its spokesperson said.

HSE response

A HSE spokesperson noted it currently recommends FFP2 masks for healthcare interactions with patients suspected or confirmed to have Covid-19 infection; interactions in areas where IPC teams advise there may be ongoing transmission of Covid-19, or unsuspected cases of Covid-19; and for care that involves the use of “aerosol-generating procedures”.

In addition, FFP2 masks “remain available” for any staff based on personal preference or where their “particular circumstances require use of these masks”.

HSE Covid-19 guidance was “reviewed and updated regularly” to take account of national, European Centre for Disease Prevention and Control and World Health Organisation guidance and changes in the disease profile, stated the spokesperson.

Asked about the HSE’s response to the expert opinion from the Faculty of Occupational Medicine, the spokesperson said the query would necessitate a request under Freedom of Information law.

Since the start of 2022, according to the spokesperson, the Health Protection Surveillance Centre had “streamlined” its reporting for Covid-19 with several reports being “restructured, amalgamated, reduced in frequency or stopped”.

“We no longer produce the interim report of the profile of Covid-19 cases in healthcare workers in Ireland. The number of healthcare worker cases [in] the previous week is reported in the weekly report on the epidemiology of Covid-19 in Ireland.

“The most reliable way to determine place of likely acquisition is through cases associated with outbreaks, though this number is not reliable as it does not consider high community circulation. The number of staff cases associated with Covid-19 outbreaks in healthcare settings is available in the Epidemiology of Covid-19 Outbreaks/Clusters in Ireland – Weekly Report.”

As of 8 August, there have been 47,502 confirmed Covid-19 cases among healthcare workers notified to the national infectious disease surveillance system this year.

“Healthcare worker status is determined both by self-classification and workplace. The definition includes anyone who self-identifies as a healthcare worker irrespective of where they work. Changes in testing policy will impact the proportion of healthcare worker cases. PCR testing is still recommended for symptomatic healthcare workers, meaning that they may be overrepresented in data on confirmed cases.”

In regard to screening of presentations to unscheduled care, the spokesperson said: “The recommendation that asymptomatic patients admitted to hospital do not generally require testing for Covid-19 aligns [with] the clinical approach which we apply for other respiratory viral infections. This is generally focused on testing symptomatic patients only. The guidance does, however, allow individual hospital settings to continue admission Covid-19 testing of all patients or some subset of patients based on local risk assessment of that service and local levels of community transmission.”

MINDO NUMBERS

907,000

people are on some form of National Treatment Purchase Fund waiting list, up almost 75,000 since July 2020, the IHCA has highlighted.

17,000 people in Northern Ireland died while on a waiting list over the past three years, according to data obtained by the Belfast Telegraph from the five Northern Ireland Health and Social Care Trusts.

1 -in-eight adults who are infected with SARS-CoV-2 experience long-term symptoms due to Covid-19, suggests a large Dutch study published in The Lancet.

+80

million people in the greater Horn of Africa are estimated to be food insecure and the region faces an “unprecedented food crisis”, according to the World Health Organisation, which has launched an appeal to the international community.

32 different drugs and metabolites were found in an analysis of 155 used syringes from the Dublin and midlands regions, outlined the Syringe Analysis Pilot Project 2022 published by the HSE and Merchants Quay.

Delayed diabetes registry remains ‘priority’

The introduction of a national diabetes registry was delayed by the pandemic, but legislative progress will be made by October, this newspaper has been informed. In September 2019, funding under the Sláintecare Integration Fund was allocated to the HSE to design and procure a national diabetes registry “demonstrator product” and to develop a full specification plan for a national diabetes registry.

“However, the support of public health and ICT [infor-

COMBINING POWER AND CONFIDENCE

AGAINST LDL-C* IN THE TREATMENT OF HYPERCHOLESTEROLAEMIA

mation and communications technology] was required and due to the Covid-19 pandemic, this work could not be continued and funding was returned,” a Department of Health spokesperson told the Medical Independent

The spokesperson said the registry remains a Government “priority”.

“Following substantial increases in investment in eHealth, the national diabetes registry is now being considered as part of a wider review of Ireland’s health information strategy and will operate as a ‘virtual’ registry.”

The spokesperson added: “It is envisaged that the

[Health Information] Bill will include a provision to enable the operation of disease-specific ‘virtual’ registries.”

This would include “a virtual national diabetes registry, where information on disease diagnoses and treatment from healthcare providers is efficiently collated, combined and quality-checked from administrative records to create a database akin to an active registry for each disease. This will greatly improve the potential to monitor rare disease prevalence in Ireland.”

Asked what other diseases could form part of these ‘virtual’ registries, the spokesperson said the Bill’s general scheme was currently being prepared for submission to Government in October.

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

familial hypercholesterolaemia. Dosage and Administration: The patient should be on and continue, an appropriate lipid-lowering diet, during treatment with Suvezen. Suvezen is not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. The recommended dose is one Suvezen tablet daily. To be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water. If co-administered with bile acid sequestrant (BAS), administration of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a BAS. Special populations: Paediatric (<18 years): Safety and efficacy has not been

start the

used

contraindicated in these

mg tablets

patients who are known to have specific types of genetic polymorphisms that can lead to increased

exposure, a lower daily dose of Suvezen is recommended. Dosage in patients with predisposing factors to myopathy: The recommended start dose is rosuvastatin 5mg in patients with pre-disposing factors to myopathy. Suvezen 40 mg/10 mg tablets are contraindicated in some of these patients. Concomitant therapy: The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir). Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where co-administration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered. Contraindications: Hypersensitivity to the active substances or excipients. Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures. Active liver disease or any serum transaminase elevations which are unexplained, persistent or exceeding 3x the upper limit of normal (ULN). Severe renal impairment (creatinine clearance <30ml/min); myopathy or receiving concomitant ciclosporin. 40mg/10mg dose contraindicated in patients with predisposing factors for myopathy/rhabdomyolysis; such factors include: Moderate renal impairment (creatinine clearance <60ml/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels of rosuvastatin may occur, Asian patients, concomitant use of fibrates. Precautions and Warnings: Skeletal muscle effects: have been reported in rosuvastatin-treated patients with all doses and in particular with doses >20mg. As with other HMGCoA reductase inhibitors, reporting rate for rhabdomyolysis is associated with use at doses >40mg. Postmarketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. If myopathy is suspected based on muscle symptoms or is confirmed by a creatine phosphokinase (CPK) level, Suvezen and any of these other agents that the patient is taking concomitantly should be immediately discontinued. All patients starting therapy with Suvezen should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, particularly if associated with malaise or fever. Creatine kinase (CK) measurement: CK should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase. If CK levels are significantly elevated at baseline (>5x ULN) a confirmatory test should be carried out within 5 – 7 days. If the repeat test confirms a baseline CK >5x ULN, treatment should not be started. Patients with pre-disposing factors for myopathy/rhabdomyolysis: Caution should be exercised in these patients. Risk: benefit of treatment should be considered and clinical monitoring is recommended. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5x ULN) or if muscular symptoms are severe and cause daily discomfort. If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing treatment at the lowest dose. Immune-mediated necrotising myopathy (IMNM): Clinically characterised by proximal muscle weakness and elevated serum CK, has been reported very rarely during or after treatment with statins, including rosuvastatin, despite discontinuation of statin treatment. In clinical trials an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives. Suvezen should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Liver effects: In controlled coadministration trials in patients receiving ezetimibe with statin, consecutive transaminase elevations ≥3x ULN have been observed. It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminases is >3x ULN. The reporting rate for serious events is higher at the 40mg dose. In patients with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome, the underlying disease should be treated prior to initiating therapy with rosuvastatin. Liver disease and alcohol: As with other HMG-CoA reductase inhibitors, rosuvastatin should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. Renal effects: Proteinuria has been observed in patients treated with higher doses of rosuvastatin and was

transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40mg. Diabetes mellitus: Some evidence suggests that statins raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (fasting glucose 5.6 – 6.9mmol/l, BMI >30kg/m2 raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. Interstitial lung disease: Exceptional cases have been reported with some statins, especially with long term therapy. Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected, statin therapy should be discontinued. Severe cutaneous adverse reactions: Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be life-threatening or fatal, have been reported with rosuvastatin. If signs and symptoms suggestive of this reaction appears, Suvezen must be discontinued immediately and an alternative treatment should be considered. Treatment with Suvezen must not be restarted at any time. Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors in combination with ritonavir. Consideration should be given both to the benefit of lipid lowering by use of Suvezen in HIV patients receiving protease inhibitors and the potential for increased rosuvastatin plasma concentrations when initiating and up titrating rosuvastatin doses in patients treated with protease inhibitors. The concomitant use with certain protease inhibitors is not recommended unless the dose of rosuvastatin is adjusted. Fibrates: The safety and efficacy of ezetimibe administered with fibrates have not been established. If cholelithiasis is suspected in a patient receiving Suvezen and fenofibrate, gallbladder investigations are indicated and therapy should be discontinued. Anticoagulants: If Suvezen is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalised Ratio (INR) should be appropriately monitored. Fusidic acid: Suvezen must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be reintroduced seven days after the last dose of fusidic acid. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e.g., for the treatment of severe infections, the need for co-administration of Suvezen and fusidic acid should only be considered on a case by case basis and under close medical supervision. Suvezen contains lactose monohydrate and sodium: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.

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

National rehab hospital moved to IEHG line management

CATHERINE REILLY

The National Rehabilitation Hospital (NRH) this year moved under the direct line management of the Ireland East Hospital Group (IEHG) despite the disbandment of Group boards in late 2021. The move occurred due to the development of the national trauma network, an NRH spokesperson commented.

The boards of the six Hospital Groups were stood down pending the creation of regional health areas, although the Group executives remain in place. A query was raised at an NRH board meeting in March about “the legal structure of Hospital Groups and their boards” following a discussion on the first performance and review meeting with the IEHG, according to minutes obtained under Freedom of Information law.

An NRH spokesperson told the Medical Independent: “The NRH is now part of the national trauma network, aligned with the Mater Hospital, which is the major trauma centre and an integral part of the IEHG. Previously, the NRH came under the national hospitals office.”

Separately, a dispute notice issued by the NRH to the HSE, under the service level agreement, remains in place.

“The dispute notice dates back to late 2019/early 2020 – it was addressed to Community Healthcare Organisation 6 before the NRH moved into the IEHG structure. A number of items are under ongoing discussion primarily in relation to some outstanding funding,” outlined the NRH spokesperson.

According to the CEO’s report to the NRH board meeting in May, “this notice has not been withdrawn until our request for appropriate funding is addressed.”

Meanwhile, there were 1,552 lost bed days at the NRH in the first six months of 2022, due to delayed transfers of care.

“High complexity care pathways are still being explored at this time,” stated the NRH’s spokesperson.

Average waiting periods for inpatient admission (based on 2021 full-year figures) were 124 days for brain injury; 90 days for the stroke specialty service; 59 days for the spinal injury programme; 60 days for the prosthetic, orthotic, and limb absence programme; and 210 days for the paediatric programme.

Single-pill combination of rosuvastatin and ezetimibe available in 3 doses**

*Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1

Ryaltris™ 25 mcg/actuation + 600 mcg/actuation nasal spray, suspension.

Prescribing information

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

Presentation: One delivered dose contains mometasone furoate monohydrate equivalent to 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to 600 mcg olopatadine. White, homogeneous suspension.

Uses: In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.

Dosage: For nasal use only. Adults and adolescents (12 years of age and over) two actuations in each nostril twice daily (morning and evening). Elderly: no dose adjustment required. Children under 12 years: not recommended. Renal and hepatic impairment: no dose adjustment expected.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. Recent nasal surgery or trauma until wound healing has occurred.

Warnings and Precautions: Instances of nasal ulceration and nasal septal perforation have been reported. Not recommended in case of nasal septum perforation. Patients using Ryaltris™ over several months or longer should be examined periodically for possible changes in the nasal mucosa and for evidence of Candida infection. Instances of epistaxis have been reported. Visual disturbance may be reported with systemic and topical corticosteroid use. Consider referral to ophthalmologist with symptoms such as blurred vision or other visual disturbances as cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported after use of systemic and topical corticosteroids. Hypersensitivity reactions, including wheezing, may occur - discontinue. Immunosuppression: use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex. Potential systemic effects of corticosteroids include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Hypercorticism and adrenal suppression may appear at higher than recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris™ in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system (CNS) depressants. Increased risk of antihistamine adverse effects with concomitant use of olopatadine or other antihistaminic drugs administered via nasal, ocular or oral route. Paediatric population: It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. Interactions: No interaction studies have been performed with Ryaltris™. Any interactions

from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination. Olopatadine: No interactions with other drugs expected. Mometasone Furoate: Cotreatment with CYP3A inhibitors should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects and patients should be monitored. Pregnancy and Lactation: Avoid use during pregnancy unless potential benefit to mother justifies potential risk to mother, foetus or infant. Assess before prescribing in lactating mothers.

Side Effects: Common: dysgeusia, epistaxis, nasal discomfort. Uncommon: dizziness, headaches, somnolence, nasal dryness, dry mouth, abdominal pain, nausea, fatigue. Rare: bacterial vaginosis, anxiety, depression, insomnia, lethargy, migraine, blurred vision, dry eye, eye discomfort, ear pain, nasal inflammation, nasal mucosal disorder, oropharyngeal pain, sneezing, throat irritation, constipation, sore tongue, laceration. Frequency not known: pharyngitis, upper respiratory tract infection, hypersensitivity (including anaphylactic reactions, angioedema, bronchospasm, dyspnoea), cataracts, glaucoma, increased intraocular pressure and nasal septum perforation.

Pack Sizes: One bottle containing 30ml suspension (240 actuations).

Legal Category: POM.

Product Authorisation Numbers: PA 1543/002/001

Product Authorisation Holder: Glenmark Pharmaceuticals s.r.o., Hvezdova 1716/2b, 140 78 Prague 4, Czech Republic.

Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.

Date of Preparation: June 2022.

Talks with NCHDs ‘will inform’ recruitment policy paper – DoH

Proposals raised in recent discussions between the Minister for Health and his officials with NCHD representatives will help inform a policy paper on recruitment, the Medical Independent (MI) has been informed.

The Sláintecare Action Plan 2022, published in June, commits the Government to develop a “policy proposals paper to enhance recruitment and retention of NCHDs”. According to the plan, this paper should be developed by the third quarter of this year.

NCHDs recently met with Minister Stephen Donnelly after IMO NCHD members voted in support of industrial action, up to and including strike action, arising from “unsafe and illegal” working hours and poor working conditions.

The issue of ongoing payroll problems has also been raised by NCHDs this month.

Asked whether recent engagements will inform the planned policy paper, a Department spokesperson said at these meetings Minister Donnelly and Department officials have heard “first-hand issues of concern to them [NCHDs] and how things may be improved”.

“A range of initiatives, many of which were proposed by NCHDs, will be given full consideration by the HSE to improve their training, working conditions, and work/life balance,” the spokesperson told MI

“Discussions and measures to address recruitment and retention for NCHDs are ongoing.”

The Sláintecare Action Plan 2022 also commits the Government to “review and enhance” the model for indus-

Medical Council embarking on ‘transformational change journey’

The Medical Council is embarking upon a “transformational change journey”, a spokesperson has informed the Medical Independent (MI)

This process will have a significant impact “across the organisation in its totality”, including on the Council, committees, and the executive, the spokesperson stated.

“One of the most critical areas of transformation to be addressed is that of organisation design – the processes, technologies, roles, and structures needed to enable the Council to fulfil its remit through the core regulatory functions of registration; education and training; professional competence; ethics; research; performance assessment; complaints and investigations; fitness to practice.

“Of equal importance are the support functions that are vital to the delivery of these regulatory functions, including corporate governance; information governance; compliance; legal; communications; finance; HR; ICT; procurement; and facilities.”

At a governance meeting with the Department of Health in March, the Council advised it would go to tender to source “an experienced organisation design company to assist with a phased organisation design project”, according to meeting minutes obtained under Freedom of Information law. “Council provided some details on the planned phase one of this redesign project with changes envisaged to

This programme provides better healthcare outcomes for patients, reduces acute presentations, and allows patients to become active partners in their own healthcare.

strengthen the investigations and complaints processes and engagement with stakeholders in this regard.”

The Council’s spokesperson told MI it was seeking a “partner organisation that brings significant expertise in the design, development, and implementation of organisation design, with experience in both regulatory and the broad healthcare environment, and preferably healthcare regulation”.

“This tender process is still in progress and no appointment has yet been made.”

The spokesperson said the Council is continuing preparations for changes to the complaints process under new legislation. A key change will allow for complaints to be initially assessed by the CEO of the Council with the assistance of authorised officers, rather than having to automatically go to the preliminary proceedings committee.

“New procedures and guidelines are being prepared by the complaints and investigations team in respect of the new complaints process, all relevant legal input is being obtained, and operational resources are being put in place to allow for smooth implementation. Sanction for additional resources have been sought to support these changes, receiving positive support from the Department of Health.

“The complaints and investigations team looks forward to working with all its stakeholders in introducing the new complaints process and will provide advance notice of commencement dates as appropriate.”

Through this pilot project we have confirmed the presence of new psychoactive substances on the drug market and the re-emergence of cocaine injecting. These findings require tailored health responses and further monitoring.

trial relations in the health sector to support delivery of reforms. This review is scheduled to take place in the third quarter of this year.

Asked what form this review will take, the Department’s spokesperson said that “as the health service undergoes significant change through the implementation of Sláintecare and its related reforms, including the introduction of regional health areas, the efficient and effective functioning of industrial relations processes in the sector will naturally be kept under review to ensure they are facilitating stakeholders during this change programme”.

“Enhancements to the model of industrial relations will be considered where these would facilitate better outcomes for patients, improve constructive interfacing with representative bodies, and improve value for public funds.”

HSE’s Reach Out Network to re-launch after pandemic interruption

DAVID LYNCH

The HSE’s Reach Out Network has reconvened after a hiatus since March 2020 and is planning a major re-launch, this newspaper has been told.

The Reach Out Network is the HSE’s staff network for employees who are lesbian, gay, bisexual, transgender, queer, intersex or asexual (LGBTQIA+).

According to minutes of the April meeting of the HSE people and culture committee, the “newly-reconvened” network had met twice in 2022 and planned a major re-launch later in the year.

“The HSE launched its first staff network for employees who are LGBTQIA+ and their allies on 21 June 2017,” a HSE spokesperson told the Medical Independent “The network met regularly until March 2020 and the onset of the Covid-19 pandemic.”

The spokesperson said the network aims to provide an enhanced voice in the workplace for HSE staff who are LGBTQIA+ and their allies, to provide a safe place to discuss issues relating to

No effort is made to pay NCHDs immediately when the error is identified and they invariably have to wait until the next payroll run for any adjustments to be made, leaving them with no funds to pay for rent or living expenses.

sexual orientation at work, and to contribute to the development of a culture at work that supports diversity, equality, and inclusion.

“In seeking to progress these aims, the Reach Out Network explicitly supports the HSE’s People Strategy 2019-2024 ,” added the spokesperson.

Separately, in July, Minister for Children, Equality, Disability, Integration, and Youth Roderic O’Gorman, told the Dáil that implementation of the National LGBTI+ Inclusion Strategy 2019-2021 was “severely impacted by the Covid-19 pandemic”.

“In particular, there were significant obstacles to the achievement of many of the actions under the ‘visible and included’ and ‘healthy’ pillars. I extended the lifetime of the strategy until the end of this year and it will be evaluated thereafter.”

The strategy contains 108 actions and Minister O’Gorman said that “relevant Departments have reported that 17 actions have been completed”.

“Work is ongoing on implementation of the remaining actions.”

Assessing the HSE’s recruitment woes

As the HSE develops a new recruitment programme, an internal review of the 2022 service plan highlights the major workforce challenges facing the Executive. David Lynch reports

Ireland’s acute hospitals may require over 15,000 extra staff by 2035 to care for a growing population, according to projections from the Economic and Social Research Institute (ESRI).

The research, which was funded by the HSE, concluded that “the largest increases in workforce are projected for health and social care professionals who are particularly required by older people in hospital”.

But the Executive has more immediate recruitment concerns, with the HSE National Service Plan 2022 (NSP 2022) outlining a target to recruit an additional 5,500-10,000 whole-time equivalent (WTE) staff this year. This, along with recruitment required to implement Sláintecare reforms, has resulted in a rethink in the Executive’s strategy.

New programme

The HSE is developing a new recruitment strategic programme, it has informed the Medical Independent (MI).

At the April meeting of the HSE people and culture committee, the National Director of Human Resources Ms Anne Marie Hoey told committee members that a new strategy was being prepared. According to minutes, she informed the meeting that “as part of the rollout of Sláintecare, the HSE is receiving funding for the delivery of services in 2022 and beyond”.

“To augment work underway in relation to recruitment, the HSE is developing a robust resourcing strategy to meet the current and future needs of the organisation.”

In response to questions from committee members, Ms Hoey said that “this development will enhance work with the education sector, regulatory and statutory bodies to support the resourcing strategy for health”. The committee asked for a follow-up paper on the strategy for retention of staff and innovative ways to attract new employees.

Asked about progress made since April, a HSE spokesperson said the new programme will be “a strategic programme under the umbrella of National HR, but collaboration across all functions, services and external stakeholders will be crucial to its success”.

“The role of the recruitment reform and resourcing programme is to implement the new model of recruitment across all areas in the HSE, together with building the necessary digital infrastructure,” the HSE’s spokesperson told MI

Competitive

The spokesperson noted the HSE was “operating in a very competitive global recruitment market”. The new programme was being developed because of the anticipated “implementation requirements of Sláintecare, together with the impact of an ageing population”.

“The aim of this programme is to ensure we maximise retention across the organisation, together with building the appropriate workforce pipelines to meet the future needs of the organisation.”

The competitive global market is a matter the HSE has made clear to Minister for Health Stephen Donnelly in recent months.

As reported last month in MI, a first quarter

review of the NSP 2022 sent to the Minister on 1 June sounded the alarm that recruitment targets will be difficult to achieve.

A copy of the review and cover letter from HSE board Chair Mr Ciarán Devane was seen by this newspaper following a Freedom of Information request. Asked about the Minister’s response to the review, a Department of Health spokesperson said the Minister acknowledged the NSP 2022 review as submitted by the HSE.

“He has asked the HSE board to maintain focus on recruitment for the remainder of the year in order to ensure maximum progress on the delivery of the funded reforms as set out in the NSP 2022,” said the Department’s spokesperson.

tens of thousands of HSE employees, leading to possible increased staff turnover.

“As the global economy opens up post-Covid, the turnover can be expected to increase in 2022,” according to the review. “Some graduates from the last two years may choose to travel, coupled with increased retirements, from those who delayed their retirement or increased their hours to assist the health services in its response to Covid.”

In order to address standard ‘staff churn’ due to retirements, resignations and promotions, “this will equate to circa 9,500 appointments to maintain existing staffing levels”.

“However, the HSE has committed to an ambitious recruitment target beyond this to meet the commitments in the National Ser-

raised by the IMO and IHCA. A particular difficulty in attracting consultants to hospitals outside the major cities has been noted by observers. Talks on a new Sláintecare consultant contract are continuing between the Department, HSE, IMO and IHCA.

In the review, the HSE said that overall staffing levels year-to-date were “+161 WTE (9.9 per cent) above the minimum resourcing target” (as of 31 March 2022).

The increase in 2022 stood at +1,778 WTE (+1.3 per cent), which was above the quarter one recruitment target of 1,617. Employment levels at the end of March 2022 showed there were 134,101 WTEs (equating to 153,282 personnel) in the HSE.

In his cover letter to the Minister, Mr Devane wrote that the review recognised the additional challenges of the impact of the recent Government decision on reversal of the Haddington Road Agreement (HRA), as well as the “impact and service implications of the response to people arriving in Ireland from Ukraine”.

Indeed, as reported last month in MI, the HSE review placed a particular focus on the restoration of pre-austerity era working hours, which the review noted had a “significant impact” on recruitment targets. In April, the Government announced it approved the Report of the Independent Hours Body, which recommended that all civil and public service employees would no longer have to work extra hours that were detailed in the HRA signed in 2013.

The HSE review said that the HRA hours reversal “is equivalent to the loss of a minimum of circa 3,800 WTEs across the HSE... Not all WTEs will be replaced or indeed be replaceable, however there will be a requirement to replace WTEs in critical patient services as a matter of priority to maintain safe patient care. As a consequence, it also brings further complications to our efforts at resourcing and financial planning for 2022.”

While the HRA working hours reversal impacted HSE staff across the board, initially there was a health exception. The Independent Hours Body excluded hospital consultants because of the ongoing negotiations regarding a new Sláintecare contract.

‘Aggressively strive’

The review concluded that the HSE was “confident that at a minimum” its recruitment policies would “result in an additional 5,500 new WTEs by year end”. This 5,500 is the “minimum resourcing target” set out in the NSP 2022, but the HSE’s review added it would “aggressively strive towards the stretch target” of 10,500 additional WTEs.

But this striving will be against some serious downwind, according to the review, which noted the “significant market supply challenges/unpredictable workforce supply”.

These include the Covid-19 pandemic, which “will continue to bring uncertainty and complexity to the planning and delivery of services in 2022”.

This impact is not just felt in services, but also in the individual decisions taken by the

vice Plan,” the review noted in its conclusion.

In recognition of the increased global competition, together with the ambitious recruitment targets, the review stated that the HSE was supplementing “robust recruitment strategies to maximise the national market with comprehensive international recruitment across the clinical grades such as nursing, HSCPs [health and social care professionals], medical and dental”.

Consultants

The review mentioned there were “particular professions where the recruitment challenge is greatest” and this challenge can be exacerbated in attracting professionals to “dense urban areas and some remote rural locations”.

The ongoing recruitment and retention crisis for medical consultants has long been

In April, the Government went along with this recommendation, however that decision has since been reversed.

According to an internal HSE memo seen by this newspaper, dated 22 June and written by Ms Hoey, “the Department [of Health] has recently confirmed the reduction in HRA hours for consultants, which are now to be included in the reversal of the HRA”.

Contacted by this newspaper, the Department’s spokesperson confirmed that consultants were now “encompassed in the reversal of Haddington Road Agreement hours”.

Asked for more information regarding this decision, the Department told MI that “engagements are currently underway with representative bodies on the Sláintecare consultant contract and accordingly, further public comment about this matter would not be appropriate at this point in time”.

The role of the recruitment reform and resourcing programme is to implement the new model of recruitment across all areas in the HSE

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

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

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

products metabolized by CYP2D6 with a narrow therapeutic index such as thioridazine, Type 1C antiarrhythmics (e.g.flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. Inhibition of P-gp: Mirabegron is a weak inhibitor of P-gp. For patients who are initiating a combination of Betmiga and digoxin, the lowest dose for digoxin should be prescribed initially. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect. The potential for inhibition of P-gp by mirabegron should be considered when Betmiga is combined with sensitive P-gp substrates e.g. dabigatran. Fertility, pregnancy and lactation: The effect of mirabegron on human fertility has not been established. Betmiga is not recommended during pregnancy and in women of child-bearing potential not using contraception. Mirabegron should not be administered during breast feeding. Refer to SPC for full guidance. Driving and use of machines: Betmiga has no or negligible influence on the ability to drive and use machines. Undesirable effects: Summary of the Safety Profile: the safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.

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

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

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

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

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

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

Reporting of suspected adverse reactions:

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

HPRA Pharmacovigilance Astellas Pharma Co. Ltd

Earlsfort Terrace, IRL - Dublin 2 Tel: + 353 1 467 1555

Tel: +353 1 6764971

Fax: +353 1 6762517

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

E-mail: Irishdrugsafety@astellas.com

His 14th walk in the park since the day he started BETMIGA1

Confidential Recipient’s office ‘should be expanded’ – Leigh Gath

The HSE Confidential Recipient for Vulnerable Persons, Ms Leigh Gath, will leave her post in September. She told Catherine Reilly about the office’s impact to date

The HSE should consider appointing a confidential recipient for vulnerable persons in each of the six planned regional health areas, according to Confidential Recipient Ms Leigh Gath.

The Confidential Recipient is “an independent person” appointed by the HSE to receive complaints and concerns (eg, allegations of abuse, negligence, mistreatment or poor care practices) in regard to older people and people with a disability accessing HSE and HSE-funded services.

Ms Gath told the Medical Independent (MI) that it is “an ideal time” for the HSE to examine expanding the office. She said the service was “well established” and “respected” in the HSE. It comprises of Ms Gath and one administrator covering the entire country. “I would absolutely love it if this office was bigger and we were able to have more of an effect.”

The HSE informed MI it was not planning to make “any additional confidential recipient appointments”.

Establishment

In December 2014 the HSE announced the appointment of Ms Gath as the first Confidential Recipient. Ms Gath is a longstanding campaigner for the rights of people with a disability and a survivor of Thalidomide. Her appointment followed the abuse scandal at Áras Attracta, a HSE residence for people with an intellectual disability in Co Mayo.

As of 2021, the office had managed over 1,200 formal concerns/complaints since its inception (as well as hundreds of informal queries). The job is tough but fulfilling, according to Ms Gath. “I love when someone calls in and says, ‘I got what I needed.’ Oh my God, that just makes my day.”

She said the office’s independence has been respected by the HSE. “My office is very much independent. The only person I answer to is [CEO] Paul Reid. That is the only person that can, if he wants to, tell me what to do. And he never does tell me what to do.”

Mr Reid is due to step down from his post in October, however. Could a new CEO with a different style affect the office’s independence? “I have been through four so far and everyone has their own styles,” said Ms Gath, who maintained that the HSE has not interfered with her work throughout her tenure.

Standing down Ms Gath will not have an opportunity to work with Mr Reid’s successor, as she will leave her role at the end of September.

She commented: “When you hear the worst of the worst every day, there is only so long that you can do it before it is starting to impact on yourself. I think that after doing this job for almost eight years, I hope I have made a difference. When I started the job I was handed a blank sheet of paper basically and told ‘okay, this is what we don’t want to happen anymore, go make a job to make sure this doesn’t happen’. I was basically left to do the job description myself. I think the HSE over the years could have been more supportive – they are supportive now.”

This lack of support related to the level of engagement from senior managers within the organisation. “There has been, over the last few years, an

increasing knowledge and support of this office from management. At the start, not so much, but over the last several years definitely.”

“But I think this office is not being used to the best of the ability that it could be. I think that really when these new six regional health departments come into being, that will be a perfect opportunity to have five other people in those health departments.”

In regard to promotion of the office, Ms Gath noted: “I don’t know if it is getting pushed by the HSE as hard as it could.”

2021 stats

Every concern/complaint that is received is reviewed by the Confidential Recipient to develop an understanding of the issues and whether these fall within the remit of the office.

For concerns falling within the remit

of the Confidential Recipient, a decision is taken as to whom the concern should be referred. “This will generally be the Chief Officer of the Community Healthcare Organisation [CHO] within which the person at the centre of the concern is being cared for,” according to the 2021 annual report.

The Confidential Recipient may decide that certain matters do not fall within the remit of her office. “In these cases, the concern is passed to the appropriate responsible person in the HSE, for example Acute Operations or in the case of private nursing homes to HIQA, and the person raising the concern is advised accordingly.”

The Chief Officer or named delegate is responsible for ensuring the concern raised with the Confidential Recipient is thoroughly examined. In all cases, a written report outlining the interim or final outcome is required to be provided to the Confidential Recipient within 15 working days.

Last year 155 formal concerns/complaints were received relating to community services (compared to 165 in 2020). Of these, 137 related to disability services including older person services, 14 related to mental health, and four to primary care.

“Separately an additional 38 acute hospitals concerns were received and were directed to the National Director, Acute Operations, and 25 informal concerns were received, which did not require CHO involvement. No private nursing home concerns were received during 2021,” outlined the annual report.

During 2021, 124 (80 per cent) of the 155 concerns/complaints were closed and 56 (36 per cent) were closed out within one month.

The concerns were in two broad categories – ‘issues of care’ and ‘safeguarding’.

Issues of care include care placement/planning, level of staff to support clients, access to equipment, financial charges, accommodation, and respite. Last year 96 concerns/complaints in the community related to care issues.

Recurring themes included chronic staff shortages in residential and community-based settings, leading to people being moved to nursing homes (sometimes against their will) because their personal assistant (PA) or home support package hours could not be filled; and “serious hospital concerns” for people with disabilities and older people.

Safeguarding concerns/complaints include alleged abuse, safety of care, staff behaviour, and “family issues”. Last year 59 safeguarding concerns/

If you are just getting minimal hours to let you exist there is nothing person-centred about that

ATTR-CM IS LIFE-THREATENING

ORAL VYNDAQEL (TAFAMIDIS)

CAN HELP PATIENTS LIVE LONGER

WITH FEWER HOSPITALISATIONS

Vyndaqel 61 mg is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)2

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.

Vyndaqelq 61 mg soft capsules (tafamidis) Prescribing Information: Before prescribing Vyndaqel please refer to the full Summary of Product Characteristics. Presentation: Vyndaqel 61 mg soft capsules. Each soft capsule contains 61 mg tafamidis. Uses: Vyndaqel is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Dosage: Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. When there is a suspicion in patients presenting with specific medical history or signs of heart failure or cardiomyopathy, etiologic diagnosis must be done by a physician knowledgeable in the management of amyloidosis or cardiomyopathy to confirm ATTR-CM and exclude AL amyloidosis before starting Vyndaqel, using appropriate assessment tools such as: bone scintigraphy and blood/urine assessment, and/or histological assessment by biopsy, and transthyretin (TTR) genotyping to characterise as wild-type or hereditary. The recommended dose is one capsule of Vyndaqel 61 mg (tafamidis) orally once daily. Vyndaqel 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine, tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Vyndaqel should be started as early as possible in the disease course when the clinical benefit on disease progression could be more evident. Conversely, when amyoid-related cardiac damage is more advanced, such as in NYHA Class III, the decision to start or maintain treatment should be taken at the discretion of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. There are limited clinical data in patients with NYHA Class IV. If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible. If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual. There are no recommended dosage adjustments for elderly patients or patients with renal or mild and moderate hepatic impairment. Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min). Tafamidis has not been studied in patients with severe hepatic impairment and caution is recommended. There is no relevant use of tafamidis in the paediatric population. Method of Administration: The soft capsules should be swallowed whole and not crushed or cut. Vyndaqel may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1 of SPC. Warnings and Precautions: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis and for one month after stopping treatment. Tafamidis should be added to the standard of care for the treatment of patients with transthyretin amyloidosis. Physicians should monitor patients and continue to assess the need for other therapy, including the need for organ transplantation, as part of this standard of care. As there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued in patients who undergo organ transplantation. Increase in liver function tests and decrease in thyroxine may occur. This medicinal product contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose.

Further information available upon request.

The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Pregnancy and Lactation: Tafamidis is not recommended during pregnancy and in women of childbearing potential not using contraception. Available data in animals have shown excretion of tafamidis in milk. A risk to the newborns/infants cannot be excluded. Vyndaqel should not be used during breastfeeding. Interactions: In a clinical study in healthy volunteers, 20 mg tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4. In vitro tafamidis inhibits the efflux transporter BCRP (breast cancer resistant protein) at the 61 mg/day tafamidis dose with IC50=1.16 μM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib). In a clinical study in healthy participants, the exposure of the BCRP substrate rosuvastatin increased approximately 2-fold following multiple doses of Page 2 of 2 2020-0065522 61 mg tafamidis daily dosing. Likewise, tafamidis inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 μM and IC50=2.36 μM, respectively, and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine). Based on in vitro data, the maximal predicted changes in AUC of OAT1 and OAT3 substrates were determined to be less than 1.25 for the tafamidis 61 mg dose, therefore, inhibition of OAT1 or OAT3 transporters by tafamidis is not expected to result in clinically significant interactions. No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis. Undesirable Effects: The following adverse events were reported more often in 176 ATTR-CM patients treated with tafamidis meglumine 80 mg compared to placebo: flatulence [8 patients (4.5%) versus 3 patients (1.7%)] and liver function test increased [6 patients (3.4%) versus 2 patients (1.1%)]. A causal relationship has not been established. Safety data for tafamidis 61 mg are not available as this formulation was not evaluated in the double-blind, placebo-controlled, randomised phase 3 study. Legal category: S1A. Marketing Authorisation Numbers: EU/1/11/717/003– 61mg (30 capsules). Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at EUMEDINFO@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500.

Last revised: 04/2021 q This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Ref: VY 61MG 2_0

complaints were received in relation to community services, with staff behaviour the largest volume reported (25).

An example provided in the annual report related to a young person with autism attending a day service. The young person had been locked in a room for an hour and the key could not be found. The young person was lying on the floor unable to be monitored through the window. After complaints were made about the service and staff behaviour, the young person was “eventually given a different service where they are much more settled and content”.

Staff deficits

There is “still a massive shortage of feet on the ground”, which is impacting upon people’s independence, said Ms Gath. She said it appeared many care workers and PAs returned to their home countries during the pandemic. The societal shift to home working may have prompted some people to leave care and PA roles.

She said “very few” employers cover the petrol/diesel costs of PAs and carers and this must be addressed.

The shortfall of staff has meant a regression in independent living for people with a disability. “It is extremely frustrating to see people getting services and supports that will allow them [only] an existence. But there is a reason why about 75 per cent of my community are unemployed. Because how can you be employed if you need supports and you are only guaranteed someone to get you up in the morning when it suits them, not you? And to put you to bed at night when it suits them, not you?”

In many areas of the country, “the agencies that work for the HSE won’t have their staff out late at night. So adults are in bed by 7 or 8 o’clock at night against their wishes because there is nobody to put them to bed any later.”

“I think the Government need to legislate that people, if they need it and if they qualify, have the right to a PA service,” said Ms Gath. She also criticised lack of access to PA services for people over 65 who acquire a disability.

“They are only entitled to home supports or home help which will only help the person with personal care and will not allow them to go outside the home with their carer.

“I think it is a money-saving exercise because you don’t have to give people as many hours if you are only giving them hours to get up, get fed, and get washed and dressed and then get put back to bed at night. If it was social care in the truest sense instead of the medical model… and if it was genuinely letting people have a life instead of an existence, then the person would be assessed on the amount of hours they actually need in order to live. Not the amount of hours they need to exist.

“I don’t defend the HSE at all ever,

but I have to say they don’t produce the money to make this happen, it is the Government through the Department of Health that produces the money to make this happen.”

While the HSE and politicians espouse the social model of disability and person-centred planning, “that doesn’t exist in many respects,” she outlined.

“If you are just getting minimal hours to let you exist there is nothing person-centred about that. The other thing is the institutions started closing after Áras Attracta, which can only be a good thing, that people are taken out of these high-walled institutions. But what is happening is they are being put into pretty, smaller institutions with flowers in the garden. Many people who are in residential and have mainly intellectual disabilities don’t get a choice of who they live with, they don’t get a choice of where they live, they don’t get a choice of getting up in the morning, they don’t get a choice of when they go to bed at night, they don’t get a choice of what they do with their day.

“So what is the difference in the lifestyle between a high-walled institution where 20 people might be sharing

sion-making committees, she added.

During the interview, Ms Gath also expressed concern about potential fragmentation or loss of services for people following the planned transfer of policy and funding responsibility for specialist community-based disability services to the Department of Children, Equality, Disability, Integration, and Youth.

Abuse incidents

MI asked Ms Gath about HSE management of serious abuse incidents and the level of transparency about these incidents. Recently, for example, there have been calls for the full release of the Brandon report to ensure knowledge and learning from the case.

Speaking generally, Ms Gath said there was a “very fine line” between “total transparency” in regard to what is published and the rights of the people who have been abused and their family. “Do their families want to be reading all about this in the newspapers; about their loved ones? Do they want to be reading if somebody was beaten up or sexually assaulted....”

She added: “These things shouldn’t be happening… but you look at the

report it to them.”

However, this agreement has not worked well from her perspective. “I would have thought a memorandum of understanding would have worked two ways,” she commented.

Ms Gath said HIQA does not revert to her with information on the actions taken when she has relayed concerns/ complaints. She said this is unsatisfactory as she is unable to follow up with families. When she sends concerns/complaints to HIQA, she receives a computer-generated letter to say it has been sent to an inspector, and this is the extent of HIQA’s response, stated Ms Gath.

“HIQA never once came back to me, never. And I asked over and over again, look, can they relook at this so at least I can go back to the families and say, ‘they have looked at it, it is okay, it is being taken care of.’ But they never once came back and said that to me….

“HIQA have… never picked up the phone [and said], ‘can we meet to see what each other is doing and to see how we can work together?’ And that would be great, but they have never done that.”

According to HIQA, it had received one piece of information from the Confidential Recipient over the last 18 months. This information was “passed to the relevant inspector” and the Confidential Recipient was informed of this. “We have an MoU with the Confidential Recipient and we will be arranging a meeting for her with our new CEO and Chief Inspector.”

a room and a low-walled institution where you have your own bedroom, but your life is still laid out before you?

“I get concerns in from time to time from families of people with intellectual disabilities going ‘my brother or sister has lived in this house for many years along with these other two people’. Now without them even being told, another person is being moved in, this person screams and roars and has upset the entire balance of the house. Where are their rights?”

Ms Gath acknowledged that certain organisations “are much better than others” and some individuals have their choices facilitated and respected.

She also told MI there was an urgent need for the Government and disability organisations to ‘future-proof’ the housing requirements of people with an intellectual disability as they age.

“These organisations and the Government – I cannot let Government off the hook here as they are the ones with the purse strings – they need to start future-proofing, thinking ahead…. The people in the HSE that are on the ground, they know all of this, they see all of this, and they are doing their very, very best in most instances I would say.”

People with a disability should be included on the HSE’s major deci-

history of Ireland, you had the laundries, the mother and baby homes in Tuam and all the rest. Ireland has a history of taking advantage of the most vulnerable. I think we have come a long way, I really do, but I don’t think that that is something you are going to wipe out in a generation. I think it’s a cultural thing in many places – that is the way it has ‘always been done’. The amount of times I have heard people say that is unreal.”

Where abuse and safeguarding concerns have come to her office, Ms Gath said her experience is they have been investigated “thoroughly” by the HSE. She added that she reverts to the families or individuals who have reported the matter and ensures they have received a response from the HSE and are satisfied for her to close the case in her office. “Nine times out of 10, they are,” she said.

Concerns received by the office about private nursing homes are sent to HIQA. MI asked Ms Gath about her relationship with the Authority. She said that when Mr Phelim Quinn was CEO, HIQA made significant efforts to organise and agree a memorandum of understanding (MoU) with the office of the Confidential Recipient. “So that if something came in on private nursing homes my office would

Ms Gath said when families contact her about private nursing homes, she now advises that they outline the concern/complaint in a registered letter to the private nursing home and copy this correspondence to HIQA. If they do not receive a prompt or adequate response, she advises they should contact the ombudsman’s office where the concern/complaint meets its remit.

New appointment

The HSE is currently in the recruitment process for a new Confidential Recipient. Ms Gath was involved in writing the job description and is the interview panel. She advised that the next Confidential Recipient will “need to be able to stand firm and dig their heels in”.

“And if they know there is something wrong, even if they are being told that something is not wrong… they need to dig their heels in and keep shouting right to the top. I haven’t had to go to Paul Reid that often about anything, I really haven’t, because really it is about relationship building, and as you manage to build relationships with the people further down the line, the issues will be solved most of the time before you get up to that level. Relationship building is basically what this job is about.”

• The Office of the Confidential Recipient for Vulnerable Persons is currently based at Vocational Training Centre, Dooradoyle, Co Limerick. Telephone: 061 482605 or 087 665 7269. Email: leigh.gath@crhealth.ie

HIQA have… never picked up the phone [and said], ‘can we meet to see what each other is doing and to see how we can work together?’

The future of emergency medicine post-Covid

Clinical Lead of the National Clinical Programme for Emergency Medicine

Dr Gerry McCarthy spoke to Niamh Quinlan about developments in the specialty during the pandemic and future requirements

The Covid-19 pandemic has placed a pressing need on healthcare services to adapt.

Dr Gerry McCarthy, Clinical Lead of the National Clinical Programme for Emergency Medicine, told the Medical Independent (MI ): “It was just enormous disruption, almost overnight. We may see another pandemic within the times we live in… [but] I don’t think any of us will ever see anything like it in our lifetime in terms of learning.”

Dr McCarthy spoke to MI about the measures implemented in emergency departments (EDs) during the pandemic and the pre-Covid issues that remain to be addressed for emergency medicine.

Alternative pathways

The emergence of Covid-19 meant that EDs had to find alternatives to congregating patients in large waiting rooms, according to Dr McCarthy.

Patients triaged as low risk, and waiting longer periods in large waiting room areas, were exposed to the risk of transmission.

Therefore, the pandemic drove innovation through the further development of alternative care pathways for suitable patients.

In this respect, three relatively new initiatives were utilised by the National Ambulance Service (NAS) National Emergency Operations Centre in Tallaght.

“So those guys have a knowledge of what the services can offer,” Dr McCarthy said. “And in the event of them taking a call, they think ‘if we assign one of these services to that call, the patient may be able to safely be kept in their home and a plan of care put in place, rather than having to come into the emergency department’.”

Pathfinder, which began in Beaumont Hospital in Dublin and was being planned prior to the pandemic, was one such initiative. Pathfinder aims to improve outcomes for older people by minimising unnecessary ED attendances and offering safe alternative care pathways for older people in their homes. Older people can be particularly vulnerable to adverse events during ED attendance and hospitalisation.

The service consists of an advanced paramedic and occupational therapist (OT) or physiotherapist responding to 112/999 calls. It also has a follow-up team of OTs and physiotherapists who undertake immediate follow-up visits as necessary.

Another initiative, Emergency Department in the Home (EDITH), provides emergency medical care and occupational therapy to adults over 65 and aims to reduce unnecessary attendances. The service, which began in February 2020, is run from St Vincent’s University Hospital (SVUH) in Dublin and is the first of its kind in Ireland. EDITH also accepts referrals from GPs, nursing homes and the SVUH ED team.

A third service Dr McCarthy highlighted to MI was the Alternative Pre-hospital Pathway (APP) Team, operating out of Cork University Hospital (CUH).

The service, which was founded in November 2019, responds to low acuity 112/999 emergency calls in the Cork area and aims to provide definitive patient care in the

community or to refer patients to the appropriate community or specialist service. It is comprised of a specialist registrar in emergency medicine and an emergency medical technician in an NAS response vehicle.

The team has access to a portfolio of the patient’s hospital results, a point-of-care ultrasound scanner and a point-of-care blood test. “They can work magic really, in terms of coming up with a safe alternative to the patient coming to the emergency department,” said Dr McCarthy.

A research article, published last year in BMC Emergency Medicine , found there was a 68 per cent non-con-

veyance rate to the ED in its first 12 months of service.

Dr McCarthy commented: “Each of them [the three services] achieves non-conveyance: In other words, a safe alternative rather than bringing the patient to the emergency department by ambulance. Which makes it worth it, both for the patient and for the use of the ambulance service.”

An initiative in the early stages of development is the ‘navigation hub’ in CUH, where GPs are encouraged to make an emailed referral to the ED. This facilitates the department to have ‘prior sight’ of the patients planning to attend.

However, it is not yet planned to roll-out these initiatives nationally.

According to Dr McCarthy, “there’s a lot of learning going on at the moment. But that’s what we’re working on.”

FIT Teams

Another initiative seeking to address wait times for older patients presenting to EDs are the Frailty Intervention Therapy (FIT) Teams. FIT Teams began in 2015 in Beaumont Hospital to respond to the needs of older patients with frailty who attend the ED. The service comprises of physiotherapy, occupational therapy, medical social work, speech and language therapy, dietetics, and pharmacy.

I really genuinely don’t believe that the closure of Nenagh and Ennis emergency departments is what has caused the problem in Limerick

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

Continued from p16 ▸

“Frailty is a big issue for us,” Dr McCarthy said. “The over-75s are increasing, they’re living longer, they’re attending emergency departments frequently. There are lots of solutions being developed… and the FIT Team is a start.”

According to a 2017 conference abstract published in the International Journal of Integrated Care , the FIT Team service aims to identify all frail patients over the age of 75 who present to the ED during core hours, and to provide “rapid” access and a comprehensive multidisciplinary team assessment to all patients identified as frail.

Dr McCarthy noted: “What we’re trying to do is move from a linear ‘we will triage you and we will see the most urgent patients before we see anybody else’ [model], to a slightly broader approach where we’re saying, ‘well, here’s what it [a post-triage phase of care] looks like… as a care bundle’.”

Wait times and beds

The National Clinical Programme for Emergency Medicine has set a target that 95 per cent of patients are admitted or discharged within a maximum of six hours of attending an ED.

In regard to achieving this standard, Dr McCarthy said: “We’re looking not great.” He also highlighted the negative effect of long waiting times and ED overcrowding on patients’ health and privacy.

According to the national inpatient survey for 2021, only 29 per cent of people said they were admitted to a ward within the target waiting time of six hours.

In June, the HSE released figures to Sinn Féin health spokesperson Deputy David Cullinane, which showed the average wait time for admission to EDs was 11.5 hours. People over 75 had a longer median wait time of 13.5 hours.

Figures from the Irish Nurses and Midwives Organisation (INMO) showed 9,961 admitted patients were awaiting a hospital bed in June.

UHL overcrowding

While ED overcrowding is a problem nationally, it has been a marked and persistent issue at University Hospital Limerick’s (UHL) ED. In May, some 1,823 patients admitted to UHL were waiting for beds. Nationally, on 13 June, there were 457 admitted patients without a bed, including 101 patients in UHL, according to INMO figures.

In June, HIQA published a report on the UHL ED following a risk-based unannounced inspection on 15 March. The Authority said demand for services “exceeded the emergency department’s capacity and was a major contributing factor to overcrowding”. Furthermore, the hospital “did not have adequate measures in place to address the issues of ineffective patient flow, insufficient nurse staffing levels and prolonged waiting times”.

Dr McCarthy said the issue of overcrowding “breaks my heart… I wish it wasn’t there. It interferes with our daily work, we know that. The problem in Limerick is beds.”

Under Government policy, the EDs in Nenagh and Ennis were closed in 2009. There have been concerns that this development added to the long waiting times and overcrowding in Limerick’s ED.

“The University of Limerick Hospital Group is the only one in the country that doesn’t have a model 3 hospital. And that must play a part in this,” stated Dr McCarthy. UL Hospitals has a good directional flow, he said. “And I really genuinely don’t believe that the closure of Nenagh and Ennis emergency departments is what has caused the problem in Limerick,” he continued. “I know it looks like that; I absolutely get that it looks like that. But I don’t believe it to be the case.”

Following the HIQA report, it was announced that the HSE’s performance monitoring and improvement unit (PMIU) would be based at UL Hospitals from 4 July for four-to-six weeks.

In a letter to staff, the Chief Officer of HSE Mid-West

Community Healthcare, Ms Maria Bridgeman, said: “The performance and improvement unit will be a dedicated resource to work collaboratively with HSE MidWest Community Healthcare and the UL Hospital Group to put in place enhanced measures to alleviate the pressure on the emergency department.”

This newspaper queried the HSE on whether the PMIU had left UL Hospitals and on progress to date. However, no response was received by the time of going to press.

Navan

Meanwhile, Dr McCarthy told MI the planned replacement of the ED at Our Lady’s Hospital, Navan, with a 24hour medical assessment unit (MAU) was “completely coherent” with the model of care published by the clinical programme.

The HSE has stated that Navan’s “reconfiguration” to a model 2 hospital was set out in the Government policy document, Securing the Future of Smaller Hospitals — A Framework for Change (2013).

On 13 June, the HSE announced plans to establish the MAU, with support from a local injuries unit. The Executive said Navan’s ED currently does not meet safe clinical standards for certain presentations.

The HSE said the MAU would still see approximately 80 per cent of the 25-to-30 patients who attended the hospital’s ED each day.

Where appropriate, patients would be triaged to Our Lady of Lourdes (OLOL) Hospital, Drogheda, and Connolly Hospital, Blanchardstown.

ly too complex and immediate to be dealt with in that place. That’s the concern in Navan,” he said. “The risk in Lourdes ED and Connolly ED is the risk of crowding.”

A working group has been established by the HSE to review the reconfiguration plans for Navan hospital. It is expected to issue its recommendations within weeks.

Staff retention

Nationally, there is “no doubt” that lack of capacity is negatively impacting hospital staff and contributing to burnout, according to Dr McCarthy.

“Of course, it would,” he said. “I mean, the feeling of helplessness, the inability to make a difference, is one of the key contributors to burnout.”

Interactions were forcibly changed by the pandemic and this impacted both patients and staff.

Dr McCarthy commented: “Sometimes… we had to look twice to see who your colleague in the resuscitation team was, because it was so hard to see anything other than their eyes. And that was particularly difficult for distressed patients.

“A fair bit of our work for the patient who has just developed a sudden serious illness or injury was reassurance… touch the elbow and smile and find something in common that makes them relax a little bit. And that all became extremely difficult during Covid.”

Dr McCarthy also recalled the fear felt by healthcare workers at the beginning of the pandemic.

“In the earliest stages, we had gone into it for all the right reasons and were ready to put ourselves in harm’s way, as it were. Those of us of an older age realised if we got it [the virus], it could be very serious.” These were “very intense times”, he added.

Many healthcare workers have experienced mental health difficulties during the pandemic. According to a study published in the Irish Journal of Medical Science in June, 45 per cent of respondents (from three Dublin hospitals) reported moderate or severe symptoms of post-traumatic stress disorder; 52 per cent of respondents reported low mood; 13 per cent of respondents reported thinking of ending their life over the previous week; and 5 per cent reported planning to end their life.

The high levels of post-traumatic symptoms found in the study were higher than the current best international estimate for healthcare workers.

However, the day after the HSE’s statement, Minister for Health Stephen Donnelly said no decision had been made about the future of the ED.

Dr McCarthy acknowledged the reaction to the HSE’s plan had been “tumultuous”. He said: “People are very wedded to their emergency department. People feel reassured that it’s immediately available.”

There were two broad themes to the model of care, Dr McCarthy stated.

“One is the recommendation to optimise the quality internal patient flow within emergency departments… And the other broad brush is, how should emergency departments support each other… in the form of what we would call an emergency care network.”

Emergency care networks (ECNs) consist of several collaborating emergency units, closely aligned with local pre-hospital services and primary care services, according to the model of care.

The on-site elements of the ECNs comprise of emergency departments, local emergency care units (such as MAUs) and local injury units.

It is vital for emergency departments and lower triage units, such as MAUs and injury units, to form strong linkages, according to Dr McCarthy.

“Ensuring that we pick out the most seriously ill and the most seriously injured at the earliest stage in their care journey is really the holy grail for us — trying to make sure that the right patient gets to the right place at the right time.”

As well as current risks associated with the Navan ED, Dr McCarthy acknowledged the capacity risk in the OLOL and Connolly Hospital EDs.

“There are two risks here: One is the wrong patient arriving in the wrong place, whose needs are clear-

There are also ongoing high levels of doctor emigration. By May 2022, Australia had issued 402 work visas to Irish doctors, compared to 272 in 2019. Commenting on the figures at the IMO AGM in May, Senior Lecturer in the RCSI Graduate School of Healthcare Management, Dr Niamh Humphries, said keys challenges for doctors included poor work/life balance and an absence of hope.

There are some supports in place, noted Dr McCarthy. He acknowledged there has been “very ready access” to employee assistance programmes. “And I have many times over the years referred people to them, and they have come back full of good news about them.”

Staff

The response of healthcare staff during the pandemic has underlined that “we have some really, really great people”, said Dr McCarthy. “And we have some incredibly talented people coming forward.”

Asked what could be done to boost staff retention, he told MI: “A real, genuine feeling that they’re appreciated goes a long way. In hectic environments, like the emergency department, ensuring people get breaks [is crucial], which is extremely difficult because there’s always something going on. But it is really, really important.”

Accessing annual leave is also difficult in emergency medicine, Dr McCarthy pointed out.

While new initiatives in EDs have offered a sense of hope, Dr McCarthy said he would not insult colleagues by failing to acknowledge the significant ongoing challenges.

“They are my colleagues. I work alongside them on a regular basis, and they are the best, they are just fantastic.”

The ultimate goal of staff is to manage and care for seriously ill and injured patients, “doing their best for them and taking pride in that,” he said.

I mean, the feeling of helplessness, the inability to make a difference, is one of the key contributors to burnout

Whether your patients’ moderate-to-severe AD is FIERCE or TAMER,

CIBINQO is a convenient once-daily oral JAK1 inhibitor for moderate-to-severe atopic dermatitis (AD) that o ers1-4

Significant skin clearance at week 12, with sustained control at week 481,5

Rapid itch relief, superior to dupilumab + TCS at week 2 for CIBINQO 200 mg + TCS, with significant results as early as day 41,6

A once-daily pill available in multiple doses that can be used with or without medicated topical therapies so you can tailor treatment to meet the individual needs of your patients1-3,7,8

CONSISTENT SAFETY PROFILE: Rigorously studied in >3100 patients across 7 clinical trials, including one ongoing LTE 9

PRESCRIBING INFORMATION CIBINQO® ▼ (ABROCITINIB)

Please refer to full Summary of Product Characteristics (SmPC) before prescribing Cibinqo®. Presentation: Film-coated tablets containing 50 mg, 100 mg, or 200 mg abrocitinib. Each tablet contains 1.37 mg, 2.73 mg, and 5.46 mg of lactose monohydrate, respectively. Indications: For the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. Dosage: Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. Posology: The recommended starting dose is 200 mg once daily. A starting dose of 100 mg once daily is recommended for patients ≥ 65 years of age. For other patients who may benefit from a starting dose of 100 mg, see sections 4.4 and 4.8 of the SmPC. During treatment, the dose may be decreased or increased based on tolerability and e cacy. The lowest e ective dose for maintenance should be considered. The maximum daily dose is 200 mg. Can be used with or without medicated topical therapies for atopic dermatitis. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks. Treatment initiation: Treatment should not be initiated in patients with a platelet count < 150 × 103/mm3, an absolute lymphocyte count (ALC) < 0.5 × 103/mm3, an absolute neutrophil count (ANC) < 1.2 × 103/mm3 or who have a haemoglobin value < 10 g/dL. Dose interruption: If a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled. Interruption of dosing may be needed for management of laboratory abnormalities. Missed doses: If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, dosing should be resumed at the regular scheduled time. Interactions: In patients receiving dual strong inhibitors of cytochrome CYP2C19 and moderate inhibitors of CYP2C9, or strong inhibitors of CYP2C19 alone (e.g., fluvoxamine, fluconazole, fluoxetine and ticlopidine), the recommended starting dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g., rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin). Renal impairment: No dose adjustment is required in patients with mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60 to < 90 mL/min. In patients with moderate (eGFR 30 to < 60 mL/min) renal impairment, the recommended dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. In patients with severe (eGFR < 30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose. The maximum daily dose is 100 mg. Cibinqo has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy. Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Cibinqo must not be used in patients with severe (Child Pugh C) hepatic impairment. Elderly: The recommended starting dose for patients aged 65 years or more 100 mg once daily. Paediatric population: The safety and e cacy of Cibinqo in children under 12 years of age have not yet been established. No data are available. Cibinqo has been studied in adolescents 12 to < 18 years of age. However, because of bone findings in juvenile rats (comparable to a 3 month old human), additional long-term data in growing adolescents is needed to conclude that the benefits outweigh the risks. Method of administration: This medicinal product is to be taken orally once daily with or without food at approximately the same time each day. In patients who experience nausea, taking Cibinqo with food may improve nausea. Tablets should be swallowed whole with water and should not be split, crushed, or chewed because these methods have not been studied in clinical trials. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Active serious systemic infections, including tuberculosis (TB), severe hepatic impairment, pregnancy, and breast-feeding. Warnings and Precautions: Serious infections: Serious infections have been reported in patients receiving Cibinqo. The most frequent serious infections in clinical studies were herpes simplex, herpes zoster and pneumonia. Treatment must not be initiated in patients with an active, serious systemic infection. Risks and benefits of treatment prior to initiating Cibinqo should be considered. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated. The patient should be closely monitored, and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Tuberculosis: Patients should be screened for TB before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered. Abrocitinib must not be given to patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, preventive therapy for latent TB should be started prior to initiation of treatment. Viral reactivation: Viral reactivation, including herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical studies. The rate of herpes zoster infections was higher in patients 65 years of age and older and patients with severe atopic dermatitis at baseline. If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy. Patients with evidence of active hepatitis B or hepatitis C (positive hepatitis C PCR) infection were excluded from clinical studies. Patients who were hepatitis B surface antigen negative, hepatitis B core antibody positive, and hepatitis B surface antibody positive had testing for hepatitis B virus (HBV) DNA. Patients who had HBV DNA above the lower limit of quantification (LLQ) were excluded. Patients who had HBV DNA negative or below LLQ could initiate treatment; such patients had HBV DNA monitored. If HBV DNA is detected, a liver specialist should be consulted. Vaccination: No data are available on the response to vaccination in patients receiving Cibinqo. Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating treatment with this medicinal product, it is recommended that patients be brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines. Thrombotic events including pulmonary embolism: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving abrocitinib. Cibinqo should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient’s risk for DVT/PE include older age, obesity, a medical history of DVT/PE, prothrombotic disorder, use of combined hormonal contraceptives or hormone replacement therapy, patients undergoing major surgery or prolonged immobilisation. If clinical features of DVT/PE occur, treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment. Malignancy (including non-melanoma skin cancers): Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical

1. Bieber T, Simpson EL, Silverberg JI, et al. N Engl J Med. 2021;384(12):1101-1112.

References:

studies with abrocitinib. Clinical data are insu cient to assess the potential relationship of exposure to abrocitinib and the development of malignancies. Long-term safety evaluations are ongoing. The risks and benefits of Cibinqo treatment should be considered prior to initiating in patients with a known malignancy other than a successfully treated NMSC or cervical cancer in situ or when considering continuing Cibinqo therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Haematologic abnormalities: Confirmed ALC < 0.5 × 10 /mm3 and platelet count < 50 × 10 /mm3 were observed in less than 0.5% of patients in clinical studies. Treatment with abrocitinib should not be initiated in patients with a platelet count < 150 × 103/mm3, an ALC < 0.5 × 10 /mm3 an ANC < 1.2 × 103/mm or who have a haemoglobin value < 10 g/dL. Complete blood count should be monitored 4 weeks after initiation of therapy and thereafter according to routine patient management. Lipids: Dose dependent increases in blood lipid parameters were reported in patients treated with abrocitinib compared to placebo. Lipid parameters should be assessed approximately 4 weeks following initiation of therapy and thereafter according to the patient’s risk for cardiovascular disease. The e ect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Patients with abnormal lipid parameters should be further monitored and managed according to clinical guidelines, due to the known cardiovascular risks associated with hyperlipidaemia. In patients with a high burden of cardiovascular risk factors, the risks, and benefits of abrocitinib compared to that of other available therapies for atopic dermatitis should be considered. If abrocitinib is chosen, interventions to manage lipid concentrations should be implemented according to clinical guidelines. Elderly: The safety profile observed in elderly patients was similar to that of the adult population with the following exceptions: a higher proportion of patients 65 years of age and older discontinued from clinical studies and were more likely to have serious adverse reactions compared to younger patients; patients 65 years and older were more likely to develop low platelet and ALC values; the incidence rate of herpes zoster in patients 65 years of age and older was higher than that of younger patients. There are limited data in patients above 75 years of age. Immunosuppressive conditions or medicinal products: Patients with immunodeficiency disorders or a first-degree relative with a hereditary immunodeficiency were excluded from clinical studies and no information on these patients is available. Combination with biologic immunomodulators, potent immunosuppressants such as ciclosporin or other Janus kinase (JAK) inhibitors has not been studied. Their concomitant use with abrocitinib is not recommended as a risk of additive immunosuppression cannot be excluded. Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Drug Interactions: Potential for other medicines to a ect pharmacokinetics of abrocitinib: Abrocitinib is metabolised predominantly by CYP2C19 and CYP2C9 enzymes, and to a lesser extent by CYP3A4 and CYP2B6 enzymes, and its active metabolites are renally excreted and are substrates of the organic anion transporter 3 (OAT3). Therefore, exposures of abrocitinib and/or its active metabolites may be a ected by medicinal products that strongly inhibit or induce theses enzymes and transporter. Dose adjustments, as appropriate, may be required. Co-administration with products which increase gastric pH: The e ect of elevating gastric pH with antacids, H2-receptor antagonists (famotidine), or proton pump inhibitors (omeprazole) on the pharmacokinetics of abrocitinib has not been studied and may reduce the absorption of abrocitinib due to the low solubility of abrocitinib at pH above 4. Potential for Cibinqo to a ect pharmacokinetics of other medicinal products: No clinically significant e ects of Cibinqo were observed in drug interaction studies with oral contraceptives. Caution should be exercised for concomitant use of abrocitinib with dabigatran. Caution should be exercised as the levels of P-gp substrates with a narrow therapeutic index, such as digoxin, may increase. The exposures of medicinal products metabolised by CYP2B6 (e.g., bupropion, efavirenz) and CYP1A2 (e.g., alosetron, duloxetine, ramelteon, tizanidine) may be decreased and of those metabolised by CYP2C19 (e.g., S mephenytoin) may be increased initially and then decreased, when used concomitantly with abrocitinib. Fertility, pregnancy, and lactation:

Women of childbearing potential: Women of reproductive potential should be advised to use e ective contraception during treatment and for 1 month following the final dose of Cibinqo. Pregnancy planning and prevention for females of reproductive potential should be encouraged. Pregnancy: There are no or limited amount of data on the use of abrocitinib in pregnant women. Studies in animals have shown reproductive toxicity. Abrocitinib has been shown to cause embryo-foetal lethality in pregnant rats and rabbits, skeletal variations in the foetuses of pregnant rats and rabbits and to a ect parturition and peri/postnatal development in rats. Cibinqo is contraindicated during pregnancy. Breast-feeding: There are no data on the presence of abrocitinib in human milk, the e ects on the breast fed infant, or the e ects on milk production. Abrocitinib was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and Cibinqo is contraindicated during breast feeding. Fertility: Based on the findings in rats, oral administration of Cibinqo may result in temporary reduced fertility in females of reproductive potential. The e ects on female rat fertility were reversible 1 month after cessation of abrocitinib oral administration. Driving and operating machinery: Cibinqo has no e ect on the ability to drive or use machines. Side E ects: The most commonly reported adverse reactions are nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%) including herpes simplex, herpes zoster, and pneumonia. Refer to SmPC for further information on side e ects. Legal Category: S1A. Marketing Authorisation Numbers: EU/1/21/1593/002 - Cibinqo 50 mg (28 film-coated tablets), EU/1/21/1593/007 - Cibinqo 100 mg (28 film-coated tablets); EU/1/21/1593/012 - Cibinqo 200 mg (28 film-coated tablets). Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 467 6500.

▼ 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.

Last revised: December 2021.

Ref: CQ 1_0 IE.

2. Simpson EL, Sinclair R, Forman S, et al. Lancet. 2020;396(10246):255-266.

3. Silverberg JI, Simpson EL, Thyssen JP, et al. JAMA Dermatol 2020;156(8):863-873.

4. Boeri M, Sutphin J, Hauber B, et al. J Dermatolog Treat. 2020 Nov 2:1-10. doi:10.1080/09546634.1832185. 5. Reich K, Silverberg JI, Papp K, et al. Presented at the Revolutionizing Atopic Dermatitis Virtual Conference; 13 June 2021. 6. Ständer S, Yosipovitch G, Simpson EL, et al. Presented at the American Academy of Dermatology Virtual Meeting Experience 2021; 23-25 April 2021. 7. Cibinqo Summary of Product Characteristics. 8. Blauvelt A, Silverberg JI, Lynde CW, et al. J Am Acad Dermatol Published online 17 August 2021. doi: 10.1016/j.jaad.2021.05.075. 9. Cork MJ, Deleuran MS, Geng B, et al. Presented at the European Academy of Dermatology and Venereology Virtual Congress 2021; 29 September-2 October 2021.

Although some clinical trials included adolescents, please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase 4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.

AD=atopic dermatitis; JAK=Janus kinase; LTE=long-term extension.

© 2022 Pfizer Inc. All rights reserved. June 2022. PP-CIB-IRL-0020

Patient portrayal.

ROBERTO, civil servant; Age: 48 BMI: 39

Saxenda® Liraglutide injection 3 mg. Please refer to the full Summary of Product Characteristics (SmPC) before prescribing. Saxenda® 6 mg/ml solution for injection in a prefilled pen. One pre-filled pen contains 18 mg liraglutide in 3 ml. Indication: Adults: Saxenda® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of ≥ 30 kg/m² (obesity) or ≥ 27 kg/m² to < 30 kg/ m² (overweight) in the presence of at least one weight-related comorbidity. Treatment with Saxenda® should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. Adolescents (≥12 years): Saxenda® can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *See table 1 in SmPC. Posology and administration: Adults: The starting dose is 0.6 mg once daily. Dose should be increased to 3.0 mg once daily in increments of 0.6 mg with at least one-week intervals to improve gastro-intestinal (GI) tolerability. If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment. Adolescents (≥12 years): A similar dose escalation schedule as for adults should be applied. The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached (see SmPC). Adults and Adolescents: Daily doses higher than 3.0 mg are not recommended. Saxenda® is administered once daily at any time, independent of meals, subcutaneously injected in the abdomen, thigh or upper arm, preferably around the same time of the day. Saxenda® must not be administered intravenously or intramuscularly. Saxenda® should not be used in combination with another GLP-1 receptor agonist. When initiating treatment in patients with type 2 diabetes mellitus, consider reducing the dose

of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of insulin or insulin-secretagogues. The safety and efficacy of Saxenda in children below 12 years of age has not been established. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Saxenda® must not be used as a substitute for insulin in patients with diabetes mellitus. Diabetic ketoacidosis has been reported after rapid discontinuation or dose reduction of insulin. There is no clinical experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and therefore Saxenda® is not recommended for use in these patients. Saxenda® is not recommended in patients: aged 75 years or more, treated with other products for weight management, with obesity secondary to endocrinological or eating disorders or to treatment with medicinal products that may cause weight gain, with severe renal impairment including end-stage renal disease, with severe hepatic impairment. Saxenda® must be used with caution in patients with mild or moderate hepatic impairment. Saxenda® is not recommended in patients with inflammatory bowel disease and diabetic gastroparesis. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists, patients should be informed of the characteristic symptoms. If pancreatitis is suspected, Saxenda® should be discontinued; if acute pancreatitis is confirmed, Saxenda® should not be restarted. In clinical trials for weight management, a higher rate of cholelithiasis and cholecystitis was observed in patients on Saxenda® than those on placebo, therefore inform patients of characteristic symptoms. Use with caution in patients with thyroid disease. An increase in heart rate was observed with liraglutide in clinical trials. Heart rate should be monitored at regular intervals and patients informed of the symptoms of increased heart rate. For patients who experience a clinically relevant sustained increase in resting heart rate, treatment with Saxenda® should be discontinued. Patients treated with Saxenda® should be advised of the potential risk of dehydration in relation

to GI side effects and take precautions to avoid fluid depletion. Signs and symptoms of dehydration, including renal impairment and acute renal failure have been reported. Patients with type 2 diabetes mellitus receiving Saxenda® in combination with insulin and/or sulfonylurea may have an increased risk of hypoglycaemia. Dizziness can be experienced mainly during the first 3 months of treatment, therefore use caution when driving or using machines if dizziness occurs. Episodes of clinically significant hypoglycaemia have been reported in adolescents (≥12 years) treated with liraglutide; patients should be informed about characteristic symptoms of hypoglycaemia and appropriate actions. Fertility, pregnancy and lactation: Saxenda® should not be used during pregnancy or breastfeeding. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Saxenda® should be discontinued. Undesirable effects: Very common (≥1/10): headache, nausea, vomiting, diarrhoea, constipation. Common (≥1/100 to <1/10): hypoglycaemia, insomnia, dizziness, dysgeusia, dry mouth, dyspepsia, gastritis, gastro-oesophageal reflux disease, abdominal pain upper, flatulence, eructation, abdominal distension, cholelithiasis, injection site reactions, asthenia, fatigue, increased lipase, increased amylase. Uncommon (≥1/1,000 to <1/100): dehydration, tachycardia, pancreatitis, delayed gastric emptying, cholecystitis, urticaria, malaise. Rare (≥1/10,000 to <1/1,000): anaphylactic reaction, acute renal failure, renal impairment. The SmPC should be consulted for a full list of side effects. Legal category: POM MA number: 5 x 3 ml pre-filled pens EU/1/15/992/003 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, Ireland. Date last revised: November 2021.

Adverse 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

Your patients with obesity have the will.

You can offer them the way.

I haVe the will to work out eVery day. But I still need help to lose weight and keep it off.

Position of occupational medicine specialists is troubling

While increasing subspecialisation in medicine has been the focus of critical commentary, the benefits of general specialisation are long established and undisputed.

The ability to hone one’s craft through years of specialist training and continuing professional development – and direct patient care – means that patients and healthcare systems have access to the latest knowledge and skills across the spectrum of medicine (although a glaring caveat in the Irish context is lack of timely patient access to this expertise).

However, the skills and knowledge of occupational medicine specialists in Ireland appear to be significantly under-appreciated by health leadership.

In the first instance, higher specialist trainees in occupational medicine complete a training programme at a level comparable to other specialties, but, unlike their peers, they are not recognised as consultants in the HSE.

This undoubtedly impacts upon the attractiveness and growth of the role and the general standing of occupational medicine specialists in some healthcare settings in Ireland. How does this translate in practice?

As reported in this edition of the Medical Independent , an expert group in the RCPI Faculty of Occupational Medicine, in late 2021, considered certain Covid-19 control measures outlined in HSE guidance at the time as inadequate in maximising staff safety and inconsistent with the employer’s duty of care to their staff. The specialists specifically examined HSE guidance on masking for healthcare workers and strongly advised the wearing of FFP2 masks for

staff working in clinical areas where Covid-19 cases may present or arise at all times, as part of a hierarchy of control measures (and higher-grade respirators for close contact with known Covid-positive patients).

These views were provided in the context of a predicted imminent surge in Covid-19 cases and were communicated to the HSE.

There was a subsequent change in guidance in favour of recommending wider use of FFP2 masks, but this has since been downgraded. This newspaper understands that several occupational medicine specialists have internally expressed concern about HSE guidance and control measures throughout the pandemic.

Several specialties have vital contributions to make to infection prevention and control guidance – particularly in a pandemic. Criticism of the guidance is not meant as a challenge to the integrity, skills, and knowledge of the authors, who have had to weigh-up existing and newly emerging evidence on a daily basis.

However, occupational medicine brings a different – and important – set of skills, knowledge, and considerations (including on health and safety law), which should be better reflected in the construction of guidance and final iterations.

As the Faculty of Occupational Medicine webpage states, occupational medicine physicians combine their knowledge of science with an understanding of legal issues surrounding workplace safety.

It should be of concern to healthcare workers – and their unions – that medical specialists with expertise on the interface of work and health have such misgivings about the HSE approach.

MINDO CARTOON

READER COMMENTS

REACTION TO OUR NEWS ARTICLE, 'POSSIBILITY OF GEM SUPPORTS TO BE DISCUSSED', 11 AUGUST

“A grant is needed. Making the only option to pursue a post-grad option into medicine a very large bank loan was unfair and short-sighted. People entering medicine should not be saddled with long-term debt. Especially considering the current payment issue across the HSE. When we speak to #StandingUp4NCHDs let’s bear in mind that, yes they are emergency taxed unfairly each rotation, charged ridiculous membership fees, and made pay for exams… they are also paying back huge student debt." Dr Hilary Murray, @artboxhill, 9 August

REACTION TO OUR NEWS FEATURE, 'PROGRESSING A POTENTIAL DONOR AUDIT IN IRELAND',

11 AUGUST

“The report noted the rate of organ donation in Ireland was 18 per million population (PMP) compared to 25 PMP in the UK and over 45 PMP in Spain."

Chris Kelly, @WuKelly, 11 August

“We are pleased to see progress in this area. We have advocated for a Potential Organ Donor Audit process for some years now." Irish Kidney Association, @IrishKidneyAs, 10 August

“@NOCA_IRL delighted to commence this work with @odti_irl and important stakeholders @hsencca @crowley_phillip @lougalvin4 and Strange Boat Donor Foundation @micel_laoire @MariaBKehoe."

National Office of Clinical Audit, @noca_irl, 10 August

REACTION TO DR LUCIA GANNON'S COLUMN, 'COMPLAINTS AND THE OVER-STRETCHING OF THE DOCTOR-PATIENT BOND', 11 AUGUST

“Perspicacious and erudite as ever, @LuciaGannon."

Dr Mike Thompson, @Eastcorkclinsoc, 9 August

REACTION TO DR SEAMUS O'MAHONY'S COLUMN, 'THE LAST OF THE CLINICIAN-ARISTOCRATS', 11 AUGUST

“If you have not read ‘Can Medicine be Cured’ I strongly recommend it. Seamus has got me to the letter. Neurology defender of the physical examination and the medical interview along with general practice." Prof Andrew Lees, @ajlees, 11 August

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Data breaches and indemnity

Indemnity issues surrounding data breaches can be complex and it is important that practices are aware of the requirements. Dr Dawn McGuire and Dr Ian Lavelle, Medico-Legal Consultants at Medical Protection, look at some cases and explain more

Claims arising from data or confidentiality breaches are not uncommon. The practice may be pursued for these alleged breaches, whether within or outside healthcare provision.

For example, Medical Protection has received claims after medical information or test results have been divulged to a patient’s relative or representative without the patient’s consent.

Claims have also been reported to us following a practice employee accidentally sending medical information to the wrong recipient or address, losing medical records in their care, and leaving medical records in a public place.

Another case centred around a member of the practice team accessing a patient’s medical records without valid reason.

Key points

It is vital that the whole practice team is familiar with data protection laws, confidentiality and information security, and are adequately trained. The Data Protection Commission provides a useful guide to data protection for organisations and employees who have day-to-day responsibility for data protection (https://www.dataprotection.ie/en/organisations).

Claims or monetary penalties arising from data loss or data breaches fall outside of healthcare indemnity and is therefore outside the scope for Medical Protection assistance.

Healthcare organisations like GP practices need to ensure adequate protection is in place for these claims. The practice manager can explore adequate indemnity protection with a public liability insurer or other appropriate insurers, for example employers’ liability or directors’ liability insurances.

Case study 1: Accessing a friend’s records

Mr T worked as an administrator in a GP practice. He heard that an old friend, Mr B, was a shadow of himself, and that his wife had left him. Mr T knew that Mr B was registered with his practice. When he was working on a late shift one day, Mr T looked into Mr B’s medical records and discovered that Mr B was recently tested for HIV and the result had come back positive. Mr T could not contain his shock and revealed this to a mutual friend when they met later the same day.

Two weeks later, the practice manager asked to speak to Mr T privately. Mr B had made a formal complaint to the practice as he suspected that someone from the practice had accessed his records and publicised his HIV status. An audit trail had revealed that Mr T had accessed Mr B’s record

without any valid reason. Mr T underwent disciplinary action and was dismissed from the practice. The practice manager wrote a very apologetic and empathic letter to Mr B.

Another month later, the practice received a letter of claim requesting compensation for Mr B’s psychological trauma. Mr B claimed that his family and friends had deserted him, and he was now a recluse and terminally depressed. The senior partner of the practice contacted Medical Protection to request assistance. She was advised to notify their public liability insurer (PLI) instead.

The practice manager was familiar with data protection law and also knew that adequate indemnity protection had to be obtained from a PLI or other appropriate insurers. The practice’s PLI took over the conduct of this claim.

Case study 2: Confirming who you are speaking to

Ms C, a receptionist, was asked to contact Ms F to inform her that her blood iron level was low and that an iron supplement prescription was ready for collection. Ms F had a miscarriage recently and had been feeling lethargic, so the blood test was recommended.

Ms C called the landline number on record and spoke to a ‘Ms F’ but did not confirm other personal details, ie, date of birth. Ms C was very sympathetic about the miscarriage, wished Ms F a speedy recovery and relayed the blood test result and prescription information. Unbeknown to her, she was speaking to the patient’s sister, who was also ‘Ms F’.

Ms F pursued the practice for a data breach claim and alleged psychological injury. She had kept the pregnancy and miscarriage from her family due to personal reasons and the unintended revelation had led to a family rift and loss of trust.

The practice manager contacted their PLI and the claim was eventually satisfactorily settled.

The practice may be pursued for these alleged breaches, whether within or outside healthcare provision

Genuair®-has it ‘clicked’ yet?

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

Genuair - a simple to use inhaler for patients with COPD4

Abbreviated Prescribing Information

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

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

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

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

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

Abbreviated Prescribing Information

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

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

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

In ORAL Solo, XELJANZ delivered rapid reduction in the signs and symptoms of RA as early as week 2, with significant reductions at month 3 vs placebo (P<0.001).1

XELJANZ® (tofacitinib) Prescribing Information:

Please refer to the Summary of Product Characteristics (SmPC) before prescribing XELJANZ 5 mg or 10 mg film-coated tablets, XELJANZ 11 mg prolonged release tablets or XELJANZ 1 mg/mL oral solution. Presentation: Film-coated

responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. Can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. In combination with MTX for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy. For the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. For the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. For the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis, and extended oligoarthritis), and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Can be given in combination with MTX or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Dosage: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of the condition for which tofacitinib is indicated. Tofacitinib is given orally, with or without food. RA and PsA: The recommended dose is 5 mg twice daily or 11 mg once daily which should not be exceeded. Treatment with tofacitinib 5 mg film coated tablets twice daily and tofacitinib 11 mg prolonged release tablet once daily may be switched between each other on the day following the last dose of either tablet. AS:

The recommended dose is 5 mg twice daily. Available data suggest that clinical improvement in AS is observed within 16 weeks of initiation of treatment. Continued therapy should be carefully reconsidered in AS patients exhibiting no clinical improvement within this timeframe. UC: The recommended dose is 10 mg twice daily for induction for 8 weeks. For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance. Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16. The recommended dose for maintenance treatment is tofacitinib 5 mg twice daily.

Tofacitinib 10 mg twice daily for maintenance treatment is not recommended in patients with UC who have known venous thromboembolism (VTE) risk factors, unless there is no suitable alternative treatment available. For patients with UC who are not at increased risk for VTE, tofacitinib 10 mg twice daily may be considered if the patient experiences a decrease in response on tofacitinib 5 mg twice daily and failed to respond to alternative treatment options for UC such as tumour necrosis factor inhibitor treatment. Tofacitinib 10 mg twice daily for maintenance treatment should be used for the shortest duration possible. The lowest effective dose needed to maintain response should be used. Polyarticular JIA and juvenile PsA: The recommended dose in patients 2 years of age and older: 10 kg - < 20 kg: 3.2 mg (3.2 mL oral solution) twice daily, 20 kg - < 40 kg: 4 mg (4 mL oral solution) twice daily, and ≥ 40 kg 5 mg (5 mL oral solution or 5 mg tablet) twice daily. Patients ≥ 40 kg treated with tofacitinib 5 mL oral solution twice daily may be switched to tofacitinib 5 mg tablets twice daily. Available data suggest that clinical improvement is observed in paediatric patients within 18 weeks of initiation. Continued therapy should be carefully reconsidered in a paediatric patient exhibiting no clinical improvement within this timeframe. Dose interruption and adjustment:

Tofacitinib treatment should be interrupted if a patient develops a serious infection until the infection is controlled. Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia. It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 0.75 x 10 9/L, an absolute neutrophil count (ANC) less than 1x10 /L or with haemoglobin less than 9 g/dL. It is recommended not to initiate dosing in paediatric patients with an absolute neutrophil count (ANC) less than 1.2 x 10 9/L or with haemoglobin less than 10 g/dL. Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. Patients with severe renal impairment the dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal renal function is 5 mg twice daily or 11 mg prolonged-release tablet once daily. Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal renal function is 10 mg twice daily. Patients with severe renal impairment should remain on a reduced dose even after haemodialysis. Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment. Patients with moderate hepatic impairment dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal hepatic function is 5 mg twice daily or 11 mg prolonged-release tablet once daily. Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal hepatic function is 10 mg twice daily. Tofacitinib should not be used in patients with severe hepatic impairment. Elderly: No dose adjustment is required in patients aged 65 years and older. Use with caution as increased risk and severity of adverse events. See also Warnings & Precautions for use in patients over 65 years of age. Paediatric population: The safety and efficacy of tofacitinib in children less than 2 years of age with polyarticular JIA and juvenile PsA has not been established. The safety and efficacy of tofacitinib in children less than 18 years of age with other indications (e.g. ulcerative colitis) has not been established. The safety and efficacy of tofacitinib prolonged-release formulation in children aged less than 18 years have not been established. Interactions: TTofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g. ketoconazole) and in patients receiving 1 or more products that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g. fluconazole). Coadministration with potent CYP inducers (e.g. rifampicin) may result in a loss of or reduced clinical response. Coadministration with potent inducers of CYP3A4 is not recommended. Contraindications: Hypersensitivity to any of the ingredients, active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections, severe hepatic impairment, pregnancy and lactation. Warnings and Precautions: Patients treated with tofacitinib should be given a patient alert card. Use in patients over 65 years of age: Considering the increased risk of serious infections, myocardial infarction, and malignancies with tofacitinib in patients over 65 years of age, tofacitinib should only be used in patients over 65 years of age if no suitable treatment alternatives are available. Combination with other therapies: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies. Tofacitinib should be avoided in combination with biologics and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporin and tacrolimus. Venous thromboembolism (VTE): Serious VTE events including pulmonary embolism (PE), some of which were fatal, and deep vein thrombosis (DVT), have been observed in patients taking tofacitinib. In a randomised post authorisation safety

LARGEST DATASET OF ANY JAKi IN RA, CAN MAKE FROM THE START 1-3,a,b

Starting as early as 2 weeks, DMARD-IR patients with RA who received XELJANZ monotherapy demonstrated a greater ACR20 response (secondary endpoint) vs placebo (30% vs 12%; P<0.001) in a phase 3, randomised, double-blind, placebo-controlled study (N=610)1,3

At month 3, significantly more DMARD-IR patients with RA who received XELJANZ monotherapy achieved ACR20 response (primary endpoint) vs placebo (59.8% vs 26.7%; P<0.001) in a phase 3, randomised, double-blind, placebo-controlled study (N=610)1

Proven in

patients evaluated across treatment arms in the clinical trial program2,b

to twice the upper limit of normal (2× ULN) versus those with D-dimer level <2×ULN. For patients with RA with known risk factors for VTE, consider testing D-dimer levels after approximately 12 months of treatment. If D-dimer test result is ≥ 2× ULN, confirm that clinical benefits outweigh risks prior to a decision on treatment continuation with tofacitinib. Tofacitinib should be used with caution in patients with known risk factors for VTE, regardless of indication and dose. Tofacitinib 10 mg twice daily for maintenance treatment is not recommended in patients with UC who have known VTE risk factors, unless there is no suitable alternative treatment available. Promptly evaluate patients with signs and symptoms of VTE and discontinue tofacitinib in patients with suspected VTE, regardless of dose or indication. Infections: Serious and sometimes fatal infections have been reported in patients administered tofacitinib. Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection. Patients should be closely monitored for infections, with prompt diagnosis and treatment. Treatment should be interrupted if a serious infection develops. As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. Tuberculosis: Patients should be evaluated for both active and latent TB prior to being treated with tofacitinib. Patients who test positive for latent TB should be treated with standard antimycobacterial therapy before administering tofacitinib. Viral Reactivation: In clinical studies viral reactivation and cases of herpes zoster have been observed. Screening for viral hepatitis should be performed in accordance with clinical guidelines prior to starting therapy with tofacitinib. The impact on chronic viral hepatitis is not known. Major adverse cardiovascular events (MACE): MACE have been observed in patients taking tofacitinib. In a randomised post authorisation safety study in patients with RA who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of myocardial infarctions was observed with tofacitinib compared to TNF inhibitors. In patients over 65 years of age, patients who are current or past smokers, and patients with other cardiovascular risk factors, tofacitinib should only be used if no suitable treatment alternatives are available. Vaccinations: Prior to initiating tofacitinib, it is recommended that all patients, particularly pJIA and jPsA patients, be brought up to date with all immunisations in agreement with current immunisation guidelines. Live vaccines should not be given concurrently with tofacitinib. Malignancy and lymphoproliferative disorder: Tofacitinib may affect host defences against malignancies. In a randomised post authorisation safety study in patients with RA who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of malignancies excluding non-melanoma skin cancer (NMSC), particularly lung cancer and lymphoma, was observed with tofacitinib compared to TNF inhibitors. Lung cancers and lymphoma in patients treated with tofacitinib have also been observed in other clinical studies and in the post marketing setting. Other malignancies in patients treated with tofacitinib were observed in clinical studies and the post marketing setting, including, but not limited to, breast cancer, melanoma, prostate cancer, and pancreatic cancer. In patients over 65 years of

age, patients who are current or past smokers, and patients with other malignancy risk factors tofacitinib should only be used if no suitable treatment alternatives are available. NMSCs have been reported in patients treated with tofacitinib; the risk of NMSC may be higher in patients treated with tofacitinib 10 mg twice daily than in patients treated with 5 mg twice daily. Periodic skin examination is recommended in patients at increased risk for skin cancer. Interstitial lung disease: Caution is recommended in patients with a history of chronic lung disease as they may be more prone to infection. Asian patients are known to be at higher risk of ILD, caution should be exercised with these patients. Gastrointestinal perforations: Tofacitinib should be used with caution in patients who may be at increased risk, e.g. history of diverticulitis or concomitant use of corticosteroids or NSAIDs. Hypersensitivity: Cases of hypersensitivity associated with tofacitinib administration have been reported. Allergic reactions included angioedema and urticaria; serious reactions have occurred. If any serious allergic or anaphylactic reaction occurs, tofacitinib should be discontinued immediately. Laboratory Parameters: Increased incidence of lymphopenia and neutropenia have been reported, and decreases in haemoglobin, which should be monitored in accordance with the SmPC. Monitor ANC and haemoglobin at baseline, 4-8 weeks and 3 monthly, ALC at baseline and 3 monthly. Tofacitinib has been associated with increases in lipid parameters, maximal effects were observed within 6 weeks. Monitoring should be performed 8 weeks after initiation and managed according to hyperlipidaemia guidelines. Increases in liver enzymes greater than 3x ULN were uncommonly reported; use caution when initiating with potential hepatotoxic medicinal products. Gastrointestinal obstruction with a non-deformable prolonged-release formulation: Caution should be used when administering tofacitinib 11 mg prolonged release tablets to patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic). Pregnancy & Lactation: Use of tofacitinib during pregnancy and breast-feeding is contraindicated. Side Effects: RA: The most common serious adverse reactions were serious infections; pneumonia, cellulitis, herpes zoster, UTIs, diverticulitis, appendicitis and opportunistic infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical studies were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension. UC: The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily were headache, nasopharyngitis, nausea, and arthralgia. Commonly reported adverse reactions (>1/100 to <1/10) across all indications were pneumonia, influenza, herpes zoster, urinary tract infection, sinusitis, bronchitis, viral upper respiratory tract infection, pharyngitis, anaemia, headache, hypertension, cough, abdominal pain, vomiting, diarrhoea, nausea, gastritis, dyspepsia, rash, arthralgia, pyrexia, peripheral oedema, fatigue, increased creatine phosphokinase. Refer to section 4.8 of the SmPC for further information on side effects, including description of selected adverse reactions. Legal Category: S1A. Marketing Authorisation Number: EU/1/17/1178/003 – 5 mg (56 film-coated tablets); EU/1/17/1178/007 – 10 mg (56 film-coated tablets); EU/1/17/1178/012 – 11 mg (28 prolonged-release tablets); EU/1/17/1178/015 1mg/mL oral solution. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com . For queries regarding product availability please contact: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, + 353 1 467 6500.

Last revised: 03/2022.

Ref: XJ 15_0.

Testing the personalities of future surgeons

Incorporating personality testing into the selection of surgical trainees needs further study

Read

by

So you’d like to be a surgeon?

The latest suggestion from medical educators and policy-makers is to use personality testing as a method to identify those most suited to being surgeons. A subliminal aim appears to be to weed-out those who might prove unable to cope with the demands of the job.

Historian Dr Agnes Arnold-Forster, writing in the online journal Psyche, referred to a long and fraught history of healthcare professionals’ “idealised or stereotyped personality traits and emotional tendencies”. “And in these stereotypes, surgeons possess some of the most obvious and culturally salient characteristics. Mostly male, authoritarian and paternalistic, the worst version of the stereotypical surgeon is volatile, insistent, even abusive — and prone to unpredictable outbursts of anger. He cuts first, asks questions later, and is never in doubt. He is good at ‘hard’ surgeries but bad at ‘soft’ skills, like compassion and communication. Academically or technically brilliant, he lacks emotional intelligence. He operates with dispassion, but occasionally his capacity for emotional detachment tips into cruelty — causing psychological harm to both himself and his patients. He is often white and, at the very least, upper middle class,” she writes.

Wow, what a devastating portrayal. Surely we have moved beyond the stereotype? Certainly surgeons of my acquaintance are good communicators; assertive, yes, but with little evidence of bombastic behaviour.

Having said that, I must own up to a fondness for Richard Gordon’s characterisation of the irascible Sir Lancelot Spratt. Spratt first appeared in Gordon’s novel Doctor in the House in 1952. The film adaptation was released in 1954 and starred Dirk Bogarde as a young medical student, and James Robertson Justice as the fearsome surgeon Spratt. A dictatorial demagogue, Spratt strode down hospital corridors dismissing the views of both his patients and his juniors.

Some of the elements mocked by Gordon are still held up as positive aspects of the surgical personality. Quick decision-making, the ability to exert authority over both patients and colleagues, and emotional discipline or self-management are all still seen by many as crucial characteristics, essential to the making of a good surgeon.

Current surgical selection and training does not translate into a settled workforce, however. In the US, the national attrition rate of general surgical residents sits at approximately 20 per cent per year — higher than any other specialty. Which is one of the reasons for the current exploration of a possible standardised, objective personality test to identify the best-fit applicants.

The most famous personality test is the Myers-Briggs Type Indicator — which is not exactly known for its reproducibility. Other personality tests are more robust. For example, the Big Five test examines personality traits in five categories: Extraversion; agreeableness; conscientiousness; emotional stability; and openness.

A 2018 study at the University of Texas looked at the relevance of the Big Five to surgical residents. Trainees were classified as either ‘low performing’ or ‘non-low performing’, and these groups were then compared with their personality test scores to see if there was any correlation between certain traits and surgical success.

This study found that non-low-performing residents (ie, the

‘good’ surgeons) scored significantly higher on certain traits — extraversion, conscientiousness, and emotional stability. The investigators concluded that the Big Five test could be a useful tool to help identify successful applicants to general surgery residency. Their research found that ‘good’ surgeons were more likely to be assertive, energetic, outgoing, efficient, organised and thorough, and less likely to be forgiving, generous, sympathetic, self-pitying or worrying.

Another study argued that personality testing indicated the existence of a ‘distinct and consistent’ ‘physician personality’. And there were ‘solid and reproducible’ differences between surgeons and other medical professionals.

But there is a sense that incorporating personality testing into the selection of surgical trainees needs further study. God forbid, but what if we homogenised the specialty to the point that we have a bunch of extroverts in every operating theatre?

The other downside to an over-reliance on personality testing in the recruitment of surgical trainees is that it ignores the role played by the culture of surgery. What does success in surgery look and feel like? To what extent might the typical surgical personality be a direct consequence of the training process? Maybe the problems in retaining surgeons have more to do with surgical culture and less to do with the characteristics of individuals.

In my estimation, answers to the attrition rate among surgeons are more likely to be found in the working environment and culture of the surgical profession. And I must agree with Dr Arnold-Forster in her conclusion: “While personality tests might have a place in surgical modernisation and diversification, they must be part of a broad ecosystem of reforms that include better mentorship, more family-friendly workplaces, greater autonomy, consequences for sexual harassment, more humane working hours, and a radical reduction in individual and institutional racism.”

Smoking, sociability and creativity

Some people reject the idea that living can entail choosing your poisons

GEORGE WINTER

Read more by George Winter at www.mindo.ie

From the darkness a click, then a flame, and finally a nimbus of light illuminating Sean Connery’s craggy features. I can’t remember the film — perhaps Dr No? But in the 1960s, when I was in short trousers, I knew that leaning against a doorframe and blowing flavoursome cigarette smoke into a Caribbean night was central to the pursuit of criminals seeking world domination.

Decades later, having read David Leigh’s contribution to The James Bond Dossier (‘James Bond: Smoking and Cigarettes’, thejamesbonddossier.com), it’s clear that instead of scaling an Alp with a fun-sized rocket launcher slung over his shoulder, Bond would have been shuffling into an emphysema clinic. Thus, “in the first chapter of  Casino Royale, he lights his seventieth cigarette of the day… and a report by the secret service Medical Officer in  Thunderball comments on his smoking sixty a day and notes that his Morland cigarettes were of a much higher nicotine content than cheaper brands.”

But in thrall to the romance of smoking, fraught negotiations with my non-smoking parents won permission to buy with my pocket money 10 ‘sweetie cigarettes’ a week. Much later, Klein et al asked this question in Pediatrics (1992, 89: 27–31): ‘Candy Cigarettes: Do They Encourage Young People to Smoke?’ found that they did, and concluded: “Elimination of these products should be part of efforts to prevent initiation of smoking by children.”

Now in long trousers — and sweetie cigarettes having

wreaked havoc on my teeth, if not my lungs — I sought the promised sophistication of brands like Peter Stuyvesant. Yes, a soothing Stuyvesant at Geneva Airport’s VIP lounge was one thing; but when it scorched one’s throat while relaxing in a vandalised cricket pavilion overlooking Belfast’s Ardoyne, it was quite another. Smoking was unpleasant, and I quit, aged about 15, with my lifetime cigarette consumption totalling around 30. Today, I enjoy smoke-free public spaces, and the health benefits of not smoking need not be rehearsed here.

Nevertheless, I was given pause for thought after reading a paper by Kearns and Fox (published online, 11 July 2022) in the journal Occupational Therapy in Mental Health, which considers ‘The Impact of Smoking Regulations on the Daily Routine of Patients Within an Irish Mental Health Setting’. Noting that in 2012, Ireland adopted as official policy the idea of a ‘tobacco-free campus’, and that an Irish inpatient mental health service (MHS) introduced a ‘smoke-free campus’ policy in 2018, the authors interviewed patients within this setting in 2019 to explore “the experiences of the smoking regulations and the potential impact on the daily routines of inpatients within a MHS.” They cite evidence that smoking within MHSs enables shared experiences with others; promotes meaningful time use; is imbued with personal meaning; may meet the needs of sensory-seeking behaviour; “and was considered a coping mechanism by the participants in this study”.

Similarly, in the Journal of Organizational Ethnography (2018, 7: 263–284) Jonrad writes persuasively about ‘Resisting the Ban’, highlighting the dilemmas in psychiatric inpatient settings, such as “the types of ethical and pragmatic issues that nurses working under a zero-tolerance smoking ban policy regime face. It also draws attention to ethical concerns that relate to the liberties of involuntary patients.”

And in a Singaporean study, when Tan investigated ‘Smok-

ing Spaces as Enabling Spaces of Wellbeing’ in the journal Health & Place (2013, 24: 173–182), while he did not wish “to systematically downplay the damaging health effects that smoking can engender, a focus on enabling smoking spaces emphasises the role of smokers as creative agents capable of (re)fashioning their own holistic and subjective versions of wellbeing”.

The author Dame Beryl Bainbridge (1932–2010) maintained that smoking was vital to her creativity, and AN Wilson, in his obituary of Bainbridge published in The Observer (4 July 2010), recalls a charity worker coming into a pub with a collecting tin for cancer research. “‘I’m sorry we’ve no small change, pet,’ she said. ‘But if it helps…’ she waved the ignited cigarette melodramatically in the air, ‘I have got cancer.’” Similarly, writer, drinker, and smoker Christopher Hitchens (1949–2011) maintained in The Guardian (14 May 2007) that smoking helped him to concentrate, recalling those “ …moments of reverie, wreathed in smoke and alone with a book, and moments of conversation, perfumed with ashtrays and cocktails and decent company, which I would not have exchanged for a year of ordinary existence.”

Today, there are those healthists who would happily deprive a mental health inpatient or a future Bainbridge and Hitchens of the opportunity to choose to knowingly risk damaging their health. Such moralising individuals long for a literary culture where the life of the mind is sustained with mineral water and wholemeal bread; they would support states like Florida to refuse a condemned man a last cigarette because the execution block is a no-smoking area; and they reject the idea that living can entail choosing your poisons.

I can’t help smiling as I imagine James Bond blowing smoke in their faces… that’s if he doesn’t succumb to a paroxysm of coughing first.

MULTIPLE CHOICE QUESTIONS

Question 1

Meibomian cyst

A. Presents at the lid margin.

B. Resolution will be speeded if topical antibiotics are used.

C. If unresolved, treatment of choice is puncturing.

D. Is associated with acne rosacea.

E. If recurrent, should alert the doctor to the possibility of sebaceous cell carcinoma.

Question 2

Question 3

Question 4

Question 5

Characteristic features of severe bronchiolitis in infants include

A. Fever with temperature above 400C.

B. Hyper-inflated chest.

C. Use of accessory muscles of respiration.

D. Basal crepitations.

E. Good response to erythromycin.

The Mirena (intrauterine progestogen) coil

A. Is effective for at least 10 years.

B. Is contraindicated if there is a history of ectopic pregnancy.

C. Is most commonly removed because of menorrhagia.

D. Recognised side-effects include breast tenderness.

E. Protects against sexually-transmitted infections.

In a patient with an indwelling catheter for long-term bladder drainage

A. Regular routine urine cultures should be taken.

B. Bathing is contraindicated.

C. No more than 10cc of water should be put into the balloon.

D. If there are no problems of blocking, a silicone catheter is the ideal choice.

E. Bypassing of urine round the catheter is an indication to increase the catheter size.

The rash of psoriasis may be aggravated or triggered by

A. Increased alcohol consumption.

B. Sunlight.

C. Cigarette smoking.

D. Anti-inflammatory drugs.

E. Streptococcal throat infection.

ESC for

treatment

patients with heart failure (HF)1

iron deficiency (ID)

Check all patients with HF regularly for anaemia and ID1

1.

2. Consider treatment with Ferinject®

symptomatic patients with ID and LVEF<45% and patients recently hospitalised for HF with ID and LVEF<50%1

Want to find out more? Scan the QR code to download the guidelines

Ferinject® (ferric carboxymaltose)

Prescribing Information - Ireland

For full prescribing information refer to the Summary of Product Characteristics (SmPC)

Active ingredient: Ferric carboxymaltose (50mg/mL)

Presentation: Solution for injection/infusion. Available as a 10mL vial (as 500mg of iron) and 20mL vial (as 1000mg of iron). Indication: Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used or if there is a clinical need to deliver iron rapidly. The diagnosis must be based on laboratory tests.

Dosage and Administration: The posology of Ferinject follows a stepwise approach:

Step 1: Determination of the iron need;

The individual iron need for repletion using Ferinject is determined based on the patient’s body weight and haemoglobin (Hb) level. The table in the SmPC should be used to determine the iron need.

Step 2: Calculation and administration of the maximum individual iron dose(s);

Based on the iron need determined, the appropriate dose(s) of Ferinject should be administered:

A single Ferinject administration should not exceed:

• 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)

The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL Ferinject) per week.

Administration rates for intravenous injection:

For iron doses of 100mg to 200mg, there is no prescribed administration time. For doses >200mg to 500mg, Ferinject should be administered at a rate of 100mg iron/min. For doses >500mg to 1,000mg, the minimum administration time is 15 min.

Administration of intravenous drip infusion:

For iron doses of 100mg to 200mg, there is no prescribed administration time. For doses >200mg to 500mg, Ferinject should be administered in a minimum of 6 mins. For doses

3. Repeat monitoring

checks at the next scheduled visit and then 1–2 times per year2

>500mg to 1,000mg, the minimum administration time is 15 mins.

Ferinject must be diluted in 0.9% m/V NaCl but not diluted to concentrations less than 2 mg iron/mL.

Step 3: Post-iron repletion assessments

Contraindications: Hypersensitivity to Ferinject or any of its excipients. Known serious hypersensitivity to other parenteral iron products. Anaemia not attributed to iron deficiency. Iron overload or disturbances in utilisation of iron. Special warnings and precautions: Parenterally administered iron preparations can cause potentially fatal anaphylactic/ anaphylactoid reactions. The risk is enhanced for patients with known allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune or inflammatory conditions. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). Ferinject should only be administered in the presence of staff trained to manage anaphylactic reactions where full resuscitation facilities are available (including 1:1000 adrenaline solution). Each patient should be observed for 30 minutes following administration. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention has been reported. Patients should be asked to seek medical advice if they experience symptoms. Serum phosphate should be monitored in patients who receive multiple administrations at higher doses or long-term treatment, and those with existing risk factors. In case of persisting hypophosphataemia, treatment with ferric carboxymaltose should be re-evaluated. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Careful monitoring of iron status is recommended to avoid iron overload. There is no safety data on the use of single doses of more than 200mg iron in haemodialysis-dependent chronic kidney disease patients. Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies.

It is recommended that treatment with Ferinject is stopped in patients with ongoing bacteraemia. In patients with chronic

infection a benefit/risk evaluation has to be performed. Caution should be exercised to avoid paravenous leakage when administering Ferinject.

Special populations: A single maximum daily dose of 200 mg iron should not be exceeded in haemodialysisdependent chronic kidney disease patients. The use of Ferinject has not been studied in children. A careful risk/ benefit evaluation is required before use during pregnancy. Ferinject should not be used during pregnancy unless clearly necessary and should be confined to the second and third trimester. Foetal bradycardia may occur during administration of parenteral irons, as a consequence of hypersensitivity. The unborn baby should be carefully monitored during administration to pregnant women. Undesirable effects: Common (≥1/100 to <1/10): Hypophosphataemia, headache, dizziness, flushing, hypertension, nausea, injection/infusion site reactions. Rare (≥1/10,000 to <1/1,000): Anaphylactoid/ anaphylactic reactions. Frequency not known: Kounis syndrome, hypophosphataemic osteomalacia. Please consult the SmPC in relation to other undesirable effects.

Legal category: POM

MA Number: PA0949/004/001

Date of Authorisation: 19.07.2007

MA Holder: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

Ferinject® is a registered trademark

Document number: IE-FCM-2200020

Date of preparation: 02/2022

Additional information is available on request

Adverse events should be reported. Reporting forms and information can be found at: https://www.hpra.ie/.

Adverse events should also be reported to Vifor Pharma UK Ltd. Tel: +44 1276 853633. Email: medicalinfo_UK@viforpharma.com

Ferinject® is recommended by the

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Iron deficiency anaemia I

ron 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. Iron deficiency in the absence of anaemia occurs more frequently. Particularly affecting growing children, premenopausal and pregnant women, IDA is increasingly a clinical condition that can also affect older people and those with chronic conditions. Several chronic diseases are frequently associated with IDA, notably chronic kidney disease, chronic heart failure, cancer, and inflammatory bowel disease.

Anaemia can be defined as a haemoglobin (Hb) concentration below the lower limit of normal for the relevant population and laboratory performing the test. 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. 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. Globally, IDA has medical and social impacts, accounting for impairment of cognitive performance in young children, adverse outcomes of pregnancy for both mothers and newborns, decreased physical and working capacities in adults, and cognitive decline in older people.

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. 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. 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.

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.

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. 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.

Pathophysiology

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.

Iron does not have an excretion regulation pathway, and dietary intake, intestinal absorption, and iron recycling have to be finely regulated.

Dietary iron is available in two forms; haem, and nonhaem 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 nonhaem 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.

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. Hepcidin is a naturally-occur-

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.

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). Regular blood donors are also at increased risk of iron deficiency. 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. Anaemias caused by genetic defects are a large group of rare, heterogeneous disorders that include haemolytic anaemias, and anaemias arising from mutations in genes that control duodenal iron absorption. A ferritin deficiency can deplete iron stores quickly and lead to IDA.

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.

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 (SF), iron, total iron-binding capacity, and/ or transferrin. 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. 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.

ring protein, secreted by the liver. It acts as a regulatory 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.

Risk factors

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 requirement. Daily iron supplementation is significantly associated with reduced risk of anaemia at term.

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

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.

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.

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. 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.

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.

Symptoms of IDA include lethargy, fatigue, dizziness, shortness of breath, palpitations, and pale skin

Treatment and management

The treatment of IDA aims to restore normal circulating Hb levels, replenish body iron stores, and improve quality-of-life and physiological function.

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. 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 two-week time frame) in anaemic patients is highly suggestive of absolute iron deficiency, even if the results of iron studies are equivocal.

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.

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. 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.

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. 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. 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.

Intravenous iron

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 issues. 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.

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. 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.

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. 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 are similar for oral and parenteral iron preparations. Hypophosphataemia has been reported with all parenteral iron preparations. This relates to the molecules complexed to the iron, rather than the iron itself.

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 inflammatory bowel disease, it is the associated comorbidity which accounts for the improved cost-effectiveness of intravenous iron in these circumstances.

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.

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). Iron in the diet comes in two forms: Haem iron, and non-haem 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.

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. Iron deficiency in the elderly has many potential contributory causes, including poor diet, reduced iron absorp-

tion, 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. 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, among all healthcare professionals in secondary and primary care settings. Primary care healthcare providers, especially GPs and general practice nurses (GPNs), play a pivotal 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.

References on request

doctorCPD.ie

To complete this module and earn free CPD points, go to www.doctorCPD.ie and answer the 10 true or false questions and complete the five MCQs based on this article.

Chronic kidney disease C

CKD is usually insidious, develops slowly over time, and most people affected are asymptomatic until the disease becomes advanced

hronic kidney disease (CKD) is a progressive renal disorder that commonly occurs in the adult population, especially in those with hypertension and diabetes. There is no cure, and the condition is associated with high morbidity and mortality rates.1 Approximately 10 per cent of adults globally are affected by some form of CKD, which results in 1.2 million deaths and 28 million years of life lost annually.2,3 CKD affects an estimated 1:10 people in the whole population, and over 500 people in Ireland develop kidney failure every year.8 By 2040, it is estimated that CKD will become the fifth leading cause of death globally.4

CKD is defined as a reduction in kidney function, with estimated glomerular filtration rate (eGFR) of <60mL/min per 1.73m², or markers of kidney damage, such as albuminuria, haematuria, or abnormalities detected through laboratory testing or imaging, and that are present for at least three months.1

CKD is usually insidious, develops slowly over time, and most people affected are asymptomatic until the disease becomes advanced (eGFR <30mL/min per 1.73 m²).8 The rate of kidney function loss varies by aetiology, exposures, and interventions but, in most cases, progression to kidney failure takes between months and decades to develop. Signs and symptoms of kidney failure result from progressive uraemia, anaemia, volume overload, electrolyte abnormalities, mineral and bone disorders, and acidaemia, and lead to death if left untreated.1 Kidney function can decline gradually over several years, or rapidly over several months. In some people, kidney function can drop so low that dialysis treatment or a kidney transplant will be required; ie, end stage kidney disease (ESKD). 9

For individuals with established CKD, addressing complications, associated comorbidities and managing symptoms in addition to protecting kidney function are important steps. Slowing the progression of CKD can be achieved through a range of lifestyle, dietary, and pharmacological strategies, which include weight loss, moderate dietary protein restriction, blood pressure and glucose control, and renin-angiotensin-aldosterone system blockade. Cardiovascular disease is a leading cause of death in patients with CKD, and is a major focus of preservative care in this population.1

Diabetes, which affects more than 250,000 people in Ireland, is one of the leading causes of CKD. Diabetes Ireland highlights the importance of screening for CKD in diabetes patients. Diabetes check-ups include the routine monitoring of kidney function so that changes can be detected early.8

CKD risk factors and aetiology

Risk factors for CKD include older age (>50 years), low birth weight, obesity, smoking, high blood pressure, diabetes, a family history of kidney disease, being of African-American decent, and long-term use of over the counter medications. Both genomic and environmental factors contribute to this complex heterogeneous disease, and CKD heritability is estimated to be high at 30–75 per cent. There is a higher incidence and prevalence of CKD in women than men, however, women have a lower risk of CKD progression, and men are more likely to develop ESKD.

The most common causes of CKD are diabetes (type 1 and type 2) and hypertension. Other causes include primary glomerulonephritis, chronic tubulointerstitial nephritis; hereditary or cystic diseases, secondary glomerulonephritis or vasculitis and plasma cell dyscrasias or neoplasm. Autoimmune diseases, such as lupus, can damage blood vessels and make antibodies against kidney tissue. In addition to known causes, CKD can also be idiopathic.1,6

CKD may result from disease processes in any of the three categories: prerenal – decreased renal perfusion pressure; intrinsic renal – pathology of the vessels, glomeruli, or tubules and interstitium; or postrenal – obstructive.5

Chronic prerenal disease occurs in patients with chronic heart failure or cirrhosis with persistently decreased renal perfusion, which increases the tendency for multiple episodes of an intrinsic kidney injury, such as acute tubular necrosis (ATN). This leads to progressive loss of renal function over time.5

Intrinsic occurs when direct damage to the kidneys causes a sudden loss in kidney function. The most common chronic renal vascular disease is nephrosclerosis, which causes chronic damage to blood vessels, glomeruli, and tubulo/interstitium. The other renal vascular diseases are renal artery stenosis from atherosclerosis or fibro-muscular dysplasia, which over months or years cause ischaemic nephropathy, characterised by glomerulosclerosis and tubulointerstitial fibrosis.5 Chronic obstruction may be due to prostatic disease, nephrolithiasis or abdominal/pelvic tumour with mass effect on ureter(s). Retroperitoneal fibrosis is a rare cause of chronic ureteral obstruction.5

Signs and symptoms

Kidney disease tends not to cause symptoms at the early stage, therefore routine screening using urine and blood

tests is important. Symptoms develop over time and can include weight loss, anorexia, oedema of the ankles, feet and hands, dyspnoea, fatigue, nocturia, haematuria, nausea, headaches, muscle cramps, headaches, and erectile dysfunction in men.7

Diagnosis

A thorough medical history, physical examination and investigative tests are required to form a diagnosis for CKD. Early CKD stages are usually asymptomatic, and symptoms manifest in stages 4 or 5. The ICGP has a useful guidance document (Chronic Kidney Disease: Diagnosis and management in primary care) on CKD for GPs.14

CKD is typically identified through routine screening with blood serum chemistry profile (serum creatinine concentration should be measured, allowing calculation of eGFR) and urinalysis (ACR-albumin: creatinine ratio) or as an incidental finding. Urine dipstick is first performed, and is a useful screening tool although it only provides a semi-quantitative assessment of level of proteinuria, as the reported value can vary according to the hydration status of the patient. Spot urine sample is sent to the laboratory to measure protein/albumin to creatinine ratio. This will detect even small levels of proteinuria and is essential for diagnosis, but is not useful for routine follow-up of patients who already have established macroalbuminuria. At the same time, a midstream urine specimen (MSU) should be sent for culture to exclude urinary tract infection. The eGFR is a useful and accurate measure of renal function, and is calculated using serum creatinine as well as the variables of age, gender and race. In the following circumstances, however, eGFR may not be accurate: Acute renal failure; patients less than 18 years of age; patients with advanced muscle wasting and amputations; and pregnancy.14

Less commonly, patients may present with symptoms such as gross haematuria, foamy urine, nocturia, flank pain, or decreased urine output. If CKD is advanced, patients may report fatigue, poor appetite, nausea, vomiting, metallic taste, unintentional weight loss, pruritus, changes in mental status, dyspnoea, or peripheral oedema.12

In assessing a patient, additional symptoms that might suggest a systemic cause such as haemoptysis, rash, lymphadenopathy, hearing loss, neuropathy; or urinary obstruction such as hesitancy, urgency, frequency or incomplete bladder emptying should be enquired about. Patients should be assessed for risk factors of kidney disease including prior exposure to potential nephrotoxins such as non-steroidal anti-inflammatory drugs (NSAIDs); antibiotic therapies such as gentamicin and chemotherapies; history of nephrolithiasis or recurrent urinary tract infections; the presence of comorbidities; family history of kidney disease; and other known genetic risk factors.12

A detailed physical examination may provide additional information regarding the underlying cause of CKD. Signs of volume depletion may reflect poor oral intake, vomiting, diarrhoea, or over diuresis, whereas signs of volume overload may be due to decompensated heart failure, liver failure, or nephrotic syndrome. The presence of arterial-venous nicking or retinopathy on retinal examination suggests long-standing hypertension or diabetes. Patients with carotid or abdominal bruits may have renovascular disease. Flank pain or enlarged kidneys should prompt consideration of obstructive uropathy, nephrolithiasis, pyelonephritis, or polycystic kidney disease. Neuropathy may be due to diabetes or less commonly vasculitis, or amyloidosis. Skin findings may include rash, palpable purpura, telangiectasias, or extensive sclerosis. Patients with advanced CKD may exhibit pallor, skin excoriations, muscle wasting, asterixis, myoclonic jerks, altered mental

status, and pericardial rub.12

Other diagnostic investigations carried out may include an ultrasound, MRI or CT scan and a biopsy. Once a diagnosis of CKD has been established, the next step is to determine staging.

Stages and classification of CKD

The stages of CKD range from 1-5. Most patients who are diagnosed as having stage 1, 2 or 3, have mild-to-moderate kidney disease and usually do not progress to ESKD. Once stage 4 is reached, damage is more severe and is usually not reversible. Dialysis or a kidney transplant may be required.9 A patient is considered to have CKD if they have abnormalities of kidney function or structure present for more than three months. The definition of CKD includes all individuals with markers of kidney damage or those with an eGFR of less than 60ml/min/1.73m 2 on at least two occasions, 90 days apart with or without markers of kidney damage. Markers of kidney disease may include: Albuminuria (ACR >3mg/mmol), haematuria (presumed or confirmed renal origin), electrolyte abnormalities due to tubular disorders, renal histological abnormalities, structural abnormalities detected by imaging (eg, polycystic kidneys, reflux nephropathy), or a history of kidney transplantation.11

CKD is classified based on the eGFR and the level of proteinuria and helps to risk stratify patients. Patients are classified as G1-G5, based on the eGFR, and A1-A3 based on the ACR albumin: Creatinine ratio.11

CKD stages include:11

 G1: GFR 90ml/min per 1.73 m2 and above.

 G2: GFR 60 to 89ml/min per 1.73m2.

 G3a: GFR 45 to 59ml/min per 1.73m2

 G3b: GFR 30 to 44ml/min per 1.73m2

 G4: GFR 15 to 29ml/min per 1.73m2

 G5: GFR < 15ml/min per 1.73m 2 or treatment by dialysis

The three levels of albuminuria include albumin-creatinine ratio (ACR):11

 A1: ACR less than 3mg/mmol (normal to mild).

 A2: ACR 3 to 30mg/mmol (moderately increased).

 A3: ACR greater than 30mg/mmol (severely increased).

Example: A person with an eGFR of 25ml/min/1.73m2 and an ACR of 15mg/mmol has CKD G4A2, and a person with an eGFR of 50ml/min/1.73m2 and an ACR of 35mg/mmol has CKD G3aA3. It is important to note that patients with an eGFR of >60ml/min/1.73m2 should not be classified as having CKD unless they have other markers of kidney disease. GFR category G2 may be over-diagnosed by eGFR because equations used to estimate GFR may give falsely low results in people with near-normal function.11

Treatment and management

There is no cure for CKD, but treatment and management can help relieve the symptoms and improve the patient’s quality of life. Treatment options and prognosis will depend on the stage of CKD. Lifestyle measures include stopping smoking, a healthy diet, restricted salt intake of less than 6g (<100mmol) per day, regular exercise, manage/ limit alcohol intake, following recommended guidelines, and avoiding over the counter NSAIDs, such as ibuprofen, unless advised by a medical professional.13

The main goals of management of CKD are to reduce overall cardiovascular risk, delay progression to renal failure and avoid complications.14 Regular reviews are recommended and should include blood pressure measurement, assessment of kidney function, review of all medications, and immunisation with influenza vaccine and pneumococcal vaccine, in addition to lifestyle advice regarding smoking, reduced salt intake and weight loss. Anaemia is common in more advanced disease and a target of 10–11.5gm/dL should be sought. If the haemoglobin is low, non-renal causes should be excluded. Management of ‘renal’ anaemia can include the provision of iron and the use of erythropoiesis stimulating agents. Regular review of medication is important to minimise nephrotoxic drugs particularly NSAIDs, and ensure doses of others are appropriate to renal function. Metformin should be avoided in patients with CKD stage G4 and G5.14,15

Risk factors for the development of CKD, such as hypertension and diabetes mellitus, should be specifically targeted. Cardiovascular complications can be reduced by attention to smoking cessation, weight loss, regular aerobic exercise, thrombotic risk, and treatment of hypercholesterolemia. Aspirin treatment should be considered for all patients with an estimated 10-year risk of cardiovascular disease of >20 per cent, so long as blood pressure is <150/90 mmHG.14 Patients with established macrovascular disease should receive treatment for hyperlipidaemia according to the current European Society of Cardiology (ESC) guidelines. Patients with diabetes and CKD but no established macrovascular disease should be offered lipid-lowering drug treatment according to the current ESC guidelines. Patients with CKD who do not have diabetes and who do not have established macrovascular disease should be

offered the option of lipid-lowering treatment according to the current ESC guidelines, if the estimated 10-year risk of cardiovascular disease is >20 per cent.14

Management of CKD patients with diabetes mellitus and microalbuminuria or proteinuria include continued efforts to achieve good glycaemic control (HbA1c 6.5–7.5 per cent, 48–58mmols/mol); prescription of an angiotensin-converting enzyme inhibitor (ACEI) (or angiotensin receptor blocker (ARB) in the presence of a firm contraindication to ACEI), titrated to full dose, followed by addition of other antihypertensive drugs in combination to reach the blood pressure goal of 130/80;23 measurement of eGFR and PCR at least once a year; referral to a nephrologist if there is in-

BRING PROTECTION TO LIFE

BY REDUCING THE RISK OF THE COMPOSITE OF DECLINING KIDNEY FUNCTION, ESKD, AND RENAL OR CV DEATH*1

FORXIGA is now approved for adult patients with CKD.2

treatment GFR

FORXIGA 10 mg

Once daily No titration required

Applicable for CKD, HFrEF, or T2D.2

*In DAPA-CKD, the primary endpoint showed that FORXIGA in conjunction with other CKD therapies reduced the relative risk of the composite endpoint of ≥50% sustained decline in eGFR, reaching ESKD, and renal or CV death by 39% (5.3% ARR) vs placebo with other CKD therapies in 4304 adult patients with CKD with an eGFR of 75 to 25 mL/ min/1.73m2 (median follow-up of 2.4 years; p<0.001).1 DAPA-CKD was stopped early due to efficacy benefit, because of the unplanned early stop, this secondary endpoint is considered nominally significant; Secondary endpoints showed that FORXIGA in conjunction with other CKD therapies reduced the relative risk of the composite of CV death or hHF by 29% (1.8% ARR: nominal p=0.009) and also reduced the relative risk of all-cause mortality by 31% (2.1% ARR; nominal p=0.004) vs placebo with other CKD therapies. There were comparable rates of the individual component of CV death, FORXIGA vs placebo (3.0% vs 3.7%; HR 0.81; 95% CI, 0.58, 1.12)1 ©AstraZeneca 2022. All Rights Reserved.

ABRIDGED PRESCRIBING INFORMATION

FORXIGA® (dapagliflozin) 5MG & 10MG FILM-COATED TABLETS.

Consult Summary of Product Characteristics (SmPC) before prescribing.

Indications: Adults and children aged 10 years and above: Type 2 diabetes mellitus: For the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance, or in addition to other medicinal products for the treatment of type 2 diabetes. Adults: Heart Failure: Indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease: Indicated in adults for the treatment of chronic kidney disease.

Presentation: Film-coated tablets. 5mg or 10mg of dapagliflozin (as propanediol monohydrate). Each 5mg tablet contains 25mg of lactose. Each 10mg tablet contains 50mg of lactose.

Dosage and Administration: Adults: Type 2 diabetes mellitus: The recommended dose is 10mg once daily. Consider a lower dose of insulin or insulin secretagogue such as a sulphonylurea when used in combination with dapagliflozin to reduce the risk of hypoglycaemia. Children and adolescents: No dose adjustment in children aged 10 years and above. No safety and efficacy data available for children below 10 years of age. Heart Failure: The recommended dose is 10mg once daily. Chronic kidney disease: The recommended dose is 10 mg once daily. Children and adolescents: <18 years: Safety and efficacy not yet established.

Elderly: ≥65 years: No dose adjustment is recommended based on age. Renal impairment: No dose adjustment is required based on renal function. Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. If GFR falls below 45 mL/min, additional glucose lowering treatment should be considered in patients with diabetes mellitus if further glycaemic control is needed. Mild or moderate hepatic impairment: No dose adjustment. Severe hepatic impairment: Starting dose of 5mg is recommended, if well tolerated, dose may be increased to 10mg. Method of administration: Forxiga can be taken orally at any time of day with or without food. Tablets should be swallowed whole.

Contraindications: Hypersensitivity to dapagliflozin, or excipients.

Warnings and Precautions: Renal impairment: Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. The glucose lowering efficacy of dapagliflozin is dependent on renal function, and is reduced in patients with GFR < 45 mL/min and is likely absent in patients with severe renal impairment. Hepatic impairment: Exposure is increased in patients with severe hepatic impairment. Use in patients at risk of volume depletion and/or hypotension: Dapagliflozin increases diuresis which may lead to a modest decrease in blood pressure, it may be more pronounced in patients with very high blood glucose concentrations. Exercise caution in patients for whom a dapagliflozin induced drop in blood pressure could pose a risk, such as patients on anti hypertensive therapy with a history of hypotension or elderly patients. Careful monitoring of volume status and electrolytes is recommended in conditions leading to volume depletion, such as acute gastrointestinal illness. In volume depleted patients temporary interruption of dapagliflozin is recommended until volume depletion is corrected. Diabetic ketoacidosis (DKA):

Rare cases of DKA, including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin. In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14mmol/L (250mg/dL). The risk of DKA must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level. In patients where DKA is suspected or diagnosed, dapagliflozin treatment should be stopped immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised. Before initiating dapagliflozin, factors in patient history that may predispose to ketoacidosis should be considered. Patients who may be at higher risk of DKA include patients with a low beta cell function reserve (e.g. patients with low C peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse. SGLT2 inhibitors should be used with caution in these patients. Restarting SGLT2 inhibitor treatment in patients experiencing a DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved. Dapagliflozin should not be used for treatment of patients with type 1 diabetes. Necrotising fasciitis of the perineum (Fournier’s gangrene): Postmarketing cases have been reported in female and male patients taking SGLT2 inhibitors. Urgent surgical intervention and antibiotic treatment is required. Advise patients to seek medical attention if they experience a combination of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Either uro-genital infection or perineal abscess may precede necrotising fasciitis. If suspected, discontinue Forxiga and institute prompt treatment (including antibiotics and surgical debridement). Urinary tract infections: Temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis. Elderly (≥65 years): Elderly patients are more likely to have impaired renal function, be treated with medicines such as anti-hypertensives or diuretics, and be at a greater risk of volume depletion. Cardiac failure: Experience with dapagliflozin in NYHA class IV is limited. Chronic kidney disease: There is no experience with dapagliflozin for the treatment of chronic kidney disease in patients without diabetes who do not have albuminuria. Patients with albuminuria may benefit more from treatment with dapagliflozin. Lower limb amputations: Counsel patients with diabetes on routine preventative foot care as an increase in cases of lower limb amputation (primarily of the toe) has been observed in long term, clinical studies in type 2 diabetes mellitus with SGLT2 inhibitors. Urine laboratory assessments: Patients will test positive for glucose in the urine due to mechanism of action. Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Forxiga.

Drug Interactions: Diuretics: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues: Consider a lower dose of insulin or insulin secretagogue when used in combination with dapagliflozin to reduce the risk of hypoglycaemia. Interference with 1,5 AG assay: Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5 AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors. Alternative methods should be used.

Pregnancy and Lactation: Not recommended during the second and third trimesters of pregnancy. Treatment should be discontinued when pregnancy is detected. Do not use whilst breast-feeding.

Ability to Drive and Use Machines: Alert patients on the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea or insulin.

Undesirable Events: Consult SmPC for full list of side effects. Very common (≥1/10): Hypoglycaemia (when used with SU or insulin). Common (≥1/100 to <1/10): Vulvovaginitis, balanitis and related genital infections, urinary tract infection, dizziness, rash, back pain, dysuria, polyuria, haematocrit increased, creatinine renal clearance decreased during initial treatment, dyslipidaemia. Uncommon (≥1/1,000 to < 1/100): Fungal infection, volume depletion, thirst, constipation, dry mouth, nocturia, vulvovaginal pruritus, pruritus genital, blood creatinine increased during initial treatment, blood urea increased, weight decreased. Rare (≥ 1/10,000 to < 1/1,000): Diabetic ketoacidosis (when used in type 2 diabetes mellitus).

Very Rare (< 1/10,000): Angioedema, necrotising fasciitis of the perineum (Fournier’s gangrene).

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

Marketing Authorisation Number: EU/1/12/795/002; EU/1/12/795/007.

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 71 00.

FORXIGA is a trademark of the AstraZeneca group of companies.

Date of API preparation: 11/2021 Veeva ID: IE-3322

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

References:

1. Heerspink HJL et al. N Engl J Med. 2020;383(15):1436–1446.

2. FORXIGA 10 mg film-coated tablets. Summary of product characteristics.

CKD = chronic kidney disease; CV = cardiovascular; DAPA-CKD = Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease; ESKD = end-stage kidney disease; hHF = hospitalisation for heart failure; HR = hazard ratio. HFrEF = heart failure with reduced ejection fraction; T2D = type 2 diabetes

Continued from p32 ▸

creasing proteinuria; and consideration of dietary protein restriction for patients with type 1 diabetes.14

Most patients with mild-to-moderate CKD will not require dialysis and can be managed in primary care. Appropriate management of patients in primary care has the potential to reduce overall cardiovascular risk and delay progression to renal failure.

New treatments: The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin is a promising treatment for certain people with CKD, which has the potential to

increase the length of time before the disease worsens. Dapagliflozin was approved in the European Union (EU) in 2021 for the treatment of CKD in adults with and without type-2 diabetes (T2D). Adding dapagliflozin to current standard care in CKD has been shown to significantly reduce the risk of having declining kidney function, ESKD, or dying from causes related to the kidneys or cardiovascular system. In the UK, NICE has recommended dapagliflozin as an option for treating some adults with CKD.16,17 Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR <25mL/min.18

For a small proportion of people with CKD, the kidneys

Acute pain in primary care and community settings

Author: Eamonn Brady MPSI, pharmacist, Whelehans Pharmacies,

and Clonmore, Mullingar.

will eventually stop working. This usually happens gradually. Options for people at this stage include dialysis (haemodialysis or peritoneal dialysis), and an alternative to dialysis for people with severely reduced kidney function is a kidney transplant. Transplant is often the most effective treatment for advanced kidney disease, but requires a donor and involves major surgery and the need for immunosuppressant medication for the rest of the patient’s life. Survival rates for kidney transplant patients are very good.13

Help and support

The Irish Kidney Association (IKA) (https://ika.ie/ ) has been supporting patients with CKD and ESKD in Ireland since 1978. They are dedicated to meeting the needs of patients and their families and carers, living with or likely to be affected by end stage renal disease. The IKA has a network of 25 branches across the country that are supported by volunteers. 9

References

1. Kalantar-Zadeh K, Jafar T, Nitsch D, Neuen B, Perkovic V. (2021). Chronic kidney disease. Lancet 398: 786–802. Available at: www.thelancet. com/action/showPdf?pii=S0140-6736%2821%2900519-5

2. Bikbov B, Purcell C, Levey A, et al. (2020). Global, regional, and national burden of chronic kidney disease, 1990–2017: A systematic analysis for the global burden of disease study 2017. Lancet 2020; 395: 709–33

3. Xie, Y, Bowe B, Mokdad A, et al. (2018). Analysis of the global burden of disease study highlights the global, regional, and national trends of chronic kidney disease epidemiology from 1990 to 2016. Kidney Int 2018; 94: 567–81

4. Foreman K, Marquez N, Dolgert A, et al. (2018). Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: Reference and alternative scenarios for 2016–40 for 195 countries and territories. Lancet 2018; 392: 2052–90

5. Vaidya S, Aeddula N. (2021). Chronic renal failure. StatPearls Publishing. Available from: www.ncbi.nlm.nih.gov/books/ NBK535404/

6. Cockwell P, Fisher L. (2020). The global burden of chronic kidney disease. Lancet. 2020; 395: 662-664

7. NHS (2019). Chronic Kidney Disease. National Health Service. Available at: www.nhs.uk/conditions/kidney-disease/symptoms/

8. Mellotte G, Moore C, Clinch T. (2022). Pharmacy supports kidney disease screening. Irish Pharmacy News. Vol 14; Issue 4; pp 26; April 2022

9. IKA. (2022). What is chronic kidney disease? Irish Kidney Association. Available at: https://ika.ie/kidneyhealth/

10. Diabetes Ireland (2022). Diabetes and kidney disease. Available at: www.diabetes.ie/diabetes-and-kidney-disease/

11. UKKA. (2022). CKA Stages. UK Kidney Association. Available at: https://ukkidney.org/health-professionals/informationresources/uk-eckd-guide/ckd-stages

12. Chen T, Knicely D, Grams M. (2019). Chronic kidney disease diagnosis and management: A review.  JAMA , 322(13), 1294–1304. doi:10.1001/jama.2019.14745

13. NHS (2019). Treatment chronic kidney disease.National Health Service. Available at: www.nhs.uk/conditions/kidneydisease/treatment/

14. Glynn L. (2016). Chronic kidney disease: Diagnosis and management in primary care. ICGP. Quality in Practice Committee. Available at: www.icgp.ie/go/library/catalogue/item/73877022BC62-6AFE-22F01E0145ADCB19/

15. UKKA (2022). CKD Stages G4 and G5. UK Kidney Association. Available at: https://ukkidney.org/health-professionals/ information-resources/uk-eckd-guide/ckd-stages-g4-and-g5

16. NHS (2022). NICE recommend dapagliflozin for people with chronic kidney disease. Available at: www.nice.org.uk/news/ article/nice-recommend-dapagliflozin-for-people-with-chronickidney-disease

17. NICE (2021). Chronic kidney disease: Assessment and management. NICE Guideline NG203. Available at: www.nice.org. uk/guidance/ng203

18. Medicines.ie (2021). Forxiga 5mg film-coated tablets/Forxiga 10mg film-coated tablets. Summary of product characteristics last updated on medicines.ie: 22/11/2021. Available at: w ww. medicines.ie/medicines/forxiga-5-mg-10-mg-film-coatedtablets-34715/spc

School of Medicine, Trinity College Dublin, commencement ceremony,10 June 2022

Diabetes and MSCs –connecting the dots

Attendees at UCD’s Charles Institute Seminar Series heard a presentation by Prof Timothy O’Brien on translational research into mesenchymal stromal cells and its potential for wound-healing in diabetes

The Charles Institute, Ireland’s national dermatology research and education centre, hosts a range of guest speakers who cover a variety of topics ranging from skin cancer to psoriasis, among many others. The series, which is sponsored by RELIFE (part of the A.Menarini group), is designed to provide expert advice from a range of distinguished national and international experts in their respective fields and is chaired by Prof Desmond Tobin, Full Professor of Dermatological Science at UCD School of Medicine and Director of the Charles Institute of Dermatology. The seminars are broadcast to attendees with a special interest in dermatology and cutaneous science in other locations, who access the talks remotely via an audio-visual link.

The seminars are held using a hybrid model, combining in-person attendance with interactive online access.

Attendees heard a presentation by Prof Timothy O’Brien of National University of Ireland Galway, who presented on the topic, ‘Therapeutic Potential for Mesenchymal Stromal Cells for Diabetic Complications: Translational Pathway in the EU and Manufacturing Considerations’. Among a range of other distinctions, Prof O’Brien was on faculty at the Mayo Clinic in the US until his return to Ireland in 2001, when he became Established Professor of Medicine and Consultant Endocrinologist in Galway. He is also responsible for establishing the Regenerative Medicine Institute (REMEDI) and is founder-Director of Orbsen Therapeutics and has led on EU consortia that have resulted in early-stage clinical trials.

Prof O’Brien has undertaken pre-clinical research into the use of mesenchymal stromal cells (MSCs) in complications related to diabetes mellitus, with a view to using these data in regulatory submissions for early-stage trials. He focused his talk on the translational aspects of MSCs and outlined the pathway from pre-clinical research, to regulatory submissions and early-stage trials, with an emphasis on cell manufacturing and EU regulations.

Capacity

Prof O’Brien provided an overview of the isolation and culture of MSCs, including adherence to the culture dish, and MSCs’ mechanism of action. MSCs have the capacity to become bone, cartilage or fat because of their differentiation capacity, said Prof O’Brien. However, MSCs also act through paracrine mechanisms via the secretion of healing and reparative substances.

He provided an overview of the manu-

facturing process for MSCs and presented Phase 1b clinical research results on intramuscular autologous MSC delivery in patients with critical limb ischaemia with no option for revascularisation. “In terms of macrovascular complications, I can say that this is safe, with no evidence of treatment-related adverse events,” Prof O’Brien told the seminar. “There were karyotypic abnormalities in the cells obtained from three out of the eight patients, although there were difficulties in expanding to the required numbers of cells. While there was a small number of patients, there is a trend towards improvement in rest pain, with some having pain resolution from a state of opiate dependence.”

Pain relief is observed in many MSC studies, including studies on osteoarthritis undertaken by his colleague at REMEDI, Prof Frank Barry. “We are going to look at what are the factors secreted by these cells that could be modulating pain,” said Prof O’Brien. Another noteworthy observation was the delay in cell administration in this autologous trial due to the need to grow the cells after the patient presents with CLI. “As some patients had disease deterioration while waiting for cell expansion, allogenic approaches for CLI may be more suitable.”

surface density, length density, and radial diffusion.” The wound-conforming matrix, he explained, is a GMP-grade collagen manufactured in Scotland. A phase 1b clinical trial has been undertaken, with results due to be published in the journal Stem Cell Research and Therapy

His group are currently collaborating on the development of cell culture conditions using macromolecular crowding with Prof Dimitrios Zeugolis at the Charles Institute. “We have identified that MV carrageenan is a functional crowder for hUC-MSC culture, and determined the optimimal conditions to enhance extracellular matrix deposition,” Prof O’Brien observed. “The hU-MSCs captured with 50µg/ml MV carrageenan significantly increased the ECM (collagen type I, III, IV, laminin and fibronectin) deposition and maintained the cell viability, proliferation and metabolic activity.

“50µg/ml MV carrageenan did not change the expression of MSC surface markers and immune phenotype markers after three days in culture, and we plan to study this technique in vivo,” he added.

Challenges

He also briefly described the REDSTARR study, which used rabbit models to look at whether MSC/stromal cells can safely treat six diabetic complications. “We found that wounds in this study treated with human CD362+ MSCs [mixed with a three-dimensional wound conforming matrix] showed an increased percentage of wound closure when compared with untreated wounds or matrix-treated wounds alone,” Prof O’Brien told the attendees. “In the present REDSTARR study, increased blood vessel formation was observed within the wound bed in the wound-conforming matrix/CD362+ cell treatment and the wound-conforming matrix groups alone. The beneficial effects included improved wound-closure, better

In cell therapy for wound-healing, Prof O’Brien told the seminar that hUC-derived MSCs have low immunogenicity in clinical application, and secrete growth factors and cytokines with anti-inflammatory and anti-fibrotic effects. However, he also outlined the challenges in establishing a pre-clinical model of wound healing. These include: Healing by contraction in some pre-clinical models, but not in humans; it is important to maintain splints attached to the skin at all times to prevent contraction; there is difficulty in measuring the real percentage of wound closure due to the presence of scabbing; there is evidence of re-epithelialisation in control mice; and scaffolds used to deliver

cells complicate analyses.

However, once these challenges can be overcome, MSCs have considerable potential to advance the wound-healing field and ultimately allow better outcomes for patients with diabetes mellitus. He gave the attendees an overview of the current GMP manufacturing process and facilities, including validation requirements.

Prof O’Brien also outlined his current research initiatives, including data that have yet to be published. He told the seminar: “[Research on] the clinical efficacy and toxicology for diabetic microvascular and macrovascular complications in clinical trials is underway, and all this is happening in parallel with development of the cell manufacturing process.

“The issues [typically faced] in MSC manufacturing in clinical trials include those related to the source — do we use bone marrow; should it be autologous or allogeneic? Do we use sort or bulk manufactured cells; and the homogeneity of the starting material [is also a consideration]. We also have to think about how we sort, for example, MACS vs FACS,” he said. “We also have to consider flask vs bioreactor expansion, passage and population doubling, xenofree manufacture, automation, and the cost of the goods themselves.”

Diabetic foot

During a lively Q&A session and clinical discussion following the presentation, Prof Tobin spoke about diabetic foot ulcers, non-healing chronic wounds, and the risk that these can become colonised or infected with bacteria. “It seems that one can only start out [in wound healing studies] with a non-infected wound and a clean environment,” he said. “I wonder if an experiment could be devised to look at the impact of MSCs on either skin commensals, or equally, on some of the pathogenic bacteria strains. If these MSCs are so immature and undifferentiated, they may potentially secrete a whole raft of different immune modulators, including some that may be antimicrobial, for example.”

Prof O’Brien responded: “We have a HRB Collaborative Doctoral Award received two years ago to study the diabetic foot, and we had six PhD students working on various aspects of the diabetic foot, from prevention through to treatment… in one project, they have actually grown bacteria from the surface of diabetic wounds and were looking at the antibacterial properties of MSCs. MSCs are now being studied in the treatment of sepsis and ARDS — Orbsen Therapeutics has just finished a trial on Covid-related acute lung injury in patients throughout the UK… the important thing is that you try to apply the technology in properly-designed trials.”

Prof Tobin remarked on how immature cells have an almost “primordial relationship with the microbiome”, whereas more differentiated cells may not.

“There was a human study in Copenhagen where the exclusion criteria included an infected foot,” Prof O’Brien commented. “It is interesting to think that some day, that would be an inclusion criterion.”

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

We are going to look at what are the factors secreted by these cells that could be modulating pain

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ACTIVE DEFENCE AGAINST ACNE

ELEVATING CONVALESCENCE TO ITS RIGHTFUL PLACE

Title: Recovery: The Lost Art of Convalescence

Author: Dr Gavin Francis

Publisher: Profile Books in association with the Wellcome Collection

Reviewer: Prof Brendan Kelly

Awise GP once told me that “rest is a real thing. Good things happen when you rest, especially after an illness.” By “rest”, she meant not working, stepping back from the usual bustle, and getting engaged in something else: Reading, walking, sitting.

My GP was (of course) correct, and she is not alone in her view. The 19th Century physician William Osler said that “patients should have rest, food, fresh air, and exercise — the quadrangle of health”. Osler was one of the brightest medical minds of his generation and possibly one of the finest ever. The emphasis he placed on rest and recuperation was deliberate, appropriate and necessary.

It is especially important to articulate the importance of rest and recovery today, when finding time for convalescence is an increasing problem for many people who struggle with distraction, excessive activity, or simple difficulty tuning-out of work and social media. After an episode of illness, rest and convalescence are essential for recovery and replenishment. We neglect them at our peril.

And yet, we do neglect them. Luckily, we now have new guidance to hand in this kind, insightful book by Dr Gavin Francis, Recovery: The Lost Art of Convalescence . Published in association with the wonderful Wellcome Collection in London, this beautiful volume explores the many shapes of recovery, how to best approach it, and ways to encourage and value healing.

Francis, as many readers will know, is a GP in Edinburgh. He has worked across four continents as a surgeon, emergency physician, medical officer with the British Antarctic Survey, and GP. He is the author of Shapeshifters and the Sunday Times bestseller Adventures in Human Being , which was a BMA Book of the Year. He also writes for The Guardian , The Times , the London Review of Books , and Granta Francis opens his new book with a quote from George Bernard Shaw:

“I enjoy convalescence. It is the part that makes the illness worthwhile.” In the text, Francis combines case studies with clinical experience and practical advice so that we, like Shaw, can make the most of convalescence and optimise our recoveries from illness. As Rachel Clarke, author of Your Life in My Hands , points out, recovery is “a wise, gentle, quietly hopeful book. Exactly what I needed this January. Beautiful words and ideas.”

I especially enjoyed Francis’s chapter about ‘The Ideal Doctor’. He points out that “doctors bring their own personalities and experience to every medical encounter”. He places particular emphasis on trust, which he describes as “the principal virtue of any therapeutic relationship”.

The book is full of reflections such as this, looking at the impact of medical practice on treatment and recovery. As surgeon Henry Marsh points out in The New Statesman , Francis’s book “is a practical guide to recovery from illness as well as a meditation on the practice of medicine. Take a holiday, says Francis, travel if you can, read books, set yourself achievable goals, don’t compare yourself to others, allow yourself time, commune with green, living things, have a pet.”

All told, Recovery is a very useful book about a lost art: Convalescence. Francis makes a compelling case that we should devote more time, attention and respect to healing, recovery and getting back on our feet. He is right: We need to give our bodies and minds an

opportunity to grow back.

This conclusion prompts another question: If convalescence is so important, why is it neglected? Why do we simply rush onwards after an episode of illness, barely pausing to take a breath, let alone take time to recover?

The most common explanation is that we are too busy, owing to endless work days, over-scheduled leisuretime, and the pressures of modern technology. As ever, we imagine that the era in which we live is significantly busier than previous ones, with no time for rest or convalescence.

But people have always felt that their generation was more stressed, more anxious and more distracted than the previous one. This is a constant feature of human nature: We believe that everything is uniquely unmanageable in our lifetimes. There is really very little evidence that this is accurate, but it is a cherished belief nonetheless.

The truth is that we have never given convalescence the attention it deserves, never sufficiently valued the body’s ability to heal, and never truly reflected on the miracle of recovery.

Osler recognised the value of convalescence, but his words survive today because they were outstanding, rather than routine, in his lifetime. Here’s hoping that Francis’s book reverses this trend and elevates convalescence to its rightful place at the heart of medical care.

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

Francis makes a compelling case that we should devote more time, attention and respect to healing, recovery and getting back on our feet

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Q1 Serena Williams recently announced her retirement from tennis. How many singles Grand Slam titles has she won in her career?

Q2 Name the rowing partnership who secured gold medals at this month’s European Championships?

Q3 Name the Irish cricket all-rounder who recently announced his retirement from the sport? This player scored the fastest ever century when Ireland defeated England at the 2011 World Cup.

Q4 Who was sent off on his home debut for Liverpool against Crystal Palace last week?

Q5 Who is the WBA, IBF, and WBO World Heavyweight boxing champion?

Q6 Name the Sligo swimmer who reached the 100 and 200 metres finals at the recent European Swimming Championships in Rome?

CROSSWORD COMPETITION

25 August 2022

The winner of the 21 July 2022 Sporting Quiz Competition is Prof Margaret Doran, Dublin 13 The winner of the 21 July 2022 Crossword is Dr Kelly Landers, Dublin 15

Q1 Which team did Shamrock Rovers beat in the first round of the Champions League A: Hibernians

Q2 Who won the Wimbledon ladies singles title? A: Elena Rybakina

Q3 Which nation holds the number one slot in the International Rugby Union world rankings after the summer tours? A: France

Q4 Who are the 2022 senior hurling champions? A: Limerick

Q5 Irish football international Shane Long has signed with which Championship club, 17 years after first signing with them? A: Reading

Q6 Which team has won the 2022 NHL Ice Hockey Stanley Cup for the third time in their history? A: Colorado Avalanche

DOWN

1 Upon (4)

2 Car operator (6)

3 Discuss the terms of a deal (9)

4 Controlling (6)

6 Surpass (6)

7 Put up with (8)

11 Perform a religious ceremony (9)

12 In any place (8)

13 Powerful (6)

MY PORSCHE EXPERIENCE AT SILVERSTONE

Ithink I’m a heartsink client for my accountant. There are so many times I ask, “can I put that down to tax?”

I tried it again with my trip to Silverstone:

- “Why did you go?”

- “To drive a pair of Porsches.”

- “Why?”

- “To write about them….”

- “Really? And did Mindo send you?”

- “No, I did it on my own bat.”

- “Did they pay?”

- “No, I paid over €1,000.”

- “So you’re telling me the sole purpose of your visit was to drive these two cars for Mindo?”

- “Of course….”

- “Look Alan, I know you’re a car nut. You know I won’t get into a car with you. You can’t tell me it was an educational trip, like the one for the Pain Society in Florence. Your income as a motoring correspondent is a pittance, you don’t make enough to write it off.”

- “Not yet… not yet.”

I don’t like working doctor-on-call. But I get paid for it. And that money is spent on me and my toys. I have tried to give Porsche UK my money before, but Covid struck. I was delighted to rebook the day and recently spent a Bank Holiday Monday over there. I had to book it three months in advance, as I wanted to drive both the Boxster and the 911. So, in midMarch, I was on the phone to Porsche Silverstone, with my wife, working out what dates suited best.

Getting over was an event in itself, but I arrived Monday morning to a decent breakfast. After the usual document signing (I didn’t have to cover the cost of a crashed Porsche, which surprised me) and driver briefing, we ventured to the track.

I had my own instructor for the morning and we chatted about lots of stuff. He explained about the right line to take, about aiming for different markers on the corners, how to hold the steering wheel in position and keep things as smooth as possible.

Swapping over to the 911 was a move into a different league. Now, the Boxster is a fine car, but the 911 – especially with the Porsche double-clutch gearbox – was a revelation. It had much more power, and to hear the engine and gearbox belch down through the gears as I dropped into a tight left-hander was pure music. The 911 felt in the right gear all of the time.

Of course, there are all sorts of magical buttons and dials and settings to play with the electronics, from normal, to sport, to super sport, or even individual. The magic the electronics can do was revealed on the ‘low-friction surfaces’, where the instructor did his

best to teach me to ‘drift’ (in a car worth €170,000 in Ireland). We also took it through its paces in a series of corners, again on low-friction surfaces, simply to “get the tail out”. The best was the ‘ice

hill’, which was a sheet of plastic over 100 metres long with two lines of water sprinklers, and he said, “drive up that”. With all electronics on, it was fine. Not fast, but it would do it. With electronics off, the fun began. Fish-tailing and drifting were unavoidable.

Porsche also had a ‘kick plate’. Again, a low-friction surface with a metal plate on the entrance, which would push the rear of the car out as you drove over it. The speed limit here was 30kph and it was amazing how much control I lost with rising speeds over this. Again, this was about speed of reflexes to opposite lock the car and drive it to safety (yes, on a wet low-friction surface).

Acceleration tests were there to demonstrate the speed of the car, followed by emergency braking. The seat belts wind back at full deceleration, so he knew I was at max brake force.

I had a demo of the emergency handbrake. Many cars with the electronic

handbrake have a facility — say, if the driver loses consciousness — the passenger can hold up the electronic handbrake lever and the car will come to an emergency stop. It’s worth seeing if your car has it and then telling your passengers.

Overall, I had approximately 140-to-150 minutes in the car for about £700. Any track day is expensive, but to be able to drive the living daylights out of two cars with a combined value of about €260,000 to me was great fun and relatively good value.

Drawbacks? We were not driving on what we all know and love as the proper Silverstone circuit, but the smaller Porsche-owned circuit, and hence I could only get the cars to a max of about 80mph. And it could get just a little crowded at times, slowing me down. Yet I’d readily do it again.

But the next venture abroad will either be to the Bill Gwynne rally school in Wales, or track driving in Zandvoort, Holland.  Watch this space.

Now, the Boxster is a fine car, but the 911 – especially with the Porsche doubleclutch gearbox –was a revelation

THE BITTERSWEET TRUTH ABOUT SUGAR

Ileft school, much to my relief and that of my teachers, in 1977. The school in question — quite a famous one, as it happens — had a curious approach to feeding children and adolescents. When I arrived in the preparatory school towards the end of the 1960s, a fairly nutritious if rather dull lunch was served each day.

At the dawn of the 1970s, it was decided to feed us on soup (Erin, I suspect, and always oxtail) with bread rolls, followed by mincemeat cooked between sheets of pastry on a vast tray and cut into squares. Aged ten, this was fine by me. However, as I hurtled into my teens, I adopted quite a different diet.

By the time I was 15 or 16 and 6’2” tall — I demonstrated in my person Euclid’s definition of a straight line having length and no breadth — my lunch consisted of a can of Coke, a packet of crisps (Tayto cheese and onion) and something called a Bobby Bar. This comprised desiccated — or desecrated, if you prefer — coconut, embedded in an ingot of caramel that threatened to pull any remaining milk teeth.

I must have eaten this every weekday for three or four years, and I seem to recall that I wasn’t alone. Of course, my parents gave me a solid breakfast (usually porridge and a boiled egg) and a very proper evening meal, my mother being an excellent cook who genuinely enjoyed feeding people.

I was thinking about this phase in my dietary life when I read about the relationship between Irish teenagers and sugary drinks. According to a Health Behaviour in School-aged Children (HBSC) survey, Irish youngsters have fallen out of love with the stuff, recording the biggest drop in consumption across the 21 EU countries surveyed.

The drop in intake of sugary drinks between 2002 and 2018 among Irish teenagers was just under 85 per cent. England came second in the league table, with a drop of almost 75 per cent.

There seems to be a socio-economic status issue, but perhaps not as marked as one might expect, with 11 per cent of the lowest group having at least one sugary drink a day, as against 4 per cent in the highest. And in most countries, including Ireland, boys are more likely to do so than girls.

Perhaps this is partly what lies behind the OECD-FAO projections for global sugar consumption for 2018-2030. Globally, they predict a rise from 168,965 to 195,923 kilotonnes (kt) but in Europe, they are forecasting a fall in sugar consumption from 27,443kt to 26,540kt over the same period (it’s important to stress that this

is about consumption, not production. EU sugar production is falling for several reasons, including the very welcome ban on neonicotinoid pesticides).

John Yudkin, the British physiologist who died in 1995, was warning anyone who would listen about the dangers of sugar since the 1950s. He had been appointed Professor of Physiology at Queen Elizabeth College, University of London, in 1945. It was here that he launched the first nutrition degree course in Europe.

His assertion that sugar leads to cardiovascular disease tended to skirt around confounding factors, something that caused Ancel Keys, of ‘Lipid Hypothesis’ fame, no stranger himself to cherry-picking data, to foam at the

mouth. Metaphorically. The global sugar industry, spooked by Yudkin’s claims, and his ability to communicate with ordinary people in ordinary language, were paying Keys to attack. But, to be fair, he probably would have taken this line anyway.

Attacking an industry that funded — and still funds — a massive amount of dietary research had consequences. Yudkin’s later academic years saw funding diminish to a trickle but his book, Pure, White and Deadly, published in 1971, was a huge success. He retired shortly afterwards.

So, having a go at sugar annoys some very powerful vested interests. More to the point, they are highly organised by contrast with, say, the dairy and beef industries, which have pretty well rolled over when it comes to the health claims made by the makers of processed foods with dubious health claims, and the ever-more powerful vegan lobby. The hyper-processed food industry has a huge interest in promoting veganism because of the demand for fake meat products.

But what sort of advice should we be giving people about sugar in the context of diet? I can speak only for myself, of course, but I think the stuff is best avoided, except as an occasional treat. For me, that could be a little homemade raspberry jam with a buttery croissant on Sundays or, if we’re having people around, maybe a very dark chocolate tart or an apple pie with plenty of fullfat cream. Oh, and the odd square of 85 per cent cocoa solids chocolate with an espresso. As for buying biscuits, I can’t remember the last time we did. And we have not had a ‘treat box’ since our children suddenly all grew up.

However, I know people who say things like, ‘I simply have to have a biscuit mid-morning’ (note the singular); or ‘if there’s chocolate in the house, I have to eat it’. Let’s face it, sugar is addictive. Withdrawing it suddenly is no fun at all.

My adherence to a fairly low-carb regimen has been sorely tested by the arrival of a new artisan bakery, Vinilo, in Lismore, where the classic sourdough, made with organic flour, is the Siren to my Greek sailor. However, I do manage to limit my consumption, and I don’t put jam on it!

WINE OF THE MONTH

Leaving sugar aside, Eamon FitzGerald of winespark.com, who used to be head buyer for Naked Wines in the UK, has a sweet deal if you come on board for a tenner a month. Essentially, you get his very cleverly-chosen wines at effectively a wholesale price.

Take, for example, the Mas Calamiac Minervois la Livinière 2019 that you can buy for €15.08, as against a retail price of €25 were the wine available elsewhere in Ireland. It’s 60 per cent Syrah, 40 per cent Grenache, dark, deep, brooding, spicy, seductive, long and lingering. Yes, I do rather like it. And to hell with Ancel Keys and veganism, I’ll have it with a juicy steak!

The drop in intake of sugary drinks between 2002 and 2018 among Irish teenagers was just under 85 per cent

RCPI Faculty of Pathology 40th Annual Symposium, 9-10 June 2022

ACCORD HEALTHCARE LAUNCH FESOTERODINE ACCORD 8MG PROLONGED-RELEASE TABLETS

Accord Healthcare has announced the launch of another medicine to add to its already extensive portfolio: Fesoterodine Accord 8mg, which comes in packs of 28 prolonged-release tablets.

Fesoterodine is indicated in adults for treatment of the symptoms that may occur with overactive bladder syndrome (increased urinary frequency and/or urgency and/or urgency incontinence).

Please refer to the summary of product characteristics (SPC) for further information. The SPC is available from the launch date at www.hpra.ie and for healthcare professionals at www.accord-healthcare.ie

Fesoterodine Accord 8mg prolonged-release tablets are available from both full line wholesalers from launch. For further information, contact Accord in Cork on 021 461 9040 or visit www.accord-healthcare.ie

RESEARCHERS AIM TO GIVE NEW LAYER OF PROTECTION TO MEDICAL DEVICES

Researchers at NUI Galway and Queen’s University Belfast are investigating how attaching sugar molecules to plastics could give medical devices a new layer of protection from infection.

The SUGARCOAT project is among 62 research collaborations supported by the Government’s Shared Island fund.

Early-career researchers

Dr Joseph Byrne, NUI Galway, and Dr Matthew Wylie, Queen’s University Belfast, are working together to tackle the issue of hospital-acquired infections associated with devices by taking preventative science to a new level. The team is attempting to harness the science behind the interaction of sugar molecules with bacterial proteins to make fluorescent materials which glow at first, darkening when they become compromised by bacteria. The technology would be attached to plastics, which coat medical devices – such as urinary catheters or endotracheal tubes – allowing clinicians to identify potential infection at an early opportunity and react faster.

Dr Byrne, Honorary Research Lecturer in the School of Biological and Chemical Sciences, NUI Galway, explained the concept: “Prevention of bacterial infections is key to fighting the challenge of antimicrobial resistance and if this isn’t possible, then early detection through innovative sensing materials could act as an alarm, allowing devices to be removed and replaced before infection becomes a more serious risk to patient health.”

Dr Wylie, Lecturer in Pharmaceutical Materials Science in Queen’s University Belfast, said: “Like many humans, sugar is something bacteria can’t resist getting a taste of. Many types of bacteria contain special proteins, which allow them to seek out and attach to sugar molecules, which they can use to grow and cause infection within the human body. Our new sugar-decorated coatings will exploit this interaction as an early warning, which has the potential to lead to the development of a new generation of medical devices, giving doctors and nurses tools to reduce risks of infection, bring down healthcare costs and decrease the need for antibiotic use in hospitals.”

The project is being provided with €193,000 from the Government’s Shared Island initiative.

The research team is supported by senior colleagues Prof Abhay Pandit, Director of CÚRAM, the Science Foundation Ireland Research Centre for Medical Devices at NUI Galway, and Prof Colin McCoy, Head of the School of Pharmacy in Queen’s University Belfast.

Medical device-associated infections account for up to half of healthcare-associated infections and people who are immunocompromised and those with cystic fibrosis (CF) are

particularly at risk, with the island of Ireland having one of the highest numbers of people with CF per capita. These infections are a major health concern to patients and incur significant expense to healthcare systems, requiring longer stays and increased antibiotic usage. The rise of antimicrobial-resistant bacteria is an urgent problem, decreasing the effectiveness of existing antibiotics. It is estimated that across EU/EEA countries, 33,000 deaths per year are associated with antimicrobial resistance, costing more than €1 billion to health services.

BOOTS IRELAND LAUNCHES NIGHT WALK IN AID OF THE IRISH CANCER SOCIETY

to provide support, and a team of lactation specialists dealing with more complex cases.”

To continue to support individuals and families, the hospital has introduced a number of service developments:

 Two full-time lactation specialists have been added to the lactation team. The introduction of a community/hospital integrated post has also enhanced the chain of support for families between hospital and home, in line with the new National Standards for Infant Feeding in Maternity Services launched nationally earlier this year. As a result, there was a 39 per cent increase in capacity for consultations with patients, between 2021 and 2022.

 The appointment of a lactation specialist specifically for the neonatal intensive care unit (NICU) has increased support for mothers and babies, in line with national infant feeding policy. As a result of the new post, a 36 per cent increase in NICU consultations was facilitated during the same period.

 Upskilling in the area of breastfeeding by midwives, with 16 midwifery staff recently achieving certification as international board-certified lactation consultants and a further 10 staff currently undergoing training to follow suit. This enables more skilled support in the area of breastfeeding to be provided to patients at ward level.

 A new breast-pump loan scheme was initiated to provide additional support for mother/baby pairs identified by the lactation team as needing short-term help to overcome challenges that arise in early days of breastfeeding.

 Twenty-seven new bedside cots were sourced and seven reclining chairs to make patients more comfortable when breastfeeding in the hospital. Feedback from mothers has been very positive, according to the Rotunda.

Boots Ireland has partnered with broadcaster Mr Darren Kennedy to launch this year’s Boots Night Walk in aid of the Irish Cancer Society night nursing service, which provides end-of-life care for people living with cancer in Ireland.

The service provides up to 10 nights of care, free to people who avail of it, and is funded almost entirely by donations. Boots Ireland has partnered with the Irish Cancer Society since 2012 and through the support of its staff, patients and customers has raised €2.5 million to date, helping to provide 7,200 nights of care.

Boots Ireland is calling upon the public to sign up and walk 5km together this autumn in support of the Irish Cancer Society night nurses. The in-person walk will take place on Friday 9 September at Dublin’s Phoenix Park, or people can sign-up to complete their 5km walk at a location of their choosing on the same date.

Irish Cancer Society night nurse Ms Mary Twohill said: “Our service enables our patients to be comfortable and in an environment where they can spend their final days with their loved ones. We’re able to support the friends and families by giving them the respite and emotional care they need when they need it most. We want to say thank you so much to everyone that’s been involved with the Boots Night Walk over the last 10 years as our job isn’t possible without you.”

For further information, visit www.bootsnightwalk.com

ROTUNDA HOSPITAL MARKS WORLD BREASTFEEDING WEEK

The Rotunda Hospital in Dublin has released new figures showing an increase in initiation rates for breastfeeding. The figures, which were issued during World Breastfeeding Week (1-7 August), showed that 72 per cent of patients in the hospital initiated breastfeeding last year, an increase of 3 per cent compared with 2020.

In addition to the increase in initiation rates, breastfeeding exclusively on discharge and mixed feeding on discharge also increased in 2021, both by 1 per cent compared to 2020.

Ms Geraldine Gordon, Clinical Midwife Specialist in Lactation at the Rotunda Hospital, said: “It is extremely positive to see an increase in breastfeeding initiation rates amongst our patient cohort in the past year. For World Breastfeeding Week this year, the global initiative is focused on supporting breastfeeding and at the Rotunda, this is a key strategic priority. We want to ensure that our patients feel supported on their breastfeeding journey, which can be challenging for many people in the early days. We have a team of dedicated midwives on hand

Ms Marina Cullen, Clinical Midwife Specialist in Lactation at the Rotunda, added: “Recent investment in breastfeeding supports enables us to help more patients each day, which includes a significant increase in daily consultations and more focused approach in supporting mothers and babies in the NICU. Where possible, we recommend that women engage with our online resources on the hospital website (www.rotunda.ie) and with community support groups before birth to help them prepare for infant feeding. This also helps to facilitate a valuable support network after discharge as they embark on their breastfeeding journey.”

PFIZER ANNOUNCES AVAILABILITY OF CIBINQO▼ (ABROCITINIB) FOR THE TREATMENT OF ADULTS WITH MODERATETO-SEVERE ATOPIC DERMATITIS IN IRELAND

Pfizer Healthcare Ireland has announced the availability of the 50mg, 100mg and 200mg doses of CIBINQO (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy, in Ireland.

The availability of abrocitinib in Ireland is based on the results of five clinical studies of more than 2,800 patients including four phase 3 studies and an ongoing long-term open label extension study. Abrocitinib demonstrated meaningful improvements across measures of symptom relief and disease control versus placebo. In one trial including an active control arm with dupilumab, which evaluated patients on background topical medicated therapy, abrocitinib 200mg was associated with a greater improvement in itch relief after two weeks than dupilumab. Abrocitinib also demonstrated a consistent safety profile across trials, including in a long-term extension study, showing a favorable benefit-risk profile.

Commenting on the announcement, Ms Caitriona McCarthy, Medical Lead, Inflammation and Immunology, Pfizer Healthcare Ireland, said: “Abrocitinib has shown significant efficacy, including relief from the trademark itch symptom, rapid improvements in skin clearance, extent and severity of disease versus placebo, and a favourable risk-benefit profile.”

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

 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 summary of product characteristics for how to report adverse reactions.

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New Secretary General

at

Irish Pharmacy Union

Ms Sharon Foley has taken up the position of Secretary General of the Irish Pharmacy Union (IPU). Ms Foley from Ballylinan Co Laois, whose appointment was announced in May, had previously served as Chief Executive Officer of the Irish Hospice Foundation since 2011.

Speaking at the outset of her tenure, Ms Foley said: “I am excited to be taking up the position of Secretary General of the Irish Pharmacy Union. The role pharmacists have been playing at the frontline of healthcare in our communities, has never been more important. As was seen through the Covid vaccine campaign the pharmacy sector can play a continually active role in supporting the national health service.

“My priority as Secretary General will be to maximise the potential of pharmacies, while ensuring that they are adequately supported by all stakeholders. It is clear that the growing shortage of pharmacists is causing significant pressure and securing Government action to address this will be a key concern of mine.”

IPU President Mr Dermot Twomey wished Ms Foley every success in the role, saying: “We are excited to be welcoming Sharon to the IPU today as our new Secretary General. She brings exemplary experience to this role as demonstrated by her highly successful tenure as CEO of both the Irish Hospice Foundation and the Crisis Pregnancy Agency.

“Ireland’s pharmacy sector is the most accessible and accessed component of our health service. There is huge ambition amongst the profession to expand our role, all for the benefit of patients. This will require action and support from Government, but with Sharon’s experience and dedication I am sure much progress will be made. On behalf of the IPU and indeed Ireland’s wider pharmacy profession I wish her every success in the role.”

Ms Foley holds a Master’s degree in Research from Trinity College Dublin, an MA in Health Promotion from NUI Galway and a BSc in Nutrition and Dietetics from Trinity

College Dublin/Technological University Dublin as well as qualifications in leadership and change management.

The IPU is the professional representative organisation for community pharmacists, with a membership of approximately 2,300 pharmacists working in more than 1,900 community pharmacies throughout the country.

Last month, the union warned of a serious shortage of pharmacists.

A survey conducted by the IPU, which was analysed by Behaviour and Attitudes and based on the responses of over 1,000 pharmacists, showed that more than half of the pharmacies surveyed had at least one open pharmacist vacancy in the past year. More than one-third indicated that these vacancies had remained for more than six months and up to one year. The report showed that at least 20 per cent of pharmacies are relying on pharmacist locums to stay open.

Of the pharmacists surveyed, 42 per cent were first registered in the UK (Great Britain and Northern Ireland). This high percentage of pharmacists qualifying outside the jurisdiction was “a significant concern and highlights the glaring lack of places for students to study pharmacy here in Ireland”. Additionally, the report showed “the severe lack of qualified pharmacists trained outside the EU choosing to work in Ireland and recommends that the registration process for non-EU pharmacists to facilitate them working in Ireland is expedited as a priority”.

As pointed out by your venerable scribe Prof Brendan Kelly in this issue, patients’ recovery after an illness or procedure is a much-neglected area of modern medical care; an afterthought that can prove expensive and counter-productive, if the objective is to prevent readmission.

Prof Kelly casts his clinical eye over the book Recovery: The

Lost Art of Convalescence by GP and author Dr Gavin Francis (see p38), which offers fascinating ruminations based on clinical experience. The overall conclusion is that the mind and body need some breathing space in which to effectively recover. Common sense, but perhaps not common knowledge. Sometimes, a hospital ward is the worst place for a recovering and potentially traumatised patient to get some rest. But

A round-up of news and oddities from left field by Dr Doug Witherspoon A room with a view to recovery: Catching the buzz around a patient's wellbeing following illness For more information and to avail of our sampling service§

IMPORTANT NOTICE: Breastfeeding is best. Neocate Syneo is a food for special medical purposes for the dietary management of Cow’s Milk Allergy, Multiple Food Protein Allergies and other conditions where an amino acid based formula is recommended. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Suitable for use as the sole source of nutrition for infants under one year of age. Refer to label for details.

5. Martin R et al. Benef Microbes. 2010. 1(4):367–82. 6. Wopereis H et al. Pediatr Allergy Immunol. 2014. 25:428–38. 7. West CE et al. J Allergy Clin Immunol. 135(1):3–13. 8. Walker WA et al. Pediatr Res. 2015. 77(1):220–228. 9. Sorensen K, et al. Nutrients. 2021 Mar 14; 13(3):935. 10. Sorensen K, et al. Nutrients. 2021 Jun 27; 13(7):2205.

± Exploratory outcomes from randomised control trials, Neocate Syneo vs Neocate LCP; † Systematic review of 4 randomised controlled trials, Neocate Syneo vs Neocate LCP. ¥ UK Observational study of real world evidence in THIN GP database, Neocate Syneo vs Alfamino, Feb 2021 (Alfamino is not currently GMS listed in ROI); ^ Clinical journey: asymptomatic and not requiring hypoallergenic

there is a little evidence to suggest that the topic might have gained a little more traction, at least in a fragmented fashion. A 2012 article in Scientific American looked at how the presence of a good hospital garden can aid recovery, and cited the experiences of three-year-old heart-transplant recipient Aidan Schwalbe. Scenes of Aidan exploring the garden at Children's Hospital Boston in the US should be inspirational to anybody involved in the design of a hospital garden (www.youtube.com/ watch?v=gea7au2CL9Y, if you want to take a quick look).

The article cites research from 1984 by environmental psychologist Roger Ulrich, who is thought to be the first researcher to use experimental controls and quantified health outcomes to assess how even having a view of a lovely garden can aid healing after a number of illnesses, infections and surgery.

Ulrich and colleagues studied a cohort of recovering gallbladder surgery patients in a suburban hospital. When all confounding factors were considered, patients with bedside windows overlooking leafy trees healed, on average, a day faster. They also required significantly less pain medication and had fewer post-surgical complications than those who simply had a wall or other patients to look at.

However, in a separate study, Ulrich and his team showed that even using the power of imagery – in the form of large ‘window view’ photographs – reduced the need for pain medication, compared to viewing simply a blank wall, plain white frame, or abstract paintings.

Closer to home, and just in the past couple of months, Cork University Hospital (CUH) has put in place tens of thousands of honeybees to help ease the anxieties of children who have suffered life-threatening reactions to bee and wasp stings. Soon, patients will also be able to watch the insects in their beehives from waiting rooms via a CCTV camera system installed at entry points to the hives.

The treatment for anaphylaxis requires immunotherapy in the form of intensive, long-term injections of venom doses to help the immune system build up a tolerance to the venom. This is conducted in the Wilton Campus, which is the national centre for the treatment of children who have suffered life-threatening allergic reactions to bee and wasp stings, and treats up to 20 anaphylaxis patients each year.

Dr Anda Dumitrescu of the Department of Paediatrics at University College Cork commented: “Visits to the hives in CUH can be facilitated with the provision of protective clothing and will enhance their experience while in hospital and improve their quality-of-life while recovering. We will need to mind the bees frequently during the summer and check them every seven-to-10 days, depending on their activity. I am a beekeeper and we could look at volunteers to help from different departments in the hospital.” Anybody with a little free time should make a bee-line to the volunteer centre post-haste.

This is all fertile ground for physicians to collaborate with landscaping specialists to improve outcomes and free-up some much-needed beds. Much is made of the ‘holistic approach’ to medicine. Surely if an objective of medical care is to prevent hospital admissions and re-admissions, more attention should be paid at policy-maker level to the wonders of proper rest and recuperation so well raised by Prof Kelly and Dr Francis.