The Medical Independnent 08 April 2021

Page 28

Training transfer set in motion

The transfer of responsibility for GP training from the HSE to the ICGP finally commenced in March after more than a decade of talks. Niamh Cahill reports

Vaccination: Hope on the horizon?

We examine the issues that have affected the roll-out of the national Covid-19 vaccination programme in general practice to-date


IMO AGM 2021 Preview

The IMO AGM takes place virtually on 17 April. Read our preview of the meeting, which features articles on issues facing community health doctors, consultants, and NCHDs



A teachable moment

Being ready for the next pandemic goes beyond science and requires looking at societal issues, writes Dr Muiris Houston



Position of Food Safety Authority of Ireland ‘being eroded’


The Food Safety Authority of Ireland (FSAI) cannot respond to the growing number and complexity of food safety risks without additional resourcing, and its position is being “eroded”, heard a special meeting of its board.

The FSAI is responsible for a range of functions to ensure food safety, including managing risks in the food chain and responding effectively to any national or international food incident or crisis.

A board meeting in November 2020 was convened to discuss submitted papers and address questions surrounding risks and opportunities, strategy, and priorities for 2021, given resourcing constraints and “changes in the FSAI’s environment”.

According to meeting minutes: “It was clarified that without additional resources we would not be in a position to keep up with the changing, growing number and

complexity of food safety risks. It was stated that this was resulting in the FSAI’s position being eroded. It was requested that a review of the FSAI’s funding model be undertaken to assess whether other income streams were feasible.”

A spokesperson for the FSAI told the Medical Independent (MI): “The FSAI received an incremental increase in funding in 2021, over the 2020 figure, which will be used to meet its regulatory and core obligations. Given the continuing increase in food alerts and the reactive work which the FSAI is required to address, it will continue to carefully manage its available resources to ensure that consumer protection is the focus of its activities in 2021.”

In 2020, MI reported that internal concerns had been expressed about the “viability” of the FSAI.

In February 2020, FSAI CEO Dr Pamela Byrne told the board the “ongoing funding situation” was having a “significant impact

upon the activities of the organisation and the morale of staff”.

There were “considerable risks to the FSAI and the consumer” due to the funding situation, noted the minutes.

The board discussed a letter from the Chair of the audit and risk committee regarding the “stark funding situation and the concern over the viability of the FSAI”.

A spokesperson at the time informed MI that funding and resourcing constraints arose from the costs of pay restoration, non-pay-related Brexit activities, and an increase in the resources required to meet legal obligations.

Meanwhile, the FSAI reported in March that, in collaboration with its official agencies, investigations were carried out into 47 unregistered food businesses in 2020, compared to 19 in 2019. These unregistered food businesses were operating illegally without the knowledge or supervision of the competent authorities.

It was recently announced that Consultant Neonatologist at Cork University Maternity Hospital, Prof Eugene Dempsey, had been appointed as the new Horgan Chair in Neonatology, INFANT Research Centre, University College Cork (UCC). The role is the first of its kind in Ireland.

Pictured L-R: Prof Geraldine Boylan, Director INFANT Centre, UCC; Prof John O’Halloran, Interim President, UCC; Prof Eugene Dempsey; and Prof Helen Whelton, Head of the College of Medicine and Health, UCC.

Some were established in domestic kitchens or private dwellings with inadequate food safety measures, as a result of the temporary closure of the food business in

Hepatitis C treatment numbers fell sharply in 2020



The numbers of people who commenced curative direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) dropped sharply to 532 last year, compared to 1,196 in 2019.

A spokesperson for the HSE National Hepatitis C Treatment Programme (NHCTP) told the Medical Independent (MI) that treatment numbers had been affected by the Covid-19 pandemic.

“This is mainly due to the disruption of primary care and the reduction in outpatient numbers in hospital,” said a spokesperson. “However, the NHCTP has remained open since the start of the Covid-19 pandemic and new patients continued to be assessed and treated. There were some delays in receiving PCR and genotyping results in the early period of the pandemic, but these have been resolved

and treatment numbers are now increasing.”

The NHCTP informed MI the target for 2021 “is to seek and treat as many as possible”.

Ireland has committed to the World Health Organisation HCV elimination targets by 2030.

However, clinicians and community workers have warned that more efforts are required to ensure treatment access for the most difficult to reach patients.

Most diagnosed cases are in people who currently, or formerly, injected drugs. HCV can be asymptomatic or mildly symptomatic for many years.

Ms Nicola Perry, Manager at Community Response, which works extensively on improving HCV treatment access, said HCV elimination required a multifaceted, multidisciplinary approach based in community settings. See news feature, p4-5.

which the people were employed due to the Covid-19 restrictions. Separately, the FSAI issued 167 food alerts and food allergen alerts in 2020, compared to 107 in 2019.

Legal classification: POM, CD (Schedule II). Marketing Authorisation numbers and pack sizes: 50 mg: PA 2242/12/4, 28 and 56 packs; 100 mg: PA 2242/12/5, 56 pack; 150 mg: PA 2242/12/6, 56 pack; 200 mg: PA 2242/12/7, 56 pack and 250 mg: PA 2242/12/8, 56 pack. Marketing Authorisation Holder: Grünenthal Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Citywest, Co. Dublin, Ireland. Further information is available upon request from Grünenthal Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Citywest, Co Dublin. Reference: 1. Palexia SR Summary of Product Characteristics. M-PLX-IE-11-20-0007 – November 2020
SR Tablets are indicated for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics1



• NEW In combination with pemetrexed and platinum chemotherapy for the firstline treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.

• NEW In combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

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 patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. 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. 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 as monotherapy 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 part of combination therapy is 200 mg every 3 weeks administered as an intravenous infusion over 30 minutes. 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. Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. Recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. For the adjuvant treatment of melanoma, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year. 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. Data from patients ≥ 65 years are too limited to draw conclusions on cHL population. Data from pembrolizumab monotherapy in patients with resected Stage III melanoma, from pembrolizumab in combination with axitinib in patients with advanced RCC, and from chemotherapy combination in patients with metastatic NSCLC, and from pembrolizumab (with or without chemotherapy) in patients receiving first line treatment for metastatic or unresectable recurrent HNSCC ≥ 75 years are limited. 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. 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. See SmPC for full details. Immune-related pneumonitis: Patients should be monitored for signs and symptoms of pneumonitis.. Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded. Refer to SmPC for information on management of immune-related pneumonitis. Immune-related colitis: Patients should be monitored for signs and symptoms of colitis, and other causes excluded. Consider the potential risk of gastrointestinal perforation. Refer to SmPC for information on management of immune-related colitis. Immune-related hepatitis: Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded. Refer to SmPC for information on management of Immune-related hepatitis. Immune-related nephritis: Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded. Refer to SmPC for information on management of immune-related nephritis. Immune-related endocrinopathies: Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment. Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. Hypophysitis has been reported in patients receiving pembrolizumab. Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes. Thyroid disorders, including hypothyroidism, hyperthyroidism and thyroiditis, have been reported in patients receiving pembrolizumab and can occur at any time during treatment. Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy. Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders. Refer to SmPC for information on management of immune-related endocrinopathies. Immune-related skin adverse reactions: Patients should be monitored for suspected severe skin reactions and other causes should be excluded. Based on the severity of the adverse reaction, pembrolizumab should be withheld for Grade 3 skin reactions until recovery to Grade ≤ 1or permanently discontinued for Grade 4 skin reactions, and corticosteroids should be administered. Cases of Stevens-Johnson syndrome (SJS) and toxic epider-


• NEW As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

• NEW As monotherapy 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.

mal necrolysis (TEN) have been reported in patients receiving pembrolizumab. For suspected SJS or TEN, pembrolizumab should be withheld and the patient should be referred to a specialised unit for assessment and treatment. If SJS or TEN is confirmed, pembrolizumab should be permanently discontinued. Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune- stimulatory anticancer agents. Other clinically significant immune-related adverse reactions: The following additional clinically significant, immune-related adverse reactions, have been reported in clinical studies or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barré syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis, encephalitis and myelitis. For Grades 3 or 4 myocarditis, encephalitis or Guillain Barré syndrome, pembrolizumab should be permanently discontinued. Refer to SmPC for information on management of significant immune-related adverse reactions. Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors. The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT): Allogeneic HSCT after treatment with pembrolizumab: 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. Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant-related complications should be made case by case. Allogeneic HSCT prior to treatment with pembrolizumab: In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. Consider the benefit of treatment with pembrolizumab versus the risk of possible GVHD in patients with a history of allogeneic HSCT. Infusion-related reactions: For Grades 3 or 4infusion reactions including hypersensitivity and anaphylaxis, stop infusion and permanently discontinue pembrolizumab. With Grades 1 or 2 infusion reactions, infusion may continue with close monitoring. Premedication with antipyretic and antihistamine may be considered. 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. Monotherapy: Very Common: anaemia, hypothyroidism, decreased appetite, headache, dyspnea, cough, abdominal pain, nausea, vomiting, constipation, musculoskeletal pain, arthralgia, asthenia, oedema, pyrexia, diarrhoea, rash, pruritus, fatigue. Common: pneumonia, thrombocytopaenia, lymphopaenia, 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, myositis, pain in extremity, arthritis, influenza like illness, chills, AST and ALT increases, hypercalcaemia, increase in blood alkaline phosphatase, blood bilirubin increased, blood creatinine increased, infusion related reaction. Frequency not known: solid organ transplant rejection. Combination with chemotherapy: Very Common: anaemia, neutropaenia, thrombocytopaenia, hypokalaemia, decreased appetite, dizziness, neuropathy peripheral, dysgeusia, headache, dyspnoea, cough, abdominal pain, alopecia, diarrhoea, nausea, vomiting, constipation, rash, pruritus, musculoskeletal pain, arthralgia, pyrexia, fatigue, asthenia, oedema, blood creatinine increased. Common: pneumonia, febrile neutropaenia, leukopaenia, lymphopaenia, infusion related reaction, hypothyroidism, hyperthyroidism, hyponatraemia, hypocalcaemia, insomnia, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, pneumonitis, colitis, dry mouth, severe skin reactions, erythema, dry skin, myositis, pain in extremity, arthritis, nephritis, acute kidney injury, chills, influenza-like illness, hypercalcaemia, ALT increase, AST increased, blood alkaline phosphatase increased. Combination with axitinib: Very Common: hyperthyroidism, hypothyroidism, decreased appetite, headache, dysgeusia, hypertension, dyspnoea, cough, dysphonia, diarrhoea, abdominal pain, nausea, vomiting, constipation, palmar-plantar erythrodysaesthesia syndrome, rash, pruritus, musculoskeletal pain, arthralgia, pain in extremity, fatigue, asthenia, pyrexia, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased. Common: pneumonia, anaemia, neutropaenia, leukopaenia, thrombocytopaenia, infusion related reaction, hypophysitis, thyroiditis, adrenal insufficiency, hypokalaemia, hyponatraemia, hypocalcaemia, insomnia, dizziness, lethargy, neuropathy peripheral, dry eye, cardiac arrhythmia (including atrial fibrillation), pneumonitis, colitis, dry mouth, hepatitis, severe skin reactions, dermatitis acneiform, dermatitis, dry skin, alopecia, eczema, erythema, myositis, arthritis, tenosynovitis, acute kidney injury, nephritis, oedema, influenza like illness,

chills, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased. PACKAGE QUANTITIES KEYTRUDA 25 mg/mL: 4 mL of concentrate in a 10 mL Type I clear glass vial. Legal Category: POM. Marketing Authorisation numbers: EU/1/15/1024/002. Marketing Authorisation holder: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. Date of revision: June 2020. © Merck Sharp & Dohme B.V. 2020. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7 or from Date of Preparation: February 2021. PSUSA. Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to MSD (Tel: 01-2998700) References 1. Keytruda Summary of Product Characteristics, January 2021, available at IE-KEY-00345 Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7 Ireland
KEYTRUDA, now publicly available for 4 additional indications, bringing the total number of indications now publicly available in Ireland to 8 * Reimbursed as of February 1st 2021 on the Oncology Drugs Management System 5057_KEYTRUDA_Reimbursement_Ad_273_395_v.indd 1 01/02/2021 12:15

Council ‘monitoring’ developments following RTÉ programme


The Medical Council “will be closely monitoring developments” surrounding the recent RTÉ Investigates programme on the Department of Health soliciting sensitive information about children with autism and their families – some of which was received from doctors without consent.

The children were involved in now dormant legal proceedings against the State regarding their educational and medical needs. The ongoing compilation of a ‘dossier’ on families was disclosed in the public interest by a Department civil servant, Mr Shane Corr, who had previously raised the matter through a protected disclosure.

The Council informed the Medical Independent (MI) it “will be in contact with the Department of Health and the HSE”, but declined to comment on its consequent actions.

The ethical guide “sets out the ethical and professional conduct requirements for doctors”, noted its spokesperson.

“The Council are aware that a multidisciplinary team is being formed to consider the issues raised in the Prime Time broadcast. We are also aware that the Data Protection Commissioner has now commenced a statutory inquiry… in relation to some of the issues raised.”

Ms Margaret Fox Lennon, a founding member of DCA Warriors, which advocates for children with additional needs and serious medical conditions, said families were extremely concerned their private medical information may have been shared without consent. “It is a huge betrayal,” she told MI

Ms Fox Lennon, who was involved in litigation on behalf of her son in the early 2000s, was aware of some families connected to DCA Warriors who had been informed by RTÉ they were on the Department database. At press time, there was no State process to inform families whether they were affected by this issue. Ms Fox Lennon called for the immediate release to families of a senior counsel report into the practice, which was commissioned by the Department last year.

She said families expected the Medical Council to investigate this matter. “There are no words I can find to express my gratitude to Shane Corr,” she added.

The Department said it had never “unlawfully” held sensitive information on children involved in dormant court cases.

PPE guidance revision not currently proposed


The HSE has no immediate plans to change guidance on personal protective equipment (PPE) for healthcare workers in the context of roll-out of the Covid-19 vaccination programme, it has confirmed.

“HSE Covid clinical guidance is continuously under review in light of emerging international evidence, data and trends,” a spokesperson told the Medical Independent

While vaccination has extensively rolled out to frontline healthcare workers, there is still uncertainty about the impact of vaccination on transmission and efficacy against some new variants.

During the pandemic, inspection reports by the Health and Safety Authority have frequently identified a lack of mask fit-testing in healthcare facilities. According to the HSE’s spokesperson, a national fit-test programme had been developed and implemented by the workplace health and wellbeing unit and is coordinated and scheduled through HSE coordinators at local level.

The HSE currently has a minimum of three months’ stocks of all PPE products in warehouses to meet medium-term demands, its spokesperson said.

“We also have secondary supply lines in place to add resilience and negate against unforeseen disruptions as they arise.”

In 2020, the total value of orders for PPE in response to the pandemic was €859 million.

HSE Service Plan may need early review

The pandemic response, including the vaccination programme, will likely have “an adverse impact” on commitments in the HSE National Service Plan 2021, according to high-level correspondence.

The plan, which was published in late February, may need to be reviewed this month due to fears that “planned levels of activity, performance and reform” will not be met.

In a letter on 15 January to Minister for Health Stephen Donnelly, the Chair of the HSE board Mr Ciarán Devane stated: “It is very likely that the continuing need to respond to the pandemic – including the delivery of the vaccination programme – will have an adverse impact on the HSE’s ability to deliver fully all the planned levels of activity, per-

formance and reform set out in the enclosed NSP 2021 in their entirety.”

“The extent of this impact is difficult to predict. We will keep the position under close review and I intend to write to you again formally in April 2021 in this regard to ensure both yourself and your officials are appropriately advised.”

Replying on 12 February, Minister Donnelly approved the NSP and noted “the emphasis and commitment for more enhanced performance reporting, which is welcome”.

The Minister asked that HSE officials engage with the Department’s Sláintecare Programme Implementation Office to report progress on the implementation of the Capacity Report 2018.

The correspondence was obtained by the Medical Independent following a Freedom of Information request.

plus a long-acting inhaled beta2-agonist. Xolair treatment should only be considered for patients with convincing IgE mediated asthma. Dosage and Administration: Treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma. Doses of more than 150mg should be divided across two or more injection sites. Patients with no known history of anaphylaxis may self-inject Xolair or be injected by a caregiver from the 4th dose onwards if a physician determines that this is appropriate. The patient or the caregiver must have been trained in the correct injection technique and the recognition of the early signs and symptoms of serious allergic reactions. Patients or caregivers should be instructed to inject the full amount of Xolair according to the instructions provided in the package leaflet. The appropriate dose and frequency of Xolair is determined by baseline IgE (IU/ml), and body weight (kg). 75-600 mg of Xolair in 1 to 4 injections may be needed for each administration. The maximum recommended dose is 600mg omalizumab every 2 weeks. See full prescribing information for conversion charts, dose determination charts and dosing instructions. Contraindications: Hypersensitivity to omalizumab or to any of the excipients. Precautions/Warnings: ♦ Not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus ♦ Xolair has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions, including those provoked by food allergy, atopic dermatitis or allergic rhinitis. ♦ Caution is warranted in patients with autoimmune diseases, immune complex-mediated conditions or pre-existing renal or hepatic impairment. ♦ Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of Xolair therapy is not recommended, however gradual discontinuation of omalizumab should be considered in all severe cases of any of the listed immune system disorders. ♦ Type I local or systemic allergic reactions, including anaphylaxis and anaphylactic shock may occur when taking omalizumab, also with onset after long duration of treatment (most occurred within 2 hours after the first and subsequent injections). Medications for treating anaphylactic reactions should always be available for immediate use following administration of Xolair. Prompt medical attention should be sought if allergic reactions occur. A history of anaphylaxis unrelated to omalizumab may be a risk factor for anaphylaxis following Xolair administration. The first 3 doses for all patients and all injections for patients with a history of anaphylaxis must be administered by a healthcare professional. ♦ Serum sickness and serum sickness-like reactions, which are delayed

allergic type III reactions, may occur when taking omalizumab, with onset typically 1-5 days after the first or subsequent injections, also after long duration of treatment. Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy. ♦ Patients with severe asthma may present with or develop systemic hypereosinopihilic syndrome or Churg-Strauss syndrome, both of which are usually treated with systemic corticosteroids. ♦ Patients on therapy with anti-asthma agents, including omalizumab, may present or develop systemic eosinophilia and vasculitis, particularly upon reduction of oral corticosteroid therapy. In these patients, physicians should be alert to the development of marked eosinophilia, vasculitic rash, worsening pulmonary symptoms, paranasal sinus abnormalities, cardiac complications, and/or neuropathy. ♦ Caution is warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic. ♦ There is a potential risk for hypersensitivity reactions for latex-sensitive individuals as the removable needle cap of the pre-filled syringe contains a derivative of natural rubber latex. ♦ If clinically needed, the use of Xolair may be considered during pregnancy and breast-feeding. Interactions: Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections. There is little potential for drug-drug interactions. In clinical trials, Xolair was commonly used in conjunction with commonly used anti-asthma medicinal products and there was no indication that the safety of Xolair was altered. Adverse reactions: ♦ Most commonly reported undesirable effects during clinical trials in adult and adolescent patients 12 years of age and older are: injection site pain, swelling, erythema, pruritus and headaches. Most commonly reported undesirable effects during clinical trials in children 6 to <12 years of age are: headache, pyrexia and upper abdominal pain. ♦ Uncommon: Pharyngitis, syncope, paraesthesia, somnolence, dizziness, postural hypotension, flushing, allergic bronchospasm, coughing, dyspeptic signs and symptoms, diarrhoea, nausea, photosensitivity, urticaria, rash, pruritus, influenza-like illness, swelling arms, weight increase, fatigue. For a full list of adverse events please refer to the SmPC.

For patients with severe persistent allergic asthma1 Think Allergy, Think IgE, Think XOLAIR® omalizumab ABBREVIATED PRESCRIBING INFORMATION for Severe Allergic Asthma. Xolair is also indicated for chronic spontaneous urticaria so for full details please refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: XOLAIR (omalizumab) solution for injection. XOLAIR 75mg solution for injection - each pre-filled syringe of 0.5ml solution contains 75mg of omalizumab. XOLAIR 150mg solution for injection - each pre-filled syringe of 1ml solution contains 150mg of omalizumab. Indications: Adults and adolescents (12 years of age and older) Add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test/in vitro reactivity to a perennial aeroallergen and have an FEV1 <80%, frequent daytime symptoms or nighttime awakenings, multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test/ in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings, multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids,
Category: Prescription-only. Pack Size: Xolair is
syringe and multipacks containing 4(4x1);6(6x1) or 10(10x1) pre-filled syringes containing 0.5ml
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Walking the hard road to HCV elimination

Amid a considerable decline in people accessing hepatitis C treatment in 2020, clinicians and community workers warn that more needs to be done to identify those requiring care, who often live on the margins of society. Catherine Reilly reports

The numbers of people who commenced curative direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) dropped sharply to 532 last year, compared to 1,196 in 2019.

A spokesperson for the HSE National Hepatitis C Treatment Programme (NHCTP) told the Medical Independent (MI) that treatment numbers had been affected by the Covid-19 pandemic.

“This is mainly due to the disruption of primary care and the reduction in outpatient numbers in hospital. However, the NHCTP has remained open since the start of the Covid-19 pandemic and new patients continued to be assessed and treated. There were some delays in receiving PCR and genotyping results in the early period of the pandemic, but these have been resolved and treatment numbers are now increasing.”

The NHCTP informed MI the target for 2021 “is to seek and treat as many as possible”.


In the storybook of medical breakthroughs, the advent of DAAs describes a revolutionary step forward for treatment of HCV.

The oral therapies, licensed in Europe since 2014, are well-tolerated and highly effective against all HCV genotypes. The treatment course is eight-to-12 weeks, sometimes extending to 24 weeks, and over 95 per cent of patients achieve a sustained virologic response.

However, many healthcare systems have been slow to re-imagine testing, treatment and support strategies for HCV, which is mainly transmitted by injecting drug-use.

People with HCV may be distrustful of hospitals due to negative experiences. Many are homeless and struggle to attend, or are not aware of, appointments. The old interferon-based treatment regimens, which were associated with a range of difficult side-effects and were less efficacious than DAAs, still influence attitudes towards testing and treatment.

Barriers to care are compounded by the fact that chronic liver disease develops over a long period. Signs and symptoms may not be evident for 20-to-30 years, until serious damage has occurred.

Ireland has committed to the World Health Organisation (WHO)’s 2030 HCV global elimination targets, set out in 2016.

Elimination is defined as a 90 per cent reduction in new chronic infections and a 65 per cent reduction in mortality, compared with the 2015 baseline. It would require diagnosis of 90 per cent of those infected and treatment of 80 per cent of those diagnosed. Underdiagnosis is recognised as a major challenge to achieving elimination.

A modelling paper published in Liver International in January reported progress

made in the timing of HCV elimination in 45 high-income countries between 2017 and 2019. The study, led by the Centre for Disease Analysis and funded by AbbVie, projected that only 11 of the countries studied would meet the HCV elimination targets by 2030. It estimated Ireland’s ‘year of elimination’ as 2037.

In 2020 the NHCTP, which is clinically led by Consultant Hepatologist Prof Aiden McCormick, described Ireland as on course to achieve the WHO 2030 goals. Since the programme was established in 2015, some 5,940 people have received DAA treatment, which is free of charge.

From 2015, a substantial annual budget for drug costs has been provided to the NHCTP (initially the NHCTP budget was €30 million per annum; currently €25 million). However, there has been criticism of the lack of resourcing for implementation of national screening guidance, published

grammes had been slow. It remains at a small scale, representing 15 per cent of treatment provision.


There are different estimates of how many people with chronic HCV infection are untreated. A written Dáil response last September by Minister for Health Stephen Donnelly stated that true prevalence of HCV in Ireland was not known.

A study published in Eurosurveillance in 2017 (Garvey et al) estimated 33,708 people in the adult population in Ireland have had previous exposure to HCV, and 19,606 had a chronic infection. The researchers examined samples collected between 2014 and 2016, which were held at the National Virus Reference Laboratory.

While treatment continues, hundreds of new infections are reported to the Health Protection Surveillance Centre every year.

likely to spread the virus, said Dr O’Carroll. Therefore, it is important to “get on top of” this situation.

In Dr O’Carroll’s experience, community-based care has worked very well. In the early days of DAA treatment, he participated in a shared care programme with the Mater Misericordiae University Hospital, Dublin, as hospital-centric care had not worked for many people.

Prior to this development, he said his practice referred 40 people to hospital with just two completing the process.

“That was very early on, when it was only in hospital. We got a shared care programme with the hospital and we got all 40 treated. If we can get people treated by their GP, we will have a much better success rate,” he told MI HCV-infected patients have continued to present to healthcare in the late stages of liver disease, according to Prof Jack Lambert, Consultant in Infectious Diseases at the Mater.

by the national clinical effectiveness committee and National Patient Safety Office in 2017, and for initiatives to enhance access to care at scale.

The NHCTP budget “is primarily utilised on drug spending”, according to the HSE. The majority of HCV drugs are still on patent. The HSE “engages in formal tender processes for its multi supplier contract for direct-acting antiviral medicines” thereby “ensuring value for money”. With regard to testing, the NHCTP said it currently funds a number of testing programmes including the community prescribing project, community outreach and the extension of seek and treat initiatives in partnership with voluntary providers.

In 2019 the NHCTP published community treatment guidelines for GPs and community pharmacists. Currently, it restricts community-based treatment to low-risk patients. Those patients with cirrhosis, organ transplantation, HIV and recurrent HCV infection, should be referred to a hospital treatment centre. It is expected that these criteria may change over time, according to the guidance. It also states that in order to participate in the HCV community treatment programme, GPs must be registered to prescribe methadone.

The NHCTP has previously acknowledged that the process of establishing community-based treatment pro-

Some 3,663 HCV infections were notified from 2014 to 2019 inclusive, although numbers have been declining annually.

The NHCTP is currently engaged in a formal epidemiological study to “determine HCV prevalence and to facilitate informed decisions regarding screening”. This study has received ethical approval and sample collection has been completed in St Vincent’s University Hospital, Dublin. The study is currently awaiting ethical approval in a number of hospitals throughout the country, with the aim of getting a “robust national prevalence figure” for the birth cohort 1965-1985.

Recently, HIQA published a draft health technology assessment (HTA) of offering once-off HCV testing to people in Ireland born between 1965 and 1985. The draft report is currently available for public consultation until 27 April.

The final report will be subject to approval by the board of HIQA. It will then be provided as advice to the Minister for Health to inform a decision on whether to provide birth cohort testing for HCV in Ireland.

Marginalised Dublin GP Dr Austin O’Carroll, who has worked extensively with marginalised communities, said there is still “a reservoir of people who are not being identified” although he believes this has lessened. These are people not engaged in services, and they are more

“We still say there is a significant burden of people [with HCV] out in the community with advanced liver disease,” Prof Lambert told this newspaper. “I’d probably say 10-to-20 per cent of the patients we are seeing have advanced liver disease and the idea is to treat people before they get advanced liver disease.”

People whose lives are “more chaotic” have not been identified in time and deteriorated into cirrhosis and hepatocellular carcinoma. “We are still seeing the complications of untreated hepatitis C in Ireland, and it has been made worse by the Covid lockdown and loss of the services that these people needed.”

He said the Mater has “opportunistically” treated HCV positive patients following their presentation to hospital for other reasons during the pandemic.

During 2020, numbers of people in receipt of methadone and Suboxone have increased – access to opioid substitution therapy (OST) being an important component of HCV prevention. However, Dr Lambert noted that some people cured of HCV, and who were on methadone maintenance, had started injecting again after changes in delivery of their programmes during restrictions. This had led to some reinfections, according to the consultant.

Currently, a peer support worker at the Mater assists people to access care and complete their treatment (one of the in-

Dr Austin O’Carroll
I’d probably say 10-to-20 per cent of the patients we are seeing have advanced liver disease and the idea is to treat people before they get advanced liver disease
Prof Jack Lambert

terventions tested in HepCare Europe, a collaboration between primary and secondary care, involving four countries and led in Ireland by Prof Lambert. The NHCTP has provided funding to continue peer support at the Mater).

Speaking last month at the 3rd EU HCV Policy Summit, Prof Lambert described peer support as a “crucial” component of treatment access. He also underlined that integrated care is the best way forward.

“Hepatitis C treatment in the community is appropriate for patients with earlier disease, the cirrhotic patients still required some involvement with specialty care services. Integrated care is still the best way forward to support widespread community networks. It is not really about the hospital or the community care, both can work with partnership, but it is a challenge. Our observation is there is still a large burden of HCV-related disease in the community who are not accessing care, these were the findings of HepCare Europe,” he told a session at the summit.

“A HCV patient may have a journey through many different services, so our patients in Ireland spend time in hospital, in the GP service, in prison, in a drug treatment service, in a homeless service and start the cycle again. So if you want to access treatment for them, you have to follow them through their journey,” Prof Lambert outlined at the session.

“Most care is still being focused on the easy to treat, not the high transmitters, and that is a challenge, we still haven’t achieved success on that, at least in Ireland. Services for HCV are not really joined up, they are not connected. There’s a lack of vertical and horizontal healthcare system partnerships. Finally for homeless people, HCV is just one of many conditions that we have to address with such individuals,” added Prof Lambert. A prevailing challenge was obtaining funding and resources as HCV projects were often pilots undertaken by institutions, private organisations, foundations, or backed by EU grants.

“Our [Irish] Government is very good at providing money for the drug but providing money for implementation is a second challenge and that is lacking in many jurisdictions.”

‘Lost to care’

Ms Nicola Perry is Manager at Community Response in Dublin, which provides a wide range of services for people experiencing problems with alcohol, hepatitis C and liver health.

Ms Perry said efforts must be intensified to identify those people “lost to care”. Some have been previously linked to services or may have received a diagnosis over the past decade.

“In the follow-up to World Hepatitis Day 2020 we were contacted by over 15 individuals, all who either were HCV positive or were speaking on behalf of a relative who was positive. Not one of these were on a treatment list. We would have concerns about the repeat incidence of this scenario amongst minority and migrant populations.”

As part of addressing this issue, she advocated retrospective records analysis to help identify patients lost to care.

Ms Perry also drew attention to people with untreated chronic HCV infections outside of Dublin. Many were not engaged with drugs services, either because they had a brief drug-using history and did not

view themselves as former drug-users, or they chose not to engage with mainstream drug services for various reasons. “We must also not forget about the numbers infected via other routes, including unsterilised tattooing, unsterilised body piercing, IV steroid use or vertical transmission.”

The pandemic has re-established certain high-risk practices such as home-based tattoo and piercings, added Ms Perry, who noted the UK government had issued warnings on this matter.

Specifically, HCV elimination requires a multifaceted, multidisciplinary approach based in community settings.

“The way to eliminate HCV in Ireland is to follow the Sláintecare model. A clear model of a cascade of care has seen huge successes in other countries – our neighbour Scotland is an excellent example of this.”

She said the stages of care – screening, testing, diagnosis, treatment, and cure –can be actioned in two-to-three visits (and fewer in straightforward situations). She advocated an evaluation of Ireland’s care cascade including epidemiological data for each stage, with information on key metrics and performance measures to be shared with stakeholders.

Ms Perry also urged the introduction and greater use of dried blood spot testing across all stakeholder groups; and more public health messaging to promote knowledge of risky behaviours, routes of transmission, where to get tested, and most importantly, that there is a cure available.

“Service providers working with at risk groups should be brought up to speed and provided with training for testing, basic HCV information and harm reduction techniques…. Service users can be well utilised as peer workers to promote knowledge among the drug using cohort, with benefits for credibility amongst their own peer group.”

Ms Perry stated that patients not on OST should be able to access treatment through their GP or HCV community liaison. Under present community treatment guidelines, if someone is not being prescribed OST, approval of their HCV treatment in the community must go individually to the NHCTP clinical advisory group. This causes unnecessary delays and stress, according to Ms Perry.

“We must seek to connect our cascade stages and form a continuum of care that places the patient’s journey at the heart of all process,” she said. “We must bring together our stakeholders, map out our care cascade and identify areas of improvement based on international strategies of success, such as those seen in Scotland and Iceland.”

Unless “comprehensive” screening is implemented “we will not be able to clearly state where we are on our road to elimination. We must screen and test in target populations. Our NHCTP must make itself accountable, [as] not just a reporting body, but a body with clear metrics and set objectives.”

Supporting people through the HCV treatment process

Ms Jennifer Mooney is a Hepatitis C Support Worker at Saol Project, an inner-city Dublin community-based educational and rehabilitation day programme for women in treatment for drug addiction. She supports people with information about HCV and in accessing care.

Many years ago, Ms Mooney went through the old pre-DAA treatment regimen, which

continues to impact attitudes to HCV testing and treat ment today. In her work with clients, Ms Mooney can also share this per sonal experience and outline the im proved side-effect profile associated with newer treatments.

“I was on the old treatment… the one with the horror stories and a lot of what people hear about that [treatment] is the truth,” Ms Mooney told MI. “These new DAAs are wonder drugs, but there is still that fear in the community.”

While people may have heard of new treatments, there remains some scepticism, she explained. There can also be a sense of despondency among people, due to the hardships they have suffered.

She has met women diagnosed decades ago, now with high Fibroscan scores, who are doubtful if it is worthwhile to go ahead. Ms Mooney also referred to a woman in her 40s with no dependents who told her, “it wouldn’t bother me to die in a few years’ time.”

“It breaks your heart to hear stuff like that, because one of the positives I’ve found from going through the whole thing from beginning to end with people, is for a lot of our service users, they have probably never completed school, they have never completed things in their life, and oh my God, the sense of empowerment they feel in themselves after going through the treatment – ‘I done that’.

“It is like a sense of pride in themselves, and then they start becoming interested in other areas of their life, to link in with the dentist or for their smears, just being a bit more positive about their own life and their own outcomes. It is much more than just a treatment for hepatitis C, once you get someone on that journey of starting to take a bit of self-care, it can change someone’s whole perspective on their own life.”

Ms Mooney and colleagues at Saol Project support clients to access testing and treatment. The project refers people to the liver centre or Clinic 6 in the Mater, and it also links in with City Clinic.

Clients are kept informed about when their appointment is coming up.

“If you look at someone in a hospital setting, they always have supports with them. But a lot of people who use drugs, they don’t have family support, they don’t have that link in. Stigma is a big thing. People often have had bad experiences, maybe with security in hospital, not feeling like they fit in. Just the fact of having somebody to meet you on the day, to ring you the day before to say ‘you have an appointment and I am going to meet you’, to sit down with them; sometimes they wouldn’t have the price of a cup of tea.”

Ms Mooney said over the past two years, approximately 50 people have been referred for treatment and all have been successfully supported to complete their course. This support continues for people with cirrhosis, for example, who require ongoing specialist care.

Ms Mooney believes efforts to improve treatment access are moving in the right direction, but that more must be done to raise awareness, reduce stigma, and ensure no-one is lost to care.



admitted patients were waiting for beds on the morning of 29 March, according to the Irish Nurses and Midwives Organisation’s (INMO) Trolley Watch figures.


of the patients on trolleys were at University Hospital Limerick, with the INMO calling on Government to “urgently intervene” in regard to the situation at the hospital.


– the percentage rise in daily Covid-19 cases during Africa’s second wave of the virus, compared to the peak of the first wave, according to research published in The Lancet


million Covid-19 cases and more than 65,000 deaths were reported in Africa between 14 February and 31 December 2020, outlined the research.


in socioeconomic value for Ireland, over 20 years, is being generated by new medicines for cancer, heart diseases, and respiratory diseases, found research commissioned by the Irish Pharmaceutical Healthcare Association.


people are on waiting lists for organ transplants (heart, lung, liver, kidney, and pancreas) at any one time in Ireland, highlighted the Irish Kidney Association during the recent organ donor awareness week.

190 transplants were carried out in 2020, which was 84 fewer than in 2019, due to the impact of Covid-19.


Call for enhanced medico-legal training for surgical trainees

There is a need to provide dedicated resources and training for surgical trainees “in the areas of risk management and open disclosure”, the IMO has told the Medical Independent (MI)

A survey of trainees’ perception of medico-legal practice in surgery, published in the February edition of the Irish Medical Journal (IMJ), found 33 per cent of trainees had already received medico-legal correspondence and 96 per cent expected to be sued in the future. Two-thirds stated the issue had made them more risk adverse.

The study was conducted by the Department of Trauma and Orthopaedics, Tallaght University Hospital. It concluded that “most surgical trainees across all levels and subspecialties anticipate medico-legal involvement during their careers”.

“Enhanced medico-legal understanding through ded-

icated training may aid in the minimisation of risk, enhancement of patient safety and positive resolution for all parties,” according to the IMJ article.

A spokesperson for the IMO told MI there “is definitely a need to provide dedicated resources and training in the areas of risk management, open disclosure, and learning

Claims management criticism ‘routinely not deserved’ – State Claims Agency

The State Claims Agency (SCA) said criticisms of “unacceptable” delays in conceding liability or agreeing quantum in medical negligence cases were “routinely not deserved”, according to a submission it made to an expert group.

The Agency made the statement in a 2018 submission to an expert group established by Government to review the system for management of clinical negligence claims. The report of the group, chaired by Mr Justice Charles Meenan, was published in December 2020 and submissions to the expert group were released. The report’s recommendations are being assessed by the departments of Health and Justice.

The SCA submission, dated August 2018, stated: “It is all too common for persons familiar with, involved in, or reporting individual cases to make public remarks critical of the management of claims by the Agency, suggesting there has been unacceptable delay in conceding liability or agreeing quantum. This kind of criticism is routinely not deserved.”

Although “personally frustrating” for those involved in the defence of such claims, it was “rarely appropriate for the Agency to respond to such criticism and it is mostly prohibited from doing so”. Therefore, it was “rare for the full unvarnished facts to be disclosed in these matters”, it contended.

Noting that submissions to the expert group may be published, the Agency said it acknowledged the “importance of transparency” and the need for the group to be able to report publicly on its work.

“However, the Agency is sometimes restricted in the details that it is free to address in public, with respect to historic and pending claims.” The SCA referenced a recent “high profile and sensitive case” at the time of the submission, in which the Agency had been criticised in the media and other forums for its case management, and in particular, for imposing obstacles to settlement.

“Nothing could have been further from the truth,” it argued.

“All of the criticism ignored the fact that the presiding judge, Mr Justice Kevin Cross, praised the manner in which the case had been managed by the Agency,” according to the submission.

“While some cases can take up to between twoto-three years to be concluded, that particular case was settled within 10 weeks of the summons being lodged. Mr Justice Cross said the case was handled in an efficient and humane manner, with all sides pulling out the stops to get the matter ready for hearing quickly.”

The SCA is responsible for ensuring the State’s liabilities are contained at the lowest achievable level.

Its submission noted that many of the recommendations and reforms proposed by the working group on medical negligence and periodic payments, and inter-departmental working group on legislation on periodic payment orders, were not in force.

“The Agency believes that much of the well-motivated interest in reform of the existing legal framework would be answered by implementation of these awaited reforms.”

following an adverse event”.

“There is also a need to provide additional supports for patients and doctors following adverse events including emotional and psychological supports.

“A formal debriefing should be provided for trainees involved in an adverse event as well as access to employee assistance programmes.”

The Civil Liability (Amendment) Act 2017 provides certain protections to healthcare professionals when making a voluntary open disclosure in accordance with the Act.

“However, unfortunately the forms and procedures for open disclosure under the Act are not conducive to an open and honest conversation following an adverse event,” said the IMO spokesperson.

“The Minister for Health recently announced that the Patient Safety (Notifiable Patient Safety Incidents) Bill is due to come before the Oireachtas health committee and will require careful scrutiny to ensure it is fit-for-purpose.”

Council to resume monitoring CPD activity


The Medical Council intends to reinstate its “risk-based framework” for monitoring doctors’ maintenance of professional competence (MPC) for the current scheme year.

Doctors will be asked to make a declaration about their MPC when renewing their registration in 2021. Doctors’ MPC declaration will be compared with professional competence scheme data to monitor compliance with requirements, a Council spokesperson told the Medical Independent.

The Medical Council receives annual reports from postgraduate training bodies which operate professional competence schemes under arrangements with the Council. These reports include continuing professional development (CPD) compliance and activity data, which are evaluated to “inform regulatory intervention”.

In spring 2020, after the onset of the pandemic, the Council announced that verification of CPD records for the 2019/20 scheme year would not be undertaken and the MPC declaration was re-

199 doctors waiting to sit PRES 3 exam to practice in Ireland

The Medical Council’s pre-registration examination system (PRES) level 3 clinical skills examination remains suspended for over a year, with 199 doctors waiting to sit the exam as of early March 2021.

Some cohorts of international medical graduates are required to complete the PRES exams to register with the Medical Council and practice in Ireland.

A spokesperson for the Medical Council told the Medical Independent on 25 March: “The medical schools host the PRES 3 exams on behalf of the Medical Council and due to the Covid pandemic, the exams scheduled for March 2020 were cancelled and it has not been

possible to reschedule.”

The Council has “been in touch with the medical schools on a number of occasions this year to see if they are in a position to host the exams again this year but in the current circumstances it will not be possible”.

As it is a clinical exam, with doctors and patients in close proximity, “this would be contrary to social distancing guidelines,” according to the Council’s spokesperson. No potential dates had so far been identified for 2021.

“We will continue to monitor the situation and once it is possible to hold the exams again, we will contact the doctors waiting to sit the PRES 3,” said the spokesperson.

Meanwhile, the Council reiterated its view that designation of alternative exams to PRES 2 made it easier for

moved from the 2020 retention process. Statements of participation were annotated to indicate “extenuating circumstances due to the ongoing coronavirus pandemic, which may have limited engagement in and recording of CPD activity for 2020/21”.

A Council spokesperson said it recognises engagement in CPD has been “different” due to the pandemic. “This has resulted in focused learning arising from adaptations to the practice of medicine, both Covid-19 and non-Covid-19-related. This gave rise to the Council’s agreement to reduce the minimum CPD requirements for the 2020/21 year. However, this does not exempt doctors from engaging in CPD; this requirement does remain mandatory.”

In the scheme year beginning 1 May 2021, doctors will be required to undertake and record 25 credits in any category (as opposed to 50 credits pre-pandemic) and one clinical/practice audit. These requirements will be kept under review “in light of a protracted pandemic”, according to the Council.

applicants to apply for registration via the PRES route.

Prior to 2016, the PRES 2 could only be undertaken “in a very limited number of test centres”. To make it easier for applicants from outside of Europe to apply for registration via the PRES route, the Council decided that new applicants would be required to pass one of the alternative exams deemed to be an acceptable equivalent.

By accepting the alternative exams, the Council “is facilitating applicants to choose from a far wider range of test centres worldwide”.

“We are actively exploring options to facilitate applicants applying for registration via the PRES route but given the importance of ensuring the integrity of the exam system, it will take time,” added the spokesperson.


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1. TRAJENTA® (linagliptin) Summary of Product Characteristics. Available at: lm-coated-tablets-34014/

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

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

Prescribing Information (Ireland) TRAJENTA® (Linagliptin)

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

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

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

marketing experience. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (<1/10,000). Adverse reactions with linagliptin 5 mg daily as monotherapy: Common: lipase increased. Uncommon: nasopharyngitis; hypersensitivity; cough; rash; amylase increased. Rare: pancreatitis; angioedema; urticaria; bullous pemphigoid. Adverse reaction with linagliptin in combination with metformin plus sulphonylurea: Very common: hypoglycaemia. Adverse reaction with linagliptin in combination with insulin: Uncommon: constipation. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 28 tablets. Legal category: POM. MA number: EU/1/11/707/003. Marketing

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V1 Date
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HUG4838 Trajenta Med Ind 370x255 - IRE v2.indd 1 15/02/2021 15:10

Mater Hospital plans to procure e-prescribing system


The Mater Misericordiae University Hospital (MMUH), Dublin, has made a ‘request for information’ (RFI) for the supply, configuration, and maintenance of an e-prescribing system.

The hospital intends to run a public procurement process in the future to supplement its existing electronic health record system with new digital tools. This would be to deliver safer care and support greater service efficiencies.

The purpose of the RFI was to gather market information that will help inform the potential scope of this procurement.

Any future system should have capability in the fol-

lowing areas: E-prescribing and medication management; clinical notes and record keeping; and the electronic recording of vital signs, clinical risk assessments and the automation of alerts/reminders to help bring efficiencies and improve patient safety.

The RIF document pointed out that, as far back as 1995, the hospital implemented ‘Clinicom’, an integrated electronic patient information system with key functions such as ADT (admit, discharge, transfer).

“Some aspects of Clinicom still remain; however, Clinicom was upgraded to ‘PatientCentre’ in 2004 giving a more user-friendly graphical interface,” according to the document.

HIQA seeks consultancy service for corporate plan development

HIQA has tendered for a “suitability qualified expert” to assist in the development of its new corporate plan.

The Authority is commencing the development of a new corporate plan to cover the period 2022-2024.

According to tender documents, the successful application will provide a range of services primarily in relation to stakeholder engagement. It will involve assessing and reporting on the feedback received to identify and understand key areas for attention and to inform strategic priorities and objectives. This includes design and facilitation of stakeholder consultation, analysis, and synthesis of stakeholder feedback.

The successful applicant will also be required to assist in strategy development and the drafting of the strategy document.

The appointed expert would be expected to facilitate an initial strategy session with the board and the executive management team; provide an analysis of the results of the session; and advise on how this will guide further stakeholder engagement.

They would also “provide a high-level analysis of an open consultation with stakeholders that will invite written submissions”.

The successful applicant would lead the wider stakeholder engagement activities, including conducting one-toone interviews by telephone or video call with HIQA staff; Government officials; and other stakeholders.

In addition, they would facilitate “four-to-six, two-hour virtual sessions with representative groups of staff”.

“The outputs of these sessions may be supplemented with output from internally run staff sessions,” according to the tender document.

HIQA may also require support with strategy implementation and any reviews or other associated work, during the life of the plan.

Meanwhile, the Authority recently published three inspection reports of hospitals that use medical exposure to ionising radiation.

Tallaght University Hospital demonstrated good compliance or substantial compliance with the regulations assessed on the day of inspection. Cork University Hospital was also found to be compliant or substantially compliant with regulations.

However, inspectors found evidence of non-compliances in Kilcreene Regional Hospital, which related to deficits of governance and management, including oversight and allocation of responsibility for medical exposures.

Ireland took a robust approach following the increase in cases in December 2020. Comparing Ireland to other countries in the review, hospitalisations per million population were lower only in Denmark and The Netherlands.”

Dr Máirín Ryan, HIQA’s Deputy CEO and Director of Health Technology Assessment, on an international review submitted to the national public health emergency team regarding public health measures and strategies to limit the spread of Covid-19.

The current pandemic is our focus and by ensuring the full capacity of the HSE board, I am ensuring that they will be in the best possible position to tackle the challenges of reform and reorganisation that will accelerate in the coming months and years.”

Minister for Health Stephen Donnelly on the appointment of Ms Anne Carrigy and Mr Brendan Whelan to the HSE board. The board is at full capacity for the first time since its establishment in 2019.

“PatientCentre has been modified and developed internally, providing the hospital with a highly comprehensive healthcare information system that is now deeply embedded in the hospital’s culture, processes and care delivery. While this effort put MMUH well ahead of its peers, MMUH now wish to underpin the successes of PatientCentre and to acquire components that are fundamental to an EHR (electronic healthcare record).”

The hospital said it wants to learn about the “current and planned products and services available in the market to assist us in informing a requirements specification for a potential future systems procurement”.

The deadline for the RIF was the end of March.

Sunbed inspections will resume ‘immediately’ upon reopening

The HSE will “immediately resume” inspection of the sunbed sector once Government Covid-19 pandemic restrictions have been lifted, the Medical Independent has been told.

The HSE National Service Plan 2021, published in February, outlined the Executive would “undertake a sunbed inspection programme” under the Public Health (Sunbeds) Act 2014.

Asked when such a programme can take place, in light of current public health restrictions, a HSE spokesperson said the pandemic continues to impact the inspection system.

The main provisions of the Public Health (Sunbeds) Act 2014 commenced on 21 July

2014. Since then, the HSE Environmental Health Service has actively enforced the legislation.

All HSE environmental health officers are authorised to enforce this legislation and the inspection of sunbed businesses does not involve any other agencies.

“Since 12 March 2020, the HSE inspection programme has been impacted due to Government restrictions on the opening of sunbed premises,” the HSE spokesperson said.

“Government level 5 restrictions in place... mean that sunbed premises are not currently operating and HSE inspections cannot therefore take place. Routine HSE inspections will immediately resume once this sector re-opens.”

President of the Medical Council Dr Rita Doyle commenting on the RTÉ Investigates report broadcast on Prime Time on Thursday 25 March. According to the report, the Department of Health secretly used information from private doctor consultations to build and maintain dossiers on children with autism who were involved in legal actions against the State.

As a doctor, last night’s Prime Time made for difficult viewing. Patient confidentiality and patient consent are key to the practice of medicine and central to the doctor-patient relationship.”


Beacon Hospital’s Post - Covid Clinic was established in March 2021 in response to increasing numbers of patients presenting with lingering complaints long after their initial Covid-19 infection.

This highly specialised MDT clinic, the first of its kind in Ireland, o ers much needed care and support to these patients as they continue in their post-covid recovery journey.

Led by Prof Seamus Linnane, the Post-Covid Clinic has the support of the full service acute hospital including Ireland’s most technologically advanced radiology and diagnostics equipment.

For more information please see the Post-Covid Clinic section of our website - or call 01 650 4860.

Patients can be referred by emailing

ICGP training transfer set in motion

The transfer of responsibility for GP training from the HSE to the ICGP finally commenced in March after more than a decade of talks. Niamh Cahill reports

It was in 2010 that the HSE first made the decision to exit the delivery of GP training and seek a new provider.

The ICGP was deemed the preferred candidate and consequently discussions between both parties commenced in earnest.

After many delays and setbacks, the transfer officially began on 5 March 2021, heralding the start of a major GP training structural reform process.

GP training

The ICGP has been preparing for the transfer for many years. In 2019, it produced a new model for the delivery of GP training, the implementation of which is due to commence on 1 July.

In 2018, the College established the GP training taskforce to design and develop a structure for the future delivery of GP training.

A year later, the final report of the taskforce – A model for the future delivery of GP training in Ireland – was completed.

It set out the pathway for new structures within GP training delivered by the ICGP over a four-year timeframe.

Currently, the College is responsible for the accreditation of the training schemes; the management and delivery of exams; and the issuing of certificates of satisfactory completion of specialist training

(CSCSTs). The primary delivery of training rests with the HSE who employ GP programme directors and assistant programme directors and provide facilities for training in many instances.

Prior to the start of the transfer, there were 68 programme directors and assistant programme directors and 12 GP scheme lecturers nationally.

From July, the recruitment of new roles to lead and provide GP training regionally will commence.

About half of existing programme directors and assistant programme directors employed by the HSE with the training schemes have opted to take a termination package. The remainder will stay on, with the ICGP as their new employer.


The taskforce report outlined the need for greater uniformity and consistency between the existing 14 GP training schemes nationally, which currently operate independently and without sufficient national oversight.

Furthermore, it sought “enhanced governance and accountability”; better future planning and innovation; IT development; better coordination of professional development; and a “strong voice for GP training” in Ireland, among other objectives.

Changes to the curriculum, improved

assessment processes and greater cooperation with other training bodies were envisaged in the report.

This year the College offered 236 places to doctors, compared to 150 training places in 2016. It is hoped numbers will rise again next year.

The report takes account of projected rises in training numbers and the need to expand training is listed among the reasons why improvements were sought.

New regions

The new model proposes four new regions:

1. Cork, Limerick, Tralee; 2. Donegal, Sligo, Galway; 3. Dublin North/North Leinster; and 4. Dublin South/South Leinster.

Each of the four regions will have a regional advisory committee, regional director of training, trainees, trainers, area leads, and educators.

The regions will be overseen by a national oversight committee for GP training, the national director of training, and the ICGP CEO.

“The description of the proposed model for GP training is future-oriented and is based on an assumption that a transitional period will be required for some arrangements, structures, and resources to be fully put in place and embedded in the model,” stated the report.

The process of aligning training prac-

tices to the new training areas is planned over a three-to-five-year period, based on the closest educational site, according to the report.

For trainees, the changes will bring “significant benefits… in terms of blending and broadening their experiences of training and training practices available within new training areas”.

“The three-to-five-year transition process will help to give confidence to current trainees and also provide clarity for future trainees.”

According to ICGP CEO Mr Fintan Foy, the College expects the full detail of what phase two (July to December) will look like to become clearer over the coming weeks. The new model will be broadly in line with that outlined in the taskforce report.

Initial changes will centre on governance and organisation of schemes. GP trainees will not be “significantly affected” during this phase, Mr Foy told the Medical Independent

This year, ICGP systems and processes will be scaled up to “drive the ongoing and continuous improvement of GP training from 2022 onwards”, he added.

Mr Foy said the third and final phase would see the College work with the HSE from January 2022 in relation to finalising the implementation of the new ICGP national GP training programme.

Vaccination: Is hope finally on the horizon?

Niamh Cahill examines the issues that have affected the roll-out of the national Covid-19 vaccination programme

The month of April is named after Greek Goddess Aphrodite, who is associated with love and fertility.

In Ireland, April 2021 marks the planned acceleration of the Covid-19 vaccination roll-out.

So just like Aphrodite, April’s dawn brings with it the promise of more fertile conditions for vaccination. It is hoped, at least.

The good news is the vaccination drive –to date fraught with disruption due to supply shortfalls and communication problems – is expected to gather pace in April.

Vaccinations will begin in pharmacies; all of the country’s 38 vaccination centres will become “operational”; and about one million vaccines are due to arrive on our shores. Furthermore, a public portal allowing people to register for the vaccine will open.

Walk-in testing centres for asymptomatic cases, without the need for referral, were opened last month in areas with high virus rates.

Planning for more localised responses to virus outbreaks with the use of antigen testing is underway.

Visits for residents in long-term care facilities have recommenced as virus cases

have fallen now that vaccination of residents has been completed.

However, Covid-19 remains a serious threat, jeopardising the loosening of restrictions and greater liberties this summer.

In mid-March, the national public health emergency team (NPHET) described the situation as “fragile”. At the end of the month, more people were being referred by GPs for Covid-19 testing. Europe was in the grip of a new virus wave as criticisms of the EU’s slow vaccination roll-out heightened.

Every movement is a potential risk to the spread of Covid-19, according to public health experts.

Vaccinating greater numbers will help reduce cases and therefore increase freedoms, according to messaging to the public.

At the time of writing, almost 200,000 of the estimated 490,000 over-70s in Ireland had received a Covid-19 vaccination.

At the end of March around 14 per cent of the Irish population had received either one or two vaccine doses. About 4 per cent of the population was fully vaccinated.

In contrast, in the US, about 14 per cent of its population had been fully vaccinated and 128 million doses administered. Around half of Israel’s population was ful-

ly vaccinated before the end of March.

In Ireland, the roll-out is slower than many would like. Some European countries have greater percentages of their population vaccinated than Ireland, such as Germany and Spain.

General practice

On 15 February, the vaccination programme for the over-70s in general practice commenced. Having spent the past year cocooning, those who received vaccination described it as a joyous event, according to GPs.

After a tough year on the frontline, their positivity was a much-needed boost for fatigued GPs and practice staff.

Unfortunately, however, it was not long before problems emerged.

Lack of vaccine supplies and inadequate communication from the HSE caused immense frustration at a time when GPs were working around the clock to ensure vaccination clinics were in place.

In some cases, due to supply shortfalls, GPs were forced to cancel vaccine clinics at the last minute, resulting in hundreds of phone calls to disappointed patients and a huge burden of work for practice staff.

Separately, in some cases, GPs received

vaccines at short notice and were left scrambling to organise clinics, often at weekends.

The temporary pause in administration of the Oxford/AstraZeneca vaccine, after a small number of very rare cases of blood clots in other European countries, has also left a mark. GPs have reported concerns among patients about receiving the vaccine following the controversy.

HSE communication processes have since improved and GPs are receiving greater notice periods about potential supply shortages. This has provided much relief to GPs, but concerns remain.

Recent vaccine deficiencies have meant that GPs due to commence vaccinating the 75-79 age group were unable to do so on schedule.

As supplies are expected to improve this month, however, GPs remain on target to complete the vaccination of all over-70s by mid-May, the IMO has said.

As the roll-out continues, GPs will have the option to participate in vaccinating medically vulnerable cohorts from April.

The IMO believes the majority of GPs will engage. But their participation will be contingent on adequate supplies being in place and effective communication from the HSE.

News Feature NIAMH
CAHILL News Feature

At the heart of the community

In advance of this month’s IMO annual general meeting, Chair of the Organisation’s public health and community health committee, Dr Ann Hogan, outlines the vital role of community health doctors and the part they have played in the response to the Covid-19 pandemic

As we prepare for the second virtual annual general meeting of the IMO in 12 months, I wanted to reflect on the role of community medical doctors over the last year and what to expect into the future. Doctors in community medicine play a vital part in a number of programmes and I hope that the pandemic has shown the importance of our role and importance to the health service.

Prior to the pandemic, community medical doctors’ main areas of work were in child health and school immunisations and we had been involved in the extension of the HPV vaccination programme to boys from September 2019. This was a significant extension of a vital public measure, and something which the IMO had been seeking for a number of years.

With the outbreak of the pandemic in March 2020, most of our normal work was suspended. Senior medical officers (SMOs) and area medical officers (AMOs) from community medical teams were re-deployed into Covid-19-related work in public health departments, occupational health departments, and in the development of Covid testing services and community assessment hubs.

Moving into the summer, we were able to provide some of our normal range of services and completed the 2019-2020 school vaccinations programme in large, centralised clinics instead of in the schools. It is a credit to all the medical, nursing and administrative staff members of the vaccination teams that, despite the closure of schools and challenges of the pandemic, we were able to complete these important programmes.

The winter of 2020 brought new challenges, with the re-opening of schools and an increase in Covid-19 cases leading to the need to maintain services, while having staff redeployed to vital public health functions. Many schools were unable to accommodate the school vaccination programmes due to the Covid-related measures introduced, including school halls and gyms being used as classrooms. Where possible, the school vaccination programme was delivered in schools, but many students were vaccinated at centralised clinics. We were able to deal with these challenges through engagement with principals in schools and through being flexible and creative in our approach.

Child health services have been significantly disrupted by the pandemic. Services were almost completely suspended during the first Covid wave and gradually reintroduced over the summer. However, the necessity for social distancing and other infection control measures has meant that numbers of children who can be seen at a clinic have reduced. There is, therefore, a significant number of children for whom important core child health checks or reviews at second tier clinics have been delayed and additional resources are required to deal with the catch up for these children.

With the approval of Covid-19 vaccines at the end of 2020, community medical doctors were required for the roll-out of vaccination to patients in nursing homes and long-stay facilities. Given the sad loss of life in these facilities in 2020 we were delighted to take up this and – again in conjunction with our nursing and administrative col-

leagues – were able to use the supplies available to vaccinate this cohort. It is heartening to see the benefit of this now being seen in these settings and I look forward to the vaccine programme having the same impact when it is fully rolled out in the wider population.

Looking to the future

In my role with the IMO, one of the longest-running and contentious issues has been the unfair treatment of AMOs by the HSE. This group of doctors work side-byside with SMO colleagues performing the same role and continue to be discriminated against. They have been particularly to the fore in the response to Covid-19, both when redeployed and as essential members of the vaccination teams.

The IMO has referred this matter to the Workplace Relations Commission for conciliation and has had extensive engagement with the HSE and Department of Health in this forum. The recent public service agreement may offer a route to finally address this long-standing unfairness.

The other key priority as we hopefully emerge from Covid is the appropriate staffing and resourcing of our community medical teams. Prior to the pandemic, there were significant gaps in teams around the country. While there has been some temporary recruitment, there are still vacancies, and, with the significant catch-up that will be required, we need to enhance and support our service.

I would conclude by thanking my colleagues for all their support during the year and for their massive contribution in response to the pandemic.

When does something cease to be ‘new’?

Dr Clive Kilgallen, Chair of IMO consultant committee, writes that it is high time the 30 per cent salary cut imposed almost a decade ago, on a substantial number of consultants, is reversed

How long before we can finally retire the divisive term ‘new-entrant’ consultant to describe those doctors who were subjected to a unilateral pay reduction of 30 per cent, which came into effect in October 2012?

Many of those who are described as ‘new-entrant’ consultants are hardly ‘new entrants’, having worked in the health service, both as NCHDs and indeed as consultants, prior to the imposed salary reduction.

Let’s retire that term by fixing the problem that created it – a unilateral, arbitrary and inequitable 30 per cent pay cut.

We need to recognise the damage done to our health service by that politically motivated salary cut. Consultant posts, once highly prized and sought after, became increasingly difficult to fill. Over 700 are now without a full-time appointment. Waiting lists for both inpatient and outpatient care grew ever longer, eventually reaching the point where they measure in the hundreds of thousands.

While the number of consultants was reducing, the demand for care was increasing. Consultants found that their services were forced to make up the shortfall brought about by vacant posts. The long-term effects were clear too. NCHDs were denied the teaching contact that they required in an environment in which consultant posts lay vacant and operational imperatives trumped all else.

Where to now?

Having denied the existence of the problem and offered only stopgap measures, in late 2019, the Government proposed a genuinely radical solution. At some point in the future, consultants would be offered a ‘public-only’ contract, and in return for foregoing private practice and private in-

come, those consultants who signed up would be paid the ‘corrected’ type A contract salary, as per the High Court settlement agreement.

Clearly, a lot of negotiation would be required before that point was reached, but the IMO, as was made very clear at the time, would not be found wanting in terms of engaging in that negotiation process. However, we made it clear that we needed a process that fairly and equitably addresses the 30 per cent pay cut.

derway. However, it is fairly standard practice that a process of negotiation designed to produce a new contract would be utilised to try to address outstanding issues that have arisen under the previous contract. This, of course, occurred prior to the publication of the current consultant contract.

Surely, though, there is no bigger legacy issue during the lifetime of the current contract than the very deliberate disadvantaging of a substantial cohort for no reason other than their appointment before, or after, a date seemingly plucked from the sky.

Is it reasonable, or even fair, to expect that negotiations on the next contract can get underway when an embedded unfairness from the previous contract remains? Is it reasonable, or even fair, to conclude a new contract when colleagues who have signed the previous contract are paid so very differently for doing the same job?

The proposal made by the Government in December 2019 survived intact into the current Programme for Government, which makes it all the more disappointing that no meaningful engagement, beyond negotiation by means of press release, has taken place to date. Despite the fact that since the beginning of the pandemic our consultants stepped up, carried on in appalling circumstances, while politician after politician paid lip service and continued with a policy of discrimination.

It is hugely important that we get that process un-

The IMO looks forward to beginning a process of engagement and negotiation with the Government and with health service management to explore these very issues. We have no doubt that it will not be plain sailing – it never is. But let there be no doubt that the process when it begins must, and must quickly, finally, and definitively bring to an end this inequality, which has damaged the health service, damaged patient care, damaged Ireland’s reputation, and broken the trust between consultants and the State. Fixing this issue would be an enormous symbol of the State valuing its highly-trained and committed doctors.

Just as we should retire the term ‘new-entrant’ consultant in this context, let’s fix the problem that caused the term to be used in the first place.

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Forward momentum on NCHD concerns in spite of Covid-19

Senior Industrial Relations Officer with the IMO, Mr Paul Maier, describes the major issues facing NCHDs at this challenging time

Since the beginning of the pandemic, the NCHD body has been at the forefront of the Covid-19 response. The IMO, on behalf of its members, engaged with the HSE on the critical issues around personal protective equipment (PPE), redeployment, annual leave, childcare, and a myriad of new arrangements as the health service reorganised.

From the outset, communication with our members, listening to their concerns and reflecting those issues back to management, has been the focus of our work. Through it all, the importance of an active and strong union was paramount and we are delighted that so many NCHDs joined the IMO this year and got involved in a network of local representatives on the ground. It is testament to the dedication of those members that so many went forward for election to serve on the NCHD national committee.

This starts with our student members, who realised very quickly this year why it was important to be a student member of the IMO. As the pandemic quickly emerged as a major threat, final year medical students had their exams accelerated. Within a matter of weeks, rumours of them being immediately pressed into service were swirling. In this time of uncertainty, we contacted our IMO student representatives on the ground, and they gathered nearly all students into membership.

The IMO served as a key source of reliable communication to this group and negotiated on their behalf with the HSE; first on the number of placements, which will be made available, then the terms of their early entry into the workforce, on the way which their preferences would be calculated, and finally on the payment of online induction activities. We were able to negotiate preferable arrangements for our members in all these areas due to the strength they held and the unified voice they possessed through the IMO.

Member engagement was also critical when it came to understanding the needs of our members on the frontline. We had to adapt to new ways of communicating with members and we relied on the local representative network of over 1,560 NCHDs in hospitals around the country. They gave us essential information on how things were going: Hours worked; changes in the services they provided; and the level of protection they were getting. We were able to advocate on a national level with the HSE on changes were required. We also increased our communication to members through regular updates, webinars and our member advisory service were always on hand to provide clarity, support, and advice.

The IMO negotiated and agreed with the HSE’s national doctors training and planning (NDTP) division to “roll over” individual training support scheme funds for NCHDs in 2020 and 2021. We inserted specific provisions into national union agreements that would allow NCHDs the ability to be paid for annual leave untaken at the end of their employment contract after hearing that NCHDs were unable to take any leave during the height of the pandemic. We secured arrangements for those who could not attend work due to falling ill with Covid that protected their overtime payments. We provided options to our members with childcare responsibilities to alter their working patterns, and if required, work from home, after many reached out to tell us the stress they felt trying to do it all. We were also centrally involved in ensuring that NCHDs were properly prioritised for vaccination and ensured that NCHDs did not fall through the cracks for second doses as a result of the changeover. Through all of these achievements, our connection and communication with members was key to the work of protecting them.


Despite the need to prioritise our response to Covid-19, the NCHD committee has also committed itself to progressing a number of long-standing issues this year.

Chief among these is the ongoing issue of illegal and dangerous working hours. Compliance with the European Working Time Directive (EWTD) was decided in 2019 as the NCHD committee’s first long-term priority, and significant work has been undertaken on progressing this mammoth issue in the past year. An EWTD survey of NCHDs reached over 1,000 doctors across the country, and provided results that showed the reality that NCHDs lived every day. Respondents nationally reported only 25 per cent compliance with an average maximum 48-hour work week and only 69 per cent compliance with a maximum 24-hour shift.

The difference with this survey from those in the past, was that NCHDs didn’t just tell us the hours they were doing, they told us what they were willing to do about it. They are willing to take action to push back on these hours, including participating in group claims, requesting inspections, and even bringing individual complaints to the Workplace Relations Commission. The willingness of members to get involved and take action is key to pushing this issue forward and make legal and contractual compliance a reality for NCHDs across the country.

of all kinds, including immigrant doctors who received their medical education abroad and doctors who immigrated to Ireland to complete medical school in Ireland. Despite a wide and ambitious agenda, the international doctors working group has made more progress on these issues than there has been in years. Through advocacy behind the scenes and through social media, under the IMO banner and in self-organised campaigns, members successfully lobbied for the required changes to the Medical Practitioners Act, allowing all NCHDs the opportunity to compete for training positions. They successfully advocated for an increase in intern and specialist training scheme positions to accommodate greater non-EU applicants.

Members are also in discussions with the HSE to create a non-scheme digital logbook as a foundation for non-scheme educational attainment. In addition, the Department of Justice has committed to expediting its processing of naturalisation applications, research has been presented to training schemes and the HSE regarding the legality of stamp 4 equivalency, and proposals are due to be sent to all Hospital Groups promoting the expansion of two-year commitments to NCHDs, permitting them to obtain a critical skills work permit.

The women in medicine working group, led by Dr Rachel McNamara, focused its efforts on a number of projects: The use of surveys to reduce uncivil workplace behaviour; a survey exploring the experience of healthcare workers who are pregnant; increasing access to flexible training positions; and an expansion of geographic localisation of training schemes to reduce cross-country moves. In these areas, significant progress has been made: Proposals are being developed to include uncivil behaviour checks in training scheme evaluations and the Your Training Counts survey from the Medical Council; the survey on pregnant healthcare workers is currently live and has had successful engagement from NCHDs across the country; the IMO is working with training schemes to expand flexible training positions and to increase interest and promotion of such roles, including through job-sharing; and exploratory discussions through the MacCraith group on medical training have found general consensus for greater localisation and more notice for required moves.

New working groups

The NCHD committee also began four new working groups which focus on specific policy areas. These groups provide a more focused and dedicated effort on issues which require deep expertise and a consistent, concerted campaign. These working groups focused on 2020 interns, international doctors, women in medicine and health and wellbeing. Each is comprised of approximately 10 NCHD members, led by a national committee chair who meets with the group quarterly and reports progress back to the national committee.

The 2020 interns group, led by Dr Jamie McGettigan, initially kept its focus on their early entry into medicine, but as the year unfolded, progressed matters like the need for increased basic specialist training, positions to ensure adequate opportunities for the expanded intern group, the need to pay all overtime worked and approved without exception, and a form of recognition for serving over one year at the intern rate of pay. On the last issue, the working group has corresponded with the HSE National Director of Human Resources proposing a solution and is prepared to make a collective claim on behalf of all interns in respect of compensation for their unique service.

The international doctors working group, led by Dr Eoin Murphy, is comprised of “international doctors”

The health and wellbeing working group, led by Dr Norella Broderick, has undertaken a series of literature reviews to better understand the impact of long working hours, night working and shifts from night-to-day working patterns on doctors, using studies on other professions such as aviation. This review includes a perspective on both physical and mental health and the shocking findings from this review are currently being compiled for publication and promotion in the media. In addition, groundwork is being laid to develop a programme of peer support and training for IMO reps to assist their colleagues in times of stress and difficulty. The group is considering the use of coaching principles and the creation of ‘Balint groups’ to allow NCHDs room to share their challenges and affirm a working reality, which can often be both deeply personally challenging and, as can be seen with the NCHD experience on working time, outright denied and contradicted by the system itself.

Through all these activities, the engagement of NCHDs and their NCHD committee, led ably by the tireless efforts of outgoing Chair Dr Paddy Hillery, have been the key to our success in the year past. Now the 2021-2022 IMO national NCHD committee, elected in one of the largest, most competitive and diverse NCHD committee elections in recent memory, has the task of bringing all of this work forward into a new era.

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An EWTD survey of NCHDs reached over 1,000 doctors across the country, and provided results that showed the reality that NCHDs lived every day

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Brintellix® (vortioxetine) film-coated tablets

Prescribing information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing, particularly in relation to side effects, precautions and contraindications.Presentation: Tablets containing 5, 10, 15 or 20mg of vortioxetine (as the hydrobromide). Indication: Treatment of major depressive episodes in adults.

Dosage: 10mg once daily. Dose may be increased to a maximum of 20mg daily or reduced to 5mg if necessary. After depressive symptoms resolve, treatment for at least 6 months is recommended. Can be taken with or without food. Elderly (≥65 years): Initial dosage is 5mg once daily. Caution advised if using doses above 10mg daily as data are limited. Children and adolescents (<18 years): Not recommended as safety and efficacy not established. Cytochrome P450 inhibitors and inducers: Consider a dose reduction of vortioxetine if a strong CYP2D6 inhibitor is added. Consider a dose adjustment if a broad CYP450 inducer is added to treatment. Renal or hepatic impairment: No dose adjustment is needed, however exercise caution given that these subpopulations are vulnerable and data on the use of Brintellix is limited. Contraindications: Hypersensitivity to the active substance or excipients. Concomitant use with non-selective, monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (e.g. moclobemide). Fertility, pregnancy and lactation: Should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus. Limited data on the use of vortioxetine in pregnant women. Animal studies have shown reproductive toxicity. Use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). It is expected that vortioxetine will be excreted into human milk, and a risk to the breastfeeding child cannot be excluded. Animal data showed no effect on fertility, sperm quality or mating performance. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far. Warnings & Precautions: Closely supervise patients, especially those at high risk, for suicide-related behaviours during first few weeks of treatment and during dose changes. Use with caution in patients: at risk of hyponatraemia; with a history of mania/hypomania; aggression/agitation; undergoing ECT; with unstable epilepsy (discontinue if seizures begin for the first time or increase in frequency); with bleeding tendencies/disorders, taking anticoagulants or medicines affecting platelet function; in patients on lithium or tryptophan; with increased intraocular pressure, or those at risk of acute narrow angle glaucoma. Monitor patients for appearance of serotonin syndrome or neuroleptic malignant syndrome and discontinue if occurs. Patients may experience feelings of aggression, anger, agitation and irritability. Patients/caregivers should seek medical advice if such behaviour emerges or aggravates. Brintellix tablets contain sodium (<1mmol/ tablet). Drug interactions: Alcoholic drinks not advisable. Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9. Potential for interactions with: MAOIs, MAO-A and MAO-B inhibitors; serotonergic medicines (e.g. triptans or tramadol); St John’s wort; products which may lower the seizure threshold, e.g. antidepressants (tricyclic, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine or bupropion. Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment. Additionally, these effects may be greater in patients who are poor metabolisers of CYP2D6. A dose adjustment may be considered if a broad cytochrome P450 inducer (e.g. rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment. There have been reports of false positive results in urine enzyme immunoassays for methadone in patients

taking vortioxetine. Exercise caution in interpreting positive drug screen results. Effects on ability to drive and operate machines: No or negligible influence however, as dizziness has been reported, use caution at the start of treatment or when the dose is changed. Adverse events: The most common adverse reaction is nausea, which is usually mild or moderate, transient and occurs within the first two weeks of treatment. The following have been reported in clinical trials and during post-marketing use: Very common (≥1/10 patients); nausea. Common (≥1/100 to <1/10); abnormal dreams, dizziness, diarrhoea, constipation, vomiting, pruritus, including generalised pruritus. Uncommon (≥1/1,000 to <1/100); flushing, night sweats. Rare (≥1/10,000 to <1/1,000); mydriasis (which may lead to acute narrow-angle glaucoma). Not known (from post-marketing reports); anaphylactic reaction, hyponatraemia, insomnia, agitation, aggression, serotonin syndrome, haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding), angioedema, urticaria, rash. Sexual dysfunction: The 20mg dose of vortioxetine was associated with an increase in sexual dysfunction. Class effect: Studies in patients ≥50 years of age, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. Not known if relevant to vortioxetine. Prescribers should consult the full SPC in relation to other side effects. Overdose: Management consisting of treating clinical symptoms and relevant monitoring. Legal category: POM, for non-renewable supply. Brintellix Tablets, blisters of: 5mg (EU/1/13/891/002) 28 tablets. 10mg (EU/1/13/891/010) 28 tablets. 15mg (EU/1/13/891/019) 28 tablets. 20mg (EU/1/13/891/028) 28 tablets. Further information available from: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co. Dublin. Tel: 01 468 9800. Date of last revision of PI: July 2020.

Reference: IE-BRIN-0214. Brintellix® is a Registered Trade Mark.

Job number: IE-BRIN-0222

Date of preparation: July 2020

Reference: 1. Brintellix Summary of Product Characteristics. Available at (Accessed: July 2020).

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Lundbeck on: 01 468 9800 Email:

Enabling people with depression to feel, think and do better

What do international comparisons of Covid-19 responses tell us?

HIQA’s recent international review of different ‘lockdown’ strategies contains an important caveat at the end.

“Public health measures adopted by countries to limit the spread of Covid-19 are constantly changing,” according to the review on public health measures and strategies to limit the spread of Covid-19.

“As such, the review may have missed relevant information that was just (or about to be) published at the time of the review. To the best of our knowledge, the review is accurate as of 12 March 2021.”

The document, which was submitted to the national public health emergency team (NPHET), was published on 22 March. This issue of the Medical Independent is out on 8 April, which is almost a month since the review was completed. A month is a long time when it comes to Covid-19.

HIQA also highlights the difficulty in comparing different countries with regard to the pandemic. The document notes that comparisons of the testing data, including test positivity, are not easy due to changes in testing criteria over time. There are also variations in the way countries define ‘tests performed’. For example, the unit may refer to the number of tests performed or the number of people tested. Also, it states that variations in the epidemiological data, such as the 14-day notification of new cases, may be observed across different data sources due to differences in underlying population data. A cynic might say that such technicalities could be used by governments to excuse subpar responses to the pandemic.

These challenges in making comparisons do not prevent the Authority from drawing some broad conclusions.

The review focused on the national response to Covid-19 in 17 countries


that were experiencing a resurgence in Covid-19 cases in October 2020 and which were identified by NPHET as being in a similar phase of pandemic response as Ireland.

HIQA says the measures that are being applied elsewhere are largely consistent. However, there are many differences in the detail between countries. The more prominent of these include how movement is restricted by numbers permitted at gatherings, events, religious services, and sporting activities; and the operating hours of businesses allowed to open within the hospitality sector.

HIQA found only five countries –Czech Republic, Ireland, Israel, Portugal, and the UK – had seen a reduction in 14-day case numbers per 100,000 population over the previous seven days to 14 March 2021, while all other countries included in the review had seen an increase. Comparing Ireland to other countries, hospitalisations per million population were lower only in Denmark and The Netherlands. Similarly, the numbers in ICU per million population were lower only in Denmark and the UK.

For the Irish Government, the review makes positive reading, as it continues to face questions about the current protracted lockdown and difficulties in the roll-out of the vaccination programme. But HIQA’s point about the limitations of the review is worth bearing in mind. Also, what would a review look like which focused more on the Government’s calamitous lifting of restrictions before the Christmas period and the almost unbearable pressure it placed on our health service? For a global pandemic, international reviews are essential to ascertain best practice and hold individual governments to account. We should also be aware of any study limitations, question how comparisons were made, and ask how critical they are of official policy.



"Credit Medical Independent they got this – crucial given the calamitous state of HSE IT in Covid." Eamon Keane, @EamonBKeane, 25 March


"It's not only the young Irish doctors that are leaving, it's also the young foreign doctors." Dr Omaima AlNajjar, @OmaimaAlnajjar, 21 March

"Yes, pandemic will add fuel to ongoing chronic emigration from non-EU community as well. We need to strive hard and take some quick actions to #PreventBrainDrain. Thanks @CathyReilly @pdmaier for bringing this to light." Dr Liqa Ur Rehman, @LiqaDr, 15 March

"I will, quite literally, skip out of the hospital in July to a life of uncertain unemployment for at least six months (maybe a dalliance with Oz or NZ for another six-to-18 months thereafter)." IrishHealthInsider, @health_irish, 20 March

"Ireland look after those who have looked after you. Our crisis is going to the critical edge. It is not just the pandemic, it's civility, it's equality, it's training opportunities, it's stability. It's a cycle, learn from the past. It's #fastTrackCitizenship, it's @WeCanBeZero, it's now." Gill Berry, @fahyberry, 20 March

"A real concern across the board for medics nurses and HSCPs."

Dr Adrienne Foran, @Ampforan, 20 March

"Like anybody needs another incentive to leave the Irish healthcare system."

Liam Callaghan, @LiamoJC, 20 March

"Could is the wrong word, it will and it is. I never wanted to leave to go to Oz, but after this year I couldn't face another in the Irish system. I am very much not alone either."

Dorarca Lynch, @Dorarca, 20 March

"1. Leaving because they will be treated with respect, given a chance at a normal life and be able to train to a high standard. 2. May not be able to get training position if they stay. Oh lord. Come July, the system is going to be even deeper in trouble."

Claire Shanahan,@ClaireShanaha10, 20 March

"We need to retain talent, training opportunities shall be family friendly, ensuring family life and progress for all doctors in Ireland esp for international doctors! #trainus4ireland #criticalskillspermitfordoctors." Dr Saira Tabassum, @SaairaDr, 20 March


"This is shocking. With Tulsa committing to offer final year social work students employment to provide support to vulnerable children and families, surely services safeguarding older people at risk can be similarly resourced with safeguarding module as part of final year?" Jeremy Chapman, @Jeremychapman15, 19 March

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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:, e-mail: medsafety@ 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,

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:; E-mail: medsafety@ Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744. References: 1 MIMS Ireland November 2020 2. Eklira® Genuair® Summary of Product Characteristics, last updated November 2019 3 Brimica® Genuair® Summary of Product Characteristics, last updated August 2019 4 Magnussen, H et al. COPD. 2019 Apr;16(2):196-205

Receiving and storing patient images

The increased use of remote consultations during the Covid-19 pandemic has caused a lot of queries about the receipt and storage of images sent by patients. Dr Rachel Birch, Medico-legal Consultant at Medical Protection, reviews the relevant guidance

The medico-legal implications of obtaining and storing images of patients, including children, are increasingly coming under the spotlight for many doctors because of the now-commonplace use of remote consultations during the pandemic.

The relevant Medical Council guidance in such situations is covered under Chapter 4 of the Guide to Professional Conduct and Ethics for Registered Medical Practitioners

Paragraph 34 provides guidance on recording and, whilst it is written in a way that is aimed at a clinician making an image or recording of the patient, in the current situation it would still apply in a remote consultation where the patient has made the image, and particularly if they have done so at the request of the clinician.

34.1 Audio, visual or photographic recordings of a patient, or a relative of a patient, in which that person is identifiable should only be made with their express consent. You should keep these recordings confidential as part of the patient’s record. You should be aware of security when sharing information by electronic means, including text, other electronic messaging or emailing, and you should do all you reasonably can to protect confidentiality. You should get consent before sharing videos, photos or other images of patients.

34.2 In exceptional circumstances, you may take images of patients using your personal mobile device. You should do so only when this is necessary for the patient’s care. The images must not identify the patient, must be kept for the minimum time needed, and must be deleted as soon as possible. You are responsible for data protection in this regard and you must comply with any rules and procedures of your employer.

Paragraph 33 addresses medical records and, in particular, paragraphs 33.1, 33.2 and 33.4 are relevant here:

33.1 Medical records consist of relevant information learned from or about patients. They include visual and audio recordings and information provided by third parties, such as relatives.

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

33.4 You must comply with data protection and other legislation relating to storage, disposal and access to records. You should understand the eight rules of data protection.

Consent and images of children

If you have asked for the parent or guardian to send a particular photograph, for example of a rash on the child’s arm or of their swollen ankle, then it would be important to remember that this image forms part of the consultation and should be stored within the patient’s medical records. It would be advisable to record the consenting discussion that you have had with the parent in the clinical record. It would also be prudent to make a note of the clinical relevance and purpose of the images to justify their use and storage.

The Medical Council advises, in Section 18 of their ethical guidance, that children and young people should be involved as much as possible in decisions about their healthcare and their views should be listened to. The age

of consent for medical treatment is 16 years. However, young people may have the capacity at an earlier age than 16 to be involved in a decision to share a photograph of them, and, if so, they should be encouraged to be involved in that decision.

Where a parent or guardian has sent a photograph unsolicited, it might seem as though they have given implied consent. However, if this would not be an image taken in the course of a normal face-to-face consultation, or if the image is of an intimate area, you should confirm with the parent or guardian that they consent to you viewing and potentially storing the image, or even sharing the image (for example, if you required a second opinion).

The Medical Council, in its ethical guidance, reminds doctors of their obligation to protect children:

26.1 You must be aware of and comply with the national guidelines and legislation for the protection of children, which state that the welfare of the child is of paramount importance.

26.2 If you believe or have reasonable grounds for suspecting that a child is being harmed, has been harmed, or is at risk of harm through sexual, physical, emotional abuse or neglect, you must report this to the appropriate authorities and/or the relevant agency without delay. You should inform the child’s parents or guardians of your intention to report your concerns taking into account that this may endanger you or the patient. Giving relevant information to appropriate authorities or statutory body for the protection of a child is a justifiable breach of confidentiality, provided that you follow the guidance in paragraph 31.3.

Under the Children First Act 2015, doctors are “mandated persons” who are legally obliged to report their concerns, as soon as practicable, to Tusla if they believe that a child has been harmed, is being harmed, or is at risk of being harmed.

If, on review of a photograph, you are concerned that a child may be at risk of harm, it is important that you take the appropriate steps to protect that child. Doctors may wish to contact Tusla and their medical defence organisations for advice in such a circumstance.

Storage and recording consultations

It would be advisable to approach your IT provider as they would be able to advise whether it would be possible to store any video consultations and photographs, and if so, how. Medical Protection is unable to provide specific advice on IT systems; however, it is important that you consider Data Protection Commission guidance on data security matters.

In any remote consultation, it is important to take careful and detailed notes, as in a face-to-face consultation, ensuring that it is clear within the records that this is a remote consultation. You might also wish to discuss with the patient how and where the consultation would be stored at the start of the consultation, being mindful that a copy of this consultation could be requested by the patient. You should ensure any personal and sensitive patient data is stored and recorded in accordance with the General Data Protection Regulation.


If it is clinically appropriate to store an image of a patient, whether adult or child, then a practice or hospital is unlikely to be criticised. The Medical Council is clear that audio and visual recordings should form part of the medical record. However, practices and hospitals may want to consider whether their IT system would allow for particularly sensitive images to be flagged as such, signalling extra caution needed when disclosing the medical record.

We strongly recommend discussing the matter further with colleagues, in order to agree on and develop a policy that creates a consistent approach. As with any new policy, all staff members should be trained on this and it should be reviewed at regular intervals and updated as necessary. It is important also to be aware that guidance available to clinicians during the pandemic is constantly evolving and you should stay updated on Medical Council and ICGP guidance.

THE MEDICAL INDEPENDENT | 8 APRIL 2021 18 Opinion Medico-Legal
If you have asked for the parent or guardian to send a particular photograph, for example of a rash on the child’s arm or of their swollen ankle, then it would be important to remember that this image forms part of the consultation and should be stored within the patient’s medical record

Throwing those curtains wide open

T“his time last year” (as many of us have been saying recently) I was getting ready to pack our car with excited children, a supportive husband and boxes of goodies that would fill the conference packs to be handed out at the third annual WiMIN conference in Belfast. The conference would take place on Saturday, and we had planned out our family excursions for Sunday –Titanic museum, Botanic Gardens, Peace Wall. I was flat out with preparations for my first “international” event – flights were booked for speakers from all over the UK and I had a team on the ground in Belfast searching for thoughtful local gifts to show our appreciation to people taking these long journeys.

About two weeks before the big day, however, the frenetic energy within me began to slow down. I sensed that all of these meticulous preparations may have been in vain. The first few Covid cases started trickling in (ominously enough, the first case on the island was a women who had travelled through Dublin and onwards to Belfast). I hastily looked into event insurance (lesson learned for the next time), but was told it would not cover cancellation due to a pandemic (you could almost see the pencil scratches where they had frantically added this clause to all of their policies). I knew that I would have to make a decision sooner rather than later, to clarify the situation

for the speakers and attendees. In a way it was easier that it was an event for doctors. The optics of gathering a bunch of vital frontline clinicians in one room would not have been good and even worse if they had all toddled back to hospitals in all four corners of the country, merrily incubating the little CoV-2 fecker in their nasal passages. So the plug was pulled and the Belfast dream was postponed to September.

August arrived. CoV-2 still around. The fecker.

Postponed to March.

February arrived. CoV-2 was still all over the country, continent, globe.

Feck this anyway.

My speakers had been extraordinarily patient with my sporadic and vague emails about flight postponements, and cancellations, and putative alternative dates.

In the end, like every single other thing that is happening right now, we all stayed in our own homes and turned on our computers at a given time, spoke our words into a tiny unseen microphone, glanced occasionally at a little blinking camera light and hoped that everyone out there wasn’t screaming “You’re on mute!” at us.

And yet, despite the miserable constraints that are suffocating us all right now, we spent the next three hours throwing our metaphorical curtains wide open and travelling into other people’s universes. Our first speakers broke that didactic Zoom barrier by engaging in a conversation with each other on screen where they shared some of the experiences they have had as medical trainees who wear the hijab. How they have been excluded from surgical theatres because no one thought about ensuring they had access to the correct surgical caps. How they have been excluded from mealtimes because of misguided

beliefs about their religion. How they have been offered sub-standard breastfeeding facilities because, well, most likely, because of their race.

Our minds were opened to the concept of neurodiversity being just as vital to the fabric of our society as biodiversity is to the natural world. We came to appreciate the potential dangers of undiagnosed autism in physicians, with significant increases in mental distress and suicidality. We learned about similar health inequities for doctors, and patients, who do not fit the traditional heterosexual norms. We were heartened by the progress that can be made when people who would formerly have felt excluded have the opportunity to meet with others in similar circumstances. We learned about the support networks that are available to migrant women, and how increased clinician awareness of traumatic experiences, such as female genital mutilation, can allow these women to heal physically and emotionally.

We considered the huge impacts of the climate crisis on global health, and discovered a myriad of changes we can make in our personal and professional lives to mitigate against it. We were encouraged to think about where our money goes – do we really want our savings to be propping up the arms or tobacco industries? And we were prompted to consider how all of us working within the all-consuming space that is medicine need external support, and were reminded to be grateful for our right-hand-men/women.

For a few hours we were able to free ourselves from our small, Covid-compressed lives and see the bigger picture.

A recording of the third annual Women in Medicine in Ireland Network (WiMIN) conference is now available for viewing on the Medcafe platform

What does the experience of Covid-19 have to teach us?

volvement, what were we thinking?

One year on from the beginning of the Covid-19 pandemic, what have we learned? It would be easy to focus on the gloomy answer to this question. But before I do, let’s acknowledge some of the positive aspects of the last year.

As a long-time sceptic of the scope of practice possible using telemedicine, I’ve been amazed at how readily doctors and patients have taken to this form of consultation. Not being able to lay a hand on a patient remains a problem for me. However, it has to be said that I’m in a minority. Patients in particular have adapted readily to the undoubted convenience of audiovisual interaction with their doctors. It has been so successful that the value of telemedicine must be one of the biggest learning points in healthcare from the pandemic. I cannot see its utility being abandoned in the new “normal” world.

Other positives include a reduction in road traffic accidents as fewer people are on the roads during lockdown. And the environmental benefits in terms of pollution levels dropping across the world are striking.

On the debit side of the equation, some of our knee jerk reactions to the new coronavirus were laughable: Where did the insatiable desire to hoard toilet paper come from? For what seemed at the time to be primarily a respiratory virus, with no obvious gastrointestinal in-

Apparently it can be explained by a concept called “social proof”. We are influenced by each other. Show us images of selfish lockdown behaviour and we are more likely to be selfish; show us noble altruists and we aspire to be like them. But strict rules around social distancing tend to be blunt instruments, when a lighter touch may well have caused less collateral damage. Tim Harford, The Financial Times ‘Undercover Economist’, said we may have done better with altruism, social pressure and clear guidance.

“Japan’s advice – to avoid the ‘three Cs’ of closed spaces, crowded places and close contact – is far more memorable to me than whatever strange combination of households, settings and exemptions the authorities... are currently allowing,” he wrote.

Some public reactions to Covid-19 surprised experts. Rather than vaccine development being a major hurdle, after watching the reaction to Covid-19, experts say the biggest future challenge will be convincing people to take the steps that are necessary to protect humankind from a threat. Dr Iruka Okeke, a Professor of Pharmaceutical Microbiology at the University of Ibadan in Nigeria, said it has been impossible to make people stay home or wear mask to avoid transmission in most countries.

“When given the choice between skipping a holiday and posing mortal risk to another’s life, sufficient numbers of people have chosen the latter and we have to presume that they will do it again,” she told Nature Medicine

Clearly, being ready for the next pandemic goes beyond science and requires looking at societal issues also. An effective pandemic response requires a clear, con-

sistent voice and an actionable message. This message needs to be individualised and must evolve over time. Risk communication experts have started looking at the best ways people can manage the flood of information during a pandemic. There’s been an ‘infodemic’ of Covid-19 fake news, and so we need new strategies for sharing reliable information.

Of course, we are nowhere near the end of the pandemic. More lessons will be learned before then. According to Andrew Pollard, the Chief Investigator for the Oxford/Astra Zeneca vaccine, “the end of this pandemic is not the end of this virus, it’s the end of an unsustainable impact on health systems. If we can convert it into something more innocuous, then we will have the end of the pandemic in sight.”

History suggests that pandemics rarely finish in a neat way. Diseases are seldom eradicated and outbreaks of Covid-19 will continue to emerge. It is our collective attitude to the disease that is likely to decide when the pandemic is over.

Harford lays out what he thinks we have learned in the past year: “I’ll remember to trust the competence of the government a little less, to trust mathematical models a bit more and to have some respect for the common sense of ordinary people.”

Rural medicine is an important part of general practice here. Readers may be interested in a virtual “Rural and Remote Medicine” conference run by the Society of Rural Physicians of Canada. It takes place from 22 to 24 April. Northern Ireland GP Declan Fox is involved and for those who would like more information his email is

The recent WiMIN conference might have taken place remotely, but it provided much needed respite and allowed us to travel into each other’s universes for a brief period of time
Read more by Dr Sarah Fitzgibbon at
Being ready for the next pandemic goes beyond science and requires looking at societal issues DR MUIRIS HOUSTON Read more by Dr Muiris Houston at @muirishouston

Why the Hippocratic oath is a load of nonsense


be sticking steadfast to the Medical Council ethical guidance in favour of bygone oaths

‘Do you seriously mean to tell me you haven’t taken the Hippocratic oath?’

Politicians say it is the little thing that trips you up and they should know, especially when it comes to the tricky arena of broadcast journalism.

So when I was asked about the Hippocratic oath on my weekly radio spot I did not see it as a tripping hazard, and treated the matter lightly enough. It was a welcome change from the usual R numbers and vaccine roll-out discussion, so I blithely confessed that not only had I not taken the oath, but I had not thought about for many a long year.

I went on innocently to suggest that if there had been a swearing in ceremony in what was then known as University College Galway, I might have been at a music session in a Quay Street pub and missed the whole thing. However, what I did have was the Medical Council guidelines and they were enough.

Not everyone appreciates a jokey comment on a local radio discussion. Some listeners were apparently incensed that I should dare to practice at all, not having undertaken a solemn oath, and kicked up a fuss.

So I took a look at this oath, in case I could read it aloud off Wikipedia and be done with it.

First, I would have had to undertake to swear by Apollo, Asclepius, Hygieia, and Panacea. Any leanings I had towards Hippocrates and his oath stopped right there. It may surprise you, but I have no fear of the Greek Gods or any hell they would send me to for oath-breaking. Zeus and his family were such a vicious incestuous bunch, I would have doubts about their medical ethics.


Question 1

Sebaceous cysts

If I had to swear to pre-Christian Gods at all I would rather the Norse Gods. But an oath of any sort is a tricky business as Uhtred Ragnarsson could tell you. Uhtred is the protagonist in the excellent Last Kingdom books and TV series, a pagan who swears an oath to King Alfred the Great and spends most of his adventurous life regretting it. An oath binds you, right or wrong, and whatever the Great but cunning Alfred does, Uhtred has to support him, although his conscience is tested sorely and often.

Not a great way for a family doctor to be – oath-bound.

We live in a secular State and it took us a long time to get here. In Ireland’s past, doctors and politicians put religion before their patients.

Those who bent the knee and kissed the bishop’s ring oversaw babies taken from young mothers and given to the rich. The ‘Rare Ould Times’ were no place to be if you were gay, a single parent, or simply had a different form of Christianity. However, those who had taken their Pius Catholic oaths and were members of secret fraternities got on just fine and found the best of jobs and opportunities. Grinding the face of the widow and the orphan into the gutter for profit and persistent drunkenness on the job were oath free zones.

I have worked with doctors of many faiths and nationalities and in all cases I hoped that they left their religion at the hospital door. I really don’t want to attend somebody whose religion tells them that an illness is God’s vengeance or twins should be left to die in the jungle.

In any case, the Hippocratic oath is a load of nonsense. There is something about treating your teachers like family (I suppose I would give most of them a lift to football and a few quid on a Saturday night, but I draw the line at Christmas presents) and women don’t seem to figure much as patients. There is something about abortion, which may be the reason those listeners took more than a passing interest.

In retrospect, I gave the best answer I could have. The Medical Council guidelines are updated regularly. Hippocrates may have had his good points, but I doubt if you could use him as a resource on the advisability of accepting a Facebook friend request from a patient.

I have, as it happens, more Scandinavian blood than Uhtred, who was born a Briton, and I am becoming more drawn to Viking myths and legends. But you will not see me pressing a sword into the hand of a patient on their death bed, so that when they die they will go to Valhalla. Any vows I have made are my own and outside of work, nobody’s business.

A. Are never seen on the scrotum.

B. Characteristically can be moved separately from the overlying skin.

C. May have a central punctum.

D. On the scalp can only be removed after shaving of the surrounding hair.

E. Are prone to infection.

Question 2

When assessing a four-to-10-year-old child with a limp, the most likely diagnostic possibilities include

A. Osgood-Schlatter disease.

B. Neoplasm.

C. Perthes’ disease.

D. Slipped capital femoral epiphysis.

E. Non-accidental injury.

Question 3

In depression, in practice

A. Approximately 50 per cent of patients suffering from depression will consult with a psychological or emotional problem.

B. Early detection results in better long-term outcome.

C. Men living alone are at a higher risk of suicide.

D. Patients with recurrent, moderate depression who have responded well to antidepressants should continue for at least nine months after recovery.

E. An adequate trial of a drug is two-to-three weeks.

Question 4

Well-recognised signs and symptoms of hypothyroidism include

A. Tinnitus.

B. Weight gain with increased appetite.

C. Atrial fibrillation.

D. Slow, gruff speech.

E. Loose bowels.

Question 5

In primary polycythaemia

A. Red and white cells produced have normal function.

B. Recognised features include generalised pruritus.

C. The spleen will be palpable in nearly all cases.

D. Untreated median survival time is only 18 months.

E. First-line of treatment is interferon.

E. FALSE. Regular venesection, taking a pint about every six-to-12 weeks.

D. TRUE. Mainly from strokes. Treatment to reduce the PCV improves this to a median of 10-to-15 years.

C. FALSE. As in other chronic myeloproliferative disorders is enlarged in about 50 per cent of cases.

B. TRUE. Also plethora, conjunctival injection, gout, headache, high blood pressure.

A. TRUE. But platelets can hypo or hyper function.


E. FALSE. Constipation, abdominal distention.

D. TRUE. And poor memory, somnolence.

C. FALSE. Bradycardia, reduced cardiac output.

B. FALSE. With decreased appetite.

A. FALSE. Hearing loss.


E. FALSE. You should try a drug for at least six weeks before considering switching therapy.

C. TRUE. As are the recently bereaved and elderly.

B. FALSE. There is no evidence for better medium- or longterm outcome with early detection.

A. FALSE. Only 20 per cent will.


E. TRUE. Suspect at any age.

D. FALSE. Usually 11-to-16-year-olds, if suspect urgently refer.

C. TRUE. With transient synovitis present in four-to-10-year-olds.

B. TRUE. Also fracture, soft tissue injury, cellulitis, septic arthritis should be considered at any age.

A. FALSE. Affects 11-to16-year-olds.


E. TRUE. Often after minor trauma.

D. FALSE. No need to shave the hair if the cyst is not infected.

C. TRUE. And cheesy, unpleasant contents.

B. FALSE. Fluctuant and cannot be moved separately from skin.

A. FALSE. Common on scalp, face, ear lobule, scrotum, but never on palms or soles as they are gland free.

D. TRUE. Monitor to ensure adherence to treatment.


Read more by Dr Pat Harrold at
Hippocrates may have had his good points but I doubt if you could use him as a resource on the advisability of accepting a Facebook friend request from a patient

Paradigm shifts in the management of breast cancer

Is surgery now a redundant procedure for certain subgroups?

 Breast cancer is the most commonly diagnosed cancer (excluding skin cancer) and the leading cause of cancer mortality in females, accounting for one-third of cancer cases diagnosed in Irish females between 2015-2017.

 The management of breast cancer has changed significantly over time due to the remarkable improvement in our disease knowledge and the unprecedented progress in science.

 I will highlight some of these significant changes in this article.

Breast cancer was described for the first time as a bulging tumour by an Egyptian surgeon in 460 BC and he believed that there was no curative treatment for this tumour, while Hippocrates thought breast cancer developed due to excess bile and surgery had a deleterious effect, and he named it ‘karkinos’, which means crab in Greek.

Dr William Halsted, a pioneer surgeon, proposed that breast cancer spread in a stepwise fashion from the breast to pectoralis muscles then to lymph nodes which work as a barrier for distant metastasis. In 1882 he documented his radical mastectomy in which he removed the breast, pectoralis muscles, and the entire axillary nodes and achieved 97 per cent local and 80 per cent locoregional control within three years. Up to 1970 it was performed in 90 per cent of breast cancer patients in the US, however, the morbidity was high despite low perioperative mortality.

In contrast to Halsted, Dr Bernard Fisher thought breast cancer was primarily a systemic disease and less surgery (eg, lumpectomy) might be appropriate and he preserved the pectoralis muscles and achieved comparable survival, while Dr David Patey preserved the pectoralis major muscle and his technique was less morbid compared to that of Halsted’s.

After the advent of widespread availability of radiotherapy and in an attempt to reduce surgical morbidity, the Surgical Adjuvant Breast and Bowel Project (NSABP) initiated the B-04 trial in 1971, which randomised 1,700 breast cancer patients with negative axillary nodes into three groups; Halsted radical mastectomy, simple mastectomy with locoregional irradiation, and simple mastectomy without irradiation. After a median follow-up of 14 years there was no difference in local treatment failure, distant metastasis or survival and this established the emerging role of simple mastectomy.

This approach encouraged the NSABP to conduct another trial in 1976 (NSABP B-06), which randomised 2000 women to total mastectomy, lumpectomy alone, or lumpectomy followed by breast irradiation. All had axillary dissection and after more than nine years of follow-up, ipsilateral breast cancer recurrence was 43 per cent and 12 per cent for lumpectomy without radiotherapy and for lumpectomy with radiotherapy, respectively, without any significant difference in distant disease-free survival (DFS) or overall survival among the three groups. The same benefit for lumpectomy and radiotherapy still stands after 20 years follow-up and the equivalence of mastectomy to breast conserving therapy (BCT) was confirmed in a meta-analysis.

Breast cancer was hypothesised to be a systemic disease with circulating tumour cells in the blood and the

cytotoxic effect of chemotherapeutic drugs on these cells led to the development of adjuvant chemotherapy after surgery. In 1971 the NSABP study using L phenylalanine mustard after radical mastectomy for patients with positive axillary nodes confirmed better DFS for the adjuvant group and Bonadonna et al, in a study for adjuvant CMF chemotherapy after radical mastectomy in primary breast cancer with positive axillary lymph nodes, showed that treatment failure occurred in 24 per cent of the control group and in 5.3 per cent of the adjuvant group after 27 months follow-up. During this era, conservative breast surgery with radiotherapy and adjuvant chemotherapy was considered the standard treatment for most breast cancer patients.

Recently, as an attempt to reduce the morbidity from axillary dissection, the ACOSOG Z0011 phase 3 trial (1999-2003) randomised female patients with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and one or two positive sentinel lymph nodes. All patients had planned lumpectomy, tangential wholebreast irradiation and adjuvant systemic therapy and those patients were randomised into axillary dissection versus no dissection and after 10 years follow-up the regional recurrence did not differ significantly between the two groups.

The result was echoed in principle by the AMAROS trial, which randomised patients with T1-2 primary breast cancer and clinically negative axillary nodes into either axillary lymph node dissection or axillary radiotherapy in cases where a positive sentinel node was identified and after a median follow-up of six years the axillary control was comparable with significantly less morbidity in the radiotherapy group. Nowadays sentinel lymph node mapping is considered the standard approach and axillary dissection is preserved for cases with high burden of nodal disease.

Neoadjuvant chemotherapy (NAC)

Neoadjuvant therapy refers to the administration of sys -

temic treatment prior to definitive surgical treatment with the aim of downstaging the tumour. This may allow less extensive surgery of the breast and/or ipsilateral axilla, possibly permitting the avoidance of mastectomy. It would also allow in vivo evaluation of the effectiveness of a selected systemic therapy, which may be a strong prognosticator for the risk of relapse.

The remarkable improvement in the treatment outcome of some cancers like head and neck, oesophageal cancer, osteosarcoma and even locally advanced breast cancer with the use of neoadjuvant systemic treatment encouraged the NSABP to randomise 1,523 women with operable breast cancer to four cycles of AC chemotherapy followed by surgery versus surgery followed by four cycles of AC chemotherapy. Although the overall survival was equivalent, the rate of breast conservative surgery (BCS) was higher in the neoadjuvant treatment arm.

As of today, neoadjuvant systemic treatment (NST) is used in 17-40 per cent of early breast cancer patients depending on their biological subtype.

Pathologic complete response (pCR) is achieved in 20 per cent of all patients after NST. The achievement of pCR depends mainly on breast cancer subtype and stage and it is achieved in approximately 40 per cent of HER2-positive cases, 23 per cent of triple-negative tumours and 0.5 per cent of luminal A tumours. However, recent studies for dual HER2 blockade for HER2-positive tumours and carboplatin-based chemotherapy regimes in triple-negative tumours have revealed pCR rates up to 68 per cent and 80 per cent. This illustrates that pCR rates after NST might increase even further in the years ahead. Nowadays the role of NAC is well-established and is the major player in trials of non-surgical treatment of breast cancer.

Radiotherapy: More is not always better Post-mastectomy radiotherapy has improved DFS and

Clinical Oncology THE MEDICAL INDEPENDENT | 8 APRIL 2021 22
Continued on p26 ▸

Flexible scheduling for your second-line non-small cell lung cancer patients*1-3

Every 3 weeks: Fixed dose 1200 mg IV (1 vial)2


Every 4 weeks: Fixed dose 1680 mg IV (2 x 840 mg vials)3

Once prepared, TECENTRIQ remains stable for up to 30 days at 2-8°C. However, to avoid the risk of contamination, immediate use is always recommended.2,3 Please see Summary of Product Characteristics for further details.2,3

*A study examined the exposure-response relationship between TECENTRIQ’s efficacy and safety in patients with non-small cell lung cancer using data from pooled Phase I and III studies in non-small cell lung cancer and urothelial carcinoma. Population pharmacokinetic-simulated exposures for the 1680mg Q4W were compared with the previously approved 1200mg Q3W. The results from the study support the interchangeable use of 1200mg Q3W and 1680mg Q4W dosing regimens for atezolizumab, as they are anticipated to demonstrate comparable efficacy and safety profiles while offering patients greater flexibility and convenience in their treatment.1

Tailor TECENTRIQ to your patients’ needs1-3

TECENTRIQ as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with EGFR mutant or ALK-positive NSCLC should have received targeted therapies before receiving TECENTRIQ.2,3 2L, 2nd line. References: 1. Morrissey, K.M et al. Cancer Chemother Pharmacol 2019; 84: 1257–1267. 2. TECENTRIQ 1,200 mg concentrate for solution for infusion Summary of Product Characteristics 27 October 2020, available on 3. TECENTRIQ 840 mg concentrate for solution for infusion Summary of Product Characteristics 27 October 2020, available on Date of item: November 2020. M-IE-00000404


For full prescribing information refer to the Summary of Product Characteristics [SmPC].

Tecentriq® (atezolizumab) ▼ 1,200 mg concentrate for solution for infusion (One 20 ml vial of concentrate contains 1,200 mg atezolizumab) and 840mg concentrate for solution for infusion (One 14 ml vial of concentrate contains 840mg of atezolizumab)

▼ 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 box below for details on how to report.

Therapeutic Indications: Tecentriq 1,200mg and 840mg: As monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) after prior platinumcontaining chemotherapy, or who are considered cisplatin ineligible and whose tumours have a PD-L1 expression ≥ 5%. As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq. Tecentriq 1,200mg: In combination with bevacizumab, paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In combination with

bevacizumab, paclitaxel and carboplatin, for patients with EGFR mutant or ALK-positive NSCLC, is indicated only after failure of appropriate targeted therapies. In combination with nab-paclitaxel and carboplatin, for the first-line treatment of adult patients with metastatic NSCLC who do not have EGFR mutant or ALK-positive NSCLC. In combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). In combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Tecentriq 840mg: In combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease. Posology and Method of Administration: The initial dose must be administered over 60 minutes and if well tolerated, subsequent infusions may be administered over 30 minutes. It must not be administered as an intravenous push or bolus. For instructions on dilution and handling, refer to SmPC. For combination therapies refer to the full prescribing information for the combination products. Recommended to treat patients until loss of clinical benefit or unmanageable toxicity or until disease progression for TNBC only. Administer Tecentriq as soon as possible if a planned dose is missed and adjust administration schedule to maintain a regular schedule. Dose reduction is not recommended. Dose delay or discontinuation may be required based on individual safety and tolerability, refer to SmPC. The safety and efficacy of Tecentriq in children and adolescents (< 18 years) has not been established, and no posology recommendation can be made. PD-L1 testing: Patients with UC or TNBC should be selected for Tecentriq treatment based on the tumour expression of PD-L1 by a validated test; refer to 1,200mg SmPC (UC); refer to 840mg SmPC (UC or TNBC). UC and 2L NSCLC: Tecentriq monotherapy: 1,200mg administered intravenously every three weeks, or 840mg administered intravenously every 2 weeks, or 1,680 mg administered intravenously every 4 weeks. 1L NSCLC: Tecentriq in combination with bevacizumab, paclitaxel, and carboplatin: Induction phase recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by bevacizumab, paclitaxel, and then carboplatin every 3 weeks for 4 or 6 cycles; followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq followed by bevacizumab, is administered by intravenous infusion every 3 weeks. Tecentriq in combination with nab-paclitaxel and carboplatin: Induction phase recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by nab-paclitaxel and carboplatin every three weeks for 4 or 6 cycles. For each 21-day cycle, Tecentriq, nab-paclitaxel, and carboplatin are administered on day 1. Nab-paclitaxel is administered on days 8 and 15. The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks. ES-SCLC: Tecentriq in combination with carboplatin and etoposide: Induction phase recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion followed by carboplatin, and then etoposide administered by intravenous infusion on day 1. Etoposide is also administered by intravenous infusion on days 2 and 3. This regimen is administered every three weeks for four cycles; followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks. TNBC: Tecentriq in combination with nab-paclitaxel: The recommended dose of Tecentriq is 840 mg administered by intravenous infusion, followed by 100mg/m2 nab-paclitaxel. For each 28-day cycle, Tecentriq is administered on days 1 and 15, and nab-paclitaxel is administered on days 1, 8, and 15. HCC: Tecentriq in combination with bevacizumab: The recommended dose of Tecentriq is 1,200 mg followed by bevacizumab 15 mg/kg of body weight, administered by intravenous infusion every three weeks. Contraindications: Hypersensitivity to Tecentriq or to any of the excipients listed in the SmPCs. Special Warnings and Precautions for Use: Refer to Tecentriq 1,200mg and 840 mg SmPCs for full description of Special Warnings and Precautions. Tecentriq is associated with immune-related adverse reactions. For suspected immunerelated adverse reactions, thorough evaluation should be performed to confirm aetiology or exclude other causes. Based on the severity of the adverse reaction, Tecentriq should be withheld and corticosteroids administered. Upon improvement to Grade ≤ 1, corticosteroids should be tapered over ≥ 1 month. Permanently discontinue treatment with Tecentriq for any recurrent Grade 3 immune-related adverse reactions, and for any Grade 4, except for endocrinopathies that are controlled with replacement hormones. Immune-related pneumonitis: Monitor patients for signs and symptoms of pneumonitis and causes other than immune-related pneumonitis should be ruled out. Treatment with Tecentriq must be permanently discontinued for Grade 3 or 4 pneumonitis. Immune-related colitis: Monitor patients for signs and symptoms of colitis. Treatment with Tecentriq must be permanently discontinued for Grade 4 (life threatening; urgent intervention indicated) diarrhoea or colitis. Immune-related hepatitis: Monitor patients for signs and symptoms of hepatitis, transaminase and bilirubin elevation. In patients without HCC, treatment with Tecentriq must be permanently discontinued for Grade 3 or Grade 4 events (ALT or AST>5.0 x ULN or blood bilirubin>3xULN). In patients with HCC, treatment with Tecentriq must be permanently discontinued if ALT or AST increases to > 10 x ULN or total bilirubin increases > 3 x ULN. Immune-related endocrinopathies: Monitor patients for clinical signs and symptoms of endocrinopathies. Thyroid function should be monitored prior to and periodically during treatment with Tecentriq. Treatment with Tecentriq should be permanently discontinued for Grade 4 hypophysitis. Immune-related meningoencephalitis: Monitor patients for clinical signs and symptoms of meningitis or encephalitis. Treatment with Tecentriq must be permanently discontinued for any grade of meningitis or encephalitis. Immune-related neuropathies: Monitor patients for symptoms of motor and sensory neuropathy. Treatment with Tecentriq must be permanently discontinued for any grade of myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome. Immune-related pancreatitis: Monitor patients closely for signs and symptoms suggestive of acute pancreatitis. Treatment with Tecentriq should be permanently discontinued for Grade 4, or any grade of recurrent pancreatitis. Immune-related myocarditis: Monitor patients for signs and symptoms of myocarditis. Treatment with Tecentriq must be permanently discontinued for Grade 3 or 4 myocarditis. Immune-related nephritis: Monitor patients for changes in renal function. Treatment with Tecentriq must be permanently discontinued for Grade 3 or 4 nephritis. Immune-related myositis: Monitor patients for signs and symptoms of myositis. Treatment with atezolizumab should be permanently discontinued for Grade 4 or 3 recurrent myositis. Infusion-related reactions (IRRs): Severe IRRs have been observed. Tecentriq must be permanently discontinued for grade 3 or 4 IRRs. Tecentriq in combination with bevacizumab, paclitaxel and carboplatin in metastatic NSCLC: Carefully consider the combined risks of the four-drug regimen of Tecentriq, bevacizumab, paclitaxel, and carboplatin before initiating treatment, refer to SmPC. Tecentriq in combination with nab-paclitaxel in metastatic TNBC: Neutropenia and peripheral neuropathies occurring during treatment with Tecentriq and nabpaclitaxel may be reversible with interruptions of nab-paclitaxel. Consult the nab-paclitaxel SmPC for specific precautions and contraindications. Tecentriq in combination with bevacizumab in HCC: Severe gastrointestinal haemorrhage, including fatal events, were reported. Screening for and subsequent treatment of oesophageal varices should be performed as per clinical practice prior to starting treatment. Bevacizumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding with the combination treatment. Diabetes mellitus can occur. Monitor blood glucose levels prior to and periodically during treatment. Please refer to the bevacizumab SmPC. Special Populations: Patients excluded from clinical trials included; baseline performance status ≥ 2, history of autoimmune disease and pneumonitis, active brain metastasis, HIV, hepatitis B or C infections, significant cardiovascular disease and patients with inadequate hematologic and end–organ function, patients who were administered a live attenuated vaccine within 28 days prior to enrolment, systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal products within 2 weeks prior to study entry; therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Use Tecentriq with caution in these populations, refer to SmPC for full list of specific precautions. Interactions: No formal pharmacokinetic drug interaction studies have been performed. Since Tecentriq is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. The use of systemic corticosteroids or immunosuppressants should be avoided before starting Tecentriq. However systemic corticosteroids or other immunosuppressants can be used to treat immune-related adverse events after starting Tecentriq, refer to SmPC. Fertility, Pregnancy and Lactation: The effect of Tecentriq on fertility and pregnancy is unknown. Women of childbearing potential must use effective contraception methods during and for 5 months after treatment with Tecentriq. Tecentriq should not be used during pregnancy, unless the clinical condition of the woman requires treatment. It is not known whether Tecentriq is excreted in human milk. A risk to newborns/infants cannot be excluded. Effects on ability to drive and use machines: Tecentriq has minor influence on the ability to drive and use machines. Advise patients experiencing fatigue not to drive and use machines until symptoms abate Undesirable Effects: Tecentriq monotherapy: Very common (≥ 1/10): cough, decreased appetite, headache, dyspnoea, musculoskeletal pain, nausea, vomiting, diarrhoea, urinary tract infections, rash, pruritus, arthralgia, back pain, pyrexia, fatigue, asthenia. Common(≥1/100to<1/10):thrombocytopenia, hypothyroidism, hypokalaemia, hyponatremia, hyperglycaemia, hypotension, pneumonitis, hypoxia, nasal congestion, nasopharyngitis, abdominal pain, colitis, dysphagia, oropharyngeal pain, infusion–related reaction, AST increased, ALT increased, hepatitis, dry skin, blood creatinine increased, influenza like illness, chills. Tecentriq in combination therapy: Very common (≥ 1/10): anaemia, thrombocytopenia, neutropenia, hypothyroidism, lung infection, leukopenia, decreased appetite, peripheral neuropathy, dyspnoea, nausea, diarrhoea, back pain, constipation, rash, pruritus, alopecia, arthralgia, pyrexia, oedema peripheral, headache, hypertension, fatigue, musculoskeletal pain, vomiting, cough, asthenia. Common(≥1/100to<1/10):hypokalaemia, hyponatremia, dysgeusia, dysphonia, stomatitis, sepsis, infusion-related reaction, hypomagnesaemia, dizziness, lymphopenia, hyperthyroidism, syncope, AST increased, ALT increased, proteinuria, blood creatinine increased, blood alkaline phosphatase increased. Refer to SmPC for full listings of adverse events. Refer to SmPC section 4.8 for instructions on reporting of suspected adverse events. Legal Category: Product subject to medical prescription which may not be renewed (A). Presentation(s) and Marketing Authorization Number(s): 1,200 mg of atezolizumab in 20 mL, pack of one vial (EU/1/17/1220/001); 840 mg atezolizumab in 14 ml, pack of one vial (EU/1/17/1220/002). Marketing Authorisation Holder: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany. Tecentriq® is a registered trademark. Further information is available from Roche Products (Ireland) Limited, 3004 Lake Drive, Citywest, Naas Road, Dublin 24. Telephone: (01) 4690700. Date of API Preparation: November 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.

In the event of a suspected adverse reaction, The Drug Surveillance Centre

Roche Products (Ireland) Limited

Telephone: (01) 4690700


Tecentriq® Summary of Product Characteristics [SmPC] is available on API M-IE-00000369 based on Tecentriq 840mg and 1,200mg SmPCs dated 27 Oct 2020

Or alternatively, report to: HPRA Pharmacovigilance


Continued from p22 ▸

overall survival based on many large randomised trials. Meta-analysis of 22 randomised trials has confirmed the benefit for patients with four or more positive axillary nodes while the Danish trial proved efficacy in T3 or more regardless of number of involved nodes.

Many randomised trials have shown that BCS plus radiation is at least equivalent to mastectomy and many studies reported lower recurrence and better survival for BCT and radiotherapy when compared with BCS alone.

The standard radiotherapy regimen in those trials was a five-week course and in an attempt to reduce the number of radiotherapy sessions, a Royal Marsden trial compared 50Gy/25 fractions versus 39Gy/13 fractions versus 42.2Gy/13 fractions, which confirmed better local control with 42.2Gy, and the equivalence of hypofractionation to conventional fraction for both BCS and mastectomy has been confirmed in many trials. One step further to reduce the radiotherapy fractions was examined by the recent FAST-Forward trial, which compared one week of radiotherapy (27Gy or 26Gy) versus the standard three weeks in patients with pT13N0-1. After five years follow-up the shorter regimen was non-inferior to the standard regimen in terms of control and cosmesis.

Biology-driven radiotherapy has been tested in two trials for elderly patients (70 years in CALGB and 65 years in Prime 11 trials). In those trials omission of radiotherapy after BCS was permitted for patients with T1-2N0 cases with favourable biology(ER/PR+ and Her2 negative). Five-year local recurrence was 4.1 per cent and 1.3 per cent for radiotherapy and no radiotherapy, respectively, without compromising survival and this practice is considered a valid option in elderly patients. Treating smaller volumes with radiotherapy is associated with less morbidity and to test this concept without compromising efficacy, accelerated partial breast irradiation (APBI) was developed. APBI is delivered only to the breast tissue immediately adjacent to the initial tumour site, typically a 1-2cm margin of breast tissue surrounding the surgical cavity. The rationale for this approach is based on the fact that most recurrences occur near the initial tumour location.

Many trials using different techniques whether 3D conformal, brachytherapy or intensity-modulated radiotherapy (IMRT) have shown non-inferiority when compared with whole breast radiotherapy in properly selected low-risk patients.

Non-surgical treatment

The initial trials for non-surgical treatment of breast cancer considered radiotherapy alone or chemoradiotherapy for patients who refused or were unfit for surgery. The excellent responses achieved using NAC have expanded those attempts.

Radiotherapy trials

The role of adjuvant radiotherapy in the management of breast cancer is well established. However, its role as a definitive treatment using conventional fractionation is still evolving.

There are no prospective comparative studies in the literature of the current standards (surgery +/− radiotherapy +/− chemotherapy/hormonal therapy) versus definitive radiotherapy. The role of definitive radiotherapy in breast cancer came about initially from reports of small case series in patients who refused or were unfit for surgery and more recently from better understanding of the radiobiology as well as the availability of radiotherapy machines, which can deliver higher doses more precisely.

Sousa et al reported 18 per cent complete response in 76 patients with locally advanced breast cancer after neoadjuvant radiotherapy, and Chargari et al achieved a seven-year local control rate of 95.8 per cent in a group of elderly patients with early breast cancer treated with radiotherapy alone. In contradiction with these good results, Zucali et al reported poor local con-

trol (50 per cent) in 94 patients with early breast cancer treated with definitive radiotherapy, but this was explained by low radiotherapy dose and delivery of treatment over a long treatment period. This explanation was confirmed by Arriagada et al, and echoed by Van Limbergen et al, who reported that in order to achieve the same local control achieved with surgery, radiotherapy dose should be 10Gy higher for T1 and 35Gy higher for T2.

The role of definitive radiotherapy in the management of breast cancer has been revisited as a result of better understanding of breast radiobiology and the development of modern radiation techniques like stereotactic irradiation and IMRT, which deliver tumoricidal doses without severe complications.

Many sites including lung, brain, spine, and prostate have adopted stereotactic ablative body radiosurgery (SABR) as a definitive treatment option in early-stage disease. SABR has many advantages with the delivery of high doses of radiation over a short period saving treatment days and overall time on the treatment machine.

In a phase 1 study by Bondiau et al for NAC given concurrently with SBRT prior to surgery, the pCR was 36 per cent, while Shibamoto et al reported 93 per cent and 92 per cent three-year overall survival and local control rates, respectively, with good cosmesis in 18 patients treated with definitive whole breast radiotherapy with stereotactic boost.

Concurrent chemoradiotherapy

Primary concurrent chemoradiotherapy (CCRT) is the first choice in treating nasopharyngeal, locally advanced cervical and anal cancers. The rationale of using CCRT is based on the radiosensitising effect of some cytotoxic drugs and the possibility of using lower radiotherapy doses to minimise the side-effects.

Several phase 3 studies exploring the effect of CCRT in early breast cancers have reported good local control, but increased cardiac and pulmonary toxicities.

However, a Japanese study for CCRT in 108 breast cancer patients with stage I-III disease reported 36 per cent pCR, and this was confirmed in a small series of five patients with breast cancer who refused surgery and were treated with concurrent chemotherapy and an advanced radiotherapy technique called tomotherapy, where only one patient had local recurrence.

Neoadjuvant chemotherapy and local treatment

In a group of patients who achieved complete remission after NAC, five-year locoregional recurrence was similar between patients who had radiotherapy alone and those who had wide local excision and radiotherapy. The five-year overall survival rates were similar for both surgery and RT (74 per cent post-RT vs 76 per cent post-surgery, P=0.9) after NAC in a study by Ring et al, while Daveau et al reported higher local recurrence for the non-surgical group; 31 per cent versus 17 per cent at 10 years with no difference in overall survival.

Is surgery a redundant procedure for certain subgroups?

There is a notable improvement in pCR with the use of modern chemotherapy regimens and targeted therapy and this raises the question of the safe omission of surgery specially if radiotherapy will be administered. However, there are two challenging problems in neoadjuvant trials; the first one is the definition of pCR and the second is the accurate diagnosis of residual disease.

So far there is no universal definition of pCR which complicates interpretation of NAC trials. Some consider absence of residual disease in both the breast and axilla as pCR, while others do not count on disease status in the axilla, some consider absence of both invasive and carcinoma in situ, while others do not take the in situ component into their account. The most accepted definition of pCR is either absence of any residual invasive cancer or any invasive and non-invasive cancer in both breast and axillary nodes.

Assessment of response after NAC

This assessment is crucial for further management and delineation of surgery. However, it might be difficult, particularly if there is significant reduction in tumour cellularity. The most commonly used methods to assess the response include clinical examination, breast ultrasound, mammogram, MRI breast, PET scan, and clip insertion into the tumour.

For better evaluation of pCR, especially if surgery will not be carried out, some investigators recommended elastography, which can discriminate stiffness in different tissues, addition of Ki-67, use of doppler ultrasound to measure tissue perfusion, dynamic contrast MRI and the use of core biopsy. However, the current imaging modalities are not accurate enough to confidently make this decision. Schaefgen et al and Lobbes et al reported a negative predictive value of pCR based on radiology of less than 90 per cent and they cannot replace the operative pathology.

Minimally invasive image-guided biopsy has shown promise in the identification of residual disease in the breast after NST and the positive predictive value for pCR was shown to be significantly high for vacuum-assisted core biopsy (VACB) and might reach 100 per cent, which makes it a very reasonable approach to assess pCR. However, the accuracy of imaging and minimally invasive image-guided biopsy is still facing a great challenge because of the different patterns of tumour response as the tumour might shrink early in the course of treatment leaving few cells to trace or there might be diffuse cell loss without significant change in the tumour size.

A combination of advanced radiologic imaging, VACB and deep learning might minimise the possibility of missing any residual disease, although the impact of residual disease on local recurrence is still controversial, especially if radiotherapy will be used after NAC. Some investigators have reported more relapse, while others denied any significant consequences based on extrapolation of data from rectal and oesophageal cancer where a watch policy is an accepted option after complete response following CCRT.

In conclusion, to answer the question of safe omission of surgery after pCR post NAC we should design a trial comparing two strategies after NST: (i) standard therapy being surgery plus radiation treatment, (ii) no breast surgery, but standard radiation treatment.

MD Anderson Cancer Centre in the US recently opened and has begun accrual on the trial ‘Identification of breast cancer patients for potential avoidance of surgery: Accuracy of image-guided percutaneous sampling compared with surgery to evaluate eradication of breast cancer after preoperative chemotherapy’ ( NCT02455791). The study is designed to evaluate whether patients with residual carcinoma can be accurately identified using state of the art image-guided fine needle aspiration and VACB.

The Netherlands Cancer Institute as well as other national and international single-centre and multicentre and cooperative groups are developing similar trials.

References on request

Clinical Oncology THE MEDICAL INDEPENDENT | 8 APRIL 2021 26
Many randomised trials have shown that BCS plus radiation is at least equivalent to mastectomy and many studies reported lower recurrence and better survival for BCT and radiotherapy when compared with BCS alone

Melanoma: An overview

Early detection of malignant melanoma remains a crucial factor in reducing mortality

Skin cancer is the most common cancer in Ireland, with 11,660 cases diagnosed in 2019. Melanoma is a serious form of skin cancer that develops from pigment-producing cells found in the upper layer of skin known as melanocytes. Less common than basal cell (BCC) and squamous cell carcinomas (SCC), melanoma is more serious because of its ability to spread rapidly to other organs, if not treated at an early stage. Melanoma is usually curable when it is detected and treated early. Once a melanoma has spread deeper into the skin or other parts of the body, it becomes more difficult to treat and can be fatal.

Excluding non-melanoma skin cancers, melanoma is the fourth most common cancer in Ireland, with approximately 160 deaths and 1,100 new cases diagnosed each year. From once being a rare cancer, the average lifetime risk for melanoma has now reached one-in-50 in many Western populations.

Since the 1960s the incidence of melanoma has increased in Caucasian populations and become one of the most frequent cancers in fair-skinned populations. Australia and New Zealand have the highest incidence of melanoma in the world and there are also high rates in Northern Europe and North America. It is less common in Asia, Africa, and Latin America.

Statistics from the National Cancer Registry Ireland (NCRI) show that the incidence of melanoma in Ireland continues to rise. With approximately 20 cases diagnosed per 100,000 persons per year, rates have increased by over 5 per cent per year in men since 1994, while female incidence rates have also increased over time, but at a lower rate of 2.7 per cent per year. Since 1994, mortality rates for melanoma in Ireland have increased by 2.3 per cent annually in females and 4.7 per cent per year in males.

Unlike other solid tumours, melanoma mostly affects young and middle-aged people. The median age of diagnosis is 57 years and the incidence increases linearly after the age of 25 years until the age of 50 years and then slows, especially in females. More than a quarter of melanoma skin cancers are diagnosed in people under the age of 50.

Melanomas typically occur on the skin but may also rarely occur in the mouth, intestines, eye (uveal melanoma), underneath a nail or on the sole of the foot. They occur most commonly on the legs in women and on the back in men.

Melanoma is considered a multi-factorial disease arising from an interaction between genetic susceptibility and environmental exposure. The primary cause of melanoma is ultraviolet light (UV) exposure in those with low levels of the skin pigment melanin. When skin is exposed to UV radiation from the sun or tanning beds, it causes skin damage, which triggers melanocytes to produce more melanin. Eumelanin and pheomelanin are two types of melanin in the skin. While eumelanin has the ability to protect the skin from sun damage, pheomelanin does not. Fair-skin contains more pheomelanin and darker-skin contains more eumelanin. People with fair skin are more susceptible to sun damage, burning and developing melanoma than dark-skinned people due to a lack of eumelanin. Melanoma occurs when DNA damage caused by UV radiation triggers mutations in the melanocytes, resulting in uncontrolled cellular growth.

Other factors contributing to an increased risk of developing a melanoma include being immunosuppressed, a family history of melanoma, a previous diagnosis of skin cancer, previous skin damage caused by sunburn or radiotherapy treatment, and phenotypic characteristics such as pale skin, red or blonde hair, blue eyes and a large number of freckles. Repeated sunburn, either by the sun or artificial sources of light, increases the risk of melanoma in people of all ages. The risk of developing skin cancer increases with age. Rare genetic conditions such as xeroderma pigmentosum also increase the risk.

The most important host risk factors are the number of melanocytic nevi, family history and genetic susceptibility. Melanocytic nevi commonly known as moles, are benign accumulations of melanocytes or nevus cells and may be congenital or acquired. Approximately 25 per cent of melanoma cases occur in conjunction with a pre-existing nevus. The total nevus count is positively correlated with melanoma risk and varies depending on the number, size, and type of nevi.

There are four main types of skin melanoma; superficial

spreading melanoma, nodular melanoma, lentigo maligna melanoma, and acral lentiginous melanoma. Another type called amelanotic melanomas are quite rare.

Superficial spreading melanoma

Approximately 70 per cent of all melanomas are superficial spreading melanomas, which are more common in people with pale skin and freckles. They initially tend to grow outwards rather than downwards, however, if they do grow downwards into the deeper skin layers, they can spread to other parts of the body.

Nodular melanoma

Nodular melanomas are faster-developing and can quickly grow downwards into the deeper layers of skin if not removed. They usually appear as a changing skin lump and are often black or red in colour. Nodular melanomas most commonly occur on the head, neck, chest or back, and bleeding or oozing is a common symptom.

Lentigo maligna melanoma

Lentigo maligna melanomas account for approximately 10 per cent of melanomas. They most commonly affect older people, especially those who have spent a lot of time outdoors. They develop slowly over a number of years and appear on areas that are often exposed to the sun, such as the face. Lentigo maligna melanomas are initially flat and devel-

Number Staging System

Stage 0 – melanoma is on the surface of the skin

Stage 1A – melanoma is less than 1mm thick

Stage 1B – melanoma is 1-2mm thick, or less than 1mm thick and the surface of the skin is broken (ulcerated) or its cells are dividing faster than usual

Stage 2A – melanoma is 2-4mm thick, or it is 1-2mm thick and ulcerated

Stage 2B – melanoma is thicker than 4mm, or 2-4mm thick and ulcerated

Stage 2C – melanoma is thicker than 4mm and ulcerated

Stage 3A – melanoma has spread into one-to-three nearby lymph nodes, but they are not enlarged. The melanoma is not ulcerated

and has not spread further

Stage 3B – melanoma is ulcerated and has spread into one-to-three nearby lymph nodes but they are not enlarged. Or the melanoma is not ulcerated and has spread into one-tothree nearby lymph nodes and they are enlarged. Or the melanoma has spread to small areas of skin or lymphatic channels, but not to nearby lymph nodes

Stage 3C – the melanoma is ulcerated and has spread into one-to-three nearby lymph nodes and they are enlarged. Or it has spread into four or more lymph nodes nearby

Stage 4 – the melanoma cells have spread to other parts of the body, such as the lungs, brain or other areas of the skin

op sideways on the surface layers of skin. They can resemble freckles, but are usually larger, darker and more defined than a normal freckle. They gradually get bigger and may change shape. At a later stage, they can grow downwards into the deeper layers of skin and form nodules.

Acral lentiginous melanoma

Acral lentiginous melanomas are a rare type of melanoma. They usually occur on the palms of the hands and soles of the feet, but can also develop around a nail, most commonly the thumb or big toenail. They can occur in all skin types, but are most common in people with dark skin.

Amelanotic melanomas are also rare, accounting for about five-in-100 melanomas. They usually have little or no colour, but may occasionally be pink or red, or have light brown or grey edges.

Diagnosis and staging

Early detection of malignant melanoma remains a crucial factor in reducing mortality. Compared to other cancers, malignant melanoma has the advantage of its cutaneous location, allowing early detection through non-invasive approaches. Pathological examination however, remains the gold standard for diagnosis. The prognosis is directly proportionate to the depth of the neoplasm, which in turn increases with time.

Normal moles (nevi) are usually round or oval, with a smooth edge, and ≤6mm in diameter. The first sign of a melanoma is often a new mole or a change in the appearance of an existing mole. Indications include changes in a mole’s colour, increase in size, irregular edges, itchiness, skin breakdown, and bleeding.

Other tools to help improve early diagnosis include the Glasgow seven-point checklist, which includes three major criteria – change in size, shape, colour, and four minor criteria – sensory change, diameter of 7mm or greater, presence of inflammation and crusting or bleeding. This checklist has been less widely adopted than the ABCDE criteria. Another paradigm is the ‘ugly duckling’ sign, based on the perception that a pigmented lesion ‘looks different from all of its neighbours’. This criteria has been shown to be sensitive for melanoma detection.

Referral to a specialist is required if a melanoma is suspected. The melanocytic nevi (mole) will be removed and sent for biopsy (excision biopsy). If cancer is confirmed, another procedure will be required to remove a wider area of skin to make sure the cancerous cells have been removed. Further tests will be carried out if there is a concern the cancer has spread into other organs, bones or the bloodstream.

Sentinel lymph node biopsy is used to determine whether the cancer has spread beyond the primary into the lymphatic system. The sentinel nodes are the first lymph nodes into which a tumour drains. Sentinel node biopsy involves injecting a tracer material to locate the sentinel nodes, which are removed and analysed in a laboratory. Because only a few lymph nodes are removed, the risk of lymphoedema is small. If the sentinel nodes are clear of melanoma, the cancer is unlikely to have spread, and removing additional lymph nodes is unnecessary.

If cancer is detected surgery to remove the remaining lymph nodes (completion lymph node dissection or completion lymphadenectomy) is performed. Other tests carried out include CT scan, MRI scan, PET scan, and blood tests.

Staging of a melanoma determines how deep it has grown and how far it has spread. Different systems used include the

Clinical Oncology THE MEDICAL INDEPENDENT | 8 APRIL 2021 28
Figure 1: Superficial spreading melanoma Figure 2: Nodular melanoma Figure 3: Lentigo maligna melanomas Figure 4: Acral lentiginous melanomas Figure 5: Amelanotic melanoma Table 1: Melanoma stages Continued on p30

The ABCDE checklist can help differentiate between a normal mole and a melanoma:

A-Asymmetry: Irregular in shape, with two parts that look very different

B-Border: Irregular or jagged in shape

C-Colour: Changes in colour

D-Diameter: The mole is larger than 6mm wide (1/4 inch wide)

E-Evolving: The mole or spot has changed during the past few weeks or months. Change in size, shape, colour, elevation, bleeding, itching or crusting

TNM (tumour, node, metastasis), number staging system (0-4) or the Clark or Breslow scale to describe how deeply the melanoma has gone into the skin.


Treatment of melanoma can include single or combined therapies, depending on the patient’s health, stage, and location of the tumour. Therapeutic approaches include surgical resection, chemotherapy, photodynamic therapy, immunotherapy, biochemotherapy, and targeted therapy. The main treatment for melanoma is surgery, and if diagnosed and treated at an early stage, surgery is usually successful. Radiotherapy after surgery usually consists of a course of five treatments a week for a number of weeks. Chemotherapy is now rarely used to treat melanoma and targeted treatments and immunotherapy are the preferred treatment options.

If undiagnosed until an advanced stage (stage IV), treatment is given to help slow the cancer’s growth, reduce symptoms, and extend life expectancy. This usually involves treatment

that targets specific genetic changes in the melanoma, such as BRAF inhibitors, or checkpoint therapies that boost the body’s immune responses to the melanoma.

If a melanoma has spread to other parts of the body, the prognosis is less favourable. Metastatic melanoma isone of the most serious types of skin cancer, and accounts for most skin cancer deaths in Ireland. The five-year survival rate for patients with stage IV melanoma is under 20 per cent, compared with over 50 per cent if the disease is diagnosed at stage III. Unresectable cancers cannot be removed through surgery.

Newer treatments such as immunotherapy and targeted treatments are showing encouraging results in advanced melanoma. A number of different medications are available, some of which can be used as a monotherapy or as combination therapy. Immunotherapy medications for advanced melanoma include ipilimumab, nivolumab and pembrolizumab. Approximately 40-to-50 per cent of people with melanoma have gene mutations. Targeted treatments such as vemurafenib, dabrafenib and trametinib can be used to specifically target these gene mutations to help slow or stop the cancer cells growing.

In 2019 the HSE approved reimbursement for encorafenib in combination with binimetinib for the treatment of adults with unresectable or metastatic melanoma with a mutation known as BRAF V600. Just over 1,000 patients in Ireland have melanoma, of whom about half have the BRAF mutation. More than 97 per cent of BRAF mutations are in the BRAF V600 gene.

In February this year (2021), after a long advocacy campaign by cancer patients, the HSE also announced that it was to reimburse adjuvant immunotherapies for stage III melanoma patients in Ireland.

While the HSE had been reimbursing three different kinds of immunotherapy drugs for melanoma patients previously, it was only for those who were at a more advanced stage. Instead, stage III patients were continually monitored through a ‘watch and wait’ strategy, though patients with certain private health insurance plans could access these drugs.

However, the HSE will now (since 1 February) reimburse nivolumab, which is used as monotherapy for the adjuvant treatment of adults with melanoma, whose cancer involves lymph nodes or metastatic disease, who have undergone complete resection.

Pembrolizumab is also in the process of being approved for reimbursement in this cohort. This can be used as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement, who have undergone complete resection also.

Survival and prevention

Survival from melanoma has increased in Ireland since the 1990s due largely to improvements in treatment for late stage tumours, as well as more patients presenting with earlier stage disease. The National Cancer Strategy 2017-2026 outlines the HSE’s plans for cancer prevention and control and prioritises the development of a national skin cancer prevention plan targeting children, outdoor workers, sunbed users and those who pursue outdoor leisure activities. Addressing the rising incidence of skin cancer, the strategy prioritised the need to develop and implement the national skin cancer prevention plan (2019-2022).

Melanoma is not always preventable, but a number of measures can be taken to reduce its occurrence. It is important that people are made aware of the dangers of UV radiation from the sun and artificial sources such as sunbeds. Wearing sunscreen is important and recommended even in winter, using a broad-spectrum, high UVA protection water resistant (UVA/UVB) sunscreen with a sun protection factor (SPF) of at least 30+ for adults and 50+ for children. It is advisable to seek shade and cover the skin as much as possible when in the sun, protect the face, ears and neck with a wide brimmed hat and wear sunglasses. Babies and young children are particularly vulnerable to sun exposure, and should always be kept out of direct sunlight.

Educating people to regularly check their skin and seek help for notable changes, can help lead to an early diagnosis of melanoma and increase the chances of successful treatment. Timely recognition, detection, rapid treatment and follow-up is key to improved outcomes and survival rates from malignant melanoma.

References on request

THE MEDICAL INDEPENDENT | 8 APRIL 2021 30 Clinical Oncology
from p28 ▸

SUTENT® Capsules (sunitinib malate)


Please refer to the Summary of Product Characteristics (SmPC) before prescribing SUTENT 12.5 mg, 25 mg or 50 mg. Presentation: Hard gelatin capsules containing sunitinib malate equivalent to 12.5 mg, 25 mg and 50 mg sunitinib.

Indications: For the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance; advanced and/or metastatic renal cell carcinoma (MRCC) in adults; unresectable or metastatic, well differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. Dosage: Therapy should be initiated by a physician experienced in the administration of anticancer agents. The recommended dose for GIST and MRCC is 50 mg taken orally, once daily, with or without food, for 4 consecutive weeks, followed by a 2-week rest period, to comprise a complete cycle of 6 weeks. For pNET 37.5 mg taken orally once daily without a scheduled rest period. Dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability. Daily dose should not exceed 75 mg nor be decreased below 25 mg for GIST or MRCC, the maximum daily dose administered during the phase 3 pNET study was 50 mg. The safety and efficacy of Sutent in patients below 18 years of age have not been established and no recommendation on a posology can be made. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Co-administration of potent CYP3A4 inhibitors or inducers should be avoided if possible, or the dose of sunitinib altered. Depigmentation of the hair or skin and occasional rash affecting the palms of hands and soles of feet commonly occur during treatment. Pyoderma gangrenosum, generally reversible after drug discontinuation, has been reported. Severe cutaneous reactions have been reported, including cases of erythema multiforme (EM) and cases suggestive of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some of which were fatal. If signs or symptoms of SJS, TEN, or EM are present, sunitinib treatment should be discontinued. Haemorrhagic events, some of which were fatal have been reported. Serious, sometimes fatal gastrointestinal complications have occurred in patients with intra-abdominal malignancies. Patients should be screened for hypertension and controlled as appropriate. Temporary suspension is recommended in patients with severe hypertension that is not controlled with medical management. Decreased absolute neutrophil and platelet counts occurred during clinical trials and complete blood counts should be performed at the beginning of each treatment cycle. Cardiovascular events, including CHF, cardiomyopathy and myocardial ischemia and myocardial infarction, some of which were fatal, have been reported. Closely monitor for clinical signs and symptoms of CHF and consider baseline and periodic evaluations of LVEF especially in patients with cardiac risk factors and/or history of coronary artery disease. If clinical manifestations of CHF present, discontinuation of sunitinib is recommended. The administration of sunitinib should be interrupted and/or dose reduced in patients without clinical evidence of CHF but with a LVEF <50% and >20% below baseline. Sunitinib should be used with caution in patients with a known history of QT interval prolongation, patients who are taking antiarrhythmics or medicinal products that can prolong QT intervals, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. Treatment-related venous thromboembolic events have been reported. Arterial thromboembolic events (ATE), sometimes fatal, have been reported including cerebrovascular accident, transient ischaemic attack, and cerebral infarction. The use of vascular endothelial growth factor (VEGF) pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections. Thrombotic Microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and haemolytic uraemic syndrome (HUS), sometimes leading to renal failure and/or a fatal outcome, has been reported with sunitinib as monotherapy and in combination with bevacizumab.

Sunitinib therapy should be discontinued in patients who develop TMA and prompt treatment is required. Baseline lab measurements and monitoring of thyroid function during treatment are required and patients treated as per standard medical practice. Pancreatitis and serious pancreatic events, some with fatal outcome have been reported. Hepatotoxicity has been observed in patients treated with sunitinib. Monitor liver function tests at baseline during each cycle of treatment, and as clinically indicated. If symptoms of pancreatitis or hepatic failure are present, treatment with sunitinib should be discontinued and the patient provided with appropriate supportive care. Cases of renal impairment, renal failure and/or acute renal failure, in some cases with fatal outcome, have been reported. Baseline urinalysis is recommended. Patients should be monitored for the development or worsening of proteinuria. Sunitinib should be discontinued in patients with nephrotic syndrome. If fistula formation occurs, treatment with sunitinib should be interrupted. Cases of impaired wound healing have been reported during sunitinib therapy and the decision to resume sunitinib therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery. Osteonecrosis of the jaw (ONJ) has been reported, the majority of cases occurred in patients who had received prior or concomitant treatment with IV bisphosphonates. Caution should therefore be exercised when sunitinib and IV bisphosphonates are used either simultaneously or sequentially. Prior to treatment with sunitinib either along with or subsequent to IV bisphosphonates, a dental examination and appropriate preventative dentistry should be considered. Invasive dental procedures are also an identified risk factor and should be avoided if possible. In case of angioedema due to hypersensitivity, treatment with sunitinib should be interrupted and medical care provided. Patients with seizures and signs/symptoms consistent with reversible posterior leukoencephalopathy syndrome should be controlled with medical management, including control of hypertension as above and temporary suspension of sunitinib is recommended. Cases of Tumour Lysis Syndrome, some fatal,

Aim to Control with SUTENT®...

• Due to its long-standing experience that continues to improve outcomes1-4

• As it offers tools to improve tolerability while protecting efficacy5-8

SUTENT is indicated for the treatment of advanced/ metastatic renal cell carcinoma (MRCC) in adults.9

have been reported. Patients should be monitored closely and treated as clinically indicated and prophylactic hydration should be considered. Serious infectionswith or without neutropenia, including some with a fatal outcome, have been reported. Uncommon cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported. Sunitinib therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated. During sunitinib treatment, decreases in blood sugar leading to loss of consciousness have been reported. In case of symptomatic hypoglycemia, sunitinib should be temporarily interrupted. Blood glucose levels in diabetic patients should be checked regularly in order to assess if anti-diabetic drug dosage needs to be adjusted to minimize the risk of hypoglycaemia. Other interactions: None. Fertility, pregnancy and lactation: Women of childbearing potential should be advised to use effective contraception and avoid becoming pregnant while receiving treatment with Sunitinib. Sunitinib should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus and is not recommended during breast-feeding. Fertility may be compromised during treatment with sunitinib. Driving and operating machinery: Patients should be advised that they may experience dizziness during treatment with sunitinib. Undesirable effects: The most important treatment-related serious adverse reactions associated with sunitinib, some fatal, are renal failure, heart failure, pulmonary embolism, gastrointestinal perforation, haemorrhages (e.g. respiratory tract, gastrointestinal, tumour, urinary tract, and brain haemorrhages) and colitis (colitis and colitis ischaemic). Very common adverse events are neutropenia, thrombocytopenia, anaemia, leukopoenia, hypothyroidism, decreased appetite, insomnia, dizziness, headache, taste disturbance, hypertension, dyspnoea, epistaxis, cough, stomatitis, abdominal pain, vomiting, diarrhoea, dyspepsia, nausea, constipation, skin discolouration, palmar-plantar erythrodysaesthesia syndrome, rash, hair colour changes, dry skin, pain in extremity, arthralgia, back pain, mucosal inflammation, fatigue, oedema, pyrexia. Commonly reported adverse events are viral infections, respiratory infections, abscess, fungal infections, urinary tract infection, skin infections, sepsis, lymphopoenia, dehydration, hypoglycaemia, depression, neuropathy peripheral, paraesthesia, hypoaesthesia, hyperaesthesia, periorbital oedema, eyelid oedema, lacrimation increased, myocardial ischemia, ejection fraction decreased, deep vein thrombosis, hot flush, flushing, pulmonary embolism, pleural effusion, haemoptysis, dyspnoea exertional, oropharyngeal pain, nasal congestion, nasal dryness, gastro-oesophageal reflux disease, dysphagia, gastrointestinal haemorrhage, oesophagitis, abdominal distention, abdominal discomfort, rectal haemorrhage, gingival bleeding, mouth ulceration, proctalgia, cheilitis, haemorrhoids, glossodynia, oral pain, dry mouth, flatulence, oral discomfort, eructation, skin exfoliation, skin reaction, eczema, blister, erythema, alopecia, acne, pruritus, skin hyperpigmentation, skin lesion, hyperkeratosis, dermatitis, nail disorder, myalgia, musculoskeletal pain, muscle spasms, muscular weakness, renal failure, renal failure acute, chromaturia, proteinuria, chest pain, pain, influenza like illness, chills, weight decreased, white blood cell count decreased, lipase increased, platelet count decreased, haemoglobin decreased, amylase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood creatinine increased, blood pressure increased, blood uric acid increased. Refer to SmPC for information on other adverse effects. Legal Category: S1A. MARKETING AUTHORISATION NUMBER(S) EU/1/06/347/001 - EU/1/06/347/008. Not all pack sizes may be marketed. The 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 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: 10/2019. Ref: ST 27_0

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 to Pfizer on 1800 633 363 or they can be reported directly via the HPRA Pharmacovigilance, Earlsfort Terrace. IRL-Dublin 2. Tel +353 1 6764971. Fax: +353 1 6762517. Website:, Email:


1. Motzer RJ, et al. J Clin Oncol 2009;27:3584–3590. 2. Motzer RJ, et al. N Engl J Med 2013;369:722–731. 3. Rini BI, et al. ECC. 25–29 September 2015. Vienna, Austria. Abstract: 17LBA. 4. Motzer RJ, et al. J Clin Oncol 2014;32:2765–2772. 5. Négrier S. Oncology 2012;82:189–196. 6. Schmidinger M, et al. Ther Adv Urol 2012;4:253–265. 7. Castellano D, et al. Cancer Treat Rev 2013;39:230–240. 8. Schmidinger M, et al. Cancer Invest 2010;28:856–864. 9. Sutent Summary of Product Characteristics.

Date of Preparation: November 2019 PP-SUT-IRL-0128 he can spend precious time with his family

Treatment resistance in malignant melanoma

Attendees at UCD’s Charles Institute Seminar Series recently heard a presentation by Dr Jens Rauch on research into malignant melanoma and the mutations that so often frustrate clinicians

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

Attendees heard a presentation from Dr Jens Rauch, Assistant Professor/Lecturer, School of Biomolecular and Biomedical Science, UCD, Group Leader, Systems Biology Ireland, UCD, who spoke on the theme of ‘Tackling Acquired Resistance Mechanisms in Malignant Melanoma’. Dr Rauch addressed the fact that malignant melanomas are among the most aggressive cancers due to their tendency to spread rapidly, as well as their wellknown resistance to targeted therapies. The introduction of RAF inhibitors has profoundly changed the treatment of BRAFV600E-driven melanoma, however, acquired drug resistance to RAF inhibition develops frequently and hinders the impressive initial response rate of these drugs, explained Dr Rauch. This resistance is mainly attributed to signalling network adaptations that bypass the drug blockade. With RAF heterodimerisation taking a central role, Dr Rauch focused on combinations of experimental and computational approaches to tackle acquired resistance in malignant melanoma. He also briefly described quantitative and qualitative signalling adaptations in resistance and outlined novel targets and inhibitor combinations.


Dr Rauch presented an overview of the prevalence of melanoma in Ireland and a synopsis of the work he has conducted with his colleagues, which showed that the vast majority of mutations driving malignant melanoma reside in the ERK/MAPK cell signalling pathway. “The frequency of drug-responsive BRAF mutations in Irish patients is less than half that in other European patients, whereas NRAS mutations are almost twice as frequent,” he told the seminar.

Dr Rauch explained to the attendees that his research has shown how a combination of structurally distinct RAF inhibitors synergistically inhibits the ERK pathway in cells bearing the BRAFV600E mutation and wildtype (WT) RAS, and cell-penetrating orthosteric peptides disrupt the KSR1/MEK complex and inhibit RAF inhibitor-resistant melanoma.

Dr Rauch also explained that he and his team sought to examine the signalling pathway from different perspectives and focus on the quantitative signalling behaviour of RAF dimers, in order to gain a better understanding of acquired resistance. “Novel RAF dimer-specific inhibitors are being developed,” he said. “People are trying to use RAF or MEK inhibitors in combination with other therapies, such as checkpoint or metabolic inhibitors, but there is still one issue that is puzzling the research community, and that’s the problem of acquired resistance,” said Dr Rauch. “Acquired resistance is based on the molecular biology, or molecular

set, of these cancers. We use RAF inhibitors that are specifically targeted at BRAFV600E-mutated melanoma… BRAFV600E is usually paired either with itself, or with BRAF wildtype, or RAF1 or ARAF.

“This is actually a classic physiological process,” he continued. “RAF dimerisation is usually required for the full activation of RAF kinase activity towards the substrate MEK and downstream signalling. This dimerisation, specifically in combination with RAF inhibitors, actually has consequences in the clinic, because the clinically-used RAF inhibitors are ineffective in RAS-mutant melanomas, because what these inhibitors do is, they actually enhance the hetero-dimerisation of these RAF kinases. So, the inhibitors can actually lead to a paradoxical activation of ERK signalling.”

In acquired resistance, Dr Rauch explained that most of the processes are based on enhanced RAF dimerisation and at the moment, most of these processes cannot be overcome by existing RAF inhibitors. “When we look at the signalling adaptations that we find in acquired resistance, they are centred around this classical RAF-ERK signalling pathway and more importantly, they are centred around the process of RAF dimerisation,” said Dr Rauch. “These network adaptations are highly patient- and tumour-specific, but what they all have in common is that they are all able to overcome this inhibition. What they also have in common is RAF dimerisation, which is the major mechanism causing clinical resistance to RAF inhibitors.”


Encapsulating his research, Dr Rauch told the seminar: “What our models suggest very clearly is that using a combination [therapy] has clear advantages and is highly synergistic in terms of inhibiting the cascade, and we could show this very clearly in an experimental way. A combination is much better to inhibit RAF dimers in BRAFV600E-mutant melanoma.”

Providing an overview of oncogenic RAS and RAF signalling, he explained that several mechanisms of RAF inhibitor resistance result in enhanced RAF dimerisation and cannot be overcome by existing RAF inhibitors. While inhibitor combinations are possible, it is unclear how the best combinations can be chosen. However, “using a combined experimental and computational approach, we built a mechanistic, dynamic model to analyse combinations of structurally different RAF inhibitors, which can efficiently suppress MEK/ERK signalling,” he told the seminar.

“We are able to predict the best RAF inhibitor combinations for cancer cells harbouring oncogenic RAS and/or BRAFV600E for synergistic inhibition of ERK signalling in melanoma cells.”

In summarising his findings, Dr Rauch said: “We can say that signalling scaffolds such as KSR1 actually seem to be good targets to inhibit BRAF- and NRAS-driven malignant melanomas, although we don’t know yet if they can be used alone or possibly in combination with other inhibitors.

“While not directly accessible with small molecule inhibitors, peptide-mediated disruption of the KSR-MEK signal-

ling complex inhibits signalling and importantly, the melanoma cells with enhanced dimerisation seem to be more sensitive to KSR/MEK inhibition.”

He and his colleagues also took a combination therapy approach with melanomas that have an acquired resistance mechanism. “In this case, we picked a cell line scenario where the primary tumour cell line has a V600E mutation and also acquired a hyperactivating NRAS mutation. What the data suggested was that a combination is highly advantageous over an individual [therapy]… ”

One important and surprising finding from the work of Dr Rauch and his colleagues showed that a combination of RAF inhibitors also works in a scenario where melanomas are driven by an oncogenic NRAS mutation, he told the attendees. “This is in complete contrast to what I mentioned earlier, when I said that RAF inhibitors would induce a sort of paradoxical activation of RAS-driven melanomas. However, when we use them in combination, we can show that combinations are quite successful… to inhibit the signalling,” said Dr Rauch. “Importantly, this is not just down to the signalling, but also has an effect on cell proliferation and invasion.”


During an interactive Q&A session, Prof Tobin touched on the genes that are most frequently mutated in cases of malignant melanoma and the bias towards a particular mutation pathway between RAS and RAF, for example. “In a typical melanoma cell, and perhaps more importantly in terms of the laboratory tools we have in vitro, if you select a melanoma cell line with the classical BRAFV600E mutation, do these cells lines respond similarly to BRAF inhibitors if they have variable other mutations?” Prof Tobin asked. “So, for example, if you have two melanoma cell lines, each with the BRAFV600E mutation but are different in their background constellation of other mutations, will the BRAF-specific inhibitor experience be similarly transacted in both cell lines or will the background mutational constellation of the cell line affect the impact of a targeted therapy?”

“That is an excellent question, and it corresponds to the clinical scenario,” Dr Rauch responded. “Melanoma, and skin cancer in general, probably have the highest mutational load. This is something we see in the clinics, where patients respond quite differently to specific treatments. However, when you look at the key oncogenic drivers such as BRAF-V600E, the BRAF inhibitors — and specifically in combination with MEK inhibitors — they are still fairly successful. For example, if you think about a stage III malignant melanoma, I think the five-year survival rate is around 65 per cent. Based on these numbers, you can see that these huge mutational loads seem to define the individual response to these inhibitors,” said Dr Rauch. “This is something that is still unexplored, because it is very difficult to compute how thousands and thousands of mutations might contribute to the response to any one given inhibitor against one hyperactivating mutation.

“I think the way out of this in the lab is to always use different cell line models in parallel which reflect at least the key mutations, but I think the only way [forward] is to do more and more personalised approaches,” he concluded, “but the field with these thousands and thousands of mutations is still an open one.”

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

Clinical Dermatology THE MEDICAL INDEPENDENT | 8 APRIL 2021 32 Article and series in association with UCD CHARLES INSTITUTE SEMINAR SERIES
Dr Jens Rauch


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Ifell in love with BMW’s 330e last year after my road test for the Medical Independent. So you will understand my excitement when I found out that I was to be given the keys to the new 530e. BMW’s flagship executive saloon, the 5-Series, is considered the cream of the crop by many, while its understudy, the 3-Series, is deemed to be less refined and exclusive than the lager sibling. The 5-Series has also been in production since 1972, so keep your eyes peeled for some manner of celebratory 40-year celebratory model in 2022.

Where I live in Dublin, there are lots of high kerbs and tight parking spots. These are the natural enemy of any car with large, ‘blingy’ alloy wheels and meant that I had to be monumentally cautious while testing the new 530e with its 20-inch alloy wheels. Luckily for me, the last bastion of pleasurable, coastal, suburban driving in South Dublin is on my doorstep, so I could cruise up and down, within my 5k, pondering the benefits of 330e vs 530e ownership. I’m making the most of this particular road for now, as bicyclists have their sights firmly set on its annexation in the name of the Dublin Bay cycle route.

Historically, Rolls Royce prided itself on refined luxury, which meant silent, comfortable driving. Its cars were given names like Phantom, Ghost, and Spirit, obviously in reference to the supernatural way in which they silently glide along the road. Well, I’ve only tested classic Rolls Royces, but the big, comfortable, silent way in which the 530e goes about its business is certainly worthy of a supernatural title. Cruising around town in a car as long and imposing as the 530e, while remaining virtually silent, is an otherworldly experience. However, I must caveat this by noting I have been driving a 33-year-old Porsche 928 around for the past three months awaiting my first press fleet car of 2021, so my views on silence and comfort may be somewhat skewed. But either way, glid-

ing along, wrapped in a delightful cocoon of premium leather and expensive electronics, the 530e is an exquisite way to travel.

As a plug-in hybrid, the new ghostly silent 530e utilises mild-hybrid technology, offering enhanced performance, reduced fuel consumption and improved driving comfort. BMW have a hybrid system available in all four- and six-cylinder variants of the new BMW 5-Series. The German firm fitted a powerful 48V starter-generator and a second battery to the 5-Series, increasing the amount of brake energy that can be regenerated and stored. This energy is used to supply the electrical system, to lighten the combustion engine’s workload and boost its power. By ‘boost its power’, I’m referring to the starter-generator, which produces an electric boost that instantly makes an additional 8kW/11hp available, enhancing overtaking and off-the-line acceleration. It also increases efficiency by assisting the engine when driving at constant speeds and improves comfort when the auto

start-stop and coasting functions are in use.

Inside the 5-series, you will find some interior features, including a larger 12.3” infotainment system, which includes BMW’s Intelligent Personal Assistant and Smartphone Integration. The new 5-Series also benefits from the latest camera and radar-based driving assistant systems, including features like steering and lane-control assistant and active cruise control to name just a few.

My test car was quite sprightly. In sport mode it wields that full ‘suck you into the chair as I blast off’ power, thanks to its clever set-up. The 530e, which is a rather large beast, gets from 0-100kph in 5.9 seconds and on to a top speed of 235Kmph, thanks to the 292 rampaging ponies under the bonnet.

Many moons ago the 3-Series BMW provided both four door saloons and sporty coupes, but then the 4-Series came on the scene and effectively turned the 3-Series into a mini 5-Series. I’ve noticed in recent years the 3-Series closing up that gap between the two cars and herein lies the issue; I think the plug-in hybrid 330e is better ‘bang for your buck’ than the 530e. I’ve managed to write this review as best I could without calling too much attention to the elephant in the room. Which is, how bloody good the 330e is and how much more competitively priced it is. I know you’ll always have the individual who preferes the size and prestige of the 530e and I’m sure they will sell very, very well, because it’s a bloody fabulous car. But, and it’s a big but, I think the 330e handles and drives better, it felt a bit quicker too and it’s significantly cheaper.

The BMW 330e M-Sport Saloon I tested in 2020 was €55,379, before taking Government grants into account, whereas the BMW 530e M-Sport Saloon I tested this week, comes in at €84,631. The starting price for the SE model 530e is €62,320. But again, if it was me, I’d have the 330e. My advice to you is test drive both and buy one of them.

MORGAN FLANAGAN CREAGH Read more at @MorganFlanaganC

Prices (incl VAT and VRT)

G30 530e M Sport Saloon LCI



Phytonic Blue


Ivory White Dakota leather with exclusive stitching/leather piping in contrast


Sub Total



Visibility pack


• High beam assist

• Laser lights

Technology pack


• Head-up display

• Loudspeaker system - harman/

kardon surround sound

• Enhanced Bluetooth with wireless charging

• BMW gesture control

• WiFi hotspot preparation

Comfort pack


• Steering wheel heating

• Bootlid operation, powered

• Comfort access

• Comfort seats, front

M Sport pro-pack


• 20” M Lt/Aly wheels Y-spoke style

846 M bicolour jet black/MT and runflat tyres

• Adaptive suspension

• M Sport braking system

• Sun protection glass

• M seat belts

• M rear spoiler

• BMW individual high-gloss shadow line with extended contents


Run-flat tyres


BMW individual lights shadow line


Split-folding rear seats


Piano black – BMW ind


Automatic air conditioning


Speedometer w/KMH readout


Parking assistant plus


BMW drive recorder


M steering wheel


M aerodynamic bodystyling


Exterior trim, high-gloss shadowline


Headlining, anthracite


Sub total


Standard options

• M Sport package

• Sport automatic transmission

• Alarm system (thatcham 1)

• Floor mats, velour

• First aid kit and triangle

• Seat heating, front

• Exterior mirrors - folding with antidazzle

• Rear-view mirror, auto dimming

• Split-folding rear seats

• eDrive exterior sound

• Ambient lighting

• Active guard

• DAB digital radio

• BMW teleservices

• BMW emergency call

• BMW online services

• Connected package professional

• BMW live cockpit professional

Total vehicle price


PRICE: €84,631



ENGINE: 530e M Sport


ROAD TAX: €170

EXTERIOR: Phytonic Blue




Fuel efficiency rating

• Comb L/100KM: 1.7

• Co2g/km: 40

Actual rating will vary with options, driving conditions,driving habits, and vehicle condition

As a plug-in hybrid, the new ghostly silent 530e utilises mildhybrid technology, offering enhanced performance, reduced fuel consumption and improved driving comfort
BMW G30 530E M SPORT SALOON LCI VARIANT SE M SPORT M SPORT EDITION M PERFORMANCE 520i €51,850 €56,680 €62,900 N/A 520d €52,100 €56,830 €62,910 N/A 520d xDrive €55,390 €60,170 €66,310 N/A 530d xDrive €68,290 €73,180 €79,460 N/A 530e €62,320 €66,940 €72,890 N/A 530e xDrive €64,960 €69,590 €75,540 N/A 545e xDrive (from 11/20 production) TBC TBC TBC N/A M550i xDrive N/A N/A N/A €103,660 5-SERIES SALOON VARIANT SE M SPORT M SPORT EDITION 520i €55,570 €60,460 €65,340 520d €55,760 €60,530 €65,310 520d xDrive €59,130 €63,960 €68,790 530d xDrive €74,780 €79,900 €85,010 530e (from 11/20 production) TBC TBC TBC 530e xDrive (from 11/20 production) TBC TBC TBC 540i xDrive €79,550 €84,920 €90,280

SPORTS QUIZ WIN €50 8 April 2021

Q1 Which nation defeated Ireland in their opening home FIFA World Cup qualifier?

Q2 Who won the top trainer award at this year’s Cheltenham festival?

Q3 As the US Masters tees off, who is the 2020 defending champion?

Q4 Name the heavyweight boxer who avenged his recent defeat by overpowering Alexander Povetkin in their rematch last month?

Q5 Who won the ladies singles at the Miami Open last week?

Q6 Who defeated Ronnie O’Sullivan to win the Cazoo Tour Championship last month?


8 April 2021

The winner of the 18 March 2021 Sporting Quiz Competition is Dr Elizabeth Cullen, Co Kildare

The winner of the 18 March 2021 Crossword is Elizabeth Thomas, Dublin 15

Q1 Who knocked Juventus out of this season’s Champions League?

A: FC Porto

Q2 Which country hosted the recent European Athletics Championships?

A: Poland

Q3 Who won the yellow jersey at this year’s Paris-Nice cycle race?

A: Max Schachmann

Q4 Which horse won the Champion Hurdle at Cheltenham at this year’s festival?

A: Honeysuckle

Q5 Who won golf’s Players Championship last weekend? A: Justin Thomas

Q6 Name the coach of the German national football team who announced his retirement earlier this month? A: Joachim Loew


1 Consider to be true (6)

5 Foot extremity (3)

7 Traveller on horseback (5)

8 Stimulate a reaction (7)

9 Attendant upon God (5)

10 Innate behaviour (8)

12 Frightened (6)

14 Violent in force (6)

17 Microorganisms (8)

18 Electronic message (5)

20 Have within (7)

21 Type of bus (5) 22

4 Suggestion (4)

5 Part of a gun (7)

6 Keep out (7)

7 Arrive at a destination (5)

11 Space between two objects (8)

12 An unknown person (7)

13 Progress (7)

15 Part of a room opposite the floor (7)

16 Cattle-breeding farm (5)

19 Piece of foliage (4))

13 - Progress (7)


15 - Part of a room opposite the floor (7)

16 - Cattle-breeding farm (5)

19 - Piece of foliage (4)

Life Mindo Quizzes THE MEDICAL INDEPENDENT | 8 APRIL 2021 36 Post your answers to: Mindo Quizzes, The Medical Independent, Greencross Publishing Ltd, Top Floor, 111 Rathmines Road Lr, Dublin 6. Closing date for entries is 19 April 2021 Solution to Crossword Competition
Answers to Sports Quiz Competition Solution to Sudoku S U D D E N A S L E E P T E A E E V R A L L E G E D C I A B I E U S U A L L Y L O V E R C L E E E A A N G E R R A C T O R E L A Y E R I N A A T O T R E A T T E N S I O N H R T T A C A V E R A G E E I L L M T N R E L I E F L E G E N D 6 9 2 8 1 3 4 7 5 4 5 1 2 6 7 8 3 9 8 3 7 4 9 5 6 2 1 5 1 8 7 3 6 2 9 4 9 7 4 1 5 2 3 8 6 2 6 3 9 8 4 1 5 7 3 8 6 5 4 9 7 1 2 7 4 9 3 2 1 5 6 8 1 2 5 6 7 8 9 4 3 5 3 6 2 3 4 9 6 1 8 7 6 2 8 8 7 4 2 7 6 3 1 2 4 1 8 SUDOKU SCRIBBLE BOX 18 MARCH 2021 ANSWERS, SOLUTIONS, AND WINNERS WIN €50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Across 1 - Consider to be true (6) 5 - Foot extremity (3) 7 - Traveller on horseback (5) 8 - Stimulate a reaction (7) 9 - Attendant upon God (5) 10 - Innate behaviour (8) 12 - Frightened (6)
- Violent in force (6)
- Microorganisms (8)
- Electronic message (5) 20 - Have within (7) 21 - Type of bus (5) 22 - Organ of sight (3) 23 - Decorative pattern (6) Down
- Long-lasting
out (7)
and recurrent
Supplied with
Suggestion (4) 5 - Part of a gun
6 - Keep
Arrive at
11 - Space between two objects
12 - An unknown
Organ of sight (3)
Decorative pattern (6)
2 Long-lasting and recurrent (7)
3 Supplied with (8)


Innovative new medicines for cancer, heart diseases and respiratory diseases are generating almost €52 billion in socioeconomic value for Ireland over 20 years, according to a new study by the WifOR Economic Research Institute for the Irish Pharmaceutical Healthcare Association (IPHA).

The study, The Value of Medicines in Ireland, examines the socioeconomic value of medicines and medicines expenditure.

It explores the macroeconomic impact of wealth and health, analysing the three leading causes of death in Ireland in 2019 – cardiovascular diseases, cancer, and respiratory diseases.

The period between 2005 and 2025 has been analysed, projecting for the remaining four of these years. In that 20-year period, medicines for cardiovascular disease generate €25.8 billion in socioeconomic value, according to the study. In cancer, the figure is €16.8 billion while €9.1 billion is the added socioeconomic value for respiratory diseases.

The total socioeconomic benefit, spread across the three therapy areas, is almost a quarter of modified gross national income (GNI) in 2019. It equates to two-and-a-half times the State’s health budget this year. On an annualised basis, the impact is €2.5 billion, which is more than the State’s €2.2 billion spend on medicines in 2019. It represents 22 per cent of the 20-year total expenditure in health. A return-on-investment analysis shows that, for every euro invested in medicines, €3.80 will be returned to the economy until 2025.

The study calculates the socioeconomic value of new medicines for the three therapy areas based

on avoided years of life lost, on fewer years lived with a disability and on avoided productivity losses.

The analysis shows that, over 20 years, new medicines for cardiovascular diseases result in 703,210 fewer years of life lost. It shows 19,416 fewer years lived with a disability. The cumulative socioeconomic impact is €25.8 billion because people are more productive for longer.

In cancer, the study shows that new medicines result in 470,785 fewer years of life lost over 20 years and 1,943 fewer years lived with a disability. The cumulative socioeconomic impact is €16.8 billion, according to the study.

In respiratory diseases, 183,397 fewer years of life are lost as a result of innovation in medicines, while 71,447 fewer years are lived with a disability. The resulting socioeconomic impact is €9.1 billion over the 20-year period.

The total impact value over 20 years is €51.7 billion. That equates to a per-capita impact of €11,000.

Prof Dennis

“Cancer, heart diseases and respiratory conditions accounted for 72 per cent of the principal causes of death in Ireland in 2019. By analysing these diseases, we wanted to demonstrate the therapeutic value of Ireland’s medicines spend in the context of overall population health. We hope this work can be a constructive input into healthcare policymaking, with a focus on value creation across society and economy rather than just considering medicines through the narrow prism of price.”

Mr Oliver O’Connor, Chief Executive of IPHA, said the originator biopharmaceutical industry was keen to quantify the real-world value of medi -

cines innovation.

“This groundbreaking study, the first of its kind in Ireland, demonstrates the impact of new medicines on patients’ lives, looking at indicators, such as life years lost without new treatments and the ability to work. It underlines the necessity to find a pathway for the sustained, predictable reimbursement of new medicines for patients. It shows how important it is for Ireland to pursue an enterprise policy that sustains the level of biopharmaceutical industry investment and builds for what is coming. It shows the positive impact of medicines innovation on patients’ lives, on our economy and on the healthcare system,” said Mr O’Connor.


The Irish Thoracic Society (ITS) is calling on the Government to take decisive action to combat the health, social and economic impact of tuberculosis (TB) and to bring Ireland in line with European neighbours in the fight against this preventable disease.

The call was made just prior to World TB Day 2020, which took place on 24 March.

ITS has joined a global call for accelerated efforts to end TB by 2030 and to mitigate the toll Covid-19 is taking on TB services worldwide.

sources and attention away from providing life-saving diagnosis and care to people suffering from TB worldwide. In addition, drug-resistant and multi-drug resistant TB pose a significant threat to gains made, making the fight against TB ever more complex and challenging.

an unprecedented TB crisis for a resource-starved service on top of an already

complex and demanding, albeit largely hidden, public health threat.”


A study has found a new ‘care bundle’ can reduce the incidence of facial pressure injuries in frontline Covid-19 healthcare workers caused by the prolonged wearing of personal protective equipment (PPE).

and Midwifery, was lead researcher on the study.

Prof Moore said, “We are acutely aware of the facial injuries, such as pressure ulcers, bruises, and skin tears that healthcare workers are experiencing due to the prolonged wearing of protective equipment during the pandemic and especially the wearing of medical face masks.


of the WifOR Economic Research Institute, said the study was designed to be a constructive input into evidence-based policymaking.

“Our analysis evidences the significant economic and societal contribution of the originator biopharmaceutical industry to Ireland. It illustrates the transformational impact of medicines innovation on mortality and morbidity. Our work shows the productivity gains generated by new medicines, using a 20-year analysis of key diseases to link medicines innovation with gains in life expectancy, workforce participation and a reduced burden on the healthcare system.

The ITS has outlined five key actions that Government needs to take including the appointment of a national TB controller, a national TB screening programme for high-risk groups, investment in contact tracing and surveillance activities, and an education and awareness programme for healthcare professionals and the public.

TB remains one of the deadliest infectious diseases and is the ninth leading cause of death worldwide. Each day nearly 4,000 people lose their lives to TB –approximately 1.5 million deaths annually – and close to 28,000 people fall ill with this preventable and curable disease. Global efforts to combat TB have saved an estimated 63 million lives since 2000. In Ireland, 267 cases of TB were notified to the Health Protection Surveillance Centre in 2019.

According to the ITS, Covid-19 is continuing to divert essential medical re-

According to Dr Marcus Butler, Consultant Respiratory Physician and Vice-President of the ITS, Ireland’s highly dedicated, but inadequately resourced, TB service is struggling to protect the health of the population. This is particularly the case for socially marginalised communities who are most susceptible to TB – those in the homeless and prison populations, as well as many in migrant communities.

“Sub-standard and overcrowded living conditions, poor nutrition, drug and alcohol misuse, as well as a weakened immune system due to other illnesses are all factors associated with increased risk of acquiring TB. Covid-19 has worsened these conditions for many, while bringing many more below the poverty line for the first time,” stated Dr Butler.

“The likelihood of rising TB cases as a result of the pandemic comes against the backdrop of increased pressure on health services, re-allocation of staffing resources and reduced numbers of people presenting with their symptoms due to Covid-19 restrictions. All of these factors are storing up

The study, led by researchers from RCSI University of Medicine and Health Sciences Skin Wounds and Trauma (SWaT) Research Centre, is published in the current edition of the Journal of Wound Care (see link): www.magonlinelibrary. com/doi/abs/10.12968/ jowc.2021.30.3.162

The research took place over a two-month period amongst healthcare workers in a large acute hospital in Ireland. In the study, approximately 300 frontline staff were provided with a care bundle, which was designed in line with international best practice and consisted of face cleansing material (WaterWipes baby wipes), moisturising balm (Eucerin Aquaphor Soothing Skin Balm), and protective tape (Mepitac Tape).

Results showed that prior to using the care bundle, 29 per cent of respondents developed a facial pressure injury, whereas after using the care bundle only 8 per cent of respondents developed such an injury. The analysis revealed that when using the care bundle, staff were almost fivetimes less likely to develop a facial pressure injury. In a secondary finding, respondents reported the bundle as easy to use, safe, and effective.

Prof Zena Moore, Director of the SWaT Research Centre and Head of the RCSI School of Nursing

“These injuries can be painful for staff and injuries in some cases can put them at increased risk of infection. This study is the first of its kind carried out at the height of the pandemic in an effort to help mitigate the occurrence of facial pressure injuries. The results tell us that when skincare is prioritised, and a systematic preventative care bundle approach is adopted, there are clear benefits for the frontline workers and the workplaces involved.”

The research was carried out by researchers from the SWaT Research Centre at RCSI in collaboration with skin care companies, WaterWipes UC, based in Drogheda, Ireland, and Beiersdorf in Hamburg, Germany. WaterWipes UC and Beiersdorf contributed in-kind products including cleansing wipes and moisturiser respectively. Fleming Medical in Limerick, Ireland, distributed the tape.

Based in RCSI’s School of Nursing and Midwifery, the SWaT Research Centre is leading cutting-edge research in the field of wound healing and t issue repair, with a specific emphasis on pressure ulcer prevention and management.



Locum GP required in North Inishowen area to cover leave for months of July, August, and September.

Group practice/fully computerised, full ancillary staff in a purpose-built primary care centre. For further information on this position contact Dr Seamus Kelly via email

Millbrae Surgery, Carndonagh, Co Donegal


Dr Alan Murtagh, Consultant Psychiatrist, IMCN 23002 will be commencing a General Adult Psychiatry and Adult ADHD Clinic from May 17th 2021

Please email referrals to or post to PO Box 13327, Maynooth, Co Kildare

For more information go to


Four sessions per week on a Tuesday and Thursday. In a modern four doctor general practice in Wicklow Primary Care Centre. Expressions of interest with CV to: Practice Manager, email:


GP wanted for family medical practice in North Cork area. Full-time preferred. Practice undergoing significant expansion and development, both academic and otherwise. Flexible terms and excellent remuneration. Practice is well supported with excellent nursing and administrative staff. Helix Health computer system.  CV to


Position available in our modern, vibrant, training practice in Co Wexford for a sessional or full-time GP. Excellent nursing and administration support. This position will suit a GP who enjoys working in a supportive team environment. Generous terms and conditions.

Contact: Please see our website for further information about the practice on


GP required in Killarney. Six sessions per week. Immediate start. Modern surgery. Sessions flexible. Rapid progress to own GMS list.

For more information or enquiries contact Laura at or 087 990 1108


Looking for a consulting room in the Galway Clinic to rent on a sessional basis? 1-8 sessions available weekly in a quiet furnished ground floor suite.

Also, if you need a separate office full-time for your medical secretary or as a clinical room for a nurse or physiotherapist, there is a smaller office available to let full-time in the same suite.

Please phone 086 804 9891 for further information.


Custom House Square Medical Centre is seeking a full-time salaried general practitioner to join a young(ish) dynamic team.

The remuneration package is best in class and the working hours and conditions are most attractive.

Have a gander at our website and if interested forward your CV to

For informal enquiries please phone Dr Peter Killeen at 087 131 4139


Seafront Medical Centre available to rent from 1st July, Main St, Blackrock, Co Louth.

Existing medical practice in this building since 1989. Superb location, prestigious building, at bus stop, free parking. Three doctor’s consulting rooms, nurses room, receptionist and secretarial area, fine reception area and back office and toilets. All rooms have plenty of natural light and windows. Terrific opportunity for enthusiastic young doctors to set up practice in underdoctored population in sought after area in perfect location. Contact  or 086 829 4445 for further information

Classifieds & Recruitment THE MEDICAL INDEPENDENT | 8 APRIL 2021 38

The first Heart-Kidney Masterclass will bring together an expert faculty of international and national speakers and chairs to explore common issues that exist for patients living with heart failure and chronic kidney disease.

The Masterclass is divided into two sessions which will focus on RAASi optimisation and iron deficiency/anaemia management highlighting areas of controversies and recent clinical updates. These interactive sessions will include a mix of plenaries, case studies and Q&A sessions that will allow for practical learning.

The meeting is aimed at healthcare professionals involved in the management of patients with CHF and CKD particularly nephrologists, cardiologists, care of the elderly physicians, general practitioners, nurses, and pharmacists.

We really hope that you will be able to join us for the Heart-Kidney Masterclass Virtual Meeting 2021.

Yours sincerely,

Classifieds & Recruitment THE MEDICAL INDEPENDENT | 8 APRIL 2021 39 This meeting has been initiated and funded by Vifor Pharma, including honoraria for the speakers. The presentation slides, clinical content and study cases have been developed by the speakers. Vifor Pharma remain responsible and have checked the content for compliance purposes. Date of Preparation | March 2021 IE-NP-2000029 VIRTUAL MEETING HEART-KIDNEY MASTERCLASS SATURDAY 17TH APRIL 2021 09:00 - 13:00 Optimising Care for Better Heart-Kidney Health: Learning from the Experts
REGISTER FOR OUR VIRTUAL MEETING AT: WWW.CONFERENCEDIARY.IE ACCESS PIN: VIFORHK21 Full scientific programme will be available to view upon completion of the registration process. 4 CPD Points Awarded
ARE YOU LOOKING FOR GP COVER? LOCUM, LONG-TERM OR PARTNERSHIP GET IN TOUCH WITH MATCHMEDICS TODAY TO FIND YOUR NEXT HIRE! CALL GRAHAM ON 087 758 4592 Email: Website Thur 22nd & Fri 23rd April For further information contact: Global Teamwork Email: 36092_JFAd_122x150mm.pdf 1 26/03/2021 11:27

A round-up of news and oddities from left field by Dr Doug Witherspoon

Memories are made of this...

Do you remember what you ate for dinner two days ago? How about three weeks and two days ago, or four years, three months and 25 days ago? If the answer to the latter is ‘yes’, you may have hyperthymesia, otherwise known as highly superior autobiographical memory (HSAM), a mysterious neurological condition whereby memories actually become clearer as time goes by.

Little is understood about this rare condition, but research is ongoing, with the hope that taking the findings from bench to bedside will achieve the objective of better treating people with memory impairment, for example in amnesia or some instances of acquired brain injury.

While most of us can remember where we were for significant life events – the most obvious example is the clichéd ‘where were you when JFK was shot’? – for most of us, regular events are stored in the short-term memory and subsequently discarded. For people with HSAM, howev-

er, their memories become clearer over time and to add to the conundrum, those few people who are confirmed to have this characteristic are identified at all ages in life, intelligence levels, and socioeconomic backgrounds. However, they do have certain traits in common, such as a propensity to think deeply about past life events. They also seem to have the ability to shut-out external distractions and concentrate very deeply, have a propensity to fantasise and daydream, and exhibit borderline compulsive behaviour, such as compiling large collections of items, for example, and organising and categorising them meticulously.

MRIs and ECGs show that people with HSAM have alterations in certain parts of their brains, but it is unknown whether this occurred naturally or as a result of them using different parts of their brains over time. Only around 100 people have been clinically diagnosed with the ‘condition’.

Unfortunately for the person with HSAM, they remember traumatic or painful life events with the same clarity as positive ones and so require the help of a physician to ‘train’ their brains to filter out the negative. As you can imagine, remembering events from years ago in exquisite clarity is also mentally exhausting. If the condition is undiagnosed, it can also be a pretty scary thing to have. Also, it’s important for our mental health to be able to let things go, but this is a luxury people with HSAM often don’t have. Paradoxically, because the mind is always exercised on past events, short-term memory can suffer as a result.

So, while it may sound like a desirable characteristic to have – imagine how easy exams would have been if you had been able to remember each lecture in microscopic detail – HSAM falls under the category of being ‘careful what you wish for’.

A chequered career

It was with some sadness and pangs of nostalgia that I noted the recent passing of sports commentator Murray Walker at the ripe old age of 97. For many of us, especially those of a particular vintage, certain commentators’ voices are synonymous with their particular sports. For example, George Hamilton is considered by many to be voice of Irish soccer; in the English game, maybe John Motson or Barry Davies; in snooker, ‘whispering’ Ted Lowe; for horse racing, see Peter O’Sullevan; Peter Allis will forever be associated with golf; and so on. (Fred Cogley for Irish rugby, anyone?) However, when it comes to motor racing, the sport will forever be linked to the excitable tones of Murray Walker. Like most famous commentators, he was sometimes prone to the occasional gaffe (affectionately referred to as ‘Murrayisms’). So as a closing tribute to him, a few of his best are listed below.

• “Mansell is slowing down, taking it easy. Oh no he isn’t – it’s a lap record!” Murray commentating on Nigel Mansell.

• “This would have been Senna’s third win in a row, if he’d won the two before.” Commentating on racing legend Ayrton Senna

• “This is an interesting circuit because it has inclines and declines. And not just up, but down as well.”

• “There are seven winners of the Monaco Grand Prix on the starting line today and four of them are Michael Schumacher.”

• “There is nothing wrong with his car, except that it’s on fire!” Similarly, he once commented: “And there’s no damage to the car. Except to the car itself.”

• “Here in Malaysia, it doesn’t rain by the bucketful, it rains by the ocean.”

• “I’m ready to stop my startwatch.”

• “Only a few more laps to go and then the action will begin. Unless this is the action, which it is!”

• “Unless I’m very much mistaken – which I am!” ‘Unless I’m Very Much Mistaken’ became the title of his autobiography.

• “Do my eyes deceive me, or is Senna’s car sounding a bit rough?”

• “I imagine that the conditions in those cars today are totally unimaginable.”

If you have anything you would like to share, please email: The Dorsal View THE MEDICAL INDEPENDENT | 8 APRIL 2021 40