The level of vitriol of the anti-vax movement that Dr Muiris Houston witnessed in Canada was on a different scale to that in Ireland
PAGE 20
The State Claims Agency (SCA) wrote to the RCSI earlier this year to confirm doctors would be covered by the clinical indemnity scheme if they were sued by patients for delayed diagnosis and treatment due to the Covid-19 pandemic, the Medical Independent (MI) can report.
In a 23 March letter to RCSI President Prof Ronan O’Connell, the Agency’s Director Mr Ciarán Breen noted the College Council’s concerns about the medico-legal consequences of delayed diagnosis and treatment because of the pandemic.
“We confirm that hospitals and individual medical practitioners will be covered by the clinical
indemnity scheme in circumstances where a patient sues a hospital and/ or practitioner alleging that he/she has suffered a personal injury as a result of an alleged delay in diagnosis or treatment,” outlined Mr Breen in the letter seen by MI following a Freedom of Information request.
“In the event that an individual practitioner receives such a letter of claim he/she has the option of a) bringing the letter of claim to the attention of the practitioner’s employing hospital, for onwards transmission to this Agency or b) sending the letter directly to the Agency, marked for the attention of the writer [Mr Breen].”
Mr Breen was responding to a letter from Prof
O’Connell on 22 March, which noted “it is very likely that litigation will be threatened against individual medical practitioners” arising from delays to patient care because of the pandemic.
“No possible liability should attach to them in such circumstances.”
At the April meeting of the RCSI Council, the response received from the SCA was described as “reassuring”.
On 25 February, Prof O’Connell also wrote to the HSE CEO Mr Paul Reid raising similar concerns.
“RCSI would welcome clear guidance from the HSE and the clinical indemnity scheme on how healthcare professionals can best protect themselves from the likely
tsunami of litigation that will inevitably follow the pandemic,” wrote Prof O’Connell.
In July, MI reported that the RCSI Council raised concerns with the Medical Council about potential patient complaints against doctors due to delays accessing clinical care during the pandemic.
According to minutes of the RCSI Council’s meeting in February, the then President of the Medical Council Dr Rita Doyle had reassured practitioners that “adverse outcomes arising from resource or pandemic-related delays would not be appropriate grounds for progressing a complaint against an individual practitioner”. She advised that “while the Council is statutorily re -
The Medical Council has drawn attention to the need for its membership to reflect the diversity of Irish society.
In a governance meeting with the Department of Health in July, representatives from the medical regulator suggested that the filling of future vacancies on the Council “should reflect the more diverse society that Ireland is, in terms of candidates being nominated for the Minister’s consideration”, according to meeting minutes obtained from the Department of Health following a Freedom of Information request.
“The Department agreed that this would be considered when seeking nominations from nominating bodies.”
The virtual governance meeting with the Department, which was the first for Council CEO Mr Leo Kearns and President Dr Suzanne
Crowe, also heard that the regulator was embarking on “a programme of change”.
The Council presented a number of key strategic issues to be addressed as part of this programme.
“These included issues relating to the rebalancing of the organisation with an emphasis on right touch regulation; education and training; staffing resources and organisational performance; guidance for doctors; governance; and stakeholder engagement,” according to the minutes.
Some changes were arising from amendments to the Medical Practitioners Act 2007 by the Regulated Professions (Health and Social Care) (Amendment) Act 2020, which will necessitate new processes relating to registration and fitness to practise. “Work is ongoing to develop a change programme to address these themes in a co-ordinated and structured manner.”
Pictured at the IHCA AGM and Annual Conference, which took place on 9 October, are (L to R): Prof Rob Landers, IHCA Vice President; Prof Alan Irvine, IHCA President; Mr Stephen Donnelly, Minister for Health; and Dr Gabrielle Colleran, IHCA Vice President
quired to investigate every complaint received, any complaints about medical practitioners are consid -
ered on the specific facts of the case and the particular situation in which the doctor is working”.
There is “significant unrest” among trainees at recent developments in relation to Sláintecare and the draft consultant contract, the IHCA annual conference heard.
At the online conference on Saturday 9 October, attended by over 300 consultants, early career doctors voiced concerns over the current contract negotiations between the IHCA, IMO, HSE, and Department of Health.
“What I can say is that for senior trainees, the recent uncertainties and upheaval over its [Sláintecare] implementation have caused significant unrest,” said Dr Niamh Murphy, Specialist Registrar in Paediatric and Adolescent Gynaecology, Coombe Women and Infants University Hospital, Dublin.
She said a “significant proportion” of the Irish Fellows and specialists with whom she previously worked in Toronto will not return to take up the proposed Sláintecare contract as it stands. She warned Ireland “will almost certainly lose out on high-skilled clinicians as they will simply find better opportunities abroad”.
The conference also heard from Dr Stefanie Croghan, Specialist Registrar in Urology, RCSI, who presented new research on the perceptions of higher specialist trainees
The cyberattack on the HSE and health service in May had a “catastrophic effect” on Children’s Health Ireland (CHI) services, its board was informed.
According to minutes of the 25 June board meeting seen by the Medical Independent (MI) following a Freedom of Information request, CHI at Crumlin and Temple Street were the hospitals “most affected” in CHI.
Board members were updated on the cyberattack’s impact on CHI activity levels. There was a reduction in inpatient activity of 40 per cent in May and 28 per cent in June. Day case activity was down 28 per cent in May and 21 per cent in June.
“Outpatient activity was down by 36 per cent in June... July activity is still expected to be affected by the cyberattack, having a further impact on the waiting lists,” according to minutes.
The same meeting heard that, by the end of June, “the majority of HSE and CHI ICT systems were now functioning to some degree.”
This month, a HSE spokesperson told MI that over 99 per cent of all “production servers and 100 per cent of all devices have been restored” across the health service.
“Acute services are almost fully restored, along with community and corporate. All of our priority systems are back online on local sites, including radiology and diagnostic systems; maternity and infant care; patient administration systems; chemotherapy; radiation oncology; radiotherapy; and laboratories.”
Restoration was a technical and operational challenge that needed to be undertaken in a “systemic and safe way”.
Staff email restoration was taking place on a phased basis. Most staff had access to email, but work was ongoing in certain areas on enabling access and accessing historical mails, according to the spokesperson.
and Fellows regarding the proposed consultant contract.
Over 93 per cent of trainees surveyed will consider working abroad rather than signing the draft contract. Respondents expressed concerns surrounding the ability to advocate for patients, provide patient care, working conditions, and perceived potential for deskilling.
“The terms have been viewed as unacceptable and risk
precipitating mass emigration of doctors from Ireland.”
Minister for Health Stephen Donnelly told the conference he would like to see a new contract agreed “within weeks”. He said pay equity “can be considered within the framework of these talks”.
*Further coverage of the IHCA conference in our next issue.
This image shows why early diagnosis and treatment compliance is so importantDAVID LYNCH david@mindo.ie
With debates about the future of Sláintecare sparked by recent resignations, David Lynch asks doctors what they think the next steps should be for the health strategy
Since its publication in 2017, the Sláintecare healthcare strategy has probably never had more media and political attention.
The wide-ranging 10year plan to achieve a universal single-tier health system has been constantly in the headlines since Ms Laura Magahy, the Executive Director of the Sláintecare Programme Office, and Prof Tom Keane, the Chairperson of the Sláintecare Implementation Advisory Council (SIAC), both resigned in early September citing concerns over implementation.
The Minister for Health Stephen Donnelly has since said that a new board is to replace the outgoing SIAC and it will be co-chaired by HSE CEO Mr Paul Reid and the Secretary General at the Department of Health Mr Robert Watt.
In July 2019, the Government approved the creation of six new regional health areas (RHAs) as part of reforming the health service. The plan has caused tension between the SIAC and the Minister (see panel below).
This tension was first highlighted in the Medical Independent (MI) back in early May when this newspaper reported that, at its December 2020 meeting, the SIAC strongly disagreed with the Minister’s view that progressing the new RHAs should be postponed as a result of the Covid-19 pandemic.
In the face of recent sustained oppo -
In early May, the Medical Independent (MI) reported on tension between the Sláintecare Implementation Advisory Council (SIAC) and the Minister for Health.
In our lead story ‘Sláintecare Council opposes Donnelly’s halt on regionalisation’, MI outlined that differing points of view on the timetable of regionalisation were raised at SIAC meetings late last year.
The promised reorganisation of the health system into six regional health areas (RHAs) is not an unimportant aspect of the 10-year health plan, but “essential”, one of the original framers of Sláintecare told MI
“Sláintecare was essentially about population-based health and delivering patient-centred services based on population catchment areas,” said Dr Michael Harty.
“That is where the regionalisation came in because we believed in [the] Sláintecare [committee] that the HSE was too centralised and it was unwieldy and very difficult to
develop a responsive health service; it was just too slow to react to the needs of patients.”
He said the plan for the RHAs “took a bit of work and that was finally agreed back in June 2019... and the Minister [for Health] at the time, and the Government at the time, adopted it as policy”.
“So it was quite disappointing, to say the least, when it has come out over the last few weeks that there was apparently a resistance identified by the advisory council to regionalisation.”
“It [regionalisation] was one of the main frameworks or reforms of Sláintecare. We saw little benefit in pouring more money into a system that was patently not working. Regionalisation was about getting over that substantial blockage or over-centralisation of the HSE.”
Writing in the last edition of MI , IHCA President Prof Alan Irvine said his Association “has long supported the restructuring of healthcare services to ensure greater
alignment between community and hospital services”. He described the current system as “excessively centralised”.
“To work effectively, all hospital and community health services should be merged into one organisation within specific geographic areas. We need to move away from a ‘command and control’ model to one that supports and enables flexibility and responsiveness at a local level. That capacity to flex and local empowerment to plan has worked successfully during the past 18 months of the pandemic and needs to be fully embraced for the future.”
Prof Orla Hardiman told MI that she agreed that the HSE is “excessively centralised and that regionalisation should be pursued”.
“We should have ‘hubs and spokes’ with major hospitals in each region providing good quality services. The budgets for hospitals and community services should not be separate,” she added.
sition criticism, Minister Donnelly has pointed to the latest Sláintecare midyear progress report, which “details a total of 112 deliverables for the first six months of this year. Of those 112 deliverables, 109 are either on track or have been progressed”.
“Given what our health service has faced in the last 18 months, this is remarkable progress and a fantastic testament to the hard work and dedication of staff right across the Department of Health, the HSE, and all of the partner organisations who work together to deliver Sláintecare,” Minister Donnelly said last month.
Doctors that MI contacted voiced support for the central aims of Sláintecare. However, they remained sceptical with the pace of implementation and concerned by recent high-profile resignations.
Clare GP and former Independent TD Dr Michael Harty has been part of the Sláintecare story from the very beginning. As a member of the Future of Healthcare Committee, he was one of the central authors of the original report, which was published in May 2017.
No longer in politics, Dr Harty described himself as “very frustrated at the way it has been handled”.
“It’s now four-and-half years since the Sláintecare report was published and things are worse now than they were
four-and-half years ago and they are only going to get worse unless Sláintecare is implemented in its entirety,” he told MI
Dr Harty said the regionalisation of the health system is fundamental to the success of the project and expressed concern about delays in rolling out the RHAs.
He also insisted that at the commencement of the strategy, the Sláintecare office should have been placed in the Department of the Taoiseach rather than in the Department of Health.
“We saw from the very beginning, if Sláintecare was placed within the Department of Health it wouldn’t have the same political clout,” he said. He noted that it took the Government 14 months to respond to the original Sláintecare report and then that response “was a substantially different action plan”.
Asked whether the political will is there to successfully implement Sláintecare, Dr Harty said: “I don’t know.”
“I would be doubtful that it is there, in terms of what Sláintecare [originally] envisaged. Because Sláintecare was not an à la carte menu; it was a very integrated, comprehensive piece of reform and it was not something that you could take this bit or that bit and ignore other bits.”
His concerns go beyond regionalisation.
“The are other things that have not been done,” he said.
“We don’t have a unique patient identifier, that was promised. That would be a huge benefit to streamline the service. We don’t have a single digital healthcare record. We looked internationally far and wide in the Sláintecare committee to look at health services that were successful in integrating care and delivering a single-tier service and those two [measures] were essential, and if you don’t have them you really aren’t going anywhere.
With the focus on resignations, restructuring, and regionalisation, it could be easily forgotten that the funding of the Sláintecare vision remains one of the biggest challenges.
Since its original publication in 2017, have the projected costs of the plan been consistent?
“I’m not aware of any significant changes to the overall cost estimates, although there has been some confusion in relation to these,” Dr Brian Turner (PhD), Department of Economics, Cork University Business School, University College Cork (UCC) told the Medical Independent
“The Sláintecare report said it was going to cost €2.8 billion over 10 years, which was a rather unusual choice of phrasing.”
“The plan envisages that, by the
Abroad
“I have been watching the discussions around Sláintecare keenly from afar,” Dr Mary Ní Lochlainn, a Specialist Registrar in Geriatric and General Internal Medicine working in the UK, told MI
“It is without a doubt that the decisions around Sláintecare and the plans made will have a huge influence on the decision-making of those of us abroad, when considering whether or not to return home in future.
“As someone working in the NHS in the UK, the idea of doing purely public work is perfectly acceptable and appealing to me. I am content with the prospect of purely public work
end of the 10-year timeframe of the plan, we would be spending €2.8 billion per annum more than at the start of the plan, over and above the increases in spending arising from medical inflation and demographic pressures, for which the report was allowing 3 per cent per annum.” Dr Turner said he thought that this 3 per cent was “a bit conservative”.
“In relation to funding in the upcoming budget, I would expect to see some funding ring-fencedfor Sláintecare implementation,” he said.
“There was a significant amount of money allocated for it last year, but listening to the Oireachtas Health Committee proceedings this morning [on Wednesday 6 October], it sounds like some of that will be unspent by the end of the year.”
idea that I cannot earn any additional money, in my personal time outside of working hours, infantilising,” she said.
“I am deeply concerned about the prospect of being moved to another hospital and what that lack of stability would mean for my family. One of the reasons I left Ireland was the prospect of moving away from loved ones every year during training. When you have a family member or spouse or partner with health problems, this is untenable, and I speak from personal experience.”
However, she added that most of these issues “appear to be easily resolvable”.
“However, I have also heard the Government have stated that the contract is non-negotiable, which is not very constructive. How will the aims of Sláintecare be achieved without a major recruitment drive of consultants?”
Dr Ní Lochlainn also said she was concerned about the recent resignations from SIAC, “which appears indicative of serious feasibility issues.”
But she noted that despite that “negativity” she agreed “that the Irish healthcare system needs reform”.
17
per cent fewer emergency surgeries were performed during the Covid-19 pandemic, according to a new report published by the RCSI National Clinical Programme in Surgery (NCPS).
30
per cent fewer elective surgeries were performed during the pandemic, the NCPS report stated.
153 per cent increase, from April 2020 to April 2021, in the number of surgical patients waiting longer than 12 months for their procedures.
15 per cent increase in the total surgical outpatient waiting list.
1
“So pouring money into the health service without substantial reform is really just doing more of the same and expecting a different result... extra money without reform is probably money poorly spent.”
One of the implicit promises of the plan is that it will improve the Irish health service to make it more attractive for doctors to stay in Ireland and work in the system. Thus, the progress of Sláintecare, or lack thereof, is being followed by members of Ireland’s medical diaspora.
and would rather live in a country with equal access to healthcare irrespective, rather than the current twotiered system.”
However, Dr Ní Lochlainn said that the details of the proposed Sláintecare consultant contract appeared “to have a lot of worrying elements to it, which I have been hearing about from peers, the media and on Twitter”.
“As someone who has always picked up extra locum shifts here and there when saving for something, I find the
“I feel privileged as both a doctor and a patient to live in a country [the UK] with universal healthcare and I look forward to such a system existing in Ireland – having trained in such a system I have seen first-hand how well it can function, for healthcare workers and patients alike. I am hopeful that the Irish Government will engage meaningfully with doctors in Ireland in order to progress this dream.”
With its promise of a universal single-tier system Sláintecare has won praise from some doctors working in disadvantaged communities. However, recent developments have sparked worry.
Prof Susan Smith, Associate Professor in the Department of General Practice-in-five consultant posts remain vacant, according to the IMO. The Organisation stated continuing difficulties in recruiting consultants were ‘hugely concerning’.
30
per cent of consultants and 30 per cent of GPs are due to retire in the next five years, according to the IMO.
Sláintecare was not an à la carte menu; it was a very integrated, comprehensive piece of reform and it was not something that you could take this bit or that bit and ignore other bitsDr Michael Harty Dr Mary Ní Lochlainn
Continued from p5 ▸
at the RCSI, and a member of the ‘GPs at the Deep End’ group told MI that GPs are concerned with some of the Sláintecare news over the past month.
“GPs working in disadvantaged communities, who are part of Deep End Ireland, were really disappointed to hear of the recent Sláintecare resignations,” she said.
AGAINST LDL-C* IN THE TREATMENT OF HYPERCHOLESTEROLAEMIA
Prof Smith added that the high-profile resignations suggest that “the programme is in serious difficulty”.
“The Sláintecare reforms included plans to deliver a health system with universal access to care, based on need and not ability to pay,” she added.
“There was also a strong emphasis on resource allocation based on need, which can address the higher healthcare needs of people living in disadvantaged communities.”
Prof Smith said that there was now an onus on political leadership to push the health plan forward.
“There is an urgent need for the Taoiseach and Government leaders to outline their commitment to
Sláintecare and to be clear exactly how they will support its implementation.”
Bureaucracy
Prof Orla Hardiman, Consultant Neurologist and Professor of Neurology at Trinity College Dublin, also described the aspirations of Sláintecare as “admirable”.
“I fully agree that we should aim to have a single-tier health system in which access is free at the point of care, that care is provided based on need rather than ability to pay, that low complexity services and procedures should be administered as close to community as possible, and that more complex services and those for rare conditions that require extensive multidisciplinary team involvement should be centralised,” she told MI
However, Prof Hardiman said that she also “worried” as to whether “there is a real appetite for this sort of radical change across the healthcare landscape”.
“I don’t think one can blame any one sector; there are many points of resistance to change.
“The most important driver will be the cross-party political will, which, as far as I can see, is not as strong as it might be.”
Describing her own experience as lead of one Sláintecare innovation programme (on headache), Prof Hardiman said the “process was extremely administration heavy, with a lot of bureaucracy that was really not necessary”.
for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia1
calcium) respectively, and 10mg ezetimibe. Indication: Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia. Dosage and Administration: The patient should be on and continue, an appropriate lipid-lowering diet, during treatment with Suvezen. Suvezen is not suitable for initial therapy.
Treatment initiation or dose adjustment, if necessary, should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. The recommended dose is one Suvezen tablet daily. To be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water. If co-administered with bile acid sequestrant (BAS), administration of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a BAS. Special populations: Paediatric (<18 years): Safety and efficacy has not been established. Elderly (>70 years): Starting dose of 5 mg rosuvastatin is recommended. The combination is not suitable for initial therapy. Hepatic impairment: Mild: No dosage adjustment is required. Moderate/Severe: Treatment with Suvezen is not recommended. Renal impairment: Mild: No dose adjustment is necessary. Moderate (creatinine clearance <60 ml/ min): The recommended start dose is rosuvastatin 5mg. Race: The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry due to increased systemic exposure. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Suvezen 40 mg/10 mg tablets are contraindicated in these patients. Genetic polymorphisms: In patients who are known to have specific types of genetic polymorphisms that can lead to increased rosuvastatin exposure, a lower daily dose of Suvezen is recommended. Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5mg in patients with pre-disposing factors to myopathy. Suvezen 40 mg/10 mg tablets are contraindicated in some of these patients. Concomitant therapy: The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir).
Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where co-administration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered. Contraindications: Hypersensitivity to the active substances or excipients.
Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures. Active liver disease or any serum transaminase elevations which are unexplained, persistent or exceeding 3x the upper limit of normal (ULN). Severe renal impairment (creatinine clearance <30ml/min); myopathy or receiving concomitant ciclosporin. 40mg/10mg dose contraindicated in patients with predisposing factors for myopathy/rhabdomyolysis; such factors include: Moderate renal impairment (creatinine clearance <60ml/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels of rosuvastatin may occur, Asian patients, concomitant use of fibrates.
Precautions and Warnings: Skeletal muscle effects: have been reported in rosuvastatin-treated patients with all doses and in particular with doses >20mg. As with other HMG-CoA reductase inhibitors, reporting rate for rhabdomyolysis is associated with use at doses >40mg. Post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. If myopathy is suspected based on muscle symptoms or is confirmed by a creatine phosphokinase (CPK) level, Suvezen and any of these other agents that the patient is taking concomitantly should be immediately discontinued. All patients starting therapy with Suvezen should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, particularly if associated with malaise or fever. Creatine kinase (CK) measurement: CK should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase. If CK levels are significantly elevated at baseline (>5x ULN) a confirmatory test should be carried out within 5 – 7 days. If the repeat test confirms a baseline CK >5x ULN, treatment should not be started. Patients with predisposing factors for myopathy/rhabdomyolysis: Caution should be exercised in these patients. Risk: benefit of treatment should be considered and clinical monitoring is recommended. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5x ULN) or if muscular symptoms are severe and cause daily discomfort. If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing treatment at the lowest dose. Immune-mediated necrotising myopathy (IMNM): Clinically characterised by proximal muscle weakness and elevated serum CK, has been reported very rarely during or after treatment with statins, including rosuvastatin, despite discontinuation of statin treatment. In clinical trials an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives. Suvezen should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Liver effects: In controlled co-administration trials in patients receiving ezetimibe with statin, consecutive transaminase elevations ≥3x ULN have been observed. It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminases is >3x ULN. The reporting rate for serious events is higher at the 40mg dose. In patients with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome, the underlying disease should be treated prior to initiating therapy with rosuvastatin. Liver disease and alcohol: As with other
HMG-CoA reductase inhibitors, rosuvastatin should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. Renal effects: Proteinuria has been observed in patients treated with higher doses of rosuvastatin and was transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40mg. Diabetes mellitus: Some evidence suggests that statins raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (fasting glucose 5.6 – 6.9mmol/l, BMI >30kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. Interstitial lung disease: Exceptional cases have been reported with some statins, especially with long term therapy. Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected, statin therapy should be discontinued. Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors in combination with ritonavir. Consideration should be given both to the benefit of lipid lowering by use of Suvezen in HIV patients receiving protease inhibitors and the potential for increased rosuvastatin plasma concentrations when initiating and up titrating rosuvastatin doses in patients treated with protease inhibitors. The concomitant use with certain protease inhibitors is not recommended unless the dose of rosuvastatin is adjusted. Fibrates: The safety and efficacy of ezetimibe administered with fibrates have not been established. If cholelithiasis is suspected in a patient receiving Suvezen and fenofibrate, gallbladder investigations are indicated and therapy should be discontinued. Anticoagulants: If Suvezen is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalised Ratio (INR) should be appropriately monitored. Fusidic acid: Suvezen must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination.
The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of fusidic acid. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e.g., for the treatment of severe infections, the need for co-administration of Suvezen and fusidic acid should only be considered on a case by case basis and under close medical supervision. Suvezen contains lactose monohydrate and sodium:
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Interactions: Contraindicated combinations: Ciclosporin.
Not-recommended combinations: Fibrates and other lipid-lowering products, protease inhibitors, transporter protein inhibitors and fusidic acid. Other possible interactions: Cytochrome P450 enzymes, antacids, colestyramine, anticoagulants, Vitamin K antagonists, erythromycin, oral contraceptive/hormone replacement therapy. When co-administering rosuvastatin with other medicinal products known to increase exposure to rosuvastatin, doses should be adjusted (see SmPC for full details). The maximum daily dose should be adjusted so that the expected rosuvastatin exposure would not likely exceed that of a 40mg daily dose of rosuvastatin taken without interacting medicinal products. Fertility, Pregnancy and Breastfeeding: No clinical data are available on the use of ezetimibe during pregnancy. Potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. If a patient becomes pregnant during use of Suvezen, treatment should be discontinued immediately. Animal studies have shown excretion of medicinal product through breast milk. However, there are no data in humans. No clinical trial data on the effects of fertility in humans. Adverse Reactions: Adverse drug reactions previously reported with one of the individual components (ezetimibe or rosuvastatin) may be potential undesirable effects with Suvezen. Common (≥1/100 to <1/10): diabetes mellitus, headache, dizziness, constipation, nausea, abdominal pain, diarrhoea, flatulence, myalgia, ALT and/or AST increased, asthenia and fatigue. Uncommon (≥1/1,000 to <1/100): decreased appetite, paraesthesia, hot flush, hypertension, cough, dyspepsia, gastroesophageal reflux disease, nausea, dry mouth, gastritis, pruritus, rash, urticaria, arthralgia, muscle spasms, neck pain, back pain, muscular weakness, pain in extremity, ALT and/or AST increased, blood CPK increased, gamma-glutamyltransferase increased, liver function test abnormal, chest pain, pain, asthenia, oedema peripheral. Rare (≥1/10,000 to <1/1,000): thrombocytopenia, hypersensitivity reactions including angioedema, pancreatitis, increased hepatic transaminases, myopathy (including myositis), rhabdomyolysis, lupus-like syndrome and muscle rupture. Very rare (<1/10,000): polyneuropathy, memory loss, jaundice, hepatitis, arthralgia, haematuria, gynaecomastia. Not known: thrombocytopenia, hypersensitivity (including rash, urticaria, anaphylaxis and angioedema), depression, peripheral neuropathy, sleep disturbances (including insomnia and nightmares), dizziness, paraesthesia, cough, dyspnoea, diarrhoea, pancreatitis, constipation, hepatitis, cholelithiasis, cholecystitis, Stevens Johnson syndrome, erythema multiforme, immune-mediated necrotising myopathy, tendon disorders (sometimes complicated by rupture), myalgia, myopathy/rhabdomyolysis, oedema, asthenia. See SmPC for full details on adverse
“Also the current system of new service development, which I presume would be eventually subsumed into a change management programme were Sláintecare to truly become operational, is not at all joined up,” she added.
“Different projects and initiatives across the HSE don’t seem to cross reference very well, and there seems to be a lot of duplication and last minute requests for data that should take weeks or months to generate and present in a robust manner. The absence of a multi-annual budget across the sector is a major problem as it is very difficult to develop projects incrementally, which is how we should be doing things.”
Prof Hardiman said the “HSE seems to have been outsourcing to management consultants in the past couple of years”.
“This seems to be a very expensive way to address problems when all of this expertise should already be within the Department of Health, which is supposed to be driving policy, and the HSE, which is supposed to be implementing policy.”
Looking at what next steps should be taken, Prof Hardiman said care needs to be delivered as close to the community as possible.
“That means in the first instance providing resources to GPs to access diagnostics,” she explained.
“We should start to look at universal access to healthcare at the first point of contact. This should be done incrementally, but in the longer term it is more efficient to invest in primary care.”
Prof Hardiman emphasised the importance of political will, multi-annual budgets and investment in “projects that link secondary to primary care services”.
The most important driver will be the cross-party political will, which, as far as I can see, is not as strong as it might beProf Susan Smith Prof Orla Hardiman
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 - www.beaconhospital.ie or call 01 650 4860.
Patients can be referred by emailing covid.recovery@beaconhospital.ie
A new study of healthcare professionals’ (HCPs) implementation of the valproate pregnancy prevention programme (PPP) reflects an “urgent” need for a stakeholder group on risk reduction, as well as the filling of vacant nursing posts, the CEO of Epilepsy Ireland has told the Medical Independent (MI)
Mr Peter Murphy was renewing the organisation’s call for these measures in light of a recent study, published in Expert Opinion on Drug Safety, examining awareness, knowledge and practice of Irish HCPs in implementing the sodium valproate (Epilim) PPP. Such prevention programmes were mandated by the European Medicines Agency (EMA) in 2018.
The research, which was funded by the Health Products Regulatory Authority (HPRA) and Health Research Board, found that continued efforts were needed to “ensure optimal implementation” of the PPP, including further targeted education and collaborative learning among HCPs.
Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-to-40 per cent of cases) and congenital malformations (in approximately 10 per cent of cases)
Women and girls of childbearing potential must not be prescribed valproate unless the conditions of the PPP are met, including an annual specialist review. The medication should only be prescribed in females if other drugs have proven ineffective.
According to the study, only 66 per cent of GPs, 82 per cent of community pharmacists, and 59 per cent of specialists (consultants/higher specialist trainees in neurology and obstetrics/gynecology) indicated that they had received in-
formation relating to the PPP, the main source being ‘Dear Doctor/Pharmacist’ letters approved by the HPRA.
Over 80 per cent of HCPs were aware of the need for patients to be referred to a specialist before starting on valproate. However, only 42 per cent of GPs, 62 per cent of pharmacists and 60 per cent of specialists were aware of the need for an annual review in line with the PPP.
Some 22 per cent of GPs said that they prescribe valproate “occasionally to frequently”; 78 per cent said they renewed a valproate prescription in the past 12 months; and four out of 73 GPs indicated they had initiated valproate treatment in the past 12 months (the PPP provides that valproate should only be initiated by a specialist in the management of epilepsy or bipolar disorder).
Knowledge of the magnitude of the risks associated with valproate use in pregnancy varied across the three HCP groups
The authors acknowledged study limitations including a low response rate.
While recognising these limitations, Mr Murphy said the findings tallied with a small patient survey undertaken by Epilepsy Ireland, which found significant deficiencies in the implementation of the PPP. Epilepsy Ireland noted the study responses from GPs as particularly concerning, with one-in-three saying they had not received communications about the PPP; four-in-five stating they did not use the patient guide; and 60 per cent ensuring their patients understood the risks and used effective contraception
Epilepsy Ireland has been calling for a stakeholder group, reporting to the Minister for Health/Department, to facilitate a “collaborative” effort on eliminating risk and monitoring the effectiveness of measures.
According to Mr Murphy, several organisations including
The HSE board Chair told the Minister for Health earlier this year that he does not intend to submit a revised National Service Plan (NSP 2021), but rather a “limited re-plan of subsets of key targets”, the Medical Independent (MI) can report.
In a letter, dated 4 May and seen by MI following a Freedom of Information request, Mr Ciarán Devane wrote to Minister Stephen Donnelly stating that a “phase two” review of the NSP 2021 “will be focused on looking forward”.
“In this phase, the strategic programmes and operational KPIs [key performance indicators] will be reviewed to determine what improvement plans need to be put in place, what is the estimated year end position and what revised targets need to be proposed,” according to the letter.
“It is not intended to submit a revised NSP 2021,” wrote Mr Devane. He said the focus would be “rather a limited re-plan of a subset of key targets”.
MI previously reported that the Covid-19 pandemic response, including the vaccination programme, would likely have “an adverse impact” on commitments in the NSP 2021, according to high-level correspondence in January between Mr Devane and Minister Donnelly. In August, MI reported that on 29 March, the Minister for Health wrote to Mr Dev-
ane regarding the need for a review of the NSP 2021.
This newspaper asked the HSE for an update on the reviews of the NSP 2021; however, no response was received by press time. In August, the HSE said that “in order to assess the impact of both the Covid-19 pandemic in early 2021 and the cyberattack in May 2021 on strategic programmes, service level targets and operational KPIs a review of NSP 2021 based on Q1 [quarter one] activity was undertaken..
“The aim was to establish progress made during the quarter and to propose, based on the latest data and information available, if revised NSP targets are required.”
State bodies have undertaken positive work since the EMA’s 2018 review. However, “there isn’t really any communication between these different organisations and State bodies.”
While not pre-empting the potential proposals from a stakeholder group, Mr Murphy said these could include better use of IT communications between primary and hospital care, as well as training initiatives.
Mr Murphy added that the filling of vacant specialist nursing posts in epilepsy services was another crucial component of the PPP.
“In 2018, the HSE approved six specialist nursing posts specifically for the implementation of the pregnancy prevention plan around valproate and four of those posts are still vacant.”
Capacity constraints in epilepsy services and the healthcare system were also impacting on implementation of the PPP.
Nevertheless, Mr Murphy said the ongoing shortfalls in risk reduction were unacceptable given the serious risks to children exposed in utero
In November 2020, Minister Stephen Donnelly announced the establishment of an inquiry into historical prescription of sodium valproate. The Department has recently communicated on a proposed meeting with patient groups.
A Department spokesperson told MI the establishment of a stakeholder group was “under consideration” by officials.
According to the HPRA, it is committed to continuing engagement with stakeholders and healthcare professionals and health system partners “responsible for implementing the Epilim pregnancy prevention programme for women and girls for whom treatment with valproate is considered to remain necessary”.
There is recent evidence of more coordination between planned retirements and approval of replacement posts, according to the Chair of the consultant applications advisory committee (CAAC), Prof Áine Carroll.
The CAAC contacted the HSE’s National Director of Human Resources (HR) Ms Anne Marie Hoey last year on the issue, according to the committee’s 2020 annual report.
Speaking to the Medical Independent (MI), Prof Carroll said: “We would have noticed some applications seemed to be coming through after the incumbent had retired. That situation seems to have changed. Succession planning does seem to be improving within the provider organisations.”
Prof Carroll emphasised the importance of succession planning in terms of ensuring continuity of services.
“It is really important to get these jobs out and advertised so that there isn’t a gap in service between somebody retiring and somebody starting in post,” she said.
As previously reported by MI, the CAAC also wrote to Ms Hoey to express concern about the prevalence of contracts of indefinite duration (CIDs) in applications for consultant posts coming before the committee in the context
of recruitment and retention for approved consultant posts.
As a result, the CAAC decided that, where an application for a post is occupied by a person holding a CID is put forward, it will only be considered if the employer can provide assurances that the recruitment requirements detailed in the HSE ‘letter of approval’ can be met.
“It’s really important, as we said in the letter to the National Director of HR, that open and transparent processes are in place for the appointment of consultants,” according to Prof Carroll.
“So we acknowledge that there are individuals who are entitled to contracts of indefinite duration. But it’s really important for the posts that are approved at CAAC that there is an open and competitive process for the filling of them. That it is not assumed by the hospital that a CID will just slip into one of those consultant posts.”
Another key issue for the committee has been the requirements whereby posts currently occupied by a permanent consultant are presented for restructuring.
The annual report states that it was agreed going forward, in such cases, the minimum requirement for the CAAC is letters of support from all the relevant parties suffices for the present.
The 1st polypill licensed for secondary prevention of cardiovascular events in Ireland
Reduce pill burden by 730 pills per year*
Capsules shown are not actual size. Capsules are Size 0. Please refer to SmPC before prescribing.
*The calculation of a reduction of 730 pills per year is based on a patient taking the three individual components of Trinomia (aspirin, atorvastatin, ramipril) on a daily basis for 365 days compared to a patient taking a Trinomia capsule once daily for 365 days.
Trinomia 100 mg/20 mg/10 mg, 100 mg/20 mg/5 mg, 100 mg/20 mg/2.5 mg hard capsules (acetylsalicylic acid, atorvastatin (as atorvastatin calcium trihydrate) and ramipril) and Trinomia 100 mg/40 mg/10 mg, 100 mg/40 mg/5 mg, 100 mg/40 mg/2.5 mg hard capsules (acetylsalicylic acid, atorvastatin (as atorvastatin calcium trihydrate) and ramipril) Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Hard capsules containing: two 50 mg acetylsalicylic film-coated tablets, two 10 mg atorvastatin film-coated tablets and one 10 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic filmcoated tablet, two 10 mg atorvastatin film-coated tablets and one 5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 10 mg atorvastatin film-coated tablets and one 2.5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablets, two 20 mg atorvastatin film-coated tablets and one 10 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 20 mg atorvastatin film-coated tablets and one 5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 20 mg atorvastatin film-coated tablets and one 2.5 mg ramipril film-coated tablet. Uses: Secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses Dosage: Oral administration. 1 capsule per day, preferably after a meal. Swallow with liquid. Do not chew or crush. Avoid grapefruit juice. Patients currently controlled with equivalent therapeutic doses of acetylsalicylic acid, atorvastatin and ramipril can be directly switched. Treatment initiation should take place under medical supervision. Cardiovascular prevention, target maintenance dose of Ramipril is 10 mg once daily. Daily dose in renal impairment based on creatinine clearance - ≥ 60 ml/min, maximum daily dose is 10 mg ramipril; 30-60 ml/min, maximum daily dose is 5 mg ramipril. Contraindicated in hemodialysis and/or with severe renal impairment (creatinine clearance <30 ml/min). Administer with caution with hepatic impairment. Perform liver function tests before initiation of treatment and periodically thereafter. Maximum daily dose is 2.5 mg ramipril and initiate treatment under close medical supervision. Contraindicated in severe or active hepatic impairment. Start treatment in very old and frail patients with caution. In patients taking elbasvir/grazoprevir concomitantly with atorvastatin, the dose of atorvastatin should not exceed 20 mg/day. Contraindications: Hypersensitivity to any component, to other salicylates, to NSAIDs, to any other ACE inhibitors, tartrazine, soya or peanut. History of previous asthma attacks or other allergic reactions to salicylic acid or other NSAIDs. Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, other kinds of bleeding. Haemophilia and other bleeding disorders. Severe kidney and liver impairment. Hemodialysis. Severe heart failure. Concomitant treatment with methotrexate at a dosage of 15 mg or more per week. Concomitant use with aliskiren-containing products with diabetes mellitus or renal impairment. Nasal polyps associated with ashma induced or exacerbated by acetylsalicylic acid. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy, lactation and in women of child-bearing potential not using appropriate contraceptive measures. Concomitant treatment with tipranavir, ritonavir, ciclosporin, glecaprevir/pibrentasvir,sacubitril/valsartan therapy. Trinomia must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. History of angioedema. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. Hypotensive or haemodynamically unstable states. Children and adolescents below 18 years of age. Warnings and Precautions: Only for use as a substitution therapy in patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses. Special populations requiring particularly careful medical supervision: Hypersensitivity to other analgesics/antiinflammatory/antipyretic/antirheumatics or other allergens. Other known allergies, bronchial asthma, hay fever, swollen nasal mucous membranes and other chronic respiratory diseases. History of gastric or enteric ulcers, or of gastrointestinal bleeding. Reduced liver and/or renal function. Particular risk of hypotension: strongly activated renin-angiotensin-aldosterone system, transient or persistent heart failure post MI, risk of cardiac or cerebral ischemia, in case of acute hypotension medical supervision including blood pressure monitoring is necessary. Deterioration of cardiovascular circulation. Glucose 6 phosphate dehydrogenase deficiency. Risk of elevated levels of uric acid. Consumption of substantial quantities of alcohol and/or have a history of liver disease. Diagnosed pregnancy, stop treatment immediately, and, if appropriate, start alternative therapy. ACE inhibitors cause higher rate of angioedema in black patients than in non-black patients. The blood pressure lowering effect of ACE inhibitors is somewhat less in black patients than non-black patients. Monitoring during treatment is required for: Concomitant treatment with NSAIDs, corticosteroids, SSRIs, antiplatelet drugs, anticoagulants, ibuprofen. Signs or symptoms suggestive of liver injury. Stop treatment temporarily prior to elective major surgery and when any major medical or surgical condition occurs. Particularly careful monitoring is required in patients with renal impairment, risk of impairment of renal function, particularly with congestive heart failure or after a renal transplant. Serum potassium: ACE inhibitors can cause hyperkalemia in patients with impaired renal function and/or in patients taking potassium supplements (including salt substitutes), potassium-sparing diuretics, trimethoprim or co-trimoxazole and especially aldosterone antagonists or angiotensin-receptor blockers, hyperkalemia can occur. Potassium-sparing diuretics and angiotensin-receptor blockers should be used with caution in patients receiving ACE inhibitors, and serum potassium and renal function should be monitored. Other situations that may increase the risk of hyperkalaemia are: age >70 years, uncontrolled diabetes mellitus, dehydration, acute cardiac decompensation or metabolic acidosis.Specific side-effects: Perform liver function tests before use and monitor periodically and with liver injury or increased transaminase levels. Use with caution with substantial alcohol use or history of liver disease. Potential risk of hemorrhagic stroke. May affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, ask patients to promptly report skeletal muscle effects (muscle pains, cramps or weakness) especially if accompanied by malasie or fever and measure CK levels, stop treatment if significantly elevated or if severe muscular symptoms occur. Prescribe with caution in patients with pre-disposing factors for rhabdomyolysis. Benefit/risk of treatment should be considered and clinical monitoring recommended. Do not measure CK following strenuous exercise or in presence of plausible alternative cause of CK increase. If CK levels significantly elevated at baseline, re-measure levels 5 to 7 days later to confirm the results. Risk of rhabdomyolsis with use of potent CYP3A4 inhibitors, transport proteins or HIV protease inhibitors. Consider alternative treatments if risk of myopathy. Consider lower starting or maximum dose and appropriate clinical monitoring with potent CYP3A4 inhibitors and medicinal products that increase the plasma concentration of atorvastatin respectively. The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, antivirals for the treatment of hepatitis C (HCV) (boceprevir, telaprevir, elvasvir/grazoprevir), erythromycin, niacin or ezetimibe. Do not co-administer with systemic fusidic acid or within 7 days of stopping fusidic acid. Where use of systemic fusidic acid considered essential, discontinue statin treatment during fusidic acid treatment. Reports of rhabdomyolysis in patients receiving fusidic acid and statins in combination. Where prolonged systemic fusidic acid needed, consider need for co-administration of Trinomia and fusidic acid on case by case basis with close medical supervision. Discontinue statin treatment if interstitial lung disease occurs. Monitor patients at risk of diabetes mellitus. Discontinue treatment if angioedema occurs and initiate emergency treatment promptly. Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated. due to the increased risk of angioedema. Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of Trimomia. Caution should be used when starting racecadotril, mTOR inhibitors and vildagliptin in a patient already taking an ACE inhibitor as there is an increased risk of angioedema. Concomitant use of ACE-inhibitors and angiotensin II receptor blockers or aliskiren is not recommended and should not be used in patients with diabetic nephropathy. Anaphylactic reactions during desensitization, consider temporary discontinuation of Trinomia during desensitization. Monitor white blood cells for neutropenia/agranulocytosis and more regularly in the initial phase of treatment, impaired renal function, concomitant collagen disease and other medicines that can change the blood picture. Cough. Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Acetylsalicylic acid: other platelet aggregation inhibitors, other NSAIDs, and antirheumatics, systemic glucocorticoids, diuretics, alcohol, SSRIs, uricosuric agents, metamizole, anticoagulant and thrombolytic therapy, digoxin, antidiabetic agents including insulin, methotrexate, valproic acid, antacids, ACE inhibitors, ciclosporin, vancomycin, interferon , lithium, barbiturates, zidovudine, phenytoin, laboratory tests. Atorvastatin: CYP3A4 inhibitors, CYP3A4 inducers, transport protein inhibitors, gemfibrozil/fibric acid derivatives, ezetimibe, colestipol, fusidic acid, colchicine, digoxin, oral contraceptives, warfarin. Ramipril: potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances, antihypertensive agents and other substances that may decrease blood pressure, vasopressor sympathomimetics and other substances, allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count, lithium salts, antidiabetic agents including insulin. Monitor as appropriate. Consider lower maximum dose of atorvastatin with potent CYP3A4 inhibitors. Pregnancy and Lactation: Contraindicated in pregnancy and breast-feeding. Women of child-bearing potential should use effective contraception during treatment. Side Effects: Ramipril: Common (≥1/100, <1/10): dyspepsia, nausea, diarrhoea, vomiting, digestive disturbances, abdominal discomfort, gastrointestinal inflammation, non-productive tickling cough, bronchitis, sinusitis, dyspnoea, headache, dizziness, rash in particular maculo-papular, blood potassium increased, myalgia, muscle spasms, chest pain, fatigue, hypotension, orthostatic blood pressure decreased, syncope. Atorvastatin: Common: dyspepsia, nausea, diarrhoea, constipation, flatulence, pharyngolaryngeal pain, epistaxis, nasopharyngitis, headache, allergic reactions, hyperglycaemia, myalgia, muscle spasms, pain in extremity, joint swelling, back pain, arthralgia, liver function test abnormal, blood creatine kinase increased. ASA: Very Common (≥ 1/10): Gastrointestinal complaints such as heartburn, nausea, vomiting, stomach ache and diarrhea, minor blood loss from the gastrointestinal tract (micro-bleeding). Common: Paroxysmal bronchospasm, serious dyspnoea, rhinitis, nasal congestion. For less frequent side effects see SmPC. Pack Sizes: Blister containing 28 hard capsules. Legal Category: POM. Product Authorisation Numbers: PA 1744/002/001-006 Product Authorisation Holder:
The horrors witnessed during the US and allied withdrawal from Afghanistan shocked the world and now the country’s healthcare system is at risk of collapse. Bette Browne reports
nless the world responds with humanitarian aid to the Afghanistan crisis, more than 14 million Afghans – one-third of the population – could face starvation, according to experts. There is also a danger that diseases such as tuberculosis (TB) and polio will become even more widespread.
The country, now under the control of the Taliban after 20 years of war, is facing a “looming humanitarian catastrophe”, the United Nations (UN) warned, while the agency’s Office for the Coordination of Humanitarian Affairs said basic servicers are collapsing and other life-saving aid is about to run out.
MSF
Médecins Sans Frontières (MSF) also expressed alarm in comments to the Medical Independent (MI)
“The Afghan healthcare system has for years been under-funded, under-resourced and under-staffed,” said Dr Tankred Stoebe, an MSF Afghanistan medical coordinator.
“The health system is hugely reliant on foreign donors and if the recent suspension of funding from the EU, the World Bank and others persists then the system will inevitably collapse with Afghan men, women, and children facing the consequences.”
The World Bank paused disbursements to its projects in Afghanistan on 24 August, due to concerns about the potential impact the Taliban government will have on the country and especially on women.
“We are deeply concerned about the situation in Afghanistan and the impact on the country’s development prospects, especially for women. We have paused disbursements in our operations in Afghanistan and we are closely monitoring and assessing the situation in line with our internal policies and procedures,” a World Bank spokesperson told CNN.
The World Bank has provided more than $5.3 billion (€4.5 billion) for development and emergency reconstruction projects and eight budget support operations in Afghanistan since April 2002. It also administers the Afghanistan Reconstruction Trust Fund, the World Bank’s largest single-country multi-donor trust fund.
The EU’s foreign policy chief, Mr Josep Borrell, said in August that “no payments are going to Afghanistan right now. No payments of development assistance until we clarify the situation.” In November 2020, the EU had promised to donate €1.2 billion over the next four years in long-
term and emergency assistance.
MSF does not take any funding from governments or agencies for its medical work in Afghanistan, so the organisation is able to continue with all of its activities, Dr Stoebe told MI
However, he added: “We have already seen the consequences of the breakdown in other health services as more and more patients come to us for treatment with few other places to turn.
“In Boost Hospital in Lashkar Gah (southern Afghanistan) we have at times seen over 750 patients per day in our emergency room, and our feeding centre for malnourished children in Herat (in the north-west) is at 200 per cent bed occupancy.”
The country desperately needs humanitarian aid to continue, Dr Stoebe emphasised. “It is inconceivable that MSF, other international organisations or NGOs could ever fill the void and run all the country’s hospitals and clin-
ics on their own. When the health and lives of millions of Afghans are in the balance, development and humanitarian aid must continue.”
His sentiments were echoed by another MSF official, Ms Martine Flokstra, who said the healthcare systems risked potential collapse. She said an already dire situation in Afghanistan’s hospitals has become worse since the Taliban takeover. Medical workers had not received salaries in months and health centres were running out of medicines amid an increase in the number of patients coming to facilities.
“So potential collapse of the healthcare system is one of our major concerns,” she told Al Jazeera.
Afghanistan has suffered terribly from four decades of uninterrupted war, first during the 1979 Soviet invasion and then in 2001 when the US ousted the Taliban following the 9/11 attacks. Today, the country remains among the world’s poorest nations, according to the United Nations Human Development Report 2020, with more than half the population living below the poverty line.
It has been reported that the 20-year war cost the US a staggering $300 million a day. But the price paid by Afghans, who now face a humanitarian and human rights nightmare, is incalculable.
Food shortages are being exacerbated by drought, the World Food Programme (WFP) emphasises, as the country is in the grip of its second drought in four years.
“We have four million people in the most difficult areas where winter just compounds the opportunity to reach them,” WFP Executive Director Mr David Beasley told Al Jazeera. He added that the programme would start to run out of food in September without additional funding.
The Covid-19 pandemic is also hitting the country hard. The UN said earlier this year that nearly half of all people being tested are positive for the virus, suggesting it is widespread. But due to low testing rates and the lack of a national death register, “confirmed cases of and deaths from Covid-19 are likely to be under-reported overall in Afghanistan,” according to a UN report in April.
The battle against polio is also threatened. Polio remains endemic in two countries – Afghanistan and Pakistan – according to the Global Polio Eradication Initiative (GPEI). “Until poliovirus transmission is interrupted in these countries, all countries remain at risk of importation of polio, especially vulnerable countries with weak public health and immunisation services and travel or trade links to endemic countries.”
A ban on house-to-house vaccination was imposed in May 2018 and became more stringent in April 2019. This led to no vaccination campaigns from April to July 2019, the GPEI said. However, it still hopes to continue its work.
“The Global Polio Eradication Initiative is closely monitoring developments in Afghanistan. GPEI partners and staff are currently assessing immediate disruptions to polio eradication efforts and the delivery of other essential health services, to ensure continuity of surveillance and immunisation activities while prioritising the safety and security of staff and frontline health workers in the country.
“The polio programme in Afghanistan has operated for many years amid insecurity and conflict, and will continue working with all factors, agencies and organisations who enable delivery of immunisation as well as deliver humanitarian assistance to populations in need across the country. The GPEI remains steadfastly committed to protecting all children from polio and supporting the provision of other essential immunisations and health services.
Potential collapse of the healthcare system is one of our major concerns
The ONLY prefilled inhaler with visual and audible feedback for confirmed dose delivery1-4
Genuair - a simple to use inhaler for patients with COPD4
Abbreviated Prescribing Information
Eklira® Genuair® 322 micrograms inhalation powder. Please consult the Summary of Product Characteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a white inhaler with an integral dose indicator and a green dosage button. Each delivered dose contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium. Also, contains lactose. Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Dosage: For inhalation use. Recommended dose is one inhalation of 322 micrograms aclidinium twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to aclidinium bromide or to any of the excipients. Warnings and Precautions: Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Use with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma. Do not use in patients with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption.
Interactions: Do not administer with other anticholinergic-containing medicinal products. No other interactions expected. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Risk to newborns/infants cannot be excluded. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Sinusitis, nasopharyngitis, headache, cough, diarrhoea, nausea. Uncommon (0.1-1%): Dizziness, blurred vision, tachycardia, palpitations, dysphonia, dry mouth, stomatitis, rash, pruritus, urinary retention. Rare (0.01-0.1%): hypersensitivity. Not known: angioedema, anaphylactic reaction. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing Authorisation Number: EU/1/12/778/002
Marketing Authorisation holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: February 2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@ hpra.ie. Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744.
Date of item: November 2020. IR-BRI-09-2020
Abbreviated Prescribing Information
Brimica® Genuair® 340 micrograms/12 micrograms inhalation powder. Please consult the Summary of Product Characteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a white inhaler with an integral dose indicator and an orange dosage button. Each delivered dose contains 396 µg aclidinium bromide (equivalent to 340 µg of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate. Also, contains lactose. Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage: For inhalation use. Recommended dose is one inhalation of 340 µg/12 µg twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Do not use in asthma. Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Discontinue if increases in pulse rate, blood pressure or changes in ECG occur. Use with caution in patients with a history of or known prolongation of the QTc interval or treated with products affecting the QTc interval. Use with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma. Hypokalaemia may occur, is usually transient and supplementation not needed. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment. Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Do not use in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Interactions: Do not administer with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products. Caution in use with methylxanthine derivatives, steroids, non-potassium-sparing diuretics, β-adrenergic blockers or medicinal products known to prolong the QTc interval. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Nasopharyngitis, urinary tract infection, sinusitis tooth abscess, insomnia, anxiety, headache, dizziness, tremor, cough, diarrhoea, nausea, dry mouth, myalgia, muscle spasms, peripheral oedema, increased blood creatine phosphokinase. Uncommon (0.1- 1%): Hypokalaemia, hyperglycaemia, agitation, dysgeusia, blurred vision, tachycardia, electrocardiogram QTc prolonged, palpitations, angina pectoris, dysphonia, throat irritation, stomatitis, rash, pruritus, urinary retention, increased blood pressure. Rare (0.01-0.1%): Hypersensitivity, bronchospasm, including paradoxical. Not known: anaphylactic reaction, angioedema. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing
Authorisation Number: EU/1/14/963/001 Marketing Authorisation holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: October 2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@ hpra.ie. Adverse events should also be reported to A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744.
“We strongly believe that the delivery of healthcare – including polio vaccination – is essential to prevent diseases and safeguard communities. Together with our partners, the people of Afghanistan, national and provincial authorities, we will do everything in our power to continue this critical work.”
It will also be a tougher battle against other diseases, such as TB and malaria. TB is a major cause of mortality in Afghanistan with an annual risk of infection of 3 per cent. The disease is affecting more women than men, with 70 per cent of reported TB cases affecting females. Pregnant women and children under five in Afghanistan are also at high risk of malaria.
“The international community has spent decades working with the people of Afghanistan to make progress. Now the international community must continue to support the people of Afghanistan if those gains are not to be reversed,” the World Health Organisation (WHO) stated, as the US and its allies left the country.
The WHO statement sought to calm fears that the world was abandoning the Afghan people amid a deepening health and humanitarian crisis. “Now, as always, we remain committed to the people of Afghanistan and will do everything possible to stay and provide assistance, especially to the most vulnerable,” the WHO said. “The people of Afghanistan need our support now more than ever. Our organisations are committed to helping and protecting them. We will stay in Afghanistan and we will deliver.
“We echo the UN Secretary-General’s call for all parties, including the Taliban, to cease all violence and comply with international humanitarian law and human rights. They must allow and facilitate safe, rapid and unimpeded access for humanitarian workers – both male and female staff – so they can deliver aid to civilians in need wherever they are.”
The reference to ensuring access to female staff in Afghanistan is particularly important. In health facilities where only male health personnel are available, utilisation of the services by women is very low because of social and cultural barriers.
“Currently, women and girls struggle to access even the most basic information about health and family planning,” according to the WHO.
“There is an unmet need for modern forms of contraception. Prenatal and postnatal care is often unavailable; specialty care, such as modern cancer and fertility treatment, is largely non-existent; routine preventative care, such as pap smears and mammograms, are almost unheard of; and a large proportion of births are still unattended by a professional.”
Human Rights Watch also emphasises that women and children in Afghanistan have a distinctly higher burden of illness and death. It is estimated that 40 per cent of children are under weight and more than 50 per cent of all deaths occur in those under the age of five. The higher death rate in women is mainly
due to maternal causes such as antepartum and postpartum haemorrhage, obstructed labour, puerperal infections, pregnancy induced hypertension, and pregnancy anaemias.
Over the past two decades, Afghanistan has depended on international donor support to fund essential services, like healthcare. But this support has been falling for years and will likely continue to do so – perhaps precipitously – following the US withdrawal, Human Rights Watch warns. “This decline in funding has already had a harmful – and life-threatening – impact on the lives of many Afghan women and girls, as it affects access to, and quality of, healthcare.”
The Taliban has made promises about treating women differently, but it is instructive to look at their record when last in power. When the Taliban ruled Afghanistan 20 years ago, their harsh version of Islamic law affected every aspect of life and had a particularly strong impact on medical care, especially as it related to women.
They banned women from medical schools and prevented male physicians from examining female patients. They forbade women studying nursing from looking at images of the human body and also outlawed the dissection of cadavers.
They imposed restrictions on the movement of women and girls that dramatically curtailed their access to healthcare. One woman described to Human Rights Watch giving birth at home unattended, as she was afraid of being beaten if she left the house. “I was scared of them,” she said. “They don’t care if you die.” The Taliban has also generally opposed the provision of modern contraception.
In the years after the US-led military invasion and the defeat of the Taliban regime in late 2001, the Afghan government and international donors gave priority to developing an effective health system, including extending access to basic health-
It said officials in the health ministry confirmed that the government previously had more ability to provide supplies to health facilities, but as donor funding declined this capacity has shrunk and sometimes disappeared.
Afghanistan has 4.6 doctors, nurses, and midwives per 10,000 people, far below the threshold for critical shortage of 23 healthcare professionals per 10,000 people set out by the WHO.
High poverty rates are another factor crippling healthcare. Poverty is alarmingly high in Afghanistan and rising dramatically. The percentage of people living below the national poverty line rose from 38 per cent in 2011 to 55 per cent in 2016. The World Bank estimated in mid2020 that the country’s economy could contract by 6-to-7 per cent in 2020 due to the Covid-19 pandemic and poverty was likely to rise to between 61 and 72 per cent – all of which was estimated before the Taliban takeover in August.
A number of donors have said they will continue to help the devastated country. At a UN conference in Geneva on 13 September, the UN Secretary General Mr António Guterres announced a $20 million (€17 million) allocation from the UN Central Emergency Response Fund to support humanitarian operations in Afghanistan.
“The people of Afghanistan need a lifeline,” he declared. “Now is the time for the international community to stand with them. The people of Afghanistan are facing the collapse of an entire country – all at once. Today, one-in-three Afghans does not know where their next meal will come from. The poverty rate is spiralling – and basic public services are close to collapse.
had for 2016-2020. This came at a time when the United Nations Development Programme (UNDP) had calculated that due to the impact of the Covid-19 pandemic, Afghanistan would need an increase of 30 per cent in international aid to maintain the level of government expenditure initially planned in the International Monetary Fund projections.
Overall development assistance to the country, according to the OECD Development Assistance Committee, was $6,862 million in 2013 and $4,053 million in 2019. The US provided a total of $16,748 million in assistance in 2010, versus $3,120 million in 2021. While some donors, such as the EU, have pledged to maintain their prior funding level, others are cutting their funds significantly.
No major donors are significantly increasing their aid to Afghanistan.
The Red Cross and Red Crescent have been in Afghanistan since 1987 and have committed to staying to help those in need.
The head of the International Committee of the Red Cross (ICRC) orthopaedic programme in Afghanistan, Mr Alberto Cairo, is continuing to oversee the ICRC's seven orthopaedic centres during a time of change and transition in the country.
The programme's largest centre, in Kabul, remains open, but operating at reduced capacity. “If we leave, who stays?
We are supposed to work in places at war,” Mr Cairo told the BBC. “The Red Cross is committed to supporting the people of Afghanistan. The Red Cross will not reduce our presence. We have worked there for 30 years. We will not stop now.”
MSF is similarly committed to its work in the country, Dr Stoebe told MI. “We are committed to carrying on our medical work in all five of our projects in Afghanistan, which never stopped even during the heaviest of the fighting, so long as the security situation allows us to.”
Attacks on healthcare
Humanitarian and healthcare workers, however, can face devastating violence. In 2020, the United Nations Assistance Mission in Afghanistan verified 90 attacks impacting healthcare delivery, 71 of which they attributed to the Taliban.
A particularly horrific example was the May 2020 attack on a hospital maternity ward, operated by MSF, in which attackers systematically killed 24 people, including mothers, women in labour, new-borns, a midwife, and two children under 10.
care to all parts of the country.
The effort led to important achievements, including significant declines in maternal mortality, and increases in provision of prenatal care, use of modern contraception, and attended births.
The life expectancy at birth of Afghan women is 66 years. One factor contributing to Afghanistan’s high rate of maternal mortality is the prevalence of child marriage. About 35 per cent of girls in Afghanistan marry before the age of 18, and 9 per cent marry before the age of 15.
Even with two decades of effort and investment, Human Rights Watch says the delivery of health services for women remains far below international standards, and progress is being eroded.
Hundreds of thousands of people have been forced to flee their homes.
“At the same time, Afghanistan faces a severe drought – the second to hit the country in four years. Many people could run out of food by the end of this month, just as winter approaches.”
He also urged international support for a ‘Flash Appeal’ for $606 million, which was launched by the UN Office for the Coordination of Humanitarian Affairs to get urgent assistance to 11 million people between September and December.
But promises of aid by the international community have fallen short in the past. At a November 2020 conference in Geneva, donors pledged about $2 billion less for the period 2021-2024 than they
Research is also taking a major hit in the country. Back in 2001, after the overthrow of the Taliban, international funding poured into Afghanistan and some universities thrived. Since 2004 the World Bank, the US Agency for International Development, and other international organisations have poured hundreds of millions of dollars into universities to support teaching, faculty training, and research. But now many academics fear for their safety.
“Researchers at risk must be able to leave and to resume their lives in countries that can provide them with safety and security,” stated a Nature editorial in August. At the same time, research leaders in Afghanistan’s neighbouring countries are staying, and they “must not be forgotten or neglected”.
We are committed to carrying on our medical work in all five of our projects in Afghanistan
2 CPD Hours
Authors: Dr Jayne Doherty, SpR in Gastroenterology, and Dr Garret Cullen, Consultant Gastroenterologist, Centre for Colorectal Disease, St Vincent’s University Hospital, Dublin
1.5 CPD Hours
Author: Eamonn Brady MPSI
2 External Credits
Authors: Dr Rehman Faryal, Prof Fionnuala Ní Áinle, Dr Barry Kevane, Department of Haematology, Mater Misericordiae University Hospital
Following his recent return to Ireland after six years in the US, specialist in stereotactic radiation Dr Daniel Cagney spoke with Pat Kelly about taking the helm of radiation oncology at the Mater Private Network and the plans for this service
Dr Daniel Cagney recently returned to Ireland following a six-year stint at the Dana-Farber Brigham and Women’s Cancer Centre in Boston, US, to take up the role of Clinical Director of Radiation Oncology at the Mater Private Network. Dr Cagney brings with him priceless experience and expertise gained at Dana-Farber Brigham, where he held a number of strategically vital positions at the world-leading cancer treatment and research facility as Consultant Radiation Oncologist, Director of Stereotactic Radiation, and Director of its MRI-Guided Radiation Programme.
Dr Cagney is Ireland’s only Fellowship-trained specialist in stereotactic radiation and on joining the Mater Private Network, he spoke with the Medical Independent (MI) about bringing cutting-edge radiation oncology services to Irish cancer patients and his passion for patient care.
Dr Cagney brings home his experience in stereotactic radiosurgery, intensity-modulated radiation therapy, and stereotactic body radiotherapy. Dr Cagney’s research and educational achievements and awards include the Richard Steevens Scholarship (2015), the St Luke’s Institute of Cancer Research Award (2016) and the Association of Residents in Radiation Oncology (ARRO) Educator of the Year (2020), among others.
Dr Cagney received his medical degree from University College Cork Faculty of Medicine. As a clinical researcher at Harvard Medical School and Dana-Farber/Brigham and Women’s Cancer Centre, he published more than 70 peer-reviewed manuscripts and book chapters in leading academic journals, including the New England Journal of Medicine, The Lancet, the Journal of Clinical Oncology, JAMA Oncology, Radiotherapy & Oncology, and the International
heat signature to their reconstructed 3D surface structure. To achieve this, 300,000 3D surface points are acquired and matched to the heat signal generated by the thermal camera, creating another dimension to track their position.
Remaining at DanaFarber for six years was not initially in Dr Cagney’s plans, as he had originally intended to stay there only for a two-year Fellowship. Whilst the appointment of Dr Cagney to the Mater Private is significant for radiation oncology in Ireland overall, he makes it clear that his main motivation for returning home is simple: “It’s exciting to be home and to bring back some of the skills I have learned over there. Being Irish and growing up here, all I really wanted to do as a trainee and as a doctor was to care for Irish patients,” he told MI. “I think that’s always the thing that draws Irish doctors home – to care for Irish patients, to care for friends and family. I have been given a fantastic opportunity at the Mater Private to work with and grow our department to have a national presence. So it’s a combination of wanting to care for Irish patients, and wanting to deliver on that vision.”
These plans at the Mater Private aim to build on its reputation nationally, he explained. “It has an excellent reputation in, for example, cardiology, spinal care and oncology, in collaboration with the cancer care programme nationally,” he said. “We are the only private hospital that has a presence nationally, in that we have a centre in Dublin and Limerick. In parallel to that, the wider goal of the Mater Private is to be a comprehensive cancer centre and that’s very much aligned with my vision, which is to provide highquality, innovative, patient-centered care, so there is an alignment of visions between the Mater Private and me.”
Journal of Radiation Oncology, Biology, Physics. He is also a Diplomate of the American Board of Radiology and a Fellow of the Faculty of Radiologists of the RCSI. The appointment coincides with Mater Private Network announcing that it will soon have the option to receive stereotactic radiation patients. The Network has also said it is implementing the ExacTrac Dynamic system, which achieves sub-millimetric radiotherapy accuracy and allows for the delivery of high-precision treatments for a wide range of cancers, including brain, spine, lung, abdominal and prostate. This system incorporates artificial intelligence and thermal-surface camera technology using a 4D thermal camera, which creates a highly accurate and reliable hybrid thermal surface by correlating the patient’s
One of the many notable achievements in Dr Cagney’s career includes a clinical revelation in stereotactic radiation. Dr Cagney previously identified an unreported pattern of intracranial failure in neuro-oncology. He also initiated the first trial of its kind to assess the safety and efficacy of combination stereotactic radiation and nanoparticles for patients with centrally-located non-small cell lung cancer and pancreatic cancer. “Historically, the management of patients with brain metastases has been a combination of surgery and radiation, known as wholebrain radiation. That works well in terms of controlling cancer, but it ultimately does have an impact on patients’ quality-of-life and day-to-day functioning,” he explained.
“Over the past 10 years, the field has moved towards trying to deliver the same outcomes in terms of cancer control, but also minimise the dose of radiation to healthy brain tissue – in other words, stereotactic or focal radiation for patients who have had resected brain tumours,” he said. “As you can imagine, we are learning more and more about that. I looked at our series in Dana-Farber Brigham and Harvard and looked at how our patients who were receiving stereotactic or focal radiation were doing.” This,
It’s exciting to be home and to bring back some of the skills I have learned over there. Being Irish and growing up here, all I really wanted to do as a trainee and as a doctor was to care for Irish patientsDr Daniel Cagney
he explained, involved carefully reviewing some 1,200 images. “We noted that there was an unusual cancer recurrence pattern in some patients – not a huge cohort, but in some patients – who received stereotactic radiation. Unfortunately, that pattern of failure could be pretty devastating in terms of the outcome,” he said.
Dr Cagney explained that this process is called pachymeningeal disease, and he and his colleagues were the first to report this pattern of failure. “I think our rationale for reporting it was to show that yes, it is important to look at better outcomes, but it’s also important to see whether this innovation was to the detriment of some patients and to think about better ways to treat those patients.”
This has led to Dr Cagney working with NRG Oncology as a co-Principal Investigator to help design a different stereotactic radiation protocol. One of the ambitions of the group is to offer preoperative stereotactic radiation, the goal of which is to reduce the rate of pachymeningeal failure in these patients.
Passion
He also discussed his work in the US to use MRI-guided delivery of radiation in real-time. At the moment, there is no MRI-guided technology in Ireland “and we are hoping that will change” to allow Dr Cagney to deliver this kind of advanced care to Irish patients. He is still involved with colleagues in Boston on co-ordinating the first trial of its kind dedicated to this area of precision oncology. “These kind of things are my passion,” he said. “Discovering, listening to patients to find out what’s important to them, as well as constantly trying to improve and innovate and leveraging technology to achieve better outcomes for these patients.” There are many additional indications for the use of stereotactic radiation that are constantly evolving and which Dr Cagney hopes to implement in Ireland, he said.
He also described the applications for the ExacTrac Dynamic system, which delivers high-precision treatments for a wide range of conditions, including cranial cancers. “Stereotactic radiation delivers high doses of sub-millimeter precision radiation and that’s convenient in a number of ways,” he said. “It has been proven to lead to better outcomes for patients in brain tumours, spinal tumours, lung cancers, liver and kidney cancers – there are lots of different indications for it now, including prostate cancer. One of the reasons it’s beneficial is that we can shorten the number of visits a patient has to make for radiation treatment.
“For example, in prostate cancer, historically that can be treated over 20 days, or even up to 37 days,” he continued. “With stereotactic radiation, we can treat it over five days, with similar outcomes, or potentially even better outcomes in terms of side-effects. There is also a convenience for patients in terms of delivering highprecision stereotactic radiation.” There are different ways to deliver stereotactic radiation, he explained, but the ExacTrac Dynamic system provides an additional safety verification. It also uses additional x-ray, thermal and surface-guided imaging. “It puts all of that information together and allows us to be 110 per cent certain that we are treating exactly the area that we want to treat,” said Dr Cagney. The inclusion of both thermal and surfaceguided imaging is a particular advantage, he added.
Across the national cancer strategy, the goal is to have a personalised medicine and personalised cancer management approach implemented for these patients, he said. “In the Mater Private, we have identified that we would like to be a comprehensive cancer centre. We want to leverage not only the traditional pillars of care delivery – surgical oncology, radiation oncology, medical oncology – but also to implement a diagnostic programme, a genomics programme, a quality-of-life and survivorship programme, and a research programme, which I am passionate about,” Dr Cagney explained. “Ultimately, the goal of that is to ensure that every patient who comes through the door is treated as an individual
and is treated to the highest quality of care, and to gather all the information we need to ensure that happens.”
The ExacTrac Dynamic system also incorporates an artificial intelligence programme, which automates certain steps within the process that allow Dr Cagney and his colleagues to speed-up the turnaround time for patients. “Currently, where things may happen in sevento-10 days, our hope is that once a patient comes into the hospital and is mapped for radiation, because of the AI tools that automate some of the processes, we would be able to treat patients in a more timely fashion,” said Dr Cagney. “I think that’s really meaningful for patients. Part of their anxiety comes from the waiting and uncertainty and we want to leverage all the tools that are available to allow us to deliver as timely a treatment as possible.”
Dr Cagney also spoke about the multidisciplinary team (MDT) that has been assembled since he returned to Ireland and joined the Mater Private. “Within radiation oncology, we have a great MDT in place,” he said. “We have a fantastic group of radiation therapists and we have hired a number of additional radiation therapists. We have a fantastic group of physicists and we are in the process of hiring additional physicists to support the service, which will go live in November.”
In a wider context, Dr Cagney sees himself and his radiation oncology colleagues as part of the wider Mater campus MDT: “We discuss all our patients in an MDT in meetings that include surgeons, oncologists, etc, and I feel I am really fortunate that it has that kind of wholecampus approach.”
Given the level of services that will be offered, combined with
the effects of Covid-19, Dr Cagney was asked if an onerous waiting list of patients is on the horizon. “Radiation oncology is kind of unique as a specialty, in that we are very much a tertiary referral centre,” he told MI. “So we are dependent on cancer being detected and a radiation indication for those cancers, and we’ll see those patients based on that. Nationally and internationally, the number of cancers being detected in screening programmes is down [during Covid-19]. When I was in Boston, cancer detection was down by something like 40 per cent across breast, cervical and lung cancers, for which there are screening programmes.
“For my department specifically, we are ready and available to see patients within 24-to-48 hours of the referral landing on our desk and that’s something I also feel very strongly about.” In common with Ireland, Dr Cagney explained that over 18 months in Boston, the practice of seeing patients virtually gained in popularity as a response to Covid-19. During that time, some 80 per cent of the patients he saw were managed virtually. “In my role as director of MRI-Guided Radiation, we were actually able to see more patients and this was significantly more convenient for patients and spared them the visit to hospital.
“It is my ambition that we would be able to offer patients more virtual appointments and make that an option for patients, because it’s certainly more convenient for them. Of course, there will still be a number of patients who need to be seen face-to-face to make a treatment determination, but my hope is that we could operate a hybrid model where some patients can safely be managed virtually.”
Dr Cagney concluded by outlining other initiatives he is striving to bring to cancer care in the Mater Private and beyond, using practical applications from clinical research. “Clinical research is something I’m very passionate about,” he told MI. “Clinical research is good cancer care. I hope to leverage some of the contacts I have made in the US and Europe and bring a clinical trials portfolio to the Mater Private and make it available nationally. These are things that we do very well through Cancer Trials Ireland and we want to grow that.
“I get my ideas for innovation from listening to patients, and that’s what I want to continue to do here. I am very fortunate to work where I do because we are a very patient-centered, high-quality innovative group and that’s the continuing mission of our department and our hospital – to put patients first, to listen to them, and to work with them. We understand that people go through an incredibly tough time when they are diagnosed with cancer and if we can make it as pain-free and stress-free as possible, that’s our goal.”
For my department specifically, we are ready and available to see patients within 24-to-48 hours of the referral landing on our desk and that’s something I also feel very strongly about
Type 2 diabetes mellitus
JARDIANCE is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance - in addition to other medicinal products for the treatment of diabetes
Heart failure
JARDIANCE is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
* In addition to glucose lowering, JARDIANCE (empagliflozin) demonstrated secondary benefits of reduction in weight and blood pressure although it is not licensed for this.
† EMPA-REG OUTCOME® was a randomised, double-blind, placebo-controlled cardiovascular outcomes trial. Patients were randomised to receive either JARDIANCE 10 mg once daily, JARDIANCE 25 mg once daily or placebo, on top of standard of care. Primary endpoint was 3-point MACE: Time to first occurrence of cardiovascular death, non-fatal MI, non-fatal stroke. 14% relative risk reduction for combined endpoint of cardiovascular death, non-fatal MI, or non-fatal stroke (ARR 1.6%). JARDIANCE has an acceptable safety profile. 2
References
1. JARDIANCE (empagliflozin) Summary of Product Characteristics. Available at https://www.medicines.ie/medicines/jardiance-10-mg-and-25-mg-film-coated-tablets-32545/spc
2. Zinman B, Wanner C, Lachin JM et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373:2117-2128. (& Supplementary Appendix)
Prescribing Information (Ireland) JARDIANCE® (empagliflozin)
Film-coated tablets containing 10 mg or 25 mg empagliflozin. Indication: Type 2 diabetes mellitus: Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance; in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, refer to the Summary of Product Characteristics. Heart failure: Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Dose and Administration:
Type 2 diabetes mellitus: The recommended starting dose is 10 mg once daily. In patients tolerating empagliflozin 10 mg once daily who have eGFR ≥60 ml/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg. Renal impairment: The glycaemic efficacy of empagliflozin is dependent on renal function. Empagliflozin should not be initiated in patients with an eGFR <60 ml/min/1.73 m2 or CrCl <60 ml/min. In patients tolerating empagliflozin whose eGFR falls persistently below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily. Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min. No dose adjustment is required for patients with an eGFR ≥60 ml/min/1.73 m2 or CrCl ≥60 ml/min.
Heart failure: The recommended dose is 10 mg empagliflozin once daily. Renal impairment: For treatment of heart failure in patients with or without type 2 diabetes mellitus, empagliflozin 10 mg may be initiated or continued down to an eGFR of 20 ml/min/1.73 m2 or CrCl of 20 ml/ min. For patients with an eGFR <20 ml/min/1.73 m2 or CrCl <20 ml/min empagliflozin is not recommended. All indications: When used with sulphonylurea or insulin a lower dose of these may be considered to reduce the risk of hypoglycaemia. If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day. Renal impairment: Empagliflozin should not be used in patients with end stage renal disease (ESRD) or on dialysis. Hepatic impairment: No dose adjustment is required for patients with hepatic impairment. Not recommended in severe hepatic impairment. Elderly patients: No dose adjustment is recommended based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account. In patients aged 85 years and older, initiation of empagliflozin therapy is not recommended due to the limited therapeutic experience. Paediatric population: No data are available. Method of administration: The tablets can be taken with or without food, swallowed whole with water. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and
Precautions: Ketoacidosis: Rare cases of ketoacidosis, including life-threatening and fatal cases, have been reported in patients with diabetes mellitus treated with SGLT2 inhibitors, including empagliflozin. The risk of ketoacidosis must be considered in the event of nonspecific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Assess patients for ketoacidosis immediately, regardless of blood glucose level. In patients where ketoacidosis is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute
serious medical illnesses. Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with empagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised. Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered. Use with caution in patients who may be at higher risk of ketoacidosis. Restarting SGLT2 inhibitor treatment in patients with previous ketoacidosis while on SGLT-2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved. Jardiance should not be used for treatment of patients with type 1 diabetes. Renal impairment: Empagliflozin should not be used in patients with ESRD or in patients on dialysis. For type 2 diabetes mellitus, as glycaemic control depends on renal function, Jardiance should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or CrCl <60 ml/min. In patients tolerating empagliflozin whose eGFR is persistently below 60 ml/min/1.73 m2 or CrCl <60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily. Empagliflozin is not recommended when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min. For heart failure, Jardiance is not recommended in patients with eGFR <20 ml/min/1.73 m2 Monitoring of renal function: Assessment is recommended prior to initiation and at least annually. Risk for volume depletion: Osmotic diuresis accompanying glucosuria may lead to a modest decrease in blood pressure. Therefore, caution should be exercised in patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75 years and older. In case of conditions that may lead to fluid loss (e.g. gastrointestinal illness), careful monitoring of volume status and electrolytes is recommended. Temporary interruption of treatment with empagliflozin should be considered until the fluid loss is corrected. Elderly: See under Dose and Administration; special attention should be given to volume intake of elderly patients in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE-inhibitors). Complicated urinary tract infections: Temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections. Necrotising fasciitis: Cases of necrotising fasciitis of the perineum (Fournier’s gangrene), have been reported in patients with diabetes mellitus taking SGLT2 inhibitors. This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment. Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis. If Fournier’s gangrene is suspected, Jardiance should be discontinued and prompt treatment should be instituted. Lower limb amputation: An increase in cases of lower limb amputation (primarily of the toe) has been observed in long-term clinical studies with another SGLT2 inhibitor, counsel patients on routine preventative footcare. Hepatic injury: Cases of hepatic injury have been reported with empagliflozin in clinical trials. A causal relationship between empagliflozin and hepatic injury has not been established. Elevated haematocrit: Haematocrit increase was observed with empagliflozin treatment. Urine laboratory assessments: Due to its mechanism of action, patients taking Jardiance will test positive for glucose in their urine. Lactose: The tablets
PC-IE-101344 Date of preparation: September 2021
contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. Interactions: Use with diuretics may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues may increase the risk of hypoglycaemia therefore, a lower dose of insulin or an insulin secretagogue may be required. The effect of UGT induction (e.g. induction by rifampicin or phenytoin) on empagliflozin has not been studied. Co-treatment with known inducers of UGT enzymes is not recommended due to a potential risk of decreased efficacy. If an inducer of these UGT enzymes must be co-administered, monitoring of glycaemic control to assess response to Jardiance is appropriate. Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by coadministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide. Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives. Fertility, pregnancy and lactation: There are no data from the use of empagliflozin in pregnant women. As a precautionary measure, it is preferable to avoid the use of Jardiance during pregnancy. No data in humans are available on excretion of empagliflozin into milk. Jardiance should not be used during breast-feeding. No studies on the effect on human fertility have been conducted for Jardiance. Undesirable effects: 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). Very common: hypoglycaemia (when used with sulphonylurea or insulin), volume depletion. Common: vaginal moniliasis, vulvovaginitis, balanitis and other genital infections, urinary tract infection (including pyelonephritis and urosepsis), thirst, constipation, pruritus (generalised), rash, increased urination, serum lipids increased. Uncommon: urticaria, angioedema, dysuria, blood creatinine increased/glomerular filtration rate decreased, haematocrit increased. Rare: necrotising fasciitis of the perineum (Fournier’s gangrene), diabetic ketoacidosis. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 10 mg; 28 tablets, 25 mg: 28 tablets. Legal category: POM. MA numbers: 10 mg/28 tablets EU/1/14/930/013; 25 mg/28 tablets EU/1/14/930/004. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, 55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Crescent Building, Northwood, Santry, Dublin 9. Prepared in July 2021
Adverse events should be reported. Reporting forms and information can be found at https://www.hpra.ie/homepage/about-us/report-an-issue. Adverse events should also be reported to Boehringer-Ingelheim Drug Safety on 01 2913960, Fax: +44 1344 742661, or by e-mail: PV_local_ UK_Ireland@boehringer-ingelheim.com
Recently, the National Clinical Programme in Surgery (NCPS) published a document, which looked at the effect Covid-19 has had on surgery. Titled
A year like no other: The impact of the SARS-COV-2 pandemic on surgical activity in Ireland , the document states there were 17 per cent fewer emergency surgeries and 30 per cent fewer elective surgeries performed during the pandemic. It also shows that, from April 2020 to April 2021, there was a 153 per cent increase in the number of surgical patients waiting longer than 12 months for their procedures. The total surgical outpatient waiting list increased by 15 per cent.
These are concerning figures.
NCPS Co-Lead Prof Deborah McNamara noted the deferral of non-essential surgery was uniformly advised at the beginning of the pandemic.
“The waiting lists we see today are the consequence of that deferral. We now need to increase surgical activity across the health service to meet the needs of these patients,” she said.
On the positive side, the document highlights the innovations implemented in response to the multiple challenges brought by Covid-19. For instance, the NCPS published guidance to surgeons on how to deliver virtual outpatient department services in March 2020. The HSE subsequently developed resources to support this transition.
From January to December 2020, HSE acute operations reported a total of 657,415 virtual consultations for both new and return attendances.
A care pathway for surgical patient triage and treatment during the pandemic was defined and a GP-Surgeon Connect service, which allowed GPs to rapidly connect with surgical experts, was established, resulting in a greater number of patients being managed in the community.
While these innovations should be welcomed, the surgical waiting list backlog now needs to be tackled with the upmost urgency.
A plan aimed at mitigating the impact of the pandemic and the cyberattack on scheduled care activity this year has recently been developed. This immediate shortterm plan, which will apply to surgery as well as other areas, is a joint approach by the HSE, the National Treatment Purchase Fund, and the Department of Health to reduce backlogs by the end of this year. This is to be achieved through waiting list management, increased capacity, and improved pathways of care. A longer term multi-annual waiting list plan, which will be overseen by a Ministerial taskforce, will also be developed. It will aim to bring waiting lists in line with Sláintecare maximum waiting times of 10 weeks for outpatients, 12 weeks for inpatient day case, and 10 days for diagnostics, over the coming years.
In this issue of the Medical Independent , we chronicle the problems the Sláintecare project currently faces. Even if introducing these maximum waiting times is long overdue, such a commitment is more than welcome given the uncertainty surrounding the future of the strategy.
"Pound foolish, penny wise?" Dr Catherine O'Donohoe, @CatherineODono7, 6 October
"Where are the IMO and the ICGP in all of this – both were instrumental in the establishment and design of the CANC ?" Dr Brendan O'Shea, @drbosheaGP, 6 October
"This scheme was brought in to ensure all pregnant women had access to medical care in pregnancy. It IMPROVED pregnancy outcomes. GPs are actually underpaid for the care. Maternity and Infant Care Scheme under threat https://medicalindependent.ie/maternity-and-infant-care-scheme-under-threat/ via @med_indonews." Dr Mary McCaffrey, @marymcc25625784, 5 October
"Why does it always seem anything related to women's health in this country is a fight. Our maternity care is nowhere where it should be due to years of underfunding. Now to prevent payments to GPs for visits needed with no alternative :( #BetterMaternityCare." Trice Hosford, @Pattieios, 5 October
"If the PCRS want to end Maternity and Infant Care Scheme with their antics, what is their plan for provision now of these appointments at over stretched maternity units? GPs form very important role in ANC/PNC/advocate for their patients! Who authorised this? @NWIHP @roinnslainte." Siobhan Whelan, @SiobhanWhelan4, 5 October
"Chipping away at the Maternity and Infant Care Scheme? But I thought @DonnellyStephen was committed to women's health."
Kate O'Hanlon, @KeyboardCouch, 5 October
"Very worrying! Where do @HSELive want all these GP visits redirected to if they are not going to reimburse? The already understaffed maternity hospitals? The understaffed and/or underfunded community midwifery services?" Liz M, @LizGreeneDublin, 5 October
"This is a deeply disturbing article. Antenatal care reduces perinatal and maternal morbidity and mortality. Shared care between primary care and hospitals is critical." Dr Nóirín Ní Rùiséil, @russellnoirin, 5 October
"This is not good news on so many levels, primary care is essential during pregnancy and beyond. Some areas need of the scheme may require review, however, the critical role that GP practice plays within the Maternity and Infant Care Scheme can't be underestimated. #bettermaternitycare."
MidwivesAssociation #WearAMask, @MidwivesIreland, 5 October
"A welcome development, however, this needs to be done in conjunction with decentralised access to treatment. Treatment needs to be accessible and available from a patient current care provider." The Hepatitis C Partnership, @HepCPartnership, 6 October
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Waiting list backlog needs to be addressed
Many doctors may not be aware that they could face scrutiny by the regulator should private messages be perceived as unprofessional, offensive or inappropriate by others. The standards expected of doctors do not change just because they are communicating online. Doctors are advised to “treat their interactions online no differently than what they would do in the physical world, with the same considerations to professionalism”, according to the IMO’s position paper on s ocial media (2013).
In the UK, the regulator closed 28 investigations on doctors’ use of social media between January 2015 and June 2017. Fourteen cases were closed without further action and a further four were closed with advice issued to the doctor. Of those which progressed further, three doctors received a warning, three were referred to their employers and two doctors had their registration suspended. In one case, a doctor agreed an undertaking about their future practice and, in another, the doctor was issued with a condition on their registration. Investigations involved the doctors’ use of Facebook, Twitter, and WhatsApp.
The Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners (the ‘Guide’) states doctors who use social media should still maintain the professional standards expected in other forms of communication.
The Guide adds: “You should always think about the possible impact on colleagues, patients or the public’s perception of the profession, before publishing comments on social media sites. You should treat patients and colleagues with respect and avoid abusive, unsustainable or malicious comments. You should make sure your comments are not defamatory or otherwise in breach of the law.”
The Medical Council further advises: “Social media sites cannot guarantee confidentiality, whatever privacy settings are used. You must not publish information about, or images of, individual patients from which those patients might be identified on publicly available platforms. You should avoid discussing or commenting on your patients on social media platforms. Further advice on maintaining confidentiality and using images of patients can be found at paragraph 34.”
The Council also acknowledges that closed professional networks online are a useful way to share experiences and case studies. It reminds doctors that they should be mindful not to give information that would
identify patients. They should also take reasonable steps to check that the network has effective security settings and privacy policies to minimise risk of information about patients becoming more widely available.
The IMO’s position paper states: “You should always be mindful that the content you generate on sites can reach a public domain regardless of your intention for the information to be public or private. If any content you post leads to the identification of the patient without their consent it may be considered to be a breach of confidentiality.”
Appropriate disclosures are not strictly limited to comments and messages – newer social media services, such as TikTok, focus on multimedia content. Photos and videos can be potentially damaging, not just in terms of confidential details they may reveal, but also in a wider professional sense. Taking pictures/videos for personal use within a hospital or practice environment is not advised, and if you intend to take pictures/ videos for a professional purpose, make sure you obtain proper consent from any patients or staff who are present, as well as someone in a supervisory role.
The organisation you represent may also have their own policies on proper usage, which you must also be aware of.
The Medical Council stipulates that if you post clinical advice online, you should always identify yourself by name. Patients, medical colleagues, and the public may rely on information that you provide online.
1. Beware of the image you present online and manage this proactively
2. Recognise that the personal and professional cannot always be separated
3. Engage with the public, but be cautious of giving personal advice
4. Respect the privacy of all patients, especially the vulnerable
5. Show your human side, but maintain professional boundaries
6. Contribute your expertise, insights and experience
7. Treat others with
consideration, politeness, and respect
8. Remember that other people may be watching you
9. Support your colleagues and intervene when necessary
10. Test out innovative ideas, learn from mistakes –and have fun
Therefore, the Medical Council advises that you must take all reasonable steps to ensure that any information or advice that you give is accurate and valid. Any information that is posted in relation to your practice or the services that you offer should be factual and verifiable. You should not make unsustainable claims for the effectiveness of treatments or exploit patients’ vulnerability or lack of medical knowledge.
Maintaining boundaries with patients
When discussing boundaries, the IMO warns that social media can “cross public and private domains, inextricably linking both professional and personal lives”. Its guidelines advise to “avoid adding/accepting your patients and their relatives into social networks”.
If a patient contacts you through your private online account it would be wise to inform them that you cannot mix professional and social relationships and, where appropriate, direct them to your professional profile. This is also advised by the Medical Council: “You should keep personal and professional use of social media separate and, as far as possible, avoid communicating with patients through personal social networking sites.”
Being mindful of the above guidance regarding private messaging platforms will also mitigate against the risk associated with the posting of what could be considered unprofessional content on social media platforms – be it in private or public social media accounts. While the above advice is in relation to discussions about or with patients and colleagues, the same advice could be applied to any ‘private’ conversation that you have with your family or friend, which may pose a risk to your professional reputation. Quite simply, whatever you discuss in a ‘private’ chat will likely leave a digital footprint and may resurface again in the future.
Humour in the form of memes and comments on Twitter, for example, may also be easily misinterpreted and reflect unfavourably on individuals and their affiliated institutions. Postings convey information about the poster’s personality, values, and priorities, and the first impression generated by this content can be lasting.
Other missteps by doctors on public social media platforms have included posting photos taken during surgery, posing with weapons or alcohol, airing frustrations that have proved offensive or harmful to a colleague or department, and the use of discriminatory or sexualised language.
It is always worthwhile considering before you post or write something on both private and public social media platforms, as well as private messaging apps, how it may be perceived out of context or in the context of a practising medical professional. It may be helpful to assume that patients, relatives, colleagues, and even the regulator may read the posts and your ‘private’ conversations.
It is worth noting that the Medical Council’s Guide is due to be updated next year. It is possible that the guidance surrounding the use of social media and messaging platforms will be updated. Medical Protection would recommend careful review of the updated guide when it becomes available.
For further advice, please contact Medical Protection or your medical defence organisation.
The level of vitriol of the anti-vax movement I witnessed in Canada was on a different scale to that experienced in Ireland
years. It hasn’t been easy on so many people. And I know that medics here received unexpected abuse in the early stages of the viral surge when routine face-to-face consultations were replaced by remote patient contact. But the level of vitriol I saw in Canada was on a different scale.
Arecent visit to see family in Saskatchewan, Canada, highlighted just how well we have done in Ireland with full Covid-19 vaccine rates running at above 92 per cent. In contrast, just as I returned home, the provinces of Alberta and Saskatchewan, were experiencing the collapse of their health systems – with hospital care of any kind no longer available unless it is Covid-related. It is the inevitable result of low immunisation rates combined with premature political decisions to reverse basic lockdown mechanisms. It was frankly quite sad to see the level of anti-science and Covid non-belief that existed in certain parts of Canada. In some cities, there was naked aggression towards hospital workers going about their jobs. In Vancouver, nurses and doctors were heckled and spat on as they walked into work. During one demonstration, protesters even blocked ambulances trying to access a hospital emergency department. My visit coincided with a federal election campaign that was ugly in tone and unacceptably threatening to Prime Minister Justin Trudeau and his supporters. Protestors who oppose Covid-19 vaccinations, masks, lockdowns, and vaccine passports repeatedly disrupted the Liberal leader’s campaign. It was the pure hate in the eyes of the protestors and their repeated jabbing of the middle finger at the politician that brought the obscenities to a new and ugly level. And whether a coincidence or not, the Covid-19 demonstrators aimed equally ugly and nasty behaviour at healthcare professionals across Canada.
Look, by now it’s a given that we’ve all had our lives turned upside down by the first global disease pandemic in 100
Now it has to be said that a broadly held view amongst Canadians was that calling a snap election in August – a full two years before his mandate expired and in the midst of an unprecedented global health threat – was an opportunistic “power grab” by Trudeau. His declared reason for having an election now – “Canadians need to choose how we finish the fight against Covid-19” – sounded less and less convincing as the campaign progressed. Whether this fully explains the unexpected diatribes at politicians and healthcare professionals is a moot point.
Some doctors and nurses in Canada have been accused of killing patients by grieving family members who don’t believe Covid-19 is real. Others have been the subject of hurtful rumours spread by people angry about the pandemic.
In the US state of Idaho, the president of the local hospital association, Brian Whitlock, confirmed physical violence, verbal abuse, and demands for alternative, unapproved
treatment were now routine experiences for hospital staff.
“We’re not frustrated with the misinformed. We’re frustrated with those who propagate the misinformation because it’s costing people their lives,” Whitlock said.
Misinformation remains rampant across North America. The occasional genuine mistake by researchers is pounced on by anti-vaxxers and non-Covid believers. A pre-print study by researchers at the Ottawa Heart Institute looked at the rate of myocarditis and pericarditis cases after Moderna and Pfizer-BioNTech vaccinations from 1 June to 31 July. The published results, suggesting an extremely high rate of heart inflammation after Covid-19 vaccination, spread like wildfire on anti-vaccination websites and social media.
The study identified 32 patients with the rare side-effects out of a total of 32,379 doses of mRNA vaccines given in Ottawa in the two-month period, finding an inordinately high rate of close to one-in-1,000 – significantly higher than other international data has shown.
But the researchers failed to record the accurate number of vaccinations given out during that two-month period. Instead of 32,379 mRNA vaccine doses administered in June and July, as the study suggests, there were actually more than 800,000 shots given out at that time, according to Ottawa Public Health. That means the true rate of side-effects is closer to one-in-25,000 – not one-in-1,000.
Despite not getting any mainstream media coverage in Canada or anywhere else at the time it was published, the study quickly spread around the world on social media. The study also showed up on numerous anti-vaccination websites, misrepresented as evidence that the rate of myocarditis had been intentionally underestimated and that thousands of children could be at risk of future heart failure after Covid-19 vaccination. An immediate retraction of the paper and a full mea culpa by the authors did little to dampen the firestorm.
Fake news is something we have to deal with. But the ready resort to violence by vaccine-deniers and other malcontents must be stopped.
Read more by Dr Sarah Fitzgibbon at www.mindo.ie
@SarahFitzWiMIN
Hands up who wants to hear another Covid story? Absolutely nobody, I would imagine. That horse is well and truly flogged, regardless of whether it is actually dead or not. But I am going to tell you how I went from a state of permanent hypervigilance and gnawing fear back to my usual premorbid low-level anxiety – back to almost, dare I say, ‘normal’.
I got Covid.
I was Pfizered in January, one of the first lucky wave of healthcare professionals to get the precious fluid into my arm. For 18 months I have worked my way through litres of hand sanitiser. I alcohol-wiped the keyboard, phone, pens, door handles, seat backs, taps. I wore plasticky aprons in the July heatwave, dark sweat stains spreading on my new, but already well-worn scrubs. I wore the mask fastidiously; no chin nappies for me. I was diligent about infection control to the point of near-obsession. But I had lunch one August Friday in our coffee room, with two colleagues, for about 20 minutes or so. It was nice to chat and laugh and share stories about non-Covidy stuff. Two days later I woke with a sore throat and a few hours after that my nose started to run. I shooshed the children out the door of my bedroom shrieking “Stay
Awayyy!!!” (I was never one to shy away from a bit of melodrama). I drove to the test centre and had my pituitary gland prodded, but I could have just handed them the already-full bag of balled-up tissues, which had been harvesting my virulent snot.
My meals were delivered to the door of my bedroom, as well as various essentials to get me through to the ‘big reveal’ of the test result. Charging cables, notebooks, wet wipes, chocolate, three different brands of tissue (my nose having already been sandpapered to ribbons by the cheap ones) and a large vat of hand sanitiser.
I waited patiently for 18 hours or so, then flipped to the ‘I’m-an-important-frontline-worker-I-need-my-resultNOW’ Verruca Salt version of myself.
And there it was.
**DETECTED**.
I stared at the screen for a while, shaking.
I knew I had to tell a lot of people. My lovely little children and husband, henceforth to be renamed my ‘household contacts’. My work colleagues, and possibly the patients I had seen on Friday? My brain scrambled to remember the new rules about contact tracing, for vaccinated/unvaccinated/15 minutes/insideoutside. I trawled through WhatsApp messages to find the ‘special number’ for public health. It was answered swiftly and helpfully and compassionately, and I was very grateful for that.
I had compiled my contact list already – it comprised of one person outside of my family and workplace. I praised myself for this, until I realised how it indicated how small my life had become. The kind doctor assured me that my Friday patients were safe from me and talked me through
the testing processes for my ‘unvaccinated household contacts’ (formerly known as my lovely children).
Over the next few days a teeny tiny thought would occasionally enter my head about my previously-irradiated lungs, and what this might mean in terms of underlying conditions. I had two choices – acknowledge these thoughts and have a full-blown panic attack on my own in a small room with no escape, or tell myself to STFU. I chose the latter.
My meals arrived at my door three times a day, sometimes with a little crayon-written note. My previous stinginess in not forking out for an en-suite bathroom came back to bite me, so now I had to text the whole house to hide in their rooms every time I needed to pee. Thankfully years of hospital hard labour has trained my bladder to be easily ignored.
I waited until everyone had gone to bed every night to sneak downstairs with my dirty dishes and laundry, switching the machines to their highest setting to boil out my filthy germs. I Domestos-ed every surface I touched.
The 10 days passed with ups and downs of boredom and wallowing and a failure to complete the long list of movies/books/jobs that I had compiled.
Afterwards, I felt bullet-proof and could stroll around supermarkets without leaping away when a stranger got within six feet of me. I feel liberated now, grateful to have escaped with just a bad cold and some deconditioning. I am acutely conscious of those who have fared less well, but hopefully we are getting some way closer to Covid becoming simply background noise in our lives.
After a recent Covid diagnosis, I am grateful to have escaped with just a bad cold and some deconditioningDR MUIRIS HOUSTON Read more by Dr Muiris Houston at www.mindo.ie @muirishouston
Fake news is something we have to deal with. But the ready resort to violence by vaccine-deniers and other malcontents must be stopped
Question 1
A. Patients mostly present between 60-to-80 years of age.
B. Untreated patients have cool, dry hands.
C. The TSH level will not be elevated before overt clinical manifestations appear.
D. Patients with severe memory problems can safely take their entire weekly dose of thyroxine at once.
E. Most patients will require 150-200μg daily of thyroxine for optimal control.
Question 2
A. Use is contraindicated in children with tics.
B. Treatment can be initiated by the GP.
C. Sustained-release preparations act for 10-to-12 hours.
D. Can cause rebound poor sleep.
E. Should not be stopped until patient is 18 years old.
Question 3
A. Most often affect 30-to-50-year-olds.
B. Are ganglions of the distal interphalangeal joint.
C. Are normally traumatic in origin.
D. Cause no symptoms other than pain.
E. Treatment of choice is steroid injection.
Question 4
In women with recurrent urinary tract infection – and normal renal tracts – appropriate helpful measures that can be advised include
A. Drink cranberry juice daily.
B. Empty the bladder before sexual intercourse.
C. Wipe back to front after micturition/defaecation.
D. Drink plenty of coffee and alcohol.
E. If recurrences associated with sexual intercourse, take a trimethoprim tablet within two hours of intercourse.
Question 5
A. Irritable mood.
B. Increased sexual activities.
C. Psychomotor retardation.
D. Change in appetite.
E. Flight of ideas.
E. TRUE. And increased talkativeness/distractibility.
D. FALSE. Another depression feature.
C. FALSE. Get psychomotor agitation. May get either in depression.
B. TRUE. And increased social activities/contacts.
A. TRUE. Or elevated mood with increased self-esteem or grandiosity.
ANSWER 5
E. TRUE. Off label use, but evidence 100mgs helps.
D. FALSE. No evidence hydration or changes in diet helps.
C. FALSE. Wipe front to back.
B. FALSE. No evidence voiding before or after intercourse helps.
A. FALSE. No longer recommended for this.
ANSWER 4
J. FALSE. Surgery is the definitive treatment.
I. FALSE. Patient may note infection or chronic drainage.
H. FALSE. 80 per cent are associated with degenerative joint disease.
G. TRUE. Of fingers or toes.
F. FALSE. 50-to-70-year-olds, mainly women.
ANSWER 3
E. FALSE. Discontinue during adolescence.
D. TRUE. Also poor appetite, hypertension, and weight loss.
C. FALSE. Six-to-eight hours.
B. FALSE. Should only be initiated by psychiatrist or paediatrician with expertise in ADHD.
A. TRUE. Not licensed for use if symptoms or family history of tics or Tourette’s symptoms.
ANSWER 2
E. FALSE. Median dose is 125μg daily. In most patients appropriate dose remains constant once established.
D. TRUE. Provided they have been initially stabilised with daily dosing.
C. FALSE. In early stages often asymptomatic.
B. TRUE. The other most useful clinical signs are slow relaxing tendon reflexes, bradycardia, and hair loss.
30-to-60-year-olds, mainly female.
A. FALSE.
ANSWER 1
Bladder cancer is a prevalent disease with substantial morbidity and mortality that requires multidisciplinary medical and surgical management
Bladder cancer is the 10th most common cancer diagnosed worldwide,1 and it is the most common urinary tract neoplasm, with urothelial carcinoma (UCC) being the most common histologic type (approximately 90 per cent).8 Metastatic urothelial cancer is the 13th most common cancer in Ireland and has a five-year survival rate of 5 per cent.14 In Ireland bladder cancer affects approximately 490 people annually.3
Bladder cancer has a higher incidence in men than women: The age-standardised incidence rate per 100, 000 person-years is 9.5 for men and 2.4 for women worldwide, and in the EU, 20 for men and 4.6 for women.2
The incidence of bladder cancer increases with age. Approximately 70 per cent of patients diagnosed with bladder cancer in Ireland are over 65 years of age and up to 15 per cent are diagnosed with metastatic disease at initial presentation.14
Tobacco smoking is the main risk factor, accounting for nearly 50 per cent of cases, followed by occupational exposure to aromatic amines, polycyclic aromatic hydrocarbons, and chlorinated hydrocarbons, which are responsible for approximately 10 per cent of all cases.2,4 The incidence of bladder cancer in smokers is almost twice that of non-smokers.3
While family history seems to have little impact, genetic predisposition has an influence on the incidence of bladder cancer via its impact on susceptibility to other risk factors.5
Other risk factors include the parasitic infection schistosomiasis; medications including pioglitazone for the management of type 2 diabetes (associated with a small increase in bladder cancer); cyclophosphamide (a chemotherapy agent used in the management of haematological malignancies); and pelvic radiation.3
Symptoms and diagnosis
Common presenting bladder cancer symptoms include microscopic haematuria, gross haematuria and infection, or obstruction.8 The most common presenting symptom seen in over 80 per cent of bladder cancer patients is painless haematuria.14 Other less common symptoms include dysuria, frequency or urgency, constitutional symptoms such as fatigue, weight loss, and rarely bone or flank pain due to metastases. There are no screening tests for the early detection of bladder cancer. Gross haematuria correlates with advanced disease stage.8
Diagnostic modalities include imaging, ultrasound, intravenous urography (IVU), CT, MRI, cystoscopy, and biopsy.8
Diagnostic methods used for bladder cancer are cystoscopy and urine cytology. Cystoscopy is an invasive tool and has low sensitivity for carcinoma in situ and is considered the gold standard for the initial management of bladder cancer. Direct visualisation of the bladder is necessary in all cases of haematuria, where there is a concern for bladder cancer, and no imaging modality is sensitive enough to re-
place the cystoscope.3 Urine cytology is non-invasive, cost-effective, and has a high specificity, but low sensitivity for low-grade urothelial tumours.11
The main role of imaging in the assessment of haematuria is to evaluate the kidneys and ureters. Ultrasound or CT may be used and guidelines differ in their recommendation regarding imagery. Ultrasound of the kidneys will identify most renal tumours; however, it can miss a small percentage of upper tract urothelial cancers which can be detected with CT scanning.3
6
The urinary bladder wall is composed of four layers: mucosa, submucosa, muscularis, and serosa.
cancers and develops from glandular cells.
There are other less common types of bladder cancer, including sarcoma of the bladder and small cell bladder cancer among others. Sarcomas of the bladder often begin in the fat or muscle layers of the bladder. Small cell bladder cancer is a rare type of bladder cancer that is likely to spread to other parts of the body.
In addition to cell type, bladder cancer may be described as non-invasive, non-muscle-invasive, or muscle-invasive.
Non-invasive: Non-invasive bladder cancer includes non-invasive papillary carcinoma and carcinoma in situ (CIS). Non-invasive papillary carcinoma is a growth found on a small section of tissue that is easily removed. This is called stage
Staging and grading7,9
The stage of a cancer describes its size, position and whether it has spread. The TNM system is a commonly used staging system. T refers to how far the tumour has grown into the bladder, and how far it has spread into the surrounding tissues. N describes whether the tumour has spread to the nearby lymph nodes. M refers to secondary or metastatic cancer if the tumour spreads to another part of the body.7 CIS or Tis means very early, high grade cancer cells are only in the innermost layer of the bladder lining.
T – Tumour9
Ta: The cancer is just in the innermost layer of the bladder lining.
T1: The cancer has started to grow into the connective tissue beneath the bladder lining.
T2: The cancer has grown through the connective tissue into the muscle. T2 is divided into T2a and T2b.
T2a: The cancer has grown into the superficial muscle.
T2b: The cancer has grown into the deeper muscle.
T3: The cancer has grown through the muscle into the fat layer. T3 is divided into T3a and T3b.
T3a: The cancer in the fat layer can only be seen under microscopic invasion.
T3b: The cancer in the fat layer can be seen on tests, or under macroscopic invasion.
T4: The cancer has spread outside the bladder. T4 is divided into T4a and T4b.
T4a: The cancer has spread to the prostate, uterus or vagina.
T4b: The cancer has spread to the wall of the pelvis or abdomen.
N - Lymph nodes
N0 means there are no cancer cells in any lymph nodes.
N1 means there are cancer cells in one lymph node in the pelvis.
N2 means there are cancer cells in more than one lymph node in the pelvis.
N3 means there are cancer cells in one or more lymph nodes just outside the pelvis.
M – Metastasis
There are three main types of bladder cancer: Urothelial carcinoma (UCC): UCC accounts for approximately 90 per cent of all bladder cancers and also for 10-to-15 per cent of kidney cancers diagnosed in adults. It begins in the urothelial cells found in the urinary tract. UCC is sometimes also referred to as transitional cell carcinoma or TCC.
Squamous cell carcinoma (SCC): Squamous cells develop in the bladder lining in response to irritation and inflammation. Over time, these cells may become cancerous. Squamous cell carcinoma accounts for about 4 per cent of all bladder cancers.
Adenocarcinoma: Adenocarcinoma accounts for about 2 per cent of all bladder
Ta. CIS is a cancer that is found on or near the surface of the bladder (stage Tis).6
Non-muscle-invasive: Non-muscle-invasive bladder cancer (NMIBC) has grown into the lamina propria, but not into the muscle. NMIBC is also referred to as superficial cancer, although this term may incorrectly suggest that the cancer is not serious. NMIBC has the possibility of spreading into the bladder muscle or to other parts of the body.6
Muscle-invasive: Muscle-invasive bladder cancer (MIBC) has grown into the bladder wall muscle and sometimes into the fatty layers or surrounding tissues or organs outside the bladder.6
M0 means the cancer has not spread to other parts of the body.
M1 means the cancer has spread to other parts of the body, such as the bones, lungs, liver, or lymph nodes. M1 can be divided into M1a and M1b:
M1a means the cancer has spread to the lymph nodes outside the pelvis.
M1b means the cancer has spread to other parts of the body, for example, bones, lungs and liver.
Grading for bladder cancer may be referred to as:7, 10
The most common presenting symptom seen in over 80 per cent of bladder cancer patients is painless haematuria
Grade 1: The cancer cells look very like normal cells. They are called low grade or well differentiated. They tend to grow slowly and generally stay in the lining of the bladder.
Grade 2: The cancer cells look abnormal. They are called moderately differentiated. They are more likely to spread into the deeper muscle layer of the bladder or to come back after treatment.
Grade 3: The cancer cells look very abnormal. They are called high grade or poorly differentiated. They grow more quickly and are more likely to come back after treatment or spread into the deeper muscle layer of the bladder.
Grading may also be referred to as lowgrade or high-grade:
Low-grade: The cancer cells are slow-growing and are less likely to spread
High-grade: The cancer cells grow more quickly and are more likely to spread. CIS is always classed as high-grade.
Pathology plays a crucial role in the management of bladder cancer. At initial diagnosis, most patients present with NMIBC, which correlates with better overall survival and prognosis. The most important factor in the pathological assessment of UC is identifying the extent of invasion for proper staging. Bladder cancers can be unifocal or multifocal. The majority of cases present as multifocal. Multifocal tumours may be multiple independent or arise from a common origin. The pathology report should include the tumour location, grade, depth, presence or absence of CIS, and whether the detrusor muscle is present in the examined specimen. The pathology report should also include the presence of LVI or variant histology. In complex cases, review by an experienced genitourinary pathologist is recommended. 8
Management of NMIBC
NMIBC is the most common diagnosed bladder cancer and refers to bladder cancers confined to the mucosa (pTa) or lamina propria (Pt1), without invasion of the bladder wall muscle. CIS, a high grade fat tumour confined to the mucosal layer, is also included in this group. pTa and pT1 appear as papillary type lesions and the number and size of tumours are important predictors for the risks of progression and reoccurrence. CIS tumours can appear as velvety changes on the bladder mucosa and often present with lower urinary tract symptoms rather than haematuria. 3
Management of NMIBC includes transurethral resection of bladder tumour (TURBT), a diagnostic and therapeutic procedure that allows the collection of samples to determine the grade and stage of bladder cancer. The samples are sent for histological assessment. NMBIC has the potential to reoccur or progress to MIBC.
The European Organisation for Research and Treatment of Cancer (EORTC) has developed a scoring model for predicting recurrence and progression.
The scoring system is based on assigning points for- number of factors; tumour diameter; prior recurrence rate; category; concurrent CIS; and World Health Organisation (WHO) 1973 tumour grade. Surveillance after treatment such as TURBT uses different modalities including regular cystoscope evaluation, CT scan and cytology. Intravesical treatments including chemotherapy agents mitomycin, epirubicin and BCG are important in the reduction of recurrence and progression rates of NMBIC. 3
Management of MIBC
While most patients presenting with bladder cancer have NMIBC, up to 25 per cent have MIBC, where cancer cells are detected in the muscularis mucosa at the time of TURBT. Tumours that extend to the muscle layer are staged T2, to the perivesical fat T3, and those that invade other organs or the pelvic side wall, T4. 3
MIBC cannot be cured with endoscopic treatments alone and requires radical therapy. Even with radical treatments the five-year survival rate is approximately 50 per cent. Treatment options for MIBC include radical cystectomy, neoadjuvant chemotherapy (NAC), urinary reservoir reconstruction, trimodal therapy, radiotherapy, and endoscopic management. 3
In radical cystectomy the prostate gland and seminal vesicles are also removed in men and the urethra is removed if a tumour is detected on urethral biopsy. In women the uterus, urethra and adjacent vaginal tissues are removed, however, the ovaries can usually be left in situ. Regional lymph nodes are also removed in both men and women. 3
The addition of NAC has been shown to account for a 5 per cent improvement in overall survival with radical cystectomy. NAC should be commenced as soon as possible and followed by surgery usually within six weeks.
Ileal conduit is the most common method of urinary reservoir reconstruction in Ireland and the UK. The Studer neobladder is another technique, but is contraindicated when a tumour has spread to the urethra.3
Trimodal therapy utilises TURBT, radiotherapy and chemotherapy. In carefully selected patients, results from trimodal therapy can match those of radical cystectomy. External beam radiotherapy should not be offered as a primary therapy and only be considered in patients unfit for cystectomy.
Endoscopic resection and diathermy for patients with un-resectable disease can improve quality-, but not quantity-of-life. 3
Standard first-line treatment for metastatic urothelial cancer is gemcitabine/ cisplatin (GC) or MVAC (methotrexate, vinblastine, adriamycin and cisplatin). About 50 per cent of patients are unfit for cisplatin-containing chemotherapy due to poor hearing, impaired renal function or comorbidity. Patients who are unable to receive cisplatin may be offered palliative chemo in the form of carboplatin/gemcitabine. This is the preferred option as it is better tolerated than methotrexate/carboplatin/vinblastine (MCAVI), but without a statistically significant difference in overall and progression-free survival. Patients unfit for platinum-based therapy have the option
of single agent taxane or gemcitabine. Although a significant number of patients have an objective response to first-line therapy, most eventually progress and require subsequent lines of therapy.14
Options for treatment in the second-line setting and beyond include immunotherapy, targeted treatment or chemotherapy. Immunotherapy has been approved by the US FDA in the second-line setting for patients with metastatic urothelial cancer who progressed on previous platinum chemotherapy. In the Irish setting, however, chemotherapy is currently the only funded treatment, and treatment options for patients who progress on chemotherapy are limited. Patients may be able to access immunotherapy or erdafitinib via compassionate access schemes, however these applications require time and are subject to approval from pharmaceutical companies.14
Bladder cancer is a prevalent disease with substantial morbidity and mortality that requires multidisciplinary medical and surgical management. Bladder cancer should be considered as two distinct diseases. NMIBC can be completely managed endoscopically with the occasional use of intravesical treatments. Strict adherence to surveillance is necessary to help prevent recurrence or progression. MIBC is more progressive and treated with radical cystectomy/radical cystoprostatectomy and ileal conduit formation following NAC. Long-term follow-up is required to monitor recurrence and functional deterioration. 3
References
1. International Agency for Research on Cancer. Estimated number of new cases in 2020, worldwide, both sexes, all ages. World Health Organisation, Geneva, Switzerland
2. Compérat E, Gontero P, Liedburg F, et al. 2021. European Association of Urology Guidelines on non–muscleinvasive bladder cancer (Ta, T1, and Carcinoma in Situ). Available at: www. sciencedirect.com/science/article/pii/ S0302283821019783#bib0015
3. Thomas A, Kelly N. Overview and factors in bladder cancer management. Hospital Professional News . Issue 88; September 2021
4. van Osch F., Jochems S, van Schooten F, Bryan R, Zeegers M. Quantified relations between exposure to tobacco smoking and bladder cancer risk: A meta-analysis of 89 observational studies. Int J Epoidemiol, 45 (2016), pp. 857-870
5. Egbers L, Grotenhuis K, Aben J, Witjes L, Kiemeney L, Vermeulen S. The prognostic value of family history among patients with urinary bladder cancer. Int J Cancer, 136 (2015), pp. 1117-1124
6. ASCO (2020). Bladder Cancer. American Society of Clinical Oncology. Available at: www.cancer.net/cancer-types/ bladder-cancer/introduction
7. Macmillan Cancer Support. (2021). Staging and grading of bladder cancer. Available at: www.macmillan.org.uk/cancerinformation-and-support/bladder-cancer/ staging-and-grading-of-bladder-cancer
8. Kaseb H, Aedulla N. (Updated 2021).
The prognosis of UC depends on multiple factors. TNM stage is the most important prognostic factor of urinary bladder carcinoma. The five-year overall survival for pT1 is 75 per cent, for pT2 is 50 per cent, and for pT3 is 20 per cent. 8 Up to 45 per cent of patients will develop complications following radical cystectomy and ileal conduit formation. The main complications include vitamin B12 deficiency, metabolic acidosis, and deterioration of renal function, urinary tract infections, and anastomotic complications.
Advanced and metastatic bladder cancer has a poor prognosis and median survival even with cisplatin-based chemotherapy is approximately 14 months. 3
Treatment of patients with advanced disease is, however, undergoing rapid changes as immunotherapy with checkpoint inhibitors (ICI), targeted therapies and antibody-drug conjugates have become options for certain patients with various stages of disease.12 The advent of ICI has transformed the treatment landscape of bladder cancer. Novel ICI have successfully shown improved outcomes in metastatic disease to such an extent that the standard of care paradigm has changed, leading to the development of different trials with the aim of determining whether ICI may have a role in early disease.13
With ongoing clinical trials increasingly showing an overall survival benefit with immunotherapy and targeted treatment for bladder cancer, it is important that Ireland keeps pace with evolving practice in order to provide the best possible care and outcomes for these patients.14
Bladder cancer. StatPearls Publishing. Available at: www.statpearls.com/ ArticleLibrary/viewarticle/18354
9. Cancer Research UK (2018). Stages bladder cancer. Available at: www.cancerresearchuk.org/about-cancer/ bladder-cancer/types-stages-grades/stages
10. Cancer Research UK (2018). Grades of bladder cancer. Available at: www. cancerresearchuk.org/about-cancer/ bladder-cancer/types-stages-grades/grades
11. Oeyen E, Hoekx L, De Wachter S, Baldewijns M, Ameye F, Mertens I. Bladder cancer diagnosis and follow-up: The current status and possible role of extracellular vesicles. Int J Mol Sci. 2019 Feb; 20(4): 821. Published online 2019 Feb 14. doi: 10.3390/ijms20040821
12. Andrew T, Lenis M, Patrick M, Lec M, Karim C, et al. Bladder cancer a review. JAMA . 2020; 324(19):1980-1991. doi:10.1001/jama.2020.17598
13. Cancer treatment reviews (2021). Recent advances in neoadjuvant immunotherapy for urothelial bladder cancer: What to expect in the near future. Available at: www.cancertreatmentreviews. com/article/ S0305-7372(20)30181-X/ fulltext#relatedArticles
14. Chew S, Darwish W, Carroll H, McCaffrey J. (2020). Updates on management of metastatic bladder cancer. Hospital Professional News . Available at: https:// hospitalprofessionalnews.ie/wp-content/ uploads/2020/09/Updates-on-managementof-metastatic-bladder-cancer.pdf
50mgs once daily
Prescribing Information: Please read the Summary of Product Characteristics (SPC) before prescribing. Presentation: Prolonged-release tablet, containing mirabegron 25mg/50mg. Indication: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Posology and method of administration: The recommended dose is 50 mg once daily. A lower dose of 25mg is recommended for specific patient populations (renal and hepatic impairment) as well as in specific patient populations in combination with strong CYP3A inhibitors such as itraconazole, ketoconazole, ritonavir and clarithromycin.
Renal impairment: End stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis): Not recommended. Severe renal impairment (GFR 15 to 29 mL/min/1.73 m2): Reduce dose to 25 mg. Severe renal impairment and concomitant strong CYP3A inhibitors: Not recommended. Moderate renal impairment (GFR 30 to 59 mL/min/1.73 m2): 50 mg. Moderate renal impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. Mild renal impairment (GFR 60 to 89 mL/min/1.73 m2): 50 mg. Mild renal impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. Hepatic impairment: Severe hepatic impairment (Child-Pugh Class C): Not recommended. Moderate hepatic impairment
(Child-Pugh B): Reduce dose to 25 mg. Moderate hepatic impairment and concomitant strong CYP3A inhibitors: Not recommended. Mild hepatic impairment (Child-Pugh A): 50 mg. Mild hepatic impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed. It may be taken with or without food Contraindications: Hypersensitivity to the active substance or to any of the excipients (see the SPC for a list of excipients). Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg. Special warnings and precautions for use: Renal impairment: Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) and, therefore, it is not recommended for use in this patient population. Data are limited in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2); based on a pharmacokinetic study a dose reduction to 25 mg is recommended in this population. This medicinal product is not recommended for use in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors. Hepatic impairment: Betmiga has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in this patient population. This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving
strong CYP3A inhibitors. Hypertension: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients. Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg). Patients with congenital or acquired QT prolongation: Betmiga, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies. However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown. Caution should be exercised when administering mirabegron in these patients. Patients with bladder outlet obstruction and patients taking antimuscarinic medicinal products for OAB: Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medicinal products for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with Betmiga; however, Betmiga should be administered with caution to patients with clinically significant BOO. Betmiga should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB. Interactions: Pharmacokinetic interactions: Mirabegron is a substrate for CYP3A4, CYP2D6, butyrylcholinesterase, uridine diphosphoglucuronosyltransferases (UGT), the efflux transporter P-glycoprotein (P-gp) and the influx organic cation transporters (OCT) OCT1, OCT2, and OCT3. Pharmacokinetic interactions involving the potential for other medicinal products to affect mirabegron exposures: Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate. Strong CYP3A inhibitors See Posology and administration above for dose adjustments recommended during concomitant use of strong CYP3A inhibitors in patients with renal or hepatic impairment. Mirabegron exposure (AUC) was increased 1.8-fold in the presence of the strong inhibitor of CYP3A/P-gp ketoconazole. CYP2D6 inhibitors: No dose adjustment is needed for mirabegron when administered with CYP2D6 inhibitors (or in patients who are CYP2D6 poor metabolisers). Inducers: Inducers of CYP3A (such as rifampicin) or P-gp may decrease the plasma concentrations of mirabegron. No dose adjustment of mirabegron is required as this effect is not expected to be clinically relevant. Pharmacokinetic interactions involving the potential for mirabegron to affect exposures to other medicinal products: Inhibition of CYP2D6: Moderate and time dependent inhibition of CYP2D6 by mirabegron may result in clinically relevant drug interactions. CYP2D6 activity recovers within 15 days after discontinuation of mirabegron. Caution is advised if mirabegron is co-administered with medicinal
products metabolized by CYP2D6 with a narrow therapeutic index such as thioridazine, Type 1C antiarrhythmics (e.g.flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. Inhibition of P-gp: Mirabegron is a weak inhibitor of P-gp. For patients who are initiating a combination of Betmiga and digoxin, the lowest dose for digoxin should be prescribed initially. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect. The potential for inhibition of P-gp by mirabegron should be considered when Betmiga is combined with sensitive P-gp substrates e.g. dabigatran. Fertility, pregnancy and lactation: The effect of mirabegron on human fertility has not been established. Betmiga is not recommended during pregnancy and in women of child-bearing potential not using contraception. Mirabegron should not be administered during breast feeding. Refer to SPC for full guidance. Driving and use of machines: Betmiga has no or negligible influence on the ability to drive and use machines.
Undesirable effects: Summary of the Safety Profile: the safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.
The frequency of tachycardia was 1.2% in patients receiving Betmiga 50 mg.
Tachycardia led to discontinuation in 0.1% patients receiving Betmiga 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving Betmiga 50 mg.
Urinary tract infections led to discontinuation in none of the patients receiving Betmiga 50 mg. Serious adverse reactions included atrial fibrillation (0.2%). Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies. The following adverse reactions were observed with mirabegron in the three 12-week phase 3 double blind, placebo controlled studies. The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be established from the available data) Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse events
are grouped by MedDRA system organ class. Infections and infestations: Common: urinary tract infection Uncommon: vaginal infection, cystitis Psychiatric disorders: Not known: Insomnia*, confusional state* Nervous system disorders: Common: headache* dizziness* Eye disorders: Rare: eyelid oedema Cardiac disorders:
Common: tachycardia Uncommon: palpitation, atrial fibrillation Vascular disorders:
Very rare: Hypertensive crisis* Gastrointestinal disorders: Common: nausea*, constipation*, diarrhoea* Uncommon: dyspepsia, gastritis Rare: lip oedema Skin and subcutaneous tissue disorders: Uncommon: urticaria, rash, rash macular, rash papular, pruritus Rare: leukocytoclastic vasculitis, purpura, angioedema* Musculoskeletal and connective tissue disorders: Uncommon: joint swelling Renal and urinary disorders:
Rare: urinary retention* Reproductive system and breast disorders: Uncommon: vulvovaginal pruritus Investigations Uncommon: blood pressure increased, GGT increased, AST increased, ALT increased (*observed during post-marketing experience) Reporting of suspected adverse reactions: see below. Legal category: POM (S1B) Marketing Authorisation number: EU/1/12/809/003 - 25mg EU/1/12/809/010 50mg. Marketing
Authorisation holder: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands. Further information is available from: Astellas Pharma Co., Ltd, 5 Waterside, Citywest Business Campus, Dublin 24. Phone: +3531 467 1555. Summary of Product Characteristics with full prescribing information available upon request. Job number: BET_2019_0002_IE Date of preparation of API: 27 May 2019.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
HPRA Pharmacovigilance Astellas Pharma Co. Ltd Earlsfort Terrace, IRL - Dublin 2 Tel: + 353 1 467 1555
Tel: +353 1 6764971 E-mail: Irishdrugsafety@astellas.com
Fax: +353 1 6762517
Website: www.hpra.ie E-mail: medsafety@hpra.ie.
American Urological Association 2021 meeting, 10-13 September 2021
Priscilla Lynch presents a round-up of the latest overactive bladder research presented at the 2021 American Urological Association meeting
Patients with Covid-19 reported experiencing severe genitourinary symptoms during infection, and new or worsening overactive bladder (OAB) symptoms after recovery, according to recent findings from two studies presented at the American Urological Association 2021 (AUA) meeting.
Prof Michael B. Chancellor, Professor of urology at Oakland University Beaumont School of Medicine, and colleagues conducted a study to determine whether genitourinary symptoms were associated with pro-inflammatory cytokines in the urine of patients with Covid-19. The analysis included 53 patients with normal renal function who were hospitalised for Covid-19 and 12 asymptomatic control patients. The researchers assessed patients with an AUA Urology Care Foundation OAB Assessment Tool to determine their urinary symptoms based on a scale of 0 to 25, with increasing scores representing increasing severity. They also collected urine samples from patients, which were then tested for SARSCoV-2 and pro-inflammatory cytokines. Patients’ median age was 64.5 years.
The median total OAB symptom score among patients with Covid-19 was 18, with a range from four to 21. Quality-of-life scores ranged from eight to 24, with a median of 19; higher scores related to better quality-of-life. Patients with symptoms of Covid-19-associated cystitis experienced increased urinary urgency, frequency, nocturia and pain as well as worsening quality-of-life, according to Prof Chancellor.
The researchers found that most patients with Covid-19 did not have the virus in their urine. However, levels of inflammato-
ry cytokines, including interleukin-6, IL-10, GRO/CXCL and C-reactive protein, were significantly increased in patients with Covid-19. These cytokines may correlate with severity and duration of Covid-19 infection, he said.
“In conclusion, our study shows that Covid-19 can have de novo and severe genitourinary symptoms that are highly bothersome,” Prof Chancellor said.
In a separate study, Dr Nivedita Dhar, a urologist at the DMC Medical Group in Michigan, and colleagues assessed OAB symptoms after patients recovered from Covid-19. Using the same OAB Assessment Tool, the researchers collected symptom and quality-of-life scores among patients who were recovering from Covid-19 in a hospital between May 22, 2020, and December 31, 2020. The median age of patients was 64.5 years and the median length of stay in the hospital was 10 days.
Dr Dhar and colleagues identified 350 patients with new or worsening OAB symptoms. In patients with a new onset of OAB symptoms, the median symptom score was 18. Individuals with worsening OAB symptoms had a median score of eight before developing Covid-19 and a median score of 19 after recovery, according to the data. Meanwhile, the median quality-of-life score among all patients was 19. In those with worsening OAB, the median quality-of-life score before Covid-19 was nine compared with a score of 20 after recovery.
The study concluded that the exacerbation of OAB symptoms following Covid-19 “was evident by increases in symptom severity scores and deteriorating quality-of-life”.
Patients rarely continue percutaneous tibial nerve stimulation (PTNS) for OAB after three years, according to new study findings presented during the AUA 2021 Annual Meeting.
Of 146 patients treated with PTNS from 2014 to 2017 at Stony Brook Medical Centre in Stony Brook, New York, 108 patients (74 per cent) completed the initial 12 week course of therapy, but only 76 (52 per cent) continued with monthly maintenance therapy. After three years, a mere 16 patients (11 per cent) still underwent PTNS, Dr Chris Du, and colleagues from Stony Brook Medicine reported in a poster presentation. The median duration of PTNS therapy was 147 days.
In multivariate analysis, only symptom improvement and neurological history were significantly associated with continuing PTNS. Symptom improvement was reported by 100 per cent of patients who remained on PTNS at three years compared
The novel muscarinic M3 receptor antagonist DA8010 significantly reduced urine frequency and urgency episodes compared with placebo in adults with OAB, according to new data presented at the virtual 2021 AUA meeting.
Dr Hee Seo Son, MD, PhD, of Yonsei University College of Medicine in South Korea, presented phase 2 trial data about the novel agent.
Dr Son and colleagues conducted the phase 2, randomised, double-blind, parallel-group, active reference- and placebo-controlled trial at 12 centres in South Korea. The study cohort included 306 patients, 69.93 per cent of whom were women. The patients had symptoms of OAB for three months prior to enrolment.
The researchers randomly assigned patients to receive one of four treatments: 2.5mg of DA8010; 5mg of DA8010; 5mg of solifenacin succinate or placebo. The treatments were administered once daily for 12 weeks. The researchers evaluated DA8010 for its clinical efficacy, safety and optimal dosage.
At 12 weeks, the mean values for 24hour frequency were -1.01 in the placebo group, -1.22 in the DA8010 2.5-mg group, -1.56 in the solifenacin succinate group and -1.67 in the DA8010 5-mg group. The difference in mean frequency was insignificant in the DA8010 groups compared with the solifenacin succinate group. However, compared with placebo, both DA8010 treatment doses exhibited significant differences in 24-hour frequency at four and eight weeks, and this difference remained significant at 12 weeks (P=.0413). Also, the 5mg dose of DA8010 was associated with significant reductions in the number of urgency episodes at four (P= .0278) and eight (P=.0092) weeks compared with placebo, according to the researchers.
Adverse drug reactions occurred in 3.95 per cent of patients in the placebo group, 6.67 per cent of patients in the DA8010 2.5mg group, 18.42 per cent of patients in the DA8010 5-mg group and 17.33 per cent of patients in the solifenacin succinate group. DA-8010 will now advance to phase 3 development.
Two new studies demonstrating the impact physical activity –whether through work, recreational or via an exercise app – has on improving urinary incontinence symptoms were presented during the 2021 AUA Annual Meeting.
Publication PD06-03 The association of physical activity and urinary incontinence in women: Results from a multi-year national survey
ical activity are associated with a decreased likelihood of stress, urge, and mixed incontinence in women.
• This relationship holds for both recreational and work-related activity.
with 60 per cent of patients who dropped out. A neurologic history was present in 56 per cent of patients who adhered to PTNS compared with 32 per cent who dropped out. It is likely that the increased urologic risk of neurogenic bladder in these patients leads to higher rates of compliance, the investigators noted. Other relevant factors, such as gender, race, Medicare coverage, smoking status, diabetes mellitus, median household income, and distance to clinic did not influence PTNS persistence.
Among the 130 patients who dropped out, the most commonly cited reasons for cessation included worsening of urinary symptoms (51 patients), time commitment (12), request for alternative treatment (12), medical comorbidities (10), and insurance issues (7).
“Despite reported symptom improvement, overall compliance remains low with this third-line treatment for OAB,” Dr Du’s team concluded.
Urinary incontinence is a significant source of morbidity among women. Studies have shown that regular physical activity can improve muscle strength and flexibility, yet there is little literature on whether physical activity may help strengthen the pelvic floor to improve incontinence. This study sought to examine the relationships between physical activity, both work and recreational, and urinary incontinence among women. A total of 30,213 women were included in analysis, of whom 23.15 per cent had stress incontinence, 23.16 per cent had urge incontinence, and 8.42 per cent had mixed incontinence.
Key findings:
• A statistically significant inverse association was found between the time spent performing moderate intensity activities (both leisure and work) and all three types of urinary incontinence.
• Moderate physical activity and a greater time spent participating in moderate phys-
Publication MP52-18 Effectiveness of appbased yoga of immortals intervention in urinary incontinence Yoga of Immortals (YOI) is a unique combination of specific yogic postures, breathing exercises, sound therapy, and meditation and is practiced by many for general wellbeing. This also targets pelvic floor muscles and focuses on the specific energy centres. The authors studied the effectiveness of YOI intervention in participants with urinary incontinence of all types.
Key findings:
• YOI intervention resulted in significant improvement in the mean scores of ICIQLUTS-QOL, ICIQ-UI-SF, frequency and severity of urinary leak, daily life activity and stress urinary incontinence.
• Majority of the participants felt 'very much better' at four weeks on PGl-scale. YOI may be an adjunctive treatment option in those inclined towards these practices.
• Being app-based, it has the added advantage of the ability to be used any time anywhere.
"These studies prove that there is a positive relationship between exercise and urinary incontinence," Dr Anger said.
One of the most common medical conditions that affects the bladder is urinary incontinence. This type of incontinence can affect both sexes, but it is most common in women. In fact, according to the American Academy of Physicians (AAP), almost 50 per cent of women in their 40s and 50s have some form of urinary incontinence. This may either be an overactive bladder or urinary stress incontinence.
1. What is urinary stress incontinence?
Urinary stress incontinence is the uncontrolled loss of urine, which occurs when a physical movement or activity like running, lifting weights, coughing or just sneezing, increases the abdominal pressure, affecting the bladder.
People may have urine leakage when coughing, sneezing or laughing. Also patients can have a urine loss while standing up, getting out of the car or having sex. Basically, any activity that increases the abdominal pressure can lead to urine loss, especially if the bladder is full.
It is very important to know that this type of incontinence is not related to psychological stress, but it can make people feel embarrassed, possibly placing limitations and changes in their work and social life.
2. What are the causes of urinary stress incontinence?
The main cause of this condition is the weakening of the pelvic floor muscles, which are the ones that support the bladder, among other pelvic structures. A secondary cause of this type of incontinence is the weakening of the urinary sphincter, which is the muscle in charge of controlling the release of urine. When these muscles become weak, anything capable of increasing the pressure outside the bladder can lead to a urine leakage.
Basically, these muscles can lose their strength due to: Childbirth: this is the most common cause of the weakening of the pelvic muscles in women. During labour, some nerves and tissues can get damaged, leading to urinary incontinence sometimes quite soon after childbirth or even many years after birth.
Chronic sneezing and coughing, obesity, smoking, drinking alcohol, and high-impact activities like weightlifting or running are included as other factors that can increase the possibilities to suffer from urinary stress incontinence.
3. How is urinary stress incontinence diagnosed?
To be sure someone suffers from urinary stress incontinence, some of the following tests will be carried out:
Urinary stress test: The patient will be asked to cough while standing to see if there is any urine leakage.
Pad test: Women have to use a sanitary pad, while men use a special pad during an entire day or just while they are exercising to see how much urine they lose.
Cystometry test: This test measures the pressure of the bladder and the urine flow.
Urine analysis: This can show if there is something abnormal in the urine like bacteria, blood, protein, or sugar.
Neurological exam: Used when needed to see if there is any problem with the pelvic nerves that can generate incontinence.
4. What are the treatments available for urinary stress incontinence?
There are many ways to treat this annoying condition, from simple bladder and pelvic muscles exercises to surgical procedures. Just by doing simple lifestyle changes such as losing some weight, avoiding caffeine, alcohol, and cigarettes, practising regular exercises, etc, the patient can reduce bladder pressure, improving their day-to-day life.
The most common exercises to improve urinary stress incontinence symptoms are the Kegel exercises, which help to strengthen the muscles of the pelvic floor. Patients can do them anywhere at any time, without being noticed. These consist of squeezing the muscles that stop the urine flow for some minutes, a few times a day. It is basically the contraction of the pelvic floor muscles.
IncontiLase is a non-invasive Er:YAG laser therapy for the treatment of mild and moderate stress urinary incontinence,
based on non-ablative photothermal stimulation of collagen neogenesis, shrinking and tightening of vaginal mucosa tissue and collagen-rich endopelvic fascia, and subsequently giving greater support to the bladder.
Regarding surgical procedures, the tension-free vaginal tape (TVT) and the trans-obturator tape (TOT) are widely performed. The TVT consists of placing a synthetic mesh around the urethra of the patient, increasing the positive pressure around the structures that allow urine flow.
The other procedure, the TOT, consists of placing a permanent tape under the urethra. The purpose is basically the same as the TVT.
The success rates of the surgical procedures are between 82 and 96 per cent. While these treatments help to reduce the symptoms of urinary incontinence, these rarely completely cure them. However, after surgery, the patient will be able to have an almost normal life, at least more than before.
For more information see https://professorbarryoreilly.ie/
Patients will be seen by appointment only.
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Paul Mulholland speaks with President of the Irish Osteoporosis Society, Prof Moira O’Brien , about the Society’s upcoming conference and the need to correct misinformation about the disease
The Irish Osteoporosis Society's (IOS) Annual Medical Conference for Health Professionals will take place virtually on 23 October 2021.
The event will see a range of experts deliver talks concerning evidence-based treatments for osteoporosis and related issues. It will also touch upon the effect the Covid-19 pandemic has had on patients and the treatment they receive.
President of the IOS, Prof Moira O’Brien, told the Medical Independent (MI) one of the major issues that has arisen during the pandemic is patients being inappropriately put on ‘drug holidays’. Prof O’Brien voiced concern about the issue to MI at last year’s conference and said it is still a problem. At this year’s event, Dr Kevin McCarroll, Consultant Physician and Geriatrician, Bone Health Unit, St James's Hospital, Dublin, will deliver a talk titled ‘Update on denosumab treatment compliance, especially during Covid-19,’ which Prof O’Brien said will address the subject. Denosumab is a monoclonal antibody drug for the treatment of osteoporosis administered as a six-monthly subcutaneous injection, which needs to be administered by a healthcare provider. Over the past year, she said many patients were informed that they could pause their treatment, as denosumab was not an essential medication. However, Prof O’Brien explained this advice was incorrect.
“You can’t just stop taking denosumab,” she explained.
“If you don’t close it off [by taking a bisphosphonate to slow the rate of bone loss], you will get vertebral fractures. And we have had a large number of patients, who have been told they can take a ‘holiday’. And that is absolutely crazy. And the amount of vertebral fractures that have occurred is because of a lack of understanding of the importance of doing the blood tests before the [denosumab] injection, and making sure that the patient gets their injection on time.”
Dr McCarroll completed a clinical Fellowship at the Mercer’s Institute for Research on Ageing and was awarded a doctorate in medicine for his thesis on vitamin D and its relationship to cognition, blood pressure, falls, and mood.
His research interests include vitamin D, bone health and cognitive impairment. He is a co-investigator in the TUDA (Trinity, Ulster, Department of Agriculture) study, which comprises 5,200 Irish adults aged over-60 and from which peer-reviewed research on vitamin D, dairy intakes, and bone health has been published.
Vitamin D
During the conference, the topic of vitamin D will be specifically addressed by Prof Bernard Walsh, Consultant Physi-
cian and Geriatrician, Bone Health Unit, St James's Hospital, Dublin, and Trinity College Dublin.
Prof Walsh is a Fellow of the Royal Colleges of Physicians of London and Edinburgh, Member of the American Society for Bone and Mineral Research, and is the author of over a hundred peer-reviewed papers. He has extensive experi-
why vitamin D is one of the most important tests that should be done in relation to osteoporosis. “Vitamin D not only protects bone, but it also helps the immune system,” she explained. “A lot of people think calcium is important. But if the vitamin D is low, the calcium will be low.”
Dr Donncha O’Gradaigh, Consultant Rheumatologist, Waterford University Hospital, will deliver a talk titled ‘Treat to Target’. It will be followed by a question and answers session, with the panel consisting of Dr O’Gradaigh, Prof Walsh, Dr McCarroll, and Prof O’Brien.
“We will seek to address the misinformation that is being put out there,” she said. “The number of people who ring the Society and, ‘well, I’m 40, and I’ve just fallen’, but when they have asked for a DEXA [scan], the GP would have said, ‘you’re not old, that can’t be osteoporosis.’ That is the level of knowledge. They need to know the risk factors and that will all be emphasised.”
Following Prof O’Brien’s opening address, Consultant Psychiatrist at and former Medical Director of St Patrick’s University Hospital, Dublin, Prof Jim Lucey, will deliver the first talk of the day at the virtual conference on the subject of mental health.
Covid-19 lockdown last year. The book deals with the heightened anxiety and distress the pandemic has brought, with multiple stressors, such as isolation, illness, grief, and financial strain; and limitations in our everyday routines. While one-in six-people experience a mental health challenge in a year, Prof Lucey explains that this has likely increased to as many as one-in-three during the pandemic.
Prof O’Brien said stress and anxiety is a strong risk factor regarding osteoporosis. “What people don’t realise is that if you are stressed, your cortisol goes up, and this is one of the highest causes of bone loss. And for people to realise the importance of various factors, such as the amount of sleep, the amount of exercise, and the correct type of exercise.”
Ms Ciara Shields, Chartered Physiotherapist, Clinical Specialist in Musculoskeletal Physiotherapy, IONA Physiotherapy, will deliver a talk on the subject of exercise. Her presentation is titled ‘Stay strong – Exercise and bone health’.
“Patients need to know how to exercise properly,” Prof O’Brien said. “And this is not just walking; they need to do weights and resistance training. With resistance training, you can do it sitting down, you can do it standing up, depending on the level of the patient and whether they have a high risk of fractures. But you have got to do it slowly. And the one thing they must not do is bend forwards. Because if they have poor bone density in their spine, and they are told to bend forwards, that will give rise to fractures.”
Another topic will be male incontinence, which will be discussed by Ms Aoife Ni Eochaidh, Chartered Physiotherapist, Clinical Specialist Physiotherapist, Women’s and Men’s Health and Continence, Bon Secours Consultants Clinic, Galway.
The conference will also feature a presentation from guest speaker, patient, Ms Sarah Buckley, who will talk about her “journey from brittle bones to full bone health”. Ms Buckley will speak about the importance of finding a cause for bone loss from her own personal experience.
“In certain cases, it is the lifestyle that is the cause of it,” according to Prof O’Brien. “And if you don’t alter that, they aren’t going to get better.” According to the IOS, some lifestyle risk factors to developing osteoporosis include: A lack of physical activity; smoking; excess alcohol; and excess caffeine.
ence on the use of parathyroid hormone as an anabolic treatment in patients with severe osteoporosis and has also taken a national and European lead in vitamin D milk supplementation.
Prof O’Brien said the talk will highlight
Prof Lucey recently published the book A Whole New Plan for Living. It proposes and explores 10 steps to help people build and practice balance and wellbeing in their daily lives.
Prof Lucey wrote the book during the
In conclusion, she pointed out that onein-two women, and one-in-four men, over the age of 50, if they do not lead a healthy lifestyle, will develop an osteoporotic fracture. “There still is the perception that it is only an old ladies’ disease, which isn’t true,” Prof O’Brien said.
Patients need to know how to exercise properly. And this is not just walking; they need to do weights and resistance training
Physiotherapist, Women’s and Men’s Health and Continence, Bon Secours
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Ciara Shields, Chartered Physiotherapist, Physiotherapy, IONA Physiotherapy, D9
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Physician and Geriatrician, Bone Health
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 31 October 2021
Q1 Who has become the new manager of Premier League strugglers Watford?
Q2 Who is the WBC world heavyweight boxing champion?
Q3 Name the quarterback who eclipsed the all-time passing yards mark last week in the NFL?
Q4 Which nation won the 2021 UEFA Nations League?
Q5 Name the Irish cyclist who announced his retirement from professional competition earlier this month?
Q6 Which racing driver won the F1 Turkish Grand Prix?
18 October 2021
The winner of the 27 September 2021 Sporting Quiz Competition is Dr E Cullen, Co Kildare
The winner of the 27 September 2021 Crossword is Dr Susannah Kingston, Co Dublin
Q1 Who are the All-Ireland Football champions for 2021? A: Tyrone
Q2 Name the horse racing trainer who returned to racing after serving a six-month suspension? A: Gordon Elliott
Q3 Who was ratified as head coach of the Kilkenny hurling team for a 24th successive season? A: Brian Cody
Q4 How many teams will participate in the new United Rugby Championship? A: 16
Q5 Name the 18-year-old Liverpool player who sustained a broken ankle in their Premier League match against Leeds? A: Harvey Elliott
Q6 Name the former world heavyweight boxing champion who recently came out of retirement and defeated Joe Fournier in his comeback fight? A: David Haye
It’s now over 10 years ago when restaurants, reacting to the global financial crisis, started to pretend that slow-cooked pork belly is posh. And despite its subsequent ubiquity, it’s still pretty cheap. Unfashionable cuts of meat, like pork belly, which is otherwise destined to be turned into streaky bacon, are the saviours of restaurants that struggle to produce a cheap menu. Ham hocks become terrines, oxtails become stews, stringy bits of adolescent lambs become fragrant casseroles. Just look at the basic set menus in rural restaurants in Europe.
The timid home cook may well think that using anything less than chicken breasts or sirloin steak requires years of training and culinary skill. Nonsense. This is the stuff that sustained our forebears.
Way back in the 17th century, King Henry IV of France expressed the hope for his people that there would be “a chicken in every pot” and the US Republican party said the same thing in 1929 (throwing in an automobile in every backyard for good measure). Clearly a chicken was a bit of a luxury – and it was the same even in my 1960s childhood.
Nowadays, whole chickens are sold for frighteningly small sums and there are so many chicken breasts on the supermarket shelves you have to wonder where the rest of the animals go.
Before Irish pig production was turned into an intensive indoor industry, most country people fattened a pig through the year, feeding it scraps, and vegetable peelings, and windfall apples. It would be killed in the autumn; some of it would be eaten fresh and lot of the meat would be salted for
While food has never been so cheap and while we have never spent proportionally less of our income on food, or time preparing it, most of us are spending more than we need to. And this is because we are addicted to the more respectable cuts of meat, the convenience of processed or prepared foods, and, of course, waste. We buy far too much food.
Slow cooking
Frugality in food is not just a way of saving money, it’s also a way of eating better. The simple fact is that many of the great dishes of the world are, essentially, the food of the poor. Or of the thrifty. Most of them involve something for which we have lost our appetite: Long, slow, gentle cooking.
This is the age of the stir-fry, the dish that can be thrown together in minutes and eaten with a fork in front of the television. And that’s not going to work with frugal food.
bacon and ham to keep. The tradition goes on in parts of France and Spain where they boast that they use every part of the animal “except the squeak”.
In just a generation or so, we found ourselves eating only the expensive bits: The fillet, the legs, the loin chops, turning up our newly urbanised noses at anything more earthy. Perhaps this is part of the collective hangover from the Great Famine; maybe we don’t like to be reminded of hard times?
Shin beef and beef cheeks start out as tough as shoe leather, but they have fantastic flavour and a certain amount of gelatine, which gives a lovely sheen to a casserole. That is provided you cook it slowly for twoto-three hours. But it can be hard to find, and I’ve never seen it in a supermarket. And most butchers turn it into mince, so you may have to ask.
Lap of lamb is that thin flap of meat that was once the animal’s abdomen and it’s the only bit of lamb that can claim to be cheap. All you have to do is to spread the surface of the meat with a mixture of stale breadcrumbs, herbs and garlic moistened with
some milk, roll it up and roast it slowly for about an hour and a half. The fat will have melted and drained away and you’re left with a lovely crisp, but succulent roast. That will comfortably feed two hungry people.
Rillettes of pork are vastly popular in France, so why not here? Perhaps it has something to do with the ridiculous demonisation of good, unprocessed fat, which comprises at least half of good rillettes. A rillettes is, simply, pork cooked with sea salt, black pepper, and a bay leaf or two until it’s very tender and can be pulled into strands, put into little pots and topped with its own fat. You simply spread it on toast or crusty bread and eat it, the French manner, with some crunchy, sharp cornichons.
All you need is a piece of belly pork without any rind. Cut it into chunks, put it in a pan, and then into the oven. Add plenty of crushed black pepper, a bay leaf or two and some salt, plus enough water just to cover the bottom of
the pan. Put on the heat and when the water starts to boil put the lid on and transfer to the oven. Cook at gas mark 2/150ºC for two hours or until the meat is very, very tender and most of the fat has melted.
Now pull the meat apart with a couple of forks so that you have a mass of strands. Spoon these into small jars or ramekins and pour over the molten fat to form a generous layer on top. Set aside to cool and store in the fridge. Use within a week or freeze.
To be properly frugal, you could always cook something else in the oven with your rillettes and I’d suggest a proper Bolognese ragù – not the usual travesty that comes under this much abused name. And remember, as the late Paolo Tullio used to say, it’s a meat sauce with a little tomato, not the other way round. Cooked at a low heat in a casserole for two or three hours, it’s transformed. I often put ours in the bottom oven of the Aga for most of the day.
There’s nothing frugal with my wine choice this month, although I agree that it’s quite amazingly affordable. Bekaa Valley Édition
Limitée 2019 (€10.99, Aldi) is an absolute steal, very French in style, certainly containing Cabernet Sauvignon and, I’m guessing, some Syrah. In a sense, it’s like a red Bordeaux that has been subtly turbocharged. It cries out for red meat but, if flesh is not your thing, I’d suggest something suitably spiced in the way of aubergine. I had to pinch myself when I realised the price!
The simple fact is that many of the great dishes of the world are, essentially, the food of the poorTOM DOORLEY
Title: The Science of Happiness
Author: Prof Brendan Kelly
Publisher: Gill Books
Reviewer: George Winter
Decades ago, during an idyllic camping trip to Finland and Norway, my wife and I lost a purse. At Tromsø Police Station a smiling officer transcribed our statement into Norwegian; I signed it… then he guffawed: “Hjör! Hjör! Hjör!” We stared at him. “You’ve just sold me your house!” he exclaimed. Our laughter erupted, mine tempered with relief that he was only joking. So, Prof Brendan Kelly’s citing of peer-reviewed studies showing that the Finns and Norwegians are among the five happiest nations in the world confirms my own experience.
Prof Brendan Kelly
But… the science of happiness? Conceding the subjective nature of happiness, Prof Kelly explains that his book “recruits the happiness science of the past few decades” to answer questions like “[i]s there a single set of guidelines, core principles or essential strategies that I can recommend to people who come to see me and apply in my own life so as to increase happiness, wellbeing, and satisfaction”? The author’s interest was also sharpened when in 2020, with his 47th birthday approaching, Prof Kelly learned of multiple worldwide studies reporting that “47 is the age of minimum wellbeing and maximum unhappiness on planet earth”. At least one reader, well past 47, is always reassured to hear Otis Clay’s, The Only Way is Up (1980).
Written in two parts, the first – ‘The Science of Happiness’ – considers ‘Who
we are’, ‘What we do’, and the ‘Six principles of a happy life’; and the second – ‘Strategies for Happiness’ – offers reflections on sleep, dreaming, diet, movement, doing, social connections, and losing oneself.
Thus far, I have had a life blessed with good health and good luck. But an unsettling thought arose as I began to read: Might this book prompt uneasy comparisons of my own life with Prof Kelly’s happiness-related principles and strategies, raising uncomfortable questions?
The answer, I am pleased to say, was yes. This well-written, thought-provoking,
and entertaining exploration of happiness-related research, afforded opportunities to examine my flaws, provided insights into their nature, and suggested possible means of amelioration. To take two (of many) examples; first, the role and relevance of dreams had passed me by (no; I had ignored them), and I shall follow up interesting evidence supporting Prof Kelly’s comment that “[w]e do not dream enough and we do not sufficiently value our dreams”. Second, the merit of social connections outlined by the author chimes with my wife’s view that I could benefit from relationships
not only with books, but with other people. Both he and she are right. Further, the ‘Connecting in the time of Covid-19’ section offers a timely perspective on human bonding.
I heartily agree with Kelly’s highlighting of the value of sleep (our bedtime is typically around 21.30), cats, gratitude, and other contributory factors to happiness. So too, losing oneself; but whereas the author got enjoyably lost in nighttime St Petersburg, I achieved it in broad daylight in what was then Leningrad, intrigued at the diverse ways in which tins of Soviet provender could be stacked in the windows of department stores. I largely share Kelly’s views on exercise, and I guess he too would endorse Rebecca Solnit’s view in Wanderlust: A History of Walking (2000) that walking is a state in which mind, body, and the world “are aligned, as though they were three characters finally in conversation together, three notes suddenly making a chord”. But even writing this while nursing an inflamed Achilles tendon, I maintain that my decades-long love of long-distance cross-country running has brought me much happiness, though admitting that immoderate bouts of strenuous activity don’t necessarily confer favours on one’s physiology. And even as I mounted my dietary high horse to demur at some of the author’s views, I was pleased with his welcome assertion that “[o]ther neglected nutrients that can help boost mental wellbeing include iodine, magnesium, and – of all things –cholesterol”, adding that dietary cholesterol “is necessary for brain health”. In presenting a science of happiness, Prof Kelly’s thoughts on meditation, mindfulness, and belief necessarily approach a boundary with philosophy, a discipline that he is clearly comfortable with. So, is happiness necessary for a well-lived life? For example, we have this Shavian assertion in Man and Superman (1903): “A lifetime of happiness! No man alive could bear it: It would be hell on earth.” And might happiness, if uninterrupted, confer an immunity to failure, denying opportunities to learn from our mistakes? In her Ideals and Illusions (1941), philosopher Susan Stebbing contemplates “the pursuit of happiness” as voiced in the American Declaration of Independence (1776). She suggests that although the ideal was fine as a principle, it had not been translated into practice, citing Clive Bell’s view that all civilisations have stood on inequality. As a result, Stebbing considers that “it was unquestioningly taken for granted that the sort of happiness appropriate to the one must for ever remain out of the reach of the other”.
My understanding of what it means to be alive is enriched by The Science of Happiness , and Prof Kelly must now order a supply of his favoured chocolate brownies and begin work on The Philosophy of Happiness
This well-written, thought-provoking, and entertaining exploration of happinessrelated research, afforded opportunities to examine my flaws, provided insights into their nature, and suggested possible means of amelioration
ASTELLAS’ AND PFIZER’S XTANDI (ENZALUTAMIDE) REDUCED RISK OF DEATH BY 34 PER CENT IN MEN WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER IN PHASE 3 ARCHES STUDY
Astellas Pharma and Pfizer announced ahead of the European Society for Medical Oncology (ESMO) Congress 2021 that Xtandi (enzalutamide) improved overall survival (OS) in the ARCHES study in men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer). The phase 3, randomised, double-blind, placebo-controlled trial compared Xtandi plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with mHSPC, and OS was a key secondary endpoint.
In the study, Xtandi plus ADT reduced the risk of death by 34 per cent (n=1,150; hazard ratio [HR]=0.66; [95 per cent confidence interval [CI]: 0.53-0.81]; p<0.0001) compared to placebo plus ADT. Median OS, which represents the time from randomisation to death due to any cause, was not reached in either treatment group. The safety profile in both study arms was consistent with findings from the primary analysis.
Results from the final analysis of the ARCHES trial were presented virtually at ESMO by Prof Andrew Armstrong, MD, Professor of Medicine, Surgery, Pharmacology and Cancer Biology, and Director of Research in the Duke Cancer Institute’s Center for Prostate and Urologic Cancers in Durham, North Carolina, US.
“Overall survival benefit has been observed in patients treated with enzalutamide in three stages of advanced prostate cancer – metastatic castration-resistant prostate cancer, non-metastatic castration-resistant prostate cancer, and now in metastatic hormone-sensitive prostate cancer,” said Prof Arm-
strong. “The results from ARCHES provide valuable data on the clinical profile of enzalutamide in this earlier disease setting.”
The primary results from the ARCHES trial were published in the Journal of Clinical Oncology in 2019. The study met its primary endpoint of radiographic progression-free survival (rPFS) as assessed by independent central review, finding that treatment with Xtandi plus ADT demonstrated a 61 per cent reduction in the risk of radiographic disease progression or death compared with ADT alone in men with mHSPC (HR=0.39; [95 per cent CI: 0.30-0.50]; p<0.001). The median follow-up time was 14.4 months. Median rPFS was not reached (NR) with Xtandi plus ADT (95 per cent CI: NR to NR) versus 19.0 months (95 per cent CI: 16.6-22.2 months) with placebo plus ADT. At the time of the primary analysis, OS data were not mature.
In the ARCHES primary analysis, grade 3 or greater adverse events (AEs; defined as severe/disabling or life-threatening) were similar for patients receiving both Xtandi plus ADT and those who received placebo plus ADT (24.3 per cent vs. 25.6 per cent). Common
AEs (occurring in at least 5 per cent of patients) that were reported more often in patients treated with Xtandi plus ADT versus those treated with ADT alone included hot flush, fatigue, arthralgia, hypertension, nausea, musculoskeletal pain, diarrhea, asthenia, and dizziness. These data supported global regulatory approvals, including European Commission marketing authorisation for mHSPC earlier this year.
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that Tremfya (guselkumab), a first-in-class treatment for adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior dis -
IL-23 receptor. It is already approved for the treatment of patients with moderate to severe plaque psoriasis. IL-23 is an important driver of the progression of inflammatory diseases including psoriasis and PsA, among others.
PsA is a multifaceted, chronic, immune-mediated inflammatory disease that is progressive and is characterised by debilitating joint damage and inflammation, in addition to enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. The pain, stiffness, and swelling of the joints and connective tissue can be severe and cause everyday tasks to become difficult. In addition, more than half of people with PsA also live with another condition, such as cardiovascular disease, osteoporosis, inflammatory bowel disease or depression. There is currently no known cure for PsA and it is estimated that up to a third of the 14 million people living with psoriasis in Europe will go on to develop PsA.
The approval for this new indication was based on results from the DISCOVER-1 and DISCOVER-2 phase 3 clinical studies, which assessed safety and efficacy of guselkumab 100mg q4w and q8w in adult patients with active PsA. DISCOVER-1 evaluated 381 participants with active PsA who had an inadequate response to standard therapies, including participants (~30 per cent) previously treated with anti-tumour necrosis factor (TNF) alpha biologics. DISCOVER-2 included 739 patients who were biologic-naïve only and had an inadequate response to standard therapies. Data from these studies was published earlier this year in The Lancet (24-weeks; DISCOVER-1, DISCOVER-2).
Prof Doug Veale, Consultant Rheumatologist at St Vincent’s University Hospital, Dublin, welcomed the news stating: “The approval of reimbursement for guselkumab in Ireland is a significant advance in precision medicine for patients who suffer from psoriatic arthritis and plaque psoriasis. Guselkumab targets a new pathway that is specific to these conditions.”
“We are excited to take another important step forward in further developing guselkumab as a significant therapy for plaque psoriasis and now psoriatic arthritis. We hope to be able to bring this anti-IL-23 therapy to many more patients with immune-mediated diseases.”
The published results show that in both studies, at week 24, adult patients with active PsA achieved statistical significance in the primary endpoint of American College of Rheumatology (ACR) 20 per cent improvement (ACR20) response (DISCOVER-1: p<0.001; DISCOVER-2: p<0.001) in both q4w and q8w guselkumab groups (DISCOVER-1: n=255; DISCOVER-2: n=493) vs the placebo groups (DISCOVER-1: n=126; DISCOVER-2: n= 246).
In addition, significant improvements in quality of life scores (36-item short-form [SF36] physical component summary) were observed in the guselkumab groups vs the placebo groups in DISCOVER-1 (p<0.001 for both doses); in DISCOVER-2, significant improvements were observed in the q4w guselkumab group vs placebo group (p=0.0056 [q8w, p=0.068]).
In DISCOVER-2, inhibition of structural damage progression was measured radiographically and expressed as the mean change from baseline in the total modified van der Heijde-Sharp (vdH-S) score. At week 24, the guselkumab q4w group demonstrated statistically significantly less radiographic progression (p=0.006) and the guselkumab q8w group showed numerically less progression than placebo (p=0.068).
At week 52, the mean change from baseline in total modified vdH-S score was similar in the guselkumab q8w and q4w groups (mean scores of 0.97 and 1.07 respectively).
JAMA DERMATOLOGY PUBLISHES DATA SHOWING UPADACITINIB ACHIEVED SUPERIORITY VERSUS DUPILUMAB FOR PRIMARY AND ALL RANKED SECONDARY ENDPOINTS IN PHASE 3B HEAD-TO-HEAD STUDY IN ADULTS WITH ATOPIC DERMATITIS
JAMA Dermatology has published 24-week results from the phase 3b Heads Up study evaluating the efficacy and safety of upadacitinib (30mg, once daily) versus dupilumab (300mg, every other week) – both as monotherapy treatments – in adults with moderate to severe atopic dermatitis who were candidates for systemic therapy.
The publication showed upadacitinib (30mg, once daily) achieved superiority compared to dupilumab for the primary endpoint, the proportion of patients with at least a 75 per cent improvement in the Eczema Severity Index (EASI 75) at week 16.
Of those treated with upadacitinib, 71 per cent achieved EASI 75 at week 16 compared to 61 per cent of those treated with dupilumab. Additionally, upadacitinib demonstrated statistically significant greater efficacy across all ranked secondary endpoints compared to dupilumab through week 16, including early reduction in itch and rates of skin clearance improvement.
Prof Brian Kirby, Consultant Dermatologist at St Vincent’s University Hospital, Dublin, who was an investigator in this study, said: “It was welcome that an Irish centre had the opportunity to participate in one of the first head-to-head studies in atopic dermatitis. Not only does this study greatly add to our understanding of this disease and its treatment, but Irish patients got the benefit of access to treatments they would not have otherwise had.”
Results for select ranked secondary endpoints include:
p<0.001), compared to 8 per cent and 39 per cent, respectively, of those treated with dupilumab.
The recommended dose of upadacitinib for atopic dermatitis is 15mg or 30mg once daily based on individual patient presentation.
• A dose of 30mg once daily may be appropriate for patients with high disease burden.
• A dose of 30mg once daily may be appropriate for patients with an inadequate response to 15mg once daily.
• The lowest effective dose for maintenance should be considered.
• For patients ≥65 years of age, the recommended dose is 15mg once daily.
The safety profile of upadacitinib in Heads Up was consistent with what was observed in the phase 3 pivotal studies, Measure Up 1, Measure Up 2, and AD Up. Through week 16, the most common adverse events were acne (15.8 per cent) for the upadacitinib group and conjunctivitis (8.4 per cent) for the dupilumab group.
Serious adverse events occurred in 2.9 per cent of those receiving upadacitinib and 1.2 per cent of those receiving dupilumab.
ease-modifying antirheumatic drug (DMARD) therapy, has been granted reimbursement in Ireland.
Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the
“Today’s approval marks an exciting breakthrough for patients in Ireland as we continue to reimagine what is possible in how diseases like active psoriatic arthritis are understood and treated,” said Dr Thorsten Giesecke, General Manager Commercial Business, Janssen
In addition, higher Psoriasis Area and Severity Index 75 per cent improvement (PASI 75), PASI 90 and PASI 100 response rates were observed in the q4w and q8w guselkumab groups vs the placebo groups (in DISCOVER-1, all unadjusted p<0.001 with PASI 100 being p=0.0005 and in DISCOVER-2, all unadjusted p<0.001).
In both studies, guselkumab was well-tolerated, and observed adverse events (AEs) were generally consistent with previous studies of guselkumab and current prescribing information.
• After one week of treatment, the upadacitinib 30mg treatment group had a 31 per cent reduction in itch (as measured by Worst Pruritus Numerical Rating Scale [NRS]) compared to 9 per cent in the dupilumab group (p<0.001).
• After two weeks of treatment, 44 per cent receiving upadacitinib achieved EASI 75 versus 18 per cent receiving dupilumab (p<0.001).
• At 16 weeks, 28 per cent of people treated with upadacitinib achieved clear skin (EASI 100; p<0.001) and 61 per cent achieved almost clear skin (EASI 90;
Serious infections were numerically higher in upadacitinib group, although at generally low levels (1.1 per cent in those who received upadacitinib and 0.6 per cent in those who received dupilumab). One treatment-emergent death due to bronchopneumonia associated with influenza A occurred in a patient who received upadacitinib. No malignancies were reported in the upadacitinib group; one non-melanoma skin cancer was reported in the dupilumab group. No major adverse cardiac events or venous thromboembolic events were reported in either treatment group.
In the placebo-controlled atopic dermatitis clinical trials, the most commonly reported adverse reactions of patients with upadacitinib 15mg or 30mg were upper respiratory tract infection, acne, herpes simplex, headache, CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza.
Up to 6 sessions per week with days negotiable. Flexible, friendly, computerised practice that aims to keep patient safety and to provide a caring and supportive work environment at its core.
Working with three other doctors, two practice nurses, three administration staff. 15-minute appointments. 30 minutes from Cork City. No house calls/nursing homes/admin. There would be an OOH commitment of approximately two evenings per month and four weekends per year.
Please contact Dr Mark Buckley mark_f_buckley@hotmail.com or 086 025 6001
(Full-time/sessions also available)
Riverwest Medical, Foynes, Co Limerick are looking for a GP to join our practice. We are a two GP practice and we are supported by an excellent nursing and administration team. We are fully computerised and our appointments are 15 minutes. We have an excellent package, paid professional indemnity, and there is no out-of-hours commitment.
Starting date is negotiable and we can accommodate a future start date for those in a current role.
Please contact us at dreileen@riverwest.ie or call Eileen on 087 296 6970 to arrange a meeting. See our website on www.riverwest.ie
Large mixed GMS/private practice Newcastle West, Co Limerick seeking a GP assistant to join our team. Initially for 6-7 sessions. Negotiable.
Fully computerised Health One and excellent practice nurse and clerical support.
No out-of-hours commitment.
Excellent renumeration.
Please contact via email aggykelly@hotmail.com for further queries
GP opportunity to take over a thriving rural practice in West Limerick. Full rural practice allowance, purpose-built premises, computerised, full ancillary staff, appointment only, no on-call commitment, thirty minute drive to nearest university. This is a two-doctor practice. We are prepared to work part-time, to ease transfer. Very favourable terms for suitable candidate/s. Contact 087 253 2584 or email catgercorrigan@yahoo.com
Cara Medical Centre, Newcastle West, Co Limerick are looking for a GP to join our practice, ideally for six sessions per week initially, open to negotiation.
We are a two GP practice and we are supported by an excellent nursing and administration team.
Fully computerised Health One software. Large mixed GMS/ private practice.
No out-of-hours commitment. Excellent renumeration. Please contact with your interest/CV to caramedical@gmail.com
Well-established GP practice requires a GP for 6+ sessions per week with a view to full-time employment in Donegal Town. Group practice/fully computerised/full ancillary staff. Email enquires to millrowfamilypractice@gmail.com
Vocationally trained GP required for Sutton Cross Surgery. 4–6 sessions. Flexible, friendly, coastal, Dublin teaching practice with a mix of GMS/private patients. We are fully computerised using Health One software and 15-minute appointments. Supported by excellent nursing and administrative staff. An attractive package is available for suitable candidates. Enquiries or CVs to manager@suttoncrosssurgery.ie or 01 8326438
GP assistant, vocationally trained required. Excellent remuneration, Health One System, Indemnity paid, secretarial and nursing supports. North Cork, 30 mins Killarney and Mallow. 60 mins Cork City.
Contact Dr Leader on 087 255 0503
Part-time practice nurse required in a busy GP practice in Stillorgan, Co Dublin for 3 sessions per week. Previous general practice experience desired, but not essential. Standard practice nurse duties. Negotiable sessions.
Please email michellehalpin1@hotmail.com to apply
Practice Nurse sought for Bayview Medical, Killiney Shopping Centre, Killiney, Co Dublin as soon as possible. Experience in Practice Nurse duties such as phlebotomy, childhood vaccinations, smear-taking ideal; other clinical skills very welcome. We are looking for a person who is flexible and an ability to work as part of a team. Generous remuneration. Interested applicants please contact sconroymedical@gmail.com with your CV
Medium sized private and GMS single-handed practice in Carrick-on-Suir, Co Tipperary is looking for a qualified GP to join in a shared/flex contract with eventual take over of the practice.
If interested, please contact 087 262 5349 or email drtimod@eircom.net
Principal retiring shortly
South African trained GP available for the months of November and December for ad hoc locums
Do you have a short term locum need this Winter?
087 758 4592 or graham.cosgrave@matchmedics.com
Choose your… Location in the Northeast Daytime/out-of-hours work Hours/shifts in out of office hours – evenings, weekends, overnight Short-/Long-term placements
INTERESTED?
Get in touch to discuss your options.
Call: 046 924 1533
Email: info@medsource.ie Website: www.medsource.ie
Applications are invited for the Basic Specialist Training Deaneries accredited by the College of Psychiatrists of Ireland. Details of the individual Deaneries and how to apply are available on the College’s website
www.irishpsychiatry.ie
Trainees who successfully complete the BST programme will be automatically eligible for Higher Specialist Training in Psychiatry. The Competition will open for applications on Friday 29th October and will close on Thursday 2nd December.
Shortlisting will apply and will be based on information supplied by applicants on their application form. Successful applicants must be entered on the Trainee Specialist Division of the Medical Register maintained by the Medical Council of Ireland by 11th July 2022 to take up their appointment.
Shortlisted candidates will be interviewed in January 2022
To advertise, email Louis at louis@mindo.ie
On the Medical Council of Ireland’s “Your Training Counts” National Trainee Survey, training in Psychiatry has received the highest D-RECT score (overall Trainee satisfaction) for the last two years.
A round-up of news and oddities from left field by Dr Doug Witherspoon
This issue's offering compiles for you a round-up of some of the more unusual research and strange events that have transpired in recent weeks. Our world is only partially recognisable from what it was like 18 months ago, but strangeness remains a constant. We begin with research that was first published in the Journal of Personality in 2018, but received more widespread attention recently and just might help you to identify some of the narcissists in your world simply by their eyebrows.
The work, titled 'Eyebrows cue grandiose narcissism', points
out that while the typical narcissist initially presents as warm and charming, there are red flags for the observant among us that can help us to give them a wide steer.
The identification of narcissists' appearance, including their faces, has been established by prior research, but the authors wanted to drill a little deeper. Specifically, they looked at "which facial features underlie perceptions of grandiose narcissism and how they convey that information".
During the course of their studies, eyebrows jumped out as an important identifying factor to help identify grandiose nar-
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cissism. "We explored the face's features using a variety of manipulations, ultimately finding that accurate judgments of grandiose narcissism particularly depend on a person's eyebrows," they wrote. They studied the basic appearance of eyebrows in this regard, including thickness and density, and conducted further studies to measure how participants' perceptions of narcissism changed when swapping narcissists' and non-narcissists' eyebrows between faces. A kind of scientific version of Mr Potato Head, if you will. "Eyebrows can enhance and diminish perceptions of narcissism, further implicating the brows’ role in narcissism perceptions," they wrote. This was based on eyebrows being the most expressive feature of the face: "Given that narcissists often behave aggressively in sexual competition and typically enjoy success in securing short-term sexual partners, their grandiose eyebrows could signal this prowess to others (Campbell & Campbell, 2009). It thus makes sense that narcissists might selectively alter their brows to appear more attractive."
A word of sympathy to the heart surgeon in Birmingham, UK, who had his precious surgical eye-glasses stolen. Mr Stephen Rooney of the Queen Elizabeth Hospital had his loupes stolen from his car, which was parked outside the hospital. A police campaign was launched to appeal for their return, explaining that only a few companies worldwide make these glasses and a replacement would take six weeks to acquire.
the woods. And yes, he'd had a few drinks.
Fifty-year-old Beyhan Mutlu went drinking with his friends, but subsequently became lost in the woods. His concerned wife raised the alarm and a search party was formed. Mr Mutlu saw them and did the right thing by joining the group, unaware that they were looking for him. All became clear as the rescue workers eventually began shouting his name in desperation after several hours, to which he simply replied from the back, "I'm here."
Perhaps it's true – maybe a long walk in the woods does help you to truly find yourself.