The Medical Independent 27 January

Drinking in the pandemic

David Lynch examines the impact that the Covid-19 pandemic has had on alcohol use and policy changes affecting the area

Slowly introducing ABF

PAGE 10

HRB clinical trials funding decision could lead to ‘inequity’ for West

PAUL MULHOLLAND

The failure of recent applications by Saolta University Health Care Group and University Hospital Limerick (UHL) to receive Health Research Board (HRB) infrastructural funding for cancer clinical trials could lead to an “inequity” for patients in the West of Ireland, heard a meeting of the National Cancer Control Programme (NCCP) in September.

Last month, when announcing cancer clinical trial funding awards, the HRB stated that Saolta and UHL would receive grants to “enable and enhance their cancer clinical trials capacity and capability over the next 15 months”.

The HRB’s outcome summary report, seen by the Medical Independent (MI), outlined that an advisory panel of international experts did not recommend infrastructural funding for the cluster/group proposals submitted by Saolta and UHL. Feedback from the international panel

showed there were “a number of issues at these sites that need to be developed, clarified and progressed”, according to the summary.

“However, the panel recommended that funds be provided to these sites to enable them to enhance their cancer clinical trials capacity and capability.”

The issue was discussed by the NCCP’s executive management committee before the HRB’s formal announcement.

The decision not to award clinical trial funding to the Saolta and UHL applications could lead to “inequity in cancer care” as patients within the region “will not be offered clinical trials, which are standard of care in medical oncology”, according to minutes of the September meeting, obtained by MI through Freedom of Information law.

Both Dr Maccon Keane, National Clinical Lead for Medical Oncology; and Saolta representatives, were due to discuss the issue with the HRB.

A vocal minority Dr Neil Black speaks with Pat Kelly about his experiences in the Irish Doctors Choir

PAGE 14

Vimovo® is indicated in adults for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID) -associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.1

The October meeting minutes also stated: “There is an anomaly where a region of the country may not have access to clinical trials.”

On 16 December, the HRB announced support for six cancer clinical trials groups and an overarching national cancer clinical trial network.

“This increases our investment in cancer clinical trials infrastructure each year by more than half a million to €4.27 million, making the HRB the lead public funder of cancer clinical trials infrastructure in Ireland,” it outlined.

The successful applicants were Children’s Health Ireland/University College Dublin (UCD); Beaumont Hospital, Dublin/RCSI; the Irish Research Radiation Group/Trinity College Dublin (TCD); University College Cork; Ireland East Hospital Group/UCD; and the Trinity Academic Group/TCD.

The national cancer clinical trial network award will be led by Prof Ray McDermott, Chief Scientific Investigator, Cancer

HSE seeks external coaching service

PAUL MULHOLLAND

The HSE is looking to put in place a “framework-type agreement” for an external coaching service for senior management.

The tender is divided into two separate lots, the first of which relates to the coaching of executive management. The second lot pertains to the coaching of senior management and other staff.

The aim is to have a panel of 20 coaches for each lot, from which staff who have budgetary provision to avail of the service can select their own coach.

The tender document states that individual coaching aims to support development and change; sustain changes that are discussed in the coaching sessions; and increase confidence to manage and enhance their role.

With regards to team coaching, the document says the benefits include improving communication, increasing employee engagement and strengthening morale.

The external suppliers are intended to provide additional support to the HSE’s own national coaching service.

“A key objective of coaching in the HSE is to develop high performing individuals across the organisation,” according to the tender.

“Coaching will support individuals to overcome challenges which they face in their job. It will also support learning and development opportunities within the organisation.”

The tender notes the HSE has a limited budget available for this project.

The College of Anaesthesiologists of Ireland National Patient Safety Day and KP Moore Medal Competition in Patient Safety 2021 took place on Friday 12 November. Pictured is Dr Mai O’Sullivan, KP Moore Medal Winner 2021. See full gallery on P34-35

Trials Ireland, and hosted by RCSI. In 2020, the HRB launched an open call to shape its investment in cancer clinical trials in Ireland over the next five years.

Legal Category: S1A. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com

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

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

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

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

PP-XEL-IRL-0668

Date of preparation: September 2021

David Coleman – Bobby Studio

Paul Mulholland reports on challenges implementing activity-based funding in Irish healthcare

Lipocomb

GET LOWER

ESC TREATMENT TARGETS1

CV risk LDL-C target

High** <1.8mmol/L

Very High* <1.4mmol/L

Lipocomb® (rosuvastatin (as zinc)/ezetimibe) Abbreviated Prescribing Information: Please refer to the Summary of Product Characteristics before prescribing. COMPOSITION* Lipocomb 10 mg/10 mg: hard capsule containing 10 mg rosuvastatin (as zinc) and 10 mg of ezetimibe. Lipocomb 20 mg/10 mg: hard capsule contains 20 mg rosuvastatin (as zinc) and 10mg of ezetimibe.

INDICATIONS*As adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. DOSAGE AND ADMINISTRATION*

Recommended daily dose is one capsule of the given strength with or without food. Lipocomb 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. Lipocomb 10 mg/10 mg and 20 mg/10mg hard capsules are not suitable for the treatment of patients requiring 40 mg dose of rosuvastatin. Children and adolescents: < 18 years should not be used. Elderly (age>70 years), moderate renal impairment (Clcr < 60 ml/min), race (Asian ancestry) and predisposing factors to myopathy: Start dose of 5 mg rosuvastatin is recommended. Mild to moderate renal impairment: no dose adjustment. Severe renal impairment (Clcr <30 ml/min): contraindicated. Hepatic impairment: Mild hepatic impairment (Child Pugh score 5 to 6): no dose adjustment. Moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction: not recommended. Active liver disease: contraindicated. Genetic polymorphisms: a lower daily dose is recommended. Co-administration: contraindicated with ciclosporin, not recommended with combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir (full list in section INTERACTIONS* below). CONTRAINDICATIONS* Hypersensitivity to the active substances (rosuvastatin, ezetimibe) or to any of the excipients, active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN), during pregnancy and breast-feeding and in women of childbearing potential not using appropriate contraceptive measures, severe renal impairment (creatinine clearance <30 ml/min), myopathy, concomitant ciclosporin. (see WARNINGS* INTERACTIONS* and PROPERTIES*). WARNINGS *Skeletal Muscle

Effects: Stop treatment if muscular symptoms with elevation of CK level > 5 xULN occur or if muscular symptoms are severe and cause daily discomfort (even if CK levels are ≤ 5 x ULN). Caution should be exercised when Lipocomb is used with fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics. Increased risk of myopathy with concomitant use of gemfibrozil. Co-administration with gemfibrozil is not recommended. Co-administration with systemic formulations of fusidic acid or within 7 days of stopping the treatment is not recommended. If the use is essential, Lipocomb

should be discontinued during fusidic acid treatment. Liver effects: Liver functions tests should be carried out 3 months following the initiation of rosuvastatin treatment. Stop treatment or reduce the dose if jaundice, hepatitis or marked elevation of hepatic enzymes (serum transaminases exceeding 3 times the upper limit of normal). Lipocomb use is not recommended in patients with moderate to severe hepatic impairment. Renal effects (proteinuria): Monitoring by dipstick testing recommended for patients treated with higher doses of rosuvastatin, in particular 40 mg. Race: Lipocomb may cause an increase in exposure in Asian subjects compared with Caucasians. Protease inhibitors: Concomitant use with certain protease inhibitors is not recommended unless adjustment. Interstitial lung disease: If suspected, treatment should be discontinued. Diabetes mellitus: Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI > 30 kg/m2, raised triglycerides, hypertension) should be monitored. Fibrates: If cholelithiasis is suspected in case of concomitant use with fenofibrate, treatment should be discontinued. Anticoagulants: If Lipocomb is added to warfarin, another coumarin anticoagulant, or fluindione, the INR should be appropriately monitored. Ciclosporin: Lipocomb is contraindicated in patients receiving concomitant ciclosporin. Paediatric population: not recommended in children < 18 years. Liver disease and alcohol: Use with caution in patients who consume excessive quantities of alcohol and/or have history of liver disease. INTERACTION(S)*Contraindicated: Ciclosporin. Not recommended combinations: protease inhibitors (e.g.atazanavir / ritonavir), transporter protein inhibitors (hepatic uptake transporter OATP1B1 / efflux transporter BCRP), gemfibrozil and other lipid-lowering products (fibrates and niacin(nicotinic acid)), fusidic acid. Precautions: Antacid, erythromycin, cytochrome P450 enzymes(inhibitor / inducer), vitamin K antagonists (e.g. warfarin or another coumarin anticoagulant), oral contraceptive/hormone replacement therapy (HRT), colestyramine, statins (atorvastatin, simvastatin, pravastatin, lovastatin, fluvastatin or rosuvastatin), other medicinal products(dapsone, dextromethorphan, digoxin, glipizide, tolbutamide, midazolam, cimetidine). PREGNANCY AND BREASTFEEDING*: Lipocomb is contraindicated in pregnancy and breastfeeding. FERTILITY* CONTRACEPTION* Women of childbearing potential should use appropriate contraceptive measures. DRIVE & USE MACHINES* Dizziness may occur. UNDESIRABLE EFFECTS* Common: Diabetes mellitus, headache, dizziness, constipation, nausea, abdominal pain, diarrhoea, flatulence, myalgia, asthenia, fatigue, ALT and/or AST increased. Uncommon: Decreased appetite, paraesthesia, hot flush, hypertension, cough, dyspepsia, gastrooesophageal reflux disease, dry mouth, gastritis, pruritus, rash, urticaria, arthralgia, muscle spasms, neck pain, back pain, muscular weakness, pain in extremity, chest pain, pain, oedema peripheral. Rare: Thrombocytopenia, hypersensitivity reactions including angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, lupuslike syndrome, muscle rupture. Very rare: Polyneuropathy, memory loss, jaundice, hepatitis, arthralgia, haematuria, gynecomastia. Not Known: Hypersensitivity

(including anaphylaxis and angioedema), depression, peripheral neuropathy, sleep disturbances (including insomnia and nightmares), dyspnea, cholelithiasis, cholecystitis, Stevens Johnson syndrome, erythema multiforme, immune-mediated necrotising myopathy, tendon disorders, sometimes complicated by rupture. OVERDOSE*. PROPERTIES* Rosuvastatin is a selective and competitive inhibitor of HMG CoA reductase, the rate-limiting enzyme that converts 3-hydroxy3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. Ezetimibe is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol and related plant sterols. PRESENTATION* Packs of 30hard capsules. Marketing Authorisation Holder: EGIS Pharmaceuticals PLC, Kereszturi ut 30-38, H-1106 Budapest, Hungary. Marketing

Authorisation Number: PA1470/004/001-

002. Legal Classification for Supply: POM. Local Representative in Ireland: Servier Laboratories (Ireland) Ltd, Second Floor, 19 Lr. George’s Street, Dun Laoghaire, Co. Dublin A96 ER84, Ireland. Tel (01) 6638110, www.servier.ie.

*For complete information, please refer to the Summary of Product Characteristics available on www.medicines.ie

Date of last revision of the text: June 2021 (Date of last approved

SmPC: March 2019) Date of Preparation September 2021, 2122 C1 LCB Press Ad CBU.

* For complete information, please refer to the complete Summary of Product Characteristics for Lipocomb® at www.hpra.ie

1. Mach et al. 2019 ESC/EAS Guidelines for the Management of Dyslipidaemias, European Heart Journal (2019) 00, 1-78’ * Patients with: documented CVD, Diabetes Mellitus with organ damages, Severe CKD (chronic kidney disease), a calculated 10 year risk of fatal CVD ≥ 10%, Familial Hypercholesterolaemia with CVD/risk factor. **Patients with: Markedly elevated single risk factors (in particular cholesterol > 8mmol/L or BP ≥ 180/110 mmHg), Familial Hypercholesterolaemia, Diabetes Mellitus, Moderate CKD (chronic kidney disease), a calculated 10 year risk of fatal CVD ≥ 5% and <10%.

Get your patient’s LDL-C down even lower to <1.8mmol/L1

Weekly ‘low-risk’ alcohol guidelines to be reviewed

DAVID

LYNCH

A review and update of the weekly low-risk alcohol guidelines is upcoming and changes in drinking patterns during the pandemic will inform the process, this newspaper has been told.

The weekly low-risk alcohol guidelines were last assessed in 2015 following a review commissioned by the HSE. The HSE Alcohol Programme has since been established and now oversees the guidelines.

“An implementation plan for the HSE Alcohol Programme is currently in development and will include an action to review and update the low-risk drinking guidelines,” a Department of Health spokesperson told the Medical Independent

The spokesperson added that the “pandemic has resulted in a significant shift towards home drinking”.

“The next review and update of the weekly low-risk

RCPI examining recognition of prior learning

CATHERINE REILLY

The RCPI is examining how recognition of prior learning “might apply in terms of access to training”, according to a spokesperson.

The College will be “examining this issue with an open mind and looking at best practice”. It will also work within the Forum of Irish Postgraduate Medical Training Bodies as “this area is common to all training bodies”.

The spokesperson was responding to a query from the Medical Independent (MI) on whether the College was examining any measures to recognise experience attained by non-EEA doctors in non-training NCHD roles, such that they may be eligible for accelerated basic specialist training (BST) programmes, for example.

Last September, Minister for Health Stephen Donnelly announced that all stamp 4 residency holders would be deemed equivalent to Irish/EU and UK nationals in the application process for postgraduate medical training posts. Previously only limited categories of stamp 4 holders were deemed equivalent in the application process and most non-EEA doctors had minimal chances of gaining a place.

In December, MI exclusively reported that Tánaiste Leo Varadkar planned to change the employment permit rules to allow non-EEA doctors apply for stamp 4 after only two years, compared to five years currently.

Typically, international doctors with stamp 4 have worked in Irish hospitals for several years in non-training roles. Many hold memberships of postgraduate colleges in Ireland and the UK.

In recent years, at least one faculty in RCPI granted exemptions to BST for doctors who had worked in non-training scheme roles on the condition of certain requirements being met. However this process was stopped without explanation, doctors previously informed MI

According to the RCPI, it “continually advocates” for doctors in terms of training and support. “The College has made RCPI educational resources available in a structured manner to non-training scheme doctors. This allows the NCHDs access to the mandatory training courses within their specialty and will meet some of their requirements if they wish to submit an application to the Medical Council for the specialist division of the register.”

The College was not developing an alternative pathway for certification of training by NCHDs in non-training roles.

alcohol guidelines will need to take cognisance of these changed drinking patterns and national and international literature.”

The current recommended weekly low-risk alcohol guidelines are less than 11 standard drinks for women and 17 standard drinks for men. A standard drink in Ireland includes a pub measure of spirits (35.5ml), a small glass of wine (12.5 per cent volume), and a half pint of ‘normal beer’. A bottle of 12.5 per cent alcohol wine has about seven standard drinks.

According to the Healthy Ireland Survey 2021, which was published last month, 42 per cent of drinkers stated they were drinking less. Binge drinking had reduced to 15 per cent of the population as compared to 28 per cent before the pandemic.

However, 44 per cent of respondents reported that their drinking had not changed during the pandemic and 13 per cent reported they were now drinking more.

Minimum unit pricing for alcohol was introduced earlier this month. See news feature, p4-5.

The RCPI, Dublin

DAVID LYNCH david@mindo.ie

Drinking patterns in the pandemic

David Lynch examines the impact that the Covid-19 pandemic has had on alcohol use and policy changes affecting the area, such as the recent introduction of minimum unit pricing

The State’s public health strategy for drug use, including alcohol, was published in July 2017. The authors of Reducing Harm, Supporting Recovery: A health-led response to drug and alcohol use in Ireland 2017–2025 could not have foreseen the pandemic and the massive repercussions Covid-19 has had on alcohol use in Ireland.

Since March 2020, pubs, restaurants, and nightclubs have been placed under various levels of stringent public health measures, including a period of more than 500 days between 2020-21 when they were entirely shut. Currently, at the time of writing, pubs and restaurants must close at 8pm.

The disruption to the nation’s drinking habits is unprecedented.

What this has meant for alcohol consumption and all its current and future ramifications for health is still being worked out.

The “clear and obvious impact” of the Covid-19 pandemic on alcohol use

“has been a further shift from on-trade alcohol use, such as pubs, clubs, and restaurants to home drinking purchased from the off-trade” in supermarkets, convenience stores, and neighborhood shops, Prof Frank Murray, Chair of the Alcohol Health Alliance and Consultant Gastroenterologist, told the Medical Independent (MI)

“In 2020, total alcohol consumption in Ireland fell by only 6 per cent despite the licensed premises being closed for 40 weeks,” he said. “Consumers have rediscovered the purchasing power of their euro, which is another good reason for the introduction of minimum unit pricing [MUP].” (See panel, p4).

A Department of Health spokesperson told MI that an upcoming review of the official “low-risk drinking guidelines” would note this “shift towards home drinking” and “take cognisance of these changed drinking patterns”.

According to the Healthy Ireland Survey 2021, published last month, 51 per cent of people indicated they drink more, smoke more, have gained weight or report a worsening in their mental health during the pandemic.

Some 42 per cent of drinkers stated they were drinking less, with binge drinking reduced to 15 per cent of the population as compared to 28 per cent pre-pandemic. Forty-four per cent of respondents said their drinking had not changed and 13 per cent said they were drinking more since Covid-19 appeared in our lives.

Parents of children aged under 18 were particularly likely to report an increase in

their drinking (16 per cent), with mothers (19 per cent) more likely than fathers (13 per cent) to be drinking more. But the majority of drinkers aged under 35 reported a decrease in their alcohol consumption. Of those drinking more during the pandemic, “the majority did not identify a need to reduce their alcohol consumption to improve their health and wellbeing,” noted the Department, which added that “depending on the extent of consumption increase, this is likely to be of concern”.

Dependence

Back in September 2020, GP Dr Garrett McGovern, founder of Priority Medical Clinic, Dublin, told MI the number of patients seeking treatment for alcohol dependence at his clinic had increased by 25 per cent during the early months of the pandemic. He said the rise in alcohol use was in response to Covid-19 and the lockdown meas-

ures and around 90 per cent of patients at the clinic were seeking treatment for problem drinking in the home.

“At first we didn’t see any increase, but lately we are seeing a number of cases caused by lockdown and a huge upsurge in drinking in the home,” Dr McGovern said in September 2020. He added that of those presenting for treatment, about 70 per cent were women and 30 per cent men.

Now over 16 months deeper into the pandemic, have these initial pandemic patterns continued?

“Interestingly, the trends have continued,” Dr McGovern told this newspaper. “In many ways the trends that occurred during the pandemic were there already pre-pandemic.”

He added that working from home has meant many people have started drinking earlier in the day.

“Pre-pandemic this would usually happen when people got home from work. But when they started to work from home it was not unusual to start drinking earlier in the day, sometimes as early as lunchtime,” he said.

“It was this change in drinking habits that was a warning flag [to patients] that maybe something was wrong and hence [they started] exploring treatment.”

Is increased drinking at home likely to continue for the foreseeable future, or will the ‘end’ of the pandemic halt this course?

“This is an excellent question and I am not sure I can answer it sufficiently as I am treating the people who presented for and started treatment, so the focus is addressing these issues,” said Dr McGovern.

“There are obviously many more people out there who are not receiving treatment

The introduction of minimum unit pricing

Minimum unit pricing (MUP) was introduced earlier this month as part of the Public Health (Alcohol) Act 2018. It sets a minimum price for off-trade alcohol. According to its supporters, its aim is to stop strong alcohol being sold at low prices in off-licences and shops.

However, the increase in prices has sparked significant opposition expressed on radio phone-in shows and national print media. One students’ union leader called MUP a “regressive measure” that could possibly increase the use of illegal drugs. Retailers have warned that people may travel north of the border to purchase cheaper alcohol (MUP has not yet been introduced in the North). Sinn Féin Health Spokesperson Deputy David Cullinane, and others, have criticised the Government for its failure to ring-fence VAT revenues from MUP for specific addiction services. Other critics have argued that there is evidence the measure will not reduce harmful drinking and that it hits the less well-off in society disproportionately.

If they continue working from home then it is likely the problem of earlier drinking will continue

Prof Frank Murray

and in those circumstances it is likely their problem drinking has escalated. If they continue working from home then it is likely the problem of earlier drinking will continue.”

However, he added if people whose problem drinking has escalated during the pandemic “are expected to return to work it is difficult to know what way that will go”.

“I have, for example, treated people in that situation who did return to work before I began to treat them and they started to secretly drink there [in work], hence another red flag that something was wrong.”

Emergency departments

The impact of the recent shift in drinking habits has also been experienced in the acute sector. In a 2017 statement, the Irish Association for Emergency Medicine (IAEM) noted that “those working in emergency departments (EDs) in Ireland witness at first hand the devastation caused to people’s lives through alcohol misuse”.

Dr Fergal Hickey, Consultant in Emergency Medicine at Sligo University Hospital and President of the IAEM, said there is anecdotal evidence of changes over the last couple of years.

“We do still see people with alcohol-related problems, but these were people who are drinking at home,” Dr Hickey told MI. “So we saw more domestic violence, we saw more people who live in the same house assaulting one another rather than down the town or on the street... more people falling down stairs. So there has been a change in pattern.”

He said patients were arriving “at different times of the day” with alcohol-related issues. “We weren’t getting them

However, while the public reaction to MUP may have been mixed, within medical circles there has been strong support.

Speaking last month, Dr Ina Kelly, IMO President and Specialist in Public Health Medicine, described it as “a really important public health intervention”.

Dr Kelly commented: “For many years along with other health colleagues the IMO has been advocating in favour of measures to reduce the level of alcohol consumption and binge drinking particularly among young people.” She added that she had “no doubt” that MUP “will save lives”.

Consultant Gastroenterologist

Prof Frank Murray told the Medical Independent it was his view that the criticism of MUP has been “largely motivated by unwillingness to accept that interventions and controls are required to reduce alcohol consumption to reduce alcohol harms”.

“This clash between progressive public health initiatives and vested interests is also going to be somewhat fraught.”

On arguments that the measure will have the greatest impact on people from lower socioeconomic groups, he said “MUP and indeed the wider set of measures within the Public Health

‘Effectiveness of one coherent voice’

While all the measures in the Public Health (Alcohol) Act have yet to be enacted, some have come into effect. These include the establishment of enclosures for alcohol in mixed sale shops in late 2020 and now the introduction of MUP. There has been strong and active support for the Act within Irish medicine going back over seven years. However, in 2017, the Medical Independent (MI) reported on concerns raised by public health doctors about the lobbying from industry against the Bill. One doctor compared it to “David versus Goliath”.

Now in 2022, what can be learned from the campaign?

The establishment of an alcohol policy framework, as enacted within the Act, was “the first time Ireland has sought to address alcohol-related harm as a public health issue”, Consultant Gastroenterologist Prof Frank Murray told MI

“The... Act, while broadly modest in its objectives, is nevertheless historic and important and very much seeks to take

all between 2am and 3am in the morning. They were coming in more spread out across the day and the week and the incidents were happening more indoors in people’s houses rather than in town. Less street assaults, but there were assaults in homes.”

Alcohol Act, target drinkers and the drivers of consumption, it makes no distinction between socio-economic demographics”.

“The modeling research, which informed MUP from 2014 (Sheffield University, UK), shows that those in the lowest income groups are the least affected as they represent both the highest level of non-drinkers (one-in-three) and better adherence to low-risk drinking guidelines.”

In terms of future measures, Prof Murray said he believes “we must implement the policy framework and the measures within the Act in full”.

“There are a number of significant measures yet to be commenced, which have the capacity to lead out on a generational change, namely transforming the content of alcohol advertising through a statutory code; the provision of accurate health information on all alcohol products [regarding] the inherent risk from alcohol use and ending all alcohol promotion on broadcast media before 9pm.”

He also said that a Statesponsored office to lead on alcohol policy should be established “that would have adequate resources and strategic intent to lead for the coming decades and strive to achieve a society free from alcohol harm”.

tentative policy measures much in the same way that tobacco consumption and the harms from smoking were identified and addressed.”

Prof Murray said the “major learning” for the public health community from the campaign “is the effectiveness of one coherent voice”.

He said that “under the stewardship” of Alcohol Action and the RCPI, the Alcohol Health Alliance Ireland was established. It included nearly 60 medical/public health organisations and leadership figures “under one umbrella”. It has “led with one voice on the need for progressive alcohol policy that would reduce the burden from alcohol-related harm”, according to Prof Murray.

“It is regrettable that evidence-based measures were opposed so vigorously by the alcohol industry and delayed through parliamentary obstructionism, but this too has been a learning curve, not just to our alliance, but to a wider international partnership who face similar challenges.”

Public health

Public health doctors have also been highlighting the health consequences arising from alcohol.

“Alcohol is directly associated with over 60 acute and chronic conditions,” Dr Ina Kelly, IMO President and Specialist in Public Health Medicine, said last month when welcoming the introduction of MUP. “[These range] from accidents and assaults to mental health problems and suicide, cardiovascular disease, liver cirrhosis, and certain cancers... research shows that there is a direct correlation between the price of alcohol, alcohol consumption, and alcohol-related deaths.”

Clearly, the public health challenge from alcohol predates Covid. Figures from the Health Research Board (HRB) show there were 54,263 cases of people being treated for problem alcohol use between 2012 and 2018.

Much of the HRB’s fieldwork for the 201920 Irish National Drug and Alcohol Survey was conducted before the pandemic and it found that one-in-five drinkers have an alcohol use disorder (AUD); this increases to one-in-three among drinkers aged 15-to24. Drinkers with AUD were 13 times more likely to experience alcohol-related harm compared to low-risk drinkers, according to the HRB survey.

The report found rates of hazardous and harmful drinking remained high. Two-in-five drinkers engaged in heavy monthly episodic (binge) drinking. But the HRB survey also found that there had been an increase in the number of people who do not drink, and the age at which young people had their first drink has also risen.

MINDO NUMBERS

40,000 people in Ireland are living with epilepsy. International Epilepsy Day will take place on Monday 14 February.

570,000 new cases of cervical cancer occurred globally in 2018, according to the World Health Organisation. January is cervical cancer awareness month.

311,000 deaths of women were caused by cervical cancer that year.

2.2 million additional Covid-19 vaccine booster doses have been administered in Ireland as of 6 January.

879,000 people are on some form of National Treatment Purchase Funding waiting list, including 96,000 children, according to the IHCA.

101 – the percentage increase in the outpatient waiting list at Cork University Maternity Hospital in 2021, the IHCA highlighted.

Dr Ina Kelly

One-in-five trainees report ‘no action’ following bullying complaints – Medical Council survey

CATHERINE REILLY

Almost one-in-five of trainees who were bullied in post told a person in authority, but “nothing happened”. A further 7 per cent informed a person in authority and did not know what happened subsequently, while 6.6 per cent told someone in authority and action was taken, according to data in the Medical Council’s recently published Your Training Counts report covering 2019/2020.

Some 67 per cent of trainees did not tell anyone in authority about the bullying. This high level of non-reporting has been “a consistent feature since the question began to be asked in 2015”, stated the Council report.

Overall, just under one-third (32.8 per cent) of respondents

in 2019 reported that they had experienced bullying and harassment in their post. This represented a decrease of 8.1 per cent from 2017 (40.9 per cent). A higher proportion of female respondents (33.7 per cent) than males (31.3 per cent) reported being bullied.

Bullying and harassment were not specifically defined as terms, but were open to the interpretation shaped by personal experience of each trainee who responded.

Over half (54.2 per cent) of respondents had witnessed a colleague being subjected to bullying or harassment,

‘Enormous number’ of ED patients in current pandemic phase

DAVID LYNCH

Emergency departments (EDs) have recently been experiencing large numbers of presentations during the current phase of the pandemic, Dr Fergal Hickey, President of the Irish Association for Emergency Medicine, has told the Medical Independent.

“If you look at the HSE and Government statements, they seem to focus exclusively on ICU admissions,” said Dr Hickey, who warned there had been less attention on the “enormous number” of patients coming through EDs.

Dr Fergal Hickey

Dr Hickey said EDs were facing a heavy workload for the foreseeable future. He referred to factors such as the difficulties posed by the recent NCHD changeover; the impact of Covid-19 on staffing levels; and the challenge of “having to process large numbers of people coming in with both overt Covid symptoms and those who present with a different problem, but turn out also to have Covid”.

He said that the high numbers of patients on trolleys was “a 12 months of the

year problem, it is not just a winter problem”.

Pointing to longstanding bed capacity shortfalls in the hospital sector, Dr Hickey said these deficiencies had made the situation more difficult during the pandemic.

“The sad thing is we knew we had inadequate bed capacity coming into this pandemic,” he added.

Dr Hickey cited 2019 figures that showed Ireland had the highest bed occupancy level in the OECD and that the number of acute beds per 100,000 of population was well below the OECD average.

He also noted that the bed capacity review has stated that 2,600 beds were needed immediately for the hospital system. Dr Hickey underlined that a significant increase in bed capacity was required.

Despite elective activity having dropped substantially because of Covid-19, the issue of high numbers of patients on trolleys remained, outlined Dr Hickey, who also noted experts’ warnings of future pandemics.

while 1.8 per cent of trainees reported witnessing such incidents on a daily basis.

Consultants represented 28.6 per cent of alleged perpetrators of bullying behaviour, while nurses and midwives represented just under one-third of alleged bullying perpetrators (30.3 per cent), as reported by respondents.

A higher percentage (23.7 per cent) of those who had experienced bullying reported their own health as being less than good, compared to 12 per cent of those who had never been bullied. Over 40 per cent of respondents (41.5 per cent) who were bullied were also involved in an adverse event, while 26.7 per cent of those who were not bullied were involved in an adverse event.

Significant uptick in Covid cert helpline calls

DAVID LYNCH

A “decline” in demand for the digital Covid certificate helpline has recently reversed, with approximately 3,700 calls to the service on 10 January.

At last September’s meeting of the health budget oversight group, there was a discussion regarding the digital Covid certificate service. The HSE “indicated that associated services in this area are expected to be stood down by the end of October and highlighted that there was a decline in the demand for the helpline services”, according to minutes.

However, a Department of Health spokesperson told the Medical Independent (MI) that the introduction of the booster vaccination campaign has meant that the helpline service would continue.

“To support the roll-out of Government policy, a helpline through the digital Covid certificate contact-centre was mobilised by the Department of Health who entered a contract with Accenture in July 2021 based on an estimated fee of €6.5 million relating to an agreed scope, assumptions and estimate volumes,”

DoH group considering consultation on gabapentinoids

CATHERINE REILLY

The early warning and emerging trends (EWET) group chaired by the Department of Health is considering a consultation process on controlling pregabalin and gabapentin, which are indicated for the treatment of epilepsy, peripheral and neuropathic pain and generalised anxiety disorder in adults.

The EWET is part of the national advisory committee on drugs and alcohol.

A Department spokesperson told the Medical Independent: “The controlling of substances under the Misuse of Drugs Acts 1977-2016 requires a clear evidence base and an analysis of the benefits and risks. If evidence exists to suggest that the scheduling of a substance would reduce its misuse or abuse, a multiple stakeholder approach is required, to in-

clude a referral to the European Commission.

“The Department is aware of control measures recently implemented in the UK and Northern Ireland and the data in respect of these measures is still under review by the respective authorities. The early warning and emerging trends group chaired by the Department of Health is considering a consultation process.”

In January 2020, National Clinical Lead of the Medicines Management Programme Prof Michael Barry wrote to GPs to “highlight the high level of prescribing of pregabalin and importantly, the risks associated with its use”, including risk of addiction.

Prof Barry’s correspondence included a summary guidance document on appropriate prescribing of pregabalin. He also advised that a prescribing analysis report of pregabalin for patients in their practice would

the spokesperson told MI .

“This service initially established a traditional agent-intensive help-line based service and quickly transitioned to a range of secure self-service digital solutions over a relatively short time, all to resolve queries that the public may have related to their digital Covid certificates.

“The digital Covid cert helpline will continue to operate to support the issuing of booster certificates and any changes to primary vaccination and booster certificates. As anticipated, calls to the helpline have increased significantly since booster certificates began to issue on 6 January with approximately 3,700 calls to the service centre on 10 January.”

issue in the coming months.

In its September 2021 newsletter, the Health Products Regulatory Authority (HPRA) highlighted “that pregabalin has been associated with reports of respiratory depression in the absence of concomitant therapy with opioids or other central nervous system (CNS) depressants, in patients with and without other risk factors for respiratory depression”, as per findings from the pharmacovigilance risk assessment committee of the European Medicines Agency.

The HPRA advised that the product information would be updated and include respiratory depression as an adverse reaction with a frequency of ‘not known’.

It was already known that concomitant use of pregabalin with opioids and/or other CNS depressants was associated with reports of respiratory failure, coma and deaths, and this risk was reflected in the product information.

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FSAI committee to prepare advice on concerns about cannabis edibles

CATHERINE REILLY

The scientific committee in the Food Safety Authority of Ireland (FSAI) is to prepare advice on the adverse health effects and level of risk associated with cannabis edibles. It follows criticism last year about the FSAI’s warnings from a “small minority”, including a public representative.

A FSAI spokesperson informed the Medical Independent

(MI) the request for advice was made from within the Authority and will aim to “shed further light” on the dangers of unwittingly or knowingly consuming food products containing tetrahydrocannabinol (THC) or other psychotropic substances, such as synthetic cannabinoids.

“The Irish Medical Journal published a peer-reviewed scientific paper in 2021 detailing the admission to Temple Street children’s hospital and medical treatment of a number of

very sick small children who had unwittingly consumed what looked like ordinary sweets, but were in fact sweets with an unknown provenance that were laced with dangerous levels of the psychotropic tetrahydrocannabinol (THC). THC is the component within cannabis that gives the user of such illicit drugs the characteristic ‘high’,” outlined the FSAI spokesperson.

Last year the FSAI issued warnings about the dangers for people – especially children and adolescents – of unwittingly consuming cannabis edibles. This information was met with public concern about the availability of such products.

However, “a small minority” of people criticised the nature of these warnings, with some believing the FSAI overstated the dangers. According to the Authority, some of these comments came through social media and were largely anonymous. Additionally, there was at least one “political intervention complaining that the FSAI publications were causing concern for students on cannabis medication”. In a parliamentary question last November, Deputy Violet-Anne Wynne (Sinn Féin) stated that warnings issued by the FSAI “through the school system may cause negative consequences for the school going children availing of the medicinal cannabis access programme [MCAP]”.

Minister for Health Stephen Donnelly responded that his Department was concerned consumption of illegal cannabis edibles would pose a significant public health risk. He said the FSAI engaged with the Department of Education when it became aware of these products being available in some school settings. He did not consider there could be any conflation with the MCAP.

The FSAI’s spokesperson informed MI that, in view of the criticism, and due to the lack of experience with the use of cannabis and cannabis components in or as food in Ireland, the Authority decided to “use the best scientific advice available in the country to further educate itself with respect to the detailed characteristics of the cannabis plant and in particular THC, one of the more than 120 cannabinoids identified to date in the cannabis plant”.

They added: “The possession and handling of the controlled substance THC, or products containing it, is dealt with under the Misuse of Drugs Act 1977 in Ireland, the implementation and enforcement of which is outside the remit of the FSAI. However, the FSAI has a role in the sale and distribution of cannabis edibles as such products fall under the provisions of EU and Irish food law.

“The proposed scientific committee work will hopefully shed further light on the dangers of unwittingly (or knowingly) consuming food products containing THC, or indeed other psychotropic substances, such as synthetic cannabinoids. It is hoped this work will be finalised early next year.”

Pre-hospital regulator has ‘reached boundaries’ of legislation, DoH warned

CATHERINE REILLY

Author: Eamonn Brady MPSI

The Pre-Hospital Emergency Care Council (PHECC) has “reached the boundaries of existing legislation” in a number of critical areas including mandatory registration and fitness to practise, its Chair “stressed” to Department of Health officials.

At a meeting of the Council in November, PHECC’s Chair Dr Jacqueline Burke reported on a recent conversation with Department officials on strengthening PHECC’s legislation, “where she had stressed that PHECC had reached the boundaries of existing legislation specific to matters of protection of title, mandatory registration of practitioners, fitness to practise, and the admission of additional grades to the register”, according to meeting minutes.

As previously reported in the Medical Independent (MI), for several years PHECC has highlighted with the Department that legislative deficiencies restrict its ability to adequately regulate pre-hospital emergency services.

Minutes of PHECC’s meeting in November reported that the Chair and executive would further engage with the Department, “sharing both recent legal advice and correspondence from the Chair of the medical advisory committee with Department officials. Further extensive legal work, currently be-

VOX BOX

The digital marketing strategies used to promote junk food are increasingly integrated, immersive, and personalised.”

Ms Kathryn Reilly, Policy Manager with the Irish Heart Foundation, commenting on the Online Safety and Media Regulation Bill, which the charity says fails to curb digital marketing of unhealthy food to children.

One hundred and fourteen people are being added to a waiting list every day in this country – a shocking fact that we cannot ignore and must give serious priority to.”

IHCA President Prof Alan Irvine commenting on the fact another 40,600 people were added to hospital waiting lists in the past year, with over 879,000 people now on public waiting lists.

ing conducted in support of strengthening PHECC’s legislative position, is expected to be submitted to the Department before year-end with a specific meeting anticipated in early 2022.”

Consideration was given to suspending the community paramedic and critical care paramedic programmes until legislation was in place, as well as the possibility of incorporating PHECC into the existing legislation model/template of other healthcare regulators.

In November, the HSE informed MI it was not appropriate to develop further cohorts of community paramedics and critical care paramedics until the required regulatory framework was in place. The Department has previously advised that its officials were considering options to strengthen the regulatory framework governing the delivery of pre-hospital care. “Considerations are ongoing. There is no further information available at this stage,” a spokesperson told MI.

Malaria

CATHERINE REILLY

Malaria antibody testing will be introduced in the coming months after changes to the donor computer system are completed, according to the Irish Blood Transfusion Service (IBTS).

“This will enable the use of an electronic questionnaire that will identify donors that have been exposed to malaria. Those donors’ responses that indicate they have been born or lived in countries endemic for malaria will be flagged by the system to test for malaria antibodies,” a spokesperson told the Medical Independent.

Under existing policy, people must wait 12 months from the day they leave a malaria-affected country/area before becoming eligible to donate. Additionally, people cannot give blood if they ever had malaria, even if fully recovered.

For a number of years, the IBTS has been planning to introduce an adapted policy involving malaria antibody testing for some potential donors. Ireland now has a significant cohort of children and adults with transfusion-dependent sickle cell disease (SCD), a genetic blood disorder that predominantly affects people of African background.

Recruiting more donors of African background to better match blood for SCD patients would help reduce the pressure on O negative blood stocks. O negative is considered the universal blood group and is always in demand, according to the IBTS. O negative accounted for 14.5 per cent of issues from January to November 2021 while the incidence of O negative in the population is around 9 per cent.

On 21 December, the IBTS announced it was importing a consignment of blood from the NHSBT to address a shortage in the blood supply, which had been affected by the pandemic and Storm Barra. It was the second time in 2021 the IBTS had imported blood from NHSBT (the Service does occasionally import a small number of rare blood units).

Stocks of the main Rh negative blood groups were under particular pressure, especially O negative, according to the IBTS.

Speaking last month, Medical and Scientific Director Prof Stephen Field said appointment cancellations and the high level of Covid-19 in the community had made it difficult to fill all donation appointments. “This means that for the last number of weeks we have been issuing more blood to hospitals than we have been able to collect.”

The intervention approach to managing this challenging problem is promising and demonstrates that, even in this very complex group, stopping medicines that may no longer be needed or appropriate is both possible and generally safe.”

medications prescribed for older people.

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antibody testing planned for first half of 2022

PAUL

Why has introducing activity-based funding been so difficult?

It is 10 years since the Government made a commitment towards introducing activity-based funding in Irish healthcare. However, progress has been slow in implementing the model.

Paul Mulholland reports

In 2012, the Government committed to moving away from the traditional method of funding healthcare through block grants. Instead, an activity-based funding (ABF) model was to be introduced. ABF is a model by which healthcare facilities are funded based on their level of activity. ABF is intended to encourage efficiency in the system by motivating hospitals to find the most cost-effective means of providing care.

The introduction of ABF in Irish healthcare represented a significant change and progress has not been straightforward. In 2014, the Healthcare Pricing Office (HPO) was established within the HSE bringing together the former ‘Casemix’ team and the former ESRI team. An Assistant National Director was assigned responsibility for the HPO and asked to develop a plan and lead on the implementation of ABF across Irish public hospitals.

The 2015-17 ABF implementation plan was prepared by the National Lead. It set out the mission and scope of the ABF programme and a high-level action plan for those years. However, in 2018, the plan was allowed to lapse, even though ABF was listed as a priority under Sláintecare.

At the end of 2018, the Medical Independent (MI) reported that a briefing paper, prepared by the HPO and submitted to the Department of Health in December 2018, stated implementation of some of the recommendations had “not progressed or stalled”.

“While considerable work has been ongoing there has been something of a hiatus in the drive for ABF for a couple of reasons,” according to the document.

The first of the reasons cited was that when the envelope of funding is not sufficient to buy the activity delivered in the ‘outgoing’ year, ABF is not possible unless the price is unilaterally reduced.

“This was necessary in 2016 – the first year of ABF – when funding was not available at the start of the year, but became available later in the year,” stated the document.

“It was also necessary in 2018 when VIP1 [Value Improvement Programme 1] and VIP2 [Value Improvement Programme 2], representing some €141 million, were required to close the ‘gap’ in acute hospitals – therefore the price effectively had to be reduced by that amount.”

The briefing paper noted “ICT infrastructure in many Irish public hospitals remains a considerable block to the further development of ABF”.

Recruitment and retention of staff in such a “niche area” was cited as another barrier.

At the time, the HPO had commenced work to develop a new ABF implementation plan.

“Work has commenced with a detailed review and assessment of the 2015-17 plan currently underway and an initial draft of the new implementation plan to be developed over March to April 2019,” outlined the document.

New implementation plan

However, the new implementation plan, which covers the years 2021-2023, was only published at the end of last year. According to the document, 39 hospitals are now receiving 70 per cent of their funding via the ABF approach. The ABF component of budgets are now set using target activity levels derived from the latest annual HIPE data.

“Hospitals and Hospital Groups can compare their actual performance against their target and interrogate their HIPE data flexibly and quickly, down to the level of individual consultant/patient, length-of-stay, etc, through a new monthly reporting system, with almost 300 users now registered,” according to the report.

There has been less ABF-related progress in the community sector. However, the report noted the approximately €1

billion paid out on an activity basis each year via the Nursing Home Support Scheme, established in 2009, and the approximately €3 billion paid out by the Primary Care Reimbursement Service, much of it in line with ABF principles.

Targets

The report confirmed that many of the targets set in the previous implementation plan have not been reached.

“A renewed focus is required on the development of a classification and funding approach for outpatient care, with progress to date limited due to significant variability in the quantity and quality of outpatient data and lack of consistency in reporting specifications,” it stated.

The HPO has commenced a pilot to collect data at patient level, with this work to be made a priority under the new plan.

Actions such as integrating performance management of ABF into organisational performance management require “a more established and mature” system before they can be implemented.

“Other actions, such as transitioning of individual hospitals towards national pricing (or understanding and quantifying why ongoing adjustments may be appropriate for some services) are still in progress, critical to the successful implementation of ABF and have been prioritised in the new implementation plan,” according to the document.

Progress on classifying and costing community and homecare services has also been limited. This work was due to transfer to the HPO from 2021.

In relation to community services, additional investment will be required to reflect the increase in workload in order to support effective management and delivery. “The specific financial, staffing, and ICT requirements will need to be detailed as the programme develops.”

The document also stated that while an extensive programme of engagement has taken place with key stakeholders in the hospital system, with ABF now established centrally, it was important to ensure the system understands how ABF works in order that they can participate in the process. The complexity of ABF and lack of understanding about it is causing delays and lack of clarity in day-today implementation, such as the annual incorporation of

ABF into budget allocation processes.

“[ABF] can appear initially complex to an outside observer, and it is clear from implementation in other jurisdictions people in the system need to first understand ABF (beyond simply the reporting burden) to see the benefit and be assured that as a system it is ‘here to stay’ in order that sufficient investment is made,” according to the new implementation plan.

The document stated that the publication of the Irish price list for the first time in 2019 provided an “excellent opportunity” for stakeholder engagement and review and refinement of the pricing model.

Other issues identified included the lack of an existing ABF workforce in Ireland, which has placed limitations on the expansion of the model.

There have also been challenges because of the economic environment in which ABF has been implemented, where overall funding could not meet the volume growth and demands on the system and the budgetary situation have led to a focus on expenditure control.

Covid-19 pandemic

To ensure financial stability for hospitals when ABF was introduced, temporary transition adjustments were put in place for hospitals operating above and below the national price. The 2015-17 implementation plan required that hospitals operating above the national price make plans to reduce their unit costs and associated need for transition payments.

Under the transition adjustment system, some hospitals’ funding is increased because their expenditure is higher than ABF prices, with some funding decreased where ABF prices are above expenditure and providing funding at the ABF price level would represent a ‘profit’ for the hospital.

“This approach is counter to the principle of ABF that efficiency in the system is rewarded,” according to the document.

“This was appropriate at the introduction of ABF in Ireland to allow the system to adjust to the new way of funding: To smooth the transition for inefficient hospitals, to allow time for improvements in activity and cost data reporting, and to enable the HPO and hospitals to better understand and account for legitimate variations in costs. However, over time these factors need to be addressed in the ABF system.”

Under the Sláintecare implementation strategy, the ABF proportion of hospital budgets is to be significantly increased by reducing transition payments. The document noted that planning for ABF in the midst of a pandemic is difficult given the level of upheaval that is imposed on the healthcare system.

“Despite this, it is important that the annual ABF processes continue as normal with the aim of returning from block grant to ABF-based budgets as soon as is feasible,” the new ABF implementation plan stated.

Therefore, the document contains plans for stakeholders to work together to review transition adjustments and develop a timetable for incremental reduction of transition adjustments to 2023, taking into account the impacts of Covid-19 on funding processes.

In his foreword to the report, HSE CEO Mr Paul Reid stated Covid-19 created major challenges in accounting for new and unknown patterns of healthcare usage and costs. Emergency measures have included temporary increases to block funding.

However, he added “ABF and its building blocks have proved useful in providing the information needed to monitor the impact and effects of the disease and make important decisions as to where resources should be deployed and will continue to be critical for health system insights and funding into the future”.

MULHOLLAND paul@mindo.ie ABF PROGRAMME IMPLEMENTATION PLAN 2021-23

Helping to Combat Cardiovascular Disease1

Controlling

The 1st Statin, ACEi & CCB combination in Ireland2

High Cholesterol and Hypertension in unison1

Lipertance® (Atorvastatin,perindopril,amlodipine): Abbreviated Prescribing Information: Please refer to the Summary of Product Characteristics before prescribing. COMPOSITION*: Lipertance 10mg/5mg/5mg, 20mg/5mg/5mg, 20mg/10mg/5mg, 20mg/10mg/10mg, 40mg/10mg/10mg film-coated tablets contain 10 mg atorvastatin (ator)/5 mg perindopril arginine (per)/5 mg amlodipine (amlo), 20mg ator/5 mg per/5 mg amlo, 20mg ator/10 mg per/5 mg amlo, 20mg ator/10 mg per/10 mg amlo, 40mg ator/10 mg per/10 mg amlo. Contains lactose as excipient. INDICATIONS*: Substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in association with primary hypercholesterolaemia or mixed hyperlipidaemia, in adult patients adequately controlled with atorvastatin, perindopril and amlodipine given concurrently at the same dose level. DOSAGE AND ADMINISTRATION*: One tablet once daily before a meal in the morning. Lipertance is not suitable for initial therapy. If a change of posology is required, the dose could be modified or individual titration with free combination may be considered. Co-administration: with elbasvir/grazoprevir or letermovir, the dose of atorvastatin should not exceed 20 mg/day. Lipertance not recommended when letermovir co-administered with ciclosporin. Elderly and patients with renal failure: frequent monitoring of creatinine and potassium. Clcr < 60 ml/min: not suitable. Hepatic impairment: should be used with caution. Lipertance is contraindicated in patients with active liver disease. Children and adolescents: should not be used. CONTRAINDICATIONS*: Hypersensitivity to the active substances or to any other ACE inhibitor or dihydropyridine derivatives or statin or to any of the excipients, active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal, during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures (see section PREGNANCY* and BREASTFEEDING*), concomitant use with the hepatitis C antivirals glecaprevir/pibrentasvir, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g., hypertrophic obstructive cardiomyopathy and high grade aortic stenosis), haemodynamically unstable heart failure after acute myocardial infarction, history of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy, hereditary or idiopathic angioedema, concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m²) (see section INTERACTIONS*), concomitant use with sacubitril/valsartan (see WARNING* and INTERACTIONS*), extracorporeal treatments leading to contact of blood with negatively charged surfaces (see INTERACTIONS*), significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (see WARNINGS*). WARNINGS*: Special warnings and precaution for use: Liver effects: liver function tests should be performed periodically and in case of transaminase levels increased, the patient should be monitored until resolution. Stop treatment if jaundice or marked elevations of hepatic enzymes (serum transaminases exceeding 3 times the upper limit of normal) and in patients with active liver disease. Use with caution in patients with hepatic impairment, who consume alcohol and/or have history of liver disease. Skeletal muscle effects: stop treatment if elevation of CK levels > 10 x ULN or muscular symptoms with elevation of CK level > 5 x ULN occur, or if rhabdomyolysis is suspected. Caution should be exercice when Lipertance is used with certain medicinal products that may increase the plasma concentration of atorvastatin and then the risk of rhabdomyolysis such as potent inhibitors of CYP3A4 or transport proteins (e.g ciclosporine, ketoconazole, letermovir, ritonavir…). Increased risk of myopathy with concomitant use of gemfibrozil and other fibric acid derivatives, antivirals for the treatment of hepatitis C, erythromycin, niacin and ezetimibe. Co-administration with systemic fusidic acid or within 7 days of stopping the treatment is not recommended. If use essential, Lipertance should be discontinued during fusidic acid treatment. Interstitial lung disease: if suspected, treatment should be discontinued. Diabetes Mellitus: In diabetic patients, glycaemic control should be closely monitored during first month of treatment. Patients with cardiac failure: use with caution. Hypotension: monitor blood pressure, renal function and potassium in patients at high risk of symptomatic hypotension (volume depleted or who have severe renin-dependent hypertension) or with symptomatic heart failure (with our without renal insufficiency), or with ischaemic heart or cerebrovascular disease. A transient hypotensive response is not a contraindication to further doses once the blood pressure has increased after volume expansion. Aortic and mitral valve stenosis/hypertrophic cardiomyopathy: use with caution and see CONTRAINDICATIONS. Kidney transplantation: no experience in case of recent transplantation. Renovascular hypertension: Increased risk of hypotension and renal insufficiency in patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients with unilateral renal artery stenosis. Renal impairment: monitor potassium and creatinine; individual dose titration with the monocomponents recommended if Clcr < 60 ml/min. In patients with renal artery stenosis, blood urea and creatinine may increase; with renovascular hypertension, risk of severe hypotension and renal insufficiency. Amlodipine may be used at normal doses in patients with renal failure. Amlodipine is not dialysable. Haemodialysis patients: use with caution. Hypersensitivity/Angioedema: stop treatment and monitor until complete resolution of symptoms. Angioedema associated with laryngeal oedema may be fatal. Combination with sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/ valsartan must not be initiated until 36 hours after taking the last dose of perindopril therapy. Perindopril therapy must not be started until 36 hours after the last dose of sacubitril/valsartan. Concomitant use of other NEP inhibitors (e.g. racecadotril) and ACE inhibitors may also increase the risk of angioedema. Concomitant use of mTOR inhibitors: Increased risk for angioedema. Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis: rarely, patients have experienced life-threatening anaphylactoid reactions, temporarily withhold treatment prior to exams. Anaphylactoid reactions during desensitisation: temporarily withhold treatment prior to exams. These reactions reappeared upon inadvertent rechallenge. Neutropenia/agranulocytosis/thrombocytopenia/anaemia: extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treated with allopurinol or procainamide, periodic monitor of white blood cell counts advised. Race: perindopril may be less effective and cause a higher rate of angioedema than in non-black. Cough: resolves after discontinuation. Surgery/Anaesthesia: stop treatment one day prior to surgery. Hyperkaliemia: frequent monitoring of blood potassium if renal insufficiency, worsening of renal function, age (>70 years), diabetes mellitus, dehydration, acute cardiac decompensation, metabolic acidosis, and concomitant use of potassium-sparing diuretics and potassium salts or supplements. Combination with lithium. not recommended Dual blockade of the renin-angiotensin-aldosterone system (RAAS): concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS is therefore not recommended. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Primary aldosteronism: Use not recommended in patients with primary hyperaldosteronism (not responding to drugs acting through inhibition of reninangiotensin system). Galactose intolerance/glucose- galactose malabsorption/total lactase deficiency: should not be taken. Sodium: ‘sodium-free’. INTERACTIONS*: Contraindicated: Aliskiren (in diabetic and impaired renal patients), Extracorporeal treatments, Sacubitril/valsartan, Glecaprevir/pibrentasvir. Not recommended: CYP3A4 inhibitors, aliskiren, concomitant therapy with ACE inhibitor and angiotensin-receptor blocker, estramustine, lithium, Co-trimoxazole (trimethoprim/sulfamethoxazole), potassium- sparing diuretics (e.g. triamterene, amiloride, eplerenone, spironolactone), potassium salts, dantrolene (infusion), grapefruit or grapefruit juice.

Precautions: CYP3A4 inducers, digoxin, ezetimibe, fusidic acid, gemfibrozil / fibric acid derivatives, transport inhibitors, warfarin, antidiabetic agents (insulins, oral hypoglycaemic agents), baclofen, non-steroidal anti- inflammatory medicinal products (NSAIDs) (including aspirin ≥ 3 g/day), racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus), colchicine, colestipol, oral contraceptives, gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin), sympathomimetics, tricyclicantidepressants/antipsychotics/anesthetics, gold, digoxin, atorvastatin, warfarin or ciclosporine, tacrolimus, antihypertensive agents and vasodilators. PREGNANCY AND BREASTFEEDING*: Lipertance is contraindicated during pregnancy and lactation. FERTILITY*: Reversible biochemical changes of spermatozoa in some patients treated by calcium channel blockers. DRIVE AND USE MACHINES*: May be impaired if dizziness, headache, fatigue, weariness or nausea. Caution is recommended especially at the start of treatment. UNDESIRABLE EFFECTS*: Very common: Oedema. Common: nasopharyngitis, hypersensitivity, hyperglycaemia, somnolence, dizziness, headache, dysgeusia, paraesthesia, vertigo, visual impairment, diplopia, tinnitus, palpitations, hypotension (and effects related to hypotension), flushing, pharyngolaryngeal pain, epistaxis , cough , dyspnoea, nausea, vomiting, abdominal pain upper and lower, dyspepsia, diarrhoea, constipation, change of bowel habit, flatulence, rash, pruritus, joint swelling, ankle swelling, pain in extremity, arthralgia, muscle spasms, myalgia, back pain, asthenia, fatigue, liver function test abnormal, blood creatine kinase increased. Uncommon: Rhinitis, eosinophilia, hypoglycaemia, hyponatraemia, hyperkalaemia reversible on discontinuation, anorexia, insomnia, mood altered (including anxiety), sleep disorder, depression, nightmares, tremor, syncope, hypoaesthesia, amnesia, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vision blurred, tachycardia, vasculitis, bronchospasm, dry mouth, pancreatitis, eructation, hepatitis either cytolytic or cholestatic, urticaria, purpura, skin discolouration, hyperhidrosis, exanthema, alopecia, angioedema, pemphigoid, photosensitivity reactions, neck pain, muscle fatigue, micturition disorder, nocturia, pollakiuria, renal failure, erectile dysfunction, gynecomastia, chest pain, pain, malaise, oedema peripheral, pyrexia, blood urea increased, blood creatinine increased, weight increase, white blood cells urine positive, weight decrease, fall. Rare: Thrombocytopenia, confusional state, neuropathy peripheral, cholestasis, psoriasis aggravation, stevens-johnson syndrome, toxic epidermal necrolysis, erythema multiforme, myopathy, myositis, rhabdomyolysis, muscle rupture, tendinopathy sometimes complicated by rupture, hepatic enzymes increased, blood bilirubin increased. Very rare: Leucopenia/neutropenia, agranulocytosis or pancytopenia, haemolytic anaemia in patients with a congenital deficiency of g-6pdh, haemoglobin decreased and haematocrit decreased, anaphylaxis, hypertonia, hearing loss, myocardial infarction secondary to excessive hypotension in high-risk patients, angina pectoris, stroke possible secondary to excessive hypotension in high-risk patients, eosinophilic pneumonia, gastritis, gingival hyperplasia, jaundice, hepatic failure, exfoliative dermatitis, lupus-like syndrome, renal failure acute. Not known: immune-mediated necrotizing myopathy, extrapyramidal disorder (extrapyramidal syndrome), Raynaud’s phenomenon. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) can be considered as a very rare complication associated with ACE inhibitor therapy. OVERDOSE*. PROPERTIES*: Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. Perindopril is an inhibitor of the enzyme that converts angiotensin into angiotensin II (Angiotensin Converting Enzyme ACE). Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. PRESENTATION*: Box of 30 film-coated tablets for Lipertance 10mg/5mg/5mg, 20mg/5mg/5mg, 20mg/10mg/5mg, 20mg/10mg/10mg, 40mg/10mg/10mg.

FOR BOTH LIPERTANCE AND LIPERCOSYL: MARKETING AUTHORISATION HOLDER Les Laboratoires Servier, 50 rue Carnot, 92284 Suresnes cedex France. www.servier.com. Marketing Authorisation number: PA0568/028/001-005 (LPT) PA0568/032/001-006 (LPC). Legal Classification for

CATHERINE REILLY catherine@mindo.ie

Minister sought internal report

Following a Ministerial request, HIQA prepared an internal report on three nursing homes that were subject to concerns in an RTÉ Investigates programme. The document again underlines the need for regulatory reform, reports Catherine Reilly

Minister of State for Mental Health and Older People

Mary Butler requested HIQA to prepare a report on its regulation of three nursing homes following an RTÉ Investigates programme in July 2021 (‘Care in Covid’ ), which broadcast allegations of abuse and poor standards of care.

The HIQA report, dated 23 July 2021, provided details on regulatory oversight of Caracalla Community Hospital and Hospice, Co Clare; Carechoice Ballynoe, Co Cork; and Tara Winthrop Private Clinic, Swords, Co Dublin. The Authority released the report to the Medical Independent (MI), with significant redactions, under Freedom of Information law.

The details of the report point to deficiencies in the current system of regulation, a matter on which HIQA itself has voiced considerable concern.

Cahercalla

Cahercalla Community Hospital and Hospice had 33 findings of non-compliance with regulations since 2015, including 15 non-compliances identified in two inspections in the first quarter of 2021. A judgment of not compliant means the provider or person in charge has failed to comply with a regulation and that considerable action is required to reach compliance.

There were also 19 findings of ‘moderate’ non-compliances since 2013. The facility had been inspected 10 times since 2013, culminating in the most recent unannounced inspection on 16 March 2021. Many of the findings of non-compliance against key regulations, which underpin the care and welfare of residents, were repeated across the inspections since 2019 (eg, Primary Regulation

9: Residents’ Rights found to be breached in the May 2019, September 2020 and January 2021 inspections).

The centre had complied with mandatory notification requirements, the number of which was redacted (these are incidents which must be reported to the Chief Inspector). HIQA had also received 11 pieces of unsolicited information about Cahercalla in the previous two years, five in 2020 and six in 2021. The nature of this information was redacted, but prompted HIQA to seek “provider assurance reports”.

The systems in place to govern and manage Cahercalla had been “a cause for concern for a significant period of time and as a consequence the provider was required to take action to strengthen their governance and oversight of the centre”.

However, the “repeated failure” of the provider to take the necessary action to strengthen governance “contributed to their inability to respond appropriately to

the outbreak of Covid-19”.

“The care of residents was negatively affected by an institutional approach to staffing which favoured staff preferences over residents’ needs,” it stated.

In February 2021, HIQA’s Chief Inspector issued a notice of a proposed decision to cancel the centre’s registration. On foot of escalating regulatory action, the centre entered an agreement with Mowlam Healthcare Ltd to oversee operations.

An inspection in March 2021 found that the revised governance and management arrangements were associated with improved care of residents.

Carechoice Ballynoe

Carechoice Ballynoe had been inspected seven times since 2013, culminating in the most recent unannounced inspection on 27 April 2021. The findings from the two most recent inspections, in 2021, had not been concluded. In prior years, two non-compliances and three ‘moderate’ non-compliances were identified. The issues of concern identified following a September 2019 inspection – relating to premises and training and staff development – were followed up in subsequent inspections, noted the report.

The centre had complied with mandatory notification requirements, details of which were redacted. All notifications had been “reviewed and risk rated and where appropriate inspectors have engaged directly with the provider”.

HIQA had received 24 pieces of unsolicited information since 2020; with 22 received in 2021 to the date of the report. The concerns raised were redacted from the report. However, it referred to unsolicited information of concern from distressed and bereaved relatives following the “large” number of Covid-19-related deaths.

In January 2021, some 45 residents at the home contracted Covid-19. The number of people who died was redacted. A section of the report covering the impact of Covid-19 was almost entirely blacked-out.

Tara Winthrop Private Clinic

Tara Winthrop Private Clinic had been inspected six times since 2014, culminating in the most recent unannounced inspection on 19 August 2020. It had two findings of non-compliance and five ‘moderate’ non-compliances. In the past two years, HIQA had received 17 pieces of unsolicited information, 12 in 2020 and five to date in 2021. Details of these concerns was redacted.

In regard to mandatory notifications, the number of which was redacted, the provider had a “good reporting culture”.

HIQA outlined that it had engaged with the centre on foot of unsolicited information and mandatory notifications.

Tara Winthrop Private Clinic was one of the first nursing homes in Ireland to experience a large outbreak of Covid-19.

During the outbreak the provider required “significant levels” of assistance

from the HSE to access appropriate quantities of personal protective equipment, Covid-19 testing, and assistance to manage and staff the centre. Details on fatalities arising from the outbreak were redacted.

“At times during the outbreak the provider did not have a system, arrangements or the resources in place to maintain the required level of contact with the relatives of residents living in the centre – understandably this led to anxiety among families and relatives.”

During the most recent inspection in August 2020, it was found that the centre “was beginning to return to normal albeit still very much affected by the devastating impact of the outbreak”.

Regulatory reform

In correspondence to HIQA after receipt of the report, Minister Butler noted its level of regulatory concern in relation to two of the nursing homes. She wrote that she “would appreciate if you could ensure that an appropriate regulatory focus on these centres is maintained”.

A HIQA spokesperson told MI it “continues to engage with and monitor those centres in line with its regulatory powers”.

Asked how many older persons’ centres were at high risk of non-compliance with regulations, HIQA’s spokesperson said the regulatory status of any given centre “is subject to constant review where any associated regulatory risk may increase or decrease in accordance with current available information”.

HIQA was continuing to engage with the Department of Health on “the need for regulatory reform”, confirmed the spokesperson.

In February 2021, HIQA published a document which set out the urgent requirement for reform of the regulatory framework for social care services.

The Authority has highlighted several issues of concern, including that the process to cancel the registration of a provider, or attach additional conditions of registration, was often slow and the legal threshold to cancel registration was very high.

According to HIQA’s February 2021 report, all the regulations and notifiable events pertaining to social care services should be reviewed as a matter of urgency.

“There is clear evidence that regulations need to be regularly reviewed to determine their effectiveness,” outlined The Need for Regulatory Reform . “Although Covid-19 has exposed further weaknesses in the regulations given the significant impact it has had on nursing homes in Ireland, we cannot lose sight of the fact that these weaknesses have been present for a significant period of time. The pandemic has only served to highlight the critical importance of the need for regulatory reform.

“In this regard, HIQA has been consistent in advocating for a review of the regulations and this is also something which was deemed good practice. Additionally, this should also include a review of the

provisions of the Heath Act 2007, that give enforcement powers to the Chief Inspector…. There is a need to ensure that while the decisions of the Chief Inspector are open to challenge, this does not place residents at unnecessary risk. At the present time, lengthy legal challenges can dilute the enforcement powers of the Chief Inspector.”

Department of Health

MI asked the Department of Health if it received regular updates on designated centres with high rates of non-compliances against HIQA regulatory standards, and if so, how it used this information.

The Department’s spokesperson commented: “Shortly in advance of publication, HIQA provides notice to the Department of reports that are due to be published. These reports are provided for the Department’s information. The Department reviews these reports to identify any trends in non-compliance and provides a summary of the reports to Minister Butler for information. Where relevant, trends identified may be highlighted as part of the Department or Ministers’ engagements with HIQA and other relevant bodies, such as the HSE or Nursing Homes Ireland.”

In regard to HIQA’s call for regulatory reform, the spokesperson said Minster for Health Stephen Donnelly and Minister Butler had approved “a two-phased approach” to examining the legislation, with a view to proposing “enhancements” to the primary and secondary legislation governing nursing homes.

“Phase one will bring forward interim enhancements to the primary legislative framework to enhance governance and oversight of nursing homes. The proposals will, amongst other things: Provide new and enhanced enforcement powers for the Chief Inspector; reduce timelines and processes for regulatory actions; and introduce a new reporting system for the reporting and publication of key operational data to support national planning in an integrated way and improve the information available.

“The Government is committed to the reform of the regulatory framework governing nursing homes and approved the inclusion of a Health (Amendment) Bill on its legislative agenda. It is expected that, subject to Government approval, a draft General Scheme will be published in early 2022, with a Bill being developed and published thereafter.”

In addition, secondary legislation will be drafted to “enhance” the current regulations. A bilateral project group comprising representatives from the Department and HIQA is supporting the legislative process, said the spokesperson.

A wider review of the regulatory framework (phase two) will commence in the second half of 2022, taking into account a programme of longer-term strategic reform considerations arising from “pandemic learning”, among other aspects.

Ms Mary Butler

Significantly improves exercise duration and reduces angina frequency1

Abbreviated Prescribing Information: Ranexa (ranolazine). Please consult the Summary of Product Characteristics (SPC) for full prescribing information. Presentation: Prolonged-release tablets containing 375 mg, 500 mg or 750 mg of ranolazine. 750 mg tablet contains E102 and lactose. Use: Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). Dosage and administration: Oral administration. Patients should be instructed to list their medication to their health care professional at each visit. Adults: Initial dose is 375 mg twice daily. After 2-4 weeks, dose should be titrated to 500 mg twice daily and, according to patient’s response, further titrated to 750 mg twice daily. Concomitant treatment with moderate CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended. Renal impairment: Careful dose titration is recommended in mild to moderate renal impairment, and contraindicated in severe renal impairment. Hepatic impairment: Careful dose titration is recommended in mild hepatic impairment, and contraindicated in moderate to severe hepatic impairment. Elderly: Dose titration in the elderly should be exercised with caution. Low weight: Dose titration in patients with low weight should be exercised with caution. Congestive Heart Failure (CHF): Dose titration in moderate to severe CHF should be exercised with caution. Paediatric patients: No data in children below the age of 18 years. Ranexa tablets should be swallowed whole and not crushed, broken or chewed. They may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Severe renal impairment. Moderate or severe hepatic impairment. Concomitant administration of potent CYP3A4 inhibitors. Concomitant administration of Class Ia or Class III antiarrhythmics other than amiodarone. Warnings and Precautions: Caution should be exercised when prescribing or up titrating ranolazine to patients in whom an increased exposure is expected. QT prolongation: Caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval. Interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy.

Renal impairment: Check renal function at regular intervals during treatment. Interactions: CYP3A4 inhibitors: Increase plasma concentrations of ranolazine. Combining ranolazine with potent CYP3A4 inhibitors is contraindicated. CYP3A4 inducers: Avoid initiation with Ranexa during administration of CYP3A4 inducers. CYP2D6 inhibitors: May increase plasma concentrations of ranolazine. Effect of ranolazine on other medicinal products: Dosage adjustment of sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range may be required. Lower doses of CYP2D6 substrates may be required. Caution with CYP2B6 substrates. Monitor digoxin levels following initiation and termination of Ranexa. Limit dose of simvastatin to 20mg once daily in patients taking Ranexa. Limit dose of atorvastatin and consider clinical monitoring in patients taking Ranexa. Monitor blood levels of tacrolimus when coadministering with Ranexa and adjust tacrolimus dose accordingly. Also recommended for other CYP3A4 substrates with a narrow therapeutic range. Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin increased in subjects with type 2 diabetes mellitus when co-administered with Ranexa. The exposure of other OCT2 substrates may also be affected. Theoretical risk that concomitant treatment with drugs known to prolong the QTc interval may increase the possible risk of ventricular arrhythmias. Pregnancy and lactation: Ranexa should not be used during pregnancy unless clearly necessary. Ranexa should not be used during breast-feeding. Effect on fertility unknown. Side-effects: Generally mild to moderate in severity and often develop within the first 2 weeks of treatment. Common (1-10%): dizziness, headache, constipation, vomiting, nausea, asthenia. Uncommon (0.1–1%): anorexia, decreased appetite, dehydration, anxiety, insomnia, confusional state, hallucination, lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paraesthesia, blurred vision, visual disturbance, diplopia, vertigo, tinnitus, hot flush, hypotension, dyspnoea, cough, epistaxis, abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort, pruritus, hyperhydrosis, pain in extremity, muscle cramp, joint swelling, muscular weakness, dysuria, haematuria, chromaturia, fatigue, peripheral oedema, increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight. In a long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients. Rare (0.1-0.01%): hyponatremia, disorientation, amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia, impaired hearing, peripheral coldness, orthostatic hypotension, throat tightness, pancreatitis, erosive duodenitis, oral hypoaesthesia, angioedema, allergic dermatitis, urticaria, cold sweat, rash, acute renal failure, urinary retention, erectile dysfunction, elevated levels of hepatic enzyme. Not known: myoclonus. Increased incidence of congestive heart failure and transient ischaemic attacks seen in patients with history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention and treated within 2 weeks with ranolazine (1000 mg twice daily [dose not approved in Europe]) in a placebo-controlled post-PCI trial. Elderly, renal impairment and low weight: In general, adverse events occurred more frequently among elderly patients and patients with renal impairment. Adverse events in patients with low body weight were similar to those of patients with higher weight. Please consult the SPC for further information.Pack size: 60 tablets. Legal category: POM. Marketing authorisation numbers: EU/1/08/462/001, 003, 005 Marketing Authorisation holder: Menarini International Operations Luxembourg S.A. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SPC. Last updated: October 2020

Date of item: November 2020. IR-RAN-12-2020

References: 1. Chaitman, B.R., et al. JAMA, 2004; 291(3): p. 309-16.

A vocal minority

Dr Neil Black speaks with Pat Kelly about his experiences in the Irish Doctors Choir, an ensemble that raises important funds for charity while spreading musical joy

The origins of the Irish Doctors Choir (IDC) can be traced back to 2017, when the European Doctors Orchestra (EDO) was getting ready for a performance of Mahler’s Symphony No 2, Resurrection , at the Ulster Hall in Belfast. As the finale of this epic requires the inclusion of a chorus, the EDO set about recruiting singers from within Irish healthcare settings, as well as offering EDO-sponsored places to medical students. The affinity and common interest among the Irish doctors led to the formation of the IDC, with well-known Irish conductor, pianist, vocal coach, oboist, and chamber musician Mr Brian MacKay agreeing to assume the role of Musical Director.

The choir developed a repertoire for ‘pop-up’ performances in healthcare settings and some of their subsequent recitals included Rachmaninoff’s All-Night Vigil in Termonfeckin, Co Louth, to benefit local charity The Gary Kelly Cancer Support Centre. The choir has also performed in Our Lady of Lourdes Hospital, Drogheda, for patients and staff and held concerts in Cork in aid of the Mercy Hospital Foundation. Among the many other venues that have been graced by the choir are the Belfast City Hospital Cancer Centre, and the Mater Misericordiae University Hospital in Dublin.

Dr Neil Black is a Consultant Physician in Endocrinology and Diabetes at the Western Health and Social Care Trust, Altnagelvin Hospital, Derry, and IDC Committee Officer. He updated the Medical Independent (MI) on the choir’s activities and plans for the future, including its important fundraising endeavours.

“I had heard of the choir and I knew that a colleague had been asked to take part in the Mahler chorus, the first concert,” he explained.

“I then bumped into an academic at Queen’s University Belfast [who spoke about the choir] – I was a bit nervous at first that it might be beyond my capabilities, especially with the works of Mahler.”

However, Dr Black joined the choir’s second workshop and found he could cope very well with the musical requirements of the all-Ireland IDC.

“The IDC is set up so that we can work on it while we work with our home choirs,” he said.

“That means that we don’t do any performances over the Christmas period, because we are all so heavily committed to our local choirs. So the aim was to try to align our current commitments, as well as work commitments, so we usually hold an event each March and in November, just before the busy Christmas season.”

In November of 2021, the IDC held a residential workshop to record audio and video, which is currently being prepared to raise money for the charity Brain Tumour Ireland, which supports people living with the condition and their families.

“In March, we are going to meet up in Maynooth University chapel to perform and record Gabriel Fauré’s Requiem and perhaps some other pieces,” said Dr Black.

“There will be a small audience, which will probably be comprised of charity representatives, and we are going to live-stream that and sell tickets to raise money for Brain Tumour Ireland.”

Profound experience

Dr Black revealed that one of his favourite pieces to perform with the IDC was Mahler’s Symphony No 2

“Performing that was a really profound experience and very intense,” he said.

“The whole symphony lasts for over an hour, but the choral section lasts for 10-to-15 minutes – it’s quite short, but really intense and powerful, and doing that one was quite a formative experience. We also enjoyed doing some of Bach’s motets and cantatas in Dublin some years ago, and that was a phenomenal experience, technically speaking. They are quite complicated and exciting, and it came off really well. I hugely enjoyed that.”

Aside from the important charity work that they do, the collegiality within the IDC cannot be understated, said Dr Black.

“We are quite widely spread out on both sides of the border, which makes networking a little more difficult,” he said.

“I had previously met one of the professors from the south and being in the choir has meant that I get to see him more often, which is really nice. Particularly for those who work in similar areas, especially around Dublin, it has been really helpful because it has forged some links in different institutions.

“In musical terms, there is definitely an important networking benefit in meeting people with similar musical interests but from different professional backgrounds. Not everybody is able to come to every event, but there is a core of about 30 or 40 people whom we see at every event and it’s always really nice to see them again.”

Dr Black and his fellow choir members also kept in touch during the Covid lockdowns via online activities. “When we did get to meet in person again, there was a huge appreciation for just being together again, which was really lovely.”

A recent report by the Institute of Public Health that reviewed more than 70 international studies highlighted the importance of the arts in the ageing population, including singing. Among the take-home messages from the research was that music and singing confer improvements in cognitive function and improved emotional health, as well as improving sense of wellbeing, social connections, and overall quality-of-life. Whilst Dr Black is not in the ageing population demographic, he acknowledged the benefits of music and singing at any age.

“One of our members is Prof Des O’Neill, a professor in elderly care, who has been involved in some of the research and has written extensively on the benefits of the arts for health,” said Dr Black.

“Personally, there is a definite benefit to taking you out of your work space – there is a clearing of the mind that happens with the process,” he told MI

“The preparation, the feeling of achievement – doctors, pharmacists, and nurses, anyone who works in healthcare really, can be ground down by it. This is a time put aside where you can interact more naturally with people whom you would otherwise be working with. I would also definitely hold to the health benefits that singing provides, such as the breathing and clarity of the mind. Even during lockdowns, instead of live rehearsals, we had online sessions with the IDC, and that really was a breath of fresh air during those times.”

Achievement

The choir members all share something personally in preparing for a performance and delivering the recital, he explained, “but it also gives you a feeling of achievement; the experience of the preparation and singing is fantastic. When the piece finishes, there is always a feeling that it was all worthwhile, and you can see that in people’s smiles and the looks on their faces.”

The IDC is currently preparing for a performance of Fauré’s Requiem to be delivered via live-stream on 11-13 March as its 2022 Spring Concert. The choir will also be resident at Maynooth College for that weekend and will be performing in the College’s chapel on the Sunday afternoon, all in aid of Brain Tumour Ireland.

To find out more details about the IDC’s Spring Concert, to book a place, or to donate, visit https://irishdoctorschoir. ie/ or email: irishdoctorschoir@gmail.com

The IDC performing in Belfast

This is a time put aside where you can interact more naturally with people whom you would otherwise be working with

Dr Neil Black

Coverdine® (perindopril arginine/indapamide/amlodipine) Abbreviated Prescribing Information: Please refer to the Summary of Product Characteristics before prescribing. COMPOSITION* Coverdine 5mg/1.25mg/5mg film-coated tablets contains 5 mg perindopril arginine (per)/1.25 mg indapamide (ind)/5 mg of amlodipine (amlo); Coverdine 5mg/1.25mg/10mg film-coated tablets: 5 mg per/1.25 mg ind/10 mg amlo; Coverdine 10mg/2.5mg/5mg film-coated tablets: 10 mg per/2.5 mg ind/5mg amlo; Coverdine 10mg/2.5mg/10mg film-coated tablets: 10 mg per/2.5 mg ind/10 mg amlo. INDICATIONS* Substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level. DOSAGE AND ADMINISTRATION* One tablet per day, preferably in the morning and before a meal. The fixed dose combination is not suitable for initial therapy. If a change of the posology is required, titration should be done with the individual components. Paediatric population: should not be used. CONTRAINDICATIONS* Dialysis patients. Patients with untreated decompensated heart failure. Severe renal impairment (Clcr < 30 mL/min). Moderate renal impairment (Clcr < 60 mL/min) for Coverdine 10mg/2.5mg/5mg and 10mg/2.5mg/10mg. Hypersensitivity to the active substances, to other sulfonamides, to dihydropyridine derivatives, any other ACE-inhibitor or to any of the excipients. History of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy (see Warnings section). Hereditary/idiopathic angioedema. Second and third trimesters of pregnancy (see Warnings and Pregnancy and lactation sections). Hepatic encephalopathy. Severe hepatic impairment. Hypokalaemia. Severe hypotension. Shock, including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis). Haemodynamically unstable heart failure after acute myocardial infarction. Concomitant use of Coverdine with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60mL/min/1.73m2) (see Interaction section), concomitant use with sacubitril/valsartan (see WARNING* and INTERACTIONS*), extracorporeal treatments leading to contact of blood with negatively charged surfaces (see INTERACTIONS*), significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (see WARNING*).WARNINGS* Special warnings: Dual blockade of the renin-angiotensin-aldosterone system (RAAS): ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Neutropenia/agranulocytosis/thrombocytopenia/anaemia: caution if collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or combination of these complicating factors, especially if pre-existing impaired renal function. Monitoring of white blood cell counts. Renovascular hypertension: increased risk of hypotension and renal insufficiency in patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients with unilateral renal artery stenosis. Hypersensitivity/angioedema, intestinal angioedema: stop treatment and monitor until complete resolution of symptoms. Angioedema associated with laryngeal oedema may be fatal. Concomitant use of mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus): patients may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment). Combination with sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/valsartan must not be initiated until 36 hours after taking the last dose of perindopril therapy. Perindopril therapy must not be started until 36 hours after the last dose of sacubitril/valsartan. Concomitant use of other NEP inhibitors (e.g. racecadotril) and ACE inhibitors may also increase the risk of angioedema. Anaphylactoid reactions during desensitization: Caution in allergic patients treated with desensitization and avoid if venom immunotherapy. Temporarily withdrawal of ACE- inhibitor at least 24 hours before desensitization. Anaphylactoid reactions during LDL apheresis: Temporarily withholding ACE-inhibitor prior to each apheresis. Haemodialysis patients: consideration to use dialysis membranes other than high flux or antihypertensive agents other than ACE inhibitors. Primary aldosteronism: use not recommended in patients with primary hyperaldosteronism (not responding to drugs acting through inhibition of the renin-angiotensin system). Pregnancy: no initiation during pregnancy, stop treatment and start alternative therapy if appropriate. Hepatic encephalopathy which can progress to hepatic coma: stop treatment. Photosensitivity: stop treatment. Precautions for use: Renal function: In certain hypertensive patients without pre-existing apparent renal lesions and for whom renal blood tests show renal insufficiency, stop treatment and restart at a low dose or with one constituent only. Monitoring of potassium and creatinine, after two weeks of treatment and then every two months during therapeutic stability period. If bilateral renal artery stenosis or single functioning kidney: not recommended. Risk of arterial hypotension and/or renal insufficiency (in cases of cardiac insufficiency, water and electrolyte depletion, in patients with low blood pressure, renal artery stenosis, congestive heart failure or cirrhosis with oedema and ascites): start treatment at low doses and increase progressively. Hypotension and water and sodium depletion: Risk of sudden hypotension in presence of pre-existing sodium depletion (in particular if renal artery stenosis): Monitoring of plasma electrolytes, re-establish blood volume and pressure, restart treatment at a reduced dose or with only one of the constituents. Sodium levels: More frequent monitoring in elderly and cirrhotic patients. Potassium levels: Hyperkalaemia: Monitoring of serum potassium if renal insufficiency, worsening of renal function, age (> 70 years), diabetes mellitus, intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis and concomitant use of potassium-sparing diuretics, potassium supplements or potassium salts, or other drugs associated with increases in serum potassium. Hypokalaemia: high risk for elderly and/or malnourished subjects, cirrhotic patients with oedema and ascites, coronary patients, patients with renal failure or heart failure, long QT interval: monitoring of serum potassium, may cause muscle disorders and rhabdomyolysis, may favour the onset of torsades de pointes, which may be fatal. Calcium levels: hypercalcemia: stop treatment before investigating the parathyroid function. Renovascular hypertension: if renal artery stenosis: start treatment at hospital at low dose; monitor renal function and potassium. Dry cough. Atherosclerosis: start treatment at low dose in patients with ischaemic heart disease or cerebral circulatory insufficiency. Hypertensive crisis. Cardiac failure/severe cardiac insufficiency: Caution if heart failure. Severe cardiac insufficiency (grade IV): start treatment under medical supervision with reduced initial dose. Aortic or mitral valve stenosis / hypertrophic cardiomyopathy: Caution if obstruction in the outflow tract of the left ventricle. Diabetic patients: If insulin dependent diabetes mellitus, start treatment under medical supervision with reduced initial dose; monitor blood glucose during the first month and/or in the case of hypokalaemia. Black people: higher incidence of angioedema and apparently less effective in lowering blood pressure than in non-blacks. Surgery / anaesthesia: stop treatment one day before surgery. Hepatic impairment: Mild to moderate: caution. Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Stop treatment if jaundice or marked elevations of hepatic enzymes. Uric acid: hyperuricemia: Increased tendency to gout attacks. Elderly: testing of renal function and potassium levels before treatment start. Dosage increase with care. Excipients: sodium-free. Choroidal effusion, acute myopia and secondary angle-closure glaucoma: discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Athletes: may cause positive doping test. INTERACTION(S)* Contraindicated: Aliskiren in diabetic or impaired renal patients, Extracorporeal treatments, Sacubitril/Valsartan. Not recommended: Lithium, Aliskiren in patients other than diabetic or impaired renal patients, Concomitant therapy with ACE inhibitor and angiotensin-receptor blocker, Estramustine, Potassium-sparing drugs (e.g triamterene,amiloride,…), Potassium salts, Co-trimoxazole (trimethoprim/sulfamethoxazole), Dantrolene (infusion), Grapefruit or grapefruit juice. Special care: Baclofen, Non-steroidal anti- inflammatory medicinal products (included acetylsalicylic acid at high doses), Antidiabetic agents (insulin, hypoglycaemic agents), Non-potassium-sparing diuretics and Potassium-sparing diuretics (eplerenone, spironolactone), Racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus), Torsades de pointes inducing drugs, Amphotericin B (IV route), glucocorticoids and mineralocorticoids (systemic route), tetracosactide, stimulant laxatives, Cardiac glycosides, Allopurinol, CYP3A4 inducers, CYP3A4 inhibitors. To be taken into consideration: Imipramine- like antidepressants (tricyclics), neuroleptics, other antihypertensive agents and vasodilatators, tetracosactide, Allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide, Anaesthetic drugs, Diuretics (thiazide or loop diuretics), Gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin), Sympathomimetics, Gold, Metformin, Iodinated contrast media, Calcium (salts), Ciclosporin, Atorvastatin, digoxin, warfarin, Tacrolimus, Simvastatin. PREGNANCY AND BREASTFEEDING* Contraindicated during the second and third trimesters of pregnancy. Not recommended during the first trimester of pregnancy and lactation. FERTILITY* Reversible biochemical changes of spermatozoa in some patients treated by calcium channel blockers. DRIVE & USE MACHINES* May be impaired due to low blood pressure that may occur in some patients, especially at the start of treatment. UNDESIRABLE EFFECTS* Very common: oedema. Common: dizziness, headache, paraesthesia, vertigo, somnolence, dysgeusia, visual impairment, diplopia, tinnitus, palpitations, flushing, hypotension (and effects related to hypotension), cough, dyspnoea, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, change of bowel habit, pruritus, rash, rash maculo-papular, muscle spasms, ankle swelling, asthenia, fatigue. Uncommon: rhinitis, eosinophilia, hypersensitivity, hypoglycaemia, hyperkalaemia reversible on discontinuation, hyponatraemia, insomnia, mood altered (including anxiety), depression, sleep disorder, hypoaesthesia, tremor, syncope, tachycardia, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, bronchospasm, dry mouth, urticaria, angioedema, alopecia, purpura, skin discoloration, hyperhidrosis, exanthema, photosensitivity reaction, pemphigoid, arthralgia, myalgia, back pain, micturition disorder, nocturia, pollakiuria, renal failure, erectile dysfunction, gynaecomastia, pain, chest pain, malaise, oedema peripheral, pyrexia, weight increased, weight decreased, blood urea increased, blood creatinine increased, fall. Rare: confusional state, blood bilirubin increased, hepatic enzyme increased, psoriasis aggravation. Very rare: agranulocytosis, aplastic anaemia, pancytopenia, leukopenia, neutropenia, haemolytic anaemia, thrombocytopenia, allergic reactions, hyperglycaemia, hypercalcaemia, hypertonia, neuropathy peripheral, stroke possibly secondary to excessive hypotension in high-risk patients angina pectoris, myocardial infarction, possibly secondary to excessive hypotension in high risk patients, eosinophilic pneumonia, gingival hyperplasia, pancreatitis, gastritis, hepatitis, jaundice, hepatic function abnormal, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, Quincke’s oedema, acute renal failure, haemoglobin decreased and haematocrit decreased. Not known: Potassium depletion with hypokalaemia, particularly serious in certain high risk populations, extrapyramidal disorder (extrapyramidal syndrome), myopia, vision blurred, acute angle-closure glaucoma, choroidal effusion, torsades de pointes (potentially fatal), rhabdomyolysis, muscular weakness, possibility of onset of hepatic encephalopathy in case of hepatic insufficiency, possible worsening of pre-existing systemic lupus erythematosus, electrocardiogram

QT prolonged, blood glucose increased, blood uric acid increased. Raynaud’s phenomenon. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) can be considered as a very rare complication associated with ACE inhibitor therapy. OVERDOSE* PROPERTIES* Perindopril is an inhibitor of the angiotensin converting enzyme (ACE inhibitor) which converts angiotensin I to angiotensin II. Indapamide is a sulfonamide derivative with an indole ring, pharmacologically related to the thiazide group of diuretics. Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. PRESENTATION* Box of 30 tablets of Coverdine 5mg/1.25mg/5mg, 5mg/1.25mg/10mg, 10mg/2.5mg/5mg and 10mg/2.5mg/10mg.

Marketing Authorisation Holder: LES LABORATOIRES SERVIER, 50 rue Carnot, 92284 Suresnes cedex France. www.servier.com. PA0568/024/002-005. Legal Classification for Supply: POM. Local Representative in Ireland: Servier Laboratories (Ireland) Ltd. Second Floor, 19 George’s Street Lower, Dun Laoghaire, Co. Dublin A96 ER84, Ireland . Tel (01) 6638110, www.servier.ie.

*For complete information, please refer to the Summary of Product Characteristics for Coverdine on www.medicines.ie.

Date of last revision of text: July 2021 (Date of last approved SmPC: July 2021) Date of preparation: September 2021. 2122C1CDEPressADCBU.

References: 1. Tòth K, on behalf of the PIANIST Investigators. Am J Cardiovasc Drugs. 2014. DOI 10.1007/s40256-014-0067-2. 2. Pall D et al, Hypertonia és Nephrologia. 2012;16(3-4):119-123. 3. Coverdine SmPC July 2021.

Covid-19 – Back to the future

An upcoming RCPI webinar will discuss the latest developments in the pandemic and include insights on the Israeli vaccination programme

The Institute of Medicine at the RCPI is bringing together leading Irish and international experts on a webinar to share updates and discuss what is now known about Covid-19.

This evening webinar on Wednesday 26 January, themed ‘Covid-19: Back to the Future’, is the latest in an ongoing series of RCPI Covid-19 updates over the last two years. Experts will discuss the latest developments in the pandemic, focussing on the fourth round of vaccinations in Israel, the Omicron variant and the role that antivirals will play going forward. The webinar will also feature some clinical case studies and is free for healthcare professionals.

The event will be chaired by RCPI President Prof Mary Horgan and Dean of the Institute of Medicine

Prof Anthony O’Regan. They will be joined by four leading voices in infectious disease medicine – Dr Tal Brosh, Head of the infectious diseases unit in the Samson Assuta Ashdod University Hospital, Ashdod, Israel; Prof Paddy Mallon, Professor of Microbial Diseases in the University College Dublin School of Medicine and Consultant in Infectious Diseases in St Vincent's University Hospital, Dublin; Dr Catherine Fleming, Consultant in Infectious Disease at Galway University Hospital; and Prof Colm Bergin, Consultant Physician in Infectious Diseases at St James’s Hospital, Dublin.

Ahead of this event, Prof O’Regan, Consultant in Respiratory and Internal Medicine at University Hospital Galway, has stressed the importance of keeping the broader community of healthcare professionals up to date with the latest developments in regard to Covid-19.

“Remarkably, it is now almost two years since the first case in Ireland. We're still learning as we go. Since the beginning, we have tried to share as much information as possible through educational webinars to help create a strong network of shared and evolving expertise.”

Prof Horgan – a Consultant in Infectious Diseases who practices on the frontline in Cork University Hospital, as well as serving on the national public health emergency team –feels that it is crucial to use every tool at our disposal to tackle this and any future waves.

“What we've learned during this pandemic is that the virus is predictably unpredictable, so it is really important now that we start planning how best to use the tools that we have developed to protect us, both individually and collectively.”

Israel

Dr Brosh is the keynote speaker, bringing insights from Israel, a country that is now administering fourth doses of vaccines and providing data that is being studied around the world on how they are dealing with Covid-19. Since 2010, Dr Brosh has served as Secretary of the advisory committee on epidemic control in the Israeli Ministry of Health, which has become the professional board for Covid-19 response. He is now co-Chairman of the advisory board on Covid-19 vaccines.

According to Dr Brosh, the recent rise of the Omicron variant presented a new challenge in decision-making, in terms of where the Israeli vaccination campaign needed to go next. “The global epidemic of the Omicron variant found the Israeli population with a fairly ‘mature’ booster – more than four or five months – and often among the most vulnerable individuals. Waning immunity was again suspected to contribute, and a decision to administer a second booster was taken lately. In my talk, I will try to present the dilemmas we confronted and the scientific background to our decisions.”

It is well documented that Israel has been at the forefront of early vaccination, reaching high population coverage in a short period of time with their primary campaign and making a clear impact on Covid-19 infections and morbidity. Coinciding with the rise of the Delta variant in June 2021, the surge in infec-

tions and resulting research found waning immunity to be the key contributory factor. The booster campaign that ensued had a remarkable impact and once again provided a blueprint for other nations to combat waning immunity in their populations.

Antivirals

Prof Bergin is the National Specialty Director for Infectious Diseases at the RCPI and Dean of Postgraduate Medical Training at the RCPI. His talk will provide an update on managing acute Covid-19 in which he will outline the role of emerging antiviral drug treatments.

“The advent of new therapies for the management of Covid-19 will serve as an additional element of the armamentarium to fight the pandemic,” Prof Bergin said. “It is, however, important to assess how these new therapies will contribute to patient outcomes and societal recovery in the setting of a well-vaccinated population and emergence of a new variant of disease, both important factors when reviewing the data available.

“Antiviral stewardship incorporating clinical governance, outcome measurement, patient safety surveillance, and fiscal accountability will be central to the programme being established.”

Infectious disease specialists

Dr Fleming will look at some clinical cases that will be relevant to doctors and health-

care professionals dealing with the disease in patients. Dr Fleming was appointed as the first Consultant in Infectious Disease at Galway University Hospital in 2004 and has since gone on to establish a comprehensive clinical service comprising of general infectious diseases, HIV, sexual health, tuberculosis, hepatitis B and, most recently, Covid-19. She is the Co-Lead of the Infectious Diseases Clinical Care Programme with a focus on Covid diagnosis and management over the past 12 months.

Another infectious disease specialist speaking at this virtual event will be Prof Mallon who will discuss the Omicron variant, as well as the potential for the emergence of further variants of concern in the future.

As a past-President of the Infectious Diseases Society of Ireland (IDSI), he joins a full line-up of IDSI committee members for this event, a group that Prof O’Regan said have been leaders in the management of this virus.

“There’s no doubt that the infectious disease specialists have led out on this, taking on a huge responsibility. Those are the people who have been very much at the frontline – not to say that other people haven't –but it's important to recognise that.”

Prof Horgan, also an IDSI committee member, stated that one of the key values of the RCPI is the widespread sharing of information. “The important thing is that we have a wide network and that we share our experiences – both scientifically and clinically – within that network. And it's great that we're able to leverage on the expertise of other countries to share their knowledge with us. I think that has been really important for the College and for our members and Fellows, that we can access that network.”

Over the last 22 months, the RCPI has held over 30 educational webinars, hybrid and in-person events on Covid-19, connecting thousands of doctors and other healthcare professionals and sharing expertise on how to treat this new disease.

Speaking ahead of the event, Prof O’Regan said he anticipates that we will see a shift from acute Covid-19 care in the acute hospital to a predominantly primary care-based approach in the future. “With the impact of vaccination and antivirals, it is hoped that the vast majority of people with Covid-19 infection will be managed in the community, and hopefully with only mild symptoms.”

For Prof Horgan, the future of the pandemic will be all about “being aware of the uncertainties that come with SARS CoV-2 infection, utilising the tools that we have at our disposal to protect our most vulnerable and scanning the horizon to ensure we are prepared for whatever the virus throws at us next”.

The advent of new therapies for the management of Covid-19 will serve as an additional element of the armamentarium to fight the pandemic

Prof

Mary Horgan

Prof Anthony O'Regan

This article was produced by the RCPI. The Institute of Medicine: Covid-19: Back to the Future webinar takes place on 26 January at 5pm and is free for all attendees. Visit www.rcpi.ie to book a place.

At the time of writing, Covid-19 cases are coming down. After record numbers over the Christmas period, driven by the Omicron variant, there is some light at the end of the tunnel. Although Omicron is the most contagious variant to date, thankfully it is not the most severe.

Earlier this month, World Health Organisation Incident Manager Dr Abdi Mahamud confirmed emerging evidence that Omicron affects the upper respiratory tract, rather than the lungs. This mainly results in milder symptoms than those associated with previous variants, which were more likely to cause pneumonia. It was noted that more studies would be required to confirm this finding. It was also pointed out that the high transmissibility of Omicron still posed a threat, particularly to countries where a high proportion of the population remain unvaccinated.

So, what now? In Ireland, the timetable for lifting restrictions has been dominating the news agenda, as it does whenever case numbers fall. As we all know by now, a public health emergency does not go away just because restrictions lift. However, some predict Omicron’s rapid spread will push Covid-19 from the pandemic phase to endemic. Vaccination will still be necessary, in addition to other measures, even if this transition occurs. It is more than likely Covid is here to stay. The hope is that in the not-too-distant future it will infect a lot fewer people and be less dangerous.

It is still far from certain how

the pandemic will evolve. A more lethal, vaccine-resistant variant could yet emerge. This scenario has more chance of coming to pass without greater commitments to global solidarity and vaccine equity to halt the spread of Covid in poorer nations.

Plans will need constant updating in order to respond to potential threats. At the same time, the regular work of Government continues. Health services have been under enormous pressure over the past two years and many existing problems have gotten worse. The IHCA recently reiterated that the “twin deficits” of a shortage of consultants and a lack of sufficient public hospital capacity needed to be addressed. The warning came as it emerged 879,277 people are now on some form of National Treatment Purchase Fund waiting list. This is an increase of over 40,600 in the past year.

“Unfortunately, with the recent increases in Covid cases, overcrowding in our emergency departments and widespread cancellation of essential scheduled care and outpatient appointments, there is little prospect of the waiting list coming under control any–time soon,” warned President of the IHCA Prof Alan Irvine.

“This is simply not good enough, irrespective of the pressures we are facing during this latest Covid wave.”

Reducing waiting lists proved difficult for previous administrations even when there was no pandemic. But this is a challenge the Government will have to face, which will not be easy even when society emerges from crisis mode.

MINDO CARTOON

READER COMMENTS

REACTION TO OUR NEWS FEATURE, 'OPIOIDS IN IRELAND: ARE WE HEADING TOWARDS A US-STYLE CRISIS', 13 JANUARY

"Delays for public patients (orthopaedic access) and decent physio definitely a contributory factor here ?" Dr Brendan O'Shea, @drbosheaGP, 13 January

"Replying to @drbosheaGP: As someone waiting years on various medical appointments right now I would suggest more than contributory factor. I'm not on opioids, but I have friends who are waiting so long and their GPs have zero options left but to try opioids to help them function while they wait.... Further issue is, by the time they do get those appointments and then wait again on treatments they are often so bad the outcomes are poor. If treated early, physio, surgery, etc, can dramatically improve quality-of-life." Orla, @OrlaNiMhaoinigh, 13 January

REACTION TO OUR NEWS FEATURE, 'DOCTORS LEADING ON CLIMATE ACTION IN 2022', 13 JANUARY

"A great article on the medical profession's role in leading on climate action, with interviews from IDE committee members @colmpbyrne and @thefamilycurse. IDE is open to anyone working in healthcare, check out http://IDE.ie to learn more and join!" Irish Doctors for the Environment, @IrishDocsEnv, 13 January

"One way of lifting yourself from the constant negativity that can pollute healthcare and related organisations is to get involved and work towards the solutions! IDE are open to anyone from Greta wannabes to having a passion for all things nature/climate/equality...." Dr Sean Owens, @thefamilycurse, 13 January

"If you are a healthcare professional and want to do something about the climate crisis please join @IrishDocsEnv. You don't need to have any prior knowledge or involvement in environmental issues. Just that you want to do something." Dr Colm Byrne, @colmpbyrne, 13 January

"Congrats @thefamilycurse – great to see GPs leading out on this most important (yes it is THE most important) issue." Dr Austin O'Carroll, @austinoc_austin, 12 January

REACTION TO OUR NEW STORY, 'NEW LEARNING ANALYTICS UNIT FOR HEALTH PROFESSIONALS', 13 JANUARY

"Fantastic step forward, delighted @COAIrl are taking a leading role."

Dr Murray Connolly, @Murray_Connolly, 17 January

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Challenges remain even if Covid-19 becomes endemic

Developing the right mindset to manage complaints

Dr Michael Devlin , Head of Professional Standards and Liaison, Medical Defence Union, provides advice on how to respond to complaints during the Covid-19 pandemic

With the second anniversary of the pandemic now looming, the effort of battling Covid-19 continues to exert a relentless toll on hospital staff and their patients.

The impact of the pandemic on waiting times has been particularly significant, according to the latest Health in Ireland Key Trends report from the Department of Health. It stated: “As of October 2021, there were 28,383 adults waiting six months or more for an elective procedure, an increase of over 25 per cent on March 2020.”

And in December, the IHCA warned that there were 897,153 people on waiting lists to be treated or assessed by a consultant, an increase of 58,478 people (7 per cent) since the start of 2021.

Such delays are hugely frustrating for doctors who are unable to provide the optimum level of care and for patients facing a long wait to see a specialist about a chronic health condition or worrying symptoms.

As a result, it’s important to consider how to communicate with patients about waiting times, delayed treatment or a delayed diagnosis and how best to handle complaints that may arise.

Based on the Medical Defence Union’s experience of advising members, here are our suggestions to help you to minimise matters from escalating.

Pre-empt problems with

good communication

Many complaints arise because patients feel they haven’t received care in a way they expected or within an expected timescale. Clear and honest communication at the outset is therefore key to managing expectations and pre-empting problems, as well as underpinning patient care, according to Medical Council guidelines.

Ensure patients appreciate the potential timescale for test results or referral appointments – be realistic rather than over-promise. Give them a clear plan of what to do should their condition not improve or worsen; or if they do not hear from another service within a certain timeframe.

Bear in mind that anxious patients may not take in everything you say so check their understanding and ask if they have any questions during a consultation, rather than as they are going out the door. This will give you an opportunity to identify and clarify any misunderstandings before they become a cause for dissatisfaction.

Prioritise record-keeping

Longer waiting times make it more likely that patients will present to another member of the team if symptoms do not resolve or their condition worsens. Effective record-keeping should help your colleagues ensure continuity of care so patients do not feel they are starting all over again

and help reduce the risk of things slipping through the net.

After each patient interaction, document what has taken place, including relevant findings on examination (including what you looked for, but didn’t find), tests, the safety netting advice given, details of any referral made, and any discussion relating to advice given or obtaining consent.

In the event of a complaint, clear records, which are made at the time, can also be invaluable in understanding what happened and in responding to concerns.

Approach complaints in good faith

It’s natural to feel dispirited when receiving a complaint, especially if the circumstances are beyond your control. However, research shows that patients’ motivations are often straightforward – such as the need for answers about their care and the desire to prevent someone else having the same experience.

If someone is critical of the care they have received, your response could make the difference between resolving the matter quickly and seeing it escalate. By understanding and addressing the cause of dissatisfaction, you have a better chance of resolving the complaint at an early stage. Reacting defensively is likely to make matters worse.

Recognise and respond quickly to concerns where possible

Any patient can say they are not happy with the service they receive, but at what point should this trigger an organisation’s complaints procedure? The simplest approach is to ask the patient. If frontline staff are trained to respond to all expressions of unhappiness with an apology and questions (such as “How has this affected you?” and “What can I do to put this

right?”), many verbal complaints may be dealt with quickly and informally.

While this may not always be possible, it is clearly better to try and settle complaints at an early stage by responding professionally to the concerns raised by the patient. The HSE’s complaints handling policy calls this approach ‘point of contact resolution’ and requires it to be completed within two working days. The HSE says staff should “provide an apology/explanation where possible and avoid apportioning blame, being argumentative or defensive”. If you are unable to deal with the issue, you will need to escalate it to your line manager, while reassuring the complainant that their complaint has been “listened to, understood, and [outlining] how this complaint will be handled beyond this point”.

Cooperate with your organisation’s complaints officer

If a complaint is made in writing it will fall to your organisation’s complaints officer to contact the complainant within two working days with an offer to meet with them, along with the clinical director or another senior member of staff. If the matter is resolved, a letter summarising what happened is sent to the complainant and the doctors involved may be sent a summary of the concerns raised.

When a complaint is not settled after a meeting, or if the complainant declines this offer, a formal complaint investigation begins and you may be asked to help your organisation put together a full written response. It is important to respond promptly as organisations are expected to issue a full response to the complainant within 30 working days or, if this is not possible, to update the complainant every 20 days regarding progress.

Although many complaints should be resolved either at the point of contact or after a written response, some may proceed to either an HSE internal complaint review or an external, independent review (eg, by the Ombudsman). Complaints that escalate in this way may signal an increased risk that the matter could be reported to the Medical Council. Therefore, it is important to seek advice at an early stage from your medical defence organisation if you are involved in an escalating complaint.

Getting a complaint response right first time is the best way to settle patients’ concerns and to reduce the risk that a complaint will escalate. Set aside adequate time and discuss the concerns raised with other team members, seeking advice if required. If you have been asked for an account of your clinical care, this should be a factual, chronological statement written with close reference to the clinical records and any relevant guidelines you followed. It is perfectly reasonable to refer to your recollection of events or your usual practice, even if not detailed specifically in the records, if this helps you to explain what you did and why.

Be sure to address all the questions that relate to your involvement. Even when the concerns don’t match your own recollection or if you believe a complaint has no merit, acknowledging the patient’s experience shows empathy and can help heal the doctor-patient relationship. Equally, it can be helpful to show that you have reflected on the issues raised in a complaint, including the learning points you have identified and addressed and how you will change your practice as a result. As mentioned earlier, complainants often want to know that something has changed and evidence of reflective practice, in line with Medical Council guidance, is one method of doing this.

Apologies are not an admission of liability

To maximise the chance of resolving the complaint, the hospital’s response is likely to be conciliatory in tone and perhaps include an apology. Contrary to the fears of many doctors, this should not be seen as an admission of wrongdoing, but recognition that things could have been done differently, even in cases where the overall care was reasonable.

Seek advice

Finally, being involved in complaints is upsetting for patients and colleagues alike. Seek support from your peers or your medical defence organisation if you are facing a complaint – don’t try to go it alone.

MDU membership is open to consultants and hospital doctors not currently in training posts working in public hospitals. To find out more information, visit www.themdu.com/ireland or follow us on Twitter @the_md

For patients not adequately controlled on dual therapy with moderate to severe COPD

UNLEASH THE PROTECTION OF TRIXEO1,2

Significant protection against exacerbations*

TRIXEO Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.1

*Significant reductions in the rate of moderate or severe exacerbations vs LAMA/LABA (24%, n=2137 vs n=2120, annual rates 1.08 vs 1.42, 95% CI 0.69–0.83; p<0.001) and ICS/LABA (13%, n=2137 vs n=2131, annual rates 1.08 vs 1.24, 95% CI 0.79–0.95; p=0.003).1,2 COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist. In the clinical trial programme for TRIXEO, LAMA/LABA refers to glycopyrronium/formoterol fumarate and ICS/LABA refers to budesonide/formoterol fumarate. ©AstraZeneca 2021. All rights reserved.

ABRIDGED PRESCRIBING INFORMATION

TRIXEO AEROSPHERE ® 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension (formoterol fumarate dihydrate/glycopyrronium/budesonide)

Consult Summary of Product Characteristics (SmPC) before prescribing

Indication: Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Presentation: Pressurised inhalation, suspension. Each single actuation (delivered dose, ex-actuator) contains 5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2 micrograms of glycopyrronium and budesonide 160 micrograms.

Dosage and Administration: The recommended and maximum dose is two inhalations twice daily (two inhalations morning and evening). If a dose is missed, take as soon as possible and take the next dose at the usual time. A double dose should not be taken to make up for a forgotten dose. Special populations: Elderly: No dose adjustments required in elderly patients.

Renal impairment: Use at recommended dose in patients with mild to moderate renal impairment. Can also be used at the recommended dose in patients with severe renal impairment or end-stage renal disease requiring dialysis, only if expected benefit outweighs the potential risk. Hepatic impairment: Use at recommended dose in patients with mild to moderate hepatic impairment. Can also be used at the recommended dose in patients with severe hepatic impairment, only if expected benefit outweighs the potential risk. Paediatric Population: No relevant use in children and adolescents (<18 years of age). Method of administration: For inhalation use.

To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient’s inhalation technique. Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product..

Contraindications: Hypersensitivity to the active substances or to any of the excipients.

Warnings and Precautions: Not for acute use: Not indicated for treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. Paradoxical bronchospasm: Administration of formoterol/glycopyrronium/budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life threatening. Treatment should be discontinued immediately if paradoxical bronchospasm occurs.

Assess patient and institute alternative therapy if necessary. Deterioration of disease: Recommended that treatment should not be stopped abruptly. If patients find the treatment ineffective, continue treatment but seek medical attention. Increasing use of reliever bronchodilators indicates worsening of the underlying condition and warrants reassessment of the therapy. Sudden and progressive deterioration in the symptoms of COPD is potentially life threatening, patient should undergo urgent medical assessment.

Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol. Use with caution in patients with clinically significant uncontrolled and severe cardiovascular disease such as unstable ischemic heart disease, acute myocardial infarction, cardiomyopathy, cardiac arrhythmias and severe heart failure. Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males or > 470 milliseconds for females), either congenital or induced by medicinal products. Systemic corticosteroid effects: May occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with

inhalation treatment than with oral corticosteroids. Systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma. Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have co existing risk factors for osteoporosis. Visual disturbances: May be reported with systemic and topical corticosteroid use. If patient presents symptoms such as blurred vision or other visual disturbances, consider ophthalmologist referral for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR). Transfer from oral therapy: Care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia: Potentially serious hypokalaemia may result from ß2-agonist therapy. This has potential to produce adverse cardiovascular effects. Caution is advised in severe COPD as this effect may be potentiated by hypoxia. Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics. Hyperglycaemia: Inhalation of high doses of ß2-adrenergic agonists may produce increases in plasma glucose. Blood glucose should be monitored during treatment following established guidelines in patients with diabetes.

Co-existing conditions: Use with caution in patients with thyrotoxicosis. Anticholinergic activity: Due to anticholinergic activity, use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop. Co-administration of this medicinal product with other anticholinergic containing medicinal products is not recommended. Renal impairment: Patients with severe renal impairment (creatinine clearance of <30 mL/min), including those with end-stage renal disease requiring dialysis, should only be treated with this medicinal product if the expected benefit outweighs the potential risk. Hepatic impairment: In patients with severe hepatic impairment, use only if the expected benefit outweighs the potential risk. These patients should be monitored for potential adverse reactions..

Drug Interactions: Co-treatment with strong CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products are expected to increase the risk of systemic side effects. Should be avoided unless the benefit outweighs the increased risk, in which case patients should be monitored for systemic corticosteroid adverse reactions.

This is of limited clinical importance for short-term (1-2 weeks) treatment.

Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms. Other antimuscarinics and sympathomimetics: Coadministration with other anticholinergic and/or long-acting ß2-adrenergic agonist containing medicinal products is not recommended as it may potentiate known inhaled muscarinic antagonist or ß2-adrenergic agonist adverse reactions. Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects. Caution required when prescribed concomitantly with formoterol. Medicinal product-induced hypokalaemia: Possible initial hypokalaemia may be potentiated by xanthine

derivatives, steroids and non potassium sparing diuretics. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. β -adrenergic blockers: ß-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concurrent use of ß-adrenergic blockers should be avoided unless the expected benefit outweighs the potential risk. If required, cardio-selective ß-adrenergic blockers are preferred. Other pharmacodynamic interactions: Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong QT interval and increase the risk of ventricular arrhythmias.

L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics. Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. Elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.

Pregnancy and Lactation: Administration to pregnant women/women who are breast-feeding should only be considered if the expected benefit to the mother justifies the potential risk to the foetus/child.

Ability to Drive and Use Machines: Dizziness is an uncommon side effect which should be taken into account.

Undesirable Events: Consult SmPC for a full list of side effects. Common (≥ 1/100 to < 1/10): Oral candidiasis, pneumonia, hyperglycaemia, anxiety, insomnia, headache, palpitations, dysphonia, cough, nausea, muscle spasms, urinary tract infection. Uncommon (≥ 1/1,000 to < 1/100): Hypersensitivity, depression, agitation, restlessness, nervousness, dizziness, tremor, angina pectoris, tachycardia, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles), throat irritation, bronchospasm, dry mouth, bruising, urinary retention, chest pain. Very Rare (< 1/10,000): Signs or symptoms of systemic glucocorticosteroid effects, e.g. hypofunction of the adrenal gland, abnormal behaviour. Not known: Angioedema, vision blurred, cataract, glaucoma.

Product subject to prescription which may be renewed (B)

Legal Category:

Marketing Authorisation Number: EU/1/20/1498/002 120 actuations

Marketing Authorisation Holder: AstraZeneca AB, SE-151 85, Södertälje, Sweden. Further product information available on request from: AstraZeneca Pharmaceuticals (Ireland) DAC, Block B, Liffey Valley Office Campus, Dublin 22. Tel: +353 1 609 7100.

TRIXEO and AEROSPHERE are trademarks of the AstraZeneca group of companies.

Date of API preparation: 10/2021

Veeva ID: IE-3166

Adverse events should be reported directly to; HPRA Pharmacovigilance, Website: www.hpra.ie Adverse events should also be reported to AstraZeneca Patient Safety on Freephone 1800 800 899

1. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. Summary of Product Characteristics. Available at www.medicines.ie

2. Rabe KF et al. Triple inhaled therapy at two glucocorticoid doses in modeate-to-very-severe COPD. N Engl J Med. 2020;383:35–48. doi: 10.1056/ NEJMoa1916046 COPD. N Engl J Med. 2020;383:35–48. doi: 10.1056/NEJMoa1916046

What I miss and don’t miss about being a GP

The constant worry over potential mistakes is something I am glad to have left behind when I changed career

DR SARAH FITZGIBBON

Read more by Dr Sarah Fitzgibbon at www.mindo.ie @SarahFitzWiMIN

Three months ago I changed my life. I stopped getting into my car to go to work, travelling across the river and up the hill. I folded my relatively new scrubs and put them in the back of the wardrobe. The cloth bag containing my stethoscope and sphyg was flung under the stairs, to join the tatty sharp-edged leather doctor’s bag that I had abandoned years ago because it bruised my calves as I lugged it up narrow northside staircases. I walked away from the life of a jobbing GP and settled myself into my small home office; slippers on, coffee machine gurgling, laptops humming.

What do I miss? Honestly, the first thoughts that spring to mind are the things that I don’t miss. I don’t miss that very faint yet omnipresent little niggling worry that today will be the day that I make a ‘big mistake’. Every day as a doctor we try our best, or at least we try to try our best. But there have been plenty of days with a seat-of-the-pants feeling to them, where the universe has somehow managed to save our bacon and, more importantly, the patient’s bacon, by subtly nudging us to double-check that INR or feel that thready pulse. There is a sense of thin-ice skating that some people thrive on, some people ignore, and which gives me low-level gastric ulceration. It is only when that threat has waned that I begin to count the number of sleepless nights over the

years, which have been spent going over the day’s clinical scenarios, wondering what tragic mistake I have made, waiting for the hours to pass so that I can rush to work to call yesterday’s heartburn lady and assure myself that she hasn’t ruptured her aorta overnight. (What do patients make of those seemingly innocuous phone calls, I wonder? Do they realise that when we casually say that we’re “just checking in to see how they are doing”, that what we really mean is we are checking that we haven’t killed them with our incompetence?)

Then there is the worry of the worry that you didn’t worry about. The patient that you thought no more about as soon as the door was closed behind them. The universe gave you no hint, no nudge, no metaphorical tap on the shoulder to remind you to check their allergies or feel their tummy. Your brain is devoid of any niggly concern about them until you see their name emblazoned underneath an expensive ivory letterhead from Messrs Gotcha

and Fleece Esq, with words like negligent and culpable swimming in front of your eyes. You still have no idea what was wrong with the patient, but you know for sure what is wrong with you and it is cold dark terror.

So I don’t miss that, though I am under no illusion that a thick cream envelope cannot still make its way through my letterbox. But there is an element of relief in knowing that I am not accumulating additional potential sources of litigation as the days pass.

What I do miss is the physical energy and warmth that comes from sharing space with another person. Smiling, chatting, observing each other’s movements. There is a dance to interpersonal interaction that is fluid and serene, while at the same time unpredictable and tense. My body misses that waltz.

I miss the worthiness of being useful. My children used to express surprise when they heard that I used to work in a hospital, “like a real doctor.” The cosy confines of a general practice surgery did not fulfil their expectations for the workplace of a life-saving hero. I thought I could stoop no lower in their estimations, until I started to go to work upstairs in the back room. In my slippers. Now I am about as heroic to them as an old sock.

I went back to the real world to give some booster jabs over Christmas (a full 10 days of holidays in late December was simply a bridge too far for my psyche to take, after years of simply being grateful to have Christmas Day off). I got to waltz again for a few hours, and chat and smile behind the FFP2. I also got to lie in bed for hours wondering if the last man I sent out the door was now lying dead behind a skip having had a massive anaphylaxis because I forgot to ask him if he was allergic to Movicol.

GPs and the challenge of frequent attenders

Recent research into the pattern of general practice consultations in the UK raises interesting questions

munity have all added to this pressure.

To explore the issue more deeply, the researchers set out to analyse the type and distribution of consultations within general practices, with a particular focus on frequent attenders.

For most areas of clinical practice, there is a sharp difference between before Covid (BC) and after Covid (AC). As we enter the third year of pandemic life, it is easy to forget what practice was like prior to March 2020. But it’s no harm to be reminded of the challenges we faced back then, as in many cases they haven’t gone away.

General practice has been under significant pressure for at least a decade. BC, consultation rates were climbing steadily and paperwork and practice administration had taken up an increasing amount of your average practitioners time. A large, long-term study, recently published in BMJ Open, shows just how much pressure GPs were (and continue to be) under.

It shows that frequent attenders now make up about four-in-10 family doctor consultations in Britain and they visit their GP five times as often as other patients on practice lists. In addition, the proportion of these patients has risen over the past two decades.

The analysis of nearly 1.7 billion consultations over 20 years, carried out by researchers from the University of Manchester, proves that GPs here and in the UK have not been crying wolf when they sounded the alarm on the rapid increases in their workload in recent years.

An ageing population, the complexity of care needs, and initiatives to shift care from hospitals into the com-

They drew on anonymised information on 1.7 billion consultations with 12.3 million patients, submitted to the Clinical Practice Research Database by 845 GP practices across the UK between April 2000 and March 2019. Some 113 practices contributed data throughout the entire study period.

They looked at consulting patterns among the top 10 per cent of consulting patients, including interactions with administrative as well as clinical staff.

All types of consultations with all staff in a practice more than doubled, rising from an annual average of 11 per person in 2000-01 to 25 in 2018-19; for GPs the equivalent figures were an annual average of five in 2000-01 to eight per person in 2015-18.

Among frequent attenders, the results were striking: All types of consultations with GPs rose from an average of 13 to 21 a year, while those with other practice staff rose from an average of 27 a year to 60 between April 2000 and March 2019. Of particular interest was that the proportion of consultations attributed to frequent attenders increased over time, particularly for face-to-face consultations. Significantly, rates of consultation fell among other patients.

Frequent attenders consulted around five times more often than the rest of the practice list, on average. There was relatively little regional variation in any of the trends studied, the only exceptions being face-to-face consultations with GPs, which were highest in Scotland and faceto-face consultations with all staff, which were highest in Northern Ireland.

And I was amazed to read that frequent attendance rates didn’t seem to be influenced either by levels of deprivation or the practice area. This clashes with evidence from Europe that frequent attenders are more likely to be female, older, have more social and psychiatric problems, taking more drugs for mental illness, have more medically unexplained symptoms, and more long-term conditions.

This is an observational study, and as such, no firm conclusions can be drawn about cause and effect. But the findings echo those of Dutch studies, researchers say, and suggest “that a relatively small number of patients are accounting for a large proportion of GP workload including face-to-face consultations”.

They conclude: “Frequent attenders appear to be a major driver for the increase in consultations that have contributed to perceptions of increased workload in g eneral practice.”

“GPs should be looking at this group of patients more closely to understand who they are and why they are consulting more frequently.”

Well, it’s not just family doctors that should be examining the problem. The Department of Health and the HSE cannot put forward meaningful workforce planning initiatives until some answers are forthcoming. It means that relying on demographic factors, such as an ageing population to calculate future staffing needs, simply won’t cut the mustard.

It’s a challenge also for the IMO and the ICGP. Both organisations need to focus on the many questions thrown up by this latest research.

In an echo of the famous Australian rock band, it looks like AC/BC will both require careful analysis if a Highway to Hell is to be avoided.

Read more by Dr Muiris Houston at www.mindo.ie @muirishouston

I don’t miss that very faint yet omnipresent little niggling worry that today will be the day that I make a ‘big mistake’

Genuair®-has it ‘clicked’ yet?

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

Genuair - a simple to use inhaler for patients with COPD4

Abbreviated Prescribing Information

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

Dosage: For inhalation use. Recommended dose is one inhalation of 322 micrograms aclidinium twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents. Contraindications: Hypersensitivity to aclidinium bromide or to any of the excipients. Warnings and Precautions: Stop use if paradoxical bronchospasm occurs and consider other treatments. Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients with myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Use with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma. Do not use in patients with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption.

Interactions: Do not administer with other anticholinergic-containing medicinal products. No other interactions expected. Please consult the SPC for more details. Fertility, pregnancy and lactation: No data on use in pregnancy. Risk to newborns/infants cannot be excluded. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects: Common (1-10%): Sinusitis, nasopharyngitis, headache, cough, diarrhoea, nausea. Uncommon (0.1-1%): Dizziness, blurred vision, tachycardia, palpitations, dysphonia, dry mouth, stomatitis, rash, pruritus, urinary retention. Rare (0.01-0.1%): hypersensitivity. Not known: angioedema, anaphylactic reaction. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM Marketing Authorisation Number: EU/1/12/778/002

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

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

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

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

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

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

should

reported

LAMA + LABA

LAMA

MULTIPLE CHOICE QUESTIONS

Question 1

Prostate specific antigen (PSA)

A. Is an enzyme whose function is to liquefy the seminal coagulation.

B. Should not be measured for at least 48 hours after digital rectal examination.

C. Takes at least six weeks to normalise after an acute urinary tract infection.

D. Elevated levels; the higher they are the greater the chance of extra-prostatic disease.

E. Normal values exclude prostate cancer.

Question 2

In the treatment of atopic eczema in adults, emollients

A. Act to keep moisture out.

B. Should be used about three-to-four times a day.

C. Use can stop when patient is asymptomatic.

D. In general the principle is the greasier the better.

E. Use does not affect the need for topical corticosteroids.

Question 3

Ophthalmic herpes zoster

A. May be indicated by zoster on the inner angle of the eye and nose.

B. In most patients causes vesiculation of the lid.

C. Is a well-recognised cause of glaucoma.

D. Should only be treated with topical acyclovir.

E. Patients should be referred to an ophthalmologist.

Question 4

People who wish to stop smoking

A. Using willpower alone will have a 10-to-15 per cent success rate at 12 months.

B. Should be told that it is never too late to stop.

C. Should only be prescribed pharmacotherapy if motivated enough to attend smoking cessation clinics.

D. While pregnant should not use nicotine replacement therapy.

E. Should understand that components of tobacco, other than nicotine, cause health damage.

Question 5

Well-recognised complications of steroid injections into joints include

A. Septic arthritis.

B. Haemarthrosis.

C. Frozen shoulder.

D. Facial flushing.

E. Vaso-vagal syncope.

E. TRUE. Well-recognised complication of any injection.

D. TRUE. Usually begins within a few hours and may last a few days.

C. FALSE. Something you might inject for.

B. TRUE. More likely in patients with bleeding disorders or who are poorly controlled on anticoagulants.

A. TRUE. Rare if proper aseptic technique used.

ANSWER 5

E. TRUE. The nicotine maintains the addiction.

D. FALSE. Nicotine is undesirable in pregnancy, but nicotine replacement therapy is preferable to smoking.

C. FALSE. Although they might have a better chance of success if they do.

B. TRUE. And that health benefits will be seen in a short time.

A. FALSE. Only 3 per cent success rate.

ANSWER 4

E. TRUE. Ophthalmic zoster has a high complication rate.

D. FALSE. Oral acyclovir is indicated, 800mg five times daily for seven days.

C. TRUE. Anterior uveitis occurs in 60 per cent of patients, 40 per cent of whom develop secondary glaucoma.

B. TRUE. It can give rise to lid margin irregularity, ptosis, and ectropion.

A. TRUE. This shows the nasociliary branch of the trigeminal nerve is affected, which is often accompanied by ocular complications.

ANSWER 3

E. FALSE. Intensive use reduces need for steroids.

D. TRUE. Though patients likely to prefer less greasy preparations.

C. FALSE. Continue all the time.

B. TRUE. And always after bathing. Patient will need 600g a week if eczema is generalised.

A. FALSE. Moisture in, pathogens out.

ANSWER 2

E. FALSE. If normal PSA and abnormal digital rectal examination, then significant risk and should be referred for biopsy.

D. TRUE. And more rapidly increasing levels confer a less favourable prognosis.

C. TRUE. Wait three months after urinary tract infection or prostatitis before measuring.

B. FALSE. Does cause a small rise, but not significant and within the error limits of the assay.

Produced by prosaic epithelium and serum levels increased by any process that disrupts the normal prostatic architecture.

A. TRUE.

FOR ALL THAT MATTERS IN MEDICINE

NEW WEBSITE COMING SOON

Osteoarthritis in focus

Evidence-based management of osteoarthritis needs to address the underutilisation of core recommended treatments and over-reliance on surgery and pharmacological agents

Osteoarthritis is a chronic degenerative joint disorder characterised by cartilage loss. It is a leading cause of pain and disability, affecting 3.3-to-3.6 per cent of the global population and is the most common form of arthritis worldwide. Osteoarthritis affects approximately 400,000 Irish people and is the most common joint disease in Ireland.

Osteoarthritis presents with joint pain and loss of function; however, the disease is widely variable and can present from an asymptomatic incidental finding to a permanently disabling disorder. Osteoarthritis is a heterogeneous disease caused by multiple factors. Risk factors for developing osteoarthritis include increasing age, female gender, obesity, anatomical factors, muscle weakness and joint injury, particularly from occupational and sports activities.

The prevalence and incidence of osteoarthritis increase with age, with a majority of individuals over the age of 65 affected. The occurrence of osteoarthritis is progressively rising due to increased life expectancy and population ageing together with a rise in obesity. Excess weight compounds the problem by putting extra strain on damaged joints.

Osteoarthritis is more common and often more severe in women, especially in the knees and hands. It often starts after the menopause. Certain occupations can place excessive loads on the joints resulting in osteoarthritis in later years. Occupations with repetitive knee-bending can result in knee osteoarthritis, while heavy manual labour may predispose to hip osteoarthritis.

Although complex, the genetic contribution to osteoarthritis is significant. The roles of genes and signalling pathways in osteoarthritis pathogenesis have been demonstrated by ex vivo studies using tissues derived from osteoarthritis patients and in vivo studies using surgically-induced osteoarthritis animal models and genetic mouse models.

Nodal osteoarthritis is one common form of osteoarthritis that runs strongly in families and particularly affects the hands of middle-aged women. In other common forms of osteoarthritis, heredity plays a small part compared with obesity, ageing and joint injury. There are some very rare forms of osteoarthritis that start at a young age and run in families and these are linked with single genes that affect collagen, which is an essential component of cartilage.

Osteoarthritis is a disease of the entire joint and is recognised as a low-grade inflammatory disease involving cartilage degradation, bone remodelling, osteophytes and synovitis. The chronic low-grade inflammation found in osteoarthritis contributes to disease development and progression. During osteoarthritis progression, the entire synovial joint, including cartilage, subchondral bone, and synovium, are involved in the inflammation process.

Osteoarthritis can be classified into two categories: Primary osteoarthritis and secondary osteoarthritis. Primary osteoarthritis is the most common subset and is diagnosed in the absence of predisposing trauma or dis-

ease. Primary osteoarthritis can be localised or generalised, the latter more commonly found in postmenopausal women, with development of Heberden’s nodes. Secondary osteoarthritis occurs with a pre-existing joint abnormality. Predisposing conditions include trauma or injury, congenital joint disorders, inflammatory arthritis, avascular necrosis, infectious arthritis, Paget disease, osteopetrosis, osteochondritis dissecans, metabolic disorders, hemoglobinopathy, Ehlers-Danlos syndrome or Marfan syndrome.

Symptoms

The presentation and progression of osteoarthritis varies greatly from person to person. The triad of symptoms are joint pain, stiffness and locomotor restriction. Patients can also present with muscle weakness and problems with balance. Pain is usually related to activity and resolves with rest. For patients in whom the disease progresses, pain is more continuous and affects activities of daily living, eventually causing severe limitations in function. Patients may also experience bony swelling, joint deformity and instability.

Osteoarthritis typically affects proximal and distal interphalangeal joints, first carpometacarpal joints, hips, knees, first metatarsophalangeal joints and joints of the lower cervical and lumbar spine, and can be mono or poly articular in presentation. Shoulder and elbow joints are also susceptible to osteoarthritis although this is much rarer. Joints can be at different stages of disease progression. Typical exam findings include bony enlargement, crepitus, effusions, and a limited range of motions. Tenderness may be present at joint lines, and there may be pain upon passive motion. Classic physical exam findings

in hand osteoarthritis include Heberden’s nodes, Bouchard’s nodes and ‘squaring’ at the base of the thumb.

Diagnosis

A thorough history and physical examination with a focused musculoskeletal exam should be carried out. Differential diagnosis can include rheumatoid arthritis, psoriatic arthritis, crystalline arthritis, haemochromatosis, bursitis, avascular necrosis, tendinitis, radiculopathy, among other soft tissue abnormalities.

There are no specific blood tests for diagnosing osteoarthritis, however, blood tests including FBC, ESR, rheumatoid factor and anti-nuclear antibodies can be ordered to rule out inflammatory arthritis.

X-rays of the affected joint can show findings consistent with osteoarthritis, such as marginal osteophytes, joint space narrowing, subchondral sclerosis, and cysts, however, radiographic findings do not correlate to the severity of condition and may not be present early in the disease. MRI is not routinely indicated for osteoarthritis workup; however, it can detect osteoarthritis at earlier stages than normal radiographs. Ultrasound can also identify synovial inflammation, effusion, and osteophytes, which can be related to osteoarthritis.

Treatments

Current therapeutic options are aimed at keeping the associated pain, inflammation, and degeneration of synovial joint tissues manageable in order to minimise the structural and symptomatic progression of osteoarthritis. Management of the disease involves both pharmacological and non-pharmacological therapies.

Pharmacotherapy involves oral, topical, and/or intra-articular options. Paracetamol and oral NSAIDs are usually the initial choice of pharmacological treatment. Topical NSAIDs are less effective than their oral counterparts, but have fewer gastrointestinal and other systemic side-effects. A proton pump inhibitor (PPI) may also be prescribed at the same time as oral NSAIDs to reduce the risk of damage to the stomach lining. Capsaicin cream may also be prescribed for osteoarthritis of the hands or knees, if topical NSAIDs have not been effective in easing pain. Capsaicin cream works by blocking the nerves that transmit pain in the treated area.

Intra-articular joint injections can be an effective treatment for osteoarthritis. Glucocorticoid injections have a variable response, however, and there is ongoing controversy regarding repeated injections. Although corticosteroid injections can ease osteoarthritis symptoms, they have limitations. They cannot repair damaged cartilage or slow the progression of osteoarthritis and relief is only temporary. There are also some risks involved with glucocorticoid joint injections including; injury to the joint tissues, mainly with repeated injections; thinning of cartilage; weakening of the ligaments of the joint; inflammation in the joint caused by a corticosteroid that has crystallised; irritation of the nerves; infection; and whitening or thinning of the skin at the injection site.

Non-pharmacologic therapy includes avoidance of activities that exacerbate pain, exercise to improve strength, weight loss if applicable, wearing suitable footwear and occupational therapy for unloading joints. Malalignment of joints should be corrected via mechanical means such as realignment knee brace or orthotics. Weight loss is an important intervention in patients who are overweight and obese. Regular exercise that keeps a person active, builds up muscle and strengthens the joints usually helps to improve symptoms. Patients should, however, be advised to avoid exercise that puts strain on joints and forces them to bear an excessive load, such as running and weight training. Activities such as swimming and cycling, where strain on joints is more controlled, are advisable.

In addition to lifestyle changes and pharmacology, patients may benefit from a number of supportive treatments that can help reduce pain and make everyday tasks easier. Not using joints can cause muscles to waste and increase the stiffness caused by osteoarthritis. Manual therapy is a technique where a physiotherapist uses their hands to stretch, mobilise and massage the body tissues to keep a patient's joints supple and flexible. Applying hot or cold packs to the affected joints can also help relieve the pain and symptoms of osteoarthritis in some people. Transcutaneous electrical nerve stimulation (TENS) if advised by a doctor or healthcare professional may help ease the pain caused by osteoarthritis, by numbing the nerve endings in the spinal cord which control pain. For osteoarthritis in the lower limbs, such as hips, knees or feet,

THERESA LOWRY-LEHNEN , RGN, GPN, RNP, PhD, Clinical Nurse Specialist and Associate Lecturer, Institute of Technology Carlow

Figure 1A and 1B: Normal joint versus joint with osteoarthritis

Source: www.arthritisireland.ie/osteoarthritis

special footwear or insoles for shoes may be helpful. Footwear with shock-absorbing soles can help relieve some of the pressure on the leg joints when walking, and special insoles may help spread weight more evenly. Leg braces and supports also work in the same way. For osteoarthritis in the hip or knee that affects mobility, the use of a walking aid, such as a stick or cane, may be beneficial. Occupational therapists can provide help and advice about using assistive devices in the home or workplace.

Osteoarthritis can affect any joint in the body, but the most common areas affected are the knees, hips and small joints in the hands. For patients with knee or hip osteoarthritis for whom pharmacological and non-pharmacological treatments have failed, joint replacement surgery/arthroplasty is the next option. Failure rates for both knee and hip replacements are quite low, and joint replacement can provide pain relief and increased functionality. The timing of surgery is important. Poor functional status and considerable muscle weakness may not lead to improved postoperative functional status versus those undergoing surgery earlier in the disease course. Most patients who undergo joint replacement tend to have a good prognosis with success rates of over 80 per cent. However, most prosthetic joints wear out in 10-to-15 years, and repeat surgery is required. A newer type of joint replacement surgery called resur-

facing uses only metal components and may be more suitable for younger patients.

If a joint replacement is not a suitable option, an operation to fuse the joint in a permanent position known as an arthrodesis, may be carried out. The joint will be stronger and less painful; however, the patient will no longer be able to move it. For patients with osteoarthritis of the knees but who are unsuitable for knee replacement surgery, an osteotomy may be performed. This involves adding or removing a small section of bone either above or below the knee joint. This helps realign the knee so weight is no longer focused on the damaged part of the knee. An osteotomy can relieve symptoms of osteoarthritis, although the patient may still need knee replacement surgery in the future.

Outlook

The prognosis for osteoarthritis patients de-

pends on the joint involved, how many joints are affected, and the severity of the disease. There is currently no cure for osteoarthritis, and all available treatments are directed towards reducing symptoms. Although significant research has been carried out and progress made in recent years, the molecular mechanisms of osteoarthritis initiation and progression is still not fully understood. The last decade has seen significant advances however, in understanding the processes that contribute to osteoarthritis and over the coming years these new insights will hopefully lead to better treatment options. Further research and a better understanding of the molecular mechanisms could accelerate the development of novel therapeutic strategies for osteoarthritis.

Traditional osteoarthritis management approaches often result in varying treat-

ments, evidence practice gaps and delayed treatment due to over demand and long waiting lists. Despite the considerable societal, economic and personal burden associated with osteoarthritis, the condition is often overlooked in healthcare strategic plans for chronic disease management. A shift is needed to promote evidence-based management of osteoarthritis and address the underutilisation of core recommended treatments and over-reliance on surgery and pharmacological agents.

Model of Care ‒ ENACt Project Osteoarthritis does not feature alongside other chronic diseases such as asthma or diabetes and there is currently no specific model of care for osteoarthritis in primary care in Ireland. The ENACt research project (2020-2024), led by researchers at the RCSI hopes to change that, and is in the process of developing a model of care for osteoarthritis in primary care to deliver best practice nationwide. The ENACt project is developing a model of care for osteoarthritis specifically tailored to the Irish healthcare system, with the goal of implementing and evaluating it on a large scale national level. The research, to be carried out in three work packages over four years, aims to identify current primary care management of osteoarthritis in Ireland and develop a model of care focusing on core interventions, education, exercise and weight loss.

References on request

Study finds treat-to-target ULT strategy manages gout effectively and safely with no cardiovascular toxicity

PRISCILLA LYNCH

New research presented at ACR Convergence 2021, the American College of Rheumatology’s (ACR) annual meeting, held online in November, shows that allopurinol and febuxostat may effectively lower urate levels when used in a treat-to-target approach.

Importantly, both urate-lowering therapies (ULT) were very effective with 90 per cent of patients reaching target urate levels. Additionally, both appeared safe, with no evidence of increased cardiovascular toxicity (Abstract #1900).

ULT is a cornerstone treatment for gout management, but there is a lack of data to support the comparative efficacy and safety of the two major oral ULTs, allopurinol and febuxostat, when prescribed in a treatto-target approach. There is also an urgent need to determine if these ULTs are safe and effective in gout patients with chronic kidney disease, a common comorbidity. Researchers conducted this multicentre, randomised, double-blind, non-inferiority trial to compare the safety and efficacy of these two therapies for gout management.

“Our trial is the first to compare allopurinol to febuxostat using the recommended treat-to-target, urate level approach. This trial demonstrates that both agents are highly effective and safe when used in this way

Gout (inflamatory

arthritis)

and, importantly, this was true in patients with chronic kidney disease as well,” said Dr James R O’Dell, Chief, Division of Rheumatology, at the University of Nebraska Medical Centre in Omaha and the study’s co-author.

For the 72-week trial, 940 patients with gout and a serum urate concentration of 6.8mg/dl or higher were randomised to receive either allopurinol or febuxostat between 2017 and 2019. Patients with persistent elevated uric acid levels in the blood, despite allopurinol treatment (300mg/dl or less), were eligible; by design over onethird of patients had chronic kidney disease, Stage 3. The trial had three phases: ULT titration from week 0-24, maintenance therapy

from week 25-48, and observation with continued, stable ULT from week 49-72.

Patients received initial doses of either 100mg of allopurinol with maximum titration to 800mg, or 40mg of febuxostat with maximum titration to 120mg (reduced to 80mg in 2019 at the request of the US Food and Drug Administration (FDA)). Patients also received anti-inflammatory treatments selected by the site investigator until the start of the third phase.

The primary outcome was the proportion of patients who had one or more gout flares during the third phase.

Similarly, effectiveness and tolerability of the two drugs in stage III chronic kidney

disease patients were examined, as were serious side-effects, and the proportion of patients who achieved a serum urate of less than 6mg/dl by the end of the second phase of the trial.

During the third phase, 35 per cent of patients taking allopurinol had one or more gout flares compared to 42 per cent of patients taking febuxostat. Overall, 80 per cent of patients in the trial achieved a serum urate level of less than 6.0mg/dl, and 92 per cent achieved a level of less than 6.8mg/dl during the second phase, with no difference between the two treatments. There were also no differences in serious side-effects between the two treatment groups, including the percentage of patients with cardiovascular events in people with or without chronic kidney disease. That final finding is important, because nearly one in every two gout patients suffers from renal insufficiency.

Allopurinol was found to be non-inferior to febuxostat when prescribed as part of a treat-to-target approach in people with gout, providing two effective, safe treatment options for managing serum urate levels long term, the study’s findings show.

“Gout is a common and increasing cause of morbidity in patients, as well a major cause of work loss,” said Dr O’Dell. “This trial shows that if a treat-to-target, uric acid-level approach with either allopurinol or febuxostat is widely adopted, chronic gout could be essentially wiped out.”

The last decade has seen significant advances however, in understanding the processes that contribute to osteoarthritis and over the coming years these new insights will hopefully lead to better treatment options

Treat to target. Daily.1,2

ADENURIC 80 mg and 120 mg film-coated tablets: Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Film-coated tablets containing 80 mg or 120 mg febuxostat. Also contains lactose monohydrate. Use: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis) in adults. Dosage and administration: Oral use with or without food. Recommended dose is 80 mg once daily. If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, 120 mg once daily may be considered.

Older people: No dose adjustment required. Renal impairment: No dosage adjustment necessary in patients with mild or moderate renal impairment. Efficacy and safety not fully evaluated in patients with severe renal impairment. Hepatic impairment: Recommended dosage in patients with mild hepatic impairment is 80 mg. Limited information available in patients with moderate hepatic impairment. Efficacy and safety has not been studied in patients with severe hepatic impairment. Children and adolescents: Safety and efficacy in children under 18 has not been established. Organ transplant recipients: No experience therefore not recommended. Contra-indications: Hypersensitivity to the active ingredient or to any of the excipients. Warnings and precautions:

Cardio-vascular disorders: Treatment with febuxostat in patients with pre-existing major cardiovascular diseases (e.g. myocardial infarction, stroke or unstable angina) should be avoided, unless no other therapy options are appropriate. Product allergy/hypersensitivity: Advise patients of signs/symptoms of allergic/hypersensitivity reactions and monitor closely for symptoms. Stop treatment immediately if serious reactions occur, including Stevens-Johnson syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock; do not re-start febuxostat at any time. Severe hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated with fever, haematological, renal or hepatic involvement in some cases. Acute gouty attacks (gout flare): Do not start treatment until an acute attack of gout has completely subsided. As with other urate lowering medicinal products, gout flares may occur during initiation of treatment. At treatment initiation flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended. If a gout flare occurs during treatment, do not discontinue. Manage the gout flare concurrently as appropriate. Continuous treatment decreases frequency and intensity of gout flares. Xanthine deposition: As with other urate lowering medicinal products, in patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome), the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract. As there has been no experience of treating gout in these patients with febuxostat such use is not recommended. Mercaptopurine/azathioprine: Not recommended in patients concomitantly treated with mercaptopurine/azathioprine. Where combination cannot be avoided, monitor patients closely. Dose reduction for mercaptopurine/ azathioprine is recommended. Theophylline: No pharmacokinetic interaction shown with febuxostat 80 mg, no data for 120 mg. Liver disorders: Liver function test is recommended prior to the initiation of therapy and periodically thereafter based on clinical judgement. Thyroid disorders: Caution in patients with alteration of thyroid function. Lactose: Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Mercaptopurine/azathioprine: On the basis of the mechanism of action of febuxostat on xanthine oxidase inhibition concomitant use is not recommended. Where the combination cannot be avoided see SmPC for dosing instructions.

Rosiglitazone/CYP2C8 inhibitors: No dosage adjustment required. Theophylline: No special caution advised for 80 mg febuxostat, no data available for 120 mg. Naproxen and other inhibitors of glucuronidation: Can be co-administered with naproxen with no dose adjustments necessary.

Inducers of glucuronidation: Monitoring of serum uric acid is recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation. Cessation of treatment of an inducer might lead

ADENURIC® is a trademark of Teijin Limited, Tokyo, Japan

Date of item: October 2019

IR-ADEN-11-2019

to increased plasma levels of febuxostat. Colchicine/indometacin/hydrochlorothiazide/warfarin: Can be co-administered with colchicine or indomethacin with no dose adjustments necessary. No dose adjustment necessary when administered with hydrochlorothiazide. No dose adjustment necessary for warfarin when administered with febuxostat. Desipramine/CYP2D6 substrates: Co administration with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds. Antacids: May be taken without regard to antacid use. Pregnancy and lactation: Do not use during pregnancy or breast-feeding. Effect on fertility unknown. Side-Effects: Clinical Studies and postmarketing experience: Common (1-10%): Gout flares, headache, diarrhoea*, nausea, liver function test abnormalities*, rash, oedema. Uncommon (0.1–1%): Blood thyroid stimulating hormone increased, diabetes mellitus, hyperlipidemia, decrease appetite, weight increase, decreased libido, insomnia, dizziness, paraesthesia, hemiparesis, somnolence, altered taste, hypoaesthesia, hyposmia, atrial fibrillation, palpitations, ECG abnormal, hypertension, flushing, hot flush, dyspnoea, bronchitis, upper respiratory tract infection, cough, abdominal pain, abdominal distension, gastrooesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort, cholelithiasis, dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular, arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis, renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria, erectile dysfunction, fatigue, chest pain, chest discomfort, blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, haemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, haematocritic decrease, blood lactate dehydrogenase increased, blood potassium increase. Rare (0.1-0.01%): Pancytopenia, thrombocytopenia, agranulocytosis**, anaphylactic reaction**, drug hypersensitivity**, blurred vision, weight decrease, increase appetite, anorexia, nervousness, tinnitus, sudden cardiac death**, pancreatitis, mouth ulceration, hepatitis, jaundice**, liver injury**, Toxic epidermal necrolysis**, Stevens-Johnson Syndrome**, DRESS**, angioedema**, generalized rash (serious)**, erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic**, rash erythematous, rash morbillifom, alopecia, hyperhidrosis, rhabdomyolysis**, joint stiffness, musculoskeletal stiffness, tubulointerstitial nephritis**, micturition urgency, thirst, blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase**. *Treatment-emergent non-infective diarrhoea and abnormal liver function tests in combined Phase III studies more frequent in patients concomitantly treated with colchicine. **Adverse reactions coming from post-marketing experience. Rare serious hypersensitivity reactions including Stevens-Johnson Syndrome and anaphylactic reaction/shock have occurred in post-marketing experience. Hypersensitivity reactions to febuxostat can be associated with the following symptoms: skin reactions characterised by infiltrated maculopapular eruption, generalised or exfoliative rashes, also skin lesions, facial oedema, fever, haematologic abnormalities such as thrombocytopenia and eosinophilia, and single or multiple organ involvement (liver and kidney including tubulointerstitial nephritis). Gout flares commonly observed soon after treatment start and in first months. Frequency decreases

DR WAN LIN NG, SpR in Rheumatology; and DR LAURA DURCAN , Consultant Rheumatologist and Physician, Beaumont Hospital, Dublin

Systemic lupus erythematosus –diagnosis and management

CASE REPORT

A 45-year-old Indian female presented with gradual onset peripheral oedema, rash and polyarticular joint swelling. Her past medical history was notable only for rheumatic heart disease in childhood. Her obstetric history included two first trimester miscarriages followed by two uncomplicated live births at full term.

On clinical examination, she was noted to have pallor with frontal alopecia, periungual erythema and 1+ peripheral oedema with synovitis in her ankles, hands and feet. Further investigation showed 2+ protein and blood on urine dipstick.

Laboratory investigations showed Hb 7.3g/dl with mild neutropaenia, lymphopaenia and thrombocytopaenia.

Renal function was normal. ESR was elevated at 84mm/ hr, CRP was 5mg/L and her urine protein creatinine ratio (UPCR) was modestly elevated at 35mg/mmol. Further tests showed her anti-dsDNA was >379IU/ml, antinuclear antibodies, anti-Ro, anti-Smith and anti RNP/SM antibodies were positive, C3 was 0.32 G/L and C4 was

Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease characterised by the presence of autoantibodies, which can cause inflammation in various organs. It is more common in women and amongst non-Caucasian populations. Although children can be affected with SLE, it is less prevalent in this population and without the gender bias seen in adults. The global prevalence of SLE is varied according to ethnicity and geography ranging from 30-150/100, 000 with incidence ranging from 2.2 to 23.1/100,000 population.

A genetic contribution to the development of SLE has been well recognised, with more than 80 genetic predispositions identified. Other factors that play a role in SLE pathogenesis include smoking, viruses such as Epstein-Barr, vitamin D deficiency, ultraviolet exposure, certain medications, environmental pollutants and epigenetic modification. Antibodies related to SLE often predate the diagnosis or symptoms for years and SLE-specific autoantibodies, such as anti-Smith antibodies and anti-double stranded DNA, are closest to the development of overt clinical symptoms.

Diagnosis

Diagnosing SLE may pose a challenge due to the clinical and serological diversity. There are several classification criteria for SLE. To diagnose SLE based on the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria, the patient needs to meet four criteria with at least one clinical and at least one immunologic (autoantibodies or low complement) in the absence of biopsy-proven nephritis. However, it allows lupus nephritis to be the sole criterion in the presence of anti-dsDNA or ANA antibodies. In our case report in this article, the patient had biopsy-proven lupus nephritis along with meeting five-of-11 clinical criteria and four-of-six immunologic criteria of the SLICC criteria. The European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria are mainly used in research studies, wherein a score of 10 or more is required with an entry criterion of an ANA ≥1:80 and then a numerical weighting attributed to the other criteria.

Management

The approach to managing SLE should be tailored to the specific organ(s) involved and general measures, which includes management of bone, reproductive, cardiovascular health, vaccinations, and the identification and management of antiphospholipid mediated disease.

General considerations in management are as follows:

0.03 G/L. Lupus anticoagulant, anti beta2 glycoprotein and anti-cardiolipin antibodies were negative.

The rash was biopsied and histology features were in keeping with leukocytoclastic vasculitis (see Figure 1).

A renal biopsy was also performed and the histological features are those of World Health Organisation (WHO) Class III lupus nephritis (see Figure 2).

She was diagnosed with systemic lupus erythematosus (SLE) by meeting five-of-11 clinical criteria and four-of-six immunologic criteria, along with a biopsy-proven lupus nephritis based on the Systemic Lupus International Collaborating Clinics (SLICC) criteria. Her management included hydroxychloroquine 400mg once daily and prednisolone 15mg once daily, tapered. She was transfused two units of red blood cells. Upon confirmation of lupus nephritis, mycophenolate mofetil (MMF) 1g twice daily was commenced with ramipril 1.25mg once daily. There was a significant improvement in disease activity following treatment as evident by the downward trend of anti-dsDNA titres and UPCR levels.

 Patients with SLE are advised to avoid direct sunlight where possible and use high factor SPF sunscreen.

 Traditional modifiable cardiovascular risk factors such as weight management, smoking cessation and management of hypertension and dyslipidaemia should be acted upon to reduce cardiovascular risk and events, which is a significant driver of SLE related mortality.

 Smokers have worse outcomes and tend to be resistant to hydroxychloroquine, so smoking cessation is of particular importance.

(A) INDUCTION THERAPY

 IV methylprednisolone 0.25-1g/day for one-to-three days followed by oral prednisolone 0.5-1mg/kg/day (max 80mg/day), then taper over several months

 Oral mycophenolate mofetil (MMF) 2-3g/day in divided doses for months OR

 IV cyclophosphamide (Euro-Lupus regime) 500mg every two weeks for three months (in non-Caucasians, MMF is preferable)

 Hydroxychloroquine 5-6.5mg/kg/day (max 400mg/day)

 Angiotensin converting enzyme inhibitor or angiotensin receptor antagonist

 Ensure vitamin D levels to be more than 40ng/ml

(B) MAINTENANCE THERAPY

 Oral MMF 1-2g/day OR

 Azathioprine 1.5-2mg/kg/day

 Taper corticosteroids

(C) POOR/NO RESPONSE TO CURRENT THERAPY

Choose alternative induction therapy

(D) REFRACTORY DISEASE

 Consider multi-target therapy (MMF plus calcineurin inhibitor)

 Rituximab

 IV immunoglobulins

 Leflunomide

Table 1: Management strategy for active proliferative lupus nephritis (Class III/IV or Mixed Class III/IV+V). Adapted from the American Journal of Kidney Diseases and The Lancet

 The inactivated influenza vaccine is recommended in patients on immunosuppression.

 The quadrivalent human papillomavirus (HPV) vaccine has good safety data in SLE and should be considered in female patients aged 11-to-26 years.

 Covid-19 vaccinations have not been specifically examined in SLE, but similar to other autoimmune diseases we recommend that patients proceed with vaccination unless a contraindication such as anaphylaxis exists. There may be some merit in holding some immunosuppressive therapies (such as methotrexate) for a short period of time to facilitate antibody response, but this is yet to be formally recommended.

 Clinical trials have demonstrated benefit of vitamin D (40-100ng/ml) on disease activity.

 It is important for women of child-bearing age to discuss contraception and have planned pregnancies, which often require a multidisciplinary approach.

Hydroxychloroquine, which works as an immunomodulator, has been one of the most important treatments for patients with SLE. Not only does it improve survival, it augments the effect of mycophenolate mofetil and also has antithrombotic properties. It is the first-line treatment for both cutaneous and arthritis manifestation of SLE. Many studies have also demonstrated the efficacy of hydroxychloroquine in improving pregnancy outcomes and reducing the risk of congenital heart block associated with anti-Ro antibody. The prescribed dose of hydroxychloroquine should be based on body weight of 5-to-6.5mg/kg or a maximum of 400mg once daily. Hydroxychloroquine has very little side-effects, but an uncommon major long-term side-effect of retinal toxicity needs to be addressed by enrolling patients for routine monitoring using imaging devices such as optical coherence tomography (OCT). Duration of therapy, higher doses (per body weight), underlying retinal disease, tamoxifen and chronic renal disease are the risk factors associated with retinal toxicity in hydroxychloroquine use. Chloroquine, although is associated with higher incidence of retinal toxicity, is an alternative for those who are intolerant or allergic to hydroxychloroquine.

a) Lupus nephritis

 Lupus nephritis occurs in up to 60 per cent of SLE patients, is most marked in non-Caucasians and is a negative prognosticator. It is suspected based on abnormalities on urinalysis in its early stages. The spot urine protein to creatinine ratio is usually more than 0.5grams and the diagnosis should be confirmed by renal biopsy unless a contraindication exists. Renal biopsy excludes other causes of proteinuria and allows us to grade and stage the nephritis; crucial information in managing these patients.

 For induction of treatment, intravenous methylprednisolone is recommended followed by a high-dose corticosteroid taper. Mycophenolate mofetil (MMF) or cyclophosphamide remains the first-line induction therapy. This is followed by a maintenance therapy with either MMF or azathioprine. An alternative induction agent can be switched to if a patient fails to response to initial treatment (see Table 1).

b) Musculoskeletal involvement

 Hydroxychloroquine is usually the first-line therapy. Joint flares often settle with a short course of corticosteroid. Other therapies such as methotrexate or azathioprine can be added for those with ongoing SLE-related synovitis. Biologics including rituximab and belimumab have been proven to be beneficial. Anti TNF-alpha inhibitors are usually avoided as they can potentially cause drug-induced lupus but in overlap syndromes in particular they can be useful.

c) Cutaneous involvement

 The use of high SPF sun screen and sun avoidance is nec-

Continued from p28 ▸ essary to prevent flares. Hydroxychloroquine is helpful in treating cutaneous lupus apart from supportive topical therapies including topical corticosteroids and tacrolimus. Discoid lupus, especially of the scalp, is often treated with intra-lesional steroid injections. Methotrexate is a good immunosuppressive for cutaneous disease. For disease refractory to antimalarials, MMF and azathioprine are effective therapies. In very resistant cutaneous disease, thalidomide and lenalidomide can be considered,

but with caution, as they are various potential toxicities. Several clinical trials involving belimumab have shown efficacy in treating cutaneous disease.

Prognosis

The predictors of progression in organ damage include age at diagnosis, race/ethnicity and socioeconomic status. Non-Caucasians, especially African-Americans, are at a greater risk of poor outcomes, which can be confounded by other variables such as income and the presence of hypertension. Other features include time of onset to diagnosis, high

For the treatment of active rheumatoid arthritis, severe recalcitrant disabling psoriasis & severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate

For the treatment of active rheumatoid arthritis, severe recalcitrant disabling psoriasis & severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate

THE METHOTREXATE AUTO-INJECTOR WITH THE PATIENT IN MIND

THE METHOTREXATE AUTO-INJECTOR WITH THE PATIENT IN MIND

disease activity score, renal and severe organ involvement, which are potential contributory factors for mortality and the development of lupus-related damage.

Undoubtedly, the wider use of simple drugs such as hydroxychloroquine has improved the prognosis of SLE in addition to the newer immunosuppressive therapies over the past few decades. On the other hand, risk reduction in thrombotic episodes has been noted in antiphospholipid antibodies-positive SLE patients using low-dose aspirin with anticoagulation, with warfarin remaining the therapy for those with a diagnosis of antiphospholipid antibody syndrome.

Nordimet (methotrexate) Solution for injection in pre-filled pen Please refer to the Summary of Product Characteristics (SmPC) for full prescribing information. Further information is available on request.

Nordimet (methotrexate) Solution for injection in pre-filled pen

initiation of therapy is recommended. Recommended initial dose 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.

Please refer to the Summary of Product Characteristics (SmPC) for full prescribing information. Further information is available on request.

Presentation: Pre-filled pen containing 7.5 mg (in 0.3 ml), 10 mg (in 0.4 ml), 12.5 mg (in 0.5 ml), 15 mg (in 0.6 ml), 17.5 mg (in 0.7 ml), 20 mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in solution for injection. Indications: Active rheumatoid arthritis in adult patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.

Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. Dosage and administration: Nordimet should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Nordimet should be performed under direct medical supervision. Nordimet is injected once weekly, administered subcutaneously. Rheumatoid arthritis:

Recommended initial dose is 7.5 mg of methotrexate once weekly.

Presentation: Pre-filled pen containing 7.5 mg (in 0.3 ml), 10 mg (in 0.4 ml), 12.5 mg (in 0.5 ml), 15 mg (in 0.6 ml), 17.5 mg (in 0.7 ml), 20 mg (in 0.8 ml), 22.5 mg (in 0.9 ml) and 25 mg (1.0 ml) methotrexate in solution for injection. Indications: Active rheumatoid arthritis in adult patients. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. Induction of remission in moderate steroid-dependent Crohn’s disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. Dosage and administration: Nordimet should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Nordimet should be performed under direct medical supervision. Nordimet is injected once weekly, administered subcutaneously. Rheumatoid arthritis: Recommended initial dose is 7.5 mg of methotrexate once weekly. Depending on the individual activity of the disease & patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Polyarthritic forms of severe, active juvenile idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20mg/m² BSA per week. Use in children < 3 years of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to

Depending on the individual activity of the disease & patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Polyarthritic forms of severe, active juvenile idiopathic arthritis: The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20mg/m² BSA per week. Use in children < 3 years of age is not recommended. Psoriasis vulgaris and psoriatic arthritis: A test dose of 5 - 10 mg subcutaneously administered one week prior to

Date Of Preparation: Aug 2021 IE/21/NOR/011-00

initiation of therapy is recommended. Recommended initial dose 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.

Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose.

Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose.

In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate. Crohn’s disease (adult patients): 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Maintenance treatment: 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission. Renal impairment, hepatic impairment or elderly patients: Please refer to SmPC. Note: When switching from oral to parenteral use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.

In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate. Crohn’s disease (adult patients): 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Maintenance treatment: 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission. Renal impairment, hepatic impairment or elderly patients: Please refer to SmPC. Note: When switching from oral to parenteral use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.

Contraindications: Hypersensitivity to methotrexate or to any of the excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency.

Contraindications: Hypersensitivity to methotrexate or to any of the excipients. Severe hepatic impairment, if serum bilirubin is > 5 mg/dl (85.5 µmol/l). Alcohol abuse. Severe renal impairment (creatinine clearance < 30 ml/min). Pre-existing blood dyscrasias (e.g. bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia). Immunodeficiency.

Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis. Ulcers of the oral cavity and known active gastrointestinal ulcer disease. Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines.

Serious, acute or chronic infections such as tuberculosis & HIV. Stomatitis. Ulcers of the oral cavity and known active gastrointestinal ulcer disease. Pregnancy. Breast-feeding. Concurrent vaccination with live vaccines. Special warnings and precautions: Patients must be clearly advised that the therapy is to be administered once a week, and not every day.

Special warnings and precautions: Patients must be clearly advised that the therapy is to be administered once a week, and not every day.

Patients receiving therapy should be appropriately monitored. Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. The possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with male and female patients of childbearing potential. Methotrexate contact with skin and mucosal membranes is to be avoided; in cases of contamination rinse the area with plenty of water. Interactions: Consult SmPC for detailed information on interactions. Undesirable

Patients receiving therapy should be appropriately monitored. Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. The possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with male and female patients of childbearing potential.

Methotrexate contact with skin and mucosal membranes is to be avoided; in cases of contamination rinse the area with plenty of water. Interactions: Consult SmPC for detailed information on interactions. Undesirable

effects: See SmPCs for full list of undesirable effects. Very common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. Abnormal liver function tests (increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache. Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis. Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic events. Pulmonary fibrosis. Pneumocystis carinii pneumonia. Shortness of breath and bronchial asthma. Pleural effusion. Acute hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. Lymphoproliferative disorders. Severe courses of bone marrow depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative disorders). Legal classification:

effects: See SmPCs for full list of undesirable effects. Very common: Stomatitis. Dyspepsia. Appetite loss. Abdominal pain. Nausea. Abnormal liver function tests (increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), alkaline phosphatase and bilirubin). Common: Leukopenia. Anaemia. Thrombopenia. Headache. Tiredness. Drowsiness. Pneumonia. Interstitial alveolitis/pneumonitis. Oral ulcers. Diarrhoea. Exanthema. Erythema. Pruritus. Uncommon: Pharyngitis. Pancytopenia. Precipitation of diabetes mellitus. Depression. Confusion. Dizziness. Enteritis. Pancreatitis. Gastrointestinal ulceration and bleeding. Cirrhosis, Fibrosis and fatty degeneration of liver. Arthralgia, myalgia, osteoporosis. Inflammation and ulceration of bladder. Renal impairment. Rare: Infection. Conjunctivitis. Sepsis. Allergic reactions. Anaphylactic shock. Hypogammaglobulinaemia. Visual disturbances. Pericarditis. Pericardial effusion. Pericardial tamponade. Thromboembolic events. Pulmonary fibrosis. Pneumocystis carinii pneumonia. Shortness of breath and bronchial asthma. Pleural effusion. Acute hepatitis. Renal failure. Anuria. Very rare: Lymphoma. Agranulocytosis. Lymphoproliferative disorders. Severe courses of bone marrow depression. Acute aseptic meningitis. Convulsions. Paralysis. Impaired vision. Retinopathy. Haematemesis. Toxic megacolon. Hepatic failure. Stevens-Johnson syndrome. Toxic epidermal necrolysis. Not known: Eosinophilia. Encephalopathy/Leukoencephalopathy. Pulmonary alveolar haemorrhage. Jaw osteonecrosis (secondary to lymphoproliferative disorders). Legal classification: POM. MA numbers: EU/1/16/1124/001 – 008. Further information available from: Nordic Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin. Date of Prescribing Information: July 2021. Item code: IE/21/NOR/008-00.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Nordic Pharma Ireland; info@ nordicpharma.ie or +353(0)1 4004141

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Nordic Pharma Ireland; info@ nordicpharma.ie or +353(0)1 4004141

The overall mortality in SLE patients remains elevated and is up to 2.6-fold higher than the general population standardised by age and sex. However, this vastly improved between the 1950s and 1990s where five-year and 10-year survival rates increased from 74.8 per cent to 94.8 per cent and 63.2 per cent to 91.4 per cent, respectively, before it plateaued. A study reported the five-, 10-, and 15-year survival rates in adult patients with SLE as 0.92, 0.85 and 0.79, respectively, in low/middle-income countries as compared to 0.95, 0.89, and 0.82, respectively, in high-income countries between 2008 and 2016. The main causes of death in patients with SLE are disease activity, chronic renal failure, cardiovascular disease, and infections. Corticosteroids have the potential to impair the immune system response towards many infectious agents, which makes patients more susceptible to infections. Moreover, high doses of corticosteroids cause weight gain, hypertension, and diabetes, which are significant cardiovascular risk factors. The damage contributed by prednisolone increases over time with the highest burden of damage at 15 years. Thus, it is of utmost importance to develop targeted management strategies to minimise prednisolone exposure. Belimumab was the first agent licenced for use in SLE in the past 50 years, with benefits seen for cutaneous, renal and articular disease, and in particular it has a role in minimising corticosteroid exposure and the associated damage. Unfortunately, this is not yet available to public patients in Ireland.

Conclusion

SLE is a multisystem inflammatory condition, which presents in a myriad of ways and is characterised by the presence of antibodies with evidence of immune dysfunction. Diagnosis can be challenging, but we are guided by specific classification tools. Hydroxychloroquine is the foundation stone of pharmacotherapy in SLE, and is well-tolerated with a multitude of benefits. Monitoring for ocular toxicity is important. For more specific organ involvement, such as nephritis, immunosuppressives in the form of either MMF or cyclophosphamide remain the mainstay of therapy. Other more targeted therapies are being developed, but it remains a challenge for patients in Ireland that belimumab is still unavailable to them.

References available on request

Figure 1: Biopsied and histology features in keeping with leukocytoclastic vasculitis

Figure 2: Histological features are those of Class III lupus nephritis

FOR ALL THAT MATTERS IN MEDICINE

NEW WEBSITE COMING SOON

SPORTS QUIZ WIN €50 27 January 2022

Q1 Which nation will Ireland play in their opening Six Nations fixture next month?

Q2 Who became the 2022 British Masters snooker champion by defeating Barry Hawkins in the final?

Q3 Life in New England is not the same since Tom Brady’s departure. Who knocked the Patriots out of the 2022 playoffs?

Q4 Name the Irish golfer who finished tied for third at the Sony Open in Hawaii and in doing so entered the world’s top 50?

Q5 Who will face Chelsea in this season’s Caraboa Cup final?

Q6 The Winter Olympics will commence next month and are being staged in Beijing. What year did that city host the summer games?

CROSSWORD COMPETITION

27 January 2022

The winner of the 23 December 2021 Sporting Quiz Competition is Dr Ann Marie O’Farrell, Co Wicklow

The winner of the 23 December 2021 Crossword is Dr Angus Newitt, Co Louth

Q1 Max Verstappen is the 2021 Formula 1 World Champion, but can you name his father who raced in Formula 1 back in the 1990s? A: Jos Verstappen

Q2 The PDC World Darts Championship is underway. Who is the defending champion? A: Gerwyn Price

Q3 Name the former Manchester City and Barcelona footballer who was forced to retire from professional football? A: Sergio Aguero

Q4 Name the Munster head coach who leaves to take over at Bath at the end of the season? A: Johann Van Graan

Q5 Who has finished the year as World Number One in the Men’s golf world rankings? A: Jon Rahm

Q6 Who was recently named as interim manager of Manchester United? A: Ralf Rangnick

The woman who shot Mussolini

In March 2021, a Dublin City Council committee voted to support the erection of a plaque to the memory of Violet Gibson, an Irish woman who shot Italian Fascist leader Benito Mussolini in 1926. It is hoped to locate the plaque at 12 Merrion Square, Gibson’s childhood home. Gibson’s story is a fascinating one that merits close attention, as evidenced by the recent resurgence of interest in her life and deeds.

Gibson was born in Dublin in 1876. Her father, a lawyer and politician, became Baron Ashbourne in 1885. Her mother was a Christian Scientist. Gibson had a relatively privileged upbringing.

Gibson suffered from psychological problems for much of her life, often described as “hysteria”. These issues were compounded or fuelled by a series of bereavements in early adulthood, including the deaths of her fiancé, two brothers, and sister-in-law.

Gibson was also plagued by physical ill-health: Scarlet fever; pleurisy; Paget’s disease; and appendicitis. Treatments were less than precise at that point in history, so Gibson unfortunately suffered from lifelong complications of unsuccessful surgery.

Against this background, Gibson increasingly turned to religions, both conventional and obscure, for meaning, solace, and support. Notwithstanding these pursuits – or possibly because of them – Gibson’s psychological problems persisted. Following the death of her brother, Victor, she spent time in a “nursing home” in Kensington. Gibson attacked her housekeeper’s daughter with a knife, was certified insane and spent a period in Holloway Sanatorium in Surrey. Clearly, her psychological problems were intensifying.

In the mid-1920s, the combination of Gibson’s life circumstances, the succession of bereavements and Gibson’s chronic problems with physical and mental ill-health became too much. In 1925, she attempted suicide in Rome, saying that she “wanted to die for God”. Somehow, Gibson survived and went on, the following year, to etch out her place in history.

In April 1926, Gibson brought a revolver with her to the Piazza del Campidoglio in Rome and shot at Benito Mussolini, just after he left an assembly of the International Congress of Surgeons. Gibson fired twice, missing once and grazing the Fascist leader’s nose with the other shot. If Mussolini had not turned his head just in time, Gibson might well have killed him and changed the course of history. In the event, Mussolini was just slightly injured and Gibson was taken away by the police.

Gibson said she shot Mussolini “to glorify God”. The Italian authorities eventually released her, but returned her to the United Kingdom, where she was diagnosed with “delusional insanity with paranoia”. Gibson spent the remainder of her life in St Andrew’s Psychiatric Hospital in Northampton.

Gibson’s tragic, fascinating story is recounted in full in an historical biography by Frances Stonor Saunders, titled The Woman Who Shot Mussolini (Faber and Faber, 2010). The Dublin City Council committee motion, from Councillor Mannix Flynn in December 2020, describes Gibson as “a committed anti-fascist”.

The motion notes that, after Gibson shot Mussolini,

“she was set upon by Mussolini’s supporters, and would likely have been lynched had the police not stepped in and arrested her. She suffered various cruelties and indignities within the fascist prison system and was then deported to England, sparing the Italians the embarrassment of a public trial. Her family had secretly arranged to have her committed to an asylum – St Andrew’s Hospital in Northampton, where Lucia Joyce, James Joyce’s daughter, would later be committed.”

The motion says that “despite repeated pleas for her freedom, she spent the rest of her life in St Andrew’s, dying in 1956. It suited both the British authorities and her family to have her seen as ‘insane’ rather than as political. It is now time to bring Violet Gibson into the public’s eye and give her rightful place in the history of Irish women and in the rich history of the Irish nation and its people.”

The decision to commemorate Gibson is a welcome, interesting one. Her story is complex. From today’s perspective, there is compelling evidence of psychological problems and even mental illness, but one must be very careful about applying the diagnostic approaches of today to people in the past. The political dimensions of her case are enormous and were undoubtedly relevant to the outcome.

The 1920s, when Gibson was sent to St Andrew’s, was a period in which large mental hospitals were a feature of life in many parts of the world, including England and Ireland. Institutions and families collaborated to perpetuate admissions, often for decades. In 1952, Gibson’s nephew, Edward, wrote to the doctor in Northampton asking if it was a statutory requirement for her to be visited twice a year. The doctor said that it was, so Edward said he would fulfil the requirement, but would only stay for “a quarter of an hour or so”. Clearly, Gibson was very much alone, abandoned in the institution. Hopefully, the commemorative plaque in Merrion Square will help reclaim her story.

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

In April 1926, Gibson brought a revolver with her to the Piazza del Campidoglio in Rome and shot at Benito Mussolini, just after he left an assembly of the International Congress of Surgeons

Prof Brendan Kelly recounts the fascinating life of Violet Gibson

St Andrew’s Hospital in Northampton, where Violent Gibson was committed in the 1920s

PROF BRENDAN

Above: Violet Gibson, Right: Benito Mussolini

College of Anaesthesiologists of Ireland, National Patient Safety Day and KP Moore Medal Competition in Patient Safety 2021

Photos: David Coleman – Bobby Studio

Pictured L to R: KP Moore Candidates Dr Peter McCauley; Dr Fiona Roberts; Dr Jack Collins; Dr Donal Rafferty; Prof George Shorten, President, College of Anaesthesiologists of Ireland (CAI); Dr Ciara Luke; Mr Conor Farrell, CAI Medical Essay Winner 2021; Dr Mai O’Sullivan, KP Moore Medal Winner 2021; and Dr Ross Free. (Absent: Dr Damien Kerrigan, remote presenter)

Dr Barry Lyons, organiser

Prof Peter Gillen; Prof Eilish McAuliffe; Dr Noelle Healy; Dr Deirdre McCoy

Dr Gillian Crowe, winner of the Membership Exam Medal Autumn 2020; and Prof George Shorten Prof Ellen O’Sullivan and Dr Fiona Roberts

Dr Barry Lyons; Mrs Helen Moore; Dr Kevin Moore; Dr Mai O’Sullivan, winner, KP Moore Medal Competition 2021; Prof George Shorten; and Ms Anna Moore Prof George Shorten

Dr Jannicke Mellin-Olsen; Prof Ellen O’Sullivan; and Mr Martin McCormack, CEO, CAI

Prof George Shorten; Dr Peter McKenna; and Dr Niamh Hayes

Dr Irene Leonard; Dr Stephen Mannion; and Dr Amy Donnelly

Prof George Shorten; and Mr Martin Bromiley, OBE, Winter College Lecturer

Mr Martin Bromiley and Prof Ellen O’Sullivan

Prof Peter Gillen; Prof Eilish McAuliffe; Dr Noelle Healy; and Dr Deirdre McCoy

SKODA’S ENYAQ IS A TOP OF THE RANGE BATTERY ELECTRIC VEHICLE

Imagine

paying €51,000 for a Skoda?

Considering the misplaced jokes over the years, this might come as a surprise to a lot of people. Not only are eyebrows raised at the potential full price of the Enyaq, there is a queue of people waiting to hand over their cash (or credit) for one at the first available chance. Skoda Ireland had sold last year’s available allocation before the car was launched to the public, plus a few more they managed to haggle from the manufacturers.

To those in the know, it is no big surprise. Personally, I have always held Skoda in high regard. J. D. Power, the famous research organisation, has been monitoring cars for years based on owners’ feedback. They have documented Skoda as topping dependability studies with fewer than 70 problems per 100 vehicles, which you might think of as a lot unless you see the overall industry average of 114.

Anyway I was invited to the press launch of the Enyaq in Dublin. Here’s a little known fact: Enyaq is derived from the Irish name Enya, Irish for Eithne, meaning “essence”, “spirit” or “principle”, or even “source of life”. The ‘E’ is for electromobility and the ‘Q’ symbolises the SUV range of Skodas. Before the end of 2022, Skoda will have nine more electric models launched. Interesting times ahead then.

So, the car. As part of the VAG family, there is overlap between the VW ID.4 and Audi Q4 e-tron. Audi retains the fastest model with their 503bhp (370kw) model, but otherwise

models overlap. Skoda will have the 80x, an all-wheel drive version later. As always, Skoda will have the value for money, practical end of the market.

I drove the Enyaq iV 80, with the 77kw battery translating into 150kw of power. With increasing numbers of battery electric vehicles (BEV) on our roads, we’ll have to get used to new figures for assessing electric power. More importantly it gave a range of 535kms, or 332 miles. For me, that’s enough to get me to Galway and back from home, a journey I have done once in the last year. Which brings me to a story I know about a local professional who drives a Tesla. If he drives to Galway he needs to recharge there, if his wife drives she can make it there and back on one charge. Work out what’s happening yourself. Recently, I stayed in Limerick for the weekend, on St Catherine’s Street. Where I was staying there were two chargers within 130m walking distance to my B&B.

Either one would give me more than enough electric charge to get home.

For those who are, let’s say, more light footed or are happy with a slower car, there’s an Enyaq 60 with 58kw battery and (WLTP) range of 412km. The 58kw battery gives 132kw of power, or 180bhp as we used to know it as. On the road price, after grants and before haggling (I wish you luck), is €44,390. Both versions are rear wheel drive and come with 310nm of torque.

And to drive, the Enyaq is lovely. Power delivery is quiet and progressive. Although rated at about 200bhp, the Enyaq weighs about two tons, and 0-100kmh/h is quoted at 8.6 seconds. To me, driving the South County Dublin roads, it felt quicker than that. Of course, being electric, with the stepless transmission and instant torque, it will always give a feeling of instant acceleration. The ride was compliant, but I was probably on the best roads in Ireland. I found the seats

comfortable and supportive and loved the soft touch of the material on the dashboard.

Almost all electric cars are ‘gearless’ (except Porsche Taycan with its two forward gears), but the Enyaq iV 80 has the gear paddles that adjust the regenerative braking, which gives an interesting driving experience. By flapping these, different regenerative modes are applied, giving varying degrees of gently coasting to a sense of gentle brakes applied.

On the test roads I managed to get lost several times (which resulted in testingthe full lock of the steering – quite good), but the remaining electric range never dropped significantly.

All Enyaqs come with the MIB infotainment systems, with 13” colour touch screen display and digital dashboard. There are 15 option packages to choose from. The list would make another piece on its own.

In case you are sitting on a fence somewhere thinking about going electric, Skoda have an App (My Skoda IV) you can download and pretend you are driving electric. It can compare your trips, fuel consumption, and emission tracking. The best bit is it will tell you when you need to charge your BEV and where your nearest charging stations are. And, in the UK in June 2021, new BEVs outsold new diesel cars.

I was asked before I took the test drive if I would be interested in buying one. I said I’m not an SUV type; I’m more into a lower saloon type car. By the time I came back I was ready to see the logic of the Enyaq.

I found the seats comfortable and supportive, and loved the soft touch of the material on the dashboard

ASTHMA SOCIETY WINTER WELLNESS CAMPAIGN UNDERWAY

The Asthma Society of Ireland last month launched its winter wellness campaign to provide advice to people with asthma on how to best manage symptoms.

The campaign includes a winter wellness support pack distributed to every member of the Asthma Society and an accompanying digital and PR campaign. It is supported by GSK.

As Ireland experiences colder weather, the 380,000 people living with asthma in Ireland may experience more severe and more frequent respiratory symptoms.

The Asthma Society said it was aware that this winter is particularly challenging for patients and carers as they seek to manage respiratory infections, weather triggers and air pollution. Many patients and carers have reported to nurses in the Asthma Society that they are feeling sicker than in previous years and are also feeling less equipped to manage their asthma or respiratory symptoms.

Furthermore, these challenges have been compounded by uncertainties surrounding the pandemic, and the increasing case numbers in Ireland over recent weeks. Patients are also indicating that they are missing the support and advice that they normally receive from healthcare professionals, as a result of diminished access to in-person GP or practice nurse appointments.

Speaking in December, Ms Ruth Morrow, Respiratory Nurse Specialist with the Asthma Society, said: “This year, in particular, we are seeing adults and children with asthma hard-hit by respiratory infections and this is having a knock-on impact on their asthma management.

“Our services have been busy with appointments and queries about weather trig-

gers, respiratory infections (including RSV and viral wheeze in children where they may never have had such severe symptoms before) and indoor air triggers. They can call the Asthma Society’s Free Adviceline on 1800 44 54 64 for a nurse appointment or message our Beating Breathlessness nurse on WhatsApp on 086 059 0132 to get ongoing support.”

Also speaking last month, Ms Sarah O’Connor, CEO of the Asthma Society, said: “We’re experiencing a much busier period on our services in recent weeks and we have been listening carefully to patients to understand what they need right now. We believe that this winter wellness support pack will be a valuable intervention to help patients build self-management skills and get control of their asthma….

“As a respiratory charity supporting patients throughout a global respiratory pandemic, our services have never been busier and we have never been more needed. We have also never been so hard-pressed financially to deliver our services with so few resources.”

Ms Eavan Daly, Director of Medical Affairs at GSK, said: “We are very pleased to be able to support the Asthma Society’s winter wellness campaign and support pack. Patient information and self-management support is one of the most important aspects of a patient organisation’s work. We are proud to support this campaign because it furthers those goals and we hope it will be useful to the 380,000 patients with asthma in Ireland.”

For more information about the Asthma Society and to download its free winter wellness support pack, visit: www.asthma.ie. To donate to the Asthma Society, visit: www.asthma.ie/donate

IRISH HEART FOUNDATION CRITICISES LACK OF JUNK FOOD CURBS IN ONLINE SAFETY BILL

The recently published Online Safety and Media Regulation (OSMR) Bill has been criticised for failing to protect children’s health by omitting explicit restrictions on junk food marketing.

The Irish Heart Foundation says the Bill fails to curb digital marketing of unhealthy food to children,

strategies used to promote junk food are increasingly integrated, immersive and personalised.”

In early November, the charity welcomed a recommendation by the joint committee on tourism, culture, arts, sport and media of a ban on advertising to children online, including ads for alcohol, high fat/salt/sugar foods, and gambling.

“Studies have shown that online junk food marketing to children is fuelling the obesity crisis and it is unfortunate that the Department has not given due regard to public health evidence, or the recommendations of the Oireachtas joint committee, with an explicit reference to banning these practices,” Ms Reilly said.

“TDs and Senators from all parties have repeatedly voiced their concerns about the rising levels of childhood overweight and obesity that persist. With the OSMR Bill, the Oireachtas had a once in a decade opportunity to protect children’s health and to be part of momentum across Europe to tackle marketing to children.

“Up to now, the interests of the food and advertising industries have been put

above the health of children in Ireland, and with the failure of the Department to include an explicit ban on junk food marketing online, this will continue. A junk food ad ban in the Bill would have been a seismic shift to put public health above private profits.

“Neither sections relating to media service codes nor online safety codes make explicit reference to bans on junk food advertising to children. Part 5, section 9, notes media codes will ensure that commercial communications ‘protect the interests of children having particular regard to the general public health interests of children’.

“Part 11, section 44 of the Bill states that online safety codes will ensure commercial communications on their services are ‘appropriate to protect the interests of users of their services, and in particular the interests of children’, but these provisions do not go far enough because they don’t adequately reflect the recommendation of the Oireachtas committee.

“These alone will not suffice and children must be explicitly protected from these forms of advertising, and they must be named in the Bill.”

APPOINTMENTS AT MEDICINES FOR IRELAND

Medicines for Ireland (MFI) recently announced the appointment of Managing Director of Accord Healthcare Ireland, Mr Padraic O’Brien, as new Chairperson of the organisation, with Mr Paul Neill, Director of Generic Products for Teva Pharmaceuticals Ireland, taking over the role of Vice Chairperson.

Donnelly in mid-December is estimated to reduce the State spend on medicines by up to €700 million, while dramatically improving access to innovative new medicines for patients nationwide.”

Newly appointed Vice Chairperson, Mr Neill, is Director of Generic Medicines for Teva Pharmaceuticals, the largest supplier of prescription medicines to the State, and has almost 20 years of experience in the pharmaceutical sector.

“As we look to the future, Medicines for Ireland will continue to engage with the Minister for Health, the Department of Health, the HSE and Government on key issues, especially on expanding access and usage of generic and biosimilar medicines. In Ireland, we continue to remain well below what is the norm in most other European states, and while much progress has been made, much more can be done in this area,” said Mr Neill.

STUDY REVEALS POTENTIAL TO REDUCE NUMBER OF MEDICATIONS PRESCRIBED FOR OLDER PEOPLE

A study by researchers at RCSI University of Medicine and Health Sciences of GP-delivered medication for older people led to an overall reduction in the number of medicines prescribed.

The research, published in PLOS Medicine, was led by Prof Susan Smith and Dr Caroline McCarthy of the Department of General Practice at RCSI.

tion group compared to the control group, with over 800 medicines being stopped in 208 intervention patients. Of the over 800 medicines ceased, 15 possible adverse events were reported, almost all of which were mild reactions that stopped once the medicine was re-introduced, indicating that stopping certain medicines in older people is generally safe.

which studies have shown is fuelling the obesity crisis.

“The Department of Tourism, Culture, Arts, Sport, and Media has failed to appreciate the key role junk food marketing plays in eroding children’s health,” said Ms Kathryn Reilly, Policy Manager with the charity.

“The digital marketing

Since its foundation in 2016, Medicines for Ireland has been promoting the benefits of the increased use of generic and biosimilar medicines in Ireland. The organisation’s core objective is to improve the way Ireland procures and supplies medicines, in order to expand the patient access to affordable, lifesaving and life-enhancing treatment.

Mr O’Brien previously served as MFI Vice President in 2020 and 2021. Through MFI, he has been actively engaging with policymakers on both a national and European level with respect to increasing access of afforda-

ble medicines for patients, as well as highlighting the need for safeguarding measures to be put in place to help mitigate threats to the supply of medicines to Ireland brought about by Brexit and Covid-19.

Following his appointment to the role of Chairperson, Mr O’Brien stated: “I am honoured to take over the role of Chairperson after a very successful year at MFI. Our strong contribution to the recent Framework Agreements on Pricing and Supply of Medicines 20212025 recently agreed with the Department of Health, the Department of Public Expenditure and Reform, and the HSE, is the culmination of two years of hard work from the MFI membership and in particular outgoing Chairperson David Delaney.

“This new framework agreement on the supply and pricing of non-originator, generic, biosimilar, and hybrid medicines announced by Minister for Health Stephen

There is an increasing number of older people living with multiple medical conditions, known as multimorbidity, who are prescribed several medicines. This creates significant challenges for the healthcare system in terms of costs, as well as for the individual (and their carers) in having to manage taking so many medicines, and for the clinicians who decide what should be taken. The SPPiRE (Supporting prescribing in older people with multimorbidity and significant polypharmacy in primary care) research project aimed to address these challenges.

This study consisted of a randomised controlled trial involving 51 GP practices and 404 patients throughout the Republic of Ireland. Older patients with multimorbidity taking at least 15 regular medicines were invited to attend a medication review with their GP. The review included screening their prescription for potentially inappropriate combinations of medicines, considering opportunities for stopping medicines and assessing the patient’s priorities for treatment. It then assessed whether this onceoff GP-delivered medication review reduced the number of medicines and improved the quality of prescribing.

There was a significant reduction in the number of medicines in the interven-

The quality of prescribing was also assessed, using a checklist of potentially inappropriate combinations of medicines. While there were no significant improvements in the quality of prescribing in the intervention group compared to the control group, overall there were improvements in both groups during the study period.

Dr McCarthy, GP and Clinical Lecturer and Research Fellow in the Department of General Practice at RCSI, said: “It’s possible that the identification of this at-risk group who are prescribed at least 15 medicines may in itself have led to improvements in prescribing. It can be daunting for GPs with limited time and resources to actively manage these prescriptions and patients can also be wary about change, particularly if they have been on a medicine a long time.”

Prof Smith, Associate Director of the HRB Primary Care Clinical Trials Network, commented: “The intervention approach to managing this challenging problem is promising and demonstrates that, even in this very complex group, stopping medicines that may no longer be needed or appropriate is both possible and generally safe.” This research was funded by the HRB Primary Care Clinical Trials Network.

GP REQUIRED

Long-established two-doctor GP training practice North Meath area seeks assistant. Flexible options available. Fully computerised, supported by excellent nursing and administrative staff. Excellent package including genuine partnership opportunity if desired.

Please email cv to drjameskeenan@gmail.com or phone 086 814 0136 for informal enquiries

GP REQUIRED

GP required for a well-established practice in East Galway (6-8 sessions). 20-minute commute from Oranmore.

Fully computerised with Socrates

Specialist Medical Accountant, RCSI Lecturer and author of Fit moneythe key to financial freedom

Now offering:

• Monthly Profit Growth Model

• Annual Accounts and Tax Returns

• Outsourced Bookkeeping and Payroll

• Support in Selling and Buying a Practice Contact 01 801 3116 for help and support

We are currently seeking a vocationally trained (MICGP or equivalent) GP for 3-4 sessions (flexible) per week, with possible additional holiday cover in Falcarragh, Co Donegal, for immediate start. Our practice is fully computerised (Helix Practice Manager) with three GPs, two full-time practice nurses, practice manager, and administration staff. Falcarragh is a busy market town surrounded by beautiful scenery and mountains, close-by white sandy beaches for surfing/watersports etc. Great work/life balance.

If interested, please send CV to Sheila O’Donnell Practice Manager at falcarraghmedicalMC21@gmail.com

Tel 086 310 0732

The HSE South currently has the following opportunity: – General Practitioner Ref: PM1122 in the GMS Scheme Ballyduff, Co. Kerry (Panel Size 1010)

Informal enquires: For practice related and contractual enquiries, please contact Ms Norah Heffernan, Primary Care Unit Manager, Cork Kerry Community Healthcare, HSE Cork Kerry Community Healthcare, Tel: 021 4923833.

Closing date for receipt of applications is: 12 noon on Friday 4th February 2022.

For further information on this post and how to apply please visit: www.hse.ie/jobs

EXCELLENT GP JOB OPPORTUNITIES

Louth, Meath, Cavan, and Monaghan

GP out-of-hours (NEDOC) and daytime surgery jobs

Great rates available Contact us on 046 924 1533, Email: info@medsource.ie

Visit our website: www.medsource.ie

Latest modules

Chronic pain control - An overview

1.5 CPD Hours

Author: Eamonn Brady MPSI

Diabetic foot disease

2 CPD Hours

Authors: Theresa Lowry-Lehnen GPN, RNP, PhD, Clinical Nurse Specialist and Associate Lecturer at IT Carlow. Member of the Irish General Practice Nurses Educational Association (IGPNEA)

The spectrum of treatment for inflammatory bowel disease

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

If you have anything you would like to share, please email: info@mindo.ie

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

Keeping up appearances: Sleeve notes on white coats

In a previous Dorsal View, we looked at studies showing how wearing a white lab coat appeared to improve the performance of participants in certain tests. Importantly, the effect was only seen when the participants were informed that they were wearing a doctor's white coat, rather than an artist's white coat, for example. But what of the patient – do they prefer their doctors to sport the lab coat, or to adopt a less formal approach to their attire?

This question occupied the minds of researchers in 2013, five years after the introduction of the bare-below-the-elbow policy in England. The researchers not only looked at patient preferences, but also the role of the coat in terms of infection transmission and an analysis of previous studies on the topic. Participants were recruited from the Ochsner Health System, comprising a hospital clinic, satellite clinic, and inpatient ward, with a total of 153 patients taking part. In general, and perhaps to be expected, 69.9 per cent of

COMBINING POWER AND CONFIDENCE

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

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

patients preferred their doctors to wear white coats, although the results are a little nuanced. “... A higher proportion of outpatients preferred coats (P=0.001), a trend most pronounced between hospital clinic (84 per cent) and ward inpatients (51.9 per cent),” wrote the authors. However, the bare-below-the-elbow look was unpopular with patients, scoring lowest on the comfort and confidence scales. Even when patients were informed of the potential risks of infection with long-sleeve coats, 86.9 per cent would still prefer their doctor to wear one. The questionnaire also included an image of a doctor in four different states of attire – a simple shirt and tie; scrubs; a white coat over scrubs; and a white coat over a shirt and tie.

On one matter, doctors and patients were in agreement: White coats are an important way to identify doctors in a busy clinical environment. In practical terms, the doctors who were surveyed preferred to wear the white coat to keep their clothes clean and carry various implements.

However, the patient's preference for what their doctor wears may have regional twists. A separate study from Australia showed a general indifference to what GPs wear, with 45 per cent of the Australian family practice patients surveyed saying they were indifferent to coats. The debate can also be broadened to consider the appropriateness of the white coat in palliative or paediatric settings, for example. In addition, it was noted that scrubs are the expected attire in an emergency department, so some of the results were quite clinic-specific.

Regarding the study in question, the authors suggest further research to include perceptions of the doctor's bag, as well as novel solutions, such as messenger-style shoulder bags and vests made of advanced antimicrobial fabrics. In concluding, they also note the ongoing debate around the potential for white coats to spread infection.

"Our findings suggest patients prefer white coats and they contribute to greater comfort and confidence in their physicians," the researchers wrote. "While our participants' knowledge about coat-carried infection risk was low, information about this theoretic risk had only a minimal influence on their opinions.

"The current available evidence has not conclusively linked white coats with increased infection rates; consequently, the contribution white coats make to medical practice should be taken into consideration before making uniform policy recommendations. We hope that our results can help guide the direction for future uniform policies."

While these may seem like superficial considerations, they also referenced previous studies, which seemed to show that communication between the doctor and patient was improved when the doctor was wearing their white coat. "A patient's first impression of a physician can instill trust by inspiring confidence and can build regard by engendering comfort," they added. "According to our study findings, both of these traits seem to be already linked in patients' minds with physicians who wear white coats."

If you wish to drill a little deeper into the results, the study is titled 'Patient preferences for doctor attire: The white coat's place in the medical profession', (Ochsner Jv.13(3); Fall 2013, PMC3776508).

Feel free to weigh-in on the debate at the email address at the top of this page with your observations, anecdotes, and opinions.