Irish Pharmacist April 2021

VOL 22 ISSUE 4

APRIL 2021

Lifestyle Motoring and book review

Reasons to be fearful

Ultan Molloy tries his level best to be positive about the present and future of community pharmacy

CLINICAL CONTENT

CPD MODULE: Pain management.

PLUS: clinical content on Rheumatology, Cardiology, and Allergic Rhinitis

HAVE COVID, WILL TRAVEL

A study has uncovered the relationship between travel and the spread of SARS-CoV-2 variants

CONTENTS

PAGE 2-11

PAGE 12-13

PAGE 16-17

PAGE 19-20

PAGE 31-36 pharmacist

NEWS A round-up of industry and healthcare news

COVID WITHOUT BORDERS An Irish study has shown the link between the second wave of Covid-19 and international travel

WAITING IN PAIN Almost 877,000 people are living with chronic pain while waiting to receive hospital care

A HIRE PURPOSE Sometimes the most obvious job candidate may not be the right one for your pharmacy

pharmac

CPD MODULE Earn 2 CPD points by completing our module on the clinical considerations in Pain Management

PAGE 37-43

PAGE 44-51

PAGE 53-56

PAGE 58

RHEUMATOLOGY An overview of recognising, treating and managing rheumatoid arthritis

CARDIOLOGY A wide-ranging look at assessing and treating hypertension

ALLERGIC RHINITIS Helping your patients to manage their hay fever symptoms this spring

ORAL HEALTH Covid-19 stress is causing one-in-five Irish people to neglect their oral health

PAGE 59

PAGE 60-61

PAGE 62-64

BOOK REVIEW Prof Brendan Kelly reviews The Ministry of Bodies, a book laced with sardonic humour that takes a sideways look at hospital care

ON YOUR BIKE A look at the rise and rise in the popularity of e-bikes, how they work, and what’s available on the market at the moment

PRODUCT NEWS A round-up of the latest product news in pharmacy, including treatment options for breast cancer, allergic rhinitis and cardiology

PAGE 23

PAGE 24-25

PAGE 26-27

PAGE 28-29

FINTAN MOORE

DR DES CORRIGAN

TERRY MAGUIRE

ULTAN MOLLOY

Editor Pat Kelly, pat@greenx.ie Creative Director Laura Kenny, laura@greenx.ie Administration Manager Daiva Maciunaite, daiva@greenx.ie Managing Director Graham Cooke, graham@greenx.ie

VOL 22 ISS 4

APRIL 2021

GreenCross Publishing was established in 2007. Publisher and Managing Director: Graham Cooke, graham@greenx.ie © Copyright GreenCross Publishing Ltd 2021.

The contents of Irish Pharmacist are protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means – electronic, mechanical or photocopy recording or otherwise – whole or in part, in any form whatsoever for advertising or promotional purposes without the prior written permission of the editor or publishers.

Disclaimer The views expressed in Irish Pharmacist are not necessarily those of the publishers, editor or editorial advisory board. While the publishers, editor and editorial advisory board have taken every care with regard to accuracy of editorial and advertisement contributions, they cannot be held responsible for any errors or omissions contained.

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NEWS

COVID-19

Covid-19 risk increases with airborne pollen — research Increased pollen concentrations correlate with higher SARS-CoV-2 infection rates, recent research has concluded. When airborne pollen levels are higher, increased SARSCoV-2 infection rates can be observed, said the authors. These results were determined by a large-scale study conducted by an international team headed by researchers at the Technical University of Munich (TUM) and the Helmholtz Zentrum München in Germany. The team presented the findings published in PNAS at an international online press conference and highlighted ways in which people in high-risk groups could protect themselves.

In the spring of 2020, the outbreak of the coronavirus pandemic appeared to coincide with the tree pollen season in the northern hemisphere. These observations prompted the international team of researchers to conduct an extensive investigation. The scientists wanted to know whether there is a demonstrable link between airborne pollen concentrations and SARS-CoV-2 infection rates.

Under the leadership of first author Dr Athanasios Damialis, the team at the Chair of Environmental Medicine at TUM collected data on airborne pollen concentrations, weather conditions and SARS-CoV-2 infections, taking into consideration the variation of infection rates from one day to another and the total number of positive tests.

In their calculations, the team also included data on population density and the effects of lockdown measures. The 154 researchers analysed pollen data from 130 stations in 31 countries on five continents.

The team showed that airborne pollen can account for, on average, 44 per cent of the variation in infection rates, with humidity and air temperature also playing a role in some cases. During intervals without lockdown regulations, infection rates were on average 4 per cent higher with every increase of 100 grains of airborne pollen per cubic meter. In some German cities, concentrations of up to 500 pollen grains per cubic metre per day were recorded during the study, which led to an overall increase in infection rates of more than 20 per cent. In regions where lockdown rules were in effect, however, the infection numbers were on average only half as high at comparable pollen concentrations.

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High pollen concentrations lead to a weaker immune response in airways to viruses that can cause coughs and colds.

When a virus enters the body, infected cells usually send out messenger proteins. This is also the case with SARS-CoV-2. These proteins, known as antiviral interferons, signal nearby cells to escalate their antiviral defences to keep the invaders at bay. Additionally, an appropriate inflammation response is activated to fight the viruses.

But if airborne pollen concentrations are high, and pollen grains are inhaled with the virus particles, fewer antiviral interferons are generated. The beneficial inflammatory response itself is also affected. Therefore, on days with a high concentration of pollen, it can lead to an increase in the number of respiratory illnesses. This also holds true for Covid-19. Whether individuals are allergic to the different pollen types is irrelevant, said the authors.

“You cannot avoid exposure to airborne pollen,” says Dr Stefanie Gilles, who is also first author of the study. “People in high-risk groups should, therefore, be informed that high levels of airborne pollen concentrations lead to an increased susceptibility to viral respiratory tract infections.”

Dr Damialis added: “When studying the spread of SARS-CoV-2, environmental factors such as pollen must be taken into account. Increased awareness of these effects is an important step in preventing and mitigating the impact of Covid-19.”

In terms of what vulnerable people can do to protect themselves, Prof Claudia TraidlHoffmann, last author and a Professor of Environmental Medicine, advised people at high risk to monitor pollen forecasts over the coming months. Prof Traidl-Hoffmann stated: “Wearing a particle-filtering mask when pollen concentrations are high can keep both the virus and pollen out of the airways.”

VOL 22 ISS 4

APRIL 2021

NEWS

CONTRACEPTION

Irish digital pharmacy launches first payment plan for long-term contraception methods Digital pharmacy service Healthwave has launched Ireland’s first pharmacy-led payment plan for long-term contraceptive methods. The launch marks the first year of Healthwave’s femalefocused initiative that, to date, has provided over 100,000 oral contraceptive pills free of charge to Healthwave members. Currently, over 500 female members of Healthwave digital pharmacy avail of the free oral contraception offer.

There is growing demand among women in Ireland for long-acting reversible contraceptives (LARCs), with many women becoming increasingly aware of

the benefits. ‘Fit and Forget’ contraceptives (LARCs) are also the most cost-effective form of contraception in the long term, but the initial up-front cost of €114 for the implant or coil can be a barrier to access. According to the Irish Family Planning Association, LARCs are 99 per cent effective, removing the risk of forgetting to take oral contraceptive pills, and last for three-to-five years.

The LARC payment plan can be paid over three instalments of €38 with an easy setup via the Healthwave website, according to Healthwave. “Our goal at Healthwave is to simplify access to medications. As the only pharmacy

platform to offer a free oral contraception service, we are now seeing the increased demand for LARCs,” said Ms Catherine McNicholas, Director of pharmacy services at Healthwave. “We are in a position to help women access their preferred form of contraception without the worry of a large up-front payment on top of the insertion fee. We hope our payment plan makes accessing LARC contraception both easier and affordable for women in Ireland... ” In 2020, the Department of Health committee ruled there was no room in the Budget for a nationwide free contracep-

tion initiative. The Minister for Health had set a 2021 date for the initiative to give time for regulatory and policy issues to be addressed and legislation to be drafted and enacted.

Ms McNicholas continued: “Female health is a key focus for us at Healthwave, with improved access to contraception at the centre. While we advocate strongly for universally free contraception and welcome calls to introduce pharmacist prescribing of progesterone-only pills, we are fully committed to continuing and expanding our original contraception initiative for Irish women.”

DERMATOLOGY

New research offers hope for improved treatment of infants with eczema New research led by scientists from Trinity College Dublin and Children’s Health Ireland, Crumlin, offers hope for the improved treatment of infants with eczema.

The research showed that corticosteroid treatments reduced disease severity and normalised immune dysregulation.

The scientists, supported by NCRC, have recently published their research in the British Journal of Dermatology.

Eczema, also known as atopic dermatitis, is the most common persistent inflammatory disease of early childhood. Sixty per cent of cases of eczema begin during the first year of life, while 85 per cent begin before a child reaches five years of age. Eczema is caused by a combination of genetic and environmental factors, but the exact mechanisms underlying the development and progression of the disease are not fully understood.

Increased local (within the skin) and systemic (within the peripheral blood circulation) in-

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flammation is evident in infants with eczema but it is not clear what effect standard treatment with topical corticosteroids (creams, gels, ointments containing corticosteroids) has on inflammation within this patient group.

In the recently published study, a team led by Dr Maeve McAleer and Prof Alan Irvine from Trinity’s School of Medicine set out to investigate responses to first-line corticosteroid treatments in in-

fants with eczema and examine the effect of corticosteroid therapy on skin and blood biomarkers of inflammation.

They recruited 74 treatment infants (<12 months of age) with moderate-to-severe eczema, through the Atopic Dermatitis Clinic at Children’s Health Ireland, Crumlin. Using minimallyinvasive skin tape stripping, skin samples were collected before and after a six-week course of

treatment with topical corticosteroids. Blood samples were also collected at both time points.

The scientists found that topical corticosteroid therapy led to an improvement in disease severity, but treatment also normalised systemic immune dysregulation in infants with eczema. Following treatment, altered skin and blood cytokine profiles approached levels seen in children without eczema.

Moreover, the results suggest that local inflammation within the skin is responsible for immune dysregulation in infants with eczema.

Prof Irvine said: “Our study shows that inflammatory signals from the skin of children with eczema leak into the system and are circulating widely. Treating the skin inflammation reduces the levels of these inflammatory signals in the blood. Collectively, these findings help to shape our understanding of the systemic effects of eczema.”

VOL 22 ISS 4

APRIL 2021

The solution to all your sourcing pains

For more information please contact: Free Phone 1800 440 440 I PharmaSource@uniphar.ie I www.uniphar.ie

NEWS

HOSPITAL PHARMACY

EAHP issues opinion focused on the application of medical device regulations Medical devices are an essential part of the delivery of high-quality healthcare to patients all across Europe. In many countries, their procurement and management in the hospital setting falls often under the authority of hospital pharmacists. To further improve the safety of medical devices for European patients, a new regulatory regime was adopted in spring 2017, encompassing both the Medical Device Regulation (MDR) and the In Vitro Medical Device Regulation. With the MDR becoming fully applicable from May 2021 onwards, the European Association of Hospital Pharmacists (EAHP) recently reiterated some of the considerations raised by hospital pharmacist in EAHP’s Statement on the Medical Device Regulation, adopted in 2014, and the EAHP’s opinion on this topic released in 2019.

The Association said it welcomes the reinforcement of the supervision of notified bodies, the strengthened clinical evaluation, and the improved surveillance and vigilance mechanisms introduced by the MDR. In relation to the latter, the EAHP said it would like to express its support for the requirements mandating manufacturers to report serious incidents and corrective actions they have taken to reduce the risk of recurrence. However, given that systems for pharmacovigilance reporting by health professionals in respect of medicines are well established across Europe, the Association said it would also like to see further empowerment of healthcare professional and patient reporting, in particular, reporting from hospital pharmacists specifically trained for this task.

Ensuring reporting processes for devices and medicines are of a similar nature will help to reduce the burden of reporting, and, by increasing the familiarity of the process to the health professional, increase the likelihood of reporting, it said, adding that targeted information campaigns should be launched to encourage and enable healthcare professionals to report suspected serious incidents to the competent authorities.

With regard to the European Database on Medical Devices (EUDAMED), EAHP main-

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tains the position that the information-sharing capabilities of this database will help increase transparency, including better access to information for the public and healthcare professionals. To further facilitate the uptake and use of EUDAMED, the EAHP reiterated its recommendation that the synergies between EUDAMED and EudraVigilance should be explored and that reporting tools used for both should be streamlined to encourage and facilitate reporting.

As for the nomenclature used for the operation of EUDAMED, the EAHP commented on the suggestions made by DG SANTE in January 2020, which stipulate that the European Commission will map the European Medical Device Nomenclature (EMDN) to the Global Medical Device Nomenclature (GMDN). This mapping is of uttermost importance for hospital pharmacists currently working with international nomenclature, it said. Consequently, the Association called on the European Commission to make the mapping of the GMDN to the EMDN fully available before May 2021, since it is of relevance for the work of hospital pharmacists. The targeted campaigns mentioned in relation to adverse event reporting could also be used for sharing information on the use of the EUDAMED with healthcare professionals, it added.

The efforts made by the MDR to enhance

patient safety are supported by EAHP. However, in relation to the establishment of a unique device identification (UDI) system, EAHP stated it would like to underline again its concerns on the integration of this system in the hospital environment. Due to the existence of a separate system for the verification of medicines to combat falsification, it is of importance that healthcare professionals are well trained in the application of the UDI system for devices to avoid any confusion between these two systems. Also, hospitals should be encouraged to facilitate the integration of the UDI system into their existing information systems and working processes, said the EAHP. It added that hospital pharmacists should be involved in the selection, procurement and evaluation of medical devices in the hospital sector with other healthcare professionals, including the management of clinical trials with medical devices and the evaluation of software classified as a medical device. In particular, medicine-containing devices should not be procured without the expertise of the hospital pharmacist — due to their knowledge and skills, hospital pharmacists are specialists in the field of all medicines procurement. They should lead in all phases of the procurement processes to ensure the continuity of supply of cost-effective and quality medicines and medical devices to patients, said the EAHP, and the close collaboration between hospital pharmacists and other healthcare professionals is not only of relevance for the procurement of medical devices, but also for their traceability. To guarantee the quality and security of the information delivered to the patient, hospital pharmacists and other healthcare professionals must work closely to comply with the obligations under the MDR. The Association concluded that it would like to emphasise again the need for close collaboration between authorities and healthcare professionals. Their training and familiarisation with the MDR are of uttermost importance for making the application of the new rules for medical devices a success in European hospitals, said the Association.

VOL 22 ISS 4

APRIL 2021

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Voriconazole

ANTI-VIRAL AGENT

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Bicalutamide Bicalutamide

IMMUNOSUPPRESSANT

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Mycophenolate Mofetil HIV-1 INFECTION AND HEPATITIS B INFECTION

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HEPATITIS B INFECTION

Entecavir Accord Entecavir

Temozolomide Accord Temozolomide

PULMONARY ARTERIAL HYPERTENSION

Ambrisentan Ambrisentan

SYSTEMIC HORMONAL PREPARATIONS

Cinacalcet Accord Granpidam

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Sildenafil

Further information is available on request from Accord Healthcare Ireland Ltd, Euro House | Euro Business Park | Little Island | Cork | T45 K857 | Ireland. Tel: 021-461 9040 or from the SmPC available on www.accord-healthcare.ie Products subject to prescription. Supply through pharmacies only. Accord Healthcare Ireland Limited, Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland and Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain.

*Pack sizes do not represent actual size. Date of Preparation: December 2020 IE-01562

NEWS

IMMUNOLOGY

RCSI School of Pharmacy researchers discover new way to halt excessive inflammation RCSI researchers have discovered a new way to ‘put the brakes’ on excessive inflammation by regulating a type of white blood cell that is critical for our immune system. The discovery has the potential to protect the body from unchecked damage caused by inflammatory diseases, said the researchers. The paper, led by researchers at RCSI University of Medicine and Health Sciences, was published recently in Nature Communications.

When immune cells (white blood cells) in our body called macrophages are exposed to potent infectious agents, powerful inflammatory proteins known as cytokines are produced to fight the invading infection. However, if these cytokine levels get out of control, significant tissue damage can occur.

The researchers have found that a protein called arginase-2 works through the energy source of macrophage cells, known as

mitochondria, to limit inflammation. Specifically, they have shown for the first time that arginase-2 is critical for decreasing a potent inflammatory cytokine called IL-1.

This discovery could allow researchers to develop new treatments that target the arginase-2 protein and protect the body from unchecked damage caused by inflammatory diseases.

“Excessive inflammation is a prominent feature of many diseases, such as multiple sclerosis, arthritis and inflammatory bowel diseases. Through our discovery, we may be able to develop novel therapeutics for the treatment of inflammatory disease and ultimately improve the quality of life for people with these conditions,” commented senior author on the paper Dr Claire McCoy, Senior Lecturer in Immunology at the RCSI. The study was led by researchers at the School of Pharmacy and Biomolecular Sciences, RCSI (Dr Claire McCoy, Dr Jennifer Dowling and Ms Remsha Afzal) in collaboration with a network of international researchers from Australia, Germany, and Switzerland.

The research was funded by Science Foundation Ireland, with initial stages of the research originating from a grant from the National Health Medical Research Council, Australia.

COVID-19 VACCINATION

Call for pharmacists to be utilised to stop vaccine targets being missed As the HSE struggled to meet its Covid-19 vaccine campaign targets, the Irish Pharmacy Union (IPU) urged the Minister for Health to boost vaccination capacity by immediately mobilising pharmacists. The IPU said there should be no further delays in enlisting pharmacists, who could potentially administer 10,000 or more vaccines a day.

Speaking about the vaccine rollout, IPU Secretary General Mr Darragh O’Loughlin said: “Starting the roll-out of vaccinations to the general population was extremely positive. Unfortunately, the HSE has not so far been able to meet its modest target of 100,000 vaccinations per

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week. While supply of vaccines has clearly been the main driver of this shortfall, capacity to administer vaccines will soon become a factor as supply improves and those targets increase.

“To avoid any further delays, we are calling for capacity to be increased by allowing pharmacists to start vaccinating using the AstraZeneca vaccine. Should the Johnson & Johnson vaccine be approved in the coming weeks, pharmacists should immediately be allocated supplies to commence vaccinating with this also.”

This approach would allow the creation of ‘two queues’, according to Mr O’Loughlin. “The GPs could continue their work

vaccinating those aged over 70 and other vulnerable groups who require mRNA vaccines. Meanwhile, pharmacists could commence vaccination of the other cohorts on the priority sequencing list, including those under 70 and key workers. The HSE has signalled its intent to start vaccinating at-risk people aged over 16; pharmacists would be ideally placed to support this function.

“Over half of the population live within 1km of a pharmacy and 85 per cent live within 5km.

Pharmacists provide a safe, effective and convenient vaccination service and have a proven track record of safely and successfully vaccinating people for

years. There is no reason to constrain the country’s vaccination capacity by not mobilising pharmacists immediately.”

He concluded by calling for all pharmacy staff to be vaccinated as frontline healthcare workers without delay. “Many pharmacists have now received their first dose of vaccine, which is extremely positive. However, a community pharmacy requires a dedicated team in order to keep its doors open to patients and the public. All these dedicated staff are facing risks every day to ensure continued supply of medicine to those who need it. There should be no further delay in protecting these key workers.”

VOL 22 ISS 4

APRIL 2021

NEW

TREATS HEARTBURN AND ACID REFLUX. ONE TABLET PER DAY. LASTS 24 HOURS. AVAILABLE IN PACKS OF 7s AND 14s.

Marketed by

CCF:22656 Date of preparation: (10-19)

ABBREVIATED PRESCRIBING INFORMATION

Product Name: Emazole Control 20 mg Gastro-Resistant Tablets Composition: Each tablet contains 20 mg esomeprazole (as magnesium dihydrate).

Description: Light pink oval film coated tablet.

Indication(s): Proton Pump Inhibitor (PPI): Short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. Dosage: Swallow tablets whole with liquid, do not chew or crush. Disperse in half a glass of non-carbonated water if difficulty in swallowing. Stir until tablets disintegrate, drink liquid with pellets immediately or within 15 min, or administer through a gastric tube. Do not chew or crush pellets.

Adults: The recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Elderly (≥ 65 years old): As per adults. Paediatric population (< 18 years): Not recommended. No relevant use in this group in the indication: “short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)”. Severe impaired renal function: Caution. Severe liver impairment: 20 mg max daily dose.

Contraindications: Hypersensitivity to esomeprazole, substituted benzimidazoles or any of the excipients. Not with nelfinavir. Warnings and Precautions for Use: On demand treatment: Contact a physician if symptoms change in character. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile. Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Absorption of vitamin B12 may be reduced due to hypo- or achlorhydria. Not recommended for long-term use as the following may also occur: Hypomagnesaemia; Risk of fracture. Consider stopping Emazole Control in cases of Subacute cutaneous lupus erythematosus (SCLE) accompanied by arthralgia. Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Emazole Control treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment. Contains glucose and sucrose.

Interactions: Effect of esomeprazole on other drugs: Co-administration with atazanavir is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. Serum levels of cilostazol, cisapride, tacrolimus, methotrexate may be increased. An interaction is observed between clopidogrel and esomeprazole, but the clinical relevance is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.

Gastric acid suppression by PPIs increase or decrease absorption of drugs with pH dependent absorption (decreased absorption of ketoconazole, itraconazole); esomeprazole inhibits CYP2C19 metabolising enzyme and could increase plasma concentrations of diazepam, citalopram, imipramine, clomipramine, phenytoin (monitor plasma levels of phenytoin), etc. resulting in need of a dose reduction; monitor INR when given with warfarin or similar. Caution as absorption of digoxin can increase. Effect of other drugs on esomeprazole: CYP2C19 and CYP3A4 inhibitors (clarithromycin, voriconazole) may increase the esomeprazole exposure. Dose adjustment not regularly required, except in severe hepatic impairment and long-term use. CYP2C19 and/or CYP3A4 inducers (rifampicin and St. John’s wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.

Pregnancy and Lactation: Caution in pregnancy due to lack of clinical data. No studies in lactating women, therefore, not recommended during breast-feeding. Ability to Drive and Use Machinery: Minor influence on the ability to drive or use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) have been reported. If affected, patients should not drive or use machines. Undesirable Effects: Common: Headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign). Uncommon: Peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritis, rash, urticaria, fracture of the hip, wrist or spine. For other side effects refer to the SPC. Marketing Authorisation Holder: IQ Pharmatek Ltd., Gurtnafleur, Old Waterford Road, Clonmel, Co. Tipperary. Marketing Authorisation Number: PA 22777/001/001. Further information and SPC are available from: Rowex Ltd, Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417. E-mail rowex@rowa-pharma.ie Legal Category: Not subject to medical prescription.

Date of Preparation: September 2019 Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing medsafety@hpra.ie or by emailing Rowex pv@rowa-pharma.ie

NEWS

SUBSTANCE MISUSE

Findings of health behaviour in school-aged children shows fewer children using substances Minister of State with responsibility for Public Health, Wellbeing and National Drugs Strategy Frank Feighan TD recently launched the Health Behaviour in School-aged Children (HBSC) Trends Report 1998-2018. The report was led by senior researcher Ms Aoife Gavin in collaboration with the HBSC research team at the Health Promotion Research Centre in NUI Galway.

Compared to the findings from 1998, the study found fewer children using substances, more than half of children exercising regularly, more children feeling pressured by school work, and more children reporting ‘feeling low’.

The HBSC is a cross-sectional study conducted in collaboration with the World Health Organisation Regional Office for Europe. It runs every four years. In 2018, 45 countries and regions participated, collecting data on health behaviours, health outcomes and the social contexts of children’s lives.

The study compared findings of health behaviour in school-aged children from 1998 to 2018.

Health risk behaviours — An overall decrease across all substance use measures:  Fewer children report currently smoking — 5.3 per cent in 2018, compared to 22.6 per cent in 1998.  Fewer children report that they have ever been drunk — 19 per cent in 2018 compared to 33 per cent in 1998.  Fewer children report cannabis use in the last year — 8.5 per cent in 2018, compared to 12.3 per cent in 1998.

Positive health behaviours — An overall improvement among young people:  More children brushing teeth more than once a day — 70.1 per cent in 2018, compared to 57.6 per cent in 1998.  More children always wearing a seatbelt in car journeys — 81.4 per cent in 2018, compared to 41 per cent in 1998.  The proportion of young people doing vigorous exercise four or more times a week has remained stable — 52.1 per cent in 2018, compared to 52.6 per cent in 1998.

Launching the report, Minister Feighan said: “I welcome the publication of this latest report from the Health Behaviour in School Aged Children Study. This international project has provided us with essential data, which has helped to shape and inform policy relating to the health and wellbeing of our

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children and young people.

“This new trends report gives us a wonderful opportunity to take stock, both of the many very significant improvements to our children’s health, and of those areas where we have not, perhaps, made as much progress as we would have liked. The information contained in this study will be of great importance in terms of future planning and policy direction regarding children’s health.”

Minister for Children, Equality, Disability, Integration and Youth Roderic O’Gorman TD said: “Ireland is headed in the right direction when it comes to the health of young people, and it is clear that past Government initiatives to support healthy choices are having a positive impact on reducing alcohol consumption and smoking, helping to keep our young people safe.

“The research also suggests that an increased emphasis is needed around supporting the positive mental health of young people, and following the impact of Covid-19, this is an issue that may become more prevalent.

In February, my Department launched the Supporting Children Campaign, which aims to outline the supports available for children and families during the pandemic. We have also increased funding for youth services in 2021, in recognition of the positive impact youth work can have on young people’s lives.

“Thanks to the HBSC research team in NUI Galway and the contributions from young people, we now have a valuable piece of research that will help to inform future healthy living initiatives aimed at improving the lives of children and young people in Ireland.”

Commenting on the findings, Co-Principal Investigator Dr Colette Kelly from the Health Promotion Research Centre at NUI Galway said: “This report is the culmination of many years of work, and brings together some good news about the health behaviours of Irish children, with a sustained decrease in substance use, for example.

“There is a continuing positive trend in children communicating with parents and reports of good places in the local area to spend free time. The report also highlights areas in need of improvement, in particular more young people are reporting that they feel pressured by school work and there is an increase in the proportion of children who report feeling low. The report provides a breakdown of age, gender and social class patterns, which provide more in-depth information on each of the indicators.”

To read the full report, visit http://www.nuigalway.ie/media/healthpromotionresearchcentre/hbscdocs/nationalreports/HBSC-Trends-Report-2021.pdf.

VOL 22 ISS 4

APRIL 2021

NEWS

TUBERCULOSIS

Trinity scientists find that binding iron improves the effect of the anti-tuberculosis drug Although tuberculosis, or TB, killed nearly as many people as Covid-19 (approx 1.8 million) in 2020, it did not receive as much media and public attention. The pandemic has proven that transmissible infection is indeed a global issue, according to Trinity College Dublin researchers. TB remains a serious public health concern in Ireland, particularly with the presence of multi-drug resistant types, and the numbers of complex cases here is continuing to rise, with cases numbering over 300 annually.

Research shows that iron is crucial for daily human function, but it is also an essential element for the survival of viruses and bacteria. For some time, scientists have known that depriving infections of iron can limit bacterial burden and help improve patient outcomes. Now scientists at Trinity College Dublin and St James’s Hospital, Dublin, have recently

applied the technique of binding iron to support the immune system and the treatment of TB, along with a new TB antimicrobial called bedaquiline. The findings were published recently in the prestigious journal the International Journal of Molecular Sciences. The research was led by Prof Joseph Keane and Dr James Phelan.

Bedaquiline has been in use for less than 10 years for multidrug resistant TB, yet last year Ireland saw its first case of TB that was bedaquiline-resistant.

It is known that even as new antituberculosis drugs are introduced, the TB bacteria will become increasingly resistant.

For some time, Dr Phelan has been looking at how to support the immune system to improve treatment effectiveness. He has previously demonstrated how an iron-binding drug, called desferrioxamine, or DFX, supports lung immunity against TB infection by driving the activa-

tion of a key metabolic pathway called glycolysis. The process of glycolysis helps immune cells make energy to fight infection, which in turn drives several signals that improve the macrophages’ (white blood cells) ability to address TB infection.

Recent data has shown that a large proportion of people suffering from TB lack this glycolytic response. However, DFX could compensate for this metabolic defect, said the authors.

As an extension of this work, the research team has now demonstrated that immune macrophage cells infected with TB bacteria, and treated with the drug bedaquiline, do a better job of killing the bacteria, if they are also treated with this iron-binder DFX. In addition, this approach also drives a panel of cytokines, or immune messengers, that could also help the macrophages to eliminate the pathogen.

Dr Phelan, Department of

Clinical Medicine, Trinity College and Senior Author of the study, said: “The use of these antimicrobials has been the mainstay for TB treatment for almost half a century now; now is the time to make these antimicrobials function better for the patient. DFX and other iron-binders could be one of the answers to this. The use of iron binders could help pave the way for the development of new host-directed-therapies. Instead of targeting the pathogen, hostdirected-therapies directly target infected cells and help them kill the pathogen. Therefore, the use of host-directed therapies as a treatment strategy could drastically improve the treatment and clinical care for patients suffering with tuberculosis and other devastating infectious diseases.”

The link to the full paper can be found in the current edition of the International Journal of Molecular Sciences: https://bit. ly/3bXNBcd.

FMD

Falsified medicine directive aiding pharmacy management — IMVO Medicines scanning under the Falsified Medicines Directive (FMD) is making a positive difference to pharmacy management, according to a recent survey by the Irish Medicines Verification Organisation (IMVO). One-in-four pharmacists surveyed say their FMD software is providing additional data that is helping with the running of their pharmacy. According to Ms Leonie Clarke, General Manager, IMVO, this reflects a growing realisation across the EU that the implementation of FMD can support better pharmacy and patient management, along with ensuring patient safety by preventing falsified medicines from entering the legal

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supply chain. IMVO has recently launched a new website (www. imvo.ie) to provide additional guidance and support on FMD. “We know from our engagement that pharmacists, hospitals, wholesalers and marketing authorisation holders (MAHs) have worked hard to meet their FMD obligations. What was encouraging to see from our survey was the wider benefits that a significant number are already experiencing, for example with expiry date tracking. We would be hopeful that the comprehensive range of guidance available on our new website will support more pharmacists in ensuring smooth and efficient scan-

ning, so the added value from FMD software could be of benefit to many more,” said Ms Clarke.

The new website is part of an expanded range of supports that IMVO, the non-profit organisation managing the national medicines verification system for Ireland, is introducing over the coming months to help pharmacies and other users of the system become comfortable with scanning and managing alerts. These include a series of webinars and full details of these will be available shortly on the IMVO website, it said.

“We recognised the enormous pressures that pharmacists have been under over the past year by

extending the ‘Use and Learn’ phase beyond its original deadline. Now, with the roll-out of the Covid-19 vaccine, like everyone, we would be hopeful that society and business life will start to return to normal across the second half of the year. While a date for ending ‘Use and Learn’ has not been finalised, we will provide ample notice. In the meantime, we would encourage any pharmacist, hospital, wholesaler or MAH who may require additional support or guidance on the implementation of the FMD or want to find out about our upcoming webinars to visit our website,” Ms Clarke added.

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FEATURE | Covid-19

Study uncovers relationship between travel and spread of SARS-CoV-2 variants Anna Wedderburn reports on a recent Irish study that demonstrated the link between the second wave of Covid-19 and international travel

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study led by Prof Patrick 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, has demonstrated that the second Covid-19 wave in Ireland was most likely to have been directly caused by international travel. This conclusion was reached by sequencing and comparing the genomes of SARS-CoV-2 found in individuals in Ireland during the first and second wave of Covid-19. Using open source databases online, such as GISAID and PANGOLIN, which map SARSCoV-2 variants across the globe, Prof Mallon and his team were able to trace the origins of the SARS-CoV-2 variants that were found in Ireland, where they came from, and when they arrived.

This study highlighted the impact that effective lockdowns can have on the SARS-CoV-2 virus. After the first lockdown in Ireland, which saw the daily reported case numbers of laboratoryconfirmed Covid-19 fall to three, the lineages of SARS-CoV-2 that were present during the first wave of Covid-19 did not reappear. Additionally, this study demonstrated that the second wave of Covid-19 in Ireland resulted directly from SARSCoV-2 infections being imported into the country, most likely through travel from continental Europe and the United Kingdom, and then spreading through-

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out the population. Finally, the data did not find any significant associations between the different SARS-CoV-2 variants found in Ireland and disease severity or clinical outcome.

FIRST VERSUS SECOND WAVE Four hospitals were included in Prof Mallon’s study: The Mater Misericordiae University Hospital, Dublin; St Vincent’s University Hospital, Dublin; Beaumont

Hospital, Dublin; and Wexford General Hospital. For the purposes of this study, the ‘first wave’ signifies March through to June 2020, while the ‘second wave’ signifies July through to December. A total of 225 samples were sequenced across the first and second waves — 134 during the first, and 91 during the second. Although this is a relatively small sample size compared to the number of cases of Covid-19 reported in Ireland, it is still sig-

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Covid-19 | FEATURE

nificant, as it includes 15.2 per cent of hospitalised cases from four major hospitals in a geographical location where the majority of SARS-CoV-2 cases in Ireland have been reported.

Furthermore, the demographics of study participants broadly reflect the demographics of hospitalised Covid-19 cases in Ireland: Average age of 65; 55 per cent male; 83 per cent Caucasian; more than 80 per cent with an underlying condition; and an overall mortality rate of 10.6 per cent. The study also included a wide geographical spread: Samples were collected from individuals residing in 12 different counties, with 68 per cent of cases residing in Dublin, 21 per cent in Wicklow, 4 per cent in Wexford, and the remaining 7 per cent spread across Clare, Galway, Kildare, Longford, Louth, Meath, Monaghan, Offaly, and Waterford.

Kingdom, was detected in only three of the sequenced samples from the second wave, all of these samples were collected in the 10 days leading up to 27 December, and comprised 15 per cent of all samples sequenced during this timeframe. This variant was first identified in the cohort on 17 December from a patient with symptoms dating back to 10 December. The final sample in this study was collected at the end of December, and it is likely that as further data is collected, the significance of the B.1.1.7 variant may become more evident.

A key finding of this study was that none of the common SARS-CoV-2 viral lineages that were detected during the first wave of Covid-19 in Ireland re-emerged during the second wave, apart from a single case

VARIANTS Prof Mallon and his research team reported 26 different lineages of SARS-CoV-2 during the first wave of Covid-19. Five of these lineages accounted for 81.8 per cent of cases, and just two accounted for 68.7 per cent of cases — with B1.1.267 accounting for 33.6 per cent of cases and B1.1 accounting for 37.4 per cent. By mid-June 2020, these SARS-CoV-2 variants were no longer detected in this cohort. This drop in detection coincided with the decline in reported cases nationally that accompanied the country-wide lockdown (falling as low as three new cases a day).

From July onwards, which for the purposes of this study is defined as the second wave, 91 SARS-CoV-2 samples were sequenced from the four hospitals. The predominant lineage reported this time was B.1.177, a variant that originated in Spain in early March 2020. This lineage was first reported in Ireland on 10 September, and overall, it accounted for 82.4 per cent of cohort cases in the second wave. Using the database GISAID, it was concluded that this B1.177 variant was introduced to Ireland multiple times from a number of European countries, with a particular emphasis on the United Kingdom.

Although the B.1.1.7 variant of concern, originating in Kent in the United

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The second wave was derived from viral genetic lineages that originated outside of Ireland and were not found in the first wave of the B1.1.70 variant collected on 21 December. Significantly, the B1.1.267 variant of SARS-CoV-2, which according to the PANGOLIN lineage website has only been identified in Ireland, has not re-emerged since the first wave. This variant evolved within Ireland during the first wave and did not spread outside of Ireland. As Prof Mallon’s study did not find a reappearance of this SARS-CoV-2 lineage during the second Covid-19 wave, it suggests that the B1.1.267 lineage of SARS-CoV-2 no longer exists and was eradicated during the first lockdown. This demonstrates the importance, relevance, and effectiveness of lockdowns alongside the control of international travel, particularly in light of the number of new SARS-CoV-2 variants

of potential concern currently emerging around the globe.

This was the first study in Ireland that looked at the genome sequences of SARSCoV-2 in the context of non-pharmaceutical interventions such as lockdowns, and alongside clinically relevant data. It was also one of the first studies of this kind to be carried out in Europe.

CONSEQUENCE OF TRAVEL In conclusion, this study shows that the first wave in Ireland was characterised by a larger number of distinct lineages, originating from continental Europe and within Ireland itself. With the first lockdown, these lineages disappeared from SARSCoV-2 infections contributing to hospitalisation among participating hospitals.

The second wave was derived from viral genetic lineages that originated outside of Ireland and were not found in the first wave. This suggests that there were multiple introductions of SARS-CoV-2 through travel during the summer of 2020, and these lineages then spread throughout the population.

Lineages that had been recorded during the first wave were not observed during the second wave, apart from a single case. This suggests that the second wave was not an inevitable residual wave originating from the initial first wave, but a second wave in its own right, originating in the same manner as the first wave did, through importation of SARS-CoV-2 from different countries. If the second wave had been derived from the first wave, it would have mirrored the lineages found within the first wave.

These data suggest that the first lockdown may have largely eradicated these commonly reported lineages from the circulating pool of transmitting viruses contributing to hospitalisations in south-east Ireland. The second wave of infections resulting in hospitalisations were largely seeded by multiple travel-related events from countries outside the island of Ireland. With hindsight, this suggests that strict control of incoming international travel (ie, compulsory quarantine) could have significantly altered the pattern of the pandemic in Ireland. l

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COMMERCIAL FEATURE

MCKESSON IRELAND

MARCH FOR MILES FOR AWARE

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or their second companywide charity initiative, the staff of McKesson Ireland came together to “March Miles for Aware” during the week of March 13th – 20th.

McKesson Ireland consists of four leading Irish Healthcare Businesses that include United Drug, Lloyds Pharmacy, Median Healthcare and TCP Homecare. Aware was chosen as the new charity partner last October after a companywide vote and a period of research and consultation with staff.

Taking park in a 5Mile virtual walk/run, the McKesson Team took to the paths to get outside and enjoy some fresh air which as we all know is so vitally important for our mental health. Sadly 1 in 10 people in Ireland experience depression and in these difficult times, Aware need extra funds now

more than ever. McKesson Ireland joined forces with Aware as their official charity

partner in 2020 to offer as much support as they possibly could to help ensure Aware can continue to provide the vital, free services it provides for individuals and families impacted by depression, anxiety and bipolar disorder.

The McKesson Ireland Team have so far raised a fantastic €21,492 for Aware and are still collecting donations for their current 5mile initiative. A big thank you to all who participated and took the time out of their week to complete their 5miles. For anyone who would like to offer a donation to the ongoing McKesson Ireland Charity Partnership or if you would simply like to follow our ongoing leaderboard, you can do so using the following link for our dedicated JustGiving Charity microsite: https://mckesson.blackbaud-sites.com/.

UNITED DRUG WEBINAR SERIES | MACRO FLOOR PLANNING 2021 REVIEW

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s part of the United Drug monthly webinar series to support the Retail Pharmacy sector to grow and optimise their Businesses, United Drug welcomed customers back in March for the topic of Macro Floor Planning for 2021. They welcomed their very own Mary Magner, United Drug’s Category Manager who gave an expert guide on how to embark upon a floor plan review to optimize your store layout.

2020 was an unprecedented year for modern retail. With the vaccination rollout this year and a hopeful return to

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a 'new normal' for retail, it is a good opportunity for pharmacies to look at their retail layout with fresh eyes and also take learnings from this most unusual past year. Key Takeaways from this webinar included: 1) Why embark upon a floor plan review 2) Explanation of the process and steps that we take when conducting a review 3) How to approach a floor plan for a green field site or post major renovations 4) Most common missteps seen in retail pharmacies in terms of macro layouts 5) How to incorporate learnings from trading through the pandemic into a re-

view of a macro layout If you missed out on the webinar and would like to recap with a recording, please contact the event organiser via email: lucia.mariaonofri@united-drug.com.

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FEATURE | Hospital care

Almost 877,000 people now waiting to see a specialist or receive care Recent figures show a dramatic increase in hospital waiting list numbers and patients waiting with chronic pain for long periods before receiving hospital treatment

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he Irish Hospital Consultants Association (IHCA) recently called for urgent action to cut waiting times as the number of people waiting to see a hospital consultant or receive treatment in Ireland’s public acute hospitals reached almost 877,000.

The increase comes as the publication of the HSE National Service Plan sparked concerns that 2021 would see a second successive year of reductions in public hospital appointments as the impact of the pandemic continues to affect the timely delivery of care.

In particular, there has been a marked increase in patients waiting with chronic pain for long periods before receiving hospital treatment — a 56 per cent increase over the past 12 months.

Chronic pain is a debilitating condition that requires timely access to care for effective treatment. However, this care is being delayed for the more than 5,300 currently on the inpatient/day case waiting list for pain relief, and particularly so

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for the over 1,700 who are waiting longer than a year for treatment. This is more than a three-fold increase in long-waiters since February 2020.

This is more than a three-fold increase in long-waiters since February 2020 RESOURCES The IHCA has urged the Government to urgently put in place the capacity and resources over the coming months to catch up on the essential hospital care that is being postponed or delayed due to the pandemic, particularly in a number of key specialties.

IHCA President Prof Alan Irvine commented: “[The] NTPF waiting list figures,

which confirm almost 877,000 people are now on some form of NTPF waiting list, again highlight the impact of hospital consultant shortages and capacity constraints on those waiting for an outpatient appointment and related treatment.

Timely access to care is vital in ensuring effective treatment and care for patients.”

The latest National Treatment Purchase Fund (NTPF) figures also show significant increases over the past 12 months in outpatient waiting lists in:  General surgery (34%, +11,412).  Orthopaedics (17%, +10,951).  Gynaecology (13%, +3,622).  Dermatology (12%, +4,888).  Urology (11%, +3,375).  Cardiology (11%, +2,850).

The almost 877,000 people on waiting lists includes 6,963 on a newly-created ‘Outpatient Suspensions’ list. This waiting list includes those previously on the outpatient list who are either not ready to proceed with their appointment, or who have accepted an invitation to access hospital care in another hospital through either an

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Hospital care | FEATURE

Large increases in outpatient waiting lists for general surgery (34%, +11,412), orthopaedics (17%, +10,951), gynaecology (13%, +3,622) and dermatology (12%, +4,888). 

56% increase in the number of patients waiting for hospital pain relief treatment since pandemic began. 

Over 1,700 now waiting longer than a year for treatment, more than a threefold increase since February 2020. 

153,000 fewer outpatient public hospital appointments now expected in 2021 through the National Service Plan. 

NTPF or HSE commissioning initiative.

The latest waiting list figures add to the concerns raised by the IHCA over the HSE’s National Service Plan, which foresees over 150,000 fewer outpatient appointments this year in public hospitals.

Prof Irvine added: “Timely access to care is vital in ensuring effective surgical treatment, and for patients waiting to be seen by consultant dermatologists, cardiologists, gynaecologists and many other specialists.

"The dramatic increases in waiting times

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we are seeing will undoubtedly adversely affect patient outcomes and lead to a rise in healthcare costs. The indirect costs of ongoing symptoms impacting on people’s quality of life and their ability to work can also be substantial.”

CHRONIC PAIN “Chronic pain is a debilitating condition that requires prompt access to care. Delays between referral and consultation in outpatient pain clinics and the current wait times

for treatment far exceed what patients or their consultants consider ideal, with potential consequences for patient health outcomes. These concerns are unfortunately replicated across most specialty areas.

“The HSE told the Oireachtas Joint Committee on Health… that there is a plan to recruit 350 additional consultants in 2021.

However, the recently published National Service Plan failed to outline how many additional consultants will be appointed and in post by the end of the year.

“There is now a grave concern at the absence of engagement by the Minister for Health and health service management with the Association to agree practical solutions to address the key factors that are driving our highly-trained specialists to emigrate at a time when they are urgently needed.

“The appointment of additional hospital consultants, on terms to be agreed with the representative organisations, is the key enabler that is required to tackle the unacceptable waiting lists and the backlog of an estimated 700,000 fewer hospital appointments that have arisen due to the pandemic last year and the expected 200,000 reduction this year,” added Prof Irvine. l

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This module is focused on sinusitis, a normally transient condition affecting the lining of the sinuses. It is expected that on completion of this module, the reader will have a greater understanding of the progression and symptoms of sinusitis, including the different types and causes, as well as treatment options and potential complications.

The use of OTC decongestant sprays and drops should be limited to 21 days to avoid ‘rebound’ complications True or False?

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Pharmacy workforce | FEATURE

PLAY TO YOUR STRENGTHS

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Sometimes the apparently obvious candidate for a job in the pharmacy may not be the best choice after all, writes Séamus Ruane MPSI

ave you ever conducted an interview for a position in the pharmacy, and having had a good look at the CVs of the candidates prior to interview, almost made your mind up in advance?

I clearly recall an incident many years ago where prior to interview, there was one clear winner. One candidate who, on the face of it, appeared to be head and shoulders above all others. Her CV was very impressive, all the necessary qualifi-

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cations and more, lots of experience with the best on-the-job training with a leading pharmacy chain, loads of extracurricular achievements and awards. More as a box-ticking exercise, and for comparison purposes, we nonetheless decided to interview four candidates.

And then along came Lucie! No pharmacy experience, no retail experience, English as a second language, yet we were completely captivated by her ability to communicate, connect, and her level of understanding of customer service.

With a sense of disbelief at what we were about to do, taking into account the amount of retail- and pharmacy-specific retraining and upskilling that would be required, we contacted the hot favourite to tell her she was not successful on this occasion, and offered the position to Lucie. In the years that followed, Lucie proceeded to become one of our most valuable and trusted members of staff, progressing to become store manager and having an infectious effect on colleagues and customers alike.

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FEATURE | Pharmacy workforce

PERFECT CANDIDATE Far too often we believe that technical skills, experience, and educational level are what make for a perfect candidate, and subsequent hire. However, positive psychology and the science of wellbeing suggest that when it comes to those we interview, our employees, and indeed ourselves, we would be far better off focusing on strengths.

Our strengths are, simply put, things that we are good at, and enjoy doing. Essentially, they represent how our brains are wired to perform at their best. When we get the opportunity to use our strengths on a daily basis, we feel more engaged and energised, experience higher levels of life satisfaction and wellbeing, and lower levels of stress.

I’m sure we’ve all heard of the phrase, ‘Nerves that fire together, wire together’, also known as long-term potentiation. When we repeatedly perform an action or have a particular thought pattern, the nerve pathway involved in that process is stimulated. With repeated stimulation, that nerve pathway becomes the path of least resistance, and over time these patterns or skills become an inherent part of who we are, and an expression of our true selves. They feel natural and effortless for us to use, and as a result we find them engaging and energising.

GIFTED As an example, I have no doubt you can easily bring to mind a colleague whom you work with, or have worked with, who just seems gifted with people. They have a constant stream of customers and fans that all want to speak to them and them alone. They seem to know the right thing to say, at the right time, every time. People just seem to light up and open up in their presence. It goes without saying that someone with such an obvious ability and strength of excelling at social connection will feel more energised, engaged, satisfied and fulfilled in a position that involves human interaction, face-to-face customer contact, and will perform their best work when afforded the opportunity to do so.

This is an obvious example, but it also stands true for the many strengths that all our staff, and indeed we ourselves, possess.

So whether it’s love of learning, leadership, creativity, or curiosity, strengths can be our multiplier. When we assign work that

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I have no doubt you can easily bring to mind a colleague whom you work with, or have worked with, who just seems gifted with people aligns to people’s strengths, we have a situation where everyone is doing more of what they do best at work, and as a result, performance improves.

When we have the opportunity to use our strengths at work, we have a more positive work experience and boost our performance, our satisfaction, and our wellbeing at work.

Obviously, the first step is to know what our strengths are. There are various surveys and questionnaires online that help us identify our unique strengths. I recommend the VIA Strengths Survey (ww.viacharacter. org) as a great introduction to the topic for you and your team. Over 11 million people worldwide have taken this scientific survey,

and the website is rich with information on how to discover, explore, and apply your strengths and those of your colleagues. If nothing else, completing the survey will give you a list of words that describes what is right about you. At its most powerful, being aware of your strengths, and those with whom you work, and actively spotting them in each other, can change conversations, cultures, attitudes, and relationships.

Some questions for you to consider:  Would it be helpful to know your strengths, and those of your colleagues and team?  When was the last time you arrived into work looking for strengths in your colleagues or in yourself?  How could it change interactions between team members if they spotted strengths in each other?  Could you allocate roles within the pharmacy that align to people’s strengths?  What would happen if you looked for strengths in someone with whom you have challenges? l If you would like to work with Séamus to boost your level of wellbeing or that of your team, he can be contacted at Tel: 0872274108 or email info@ithrive.ie.

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COMMENT | Editorial

Send your comments to hello@irishpharmacist.ie or by post to Pat Kelly, Editor, Irish Pharmacist, GreenCross Publishing Ltd, Top Floor, 111 Rathmines Road Lower, Dublin 6, D06K5F6.

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The rocky road to OTC ED medication

t’s a welcome development that medication for the treatment of erectile dysfunction (ED) is now approved for OTC sale in Ireland. It is another recognition of Irish pharmacists’ healthcare knowledge and expertise and it takes a little pressure off patients who previously had to fork out for a GP consultation for such matters. But as we all know, it was not always a simple process for men to address ED, not to mention the associated stigma.

Therefore, as a little light diversion, a brief stroll down ‘Healthcare Memory Lane’ might provide some context.

For example, in centuries past, impotence was in fact considered a crime and legitimate grounds for divorce; the process by which men were forced to prove their bona fides was a tortuous one, where dignity and anonymity had no place.

Indeed, divorce itself was often available only for the well-heeled, particularly in 16th and 17th Century France, Spain and England, however a man’s inability to perform in the bedroom was considered reasonable grounds. The Church was dominant in those times and it decreed that the prime objective of marriage was to procreate. The earliest records of such divorce cases stretch back to the 14th Century.

The harrowing process began with a wife making the accusation of impotence before an ecclesiastical court. According to a number of historians, the husband was then offered the chance to clear his name via an examination of his genitalia by what you might call a ‘multidisciplinary team’ of doctors, clergymen, celibate priests and midwives. The examination included scrutiny of the shape and colour of the appendage and amount of testes, as well as whatever process was employed to determine whether or not he could achieve an

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erection and deliver the required amount of reproductive fluid. Natural tension and skin elasticity were also assessed.

The local gutter press were most keen to report on such trials (how little some things have changed!), potentially resulting in very public humiliation. If you were a nobleman, the shame was extreme.

If the husband chose to defend the accusation, a ‘Trial by Congress’ was arranged on neutral territory, whereby the couple were compelled to have sex in front of a panel of judges. A kind of ‘XXX Factor’, if you will.

The husband was given two hours to prove he could ‘perform’. If he could not do so, the marriage was dissolved. Naturally, potential underlying causes of ED were the last thing on anyone’s mind. However, in some cases, a three-year ‘window’ before annulment was granted in case the problem resolved itself.

Litigant women did not escape invasive humiliation either — if a woman claimed that the marriage was never consummated, she had to prove her virginity at the Trial by Congress. Since a woman’s reproductive and urinary system were believed to be the same, she would have been made to drink a diuretic and if she urinated immediately, it was judged that her hymen had been compromised. In some cases, a physical examination was also deemed necessary, whereby the woman was bathed and laid in front of a team of doctors and midwives. I will not assault our dear readers’ sensibilities with the details.

And now, here we are. I hope this light diversion was a brief distraction from the serious issues that we all face.

For today’s men, at least the ‘crime’ of ED is not one of them.

THAR AN GCUNTAR AS GAEILGE Is féidir leis an CoVid go léir ar domhan a chur i gcanna ‘Coke’, agus bheadh spás le spáráil.

Ar ndóigh, mar eolaí, d’fhéadfaimis a thabhairt i gcrích gur féidir le ruainne beag víreas (le leithead nanaiméadar) luí isteach i spás beag cosúil le canna alúmanaim. É sin ráite, seasann an cheist, cé a dhéanann an stuif seo a réiteach?

Cé eile ná Christian Yates. Is Léachtóir Sinsearach i mBitheolaíocht Matamaitice é, in Ollscoil Bath, sa Bhreatain. Admhaigh Yates nach raibh tuairim dá laghad aige faoin mhéid a bheadh ann, ach bhí sé fiosrach mar gheall ar an iarratas. Léirigh sé, cheap sé go mbeadh sé ar cheann de dhá chás, &#39;&#39;linn snámha Oilimpeach nó spúnóg tae&#39;&#39;.

Thosaigh an háireamh leis an gcomhaireamh laethúil na gcásanna dearfacha, chomh maith leis na cásanna neamhshiomptómacha, nár tuairiscíodh.

An tuairim seo, curtha le sonraí ón Institiúid um Méadrach agus Meastóireachta Sláinte, meastar go bhfuil fíor an líon daoine atá ionfhabhtaithe gach lá sa réigiún 3 mhilliún.

Bhog Yates ar aghaidh ansin chun líon na ndaoine nach bhfuil atá ionfhabhtaithe ach nach bhfuil sa chomhaireamh laethúil a chuir san áireamh. Mar gheall ar go mbíonn ualach víreasach ard ag tromlach na n-othar ar an séú lá den ionfhabhtú agus meath ina dhiaidh sin ba chríoch phointe é seo lena chur san áireamh.

Tar éis an chritéir cuimsithe a leagadh amach, d’amharc Yates ar meán na gcáithníní víreasacha a fhaightear i ngach othar ionfhabhtaithe le CoVid. Chun é seo a dhéanamh, fuair Yates tagairt do staidéar neamhfhoilsithe. Bunaithe ar an staidéar seo, tá meastacháin gharbh le haghaidh buaic an víreas idir 1 billiún agus 100 billiún cáithnín víris.

Bheartaigh Yates obair leis an uimhir i lár an raoin sin (meán geoiméadrach), 10 mbilliún. Tháinig Yates ar an gconclúid go bhfuil thart ar dhá chéad cáithnín víris ar domhan ag aon am amháin.

Ansin, mheas Yates an trastomhas, ag 80120 nanaiméadar, mar is eol dúinn, atá aon bhilliún de mhéadar atá míle uair níos tanaí ná gruaig dhaonna.

Ríomh Yates toirt iomlán na gcáithníní go léir a cheaptar a bheith ann ag aon am amháin, ag an ráta reatha ionfhabhtaithe.

Ba é an toradh ná 120 millilítear. Tháinig Yates ar an gconclúid gurb é 160 millilítear an toirt iomlán a thógann cáithníní CoVid iomlána an domhain. Beag go leor le feistiú i 6 gloine bhiotáille. Fiú agus cuntas á thabhairt ar an méid breise féideartha de phróitéiní, níor sháraigh an toirt iomlán thar an gcanna coke.

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Opinion | COMMENT

State of the Union

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BECAUSE OF HUMAN NATURE, BEING AT THE HEAD OF THE IPU IS SOMETHING AKIN TO COACHING THE IRISH RUGBY TEAM, WRITES FINTAN MOORE

t often strikes me that working in the upper echelons of the IPU must be a lot like being the head coach of the Irish rugby team. When things go wrong, there is a slew of negative comment online, but when things go right, you don’t get the equivalent amount of positive reaction. A lot of that is down to human nature. People prefer to complain at length in different ways when upset, whereas if they’re happy, they tend to be quietly content. The situation for the IPU is even tougher in ways, given pharmacists have spent years in a version of the Red Queen’s race in Alice Through the Looking Glass, where “it takes all the running you can do, to keep in the same place. If you want to get somewhere else, you must run at least twice as fast as that.”

Keeping pharmacists pretty much in the same place has been an achievement, but it’s not the kind of thing that gets you commemorated with a statue. Nevertheless, it’s worth thinking back to the aftermath of the 2009 strike, when many of us, including myself, reckoned that the following years would see many pharmacies close. The only issue of debate in most discussions was whether the bottom 5 or 10 per cent would shut, or could the numbers get worse again. Rolling forward to 2021 and we actually have hundreds more pharmacies open now than in 2009, so it’s fair to say that the IPU has been doing something right. If the opposite had happened and hundreds were closing, then I’m sure people would be accusing the IPU of not doing enough.

Of course, it’s not all sweetness and light at the coalface. We’re still waiting on some kind of FEMPI reversal, but we’re not alone there. Talk to any dentist who operates the DTSS, and you’ll find they’re not too happy either. The IMO has clawed money back, but they have also had the GP visit cards rammed down their surgeries for under-sixes and over70s, with all the associated paperwork. Over the last few years we got screwed on the return of stock because of the nonsensical ‘10-day rule’. The operation of the various schemes has gotten more complex, with restrictions on

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phased dispensing and dispensing of ONS, diabetic test strips and Versatis. The HighTech hub is bit of a pain in the backside, but that’s counterbalanced by the fact that we can’t be guilt-tripped or pressurised into giving emergency supplies because some hospital consultants or their staff aren’t doing their jobs. The Hardship Scheme is still a hardship — for the pharmacists who choose to do it — if we all stopped, then it would be fixed within a month. The other obvious cluster-fudge in our working life is the operation of FMD scanning, which should be a priority for review, rather than passed off as a done deal.

So it’s easy to list what’s wrong, and that’s not even the full kit and caboodle of irritants.

On the plus side, the introduction of MAP for medical card patients at a fair fee was a solid achievement. Getting a reasonable rate for flu vaccinations took a few years and a pandemic, but we have it now. The IPU staff do a great job adapting to changing regulations and CPD requirements, especially over the last 12 months. Having up-to-date information and SOPs available to download is a great timeand money-saver. Like the downsides list, this isn’t a comprehensive list of the upsides.

The big question going forward is a bit like the head coach question — would change be a change for the better, or would it just be change for the sake of change?

CHEAP AND NASTY

Shoplifting in retail pharmacy is one of those inevitabilities, like death and taxes.

My potential losses get minimised somewhat by tending not to have much of value worth taking. We have sorted out some issues by just having empty boxes on display for razor blades, with the actual stock behind the counter. However, we can’t protect everything, so we still get some attention from the light-fingered brigade. We had a trio of females in recently who managed a sweep of a few items, despite being watched by a staff member who instantly thought they were dodgy. When we watched back

on the cameras, we saw that they managed to slickly steal about half a dozen items.

The funny thing was that they selected the cheapest crap in the fake tan section, and took make-up testers instead of stock. Their total haul had a retail value of about €13. If they put that kind of effort into a proper job, they would do better in life.

JOINING THE DOTS

The other inevitability for a lot of pharmacies is being the victim of more serious crime, especially armed raids with the threat of violence, and occasionally actual violence. If this happens, it is worth being aware that the gardaí are not particularly good at connecting different crimes that were clearly carried out by the same offender. As an example, a few years ago, both my pharmacy and another in the same area were raided a few days apart by a guy in motorcycle gear and helmet, who escaped on a very distinctive motorbike. When the scumbag got arrested for our robbery because of the outside CCTV of the motorbike, the gardaí would never have connected him to the other raid, except for the fact that a locum pharmacist worked in both places and immediately saw the obvious link.

So I’m not sure how it might be organised, or by whom, but a central database of information on all pharmacy raids could be a useful tool. There is a limited number of these raiders, and a lot of them are repeat offenders.

They almost inevitably get out on bail and are liable to carry out more raids while waiting for trial. If there was a pooled record of all these crimes, including uploaded CCTV footage, available to pharmacists then we would be able to see the links ourselves and pass this on to the relevant gardaí. l CONTRIBUTOR INFORMATION

Fintan Moore graduated as a pharmacist in 1990 from TCD and currently runs a pharmacy in Clondalkin. His email address is: greenparkpharmacy@gmail.com.

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COMMENT | Opinion

I S T H E L E T H AL F A T -B U R N E R D NP A N OT H E R C A S E O F PA R A C E L S U S BEING RIG HT ?

DR DES CORRIGAN WEIGHS THE EVIDENCE AGAINST DNP WITH THE MUSINGS OF THE HISTORICAL 'FATHER OF TOXICOLOGY'

M

edia reports at the beginning of February referred to the closure of an online business www.FatBurney. com based in Clonmel, which was selling diet pills alleged to contain 2,4-dinitrophenol (DNP). At the same time, the Advisory Committee on the Misuse of Drugs in the UK advised that DNP was a poison and not a drug. In fact it appears to be both, hence the reference to the 16th Century Swiss physician and alchemist Philippus Aureolus Theophrastus Bombastus von Hohenheim — known simply as Paracelsus — who, as the father of toxicology, famously said that all substances were poisons, but that it was the dose that distinguished a remedy from a poison.

The therapeutic

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use of DNP for weight loss actually arose from studies of its poisonous effects in ammunition workers in France during the Great War. It was observed that factory workers and soldiers occupationally exposed to high levels, when DNP was used to manufacture explosives, subsequently lost weight. Despite the fact that 36 deaths involving DNP were reported from France in 1919, its reputation as a weight loss agent led to a clinical trial in 1933 that showed a relationship between dose and the extent of weight loss. By uncoupling oxidative phosphorylation, it increases metabolic rate, glycolysis and lipolysis, thus reducing fat deposits.

Soon after its clinical use, signs of toxicity were reported, such as rash and cataracts, as more people started to use the drug with or without a prescription.

When deaths were reported again, con-

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Opinion | COMMENT

trols were introduced, making it illegal to purchase DNP. This led to a rapid decline in use and indeed reported deaths.

More recently, it has reappeared as a black market product used by weightlifters and body-builders to sculpt muscles by removing ('shredding') fat. As such, it is another performance- and imageenhancing drug (PIED) along with melatonin and anabolic steroids. Kilogramme quantities of the powder or thousands of tablets supposedly containing DNP are available for purchase on the Internet.

The consequences for users can be severe, as the documented side-effects, according to a 2014 report from the National Poisons Information Service in the UK, involve a combination of fever (47 per cent of cases), tachycardia (43 per cent), sweating (37 per cent), nausea and vomiting (27 per cent), breathing difficulties (23 per cent), and death. Longer-term, there is the risk of damage to heart muscle, acute kidney injury, gastroenteritis, anorexia (not surprisingly), in addition to agranulocytosis, neutropaenia and deafness. Neurological consequences include confusion, agitation, convulsions and coma. According to an article in the Journal of Medical Toxicology, there were 62 published deaths by 2011, many of them since 2002. In Australia, where DNP was rescheduled in 2017 as a substance of “such danger to health as to warrant prohibition of sale, supply and use”, 24 cases of exposure to it resulting in hospitalisation were reported in New South Wales alone between 2004 and 2018.

Four deaths since 2015 were recorded, two of them since rescheduling. In the UK, the Emergency Medicine Journal recorded five fatalities between 2007 and 2013 out of 30 separate cases of exposure reported to the UK National Poisons Information System.

In the US, three deaths were recorded in a 2016 report. Here, the death of a man in his mid-20s was linked to DNP-containing diet 'pills' in May 2015, according to a report in the Irish Examiner.

The UK government has announced that it will consider amending their Poisons Act

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to include DNP so that only registered pharmacists could sell it, and then only to someone with a Home Office licence.

Since there are unlikely to be many of the latter, the hope is to restrict the availability of the substance. In view of the alleged case in Clonmel and the international evidence of its toxicity, it is perhaps time for our own poisons council (Comhairle na Nimheanna) to consider a similar restriction on the supply of DNP. UK authorities have ruled out scheduling it under their Misuse of Drugs Act but if anabolic steroids can be scheduled

Kilogramme quantities of the powder or thousands of tablets supposedly containing DNP are available for purchase on the Internet

under our MDA, then it is not unreasonable to at least consider such an approach for DNP. Legal control, either as a poison or a controlled drug, would at the very least make the enforcement role of the Food Safety Authority of Ireland, the HPRA and the HSE that bit easier, as well as helping save the lives of those foolish enough to believe the hype surrounding this 'fat burner'.

Given all that is known about the dangers of DNP ingestion, to come across a 2019 article in Cells titled '2,4-dinitrophenol as medicine' was a total surprise.

The author envisages a possible role for DNP as a mitochondrial uncoupler that lowers reactive oxygen species (ROS) production, thereby delaying or preventing diseases such as multiple sclerosis, Huntington's, Alz-

heimer's, Parkinson's and amyotrophic lateral sclerosis (ALS). He proposes the use of lower weight-neutral doses rather than the doses usually used to induce weight loss. Comparison is made in the article with the way warfarin was repurposed from its origins as a rodenticide to become a standard anticoagulant in millions of patients. The other comparator quoted is thalidomide, which caused horrendous birth defects when used by pregnant women as a tranquilliser and for morning sickness. Newer research has resulted in a re-evaluation of this teratogenic drug in the possible treatment of leprosy, of multi-drug resistant tuberculosis and as an anti-angiogenesis agent in multiple myeloma. It was an even greater surprise to read that despite the UK denial that DNP is a drug, that the FDA has granted it Investigational New Drug (IND) approval for clinical safety and tolerability testing in the above conditions and also in Duchenne Muscular Dystrophy and in traumatic brain injury. The authors' enthusiasm for the therapeutic use of DNP in neurodegenerative diseases could be explained by the fact that the company he founded has been awarded orphan drug designation by the FDA for a pro-drug of DNP in Huntington’s disease.

Thus, we are likely to hear more of this drug in medicine and perhaps our friend Paracelsus will be proved right again. l CONTRIBUTOR INFORMATION Dr Des Corrigan, Best Contribution in Pharmacy Award (winner), GSK Medical Media Awards 2014, is a former Director of the School of Pharmacy at TCD and won the Lifetime Achievement Award at the 2009 Pharmacist Awards. He was chair of the Government’s National Advisory Committee on Drugs from 2000 to 2011.

He currently chairs the Advisory Subcommittee on Herbal Medicines and is a member of the Advisory Committee on Human Medicines at the IMB. He is a National Expert on Committee 13B (Phytochemistry) at the European Pharmacopoeia in Strasbourg and he is an editorial board member of the Journal of Herbal Medicine and of FACT — Focus on Alternative and Complementary Therapy.

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COMMENT | Opinion

Ireland shot itself in the foot, not in the arm WHEN POLITICS INTERFERES WITH THE VACCINE SURVEILLANCE PROCESS, WE MOVE TO EMOTION INFORMING BELIEFS AND DECISIONS, WRITES TERRY MAGUIRE

I

n the 1960s, US President Johnson was considering mandatory vaccination to eradicate a number of infectious diseases, but was advised against. The move would, he was told, cause 30,000 cancer deaths and 100,000 heart deaths. The President asked how the advisor knew this, to which the adviser replied that this was the annual number of deaths from cancer and heart disease in the US but with mandatory vaccination, each one would be causally linked to a vaccine. This was a powerful insight but not one that has been informing the actions of many European countries, including Ireland, in the middle of March.

Irish health authorities made a major mistake on Monday 15 March and it could cost lives. Prof Karina Butler, chair of the National Immunisation Advisory Committee, was quoted in a statement on the organisation’s website: “The vaccine is proven to be very effective against severe Covid-19 disease, which is associated with a risk of clotting events… We have taken this step [to defer use] out of an abundance of caution.”

Abundance of caution! It could be straight from WB Yeats or Seamus Heaney.

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The European Medicines Agency (EMA), which advises the Health Products Regulatory Authority, did not view the need for a precautionary stoppage in vaccination, confident in the safety and efficacy of the AZ vaccine, while it undertakes an assessment of 37 blood clotting events in patients recently vaccinated. The World Health Organisation agreed there is most likely not causal link.

SOCIAL MEDIA NOISE A month previous, there was much social media noise in the US about deaths linked to Covid-19 vaccines. The FDA investigated 1,117 deaths in people who had a vaccine within a few days of death. Given that there were some 40 million vaccines administered in the US at that time and the majority of those were to the elderly and the clinically vulnerable, it was quickly established that this was the normal expected number of deaths, but the damage had been done. The anti-vaxx websites were alight and the conspiracies multiplied.

The day this controversy hit the news, and before Ireland suspended the vaccine, I had three phone calls to the pharmacy, each from people asking if the vaccine was

safe for them, as they were taking aspirin. This is logical thinking; if I’m taking aspirin to avoid blood clots, then I have a blood-clotting problem and if the vaccine causes clotting, it is more dangerous for me. Logical, but wrong.

The deferment of 30,000 AZ vaccinations was a mistake as there was no link. The 37 clotting events (15 deep-vein thrombosis and 22 pulmonary embolisms) identified events will be fully investigated, as each of the 1,117 deaths in the US were investigated. This is the process, but 37 events from 17 million is a rate of 0.007 per 1,000 and, as one commentator suggested, the contraceptive pill has been shown to cause clotting at a rate of 0.06 per 1,000 and that, it seems, is totally acceptable. The contraceptive pill is causally linked with blood clotting, the vaccine is not, but Covid-19 has clotting as a serious complication of the infection. Ironically, in this population size there would be 350 events expected in a month, so it could be argued that, using these figures, the vaccine is stopping clots.

Then the EMA announced there was no link and European countries, including Ireland, resumed their vaccination programmes. But the damage had been done.

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Opinion | COMMENT

Medical authorities in many EU countries, including Germany, France and Italy, will have converted those with vaccine hesitancy into anti-vaxxers, if only against one of the Covid-19 vaccines Medical authorities in many EU countries, including Germany, France and Italy, will have converted those with vaccine hesitancy into anti-vaxxers, if only against one of the Covid-19 vaccines.

EFFICACY The EU has had an issue with the AZ vaccine from the start that is political, not scientific.

German media, at the time it was being approved, reported that the vaccine was only 6 per cent effective in the over-65 age group.

This was completely wrong and it seems the 6 per cent figure came from the number of over-65 year-olds in the clinical trial of 24,000 patients. Its efficacy in this age group has since been established as equivalent to younger age groups. France was too quick to echo the German concerns on efficacy, even when German authorities were attempting to clarify the media error.

Post-marketing surveillance of all new medicines allows for the identification of very rare side-effects. This is vital for public safety and this is happening for Covid-19 vaccines. This work must be allowed to proceed and if there are side-effects as yet undetected, then decisions should only be made on the science.

But when politics, implicit or explicit, interferes with this surveillance process, we move to emotion informing beliefs and decisions. Too many people across the EU had their vaccination schedules delayed, too many people decided not have the vaccine at all because of perceived yet non-

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existent risk and sadly, some people will contract Covid-19 in the third surges raging in the EU, will die and in some cases, the cause will be clotting as a complication of Covid-19.

Irish medicine authorities must work extra hard explaining to the population that they were too hasty in adopting their “abundance of caution” and that, frankly, they made a mistake and they wish to apologise.l

CONTRIBUTOR INFORMATION

Terry Maguire owns two pharmacies in Belfast.

He is an honorary senior lecturer at the School of Pharmacy, Queen’s University Belfast. His research interests include the contribution of community pharmacy to improving public health.

27

COMMENT | Opinion

Reasons to be cheerful — or fearful

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ULTAN MOLLOY TRIES HIS BEST TO BE POSITIVE ABOUT THE END OF LOCKDOWNS AND THE PHARMACY SECTOR

feel like my brain has been in a holding pattern for the last month. Answers to questions like ‘any craic?’ or ‘what did you get up to on the weekend?’ are always delivered with irony.

A Zoom call with friends one Saturday evening only served to compound my present sense of inertia. The realisation of mass vaccination, and of trips away, away anywhere other than the pharmacy and the supermarket, seem to be close enough

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to touch. I can’t let myself dream too vividly. The heartache of those dreams not becoming a reality in the near future would be all too much. I will be getting my passport renewed though, given it expires in June. Just in case.

I was in Galway today for some essential shopping and it is apparent that the lockdown has come to an end for many. I spoke to a friend on the aforementioned Zoom call who said that Dublin is very

much in lockdown in his locality, and being monitored closely by the local gardaí.

He’s at the end of his tether with a small child in the middle of Dublin, expensive childcare, and endless Zoom meetings for his work.

WHAT ELSE IS GOING ON, PAST MORE OF THE SAME? I was reflecting on a financial planning article from 2016 that I wrote here in Irish

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Opinion | COMMENT

Pharmacist, and we’re nearly five years on from its publication. I’ll have to dig it out. I wasn’t as bullish as hindsight suggests I should have been when it comes to the stockmarket, if it was mentioned at all.

I’ve cashed-out much of our meagre company funds invested in stocks to afford us some cash flow for our new business, as the market appears to be somewhat overheated. Time will tell if this is a sensible course of action, or complete folly, given deposit account rates of interest are below the present rate of inflation. ‘If you’re not in, you can’t win’, and all that.

Not being particularly optimistic, or bullish, about the community pharmacy sector as an investment remains a theme in my life, and much of my writing also perhaps. We do have a lot to be thankful for over the recent short term, however.

We have not been closed down, as we’re an essential service, allowing us to care for our communities and keep our friends and colleagues employed. We have seen advances in the use of technology, such as Healthmail, which overall has been a good thing, albeit in its infancy (I hope!), given it could be so much better and needs to be customer-led, having had some issues with surgeries directing patients to preferred pharmacies. Preferred by the surgery, like, or at least the prescriber, and not necessarily the patients. There I go again with the flip-side of a positive outlook. You can’t say I didn’t try.

THE FUTURE Perhaps Amazon, or a version of it, will shake up the Irish pharmacy market in time. As things stand, the primary operating model appears to continue to be as boringly traditional as it has been for the last couple of decades, albeit significantly less profitable. Prescription item volumes increasing, and an ageing population, will present opportunities, no doubt.

We have, however, in excess of 80 per cent of those items dispensed under Government schemes,

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and little opportunity to develop our nonGovernment associated remuneration possibilities. It’s been all about the GPs really, after token discussions around parity and professional engagement around community pharmacist involvement in the Covid vaccination roll-out. Ten years on, the minor ailment scheme, new medicines scheme, chronic illness management in pharmacies, etc, all seem to be no closer, so that’s just the way it is going to be. For now, anyway.

Not being particularly optimistic, or bullish, about the community pharmacy sector as an investment remains a theme in my life HIGH AGENCY A friend of mine shared the concept of having ‘high agency’ with me this week.

Google says: “High agency is a sense that the story given to you by other people about what you can/cannot do is just that — a story. And that you have control over the story. A high agency person looks to bend reality to their will. They either find a way, or they make a way.” I love it. I’ve come across these kinds of people over the years, and while I’m perhaps of moderate agency at present, I found the whole concept liberating and encouraging. High agency can be developed. We can develop it, and we can develop greater agency. There are ways to make things happen, and it can be helped significantly by one’s mindset and attitude, along with relationship skills and a healthy winwin strategy. Thank you, Mr

Covey, and your seven habits. Victim or victor, and all that too!

So, anyway, have a good month ahead.

Hopefully we’ll have half the country vaccinated by the time you’re reading this, and the civil servants who just can’t be bothered to consider a better way of using the Irish pharmacy network to deliver to its full potential for the Irish public will have been promoted to their level of respective incompetence. At least away from anything to do with the community pharmacy budget. Or is that the ‘drugs budget’? Maybe considering it as a professional healthcare network supported by dispensing fee payments is a good place to start. Then maybe follow on in discussions like the GPs, with ‘resource us appropriately to do our job, or patients will die’. Community pharmacists won’t have enough time to give to patients in the consultation room in order to support their self-care adequately, and prevent those up to 25 per cent of medicines-related hospital admissions. We still have FEMPI in place. Meanwhile, the fee payments to GPs have increased by 30 per cent between 2014 and 2019 (€453 million to €589 million), and we will now no doubt see another large jump following tens of thousands of €30 phone calls on top of this, given the present crisis. Most GPs are doing a fantastic job I suspect, but it surely doesn’t have to be either GPs, or else pharmacists, who get appropriately remunerated, does it?

Sure, it will all be grand I’m sure. Our ape-like ancestors appeared on the planet about seven million years ago, and we started using tools about 2.5 million years ago. No doubt it will all work out, developing further our ‘high agency’ skillset, at least for another while anyway. l CONTRIBUTOR INFORMATION Ultan Molloy is a business and professional performance coach, pharmacist, facilitator and development specialist. He works with other pharmacists, business owners and third parties to develop business strategies. Ultan can be contacted on 086 1693343.

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Pain | CPD MODULE

This CPD module has been facilitated by

TRUE/FALSE QUESTIONS Q1 According to The Pain in Europe survey,

published in 2006, almost 30 per cent of individuals with chronic pain report pain daily.

True or false?

Q2 Symptoms of neuropathic pain include

pain that is described as aching, boring, worse on movement, anatomically defined, with fluctuations in severity.

pharmacist

Pain control

This module will focus on certain aspects of analgesia, including distinguishing different types of pain, particularly chronic pain. A holistic approach to pain control is outlined, as well as pain’s impact on the patient, including its causes and treatment options. On completion of this module, it is expected the reader will have a greater understanding of the suitability of different types of analgesia and how the pharmacist can educate the patient on aspects of self-care, among other considerations.

True or false?

AUTHOR: Eamonn Brady MPSI

Q3 Carpal tunnel syndrome is a type of neurological pain.

True or false?

Q4 Males are among the most common risk groups for under-treatment for pain.

True or false?

COMPLETE THIS MODULE ONLINE You can check your answers to the T/F and MCQ questions on PharmacistCPD.ie.

Successful completion of this module will earn you 2 CPD credits.

Q5 Patients with renal problems should avoid paracetamol.

CHRONIC VS ACUTE PAIN

True or false?

Q6 Studies in recent years indicate

anticonvulsants, for example, gabapentin, pregabalin and carbamazepine, may not be as effective as first thought for pain and there may be increasing evidence of abuse.

True or false?

Q7 Opioid analgesics can cause diarrhoea if used long-term.

True or false?

Q8 In relation to pain relief,

antidepressants, for example amitriptyline, duloxetine and fluoxetine, work by interfering with the way nerve impulses are transmitted and ease some types of pain.

True or false?

Q9 Topical analgesics have less risk of side-effects.

True or false?

Q10 Codeine is the worst culprit for

chronic daily headache. Codeine-based medicines can bring on chronic daily headaches after only three days of use.

True or false?

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In general terms, most people associate pain with some direct cause. It could be from a sports injury, or toothache, perhaps an accident that has resulted in a broken limb.

In cases like these, you have an attributable acute pain, which you can then do something about. If it’s toothache, you go to the dentist, the problem gets fixed, and the pain is gone. If it’s a broken arm, you go to hospital, have the usual procedures — x-rays, plaster, etc, are carried out and with the right convalescence, the patient returns to normal.

For many though, pain is something which is not acute or for which there is a simple ‘cause and effect’ route to fix the problem. Pain is a constant factor in their lives, something which they manage every day. The reason they have pain may be attributable to one or more different causes; however, it is evident that their pain can have a wholly debilitating effect, not just on their quality of life, but also for those around them. This is chronic pain.

The 2006 National Disability Survey Ireland (CSO, 2008) stated that pain was one of the most common disability types reported.

Almost 50 per cent of individuals reported pain as the main cause of their disability and of those, 34 per cent indicated arthritis as the most common cause of injury or illness.

Almost 20 per cent stated the pain disability was caused by an accident or injury.

The Pain in Europe survey, published in 2006 by Harald Breivik, indicated for Ireland:  13 per cent of the Irish population and 27 per cent of Irish households are affected by chronic pain.  21 per cent of people with chronic pain report pain so severe they sometimes wish to die.  The average age of individuals with chronic pain is 48, with only a slightly higher gender bias towards women (W 52% — M 48%)  The average duration of chronic pain is 4.9 years, although almost 20 per cent of individuals with chronic pain have experienced it for >20 years.  Almost 70 per cent of individuals with chronic pain report pain on a daily basis.  34 per cent felt pain impacted on employment.  15 per cent of sufferers report losing a job due to their chronic pain.  19 per cent were diagnosed with depression due to chronic pain.

WHAT IS CHRONIC PAIN?

Chronic pain can be defined as pain which has lasted longer than what

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pharmacist

CPD MODULE | Pain

This CPD module has been facilitated by

A general classification is detailed below.

OTHER CAUSES

FIGURE 1: ‘Reported Causes of Pain’ from the PRIME study

would be considered as ‘normal’ healing time, perhaps as part of recovery from illness or injury — generally more than three months.

Chronic pain may be attributable to an event, such as an accident, developing from acute pain. Opinion differs as to whether previous acute pain is always the root cause of chronic pain or simply appears, sometimes without an initial cause.

In some cases, especially in relation to sports injury in contact sports, the underlying chronic pain may appear sometime after an event.

Pain may also be related to another condition. Surveys show that in Ireland, 35 per cent of reported chronic pain was arthritis-related. It may site-specific, ie, back, knee, and wrist, however 80 per cent of sufferers in Ireland report that their pain relates to more than one site.

TYPES OF CHRONIC PAIN

Pain can be classified either by type of pain, or by body region. Classes of pain types include:  Nociceptive pain: Aching, boring, worse on movement, anatomically defined, fluctuates in severity.  Neuropathic pain: Burning sensation, sharp stabbing type, tingling, transient limb pain (shooting), associated with allodynia (experience of pain from a nonpainful stimulation of the skin, such as light touch), hypersensitivity, or other sensory changes.  Mixed nociceptive and neuropathic pain: Combination of symptoms.  Visceral pain: Dull, non-specific,

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difficult to pinpoint.  Autonomic symptoms: Physiological changes (colour, temperature), sweating.

CAUSES OF CHRONIC PAIN

The cause of chronic pain is often difficult to determine and there are often many aspects to consider. It is this indeterminate nature that can present the biggest obstacle to health professionals to establishing proper diagnosis of the condition.

The infographic above on ‘Reported Cause of Pain’ from the PRIME study, NUIG 2011, illustrates the problem further.

Chronic pain can be attributed to a wide range of identifiable causes — acute injury, arthritis, migraine, or fibromyalgia, for example.

Chronic pain may arise from anatomical site-related general medical conditions.

Site-specific pain includes:  Abdominal (ie, peptic ulcer, irritable bowel syndrome, pancreatitis, hernias, diverticular disease).  Gynaecological (ie, endometriosis).  Obstetric (ie, symphysis pubis dysfunction).  Urological (ie, interstitial cystitis).  Cardiovascular (ie, ischaemic heart disease, coronary heart disease, angina, peripheral vascular disease, etc).

Chronic pain may also result from disease conditions including:  Rheumatological — conditions such as rheumatoid arthritis, osteoarthritis or fibromyalgia.  Endocrine — conditions such as hypothyroidism (joint pain), diabetes.  Infectious — diseases such as hepatitis C, post-herpetic neuralgia.  Malignancy — cancer pain and pain from treatment (ie, radiation, chemotherapy or surgery). (Source: Warrell et al (2004); BMJ Best Practice (2009)) TREATMENT

Before moving on to treatment, it is worth noting that, according to figures from the

MUSCULOSKELETAL

HEADACHE AND/OR MIGRAINE

NEUROLOGICAL

PSYCHOLOGICAL CAUSES

Osteoarthritis Rheumatoid arthritis Osteomyelitis Osteoporosis Ankylosing spondylitis Myofascial diseases Polymyalgia rheumatica Polymyositis Fractures Chronic or repetitive overuse Carpel tunnel syndrome Muscular strains Faulty posture Mechanical low-back pain

Cluster headaches Migraine Trigeminal neuralgia Giant cell (temporal) arteritis Glaucoma Smoking Alcohol Temporo-mandibular joint dysfunction Drug or substance overuse or misuse

Diabetic sensorimotor polyneuropathy (up to 25% of diabetics) Spinal stenosis Brachial plexus traction injury Thoracic outlet syndrome Post-herpetic neuralgia Multiple sclerosis Alcoholism Thyroid disease Pernicious anaemia Infections (ie, HIV), polyneuropathies Polyradiculopathie

Depression, Anxiety, Personality disorders Sleep disturbances

TABLE 1: General pain classification

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Pain | CPD MODULE

This CPD module has been facilitated by

MEDICATION

CAN BE USED FOR?

WHAT ARE THE BENEFITS?

WHAT ARE THE SIDE-EFFECTS?

Paracetamol

To treat pain anywhere in the body.

Can be used alone or with other drugs such as NSAIDs or a codeinelike opioid, such as co-codamol and co-dydramol.

Relieves pain quickly. Has few side-effects and is considered generally safe if used within the recommended dose.

Side-effects from paracetamol are rare, if taken within safe limits. However, taking more than the amount recommended (more than eight tablets in a day) is extremely dangerous.

Oral non-steroid antiinflammatories (NSAIDs), for example ibuprofen, diclofenac, etoricoxib, ketorolac, piroxicam, naproxen and celecoxib, in the form of a tablet

Low back pain.

Relieves pain quickly.

Hip or knee osteoarthritis pain (pain that affects your joints).

Reduces pain caused by inflammation, for example in joints.

Side-effects can include: Stomach pain, diarrhoea, heartburn, high blood pressure, rash, dizziness and headaches.

In a small number of people, NSAIDs can cause heart problems. Over-use can be associated with serious bleeding. For this reason, you must not use NSAIDs with aspirin. If you have asthma, there is a risk of it becoming worse when taking NSAIDs. COX-2 inhibitors are a type of NSAID that directly targets cyclooxygenase-2, COX-2. Examples include celecoxib and etoricoxib. They demonstrate a significantly reduced risk for upper and lower gastrointestinal complications compared with conventional NSAIDs. However, evidence suggests that some of these agents, at some doses, may be associated with an increased risk for cardiovascular adverse events compared with no therapy.

COX-2 inhibitors are best avoided in patients with cardiovascular issues.

Topical non-steroid antiinflammatory drugs (NSAIDs), for example ibuprofen, diclofenac, etoricoxib, ketorolac, piroxicam

Should be considered when treating localised musculoskeletal pain, particularly if unable take NSAID tablets. Should be used for a short time.

Works directly on the affected area of the body.

Less risk of side-effects as the medication does not go through the whole body.

Other topical medicines (medication applied to the skin in the form of creams, gels or patches), for example: Capsaicin, lidocaine patch, and rubefacients (substance that produces redness of the skin)

Should be considered for nerve pain or musculoskeletal pain which hasn’t improved with other medication, or if unable to take other medication.

Works directly on the affected area of the body.

Less risk of side-effects as medication does not go through the whole body.

Opioids, for example codeine, dihydrocodeine, tramadol, oxycodone, hydrocodone, tapentadol, morphine, diamorphine, transdermal fentanyl, buprenorphine and methadone

Should be considered for chronic low-back pain or osteoarthritis.

Should only be continued if there is ongoing pain relief. Some opioids are weak (for example codeine) and some are strong (for example, morphine). Because opioids can have serious side-effects, their longterm use should only be considered after a detailed discussion with a GP.

These are strong painkillers which reduce the intensity of pain and improve physical symptoms and day-to-day living.

Common side effects include: Feeling sick, being sick, feeling dizzy, constipation, feeling sleepy, feeling confused, breathing problems.

Anticonvulsants, for example gabapentin, pregabalin and carbamazepine

This medication is commonly used to treat epilepsy but can also help nerve pain.

Can stop nerve impulses causing some types of pain. Recent studies indicate they may not be as effective as first thought for pain and increasing evidence of abuse.

Side-effects may be worse in the first few days, when your body is getting used to new medication. The most common side-effects include: Dizziness, drowsiness, weight gain, rash, dry mouth, feeling sick, being sick.

Work by interfering with the way nerve impulses are transmitted and ease some types of pain.

Different antidepressants have different side-effects, and side-effects are rare with some of them.

When you first start to take amitriptyline or duloxetine, you may experience: Dry mouth, feeling sick, dizziness, urinary retention, constipation, drowsiness, problems sleeping, anxiety, agitation, problems with the central nervous system.

Antidepressants, for example amitriptyline, duloxetine and fluoxetine

Musculoskeletal pain (pain that affects your muscles, ligaments and tendons and joints).

As well as helping people who have depression, this medication can help others with chronic pain.

Amitriptyline (or nortriptyline) should be considered for treatment of fibromyalgia (chronic widespread pain) and nerve pain.

Duloxetine should be considered for treatment of nerve pain. Fluoxetine should be considered for treatment of fibromyalgia.

Rare side-effects can include: Skin rash; kidney and liver problems, if higher than the recommended dose is taken.

Side-effects associated with longer-term use of opioids include: Feeling lethargic, headaches, stomach problems (including constipation), urinary problems, reduced immunity to infections, hormone problems, dry mouth, over-sensitivity to pain, or pain getting worse, addiction, mood changes, sleep disturbances.

Less common side-effects include: Swollen legs, blurred vision, headaches, diarrhoea and tremors (movement disorders).

TABLE 2: Overview of pain medications

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CPD MODULE | Pain

Pain in Europe study (Breivik et al, 2006), 40 per cent of respondents, when asked to describe their care, said it was “inadequate”.

Leading on from that, there is substantial evidence based on WHO figures that chronic pain is massively under-treated across the globe. This is due to a variety of factors, such as access to medicines and specialist help.

Another contributing factor comes from sufferers themselves. Individuals with chronic pain often do not seek help with pain. This occurs for a variety of reasons, including religion, fear, finances, culture and a feeling that healthcare professionals may feel the individual’s pain is ‘imaginary’.

Indeed, the fear of stigma and disbelief, especially with females, is the most common reason in Ireland for not seeking help with chronic pain.

The most common groups at risk of undertreatment for pain are:  Elderly.  Female.  Individuals with emotional or cognitive dysfunction.  Individuals who do not speak English as a first language.

MEDICATION

A successful outcome from GP visits should be a pain management plan. It is highly likely that as part of this, some form of painrelieving medication will be prescribed.

Ideally, advise on promotion of self-help, self-management and other treatments to help improve their condition and add value to the benefit offered by medication.

Given the wide and varied nature of chronic pain, there can be a myriad of medication options. The effectiveness of medication depends on the nature and severity of the pain.

Types of medications, their benefits and potential side-effects are shown in the table opposite.

Regarding treatment of chronic pain caused by headache (ie, migraine), in addition to standard paracetamol and NSAIDs, triptans are considered the most effective to combat acute attacks if ordinary analgesics do not work.

These include:  Almotriptan.

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 Frovatriptan.  Sumatriptan.  Zolmitriptan.  Eletriptan.  Naratriptan.

All are POM, apart from sumatriptan, with an OTC version recently becoming available in Ireland.

SELF-HELP Pain Management Programme

The Pain Management Programme (PMP) is a psychologically-based rehabilitative treatment for people with persistent pain. It is delivered in a group setting by a multidisciplinary team of experienced healthcare professionals working closely with patients. The main aim is to teach a group of patients with similar problems about pain, how best to cope with it, and how to live a more active life. Referral to a Pain Management Programme is usually through the general practitioner to your local pain clinic.

There are public pain management programmes in*:  St Vincent’s University Hospital, Dublin.  The Adelaide and Meath Hospital (Tallaght), Dublin.  The Mater Misericordiae University Hospital, Dublin.  Mercy University Hospital, Cork. *This list not exhaustive Physical therapy

Physical therapy covers a number of different treatment types, which can be beneficial for chronic pain, especially pain due to musculoskeletal disorders.  Hot or cold (ice) pack treatment.  Ultrasound.  Peripheral nerve stimulation/ transdermal electronic nerve stimulation (TENS).

A chartered physiotherapist can help with manual therapy, which helps to increase tissue extensibility and range of movement, thereby decreasing pain. Manual therapy can also help with alignment and joint mechanics issues, which in itself can also help alleviate pain.

Therapeutic exercise — Such as hydrotherapy, can restore joint movement and flexibility and strengthen and condition

muscles to help movement, thereby reducing pain.

Patient education — Can support physical therapy in a self-help or homebased manner. Reading and learning about their condition can assist in management of their own pain.

Exercise — Staying active can be the key to improving chronic pain symptoms. Any activity that increases mobility can have not only a positive physical benefit, but also an affirming mental health benefit.

Cognitive behavioural therapy (CBT)

CBT is a proven ‘talk therapy’, the primary aim of which is to learn how to recognise and manage negative thinking or unhelpful beliefs that lead to increased distress.

Generally delivered on a one-to-one basis, the participant is taught techniques and strategies to enable them to challenge their thoughts and change their attitude, leading to a change in future behaviour. Through regular attendance, confidence builds, leading to positive goal-setting. These goals should relate to achieving resumption of activities previously restricted by pain.

Learning problem-solving strategies and stress reduction techniques will help achieve a successful outcome.

Over-the-counter painkillers: Chronic daily headaches and codeine risks

Taking painkillers for longer than 15 days (three days for codeine) runs the risk of medication-overuse headaches. The headaches caused by painkiller overuse last an average of four or more hours. After taking a painkiller for headaches for a prolonged period of time, the body becomes used to the painkillers. A ‘rebound’ or ‘withdrawal’ headache then develops if the patient does not take a painkiller within a day or so of the last dose. The patient thinks this is just another headache, and so takes a further dose of painkiller.

When the effect of each dose has worn off, a further withdrawal headache develops, and so on. A vicious cycle develops as the sufferer gets headaches every day or most days and then ends up taking more painkillers, which only makes the headaches worse. Unless the overused painkillers are stopped completely, the

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headaches are likely to continue. This phenomenon only seems to occur when taking painkillers for headaches; it does not seem to occur when taking painkillers regularly for other conditions, such as arthritis.

Medication-overuse headache is the third-most common cause of headache after migraine and tension-type headache.

About one-in-50 people develop this problem at some time in their life. It can occur at any age but is most common in people in their 30s and 40s. It is more common in women than men. The pain of medication-overuse headache is often described as ‘overwhelming’ and tends to be worse first thing in the morning, or after exercise. It may be a constant ‘dull’ headache, with spells when it gets worse.

Codeine is the most common cause of chronic daily headaches.

Codeine is the worst culprit for chronic daily headache. Codeine-based medicines can bring on chronic daily headaches after only three days of use.

HOW TO KNOW IF A PATIENT IS ADDICTED TO CODEINE

Addiction to codeine can occur by taking over-the-counter remedies containing codeine for longer than the recommended three days. If a patient answers ‘yes’ to any of the following questions, they may be addicted to codeine.  Do you feel you need to take the codeine products for longer time periods than instructed on the box?  Do you find yourself buying more

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and more pills?  Do you feel you need to take more than the recommended dose?  Do you start to feel unwell when you stop taking the medicine but feel better when you start taking the medicine again?

These symptoms will not occur if they follow the recommended dosage instructions written on the medicine box.

Common over-the-counter remedies which contain codeine: Many painkillers containing codeine are household names. Examples include the painkillers Solpadeine, Maxilief, Panadeine, Nurofen Plus and Veganin Plus.

THE PHARMACIST’S ROLE

It is not just about medication, although regular review of the continued suitability of all medications used by those with chronic pain is vital. For many, the pharmacy is becoming the first port of call when a health problem, especially pain-related, arises. Using some of the ideas regarding questions, pain diary, etc, will really help in enabling people to make better informed decisions about their own next step. Becoming familiar with local resources like physios, support groups, condition-specific charities and signposting these will only add value to a positive perception. l References on request Written by Eamonn Brady (MPSI), owner of Whelehans Pharmacies in Mullingar

Check your answers against the latest module on pharmacistcpd.ie Successful completion of this module will earn you 2 CPD credits

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MCQs MCQ 1

Chronic pain is a significant health and socioeconomic issue in Ireland. According to the most recognised survey of the condition, what percentage of Irish households are affected by chronic pain?

1. 7% 2. 19% 3. 27% 4. 35%

MCQ 2

One of the biggest obstacles for health professionals in the effective treatment of chronic pain is establishing a proper diagnosis in the first instance. This is due to the often indeterminate nature of the symptoms presented, with no obvious attributable cause. In the NUIG PRIME study 2011, what percentage of reported cases of those surveyed were described as ‘unknown’?

1. 15% 2. 28% 3. 33% 4. 43%

MCQ 3

There is substantial evidence from the WHO that chronic pain is massively under-treated across the globe. One of the most significant contributing factors to this is the high number of individuals or groups who, for a wide variety of reasons, often do not seek help with their pain.

This too is reflected in the under-treatment of the condition in Ireland. For females in Ireland, which is the most common reason or not seeking help?

(Choose all that apply) 1. Religion.

2. Fear of stigma and disbelief.

3. Financial worries.

4. Fear of treatment itself.

5. Cultural constraints.

MCQ 4

When considering the use of an antidepressant in the treatment of chronic pain, which of the following would be most suited to the treatment of fibromyalgia? (Choose all that apply) (a) Venlafaxine. (b) Amitriptyline. (c) Fluoxetine. (d) Mirtazapine.

MCQ 5

Regarding the treatment of chronic pain caused by headache, ie, migraine, triptans are considered most effective in combating acute attacks. To the relief of migraine sufferers throughout Ireland, which of the following is now available OTC in Ireland? (Choose all that apply) (a) Zolmitriptan. (b) Naratriptan. (c) Almotriptan. (d) Sumatriptan. (e) Eletriptan.

Disclaimer: Brands mentioned in this article are meant as examples only and not meant as preference to other brands.

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Rheumatology | IN FOCUS

FOCUS ON

R H E U M ATO I D A RT H R I T I S

EAMONN BRADY MPSI LOOKS AT THE CLINICAL CONSIDERATIONS IN TREATING RHEUMATOID ARTHRITIS

A

rthritis is a general term used for the condition; however, there are over 100 types of arthritis.

The two most common types of arthritis are osteoarthritis and rheumatoid arthritis (RA).

RA is one of the most debilitating forms of the condition.

PREVALENCE

Estimates show that the condition effects 0.5-to-1.5 per cent of the world’s population, being more prevalent in the West than in developing countries. Arthritis Ireland estimates there are as many as 40,000 individuals (1.22 per cent) with rheumatoid arthritis in Ireland and that 70 per cent of the rheumatoid arthritis affected population are women.

RA occurs because of the body’s immune system attacking the joints and causing inflammation of the lining of a joint and the tissues surrounding it. While 1 per cent of the population suffers from rheumatoid arthritis, about 80 per cent of sufferers develop it between the ages of 35 and 50, therefore predominantly affecting individuals of working age. About onein-20 of affected people have a severe form of it, with many joints affected. Up to half of all patients are unable to work within 10 years of diagnosis.

RHEUMATOID ARTHRITIS AND WORK

Some of the figures below show the extent to which RA has a dramatic impact on the working population.  Approximately 75 per cent of new diagnoses are of individuals who are working

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at the time of diagnosis.  The ability to work is affected in around 50 per cent of individuals within five years of diagnosis, with every third individual diagnosed with RA becoming completely work-disabled.  Up to 85 per cent of individuals with RA who can work will experience an average of 40 lost work days annually due to the condition.  A report in 2002 indicated that 22 per

cent of individuals diagnosed with RA will stop working altogether within five years due to their condition.  A further 18 per cent will cease to work within five years of diagnosis due to a combination of RA and other factors, such as depression.

The factors shown above present a significant annual cost to the State’s economy.

Research by Arthritis Ireland in 2008 estimated the annual indirect cost of lost pro-

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IN FOCUS | Rheumatology

duction time due to all forms of arthritis to be €1.6 billion and found that 70 per cent of individuals diagnosed with RA in Ireland were not able to work outside their home.

As of 2020, rheumatic and musculoskeletal diseases (RMD) are known to affect up to 60 per cent of the 120 million EU citizens, at an estimated cost of €240 billion, with direct costs of 2 per cent of EU GDP. In Ireland, approximately 40,000 people have RA, with an estimated cost of €19,596 per patient/year, and overall economic cost of approximately €544 million. While there have been significant advances in the treatment of RA, there are no cures, therefore patients require lifelong treatment.

WHAT IS RA? Arthritis means inflammation of the joints.

The condition can progress swiftly to become severe and disabling in a short period of time. The disease primarily affects the synovial joints, resulting in pain, deformity and eventual functional limitation.

RA also increases the risk to sufferers of development of other diseases together with a significantly increased risk of premature death. RA is an autoimmune disease. Usually, the body's immune system produces white cells and proteins called antibodies to destroy foreign substances such as viruses and bacteria. With autoimmune diseases, the immune system mistakes the body’s own tissue as foreign and attacks it, leading to inflammation.

SYMPTOMS OF RA Symptoms can initially develop quite slowly and can occur either as a single episode of stiff and painful joints which may last some months, or as an aggressive and destructive condition which progresses rapidly.

Atypically, it starts with the small bones of the hands and feet, with discomfort and some swelling often being the first symptoms. Stiffness, especially in the morning, is a classic symptom of RA; this stiffness often reduces during the day (for osteoarthritis, the symptoms tend to get worse as the day goes on). The hands, wrists, feet, ankles, and knees are affected in over 80 per cent of cases. The symptoms are often symmetrical, meaning that both sides are affected equally, ie, both knees affected equally. In advanced

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cases of the condition, most joints are become affected.

Rheumatoid nodules may develop; these are fleshy lumps resulting from synovitis that usually appear on hands, feet, and elbows.

These are not painful, but they can cause difficulty using hands.

Up to 30 per cent of patients may present with non-arthritis type symptoms without obvious joint swelling, such as malaise (general feeling of being unwell), weight loss and myalgia (muscle pain). Depression can be a feature of RA. RA is thought to be associated with an increased rate of cardiovascular disease and there is evidence of an increased mortality rate from heart-related problems in RA patients.

In summary, the main symptoms of RA are:  Joint swelling.  Pain/stiffness (commonly in morning and lasting more than one hour).  Weakness.  Deformity.  Fatigue.  Malaise.  Fever.  Weight loss.  Depression.

CAUSES OF RA The exact cause is unknown but there is a genetic link, as RA tends to run in families.

RA is three times more common in women than in men. It is common for the symptoms of RA to improve during pregnancy — this suggests that hormones and the immune system may be involved in triggering the condition. Certain lifestyle aspects such as obesity and smoking can be factors, with the risk of developing rheumatoid arthritis being almost twice as high in smokers compared to non-smokers. For reasons unknown, RA onset is twice as common in winter than in other seasons.

DIAGNOSIS OF RA It is important to start treatment of RA early because the earlier it is started, the more effective it will be. However, there are several challenges to achieving this early diagnosis. If not treated, the condition may lead to serious disability. It can be difficult to diagnose RA because many other condi-

tions may make the joints painful. People may feel the symptoms are minor or may be simply normal signs of ageing. The National Audit Office in the UK suggests that around 50-to-75 per cent of individuals with RA do not visit their GP until their symptoms have been present for more than three months, with as many as 20 per cent waiting a year or more before seeking medical advice.

Symptoms are a good indicator of the condition. However, x-rays of joints and blood tests such as testing for the presence of a ‘rheumatoid factor’ or an ‘anti-CCP antibody’ can be more conclusive in diagnosing the condition.

Formal diagnosis is based on the American College of Rheumatology (ACR) diagnostic criteria.

According to the ACR criteria for diagnosis of RA, at least four of the following symptoms must be present: 1. Morning stiffness in affected joints lasting at least one hour.

2. Soft tissue swelling of at least three joint areas.

3. Swelling of finger, hand, or wrist joints.

4. Symmetrical swelling, ie, equal both sides.

5. Rheumatoid nodules.

6. Presence of rheumatoid factor (rheumatoid factor is an autoantibody which shows up in blood tests and is an indicator of arthritis).

7. Erosion of bone which shows up in xrays, particularly in hand, wrist, or feet joints.

RAPIDLY-PROGRESSIVE RA RA can be rapidly progressive in some patients. In these cases, treatment must be started early to prevent irreversible joint and other damage. Indications that the disease is rapidly progressing include high ESR or Creactive protein levels (indicators of inflammation in blood tests), early erosive damage on x-rays, increasing number of affected joints, disability early in the condition, high levels of rheumatoid factor and the presence of extra-articular features at diagnosis.

Extra-articular features include non-joint symptoms of RA such as damage to skin, heart, lungs, and eyes.

TREATMENT OF RA

Self-help  Find a balance between exercise and

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rest. Swimming is an excellent activity because it strengthens muscles and joints without putting any strain on them.  Losing excess weight will reduce the pressure on joints.  Try to eat a healthy, balanced diet and cut down on saturated fats.  A hot water bottle is useful when joints feel stiff and painful; try an ice pack if they are hot and irritated.  Omega 3 fish oil has been proven to have a mild anti-inflammatory effect.

Physiotherapy The aim of physiotherapy is to reduce pain and stiffness, prevent deformity, maximise function and to improve independence and quality of life.

On presentation, the physiotherapist will conduct a functional assessment (transfer status, gait analysis, activities of daily living, etc), range of movement of all joints, strength, posture, and respiratory status to establish an individual’s current position. This then forms a solid platform to measure progress going forward.

The physiotherapist will generally recommend activities that can be either active (such as education and exercise), or passive (isometric or range of movement exercises, thermotherapy, electrotherapy such as Transcutaneous Electrical Nerve Stimulation (TENS) or ultrasound therapy) or a combination of both.

They may also refer patients to occupational therapy for a more ‘work based’ assessment of individual needs.

Exercise and physiotherapy are used to maintain or to improve muscle tone to prevent or correct deformities and to maintain or increase joint mobility and function. Exercise has been shown to be particularly beneficial to people affected by rheumatoid arthritis, as they are often physically inactive. This is where a physiotherapist is important, as they can assess the person’s limits to ensure they are not under- or overdoing exercise, depending on the extent of the condition and other factors.

Podiatry Evidence suggests that almost all rheumatoid arthritis suffers will experience problems with the bones of the feet, and that this

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is a significant cause of pain, mobility impairment and functional limitation. For 25 per cent of individuals with RA problems, their feet are the main cause of their walking impairment, with 75 per cent reporting that the effect of the condition on their feet contributes to their functional limitation.

A consultation with a podiatrist can help. Through examination, they will be able to make recommendations regarding footwear and orthoses to aid comfort and improvement. Custom-built shoes and insoles have been shown to be considerably more effective than those that are mass produced (and therefore cheaper).

(NSAIDs), such as ibuprofen and diclofenac, reduce inflammation and so relieve pain and swelling.  Disease-modifying antirheumatic drugs (DMARDs) such as sulfasalazine and methotrexate work to slow down the disease process and delay joint damage.  Biological medicines including infliximab, etanercept, adalimumab and rituximab have been developed in recent years. These are only used if other treatments are unsuccessful.  JAK Inhibitors are a newer class of oral medicines that can be prescribed where the options above are unsuccessful.

CURRENT GUIDELINES

There is no cure for arthritis, however medicines can relieve symptoms and reduce progression Surgery Irrespective of medical advances in the treatment of RA, there will be a number of affected individuals who will nonetheless develop irreversible joint or tendon damage. For these individuals, surgery can provide a return of functional ability, a decrease in symptoms and pain, and avoid deformity and disability, helping them return to a ‘normal’ life.

Typically, surgical interventions involve joint replacement, (commonly hip, knee, shoulder, elbow, and hand joints). Evidence shows that a higher success rate is achieved if early consideration is given to surgery, before substantial joint damage has occurred, or disability has developed.

Medication There is no cure for arthritis, however medicines can relieve symptoms and reduce progression. In brief, the treatment options for RA are as follows:  Painkillers such as paracetamol may help to relieve pain, although they will not affect the progression of arthritis.  Anti-inflammatory medicines, known as non-steroidal anti-inflammatory drugs

Current guidelines recommend early diagnosis and early referral (ideally within three months of symptom onset) to a rheumatologist for the introduction of DMARDs.

MORE DETAILS ON MEDICINES USED

Pain control Although DMARDs may be introduced at time of diagnosis, they have a slow onset of action and can take weeks for an improvement. Therefore, DMARDs have little or no impact on acute pain. Most patients will require at least initial courses of analgesics or NSAIDs. The need for painkillers may be reduced once the DMARDs start to exert their effect after a few weeks.

Paracetamol Paracetamol on its own is seldom sufficient to control acute pain in RA; however, there is evidence that regular dosing of paracetamol enhances the painkilling effects of NSAIDs in RA. Therefore, a combination of paracetamol and NSAID may allow a reduction of the NSAID dosage and therefore reduce the risk of side-effects of NSAIDs. Opioid analgesics Opioid analgesics such as tramadol may be used during acute attacks of RA, especially in elderly patients who may not be able to tolerate NSAIDs. Their continuous/ long-term use is not recommended due to the risk of addiction, cognitive impairment (ie, memory loss, confusion), constipation and respiratory depression. Paracetamol/

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opioid combinations such as Solpadeine or Ixprim are sometimes used in acute RA patients, especially in those at risk of developing problems with excessive NSAID use.

Corticosteroids Corticosteroids, such prednisolone, are useful in the management of acute pain and have disease-modifying properties.

Over the short-term, they exert an effect on the symptoms of RA, but their efficacy diminishes over time. The preferred method of administration of corticosteroids is intra-articular injection (directly into the joint), ie, Depo-Medrone injection. This produces rapid symptom relief and does not cause the side-effects of oral corticosteroids, such as stomach irritation. However, the effects of intra-articular steroid injections can wear off within a month, so they are not a long-term solution. Where there are multiple joints involved, local injection directly into the joints is not possible, so an intramuscular injection (ie, 120mg methylprednisolone) may be given while waiting for DMARDs to take effect.

Oral corticosteroids should only be used in conjunction with DMARDs until the DMARDs take effect or for flare-ups in between. Long-term use of even low-dose corticosteroids may result in osteoporosis and other steroid-related side-effects such

42

as weight gain, thinning skin, easy bruising, and high blood pressure.

NSAIDs NSAIDs reduce swelling and stiffness in addition to providing pain relief, and they improve quality of life in most cases with acute RA. However, side-effects include gastric irritation, kidney damage, fluid retention and skin reactions, as well as evidence linking selective COX-2 inhibitors (ie, Etoricoxib, Celecoxib) to increased risk of myocardial infarction. Also, the European medicines watchdog issued a warning in July 2013 stating that diclofenac can significantly increase the risk of heart problems such as heart attack and stroke in those already at risk of these problems. Long-term use of NSAIDs is not recommended, especially in patients with known cardiovascular and gastrointestinal problems and only one NSAID should be used at any one time.

DMARDs DMARDs help to ease symptoms and slow down the progression of RA. When antibodies attack the tissue in the joints, they produce chemicals that can cause further damage to the bones, tendons, ligaments, and cartilage. DMARDs block the effects of these chemicals. The earlier a DMARD is

started, the more effective it will be. They must be started by a consultant rheumatologist; therefore, it is important to seek treatment with a rheumatologist early if showing signs of RA. The most used DMARDs include methotrexate, hydroxychloroquine, and sulfasalazine. These are often known as conventional DMARDs since the advent of biological DMARDs in recent years. Similar efficacy has been reported for methotrexate and sulfasalazine in studies of up to 12 months. The response of DMARDs is usually monitored every one-to-three months initially until symptoms improve.

Methotrexate is often the first choice DMARD for RA. It can be taken on its own or in combination with another DMARD. The most common side-effects of methotrexate are sickness, diarrhoea, mouth ulcers, hair loss or hair thinning, and rashes on the skin. Regular blood tests to monitor blood count and liver are required, as methotrexate can cause potentially very serious liver and blood count problems. Very rarely, it can affect the lungs, so chest x-rays and possibly breathing tests are performed when starting methotrexate. This is to provide a comparison if the patient develops shortness of breath or a persistent dry cough while taking methotrexate. Most people tolerate methotrexate well and more than 50 per cent of patients take it for at least five years.

Methotrexate improves symptoms by 50-to-80 per cent, slows the rate of joint destruction (as seen on x-ray) and improves function and quality of life.

Doses of methotrexate up to 20mg weekly may be needed. Parenteral administration (SC, IM, starting at 7.5-10mg weekly) may be considered in severe acute RA if oral treatment is ineffective or in those unable to tolerate oral methotrexate. It takes six-to-12 weeks for methotrexate to start working.

Methotrexate may also be combined with biological treatments. It is very important to emphasise that methotrexate is a weekly dose. Giving it daily is a potentially serious medication error.

Sulfasalazine has a slow onset of effect (one-to-three months). Patients may need to discontinue long-term treatment of sulfasalazine due to gastrointestinal complaints.

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Hydroxychloroquine takes several weeks to exert its effect. It has been reported to be less effective than the other DMARDs but is well tolerated; therefore, it may be useful in mild disease or in combination therapy. However, it can cause eye damage, so regular eye checks are needed.

It is important to keep taking DMARDs, even if there is no improvement at first.

Many patients must try two or three types of DMARD before finding the one that is most suitable for them. Once the most suitable DMARD is found, the patient will usually have to take it long term.

Immunosuppressants Azathioprine (Imuran) and Ciclosporin (Neoral) tend to be reserved for severe RA, when other DMARDs are ineffective or inappropriate. They tend to be last-line, as they have many potential serious sideeffects, mainly due to their suppression of the immune system.

Biological DMARDs Biological treatments include TNF-alpha inhibitors (etanercept, infliximab, adalimumab and certolizumab), rituximab and tocilizumab. Etanercept (Enbrel) and adalimumab (Humira) are most prescribed biological treatments for RA in Ireland.

In general, use of biological agents is reserved for patients with moderate-to-severe active RA where conventional DMARDs have failed. They are usually taken in combination with methotrexate or sometimes with another DMARD. They work by stopping chemicals in the blood from activating the immune system to attack the lining of joints. They are given by subcutaneous injection.

Side-effects from biological treatments are usually mild and include skin reactions at the site of injection, infections, nausea, fever, and headaches. They should be used in caution in patients who have had tuberculosis (TB), septicaemia and hepatitis B in the past. There is a slight risk that biological treatments can reactivate these conditions and, in rare cases, trigger new autoimmune problems.

JAK INHIBITORS JAK Inhibitors are also known as targeted

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synthetic DMARDs (tsDMARDs) and are a therapeutic class that inhibit JAK. There are two JAK inhibitors authorised in Ireland, tofacitinib (Xeljanz) and baricitinib (Olumiant), and they come in oral form. They can be prescribed in addition to methotrexate or as monotherapy instead of methotrexate in patients who are not getting sufficient benefit from or are intolerant to methotrexate. Concurrent use of JAK inhibitors with biological DMARDs is contraindicated and JAK inhibitors should not be used with live vaccines.

Concurrent use of JAK inhibitors with biological DMARDs is contraindicated and JAK inhibitors should not be used with live vaccines HOW JAK INHIBITORS WORK Janus kinase (JAK) are intracellular enzymes that transmit signals from cytokines binding to receptors on the cell surface to signal transducers and activators of transcription (STATs), which drive pro-inflammatory cellular responses. JAK inhibitors block this inflammatory pathway.

ADVANTAGES OF JAK INHIBITORS Although DMARDs result in disease suppression for many patients with RA, only approximately 30 per cent achieve complete remission, and the majority of patients treated with biologics experience disease exacerbation following cessation of treatment. The route of administration is also an important consideration, with the results of two studies suggesting that patients with RA may prefer therapies taken orally rather than those taken by injection. The benefits of JAK inhibitors can be seen in as little as a few days to two weeks, whereas previous biologics (DMARDs) can take several weeks for full benefit. Maximum benefit from JAK inhibitors is seen within six months.

SIDE-EFFECTS AND MONITORING JAK inhibitors increase risk of infections (bacterial, fungal, viral) and increase the risk of the likes of tuberculosis and herpes zoster (shingles). They increase cancer risk through their suppression role on the immune system. As with DMARDs, JAK inhibitors can affect blood counts so can increase risk of anemia, thrombocytopaenia, and neutropaenia. Pre-treatment screening and ongoing monitoring for TB and hepatitis B and of LFTs and FBC are required; periodic examination for skin cancer, especially in those at risk; monitoring for infections, including herpes zoster (especially in the elderly) and lipids is advised; and patients are advised to seek medical attention if symptoms suggestive of infections occur. JAK inhibitors have a shorter half-life than other DMARDs, so negative symptoms can be reversed relatively quickly if they need to be stopped due to negative effects.

TAPERING THERAPY Current guidelines suggest that rheumatologists should consider tapering treatment six months after achieving the treatment target. The suggested order of tapering is: 1) Glucocorticoids, such as prednisolone; 2) Biological DMARDs; and 3) Conventional DMARDs such as methotrexate. Glucocorticoids should be dosereduced and discontinued typically within six months initially. When tapering a biological DMARD, the dose should be reduced rather than stopped suddenly, due to the significantly higher rate of flareups with sudden discontinuation. Therapy with the conventional DMARD (ie, Methotrexate) should continue while the biological DMARD is being reduced; patients should be educated on the need for urgent re-evaluation by their rheumatologist at the early signs of an RA flare-up. In general, medication-free remission is not sustained in patients with RA; two out of three patients who stop all treatment, including methotrexate, experience flares within a year. l References on request

43

IN FOCUS | Cardiology

C U R R E N T T R E ATM E N TS I N

HYPERTENSION

EAMONN BRADY MPSI PROVIDES AN OVERVIEW OF THE VARIOUS FACTORS TO BE CONSIDERED IN ASSESSING AND MANAGING HYPERTENSION

C

ardiovascular disease (CVD) is the number-one cause of death worldwide. Hypertension is the leading cause of CVD; it is responsible for 51 per cent of total global mortality from stroke and 45 per cent of mortality from ischaemic heart disease.

The amount of adults with raised blood pressure increased from 594 million in 1975 to 1.13 billion in 2015. In Ireland, CVD is responsible for approximately 10,000 deaths each year, which is equivalent to 36 per cent of all deaths.

According to a study by TILDA in 2015, hypertension (high blood pressure) affects up to 64 per cent of the over-50s in Ireland.

Hypertension is generally asymptomatic, therefore routine checks are essential, especially for those over 50. Blood pressure was traditionally measured with a sphygmomanometer, which used the height of a column of mercury to reflect the circulating pressure. Today, BP values are still reported in millimetres of mercury (mmHg), though aneroid and electronic devices do not use mercury.

CAUSES

The cause of hypertension in 90-to-95 per cent of all cases is unknown, known as ‘primary hypertension’. Secondary high blood pressure is hypertension that is caused by a known medical condition (rare). Secondary hypertension can be caused by adrenal disease, ie, Cushing syndrome, kidney disease and the use of some medications, such

44

relaxes and the ventricles can refill with blood. Both diastolic and systolic pressure are important risk factors for CVD. Historically, greater emphasis was placed on diastolic values, but systolic is now considered the better predictor of CVD risk. 120mmHg systolic and 80mmHg diastolic is considered normal blood pressure. SBP continues to increase between the ages of 30 and 84 and over, while DBP increases until the age of 60, then decreases until at least 84 years of age. Isolated systolic hypertension (elevated systolic but not diastolic pressure) is the most prevalent type of hypertension in those aged 50 and over. as NSAIDs (ibuprofen and diclofenac), steroids, amphetamines and cocaine.

There is evidence that hypertension runs in families, but this can also be due to behavioural reasons learned or acquired from families, such as heavy drinking. Race can also influence high blood pressure. For example, there is a much higher incidence of hypertension in the black African and African-Caribbean population.

SYSTOLIC AND DIASTOLIC BLOOD PRESSURE

The systolic blood pressure (SBP) is the top number on the reading. It is the peak pressure of blood in the arteries as the ventricles pump blood out of the heart to the rest of the body. Diastolic blood pressure (DBP) is the bottom number on the reading. It is the minimum pressure in the arteries as the heart

MEASURING HYPERTENSION

The most accurate method of measuring blood pressure is the use of upper-arm monitors. Healthcare providers must ensure monitors are regularly recalibrated and maintained. Allow the patient to sit comfortably for five-to-10 minutes in a quiet room before measuring his/her blood pressure.

Make sure the cuff is the correct size. Ensure clothing does not restrict the arm, ie, place the cuff on bare skin, not clothing. If the arm tightens with rolled-up clothing, the arm may need to be slipped out of a sleeve.

The patient should sit with back straight and supported; legs not crossed and have had no caffeine, tobacco and alcohol within the previous half hour. The arm should be positioned at heart height, ie, sitting on a chair with arm resting on table, the palm of the hand facing upwards. Blood pressure should

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Cardiology | IN FOCUS

be measured in both arms as many patients, especially the elderly, have different readings between arms. If the difference between the two readings remains more than 15mmHg on the second reading, measure subsequent blood pressure in the arm with higher readings for subsequent measurements. If the difference is greater than 10mmhg for diastolic and 15mmHg for systolic on three readings, the patient should be referred for further evaluation. There is recent evidence that suggests a small difference in arm blood pressure is associated with a higher risk of cardiovascular events. Heart rate should also be recorded, as resting heart rate is another predictor of CVD fatal events.

In patients with different symptoms of postural hypotension, including postural dizziness or falls, if they have type 2 diabetes and are 80 years or older, firstly measure their blood pressure seated and allow the patient to stand for at least one minute then repeat a seated measurement.

consumption of oily fish, fruit and vegetables can reduce this high risk. The WHO has estimated that 2.5 million deaths could be prevented every year if the consumption of salt was decreased to the recommended daily allowance.  Alcohol — Over-consumption of alcohol can damage heart muscles and increase the risk of CVD. Women should consume no more than two standard units per day and no more than three per day in males.

RISK FACTORS

Non-modifiable risk factors are those that can’t be controlled.  Age — The risk of stroke doubles after the age of 55.  Gender — Men have a greater risk of CVD than pre-menopausal women. Once a woman is past menopause, the risk is the same as a man.  Genetics — Family history of CVD is a high risk. If a person’s parents have suffered from CVD, it can increase their risk by 50 per cent.  Diabetes — Two-to-four times more likely to get CVD than a person who does not have diabetes.  Socioeconomic status — Being poor has an impact on stress, anxiety and depression, which increases the risk.  Ethnicity — Those of African ancestry have a higher risk than any other ethnicity.

Hypertension increases the risk of CVD. Evidence also suggests that high blood pressure can predispose people to the development of cognitive impairment, dementia, kidney damage, eye damage and sexual dysfunction.

LIFESTYLE RISK FACTORS FOR CVD (MODIFIABLE)

Smoking — makes the blood thicker, therefore causes clots inside the arteries and veins. If a smoker quits, it decreases cardiovascular risk close to the risk of a person who has never smoked.  Physical Inactivity — the WHO believes that 60 per cent of the world is not active.

There is evidence that doing more than two hours and 30 minutes of moderate physical exercise weekly, ie, brisk walking or an hour of vigorous physical activity every day, can reduce the risk of CVD by 30 per cent.  Obesity — There are 400 million people worldwide who are obese and one billion who are overweight. Obesity leads to hypertension, atherosclerosis, diabetes, etc, which puts one at a greater risk of CVD.  High fat and sodium diet — A diet high in saturated fat is estimated to cause 31 per cent of coronary heart disease and 11 per cent of strokes worldwide. Increased 

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If a person’s parents have suffered from CVD, it can increase their risk by 50 per cent NON-MODIFIABLE RISK FACTORS

CALCULATING CARDIOVASCULAR DISEASE RISK Systematic coronary risk estimation (SCORE) estimates the 10-year risk of fatal cardiovascular disease, assists in making logical decisions and can help to avoid over-treatment and under-treatment.

SCORE is estimated by investigating modifiable and non-modifiable risk factors a

person may have.

As shown in Figure 1, those at low-tomoderate risk may be given lifestyle advice to maintain, while high-risk persons may be candidates for lifestyle advice as well as drug treatments. If a person is in the very highrisk category, drug treatment is usually the required course of action.

That being said, people over the age of 60 should be interpreted more leniently, as age is a non-modifiable risk. CVD risk guidelines are available at the back of the BNF. A commonly used chart is the Joint British Societies Cardiovascular Disease Risk Prediction Chart.

All adults over 40 and younger adults with a family history of premature CVD should have their CVD risk formally calculated.

Men are at a higher CVD risk than women because women’s risks are deferred for 10 years, not avoided. It is important to note that the CVD risk guidelines have only been validated on white Caucasians and therefore should be used in caution for other races.

For example, patients from the Indian subcontinent will have a CVD risk of about 1.4 times that predicted by the charts.

There is no need to use CVD risk charts for those with diabetes, as most people with diabetes will have a 10-year CVD risk of ≥20%.

The QRISK3 tool can be used to test CVD risk in people with type 2 diabetes and others under the age of 84. QRISK3 is a well-established calculator that estimates the risk for CVD in the next 10 years.

DIAGNOSIS OF HYPERTENSION All adults should have their BP measured routinely every five years. Readings should be taken more frequently in those who have had high normal readings or higher in the

RISK CATEGORIES

SYSTEMATIC CORONARY RISK ESTIMATION (10 YEAR)

Very high risk

≥10%

High risk

≥5% & <10%

Moderate risk

>1% & <5%

Low risk

<1%

FIGURE 1: Risk assessment

45

IN FOCUS | Cardiology

past. The 2018 European Society of Hypertension – European Society of Cardiology classification of BP is outlined in Figure 2. A diagnosis of hypertension should be based on multiple clinic readings taken on separate occasions because blood pressure can vary throughout the day and can be raised by white coat and/or masked hypertension.

Research suggests that clinic systolic blood pressure (SBP) measurements can be 5-15mmHg higher than SBP levels obtained by ambulatory blood pressure monitoring (ABMP) and home blood pressure monitoring (HBPM). Therefore, ABMP and HBPM can give more accurate readings.

AMBULATORY BLOOD PRESSURE MONITORING (ABPM) If a patient’s clinical blood pressure is between 140mmHg/90mmHg-180mmHg/90mmHg, ABPM may be offered. ABPM is better known as 24-hour BP monitoring. ABPM is the most preferred method of diagnosis because of its efficiency and accuracy.  Make sure there are two measurements taken per waking hour, ie, 8am and 10pm.  Use the mean value of 14 measurements throughout the person’s usual waking hours to ensure an accurate diagnosis of hypertension.

HOME BLOOD PRESSURE MONITORING (HBPM) If ABPM is not suitable for a person, HBPM can be used instead as an alternative to di-

agnose hypertension.  The person must record two consecutive readings one minute apart, while the person is seated.  Record blood pressure morning and evening, for four-to-seven days.  The measurements for the first day may be discarded and the mean of the other recorded days are used to confirm hypertension.

If a patient has severe hypertension (180/120mmHg or higher), immediate treatment must be considered, without waiting for ABPM and HBPM results. If there are no signs of target organ damage, a clinic blood pressure measurement must be carried out again within seven days.

All hypertensive patients should have a thorough history and physical examination, assessing for evidence of target organ damage and potential causes of secondary hypertension. A formal CVD risk assessment must be carried out, ie, QRISK3.

Routine investigations should include urinalysis (protein and blood), serum creatinine and electrolytes, blood glucose, serum total, haemoglobin, HDL cholesterol and a 12- lead ECG.

TREATMENT The goal of treating hypertension is to achieve the maximum reduction in the risk of cardiovascular morbidity and mortality.

CATEGORY

SYSTOLIC BP MMHG

DIASTOLIC BP MMHG

Optimal

<120

<80

Normal

120-129

80-84

High normal

130-139

85-89

Hypertension mild/stage 1

140-159

90-99

Hypertension moderate/stage 2

160-179

100-109

Hypertension severe/stage 3

≥180

≥110

Isolated systolic hypertension

≥140

<90

FIGURE 2: Classification

46

NON-PHARMACOLOGICAL MEASURES WHICH LOWER BP Weight reduction, reduction of excessive alcohol intake (to <17 units/week for men and to <11 units/week for women), reduction of salt intake (to <5g/day ≈ 1 teaspoon), decrease caffeine consumption, decrease saturated and total fat intake, an increase in fruit and vegetable consumption and regular dynamic physical exercise all lower BP. Additional factors that reduce CVD risk include cessation of smoking, replacement of saturated fats with mono-unsaturated fats, and increased oily fish consumption. Effective implementation of these measures requires enthusiasm, knowledge, patience, and considerable time. It should also be backed-up with simple, clear, written information. If drug therapy is required, all these measures should be continued in parallel.

PHARMACOLOGICAL TREATMENT Studies have shown that antihypertensive treatment causes a significant reduction in mortality for cardiovascular events. The reduction in cardiovascular risk is relative to the fall in hypertension rather than the types of hypertensive drugs used. The reduction in cardiovascular risk is relative to the fall in hypertension rather than the types of hypertensive drugs used. Trials have shown that lowering blood pressure achieves a 35-to-40 per cent risk reduction for stroke, a 20-to-25 per cent reduction for myocardial infarction, and a 50 per cent reduction for heart failure.

WHEN TO INITIATE TREATMENT? Treat all those with sustained blood pressure of ≥160/100mmHg. Treat all those with borderline blood pressures (Grade 1 hypertension) of 140-159mmHg systolic or 90-99mmHg diastolic if they also fall into one of the following categories: 1. Presence of cardiovascular disease.

2. Presence of target organ damage, ie, kidney damage, heart failure, retinopathy (eye damage).

3. Patient has diabetes.

Those with a greater than 20 per cent risk of having a cardiovascular event over the next 10 years, ie, ≥5% risk of dying from CVD over the next 10 years.

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C

M

Y

CM

MY

CY

CMY

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Konverge Plus is indicated for the treatment of essential hypertension as an add on therapy in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. Konverge Plus is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine).

Legal Category: POM. Marketing Authorisation Number: PA 865/19/1-5. Marketed by: A. Menarini Pharmaceuticals Ireland. Further information: Available on request from A. Menarini Pharmaceuticals Ireland Ltd, Castlecourt, Monkstown Farm, Monkstown, Co. Dublin or may be found in the SmPC available at www.medicines.ie Date of Item: March 2021 Item Code: IR-KON-06-2021

IN FOCUS | Cardiology

CLINIC BP (MMHG)

(NICE) RECOMMENDATION

<140/90

Check BP ever five years, more if closer to 140/90mmHg.

140/90-179/119

Offer ABPM (HBPM if ABPM is not suitable).Assess CVD risk.

Investigate organ damage.

≥180/120

Assess organ damage, consider immediate treatment, repeat clinic BP within seven days if no organ damage is detected.

Same day referral if signs of life-threatening symptoms, retinal haemorrhage or papilloedema.

Clinical judgement to be used for people with frailty and multimorbidity.

Figure 3: NICE recommendations 1

ABPM OR HBPM (MMHG)

(NICE) RECOMMENDATION

<135/85

Check every five years, more if closer to 140/90mmHg. If evidence of target organ damage, consider different causes.

135/85-149/94 (stage 1)

Age >80 with clinic BP >150/90mmHg — lifestyle advice should be offered, and treatment considered.

Age <80 with CVD, diabetes, renal disease, target organ damage or a 10-year CVD risk ≥10% lifestyle advice should be offered and discuss treatment.

Age <60 with CVD risk <10% — lifestyle advice should be offered and discuss treatment.

Age <40 — specialist evaluation.

≥150/95 (stage 2)

Lifestyle advice and treatment should be discussed.

Age <40 — specialist evaluation

FIGURE 4: NICE recommendations 2

TYPES OF MEDICATION

Angiotensin converting enzyme (ACE) inhibitors: Reduce blood pressure by relaxing the blood vessels. Adverse effects include hypotension (may be profound after the first dose, especially in those with heart failure and renovascular disease), persistent dry cough (5-to-35 per cent), hyperkalaemia (caution with co-prescription with potassium-sparing diuretics or NSAIDs), and angio-oedema (condition that causes swelling of face and tongue).

They are contraindicated in patients with renovascular disease and should be avoided in women of childbearing potential. ACE inhibitors may also be prescribed for heart failure, diabetic nephropathy and chronic renal failure. ACE inhibitors, for which there

48

are generics available and can be given once-daily, include Ramipril and Lisinopril, making them very popular.

The incidence of cough appears to be higher in women. It is a persistent dry cough which is worse when lying down and generally doesn’t start for 24 hours after starting an ACE inhibitor.

Calcium channel blockers (CCBs): There are two types, the longer-acting dihydropyridine CCBs (nifedipine (modified release), amlodipine), and non-dihydropyridine agents (diltiazem, verapamil).

Side-effects of the dihydropyridine CCBs include peripheral oedema, flushing and headache. The non-dihydropyridine CCBs should be avoided in patients with heart failure and

used with caution in combination with betablockers. Amlodipine and lercanidipine are the most commonly used CCBs because they only need to be taken once daily and have fewer side-effects and interactions than non-dihydropyridine CCBs. Thiazide diuretics: Anti-hypertensive effect is gradual in onset and persists for up to 24 hours. Erectile dysfunction (reversible on discontinuation) is a side-effect in men.

High doses cause potassium levels to fall (hypokalaemia), uric acid levels to rise (increasing risk of gout), glucose levels to rise, leading to risk of diabetes (particularly in combination with a beta blocker), and lipids such as cholesterol to rise. High doses have no advantage in blood pressure control and should not be used.

Diuretics should be avoided in patients on lithium therapy and those suffering from gout. Thiazides can also be prescribed for heart failure. Higher doses are generally used to treat heart failure; therefore, stronger loop diuretics such as furosemide are more often used for heart failure. Hypokalaemia is rarely seen with thiazide diuretics, as the dose used for hypertension is low and they are often given in combination with drugs that increase potassium, ie, ACE inhibitors or angiotensin 2 inhibitors. However, careful monitoring of patients taking digoxin is required due to the risks of digoxin toxicity if hypokalaemia occurs. To gain maximum benefits from a diuretic, sodium restriction is advised, ie, reduced salt in diet (less than 6g per day).

Studies have shown that low-dose thiazides reduce most morbidity and mortality outcomes in patients with moderate-to-severe hypertension.

Angiotensin II receptor inhibitors (ARBs): They have similar indications, efficacy, cautions and side-effects as ACE inhibitors, but have a reduced incidence of cough and angio-oedema due to the lack of an effect on the kinin system. They are a popular alternative to ACE inhibitors as they don’t cause a cough. As with ACE inhibitors, ARBs may be prescribed for heart failure and diabetic nephropathy.

Alpha-blockers: They are generally used in combination with other agents, particularly in patients with other problems such as prostatism (prostate problems

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IN FOCUS | Cardiology

that affect 40 per cent of older men), type 2 diabetes and high cholesterol. They have modest lipid profile benefits (ie, reduce total cholesterol, LDL, total triglycerides and increase in HDL). Short-acting agents are associated with postural hypotension and are best avoided in patients with heart failure, ie, doxazosin, alfuzosin.

Beta blockers: NICE has stated that beta-blockers should no longer be routine first-line agents in hypertension. This decision is based on the evidence that the most used beta-blockers at usual doses carries high risk of provoking type 2 diabetes.

Beta blockers also are less effective in older or black African patients.

However, beta blockers can still be considered in the treatment of hypertension in cases which include younger patients, particularly those who cannot tolerate ACE inhibitors and angiotensin 11 inhibitors, women of childbearing age and patients with an increased sympathetic drive. Some patients have a compelling reason for using beta blockers, ie, angina, myocardial infarction and heart failure.

The above guidelines are not intended to be strictly adhered to; they are intended to give prescribers some guidance.

Adverse effects include lethargy, bradycardia (slow heart beat), cold hands and feet, worsening of symptoms of peripheral vascular disease and Raynaud’s syndrome, CNS effects such as impaired concentration and memory, vivid dreams (these are less frequent with the water-soluble beta-blockers

such as atenolol and sotalol), aches in limbs, fatigue during exercise and metabolic effects (increased triglycerides, reduced HDL cholesterol). They are contraindicated in asthma.

Direct renin inhibitor: Aliskiren (Rasilez) was launched in the last 15 years.

It works on the renin-angiotensin system in a slightly different way from ACE inhibitors and ARBs. A Drug and Therapeutics bulletin concluded that there is no evidence to justify replacing an ARB or ABE with aliskiren in patients with kidney disease, diabetes or heart failure. Other studies indicate its benefits do not outweigh the risks of taking aliskiren.

Aldosterone antagonists: Block the hormone aldosterone, which can cause fluid and salt retention, which in turn contributes to high blood pressure. They can increase potassium levels, which can cause muscle weakness, a low heart rate and fatigue.

Other side-effects include dizziness, dry mouth, skin rash and stomach upset. These medications are usually used in conjunction with other drugs. They are prescribed in Step 4 (Figure 5) of treatment, ie, spironolactone and eplerenone.

Centrally-acting agents: Methyldopa can be used during pregnancy; it is otherwise rarely used as it is poorly tolerated. Methyldopa causes dizziness, drowsiness, headache, dry mouth, stuffy nose, confusion and depression.

Other vasodilators: Hydralazine, minoxidil and sodium nitroprusside all directly relax smooth muscle and can

rapidly reduce BP. Should be reserved for use under hospital supervision to treat hypertensive crisis.

CHOOSING MEDICATION The choice of agent is determined by many factors, which include:  The cardiovascular risk profile of the patient.  The presence of other conditions, including cardiovascular disease, diabetes, renal disease and benign prostatic hypertrophy.  The patient’s previous response to anti-hypertensive drugs (favourable or unfavourable).  The cost of drugs.  Interactions with medication the patient is taking for other conditions.  If a woman is of childbearing age, is considering pregnancy, pregnant or breastfeeding.

NICE has (Hypertension in Adults: Diagnosis and Management, 2019) created an updated summary of the previous work on recommended treatment by the BIHS (formerly BHS), as seen in Figure 5 below.

According to MHRA drug safety updates, ACE inhibitors and angiotensin-II receptor antagonists (ARB) are not recommended for women planning pregnancy. When choosing an antihypertensive medication for black African or AfricanCaribbean adults, consider an angiotensin-II receptor antagonist (ARB), in preference to an angiotensin-converting enzyme (ACE) inhibitor.

TREATMENT

TYPE 2 DIABETES (ANY FAMILY ORIGIN)

AGE <55 (NOT BLACK AFRICIAN OR AFRICAN CARIBBEAN)

AGE ≥ 55

BLACK AFRICAN OR AFRICIAN CARIBBEAN

STEP 1

ACEi or ARB

ACEi or ARB

CCB

CCB

STEP 2

ACEi or ARB + CCB or thiazide-diuretic

ACEi or ARB + CCB or thiazide-diuretic

CCB + ACEi or ARB or thiazide-diuretic

CCB + ACEi or ARB or thiazide-diuretic

STEP 3

ACEI or ARB + CCB + thiazide-diuretic

STEP 4

Confirmation of resistant hypertension: Check for postural hypotension and confirm elevated BP with ABPM or HBPM. Consider seeking expert advice or adding: (1) a Beta blocker or alpha blocker if blood potassium is >4.5mmol/l or (2) a low dose of spironolactone if blood potassium is ≤4.5mmol/l.

Figure 5: Treatment options

50

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Cardiology | IN FOCUS

BLOOD PRESSURE TARGETS WITH TREATMENT Blood pressure must be reduced and maintained at the following targets:  Age <80 years — Clinical BP <140/90mmHg & ABPM/HBPM <135/85mmHg.  Age ≥80 years — Clinical BP <150/90mmHg & ABPM/HBPM <145/85mmHg.  Pregnant — Clinical BP 135/85mmHg.

INTERACTIONS OF OTC MEDICATIONS WITH HYPERTENSIVE DRUGS

NSAIDs Ibuprofen is probably the most clinically significant OTC interaction with anti-hypertensive agents. Ibuprofen (and all other NSAIDs) can increase systolic blood pressure by as much as 5-10mmHg due to fluid and salt retention. Paracetamol-based analgesics are safer in hypertensive patients.

Decongestants Pseudoephedrine and phenylephrine (ie, Sudafed, Actifed) are best avoided in hypertensive patients as they cause a short-term increase in blood pressure.

Antacids Some antacids such as Gaviscon have high sodium content and if used on a regular basis, can cause fluid retentions and reduce the effects of antihypertensive drugs. Low-sodium antacids such as Maalox are a better alternative for hypertensive patients. Bear in mind that Maalox does not have the same alginate protective coating effect on the oesophagus as alginate-based antacids like Gaviscon; it’s about balancing benefits and risks.

SPECIAL PATIENT GROUPS

Elderly Hypertension becomes more common with age. More than 60 per cent of overall cases of hypertension are prevalent in people over the age of 60. As our world population ages, the increase of sedentary lifestyles leads to higher body weight and therefore the rise of hypertension. Studies have estimated that there will be a 15-to-20 per cent worldwide increase of reported hypertension by 2025, reaching 1.5 billion cases. Isolated systolic hypertension (ISH) is mostly prevalent in people over 50; it is caused by arteriosclerosis and fatty

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deposits on walls of arterial blood vessels.

ISH is evident in 60-to-75 per cent of cases of hypertension in elderly people. It includes the rising of SBP, while DBP stays the same or even declines. Elderly patients should be advised about the modifiable measures. Most elderly people with hypertension need drug therapy. Studies include that monotherapy only met blood pressure targets in 40-to-50 per cent of cases, so drug combinations are often required. The addition of one or two other hypertension medications have proven to reduce the side-effects of the first one. Initiation of therapy should be gradual, especially in frail individuals. The HYVET study in 2008 showed that older patients with hypertension will benefit from hypertensive therapy much more than younger patients because of a greater absolute risk. The HYVET study showed a significant reduction in deaths in elderly patients using anti-hypertensive drugs. Thiazide diuretics and the dihydropyridine CCBs are particularly effective in older patients and in those with ISH.

Ibuprofen is probably the most clinically significant OTC interaction with antihypertensive agents Diabetes The co-existence of hypertension and diabetes mellitus (either type 1/2) substantially increases the risk of complications, including stroke, coronary heart disease, congestive heart failure and peripheral vascular disease and increases cardiovascular mortality. For example, type 2 diabetics have a two-to-four fold higher risk of developing coronary heart disease and CVD accounts for 65-to-75 per cent of deaths in people with diabetes. The development of hypertension may be due to the onset of diabetic nephropathy in type 1 diabetics. In both type 1 and 2, the threshold for starting treatment is BP ≥140/90mmHg. Previously, the blood pressure treatment target for diabetics was <130/80mmHg if there were

signs of kidney damage. In 2019, NICE updated these recommendations, as there was no sufficient evidence to suggest that lower blood pressure targets for diabetics reduced the rate of CVD. Therefore, people with diabetes (with signs of kidney disease) now have the same blood pressure targets as people who do not have diabetes. Evidence supports the use of many drugs, particularly the ACE inhibitors or ARBs. Maintaining normal BP with the use of ACE inhibitors or ARBs reduces the rate of decline in renal function. NICE advises that the first-line antihypertensive drug for type 2 diabetes should be a once-daily generic ACE inhibitor, ie, Lisinopril, Ramipril or an ARB, ie, Losartan or Irbesartan.

Pregnancy Women may have pregnancy-induced hypertension, ie, hypertension which develops after the 20th week of pregnancy. The most worrying form of hypertension in pregnancy is pre-eclampsia, a potentially life-threatening condition. Rest remains the integral part of the management of hypertension in pregnancy. Most anti-hypertensive drugs are contraindicated in pregnancy. ACE inhibitors and angiotensin II inhibitors are particularly teratogenic, so must be avoided.

The first treatment for pre-eclampsia is labetalol. If labetalol is not suitable, nifedipine is recommended and if labetalol and nifedipine are not suitable, methyldopa is recommended. The best choice is based on preexisting treatment, side-effects, foetal risks and the woman’s preference. A once-daily dose is more suitable for a pregnant person.

Aspirin 75-150mg once daily can be offered from 12 weeks for a woman with chronic hypertension. NICE 2019 has stated that the blood pressure target for a pregnant woman is 135/85mmHg. l References on request

Disclaimer: Brands mentioned in this article are meant as examples only and not meant as preference to other brands.

Written by Eamonn Brady (Pharmacist), Whelehans Pharmacies, 38 Pearse St and Clonmore, Mullingar. Tel 04493 34591 (Pearse St) or 04493 10266 (Clonmore). www.whelehans.ie.

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Allergic rhinitis | IN FOCUS

M A N AG E M E N T O F

ALLERGIC RHINITIS EAMONN BRADY MPSI PROVIDES AN OVERVIEW OF ALLERGIC RHINITIS, INCLUDING DIAGNOSIS AND TREATMENT OPTIONS

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llergic rhinitis is inflammation of the nasal passages caused by an allergen, such as pollen, dust, mould, or skin flakes from certain animals. Hay fever is a type of allergic rhinitis caused by pollen or spores. Hay fever affects the nose, sinuses, throat, and eyes.

Hay fever usually occurs during the spring and summer months.

Exactly when it occurs depends on which pollens the person is allergic to. From May to July, grass and flowers are in pollen, so this is the most common time for hay fever. The most common type of allergic rhinitis is hay fever, so I will refer to hay fever commonly in this article.

Trees, grass, and plants release pollen as part of their reproductive process.

Mould and fungi also release tiny reproductive particles, called spores, which also cause allergies. People with hay fever can experience symptoms at various times of the year, depending on which pollens or spores they are allergic to. Grass is the commonest allergen implicated with symptoms of hayfever.

Hay fever is a common condition that affects around 20 per cent of the population. Hay fever is more likely if there is a family history of aller-

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gies, particularly asthma or eczema.

It is estimated that up to 50 per cent of asthmatics and up to 30 per cent of eczema sufferers also have allergic rhinitis. Hay fever usually begins in the early teens and peaks when a person is in their twenties.

SYMPTOMS

Symptoms of hay fever include sneezing, running nose, watery eyes, nasal congestion, itching in the throat, eyes and ears and swelling around the eyes. Patients with asthma often find that asthma symptoms, such as wheezing and breathlessness, get worse when they have hay fever as well. Sometimes, asthma symptoms only occur during the hay fever season.

ALLERGIC REACTION

Allergic rhinitis is an autoimmune condition, so symptoms occur when the immune system overreacts to a normally harmless substance, ie, pollen. When the body encounters an allergen, cells in the lining of the nose, mouth and eyes release histamine, triggering symptoms of an allergic reaction.

PROGNOSIS

Hay fever cannot be cured completely.

Data suggests children sometimes improve with age, although many have persistent and worsening symptoms. In

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IN FOCUS | Allergic rhinitis

adults, the condition is usually persistent, with some improvement in older age.

Hay fever can cause serious symptoms if left untreated. Total nasal obstruction may cause sleep apnoea, frequent sinus infections, interference with daytime breathing and ear infections.

Seasonal vs perennial hay fever — If allergen exposure is seasonal, the most likely culprits are tree, flower and grass pollen and the symptoms are predictable and reproducible. Seasonal allergic rhinitis may therefore be diagnosed by the history alone.

By comparison, classic perennial allergic rhinitis is associated with nasal symptoms, which occur for more than two hours per day and for more than nine months of the year. Perennial allergic rhinitis usually reflects allergy to indoor allergens like dust mites and animal fur. In perennial allergic rhinitis, nasal congestion is common while itchy and streaming eyes is less frequent.6 Pollen count — Hay fever symptoms are likely to be worse if the pollen count is high. This is not determined simply by how many flowers there are, but also by the weather. The amount of sunshine, rain or wind affects how much pollen plants release. Hay fever symptoms tend to begin when the pollen count is over 50. The pollen count is highest in the early evening, so hay fever sufferers are advised to avoid going outdoors at this time. On humid and windy days, pollen spreads easily. On rainy days, pollen may be cleared from the air, causing levels to fall.

DIAGNOSIS To determine if a patient has allergic rhinitis, the doctor will ask questions to determine the cause and type of allergy, including the time of day and year the rhinitis occurs (to distinguish seasonal and perennial rhinitis), family history of allergies, medical history, information about medication used, including decongestants, which can cause a rebound effect, and information on pets.

The doctor will examine the inside of the nose with an instrument called a speculum. The eyes, ears, and chest may also be examined.

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Skin tests may be performed. Patients are usually tested for a panel of common allergens. Skin tests are rarely needed to diagnose mild seasonal allergic rhinitis, since the cause is usually obvious. The skin test is not appropriate for children younger than age three. Patients should not take antihistamines for 12-to-72 hours prior to the skin test, otherwise the allergy will not show up. Tiny amounts of suspected allergens are applied to the skin with a needle prick or scratch. The patient is tested with selected diagnostic vaccines of tree, grass, or weed pollen, mould, house dust mite, and/or animal allergens.

A hive will develop at skin test site within 20 minutes if there is an allergy. Skin al-

Hay fever can cause serious symptoms if left untreated lergy tests are popular because they are convenient and inexpensive. They are not 100 per cent accurate.

The doctor may take a nasal smear.

The nasal secretion is examined microscopically for factors that might indicate a cause, such as increased numbers of white blood cells, indicating infection, or high eosinophil count. High eosinophil counts indicate an allergic condition.

Blood tests for IgE immunoglobulin production may also be performed. One test is called the radioallergosorbent test (RAST), used to detect increased levels of allergen specific IgE in response to particular allergens. Further tests may involve a CT scan or a nasal endoscope.

TREATMENT People suffering from hay fever need to try to reduce explosive to triggers such as pollen and dust. I will deal with tips on how to reduce exposure to triggers later in this article. As total avoidance of triggers is impossible, medication is often needed to control symptoms. Treatment in advance

of first symptoms is an important aspect of management of hay fever. For example, starting treatment in April, prior to the normal summer increase in pollen count. There are many treatments available to relieve the symptoms. These include antihistamine tablets, nasal sprays, and eye drops. Some can only be prescribed by a GP, but many are available over the counter (OTC) in pharmacies.

ANTIHISTAMINES Antihistamines are the most frequently used oral medicines for the treatment of hay fever. Many are available without prescription and are a reasonable firstline choice for many patients. They are effective in relieving eye symptoms, runny nose, sneezing and nasal irritation but have negligible effect on nasal congestion.

Antihistamines are useful in patients with troublesome symptoms at multiple sites, ie, itching of roof of the mouth, throat, or eyes. However, antihistamines may have side-effects and drug interactions.

There are two main groups of antihistamines: First generation and second generation.  First-generation antihistamines (‘Sedative’) Sedation is the most common side-effect of these drugs and may affect the patient’s ability to drive and operate machinery and concentrate. They should not be used in patients with prostatic hypertrophy or narrow angle glaucoma. Tolerance to their side-effects may develop. Chlorpheniramine (Piriton) is available OTC in pharmacies. Chlorpheniramine can cause mild drowsiness.  Second-generation antihistamines. (‘Non-sedative’) Examples include desloratadine, fexofenadine, levocetirizine, loratadine and cetirizine. They only require once-daily dosage and are non-drowsy. Loratadine and cetirizine have long been available OTC without prescription. As of 2021, fexofenadine 120mg (Telfast) is available without prescription OTC in pharmacies in consultation with a pharmacist. The non-sedating antihistamines are fast acting, have no reported cardiac side-effects,

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IN FOCUS | Allergic rhinitis

and are not affected by the presence of food in the stomach. However, loratidine is best avoided in elderly patients and patients with liver problems.

DECONGESTANTS Decongestants have a limited role in hay fever and should be reserved for periods of severe nasal congestion.

Nasal decongestants sprays and drops such as Xylometazoline (ie, Otrivine) should not be used for longer than threeto-five days because of the possibility of rebound congestion, which makes the problem worse.

CORTICOSTEROIDS Nasal drops and sprays reduce inflammation and swelling of the nasal mucosa and in normal dosage side-effects are minimal. It is best to start treatment a few weeks before the season begins. All corticosteroid nasal sprays appear to have similar efficacy. Fluticasone (ie, Nasofen), beclomethasone (ie, Beconase), Triamcinolone (ie, Nasocort) Mometasone (ie, Nasonex) are the most regularly used. People find the once-daily dosage regimen of Fluticasone, Triamcinolone and Mometasone convenient.

Side-effects are mild and transient and consist of nasal irritation and stinging, dryness, sneezing, sore throat, nose bleeds and fungal overgrowth. They should be avoided during nasal infections. Flixonase and Beconase are available to buy OTC in pharmacies. Oral steroids, ie, prednisolone or depot injections, ie, triamcinolone (Kenalog) are only prescribed for certain groups of patients, such as those doing exams or those with severe continuous symptoms despite adequate standard therapies.

OTHERS Ipratropium bromide nasal spray (ie, Rinatec) may be prescribed where running nose is the predominant symptom.

It does not relieve itching, sneezing or nasal blockage.

Azelastine (ie, Rhinolast) is a prescription-only nasal antihistamine spray with a rapid onset of action. It may provide an

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effective and safe alternative to oral medications. Otrivine Antistin eye drops are fast-acting antihistamine eye drops available OTC.

HAY FEVER AND PREGNANCY Topical corticosteroids (sprays and drops) should be used in preference to antihistamine tablets if drug treatment is needed. Topical corticosteroids can be used but high doses of oral corticosteroids should be avoided. Sodium cromoglycate is safe to use. The sedating antihistamines, chlorpheniramine (Piriton) and promethazine (Phenergan) may be prescribed in severe cases and only if topical treatment is ineffective.

IMMUNOTHERAPY Immunotherapy is the use of allergen vaccines containing house dust mite, animal fur or extracts of grass or tree pollen. By gradually increasing the patient’s exposure to the allergen that causes the allergy, the patient becomes tolerant to it.

Immunotherapy is only used in patients with severe symptoms and must be done by a specialist. However, long-term relief can be achieved. Grazax is a grass pollen extract available in tablet form which is now available on prescription for patients who have failed to respond to other hay fever treatments. Grazax must be started at least four months before pollen season and should be continued for up to three years.

PREVENTION The pollen count is often given with TV, radio, Internet, or newspaper weather forecasts. If it is humid or windy, the pollen count is likely to be higher. Generally, the pollen count is highest in the early evening, so try to avoid going outside around this time. Keep windows and doors shut in the house if it gets too warm, try drawing the curtains to keep out the sun and keep the temperature down. Avoid cutting grass, playing, walking, or camping in grassy areas. Change clothes and take a shower after being outdoors to remove the pollen from the body. Wear wrap-around sunglasses to stop pollen getting in the eyes when outdoors. Keep car windows

closed and consider buying a pollen filter for the air vents in the car. Keep fresh flowers out of the house, and vacuum (ideally using a machine with a HEPA filter) and damp dust regularly. Do not smoke and stop other people from smoking in your house. Smoke irritates the lining of the nose, eyes, throat, and airways, which can make symptoms worse. Keep pets out of the house during the hay fever season; if pets normally come indoors, wash regularly to remove any pollen.

ALLERGIC RHINITIS AND ITS IMPACT ON ASTHMA (ARIA) GUIDELINES The ARIA guidelines were developed during a World Health Organisation (WHO) workshop in 1999 by a panel of experts.

They were updated in 2008.

The ARIA guidelines have changed the terms that were traditionally used to describe allergic rhinitis. Allergic rhinitis is no longer described as seasonal when it occurs during the summer months and perennial when it occurs all year round.

Instead, allergic rhinitis can either be:  Intermittent: symptoms are present for up to four days a week, or for up to four weeks in a row; or  Persistent: Symptoms are present for more than four days a week, or for more than four weeks in a row.

These terms have been changed to better reflect the reality of people’s symptoms. Previously, ‘seasonal’ used to mean an allergic reaction at a particular time of the year, usually caused by outdoor allergens, such as pollen. Perennial meant that the allergic reaction symptoms lasted all year, and were usually caused by indoor allergens, such as dust mites. Pollens can be present and cause allergic reaction symptoms throughout the year, and those with allergies to all year allergens, such as dust mites, may not have their symptoms all year round. l References on request Written by Eamonn Brady (MPharm) who graduated from School of Pharmacy, Robert University, Aberdeen in 2000 and owns two Whelehans pharmacies in Mullingar.

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FEATURE | Oral health

Covid stress

causes one-in-five Irish people to spend less time on

teeth & oral health A new study has highlighted the effects on patients’ oral health due to the psychological impact of the pandemic

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ovid-19 has impacted Irish people’s oral health, with pandemicrelated stress causing one-fifth of people (20 per cent) to devote less time to oral health, recent research has shown.

The ‘Mind Your Mouth’ survey was published to coincide with World Oral Health Day on 20 March. The research of 1,000 people in Ireland across age, gender, region and socio-economic groupings provided unique insights into the impact of Covid-19 on the nation’s oral health and oral health habits.

One-fifth of respondents said Covid19-related stress meant they were brushing and flossing less, and almost one-third (30 per cent) of those surveyed said they were experiencing teeth-clenching and grinding since the pandemic began. Of those respondents who were grinding and clenching their teeth, 60 per cent attributed these oral health problems to Covid-related stress.

Conversely, the findings also show that 38 per cent of people surveyed said that Covid-19 saw them change their oral health habits for the better, and that 15 per cent of respondents are flossing more, and almost one-quarter (23 per cent) are brushing more. Almost one-fifth of respondents (19 per cent) said the reason that they changed their oral health habits was because they had more free time. This is especially true among younger people, with 33 per cent of 18-to24 year-olds and onequarter (25 per cent) of high-earners saying they have more time.

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AWARENESS The survey also shows that more broadly, there are very high awareness levels across age groups on how to maintain good oral health — 76 per cent of respondents said they are aware of the role that regular flossing and chewing sugar-free gum plays in supporting oral health.

Similarly, almost half (44 per cent) agree that there is a link between chewing sugar-free gum and good oral health, and this connection is best understood among the younger age groups — 55 per cent of 18-to-24 year-olds and 49 per cent of 25-to-34 year-olds.

Commenting on the findings, Dr Catherine Waldron, Postdoctoral Oral Health Researcher, said: “The fact that some people are spending more time brushing and flossing their teeth during Covid-19 is to be welcomed, as are the very high awareness levels of the benefits of brushing, flossing and chewing sugarfree gum to support good oral health.

“However, the survey also shines a light on the impact of pandemic-related stress on our nation’s oral health. It is causing one-fifth of respondents to spend less time brushing and flossing and stress is also a major contributory factor in significant numbers of people who are grind-

ing and clenching their teeth. The message is clear: Even during the pandemic, people should visit their dental hygienist and in between appointments, brush, floss and chew sugar-free gum regularly to maintain good oral health.”

ORAL HEALTH PROGRAMME Concern about contracting Covid-19 isn’t the only factor causing people to delay their visit to the dental hygienist — 32 per cent of respondents said they had delayed due to a lack of available appointments, while 15 per cent of respondents said their financial and work situation was the cause of the delay. This factor rises significantly in the 35-to-44 year grouping, with one-quarter (25 per cent) citing this as a reason for delaying visits.

Ms Linda Phelan, President of the Irish Dental Hygienists’ Association (IDHA), said: “People should visit their dental hygienist regularly for a check-up and in between appointments, we recommend that they followed a balanced, comprehensive oral health programme that includes daily brushing and flossing, eating a healthy diet full of fruit, vegetables and dairy and chewing sugar-free gum for at least 20 minutes after eating and drinking.

“While concerns around contracting Covid-19 are entirely understandable, particularly among older age groups, it is also vitally important that people maintain good oral health throughout the pandemic.

The research was commissioned by Mars Wrigley in partnership with the Irish Dental Hygienists’ Association (IDHA). l

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Book review | LIFESTYLE

Life and death (and the absurd) in a modern hospital TITLE:

The Ministry of Bodies

AUTHOR:

Prof Seamus O’Mahony

PUBLISHER:

Head of Zeus (2021)

REVIEWER:

Prof Brendan Kelly

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any years ago, a physician with whom I trained stopped in the middle of a ward round, turned to the assembled team and made one of his occasional pronouncements. “Modern medicine,” he proclaimed, “is an extraordinary mix of breathtaking efficiency and heart-stopping absurdity.

In the no-man’s land between these extremes, medicine happens. I have no idea how it happens, but it does.” With this, he turned on his heel and shot up the stairs. We trotted after him, suitably mystified.

I have no doubt that this physician would enjoy Prof Seamus O’Mahony’s new book, The Ministry of Bodies. O’Mahony has previously written The Way We Die Now (2016), which won a BMA Book Award, and Can Medicine Be Cured? The Corruption of a Profession (2019).

Both have been acclaimed and translated into different languages.

In The Ministry of Bodies, O’Mahony presents a series of vignettes, stories, reflections and insights into the nature of hospital life, the nature of medicine and — to an extent — the nature of the human condition.

O’Mahony covers this territory with pith and wit, delivering a mix of curiosities, insights, and quiet reflections, laced with a piercing sense of humour.

The book is gripping: I read it over a weekend and laughed aloud repeatedly. If you have ever worked in a hospital, find yourself a copy of this book. Read it at once.

At times, O’Mahony’s tone is not unlike that of Henry Marsh, the celebrated neurosurgeon and author of Do No Harm: Stories of Life,

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Death and Brain Surgery (2014) and Admissions: A Life in Brain Surgery (2017). Marsh also featured in a wonderful movie, The English Surgeon, based on his work with neurosurgeons in the former Soviet Union. Both Marsh and O’Mahony share an unshakable belief in the core values of medicine, a deep commitment to patient care and a distinct distaste for some of the realities of healthcare delivery today. Both are admirable physicians and first-rate writers.

O’Mahony, however, has added a razorsharp sense of the absurd to both this book and his previous one, Can Medicine Be Cured? At one moment, O’Mahony can discuss patient care, just like Marsh does, but a sentence later, O’Mahony’s wit is more akin to that of Adam Kay, the former junior doctor and author of the wildly successful This Is Going to Hurt (2017). Some of the absurdities that O’Mahony highlights are, of course, intrinsic to hospitals, but some feature in all organisations that are large enough to have professional managers.

And, of course, some of the incongruities that O’Mahony identifies are simply part of human nature, writ large in the setting of illness.

There are some hugely important points about medicine here too, amid O’Mahony’s observations about day-to-day care and his unerring instinct for the absurd. I was especially struck by O’Mahony’s comments about his admission to the coronary care unit. O’Mahony “was as weak and dependent as a baby”, but “what surprised me was that I did not rebel against this vulnerability. I simply wanted the doctors and nurses to look after me.” O’Mahony told the doctor “to do whatever he thought was best. It wasn’t that I was indifferent — I was anxious to recover — but I didn’t want information, choices, agency, control; I simply wanted to feel safe, comforted.” That is what we all want when we are sick. It

is a beautiful truth, directly told.

Passages like this make O’Mahony’s book more than a succession of (very) funny anecdotes, more than the cri de coeur of an experienced physician and more than an exceptionally competent exercise in medical writing. No, at its heart, this is a book about how to be a good doctor. The key to this is O’Mahony’s remarkable moral compass, which is in clear evidence as he navigates the perils, pitfalls and extraordinary potential of what many now call ‘healthcare delivery’, but should properly call ‘medicine’.

O’Mahony’s moral compass is focused firmly on his patients: Their needs, their experiences and what we, as doctors, nurses and others, can offer to help. Delivering proper medical care is the beating heart of this narrative. Everything else is judged solely by its relationship to this task, as it should be.

O’Mahony is deeply tolerant of anything that furthers good medical care and deeply sceptical about anything that impedes it or is so far removed as to be irrelevant. His mordant wit is drawn to instances of the latter, but — make no mistake — there is an utterly uncompromised idealist here, beneath the layers of sardonic humour.

Early in the book, O’Mahony writes that young people become doctors for two reasons: “Status and a good living.” Much as he might deny it, O’Mahony proves the precise opposite. This book is driven by a profound commitment to medicine, a passion for communication and a sense of vocation that is as valuable as it is rare. The book is also very, very funny.

More, please. l Prof Brendan Kelly is Professor of Psychiatry at TCD and co-author, with Profs Gautam Gulati and Walter Cullen, of Psychiatry Algorithms for Primary Care (Wiley Blackwell, 2021)

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LIFESTYLE | Motoring

Electric love – e-bikes DR ALAN MORAN LOOKS AT THE INCREASINGLY POPULAR WORLD OF E-BIKES

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bout four years ago I wrote an article on e-bikes that made me a big fish in a small pond. Normally I write about cars (did I tell anyone I love cars?) and have been doing so for over 20 years. But I decided I’d write about the latest upcoming trend, mainly because my wife had bought one and to say she loved it was an understatement. By the way, I have one car, two motorbikes, and four bikes, plus one tandem. So we are a cycling family in a way.

At the time e-bikes were sensible, which means heavy. Bike batteries remain heavy, which any electric car manufacturer will tell you as they spend sleepless nights worrying about the weight of their cars.

With heavy batteries, the bike needs a heavier frame, heavier tyres and heavier brakes. But over the last few years they’ve been using different aluminium alloys and the bikes have become lighter. So much so, it is possible to have one that would be hard to tell from a conventional bike.

HOW THEY WORK Anyway, e-bikes essentially are bicycles that come with motors in three different places: The front hub, the rear hub and the centre. The centre works out best for weight distribution as it is best to have the centre of gravity in the, em, centre. Batteries can be in the back on a carrier, or attached to, (or within, better again) one of the down tubes. Again, the down tubes are best but it means batteries are not as easily interchangeable. Disc brakes, preferably hydraulic, are best. Gears can be derailleur like a racing bike, or hub. Rohloff are the best (and cost about an extra €1,000) but Shimano make a very good second best, for a significantly reduced cost. With

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hub gears it is possible to get an e-bike with a belt drive, a bit like the fan belt of a car. These can last up to 25,000km before they need replacing, unlike chains. And they don’t need chain oil, hence they don’t get messy and greasy, leaving stains on your clothes.

Range is dependent on the size of the battery and how you use it. It is possible to have a battery that will last 80km, but using it on hilly terrain (they don’t recharge going downhill) with max assistance will see it run flat in 30-40km, and then you’ll have a heavy bike to pedal home.

BICYCLE OR MPV? Which brings me to an important point.

Generally, what is available in Ireland is ‘pedal assist’. When you’re pedalling, it assists. Stop pedalling and the help disappears. E-bikes are also available that assist by twisting a throttle, rather like a motorbike. Some members of An Garda Síochána will argue that a pedal assist bike is a mechanically-propelled vehicle (MPV), and hence needs a licence and insurance.

Whenever I looked for insurance for a motorbike I was always asked for the registration. So until the day I can register the bike, and get a registration plate, I would suggest to the gardaí that if they could tell me where I could register the bike then I’d be happy to comply.

In February, the Government confirmed that, under current Irish law, e-bikes are not classed as MPVs or as pedal bicycles, but announced its approval to draft legislation on e-scooters and e-bikes in the forthcoming Road Traffic (Miscellaneous Provisions) Bill. This, the Government says, will allow for the introduction of appropriate regulations for these types of vehicles. E-bikes will be legislated for, using

EU standards as a reference point and will be treated mainly in the same way as pedal cycles, while the more powerful models of e-bike will be treated as light mopeds.

WHAT’S ON THE MARKET With all that in mind, let’s have a look at some of the e-bike brands currently on the market. To my mind, one of the best-looking bikes is the Van Moof. It has a 250 watt (powerful enough) front motor, with four power levels, and a range of 60-120km. It can get to a 50 per cent charge in 80 minutes with its integrated battery, with full charge in four hours, and looks brilliant.

Only problem is, you’ll probably have to go to the Netherlands, Germany or the US to buy one.

Available in Ireland, Cannondale (called the Cannondale Quick Neo) would be known for their quality frames in the racing fraternity, but not for their value for money. The battery is hidden in the down tube, and hence is small. Range is described as up to 75km.

Also at the upper end of the price spectrum is the Gocycle GXi. Designed by an ex car designer, it features many ‘why didn’t we think of those before’ features. It can vary the amount of assistance given, so you can configure that unless you’re hitting 200 watts, it sits and watches you do the work. Once you’ve reached your limit, it gently kicks in. For those living in apartments who don’t want to leave an expensive e-bike in the bike park or shed, it folds up neatly. (By the way, for a seriously good folding bike, not an e-bike, look no further than the Brompton... Another day’s work.)

If you thought these were expensive, there’s the Trek Madone SLR eTap. Not just electric pedal assist, it has electric gear changes. Priced at around €12,000, these

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Motoring | LIFESTYLE

could easily be mistaken for a proper road racing bike. Don’t worry, Trek has bikes from €2,000 upwards too. The best description of their range of e-bikes is ‘vast’.

Raleigh has made great bikes over the years. Their current e-bikes tick a lot of the boxes as above, with a central motor and comfortable ride. We, as in ‘The Royal We’, rented one during our summer holidays (staycation) in Ireland (when the lockdown eased) and I have to say I was not impressed by the motor. Maybe there was some tidying-up to do with the pedal sensors. As with all e-bikes, try before you buy.

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WHERE TO BUY Now, I cannot leave this article without mentioning two sources from which to buy your bikes. One is recently established in Dublin; Decathlon. They seem to have bikes when no-one else does, and they have a range of e-bikes now for sale.

The range of their lowest-cost model is 2035kms, with the higher cost model having a range of 50-90kms.

The other source is Easy Motion, a Dublin based e-bike specialist. I am a great believer in supporting locally-based businesses, especially what is known in the sport as the LBS, or the local bike shop, who always ap-

pear to have a friendly face with a greasy rag and a spanner to help out in emergencies.

SO, IN CONCLUSION...

E-bikes are a great addition to a family’s transport needs. We need more cyclists on the road to increase our cardiovascular health, reduce pollution, and, dare I say it, take my beloved cars from our cities. Our lungs need it, our cities need it, as does our planet. And the more people we have cycling, the more people we have who understand the needs of cyclists, who will convince selfish motorists that we need to share our roads as well as our atmosphere. l

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PRODUCT NEWS

ALLERGIES

TELFAST ALLERGY 120MG FILM-COATED TABLETS Sanofi has announced the release of Telfast® Allergy 120mg Film-coated tablets, a new-generation antihistamine that provides fast, long-lasting and non-drowsy relief for seasonal allergy symptoms.

Telfast® Allergy 120mg Filmcoated tablets contain fexofenadine hydrochloride, a new generation antihistamine that provides fast, long-lasting and non-drowsy relief for seasonal allergy symptoms.

It works by preventing the effects of histamine, a substance produced by the body when exposed to certain allergens, such as pollen.

Available now from pharmacies without prescription, Telfast® Allergy 120mg Film-coated tablets fexofenadine hydrochloride get to work to relieve nose, throat and eye symptoms within one hour. Just one tablet a day offers long-lasting 24-hour relief, with a clinically proven non-drowsy formula, suitable for adults and children 12 years and older.

CARDIOLOGY

CARDIOLOGISTS GET TO THE HEART OF THE MATTER WITH SPECIAL FOCUS ON COENZYME Q10 Cardiological science publications do not have a tradition of writing about nutritional supplements. That makes it even more noteworthy that the Journal of the American College of Cardiology (JACC) recently featured an article about the vitamin-like compound coenzyme Q10. What is especially noteworthy is that no less than four of the published studies mentioned in the article are conducted with Pharma Nord’s coenzyme Q10

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Telfast® Allergy 120mg Film-coated tablets fexofenadine hydrochloride is available from leading and independent pharmacies, priced at RRSP €12.99 for 30 film-coated tablets.

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Date of Preparation: September 2020 Adverse events should be reported.

Reporting forms and information can be found at: www.hpra.ie E-mail: medsafety@hpra.ie. Adverse events

Holder: Sanofi-aventis Ireland Ltd., T/A SANOFI

should also be reported to Sanofi Ireland -

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formulation.

When you read the world’s leading cardiological science publication the JACC is considered to be, you expect to find information about advanced heart drugs and groundbreaking surgery techniques.

News about nutritional supplements is normally not something that takes up a lot of space. Nonetheless, the 9 February issue of JACC contains a special focus seminar named 'Nutritional Supplements and the Heart'.

In this section, two leading cardiologists, Dr Albert E Raizner from the Houston Methodist Sugar Land Hospital in Texas, and Dr.Miguel A Quiñones, from Houston Methodist Willowbrook Hospital, Texas, describe multiple studies that

have been conducted with the vitamin-like compound, coenzyme Q10, which we humans have in particularly great concentrations in our heart muscle tissue.

Pharma Nord’s Q10 is highlighted No less than four of the included studies have been conducted using Pharma Nord’s coenzyme Q10 formula that is known and used by researchers worldwide because of its documented quality and bioavailability.

Among the studies mentioned by the two cardiologists in their article is Q-Symbio, a double-blind, placebo-controlled intervention trial of 420 patients that was published in 2014 in JACC, Heart Failure. They call it perhaps the most persuasive evidence in favour of using

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APRIL 2021

PRODUCT NEWS

TUBERCULOSIS

AHEAD OF WORLD TB DAY 2021, IRISH THORACIC SOCIETY CALLS FOR THE FUTURE-PROOFING OF HEALTHCARE SERVICES IN THE BATTLE AGAINST INFECTIOUS DISEASES — CONCERN AT POTENTIAL FOR RISE IN TB NUMBERS DUE TO PANDEMIC Ahead of World TB Day 2021 on 24 March, the Irish Thoracic Society (ITS) called on the Government to take decisive action to combat the hidden but very real and devastating health, social and economic impact of tuberculosis (TB) and to bring Ireland in line with our European neighbours in the fight against this preventable disease. The call comes as the ITS joins a global call for accelerated efforts to end TB by 2030 and to mitigate the toll that Covid-19 is taking on TB services worldwide.

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

28,000 people fall ill with this preventable and curable disease. Global efforts to combat TB have saved an estimated 63 million lives since 2000. In Ireland, 267 cases of TB were notified to the Health Protection Surveillance Centre in 2019.

Covid-19, now in its second year, is continuing to divert essential medical resources and attention away from providing life-saving diagnosis, medicine and care to people suffering from TB worldwide. In addition, drugresistant and multi-drug resistant TB pose a significant threat to gains made, making the fight against TB ever more complex and challenging.

NINTH-LEADING CAUSE OF DEATH

LIKELIHOOD OF RISING TB CASES

As the world continues its battle against another infectious disease, Covid-19, TB remains one of the world’s deadliest infectious killers and is the ninth-leading cause of death worldwide. Each day, nearly 4,000 people lose their lives to TB – approximately 1.5 million annually – and close to

According to Dr Marcus Butler, Consultant Respiratory Physician and Vice-President of the Irish Thoracic Society, Ireland’s highly dedicated but inadequately resourced TB service is struggling to protect the health of the population. This is particularly so for its most vulnerable

coenzyme Q10.

Helps cells make energy One of coenzyme Q10’s key functions is to serve as an energy catalyst that helps cells convert fat, carbohydrate, and protein into ATP (adenosine triphosphate), which is energy stored in molecular form for future use. The process takes place inside the mitochondria, which are microscopic 'powerhouses' that our cells are packed with.

Heart muscle cells have a particularly great need for energy and therefore have substantially higher mitochondrial density than other cell types.

What the two cardiologists also address is the fact that the body synthesises both coenzyme Q10 and

cholesterol are essentially made from the same organic compound. Because they share the same biochemical pathway, blocking the cholesterol production also affects levels of coenzyme Q10. This disruption of the body’s endogenous coenzyme Q10 synthesis is one of the things that scientists are interested in investigating, and numerous studies have looked into the effect of giving supplements to compensate for the depletion.

Coenzyme Q10 supplements have been around for decades and they are some of the most frequently used preparations among seniors worldwide. One thing about this natural compound that makes it challenging to take in supplement form is that the body has difficulty

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APRIL 2021

and socially marginalised communities who are most susceptible to TB – those in the homeless and prison populations, as well as many in our migrant communities: “Sub-standard and overcrowded living conditions, poor nutrition, drug and alcohol misuse, as well as a weakened immune system due to other illnesses are all factors associated with increased risk of acquiring TB. Covid-19 has worsened these conditions for many, while bringing many more below the poverty line for the first time.

“The likelihood of rising TB cases as a result of the pandemic comes against the backdrop of increased pressure on health services, re-allocation of staffing resources and reduced numbers of people presenting with their symptoms due to Covid-19 restrictions. All of these factors are storing up an unprecedented TB crisis for a resource-starved service on top of an already complex and demanding, albeit largely hidden, public health threat.

“The fragility of Ireland’s health infrastructure has been highlighted by the strain our healthcare service was placed under by the surges in Covid-19 cases over the last 12 months. This is partly due to chronic under-investment in appropriate infrastructure to care for patients with infectious diseases such as TB and Covid-19. Urgent action is needed to future-proof our healthcare settings and services in the battle against infectious diseases.”

To mark World TB Day 2021, countries were urged to implement the priority recommendations outlined in the 2020 progress report on TB issued by the United Nations Secretary-General António Guterres and the World Health Organisation. At national level, these echo the central recommendations in the National Guidelines for the Prevention and Control of TB in Ireland launched in 2010 and reiterated in three subsequent reports.

with absorbing it. At temperatures below 49 degrees Celsius, the coenzyme Q10 molecules aggregate and form large, indigestible crystals that cannot pass through the intestinal wall and enter the bloodstream.

Pharma Nord has solved that problem by developing a special manufacturing method that involves using different types of oil and a patented heat treatment.

This alters the surface of the crystals in such a way that they are able to dissolve completely at normal body temperature in the stomach. You can read about why Pharma Nord’s Q10 formulation has become the preferred choice among researchers worldwide because of its exceptionally good bioavailability.

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PRODUCT NEWS

CYSTIC FIBROSIS

SPOTLIGHT ON IMPACT AND LEGACY OF COVID-19 FOR PEOPLE WITH CF AT CYSTIC FIBROSIS IRELAND ANNUAL CONFERENCE The impact and legacy of COVID-19 on the lives of people with cystic fibrosis (CF) is among the key issues being addressed at Cystic Fibrosis Ireland’s forthcoming annual conference, taking place virtually from April 6-7. Open to people with CF and their families, attendance is completely free of charge – to register, simply visit www.cfireland.ie.

The conference, which comes ahead of 65 Roses Day, Cystic Fibrosis Ireland’s annual fundraising appeal on Friday April 9, will be addressed by leading immunologist, Prof Luke O’Neill, on the legacies of Covid-19 In addition, the results of a study on how the pandemic has dramatically altered the lives of people with CF, both mentally and physically, will be presented to attendees. The research will shine a spotlight on the significant adjustments people have had to make as to how they live their everyday lives, from cocooning to accessing healthcare, from virtual college lectures to working from home, with concerning levels of stress and anxiety being reported.

Ireland has the highest incidence of CF in the world with more than 1,400 people living with CF. Indeed, the incidence of CF in Ireland among the indigenous population is almost three times the average rate in other EU countries and the USA. We also have some of the most severe forms of the disease.

For Philip Watt, CEO of Cystic Fibrosis Ireland, new treatments are altering the lives of people with cystic fibrosis across the country: “According to the latest report from the Cystic Fibrosis Registry of Ireland, almost 12 per cent of the CF population is now over 40 years of age compared with just 4 per cent in 2009. This is very steady and encouraging progress in a relatively short period of time. One of the signs of hope for people with CF is that more people with the condition are feeling well enough to start a family. This would have been almost unheard of just 20 years ago. One of the contributing factors to these positive developments are new and innovative drug therapies such as Kalydeco, Orkambi, Symkevi and Kaftrio – long-campaigned for – which are beginning to turn CF into a more manageable chronic disease.”

FROM COVID-19 TO FERTILITY TO NEW THERAPIES The conference will feature contributions from a number of CF experts as well as hear first-hand accounts from people living with the condition. Among the range of topics being addressed at the meeting are CF-related diabetes, barriers to healthy eating, managing oral health for people with CF, and the challenges faced by those wishing to start a family. Unfortunately, many people with CF, as a result of their condition, cannot conceive naturally and may require extremely costly fertility treatment. Cystic Fibrosis Ireland is urging the Government, as part of new legislation on assisted human reproduction, to put the necessary funding in place to assist people with CF who need fertility treatment supports.

You can follow Cystic Fibrosis Ireland on Facebook at @ CysticFibrosisIreland, and on Twitter and Instagram @cf_ireland.

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BREAST CANCER

ENHERTU APPROVED IN THE EU FOR THE TREATMENT OF HER2POSITIVE METASTATIC BREAST CANCER • Approval based on the DESTINYBreast01 phase 2 trial which showed clinically meaningful and durable responses in patients with previously treated disease Daiichi Sankyo and AstraZeneca’s ENHERTU (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens.

In Europe, approximately 531,000 cases of breast cancer in women are diagnosed annually, with an estimated one-in-five cases being HER2-positive. The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe.

“One-in-five women with breast cancer have HER2-positive disease and those with previously-treated metastatic disease often progress quickly,” said Prof Fabrice André, Head of Research, Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France. “One of the biggest challenges in this setting has been identifying treatment strategies that produce a durable response.

The DESTINY-Breast01 trial showed a breadth, depth and durability of response not previously seen in this patient population.”

Approval by the European Commission of ENHERTU on 18 January 18 was based on positive results from the single arm, pivotal phase 2 DESTINY-Breast01 trial. After a median follow-up of 20.5 months, ENHERTU showed a confirmed objective response rate of 61.4%, including a 6.5% complete response rate and a 54.9% partial response rate, and an estimated median duration of response of 20.8 months in 184 patients with HER2-positive metastatic breast cancer who had received at least two previous lines of therapy. This analysis was presented at the 2020 San Antonio Breast Cancer Symposium. A previous analysis with a median of 11.1 months of follow-up was published in The New England Journal of

Medicine in February 2020.

The safety of ENHERTU has been evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4mg/kg in clinical studies. The median duration of exposure to ENHERTU was 9.8 months (range: 0.7 to 37.1 months). The most common adverse reactions were nausea (79.9%), fatigue (60.3%), vomiting (48.7%), alopecia (46.2%), constipation (35.9%), decreased appetite (34.6%), anaemia (33.8%), neutropaenia (32.5%), diarrhoea (30.8%), thrombocytopaenia (23.1%), cough (21.4%), leukopenia (20.5%) and headache (20.1%).

Cases of interstitial lung disease (ILD) or pneumonitis were reported in 15.0% of patients. In 2.6% of patients, ILD lead to death.

Patients should be advised to immediately report cough, dyspnoea, fever and/or any new or worsening respiratory symptoms.

Patients should be monitored for signs and symptoms of ILD or pneumonitis and those with suspected ILD or pneumonitis should be evaluated by radiographic imaging, preferably a computed tomography (CT) scan. Patients with a history of ILD or pneumonitis may be at increased risk.

“This expedited review underscores the practice-changing potential of ENHERTU for patients in the metastatic setting,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo.

“ENHERTU is the first-ever new medicine to be approved for breast cancer in Europe on the basis of phase 2 single arm data, and one of the fastest accelerated assessment procedures for an application in oncology.”

“ENHERTU is already transforming outcomes for patients with HER2-positive metastatic breast cancer in the US and Japan, and this approval enables us to bring the benefits of this medicine to patients in the EU,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca.

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APRIL 2021

For all that matters in medicine AVAILABLE IN PRINT AND DIGITAL

Introducing the Voltarol Emulgel Extra Strength 2% w/w Gel easy-to-open cap* Powerful Anti-Inflammatory Provides All-Day Joint & Muscle Pain Relief** Making life easier for your patients with pain in their hands Contains a unique permeation enhancer – up to 3x increased skin permeation of diclofenac†1 Clinically proven to demonstrate deep penetration into tissue2 Reduces pain on movement – to help patients get moving again

Patient convenience – twice daily application for clinically proven 12 hour-pain relief

The No 1 selling topical pain relief brand3 Find out more at our dedicated healthcare website GSKHealthPartner.com *100g pack only. **with twice daily application. †compared with Voltarol Emulgel 1% in vitro study.

1. Quartarone & Hasler-Nguyen 2014; GSK data on file 2. Seefried et al. Ther Adv Musculoskel Dis (2020) Vol. 12: 1-13. 3. GSK data on file, IQVIA value sales data MAT w/c 28/02/2021 Product Information: Please consult the Summary of Product Characteristics for full product information. Voltarol Emulgel Extra Strength 2% w/w Gel (diclofenac). Indications: For the local symptomatic relief of pain and inflammation in trauma of tendons, ligaments, muscles and joints, localised forms of soft tissue rheumatism. Dosage: Adults and adolescents 14 years and over: 2g to 4g of gel, applied topically 2 times daily – morning and evening. Maximum recommended treatment duration is 14 days. Patients should consult their doctor if the condition does not improve within 7 days or worsens. Contraindications: Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Hypersensitivity to any other ingredient of the gel. Use in third trimester of pregnancy. Use in children and adolescents aged less than 14 years.

Warnings and precautions: Apply only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes and should never be taken by mouth. Application over extensive areas for prolonged periods or application in excess of recommended dosage may give rise to systemic effects. These include gastrointestinal disturbances and bleeding, irritability, fluid retention, rash, hepatitis, renal dysfunction, anaphylaxis and rarely blood dyscrasias, bronchospasm and erythema multiforme. Discontinue if rash develops. Use with caution in patients with a history of peptic ulcers, gastrointestinal bleeding, hepatic or renal insufficiency, or bleeding diathesis, or intestinal inflammation. Pregnancy and lactation: The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary.

Only use during lactation on the advice of a health professional. Contraindicated during the third trimester of pregnancy. Should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time. Side effects: Very rare: rash pustular, hypersensitivity (including urticaria), angioedema, asthma, photosensitivity reaction. Rare: Dermatitis bullous. Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. Overdose: The low systemic absorption of topical diclofenac renders overdosage extremely unlikely. MA Holder: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Number: PA 678/140/3. Legal Category: Pharmacy only. Text revised: June 2020. Further information available on request. Contains diclofenac diethylammonium. Always read the label/leaflet.

Trade marks are owned by or licensed to the GSK group of companies. PM-IE-VOLT-21-00011.